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Start Preamble have a peek at this site Centers for Medicare where to buy zithromax over the counter &. Medicaid Services (CMS), HHS. Extension of timeline for publication of final rule. This notice announces an extension of the timeline for publication where to buy zithromax over the counter of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule.

As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O. Wilson, (410) where to buy zithromax over the counter 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law.

The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' where to buy zithromax over the counter (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician.

A new exception for donations of cybersecurity technology and related where to buy zithromax over the counter services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and where to buy zithromax over the counter the continuation of effectiveness of the proposed rule.

Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification where to buy zithromax over the counter for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020.

However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, where to buy zithromax over the counter 2021. Start Signature Dated. August 24, 2020.

Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of where to buy zithromax over the counter Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20.

8:45 am]BILLING CODE 4120-01-PToday, where to buy zithromax over the counter the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced over $117 million in quality improvement awards to 1,318 health centers across all U.S. States, territories and the District of Columbia. HRSA-funded health centers will use these funds to further strengthen quality where to buy zithromax over the counter improvement activities and expand quality primary health care service delivery.“These quality improvement awards support health centers across the country in delivering care to nearly 30 million people, providing a convenient source of quality care that has grown even more important during the buy antibiotics zithromax,” said HHS Secretary Alex Azar.

€œThese awards help ensure that all patients who visit a HRSA-funded health center continue to receive the highest quality of care, including access to buy antibiotics testing and treatment.”Health centers deliver comprehensive care to people who are low-income, uninsured or face other obstacles to getting health care. On top of the safety-net that they provide, health centers have been on the front lines preventing and responding to the buy antibiotics public health emergency, including providing over 3 million buy antibiotics tests. Health centers continue to provide essential services for our nation’s most vulnerable and medically underserved populations, including those who often do not have access to care, before, during and after the buy antibiotics zithromax.HRSA’s quality improvement awards recognize the highest performing health centers nationwide as well as those health centers that have where to buy zithromax over the counter made significant quality improvements from the previous year.Health centers are recognized for achievements in various areas. Improving cost-efficient care delivery.

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Advancing the use of health information where to buy zithromax over the counter technology. And Achieving patient-centered medical home recognition.“Nearly all HRSA-funded health centers have demonstrated improvement in their clinical quality measures reflecting HRSA’s strong commitment to providing high value health care,” said HRSA Administrator Tom Engels. €œHealth centers serve approximately 1 in 11 people nationally. These awards will support health centers as where to buy zithromax over the counter they continue to be a primary medical home for communities around the country.

Today, nearly 1,400 health centers operate nearly 13,000 service delivery sites nationwide.”For a list of today’s award recipients, visit. Https://bphc.hrsa.gov/programopportunities/fundingopportunities/qualityimprovement/index.html To locate a HRSA-funded health center, visit. Https://findahealthcenter.hrsa.gov/..

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The department’s zithromax 500mg dosage suit alleges Brozen, the Petersons and Generale committed fiduciary violations when Brozen sold the ESOP’s stock for less than it was worth. The two trusts set up to benefit the Petersons’ children were also knowing participants in the ERISA violations, and received millions of dollars that should have gone to the ESOP. €œInstead of acting with undivided loyalty to the plan and the participant employees, as was their legal duty, the RVNB fiduciaries transferred most of the retirement plan’s value from the plan and its employee owners to company insiders and relatives at the employees’ expense,” said Acting Assistant Secretary of Labor for the Employee Benefits Security Administration Ali Khawar. In its complaint, the department alleges that, at the time of the stock sale, the ESOP owned stock that was worth between zithromax 500mg dosage $44.8 and $58.2 million.

Rather than ensure that the ESOP received full value for its 100 percent ownership of the company, the department alleges that Brozen, the Petersons and Generale caused RVNB to redeem the ESOP’s entire ownership interest for just $12.5 million, effectively transferring the rest of the stock’s value to the Petersons and their children’s trusts at the expense of the employee participants of the RVNB plan. RVNB was subsequently sold for $200 million along with other assets to a third party for zithromax 500mg dosage $252 million. The complaint seeks to recover all plan losses and enjoin defendants from acting as trustee, fiduciary or service provider in any ESOP transaction. “Under the zithromax 500mg dosage Employee Retirement Income Security Act of 1974, fiduciaries must act with prudence and undivided loyalty to plan participants and refrain from engaging in the sort of prohibited transactions alleged here” said U.S.

Department of Labor Regional Solicitor John Rainwater. €œThe U.S. Department of zithromax 500mg dosage Labor will use every tool available to protect and promote the security of employee benefits and retirement earnings of America’s workers.” RVNB Holdings Inc. Formerly operated as All My Sons, a moving and storage enterprise comprised of multiple offices at locations throughout the U.S.

Learn more zithromax 500mg dosage about EBSA.FORT MYERS, zithromax z pak price without insurance FL – The U.S. Department of Labor’s Occupational Safety and Health Administration has signed a strategic partnership with Manhattan Construction Florida Inc. To promote worker safety and health at the Southwest Florida zithromax 500mg dosage International Airport expansion project in Fort Myers. The University of South Florida On-site Safety and Health Consultation Program is also a partner in the effort.The partnership seeks to prevent worker injuries and exposure to hazards during a terminal expansion construction project by developing a contractor-government approach to safety and health.

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DALLAS – The where to buy zithromax over the counter U.S http://morecookiesplease.com/sample-page/. Department of Labor has filed a complaint in federal court seeking to recover $35 million in losses and alleging that three members of a Carrollton moving and storage company’s board of directors and a trustee of the company’s employee stock ownership plan allowed the sale of the ESOP’s ownership interest for less than its market value in violation of the Employee Retirement Income Security Act.Following an investigation by the Employee Benefits Security Administration, the department filed suit in the U.S. District Court for the Eastern District of Texas, Sherman Division, against the trustee of RVNB Holdings Inc.’s ESOP Neil where to buy zithromax over the counter Brozen and board members Robert Peterson, Vasilia Peterson and Paul Generale. The suit also includes the 2012 irrevocable trusts of the Petersons’ children. The department’s suit alleges Brozen, the Petersons and Generale committed fiduciary violations where to buy zithromax over the counter when Brozen sold the ESOP’s stock for less than it was worth.

The two trusts set up to benefit the Petersons’ children were also knowing participants in the ERISA violations, and received millions of dollars that should have gone to the ESOP. €œInstead of acting with undivided loyalty to the plan and the participant employees, as was their legal duty, the RVNB fiduciaries transferred most of the retirement plan’s value from the plan and its employee owners to company insiders and relatives at the employees’ expense,” said Acting Assistant Secretary of Labor for the Employee Benefits Security Administration Ali Khawar. In its complaint, the department alleges where to buy zithromax over the counter that, at the time of the stock sale, the ESOP owned stock that was worth between $44.8 and $58.2 million. Rather than ensure that the ESOP received full value for its 100 percent ownership of the company, the department alleges that Brozen, the Petersons and Generale caused RVNB to redeem the ESOP’s entire ownership interest for just $12.5 million, effectively transferring the rest of the stock’s value to the Petersons and their children’s trusts at the expense of the employee participants of the RVNB plan. RVNB was subsequently sold for $200 million along with other where to buy zithromax over the counter assets to a third party for $252 million.

The complaint seeks to recover all plan losses and enjoin defendants from acting as trustee, fiduciary or service provider in any ESOP transaction. “Under the Employee Retirement Income Security Act of 1974, fiduciaries must act with prudence and undivided loyalty where to buy zithromax over the counter to plan participants and refrain from engaging in the sort of prohibited transactions alleged here” said U.S. Department of Labor Regional Solicitor John Rainwater. €œThe U.S. Department of Labor will use every tool available to protect and promote the security of employee where to buy zithromax over the counter benefits and retirement earnings of America’s workers.” RVNB Holdings Inc.

Formerly operated as All My Sons, a moving and storage enterprise comprised of multiple offices at locations throughout the U.S. Learn navigate here more about EBSA.FORT MYERS, FL – The where to buy zithromax over the counter U.S. Department of Labor’s Occupational Safety and Health Administration has signed a strategic partnership with Manhattan Construction Florida Inc. To promote worker safety and health at the Southwest where to buy zithromax over the counter Florida International Airport expansion project in Fort Myers. The University of South Florida On-site Safety and Health Consultation Program is also a partner in the effort.The partnership seeks to prevent worker injuries and exposure to hazards during a terminal expansion construction project by developing a contractor-government approach to safety and health.

Participants will focus on the use of personal protective equipment, heat illness prevention. Hazards related to falls where to buy zithromax over the counter. Struck-by and caught-in objects. Electrical equipment and work practices where to buy zithromax over the counter. Fire protection and prevention.

Safe use of hand and where to buy zithromax over the counter power tools. And silica and noise exposure. The partnership will also encourage contractors to develop and implement safety and health programs, and provide safety and health training to employees, employers and supervisors. €œWorker safety and health partnerships rely on the collaboration between OSHA, management and labor to leverage resources and maximize results,” said OSHA Area where to buy zithromax over the counter Office Director Danelle Jindra in Tampa, Florida. €œWhile each partnership is unique, they all demonstrate a commitment to ensuring all workers end their workday safely.” The Southwest Florida International Airport expansion project includes constructing a connectorbetween the three existing concourses, consolidating the Transportation Security Administration securitycheckpoints, as well as providing additional seating, concession spaces and a business lounge.

In total, more than 164,000 square feet of space will be remodeled, and 117,000 square feet of space will be added to where to buy zithromax over the counter the airport terminal. OSHA’s Strategic Partnership Program works with employers, employees, professional and trade associations, labor organizations and other interested stakeholders to establish specific goals, strategies and performance measures to improve worker safety and health. Learn more about OSHA and the laws the agency enforces..

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Notice Can you get cipro without a prescription zithromax 500mg price in canada. The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be zithromax 500mg price in canada posted on SAMHSA's website prior to the meeting at. Https://www.samhsa.gov/​about-us/​advisory-councils/​meetings.

The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED). September 29, zithromax 500mg price in canada 2020, 1:00 p.m.—TBD (ET)/Open. The meeting will be held at SAMHSA Headquarters, 5600 Fishers Lane, Rockville, Maryland 20857, Pavilions A and B. The meeting can be accessed via webcast at. Https://protect2.fireeye.com/​url?.

€‹k=​766a2ec8-2a3f2718-766a1ff7-0cc47a6a52de-658aca2b78455d15&​u=​ https://www.mymeetings.com/​nc/​join.php?. €‹i=​PWXW1647116&​p=​4987834&​t=​c or by joining the teleconference at the toll-free, dial-in number at 877-950-3592. Passcode 4987834. Start Further Info Pamela Foote, ISMICC Designated Federal Officer, SAMHSA, 5600 Fishers Lane, 14E53C, Rockville, MD 20857. Telephone.

240-276-1279. Email. Pamela.foote@samhsa.hhs.gov. End Further Info End Preamble Start Supplemental Information I. Background and Authority The ISMICC was established on March 15, 2017, in accordance with section 6031 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C.

App., as amended, to report to the Secretary, Congress, and any other relevant federal department or agency on advances in SMI and SED, research related to the prevention of, diagnosis of, intervention in, and treatment and recovery of SMIs, SEDs, and advances in access to services and supports for adults with SMI or children with SED. In addition, the ISMICC will evaluate the effect federal programs related to SMI and SED have on public health, including public health outcomes such as. (A) Rates of suicide, suicide attempts, incidence and prevalence of SMIs, SEDs, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room boarding, preventable emergency room visits, interaction with the criminal justice system, homelessness, and unemployment. (B) increased rates of employment and enrollment in educational and vocational programs. (C) quality of mental and substance use disorders treatment services.

Or (D) any other criteria determined by the Secretary. Finally, the ISMICC will make specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with SMI or children with SED. Not later than one (1) year after the date of enactment of the 21st Century Cures Act, and five (5) years after such date of enactment, the ISMICC shall submit a report to Congress and any other relevant federal department or agency. II. Membership This ISMICC consists of federal members listed below or their designees, and non-federal public members.

Federal Membership. Members include, The Secretary of Health and Human Services. The Assistant Secretary for Mental Health and Substance Use. The Attorney General. The Secretary of the Department of Veterans Affairs.

The Secretary of the Department of Defense. The Secretary of the Department of Housing and Urban Development. The Secretary of the Department of Education. The Secretary of the Department of Labor. The Administrator of the Centers for Medicare and Medicaid Services.

And The Commissioner of the Social Security Administration. Non-Federal Membership. Members include, 14 non-federal public members appointed by the Secretary, representing psychologists, psychiatrists, social workers, peer support specialists, and other providers, patients, family of patients, law enforcement, the judiciary, and leading research, advocacy, or service organizations. The ISMICC is required to meet at least twice per year. To attend virtually, submit written or brief oral comments, or request special accommodation for persons with disabilities, contact Pamela Foote.

Individuals can also register on-line at. Https://snacregister.samhsa.gov/​MeetingList.aspx. The public comment section is scheduled for 2:15 p.m. Eastern Time (ET), and individuals interested in submitting a comment, must notify Pamela Foote on or before September 18, 2020 via email to. Pamela.Foote@samhsa.hhs.gov.

Up to three minutes will be allotted for each approved public comment as time permits. Written comments received in advance of the meeting will be considered for inclusion in the official record of the meeting. Substantive meeting information and a roster of Committee members is available at the Committee's website. Https://www.samhsa.gov/​about-us/​advisory-councils/​meetings. Start Signature Dated.

Agenda with where to buy zithromax over the counter call-in information will be posted on SAMHSA's website prior Can you get cipro without a prescription to the meeting at. Https://www.samhsa.gov/​about-us/​advisory-councils/​meetings. The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED). September 29, 2020, where to buy zithromax over the counter 1:00 p.m.—TBD (ET)/Open.

The meeting will be held at SAMHSA Headquarters, 5600 Fishers Lane, Rockville, Maryland 20857, Pavilions A and B. The meeting can be accessed via webcast at. Https://protect2.fireeye.com/​url?. €‹k=​766a2ec8-2a3f2718-766a1ff7-0cc47a6a52de-658aca2b78455d15&​u=​ https://www.mymeetings.com/​nc/​join.php?.

€‹i=​PWXW1647116&​p=​4987834&​t=​c or by joining the teleconference at the toll-free, dial-in number at 877-950-3592. Passcode 4987834. Start Further Info Pamela Foote, ISMICC Designated Federal Officer, SAMHSA, 5600 Fishers Lane, 14E53C, Rockville, MD 20857. Telephone.

240-276-1279. Email. Pamela.foote@samhsa.hhs.gov. End Further Info End Preamble Start Supplemental Information I.

Background and Authority The ISMICC was established on March 15, 2017, in accordance with section 6031 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to report to the Secretary, Congress, and any other relevant federal department or agency on advances in SMI and SED, research related to the prevention of, diagnosis of, intervention in, and treatment and recovery of SMIs, SEDs, and advances in access to services and supports for adults with SMI or children with SED. In addition, the ISMICC will evaluate the effect federal programs related to SMI and SED have on public health, including public health outcomes such as. (A) Rates of suicide, suicide attempts, incidence and prevalence of SMIs, SEDs, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room boarding, preventable emergency room visits, interaction with the criminal justice system, homelessness, and unemployment.

(B) increased rates of employment and enrollment in educational and vocational programs. (C) quality of mental and substance use disorders treatment services. Or (D) any other criteria determined by the Secretary. Finally, the ISMICC will make specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with SMI or children with SED.

Not later than one (1) year after the date of enactment of the 21st Century Cures Act, and five (5) years after such date of enactment, the ISMICC shall submit a report to Congress and any other relevant federal department or agency. II. Membership This ISMICC consists of federal members listed below or their designees, and non-federal public members. Federal Membership.

Members include, The Secretary of Health and Human Services. The Assistant Secretary for Mental Health and Substance Use. The Attorney General. The Secretary of the Department of Veterans Affairs.

The Secretary of the Department of Defense. The Secretary of the Department of Housing and Urban Development. The Secretary of the Department of Education. The Secretary of the Department of Labor.

The Administrator of the Centers for Medicare and Medicaid Services. And The Commissioner of the Social Security Administration. Non-Federal Membership. Members include, 14 non-federal public members appointed by the Secretary, representing psychologists, psychiatrists, social workers, peer support specialists, and other providers, patients, family of patients, law enforcement, the judiciary, and leading research, advocacy, or service organizations.

The ISMICC is required to meet at least twice per year. To attend virtually, submit written or brief oral comments, or request special accommodation for persons with disabilities, contact Pamela Foote. Individuals can also register on-line at. Https://snacregister.samhsa.gov/​MeetingList.aspx.

The public comment section is scheduled for 2:15 p.m. Eastern Time (ET), and individuals interested in submitting a comment, must notify Pamela Foote on or before September 18, 2020 via email to. Pamela.Foote@samhsa.hhs.gov. Up to three minutes will be allotted for each approved public comment as time permits.

Written comments received in advance of the meeting will be considered for inclusion in the official record of the meeting. Substantive meeting information and a roster of Committee members is available at the Committee's website. Https://www.samhsa.gov/​about-us/​advisory-councils/​meetings. Start Signature Dated.

September 1, 2020. Carlos Castillo, Committee Management Officer. End Signature End Supplemental Information [FR Doc. 2020-19680 Filed 9-3-20.

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Start Preamble Start Printed Page 65524 (iv) MIPS Reweighting Based on Extreme can i take ibuprofen with zithromax and Uncontrollable Circumstances (A) MIPS Applications for Reweighting for the CY 2021 Performance Period/2023 MIPS Payment Year Based on Extreme and Uncontrollable Circumstances We anticipate that the national PHE for buy antibiotics will continue through CY 2021. Therefore, we remind clinicians that the application-based extreme and uncontrollable circumstances policy, as described in § 414.1380(c)(2)(i)(A)( 6 ) and (c)(2)(i)(C)( 2 ), will be available for the CY 2021 performance period/2023 MIPS payment year (85 FR 84916 through 84917). Please refer to can i take ibuprofen with zithromax https://qpp.cms.gov/​about/​buy antibiotics19?. €‹py=​2021 for details.

The application allows clinicians, groups, and virtual groups significantly impacted by the PHE for buy antibiotics to request can i take ibuprofen with zithromax reweighting for any or all MIPS performance categories. Under this policy, if a clinician, group, or virtual group submits a reweighting application and also submits data for a performance category for which an application was submitted, the data submission will override the application, and the clinician, group, or virtual group will be scored on the data submitted. Additionally, if an application is submitted for one performance category only, and data is submitted for the other 2 performance categories, only the performance category for which the application was submitted will be reweighted and the other performance categories will be scored. We believe this approach maintains a balance of can i take ibuprofen with zithromax encouraging participation in the Quality Payment Program while still providing for flexibility in weighting the performance categories for those who have been affected by the national PHE for buy antibiotics.

Please refer to https://qpp.cms.gov/​about/​buy antibiotics19?. €‹py=​2021 for can i take ibuprofen with zithromax more information. (B) MIPS Reweighting Based on Extreme and Uncontrollable Circumstances. Automatic and Application-Based Policies Clarification Under the application-based extreme and uncontrollable circumstances policy codified at §  414.1380(c)(2)(i)(A)( 6 ) for the quality, cost, and improvement activities performance categories and at § 414.1380(c)(2)(i)(C)( 2 ) for the promoting interoperability performance category, clinicians who are subject to extreme and uncontrollable circumstances may submit an application to CMS to request reweighting of a performance category or categories.

We also established an automatic extreme and uncontrollable circumstances policy at § 414.1380(c)(2)(i)(A)( 8 ) for the quality, cost, and improvement activities performance categories and at § 414.1380(c)(2)(i)(C)( 3 ) for the promoting interoperability performance category, under which we automatically reweight can i take ibuprofen with zithromax the performance categories for clinicians who are located in an area affected by extreme and uncontrollable circumstances as identified by us. Based on stakeholder inquiries, we recognize not all stakeholders understand how individual MIPS eligible clinicians who are eligible for reweighting under the automatic extreme and uncontrollable circumstances policy and who also submit an application for reweighting based on extreme and uncontrollable circumstances are affected by the intersection of these policies. Currently, under both the application-based and automatic extreme and uncontrollable circumstances can i take ibuprofen with zithromax policies, if a MIPS eligible clinician who is located in an area affected by extreme and uncontrollable circumstances as identified by CMS submits data for any of the MIPS performance categories by the applicable submission deadline for the MIPS performance period, they will be scored on each performance category for which they submit data, and the performance category will not be reweighted to zero percent in the final score. Under the automatic extreme and uncontrollable circumstances policy, the other performance categories for which data was not submitted will remain reweighted to zero percent (82 FR 53898, 83 FR 59874).

Additionally, as described in the CY 2019 PFS final rule (83 FR 59874), under the automatic extreme and uncontrollable circumstances policy, a MIPS eligible clinician who is located in an area affected by extreme and uncontrollable circumstances as identified by CMS will Start Printed Page 65525 not be scored can i take ibuprofen with zithromax on the cost performance category. As we stated in the CY 2019 PFS final rule (83 FR 59874), if a MIPS eligible clinician is located in an affected area, we would assume the clinician does not have sufficient cost measures applicable to him or her and assign a weight of zero percent to that category in the final score, even if we receive administrative claims data that will enable us to calculate the cost measures for that clinician. The following example is intended to illustrate the intersection of the automatic and application-based extreme and uncontrollable circumstances policies. A MIPS can i take ibuprofen with zithromax eligible clinician who is located in an area affected by extreme and uncontrollable circumstances as identified by CMS and eligible for the automatic extreme and uncontrollable circumstances policy submits an application for reweighting based on extreme and uncontrollable circumstances.

The application requests reweighting for the Promoting Interoperability performance category, and the clinician submits data for the quality and improvement activities performance categories. The clinician will be scored can i take ibuprofen with zithromax on the quality and improvement activities performance categories because they submitted data for those categories. The cost performance category is reweighted to zero percent under the automatic extreme and uncontrollable circumstances policy, as discussed above. And the Promoting Interoperability performance category is also reweighted to zero percent under the automatic extreme and uncontrollable circumstances policy.

The application can i take ibuprofen with zithromax for reweighting was not needed in this example to reweight the Promoting Interoperability performance category. Please refer to https://qpp.cms.gov/​about/​buy antibiotics19?. €‹py=​2021 for can i take ibuprofen with zithromax more information. (v) Redistributing Performance Category Weights for Facility-Based Measurement (A) Background In the CY 2018 Quality Payment Program final rule, we established facility-based measurement under section 1848(q)(2)(C)(ii) of the Act which provides that the Secretary may use measures used for payment systems other than for physicians, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories (82 FR 53752 through 53767).

Scoring under facility-based measurement was available can i take ibuprofen with zithromax for clinicians beginning with the CY 2019 performance period/2021 MIPS payment year. We established facility-based measurement to better align incentives between facilities and the MIPS eligible clinicians who provide services there (82 FR 53753). For more background on facility-based measurement, we refer readers to both the CY 2018 Quality Payment Program final rule (82 FR 53752 through 53767) and the CY 2019 PFS final rule (83 FR 59856 through 59867). (B) Redistribution of Performance Category Weights Under Facility-Based Measurement In the CY 2019 PFS final rule, we can i take ibuprofen with zithromax established that clinicians and groups would not need to elect or opt-in to facility-based measurement, but instead we would automatically apply facility-based measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement and who would benefit by having a higher combined quality and cost performance category score (83 FR 59863).

In this same final rule, we finalized policies for redistributing weight among the performance categories for the CY 2019 performance period/2021 MIPS payment year under § 414.1380(c)(2)(ii)(C). Under those redistribution policies, if the cost performance category is reweighted to zero percent of the final score, its weight is redistributed entirely to the quality performance category, unless the quality performance category is reweighted to zero percent, in which case the quality and cost performance can i take ibuprofen with zithromax category weights would be redistributed to the improvement activities and Promoting Interoperability performance categories. A clinician or group could have the weight of the cost performance category redistributed because they did not meet the case minimum for any of the measures in the cost performance category. Because facility-based measurement always includes both the quality and cost performance categories, it is possible a clinician or group would be scored on the cost performance category under facility-based measurement but not outside of facility-based measurement.

There are can i take ibuprofen with zithromax two common scenarios for a facility-based clinician or group which could occur in the CY 2019 performance period/2021 MIPS payment year. In the first scenario, a facility-based clinician or group meets the case minimum for at least one cost performance category measure and receives a cost performance category percent score as defined at § 414.1380(b)(2). The respective quality and cost scores will be multiplied by the available points in the quality performance category (45 points) and the available points in the cost performance category (15 points) to can i take ibuprofen with zithromax determine the combined contribution of the quality performance category and the cost performance category to the final score out of the available 60 points. In the second scenario, a facility-based clinician or group does not meet the case minimum for any cost performance category measure and the cost performance category weight is redistributed to the quality performance category so the quality performance category score alone determines the score out of the available 60 points.

Table 65 can i take ibuprofen with zithromax shows these two scenarios. Start Printed Page 65526 In the CY 2020 PFS final rule, we established a redistribution policy for the CY 2020 performance period/2022 MIPS payment year at § 414.1380(c)(2)(ii)(D), for scenarios when the cost performance category weight is redistributed to the Promoting Interoperability performance category, as well as to the quality performance category (84 FR 63028). Under this policy, the weights of the combined quality and cost performance categories could be different for a clinician or group under facility-based measurement and outside of facility-based measurement in circumstances in which the clinician or group was not scored on the cost performance category outside of facility-based measurement but was scored on all other performance categories. Table 66 shows the scenario in which the combined weights of the quality and cost performance categories differ if cost is included, which occurs when the cost performance category is can i take ibuprofen with zithromax redistributed, and all other categories are scored.

We established similar redistribution policies for CY 2021 performance period/2023 MIPS payment year and CY 2022 performance period/2024 MIPS payment year at § 414.1380(c)(2)(ii)(E) and (F) in that same rule (84 FR 63029 through 63031), which also described situations where the combined weight of the cost and quality performance categories was not always consistent. For more on the background and proposed policies related to redistribution of performance categories, please see section IV.A.3.e.(2)(b)(iii) can i take ibuprofen with zithromax of this final rule. Based on inquires we received from clinicians who were eligible for facility-based measurement, we believe our policy for determining the combined quality and cost performance category scores via facility-based measurement and outside of facility-based measurement is not ideal because it could result in a facility-based clinician or group receiving a lower final score than they would otherwise receive outside of facility-based measurement. We considered whether this more complex consideration of the scores and the weights in the performance categories necessitated a reconsideration of an opt-in requirement for facility-based measurement.

However, we believe that establishing can i take ibuprofen with zithromax such a requirement would create administrative burden for clinicians and groups. Instead of adding an opt-in requirement, we proposed a new policy to determine the MIPS final score for clinicians and groups who are eligible for facility-based measurement. We proposed at § 414.1380(e)(6)(vi)(B) that beginning with the CY 2022 performance period/2024 MIPS payment year, the MIPS quality and cost performance category can i take ibuprofen with zithromax scores will be based on the facility-based measurement scoring methodology unless a clinician or group receives a higher MIPS final score through another MIPS submission. Under this proposed policy, we will calculate two final scores for clinicians and groups who are facility-based.

One score will be based on the clinician or group's performance and the weights of the performance categories if facility-based measurement did not apply, and the other will be based on the application of facility-based measurement. The example below shows how this can i take ibuprofen with zithromax proposed policy will apply for a facility-based group that did not meet the case minimum for any of the cost measures but was scored on all other performance categories. As a result of this policy, the group in this example will receive a final score on the basis of their performance outside of facility-based measurement because they have obtained a higher final score through the combination of their submitted quality measures, submitted improvement activities and submitted promoting interoperability measures. We solicited can i take ibuprofen with zithromax comments on this proposal.

We received public comments on the redistribution of performance category weights under facility-based measurement. The following is a summary of can i take ibuprofen with zithromax the comments we received and our responses. Comment. A few commenters supported CMS' proposal to take the higher of the two scores when Start Printed Page 65527 determining the final score for facility-based eligible clinicians and groups.

One commenter suggested that CMS adopt can i take ibuprofen with zithromax this policy starting from CY 2021 performance period/2023 MIPS payment year. Response. We thank the commenters for their support and feedback and note that, as mentioned in the 2021 Facility-Based Measurement Quick Start Guide, because the FY 2022 total performance score from the Hospital Value-Based Purchasing Program will be unavailable, we will not be able to calculate MIPS facility-based scores for the CY 2021 MIPS performance period/2023 can i take ibuprofen with zithromax MIPS payment year.[] Please refer to https://qpp-cm-prod-content.s3.amazonaws.com/​uploads/​1293/​2021%20MIPS%20Facility%20Based%20Quick%20Start%20Guide.pdf for more information. After consideration of public comments, we finalize the proposal at § 414.1380(e)(6)(vi)(B) that beginning with the CY 2022 performance period/2024 MIPS payment year, the MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology unless a clinician or group receives a higher MIPS final score through another MIPS submission.

F. MIPS Payment Adjustments (1) Background For our previously established policies regarding the final score used to determine MIPS payment adjustments we refer readers to the CY 2021 PFS final rule (85 FR 84917 through 84926), CY 2020 PFS final rule (84 FR 63031 through 63045), CY 2019 PFS final rule (83 FR 59878 through 59894), CY 2018 Quality Payment Program final rule (82 FR 53785 through 53799) and can i take ibuprofen with zithromax CY 2017 Quality Payment Program final rule (81 FR 77329 through 77343). In the CY 2022 PFS proposed rule (86 FR 39453 through 39458), we proposed. (1) To select the can i take ibuprofen with zithromax mean as our methodology for calculating the performance threshold.

(2) to establish the performance threshold for the 2024 MIPS payment year using 2019 MIPS payment year data. (3) to can i take ibuprofen with zithromax establish the additional performance threshold for exceptional performance for the 2024 MIPS payment year. And (4) to update the scoring hierarchy to include subgroups. In addition, we are including information about our timing for providing MIPS performance feedback to clinicians for the performance period in 2020.

(2) Establishing the Performance Threshold Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, the Secretary shall compute a performance threshold can i take ibuprofen with zithromax with respect to which the final scores of MIPS eligible clinicians are compared for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, and which may be reassessed every 3 years) of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act included a special rule for the initial 2 years of MIPS, can i take ibuprofen with zithromax which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act and an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act, each of which shall be based on a period prior to the performance period and take into account data available for performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary. Section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 (Pub.

L. 115-123, February 9, 2018) amended section 1848(q)(6)(D)(iii) of the Act can i take ibuprofen with zithromax to extend the special rule to apply for the initial 5 years of MIPS instead of only the initial 2 years of MIPS. In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which includes an additional special rule for the third, fourth, and fifth years of MIPS (the 2021 through 2023 MIPS payment years). This additional special rule provides, for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act, in addition to the requirements specified in section 1848(q)(6)(D)(iii) of the Act, the Secretary shall increase the performance threshold for each of the third, fourth, and fifth years to ensure a can i take ibuprofen with zithromax gradual and incremental transition to the performance threshold described in section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) with respect to the sixth year (the 2024 MIPS payment year) to which the MIPS applies.

We have applied these special rules for the past 5 years to provide for a gradual and incremental transition to the year 6 performance threshold. For further information can i take ibuprofen with zithromax on established performance threshold policies we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77333 through 77338), CY 2018 Quality Payment Program (82 FR 53787 through 53794), CY 2019 PFS final rule (83 FR 59880 through 59883), the CY 2020 PFS final rule (84 FR 63031 through 63037), and the CY 2021 PFS final rule (85 FR 84919 through 84923). We codified the performance thresholds for each of the first 5 years of MIPS at § 414.1405(b)(4), (5), (6), (7), and (8) as presented in Table 68. Start Printed Page 65528 In the CY 2020 PFS final rule (84 FR 63031 through 63037) at § 414.1405(b)(7) and (8), we finalized the performance thresholds for the 2022 and 2023 MIPS payment years at 45 and 60 points, respectively, an increase of 15 points each year until the 2024 MIPS payment year, for which we estimated that the performance threshold would be 74.01 points.

We believe that this approach effectively provided can i take ibuprofen with zithromax for a gradual and incremental transition to the performance threshold we had estimated for the 2024 MIPS payment year, as required by the statute. Beginning with the 2024 MIPS payment year, section 1848(q)(6)(D)(i) of the Act requires the performance threshold to be the mean or median (as selected by the Secretary) of the final scores for all MIPS eligible clinicians with respect to a prior period specified by the Secretary. That section also provides that the Secretary may reassess the selection of the mean or can i take ibuprofen with zithromax median every 3 years. Thus, we considered whether to use the mean or median as the methodology for determining the performance threshold.

We will use this methodology to determine a performance threshold for each of the following 3 years. The 2024 MIPS payment year, 2025 MIPS payment can i take ibuprofen with zithromax year, and 2026 MIPS payment year. We would then reassess and establish the methodology (mean or median) that we will use for each of the next 3 years (2027 MIPS payment year, 2028 MIPS payment year, and 2029 MIPS payment year). At the time of drafting of this final rule, we have final score data from the CY 2017 performance period/2019 MIPS payment year through the CY 2020 performance period/2022 MIPS payment year available to use in our assessment of whether to use the mean or can i take ibuprofen with zithromax median as our methodology for the next 3 years.

At this time, however, the targeted review process (see § 414.1385) for the CY 2020 performance period/2022 MIPS payment year has not yet concluded, and the data for the CY 2020 performance period/2022 MIPS payment year may be subject to change as a result of targeted review which began on August 2, 2021, and will conclude on November 29, 2021, at 8:00 p.m., eastern standard time. For more information on the targeted review process, see our can i take ibuprofen with zithromax announcement sent to our list serve on September 27th, 2021 available at https://qpp-cm-prod-content.s3.amazonaws.com/​uploads/​1631/​2020%20Scoring%20Updates_​EUC%20Reweighting%20Requests%20Extension_​Listserv.pdf. We do not believe it would be appropriate to consider mean and median final scores from the CY 2020 performance period/2022 MIPS payment year for purposes of establishing the performance threshold for the 2024 MIPS payment year in this final rule when those scores may be subject to change as a result of the targeted review process. Furthermore, we are not utilizing final scores from the CY 2020 performance period/2022 MIPS payment for the creation of our regulatory impact analysis model.

For a detailed discussion of the RIA methodology, can i take ibuprofen with zithromax including the basis of our decision to not use CY 2020 performance period/2022 MIPS payment year data, please see section VI.F.18.a of this final rule. From our review of the data available to us, we have identified the mean and median final scores for each of the 2019 through 2021 MIPS payment years, as shown in Table 69. These six values represent the prior year mean and median final scores that can i take ibuprofen with zithromax we considered for the 2024 MIPS payment year performance threshold. As shown in Table 69, using the median final score gives a possible range of performance thresholds from 89.71 points to 99.63 points.

Given our performance threshold of 60 points in year 5, these values would result in an increase of 29.71 points to 39.63 points for year 6. Selecting the median of final scores as our methodology would, at a minimum, nearly double the annual increase in the performance threshold can i take ibuprofen with zithromax of 15 points that we had from year 2 to year 5 of the program. Section 1848(q)(6)(D)(iv) of the Act required that we increase the performance threshold for each of the third, fourth, and fifth years of MIPS to ensure a gradual and incremental transition to the performance threshold we estimated with respect to the sixth year of MIPS. In prior rules we estimated the year six Start Printed Page 65529 performance threshold to be 74.01 points and used this estimate to determine how to gradually raise the performance threshold (83 FR 59881, 84 FR 63032, 84 FR 40802) can i take ibuprofen with zithromax.

Although section 1848(q)(6)(D)(iv) of the Act does not require this approach for the sixth year and subsequent years of MIPS, we believe that it is appropriate to set the performance threshold at a level that is in line with our previous estimates for year 6. We believe that continuing the gradual and incremental increase into year 6 would provide consistency to our stakeholders. After evaluating the can i take ibuprofen with zithromax possible values shown in Table 69, we believe that using the mean as our methodology would continue this approach. Using the mean final score as the methodology would yield a possible range of performance thresholds from 74.65 points to 85.61 points (rounded to 75 points and 86 points respectively).

Given our performance threshold of 60 points in year 5, these values would result in an increase of can i take ibuprofen with zithromax 15 points to 26 points for year 6. Given these values and our annual performance threshold increases of 15 points for years 2 to 5 of the program, 75 is the value that is most consistent with the gradual and incremental approach that we have elected to continue. Therefore, we proposed at § 414.1405(g) that for each of the 2024, can i take ibuprofen with zithromax 2025, and 2026 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible clinicians from a prior period as specified under § 414.1405(b). This methodology will be used for MIPS payment years 2024 through 2026 of the program after which we will reassess the methodology for MIPS payment years 2027 through 2029.

In addition to selecting the methodology (mean or median), section 1848(q)(6)(D)(i) of the Act also requires us to specify a prior period from which we will use the final scores for all MIPS eligible clinicians to calculate the mean or median. As shown in Table 69, the mean can i take ibuprofen with zithromax final scores are 74.65, 87, and 85.61 points for MIPS payment years 2019 through 2021 respectively. In previous rules (83 FR 59881, 84 FR 63032), we used the MIPS payment year 2019 mean final score to estimate a performance threshold of 74.01 points for year 6 of the program. Our data have been updated to reflect completed targeted reviews since the time we made can i take ibuprofen with zithromax this estimate, and the mean final score for the 2019 MIPS payment year is now 74.65 points (see Table 69).

This value would be an increase of almost exactly 15 points from the MIPS payment year 2023 performance threshold of 60 points, which is identical to the increases of the previous 3 years and consistent with our intention to continue the gradual and incremental approach that has been utilized in prior years. After reviewing the available final score data, we proposed at § 414.1405(b)(9) to use the MIPS payment year 2019 as the prior period and the rounded mean final score of 75 points as the year 6 performance threshold. When we establish the performance threshold for future MIPS payment years in future rulemaking, we will reassess can i take ibuprofen with zithromax using the mean final score for MIPS payment year 2019 as mean final scores for subsequent years become available. We solicited comments on these proposals, as well as the alternative methodology of the median that we considered but did not propose.

Additionally, we solicited comments on calculating the performance threshold using an alternative year's final scores that we considered can i take ibuprofen with zithromax but did not propose. We received public comments on establishing the performance threshold. The following can i take ibuprofen with zithromax is a summary of the comments we received and our responses. Comment.

One commenter requested that CMS not roll back or reduce the performance threshold from its current value with the transition to MVPs in future years. The commenter believes that the extended phase in can i take ibuprofen with zithromax of the performance threshold under traditional MIPS was not necessary and had the unintended consequence of clinicians not taking MIPS as seriously as they should have. The commenter also stated that any phase-in does not advance the goals of transitioning to value-based care. Response can i take ibuprofen with zithromax.

In future years of the program we will evaluate the data available to us and select a performance threshold in accordance with the requirements of the statute. The gradual and incremental increase in the performance threshold gave clinicians time to anticipate the transition to the statutorily mandated methodology for the performance threshold beginning in year six. The CY 2022 performance period/2024 MIPS payment year is the can i take ibuprofen with zithromax first year of the program where CMS does not have additional flexibilities and must set the performance threshold at the mean or median of a prior year's final scores, thus ending the performance threshold transition period. While we agree with the commenter that further phase in of the performance threshold is not needed, it is possible the performance threshold numerical value for a future year could be lower than the numerical value for the CY 2022 performance period/2024 MIPS payment year, depending on the final score data available.

Comment can i take ibuprofen with zithromax. One commenter believes that data from the CY 2019 performance period/2021 MIPS payment year is a better basis for creating performance thresholds than the CY 2017 performance period/2019 MIPS payment year. The commenter believes that the entire structure of the program as far as scoring was very different in 2017 can i take ibuprofen with zithromax and that 2019 offers a more accurate picture compared to 2017. Response.

We understand that the program has undergone modifications since the CY 2017 performance period/2019 MIPS payment year. However, we have previously stated our can i take ibuprofen with zithromax intent to use a gradual and incremental approach to raising the performance threshold. For reference, the mean and median final scores for CY 2019 performance period/2021 MIPS payment year are 85.61 and 92.30 respectively and would represent an increase in the performance threshold of 25.61 or 32.3 points. We raised the performance threshold 12 points from CY 2017 performance period/2019 MIPS payment year to CY 2018 performance period/2020 MIPS payment year and raised the can i take ibuprofen with zithromax performance threshold 15 points in each subsequent year.

We believe that raising the performance threshold 15 points in CY 2022 performance period/2024 MIPS payment year is consistent with our gradual and incremental approach. We recognize that clinicians are facing ongoing difficulties due to the PHE, and we believe that choosing the lowest performance threshold value available to us would gradually increase the performance threshold while minimizing disruption to clinicians during this emergency. Comment can i take ibuprofen with zithromax. Several commenters supported setting the performance threshold at 75 and using the mean from a prior performance period.

Some commenters can i take ibuprofen with zithromax stated the 15-point increase aligns with the gradual increase over the last 4 years. One commenter stated it was an attainable goal. A few commenters stated this meant having a larger budget neutral pool to redistribute funds, but one commenter requested more information about impact to their specialty. One commenter supported that it was the lowest of the possible can i take ibuprofen with zithromax options.

Response. We thank the commenters for their support for setting the performance threshold for the CY 2022 performance period/2024 MIPS payment year at 75 points, for noting that the 15-point increase is the same magnitude as the change in prior years, and for noting that the performance threshold selected was the lowest can i take ibuprofen with zithromax of the Start Printed Page 65530 possible options. Overall information on prior year's final scores can be found in the corresponding Quality Payment Program Experience Report and specialty specific information can be found in the Public Use File in the QPP resource library ( https://qpp.cms.gov/​resources/​resource-library ). Comment can i take ibuprofen with zithromax.

A few commenters expressed concern with the proposed performance threshold, specifically for small practices. A few commenters requested setting a separate performance threshold for small practices at a value such as 60, or setting the performance threshold for other practices higher at 85 points. Response can i take ibuprofen with zithromax. We appreciate this feedback from commenters.

However, as we previously discussed, the statute requires us to can i take ibuprofen with zithromax set the performance threshold at the mean or median of a prior period's final scores, and we do not have the statutory authority to establish a separate performance threshold for small practices. We also note that CMS does not have the authority to waive the statutory requirements for setting the performance threshold using our extreme and uncontrollable circumstances policies or section 1135 of the Act. We encourage the commenters to look at our estimates of how our proposed policies will affect the payment adjustments, broken down by practice size, for the MIPS 2024 payment year in our regulatory impact analysis (see section VI.F.18.e of this final rule). As shown in the impact analysis, we project the discrepancy in payment adjustments between large and small practices to can i take ibuprofen with zithromax shrink as a cumulative result of our policies, including raising the performance threshold.

Comment. Many commenters opposed the proposed performance can i take ibuprofen with zithromax threshold and recommended that CMS lower the performance threshold. Most of these commenters requested that CMS explore ways to use its authority to adjust the performance threshold beginning with the CY 2022 performance period/2024 MIPS payment year. Commenters specifically requested that CMS consider emergency authorities under the can i take ibuprofen with zithromax PHE such as the section 1135 waiver authority or its Extreme and Uncontrollable Circumstances policy.

Commenters noted the stress of the continuing zithromax on practices. That the proposed performance threshold of 75 points represents a significant increase from the 30 points in 2019 or 45 points for 2020. A few commenters acknowledged that CMS has chosen the lowest value can i take ibuprofen with zithromax possible (75 points), but the commenters believe that positive payment adjustments will become more difficult to obtain, especially as the buy antibiotics zithromax continues. One commenter expressed concern that clinicians may become frustrated and lose motivation to engage with the MIPS program.

Another commenter stated that the steep increases in the performance threshold assumes that practices will not can i take ibuprofen with zithromax only perform, as well as they did before buy antibiotics but that they will be able to perform better than before. Some commenters stated that CMS should establish a transitional policy that recognizes the impact of the buy antibiotics PHE. One commenter appreciated the flexibilities that CMS has put in place during the zithromax and urges CMS not to flip a switch in 2022 as if the past 3 years have been business as usual. A few commenters suggested lower can i take ibuprofen with zithromax performance threshold levels, including 60, 50 and 45.

One commenter requested that CMS delay the increase to the performance threshold until the implementation of MVPs. Response can i take ibuprofen with zithromax. We understand the commenters concern about the stress the PHE is putting on practices. However, we do not have the authority to set the performance threshold for MIPS payment year 2024 at a value other than the mean or median of the final can i take ibuprofen with zithromax scores with respect to a prior period, as required by section 1848(q)(6)(D)(i) of the Act.

We agree that positive payment adjustments could be more difficult to obtain with a higher performance threshold and are actively working to keep clinicians engaged with the introduction of MVPs which provide a streamlined way for clinicians to participate in the program with a set of measures that are relevant to their practice. We understand that the performance threshold of 75 represents a steep increase from the pre-zithromax performance threshold of 45 points, which was applicable for the CY 2019 performance period/2021 MIPS payment year. For the past 4 years we have finalized increases of 15 can i take ibuprofen with zithromax points. We increased the performance threshold from 15 to 30 between the CY 2018 and 2019 performance periods/2020 and 2021 MIPS payment years, from 30 to 45 between the CY 2019 and 2020 performance periods/2021 and 2022 MIPS payment years, and from 45 to 60 between the CY 2020 and 2021 performance periods/2022 and 2023 MIPS payment years.

We acknowledge the commenter's concern that this increase assumes that clinicians will not only perform, as well as they did before buy antibiotics but that they will be able to can i take ibuprofen with zithromax perform better than before. We note that the proposed increase of 15 points is the same as the increase in the previous 3 years and was based on a gradual and incremental approach to setting the performance threshold. As discussed previously, we are statutorily required to set the performance threshold for the 2024 MIPS payment year at the mean or median of the final scores with respect to a prior period, and we do not have the flexibility to choose other values. We appreciate the commenter's suggestion to adopt a transitional policy for the performance threshold due to the PHE but reiterate can i take ibuprofen with zithromax that we do not have the flexibility to do so due to the statutory requirements discussed previously.

We also note that CMS does not have the authority to waive the statutory requirements for setting the performance threshold under section 1135 of the Act. Comment can i take ibuprofen with zithromax. A few commenters opposed the proposed performance threshold for specialty related or practice related reasons. A few commenters were specifically concerned about groups or specialties that can only be measured on two can i take ibuprofen with zithromax performance categories.

One commenter expressed their opinion that setting the performance threshold at the mean or median of prior final scores of all MIPS eligible clinicians in a prior period was an unfair standard for their specialty because they are limited in their ability to report under the Promoting Interoperability performance category. They stated this limitation gives them fewer opportunities to amass points. Another commenter stated that their group was unable to report Promoting Interoperability performance can i take ibuprofen with zithromax category measures and would be reweighted in a manner that would increase their cost category weight. A different commenter stated that they have a limited number of quality measures that they can report.

As a result, they stated that for groups such as theirs that have limited measures and a high-weighted quality can i take ibuprofen with zithromax category, CMS now requires 100 percent quality to meet the performance threshold or otherwise they would receive a negative MIPS payment adjustment. One commenter expressed concern that CRNAs cannot report 6 of the measures in the MIPS Anesthesia Measure set because they do not provide relevant services. The commenter suggested CMS should address how specialties such as anesthesia can meet the performance threshold, perhaps through the use of CAHPS data or by allowing them to report additional Improvement Activities. Response can i take ibuprofen with zithromax.

We understand that different specialties sometimes face challenges with not being able to report Start Printed Page 65531 measures and activities for every performance category. We agree that the final scores of these clinicians may be based on fewer can i take ibuprofen with zithromax categories than they would be for a clinician reporting all 4 performance categories. However, we remind clinicians that even if their final score is based on fewer than 4 performance categories they still have the ability to score anywhere from 0 to 100 points for their final score, just as a clinician reporting all 4 performance categories would. In this way, we do not believe that a performance threshold of 75 points is disadvantageous to clinicians reporting fewer than 4 performance categories.

As stated below, we also encourage clinicians that do not have enough quality measures relevant to their scope of practice to work with their specialty societies to provide recommendations during the specialty measure set solicitation process and to consider reporting a relevant MVP when can i take ibuprofen with zithromax one becomes available. We note, for the commenter who stated that not being able to report Promoting Interoperability would cause their group to be reweighted in a manner that would increase their cost category weight, that the cost category weight would only increase if a group was reweighted for the Promoting Interoperability and Quality performance categories. If a group can i take ibuprofen with zithromax is reweighted for the Promoting Interoperability performance category only, the cost category weight remains at 30 percent. We believe the commenter who stated that they have a limited number of quality measures that they can report is referring to the possibility that if the weight of other performance categories is redistributed to the quality category, a clinician may need to achieve a high score in quality in order to exceed the proposed performance threshold of 75 points.

We understand can i take ibuprofen with zithromax that some clinicians may not have 6 measures in the Quality performance category that are relevant to their practice. To address this, we have our eligible measure applicability policy within the quality performance category to reduce the denominator of required measures for the MIPS CQM and Medicare Part B claims collection types, in the event that a clinician has less than 6 applicable measures to report. In this way, clinicians can be scored on the quality measures that are relevant to their scope of practice. For more information on the eligible measure applicability policy please see the CY 2017 through CY 2019 PFS final rules (81 FR 77290 can i take ibuprofen with zithromax through 77291, 82 FR 53750 through 53732).

For the commenter's concerns on the specialty measures available, we solicit stakeholder recommendations for new specialty measure sets and revisions to existing specialty sets on an annual basis. We urge stakeholders to work with their specialty societies to provide recommendations during the specialty measure set solicitation process can i take ibuprofen with zithromax (for more information please see the QPP resource library at http://www.qpp.cms.gov ). We are also developing MIPS Value Pathways (MVPs) to provide clinicians with a simplified method to report measures that are relevant to their practice and we encourage them to report an MVP when one that is relevant to their scope of practice is available. We thank the commenter for their suggestion to expand the use of CAHPS or to allow clinicians to report additional improvement activities if they cannot report 6 quality measures.

Comment can i take ibuprofen with zithromax. Many commenters expressed concern that the proposal to increase the performance threshold to 75 points would increase the number of clinicians receiving a negative payment adjustment and decrease the number of clinicians with positive or neutral adjustments. Many commenters also stated their concern that the increase in the performance can i take ibuprofen with zithromax threshold comes with several proposed policies to remove bonuses and floors for quality measures and proposals to change quality data completeness which may lower the MIPS final score. A few commenters requested that CMS reconsider the reporting and scoring policies, delay the scoring policies, or gradually phase in the scoring changes, especially if CMS finalized the proposed performance threshold.

One commenter specifically requested continuing current scoring for an additional can i take ibuprofen with zithromax year. A few commenters noted the difficulty of achieving the performance threshold now compared to a few years ago because of the scoring changes. A few commenters noted the cost of participating in MIPS versus the potential incentive. One commenter cited a study on the cost to participate in MIPS and expressed concern that clinicians can i take ibuprofen with zithromax would still get negative MIPS payment adjustment after these costs due to a premature increase in the performance threshold following 3 years of flexibilities due to the buy antibiotics PHE.

Response. We acknowledge the commenters concerns regarding the increased burden on clinicians due to the buy antibiotics PHE and agree that the statutory formula for determining the performance threshold beginning with the 2024 MIPS payment year could lead can i take ibuprofen with zithromax to additional clinicians receiving a negative payment adjustment. The MIPS is a budget neutral program and is designed in the statute to balance the positive payment adjustments of clinicians who score above the performance threshold against the negative payment adjustments of clinicians whose scores are below the performance threshold. We encourage the commenter to look at our estimates of how our proposed policies will affect the payment adjustments for the MIPS 2024 payment year in our regulatory impact analysis (see section VI.F.18.e of this final rule).

In light of the continuing burden of the can i take ibuprofen with zithromax PHE we are making changes to some scoring flexibility proposals including postponing the removal of the 3-point scoring floor on quality measures and keeping the data completeness threshold at 70 percent (see section IV.A.3.e.(1)(c)(iii)(B) of this final rule). We are also introducing some new flexibilities including a 7-point floor for scoring new measures in their first year and a 5-point floor in their second year (see section IV.A.3.e.(1)(c)(iii)(B) of this final rule). Comment can i take ibuprofen with zithromax. A few commenters discussed refinements for the performance threshold methodology.

One commenter suggested CMS determine what the mean or median of “raw” or “achievement” final performance scores would be and can i take ibuprofen with zithromax use that figure to set the 2022 threshold. The commenter stated that CMS only uses the base quality measure score, absent any bonus points, to determine improvement scoring in the Quality category. Therefore, the commenter stated that method could be used in setting the performance threshold as well. Another commenter recommended that CMS evaluate balancing the reported data from 2019, 2020, and 2021 to control for self-selection bias since the commenter can i take ibuprofen with zithromax believed MIPS reporting has been fundamentally voluntary for these performance periods.

One commenter asked what the agency's intent is with respect to performance thresholds and quality benchmark data going forward given that CY 2022 performance period/2024 MIPS payment year benchmarks will be based on CY 2022 performance period data while CY 2024 performance period/2026 MIPS payment year benchmarks appear to revert to performance period 2017 data. The commenter noted the performance threshold is based can i take ibuprofen with zithromax on CY 2017 performance period data while benchmarks are proposed to be based on CY 2022 performance period data. Response. We appreciate the commenter's suggestion to use a “raw” or “achievement” score to set the performance threshold.

We interpret the Start Printed Page 65532 suggestion of “raw” or “achievement” scores to can i take ibuprofen with zithromax mean removing any performance category bonuses, final score bonuses or improvement scoring. We note section 1848(q)(6)(D)(i) of the Act requires us to set the performance threshold using composite performance scores, which we refer to as the final score as defined under § 414.1305 (81 FR 77319 through 77320). We do not believe can i take ibuprofen with zithromax that the statute allows us to use “raw” or “achievement” scores when setting the performance threshold. We thank the commenter for the suggestion of balancing the scores from 2019, 2020, and 2021 but reiterate that the statute requires us to choose the mean or median from a prior period and does not allow us to balance scores from multiple years.

We refer the commenter to section IV.A.3.e(1)(c)(ii) of this final rule, where we are not finalizing our proposal to use performance period benchmarks and instead we will continue to use historic quality benchmarks for the CY 2022 performance period/2024 MIPS payment year will be based on CY 2020 performance period data. In regards to the comment on using 2017 data for purposes of the CY 2024 performance period/2026 MIPS payment year benchmarks, we note that we have not yet made any proposals on quality benchmarks for the CY 2024 performance period/2026 MIPS can i take ibuprofen with zithromax payment year. Comment. One commenter supported can i take ibuprofen with zithromax the larger size of positive payment adjustments that a higher performance threshold would cause due to a greater quantity of money being redistributed through BN, but requested more information on the impact to specialties and practices.

The commenter stated that this information will give societies a stronger argument for their membership as to why clinicians should continue to participate in MIPS. Response can i take ibuprofen with zithromax. We encourage the commenter to read our projections of the impact of the Quality Payment Program Finalized policies on payment adjustments for MIPS payment year 2024 in our Regulatory Impact Analysis (see section VI.F.18.e of this final rule). We also note that CMS publishes a Quality Payment Program Experience Report and Public Use File at https://qpp.cms.gov/​resources/​resource-library.

A detailed breakdown of a prior year's scores can be found in the QPP Experience Report and specialty specific information can can i take ibuprofen with zithromax be found in the Public Use File. After consideration of public comments, we are finalizing our proposal at § 414.1405(g) that for each of the 2024, 2025, and 2026 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible clinicians from a prior period as specified under § 414.1405(b). We are also finalizing our proposal at § 414.1405(b)(9) to use the MIPS payment year 2019 as the prior period and the can i take ibuprofen with zithromax rounded mean final score of 75 points as the year 6 performance threshold. (3) Additional Performance Threshold for Exceptional Performance Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to compute, for each year of the MIPS (beginning with the 2019 MIPS payment year and ending with the 2024 MIPS payment year), an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors for exceptional performance under section 1848(q)(6)(C) of the Act.

For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold. (1) The threshold shall be the score that is equal to the 25th can i take ibuprofen with zithromax percentile of the range of possible final scores above the performance threshold determined under section 1848(q)(6)(D)(i) of the Act. Or (2) the threshold shall be the score that is equal to the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act. Under section 1848(q)(6)(C) of the Act, a MIPS eligible can i take ibuprofen with zithromax clinician with a final score at or above the additional performance threshold will receive an additional MIPS payment adjustment factor and may share in the $500 million of funding available for the year under section 1848(q)(6)(F)(iv) of the Act.

We note that under section 1848(q)(6)(F)(iv) of the Act, funding is available for additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act only through the 2024 MIPS payment year, which is the sixth year of the MIPS program. In the CY 2020 PFS final rule (84 FR 63037 through 63040), we used the special rule under section 1848(q)(6)(D)(iii) of the Act to set the additional performance threshold at 85 points can i take ibuprofen with zithromax for the 2022 and 2023 MIPS payment years. We note that the special rule under section 1848(q)(6)(D)(iii) of the Act applies only to the initial 5 years of MIPS, so we cannot use that rule to establish the additional performance threshold for the 2024 MIPS payment year. As noted above, under section 1848(q)(6)(D)(ii) of the Act, we may set the additional performance threshold at either.

(1) The 25th percentile of the range of possible final scores above the performance threshold, or (2) the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores can i take ibuprofen with zithromax at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act. In the CY 2022 PFS proposed rule (86 FR 39453), for illustrative purposes, we referenced the possible additional performance thresholds shown in Table 70. Note that mean or median refers can i take ibuprofen with zithromax to the methodology for calculation of the performance threshold. As can be seen in Table 70, the potential values for the additional performance threshold range from a low of 81.26 to a high of 100.

However, to remain consistent with our gradual and incremental approach, we proposed to use the mean as our methodology for setting the performance threshold during the next 3 years and Start Printed Page 65533 we proposed to use the final score data from MIPS payment year 2019. We are finalizing these proposals can i take ibuprofen with zithromax in section IV.A.3.f.2 of this final rule. The selection of the mean for the methodology and final score data from the 2019 MIPS payment year leaves us with the options in the first column of Table 70 for where we can set the additional performance threshold. With a performance threshold of 75 points for the 2024 MIPS payment year based on final scores for the 2019 MIPS payment year, the can i take ibuprofen with zithromax calculation methods in section 1848(q)(6)(D)(ii) of the Act give us two possible options for where we can set the additional performance threshold for MIPS payment year 2024.

The first calculation method (described in section 1848(q)(6)(D)(ii)(I) of the Act), using the range of possible final scores above the proposed performance threshold for the 2024 MIPS payment year, yields a value of 81.26 points (the 25th percentile of the range of 75.01 to 100). The calculation is as can i take ibuprofen with zithromax follows. 75.01 + [(100−75.01) * 0.25] = 81.26. The second calculation method (described in section 1848(q)(6)(D)(ii)(II) of the Act), the 25th percentile of the actual final scores for the 2019 MIPS payment year at or above the proposed performance threshold for the 2024 MIPS payment year, yields a value of 88.94.

For the second calculation method, we will apply the 25th percentile calculation of (n+1)p/100 to the 2019 MIPS payment year final score data that are can i take ibuprofen with zithromax at or above 75. We considered using each of these methods, but we do not believe that it would be appropriate to lower the additional performance threshold to 81.26 points from its present value of 85 points. Maintaining or increasing the additional performance threshold will serve as a greater incentive to clinicians to continue to improve their performance on the MIPS measures and activities and to achieve can i take ibuprofen with zithromax exceptional performance. We believe that an additional performance threshold of 88.94 points rounded to 89 points is appropriate.

This is an increase of 4 points from the prior year, which we believe is a gradual increase. Therefore, using the second calculation method described above, we proposed at § 414.1405(d)(7) to set the additional performance threshold for the 2024 MIPS payment year at can i take ibuprofen with zithromax 89 points. We solicited comments on these proposals, as well as the alternative additional performance thresholds listed that we considered but did not propose. We received public comments on the additional performance can i take ibuprofen with zithromax threshold for exceptional performance.

The following is a summary of the comments we received and our responses. Comment can i take ibuprofen with zithromax. A few commenters expressed concern about the exceptional performance funding under section 1848(q)(6)(F)(iv) of the Act ending after the CY 2022 performance period/2024 MIPS payment year. One commenter believes that eliminating this funding is contradictory to the mission of the Quality Payment Program as it provides an additional incentive for improving performance.

A few commenters expressed concerns about the cost of participating in MIPS and that the majority of the MIPS adjustment has been funded from the exceptional performance funding under section 1848(q)(6)(F)(iv) of the Act rather than from negative payment can i take ibuprofen with zithromax adjustments. Some commenters requested that CMS work with Congress to extend the funding. Response can i take ibuprofen with zithromax. We acknowledge the commenters' concern about the exceptional performance funding under section 1848(q)(6)(F)(iv) of the Act ending after the CY 2022 performance period/2024 MIPS payment year.

We acknowledge that in previous years the additional performance threshold has funded a large portion of positive MIPS payment adjustments. However, we point the commenter to our Regulatory Impact can i take ibuprofen with zithromax Analysis (see section VI.F.18.e of this final rule) where we estimate that positive MIPS payment adjustments funded by BN will be much higher than in previous years. Comment. A few commenters suggested that CMS should consider using the section 1135 waiver authority it has under the PHE or its Extreme and Uncontrollable can i take ibuprofen with zithromax Circumstances policy to waive the statutory requirement to set the additional performance threshold at either.

(1) The 25th percentile of the range of possible final scores above the performance threshold, or (2) the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act, and instead keep the additional performance threshold at 85 points in 2022. Response. We note that CMS does not have the authority to waive the statutory requirements for setting the additional performance threshold using our extreme and uncontrollable circumstances policies or section 1135 of the can i take ibuprofen with zithromax Act. Comment.

One commenter acknowledged the two statutory options CMS presented for the additional performance threshold (81.26 and can i take ibuprofen with zithromax 88.94), but urged CMS to use PHE authorities to maintain the additional performance threshold at 85 points instead of 89 points. The commenter stated that it gives clinicians a final opportunity to qualify for this funding and takes into account the unusual operational and clinical circumstances present during the buy antibiotics zithromax. Response can i take ibuprofen with zithromax. We agree with the commenter that there have been unusual operational and clinical circumstances for clinicians during the buy antibiotics zithromax.

However, we are not aware of any PHE authorities available to CMS that would allow us to set the additional performance threshold for the 2024 MIPS payment year at any value other than those resulting from the calculation methods described in section 1848(q)(6)(D)(ii) of the Act. Comment can i take ibuprofen with zithromax. A few commenters supported the additional performance threshold. One commenter stated that the increase to the additional performance threshold increases the difficulty but still can i take ibuprofen with zithromax makes the additional positive payment adjustment an attainable goal.

Response. We thank the commenters for their support. Comment can i take ibuprofen with zithromax. A few commenters supported a lower additional performance threshold.

Some commenters can i take ibuprofen with zithromax requested that CMS select the option of 81 points rather than the proposed 89 points to account for loss of score potential due to removal of bonus points in the quality performance category and the increased weight of the cost performance category. One commenter noted that CMS has the latitude to select 81 points as it meets the 25th percentile of possible scores and believes that the lower additional performance threshold will incentivize a greater number of clinicians. The commenter also noted that choosing a lower additional performance threshold will allow CMS to can i take ibuprofen with zithromax both reward top performers in MIPS and incentivize more of them by setting reasonable thresholds to reward them for their performance. Other commenters requested keeping the additional performance threshold at 85 points.

Response. We established the additional performance threshold at 85 points for the 2022 and 2023 MIPS payment years in the CY 2020 PFS can i take ibuprofen with zithromax final rule (84 FR 63037 through 63040). We do not believe that it is appropriate to set the additional performance threshold at a lower value (81 points) than it was set at for the CY 2020 performance period/2022 MIPS payment year nor do we have the authority to keep the additional Start Printed Page 65534 performance threshold at 85 points as was requested by the commenter. We believe that 89 points can i take ibuprofen with zithromax is an appropriate value to incentivize the highest performing clinicians, given that the threshold has been 85 points for the past 2 years.

After consideration of public comments, we are finalizing the proposal at § 414.1405(d)(7) to set the additional performance threshold for the 2024 MIPS payment year at 89 points. (4) Example of Adjustment Factors Figure A provides an illustrative example of how various final scores will be converted to a MIPS payment adjustment factor and potentially an additional MIPS payment adjustment factor, using the statutory formula and based on our finalized policies for the 2024 MIPS payment year. In Figure A, can i take ibuprofen with zithromax the performance threshold is set at 75 points. The applicable percentage is 9 percent for the 2024 MIPS payment year.

The MIPS payment adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest possible score can i take ibuprofen with zithromax which receives the negative applicable percentage (negative 9 percent for the 2024 MIPS payment year) and resulting in the lowest payment adjustment, and 100 being the highest possible score which receives the highest positive applicable percentage and resulting in the highest payment adjustment. However, there are two modifications to this linear sliding scale. First there is an exception for a final score between zero and one-fourth of the performance threshold can i take ibuprofen with zithromax (zero and 18.75 points based on the performance threshold of 75 points for the 2024 MIPS payment year). All MIPS eligible clinicians with a final score in this range will receive the lowest negative applicable percentage (negative 9 percent for the 2024 MIPS payment year).

Second, the linear sliding scale line for the positive MIPS payment adjustment factor is adjusted by the scaling factor, which cannot be higher than 3.0. If the scaling factor can i take ibuprofen with zithromax is greater than zero and less than or equal to 1.0, then the MIPS payment adjustment factor for a final score of 100 will be less than or equal to 9 percent. If the scaling factor is above 1.0 but is less than or equal to 3.0, then the MIPS payment adjustment factor for a final score of 100 will be greater than 9 percent. Only those MIPS eligible clinicians with a final score equal to 75 points (which is the finalized performance threshold) will receive a can i take ibuprofen with zithromax neutral MIPS payment adjustment.

Because the performance threshold is 75 points, we anticipate that more clinicians will receive a positive adjustment than a negative adjustment and that the scaling factor will be less than 1 and the MIPS payment adjustment factor for each MIPS eligible clinician with a final score of 100 points will be less than 9 percent. Start Printed Page 65535 Table 71 illustrates the changes in payment adjustment based on the final policies from the CY 2021 PFS final rule (85 FR 84923 through 84925) for the 2023 MIPS payment year and the final policies for the 2024 MIPS payment year, as well as the applicable percent required by section 1848(q)(6)(B) of the Act. Start Printed Page 65536 (5) Final Score Hierarchy can i take ibuprofen with zithromax Used in Payment Adjustment Calculation In the CY 2021 PFS final rule (85 FR 84917 through 84919), we modified the final score hierarchy that applies when more than one final score is associated with a TIN/NPI, as displayed in Table 72. Beginning with the CY 2021 performance period/2023 MIPS payment year, if a TIN/NPI has a virtual group final score associated with it, we use the virtual group final score to determine the MIPS payment adjustment.

If a TIN/NPI does not have a virtual group final score associated with it, we use the highest can i take ibuprofen with zithromax available final score associated with the TIN/NPI to determine the MIPS payment adjustment. Start Printed Page 65537 In the CY 2022 PFS proposed rule (86 FR 39457), we proposed policies applicable to subgroups, including a definition of a subgroup at § 414.1305 as a subset of a group which contains at least one MIPS eligible clinician and is identified by a combination of the group TIN, subgroup identifier, and each eligible clinician's NPI. Each clinician in a subgroup would be identifiable can i take ibuprofen with zithromax by a unique TIN/NPI combination just as in any MIPS group or APM Entity. In addition, a clinician, group, subgroup, or APM Entity could choose more than one MIPS reporting option for a performance period.

A clinician, group, subgroup, or APM Entity could choose to report through MVPs, traditional MIPS, and/or the APP (assuming they are eligible for each of these reporting options) for a performance period. As a result, there could be more than one final score for a clinician, group, subgroup, or APM Entity for a performance period from MVPs, traditional MIPS, and/or can i take ibuprofen with zithromax the APP. Therefore, we proposed to update the scoring hierarchy to include subgroups and to specify that the scoring hierarchy would apply with respect to any available final score that is associated with a TIN/NPI from MVPs, traditional MIPS, and/or the APP. The proposed can i take ibuprofen with zithromax updated scoring hierarchy can be seen in Table 73.

We solicited comments on this proposal. We received public comments on the proposed updated scoring hierarchy. The following is a can i take ibuprofen with zithromax summary of the comments we received and our responses. Comment.

A few can i take ibuprofen with zithromax commenters requested clarification on the scoring hierarchy. One commenter expressed concerns with the modified hierarchy, citing the complexity of adding subgroups to MIPS and concerns about allowing ACO clinicians to report outside the ACO. The commenter recommended that to reduce complexity, ACO performance should be evaluated at the ACO level for MIPS evaluations. Another commenter noted confusion about can i take ibuprofen with zithromax how payment adjustments would be calculated and applied for clinicians reporting an MVP as part of a subgroup.

Response. We acknowledge the commenters concern can i take ibuprofen with zithromax about the complexity of the scoring hierarchy for ACO reporters. However, we disagree with the recommendation that ACOs only be evaluated at the ACO level. CMS is introducing subgroups to collect data at a more granular level that will be more useful for can i take ibuprofen with zithromax beneficiaries to use to make informed healthcare decisions.

Having data at the subgroup level will allow beneficiaries to evaluate performance data, especially performance data about specialists, that is more closely related to the actual clinicians the beneficiaries may see for their medical care. We also note that subgroup scores will not be rolled up to the ACO level. If a TIN reports as a subgroup, the subgroup score would only be applicable to the NPIs in the subgroup can i take ibuprofen with zithromax. Comment.

A few can i take ibuprofen with zithromax commenters supported the proposed scoring hierarchy. Commenters appreciated CMS' intent to select the highest final score achieved for a TIN/NPI across the QPP pathways for individual, group subgroup or APM entity. Response. We thank the commenter for their support can i take ibuprofen with zithromax.

Comment. One commenter asked CMS to confirm can i take ibuprofen with zithromax that a MIPS eligible clinician that participates in MVPs via multiple subgroups would receive the highest final score that can be attributed to their TIN/NPI combination from any reporting option (traditional MIPS, APP reporting, or any MVP subgroup reporting) and participation option (as an individual, group, subgroup, or APM Entity (with the exception of virtual groups). Response. The commenter is correct that, with the exception of virtual groups, a MIPS eligible clinician will receive the highest final score that can be attributed to their TIN/NPI can i take ibuprofen with zithromax combination from the listed reporting options (traditional MIPS, APP, or MVPs) and participation options (individual, group, subgroup, or APM entity).

After consideration of public comments, we are finalizing the proposed updated scoring hierarchy as proposed. G. Review and Correction of MIPS Final Score (1) Feedback and Information To Improve Performance Under section 1848(q)(12)(A)(i) of the Act, we are at a minimum can i take ibuprofen with zithromax required to provide MIPS eligible clinicians with timely (such as quarterly) confidential feedback on their performance under the quality and cost performance categories beginning July 1, 2017, and we have discretion to provide such feedback regarding the improvement activities and Promoting Interoperability performance categories. In the CY 2018 Quality Payment Program final rule (82 FR 53799 through 53801), we finalized that on an annual basis, beginning July 1, 2018, performance feedback will be provided to MIPS eligible clinicians and groups for the quality and cost performance categories, and if technically feasible, for the improvement activities and advancing care information (now called the Promoting Interoperability) performance categories.

On July 1, 2018, we provided the can i take ibuprofen with zithromax first performance feedback for the Quality Payment Program. The second performance feedback was provided on July 1, 2019. In the CY 2021 PFS proposed rule (85 FR 50321), we noted that we aim to provide performance feedback on or around July 1 of each year, but due to the PHE and buy antibiotics, we estimated that we would provide performance feedback for the performance period in 2019 in late July Start Printed Page 65538 or early August of 2020. The third performance feedback (for the CY 2019 performance period) was can i take ibuprofen with zithromax provided on August 5, 2020.

In the proposed rule, we noted that similar to the CY 2019 performance period, due to the PHE for buy antibiotics, we may provide performance feedback for the CY 2020 performance period after July 1, 2021. Although we aim to provide can i take ibuprofen with zithromax performance feedback on or around July 1 of each year, it is possible that the release date could be later than July 1 depending on the circumstances. We provided performance feedback for the CY 2020 performance period on August 2 and September 27, 2021. We direct readers to qpp.cms.gov can i take ibuprofen with zithromax for more information.

h. Third Party Intermediaries We refer readers to §§ 414.1305 and 414.1400, the CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390), the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819), the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS final rule (84 FR 63049 through 63080), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (85 FR 84926 through 84947) for our previously established policies regarding third party intermediaries. As discussed in can i take ibuprofen with zithromax the CY 2022 PFS proposed rule (86 FR 39458), we proposed to make several changes. (1) Reorganization and consolidation of § 414.1400 generally.

(2) new third party intermediaries can i take ibuprofen with zithromax general requirements. (3) new requirements specific to both QCDRs and qualified registries. (4) new requirements specific to only QCDRs. And (5) remedial action and can i take ibuprofen with zithromax termination of third parties.

(1) Reorganization and Consolidation of § 414.1400 Generally We recognize that many of our policies for third party intermediaries are similar or verbatim, and yet in prior rules, we have described them separately. To minimize can i take ibuprofen with zithromax the lengthiness and burden of reading our policies, we proposed to consolidate our regulatory text under § 414.1400. To be clear, our proposed updates would not change previously finalized requirements for third party intermediaries, but would bring more clarity and simplicity to the regulatory text. These changes are discussed by topic in more detail below.

We also note that can i take ibuprofen with zithromax in several places at § 414.1400 the regulation text was only updated to reflect both the applicable MIPS performance period/MIPS payment year. (a) Reorganization for Requirements Related to MIPS Performance Categories That Must Be Supported by Third Party Intermediaries We previously established in the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364), further revised in the Quality Payment Program provisions in the CY 2019 and CY 2020 PFS final rules ((83 FR 60088 and 84 FR 63049 through 63052, respectively), and further clarified our requirements for QCDRs, qualified registries, and health IT vendors with regards to submitting data for the purposes of the MIPS program in the Quality Payment Program provisions in the CY 2021 PFS final rule. Our current policy, codified at § 414.1400(a)(2), states that, beginning with the CY 2021 performance period/2023 MIPS payment year, QCDRs and qualified registries must be able to submit data for all of the following MIPS performance categories, and Health IT vendors can i take ibuprofen with zithromax must be able to submit data for at least one of the following MIPS performance categories. Except as provided under paragraph (a)(2)(ii), QCDRs, qualified registries, and health IT vendors must be able to submit data for all of the following MIPS performance categories.

Quality, except can i take ibuprofen with zithromax. ++ The CAHPS for MIPS survey. And ++ For qualified registries and Health IT vendors, QCDR measures. Improvement can i take ibuprofen with zithromax activities.

And • Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT. However, a third party intermediary may be excepted from this requirement if its MIPS eligible clinicians, groups or virtual groups fall under the can i take ibuprofen with zithromax reweighting policies at § 414.1380(c)(2)(i)(A)( 4 ) or ( 5 ) or (c)(2)(i)(C)( 1 ) through ( 7 ) or (c)(2)(i)(C)(9)). ++ Health IT vendors that do not support MIPS Value Pathways must be able to submit data for at least one of the MIPS performance categories described in paragraphs (a)(2)(i)(A) through (C) of this section. ++ Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT.

However, a third party intermediary may be can i take ibuprofen with zithromax excepted from this requirement if its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 ) or ( 5 ) or § 414.1380(c)(2)(i)(C)( 1 ) through ( 7 ) or § 414.1380(c)(2)(i)(C)( 9 )). In an effort to simplify, we proposed reorganizing the existing language at § 414.1400(a)(2). Specifically, we proposed providing updates to separately identify and provide clarity to can i take ibuprofen with zithromax data submission requirements since data requirements vary based on third party intermediary type and to provide clarification to exceptions to Promoting Interoperability for virtual groups and subgroups. We proposed the following updates.

To revise and redesignate existing paragraph at § 414.1400(a)(2) through (a)(2)(i) to proposed paragraphs § 414.1400(b)(1)(i) and (c)(1) can i take ibuprofen with zithromax through (c)(1)(i) to state the following. To state at proposed § 414.1400(b)(1)(i), beginning with the CY 2021 performance period/2023 MIPS payment year, QCDRs and qualified registries must be able to submit data for all of the following MIPS performance categories. Quality, except. ++ The CAHPS can i take ibuprofen with zithromax for MIPS survey.

And ++ For qualified registries, QCDR measures. Improvement can i take ibuprofen with zithromax activities. And Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless. ++ The third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 )( i ) through ( iii ) or (c)(2)(i)(C)( 1 ) through (7) or (c)(2)(i)(C)( 9 )).

To state at proposed can i take ibuprofen with zithromax § 414.1400(c)(1), beginning with the CY 2021 performance period/2023 MIPS payment year, health IT vendors must be able to submit data for the MIPS performance categories as follows. To state at proposed § 414.1400(c)(1)(i) through (c)(1)(i)(B), health IT vendors that support MVPs must be able to submit data for all of the MIPS performance categories. Quality, except can i take ibuprofen with zithromax. ++ The CAHPS for MIPS survey.

And ++ QCDR measures can i take ibuprofen with zithromax. Improvement activities. And To revise and redesignate existing paragraph at § 414.1400(a)(2)(iii) to proposed paragraph § 414.1400(c)(1)(i)(C) state, Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless. ++ The third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 )( i ) through ( iii ) or (c)(2)(i)(C)( 1 ) through can i take ibuprofen with zithromax ( 7 ) or (c)(2)(i)(C)( 9 ).

• To revise and redesignate existing paragraph at § 414.1400(a)(2)(ii) to proposed paragraph § 414.1400(c)(1)(ii) to state, health IT vendors that do not support MVPs must be able to submit data for at least one of the MIPS Start Printed Page 65539 performance categories described in paragraphs (c)(1)(i) through (iii) of this section. We proposed to create a can i take ibuprofen with zithromax new requirement at § 414.1400(c)(1)(iii) for health IT vendors to support MVPs. For more information on this proposal, please refer to section “proposed new requirement for third party intermediaries to support MVPs and the APP” at section IV.A.3.h.(2)(b)(i) of this final rule. To move the current Health IT vendor requirements from paragraphs §§ 414.1400(a)(2)(ii) through (iii) and (d) to a new paragraph applicable to Health IT vendor requirements at § 414.1400(c).

This will separately identify and provide clarity can i take ibuprofen with zithromax to data submission requirements specific to Health IT vendors. To move the current CMS-approved survey vendor requirements from paragraphs (a)(3) and (e) to a new paragraph applicable to CMS-approved survey vendor requirements at § 414.1400(d). We proposed to can i take ibuprofen with zithromax the redesignate paragraph (a)(3) current requirements to paragraph (d)(1) CMS-approved survey vendors may submit data on the CAHPS for MIPS survey for the MIPS quality performance category. For the current requirements at paragraph (e), we proposed to move up those requirements to paragraph (d)(2).

To redesignate paragraph (a)(4) as can i take ibuprofen with zithromax paragraph (a)(2). To redesignate paragraph (a)(5) as paragraph (a)(3). We solicited public comments on our proposals. We did can i take ibuprofen with zithromax not receive public comments on these proposals, and therefore, we are finalizing them as proposed.

(b) Reorganization for Requirements Related QCDR and Qualified Registries Self-Nomination We proposed to consolidate and redesignate the existing language at § 414.1400(b)(1) and (c)(1) to proposed § 414.1400(b)(2) to reference both QCDR and qualified registries. We proposed this consolidation to provide clarity and alignment with the can i take ibuprofen with zithromax aforementioned proposals and consolidate the duplicative criteria of QCDRs and qualified registries. As discussed below, we also proposed to consolidate and redesignate the performance feedback requirements previously at existing § 414.1400(b)(1) and (c)(1) to § 414.1400(b)(3)(iii). We proposed to state at § 414.1400(b)(2), Self-nomination.

For the CY 2018 and 2019 performance periods/2020 and 2021 MIPS payment years, entities seeking to qualify as a QCDR or qualified registry must self-nominate September 1 until November 1 of the CY preceding the applicable performance can i take ibuprofen with zithromax period. For the CY 2020 performance period/2022 MIPS payment year and future years, entities seeking to qualify as a QCDR or qualified registry must self-nominate during a 60-day period during the CY preceding the applicable performance period (beginning no earlier than July 1 and ending no later than September 1). Entities seeking to qualify as a QCDR or qualified registry for a performance period must provide all information required by CMS at the time of self-nomination and must provide any additional can i take ibuprofen with zithromax information requested by CMS during the review process. For the CY 2019 performance period/2021 MIPS payment year and future years, existing QCDRs and qualified registries that are in good standing may attest that certain aspects of their previous year's approved self-nomination have not changed and will be used for the applicable performance period.

We also proposed removing the last two sentences of existing § 414.1400(b)(1), which are duplicative with existing § 414.1400(b)(3)(iii). We proposed consolidating this language can i take ibuprofen with zithromax with existing paragraph (b)(3)(iii). We solicited public comments on our proposals. The following is a can i take ibuprofen with zithromax summary of the comments we received and our responses.

Comment. One commenter suggested that we refine the QCDR option under MIPS to streamline the self-nomination process, and to provide better incentives for organizations, including medical associations, to continue to invest in their QCDRs and develop new, meaningful measures for specialists to use for MIPS reporting and other clinical and research can i take ibuprofen with zithromax purposes. Response. We thank the commenter for their suggestion.

We may consider it for future can i take ibuprofen with zithromax rulemaking. Comment. One commenter expressed support for the updates that CMS has made to can i take ibuprofen with zithromax the QCDR and qualified registry self-nomination process, including the development of the measure submission portal at QualityPaymentProgram.cms.gov. Response.

We thank the commenter for their support. After consideration of public comments, we are finalizing these can i take ibuprofen with zithromax policies as proposed. (c) Reorganization for Requirements Related to QCDR and Qualified Registries Conditions for Approval We refer readers to existing § 414.1400(b)(2) for QCDR conditions for approval and existing § 414.1400(c)(2) for qualified registries conditions for approval. In this final rule, we proposed the following can i take ibuprofen with zithromax in order to better organize, consolidate the duplicative criteria of QCDRs and qualified registries, and refer to both “QCDR and qualified registry” instead of one or the other.

• We proposed to redesignate existing paragraph (b)(2) to proposed paragraph (b)(3) and to revise the paragraph heading as, Conditions for approval. We also proposed to update the reference to both QCDR and qualified registry in proposed can i take ibuprofen with zithromax paragraph (b)(3). We proposed to revise to include both QCDR and qualified registry and redesignate existing paragraph (b)(2)(i) to proposed paragraph (b)(3)(i). We proposed to revise and redesignate existing paragraph (b)(2)(ii) to paragraph (b)(3)(ii).

We also can i take ibuprofen with zithromax proposed to extend our policy for collaboration. For more information on this proposal, please refer to section “collaboration of entities to become a QCDR and proposal to extend policy for collaboration of entities to become a qualified registry” at section IV.A.3.h.(3)(a)(ii) of this final rule. As discussed above, we proposed to consolidate and redesignate can i take ibuprofen with zithromax the performance feedback requirements previously at existing § 414.1400(b)(1) and (c)(1) to § 414.1400(b)(3)(iii). Furthermore, to consolidate similar performance feedback requirements, we also proposed to revise and redesignate existing paragraph (b)(2)(iii) to paragraph (b)(3)(iii) to state, beginning with the CY 2021 performance period/2023 MIPS payment year, require the QCDR or qualified registry must to provide performance feedback to their clinicians and groups at least 4 times a year, and provide specific feedback to their clinicians and groups on how they compare to other clinicians who have submitted data on a given measure within the QCDR or qualified registry.

Exceptions to this requirement may occur if the QCDR or qualified registry submits notification to CMS within the reporting period promptly within the month of realization of the impending deficiency and provides sufficient rationale as to why they do not believe they would be able to meet this requirement (for example, if the QCDR does not receive the data from their clinician until the end of the performance period). • We proposed to consolidate and redesignate paragraphs (b)(2)(iv) and (c)(2)(iii) in their entirety, into a new paragraph (b)(3)(v), and to correct a typographical error in which the word “MIPS” was omitted can i take ibuprofen with zithromax in the first sentence. Start Printed Page 65540 We proposed to consolidate and redesignate paragraphs (b)(2)(v) and (c)(3)(iv), in their entirety, into a new paragraph (b)(3)(vi). We solicited public can i take ibuprofen with zithromax comments on our proposals.

We did not receive public comments on these proposals, and therefore, we are finalizing them as proposed. (d) Reorganization for Requirements can i take ibuprofen with zithromax Related to QCDR Measures (i) Reorganization for Requirements Related to QCDR Measures for the Quality Performance Category We refer readers to existing language at § 414.1400(b)(3) for QCDR measures for the quality performance category. We currently define “QCDR measure” at existing § 414.1400(b)(3). We recognize that the QCDR measure definition is referred to throughout our policies and that it is not specific to § 414.1400(b)(3) or third party intermediaries.

Therefore, to provide further clarity and to better align with the current policy, we proposed moving the QCDR measure definition to the definitions section can i take ibuprofen with zithromax at § 414.1305. We also proposed the following revisions to better organize regulation text at § 414.1400(b)(4) and to update cross-references to correspond to the new section numbers as reflected in this final rule. We proposed to redesignate paragraphs (b)(3)(i), (b)(3)(i)(A), and (b)(3)(i)(B) can i take ibuprofen with zithromax to definitions at § 414.1305. We proposed to revise and redesignate existing paragraph (b)(3)(ii) to proposed paragraph (b)(4)(i) to state, for the CY 2018 performance period/2020 MIPS payment year and future years, at the time of self-nomination an entity seeking to become a QCDR must submit the following information for any measure it intends to submit for the payment year.

++ For MIPS quality measures, the entity must submit specifications including the MIPS measure IDs and specialty-specific measure sets, as applicable. + For QCDR measures, the entity must submit for CMS-approval measure specifications including can i take ibuprofen with zithromax. Name/title of measures, NQF number (if NQF- endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. In addition, no later than 15 calendar days following CMS approval of any can i take ibuprofen with zithromax QCDR measure specifications, the entity must publicly post the measure specifications for that QCDR measure (including the CMS- assigned QCDR measure ID) and provide CMS with a link to where this information is posted.

We also proposed adding a header to state, “QCDR measure self-nomination requirements”. We believe adding a heading will help readers clearly distinguish QCDR measure self-nomination requirements. We proposed moving existing paragraph (b)(3)(iii) in its entirety to proposed paragraph (b)(4)(ii) and adding a can i take ibuprofen with zithromax header to state, “QCDR measure submission requirements”. We believe adding a heading will help readers clearly distinguish QCDR measure submission requirements.

• We proposed moving existing paragraphs (b)(3)(v) through (v)(C)( 1 ) in its entirety, to can i take ibuprofen with zithromax proposed paragraphs (b)(4)(iii) through (b)(4)(iii)(A)( 3 ). • We proposed to revise and redesignate existing paragraph at (b)(3)(v)(C)( 2 ) to paragraph (b)(4)(iii)(A)( 3 )( i ) to state, to be included in an MVP for the CY 2022 performance period/2024 MIPS payment year and future years, a QCDR measure must be fully tested. We proposed moving existing paragraph can i take ibuprofen with zithromax (b)(3)(vii) in its entirety, to paragraph (b)(4)(iv). (ii) Reorganization for Requirements Related to QCDR Measure Approval Criteria We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375) and the Quality Payment Program provisions in the CY 2020 PFS final rule (84 FR 63059), where we finalized existing § 414.1400(b)(3)(v).

At § 414.1400, we proposed to reorganize and make minor updates to the existing requirements at paragraph (b)(3)(v) to proposed paragraph (b)(4)(iii). We proposed to reorganize the existing can i take ibuprofen with zithromax requirements so that QCDR measure approval at paragraph (b)(3)(v) is discussed before QCDR measure considerations at paragraph (b)(3)(iv). Therefore, we proposed the following revisions. To revise and redesignate can i take ibuprofen with zithromax existing paragraph (b)(3)(v) “QCDR measure requirement for approval include” to proposed paragraph (b)(4)(iii) and add a heading to state, “QCDR measure approval criteria”.

We believe adding a heading will help readers clearly distinguish QCDR measure approval criteria. We also proposed to include the following updates. ++ Move can i take ibuprofen with zithromax existing paragraph (b)(3)(v) to proposed revised paragraph (b)(4)(iii)(A) to state, QCDR measure requirements for approval are. ++ Move existing paragraph (b)(3)(v)(A) in its entirety to proposed paragraph (b)(4)(iii)(A)( 1 ).

++ Move existing paragraph (b)(3)(v)(B) can i take ibuprofen with zithromax in its entirety to proposed paragraph (b)(4)(iii)(A)( 2 ). ++ Revise existing paragraphs (b)(3)(v)(C) and (b)(3)(v)(C)( 1 ) to proposed paragraph (b)(4)(iii)(A)( 3 ) to state, beginning with the CY 2022 performance period/2024 MIPS payment year, all QCDR measures must meet face validity. To be approved for the CY 2023 performance period/2025 MIPS payment year, all QCDR measures must be must meet face validity for the initial MIPS payment year for which can i take ibuprofen with zithromax it is approved. For subsequent years after being initially approved, all QCDR measures must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination.

++ Move existing paragraph (b)(3)(v)(C)( 2 ) in its entirety to proposed paragraph (b)(4)(iii)(A)( 3 )( i ). ++ Move existing paragraph can i take ibuprofen with zithromax (b)(3)(v)(D) in its entirety to proposed paragraph (b)(4)(iii)(A)( 4 ). ++ Move existing paragraph (b)(3)(v)(E) in its entirety to proposed paragraph (b)(4)(iii)(A)( 5 ). We solicited public comment on can i take ibuprofen with zithromax our proposals.

The following is a summary of the comments we received and our responses. Comment. A few commenters supported the measure requirement can i take ibuprofen with zithromax for face validity testing of measures and stated it should be extended for future years. One commenter noted particular concern for the face validity testing requirement, as the testing process is arduous and funding, staff, and other resources have been significantly reduced due to the PHE for buy antibiotics.

A few commenters suggested that CMS delay the deadline for full QCDR measure testing to 2023 or later due to the impact of can i take ibuprofen with zithromax buy antibiotics on providers and registries. Another commenter suggested that CMS limit the face validity testing requirement, stating that because the buy antibiotics extreme and uncontrollable circumstances exception decreased the number of groups reporting to MIPS through QCDRs, the face validity testing requirement should be limited to the first 2 years for which measures are approved or until 2 years after the end of the buy antibiotics PHE. Several commenters expressed concerns with QCDR measure testing requirements and pointed can i take ibuprofen with zithromax to the significant burden of these requirements. One commenter expressed the belief that a barrier to use of QCDR measures is the requirement that they be fully tested, which is Start Printed Page 65541 extremely burdensome for QCDR measure owners.

Another commenter asked for clarification as to what constitutes acceptable measure testing. Commenters requested that can i take ibuprofen with zithromax CMS develop a transparent and consistent process for evaluating QCDR testing approaches and results. Commenters noted that failure to ease the QCDR requirements may result in interested parties opting to not participate in the QCDR program. Response can i take ibuprofen with zithromax.

We note that we did not propose to substantively modify the measure requirement for face validity and testing in the proposed rule, such as to delay these requirements. The existing requirement (85 FR 84939) at § 414.1400(b)(3)(v)(C)( 1 ) states that, for a QCDR measure to approved for the CY 2022 performance period/2024 MIPS payment year it must meet face validity. To be approved for the CY 2023 performance period/2025 MIPS payment year can i take ibuprofen with zithromax and for each subsequent year, a QCDR measure must meet face validity for the initial MIPS payment year for which it is approved. Separately, paragraph (b)(3)(v)(C) provides that, beginning with the CY 2022 performance period/2024 MIPS payment year, a QCDR measure must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination.

In addition, paragraph (b)(3)(v)(C)( 1 ) requires that, for each subsequent year, for which a QCDR measure is approved, it can i take ibuprofen with zithromax must be fully tested. We intended our proposed reorganization of these standards at paragraph (b)(4)(B)(iii)( 3 ) to track these existing requirements. In regards to what constitutes acceptable testing and the burden associated with, and possible delay of such testing, we refer readers to our discussion of can i take ibuprofen with zithromax this and related issues in past rules (85 FR 27594 through 27595. 85 FR 84940.

85 FR 84926. 85 FR can i take ibuprofen with zithromax 84936. 84 FR 63066. 84 FR 63065 can i take ibuprofen with zithromax through 63067.

83 FR 59901 through 59902. 82 FR 53805 through 53806) and guidance documents, including the current CMS Measures Management System Blueprint for additional guidance in measure testing at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​MMS/​Downloads/​Blueprint.pdf. Although we did not address any changes to the QCDR measure testing requirement at § 414.1400(b)(3)(v)(C)( 1 ) in the CY 2022 PFS proposed rule, based on public comments received on our proposals, we are considering proposing in next year's rulemaking to further delay this requirement for traditional MIPS until the CY 2024 performance period/2026 MIPS payment year, can i take ibuprofen with zithromax instead of the CY 2023 performance period/2025 MIPS payment year as previously finalized. We clarify that this delay would not modify the existing requirement at paragraph (b)(3)(v)(C)( 2 ), to be included in an MIPS Value Pathway for the 2024 MIPS payment year and future years, a QCDR measure must be fully tested.

Comment can i take ibuprofen with zithromax. One commenter suggested that CMS provide more meaningful credit/incentivization for measure testing participation given the difficulty to motivate practices to engage in measure testing. The commenter suggested an improvement activity credit for measure testing given the difficulty to motivate practices to engage in measure testing. Response can i take ibuprofen with zithromax.

We thank the commenter for their suggestion. We may consider it for can i take ibuprofen with zithromax future rulemaking. We encourage the commenter to visit the 2021 Improvement Activities Inventory for additional guidance on improvement activities that focus on QCDR participation at https://qpp-cm-prodcontent.s3.amazonaws.com/​uploads/​1189/​2021%20Improvement%20Activities%20List.zip. After consideration of public comments, can i take ibuprofen with zithromax we are finalizing these policies as proposed.

(iii) Reorganization for Requirements Related to QCDR Measure Considerations for Approval We refer readers to the Quality Payment Program provisions in the CY 2019 PFS final rule (84 FR 63198 through 63199), where we finalized existing § 414.1400(b)(3)(iv) “QCDR measure considerations for approval.” We proposed to reorganize and make minor updates to the language at existing paragraph (b)(3)(iv) to paragraph (b)(4)(iii)(B). We proposed to reorganize the existing requirements so that QCDR measure approval at paragraph (b)(3)(v) is discussed before QCDR measure considerations at paragraph (b)(3)(iv). We also proposed to redesignate existing paragraph (b)(3)(vi) to can i take ibuprofen with zithromax paragraph (b)(4)(iii)(C). Specifically, we proposed the following revisions.

To revise and redesignate existing paragraph (b)(3)(iv) can i take ibuprofen with zithromax “QCDR measure considerations for approval include” to paragraph (b)(4)(iii)(B) “QCDR measure considerations for approval include, but are not limited to”. • Move existing paragraphs (b)(3)(iv)(A) in its entirety to paragraph (b)(4)(iii)(B)( 1 ). • Move existing paragraph (b)(3)(iv)(B) in its entirety to paragraph (b)(4)(iii)(B)( 2 ). • can i take ibuprofen with zithromax Move existing paragraph (b)(3)(iv)(C) in its entirety to paragraph (b)(4)(iii)(B)( 3 ).

• Move existing paragraph (b)(3)(iv)(D) in its entirety to paragraph (b)(4)(iii)(B)( 4 ). • Move existing paragraph (b)(3)(iv)(E) in its can i take ibuprofen with zithromax entirety to paragraph (b)(4)(iii)(B)( 5 ). • Move existing paragraph (b)(3)(iv)(F) in its entirety to paragraph (b)(4)(iii)(B)( 6 ). • Move existing paragraph (b)(3)(iv)(G) in can i take ibuprofen with zithromax its entirety to paragraph (b)(4)(iii)(B)( 7 ).

• Revise and consolidate existing paragraph (b)(3)(iv)(G)( 1 ) to paragraph (b)(4)(iii)(B)( 7 )( i ) to state that QCDR link their QCDR measures as feasible to at least one cost measure, improvement activity, or an MVP at the time of self-nomination. • Revise and redesignate existing paragraph (b)(3)(iv)(G)( 2 ) to paragraph (b)(4)(iii)(B)( 7 )( ii ) to state that in cases where a QCDR measure does not have a clear link to a cost measure, improvement activity, or an MVP, CMS would consider exceptions if the potential QCDR measure otherwise meets the QCDR measure requirements and considerations. • Move existing paragraph (b)(3)(iv)(H) in its entirety to paragraph (b)(4)(iii)(B)( 8 ) can i take ibuprofen with zithromax. • Move existing paragraph (b)(3)(iv)(I) in its entirety to paragraph (b)(4)(iii)(B)( 9 ).

• Revise and redesignate existing paragraph (b)(3)(iv)(J) to paragraph (b)(4)(iii)(B)( 10 ) to state beginning with the CY 2020 performance period/2022 MIPS payment can i take ibuprofen with zithromax year, CMS places greater preference on QCDR measures that meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods. Those that do not, may not continue to be approved. • Move existing paragraph (b)(3)(iv)(J)( 1 ) in its entirety to paragraph (b)(4)(iii)(B)( 10 )( i ). • Move existing paragraph (b)(3)(iv)(J)( 2 ) to paragraph reserve (b)(4)(iii)(B)( 10 )( can i take ibuprofen with zithromax ii ).

Move existing paragraph (b)(3)(vi) in its entirety to paragraph (b)(4)(iii)(C). We can i take ibuprofen with zithromax solicited public comments on our proposals. The following is a summary of the comments we received and our responses. Comment can i take ibuprofen with zithromax.

The commenter suggested that we assess whether the limit on the number of QCDR measures available (30 measures) should be revised. Response. We thank can i take ibuprofen with zithromax the commenter for their suggestion. We may consider it for future rulemaking.

Start Printed can i take ibuprofen with zithromax Page 65542 After consideration of public comments, we are finalizing these policies as proposed. (iv) QCDR Measure Rejection Criteria We refer readers to the existing requirements at § 414.1400(b)(3)(vii). We proposed reorganizing existing requirements at paragraph (b)(3)(vii) to proposed paragraph (b)(4)(iv). Therefore, we proposed the can i take ibuprofen with zithromax following revisions.

• To revise and redesignate existing paragraph (b)(3)(vii) “QCDR measure rejection criteria” to paragraph (b)(4)(iv) and add a heading to state, QCDR measure rejection criteria. We believe can i take ibuprofen with zithromax adding a heading will help readers clearly distinguish measure rejection criteria. We also proposed to include the following updates. • To move existing paragraph (b)(3)(vii) to proposed paragraph (b)(4)(iv) to state, QCDR can i take ibuprofen with zithromax measure rejection criteria.

Beginning with the CY 2020 performance period/2022 MIPS payment year, QCDR measure rejection considerations include, but are not limited to. Move existing paragraphs (b)(3)(vii)(A) through (L) in their entirety to (b)(4)(iv)(A) through (L). We solicited public comments on can i take ibuprofen with zithromax our proposals. We did not receive public comments on these proposals, and therefore, we are finalizing them as proposed.

(e) Reorganization for Requirements Related to Remedial Action and Termination of Third Party Intermediaries We refer readers to § 414.1400(f), the CY 2017 Quality Payment Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 through 59910), the CY 2020 PFS final rule (84 FR 63077 through 63080), and the can i take ibuprofen with zithromax CY 2021 PFS final rule (85 FR 84930 through 84937) for previously finalized policies for remedial action and termination of third party intermediaries. With the proposed updates being made at § 414.1400, we proposed to redesignate the following sections. We proposed to redesignate current paragraph (f) as paragraph (e) and to update cross-references to correspond to the new section numbers as reflected in this final rule. We also proposed to redesignate current paragraph (g) as paragraph (f) and to update cross-references to correspond to the new section can i take ibuprofen with zithromax numbers as reflected in this final rule.

We solicited public comments on these proposals. We did not receive can i take ibuprofen with zithromax public comments on these proposals, and therefore, we are finalizing them as proposed. (2) Third Party Intermediaries General Requirements We refer readers to previously established § 414.1400(a) and the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364), and as further revised in the CY 2019 PFS final rule (83 FR 60088), CY 2020 PFS final rule (84 FR 63049 through 63052), CY 2021 PFS final rule (85 FR 84926 through 84947) for our established policy regarding third party intermediaries general requirements. In the CY 2022 PFS proposed rule, we proposed two changes for third party intermediaries.

(1) Third party intermediary submissions for can i take ibuprofen with zithromax APM Entities. And (2) MIPS performance categories that must be supported by third party intermediaries. We also solicited comment on can i take ibuprofen with zithromax third party intermediaries that derive data from CEHRT. These proposals and the request for comments are discussed in more detail below.

(a) Third Party Intermediary Submissions for APM Entities As finalized in the Quality Payment Program provisions in the CY 2021 can i take ibuprofen with zithromax PFS final rule (85 FR 84895), APM Entities now have the option of reporting to MIPS on behalf of the MIPS eligible clinicians participating in their APM Entity. They have the option of reporting to traditional MIPS or via the APP (85 FR 84859). APM Entities have historically used Third Party Intermediaries for submitting their quality measures to their APMs, rather than to MIPS, however, these third party intermediaries now have the opportunity to submit these data for purposes of MIPS. In the CY 2022 PFS proposed rule, we proposed to add APM Entities to § 414.1400(a)(1), expanding can i take ibuprofen with zithromax the general participation requirements of third party intermediaries to third party intermediaries reporting to MIPS on behalf of APM Entities in order to align reporting requirements for all participants in MIPS.

We note that the Promoting Interoperability performance category is scored for APM Entities based on data submitted by the participant MIPS eligible clinicians and groups as described at § 414.1317(b)(1), and therefore, would not be required to be submitted by the third party intermediary on behalf of the APM Entity. We solicited comments can i take ibuprofen with zithromax on this proposal. We did not receive public comments on this proposal, and therefore, we are finalizing it as proposed. (b) MIPS Performance Categories That Must Be Supported by Third Party Intermediaries We refer readers to previously established § 414.1400(a)(2) and the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364), and as further revised in the CY 2019 PFS final rule (83 FR 60088), CY 2020 PFS final rule (84 FR 63049 through 63052), CY 2021 PFS final rule (85 FR 84926 through 84947) for our established policy regarding the types of MIPS data that third party intermediaries may submit.

In the CY 2022 PFS proposed rule, we proposed new requirements in alignment with our proposals can i take ibuprofen with zithromax in sections IV.A.3.b.(2)(c), IV.A.3.b.(4)(e) and IV.A.3.b.(3)(e) of this final rule to adopt MVPs and subgroups. (i) New Requirement for Third Party Intermediaries To Support MVPs and the APP As described in the Quality Payment Program provisions finalized in the CY 2021 PFS final rule (85 FR 84849), MVPs should include measures and activities from the quality, cost, improvement activities, and Promoting Interoperability performance categories. As described in section IV.A.3.b.(2)(c)(i) of this final rule, we discussed our proposals related to furthering our transition to can i take ibuprofen with zithromax MIPS Value Pathways (MVPs). As MVPs are implemented, proposed beginning with the CY 2023 performance period/2025 MIPS payment year, we also proposed the methods in which an MVP participant may report on an MVP or the APP.

Since QCDRs, qualified registries, and health IT vendors are required under existing § 414.1400(a)(1) to submit data can i take ibuprofen with zithromax for quality, improvement activities, and promoting interoperability, we believe they would have the experience needed to support MVP and APP reporting. Therefore, we proposed to create a new requirement at § 414.1400(b)(1)(ii) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. QCDRs and qualified registries may also support the APP. Additionally, we proposed to create a new requirement at paragraph § 414.1400(c)(1)(iii) to state that beginning with the CY 2023 performance period/2025 MIPS payment year, can i take ibuprofen with zithromax Health IT vendors must support MVPs that are applicable to the Start Printed Page 65543 MVP participants on whose behalf they submit MIPS data.

Health IT vendors may also support the APP. Based off historical participation, we are aware that some third party intermediaries (QCDRs and qualified registries) support a single specialty or subspecialty, can i take ibuprofen with zithromax while others support multiple specialties. Therefore, we believe that it is not appropriate to expect that all third party intermediaries are able to support all MVPs that are implemented in the program. Rather, the third party intermediaries should identify and support MVPs that are relevant to the clinicians and groups they support.

We do not believe that CMS-approved survey vendors will be able to support MVP reporting, because they are historically limited, in that they only support the CAHPS can i take ibuprofen with zithromax for MIPS Survey Measure. As discussed in section IV.A.3.b.(2)(c) of this final rule, MVPs will start with the CY 2023 performance period/2025 MIPS payment year. We believe this delay in implementation will allow third party intermediaries sufficient time can i take ibuprofen with zithromax for programming and system preparation for MVP reporting success. We solicited comments on our proposals.

The following is a summary of the comments we received and our responses can i take ibuprofen with zithromax. Comment. One commenter supported third party intermediaries only reporting on the MVPs that reflect their participant needs but suggested third-party intermediaries be able to choose which MVPs they wish to support. The commenter expressed concerns about MVPs being arbitrarily assigned to third-party intermediaries can i take ibuprofen with zithromax.

One commenter noted that supporting an entire MVP is very different from supporting the inclusion of specific QCDR measures in an MVP and could carry much more burden for the registry and sought clarification of whether CMS will assign specific MVPs to a QCDR or qualified registry. Response can i take ibuprofen with zithromax. We thank the commenter for their support. At this time, CMS does not intend on assigning specific MVPs to a third party intermediary.

As described in can i take ibuprofen with zithromax the CY 2022 PFS proposed rule (86 FR 39462), we proposed at § 414.1400(b)(1)(ii) and (c)(1)(iii) that QCDRs, qualified registries, and Health IT vendors must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. We refer readers to Appendix 3 of this final rule, where discuss the MVPs being finalized beginning with the CY 2023 performance period/CY 2025 MIPS payment year, around the clinical topics of stroke care, heart disease, rheumatology, chronic conditions, emergency medicine, anesthesia, and lower extremity joint repair. QCDRs, qualified registries, and Health IT vendors that support MVP participants, who work in the aforementioned can i take ibuprofen with zithromax clinical areas will be required to support these MVPs, as applicable. Furthermore, we expect that QCDRs, qualified registries, and Health IT vendors who support MVPs would support all measures and activities, across the quality, PI, and improvement activities performance category that are included in the MVP (cost measures and population health measures are calculated by CMS and do not require data submission by a third party intermediary or a clinician).

The expectation that the QCDR and qualified registry support measures and activities across all three performance categories is not new, as these third party intermediaries are currently required to do so. We believe allowing QCDRs to only support specific QCDR measures can i take ibuprofen with zithromax in an MVP creates undue burden on the MVP Participant who would need to find other means to complete MVP reporting requirements. This may deter clinicians from utilizing a third party intermediary. For the time being, CMS does not intend on assigning specific MVPs to a can i take ibuprofen with zithromax third party intermediary.

It is required for QCDRs, qualified registries, and Health IT vendors to identify (CMS approved) MVPs that are relevant to the clinicians they support and report on those. Comment can i take ibuprofen with zithromax. One commenter supported third party intermediaries supporting MVPs but requested clarification on whether a QCDR would be responsible for validating an MVP participant's performance on population health measures and/or providing “enhanced” performance feedback, including performance data comparing the performance of similar clinicians who report on the same MVP. Response.

Third party intermediaries will not be expected to validate the performance on the current population health measures, since they are administrative claims-based and do not can i take ibuprofen with zithromax require external data submission. The responsibility of identifying the population health measure that should be calculated will fall to the MVP participant to determine at the time of MVP registration. CMS calculates these measures based can i take ibuprofen with zithromax on administrative claims data. In the CY 2022 PFS proposed rule (86 FR 39383), we describe our proposal to include comparative performance feedback within the annual performance feedback that CMS currently provides under traditional MIPS.

While CMS intends to provide this enhanced feedback through our existing performance feedback processes, QCDRs and qualified registries will still be required to provide clinicians they support with performance feedback as described at § 414.1400(b)(iii) and (c)(ii), regardless of whether the clinician chooses to report through traditional MIPS or an MVP. Comment can i take ibuprofen with zithromax. One commenter suggested that CMS mandate that EHR vendors support the quality measures in MVPs, otherwise clinicians would be forced to join multiple registries with the cost exceeding the maximum penalty. Response can i take ibuprofen with zithromax.

To clarify, health IT vendors (such as EHRs), QCDRs, and qualified registries who support MVPs are required to support all measures and activities available in the MVP across the quality, improvement activities, and promoting interoperability performance categories. The exceptions to this requirement are the cost measures and population health measures, which do not require external data submission to be calculated can i take ibuprofen with zithromax. In addition, some MVPs may include QCDR measures, which are only reportable through a QCDR. In instances where QCDR measures are included in an MVP, a qualified registry or health IT vendor will be expected to support all other quality measures included within the MVP.

Comment can i take ibuprofen with zithromax. One commenter expressed concerns about layering another auditing requirement on QCDRs and qualified registries when MVPs are finalized as this could increase regulatory complexity and result in added work and burden without making a significant difference in the quality of data submitted. One commenter requested that CMS add more detail in future requirements for third-party intermediaries to validate data submitted by MVP can i take ibuprofen with zithromax participants. Response.

We disagree with the commenter. QCDRs and qualified registries are currently required to conduct data validation on data that is submitted to CMS for purposes of the MIPS program, to ensure can i take ibuprofen with zithromax the data is true, accurate, and complete. We refer readers to section IV.A.3.h.(3)(a)(iii) of this final rule for a detailed discussion of those requirements. The current can i take ibuprofen with zithromax data validation requirements that are utilized in traditional MIPS, will also be applied to MVP submissions.

MVPs are considered a method of reporting under MIPS, but is nonetheless a part of the program. Therefore, the requirements and expectations remain the same— QCDRs and qualified registries must conduct data validation on data submitted to CMS for purposes of the MIPS program, regardless of whether Start Printed Page 65544 the data is submitted under can i take ibuprofen with zithromax traditional MIPS or through an MVP. In the future, data validation information that is covered in the Self-Nomination Toolkit for QCDRs and qualified registries available at https://qpp-cm-prod-content.s3.amazonaws.com/​uploads/​1083/​2021%20Self-Nomination%20Toolkit%20for%20QCDRs%20and%20Qualified%20Registries.zip will also include MVPs. Comment.

One commenter requested clarification on whether QCDRs and qualified registries are required or permitted to support the APP, stating that the preamble states this is a requirement while the regulatory text says that QCDRs and qualified registries can i take ibuprofen with zithromax may support the APP. The commenter opposed a requirement for QCDRs and qualified registries to support the APP. Response can i take ibuprofen with zithromax. In the CY 2021 PFS final rule (85 FR 84859), we discussed that APM Entities have the option of reporting to MIPS on behalf of the MIPS eligible clinicians participating in their APM Entity.

Additionally, there is an option of reporting to traditional MIPS or via the APP. Furthermore, in the proposed rule (86 FR 39462), we proposed to add APM Entities to § 414.1400(a)(1), expanding the general participation requirements of third party intermediaries to third party intermediaries reporting to MIPS on behalf of APM can i take ibuprofen with zithromax Entities in order to align reporting requirements for all. We want to note that QCDRs and qualified registries would not be required to support the APP, but may do so. If QCDRs can i take ibuprofen with zithromax and qualified registries would like to support the APP, they would need to meet all of the other requirements of being a QCDR or qualified registry reporting to MIPS (with the exception of PI reporting, which has some exceptions) as described above.

After consideration of public comments, we are finalizing these policies as proposed. (ii) Requirements for All can i take ibuprofen with zithromax Third Party Intermediaries To Support Subgroup Reporting As proposed in section IV.A.3.b.(3) of this final rule, subgroup reporting would allow clinicians in multispecialty practices to participate in MIPS more meaningfully. Since subgroups would be implemented concurrently with MVPs, it is important that third party intermediaries have the capability to support subgroup reporting of MVPs. As described above, we believe QCDRs, qualified registries, and health IT vendors would have the capacity to support MVP and APP reporting.

In the CY 2022 PFS proposed rule, we proposed to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY can i take ibuprofen with zithromax 2023 performance period/2025 MIPS payment year. Therefore, we proposed to revise § 414.1400(a)(1) to state that MIPS data may be submitted on behalf of a MIPS eligible clinician, group, virtual group, subgroup or APM Entity by any of the following third party intermediaries. QCDR. Qualified registry.

Health IT vendor. Or CMS-approved survey vendor. We believe it is imperative for all third party intermediaries to be able to support subgroup reporting as we envision that to be the future of the program. While the CAHPS for MIPS survey vendors cannot support MVPs or the APP, we believe they can support the reporting of the CAHPS for MIPS measure within an MVP and the APP, if a subgroup decides to report on that measure.

Due to the limited experience, CAHPS for MIPS survey vendors have in quality reporting, we do not believe it is feasible for them to support MVP reporting since MVP reporting would require experience with reporting across the performance categories and the use of several collection types for quality reporting. However, there may be instances where the CAHPS for MIPS survey measure may be included in an MVP. For example, in the Optimizing Chronic Conditions Management MVP, as described in Appendix 3. MVP Inventory, of this final rule.

In such instances, if groups or subgroups would like to report this measure, they should be able to utilize a CAHPS for MIPS survey vendor to do so. We believe it is important that all third party intermediaries support subgroup reporting in order to support meaningful quality reporting. We understand that there may be a level of burden to third party intermediaries that are required in supporting subgroup reporting by requiring them to support another clinician type. However, we believe that requiring third party intermediaries to support subgroup reporting will allow for clinicians to participate in a manner that is more meaningful.

We noted in section IV.A.3.b.(4)(f)(ii)(D) of this final rule, subgroups would have to register through the MVP participant registration process. Third party intermediaries would need to be able to track the subgroup identifiers and support the data submission process accordingly. We solicited comments on our proposal. The following is a summary of the comments we received and our responses.

Comment. A few commenters expressed concern regarding the burden for registries to identify and validate subgroup reporting. Response. To clarify, as discussed in section IV.A.3.b.(4)(f)(ii)(D) of this final rule, subgroups must self-identify and register through a registration process in order to be considered a subgroup.

The subgroup would need to register directly through the MVP registration process, that is done separately and not through a third party intermediary. Therefore, we believe there is no burden to registries to identify the subgroups. As MVP participants such as subgroups enroll to use the services of a registry, the subgroup will share with the registry their CMS-assigned identifier and a list of participants within that subgroup. The registry will need to submit the subgroup identifier information with the subgroup's data at the time of submission.

We understand there may be concerns in scenarios in which subgroups inadvertently provide an incorrect subgroup identifier to the registry. We will take that into consideration for future rulemaking, as we determine whether there are additional system safeguards, such as a system rejection of an incorrect identifier can be implemented to limit the occurrence of such issues. With regards to data validation, all QCDRs and qualified registries will continue to be held to the data validation requirements that currently exist, regardless of whether a clinician or group decides to participate in MVP reporting or traditional MIPS reporting. While we understand there is a level of burden associated with data validation, we believe the benefit outweighs the burden to ensure that all data submitted to CMS is true, accurate, and complete.

Comment. One commenter suggested that CMS delay its proposal requiring third party intermediaries to support subgroup reporting to allow more time for registries to implement reporting processes. Several commenters expressed concern that subgroup reporting will impose a large increase in burden on registries, particularly with respect to how registries validate NPIs. A few commenters expressed concern that QCDRs may lack the capacity to support subgroup reporting.

Response. We disagree with the need for further delay. We intentionally proposed MVPs and subgroup reporting with a delayed implementation to account for the time that clinicians, third party intermediaries, and healthcare organizations would need to prepare to operationalize MVP and subgroup reporting. We believe the availability of subgroup reporting Start Printed Page 65545 should go hand-in-hand with the implementation of MVPs, and therefore, should be jointly available beginning with the CY 2023 performance period/2025 MIPS payment year.

The delayed implementation should provide third party intermediaries sufficient time for system and operation preparations for subgroup reporting. In addition, we do not believe that subgroup reporting will impose a large increase in burden to registries. We refer readers to section IV.A.3.b.(3) of this final rule, for further discussion of validation requirements. Subgroups are derived from their affiliated TINs who would have otherwise reported traditional MIPS through a registry.

After consideration of public comments, we are finalizing this policy as proposed. (c) Request for Comment on Third Party Intermediaries That Derive Data From CEHRT For third party intermediaries that will be submitting quality measure data on behalf of MIPS eligible clinicians, we believe that EHR systems will be able to provide measure results for a set of providers that are part of a subgroup where required for subgroup reporting. We note that the existing CEHRT definition for eligible clinicians at § 414.1305 includes the 45 CFR 170.315(c)(4) “Clinical quality measures—filter” as an optional element. This criterion requires health IT to be able to filter CQM results at both patient and aggregate levels.

Moreover, a Health IT Module must be able to filter by a single proposed data element (for example, provider type) or a combination of any of the data elements). Historically, the “Clinical quality measures—filter” at 45 CFR 170.315(c)(4)” (CQM-filter) criterion has been applicable for certified health IT modules supporting quality measurement for participants in certain APMs. We believe technology certified to this optional criterion could support subgroup reporting via third party intermediaries that derive data from CEHRT by ensuring that an EHR can produce CQM results filtered for a specific group of provider NPIs that are part of a subgroup. These filtered CQM results could then be shared with a third party intermediary, which provides this data for reporting to CMS.

However, we also believe health IT developers are offering non-certified functionality that can effectively support reporting of measure results for a subgroup. As a result, we did not propose any changes at this time to the language in the CEHRT definition for eligible clinicians regarding the “optional” status of technology certified to the CQM-filter criterion. We are interested in general feedback from stakeholders on the current capabilities of third party intermediaries that derive data from CEHRT to successfully receive and transmit data to CMS for CQMs based on subgroups. Capabilities of EHR systems to support subgroup reporting, including reporting facilitated by third party intermediaries, and whether requiring the adoption of technology certified to the CQM-filter criterion would help to support subgroup reporting.

And challenges which entities may face in meeting requirements to report on subgroups when deriving data from CEHRT. We solicited feedback on this topic. Comment. A few commenters responded to CMS' request for information regarding CEHRT and third party intermediaries.

One commenter urged CMS to establish clear expectations and guidelines to ensure data security and to define roles and responsibilities for data validation and data cleaning. Another commenter recommended that CMS consider making the CQM filter criterion mandatory for CEHRT because, otherwise, organizations would likely be required to contract with qualified registries/QCDRs to submit MIPS data. Another commenter disagreed, stating that as a developer of CEHRT that provides CQM functionality, they do not believe that the CQM-filer criterion is necessary. Response.

We thank commenters for the feedback received through this request for information. We may consider this information to inform future rulemaking. (3) New Requirements for Both Qualified Clinical Data Registries (QCDRs) and Qualified Registries (a) Background We refer readers to §§ 414.1305 and 414.1400, the CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390), the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819), the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS final rule (84 FR 63049 through 63080), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (85 FR 84926 through 84947) for our previously established policies regarding QCDRs and qualified registries. In the CY 2022 PFS proposed rule, we proposed several changes for both QCDRs and qualified registries.

(1) New requirement for approved QCDRs and qualified registries that have not submitted performance data. (2) collaboration of entities to become a QCDR and qualified registry. And (3) data validation audit and targeted audit requirements. These proposals are discussed in more detail below.

(i) New Requirement for Approved QCDRs and Qualified Registries That Have Not Submitted Performance Data We require that both QCDRs and qualified registries must have a minimum of 25 participants signed up by the prior performance period at existing § 414.1400(b)(2) and (c)(2). We refer readers to CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390), the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819), the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS final rule (84 FR 63049 through 63080), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (85 FR 84926 through 84947). We identified a number of QCDRs and qualified registries that have continued to self-nominate to become a third party intermediary for the MIPS program, but have not submitted clinician, group or virtual group data to CMS. As the MIPS program continues to mature, we wish to reduce the number of vendors that self-nominate to become a qualified vendor, but do not actively participate in the MIPS program.

We believe that maintaining these vendors who do not actively participate does not provide a benefit to the MIPS program, rather it creates stakeholder confusion by including these vendors in our qualified postings. We proposed a two-tiered approach to solve this issue. First, we proposed to create a new requirement at § 414.1400(b)(3)(vii) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023. Exceptions to this requirement may occur if data is received for the CY 2021 performance period/2023 MIPS payment year.

Under this scenario, QCDRs and qualified registries would not need to submit a participation plan for CY 2023 of the self-nomination period. If they do not submit data, their participation plan must be submitted as part of self-nomination for CY 2023 and must be accepted by CMS to continue to be an approved QCDR or qualified registry. Start Printed Page 65546 Secondly, we proposed to codify a new requirement at paragraph (b)(3)(viii) to state, beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. For example, for the CY 2024 performance period/2026 MIPS payment year, vendors will be required to have submitted performance data for the CY 2021 and 2022 performance periods/2023 and 2024 MIPS payment years.

Under this proposal, the participation plan must explain the QCDR's or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third party intermediary on behalf of clinicians or groups. The vendor must also explain why they should still be allowed to participate as a qualified vendor. We note that this proposed participation plan was modeled off of the current requirement for QCDR measure participation at existing § 414.1400(b)(3)(iv)(J)( 1 ) (redesignated to proposed paragraph (b)(4)(iii)(B)(10)( i )). We solicited comments on this proposal.

The following is a summary of the comments we received and our responses. Comment. A few commenters disagreed with the proposal to require a participation plan for approved QCDRs that did not submit data for 2 years preceding the applicable self-nomination period. One commenter stated that the buy antibiotics PHE reduced reporting by eligible clinicians to QCDRs.

Response. While we are sympathetic and acknowledge that the impact the PHE may have had on reduced reporting, we note that we are proposing an incremental approach to assess QCDR data reporting. This includes the first proposal which would apply to any QCDR or qualified registry that has not submitted data to CMS since the inception of MIPS (CY 2017). We believe a QCDR should have been able to report data to CMS for years preceding CY 2021.

Specifically, we believe a QCDR should have been able to report data to CMS for CY 2019. If a QCDR was new in CY 2020 and did not submit data to CMS, the QCDR still has CY 2021 to report for clinicians which in turn, satisfies this requirement. Furthermore, the proposal provides QCDRs and qualified registries the opportunity to submit participation plans, which could support the decision to allow a QCDR or qualified registry to continue their MIPS participation. This plan would outline possible reasons for low/no reporting to CMS and the efforts the QCDR plans to take to further encourage their clinicians to submit data to CMS.

Some examples include but are not limited to. A reduction in associated fees, improvement of an EHR interface to reduce data extraction burden, expansion of the numbers/types of measures the QCDR chooses to report, etc. As such, this proposal would not immediately remove a QCDR or qualified registry from participating as a third party intermediary. As discussed above, we want to reduce the number of vendors that self-nominate to become a qualified vendor, but do not actively participate in the MIPS program.

We believe that maintaining these vendors who do not actively participate does not provide a benefit to the MIPS program. We note that our goal is to decrease the operational burden on CMS and those vendors who do not submit MIPS data to CMS. CMS would decrease its operational burden by not having to go through the vetting process of these entities or monitor program compliance during the year. Additionally, we believe that we can better utilize the resources used for vendors that do not submit MIPS data elsewhere to improve the MIPS program.

Furthermore, vendors who choose not to submit MIPS data to CMS are depriving CMS of data that would benefit the MIPS program. Lastly, vendors who do not submit data will decrease their burden in the long-term by not self-nominating year after year. Comment. One commenter disagreed with the proposal for QCDRs and qualified registries who do not submit data 2 years preceding the applicable self-nomination period to submit a participation plan at the time of self-nomination.

The commenter noted that CMS would also require the participation plan to include moving users over to submit their MIPS data through the qualified registry. The commenter expressed concern that this policy would create significant demand on QCDRs specifically, due to the already cumbersome Eligible Measure Applicability (EMA) process required for qualified registries. The commenter currently uses both the qualified registry and QCDR to collect data, however, the commenter only submits the data to CMS through the QCDR. Response.

We disagree with the commenter's interpretation of this policy. The intention of the participation plan requirement is to explain the QCDR's or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third party intermediary on behalf of clinicians or group and to explain why they should still be allowed to participate as a qualified vendor. The participation plan will not require moving users over to submit their MIPS data through the qualified registry and that this policy would create significant demand on QCDRs. We note that during the CY 2019 MIPS performance period, the Eligible Measure Applicability (EMA) process was updated to be applicable to collection types (that is, EMA applies to Part B Claims measures and MIPS clinical quality measures (CQMs) but does not apply to electronic clinical quality measures (eCQMs), QCDR measures, or Web Interface) rather than third party intermediaries.

As such, EMA does not apply to QCDRs and qualified registries as an entity, rather it could apply to MIPS CQMs that the QCDR or qualified registry is approved to support. We encourage third party intermediaries to participate as a QCDR if they intend to self-nominate their own QCDR measures or use another QCDR's measures (with permission from the QCDR who owns the measure) or as a qualified registry if they plan to support their clients through the reporting of CQMs or eCQMs only. After consideration of public comments, we are finalizing these policies as proposed. (ii) Collaboration of Entities To Become a QCDR and Proposal To Extend Policy for Collaboration of Entities To Become a Qualified Registry (A) Background In the CY 2017 Quality Payment Program final rule (81 FR 77377), we finalized to allow collaboration of entities to become a QCDR based on our experience with the qualifying entities wishing to become QCDRs for performance periods.

We stated that we believed our previously finalized policy supporting entity collaboration should be continued under MIPS. Therefore, we discussed that an entity that may not meet the criteria of a QCDR solely on its own, but could do so in conjunction with another entity and would be eligible for qualification through collaboration with another entity. Additionally, we finalized at § 414.1400(b)(2)(ii), specifically for QCDRs, that if the entity uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the Start Printed Page 65547 responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period.

For example, an entity, such as a specialty society, that needs technical support may partner with an outside entity such as a health IT vendor to qualify as a QCDR. While entities, such as QCDRs, Health IT vendors, and qualified registries, can collaborate with external organizations, those entities could only do so to meet requirements to be a QCDR. We did not explicitly create a policy for entities to collaborate to meet the requirements to be a qualified registry. (B) Proposal To Extend to Qualified Registries We believe we should extend the previously finalized policy to apply to entities that wish to collaborate to become a qualified registry as well because extending this policy to qualified registries would also help smaller specialty societies that may not have the resources on their own to become a qualified registry.

This will allow those societies to be able to partner with other entities to meet the definition of a qualified registry. Therefore, in the CY 2022 PFS proposed rule, we proposed to revise and redesignate existing paragraph (b)(2)(ii) to new paragraph (b)(3)(ii) to state, if the entity seeking to qualify as a QCDR or qualified registry uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period. For example, an entity, such as a specialty society, that needs technical support may partner with an outside entity such as a health IT vendor to qualify as a qualified registry.

We solicited comments on this proposal. We did not receive public comments on this proposal, and therefore, we are finalizing it as proposed. (iii) Data Validation Audit and Targeted Audit Requirements (A) Information Required at the Time of Self-Nomination In the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367. 81 FR 77383 through 77384) we discussed our expectation for QCDRs and qualified registries to conduct validation on the data they intend to submit for the MIPS performance period.

We also discussed that the full self-nomination process would require the following. A submission of basic information, a description of the process the QCDR and qualified registry will use for completion of a targeted audit of a subset of data prior to submission, the provision of a data validation plan along with the results of the executed data validation plan by May 31 of the year following the performance period. Additionally, in the Quality Payment Program provisions in the CY 2021 PFS final rule (85 FR 84930 through 84937. 85 FR 84944 through 84947) at existing § 414.1400(b)(2)(iv) and (v), and (c)(2)(iii) and (iv), we finalized the data validation audit requirements as condition for approval.

While we did finalize the requirements for the data validation audits as condition for approval, we did not codify the requirements for QCDR and qualified registries to submit data validation plan during self-nomination along with the results of the executed data validation plan by May 31 of the year following the performance period. In order to provide clarification and to better align with the previously finalized policy (81 FR 77366 through 77367. 81 FR 77383 through 77384), we proposed to codify the following revisions. As stated in previous polices (81 FR 77366 through 77367;81 FR 77383 through 77384), QCDRs and qualified registries are required to submit the results of their data validation plan to CMS by May 31 of the year following the performance period.

Therefore, we proposed to codify at § 414.1400(b)(3)(v)(G)( 1 ) to state that QCDRs and qualified registries must conduct validation on the data they intend to submit for the applicable MIPS performance period, and provide the results of the executed data validation plan by May 31st of the year following the performance period. Furthermore, QCDRs and qualified registries are required to submit their data validation plan explaining their process of data validation submission annually during self-nomination, and it must be approved by CMS for before use. To provide further clarity and to better align with the existing policy (81 FR 77366 through 77367. 81 FR 77383 through 77384), we also proposed to codify a new requirement at § 414.1400(b)(3)(iv) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination, for CMS' approval, and may not change the plan once approved, without the prior approval of the agency.

As discussed above we proposed to codify at § 414.1400(b)(3)(iv) to provide further clarity to better align with previous policies. Therefore, we proposed to reorganize at § 414.1400(b)(2)(iv) though (viii) to better align with the above changes. We proposed with the following revisions. We proposed to revise and redesignate existing paragraph (b)(2)(iv) to paragraph (b)(3)(v) to state, that beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct annual data validation audits in accordance with this paragraph (b)(3)(v).

We proposed to revise and redesignate existing paragraph (b)(2)(iv)(A) to paragraph (b)(3)(vi)(A) to state that, if a data validation audit under paragraph (b)(3)(v) identifies one or more deficiency or data error, the QCDR or qualified registry must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year. We proposed to revise and redesignate existing paragraph (b)(2)(v) to paragraph (b)(3)(vi) to state that beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct targeted audits in accordance with this paragraph (b)(3)(vi). We proposed to revise and redesignate paragraph (b)(2)(vi) to paragraph (b)(3)(vii), to state for the CY 2023 performance period/2025 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for any of the CY 2017 through 2021 performance periods/2019 through 2023 MIPS payment years must submit a participation plan for CMS' approval. This participation plan must include the QCDR's detailed plans and changes to encourage eligible clinicians and groups to submit data on the low-reported QCDR measure for purposes of the MIPS program.

• We proposed to revise and redesignate existing paragraph (b)(2)(vii) to paragraph (b)(4)(viii) to state that beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. Start Printed Page 65548 The following is a summary of the comments we received and our responses. Comment. Several commenters expressed concerns about the “overly burdensome” nature and significant cost of the CMS data validation audit requirements for third party intermediaries.

One commenter expressed concerns with the randomized auditing resulting in an unintended consequence of increasing burden on small and mid-sized group practices because of the low number of participants reporting via the qualified registry as individuals. One commenter stated that the audit requirements are duplicative, unnecessary, and do not enhance data quality and validity because QCDRs already have rigorous internal data and quality standards. A few commenters stated that clinicians and registries were impacted by the buy antibiotics zithromax, specifically that dozens of audits were conducted and QCDRs and qualified registries have encountered practices struggling to collect and report data while a majority of their time and effort has been spent on responding to the buy antibiotics zithromax. Response.

While we understand that data validation requires a level of effort, time, and cost by the QCDRs and qualified registries, we disagree that this causes undue burden. While we acknowledge and appreciate the efforts and participation of all group practices of varying sizes including small and mid-sized groups, we believe it is important to hold all practices to the same standards for data validation audits to ensure that all data submitted is true, accurate, and complete. As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367. 81 FR 77383 through 77384), we expect that QCDRs and qualified registries would conduct validation on the data they intend on submitting for the MIPS performance period and provide the results of the data validation to CMS in the form of a data validation execution report by May 31st of the year following the performance period.

As noted in the CY 2017 PFS final rule (81 FR 77366 through 77367), we believe it is necessary to establish a requirement that QCDRs conduct data validation to ensure they are actively monitoring the data they submit to CMS for purposes of a pay-for-performance program. We also believe it is important for QCDRs to validate the data that they intend to submit to us for purposes of the MIPS program to ensure that the data submitted is true, accurate, and complete (85 FR 84936). We disagree that audit requirements are duplicative, unnecessary, and do not enhance data quality and validity because QCDRs already have rigorous internal data and quality standards. While we appreciate that many QCDRs already have rigorous internal data and quality standards, we are not asking QCDRs to duplicate work.

If QCDRs have their own auditing requirements, they can use the same auditing process or combine the efforts to reduce duplication as long as they meet the data validation requirements specified by the regulation at a minimum (81 FR 77366 through 77367. 81 FR 77383 through 77384). For example, if a QCDR already audits 10 percent of their data prior to submission for all performance categories, this would meet the 3 percent portion of the data validation requirement. Additionally, despite our requirements to have validation audits, each year there are still some QCDRs that submit inaccurate data.

As payment adjustments increase, this could adversely affect a practice with respect to their payment because these payment calculations were based on inaccurate data submitted to CMS. Furthermore, while we do acknowledge that the impact of the PHE for buy antibiotics may have affected some providers and registries ability to conduct audits due to practices struggling to collect and report data due to majority of their time and effort being spent on responding to the buy antibiotics zithromax, as stated above, we believe it is important to enforce the requirements for data validation audits to ensure all data submitted is true, accurate, and complete. We will continue to assess the implications of the PHE for buy antibiotics and will consider whether to make any policy changes in future rulemaking. Comment.

One commenter expressed that NCQA data validation alleviates the burden on health plans having to perform their own audit of data received from an HIE and on providers from having to respond to data requests from health plans. This commenter suggested that CMS leverage NCQA processes for data validation. Response. We thank the commenter for their suggestion.

We may consider it for future rulemaking. After consideration of public comments, we are finalizing these policies as proposed. (4) New Requirements Specific to QCDRs (a) Background We refer readers to § 414.1400(b), the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375), the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814), the CY 2019 PFS final rule (83 FR 59900 through 59906), the CY 2020 PFS final rule (84 FR 63058 through 63074), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (84937 through 84944) for where we previously finalized standards and criteria for QCDRs, specifically QCDR measure requirements. In this section, we proposed to update policies related to QCDR measure rejections.

(b) QCDR Measures (i) QCDR Measure Rejections (A) New QCDR Measure Rejection Criteria We refer readers to the Quality Payment Program provisions in the CY 2020 PFS final rule (84 FR 63070 through 63073) at § 414.1400(b)(3)(vii) where we have previously adopted QCDR measure rejection criteria. In the CY 2022 PFS proposed rule, we proposed to add two new criteria. (1) QCDR does not have permission to use a QCDR measure. And (2) QCDR not approved or not in good standing.

These are discussed in more detail below in this section. (aa) QCDR Does Not Have Permission To Use a QCDR Measure In the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814), we discussed that beginning with the 2018 performance period and for future program years, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. We noted that the QCDR measure owner (QCDR vendor) would still own and maintain the QCDR measure, but would allow other QCDRs to utilize their measure with proper notification. We intended for this policy to help reduce the number of QCDR measures that are similar in concept or clinical topic, or duplicative of other QCDR measures that are being approved.

Additionally, in the Quality Payment Program provisions in the CY 2020 PFS final rule (84 FR 63070 through 63073) at § 414.1400(b)(3)(vii), we finalized the QCDR measure rejection criteria considerations. We noted that these considerations would help to ensure that QCDR measures are meaningful and measurable. Although we finalized the QCDR measure rejection criteria, we did not codify that QCDRs may seek permission from another QCDR to use an existing measure that is owned by another QCDR. In order to provide further clarity to the existing policies (82 FR 53813 through 53814.

84 FR Start Printed Page 65549 63070 through 63073), we proposed to codify a new requirement and add a rejection criterion at § 414.1400(b)(4)(iv)(M) to state, a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. We solicited comments on this proposal. The following is a summary of the comments we received and our responses. Comment.

A few commenters supported the proposal to add the rejection criterion that “A QCDR does not have permission to use QCDR measure owned by another QCDR for the applicable performance period” because CMS currently allows QCDRs to seek permission from another QCDR to report on an existing measure that is owned by the other QCDR, and because if a QCDR would like to use an existing QCDR measure that is owned by another QCDR, it must obtain permission from the QCDR measure owner that it can use the measure for the performance period and include proof of such permission in its self-nomination application. Response. We thank the commenters for their support. After consideration of public comments, we are finalizing this policy as proposed.

(bb) QCDR Not Approved or Not in Good Standing Additionally, if a QCDR measure owner is not approved or is not in good standing, any QCDR measures associated with that QCDR would also not be approved. We believe it is important to have an approved QCDR measure owner for all approved QCDR measures. This would ensure that there is active involvement by the QCDR measure owner so that any potential measure issues can be mitigated during the specified MIPS performance period. For example, any mid-year guideline changes or measure questions would need to be immediately clarified to avoid negative impacts to clinicians such as the inability to construct a benchmark due to an error in the measure specifications.

Therefore, we proposed to codify another rejection criterion at § 414.1400(b)(4)(iv)(N) to state that, if a QCDR measure owner is not approved during a given self-nomination period, any associated QCDR measures with that QCDR would also not be approved. We solicited comments on this proposal. We have received inquiries from stakeholders on what can be done in circumstances when an active QCDR wishes to use an inactive QCDR's measure. We are interested in feedback from stakeholders on what should be done in such circumstances.

For example, what should happen if “QCDR A” is using “QCDR B's” measures in a given performance period and “QCDR B” is terminated mid performance period?. Alternatively, what if “QCDR A” is using a measure from “QCDR B” and “QCDR B” decides not to self-nominate for the subsequent performance period?. While “QCDR A” could partner with “QCDR B” as described at § 414.1400(b)(3)(ii), are there other policy options we should consider to minimize impact to the MIPS eligible clinician who has selected the QCDR measure for reporting?. We solicited comments on the above circumstances.

The following is a summary of the comments we received and our responses. Comment. A few commenters disagreed with the proposal to add a rejection criterion requiring permission to use an inactive QCDR's measures. One commenter stated that there is no evidence that inactive QCDRs are withholding access to these measures.

The commenter noted the ability of QCDRs to license measures allows QCDRs to ensure the appropriate use of their measures and incentivizes organizations to invest in developing new and improved measures. The commenter suggested that CMS should continue its policy that allows active or inactive QCDR measure owners to choose to license their measures only to QCDRs that have the experience and expertise to properly implement a measure in a particular specialty. Therefore, there is no reason to change CMS' current policy under which an active QCDR that wishes to use an inactive QCDR's measure can approach the inactive QCDR and the two QCDRs can negotiate an agreement regarding the transfer of ownership if the active QCDR has the appropriate experience and expertise in QCDR measure development. In the event that such agreement cannot be reached between the two parties, the inactive QCDR can decline to license rights to the QCDR measure.

One commenter suggested that CMS require that either there be an agreement between the two QCDRs to transfer ownership of the measure or that the initial QCDR should maintain their measures and license it to other QCDRs. Response. We thank the commenters for their comments and suggestions. We clarify that if a QCDR measure owner is not approved or is not in good standing, any QCDR measures owned or maintained with that QCDR would also not be approved.

We disagree that the proposal to add a rejection criterion requiring permission to use an inactive QCDR's measures is not supported by evidence that inactive QCDRs are withholding access to these measures. We note that there have been instances where active QCDRs have inquired about using QCDR measures of inactive QCDR measure stewards. We also disagree that this policy is not needed. We believe it is imperative that all QCDR measures in the MIPS program have an active QCDR measure steward to provide ongoing maintenance and updates to QCDR measures.

For example, recently, a QCDR who shares their measures with several other QCDRs discovered multiples discrepancies, including risk adjustment calculation issues. If they had not been an active QCDR and performing quality assurance on these QCDR measures, this issue would likely not have been discovered and resolved. We do agree that the ability of QCDRs to license measures allows QCDRs to ensure the appropriate use of their measures and incentivizes organizations to invest in developing new and improved measures. We also agree that active or inactive QCDR measure owners may choose to license their measures only to QCDRs that have the experience and expertise to properly implement a measure in a particular specialty.

Furthermore, this process is consistent with what CMS requires for all other measures available for all clinicians to report in the MIPS program (the non-QCDR measures). That is, every measure in the program needs an active measure steward that agrees to support and maintain the measure. A non-active QCDR cannot be compelled to meet this requirement. In this context, we interpret the commenter's reference to a “policy under which an active QCDR that wishes to use an inactive QCDR's measure can approach the inactive QCDR and the two QCDRs can negotiate an agreement regarding the transfer of ownership”, to apply to our statements regarding QCDR licensing as discussed in the CY 2018 PFS final rule (82 FR 53813).

There we noted that, beginning with the 2018 performance period and for future program years, a QCDR vendor may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. While we thank the commenter for the suggestion to require the transfer of ownership of a measure from an inactive QCDR to an active QCDR or that the inactive QCDR should maintain the measure and license it to active QCDRs, we note that such approaches are beyond the scope of our regulations, which in this case is limited to approval and disapproval criteria for QCDRs and Start Printed Page 65550 QCDR measures. We are considering building out additional policies to ensure that all QCDR measures that are used/owned are properly maintained throughout the performance period. After consideration of public comments, we are finalizing this policy as proposed.

(5) Remedial Action and Termination of Third Party Intermediaries We refer readers to § 414.1400(f), the CY 2017 Quality Payment Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 through 59910), the CY 2020 PFS final rule (84 FR 63077 through 63080), and the CY 2021 PFS final rule (85 FR 84930 through 84937) for previously finalized policies for remedial action and termination of third party intermediaries. In the Quality Payment Program provisions in the CY 2019 PFS final rule (83 FR 59908 through 59910), we discussed that the threshold for “inaccurate, unusable or otherwise compromised” may be met if the submitted data includes TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies that affect more 3 percent of the total number of MIPS eligible clinicians or groups for which data was submitted by the third party intermediary. We proposed to update the existing language at § 414.1400(f)(3)(ii) to broadly explain that it is up CMS' discretion on whether third party intermediaries' inaccuracies may lead to possible remedial action or termination. As discussed earlier, we proposed consolidating and redesignating the existing language at § 414.1400(f) as paragraph (e) and § 414.1400(g) as paragraph (f) to provide clarity and alignment with the aforementioned proposals to consolidate the duplicative criteria of QCDRs and qualified registries.

Therefore, we proposed to revise and redesignate existing language at § 414.1400(f)(3)(ii) to paragraph (e)(3) to state, contains data inaccuracies affecting the third party intermediary's total clinicians may lead to remedial action/termination of the third party intermediary for future program year(s) based on CMS discretion. We did not receive public comments on this policy, and therefore, we are finalizing it as proposed. I. Public Reporting on the Compare Tools Hosted by the U.S.

Department of Health &. Human Services (HHS) In the CY 2022 PFS proposed rule, we proposed to amend § 414.1395(c) to add a 1-year delay of publicly reporting new improvement activities and Promoting Interoperability measures and attestations reported via MVP. We also proposed a one-time, 1-year delay to subgroup-level public reporting, such that subgroup-level public reporting will begin with CY 2024 performance information available in 2025, and each year thereafter, on the Compare Tools hosted by the U.S. Department of Health and Human Services (HHS), referred to as “compare tool” throughout this final rule, available at https://www.medicare.gov/​care-compare/​ and data.medicare.gov, as technically feasible.

We proposed to add facility affiliations, beyond the hospital affiliations currently displayed on individual profile pages. Additional facility affiliations would include. Inpatient rehabilitation facilities (IRFs). Long-term care hospitals (LTCHs).

Skilled nursing facilities (SNFs). Inpatient psychiatric facilities (IPFs). Home health agencies (HHAs). Hospices.

And dialysis facilities. Finally, we solicited comments on publicly reporting utilization data on clinician and group profile pages (86 FR 39466 through 39469). For previous discussions on public reporting, we refer readers to the CY 2016 PFS final rule (80 FR 71116 through 71123), the CY 2017 Quality Payment Program final rule (81 FR 77390 through 77399), the CY 2018 Quality Payment Program final rule (82 FR 53819 through 53832), the CY 2019 PFS final rule (83 FR 59910 through 59915), the CY 2020 PFS final rule (84 FR 63080 through 63083), the CY 2021 PFS final rule (85 FR 84947 through 85 FR 84948) and the Care Compare. Doctors and Clinicians Initiative Page at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Compare-DAC.

(1) MVP and Subgroup Public Reporting The introduction of MVPs and subgroup reporting provides for new types of performance information that are available for public reporting, provided they meet the established public reporting standards at § 414.1395(b). In consideration of our MVP and subgroup performance information public reporting proposals, we wish to remind readers that all submitted MIPS performance information is available for public reporting (81 FR 77395 through 77397). Additionally, we previously finalized at § 414.1395(c) that, for each program year, CMS does not publicly report any first-year measures for the first 2 years, meaning any measure in its first 2 years of use in the quality and cost performance categories. We also note that MIPS performance category and composite final scores for MIPS eligible clinicians participating in MVPs will continue to be publicly reported as required under section 1848(q)(A)(i)(I) of the Act and finalized at § 414.1395(a)(1)(i).

We believe delaying public reporting of certain MVP and subgroup performance information provides a catalyst to encourage clinician participation in MVPs and subgroups while they familiarize themselves with these options. For this reason, we proposed, for individuals, groups, and subgroups reporting via MVP, to add a 1-year delay for publicly reporting new improvement activities and Promoting Interoperability measures and attestations, as technically feasible. This means that new improvement activities and Promoting Interoperability measures and attestations would be available for public reporting at their inception in traditional MIPS, but we would delay public reporting of new improvement activities and Promoting Interoperability measures and attestations by 1 year after inception for those reporting via MVP. We note that improvement activities and Promoting Interoperability measures and attestations that have already been in MIPS for more than 1 year and become newly available as part of an MVP would be available for public reporting in the first year the MVP is in the program.

That is, non-first year improvement activities and Promoting Interoperability measures and attestations that are newly part of an MVP would be available for public reporting in the first year the MVP is in the program (86 FR 39466 through 39467). Table 74 further clarifies when this 1-year delay would apply. Start Printed Page 65551 We recognized that under this proposal, we would be further delaying the release of performance information for improvement activities and Promoting Interoperability measures and attestations reported via MVP. Because of this, as a potential incentive, we also considered whether to delay public reporting of quality and cost measure information reported via MVP by 1 additional year, for a total of 3 years.

We solicited comments on our proposal to delay public reporting of new improvement activities and Promoting Interoperability measures and attestations reported via MVP by 1 year, as well as any feedback on alternate approaches we should consider spurring clinicians to report performance data on MVPs while making performance data available for patients on the compare tool. We proposed to amend this MVP public reporting policy at § 414.1395(c)(2) to state CMS does not publicly report any MVP data on new improvement activities or Promoting Interoperability measure, objective, or activity included in an MVP for the first year in which it is included in the MVP. We also proposed to amend § 414.1395(c)(1) to state that CMS does not publicly report any data on new quality or cost measure for the first 2 years in which it is in the program, after which CMS evaluates the measure to determine whether it is suitable for public reporting under § 414.1395(b). Currently, § 414.1395(c) refers to these quality and cost measures as “first year measures”.

We proposed to change “first year measures” to “new measures” (86 FR 39467). The introduction of MVPs and subgroup reporting in MIPS provides for new types of performance information that are available for public reporting, provided they meet the public reporting standards. Currently, we display information on profile pages at the individual clinician and group level, since this is the level of information we provide for and at which patients and caregivers search for on the compare tool. To ensure that patients and caregivers have access to subgroup performance information, we proposed creating a separate workflow from the established ones for individuals and groups, since we only display information at the level at which it was publicly reported (86 FR 39467).

That is, we only publicly report individual-level performance information on individual clinician profile pages and group-level performance information on group profile pages. We do not publicly report group-level performance information on individual profile pages or individual-level information on group profile pages, as doing so would not be truly representative of either the group's or individual's own performance, and we do not want to mislead website users. Instead, we would link from the individual or group profile page to the corresponding subgroup performance information. That is, we proposed to create a subgroup public reporting workflow, in which we would indicate with plain language on an individual profile page that the clinician reports performance information as part of a subgroup or on a group profile page that the group has subgroups for purposes of performance information and then link to that subgroup's performance information.

Future user testing would determine how to best display and put in plain language subgroup performance information. Subgroup performance information will also be available on http://data.medicare.gov/​. Subgroups represent a new type of reporting for MIPS, that is available for clinicians reporting on MVPs or via the APP. For this reason, we also proposed to delay all subgroup-level public reporting for 1 year, including measures, activities and attestations across the quality, cost, improvement activities, and Promoting Interoperability performance categories in order to encourage clinician participation in subgroups without the risk of displaying subgroup performance information as clinicians familiarize themselves with the option of subgroup reporting.

This would only be a one-time delay in public reporting of subgroup-level information. That is, we would not publicly report any CY 2023 subgroup-level measure, attestation, or activity performance information. This information would be available for public reporting beginning with CY 2024 performance period/2026 MIPS payment year. We would publicly report CY 2024 performance period/2026 MIPS payment year subgroup information and for each performance period thereafter if the information meets our established public reporting standards.

Since we are moving toward more granular level performance information, we believe delaying subgroup public reporting by 1 year provides an incentive for subgroup participation and experience. As an alternative, we also considered a 1-year public reporting delay of performance information for all new subgroups each performance year, as technically feasible. For example, subgroups that begin in CY 2023 are not eligible for public reporting until CY 2024, subgroups that begin in CY 2024 are not eligible for public reporting until CY 2025, and so on for each subsequent year. Another alternative we considered was to publicly report all subgroup performance information without delay and provide new subgroups the opportunity to opt-out, during the preview period, of having their performance information publicly reported for their first year.

Some subgroups may want to have their performance information publicly reported and having an overall 1-year delay may be a disincentive to subgroup participation. We solicited comments on these considerations. We noted that MIPS performance category and composite final scores for MIPS eligible clinicians participating in MVPs will continue to be publicly reported for those participating in subgroups, as required under section 1848(q)(A)(i)(I) of the Act and finalized at § 414.1395(a)(1)(i), and will not be delayed by 1 year for public reporting. We also solicited comments on additional factors that we should consider as we look to expand the availability of MVP and subgroup data on the compare tools.

For example, Start Printed Page 65552 should there be a certain threshold of MVPs available, or clinicians participating in MVPs prior to public reporting?. For public reporting of subgroups, are there factors we should consider to make this information usable to the patient but reflective of the subgroups characteristics and composition?. Should we test an indicator of MVP participation for compare tool profile pages to see if this is useful information for patients making healthcare decisions?. We solicited comments on this proposal and additional ways public reporting may encourage MVP participation.

The following is a summary of the comments we received and our responses. Comments. Several commenters supported the proposal to delay, by 1 year, the public reporting of new improvement activities and Promoting Interoperability measures attestations reported through MVPs. One commenter requested clarification as to why new Promoting Interoperability measures and attestations would be delayed only for MVP participants.

While some commenters supported the delay, they recommended extending the delay beyond 1 year. Two commenters stated a concern that delaying public reporting for MVPs and not traditional MIPS may be confusing for patients. One of the commenters recommended adding a note to profile pages explaining why there may not be performance information. The same commenter also recommended that instead of delaying public reporting for MVPs, CMS should allow MVP participants to opt-out of public reporting for their first year.

Another commenter recommended beginning public reporting MVP performance information only once MVP reporting becomes mandatory. Response. We agree with most commenters that a 1-year delay of new improvement activities and Promoting Interoperability measures and attestations is an appropriate way to incentivize participation in MVPs. We also want to clarify that we proposed this 1-year delay as an incentive because new quality and cost measures already have a delay in public reporting for the first 2 years of use for clinicians in traditional MIPS.

This delay is for new improvement activities and Promoting Interoperability measures, objectives, and activities in all MVPs whether they are new or existing MVPs. We appreciate the recommendations to extend the delay beyond 1 year, to allow MVP participants to opt-out of public reporting in their first year, and to only publicly report performance information reported via MVPs once MVP reporting becomes mandatory. We do believe that a 1-year delay is enough time to allow clinicians to familiarize themselves with MVPs as we do not want to further delay valid performance information that consumers can use to make informed healthcare decisions. It is for this same reason that we do not want to have MVP participants opt-out of public reporting or to delay public reporting of performance information reported via MVPs until MVP reporting becomes mandatory.

We also want to clarify that performance information available via MVPs is the same as the performance information available in traditional MIPS and that we are required to publicly report performance information submitted by MIPS eligible clinicians. We do not believe that a delay for MVP participants and not traditional MIPS will be confusing to website users. Under traditional MIPS, we delay public reporting of new quality and cost measures by 2 years, and this has not caused any confusion to date. We also clarify that improvement activities and Promoting Interoperability measures and attestations that are already in traditional MIPS will be available for public reporting without any 1-year delay.

After consideration of public comments, we are finalizing this policy as proposed. Comment. Several commenters supported the one time, 1-year delay of subgroup public reporting, such that subgroup public reporting will begin with the availability of CY 2024 performance period/2026 MIPS payment year performance information. One commenter recommended extending the delay to 3 years.

Response. We agree that a one-time 1-year delay is enough time for participants to familiarize themselves with this subgroup-level reporting. We also clarify that CY 2023 performance period/2025 MIPS payment year subgroup-level measure, attestation, or activity performance information across all MIPS performance categories would not be available for public reporting. We would begin publicly reporting subgroup-level performance information with CY 2024 performance period/2026 MIPS payment year, which would be available for public reporting in CY 2025.

After consideration of the public comments, we are finalizing this policy as proposed. After consideration of all of the public comments received on MVP and subgroup public reporting, we are finalizing all policies in this section as proposed. We did not receive any public comments on the proposal to create a separate subgroup workflow, and therefore, are finalizing it as proposed. (2) Publicly Reporting APM Performance Pathway Information In the CY 2021 Quality Payment Program final rule, we finalized to establish an APM performance pathway (APP) beginning in the 2021 MIPS performance year.

This is an optional MIPS reporting and scoring pathway for MIPS eligible clinicians who participate in MIPS APMs. We also note that since APP participants are MIPS eligible clinicians, their MIPS performance category and composite final scores will be publicly reported as required under section 1848(q)(A)(i)(I) of the Act and finalized at § 414.1395(a)(1)(i). In the CY 2017 Quality Payment Program final rule, we finalized, as technically feasible, to use ACO profile pages as a guide to publicly reporting more APM data (81 FR 77398). Currently, groups who participate in an ACO have an indicator showing their participation, as well as a link to the ACO profile page with available performance information.

User testing has shown that website users find the ACO information meaningful and displayed in a user-friendly way. For this reason, we plan to continue this approach for APM performance information, including that which comes in via the APP, as technically feasible. We also solicited comments on alternative ways to publicly report performance information reporting via APPs and additional considerations to publicly reporting this information (86 FR 39467). We did not receive public comments on alternative ways to publicly report performance information reported via APPs or any additional considerations to publicly reporting this information.

(3) Facility Affiliations Compare tool profile pages for clinicians currently provide demographic information, including names, addresses, phone numbers, medical specialties, APM affiliations, Medicare assignment status, board certifications, education and residency, gender, and group and hospital affiliations. User testing consistently shows that Medicare patients and caregivers find value in these types of information. For hospital affiliations, website users have consistently noted the importance of understanding up front the relationships clinicians may have with facilities where they perform services when searching for a clinician. Specifically, patients and caregivers have noted during user testing that hospital affiliation is important to them, Start Printed Page 65553 since they may be looking for a clinician to perform a procedure at a hospital or want to know the hospitals a clinician could potentially admit them if needed.

Linking from the clinician profile page to their affiliated hospital page has provided a seamless experience for patients and caregivers, as they do not need to separately search for clinicians and hospitals. Rather, they can navigate to a hospital profile page directly from the clinician's profile page. With these user testing findings in mind, and because the Compare Tools include information on a number of other types of facilities beyond hospitals, we believe it would benefit patients and caregivers to also be able to navigate from clinician profile pages to profile pages for other types of facilities such as. IRFs.

Hospices. And dialysis facilities (86 FR 39468). Expanding the types of clinician-facility affiliations, beyond hospital affiliation, publicly reported would allow us to provide additional information about clinicians with or without any hospital affiliation but who are affiliated with other types of facilities. User testing with patients and caregivers has shown that facility affiliations not only for hospitals but also for IRFs, LTCHs, SNFs, IPFs, HHAs, hospices, and dialysis facilities would be helpful to their healthcare decision-making.

Specifically, we proposed adding affiliations to clinician profile pages for each of the following types of facilities, pending the results of user testing, as applicable and technically feasible. IRFs. LTCHs. SNFs.

IPFs. HHAs. Hospices. And dialysis facilities.

User testing will determine how to best display these affiliations on compare tool clinician profile pages. To determine clinician affiliations to these facilities, we would use claims data the same way we do to display the hospital affiliations currently available on clinician profile pages (77 FR 69165). We build the clinician-hospital affiliations based on observing a clinician practicing at a given hospital caring for at least three different Medicare patients on three different dates of service in the preceding 6 months, as documented in Medicare claims. We would use similar criteria for determining additional facility affiliations.

Clinicians can email the Quality Payment Program Service Center at http://www.QPP@cms.hhs.gov if they believe their facility affiliations are displayed incorrectly. We solicited comments on the proposal to add affiliations to clinician profile pages for each of the following types of facilities and link to the specific facility's page on the compare tool. IRFs. LTCHs.

And dialysis facilities. Further, we also solicited comment on whether there should be a limit on the number of procedures done or conditions treated at a given facility to determine clinician-facility affiliations. The following is a summary of the comments we received and our responses. Comments.

Several commenters supported adding facility affiliations beyond hospital affiliations to clinician profile pages on the compare tools. Specifically, these commenters supported the addition of affiliations for all facilities proposed, including IRFs, LTCHs, SNFs, IPFs, HHAs, hospices, and dialysis facilities. One commenter also recommended including clinicians' role as SNF medical directors on their profile pages. A few commenters noted concern, with two of these commenters opposing the proposal, related to the threshold for determining facility affiliations and how CMS would handle a clinician with multiple affiliations.

These commenters believed that the three different Medicare patients on three different dates of service in the preceding 6 months threshold may be too low for determining facility affiliations. One of the commenters recommended CMS conduct user testing to determine how consumers react when a clinician is affiliated with multiple facilities or with a facility that has poor quality ratings. Another commenter requested clarification on how we plan to obtain and verify facility affiliation and noted concern about location and specialty accuracy. Response.

We agree with commenters that adding affiliations to facilities beyond hospitals, on clinician profile pages, will aid patients in making healthcare decisions. We currently do not have a mechanism or source of data for verifying medical director or other healthcare administrative roles in SNFs or other types of care settings. Rather, if the clinician has filed a claim, it is because that clinician is actively treating patients and furnishing healthcare services, even if they also have an administrative role. We would not have information to report for a medical director or other healthcare administrator unless they have filed a claim.

We understand the commenters concern and will explore alternative data sources that are found to be reliable. Regarding the concern about a clinician having multiple affiliations, we have user tested clinician profile pages that display multiple facility affiliations and have found that if a clinician has multiple affiliations, beneficiaries and their caregivers consider it important for them to know when making healthcare decisions. We also want to note that the threshold for determining facility affiliations has been reliable for determining the hospital affiliations that are currently on clinician profile pages, which is why we proposed using this threshold for the additional facility affiliations. We will continue to monitor this process as we expand using our currently methodology to affiliate other settings of care to clinicians.

In response to questions regarding how we plan to obtain and verify facility affiliation, we plan to determine additional facility affiliations by using claims data in the same way we determine the hospital affiliations currently on clinician profile pages. This analysis includes reviewing claims for clinicians practicing at a given facility caring for at least three different Medicare patients on three different dates of service in the preceding 6 months, as documented in Medicare claims. Clinicians can email the Quality Payment Program Service Center at http://www.QPP@cms.hhs.gov with the correct information if they believe their facility affiliations are displayed incorrectly, as they do today for hospital affiliation. We would then manually edit the affiliation on the website.

This manual edit would remain in effect for 6 months only. To ensure a more permanent change, clinicians must update their information in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS). For more information, clinicians can visit the Care Compare. Doctors and Clinicians Initiative Page at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Compare-DAC.

Regarding the accuracy of clinician specialty and location, we note that this information is obtained from the PECOS. We rely on clinicians to ensure that their information in PECOS is up to date to ensure the most accurate information is publicly reported. After consideration of public comments, we are finalizing this policy as proposed. (4) Utilization Data Request for Information Under section 104(e) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), beginning with 2016, the Secretary is required to integrate utilization data information on Start Printed Page 65554 Physician Compare.[] To satisfy section 104(e) of the MACRA, we previously implemented a policy to begin to include utilization data in a downloadable format in late 2017 using the most currently available data, and previously finalized that the specific codes to be included will be determined via data analysis and reported at the eligible clinician level (80 FR 71130).

We finalized to continue to include utilization data in the downloadable database (81 FR 77398). This information continues to be available today on www.data.cms.gov/​provider-data. To date, we have gathered utilization data for procedures from physician/supplier Medicare Part B non-institutional claims on certain services and procedures and published it in the public use file (PUF) file entitled “Physician and Other Supplier Data.” These data are useful to the healthcare industry, healthcare researchers, and other stakeholders who can accurately interpret these data and use them in meaningful analyses. However, this information is presented in a technical way that is not easily accessible or usable by patients, who do not frequently visit data.cms.gov or understand medical procedure coding.

This information also does not provide detail on the specific conditions clinicians treat, though in select cases it may be inferred by the clinicians and researchers reviewing this information. Section 10331(b)(3) of the Affordable Care Act requires that for public reporting, to the extent practicable, to include processes to assure that the data made available provides a robust and accurate portrayal of a clinician's performance. In our efforts to continue to provide patients and caregivers with meaningful information to make informed healthcare decisions, we believe utilization data may also have a place on clinician and group profile pages, if presented in a consumer-friendly way. We envision utilization data on patient-facing profile pages providing two main areas of benefit.

The first is allowing for more granular clinician searches, so that patients not only find specific types of clinicians but also those clinicians experienced in performing specific types of procedures and/or treating specific conditions. The second is providing categories of utilization data in a more plain language display that is usable to patients and their caregivers. In summary, utilization data could provide information to Medicare patients and their caregivers on the specific diagnoses clinicians treat and the frequency with which certain services or procedures are performed by a clinician or group and/or which types of clinicians do not provide certain services. For example, someone with severe arthritis of the knee may want to search for an orthopedic surgeon who specifically does knee replacements.

The way the clinician search works currently would only show results for “orthopedic surgeons” generally. That is, the patient would not see which of these clinicians specialize in this procedure, and likely would need to spend time calling clinicians to ascertain more detail. This could similarly be the case for finding a clinician who focuses on treatment of a certain condition. We believe indicating which clinicians focus on certain procedures or conditions would relieve some of this patient burden, as it would yield more specific search results.

There are a number of factors that could influence how procedure- and condition-specific information is determined, which is why we solicited comments on this topic in several areas. For display purposes, we may wish to apply a minimum experience level, such as the number of times a clinician performed a procedure or treated a condition, before a clinician profile is annotated to indicate experience with the condition or procedure. Regarding the methods in which we would identify clinician volume of procedures conducted or treat specific conditions, we would need to set a threshold for making these assertions. We have considered several options.

The threshold could be based on the number of times a clinician has performed a procedure or treated a condition within a certain time-period, or the proportion of the clinician's practice that is represented by the procedure or condition. Alternatively, thresholds may be devised based on ranking clinicians compared to their peers (specialty and geography may be considered when defining peers) in volume of procedures performed or frequency with which they treat each condition. We note also that these approaches utilize Medicare claims data only. That is, these data would not include procedures performed or conditions treated for patients who have other types of insurance, since this information is not available.

We also acknowledge that this utilization data only represents the care provided to Medicare beneficiaries and clinicians offer care to those with other forms of insurance. This disclaimer could be added to any data that may be publicly reported. We solicited comments on these approaches and whether there are any additional ones we should consider. Additionally, because the Compare Tools utilize a location-based search, national or local thresholds may be appropriate.

For example, clinicians in urban centers may specialize in a small number of procedures that they perform on a weekly basis, while a clinician in a rural area might be the most experienced at a given procedure, but not have comparable volume to the urban clinician who practices a very narrow scope. We solicited comments on these considerations, as well as if there are others. We also solicited comments on the potential types of utilization data that, if publicly reported, could help Medicare patients and their caregivers make informed healthcare decisions, as well as on technical considerations for presenting a specific affiliation between clinicians and diagnoses and/or procedures. Specifically, we solicited comments on.

The types of conditions and procedures that would most benefit patients' clinician searches. Important features and considerations for clinician searches by conditions or procedures. The lookback period for Medicare claims in order to identify a clinician's volume of procedures balancing frequency with recent experience (for example, 6 months, 1 year, 2 years). Clinician specialties or conditions with special considerations (for example, non-patient facing clinicians).

The maximum number of conditions treated or procedures performed to display on a given clinicians profile page. And Methods to set a threshold of treatment volume to display that a clinician commonly performs a procedure or treats a condition. For example, the threshold could be. (1) The number of times a clinician treated a condition or performed a procedure.

(2) the total scope that a condition or treatment represents in a clinician's practice. Or (3) the clinician's rank—either overall among all clinicians or among a subset of clinicians—in the number of times that clinician treated a condition or performed a procedure. Any other factors or considerations not listed above. We received public comments on considerations for publicly reporting utilization data.

We thank the commenters' feedback and will take these comments into consideration in future years. Start Printed Page 65555 4. Overview of the APM Incentive (a) Overview Under the Quality Payment Program, eligible clinicians who are Qualifying APM Participants (QPs) for a year are eligible to receive an APM Incentive Payment in the corresponding payment year for payment years 2019 through 2024. In the CY 2017 Quality Payment Program final rule (81 FR 77480 through 77489), we finalized at § 414.1450(d) that this payment is made based on the clinician's QP status in the QP Performance Period that is 2 years prior (for example, the 2021 payment will correspond to the 2019 performance year), and at § 414.1450(b)(1) that the payment is equal to 5 percent of the estimated aggregate payments for covered professional services in the base period (the year between the QP performance and payment years).

We also finalized at § 414.1450(c)(1) (82 FR 31729) that the APM Incentive Payment will go to the TIN associated with the Advanced APM Entity through which an eligible clinician becomes a QP during the QP Performance Period. In 2019, our first year of making APM Incentive Payments, we learned that the amount of time between the QP Performance Period (during which QP status is attained) and the QP payment year (during which APM Incentive Payments are issued) creates challenges to disbursing the payment for some QPs in a routine and efficient manner, for example for QPs who may have changed practices in the interim. Consistent with section 1833(z) of the Act, QP status is determined for, and connected to, an eligible clinician (identified by their NPI) for the QP payment year based on their Advanced APM participation during the QP Performance Period. In the proposed rule, we stated that we do not believe that changes in a QP's practice or TIN in the interim year between the QP determination and the QP payment year should affect a QP's ability to receive the APM Incentive Payment.

To address some of the unanticipated challenges we encountered in disbursing the APM Incentive Payments, in the CY 2021 PFS final rule, we finalized a hierarchy, codified at § 414.1450, that, based on our experience and lessons learned in making payments in 2019, provides more ways to identify an appropriate TIN to which we can make the APM Incentive Payment when a QP has experienced changes in their practice or TIN since the performance year in which they attained QP status. (c) APM Incentive Payment Recipient In the 2021 PFS final rule (85 FR 84472), we revised our approach to identifying the TIN or TINs to which we make the APM Incentive Payment and established a process that enables QPs to provide CMS with updated enrollment information that could be used to complete the payment in the event our approach does not yield an appropriate TIN or TINs to which to send their APM Incentive Payments. The process for those QPs to update their information, as well as a preliminary list of NPIs to whom it may be applicable, is included in a public notice published annually in the Federal Register. We explained in the CY 2021 PFS final rule that the revised approach would involve looking at a QP's relationship with TINs at different, specified periods in time, as well as considering the relationships such TINs have with certain APM Entities and Advanced APMs.

We stated that we believe this revised approach enables us to more appropriately identify TINs with which QPs currently have relationships to receive other Medicare payments, and through which the QPs likely would anticipate receiving their APM Incentive Payments. We noted that, when the QP is no longer affiliated with the TIN through which they achieved QP status, this approach will prioritize identifying an alternate TIN with which the QP is affiliated at the time the APM Incentive Payment is made, and to which it is appropriate to make the payment. The approach we adopted also serves to reduce uncertainty for QPs as they anticipate the APM Incentive Payments, as well as potential delays in our ability to make their payments. To improve and expand the ways we identify the TIN(s) to which we make the APM Incentive Payment for a QP in a timely and efficient manner, we finalized a policy to sequentially apply a decision hierarchy and codified the hierarchy in § 414.1450(c).

We apply the hierarchy by beginning at the first step, and if we are unable to identify one or more TINs with which the QP has a current affiliation at this step, we move to the next and successive steps of the hierarchy until we do identify one or more TINs with which the QP is affiliated. As discussed in the CY 2021 PFS final rule, if we identify more than one TIN at the applicable step in the hierarchy, we divide the APM Incentive Payment proportionally between the QP's TINs based on the relative paid amount for Part B covered professional services that are billed through each of the TINs. We proposed to clarify that, when we divide the APM Incentive Payment between two or more TINs, we apportion the APM Incentive Payment among TINs based on the share of total payments for covered professional services made to each TIN in the same base year that we use to calculate the APM Incentive Payment for the year. To calculate the APM Incentive Payment, we sum the total estimated aggregate payments for covered professional services for a QP for the base year, which is based on claims submitted for covered professional services, as codified at § 414.1450(b)(1) through (3).

We proposed to codify this policy at § 414.1450(c). In the course of making APM Incentive Payments during CY 2020 PFS final rule, we explored the possibility of expanding our search at each step of the hierarchy at § 414.450(c) to identify potential payee TINs that are associated with the QP during the QP payment year. Based on our findings, we stated we believe expanding our search in this way would enable us to make payments earlier in the calendar year and reduce the number of QP NPIs for whom we cannot identify a payee TIN using our hierarchy, and thus, rely on our public notice to request additional information. Therefore, we proposed to revise the hierarchy at § 414.1450(c) so that, using the criterion described in each step of our current regulation, we would first seek to identify a TIN associated with the QP during the base year, and if no such TIN is identified in the base year, we would then seek to identify a TIN associated with the QP during the payment year.

We have found in many instances that there are changes in enrollment information in PECOS for a QP over the span of 2 years between the QP performance period and payment year. By using enrollment information for the QP during the payment year, we are more likely to identify an appropriate TIN to which to make the APM Incentive Payment hierarchy. Under the proposal, applying the steps in the APM Incentive Payment hierarchy, we would make the APM Incentive Payment to one or more solvent TINs associated with the QP, identified by paid Medicare Part B claims for covered professional services and associated PECOS enrollment information during the base period. And if no such TIN is identified, we will make the payment to such TINs associated with the QP during the payment year.

We proposed to codify this policy in the regulation at § 414.1450(c). If no such TIN or TINs can be identified at a particular step, we will Start Printed Page 65556 move to the next and successive steps listed in § 414.1450(c)(1) through (8) until we identify one or more solvent TINs with which the QP is associated, and then would make the APM Incentive Payment to any such TIN(s). If more than one TIN is identified at a step based on paid claims during the applicable year either the base year or payment year, as we explain earlier and proposed to codify in the regulation under § 414.1450(c), would divide the APM Incentive Payment proportionately among such TINs according to the relative total paid amounts for Part B covered professional services to each TIN in same the base year we use to calculate the APM Incentive Payment. We proposed, for each step in the APM Incentive Payment decision hierarchy, we would first search for a payment TIN or TINs associated with the QP during the base period.

If no such TIN is found during the base year, we would search for any TIN or TINs that are similarly situated with respect to the criterion at that step in the hierarchy and associated with the QP during the payment year. If such a TIN or TINs are found, we would make the APM Incentive Payment to such TIN or TINs. We will continue at each step in the hierarchy to first attempt to identify the relevant base year TIN or TINs associated with the QP because, as noted in the proposed rule, we believe such TINs are more likely to be associated with the APM Entity through which the QP attained their QP status during the QP performance period. However, if no such TIN is found in the base year, we would proceed at that step to search for a TIN or TINs with which the QP is associated in the payment year.

We explained that we believe this approach creates the greatest opportunity to identify and pay an appropriate TIN as efficiently and early as possible during the payment year. The proposed change would maintain the current hierarchy while adding a sub-step at each level in which we would conduct our search based on more current enrollment information. The proposed change would allow for the identification of an appropriate TIN or TINs at each step by first checking the base year, and then checking the payment year before moving on to the next step in the process. We stated we believe that by maintaining the current hierarchy we would continue to incent Advanced APM participation by prioritizing making payments to TINs affiliated with Advanced APMs, even if they are not in the same Advanced APM Entity through which QP status originally was achieved.

For example, we stated that we anticipate that many eligible clinicians who earned QP status in 2020 through a practice participating in the CPC+ model will join the new Primary Care First (PCF) model in 2022. In the event the eligible clinician's CPC+ participant TIN is no longer active, our proposed modification to the hierarchy would enable us to pay the APM Incentive Payment to a TIN participating in the PCF model in 2022. We stated that we continue to believe it would be appropriate to first identify the relevant base year TIN or TINs at each step in of the hierarchy because we believe those TINs are more likely to be associated with the APM Entity through which the QP attained their QP status during the QPs performance period. However, if no TIN is found in the base year, we would proceed to identify any TINs associated with the QP in the payment year, and then use the same process for the subsequent steps in the hierarchy until we identify one or more TINs associated with the QP at a particular step for a particular year (base year or payment year).

We explained that we believe this approach will be a more efficient and expeditious way to identify a TIN or TINs to which to make the APM Incentive Payment for QPs. We solicited comments on this proposal to amend our APM Incentive Payment decision hierarchy to include an additional attempt to identify and pay, at each step, one or more solvent TINs associated with the QP during the payment year when no such TIN is identified for the QP in the base year. We received several comments on this proposal. Comment.

We received many public comments in support of this approach to identifying payee TINs during the payment year. Response. We thank commenters for their support of this policy. Comment.

We received two public comments advocating that the APM Incentive Payment should be paid directly to the ACO or APM Entity. Response. We disagree with this comment for several reasons. First, the APM Incentive Payment is not earned by the APM Entity in the way a shared savings payment may be earned by the ACO under the Shared Savings Program.

Although QP determinations are in some cases are made at the APM Entity group level, QP status is conferred on an individual eligible clinician. As a result, the individual QP is excluded from the MIPS reporting and payment adjustment requirements, and it is the QP who earns the APM incentive payment. Therefore, the payment is disbursed for the eligible clinician who is a QP to a TIN that is affiliated with the QP, even in instances where the QP is no longer affiliated with the APM Entity. The payment is designed as an incentive in lieu of the pursuance of a MIPS payment adjustment.

CMS makes the APM Incentive Payment to one or more TINs to which the QP has reassigned their billing rights. Thus, the QP and TIN may resolve between themselves the handling of the APM Incentive Payment. Some APM Entities are the same as the Medicare enrolled TIN to which QPs have reassigned their Medicare payment rights, and to which we would make the APM Incentive Payment. Other APM Entities, such as ACOs, are not.

For these reasons, we do not make the APM Incentive Payment directly to an ACO, and we do not believe it would be appropriate to do so. Comment. One commenter suggested that we should allow QPs to individually identify their preferred payee TIN to receive the APM Incentive Payment. Response.

It would not be practically feasible for every QP to individually identify a recipient TIN for the QP incentive payment. Our experience working with PECOS and other voluntary systems, including our annual public notice, indicate that requiring individual eligible clinicians to elect a recipient TIN for the incentive payment could cause significant delays in completing the payments. These delays would be of such duration that CMS would likely miss the statutory deadline of December 31 of the payment year in which we are required to have completed these payments. Further, some QPs might never complete the prerequisite step, which would make it difficult if not impossible to disburse APM Incentive Payments for them.

Moreover, eligible clinicians are not without an opportunity to indicate to CMS the TINs with which they have current billing arrangements. In fact, all Medicare enrolled eligible clinicians are required to update their billing information, including reassignments within the PECOS system within a specified timeframe. By ensuring PECOS is updated at all times, eligible clinicians have an opportunity to ensure that if they become QPs for a year, the APM Incentive Payment will be received by a TIN to which they have reassigned their billing rights. We believe it is both appropriate and efficient for clinicians to use the longstanding and required processes that are in place to update their billing information, which enables us to identify one or more appropriate TINs to which to make the APM Incentive Payment.

Finally, we have established in regulations a payment decision Start Printed Page 65557 hierarchy that specifies how we will identify the TIN or TINs to which we will distribute the APM Incentive Payment. One of the main purposes for establishing this hierarchy and for updating it this year is to provide predictability for eligible clinicians regarding the APM Incentive Payment disbursements. After consideration of the public comments, we are finalizing our proposed update to the APM Incentive Payment decision hierarchy, and amending our regulation at § 415.1415(c), as proposed. C.

Advanced APMs 1. Qualifying APM Participant Determination a. General Overview In the CY 2017 Quality Payment Program final rule (81 FR 77439 through 77445), we finalized our policy at § 414.1425(b) for Qualifying APM Participant (QP) determinations. For the purposes of making QP determinations, an eligible clinician must be present on the Participation List of an APM Entity in an Advanced APM on one of the “snapshot dates” (March 31, June 30, or August 31) for the QP Performance Period.

An eligible clinician included on a Participation List on any one of such dates is included in the APM Entity group even if that eligible clinician is not included on that Participation List at one of the prior- or later-listed dates. We perform QP determinations for the eligible clinicians in an APM entity group three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP snapshot dates. An eligible clinician can be determined to be a QP only if the eligible clinician appears on the Participation List on a snapshot date that we use to determine the APM Entity group and to make QP determinations at the APM Entity group level based on participation in the Advanced APM. For eligible clinicians who appear on a Participation List in more than one APM Entity, but do not to achieve QP status based on any APM Entity level determinations, we make QP determinations at the individual level as described in § 414.1425(c)(4).

Likewise, for eligible clinicians on an Affiliated Practitioner list for an Advanced APM we make QP determinations at the individual level three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination snapshot dates as described in § 414.1425(b)(2). B. QP Thresholds and Partial QP Thresholds Section 1833(z)(2)(B) of the Act describes the thresholds for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year. The Medicare Option, based on Part B payments for covered professional services or counts of patients furnished covered professional services under Part B, has been applicable since payment year 2019.

The All-Payer Combination Option, which uses the Medicare Option, as well as an eligible clinician's participation in Other Payer Advanced APMs, is applicable beginning in the payment year 2021. In the CY 2017 Quality Payment Program final rule (81 FR 77433 through 77439) we finalized our policy for the Medicare Option as codified at § 414.1430(a) and for the All-Payer Option at § 414.1430(b). Section 114 of Division CC of the CCA amended section 1833(z)(2)(B) of the Act with regard to payment years 2023 and 2024 (which correspond respectively to performance years 2021 and 2022), by freezing for such years the applicable payment amount and patient count thresholds for an eligible clinician to achieve QP status. Specifically, the CAA amended section 1833(z)(2)(B) of the Act to continue the QP payment amount thresholds that apply in payment years 2021 and 2022 to payment years 2023 and 2024.

Additionally, the CAA amended section 1833(z)(2)(D) of the Act to require that, for payment years 2023 and 2024, the Secretary use the same percentage criteria for the QP patient count threshold that are applied in payment year 2022. As such, the Medicare Option QP thresholds for payment years 2023 and 2024 (performance years 2021 and 2022) will remain at 50 percent for the payment amount method and 35 percent for the patient count method. The CAA also amended section 1848(q)(1)(C)(iii) of the Act to extend through payment year 2024 the Partial QP thresholds that are established for payment years 2021 and 2022. Therefore, the Partial QP thresholds for payment years 2023 and 2024 (performance years 2021 and 2022) will remain at 40 percent for the payment amount method and 25 percent for the patient count method.

For performance years beginning with 2023 (corresponding to payment years beginning with 2025) the statute prescribes the QP thresholds for the payment amount method, and the QP thresholds we established for the patient count method at § 414.1430 will take effect. Specifically, for performance years beginning with 2023, the Medicare Option QP thresholds will be 75 percent for the payment amount method and 50 percent for the patient count method. The Partial QP thresholds under the Medicare Option will be 50 percent for the payment amount method and 35 percent for the patient count method. Under the All-Payer Combination Option, the QP thresholds for performance years 2021 and 2022 (corresponding to payment years 2023 and 2024) will be 50 percent for the payment amount method and 35 percent for the patient count method.

The Partial QP thresholds for performance years 2021 and 2022 will be 40 percent for the payment amount method and 25 percent for the patient count method. In order to become a QP through the All-Payer Combination Option, eligible clinicians must first meet certain threshold percentages under the Medicare Option. For performance years 2021 and later (corresponding to payment year 2023 and later), the minimum Medicare Option threshold an eligible clinician must meet for the All-Payer Combination Option is 25 percent for the payment amount method or 20 percent under the patient count method. Start Printed Page 65558 Although we included proposed amendments to our regulation at § 414.1430(a)(1) and (2) in the CY 2022 PFS proposed rule to reflect the changes made by the CAA to the QP and Partial QP Thresholds under the Medicare Option payment amount method, we inadvertently neglected to discuss those proposed amendments in the preamble.

Additionally, we inadvertenly did not include proposed regulation text at § 414.1430(a)(3) or (4) to reflect the amendments made by the CAA to the QP and Partial QP thresholds under the Medicare Option patient count method. Or to the regulation text at § 414.1430(b) to reflect amendments to the All Payer Option payment amount and patient count QP and Partial QP thresholds. However, we believe it is preferable to revise the regulation text to consistently and accurately reflect the statutory threshold percentages for each year in accordance with the CAA amendments for both the Medicare Option and All Payer Option and for both the payment amount and patient count methods for each of the options. Therefore, we are finalizing the proposed amendments to § 414.1430(a)(1) and (2) and making amendments to § 414.1430(a)(3) and (4).

And § 414.1430(b)(1) through (4) to reflect the applicable statutory threshold percentages as amended by the CAA. We received four public comments, all in support of the statutory changes to the QP and Partial QP threshold levels. We thank the commenters for their input and will implement the amendments made by the CAA as discussed and revise the regulation at § 414.1430 as proposed. V.

Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ), we are required to publish a 60-day notice in the Federal Register and solicit public comment before a “collection of information” requirement is submitted to the Office of Management and Budget (OMB) for review and approval. For the purposes of the PRA and this section of the preamble, collection of information is defined under 5 CFR 1320.3(c) of OMB's implementing regulations.

To fairly evaluate whether an information collection should be approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our burden estimates. The quality, utility, and clarity of the information to be collected.

Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques. We solicited public comment on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements. A. Wage Estimates To derive average costs, we used data from the U.S.

Bureau of Labor Statistics' May 2020 National Occupational Employment and Wage Estimates for all salary estimates ( http://www.bls.gov/​oes/​current/​oes_​nat.htm ). In this regard, Table 76 presents the mean hourly wage, the cost of fringe benefits and overhead (calculated at 100 percent of salary), and the adjusted hourly wage. Start Printed Page 65559 For the CY 2019 and CY 2020 PFS final rules, we used the BLS wage for “Physicians and Surgeons” (occupation code 29-1060) to estimate the cost for Physicians. In BLS' most recent set of occupational wage rates (dated May 2020) they have discontinued this occupation in their wage data.

As a result, in order to estimate the burden for Physicians, similar to the estimates in the CY 2021 PFS final rule (85 FR 84958), we are using a rate of $217.32/hr which is the average of the following BLS occupations and adjusted wage estimates. As indicated, we adjusted BLS' hourly wage estimates by a factor of 100 percent to obtain the adjusted hourly wage estimate. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of Start Printed Page 65560 estimating these costs vary widely from study to study. Nonetheless, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

B. Information Collection Requirements (ICRs) 1. ICRs Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802 and 414.806) The following provisions will be subject to the standard PRA process under OMB control number 0938-0921 (CMS-10110). The standard PRA process includes the publication of 60- and 30-day Federal Register notices that will provide the public with opportunities for public review and comment.

We expect to publish the 60-day notice shortly after the publication of this final rule. The new provisions at §§ 414.802 and 414.806 will implement new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of Division CC, Title IV of the CAA, 2021 (for the purposes of this section of this final rule, hereinafter is referred to as “section 401”), which requires manufacturers without a Medicaid drug rebate agreement to report ASP information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological. Specifically, to implement the new reporting requirements for manufacturers without Medicaid drug rebate agreements, we proposed to modify. (1) The definition of drug at § 414.802.

And (2) the regulations describing civil money penalties at § 414.806. The new requirements will improve the accuracy of reported payment limits and limit the use of WAC-based pricing. For the purposes of section 401's new reporting requirements, for manufacturers without Medicaid drug rebate agreements, confidentiality requirements appear in section 1847A(f)(2)(D) of the Act which states that the ASP data are confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs or biologicals by such manufacturer or wholesaler, except—as the Secretary determines to be necessary to carry out section 1847A of the Act (including the determination and implementation of the payment amount), or to carry out section 1847B of the Act. To permit the Comptroller General of the United States to review the information provided.

To permit the Director of the Congressional Budget Office to review the information provided. To permit the MedPAC to review the information provided. And to permit the Medicaid and CHIP Payment and Access Commission to review the information provided. For manufacturers with Medicaid drug rebate agreements, confidentiality requirements appear in section 1927(b)(3)(D) of the Act which states that the ASP data are confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler, prices charged for drugs by such manufacturer or wholesaler, except—in relevant part, as the Secretary determines to be necessary to carry out section 1847A of the Act (including the determination of the payment amount), or to carry our section 1847B of the Act, to permit the Comptroller General to review the information provided, to permit the Director of the Congressional Budget Office to review the information provided, and to permit the Executive Director of the Medicare Payment Advisory Commission (MedPAC) and the Executive Director of the Medicaid and CHIP Payment and Access Commission to review the information provided.

The burden associated with these requirements is the time and effort required by manufacturers of drugs and biologicals payable under Medicare Part B to prepare and submit the required ASP data to CMS. We have previously estimated the burden associated with ASP reporting requirements for manufacturers with Medicaid drug rebate agreements. Because section 401 extends the ASP reporting requirements to manufacturers without Medicaid drug rebate agreements, we are updating our burden estimates to account for the additional manufacturers who will now be required to report ASP data to us. As described in section III.D.1.

Of this final rule, in considering whether to exclude repackagers from the reporting requirements at section 1847A(f)(2) of the Act, we conducted analyses to estimate. (1) The proportion of repackaged products in our existing ASP data. (2) the number of new ASP submissions we can expect as a result of the new reporting requirements under section 401. And (3) the proportion of those (new) submissions that involve repackaged products.

Based on our existing ASP data, 547 manufacturers (respondents) report ASP data to us. Of these, 331 respondents have products for which they are required to submit ASP data, and 216 respondents have products for which they currently submit ASP data voluntarily, but will now be required to do so under section 1847A(f)(2) of the Act. (331 + 216 = 547) We also estimate that under the new reporting requirements of section 401, a total of 568 respondents have products for which they will now be required to report ASP data to us. The 568 includes the 216 respondents (above) and 361 respondents who have products (identified by us) for which they will now be required to submit ASP data under section 1847A(f)(2) of the Act and did not previously voluntarily submit these data to us.

There were 9 respondents who voluntarily submitted ASP data for some, but not all, of their products identified in our analysis. (216 + 361−9 overlap = 568) We estimate a total of 740 respondents will report ASP data to us. This includes the 547 respondents who currently submit ASP data to us (voluntarily, or as currently required), and the 361 respondents who have products (identified by us) for which they will now be required to submit ASP data under section 1847A(f)(2) of the Act and did not previously voluntarily submit these data to us. However, there were 168 respondents who currently are required to submit ASP data to us, or who voluntarily submit ASP data to us, for whom we identified additional products that they did not previously submit ASP data, and will now be required to submit ASP data for these additional products under the new reporting requirements of section 401.

(547 + 361−168 overlap = 740) These respondents submit ASP data four times per year for a total of 2,960 submissions (740 respondents × 4 submissions/year). Based on our experience with ASP data reporting, we continue to estimate that the time associated with reporting, record keeping, and third-party disclosure for ASP data reporting is 13 hours. 10 hours to review instructions and search existing data resources and 3 hours to gather the data, compile the data, submit via electronic media and upload to the automated system. This estimate includes labor costs for respondents to extract data from their information systems and to compile and submit the ASP data, including signature, to CMS via the internet-based automated system and electronic media.

This estimate also includes the cost of the compact disc (CD) and overnight mail service used to report the data, Start Printed Page 65561 time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. Based on these analyses and assumptions, we estimate an annual burden of 38,480 hours (2,960 submissions/yr × 13 hours per response) at a cost of $1,495,332.80 (38,480 hr × $38.86/hr), rounding to $1,495,333. We solicited comment on the likely costs or savings manufacturers from this provision. We did not receive public comments on the analyses or the estimates.

We are finalizing the definition of the term “drug” at § 414.802 as proposed. 2. ICRs Regarding the Medicare Shared Savings Program (Sections VI.F.8.a. And b.) Section 1899(e) of the Act provides that chapter 35 of title 44 U.S.C., which includes such provisions as the PRA, shall not apply to the Shared Savings Program.

Accordingly, we are not setting out burden under the authority of the PRA. Please refer to sections VI.F.8.a. And b. Of this final rule for a discussion of the impacts associated with this rule's changes to the Shared Savings Program's quality reporting requirements, quality performance standard, beneficiary assignment methodology, repayment mechanism requirements, requirements for disclosure of prior participation in the Shared Savings Program by the ACO, ACO participants, and ACO providers/suppliers, requirements for ACOs to submit sample ACO participant agreements and executed ACO participant agreements to CMS, and beneficiary notification requirements.

3. ICRs Regarding the Medicare Ground Ambulance Data Collection System (§ 414.626) Section 1834(l)(17) of the Act requires that the Secretary develop a ground ambulance data collection system that collects cost, revenue, utilization, and other information determined appropriate by the Secretary with respect to providers of services and suppliers of ground ambulance services (ground ambulance organizations). Section 1834(l)(17)(I) of the Act states that the PRA does not apply to the collection of information required under section 1834(l)(17) of the Act. Accordingly, this collection of information section does not set out any burden for the proposed provisions that we are finalizing in this final rule.

Please see section VI. Of this final rule for a discussion of the estimated impacts. We received no public comments on the collection of information requirements for the Medicare Ground Ambulance Data Collection System. We are finalizing as proposed.

4. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) Expanded Model (§§ 410.79, 414.84, 424.205, and 424.502) In section III.L. Of this final rule, we finalize policies necessary to shorten the Medicare Diabetes Prevention Program (MDPP) services period to one (1) year on a prospective basis, amend and update the amount of the performance payments for the Core Sessions and Core Maintenance Sessions, and make changes to eliminate the ongoing maintenance phase for MDPP beneficiaries who start MDPP set of services on or after January 1, 2022. In addition, we are finalizing a provision to waive the provider enrollment Medicare application fee for all organizations enrolling in Medicare as MDPP suppliers during the MDPP expanded model on or after January 1, 2022.

We expect the finalized policies will increase the number of eligible organizations willing to enroll as MDPP suppliers. We also anticipate that the shortened service period will make MDPP more marketable to beneficiaries in that their time commitment is reduced and less intimidating with a 12-month vs. 24-month service period. We anticipate the shortened MDPP services period will reduce the recordkeeping burden for suppliers.

Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the MDPP expanded model, from the provisions of the PRA. Accordingly, this collection of information section does not set out any burden for the provisions. Please see section VI. Of this final rule for a discussion of the estimated impacts.

5. ICRs for Prepayment and Post-Payment Definitions, Documentation Request Timeframes, and Payment Denials for Noncompliance With Documentation Requests (§§ 405.902, 405.903, 405.929, and 405.930) In section III.N.2. Of this final rule, we proposed to. (1) Define key terms including “additional documentation,” “additional documentation request,” “post-payment medical review,” and “prepayment medical review;” (2) codify contractors' authority to request additional documentation for prepayment and post-payment review within established timeframes.

(3) codify timeframes for response to requests for documentation. (4) codify result of a failure to comply with prepayment or post-payment documentation request(s) by a provider or supplier, specifically denial of payment. The codification of contractor authority to request additional documentation for post-payment reviews, associated timeframes, and resulting denials for failure to comply with these requests is not subject to the PRA per 5 CFR 1320.3(h)(9). The request for additional documentation will be on a case-by-case basis using non-standardized follow-up questions.

With regard to the (1) definitions for “additional documentation” and “additional documentation request,” “post-payment medical review,” and “prepayment medical review;” (2) the codification of contractor authority to Start Printed Page 65562 request additional documentation for pre-payment reviews. (3) the associated provider and supplier timeframes for providing additional documentation from the pre-payment reviews. And (4) possible denials for failure to comply with these requests, we do not expect that these proposals will affect our information collection burden estimates because these policies do not require providers or suppliers to submit any more documentation to CMS than what is already approved by OMB under control number 0938-0969 (CMS-10417). The regulations simply codify certain requirements by clarifying definitions, timeframes, and results for noncompliance.

We did not receive public comments on this provision, and therefore, we are finalizing as proposed. 6. ICRs Regarding the Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan (§ 423.160(a)) Pending our finalization of the following provisions, the changes will be subject to the standard PRA process under OMB control number 0938-1396 (CMS-10755) to give stakeholders optimal opportunity to comment on our burden for this provision, given how dynamic the burden for EPCS is. The standard PRA process includes the publication of 60- and 30-day Federal Register notices that will provide the public with opportunities for public review and comment.

We expect to publish the 60-day notice shortly after the publication of the final rule. The purpose of this provision is to continue to implement section 2003 of the SUPPORT for Patients and Communities Act, which requires that the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program beginning January 1, 2021, subject to any exceptions, which HHS may specify. We refer readers to the CY 2021 PFS final rule (85 FR 84472) for our previously finalized requirements and burden for the first phase of implementing this statutory mandate, which required prescribers to use the NCPDP SCRIPT 2017071 standard for Electronic Prescription for Controlled Substances (EPCS) prescription transmissions. The purpose of this final rule is to delay the date for CMS to begin taking compliance actions, implement certain exceptions to the mandate, and implement a compliance threshold.

In the CY 2021 PFS final rule, we estimated that the one-time burden to implement this provision would be 828,750 hours (165,750 prescribers * 6 hr) at a cost of $36,418,590 (994,500 hr * $36.62/hr). We arrived at the estimate of 165,750 prescribers having to implement EPCS based on taking the 425,000 Part D prescriber practices, and decreasing that amount by 60 percent to account for the 60 percent of prescriber practices that likely already had EPCS in place by January 1, 2021. Based on our current PDE data, we estimate that 70 percent of Part D prescribers already conduct EPCS,[] which would leave 30 percent of Part D prescribers that would have to implement EPCS, if we did not propose any exceptions to this mandate. We also proposed that prescribers writing prescriptions for beneficiaries in long term care facilities will have an extension for those prescriptions until January 1, 2025 along with the following exceptions to the EPCS mandate.

(1) For prescriptions issued when the prescriber and dispensing pharmacy are the same entity. (2) cases where prescribers issue only a small number of Part D. (3) cases where a prescriber's NCPDP database address is in a geographic service area of an emergency or disaster declared by a Federal, State or local government entity. And (4) cases where a prescriber has received a CMS-approved waiver.

These exceptions will result in fewer prescribers being required to conduct EPCS. Based on our PDE data, we believe that these exceptions will substantially decrease the number of prescribers having to implement EPCS as a result of this regulation. We have listed the exceptions and the estimated number of prescribers falling under each exception in Table 79.[] We do not anticipate that our proposal to include a compliance threshold of 70 percent will have any material effect on the impact of this provision. The reason for this is that based on our PDE data and conversations with prescribers, we believe that the 30 percent or less of the time that prescribers are not e-prescribing is because they are unable to e-prescribe, so they would have applied for a waiver.

Although there are sometimes scenarios where beneficiaries may request that their prescriptions not be transmitted electronically, it appears as though those circumstances are not enough to make a material impact, since beneficiaries often change their views when they are given countervailing reasons that the prescriptions should be transmitted via EPCS. Start Printed Page 65563 Table 79 gives our estimate of the number of prescribers affected by our exceptions broken down by the type of exception. As shown in Table 79, we estimate that our exceptions will exempt approximately 582,664 prescribers from the EPCS requirement, which consistutes approximately 38 percent of prescribers, since there are an estimated 1,548,221 Part D prescribers [] (582,664/1,548,221). Since the number of exempted prescribers from this mandate far exceeds the number of prescribers who currently do not e-prescribe controlled substances in Part D, we do not expect that the total number of Part D prescribers who electronically prescribe controlled substances will increase following our implementation of this mandate.

As a result, we do not believe there will be a measurable impact to the prescriber community as a whole, once this provision is finalized. However, for individual prescribers who have to implement this mandate, we expect that the implementation costs will be the same amounts that we finalized in the CY 2021 PFS final rule. Based on the modeling that we have seen, we have found that EHR companies provide the initial set-up of e-prescribing software free of charge, provided the prescribers pay the per transaction cost of $1.88 mentioned in the CY 2021 PFS final rule. Based on the comments received on our CY 2021 PFS proposed rule, we understand that implementing EPCS can lead to technological glitches, and then fixing those issues.

We understand that the EHR companies remedy the issues free of charge. However, we also understand that such fixes take time away from the medical office staff. We estimate that such fixes would take the staff approximately 1 extra hour from the estimate given in our CY 2020 PFS proposed rule, when averaged across all prescribers. As a result, we have changed our one-time burden estimate of e-prescribing set-up from 5 hours to 6 hours per provider, which means a total of 994,500 hours (165,750 prescribers * 6 hr) at a cost of $36,617,490 (994,500 hr * $36.82/hr), since we anticipate that this work will be completed by an Administrative Support Worker.

In this regard, the impact of this rule is plus 1 hour per response, plus 165,750 hours (165,750 prescribers × 1 hr/response), and $6,102,915 (165,750 hr × $36.82/hr). We proposed that prescribers have the ability to apply for a waiver from the EPCS requirement, should they be facing circumstances beyond their control that prevent them from e-prescribing, and these circumstances are not the result of a natural disaster or emergency. Due to the high prevalence of EPCS, the miniscule compliance actions that we proposed for non-compliance, and the number of prescribers that we expect to exempt from the mandate, we only expect to receive about 100 attestations per year. Although we proposed certain fields be in this attestation, these were minimal, and there was no accompanying documentation required.

(Note, as outlined in section II.Q. Of this final rule, to meet the standard for a waiver, prescribers must provide documentation showing the existence of a circumstance beyond their control and that such a circumstance prevents them from conducting EPCS.) We expect that each attestation will take 10 minutes (0.1667 hr) for a prescriber at $217.32/hr to complete. In aggregate, CMS estimates an annual burden for filling out attestations of 16.67 hours (100 attestations × 0.1667 hr) at a cost of $3,622.72 (16.67 hr × $217.32/hr). In addition, we solicit comment on any other potential information collection implications.

We received no comments on our proposed burden estimates and assumptions, and have finalized our provision as proposed. As a result, we are finalizing our burden estimates and assumptions as proposed. Start Printed Page 65564 7. ICRs Regarding Open Payments Provisions Included in the CY 2022 PFS (42 CFR Part 403) The following requirement and burden changes will be submitted to OMB for approval under control number 0938-1237 (CMS-10495).

The following estimates burden changes to the Open Payments final rule at §§ 403.900 through 403.914 in this final rule. A. Payment Context Field for Teaching Hospitals The mandatory context field is a new requirement for reporting entities submitting and attesting to records that are attributed to teaching hospitals only. The field will be freeform text entry.

We estimate that for each applicable manufacturer and applicable group purchasing organization (GPO), the inclusion of this field for collection and reporting activities will average an additional 6 total hours. The applicable instrument for these activities in the current PRA package is the “General-Research-Ownership Submission Data Elements”. At the support staff cost per FTE of $42.40/hr, this will increase costs by $254.40 (6 hr × $42.40/hr) per applicable manufacturer or applicable GPO submitting teaching hospital records. However, because we anticipate fewer disputes due to this field, we believe it will decrease dispute resolution by 2 total hours for support staff at $42.40/hr respectively, reducing costs by $84.80 (2 hr × $42.40/hr) per applicable manufacturer and applicable GPO.

This results in a net increase in burden for each applicable manufacturer and applicable GPO submitting teaching hospital records of $169.60 ($254.40−$84.80). In Program Year (PY) 2019, 794 applicable manufacturers and applicable GPOs submitted at least one teaching hospital record, meaning the increase in burden will be a total of 3,176 hours (4 hours × 794 reporting entities) at a cost of $42./40/hr or a total of $134,662.40 (3,176 × $42.40). In addition, we estimate this will reduce teaching hospital dispute resolution estimates by 2 hours per support staff FTE at $37.82/hr or $75.64 (2 hr × $37.82/hr) per teaching hospital with records attributed to them. In PY 2019, 1,202 hospitals had record attributed to them, so for teaching hospitals we estimate a total burden reduction of 2,404 hours at a cost of $90,919.28 (2,404 × $75.64).

In aggregate, we estimate an annual burden of 772 hours (3,176−2,404) at a cost of $43,743.12 ($134,662.40−$90,919.28). B. Optional Annual Recertification The annual recertification is voluntary for applicable manufacturers or applicable group purchasing organizations. We approximate that 15 percent of applicable manufacturers and group purchasing organizations, or 240 reporting entities (0.15 [1,595 applicable manufacturers and applicable GPOs]) will complete and submit the proposed optional annual recertification.

We anticipate that it will be a simple check box form to be included in the AM (Attestation) and GPO (Attestation) Annual IC Requirement and the “Attestation and Assumptions Screen Shots” Instrument in the existing PRA package. We estimate that it will take 0.5 hours at $42.40/hr for support staff to complete and submit the recertification. In aggregate, we estimate an added annual burden of 120 hours (240 entities × 0.5 hr/response) at a cost of $5,088 (120 hr × $42.40/hr). C.

Defining a Physician-Owned Distributorship (42 CFR 403.902) The new definition is not subject to the PRA since it will not revise, add, or remove any collection of information requirements or burden. D. Disallowing Record Deletion Without Reason (§ 403.904(a)(3)) This provision clarifies that entities are not permitted to delete records without reason once their timeliness, completeness, and accuracy has been attested to. In order to ensure compliance with this requirement, a freeform text dialogue box will be added to the system when records are deleted that asks the applicable manufacturer or GPO to input a reason for the deletion.

This will be included in the AM (Data collection and submission) and Applicable GPO (Data Collection and Submission) IC requirements and the “Open Payments User Guide” Instrument in the existing PRA package. We anticipate that this will take an average of 2 hours at $42.40/hr to input a reason for the deletion. In aggregate, we estimate an added annual burden of 80 hours (40 applicable manufacturers or GPOs deleting records annually × 2 hr/response) at a cost of $3,392 (80 hr × $42.40/hr). E.

Disallow Publication Delays of General Payments A very small number of general payments are delayed from publication by reporting entities every year, and these records will simply either be reported as research records instead, or not delayed at all. Therefore, we anticipate a negligible burden for this provision. F. Short Term Loans (§ 403.902) This provision is merely a clarification of an existing requirement in regulation text.

The purpose of this language is to clarify that the exemption for short-term loans from reporting requirements only applies for loans of less than 91 cumulative days per calendar year. In other words, multiple short-term loans in a calendar year will still meet reporting requirements if they add up to 91 days or greater. We do not believe this provision will change reporting behavior, and therefore do not anticipate an increase in burden. G.

Remove General Ownership Records Currently the Open Payments system allows for a reporting entity to submit either a general record with a nature of payment category of ownership, or an ownership and investment interest record. For Program Years 2015-2019, approximately 92 applicable Start Printed Page 65565 manufacturers and GPOs reported records with the nature of payment category of ownership. Since reporting these general records as ownership records will require the addition of two additional pieces of information, we anticipate that it will take these 92 entities an additional 3 hours at $42.40/hr to report the two extra fields. In aggregate, we estimate an added annual burden of 276 hours (92 entities × 3 hr/response) at a cost of $11,702 (276 hr × $42.40/hr).

This will be included in the AM (Data collection and submission) and Applicable GPO (Data Collection and Submission) IC requirements and the “Open Payments User Guide” Instrument in the existing PRA package. h. Updated Contact Information (§ 403.908(c)(3)) This provision creates a requirement for reporting entities to keep their contact information up to date with CMS. The ability to communicate with a reporting entity is important because CMS may need to contact the entity in the case of perceived issues with the records.

Applicable manufacturers and applicable GPOs will only be required to update their contact information if the two contacts provided become obsolete due to a change in the organization. This will also only apply to entities that do not have records to report for 2 years after a program year in which they reported. Therefore, we anticipate that it will only affect approximately 30 applicable manufacturers and applicable group purchasing organizations. We estimate that it will take 0.5 hours at $42.40/hr to update the contact information.

In aggregate, we estimate an added annual burden of 15 hours (30 entities × 0.5 hr/response) at a cost of $636 (15 hr × $42.40/hr). This will be included in the AM (Data collection and submission) and Applicable GPO (Data Collection and Submission) IC requirements and the “Open Payments User Guide” Instrument in the existing PRA package. I. Summary 8.

The Quality Payment Program (QPP) (42 CFR Part 414 and Section IV. Of This Final Rule) The following QPP-specific ICRs reflect this final rule's policy changes as well as adjustments to the policies that have been finalized in the CY 2017 and 2018 Quality Payment Program final rules (81 FR 77008 and 82 FR 53568, respectively), the CY 2019, CY 2020, and CY 2021 PFS final rules (83 FR 59452, 84 FR 62568 and 85 FR 84472, respectively). A. Background (1) ICRs Associated With MIPS and Advanced APMs There is a series of ICRs associated with the Quality Payment Program, including for MIPS and Advanced APMs.

The MIPS ICRs consist of. Registration for virtual groups (see section V.B.8.b of this final rule). QCDR self-nomination applications and other requirements (see section V.B.8.c.(2) of this final rule). Qualified registry self-nomination applications and other requirements (see section V.B.8.c.(3) of this final rule).

CAHPS survey vendor applications (see section V.B.8.c.(4) of this final rule). Health IT vendors (see section V.B.8.c.(5) of this final rule). Open Authorization credentialing and token request process (see section V.B.8.d of this final rule). Quality Payment Program Identity Management Application Process (see section V.B.8.e.(3) of this final rule).

Quality performance category data submission by Medicare Part B claims collection type (see section V.B.8.e.(4) of this final rule), QCDR and MIPS CQM collection type (see section V.B.8.e.(5) of this final rule), eCQM collection type (see section V.B.8.e.(6) of this final rule), MVP Quality submission (see section V.B.8.e.(7)(a)(iii) of this final rule), and CMS Web Interface collection type (see section V.B.8.e.(8) of this final rule). CAHPS for MIPS survey beneficiary participation (see section V.B.8.e.(9) of this final rule). Group registration for CMS Web Interface (see section V.B.8.e.(10) of this final rule). Group registration for CAHPS for MIPS survey (see section V.B.8.e.(11) of this final rule).

MVP registration (see section V.B.8.e.(7)(a)(i) of this final rule). Subgroups registration (see section V.B.8.e.(7)(a)(ii) of this final rule). All for quality measures (see section V.B.8.f of this final rule). Reweighting applications for Promoting Interoperability and other performance categories (see section V.B.8.g.(2) of this final rule).

Promoting Interoperability performance category data submission (see section V.B.8.g.(3) of this final rule). Call for Promoting Interoperability measures (see section V.B.8.h of this final rule). Improvement activities performance category data submission (see section V.B.8.i of this final rule). Nomination of improvement activities (see section V.B.8.j of this final rule).

Nomination of MVPs (see section Start Printed Page 65566 V.B.8.k of this final rule). And opt-out of Physician Compare for voluntary participants (see section V.B.8.o of this final rule). The ICRs for Advanced APMs consist of. Partial Qualifying APM Participant (QP) election (section V.B.8.m of this final rule).

Other Payer Advanced APM identification. Payer Initiated and Eligible Clinician Initiated Processes (sections V.B.8.n.(1) and V.B.8.n.(2) of this final rule). And submission of data for QP determinations under the All-Payer Combination Option (section V.B.8.n.(3) of this final rule). (2) Summary of Quality Payment Program Changes.

MIPS We have included the change in estimated burden for the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years due to the finalized policies and information collections in this final rule. The finalized policies in this rule impact the burden estimates for the CY 2022 and CY 2023 MIPS performance periods/2024 and 2025 MIPS payment years. However, our currently approved burden estimates for the CY 2021 performance period (85 FR 84958 through 84998) approved by OMB on May 28, 2021, included estimated burden due to finalized policies and assumptions for the CY 2021 and CY 2022 performance periods/2023 and 2024 MIPS payment years. The currently approved estimated burden for the package does not include the CY 2023 performance period/2025 MIPS payment year.

To understand the burden implications of the policies finalized in this final rule relative to the current package that was approved by OMB on May 28, 2021. We have subtracted the burden for the policies and information collections set forth for the CY 2021 performance period/2023 MIPS payment year in the CY 2021 PFS final rule (see Table 128). We have revised our burden estimates for the CY 2022 performance period/2024 MIPS payment year due to the finalized policies in this rule and changes for continuing the policies and information collections set forth in the CY 2021 PFS final rule into the CY 2022 performance period/2024 MIPS payment year (see Table 129). We are setting forth new burden for the CY 2023 performance period/2025 MIPS payment year (see Table 130), meaning that there will be no currently approved figures for these estimates.

In the CY 2022 PFS proposed rule (86 FR 39479 through 39528), we compared our proposed burden estimates for the CY 2022 and 2023 performance periods/2024 and 2025 MIPS payment years to the CY 2022 performance period/2024 MIPS payment year in the CY 2021 PFS final rule (85 FR 84994). We believe that using the approach described above for the final rule will help readers easily understand and follow the changes in the estimated burden due to the policies and assumptions in the CY 2022 PFS final rule relative to the currently approved burden. The following nine MIPS ICRs show changes in burden due to the finalized policies in this rule. (1) QCDR self-nomination applications.

(2) Qualified Registry self-nomination applications. (3) Quality performance category data submission by QCDR and MIPS CQM collection type. (4) Quality performance category data submission by eCQM collection type. (5) Group registration for CMS Web Interface.

(6) CMS Web Interface submission burden. (7) Reweighting applications for Promoting Interoperability and other performance categories. (8) Promoting Interoperability performance category data submission. And (9) Nomination of improvement activities.

In aggregate, we estimate the finalized policies will result in a net increase in burden of 3,805 hours and $358,305 for the CY 2022 performance period/2024 MIPS payment year. The remaining changes to our currently approved burden estimates are adjustments due to the revised burden assumptions based on the updated data available at the time of publication of this final rule. We have also added 3 new ICRs (MVP Registration, MVP Quality Submissions, and Subgroups Registration) for the associated burden related to the policies for implementation of MVPs and subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. The MVP and subgroup registration ICRs reflect the burden associated with the MVP and subgroup registration requirements described in section IV.A.3.b(4)(f) of this rule.

The MVP quality submission ICR reflects the change in burden associated with the requirements for the quality performance category of MVPs described in section IV.A.3.b(4)(d)(ii) of this rule. With these new ICRs and the other policy changes discussed for the CY 2022 performance period/2024 MIPS payment year, we estimate the finalized policies will result in a net increase in burden of 1,383,049 hours and $139,501,770 for the CY 2023 performance period/2025 MIPS payment year. As discussed above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimates for comparison. We are not making any changes or adjustments to the following ICRs.

Registration for virtual groups. CAHPS survey vendor applications. Quality Payment Program Identity Management Application Process. Group registration for CAHPS for MIPS survey.

CAHPS for MIPS survey beneficiary participation. Open Authorization (OAuth) Credentialing and Token Request Process. Nomination of MVPs and call for Promoting Interoperability measures. See section V.B.8.

Of this final rule for a summary of the ICRs, the overall burden estimates, and a summary of the assumption and data changes affecting each ICR. The accuracy of our estimates of the total burden for data submission under the quality, Promoting Interoperability, and improvement activities performance categories may be impacted by two primary factors. First, we are unable to predict with absolute certainty who will be a QP for the CY 2022 performance period/2024 MIPS payment year. New eligible clinician participants in Advanced APMs who become QPs will be excluded from MIPS reporting requirements and payment adjustments, and as such, are unlikely to report under MIPS.

While some current Advanced APM participants may end participation such that the APM Entity's eligible clinicians may not be QPs for a year based on § 414.1425(c)(5), and thus be required to report under MIPS. Second, it is difficult to predict what Partial QPs, who can elect whether to report to MIPS, will do in the CY 2022 performance period/2024 MIPS payment year compared to the CY 2019 performance period/2021 MIPS payment year, and therefore, the actual number of Advanced APM participants and how they elect to submit data may be different than our estimates. However, we believe our estimates are the most appropriate given the available data. Additionally, we will continue to update our estimates annually as data becomes available.

In the 2022 PFS proposed rule (86 FR 39480), we discussed a recent JAMA article (Khullar, et al., 2021) [] which included new data on the burden involved in submitting data for the Quality Payment Program. We have chosen not to include this data in our estimates because of the small sample size included (30 TINs, half of which are APM participants, which we do not include in our estimates). In addition, the article did not indicate the time Start Printed Page 65567 spent per activity involved in submissions for MIPS, so we are unable to determine if the totals in the article represent only the activities relevant for regulatory burden or separate the totals for the individual ICRs. We solicited comment on our assumptions for estimating the burden for clinicians submitting data for the Quality Payment Program.

We did not receive public comments regarding our burden estimates for clinicians submitting data in the Quality Payment Program. We are finalizing to not include the data from the above referenced article in our assumptions. We made updates to our figures to correct a few technical errors that we observed in the CY 2022 PFS proposed rule. (3) Summary of Quality Payment Program Changes.

Advanced APMs For these ICRs (identified above under, “ICRs Associated with MIPS and Advanced APMs”), the changes to currently approved burden estimates are adjustments based on updated projections for the CY 2022 performance period/2024 MIPS payment year. We did not implement any changes to the Other Payer Advanced APM identification. Eligible Clinician Initiated Process and submission of Data for QP determinations under the All-Payer Combination Option ICRs. (4) Framework for Understanding the Burden of MIPS Data Submission Because of the wide range of information collection requirements under MIPS, Table 82 presents a framework for understanding how the organizations permitted or required to submit data on behalf of clinicians vary across the types of data, and whether the clinician is a MIPS eligible clinician or other eligible clinician voluntarily submitting data, MIPS APM participant, or an Advanced APM participant.

As shown in the first row of Table 82, MIPS eligible clinicians and other clinicians voluntarily submitting data will submit data either as individuals, groups, or virtual groups for the quality, Promoting Interoperability, and improvement activities performance categories. Note that virtual groups are subject to the same data submission requirements as groups, and therefore, we will refer only to groups for the remainder of this section unless otherwise noted. We want to note that we have included subgroups to Table 82 due to the introduction of subgroups for clinicians choosing to report MVPs or the APP in the CY 2023 performance period/2025 MIPS payment year described in section IV.A.3.b.(2)(d)(ii) of this final rule. Because MIPS eligible clinicians are not required to submit any additional information for assessment under the cost performance category, the administrative claims data used for the cost performance category is not represented in Table 82.

For MIPS eligible clinicians participating in MIPS APMs, the organizations submitting data on behalf of MIPS eligible clinicians will vary between performance categories and, in some instances, between MIPS APMs. As discussed in section IV.A.3.c. Of this final rule, for clinicians in APM Entities, the APM Performance Pathway is available for both ACO and non-ACOs to submit quality data. Due to data limitations and our inability to determine who will use the APM Performance Pathway versus the traditional MIPS submission mechanism for the CY 2022 performance period/2024 MIPS payment year, we assume ACO APM Entities will submit data through the APM Performance Pathway, using the CMS Web Interface option, and non-ACO APM Entities will participate through traditional MIPS, thereby submitting as an individual or group rather than as an entity.

We also want to note that as finalized in section IV.A.3.d.(1)(d) of this final rule, we are finalizing to extend the CMS Web Interface as a collection type beyond the CY 2022 performance period/2024 MIPS payment year for clinicians participating in the Shared Savings Program. Per section 1899 of the Act (42 U.S.C. 1395jjj), submissions received from eligible clinicians in ACOs are not included in burden estimates for this final rule because quality data submissions to fulfill requirements of the Shared Savings Program are not subject to the PRA. For the Promoting Interoperability performance category, group TINs may submit data on behalf of eligible clinicians in MIPS APMs, or eligible clinicians in MIPS APMs may submit data individually.

For the improvement activities performance category, we will assume no reporting burden for MIPS APM participants. In the CY 2017 PFS final rule, we described that for MIPS APMs, we compare the requirements of the specific MIPS APM with the list of activities in the improvement activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians (81 FR 77185). Although the policy allows for the submission of additional improvement activities if a MIPS APM receives less than the maximum improvement activities performance category score, to date all MIPS APM have qualified for the maximum improvement activities score. Therefore, we assume that no additional submission will be needed.

Eligible clinicians who attain Partial QP status may incur additional burden if they elect to participate in MIPS, which is discussed in more detail in the CY 2018 PFS final rule (82 FR 53841 through 53844). Start Printed Page 65568 The policies finalized in the CY 2017 and CY 2018 Quality Payment Program final rules, the CY 2019, CY 2020, and CY 2021 PFS final rules, and continued in this final rule create some additional data collection requirements not listed in Table 82. These additional data collections, some of which are currently approved by OMB under the control numbers 0938-1314 (Quality Payment Program, CMS-10621) and 0938-1222 (CAHPS for MIPS, CMS-10450), are as follows. Additional ICRs Related to MIPS Third-Party Intermediaries (See Section V.B.8.c) • Self-nomination of new and returning QCDRs (81 FR 77507 through 77508, 82 FR 53906 through 53908, and Start Printed Page 65569 83 FR 59998 through 60000) (OMB 0938-1314).

Self-nomination of new and returning registries (81 FR 77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59997 through 59998) (OMB 0938-1314). Approval process for new and returning CAHPS for MIPS survey vendors (82 FR 53908) (OMB 0938-1222). Open Authorization Credentialing and Token Request Process (New) (OMB 0938-1314) (see section V.B.8.d). Additional ICRs Related to the Data Submission and the Quality Performance Category (See Section V.B.8.e) Additional ICRs Related to the Promoting Interoperability Performance Category (See Section V.B.8.g) Reweighting Applications for Promoting Interoperability and other performance categories (82 FR 53918 and 83 FR 60011 through 60012) (OMB 0938-1314).

Additional ICRs Related to Call for New MIPS Measures and Activities (See Sections V.B.8.f, V.B.8.h, V.B.8.j. And V.B.8.k) Nomination of improvement activities (82 FR 53922 and 83 FR 60017 through 60018) (OMB 0938-1314). Call for new Promoting Interoperability measures (83 FR 60014 through 60015) (OMB 0938-1314). Call for MIPS quality measures (83 FR 60010 through 60011) (OMB 0938-1314).

Nomination of MVPs (OMB 0938-1314). Additional ICRs Related to MIPS (See Section V.B.8.o) Opt out of performance data display on Physician Compare for voluntary reporters under MIPS (82 FR 53924 through 53925 and 83 FR 60022) (OMB 0938-1314). Additional ICRs Related to APMs (See Sections V.B.8.m and V.B.8.n) Partial QP Election (81 FR 77512 through 77513, 82 FR 53922 through 53923, and 83 FR 60018 through 60019) (OMB 0938-1314). Other Payer Advanced APM determinations.

Payer Initiated Process (82 FR 53923 through 53924 and 83 FR 60019 through 60020) (OMB 0938-1314). Other Payer Advanced APM determinations. Eligible Clinician Initiated Process (82 FR 53924 and 83 FR 60020) (OMB 0938-1314). Submission of Data for All-Payer QP Determinations (83 FR 60021) (OMB 0938-1314).

b. ICRs Regarding the Virtual Group Election (§ 414.1315) This rule is not implementing any new or revised collection of information requirements or burden related to the virtual group election. The virtual group election requirements and burden are currently approved by OMB under control number 0938-1343 (CMS-10652). Consequently, we are not making any changes to the virtual group election process under that control number.

C. ICRs Regarding Third-Party Intermediaries (§ 414.1400) The finalized requirements and burden associated with this rule's data submission changes related to qualified registries and QCDRs will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). In section IV.A.3.h. Of this rule, we are finalizing policies related to the third-party intermediary regulations at § 414.1400.

Specifically, we are finalizing. (1) Requirement for third-party intermediaries to submit MIPS data for APM Entities. (2) requirement for QCDRs and qualified registries to support MVPs, QCDRs and qualified registries may also support the APP. (3) requirement for all QCDRs and qualified registries to support subgroup reporting.

(4) requirements for approved QCDRs and qualified registries that have not submitted performance data. And (5) new QCDR measure rejection criteria. The burden associated with each of these topics is discussed separately below for qualified registries, QCDRs, and survey vendors. (1) Background Under MIPS, the quality, Promoting Interoperability, and improvement activities performance category data may be submitted via relevant third-party intermediaries, such as qualified registries, QCDRs, and health IT vendors.

Data on the CAHPS for MIPS survey, which counts as either one quality performance category measure, or towards an improvement activity, can be submitted via CMS-approved survey vendors. Entities seeking approval to submit data on behalf of clinicians as a qualified registry, QCDR, or survey vendor must complete a self-nomination process annually.[] The processes for self-nomination for entities seeking approval as qualified registries and QCDRs are similar with the exception that QCDRs have the option to nominate QCDR measures for approval for the reporting of quality performance category data. Therefore, differences between QCDRs and qualified registry self-nomination are associated with the preparation of QCDR measures for approval. (2) QCDR Self-Nomination Applications As described below, in this rule we are adjusting the number of self-nomination applications based on current data (from 82 to 84), change the number of QCDR measures submitted for consideration by each QCDR at the time of self-nomination (from 2 to 12), and adjust the average time required to submit information for each QCDR measure (from 2.5 hours to 0.75 hours).

(a) Self-Nomination Process and Other Requirements In section IV.A.3.h.(1) of this rule, we are reorganizing and consolidating § 414.1400 generally. We assume that this provision does not change the existing requirements for third-party intermediaries during the self-nomination process. Therefore, we are not revising our burden estimates related to these provisions. We refer readers to § 414.1400 which states that QCDRs interested in submitting MIPS data to us on behalf of a MIPS eligible clinician, group, or virtual group will need to complete a self-nomination process to be considered for approval to do so.

We also refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77507 through 77508), CY 2018 Quality Payment Program final rule (82 FR 53906 through 53908), CY 2019 PFS final rule (83 FR 59998 through 60000), the CY 2020 PFS final rule (84 FR 63116 through 63121) and the CY 2021 PFS final rule (85 FR 84964 through 84969) for our previously finalized requirements and burden for self-nomination of QCDRs and nomination of QCDR measures. In section IV.A.3.h.(2)(a) of this rule, we are finalizing to add APM Entities to § 414.1400(a)(1), and expand the general participation requirements of third-party intermediaries, to third-party intermediaries reporting to MIPS on behalf of APM Entities reporting to MIPS in order to align reporting requirements for all participants in Start Printed Page 65570 MIPS. We are also finalizing that beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support the APP, and MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. As finalized in the CY 2017 PFS final rule, third-party intermediaries currently support MIPS data submission on behalf of eligible clinicians (81 FR 77016).

APM Entities have historically used third party intermediaries for submitting their quality measures to their APMs. Additionally, QCDRs, qualified registries and health IT vendors are required under existing § 414.1400(a)(1) to submit data for the quality, improvement activities, and Promoting Interoperability performance categories in MIPS. Therefore, we anticipate no additional steps being added to the self-nomination process as a result of this provision for third-party intermediaries to submit MIPS data on behalf of APM Entities, and to support measures and activities in MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. For this final rule, we assume that there will be no impact on the time required for QCDRs to complete either the simplified or full self-nomination process because of the above provisions.

Additionally, we are finalizing to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year. We anticipate that at the time of self-nomination, QCDRs would be using a checkbox to indicate their compliance for the requirement to support data submission for subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. We assume that this will not impact the overall time estimated for QCDRs to submit their information at the time of self-nomination. Therefore, as discussed in the CY 2022 PFS proposed rule (86 FR 84965) we did not make any adjustments in the time required for QCDRs during the simplified or full self-nomination process because of this provision.

However, we anticipate that third-party intermediaries will need to make administrative changes to their existing workflows for submission of MVPs and APP data for clinicians participating as subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. We refer readers to section VI.F.18.g(2)(f) of this final rule where we discuss our impact analysis. In section IV.A.3.h.(3)(a)(iii) of this rule, to provide further clarity and to better align with the existing policy (81 FR 77366 through 77367. 81 FR 77383 through 77384), we are finalizing to codify that QCDRs, and qualified registries must conduct validation on the data they intend to submit for the applicable MIPS performance period and provide the results of the executed data validation plan by May 31st of the year following the performance period.

Additionally, we are finalizing to codify a new requirement at § 414.1400(b)(3)(iv) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination, for CMS' approval, and may not change the plan once approved, without the prior approval of the agency. We anticipate that this provision does not make any changes to the existing data validation requirements for QCDRs and qualified registries. Through this provision, we are codifying the finalized policies related to data validation for QCDRs and qualified registries in previous rules. In the CY 2022 PFS proposed rule (86 FR 39483), we did not revise our burden estimates as a result of the above provision because the associated burden was captured in the CY 2017 PFS final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999) and submitted to OMB for approval under control number 0938-1314 (CMS-10621).

In section IV.A.3.h(3)(a)(i) of this final rule, we are finalizing new requirements for approved QCDRs and qualified registries that have not submitted performance data. First, we are finalizing to create a new requirement at § 414.1400(b)(3)(vii) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023. If the QCDRs and qualified registries did not submit data, their participation plan must be submitted as part of self-nomination for the 2023 self-nomination period and must be accepted by CMS to continue to be an approved QCDR or qualified registry. We are also finalizing to codify a new requirement at paragraph § 414.1400(b)(3)(viii) to state that, beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval.

Under this provision, the participation plan must explain the QCDR and/or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third-party intermediary on behalf of clinicians or groups. The vendor must also explain why they should still be allowed to participate as a qualified vendor. Based on our review of the existing list of approved QCDRs that did not submit performance data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year), we estimate that approximately 10 QCDRs will submit participation plans for the CY 2022 and the CY 2023 self-nomination periods. Similar to our assumptions for submission of a Corrective Action Plan (CAP) in the CY 2021 PFS final rule (85 FR 84968), we anticipate that the effort involved in developing a participation plan including the policies specified in this rule and submitting it to CMS is likely to be no more than 3 hours for a computer systems analyst at a rate of $95.22/hr.

For the CY 2022 performance period/2024 MIPS payment year, we estimate an annual burden of 30 hours (3 hr × 10 participation plans) at a cost of $2,857 (30 hr × $95.22/hr) for QCDRs that will need to develop and submit a participation plan. In section IV.A.3.h.(4) of this rule, we are finalizing to codify new requirements that if a QCDR measure owner is not an approved active QCDR for a given self-nomination period, that QCDR measure will not be available for use. Additionally, we are finalizing to codify a new requirement in section IV.A.3.h.(4)(a)(i)(A) of this rule and add a rejection criterion at § 414.1400(b)(4)(iv)(M) to state, a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. It was finalized in the CY 2018 PFS final rule (82 FR 53813) that beginning with the CY 2018 performance period/2020 MIPS payment year, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR.

Additionally, in the CY 2020 PFS final rule (84 FR 63070 through 63073), we finalized the QCDR measure rejection criteria considerations. Specifically, we stated that all previously approved QCDR measures and new QCDR measures would be reviewed on an annual basis (as a part of the QCDR measure review Start Printed Page 65571 process that occurs after the self-nomination period closes on September 1st) to determine whether they are appropriate for the program. In the CY 2020 PFS final rule, we indicated to stakeholders that as information becomes available in future years, we will revisit our assumptions to better reflect the impact of these requirements on QCDRs and the quantity of measures annually (84 FR 63118 through 63119). As discussed in the CY 2019 PFS final rule (83 FR 60000) and CY 2020 PFS final rule (84 FR 63118), we are not accounting for QCDR measure licensing costs as part of our burden estimate.

Based on the number of QCDR measures submitted at the time of self-nomination for the CY 2021 performance period/2023 MIPS payment year, we assume that 82 QCDRs will submit 984 measures for consideration in the CY 2022 performance period/2024 MIPS payment year, approximately 12 measures per QCDR, on average. We anticipate that out of the 984 measures, 820 measures will be existing or borrowed measures, approximately 10 measures submitted per QCDR self-nomination application. The remaining 104 measures will be new measures, approximately 2 measures on average per QCDR. Using the above assumption that each QCDR submitting measures for approval during the self-nomination process will submit approximately 12 measures (10 existing or borrowed measures + 2 new measures), we estimate an increase of 10 measures from the currently approved estimate of 2 measures per QCDR.

The estimated increase in the total number of measures submitted by a QCDR at the time of self-nomination is due to the inclusion of the existing or borrowed QCDR measures in our assumptions. Additionally, we anticipate that less information is needed for a QCDR to submit an existing or borrowed measure for approval, therefore, we estimate that the time needed for a QCDR to submit an existing or borrowed measure is 0.5 hours, independent of the selection of the simplified or full self-nomination process. Consistent with our assumption in the CY 2020 PFS final rule (84 FR 63119), we continue to estimate that each QCDR will require 2 hours to submit a new QCDR measures for approval, independent of the selection of the simplified or full self-nomination process. To account for the difference in the time for submission of new vs existing QCDR measures for approval, we are using the weighted average to estimate the time required for QCDR measure submission at the time of self-nomination.

Therefore, we assume that the weighted average of the time required for each QCDR to submit a new or existing or borrowed measure for approval during the self-nomination process is 0.75 hours [((2 new measures × 2 hours) + (10 existing or borrowed measures × 0.5 hours))/total # of measures (12)]. Based on the above assumptions, we are finalizing to revise our estimates in the amount of time required for a QCDR to submit measures during the self-nomination process from a total of 2 hours to approximately 0.75 hours, a decrease of 1.75 hours from the currently approved estimated burden per QCDR measure submission. In the CY 2019 PFS final rule, we estimated that it would take 0.5 hours and 3 hours for a QCDR to submit all the required information during the simplified and full self-nomination process, respectively (83 FR 59999). Based on our experience with the amount of time needed for QCDRs during the 2020 self-nomination period, we assume that the estimated time of 3 hours per QCDR for a full self-nomination process is an overestimate and therefore, are adjusting our estimated time required for the QCDR full-self-nomination process to 2.5 hours, a decrease of 0.5 hours.

We are not making any adjustments in the amount of time needed for simplified self-nomination process. For this final rule, we are adjusting the number of QCDRs that submitted applications for self-nomination from 90 to 84 based on the actual number of applications received during the CY 2021 self-nomination period for the CY 2022 performance period/2024 MIPS payment year, an increase of two applications from the currently approved estimate of 82. This is a decrease of 6 from the estimate of 90 provided in the CY 2022 PFS proposed rule (86 FR 39484). For QCDRs that submit measures as part of their self-nomination process, while simultaneously accounting for the estimated increase in the number of existing or borrowed QCDR measures submitted with the self-nomination application and the decrease in the estimated time for the QCDR full-nomination process, we are finalizing to revise our estimated time for the QCDR self-nomination process to a minimum of 9.5 hours [0.5 hours for the simplified self-nomination process + (12 measures × 0.75 hr/measure for QCDR measure submission)] and a maximum of 11.5 hours [2.5 hours for the full self-nomination process + (12 measures × 0.75 hr/measure for QCDR measure submission)], an increase of 4 hours at a cost of $ 380.88 (4 hr × $95.22/hr) and 3.5 hours at a cost of $333.27 (3.5 hr × $95.22/hr) from the currently approved burden per respondent estimate in the CY 2021 PFS final rule (85 FR 84965).

Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84967), based on updated data for the number of QCDR applications submitted during the CY 2020 self-nomination period, we are adjusting our estimate that 18 QCDRs will submit targeted audits for the CY 2022 performance period/2024 MIPS payment year, an increase of 1 from the currently approved estimate of 17 targeted audits in the CY 2021 PFS final rule (85 FR 84965). This is a decrease of 2 compared to our estimate of 20 targeted audits in the CY 2022 PFS proposed rule (86 FR 39484). Using the currently approved unchanged burden per respondent estimate, the estimated burden associated with QCDRs completing targeted audits will range from 90 hours (18 audits × 5 hr/audit) at a cost of $8,570 (18 audits × $476.10/audit) for the simplified self-nomination process to 180 hours (18 audits × 10 hr/audit) at a cost of $17,140 (18 audits × $952.20/audit) for the full self-nomination process (see Table 68 for the cost per audit). We assume that this would adjust our burden estimates for targeted audits by +5 hours (+1 respondents × 5 hr/audit) at a cost of $476 (5 hrs × $95.22/hr) and +10 hours (+1 respondents × 10 hr/audit) at a cost of $952 (10 hrs × $95.22/hr) for the simplified and full self-nomination process, respectively.

Based on the assumptions discussed in this section, we provide an estimate of the total annual burden associated with a QCDR self-nominating to be considered “qualified” to submit quality measures results and numerator and denominator data on behalf of MIPS eligible clinicians. As shown in Table 83, we assume that the staff involved in the QCDR self-nomination process will continue to be computer systems analysts or their equivalent, who have an average labor rate of $95.22/hr. Using the change in the number of respondents and the estimated time per respondent for QCDRs that submit measures for approval during the self-nomination process, the annual burden for the simplified and full-self nomination process will range from 798 hours (84 QCDRs × 9.5 hr) to 966 hours (84 QCDRs × 11.5 hr) at a cost ranging from $75,986 (798 hr × $95.22/hr) and $91,983 (966 hr × $95.22/hr), respectively. As shown in Table 83, combined with our adjusted estimate of annual burden for targeted audits and the burden for submission of participation plans, we are finalizing to revise our estimated Start Printed Page 65572 burden for the QCDR self-nomination process, ranging from 918 hours [798 hr (84 QCDRs × 9.5 hr) + 90 hr (18 audits × 5 hr) + 30 hr (10 participation plans × 3 hr)] at a cost of $87,413 [$75,986 (798 hr × $95.22/hr) + $8,570 (18 audits × $476.10/audit) + $2,857 (30 hr × $95.22/hr)] for a simplified self-nomination process to 1,176 hours [966 hr (84 QCDRs × 11.5 hr) + 180 hr (18 audits × 10 hr) + 30 hr (10 participation plans × 3 hr)] at a cost of $111,980 [$91,983 (966 hr × $95.22/hr) + $17,140 (18 audits × $952.20/audit) + $2,857 (30 hr × $95.22/hr)] for the full self-nomination process.

As shown in Table 84, for the CY 2022 performance period/2024 MIPS payment year, independent of the change to our per response time estimate, the estimated increase in 2 respondents from the currently approved 82 respondents to 84 results in an increase of between +19 hours (+2 respondents × 9.5 hrs/respondent for the simplified self-nomination process) and +23 hours (+ 2 respondents × 11.5 hrs/respondent for the full self-nomination process) at a cost of between +$1,809 (+2 respondents × $904.60/respondent for the simplified self-nomination process) and +$2,190 (+2 respondents × $1,095.03/respondent for the full self-nomination process) (see Table 83 for the cost per QCDR). Accounting for the change in time required for the QCDR self-nomination process results in an adjustment of between +328 hours (82 respondents × +4 hr for the simplified self-nomination process or also referred to as minimum burden) at a cost + $31,232 [82 respondents × $380.88 (+4 hr × $95.22/hr)/respondent) and +287 hours (82 respondents × 3.5 hr for the full self-nomination process or also referred to as maximum burden) at a cost of and +$27,328 (82 respondents × $333.27 (+3.5 hr × $95.22/hr)/respondent). The reason for the increase in minimum burden compared to the maximum burden is due to an increase in the change in the number of hours required for the simplified self-nomination process compared to the increase in the number of hours for the full self-nomination process. In aggregate, when these impacts are combined with the estimate for targeted audits and participation plans discussed above, the net impact ranges between + 382 hours [19 hr (+2 respondents × 9.5 hrs/respondent) + 5 hr (+1 targeted audit × 5 hrs/audit) + 30 hr (10 participation plans × 3 hr/plan) + 328 hr (82 respondents × 4 hr)] at a cost of $36,374 ($1,809 + $476 + $2,857 + $31,232) for the simplified self-nomination process (also referred to as minimum burden) and +350 hours [23 hr (+2 respondents × 11.5 hrs/respondent) + 10 hr (+1 targeted audits × 10 hrs/audit) + 30 hr (10 participation plans × 3 hr/plan) + 287 hr (+82 respondents × 3.5 hr)] at a cost of $33,328 [$2,190 (+2 respondents × $1,095.03/respondent + $952 (10 hr × $95.22/hr) + $2,857 (30 hr × $95.22/hr) + $27,328 (82 respondents × $333.27/respondent)] for the full self-nomination process (also referred to as maximum burden) for the CY 2022 performance period/2024 MIPS payment year.

As discussed above in this section of the rule, we are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year. Therefore, we estimate the total change in burden for the QCDR self-nomination process would be 918 hours at a cost of $87,413 for the simplified self-nomination process (also referred to as minimum burden) and 1,176 hours at a cost of $111,980 for the full self-nomination process (also referred to as maximum burden). For the purposes of calculating estimated change in burden in Tables 128, 129, and 130 of this final rule, we use only the maximum burden estimate. Start Printed Page 65573 (b) QCDR Measure Requirements In the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814), we discussed that beginning with the CY 2018 performance period/2020 MIPS payment year and for future program years, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR.

Additionally, in the CY 2020 Quality Payment Program rule (84 FR 63070 through 63073) we finalized the QCDR measure rejection criteria considerations. In section IV.A.3.h.(4)(a)(i)(A)(aa) of this rule, we are finalizing to codify a new requirement and add a rejection criterion that a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. Additionally, we are finalizing to codify new requirements that if a QCDR measure owner is not an approved active QCDR for a given self-nomination period, that QCDR measure will not be available for use. The inactive QCDR measure owner has the option to transfer ownership of the QCDR measure to an active QCDR or agree upon terms set forth with the active QCDR allowing co-ownership of the QCDR measure.

We refer readers to section IV.A.3.h.(4)(a)(i)(A) of this rule for additional details on the finalized policies for transfer of ownership of QCDR measures. This provision is to codify the existing requirements for the QCDR self-nomination process. We are not adjusting our burden estimates as result of this provision because we assume that this does not change the requirements, or the time required for a QCDR to submit information for a QCDR measure at the time of self-nomination. Additionally, we are finalizing to codify another rejection criterion at § 414.1400(b)(4)(iv)(N) to state that, if a QCDR measure owner is not approved during a given self-nomination period, any associated QCDR measures with that QCDR will also not be approved.

We are not revising our burden estimates as a result of the above provision because we assume that there will not be additional requirements for QCDRs to submit at the time of self-nomination. This is part of the measure specification requirements for QCDRs which submit measures for approval during the self-nomination process. (3) Qualified Registry Self-Nomination Process and Other Requirements The requirements and burden associated with this rule's data submission changes related to qualified registries will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to § 414.1400 which states that qualified registries interested in submitting MIPS data to us on behalf of MIPS eligible clinicians, groups, or virtual groups need to complete a self-nomination process to be considered for approval to do so.

We also refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77507 through 77508), CY 2018 Quality Payment Program final rule (82 FR 53906 through 53908), CY 2019 PFS final rule (83 FR 59997 through 59998), CY 2020 PFS final rule (84 FR 63114 through 63116) and the CY 2021 PFS final rule (85 FR 84967 through 85 FR 84969) for our previously finalized requirements and burden for self-nomination of qualified registries. In section IV.A.3.h.(1) of this rule, we are finalizing reorganization and consolidation of § 414.1400 generally. We assume that this provision does not change the existing requirements for third-party intermediaries during the self-nomination process. Therefore, we did not revise our burden estimates related to these provisions.

In section IV.A.3.h.(2)(a) of this rule, we are finalizing to add APM Entities to § 414.1400(a)(1), expanding the general participation requirements of third-party intermediaries, to third party intermediaries reporting to MIPS on behalf of APM Entities reporting to MIPS to align reporting requirements for all participants in MIPS. We are also finalizing that beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support APP, and MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. As finalized in the CY 2017 PFS final rule, third-party intermediaries currently support MIPS data submission on behalf of eligible clinicians (81 FR 77016). APM Entities have historically used third party intermediaries for submitting their quality measures to their APMs.

Additionally, QCDRs, qualified registries and health IT vendors are required under existing § 414.1400(a)(1) to submit data for the quality, improvement activities, and promoting interoperability performance categories in MIPS. Similar to our discussion for QCDRs above, we anticipate no additional steps being added to the qualified registry self-nomination process as a result of this provision for third-party intermediaries to submit MIPS data on behalf of APM Entities, and to support measures and activities in MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. For this final rule, we assume that there will be no impact on the time required for qualified registries to complete either the simplified or full Start Printed Page 65574 self-nomination process because of the above provisions. Additionally, we are finalizing to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year.

We anticipate that at the time of self-nomination, qualified registries would be using a checkbox to indicate their compliance for the requirement to support data submission for subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. We assume that this would not impact the overall time estimated for qualified registries to submit their information at the time of self-nomination. Therefore, we are not making any adjustments in the time required for qualified registries during the simplified or full self-nomination process because of this provision. However, we anticipate that third-party intermediaries would need to make administrative changes to their existing workflows for submission of MVPs and APP data for clinicians participating as subgroups beginning with the CY 2023 performance period/2025 MIPS payment year.

We refer readers to section VI.F.18.g.(2)(f) of this rule where we discuss our impact analysis. For this final rule, we are adjusting the number of qualified registries that submitted applications for self-nomination from 210 to 147 based on the number of applications received during the CY 2021 self-nomination period for the CY 2022 performance period/2024 MIPS payment year, a decrease of 36 applications from the currently approved estimate of 183. This is also a decrease of 63 from the estimate of 210 provided in the CY 2022 PFS proposed rule (86 FR 39487). Therefore, we are revising our estimates for this information collection related to the qualified registry self-nomination process.

We are not making any new adjustments to the estimated burden per respondent as a result of this updated data. Based on our estimates in the CY 2021 PFS final rule (85 FR 84967) and the updated data received for the number of qualified registries that submitted self-nomination applications, we are adjusting the estimated number of qualified registries that will submit targeted audits for the CY 2022 performance period/2024 MIPS payment year. Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84967) and based on the updated data received from the CY 2021 self-nomination period, we are adjusting our estimate that 46 qualified registries will be required to conduct targeted audits, a decrease of 10 from the currently approved estimate of 56 in the CY 2021 PFS final rule (85 FR 84965). Therefore, we estimate the total impact associated with qualified registries completing targeted audits will range from 230 hours (46 registries × 5 hours/audit) at a cost of $21,901 (46 registries × $476.10/audit) to 460 hours (46 registries × 10 hours/audit) at a cost of $43,801 (46 registries × $952.20/audit) for the simplified and full self-nomination process, respectively (see Table 83 for the cost per audit).

We assume that this would adjust our burden estimates for targeted audits by −50 hours (−10 respondents × 5 hr/audit) at a cost of −$4,761 (−50 hrs × $95.22/hr) and + −100 hours (−10 respondents × 10 hr/audit) at a cost of −$9,522 (−100 hrs × $95.22/hr) for the simplified and full self-nomination process, respectively. Using our currently approved time per response estimate of 3 hours, the resulting adjustment in burden for QCDRs and qualified registries to submit CAPs is 30 hours (10 respondents × 3 hrs/respondent) at a cost of $2,857 (30 hours × $95.22/hr). In section IV.A.3.h.(3)(a)(i) of this final rule, we are finalizing new requirements for approved QCDRs and qualified registries that have not submitted performance data. First, we are finalizing to create a new requirement at paragraph at § 414.1400(b)(3)(vii) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023.

Exceptions to this requirement may occur if data is received for the CY 2021 performance period/2023 MIPS payment year. Under this scenario, QCDRs and qualified registries will not need to submit a participation plan for the CY 2023 self-nomination process. If the QCDRs and qualified registries did not submit data, their participation plan must be submitted as part of self-nomination for the CY 2023 MIPS self-nomination period and must be accepted by CMS to continue to be an approved QCDR or qualified registry. We are also finalizing to codify a new requirement that, beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval.

Under this provision, the participation plan must explain the QCDR and/or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third-party intermediary on behalf of clinicians or groups. The vendor must also explain why they should still be allowed to participate as a qualified vendor. Based on our review of the existing list of approved qualified registries that did not submit performance data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year), we estimate that 19 qualified registries would submit participation plans for the CY 2023 self-nomination period. Similar to our assumptions used for submission of a CAP in the CY 2021 PFS final rule (85 FR 84968), we anticipate that the effort involved in developing a participation plan including the policies specified in this rule and submitting it to CMS is likely to be no more than 3 hours for a computer systems analyst at a rate of $95.22/hr.

For the CY 2023 performance period/2025 MIPS payment year, we estimate an annual burden of 57 hours (3 hr × 19 participation plans) at a cost of $5,428 (57 hr × $95.22/hr) for qualified registries to develop and submit a participation plan. As stated above, based on the number of self-nominations received for the CY 2022 performance period/2024 MIPS payment year, we are finalizing to adjust the estimated number of qualified registries that will self-nominate for the CY 2022 self-nomination period to 147, a decrease of 36 from the currently approved estimate of 183 in the CY 2021 PFS final rule (85 FR 84969). In the CY 2019 PFS final rule, we estimated that it would take 3 hours for a qualified registry to submit all the required information during the full self-nomination process (83 FR 59998). Based on our experience with the self-nomination process, we believe that the number of fields needed to be submitted for a qualified registry are fewer than those needed for a QCDR.

We assume that our previous assumption of 3 hours is an overestimate. Therefore, we are adjusting the estimated time required for a qualified registry submitting a full-self-nomination process to 2 hours, a decrease of 1 hour. We assume that the staff involved in the qualified registry self-nomination process will continue to be computer systems analysts or their equivalent, who have an average labor rate of $95.22/hr. Using the change in estimated burden per respondent time, associated with the self-nomination process range from a minimum of 0.5 hours to a maximum of 2 hours, we Start Printed Page 65575 estimate that the annual burden would range from 74 hours (147 qualified registries × 0.5 hr) to 294 hours (147 qualified registries × 2 hr) at a cost ranging from $7,046 (74 hr × $95.22/hr) and $27,995 (294 hr × $95.22/hr), respectively (see Table 85).

Both the minimum and maximum burden shown in Table 85 reflect the adjustments to the number of respondents due to availability of more recent data. Combined with our estimates of burden associated with completing targeted audits and developing and submitting participation plans and corrective action plans, our total burden estimate ranges from 391 hours [74 hr (147 qualified registries × 0.5 hr) + 57 hr (+19 participation plans × 3 hr/plan) + 230 hr (46 targeted audits × 5 hours/audit) + 30 hr (10 CAPs × 3 hr) at a cost of $37,232 [$7,046 (74 hr × $95.22/hr) + $5,428 (57 hr × $95.22/hr) + $21,901 (46 registries × $476.10/audit) + $2,857 (30 hours × $95.22/hr)] to 841 hours [294 hr (147 qualified registries × 2 hr) + 57 hr (+19 participation plans × 3 hr/plan) + 460 hr (46 targeted audits × 10 hours/audit) + 30 hr (10 CAPs × 3 hr)] at a cost of $80,081 [$27,995 (294 hr × $95.22/hr) + $5,428 (57 hr × $95.22/hr) + $43,801 (46 registries × $952.20/audit) + $2,857 (30 hours × $95.22/hr) for the simple self-nomination process (see minimum burden in Table 85) and full self-nomination process (see maximum burden in Table 85) respectively. Based on the assumptions discussed in this section, we provide an estimate of the total annual burden associated with a qualified registry self-nominating to be considered “qualified” to submit quality measures results and numerator and denominator data on MIPS eligible clinicians. As shown in Table 86, for the CY 2022 performance period/2024 MIPS payment year, independent of the change to our per response time estimate, the estimated decrease in 36 respondents from the currently approved 183 respondents to 147 results in a change of −18 hours (−36 respondents × 0.5 hrs/respondent) at a cost of −$1,714 (−18 hours × $95.22/hr) for the simplified self-nomination process and a change of −72 hours (−36 respondents × 2 hrs/respondent) at a cost of −$6,856 (−72 hours × $95.22/hr).

Accounting for the change in time required for the qualified registry self-nomination process results in an adjustment of 0 hours for the simplified self-nomination process and −183 hours (183 respondents × −1 hours) at a cost of −$17,425 (−183 hours × $95.22/hr) for the full self-nomination process. When the above impacts are combined with the estimates for targeted audits, participation plans and corrective action plans discussed above, the net impact ranges between −11 hours [−18 hr (−36 respondents × 0.5 hrs/respondent) + 0 hr +−50 hr (−10 audits × 5 hr/audit) + 57 hr (+19 participation plans × 3 hr/plan) + 0 hr)] at a cost of −$1,046 [(−$1,713 (−18 hours × $95.22/hr) + $0 +−$4,761 (−50 hrs × $95.22/hr) + $5,428 (+57 hr × $95.22/hr) + $0)] for the simplified self-nomination process and −298 hours [(−72 hr (−36 respondents × 2 hrs/respondent) + −183 hr (183 respondents × −1 hours) + −100 hr (−10 audits × 10 hr/audit) + 57 hr (+19 participation plans × 3 hr) + 0 hr)] at a cost of −$28,375 [(−$6,856 (−72 hours × $95.22/hr)−$17,425 (−183 hours × $95.22/hr)−$9,522 (−100 hrs × $95.22/hr) + $5,428 (+57 hr × $95.22/hr) + $0)] for the full self-nomination process for the CY 2022 performance period/2024 MIPS payment year. As discussed above in this section of the rule, we are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year. Therefore, we estimate the total change in burden for the qualified registry self-nomination process would be 391 hours at a cost of $37,232 for the simplified self-nomination process and 841 hours at a cost of $80,081 for the full self-nomination process.

For the purposes of calculating estimated change in burden in Tables 128, 129, and 130 of this final Start Printed Page 65576 rule, we use only the maximum burden estimate. We received public comments for our burden estimates related to QCDRs and qualified registries. The following is a summary of the public comments received for the Quality Payment Program ICRs regarding the burden estimates for QCDR and qualified registries. Comment.

One commenter did not agree with CMS burden estimates for audits conducted by QCDRs and qualified registries and shared their belief that the time required for a QCDR was two to three-fold more than CMS estimates. The commenter shared their concern that our estimate does not accurately represent the total amount of time it takes for a QCDR or qualified registry to conduct data audits. Response. We would like to clarify that our burden estimates provided for the QCDR and qualified registry self-nomination process are not intended to capture the holistic total annual time for a QCDR or a qualified registry to participate in MIPS.

Our burden estimate of 9.5 hours to 11.5 hours for the QCDR and 0.5 hours to 2 hours for the qualified registry self-nomination process specifically includes the estimated time it takes for a QCDR or qualified registry to populate and submit a self-nomination form and QCDR measures, if applicable. These burden estimates do not include any time needed to comply with third-party intermediary requirements outside of the self-nomination process. We believe our burden estimate is a reasonable average across all respondents based on our review of the nomination process, the information required to complete the nomination form, and the criteria required to self-nominate as a QCDR or registry. After consideration of public comments, we are not making any changes to our estimates of the time required for the QCDR and qualified registry self-nomination process.

(4) Survey Vendor Requirements In section IV.A.3.h(2)(b)(ii) of this rule, we are finalizing to require CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year. Because of this provision, we anticipate no additional steps being added to the requirements for CAHPS for MIPS survey vendors to submit a participation form and assume there would be no impact on the time required for the survey vendors. Therefore, we are not making any adjustments in the time required for CAHPS survey vendors to submit their information because of this provision. The requirements and burden for CAHPS survey vendors to submit data for eligible clinicians are currently approved by OMB under control number 0938-1222 (CMS-10450).

Consequently, we are not making any changes to the CAHPS for MIPS Survey vendor information collection request under that control number. (5) Health IT Vendors In section IV.A.3.h.(2)(b) of this rule, we are finalizing to create a new requirement at paragraph § 414.1400(c)(1)(iii) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, health IT vendors must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. Health IT vendors may also support the APP. Additionally, we are finalizing to require health IT vendors to support subgroup reporting beginning with the CY 2023 performance period/2025 MIPS payment year.

We do not anticipate any requirement or burden changes as it relates to the support of reporting data. As stated in the CY 2019 PFS final rule (83 FR 59998), health IT vendors are not included in the burden estimates for MIPS. D. ICR Regarding Open Authorization (OAuth) Credentialing and Token Request Process This rule is not implementing new or revised collection of information requirements or burden related to the identity management application process.

The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the identity management application process under that control number. E. ICRs Regarding Quality Data Submission (§§ 414.1318, 414.1325, 414.1335, and 414.1365) (1) Background We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77502 through 77503), CY 2018 Quality Payment Program final rule (82 FR 53908 through 53912), CY 2019 PFS final rule (83 FR 60000 through 60003), CY 2020 PFS final rule (84 FR 63121 through 63124), and the CY 2021 PFS final rule (85 FR 84970 through 84974) for our previously finalized requirements for data submission for the quality performance category.

Under our current policies, two groups of clinicians must submit quality data under MIPS. Those who submit as MIPS eligible clinicians and those who submit data voluntarily but are not subject to MIPS payment adjustments. Clinicians are ineligible for MIPS payment adjustments if they are newly Start Printed Page 65577 enrolled to Medicare. Are QPs.

Are partial QPs who elect to not participate in MIPS. Are not one of the clinician types included in the definition for MIPS eligible clinician. Or do not exceed the low-volume threshold as an individual or as a group. (2) Changes and Adjustments to Quality Performance Category Respondents To determine which QPs should be excluded from MIPS, we used the Advanced APM payment and patient percentages from the APM Participant List for the final snapshot date for the 2019 QP performance period.

From this data, we calculated the QP determinations as described in the Qualifying APM Participant (QP) definition at § 414.1305 for the CY 2022 performance period/2024 MIPS payment year. Due to data limitations, we could not identify specific clinicians who have not yet enrolled in APMs, but who may become QPs in the future CY 2022 performance period/2024 MIPS payment year (and therefore will no longer need to submit data to MIPS). Hence, our model may underestimate or overestimate the number of respondents. In the CY 2019 PFS final rule, we finalized limiting the Medicare Part B claims collection type to small practices beginning with the CY 2019 performance period/2021 MIPS payment year and allowing clinicians in small practices to report Medicare Part B claims as a group or as individuals (83 FR 59752).

As in the CY 2021 PFS final rule, we continue to use CY 2019 performance period/2021 MIPS payment year data to estimate the number of respondents in the CY 2022 PFS final rule. There may be an undercount in submissions due to the PHE for buy antibiotics, because of the automatic extreme and uncontrollable circumstances policy, and application-based policy that allowed clinicians to elect not to submit during the submission period for the CY 2019 performance period/2021 MIPS payment year that we are using to inform our burden estimates. Despite this limitation, we believe the data from the CY 2019 performance period/2021 MIPS payment year is still the best data source available as it most accurately reflects the impacts of policies finalized in previous rules and trends toward increased group reporting. In section IV.A.3.d.(1)(d) of this rule, we are finalizing to continue the CMS Web Interface measures as a collection type for the CY 2022 performance period/2024 MIPS payment year.

Additionally, we are finalizing to sunset the CMS Web Interface measures as a collection type/submission type starting with the CY 2023 performance period/2025 MIPS payment year. In the CY 2021 PFS final rule (85 FR 84981), we finalized the sunset of CMS Web Interface as a collection type for the CY 2022 performance period/2024 MIPS payment year. We refer readers to the CY 2021 PFS final rule for discussion on our assumptions for the CY 2022 performance period/2024 MIPS payment year, where we estimated a burden of zero due to our assumption that all Web Interface respondents will alternately utilize either the MIPS CQM and QCDR or eCQM collection types. Based on the number of groups that submitted quality performance data via the CMS Web Interface in the CY 2019 performance period/2021 MIPS payment year, we are not able to ascertain what alternative collection type(s) the groups would elect.

In order to estimate the number of groups that will select each of these collection types, we first clustered the number of groups which submitted data via the CMS Web Interface collection type during the CY 2019 performance period/2021 MIPS payment year by practice size (between 25 and 49 clinicians, between 50 and 99 clinicians, etc.). Then, for each cluster, we allocated these groups to each of the MIPS CQM and QCDR and eCQM collection types based on the percent of TINs that submitted MIPS data via these two collection types. For example, of the 1,629 TINs with a practice size of 25 to 49 clinicians which submitted data for the CY 2019 performance period/2021 MIPS payment year, 1,066 (65 percent) submitted data via the MIPS CQM and QCDR collection type and 563 (35 percent) submitted data via the eCQM collection type. We applied these percentages to the 7 TINs with a practice size of 25 to 49 clinicians which submitted data via the CMS Web Interface collection type for the CY 2019 performance period/2021 MIPS payment year to estimate that 4 (7 TINs × 0.56) would elect to submit data via the MIPS CQM and QCDR collection type and the remaining 3 (7 TINs × 0.44) would elect to submit data via the eCQM collection type.

In total, beginning with the CY 2023 performance period/2025 MIPS payment year, we estimate that 64 of the 114 groups that submitted data via the CMS Web Interface collection type for the CY 2019 performance period/2021 MIPS payment year will submit quality data via the MIPS CQM and QCDR collection type and 50 groups will now submit quality data via the eCQM collection type. We note that 114 groups are an increase of 114 from our currently approved estimate of 0 groups in the CY 2022 performance period/2024 MIPS payment year. We also performed this analysis to determine the number of clinicians that will be affected and will need to submit quality data via an alternate collection type beginning with the CY 2023 performance period/2025 MIPS payment year. In total, of the estimated 45,599 individual clinicians affected by this provision, we estimate that 11,432 will submit quality data as part of a group via the MIPS CQM and QCDR collection type and 34,167 will submit quality data as part of a group via the eCQM collection type.

These estimates are reflected in Tables 90 and 92 and the associated changes in burden are reflected in Tables 91 and 93. In aggregate, as discussed in section V.B.8.p. Of this final rule, we estimate the provision to sunset the CMS Web Interface measures as a collection type/submission type will result in a net decrease in quality performance data reporting burden while acknowledging the additional financial impacts on clinicians as discussed in section VI.F.18.g.(2)(a) of the Regulatory Impact Analysis. We assume that 100 percent of ACO APM Entities will submit quality data to CMS as required under their models.

While we do not believe there is additional reporting for ACO APM entities, consistent with assumptions used in the CY 2020 and CY 2021 PFS final rules (84 FR 63122 and 85 FR 84972), we include all quality data voluntarily submitted by MIPS APM participants at the individual or TIN-level in our respondent estimates. As stated in section V.B.8.e.(2) of this final rule, we assume non-ACO APM Entities will participate through traditional MIPS and submit as an individual or group rather than as an entity. To estimate who will be a MIPS APM participant in the CY 2022 performance period/2024 MIPS payment year, we used the Advanced APM payment and patient percentages from the APM Participant List for the final snapshot date for the 2019 QP performance period. We elected to use this data source because the overlap with the data submissions for the CY 2019 performance period/2021 MIPS payment year enabled the exclusion of Partial QPs that elected to not participate in MIPS and required fewer assumptions as to who is a QP or not.

Based on this information, if we determine that a MIPS eligible clinician will not be scored as a MIPS APM, then their reporting assumption is based on their reporting as a group or individual Start Printed Page 65578 for the CY 2019 performance period/2021 MIPS payment year. Our burden estimates for the quality performance category do not include the burden for the quality data that APM Entities submit to fulfill the requirements of their APMs. The burden is excluded from this collection of information section but is discussed in the regulatory impact analysis section of this final rule because sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 1315a(d)(3), respectively) state that the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models tested under section 1115A of the Act (or section 3021 of the Affordable Care Act) are not subject to the PRA.[] Tables 84, 85, and 86 explain our revised estimates of the number of organizations (including groups, virtual groups, and individual MIPS eligible clinicians) submitting data on behalf of clinicians segregated by collection type.

Table 87 provides our estimated counts of clinicians that will submit quality performance category data as MIPS individual clinicians or groups in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years based on data from the CY 2019 performance period/2021 MIPS payment year. For the CY 2022 performance period/2024 MIPS payment year, respondents will have the option to submit quality performance category data via Medicare Part B claims, direct, and log in and upload submission types, and Web Interface. For the CY 2023 performance period/2025 MIPS payment year, respondents will no longer have the option to submit quality performance category data via the Web Interface. We estimate the burden for collecting data via collection type.

Medicare Part B claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface. We believe that, while estimating burden by submission type may be better aligned with the way clinicians participate with the Quality Payment Program, it is more important to reduce confusion and enable greater transparency by maintaining consistency with previous rulemaking. For the CY 2023 performance period/2025 MIPS payment year, we are finalizing in section IV.A.3.b.(2)(c) of this rule that clinicians in MIPS will have the option to submit measures and activities in MVPs. We refer readers to section IV.A.3.b.(4)(d) of this rule for additional details on the reporting requirements for MVPs.

For the quality performance category of MVPs, we assume that MVP Participants will choose to report via the Medicare Part B claims, QCDR, MIPS CQMs, and eCQMs collection type. Table 99 of this rule includes the estimated burden for collecting data for the quality performance category of MVPs. As shown in Table 87, using participation data from the CY 2019 performance period/2021 MIPS payment year, combined with the estimate of QPs for the CY 2022 performance period/2024 MIPS payment year, we estimate a total of 625,703 clinicians will submit quality data as individuals or groups in each of the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years, a decrease of 25,811 clinicians when compared to our estimate of 651,514 clinicians in the CY 2021 PFS final rule (85 FR 84972). For the CY 2022 performance period/2024 payment year, we estimate 28,252 clinicians will submit data as individuals for the Medicare Part B claims collection type.

279,247 clinicians will submit data as individuals or as part of groups for the MIPS CQM and QCDR collection type. 273,819 clinicians will submit data as individuals or as part of groups via eCQM collection types. And 44,385 clinicians will submit as part of groups via the CMS Web Interface. Compared to the CY 2022 performance period/2024 MIPS payment year burden estimated in the CY 2021 PFS final rule (85 FR 84972), these are decreases from the estimates of 29,273, 295,941, and 326,300 for Medicare Part B claims, MIPS CQM and QCDR, eCQM, and an increase of 44,385 for the CMS Web Interface collection types, respectively.

These adjustments are due to the availability of updated data from the CY 2019 performance period/2021 MIPS payment year and the delay in sunsetting the CMS Web Interface from the CY 2022 performance period/2024 MIPS payment year to the CY 2023 performance period/2025 MIPS payment year. For the CY 2023 performance period/2025 MIPS payment year, we estimate 25,427 clinicians will submit data as individuals for the Medicare Part B claims collection type. 288,637 clinicians will submit data as individuals or as part of groups for the MIPS CQM and QCDR collection type. 311,326 clinicians will submit data as individuals or as part of groups via the eCQM collection type.

Table 87 provides estimates of the number of clinicians to collect quality measures data via each collection type, regardless of whether they decide to submit as individual clinicians or as part of groups. Because our burden estimates for quality data submission assume that burden is reduced when clinicians elect to submit as part of a group, we also separately estimate the expected number of clinicians to submit as individuals or part of groups. Start Printed Page 65579 Because MIPS eligible clinicians may submit data for multiple collection types for a single performance category, the estimated numbers of individual clinicians and groups to collect via the various collection types are not mutually exclusive and reflect the occurrence of individual clinicians or groups that collected data via multiple collection types during the CY 2019 performance period/2021 MIPS payment year. We captured the burden of any eligible clinician that may have historically collected via multiple collection types, as we assume they will continue to collect via multiple collection types and that our MIPS scoring methodology will take the highest score where the same measure is submitted via multiple collection types.

Table 88 uses methods similar to those described to estimate the number of clinicians that will submit data as individual clinicians via each collection type in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. For the CY 2022 performance period/2024 MIPS payment year, we estimate that approximately 28,252 clinicians will submit data as individuals using the Medicare Part B claims collection type. Approximately 40,507 clinicians will submit data as individuals using MIPS CQM and QCDR collection type. And approximately 40,446 clinicians will submit data as individuals using eCQMs collection type.

Based on performance data from the CY 2019 performance period/2021 MIPS payment year, these are decreases of −1,021, −833, and −1,809 respondents from the currently approved estimates of 29,273, 41,340, and 42,255 for the Medicare Part B claims, MIPS CQM and QCDR, and eCQM collection types, respectively. As shown in Table 88, for the CY 2023 performance period/2025 MIPS payment year, we estimate that approximately 25,427 clinicians will submit data as individuals using the Medicare Part B claims collection type. Approximately 36,456 clinicians will submit data as individuals using MIPS CQM and QCDR collection type. And approximately 36,401 clinicians will submit data as individuals using eCQMs collection type.

As stated above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. Start Printed Page 65580 Consistent with the policy finalized in the CY 2018 Quality Payment Program final rule that for MIPS eligible clinicians who collect measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection types and submit more than the required number of measures (82 FR 53735 through 54736), we will score the clinician on the required measures with the highest assigned measure achievement points and thus, the same clinician may be counted as a respondent for more than one collection type. Therefore, our columns in Table 88 are not mutually exclusive. Table 89 provides our estimated counts of groups or virtual groups that will submit quality data on behalf of clinicians for each collection type in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years.

We assume that clinicians that submitted quality data as groups in the CY 2019 performance period/2021 MIPS payment year will continue to submit quality data either as groups or virtual groups for the same collection types as they did as a group or TIN within a virtual group for the CY 2022 and 2023 performance periods/2024 and 2025 MIPS payment years. Specifically, for the CY 2022 performance period/2024 MIPS payment year we estimate that 11,529 groups and virtual groups will submit data for the MIPS CQM and QCDR collection type on behalf of 243,169 clinicians. 8,127 groups and virtual groups will submit for eCQM collection types on behalf of 249,878 eligible clinicians. And 114 groups will submit data via the CMS Web Interface on behalf of 44,385 clinicians.

These are decreases of −75 and −93 respondents from the currently approved estimates of 11,604, and 8,220 groups and virtual groups for the MIPS CQM and QCDR and eCQM collection types, and an increase of +114 groups from the currently approved estimates of 0 groups for the CMS Web Interface collection types, respectively. As shown in Table 89, for the CY 2023 performance period/2025 MIPS payment year we estimate that 10,434 groups and virtual groups will submit data for the MIPS CQM and QCDR collection type on behalf of 313,038 clinicians and 7,359 groups and virtual groups will submit for eCQM collection types on behalf of 339,109 eligible clinicians. As stated above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. The reason for the difference in estimated number of respondents from the estimates for the CY 2022 performance period/2024 MIPS payment year described above, is due to the sunset of the CMS Web Interface as a collection type and the implementation of MVPs beginning with the CY 2023 performance period/2025 MIPS payment year.

As the data does not exist for APM performance pathway or MIPS quality measures for non-ACO APM entities, we assume non-ACO APM Entities will participate through traditional MIPS and base our estimates on submissions received in the CY 2019 performance period/2021 MIPS payment year. Start Printed Page 65581 The burden associated with the submission of quality performance category data have some limitations. We believe it is difficult to quantify the burden accurately because clinicians and groups may have different processes for integrating quality data submission into their practices' workflows. Moreover, the time needed for a clinician to review quality measures and other information, select measures applicable to their patients and the services they furnish, and incorporate the use of quality measures into the practice workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician's practice and by the collection type.

For example, clinicians submitting data via the Medicare Part B claims collection type need to integrate the capture of quality data codes for each encounter whereas clinicians submitting via the eCQM collection types may have quality measures automated as part of their EHR implementation. We believe the burden associated with submitting quality measures data will vary depending on the collection type selected by the clinician, group, or third-party. As such, we separately estimated the burden for clinicians, groups, and third parties to submit quality measures data by the collection type used. For the purposes of our burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and eCQM collection types, we also assume that, on average, each clinician or group will submit 6 quality measures.

For the CY 2023 performance period/2025 MIPS payment year we refer readers to section IV.A.3.b.(4)(d) of the rule for the changes related to MVP and subgroup reporting requirements. In terms of the quality measures available for clinicians and groups to report for the CY 2022 performance period/2024 MIPS payment year, we are finalizing that the total number of quality measures will be 200. The new MIPS quality measures finalized for inclusion in MIPS for the CY 2022 performance period/2024 MIPS payment year and future years are found in Table Group A of Appendix 1. MIPS quality measures with substantive changes can be found in Table Group D of Appendix 1.

And MIPS quality measures finalized for removal can be found in Table Group C of Appendix 1. These measures are stratified by collection type in Table 90, as well as counts of new, removed, and substantively changed measures. Start Printed Page 65582 For the CY 2022 performance period/2024 MIPS payment year, we are finalizing a net reduction of 9 quality measures across all collection types compared to the 209 measures finalized for the CY 2021 performance period/2023 MIPS payment year (85 FR 84974). Specifically, as discussed in section IV.A.3.d.(1)(e) of this rule, we are finalizing to add 1 new administrative claims outcome measure, remove 13 quality measures, and make substantive updates to 87 quality measures.

We do not anticipate that our provision to remove these measures will increase or decrease the reporting burden on clinicians and groups as respondents generally are still required to submit quality data for 6 measures. For the change in associated burden related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99 of this section. (3) Quality Payment Program Identity Management Application Process This rule is not implementing any new or revised collection of information requirements or burden related to the identity management application process. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621).

Consequently, we are not making any changes to the identity management application process under that control number. (4) Quality Data Submission by Clinicians. Medicare Part B Claims-Based Collection Type This rule is not implementing any new or revised collection of information requirements related to the submission of Medicare Part B claims data for the quality performance category. However, we are adjusting our currently approved burden estimates based on more recent data.

For the change in associated burden related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99 of this section. The following burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77501 through 77504), CY 2018 Quality Payment Program final rule (82 FR 53912), CY 2019 PFS final rule (83 FR 60004 through 60005), CY 2020 PFS final rule (84 FR 63124 through 63126) and the CY 2021 PFS final rule (85 FR 84975 through 84976) for our previously finalized requirements and burden for quality data submission via the Medicare Part B claims collection type. As noted in Table 88, based on data from the CY 2019 performance period/2021 MIPS payment year, we assume that 28,252 individual clinicians will collect and submit quality data via the Medicare Part B claims collection type.

In this rule, we are finalizing to adjust the number of Medicare Part B claims respondents from the currently approved estimate of 29,273 to 28,252 (a decrease of 1,021) based on more recent data and our methodology of accounting only for clinicians in small practices who submitted such claims data in the CY 2019 performance period/2021 MIPS payment year rather than all clinicians who submitted quality data codes to us for the Medicare Part B claims collection type. As shown in Table 91, consistent with our currently approved per response time figures, we estimate that the burden of quality data submission using Medicare Part B claims will range from 0.15 hours (9 minutes) for a computer systems analyst at a cost of $14.28 (0.15 hr × $95.22/hr) to 7.2 hours for a computer systems analyst at a cost of $685.58 (7.2 hr × $95.22/hr). The burden will involve becoming familiar with MIPS quality measure specifications. Consistent with our currently approved per response time figures, we believe that the start-up cost for a clinician's practice to review measure specifications is 7 hours, consisting of 3 hours at $114.24/hr for a medical and health services manager, 1 hour at $217.32/hr for a physician, 1 hour at $48.16/hr for an LPN, 1 hour at $95.22/hr for a computer systems analyst, and 1 hour at $40.02/hr for a billing and posting clerk.

We are not revising our currently approved per response time estimates. As shown in Table 91, considering both data submission and start-up requirements for our adjusted number of clinicians, the estimated time (per clinician) ranges from a minimum of 7.15 hours (0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this regard the total annual time for the CY 2022 performance period/2024 MIPS payment year ranges from 202,002 hours (7.15 hr × 28,252 clinicians) to 401,178 hours (14.2 hr × 28,252 clinicians). The estimated annual cost (per clinician) ranges from $758 [(0.15 hr × $95.22/hr) + (3 hr × $114.24/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr) + (1 hr × $217.32/hr)] to a maximum of $1,429.02 [(7.2 hr × $95.22/hr) + (3 hr × $114.24/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr) + (1 hr × $217.32/hr)].

The total annual cost for the CY 2022 performance period/2024 MIPS payment year ranges from a minimum of $21,407,105 (28,252 clinicians × $758) Start Printed Page 65583 to a maximum of $40,372,673 (28,252 clinicians × $1,429.02). As shown in Table 91, for purposes of calculating total burden associated with the Claims collection type for the CY 2023 performance period/2025 MIPS payment year only the maximum burden is used. The decrease in the number of annual respondents results in an estimated total annual time of 361,063 hours (14.2 hr × 25,427 clinicians) for the CY 2023 performance period/2025 MIPS payment year. Using the currently approved unchanged estimate for cost per respondent, the total annual cost for the CY 2023 performance period/2025 MIPS payment year is $36,335,692 (25,427 clinicians × $1,429.02 per respondent).

Table 91 summarizes our estimated range of total annual burden associated with clinicians submitting quality data via Medicare Part B claims for both the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. As shown in Table 91, using the unchanged currently approved hours per respondent, we estimate that the burden per respondent for quality data submission using the Medicare Part B Claims collection type will range from $758 to $1,429.02. The decrease in number of respondents from 29,273 to 28,252 results in a total adjustment of between −7,300 hours (−1,021 respondents × 7.15 hr/respondent) at a cost of −$773,918 (−1,021 respondents × $758/respondent) and −14,498 hours (−1,021 respondents × 14.2 hr/respondent) at a cost of −$1,459,029 (−1,021 respondents × $1,429.02/respondent). For purposes of calculating total burden associated with this final rule as shown in Tables 125, 126, 127, and 128, only the maximum burden is used.

As shown in Table 92, for purposes of calculating total burden associated the CY 2023 performance period/2025 MIPS payment year only the maximum burden is used. We are setting forth our CY 2023 performance period/2025 MIPS payment year estimate as new burden, which results in an increase of 361,063 hours (25,427 respondents × 14.2 hr/respondent) at a cost of $36,355,692 (25,427 respondents × $1,429/respondent). Start Printed Page 65584 (5) Quality Data Submission by Individuals and Groups Using MIPS CQM and QCDR Collection Types The following requirement and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77504 through 77505), CY 2018 Quality Payment Program final rule (82 FR 53912 through 53914), CY 2019 PFS final rule (83 FR 60005 through 60006), CY 2020 PFS final rule (84 FR 63127 through 63128), CY 2021 PFS final rule (85 FR 84977 through 84979) for our previously finalized requirements and burden for quality data submission via the MIPS CQM and QCDR collection types.

For the change in associated burden for quality data submission related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99. As noted in Tables 84, 85, and 86, and based on data from the CY 2019 performance period/2021 MIPS payment year, for the CY 2022 performance period/2024 MIPS payment year, we assume that 279,247 clinicians will submit quality data as individuals or groups using MIPS CQM or QCDR collection types. 52,036 clinicians will submit as individuals and the remaining 279,223 clinicians will submit as members of 11,527 groups and virtual groups. This is an increase of 10,696 individuals and a decrease of 32 groups from the estimates of 41,340 individuals and the 11,559 groups provided in the CY 2021 PFS final rule (85 FR 84977).

Given that the number of measures required for clinicians and groups is the same, we expect the burden to be the same for each respondent collecting data via MIPS CQM or QCDR, whether the clinician is participating in MIPS as an individual or group. Under the MIPS CQM and QCDR collection types, the individual clinician or group may either submit the quality measures data directly to us, log in and upload a file, or utilize a third-party intermediary to submit the data to us on the clinician's or group's behalf. We estimate that the burden associated with the QCDR collection type is similar to the burden associated with the MIPS CQM collection type. Therefore, we discuss the burden for both together below.

For MIPS CQM and QCDR collection types, we estimate an additional time for respondents (individual clinicians and groups) to become familiar with MIPS quality measure specifications and, in some cases, specialty measure sets and QCDR measures. Therefore, we believe that the burden for an individual clinician or group to review measure specifications and submit quality data is total of 9 hours at a cost of $922.76 per response. This consists of 3 hours at $95.22/hr for a computer systems analyst (or their equivalent) to submit quality data along with 2 hours at $114.24/hr for a medical and health services manager, 1 hour at $95.22/hr for a computer systems analyst, 1 hour at $48.16/hr for an LPN, 1 hour at $40.02/hr for a billing clerk, and 1 hour at $217.32/hr for a physician to review measure specifications. Additionally, clinicians and groups who do not submit data directly will need to authorize or instruct the qualified registry or QCDR to submit quality measures' results and numerator and denominator data on quality measures to us on their behalf.

We estimate that the time and effort associated with authorizing or instructing the quality registry or QCDR to submit this data will be approximately 5 minutes (0.083 hours) at $95.22/hr for a computer systems analyst at a cost of $7.90 (0.083 hr × $95.22/hr). Overall, we estimate 9.083 hr/response (3 hr + 2 hr + 1 hr + 1 hr + 1 hr + 1 hr + 0.083 hr) at a cost of $922.76/response [(3 hr × $95.22/hr) + (2 hr × $114.24/hr) + (1 hr × $217.32/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr) + (0.083 hr × $95.22/hr)]. For the CY 2022 performance period/2024 MIPS payment year, in aggregate, we estimate a burden of 472,643 hours [9.083 hr/response × (40,507 clinicians submitting as individuals + 11,527 groups submitting via QCDR or MIPS CQM on behalf of individual clinicians or 52,036 responses)] at a cost of $ $48,016,739 (52,036 responses × $922.76/response). For the CY 2023 performance period/2025 MIPS payment year, in aggregate, we estimate a burden of 425,902 hours [9.083 hr/response × (36,456 clinicians submitting as individuals + 10,434 groups submitting via QCDR or MIPS CQM on behalf of individual clinicians or 46,890 responses)] at a cost of $43,268,216 (46,890 responses × $922.76/response).

Based on these assumptions, we have estimated in Start Printed Page 65585 Table 93 the burden for these submissions. As shown in Table 94, using the unchanged currently approved hours per respondent burden estimate, the decrease of 913 respondents from 52,944 to 52,036 for the CY 2022 performance period/2024 MIPS payment year results in a decrease of −8,247 hours (−908 respondents × 9.083 hr/respondent) and −$837,866 (908 respondents × $922.76/respondent). We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 425,902 hours (46,890 respondents × 9.083 hr/respondent) and $43,268,216 (46,890 respondents × $922.76/respondents). Start Printed Page 65586 (6) Quality Data Submission by Clinicians and Groups.

ECQM Collection Type The following requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77505 through 77506), CY 2018 Quality Payment Program final rule (82 FR 53914 through 53915), CY 2019 PFS final rule (83 FR 60006 through 60007), CY 2020 PFS final rule (84 FR 63128 through 63130) and the CY 2021 PFS final rule (85 FR 84979 through 84980) for our previously finalized requirements and burden for quality data submission via the eCQM collection types. For the change in associated burden for quality data submission related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99 of this section. Based on CY 2019 performance period/2021 MIPS payment year data, for the CY 2022 performance period/2024 MIPS payment year, we assume that 322,392 clinicians will elect to use the eCQM collection type.

40,446 clinicians are expected to submit eCQMs as individuals. And 8,127 groups and virtual groups are expected to submit eCQMs on behalf of the remaining 273,819 clinicians. This is a decrease of 2,109 individuals and 27 groups from the estimates of 42,555 individuals and 8,154 groups provided in the CY 2021 PFS final rule (85 FR 84979). We expect the burden to be the same for each respondent using the eCQM collection type, whether the clinician is participating in MIPS as an individual or group.

Under the eCQM collection type, the individual clinician or group may either submit the quality measures data directly to us from their eCQM, log in and upload a file, or utilize a third-party intermediary to derive data from their CEHRT and submit it to us on the clinician's or group's behalf. To prepare for the eCQM collection type, the clinician or group must review the quality measures on which we will be accepting MIPS data extracted from eCQMs, select the appropriate quality measures, extract the necessary clinical data from their CEHRT, and submit the necessary data to a QCDR/qualified registry or use a health IT vendor to submit the data on behalf of the clinician or group. We assume the burden for collecting quality measures data via eCQM is similar for clinicians and groups who submit their data directly to us from their CEHRT and clinicians and groups who use a health IT vendor to submit the data on their behalf. This includes extracting the necessary clinical data from their CEHRT and submitting the necessary data to a QCDR/qualified registry.

We estimate that it will take no more than 2 hours at $95.22/hr for a computer systems analyst to submit the actual data file. The burden will also involve becoming familiar with MIPS quality measure specifications. In this regard, we estimate it will take 6 hours for a clinician or group to review measure specifications. Of that time, we estimate 2 hours at $114.24/hr for a medical and health services manager, 1 hour at $217.32/hr for a physician, 1 hour at $95.22/hr for a computer systems analyst, 1 hour at $48.16/hr for an LPN, and 1 hour at $40.02/hr for a billing clerk.

Overall, we estimate a cost of $812.76/response [(2 hr × $95.22/hr) + (2 hr × $114.24/hr) + (1 hr × $217.32/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr)]. For the CY 2022 performance period/2024 MIPS payment year, in aggregate, we estimate a burden of 388,584 hours [8 hr × 48.573 (40,446 clinicians + 8,127 groups and virtual groups)] at a cost of $39,812,374 (48,573 responses × $819.64/response). For the CY 2023 performance period/2025 MIPS payment year, in aggregate, we estimate a burden of 350,186 hours [8 hr × 43,773 (36,401 clinicians + 7,372 groups and virtual groups)] at a cost of $35,878,102 (43,773 responses × $819.64/response). Based on these assumptions, we have estimated in Table 95 the burden for these submissions.

Start Printed Page 65587 As shown in Table 96, using the unchanged currently approved hours per respondent burden estimate, the decrease of 1,902 respondents from 50,475 to 48,573 for the CY 2022 performance period/2024 MIPS payment year results in a total difference of ×15,216 hours at a cost of ×$1,558,955. For CY 2023 performance period/2025 MIPS payment year, we are setting forth our estimate as new burden, which represents an increase of 350,184 hours (43,773 respondents × 8 hr/respondent) and $35,878,102 (43,773 respondents × $819.64/respondent). Start Printed Page 65588 (7) ICRs Regarding Burden for MVP Reporting Section IV.A.3.b.(2)(d) of this rule describes provisions related to implementing MVPs beginning with the CY 2023 performance period/2025 MIPS payment year. The MVPs will include the Promoting Interoperability performance category as a foundational element and incorporate population health claims-based measures, as feasible, along with the relevant measures and activities in the quality, cost, and improvement activities performance categories.

For the CY 2023 performance period/2025 MIPS payment year, we are finalizing an inventory of seven MVPs included in Appendix 3. MVP Inventory of this rule to assess performance across MVPs for the quality, cost, improvement activities, and Promoting Interoperability performance categories. Additionally, in section IV.A.3.b.(2)(b)(i) of this rule, we are finalizing to use the term “MVP Participant” to refer to clinicians who will choose to participate in MIPS for reporting MVPs. The following new ICRs reflect the burden associated with the first year of data collection related to the implementation of MVPs and subgroup reporting in the CY 2023 performance period/2025 MIPS payment year as described in section IV.A.3.b.(2)(c) of this rule.

The requirements and burden associated with the implementation of MVPs and subgroups will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). While MVP respondents report on all performance categories, we believe that for purposes of data submission, the burden for clinicians submitting information for the Promoting Interoperability and improvement activities performance categories of MVPs will be consistent with the currently approved estimated burden per respondent for clinicians submitting data for these performance categories in traditional MIPS. We acknowledge that clinicians participating through MVPs will have fewer requirements to meet for the improvement activity performance category as discussed in section IV.A.3.b.(4)(d)(iv) of this final rule. We assume that these requirement changes will not significantly lower the burden for clinicians reporting MVPs.

Therefore, we will not add additional ICRs to capture the burden for the Promoting Interoperability and Improvement Activity performance categories. For this rule, we are finalizing to create a separate ICR for estimating the burden associated with data submission for the Quality performance category of MVPs. We considered whether we should have a separate ICR to estimate burden for submission of measures and activities in the Promoting Interoperability performance category of MVPs. Based on our assumption above that the burden for clinicians submitting information for these performance categories of MVPs will be consistent with the currently approved estimated burden per respondent for clinicians submitting data in traditional MIPS, we anticipate that the separate ICRs will not be of value to clinicians.

We solicited comment on our proposal to distinctly estimate burden only for data submission in the Quality performance category of MVPs and whether we should revise the MVP submission ICR to include all the four MIPS performance categories and whether our assumptions on Promoting Interoperability and Improvement Activities should be modified for MVPs. We did not receive public comments on this provision. We are finalizing as proposed. (a) Burden for MVP Quality Submission In section IV.A.3.b.(4)(d)(ii) of this rule, we are finalizing to implement voluntary MVP reporting beginning with the CY 2023 performance period/2025 MIPS payment year.

Therefore, clinicians participating in MIPS will have the option to voluntarily submit data using MVPs starting with the CY 2023 performance period/2025 MIPS payment year. While we recognize the implementation of MVPs in MIPS will result in a burden for registration, we also assume that MVP reporting will result in a decline in burden for MVP participants due to the finalized changes in the MVP reporting requirements described in section IV.A.3.b.(4)(d) of this rule. We anticipate that the clinicians choosing to participate in MIPS for reporting MVPs will need to select from a reduced inventory of measures and activities for the quality and improvement activities performance categories. This reduction in burden is described in the quality, improvement activities and Promoting Interoperability performance categories sections below.

For the ICRs related to MVP participants, we used the MIPS submission data from the CY 2019 performance period/2021 MIPS payment year. Based on our review of the inventory of 7 MVPs in Appendix 3. MVP Inventory of this rule and the existing submission trends in MIPS for the measures and activities included in these MVPs, we anticipate that 10 percent of the clinicians who participate in traditional MIPS in the CY 2022 performance period/2024 MIPS payment year will report MVPs in the CY 2023 performance period/2025 MIPS payment year. Given that MVPs are new, voluntary, and represent a Start Printed Page 65589 reduction in burden per response, we believe that we should be conservative in estimating the number of clinicians submitting through MVPs during the initial year.

Given that MVPs are a new mechanism available for clinicians, we believe that initial participation numbers will be relatively low. In an effort to be conservative in our estimate of burden reduction due to MVP reporting and reflect the anticipate low uptake by clinicians in the first year of MVP availability, we assume that a total of 10 percent of MIPS submitters will become MVP participants in the CY 2023 performance period/2025 MIPS payment year. As described in section IV.A.3.b.(2)(c)(ii) of this rule, beginning with the CY 2023 performance period/2025 MIPS payment year, we are finalizing voluntary subgroup reporting within MIPS limited to clinicians reporting the MVP or the APP. We recognize the implementation of subgroups for clinicians to participate in MVP and APP reporting in MIPS will result in additional burden.

However, we believe that subgroup participation option will allow clinicians in certain specialties and subspecialties to report on measures and activities meaningful to the scope of care provided. We anticipate that public reporting of subgroup performance information will allow patients to identify clinicians in multispecialty groups that are representative of the care specific to their clinical condition. Clinician participation in subgroups is new to MIPS and we do not have any historical participation data to estimate the submission burden for clinicians who will choose to participate as subgroups for reporting the MVP or the APP. We refer readers to section IV.A.3.b.(3) of this final rule for details on the provisions related to subgroup composition.

We anticipate that the subgroup reporting option will increase reporting and allow clinicians in specialties to report on measures and activities meaningful to their practice. Due to the delay in implementation of subgroup reporting in the CY 2023 performance period/2025 MIPS payment year, we anticipate that there is an adequate amount of time for clinicians that historically participate in MIPS to determine if they will be able to participate as subgroups for reporting on the measures and activities in an MVP. However, due to the limited number of MVPs available for clinicians to choose, the additional burden involved in reporting, and also given the voluntary option to participate as subgroups for reporting the MVPs or the APP, we anticipate that a relatively small number of clinicians will choose to participate as subgroups in the CY 2023 performance period/2025 MIPS payment year. Therefore, we assume there will be 20 subgroups reporters in the CY 2023 performance period/2025 MIPS payment year.

We assume that more clinicians will choose to participate as subgroups in future years. We solicited comment on our MVP and subgroup reporting assumptions for the CY 2023 performance period/2025 MIPS payment year. We received public comments on our MVP and subgroup reporting assumptions for the CY 2023 MIPS performance period/2025 MIPS payment year. The following is a summary of the comments we received and our responses.

Comment. One commenter stated that our estimate that 10 percent of eligible clinicians would report as MVP participants in the first year of implementation is low. The commenter shared their belief that the number of MVP participants would be higher because of the reduced reporting burden associated with MVP reporting. Response.

We thank the commenter for their feedback. We acknowledge the commenter's concern that our assumptions for MVP reporting are low. We agree with the commenter that MVP reporting is associated with a reduction in reporting burden. However, we believe that our estimates are appropriate because there would be a limited number of MVPs available for all clinicians during the CY 2023 performance period/2025 MIPS payment year.

We expect that there would be increased participation in MVP reporting as more MVPs become available for clinicians in future years. We plan to revise our estimates for future years as more data becomes available. After consideration of public comments, we are finalizing our proposed estimate for the number of MIPS eligible clinicians that would participate in MVP reporting during the CY 2023 performance period/2025 MIPS payment year. (i) Burden for MVP Registration.

Individuals, Groups and APM Entities Beginning with the CY 2023 performance period/2025 MIPS payment year, we are finalizing that clinicians interested in participating in MIPS through MVP reporting would be required to complete an annual registration process described in section IV.A.3.b.(4)(f) of this rule. At the time of registration, MVP participants would need to select a specific MVP, a population health measure and if administrative claims measures are included in the selected MVP, the MVP participants would also need to choose an applicable administrative claims measure in the MVP. We refer readers to section IV.A.3.b.(4)(f) of this rule for additional details on MVP registration requirements. Due to the delay in implementation of MVPs to the CY 2023 performance period/2025 MIPS payment year, we anticipate that there is an adequate amount of time for clinicians that historically participate in MIPS to determine if the measures and activities in an MVP are applicable to the scope of care provided.

In Table 97, we estimate that the registration process for clinicians choosing to submit MIPS data for the measures and the activities in an MVP would require 0.25 hours of a computer systems analyst's time, similar to the currently approved burden of group registration process for CMS Web Interface finalized in the CY 2021 PFS final rule (85 FR 84983) for the CY 2023 performance period/2025 MIPS payment year. We assume that the staff involved in the MVP registration process will mainly be computer systems analysts or their equivalent, who have an average labor cost of $95.22/hour. As discussed above, based on data from the CY 2019 performance period/2021 MIPS payment year, we assume that approximately 10 percent of the clinicians that currently participate in MIPS would submit data for the measures and activities in an MVP. Note that we apply this 10 percent calculation after adding the clinicians who begin submitting though the CQM and eCQM collection types due to the sunset of Web Interface in the CY 2023 performance period/2025 MIPS payment year.

For the CY 2023 performance period/2025 MIPS payment year, we assume that a total of 25,798 submissions will be received for the measures and activities included in MVPs. This total includes our estimate of 20 subgroup reporters that would also be reporting MVPs in addition to MVP reporters who currently participate in MIPS. Therefore, we assume that the total number of individual clinicians, groups, subgroups and APM Entities to complete the MVP registration process is 12,917. We estimate that the total cost to clinicians participating as individuals and groups associated with the MVP registration process would be approximately $307,465.

Table 97 includes our burden assumptions related to the MVP registration process for clinicians participating in MIPS for Start Printed Page 65590 reporting MVPs as individuals, groups, subgroups, and APM Entities. (ii) Burden for Subgroup Registration We are finalizing the proposal to add a separate ICR to estimate the burden associated with subgroup registration to capture the subgroup registration requirements in section IV.A.3.b.(4)(f)(ii)(D) of this rule. In section IV.A.3.b.(3)(b)(ii) of this rule, we finalized the definition of a subgroup at § 414.1305 as a subset of a group, as identified by a combination of the group TIN, the subgroup identifier, and each eligible clinician's NPI. In addition to the burden for MVP registration process described above, clinicians who choose to form subgroups for reporting the MVPs or the APP will need to submit a list of each TIN/NPI associated with the subgroup and a plain language name for the subgroup in a manner specified by CMS, described in section IV.A.3.b.(4)(f)(ii)(D) of this rule.

As discussed above, we estimate that clinicians will choose to form 20 subgroups for reporting the measures and activities in MVPs. Additionally, we estimate that clinicians who choose to participate as subgroups for reporting MVPs will require a minimum of 0.5 hours per subgroup respondent to submit the finalized requirements for subgroup registration. We assume that the staff involved in the subgroup registration process will mainly be computer systems analysts or their equivalent, who have an average labor cost of $95.22/hr. We assume that all subgroups would report MVPs, the burden associated with subgroup quality reporting will be included with the MVP quality reporting ICR.

The burden associated with subgroup submissions for Promoting Interoperability and improvement activities will be included with those ICRs. (iii) Burden for MVP Quality Performance Category Submission In the CY 2017 PFS final rule (81 FR 77100 through 77114), we established the submission criteria for quality measures (excluding the CMS Web Interface measures and the CAHPS for MIPS survey measure) at § 414.1335, which requires a MIPS eligible clinician, group, or virtual group that is reporting on Qualified Clinical Data Registry (QCDR) measures, MIPS clinical quality measures (MIPS CQMs), electronic CQMs (eCQMs), or Medicare Part B claims measures to submit data on at least six measures, including at least one outcome measure. As discussed in section IV.A.3.b.(4)(d)(ii) of this final rule, we finalized the proposal that except as provided in paragraph Start Printed Page 65591 § 414.1365(c)(1)(i), an MVP Participant must select and report 4 quality measures, including 1 outcome measure (or, if an outcome measure is not available, 1 high priority measure, included in the MVP. The decrease in the number of required measures in the quality performance category from 6 to 4 is a two-thirds reduction in the number of measures needed for eligible clinicians to submit data for the quality performance category in MVPs described in Appendix 3.

MVP Inventory of this final rule. Therefore, we estimate that the time for submitting the measures in the MVP quality performance category would, on average, take two-thirds of the currently approved burden per respondent for the quality performance category as it does to complete a MIPS quality submission through the CQM, eCQM, and Claims submission types. As described above in this section of the final rule, we estimate that 10 percent of the clinicians who participated in MIPS for the CY 2019 performance period/2021 MIPS payment year would submit data for the quality performance category of MVPs beginning with the CY 2023 performance period/2025 MIPS payment year. We anticipate that there would be 20 subgroups reporters in the CY 2023 performance period/2025 MIPS payment year.

As shown in Table 99, we estimate that approximately 2,825 clinicians would submit data for the MVP quality performance category using the Medicare Part B claims collection type. Approximately 5,210 clinicians and 10 subgroups would submit data using MIPS CQM and QCDR collection type. And approximately 4,862 clinicians and 10 subgroups would submit data using eCQMs collection type. We want to note that we used the same methodologies used in sections V.B.8.e.(4), V.B.8.e.(5) and V.B.8.e.(6) to estimate the quality submission burden for each collection type.

As shown in Table 99, for the clinicians and subgroups submitting data for the MVP quality performance category, we estimate a burden of 26,670 hours (9.44 hr × 2,825 clinicians) at a cost of $2,691,329 (2,825 respondents × 952.68/respondent) for the Medicare Part B claims collection type, 31,163 hours [5.97 hr × 5,220 (5,210 + 10)] at a cost of $3,211,216 (5,220 × 615.18/respondent) for the MIPS CQM and QCDR collection type, and 25,822 hours [5.3 hr × 4,872 (4,862 + 10) respondents] at a cost of $2,662,191 (4,872 × 546.43/respondent) for the eCQM collection types. Start Printed Page 65592 (8) Quality Data Submission via CMS Web Interface The finalized requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). Background In the CY 2021 PFS final rule, we finalized our policy to sunset the CMS Web Interface measures as a collection type/submission type starting with the CY 2022 performance period/2024 MIPS payment year. As a result of this provision, for the CY 2022 performance period/2024 MIPS payment year, we estimated a burden of zero due to our assumption that all Web Interface respondents will alternately utilize either the MIPS CQM and QCDR or eCQM collection types (85 FR 84981).

In section IV.A.3.d.(1)(d) of this rule, we are finalizing to continue the CMS Web Interface measures as a collection type for the CY 2022 performance period/2024 MIPS payment year. Additionally, we are finalizing to sunset the CMS Web Interface measures as a collection type for the CY 2023 performance period/2025 MIPS payment year. For this final rule, we estimate burden for the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. For the CY 2022 performance period/2024 MIPS payment year, we assume that 114 groups will submit quality data via the CMS Web Interface based on the number of groups who completed 100 percent of reporting quality data via the Web Interface in the CY 2019 performance period/2021 MIPS payment year.

This is an increase of 114 groups from the currently approved number of 0 groups provided in the CY 2021 PFS final rule (85 FR 84981 due to the provision to continue with the CMS Web Interface as a collection type for the CY 2022 performance period/2024 MIPS payment year. We estimate that 44,385 clinicians will submit as part of groups via this method, an increase of 44,385 from our currently approved estimate of 0 clinicians. The estimated burden associated with the group submission requirements is the time and effort associated with submitting data on a sample of the organization's beneficiaries that is Start Printed Page 65593 prepopulated in the CMS Web Interface. Our burden estimate for submission includes the time (61 hours and 40 minutes or 61.67 hours) needed for each group to populate data fields in the web interface with information on approximately 248 eligible assigned Medicare beneficiaries and submit the data (we will partially pre-populate the CMS Web Interface with claims data from their Medicare Part A and B beneficiaries).

The patient data either can be manually entered, uploaded into the CMS Web Interface via a standard file format, which can be populated by CEHRT, or submitted directly. Each group must provide data on 248 eligible assigned Medicare beneficiaries (or all eligible assigned Medicare beneficiaries if the pool of eligible assigned beneficiaries is less than 248) for each measure. In aggregate, we estimate a burden for the CY 2022 performance period/2024 MIPS payment year of 7,030 hours (114 groups × 61.67 hr) at a cost of $669,433 (114 groups × $5,872.21/group). For the CY 2023 performance period/2025 MIPS payment year, we are finalizing to revise our estimated burden to zero due to our assumption that with the finalized policy to sunset the CMS Web Interface as a collection type, all Web Interface respondents will alternately utilize either the MIPS CQM and QCDR or eCQM collection types.

Based on the assumptions discussed in this section, Table 100 summarizes the finalized estimated burden for groups submitting to MIPS via the CMS Web Interface. (9) Beneficiary Responses to CAHPS for MIPS Survey This rule is not implementing any new or revised collection of information requirements or burden related to the CAHPS for MIPS survey. The CAHPS for MIPS survey requirements and burden are currently approved by OMB under control number 0938-1222 (CMS-10450). Consequently, we are not making any changes to the CAHPS for MIPS Survey process under that control number.

(10) Group Registration for CMS Web Interface The finalized requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). In the CY 2021 PFS final rule, we finalized to sunset the CMS Web Interface measures as a collection type/submission type starting with the CY 2022 performance period/2024 MIPS payment year. As a result, we estimated that there will be zero hours and $0 burden for group registration for the CMS Web Interface for the CY 2022 performance period/2024 MIPS payment year (85 FR 84984). As discussed in section IV.A.3.d.(1)(d) of this final rule, we are finalizing to continue the CMS Web Interface measures as a collection type for the CY 2022 performance period/2024 MIPS payment year.

We are also finalizing to sunset the CMS Web Interface as a collection type starting with the CY 2023 performance period/2025 MIPS payment year. Start Printed Page 65594 Groups interested in participating in MIPS using the CMS Web Interface for the first time must complete an online registration process. After first time registration, groups will only need to opt out if they are not going to continue to submit via the CMS Web Interface. In Table 102, we estimate that the registration process for groups under MIPS involves approximately 0.25 hours at $95.22/hr for a computer systems analyst (or their equivalent) to register the group.

Because we are finalizing to sunset the CMS Web Interface beginning with the CY 2023 performance period/2025 MIPS payment year, it is possible that fewer groups will elect to register to submit quality data for the first time in the performance year prior to the collection type/submission type no longer being available. However, we currently have no data with which to estimate what the associated reduction may be. Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84983), we continue to assume that approximately 90 groups will elect to use the CMS Web Interface for the first time during the CY 2022 performance period/2025 MIPS payment year based on the estimated number of new registrations during the CY 2021 performance period/2023 MIPS payment year. As shown in Table 102, we estimate a burden of 23 hours (90 new registrations × 0.25 hr/registration) at a cost of $2,190 (22.5 hr × $95.22/hr).

As shown in Table 103, the estimated increase in the number of groups registering for the CMS Web Interface collection type to submit the MIPS data and the estimated increase in burden per respondent results in adjustment to the total time burden of +23 hours (+90 respondents × 0.25 hr/respondent) at a cost of $2,190 for the CY 2022 performance period/2024 MIPS payment year. For the CY 2023 performance period/2025 MIPS payment year, our finalized burden estimate is zero hours and $0. (11) Group Registration for CAHPS for MIPS Survey This rule is not implementing any new or revised collection of information requirements or burden related to the group registration for the CAHPS for MIPS Survey. The CAHPS for MIPS survey requirements and burden are currently approved by OMB under control number 0938-1222 (CMS-10450).

Consequently, we are not making any changes to the CAHPS for MIPS Survey registration process under that control number. F. ICRs Regarding the Call for MIPS Quality Measures This rule is not implementing any new or revised collection of information requirements or burden related to the call for MIPS quality measures. However, outside of the rulemaking process we replaced the existing tool for stakeholders beginning with the 2021 Annual Call for Measures.

As described below, to account for the updated tool (MERIT), we are finalizing to revise our currently approved burden estimates. The updated tool and revised burden will be submitted to OMB under control number 0938-1314 (CMS-10621). Beginning with the 2021 Annual Call for Measures, we replaced the customary Office of the National Coordinator (ONC) Issue Tracking System Jira platform that stakeholders Start Printed Page 65595 used to submit candidate quality measure specifications and all supporting data files for CMS review with the MUC Entry/Review Information Tool (MERIT). For the ONC Issue Tracking System Jira platform used by stakeholders, the approved estimated time for a practice administrator to identify, propose, and link to a quality measure is 0.9 hours and for a clinician to identify, propose, link to quality measure, and complete the Peer Review Journal Article form is 4.6 hours (0.6 hours to identify, propose, and link to quality measure (84 FR 63132) and 4 hours to complete the Peer Review Journal Article Form (84 FR 63133), with a total estimated time of 5.5 hours per quality measure submission.

Based on the stakeholder experience with the updated tool and additional information collected at the time of submission, we estimate that it will add approximately 1.5 hours for the practice administrator at $114.24/hr and 0.5 hours at $217.32/hr for a clinician to identify, propose, and link the quality measure, and reduce approximately 2 hours at $217.32/hr for a clinician to complete the Peer Review Journal Article Form, resulting in a new estimated time of 2.4 hours for a practice administrator and 3.1 hours for a clinician, and an unchanged total estimated time of 5.5 hours per quality measure submission. In order to account for the implementation of the MERIT tool starting with the 2021 Annual Call for Measures, we are revising the estimated time required for a practice administrator to identify, propose, and link to a quality measure to 2.4 hours (from 0.9 hr) and a clinician to identify, propose, link to quality measure, and complete the Peer Review Journal Article Form to 3.1 hours (from 4.6 hr), resulting in a total estimated time of 5.5 hours per quality measure submission. Based on the number of submissions received during the CY 2020 Call for Quality Measures process, we anticipate receiving the same number of 28 submissions during the CY 2021 Call for Quality Measures process (84 FR 63132). Although the total estimated time of 5.5 hours for completing a quality measure submission using the MERIT tool (see Table 104) is the same estimated time as the ONC Issue Tracking System Jira platform, we need to account for the changes to the individual components of the estimated time required by a practice administrator and clinician using the MERIT tool.

Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84984), we estimate an annual burden of 154 hours (28 submissions × 5.5 hr/measure). Thus, we are finalizing to adjust our estimated annual burden from $30,197 (28 submissions × [(0.9 hr × $110.74/hr) + (4.6 hr × $212.78/hr)) to $26,541 (28 measures × [(2.4 hr × $114.24/hr) + (3.1 hr × $217.32/hr)]) a difference of −$4,329 for the CY 2022 performance period/2024 MIPS payment year. As shown in Table 105, using our currently approved burden estimates, the redistribution of the estimated time needed for the clinician and practice administrator as discussed above, we are estimating an adjustment of 0 hours at a cost of −$4,329 for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of $26,541 (28 measures × $947.89/respondent).

Start Printed Page 65596 g. ICRs Regarding Promoting Interoperability Data (§§ 414.1375 and 414.1380) (1) Background For the CY 2022 performance period/2024 MIPS payment year, clinicians and groups can submit Promoting Interoperability data through direct, log in and upload, or log in and attest submission types. With the exception of submitters who elect to use the log in and attest submission type for the Promoting Interoperability performance category, which is not available for the quality performance category, we anticipate that individuals and groups will use the same data submission type for both of these performance categories and that the clinicians, practice managers, and computer systems analysts involved in supporting the quality data submission will also support the Promoting Interoperability data submission process. The following burden estimates show only incremental hours required above and beyond the time already accounted for in the quality data submission process.

Although this analysis assesses burden by performance category and submission type, we emphasize that MIPS is a consolidated program and submission analysis, and decisions are expected to be made for the program as a whole. (2) Reweighting Applications for Promoting Interoperability and Other Performance Categories The finalized requirements and burden associated with this rule's data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53918 through 53919), CY 2019 PFS final rule (83 FR 60011 through 60012), CY 2020 PFS final rule (84 FR 63134 through 63135), and the CY 2021 PFS final rule (85 FR 84984 through 84985) for our previously finalized requirements and burden for reweighting applications for Promoting Interoperability and other performance categories. As established in the CY 2017 and CY 2018 Quality Payment Program final rules, MIPS eligible clinicians who meet the criteria for a significant hardship or other type of exception may submit an application requesting a zero percent weighting for the Promoting Interoperability, quality, cost, and/or improvement activities performance categories under specific circumstances (81 FR 77240 through 77243, 82 FR 53680 through 53686, and 82 FR 53783 through 53785).

Respondents who apply for a reweighting of the quality, cost, and/or improvement activities performance categories have the option of applying for reweighting of the Promoting Interoperability performance category on the same online form. We assume that respondents applying for a reweighting of the Promoting Interoperability performance category due to extreme and uncontrollable circumstances will also request a reweighting of at least one of the other performance categories simultaneously and not submit multiple reweighting applications. Table 106 summarizes the burden for clinicians to apply for reweighting of the Promoting Interoperability performance category to zero percent due to a significant hardship exception or as a result of a decertification of an EHR. Based on the number of reweighting applications received by March, 2021 for the CY 2020 performance period/2022 MIPS payment year, we assume 20,192 respondents (eligible clinicians or groups) will submit a request to reweight the Promoting Interoperability performance category to zero percent due to a significant hardship or EHR decertification and an additional 22,635 respondents will submit a request to reweight one or more of the quality, cost, Promoting Interoperability, or improvement activities performance categories due to an extreme or uncontrollable circumstance.

For the CY 2022 performance period/2024 MIPS payment year, we estimate that a total of 42,797 reweighting applications will be submitted. This is a decrease of 9,302 respondents compared to our currently approved estimate of 52,099 respondents (85 FR 84984). This decrease is likely due to the provision in section IV.A.3.e.(2)(b)(iv)(A) of this rule to automatically reweight the Promoting Interoperability performance category for small practices who previously had to apply for reweighting. For the CY 2020 performance period/2024 MIPS payment year, 13,894 respondents requested reweighting due to significant hardship for small practices.

Similar to the data used to estimate the number of respondents in the CY 2021 PFS final rule, our respondent estimate includes a significant number of applications submitted as a result of a data issue CMS was made aware of and is specific to a single third-party intermediary. While we do not anticipate similar data issues to occur in each performance period, we do believe future similar incidents may occur and are electing to use this data without adjustment to reflect this belief. Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84984), our respondent estimate does not include reweighting Start Printed Page 65597 applications submitted during the extended period ending November 29, 2021 due to the PHE for buy antibiotics, as we do not believe it would be an accurate basis of future estimates for reweighting application submissions. We assume that, out of our total respondent count of 42,797 above, we estimate that 22,605 respondents (eligible clinicians or groups) will submit a request for reweighting the Promoting Interoperability performance category to zero percent due to extreme and uncontrollable circumstances, insufficient internet connectivity, lack of control over the availability of CEHRT, or as a result of a decertification of an EHR.

In the CY 2021 PFS final rule (85 FR 84984) we discussed that, beginning with the CY 2019 performance period/2021 MIPS payment year, APM Entities may submit an extreme and uncontrollable circumstances exception application for all four performance categories and applicable to all MIPS eligible clinicians in the APM Entity group. As discussed in this section of this final rule, due to data limitations and our inability to determine who will use the APP versus the traditional MIPS submission mechanism for the CY 2022 performance period/2024 MIPS payment year, we assume ACO APM Entities will submit data through the APP and non-ACO APM Entities will participate through traditional MIPS, thereby submitting as an individual or group rather than as an entity. Therefore, we limited our analysis to ACOs that were eligible for an exception due to extreme and uncontrollable circumstances during the CY 2020 performance period/2022 MIPS payment year and elected not to report quality data. Based on this data, we estimate that 30 APM Entities will submit an extreme and uncontrollable circumstances exception application for the CY 2022 performance period/2024 MIPS payment year.

Combined with our aforementioned estimate of 42,797 eligible clinicians and groups, the total estimated number of respondents for the CY 2022 performance period/2024 MIPS payment year is 42,827. Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84984-84985), we continue to estimate it will take 0.25 hours for a computer system analyst to complete and submit the application. As shown in Table 106, we estimate an annual burden of 10,707 hours (42,827 applications × 0.25 hr/application) and $1,019,521 (10,707 hr × $95.22/hr). As shown in Table 107, using our currently approved burden estimates, the decrease in the estimated number of respondents (from 52,099 to 42,827 respondents) results in an adjustment of minus 2,318 hours (9,272 respondents × 0.25 hr/respondent) and minus $220,720 for the CY 2022 performance period/2024 MIPS payment year.

We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 10,707 hours (42,827 respondents × 0.25 hr/respondent) and $1,019,521 (10,707 hours × $95.22/respondents). Start Printed Page 65598 (3) Submitting Promoting Interoperability Data The requirements and burden associated with this rule's data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77509 through 77511), CY 2018 Quality Payment Program final rule (82 FR 53919 through 53920), CY 2019 PFS final rule (83 FR 60013 through 60014), CY 2020 PFS final rule (84 FR 63135 through 63137), and the CY 2021 PFS final rule (85 FR 84985 through 84987) for our previously finalized requirements and burden for submission of data for the Promoting Interoperability performance category. In section IV.A.3.d.(4)(d)(ii) of this final rule, we are finalizing the additional requirement that MIPS eligible clinicians must attest to conducting an annual assessment of the High Priority Guides of the SAFER Guides beginning with the CY 2022 performance period/2024 MIPS payment year.

Clinicians will complete this attestation by checking a box when they submit their Promoting Interoperability performance category data. We estimate that this requirement will add an additional minute to the current estimated time it takes to complete the submission of Promoting Interoperability data. In the CY 2022 PFS proposed rule, we assumed no change in estimates as result of the proposal to modify the Provide Patients Electronic Access to Their Health Information measure to require MIPS eligible clinicians to ensure that patient health information remains available to the patient (or patient-authorized representative) to access indefinitely (86 FR 39509). As discussed in section IV.

Of this final rule, this policy is not being finalized as proposed at this time. As shown in Table 108, based on data from the CY 2019 performance period/2021 MIPS payment year, we estimate that a total of 51,647 respondents consisting of 40,172 individual MIPS eligible clinicians and 11,475 groups and virtual groups will submit Promoting Interoperability data. Since our CY 2021 PFS final rule estimated 53,636 respondents, this represents a decrease of 1,989 respondents (51,647 respondents −53,636 active respondents). We assume that MIPS eligible clinicians previously scored under the APM scoring standard, as described in the CY 2020 PFS final rule, will continue to submit Promoting Interoperability data (84 FR 63006) in a similar way through the APP.

As a result, we do not anticipate any change in burden. Each MIPS eligible clinician in an APM Entity reports data for the Promoting Interoperability performance category through either their group TIN or individual reporting. Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 U.S.C.

1315a, respectively) state that the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models are not subject to the PRA. However, in the CY 2019 PFS final rule, we established that MIPS eligible clinicians who participate in the Shared Savings Program are no longer limited to reporting for the Promoting Interoperability performance category through their ACO participant TIN (83 FR 59822 through 59823). Burden estimates for this final rule assume group TIN-level reporting as we believe this is the most reasonable assumption for the Shared Savings Program, which requires that ACOs include full TINs as ACO participants. Start Printed Page 65599 As discussed in section IV.A.3.b.(2)(c)(ii) of this final rule, we will be introducing subgroup reporting in CY 2023 performance period/2025 MIPS payment year.

As we discussed above in this section of the final rule, we estimate that there will be 20 subgroup submissions in CY 2023 performance period/2025 MIPS payment year, each of which will have burden related to the submission of Promoting Interoperability data. We have included this burden in Table 109. With the inclusion of the additional minute (0.02 hr) to attest to conducting an annual assessment of the High Priority Guides of the SAFER Guides, we are adjusting our estimate of the time required for an individual or group to submit Promoting Interoperability data from 2.67 hours to 2.69 hours (2.67 hr + 0.02 hr). As shown in Table 110, the total burden estimate for submitting data on the specified Promoting Interoperability objectives and measures is estimated to be 138,930 hours (51,647 respondents × 2.69 incremental hours for a computer analyst's time above and beyond the physician, medical and health services manager, and computer system's analyst time required to submit quality data) and $13,228,915 (138,930 hr × $95.22/hr)).

As shown in Table 111, with the introduction of subgroup reporting in CY 2023 performance period/2025 MIPS payment year, the total burden for submitting data on the specified Promoting Interoperability objectives and measures is estimated to be 138,984 hours (51,667 respondents × 2.69 incremental hours for a computer analyst's time above and beyond the physician, medical and health services manager, and computer system's analyst time required to submit quality data) and $13,234,078 (138,984 hr × $95.22/hr)). Start Printed Page 65600 Table 112, using our updated per respondent burden estimate (+0.02 hr/response), the decrease in number of respondents and SAFER guide attestation requirement results in a total adjustment of −4,278 hours at a cost of −$407,351 for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 138,984 hours (51,667 respondents × 2.69 incremental hours for a computer analyst's time above and beyond the physician, medical and health services manager, and computer system's analyst time required to submit quality data) and $13,234,078 (138,984 hours × $95.22/hour). h.

ICRs Regarding the Nomination of Promoting Interoperability (PI) Measures This rule is not implementing any new or revised collection of information requirements or burden related to the nomination of Promoting Interoperability measures. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the process for nomination of Promoting Interoperability measures under that control number. I.

ICR Regarding Improvement Activities Submission (§§ 414.1305, 414.1355, 414.1360, and 414.1365) The finalized requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77511 through 77512), CY 2018 Quality Payment Program final rule (82 FR 53920 through 53922), CY 2019 PFS final rule (83 FR 60015 through 60017), CY 2020 PFS final rule (84 FR 63138 through 63140) and the CY 2021 PFS final rule (85 FR 84987 through 84989) for our previously finalized requirements and burden for submission of data for the improvement activities performance category. In section IV.A.3.d.(3) of this rule, we are finalizing to. (1) Revise group reporting requirements for the 50 percent threshold to address subgroups.

(2) add 7 new improvement activities, modify 15 existing improvement activities, and remove 6 previously adopted improvement activities for the CY 2022 performance period/2024 MIPS payment year and future years. (3) revise the “Drug Cost Transparency to include requirements for use of real-time benefit tools” improvement activity. And (4) add the buy antibiotics “Clinical Data Reporting with or without Clinical Trial” improvement activity for CY 2022 performance period/2024 MIPS payment year and future years. Additionally, we are finalizing to adjust our currently approved burden estimates based on more recent data.

Specifically, we are finalizing to revise § 414.1360(a)(2) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, each improvement activity for which groups and virtual Start Printed Page 65601 groups submit a yes response in accordance with paragraph (a)(1) of this section must be performed by at least 50 percent of the NPIs that are billing under the group's TIN or virtual group's TINs or that are part of the subgroup, as applicable. And the NPIs must perform the same activity during any continuous 90-day period within the same performance year. In section IV.A.3.d.(3)(b) of this rule, we discussed stakeholder requests through the Quality Payment Program help desk to apply the 50 percent threshold to a portion of clinicians in a group. We anticipate that clinicians will find applicable and meaningful activities specific to practice size, specialty, or practice setting.

Therefore, we assume that the provision to apply the 50 percent minimum threshold to clinicians who submit for the improvement activity performance category as part of groups, virtual groups, or choose to participate as subgroups beginning with the CY 2023 performance period/2025 MIPS payment year will not present additional complexity or burden. We do not believe the changes to the improvement activities inventory will impact time or financial burden on stakeholders because MIPS eligible clinicians are still required to submit the same number of activities and the per response time for each activity is uniform. Therefore, we are not adjusting the estimated time of 5 minutes (per response) currently approved for improvement activities submission. As represented in Table 113, based on data from the CY 2019 performance period/2021 MIPS payment year, we estimate that a total of 81,562 respondents consisting of 63,845 individual clinicians and 17,717 groups will submit improvement activities during the CY 2022 performance period/2024 MIPS payment year.

Since our currently approved burden sets out 79,927 respondents, this represents an increase of 1,635 respondents (81,562 respondents−79,927 active respondents). This is an increase of 1,242 individuals and 393 groups from the estimates of 62,603 individuals and 17,324 groups provided in the CY 2021 PFS final rule (85 FR 50362). As discussed in sections V.B.8.e. And V.B.8.g.(3) of this final rule regarding our estimate of clinicians and groups submitting data for the quality and Promoting Interoperability performance categories, we are finalizing to update our estimates for the number of clinicians and groups that will submit improvement activities data based on projections of the number of eligible clinicians that were not QPs or participating in an ACO in the CY 2019 performance period/2021 MIPS payment year but will be QPs in the CY 2022 performance period/2024 MIPS payment year, and will therefore not be required to submit improvement activities data.

As discussed in section IV.A.3.b.(2)(c)(ii) of this final rule, we are finalizing subgroup reporting in the CY 2023 performance period/2025 MIPS payment year. As we discussed in section V.B.8.e.(7)(a) of this final rule, we estimate that there will be 20 subgroup reporters in the CY 2023 performance period/2025 MIPS payment year, each of which will have burden related to the submission of improvement activities. We have included this burden in Table 114. Start Printed Page 65602 Consistent with the CY 2021 PFS final rule, we continue to estimate that the per response time required per individual or group is 5 minutes for a computer system analyst to submit by logging in and manually attesting that certain activities were performed in the form and manner specified by CMS with a set of authenticated credentials (84 FR 63140).

As shown in Table 115, we estimate an annual burden of 6,770 hours (81,562 responses × 0.083 hr) at a cost of $644,639 (6,770 hr × $95.22/hr)) for the CY 2022 performance period/2024 MIPS payment year. As shown in Table 116, with the introduction of subgroup reporting in the CY 2023 performance period/2025 MIPS payment year, we estimate an annual burden of 6,771 hours (81,582 responses × 0.083 hr) and $644,735 (6,771 hr × $95.22/hr). Start Printed Page 65603 As shown in Table 117, using our unchanged currently approved per respondent burden estimate, the increase in the number of respondents results in an adjustment of 109 hours at a cost of $10,379 (109 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 6,771 hours (81,582 responses × 0.083 hr) at a cost of $644,735 (6,771 hr × $95.22/hr).

j. ICRs Regarding the Nomination of Improvement Activities (§ 414.1360) The requirements and burden associated with this rule's data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53922), CY 2019 PFS final rule (83 FR 60017 through 60018), CY 2020 PFS final rule (84 FR 63141) and the CY 2021 PFS final rule (85 FR 84989 through 85 FR 84990) for our previously finalized requirements and information collection burden for the nomination of improvement activities. In section IV.A.3.d.(3)(c)(i)(B) of this rule, we are finalizing.

(1) To revise the required criteria for improvement activity nominations received through the Annual Call for Activities. (2) changes to the timeline for improvement activities nomination during a PHE. And (3) to suspend activities that become obsolete or impacted by clinical practice guideline changes from the program when this occurrence happens outside of the rulemaking process. In section IV.A.3.d.(3)(c)(i)(B)(cc) of this rule, we are finalizing 2 new criteria that beginning with the CY 2022 Annual Call for Activities MIPS improvement activities.

(1) Should not duplicate other improvement activities in the Inventory. And (2) should drive improvements that go beyond purely common clinical practices. Additionally, we are finalizing to increase the number of criteria stakeholders are required to meet when submitting an activity provision from a minimum of 1 to all 8 criteria, which includes the two new provision criteria. We believe that this provision will provide clearer guidance to stakeholders when submitting a nomination for an improvement activity.

In the CY 2021 PFS final rule, we estimated that it would require 0.6 hours for a medical and health services manager or equivalent and 0.4 hours for a physician to link the nominated improvement activity to existing and related cost and quality measures (85 FR 84989). Given that our current approved estimated time per respondent to nominate an improvement activity is 3 hours (1.8 hours for a medical and health services manager or equivalent and 1.2 hours for a physician), we assume that the new requirement to meet all 8 criteria will require approximately 1 hour at $114.24/hr for a medical and health services manager to identify and submit an activity and 0.4 hours at a rate of $217.32/hr for a clinician to review each activity. Combined with our currently approved burden estimate, we are finalizing to revise our estimate to 2.8 hours at $114.24/hr for a medical and health services manager or equivalent and 1.6 hours at $217.32/hr for a physician to nominate an improvement activity. This represents a change of +1 Start Printed Page 65604 hours (2.8 hr − 1.8 hr) for a medical and health services manager or equivalent and +0.4 hours (2 hr − 1.6 hr) for a physician and an overall increase of 1.4 hours.

We considered whether we should double our estimates for nomination of an improvement activity to 6 hours. Since only 2 of the required 8 criteria are new, we assume that stakeholders are familiar with the existing criteria and will not need additional time to review but will need the additional time to verify and confirm if the considered activity meets all the 8 criteria. We solicited comment on our estimate to revise the time for nomination of an improvement activity to 4.4 hours and if there are additional burden implications that we should consider for above provisions to revise the criteria. We did not receive public comments on the proposed burden estimates for this information collection.

We are finalizing as proposed. The burden estimates have not been updated from the CY 2021 PFS proposed rule (86 FR 39514 through 39516). In the CY 2021 PFS final rule, we finalized an exception stating that during the PHE, stakeholders can nominate improvement activities outside of the established Annual Call for Activities timeframe (85 FR 84989). Instead of only accepting nominations and modifications submitted February 1st through July 1 each year, we would accept nominations for the duration of the PHE as long as the improvement activity is still relevant.

No other aspects of the Annual Call for Activities process would be affected (for example, criteria for nominating improvement activities, considerations for selection of improvement activities, or weighting policies would all still apply). In section IV.A.3.d.(3)(c)(i)(B)(aa) of this rule, we are finalizing to clarify that in order to implement a new improvement activity for a PHE during the same year as the nomination, the nomination will need to be received no later than January 5th of the nomination year to be included in a rule for notice-and-comment rulemaking during that fiscal or calendar year, a necessary precursor to implementation if it were to be finalized, as described above. We believe this provision will not affect our currently approved burden estimates since we assume that the number of nominations will not change, but it will make an activity available for reporting to clinicians in the same performance year it was intended to be implemented. Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84989), we expect additional nominations may be received as a result of this change.

However, we do not have any data with which to estimate what the additional number may be. As a result, we are not making any changes our currently approved burden estimate. In section IV.A.3.d.(3)(c)(i)(C)(aa) of this rule, we are finalizing that beginning with the CY 2022 performance period/2024 MIPS payment year, for each improvement activity that is in the Inventory, if applicable, and impacted by significant changes or errors prior to the applicable data submission deadline, it will be removed from the program as soon as possible. In the CY 2020 PFS final rule (84 FR 62988 through 62990), we finalized the factors for consideration in removing improvement activities.

Following the publication of the CY 2021 PFS proposed rule, the improvement activities team became aware that clinicians could no longer complete the activity from April 1 through December 31, 2020, because one of the improvement activities in the Inventory had expired on March 31, 2020. We do not anticipate any burden for stakeholders because of the above provision as described, the policy does not change requirements for the nomination of improvement activities. This provision will help avoid stakeholder confusion and ensure the accuracy of the available activities in the Inventory. Therefore, we are not making any changes to our estimated burden due to the above policy.

Additionally, consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84990) we continue to use our currently approved assumption that we will receive 31 nominations of new or modified activities which will be evaluated for the Improvement Activities Under Consideration (IAUC) list for possible inclusion in the CY 2023 Improvement Activities Inventory as we believe this estimate is more realistic than basing our estimate on the number of nominations received during the 2021 Annual Call for Activities. As shown in Table 118, accounting for the change in burden per respondent estimate due to the provision to require all the 8 criteria for nomination of an improvement activity as described above in this section, we are adjusting our estimated annual information collection burden to 136 hours (31 nominations × 4.4 hr/nomination) at a cost of $20,695 (31 × [(2.8 hr × $114.24/hr) + (1.6 hr × $217.32/hr)]). Start Printed Page 65605 As shown in Table 119, using our unchanged estimate of the number of activities nominated, the increase in the burden per nomination results in a change of 43 hours (31 nominations × 1.4 hr/nomination) at a cost of $6,492 (31 activities × [(1 hr × $114.24/hr) + (0.4 hr × $217.32/hr)]) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 136 hours (31 nominations × 4.4 hr) at a cost of $20,695 (31 × [(2.8 hr × $114.24/hr) + (1.6 hr × $217.32/hr)]).

k. Nomination of MVPs This rule is not implementing any new or revised collection of information requirements or burden related to the nomination of MVPs for inclusion in the Quality Payment Program. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the MVP nomination process under that control number.

L. ICRs Regarding the Cost Performance Category (§ 414.1350) The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process (OMB control number 0938-1197. CMS-1500 and CMS-1490S) is used to collect data on cost measures from MIPS eligible clinicians.

MIPS eligible clinicians are not required to provide any documentation by CD or hardcopy. Moreover, the policies in this rule do not result in the need to add or revise or delete any claims data fields. Consequently, we are not making any changes to this information collection under that control number. M.

ICRs Regarding Partial QP Elections (§§ 414.1310(b) and 414.1430) This rule is not implementing any new or revised collection of information requirements related to the Partial QP Elections to participate in MIPS as a MIPS eligible clinician. However, we are finalizing to adjust our currently approved burden estimates based on updated projections for the CY 2022 performance period/2024 MIPS payment year. The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). As shown in Table 120, based on our predictive QP analysis for the 2022 QP performance period/2024 MIPS payment year, which accounts for historical response rates in the CY 2020 performance period/2022 MIPS payment year, we are revising our estimate that 150 APM Entities and 100 eligible clinicians (representing approximately 9,000 Partial QPs) will make the election to participate as a Partial QP in MIPS, a total of 250 elections which is a decrease of 50 from the 300 elections that are currently approved by OMB under the aforementioned control number.

We continue to estimate it will take the APM Entity representative or eligible clinician 15 minutes (0.25 hr) to make this election. In aggregate, we are revising our estimated annual burden to 63 hours (250 respondents × 0.25 hr/election) and $5,999 (63 hr × $95.22/hr). Start Printed Page 65606 As shown in Table 121, using our unchanged currently approved per respondent burden estimate (85 FR 84991), the decrease in the number of Partial QP elections results in an adjustment of 12.5 hours (−50 elections × 0.25 hr) at a cost of −$1,191 (−12.5 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 63 hours (250 respondents × 0.25 hr/election) at a cost of $5,999 (63 hr × $95.22/hr).

n. ICRs Regarding Other Payer Advanced APM Determinations. Payer-Initiated Process (§ 414.1445) and Eligible Clinician Initiated Process (§ 414.1445) The following burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). (1) Payer Initiated Process (§ 414.1445) This rule is not implementing any new or revised collection of information requirements related to the Payer-Initiated Process.

However, we are adjusting our currently approved burden estimates based on updated projections for the CY 2022 performance period/2024 MIPS payment year. As shown in Table 122, based on the actual number of requests received in the 2020 QP performance period, we are revising our estimate that for the 2023 QP performance period, 15 payer-initiated requests for Other Payer Advanced APM determinations will be submitted (6 Medicaid payers, 6 Medicare Advantage Organizations, and 3 remaining other payers), a decrease of 65 from the 80 total requests currently approved by OMB under the aforementioned control number. We continue to estimate it will take 10 hours for a computer system analyst per arrangement submission. We are revising our estimated annual burden to 150 hours (15 submissions × 10 hr/submission) and $14,283 (150 hr × $95.22/hr).

As shown in Table 123, using our unchanged currently approved per respondent burden estimate (85 FR 84992), the decrease in the number of payer-initiated requests from 800 to 150 results in an adjustment of −650 hours (−65 requests × 10 hr) at a cost of −$61,893 (−650 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 150 hours (15 requests × 10 hr) at a cost of $14,283 (150 hr × $95.22/hr). Start Printed Page 65607 (2) Eligible Clinician Initiated Process (§ 414.1445) This rule is not implementing any new or revised collection of information requirements or burden related to the Eligible-Clinician Initiated Process. As described below, we are adjusting our currently approved burden estimates based on updated projections for the CY 2022 performance period/2024 MIPS payment year.

As mentioned above, the new and adjusted burden will be submitted to OMB for approval. As shown in Table 124, based on the actual number of requests received in the 2020 QP performance period, we estimate that in CY 2022 for the 2023 QP performance period, 15 Eligible-Clinician Initiated request for Other Payer Advanced APM determinations will be submitted, a decrease of 135 from the 150 total requests currently approved by OMB under the aforementioned control number. We continue to estimate it will take 10 hours for a computer system analyst per arrangement submission. We are adjusting our estimated annual burden to 150 hours (15 submissions × 10 hr/submission) and $14,283 (150 hr × $95.22/hr).

As shown in Table 125, using our unchanged currently approved per respondent burden estimate (85 FR 84993), the decrease in the number of eligible clinician-initiated requests from 150 to 15 results in an adjustment of −1,350 hours (−135 requests × 10 hr) at a cost of −$128,547 (−1,350 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 150 hours (15 submissions × 10 hr/submission) at a cost of $14,283 (150 hr × $95.22/hr). Start Printed Page 65608 (3) Submission of Data for QP Determinations Under the All-Payer Combination Option (§ 414.1440) This rule is not implementing any new or revised collection of information requirements related to the Submission of Data for QP Determinations under the All-Payer Combination Option. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621).

Consequently, we are not making any changes under that control number. O. ICRs Regarding Voluntary Participants Election To Opt-Out of Performance Data Display on Physician Compare (§ 414.1395) This rule is not implementing any new or revised collection of information requirements related to the election by voluntary participants to opt-out of public reporting on Physician Compare. As described below, we are adjusting our currently approved burden estimates based on data from the CY 2019 performance period/2021 MIPS payment year.

The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53924 through 53925), CY 2019 PFS final rule (83 FR 60022), CY 2020 PFS final rule (84 FR 63145 through 63146) and the CY 2021 PFS final rule (85 FR 84993) for our previously finalized requirements and burden for voluntary participants to opt-out of public reporting on Physician Compare. In the CY 2021 PFS final rule (85 FR 84993), we estimated that 10 percent of the clinicians and groups who voluntarily participate in MIPS would opt out of public reporting. Based on the number of opt-out eligible clinicians that chose to opt-out of public reporting in the CY 2019 performance period/2021 MIPS payment year, we are revising our estimates.

We anticipate that 0.1 percent of the total clinicians and groups who will voluntarily participate in the CY 2022 performance period/2024 MIPS payment year will also elect not to participate in public reporting. This results in a total of 38 (0.001 × 37,934 voluntary MIPS participants) clinicians and groups, a decrease of 3,448 from the currently approved estimate of 3,486. Voluntary MIPS participants are clinicians that are not QPs and are expected to be excluded from MIPS after applying the eligibility requirements set out in the CY 2019 PFS final rule but have elected to submit data to MIPS. As discussed in the RIA section of the CY 2019 PFS final rule, we continue to estimate that 33 percent of clinicians that exceed one (1) of the low-volume criteria, but not all three (3), will elect to opt-in to MIPS, become MIPS eligible, and no longer be considered a voluntary reporter (83 FR 60050).

Table 126 shows that for these voluntary participants, we continue to estimate it will take 0.25 hours for a computer system analyst to submit a request to opt-out. In aggregate, we estimate an annual burden of 10 hours (38 requests × 0.25 hr/request) and $952 (10 hr × $95.22/hr). Start Printed Page 65609 As shown in Table 127, using our unchanged currently approved per respondent burden estimate, the decrease of 3,448 opt outs by voluntary participants results in an adjustment of −862 hours (−3,448 requests × 0.25 hr) at a cost of $−82,079 (−862 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 10 hours (38 requests × 0.25 hr/request) at a cost of $952 (10 hr × $95.22/hr).

p. Summary of Annual Quality Payment Program Burden Estimates Table 128 summarizes this final rule's total burden estimates for the Quality Payment Program for the CY 2021, CY 2022 and CY 2023 performance periods/2023, 2024, and 2025 MIPS payment years. As discussed earlier, for this final rule, we are subtracting the currently approved burden for the CY 2021 performance period/2023 MIPS payment year. As shown in table 128, this represents a decrease in burden of 1,479,672 hours and $144,576,960.

In the CY 2021 PFS final rule, the total estimated burden for the CY 2022 MIPS performance period/2024 MIPS payment year was 1,473,741 hours at a cost of $144,034,968 (85 FR 84994). Accounting for updated wage rates and the subset of all Quality Payment Program ICRs discussed in this rule compared to the CY 2021 PFS final rule, the total estimated annual burden of continuing policies and information set forth in the CY 2021 PFS final rule into the CY 2022 performance period/2024 MIPS payment year is 1,468,566 hours at a cost of $148,078,846. These represent a decrease of 5,175 hours and an increase of $4,043,878. To understand the burden implications of the policies in this rule, we provide an estimate of the total burden associated with continuing the policies and information collections set forth in the CY 2021 PFS final rule into the CY 2022 performance period/2024 MIPS payment year.

This burden estimate of 1,424,586 hours at a cost of $143,651,994 reflects the availability of more accurate data to account for all potential respondents and submissions across all the performance categories and more accurately reflect the exclusion of QPs from all MIPS performance categories, a decrease of 43,980 hours and $4,426,813. This burden estimate is lower than the burden approved for information collection related to the CY 2021 PFS final rule due to updated data and assumptions. Our total burden estimate for the CY 2022 performance period/2024 MIPS payment year is 1,428,391 hours and $144,014,757, which represents a decrease of 40,175 hours and $4,068,418 from the CY 2021 PFS final rule. The difference of +3,805 hours (43,980 hours−40,175 hours) and +$358,395 ($4,426,813−$4,068,418) between this estimate and the total burden shown in Table 128 is the increase in burden associated with impacts of the policies for the CY 2022 performance period/2024 MIPS payment year, which includes the re-introduction of the CMS Web Interface measures as a collection type/submission type.

Table 128 also offers a comparison between the total currently approved estimated burden from the CY 2021 PFS final rule and our estimated burden for the CY 2023 performance period/2025 MIPS payment year. As discussed above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. Our total burden estimate for the CY 2023 MIPS performance period/2025 MIPS payment year is 1,383,049 hours and $139,501,770. We have included Table 128 to assist in understanding these differences.

Note that the difference between the burden estimates for the CY 2022 and 2023 MIPS performance periods/2024 and 2025 MIPS payment years is entirely due to the policies to introduce MVP and subgroup reporting and sunset the CMS Web Interface measures as a collection type/submission type beginning in the CY 2023 MIPS performance period/2025 MIPS payment year. Start Printed Page 65610 Start Printed Page 65611 Start Printed Page 65612 Start Printed Page 65613 Table 131 represents averages for the estimated changes in burden for the CY 2021, 2022, and 2023 performance periods/2023, 2024, and 2025 MIPS payment years. Table 132 provides the reasons for changes in the estimated burden for information collections in the Quality Payment Program segment of this final rule. We have divided the reasons for our change in burden into those related to new policies and those related to adjustments in burden from continued Quality Payment Program Year 5 policies that reflect updated data and revised methods.

Start Printed Page 65614 Start Printed Page 65615 Start Printed Page 65616 C. Summary of Annual Burden Estimates for Changes Start Printed Page 65617 VI. Regulatory Impact Analysis A. Statement of Need In this final rule, we are finalizing payment and policy changes under the Medicare PFS and required statutory changes under the Consolidated Appropriations Act, 2021 and sections 2003 and 2005 of the SUPPORT for Patients and Communities Act of 2018.

We also are finalizing changes to payment policy and other related policies for Medicare Part B. In addition, this final rule will make modest revisions to certain Medicare provider and supplier enrollment regulatory provisions and add already existing provider and supplier requirements pertaining to prepayment and post-payment review activities. This final rule is necessary to make policy changes under Medicare FFS and to address various provider and supplier enrollment issues. Therefore, we included a detailed Regulatory Impact Analysis (RIA) to assess all costs and benefits of available regulatory alternatives and explain the selection of these regulatory approaches that we believe adhere to statutory requirements and, to the extent feasible, maximize net benefits B.

Overall Impact We examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub.

L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

An RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimated, as discussed in this section, that the PFS provisions included in this final rule will redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we prepared an RIA that, to the best of our ability, presents the costs and benefits of the rulemaking.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, practitioners and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details, see the SBA's website at http://www.sba.gov/​content/​table-small-business-size-standards (refer to the 620000 series)).

Individuals and States are not included in the definition of a small entity. The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. Start Printed Page 65618 The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.

Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this final rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. Medicare does not pay rural hospitals for their services under the PFS. Rather, the PFS pays for physicians' services, which can be furnished by physicians and NPPs in a variety of settings, including rural hospitals.

We did not prepare an analysis for section 1102(b) of the Act because we determined, and the Secretary certified, that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on State, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158 million. This final rule will impose no mandates on State, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. Since this final rule does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. We prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this final rule.

Details the costs and benefits of the rule. Analyzes alternatives. And presents the measures we will use to minimize the burden on small entities. As indicated elsewhere in this final rule, we discussed a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services, and to implement provisions of the statute.

We provide information for each of the policy changes in the relevant sections of this final rule. We are unaware of any relevant Federal rules that duplicate, overlap, or conflict with this final rule. The relevant sections of this final rule contain a description of significant alternatives if applicable. C.

Changes in Relative Value Unit (RVU) Impacts 1. Resource-Based Work, PE, and MP RVUs Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve BN. Our estimates of changes in Medicare expenditures for PFS services compared payment rates for CY 2021 with payment rates for CY 2022 using CY 2020 Medicare utilization.

The payment impacts described in this final rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and will depend on the mix of services he or she furnishes. The average percentage change in total revenues will be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and non-Medicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems.

For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are paid under the Clinical Laboratory Fee Schedule (CLFS). The PFS update adjustment factor for CY 2022, as specified in section 1848(d)(19) of the Act, is 0.00 percent before applying other adjustments. In addition, section 101 of Division N of the CAA provided a 3.75 percent increase in PFS payment amounts for services furnished on or after January 1, 2021, and before January 1, 2022 and required that the increase shall not be taken into account in determining PFS payment rates for subsequent years. The expiration of this 3.75 percent increase in payment amounts will result in the CY 2022 conversion factor being calculated as though the 3.75 percent increase for the CY 2021 conversion factor had never been applied.

To calculate the CY 2022 PFS conversion factor (CF), we took the CY 2021 conversion factor without the 1-year 3.75 percent increase provided by the CAA and multiplied it by the BN adjustment required as described in the preceding paragraphs. We estimate the CY 2022 PFS CF to be 33.5983 which reflects the BN adjustment under section 1848(c)(2)(B)(ii)(II) of the Act, the 0.00 percent update adjustment factor specified under section 1848(d)(19) of the Act, and the expiration of the 3.75 percent increase for services furnished in CY 2021, as provided in the CAA. We estimate the CY 2022 anesthesia CF to be 20.9343 which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments. Start Printed Page 65619 Table 136 shows the payment impact of the policies contained in this final rule on PFS services.

To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues will be different from those shown in Table 136 (CY 2022 PFS Estimated Impact on Total Allowed Charges by Specialty). The following is an explanation of the information represented in Table 136. • Column A (Specialty). Identifies the specialty for which data are shown.

• Column B (Allowed Charges). The aggregate estimated PFS allowed charges for the specialty based on CY 2020 utilization and CY 2021 rates. That is, allowed charges are the PFS amounts for covered services and include coinsurance and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty.

• Column C (Impact of Work RVU Changes). This column shows the estimated CY 2022 impact on total allowed charges of the changes in the work RVUs, including the impact of changes due to potentially misvalued codes. • Column D (Impact of PE RVU Changes). This column shows the estimated CY 2022 impact on total allowed charges of the changes in the PE RVUs.

• Column E (Impact of MP RVU Changes). This column shows the estimated CY 2022 impact on total allowed charges of the changes in the MP RVUs. • Column F (Combined Impact). This column shows the estimated CY 2022 combined impact on total allowed charges of all the changes in the previous columns.

Column F may not equal the sum of columns C, D, and E due to rounding. Start Printed Page 65620 Start Printed Page 65621 2. CY 2021 PFS Impact Discussion a. Changes in RVUs The most widespread specialty impacts of the RVU changes are generally related to the changes to RVUs for specific services resulting from the misvalued code initiative, including RVUs for new and revised codes.

The estimated impacts for some specialties, including diagnostic testing facilities, portable x-ray, podiatry, hand surgery, and geriatrics, reflect increases relative to other physician specialties. These increases can be attributed largely to the update to clinical labor pricing as the services that these specialties furnish involve a higher proportion of clinical labor cost that is reflected in their PE RVUs. These increases are also due to increases in value for particular services after considering the recommendations from the American Medical Association (AMA)'s Relative Value Scale Update Committee (RUC), and CMS review and increased payments resulting from updates to supply and equipment pricing. The estimated impacts for several specialties, including interventional radiology, vascular surgery, radiation oncology, and cardiology, reflect decreases in payments relative to payment to other physician specialties which are largely the result of the redistributive effects of the clinical labor pricing update.

The services furnished by these specialties involve proportionally higher supply or equipment item costs, and therefore are affected negatively by the updates to clinical labor pricing. Since PE is budget neutralized within itself, increased pricing for clinical labor holds a corresponding relative decrease for other components of PE such as supplies and equipment. These decreases are also due to the revaluation of individual procedures based on reviews by the AMA RUC and CMS, as well as decreases resulting from the continued phase-in implementation of the previously finalized updates to supply and equipment pricing. The estimated impacts also reflect decreases due to continued implementation of previously finalized code-level reductions that are being phased in over several years.

For independent laboratories, it is important to note that these entities receive approximately 83 percent of their Medicare revenues from services that are paid under the CLFS. As a result, the estimated 2 percent decrease for CY 2021 is only applicable to approximately 17 percent of the Medicare payment to these entities. We often receive comments regarding the changes in RVUs displayed on the specialty impact table (Table 136), including comments received in response to the valuations. We remind stakeholders that although the estimated impacts are displayed at the specialty level, typically the changes are driven by the valuation of a relatively small number of new and/or potentially misvalued codes.

The percentage changes in Table 136 are based upon aggregate estimated PFS allowed charges summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty, and compared to the same summed total from the previous calendar year. Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty. To illustrate how impacts can vary within specialties, we created a public use file that models the expected percentage change in total RVUs per practitioner. Using CY 2020 utilization data, Total RVUs change between −1 percent and 1 percent for more than 90 percent of practitioners, representing more than 81 percent of the changes in Total RVUs for all practitioners, with variation by specialty.

Many specialties, such as chiropractic, clinical social worker, family practice, internal medicine and emergency medicine, exhibit little variation in changes in total RVUs per practitioner. For these specialties, more than 90 percent of these practitioners will experience a change in Total RVUs between −1 percent and 1 percent. Other specialties exhibit more variation in changes in total RVUs per practitioner. For example, for diagnostic testing facilities, 39 percent of IDTFs will experience a 2 percent or more decrease in Total RVUs, but these suppliers represent only 33 percent of Total RVUs for this specialty.

Meanwhile, one percent of IDTFs will experience 10 percent or more increases in Total RVUs and these suppliers account for 33 percent of Total RVUs for this specialty. We also note the code level RVU changes are available in the Addendum B public use file that we make available with each rule. Many commenters requested that CMS maintain the 3.75 percent increase in PFS payment amounts that was specified under section 101 of the CAA for services furnished during CY 2021. We remind commenters that this increase was provided through a time-limited amendment to the statute, which CMS does not have legal authority to alter.

The expiration of this 3.75 percent increase in payment amounts will result in the CY 2022 conversion factor being calculated as though the 3.75 percent increase for the CY 2021 conversion factor had never been applied. Several commenters requested clarification regarding whether the specialty impacts displayed in Table 136 reflected the expiration of the 3.75 percent CAA provision for CY 2022. We can clarify for the commenters that the specialty impacts displayed in Table 136 reflect changes that take place within the pool of total RVUs. The specialty impacts table therefore includes any changes in spending which result from finalized policies within BN (such as the revaluation of E/M codes in CY 2021 or the clinical labor Start Printed Page 65622 pricing update in CY 2022) but does not include any changes in spending which result from finalized policies outside of BN.

The expiration of the 3.75 percent CAA provision for CY 2022 is a statutory change that takes place outside of BN, and therefore, is not captured in the specialty impacts displayed in Table 136. b. Impact Column F of Table 136 displays the estimated CY 2022 impact on total allowed charges, by specialty, of all the RVU changes. A table showing the estimated impact of all of the changes on total payments for selected high volume procedures is available under “downloads” on the CY 2022 PFS final rule website at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysisianFeeSched/​.

We selected these procedures for sake of illustration from among the procedures most commonly furnished by a broad spectrum of specialties. The change in both facility rates and the nonfacility rates are shown. For an explanation of facility and nonfacility PE, we refer readers to Addendum A on the CMS website at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysisianFeeSched/​. D.

Effect of Changes Related to Telehealth Services Before the PHE for buy antibiotics, approximately 15,000 FFS Medicare beneficiaries received a Medicare telemedicine service each week. According to a report prepared by the Assistant Secretary for Planning and Evaluation (ASPE),[] in the last week of April 2020, nearly 1.7 million beneficiaries received telehealth services. By April 2020, nearly half of all Medicare primary care visits were telehealth encounters, a level consistent with health care encounters more broadly. There are approximately 271 services currently included on the list of Medicare telehealth services, including more than 165 that were added on a temporary basis during the PHE for buy antibiotics (including service categories such as emergency department visits, initial inpatient and nursing facility visits, and discharge day management services) that are covered through the end of the PHE.

Preliminary data show that between mid-March and mid-October 2020, over 24.5 million out of 63 million Medicare beneficiaries and enrollees have received a Medicare telemedicine service during the PHE. It is important to note that preliminary data reflect that the largest increases in services furnished via telehealth communications systems, by beneficiary access/volume, were for services that were already on the Medicare telehealth services list before the PHE. As discussed in section II.D. Of this final rule, we are finalizing our proposal to amend the regulatory definition of interactive telecommunications system for purposes of Medicare telehealth services to include audio-only communication technology under certain circumstances for mental health services furnished to established patients in their homes.

We anticipate that this policy will increase utilization of Medicare telehealth mental health services relative to utilization that will occur without the change. The estimated cost impact on overall Medicare services is unclear, though these changes will largely maintain current policies and access to the specific mental health services that are available to beneficiaries during the PHE. By requiring that a modifier be appended to the claim to identify that the service was furnished via audio-only communication technology, we will be able to closely monitor utilization and address any potential concerns regarding overutilization through future rulemaking. Comment.

Commenters were very supportive of our proposal to allow for mental health services to be furnished using audio-only communications technology. A few commenters, while supportive of the use of audio-only communications technology during the PHE, urged CMS to further study and evaluate the safety and effectiveness of the audio-only modality for various levels of care and treatments to determine appropriateness of continuing payment after the PHE expires. Commenters supported the proposal to create a service-level modifier to identify mental health telehealth visits “furnished to a beneficiary in their home using audio-only communications technology.” Response. We are finalizing creation of a service-level modifier that would identify mental health telehealth services furnished to a beneficiary in their home using audio-only communications technology.

We anticipate that our policy of allowing mental health services to be furnished using audio-only communications technology this will have a positive impact on access to care for mental health services and contribute to overall health equity. Section 123 of the CAA removed the geographic and site of service restrictions for telehealth services furnished for the purpose of diagnosis, evaluation, or treatment of a mental health disorder, and required as a condition of payment for these telehealth services furnished in the patient's home that a physician or practitioner furnish an in-person, non-telehealth service to a beneficiary within 6 months prior to the first time the physician or practitioner furnishes a telehealth service to the beneficiary, and thereafter, at intervals as specified by the Secretary. Section 125 of the CAA created a new Medicare provider type—the rural emergency hospital, effective beginning in CY 2023—and added rural emergency hospitals to the list of eligible telehealth originating sites at section 1834(m)(4)(C)(ii) of the Act. As discussed in section II.D.

Of this final rule, we will require, as a condition of payment for a telehealth service described in section 1834(m)(7) of the Act, that the billing physician or practitioner must have furnished an in-person, non-telehealth service to the beneficiary within the 6-month period before the date of service of a telehealth service as specified in section 1834(m)(7)(B)(i) of the Act, and proposed in this final rule that an in-person, non-telehealth service to the beneficiary must occur at 12-month intervals for subsequent care, with the possibility for exceptions that must be documented by the practitioner in the medical record. We solicited comment on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service, and we are finalizing a policy to allow this. Given that the removal of the geographic and site of service restrictions for telehealth will expand the availability of mental health services, we anticipate that utilization of these mental health services will be comparable to observed utilization for mental health services during the buy antibiotics PHE. We received public comments on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service.

The following is a summary of the comments we received and our responses. Comment. Many commenters agreed with the alternative policy we considered to allow the required in- Start Printed Page 65623 person, non-telehealth service to be furnished by another physician or practitioner of the same specialty and subspecialty in the same group as the practitioner who furnishes the mental health telehealth services to the beneficiary if the practitioner who furnishes the telehealth services is unavailable. Response.

We are adopting the alternative policy discussed in the proposed rule to allow a clinician's colleague in the same subspecialty in the same group to furnish the in-person, non-telehealth service to the beneficiary if the original practitioner is unavailable. This is also consistent with longstanding policy, which defines an established patient as an individual who receives professional services from the physician/NPP or another physician of the same specialty and subspecialty who belongs to the same group within the previous 3 years, for purposes of billing for E/M services. While the language in the CAA states that the physician or practitioner furnishing the in-person, non-telehealth service must be the same person as the practitioner furnishing the telehealth service, we believe this policy would be consistent with statutory requirements, because we have historically treated the billing practitioner and other practitioners of the same specialty or subspecialty in the same group as if they were the same individual. After consideration of public comments, we are finalizing our alternative policy that a practitioner in the same subspecialty and the same group may furnish the in-person, non-telehealth service to the same beneficiary, if the original practitioner is unavailable.

With regard to our policy to retain all services added to the Medicare telehealth services list on a Category 3 basis until the end of CY 2023, we believe the establishment of this certain end date will provide clarity to the stakeholder community but will have a negligible impact on PFS expenditures. For example, services that have already been added to the permanent telehealth services list are furnished via telehealth, on average, less than 0.1 percent of the time they are reported. Further, although data is still being collected, in our initial review of the data, we have not noticed an increase in the overall utilization trend for these services suggesting that practitioners may be furnishing these services via telehealth as replacement for in person encounters. The statutory conditions on payment for Medicare telehealth services under section 1834(m) of the Act, such as the originating site requirements related to geographic location and site of service, have limited increases in telehealth service utilization outside of the PHE for buy antibiotics.

However, we believe there is value in allowing physicians to furnish services added to the Medicare telehealth services list on a Category 3 basis, and for patients to receive broader access to this care through telehealth, through the end of CY 2023 in order to ease the transition from the PHE. Additionally, for services added to the Medicare telehealth list on a Category 3 basis, outside of the circumstances of the PHE for buy antibiotics, all of the statutory restrictions under section 1834(m) of the Act will also apply to these services. Therefore, we do not anticipate any significant increase in utilization. E.

Effect of Changes Related to Services Furnished in Whole or in Part by PTAs and OTAs As discussed in section II.H.1., we are finalizing proposed revisions to the current de minimis policy for services furnished in whole or in part by PTAs/OTAs that we finalized in CY 2020 PFS final rule (84 FR 62702 through 62708) under which the CQ or CO modifier applies when the PTA or OTA furnished more than 10 percent of a service or a 15-minute unit of service. Beginning January 1, 2022, CMS will apply a 15 percent reduction to the payment amount for a physical or occupational therapy service when the CQ/CO modifier is applied to the service. Our revision to the de minimis policy will allow the PT/OT to bill without the CQ/CO modifier for the final 15-minute unit (in a multi-unit billing scenario) when the PT/OT meets the billing threshold of 8 minutes, which is when the minutes are greater than the midpoint (7.5 minutes) of the 15-minute unit, regardless of any minutes provided by the PTA/OTA for that final unit. Under the policy we are finalizing, the PT/OT services will not be discounted as the result of any “left-over” minutes provided by the PTA/OTA when the therapist provides enough minutes on his or her own to meet the billing threshold amount.

In these scenarios, the PTA's/OTA's minutes are considered immaterial for the purposes of billing. For example, if the PT/OT provided 23 minutes of a 15-minute service and the PTA/OTA provided another 20 minutes of the same service—three units of service can be billed for the 43 total minutes (38 minutes through 52 minutes). Here, one full 15-minute unit of service is billed without the CQ/CO modifier for the PT/OT service with 8 minutes remaining, and one full unit of service is billed with the CQ/CO modifier for the service provided by the PTA/OTA with 5 minutes remaining. Under the policy, the third unit is billed without the CQ/CO modifier because the 8 minutes provided by the PT/OT meets the billing threshold amount.

However, under our current de minimis policy, the 5 minutes provided by the PTA/OTA is more than 10 percent (it is 38 percent of the total service−PTA/OTA minutes divided by the total of PTA/OTA + PT/OT minutes. 5 divided by 13 = 38 percent) meaning the CQ/CO modifier is applied to the third and final unit of service. Under our current de minimis policy, under which the CQ/CO modifier is applied whenever the PTA/OTA provides more than 10 percent of a service whether or not the PT/OT furnishes enough of the service to bill for it without the portion furnished by the PTA/OTA, stakeholders have expressed concern that the PT/OT has a financial incentive not to have the PTA/OTA provide any additional minutes, regardless of the individual patient's needs, when those minutes of service lead to a reduced payment for a unit of a service. There may be a cost implication to this policy as fewer billing scenarios may result in application of the CQ/CO modifiers and consequent payment reduction.

However, we believe that basing our policy on a “midpoint rule” in which the PT/OT provides enough minutes on their own (8 or more minutes) to bill for the final unit of a billing scenario could eliminate the PT's/OT's financial incentive to not provide appropriate therapy to an individual patient when it is furnished by the PTA/OTA. On the other hand, if we were to continue with our de minimis standard to apply to all billing scenarios for PTA/OTA services that exceed the 10 percent standard, we are uncertain how to gauge the overall costs of this policy because of the possible altered PT/OT behavioral change that is due to the financial incentives built into that policy as discussed above. F. Other Provisions of the Regulation 1.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) In section III.A. Of this final rule, we make multiple provisions related to RHCs and FQHCs. In terms of estimated impacts to the Medicare program, Payment for Attending Physician Services Furnished by RHCs or FQHCs to Hospice Patients as required by section 132 of the CAA, 2021 and Concurrent Billing for CCM and Start Printed Page 65624 Transitional Care Management TCM Services for RHCs and FQHCs will have negligible impact to Medicare spending. Section 130 requires that all independent RHCs are now subject to the per-visit limit (which is also referred to as “cap”) and phases in an increase in the statutory payment cap over an 8-year period.

The cap in CY 2021, for services furnished after March 31, is set at $100 per visit, then at $126 per visit in 2022. At $139 per visit in 2023. At $152 per visit in 2024. At $152 per visit in 2025.

At $165 per visit in 2026. At $178 per visit in 2027. And at $190 per visit in 2028. Beyond 2028, the limit is updated by the applicable Medicare Economic Index (MEI).

This provision also controls the annual rate of growth in payments to certain provider-based RHCs whose payments are currently higher than the payment limit. Each year, but for services provided after March 31 in 2021, the payment limit shall be set at the greater of. (1) The RHC per visit amount from the prior year, increased by the percentage increase in the applicable MEI. And (2) the cap limits applicable to each year as described above.

In order to be eligible for this “grandfathering” policy, the RHC must have been based in a hospital with fewer than 50 beds and enrolled in Medicare as of December 31, 2019. Section 2 of Public Law 117-7, enacted on April 14, 2021, made technical corrections to section 130. First, for an RHC that is hospital-based and whose parent hospital has fewer than 50 beds, the date by which the RHC must be Medicare-certified, in order to be grandfathered, was changed from December 31, 2019 to December 31, 2020. Next, a clinic that is owned by a hospital with fewer than 50 beds and that submitted certain applications (received by Medicare) for certification as a Medicare RHC prior to the end of 2020 can be grandfathered, and its clinic-specific cap is to be set based on its 2021 cost per visit.

Lastly, a grandfathered RHC must continue to be owned by a hospital with fewer than 50 beds. If the parent hospital exceeds 50 beds, the RHC will lose its grandfathered status. Table 137 are the FY estimates (in millions) for the impact of section 130, which improves payments to RHCs. These providers are currently paid an all-inclusive rate (AIR) for all medically necessary medical and mental health services, and qualified preventive health services furnished on the same day (with some exceptions).

The AIR is subject to a payment limit, except for certain provider-based RHCs that have an exception to the payment limit. The RHC payment limit per visit for CY 2021 is $87.52, which is 1.4 percent higher than the CY 2020 payment limit of $86.31. In section III.B. Of this final rule, we discuss that we proposed to revise the regulatory requirement that an RHC or FQHC mental health visit must be a face-to-face (that is, in person) encounter between an RHC or FQHC patient and an RHC or FQHC practitioner to also include encounters furnished through interactive, real-time telecommunications technology, but only when furnishing services for the purposes of diagnosis, evaluation, or treatment of a mental health disorder.

According to our analysis of Medicare Part B claims data for services furnished via Medicare telehealth under the PFS during the PHE, use of telehealth for many professional services spiked in utilization around April 2020 and diminished over time, but not to pre-zithromax levels. In contrast, Medicare claims data suggests that for mental health services both permanently and temporarily added to the Medicare Telehealth list, subsequent to April 2020, the trend is toward maintaining a steady state of usage over time. Given the expanded availability of mental health services at RHCs and FQHCs, we do anticipate that this policy will increase spending. However, we are not certain of the magnitude of this increase, since it is not clear at this time how or whether trends related to utilization of communication technology during the PHE will continue after such a time that the PHE were to end.

While the estimated cost impact of this provision is unclear, the requirement that a modifier be appended to the claim to identify that the service was furnished via audio-only communication technology will allow us to closely monitor utilization and address any potential concerns regarding overutilization through future rulemaking. 2. Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802 and 414.806) This provision implements new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of the CAA (for the purposes of this section of this final rule, hereinafter is referred to as “section 401”). These new requirements will improve the accuracy of reported payment limits and limit the use of WAC-based pricing.

As described in section III.D.1. Of this final rule, in considering whether to exclude repackagers from the reporting requirements at section 1847A(f)(2) of the Act, we conducted two analyses to estimate. (1) The proportion of repackaged products in our existing ASP data. (2) the number of new ASP submissions we can expect as a result of the new reporting requirements under section 401.

And (3) the proportion of those (new) submissions that involve repackaged products. Additionally, while we believe it will impact reporting volume and payment limits under section 1847A of the Act for many billing and payment codes, we are unable to estimate the magnitude of these effects for the following reasons. We estimate. (1) 361 non-reporting manufacturers (of either single source or multiple source drugs) will now be required to report ASP data under section 1847A(f)(2) of the Act.

And (2) 6114 products payable under Part B that these non-reporting manufacturers sell. However, we do not know which Healthcare Common Procedure Coding System (HCPCS) code payment limits will be impacted by these 6114 products, nor do we know the sales volume of these 6114 products. Because this information is used to calculate volume-weighted ASP payment limits, we are unable to quantitatively estimate the economic impacts of this provision (that is, the likely costs or savings) on beneficiaries, the government, and other Start Printed Page 65625 stakeholders. (We note that the economic impacts on manufacturers, as a result of the information collection requirements of this provision is discussed in section V.

Of this final rule.) For single source drugs, these changes may result in lower payment limits because, typically, the WAC-based pricing is higher than ASP plus 6 percent. This then translates to cost savings for both the government and beneficiaries, who will pay coinsurance on a lesser amount. However, for the reason stated previously, we are unable to predict the magnitude of this effect. Similarly, payment limits for multiple source drugs could increase or decrease, and we are unable to predict the direction or magnitude of specific or aggregate effects at this time.

We do not anticipate that this provision of this final rule will necessitate the revision of existing Medicaid Drug Rebate Agreements. We welcomed comment on (1) the likely costs or savings to beneficiaries, the government, and other stakeholders and (2) other related impacts of this provision. We received public comments on the likely costs or savings to beneficiaries, the government, and other stakeholders, and other related impacts of this provision. The following is a summary of the comments we received and our responses.

Comment. One commenter suggested that CMS exclude repackagers from the proposed ASP reporting requirements. They stated that requiring all repackagers to report would likely be duplicative and increase the burden on all parties without providing tangible benefit. They recommend repackagers who already report ASP data continue to do so, but that CMS not require repackagers, as a group, to be subject to the reporting requirements at this time.

Response. We are not persuaded that repackagers should be excluded at this time. In order to maintain consistency and integrity of the ASP data for those manufacturers with and without Medicaid drug rebate agreements, and for operational reasons, we do not believe it is appropriate to exclude repackagers from the ASP reporting requirements. If warranted, we could revisit this in future rulemaking.

Comment. One commenter concluded that CMS' analysis and proposal not to exclude repackagers without a rebate agreement from reporting ASP data is reasonable. The commenter stated given that repackagers with a rebate agreement are required to report ASP data, it is reasonable not to exclude repackagers without a rebate agreement from the requirements of section 401. They added that having ASP data from repackagers with and without rebate agreements could also permit future analysis of the effect of repackagers' ASP submissions on Medicare Part B payment rates.

Response. We agree it is reasonable not to exclude repackagers without a Medicaid drug rebate agreement and thank the commenter for their feedback. After consideration of public comments, we are finalizing as proposed. 3.

Determination of ASP for Certain Self-Administered Drug Products a. Anticipated Effects This provision implements new statutory requirements under section 1847A(g) of the Act, as amended by section 405 of the CAA 2021, (for the purposes of this section of this final rule, hereinafter is referred to as “section 405”). As identified by the OIG studies discussed in section III.D.2. Of this final rule, the CMS payment-limit determination under section 1847A of the Act includes all versions of a product marketed under a single FDA approval, and consistent with section 1847A(b)(5) of the Act, the payment-limit determination does not exclude products based on packaging.

Thus, the volume-weighted, average-ASP determination can include self-administered versions that may lead to increased program and beneficiary costs because of distorted ASP-based payment limits. In particular, the OIG studies identified two billing and payment codes that included self-administered NDCs. The OIG study determined that as a result of the inclusion of these NDCs in the calculation of the ASP payment limit, Medicare payment amounts remained inflated in 2017 and 2018, causing the program and its beneficiaries to pay an additional $497 million during this period. Since 2014, current payment methodology has resulted in an additional $173 million in Medicare beneficiary coinsurance for these two NDCs.

(See OIG's July 2020 report titled, “Loophole in Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds of Millions of Dollars,” available at https://oig.hhs.gov/​oei/​reports/​OEI-BL-20-00100.asp. ) Implementation of the regulatory changes has the potential to result in decreased payment limits for identified billing and payment codes that could, in turn, substantially reduce Medicare and beneficiary expenditures, as described in the OIG study. Since section 1847A(g)(3) of the Act requires CMS to implement the required payment changes beginning on July 1, 2021, these potential savings may be observed within the year. By adding sections 1847A(g)(1) and (2) of the Act, section 405 also directs the OIG to conduct future studies with same or similar methodologies to those in the July 2020 report and directs CMS to apply the lesser of payment methodology to the applicable billing and payment codes.

This has the potential to result in additional savings to the program and beneficiaries if additional products are identified by these periodic OIG studies. B. Expected Benefits Codifying the provisions set forth by section 405 will permit to CMS to apply the lesser of payment methodology at section 1847(g)(2) of the Act to billing and payment codes identified by future OIG studies (described in section III.D.2. Of this final rule).

This provision addresses distorted payment limits for these products and may result in payment amounts that are better aligned with versions of these products that are payable under Part B (for example, versions that are usually not self-administered). Although we are unable to quantify the total magnitude of the potential savings, these changes have the potential to substantially reduce program expenditures and beneficiary coinsurance. 4. Appropriate Use Criteria Section 1834(q)(2) of the Act, as added by section 218(b) of the Protecting Access to Medicare Act (PAMA), established a program to promote the use of appropriate use criteria (AUC) for applicable imaging services furnished in an applicable setting.

In the CY 2019 PFS final rule (83 FR 59452), we performed an RIA for this program. In this final rule, we are finalizing our proposal to begin the payment penalty phase of the program on the later of January 1, 2023 or the January 1 of the year after the year in which the PHE for buy antibiotics ends. Because, under our provisions, the payment penalty phase will be further delayed, we are updating the estimates for incremental changes from the RIA from the CY 2019 PFS final rule. Since we did not propose new policy requirements nor do we have sufficient reason to change any of the assumptions made in the RIA finalized in the CY 2019 PFS (83 FR 60034 through 60044), we are only updating the analysis to reflect 2019 Medicare claims data (updated from 2014).

We identify four incremental changes from the CY 2019 Start Printed Page 65626 PFS final rule estimates due to updated claims data. (1) Impact of required AUC consultations by ordering professionals. (2) impact to Medicare beneficiaries. (3) process efficiencies to potentially offset the estimated burden on Medicare beneficiaries.

And (4) impact on transmitting orders for advanced diagnostic imaging services. Each of these incremental changes results in a lower estimate. a. Impact of Required AUC Consultations by Ordering Professionals As discussed in detail in the CY 2019 PFS final rule (83 FR 60035 through 60037), the annual impact estimate of consultations by ordering professionals was $70,001,700.

In our estimates, we calculated the burden for auxiliary personnel to consult AUC under the direction of an ordering professional and the burden for ordering professionals to perform the consultation directly. We estimated that 90 percent of consultations will be performed by a medical assistant (occupation code 31-9092) and 10 percent of consultations will be performed by a general practitioner (occupation code 29-1062). We estimated that 43,181,818, 2-minute consultations occur annually. Using 2019 Medicare claims data as our basis for the analysis, we proposed to change the methodology used to determine the volume of consultations and proposed to use more granular data that will reduce potential double-counting of advanced diagnostic imaging services.

For example, an imaging service furnished in an outpatient hospital department could have two claims associated with that service. There could be a claim from the facility and a claim from the physician that interprets that imaging service. In the CY 2019 RIA (83 FR 60034 through 60044) we were concerned that the estimate of 43,181,818 consultations may be an overestimate because it took into account total claims. For this CY 2022 RIA, we proposed to change the method of counting the total number of advanced diagnostic imaging services that will be furnished under the AUC program which will correspond to the total number of consultations.

Using the Integrated Data Repository we identified Medicare claims using the following parameters. (1) 2019 date of service. (2) claim lines containing one of the procedure codes identified in CR10481 and CR11268 at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​2018Downloads/​R2040OTN.pdf and https://www.cms.gov/​files/​document/​r2404otn.pdf, respectively. And (3) claims types of outpatient or practitioner.

Claims were then separated based on the setting in which the imaging service was furnished and further by claim type. Using only services billed on the professional claim type, the total number of claim lines containing one of the identified procedure codes was included to total 30,359,901 advanced diagnostic imaging services estimated to be subject to the AUC program. By using this combination, we believe we can reduce the risk of double-counting services to obtain a more accurate estimate of total number of diagnostic imaging services subject to the AUC program. Therefore, this analysis will use the estimate of 30,359,901 AUC consultations.

Using the May 2020 BLS mean hourly wages, we update our estimates for a medical assistant (occupation code 31-9092) with mean hourly wage of $17.75 and 100 percent fringe benefits for 90 percent of consultations (910,797 hours) to be $30,511,701 (910,797 hours × $33.50/hour). The occupation for general practitioner is no longer listed on the BLS so, instead, we update our estimate using the occupation code for general internal medicine physician (29-1216) with mean hourly wage of $101.42 and 100 percent fringe benefits for 10 percent of consultations (101,200 hours) to be $20,527,408 (101,200 hours × $202.84/hour). The updated total annual estimated impact of consultations is $51,039,109, for an incremental change (reduction) of $18,962,591. B.

Impact to Medicare Beneficiaries In the CY 2019 PFS final rule, we estimated that the additional 2-minute consultation would impact the Medicare beneficiary when their advanced diagnostic imaging service is ordered by the ordering professional by introducing additional time to their office visit. For this update, we used the updated number of consultations calculated above from claims data, as well as the May 2020 BLS mean hourly wage. To estimate this annual cost, we multiplied the annual burden of 1,011,997 hours by the BLS occupation code that represents all occupations in the BLS (00-0000) as mean hourly wage plus 100 percent fringe ($54.14/hr) for a total estimate of $54,789,518 per year for an incremental change (reduction) of $13,211,482. We also estimated that, over time, process efficiencies may be implemented.

We assumed that 50 percent of practices implemented an improvement process that streamlined AUC consultation so Medicare beneficiaries spent the same amount of time in the physician's office regardless of whether an advanced diagnostic imaging service was ordered. The updated estimate that such an improvement process could offset the estimated burden on Medicare beneficiaries by $27,394,759 annually for an incremental change (reduction) of $6,605,741. C. Impact on Transmitting Orders for Advanced Diagnostic Imaging Services In the CY 2019 PFS final rule, we estimated that including AUC consultation information on the order for an advanced diagnostic imaging service to the furnishing professional or facility is estimated as the additional 5 minutes spent by a medical secretary (occupation code 43-6013).

To update this estimate, we use the May 2020 mean hourly wage of $18.75 plus 100 percent fringe benefits to transmit the order for the advanced diagnostic imaging service. In aggregate, we assumed in the CY 2019 PFS final rule that 40,000,000 advanced diagnostic imaging services are ordered annually. We proposed to update that number to match the total number of AUC consultations proposed earlier in this RIA to 30,359,901, so the updated total annual burden to communicate additional information in the order is estimated as $94,495,192 ($18.75/hr × 2 × 0.083 hr × 30,359,901 orders) for an incremental change (reduction) of $20,044,808. D.

Impact on Furnishing Professionals and Facilities As described in the CY 2019 PFS final rule, we identified an estimated 174,064 furnishing professionals (comprising radiologists, ASCs, IDTFs and hospitals) and assumed that every identified furnishing professional will choose to update their processes for the purposes of the AUC program in the same way by purchasing an automated solution to report AUC consultation information which was estimated to cost $10,000 for each furnishing professional. We update this cost to account for inflation and therefore the updated estimated cost is $10,636.07 ($10,000 adjusted for inflation to 2021 dollars) for a total estimated one-time update cost of $1,851,356,888.48 (174,064 × $10,636.07). E. Appropriate Use Criteria for Advanced Diagnostic Imaging Services As described in the CY 2019 PFS final rule, we assumed that there may be some savings to the Medicare program due to the AUC program requirements and potential decreases in inappropriate utilization of advanced diagnostic imaging services.

This assumption was based on literature describing prior Start Printed Page 65627 experiences with clinical decision support in a pilot project conducted in Minnesota, a retrospective cohort study on evidence-based clinical decision support for lumbar MRI, brain MR and sinus CT and local implementation of clinical decision support, and we estimated that savings may account for $700,000,000 savings per year. f. Summary of Delay-Attributable Changes and Discounted Rates Table 138 summarizes the substantive changes from the CY 2019 PFS final rule to the CY 2022 PFS final rule impact estimates. The effect of a 3-year delay is approximated by applying 3 years' worth of discounting at 7 percent or 3 percent discount rates (Circular A-4, https://www.whitehouse.gov/​sites/​whitehouse.gov/​files/​omb/​assets/​regulatory_​matters_​pdf/​a-4.pdf ).

5. Removal of Selected National Coverage Determinations (NCDs) We proposed to remove two older NCDs that no longer contain clinically pertinent and current information or that involve items or services that are used infrequently by beneficiaries. Generally, proactively removing obsolete or unnecessary NCDs removes barriers to innovation and reduces burden for stakeholders and CMS. The two NCDs fall into two impact categories.

First, eliminating an NCD for items and services that were previously covered means that the item or service will no longer be automatically covered by Medicare. Instead, the coverage determinations for those items and services will be made by Medicare Administrative Contractors (MACs). Second, if the previous national coverage determination barred coverage for an item or service under title XVIII, MACs will now be able to cover the item or service if the MAC determines that such action is appropriate under the statute. We believe that allowing local contractor flexibility in these cases better serves the needs of the Medicare program and its beneficiaries since we believe the future utilization for items and services within these policies will be limited, each affecting less than one percent of the Medicare FFS population.

For the one NCD where NCD removal changes coverage from limited national coverage to MAC discretion, claims data from 2019 shows that less than one percent of the Medicare population is affected. Specifically, NCD 180.2 Enteral and Parenteral Nutrition Therapy provided coverage with limitations. Where in 2019 CMS paid 1,643,739 Medicare FFS claims for 83,551 unique beneficiaries totaling CMS payments of $356,228,606. While we have claims data available for 2020, the data shows a decrease in claims, unique beneficiaries and total amount paid by CMS.

We believe this may be due in part to the buy antibiotics zithromax. However, we do not have any information to be able to say that conclusively. The change could be due to other factors not examined here. We estimate there will be de minimis change to 2022 payments, compared to 2019 or 2020 because, as discussed in section III.F.

Of the final rule, local contractors have finalized two LCDs, effective for dates of service on or after September 5, 2021 that will continue to provide parenteral and enteral nutrition coverage for Medicare beneficiaries, after removal of NCD 180.2. Therefore, we believe that removing this NCD will not result in significant changes to payments. For the one non-covered NCD to be eliminated, Positron Emission Tomography (PET) Scans under NCD 220.6, we did not expect to find historical claims data for the non-oncologic uses of PET at issue. We broadly noncover non-oncologic indications of PET, in other words, we required that every non-oncologic indication for PET must have its own NCD in order to receive coverage.

Because this NCD provides for noncoverage on non-oncologic indications, we do not have accurate claims data to estimate total impact. However, based on the service, we expect future claims to affect less than one percent of Medicare FFS beneficiaries. As discussed in section III.F. Of this final rule, the NCD allows coverage for diagnostic PET imaging for oncologic uses not already determined by an NCD, to be made at the discretion of local MACs.

We believe that extending local contractor discretion for non-oncologic indications of PET provides an immediate avenue to potential coverage in appropriate Start Printed Page 65628 candidates and provides a framework that better serves the needs of the Medicare program and its beneficiaries. For clarity, we did not propose to change any other subsections of 220.6. Thus, the NCDs listed at 220.6.1 through 220.6.20 will not be changed by this provision. 6.

Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation As discussed in section III.H., Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR), of this final rule, we proposed largely conforming changes throughout §§ 410.47 (PR) and 410.49 (CR/ICR). These changes are intended to ensure consistency and accuracy in terminology, definitions and requirements where appropriate across PR and CR/ICR conditions of coverage. Specific to PR, we proposed to remove the requirement for direct physician-patient contact related to the periodic review of the patient's treatment plan because such interaction within the PR program is not necessary for all patients and can be specified, as needed, in individualized treatment plans (ITPs). We also proposed to add coverage of PR for beneficiaries who were hospitalized with a buy antibiotics diagnosis and experience persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospital discharge.

After considering public comments and additional clinical evidence, we are finalizing the revisions to improve consistency and accuracy across PR and CR/ICR conditions of coverage as proposed. We are also finalizing the removal of the PR requirement for direct physician-patient contact. We are expanding upon our proposal to cover PR for beneficiaries who were hospitalized with a buy antibiotics diagnosis and experience persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospital discharge. We are removing the proposed hospitalization requirement and finalizing coverage of PR for beneficiaries who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least 4 weeks.

We did not receive public comments on the proposed impact so we use the same methodology in estimating the impact of the final expansion of coverage for PR below. In assessing the impact of these provisions, we note that the expansion of PR coverage may increase utilization. Based on the low utilization rate discussed below, we do not believe the other revisions will significantly impact utilization and the Medicare program. To estimate the potential increase from the expansion of coverage for PR, we searched the literature for articles that evaluated the utilization rate of PR for the currently eligible diagnosis of chronic obstructive pulmonary disease (COPD) in order to determine the historical utilization trends of this service.

Nishi et al. (2016) investigated the number of Medicare beneficiaries with COPD who received PR from January 1, 2003 to December 31, 2012. Their results included both individuals who had experienced hospitalizations for COPD and those who were outpatients only. The number of unique patients with COPD who initially participated in PR during the study period was 2.6 percent in 2003 (before conditions of coverage at § 410.47 were established) and 2.88 percent in 2012 (after conditions of coverage at § 410.47 were established).[] In 2019, Spitzer, et al.

Published an article based on Medicare claims data from 2012, finding that 2.7 percent of eligible Medicare beneficiaries received PR within 12 months of hospitalization with COPD.[] Using claims data from FFS Medicare beneficiaries hospitalized for COPD in 2014, Lindenauer et al. (2020) reported that only 3 percent initiated PR within 1 year of their hospital discharge.[] Taken together, this data informs us that utilization of PR in the Medicare population is very low, and that the majority of patients who avail themselves of this service do so, post hospitalization. There are limitations to applying this data to identify the utilization rate of PR to the conditions of coverage specified at § 410.47. Most notably, some of these studies included patients whose services were billed with non-PR respiratory therapy codes (G0237, G0238 and G0239), instead of only patients whose services were billed with the PR code (G0424).

But the authors also limited patient inclusion to those with a principal or secondary COPD diagnosis, so we believe this suggests that 3 percent is an upper bound for the utilization of PR currently in Medicare beneficiaries. Given that participation in PR has remained steady for many years, we do not expect this pattern to change. As such, for the purposes of this analysis, we assume that 3 percent of eligible beneficiaries under the expansion of coverage (beneficiaries who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least 4 weeks) will participate in PR. To identify the eligible beneficiaries under our provision, we first identify the number of beneficiaries who had buy antibiotics using the Preliminary Medicare buy antibiotics Data Snapshot.[] At the time of writing, the Snapshot included data from January 1, 2020 to July 24, 2021, and identified 4,656,553 total buy antibiotics cases for Medicare beneficiaries.

Using Medicare FFS data from February 24, 2020 to September 27, 2020 as compared to the same time frame in 2015 through 2019, Tarazi et al. (2021) found that the buy antibiotics related mortality rate, defined as death within 60 days of buy antibiotics diagnosis, was 17.5 percent.[] To calculate the number of beneficiaries that survive buy antibiotics to be eligible for PR under our coverage expansion, we reduced 4,656,553 by 17.5 percent (814,897) to 3,841,656 beneficiaries. A paper published by the Tony Blair Institute for Global Change [] states that the buy antibiotics Symptom Study led by King's College London indicated that about 10 percent of survey participants reported symptoms (including shortness of breath and other symptoms like fatigue, headache and loss of smell) beyond a four-week recovery period. Using this information, we estimate that the patient population we are expanding PR coverage to, those who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least 4 weeks, to be 384,166 beneficiaries (3,841,656 × 0.10).

Based on our assumption of utilization above, 3 percent, for the newly covered patient population, we estimate 11,525 Start Printed Page 65629 beneficiaries will receive PR (384,166 × 0.03). Medicare covers PR for a maximum of 72 sessions. Using 2018 and 2019 Medicare claims data from the Chronic Conditions Data Warehouse (CCW), beneficiaries on average completed 14 sessions of PR. If we assume patients eligible based on our expansion of coverage will participate, on average, in the same number of sessions, we estimate the expansion of coverage will increase PR utilization by 161,350 sessions annually (11,525 beneficiaries × 14 average sessions completed per beneficiary).

Claims for PR are submitted using CPT code G0424. Our analysis of Medicare claims data indicates that 97.54 percent of PR sessions are billed under the Hospital OPPS at $55.66 (national average price) for an estimated total of $8,759,815 (161,350 PR sessions × 0.9754 × $55.66). The remaining 2.46 percent of PR sessions are billed under the PFS, with 2.12 percent of PR sessions furnished in a physician's office which has a national average price of $30.36 and 0.34 percent billed by a physician when PR was furnished in a HOPD which has a national average price of $13.96. Taken together, the estimated total for this remaining 2.46 percent of PR sessions is $111,508 ((161,350 PR sessions × 0.0212 × $30.36) + (161,350 PR sessions x 0.0034 × $13.96)).

We estimate the total added cost to the Medicare program of this expansion of coverage to be $8,871,323 ($8,759,815 + $111,508) annually during and immediately following the PHE for buy antibiotics. The impact of our final rule increases the final estimate by $6,709,876 which reflects the larger patient population that will be eligible for PR. Removing the proposed hospitalization requirement increased the number of eligible beneficiaries by 290,555. As buy antibiotics cases decline, we expect the annual impact to decrease because eligible patient populations will likely decrease.

However, we are unable to estimate the longer term impact of our provisions due to the unpredictable nature of the PHE and the lack of long term data on buy antibiotics. 7. Medical Nutrition Therapy As discussed in section III.I., Medical Nutrition Therapy (MNT), of this final rule, we proposed to remove the restriction that patients only be referred to MNT by the treating physician and update the glomerular fiation rate (GFR) eligibility for patients with chronic kidney disease. We do not anticipate any significant increase in utilization of MNT services resulting from our revisions.

Despite various policy changes that could have improved use, such as increasing payment via adding work RVUs to MNT codes in 2006, approving MNT for telehealth coverage in 2005 and including registered dieticians (RDs) and nutrition professionals as telehealth distant site providers, and waiving out-of-pocket costs to beneficiaries, MNT participation remains under 2 percent of eligible beneficiaries. Based on an analysis of Medicare claims data from 2018, 2019, 2020, we identify the utilization rate of MNT services among eligible beneficiaries to be between 1.5 and 1.8 percent. Although MNT is covered by many State Medicaid programs and private insurers, use is low in the US.[] The Academy of Nutrition and Dietetics recognizes that research specific to the underuse of MNT services is scant.[] Anecdotal reports and related research on diabetes self-management training point to a multitude of reasons why utilization of the MNT services benefit have remained low. These potential barriers include lack of awareness of MNT by patients and clinicians, inconsistent coverage for MNT services by non-Medicare payers, patient travel and time issues to receive the services and lack of availability of services from RDs who may perceive the process of Medicare enrollment/insurance credentialing and billing as being burdensome and complex.[] Of about 100,000 RDs in the US, only 1,589 submitted Medicare FFS MNT claims in 2017.

One study revealed that less than half of RDs providing MNT services in an ambulatory care setting indicated they were not Medicare providers due to reasons such as perceived low reimbursement rates, not providing MNT to Medicare eligible patients, not knowing how to become a Medicare provider, and providing MNT to Medicare patients for diagnoses not covered by Medicare.[] Our revisions may increase beneficiary access to the MNT benefit and reduce primary care physician burden since we proposed that referrals can come from other physicians and not only from the physician treating the patient for their diabetes or kidney disease. Although, as discussed above, we do not expect the changes to make a significant impact on the Medicare program. We do not anticipate increased administrative burden as documentation in the medical record of any referred service is already a part of discharge planning in the hospital setting. The changes to the GFR requirements are to conform our regulation to updated clinical standards and also do not pose a significant change.

8. Medicare Shared Savings Program a. Modifications to the Shared Savings Program Quality Reporting Requirements Under the APP and the Quality Performance Standard In section IV.A.3.d.(1)(d) of this final rule, we are extending the use of the CMS Web Interface as a collection type for the Quality Payment Program for performance years 2022, 2023, and 2024 for Shared Savings Program ACOs reporting under the APP. In section III.J.1.c.

Of this final rule, we are finalizing that in order for ACOs to meet the quality reporting requirements under the Shared Savings Program for performance year 2022 and subsequent performance years, ACOs must meet the following requirements. For performance years 2022, 2023, and 2024. An ACO must report on either. (a) The ten CMS Web Interface measures and administer a CAHPS for MIPS survey and CMS will calculate the two claims-based measures included under the APP, or (b) The three eCQMs/MIPS CQMs and administer a CAHPS for MIPS survey and CMS will calculate the two claims-based measures included under the APP.

If an ACO chooses to report the three eCQMs/MIPS CQMs, its performance on all three eCQMs/MIPS CQMs will be used for purposes of MIPS scoring under the APP. If an ACO decides to report both the ten CMS Web Interface measures and the three eCQMs/MIPS CQMs, it will receive the higher of the Start Printed Page 65630 two quality scores for purposes of the MIPS Quality performance category. For performance year 2025 and subsequent years. The ACO must report the three eCQMs/MIPS CQMs and administer a CAHPS for MIPS survey and CMS will calculate the two claims-based measures included under the APP.

Absent the related provision analyzed below to reduce the quality performance standard for PY 2023 to the 30th percentile MIPS Quality performance category score, the changes to the quality reporting requirements, including the accommodation to continue the availability of the CMS Web Interface as a reporting mechanism under the APP will likely provide an easier path for a meaningful subset of ACOs that would otherwise have faced difficulty meeting the quality performance threshold previously established in rulemaking for PY 2023. However, we estimate that nearly all such ACOs would already have met the lower 30th percentile performance standard in PY 2023 without the additional reporting flexibility. Of the relatively few, remaining ACOs that we estimate would have failed to meet the lower 30th percentile performance standard without the additional reporting flexibility, we estimate that about half (on average) will meet the quality performance standard as a result of the quality reporting flexibility adopted in this final rule, and thereby further increase shared savings payments to ACOs by about $20 million in PY 2023. In section III.J.1.d.

Of this final rule, we are finalizing, with modifications, the proposal to freeze the quality performance standard at the 30th percentile across all MIPS Quality performance category scores for performance year 2023, and to establish incentives to encourage ACOs to begin the transition to eCQM/MIPS CQM reporting in performance year 2022 and performance year 2023. The quality performance standard will increase to the 40th percentile across all MIPS Quality performance category scores for performance years 2024 and subsequent performance years. The quality performance standard is the minimum performance level ACOs must achieve in order to share in any savings earned, avoid maximum shared losses under certain payment tracks, and avoid quality-related compliance actions. We are finalizing that, with the exception of an ACO in the first performance year of its first agreement period, an ACO will meet the quality performance standard under the Shared Savings Program by reporting quality data via the APP established under § 414.1367 according the method of submission established by CMS and for.

Performance years 2022 and 2023. ++ Achieving a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, or ++ If the ACO reports the three eCQMs/MIPS CQMs, meeting the data completeness requirement at § 414.1340 and the case minimum requirement at § 414.1380 for all three measures, and achieves a quality performance score equivalent to or higher than the 10th percentile of the performance benchmark on at least 1 of the 4 outcome measures in the APP measure set and a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least 1 of the 5 remaining measures in the APP measure set. Consequently, the ACO would be required to meet the performance benchmark on either 2 outcome measures (one measure at the 10th percentile and the other at the 30th percentile), or 1 outcome measure at the 10th percentile and any other measure in the APP measure set at the 30th percentile. If the ACO (1) does not report any of the 10 CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and (2) does not administer a CAHPS for MIPS survey, the ACO would not meet the quality performance standard.

Performance year 2024 and subsequent performance years. Achieving a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. If the ACO (1) does not report any of the 10 CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and (2) does not administer a CAHPS for MIPS survey, the ACO would not meet the quality performance standard. Our analysis of quality performance data reported by ACOs for performance years starting during 2019 indicates that about 20 percent of ACOs would have failed a quality performance standard defined as the 40th percentile across all MIPS Quality performance category scores.

There is significant uncertainty whether PY 2023 will play out similarly to the baseline data. The fraction of ACOs that would ultimately fail to meet a higher standard in PY 2023 could change significantly if the universe of MIPS Quality performance category scores improves relative to ACOs' quality performance scores, or alternatively if ACOs, particularly ACOs at risk of failing, respond to the increased quality performance standard by boosting their performance. Utilizing a Monte Carlo approach, assuming that the simulated poor performing ACOs have a 50 percent chance of improving their quality performance beyond the 40th percentile, if CMS kept the quality performance standard at the 40th percentile, then the cost of reducing to the 30th percentile in 2023 will be $190 million (range $10 million to $370 million). There is a wide range because slight changes in quality scoring at the low end of the distribution could render the 40th percentile more or less of an effective point of discrimination among ACOs earning shared savings.

B. Modifications to Other Shared Savings Program Requirements We do not anticipate a material aggregate impact for the other changes we are finalizing as proposed related to the Shared Savings Program, specifically. Revisions to the definition of primary care services used in the Shared Savings Program's beneficiary assignment methodology (section III.J.2. Of this final rule).

Revisions to the repayment mechanism arrangement policy, including changes to the calculation and recalculation of repayment mechanism amounts (section III.J.3. Of this final rule). Revision of the requirements concerning disclosure of prior participation in the Shared Savings Program by the ACO, ACO participants, and ACO providers/suppliers, and revisions to Shared Savings Program requirements to reduce the frequency and circumstances under which ACOs submit sample ACO participant agreements and executed ACO participant agreements to CMS (section III.J.4. Of this final rule).

And revisions to the beneficiary notification requirement as it applies to ACOs under prospective assignment and ACOs under preliminary prospective assignment with retrospective reconciliation (section III.J.5. Of this final rule). However, as we note in section III.J.3. Of this final rule, lower required repayment mechanism amounts could reduce costs for ACOs in fees charged by financial institutions for letters of credit and by insurance companies for surety bonds.

We estimate that such relief, in total for all participating ACOs, could be worth $2 to $4 million annually under the approach we are finalizing (assuming a reduction of approximately $196 million in repayment mechanism amounts, in aggregate). Start Printed Page 65631 We also note that the revisions we are finalizing to the definition of primary care services used in the assignment methodology may have differing effects on a subset of participating ACOs, for example, by leading a beneficiary to be assigned to a competing ACO, for a small subset of beneficiaries. We do not anticipate such ACO-level changes will result in a net impact on program spending overall. 9.

Medicare Ground Ambulance Data Collection System In section III.K. Of this final rule, we finalized our proposed changes to the Medicare Ground Ambulance Data Collection System including the proposed change to the data collection period and data reporting period for selected ground ambulance organizations in year 3, proposed revisions to the timeline for when the payment reduction for failure to report will begin and when the data will be publicly available, and proposed revisions to the Medicare Ground Ambulance Data Collection Instrument. We stated in the proposed rule that while we believed that these changes and clarifications will be well received by the ground ambulance stakeholders, we did not believe that these changes will have any substantive impact on the cost or time associated with completing the Medicare Ground Ambulance Data Collection Instrument. We also noted in the proposed rule that the overall length of the Medicare Ground Ambulance Data Collection Instrument would be the same as previously finalized (84 FR 62888) with these changes.

Additionally, some of the instructions which we proposed to add were intended to improve clarity and may therefore reduce the time the ground ambulance organizations spend addressing the questions. We did not receive any public comments on our estimated impact on the cost or time associated with completing the Medicare Ground Ambulance Data Collection Instrument. As we discussed in section III.K of this final rule, we are finalizing our proposed changes to the Medicare Ground Ambulance Data Collection System. 10.

Medicare Diabetes Prevention Program Expanded Model a. Effects of Provisions Relating to the Medicare Diabetes Prevention Program Expanded Model (1) Effects on Beneficiaries We proposed to modify certain Medicare Diabetes Prevention Program (MDPP) expanded model policies to. (1) Allow CMS to remove the ongoing maintenance phase (months 13-24) of the MDPP set of services for those beneficiaries who started their first core session on or after January 1, 2022. (2) update the performance payments for the MDPP set of services in the core and core maintenance performance periods.

And (3) waive the Medicare provider enrollment application fee for all organizations enrolling as MDPP suppliers on a prospective basis. These changes will have a positive impact on beneficiaries' health by increasing the capacity of MDPP eligible organizations to enroll in Medicare as MDPP suppliers and increasing access to the MDPP set of services for beneficiaries. Eligible beneficiaries receive these services as preventive services, which require no copays or cost sharing. These changes address MDPP supplier and beneficiary needs based upon all available monitoring and evaluation data.

The changes are also responsive respond to stakeholder comments. (2) Effects on the Market Currently, more than 1,000 organizations nationally are eligible to become MDPP suppliers based on their preliminary or full CDC Diabetes Prevention Recognition Program (DPRP) status. However, only 27 percent of eligible organizations are participating in MDPP. We anticipate that the removal of the second year of the MDPP set of services will make MDPP attractive and feasible to more MDPP eligible organizations.

Not only does a 12-month MDPP services period align with that of the CDC's National DPP and the DPP model test, our data show that only 10 percent of enrolled MDPP participants continue with the Ongoing Maintenance phase sessions (Year 2), and the majority are reaching their weight loss milestone within the first 6 months of the set of MDPP services. Stakeholders report that the second year of MDPP, or the ongoing maintenance phase, is cost prohibitive due to the costs to retain beneficiaries in year 2 of the expanded model as well as the costs to deliver an additional year of the expanded model that is not supported by the CDC National DPP curriculum. The CDC's National DPP curriculum supports a 1-year program and suppliers have found it difficult to extrapolate the curriculum to a second year. Additionally, MDPP suppliers commented that they have an increasingly difficult time making the business case for MDPP given the costs associated with the ongoing maintenance phase and the low performance payments associated with the second year.

Given the low volume of participants continuing in the second year of MDPP, delivering the MDPP ongoing maintenance period creates an undue burden to MDPP suppliers. The cost to offer and deliver the sessions to a small cohort of individuals outweigh the maximum payments available from Medicare. Stakeholders have consistently commented that CMS should shorten the MDPP expanded model to 1 year, with payment levels at least equivalent to the levels provided in the DPP model test. For example, during the DPP model test, suppliers were paid an average of $462 per beneficiary for the 1-year model test.

The second year has made delivering MDPP both financially unattractive and unstainable for many of the current and eligible MDPP suppliers. Suppliers have reported that it is very difficult to engage and retain beneficiaries in a second year, and the reimbursement levels for a second year are inadequate to cover supplier costs. We proposed to shorten the MDPP service period to 1 year and increase the performance payments in the first year. These changes respond to stakeholder feedback and may alleviate some of the difficulty retaining MDPP participants during the core maintenance phase of the expanded model.

(3) Burden Related to Information Collection Requirements—No impact (a) Supplier Standards MDPP suppliers may encounter the Medicare enrollment fee during the following Medicare provider enrollment transactions. Initial enrollment. Revalidation (every 5 years for MDPP). Or the addition of a new practice location.

The provider/supplier enrollment fee for Calendar Year 2021 is $599. Although MDPP suppliers may submit a written request to CMS for a hardship exception to the application fee in accordance with § 424.514, many will not qualify and the hardship application process will simply add more burden on the organization. We have heard from the CDC as well as other stakeholders that the enrollment fee is a potential barrier to eligible MDPP suppliers who will not otherwise enroll in Medicare except for MDPP. Approximately 39 percent of our current suppliers are non-traditional suppliers that serve their local communities and play a critical role in enrolling more diverse, equitable, and inclusive cohorts of Medicare beneficiaries to MDPP.

These non-traditional suppliers include, but are not limited to YMCAs, county health departments, community health centers, and non-profit organizations that focus on health education, and otherwise will neither enroll nor be able Start Printed Page 65632 to enroll as a Medicare supplier at all if it were not for MDPP. They often serve as trusted sources of health information for their communities. However, they also represent a large number of eligible organizations who have not enrolled in Medicare as MDPP suppliers. We anticipate that waiving the enrollment fee on a prospective basis along with the other programmatic adjustments are likely to result in more MDPP suppliers, increased beneficiary access to MDPP services, and an ongoing reduction of the incidence of diabetes in eligible Medicare beneficiaries, in both urban and rural communities.

In April 2020, CMS waived all provider enrollment application fees as part of the buy antibiotics Emergency Declaration Blanket Waivers for Health Care Providers. As a result, we saw an increase in MDPP supplier enrollment. We believe that granting a waiver of the fee for MDPP suppliers to extend beyond the buy antibiotics Emergency Declaration Blanket Waiver, along with the other change to MDPP, may stimulate MDPP supplier enrollment and enhance the MDPP evaluation. We proposed waiving the Medicare provider enrollment fee beyond buy antibiotics Emergency Declaration Blanket Waivers for Health Care Providers because the enrollment fee creates a potential barrier to MDPP supplier enrollment, beneficiary access to the program, and subsequently, our ability to evaluate MDPP.

Specifically, we proposed, to waive the enrollment fee as described in section 1866(j)(2)(C)(i) and (ii) of the Act during the MDPP expanded model test phase. (b) Payment for MDPP Services Our regulations at § 414.84 specify the payments MDPP suppliers may be eligible to receive, payments for furnishing MDPP services, and meeting performance targets related to beneficiary weight loss and/or attendance. MDPP suppliers are paid by CMS by submitting claims for MDPP beneficiaries using claim form CMS-1500 ( https://www.cms.gov/​Medicare/​CMS-Forms/​CMS-Forms/​Downloads/​CMS1500.pdf ). As a condition for payment, claims submitted by MDPP suppliers must be for services furnished to eligible beneficiaries in accordance with § 414.84(b) and (c).

We have streamlined the performance payments so that they are easier to understand and suppliers receive larger payments for participants reaching attendance and weight loss performance-based milestones. For example, the attendance-based performance payments are based on a standardized per-session rate, paid after the 1st, 4th, and 9th sessions attended during the core sessions interval, and after attending the two (2) sessions during each of the core maintenance intervals. We have redistributed all the Year 2 ongoing maintenance sessions phase performance payments to certain core and core maintenance session performance payments in Year 1. As finalized, the maximum payment of $705 over a 1-year service period is $1 more than the current maximum payment of $704 under the original 2-year payment structure.

We believe eliminating the second year and its associated payments while increasing the first-year payments will result in a more financially sustainable expanded model. Increasing the first year MDPP payment amounts should not negatively affect a supplier's performance (for example, participants' weight loss). As finalized, we increased the per session payments to $35, with suppliers receiving $53 more per beneficiary who attends the 4th core session compared to current payments and $27 more than proposed. We increased the attendance-based payments in response to stakeholder comments and maintained the 5 percent weight loss payments.

Although some of the largest payments to suppliers are still driven by weight loss achievement, the maximum payment for attendance only is finalized at $455 compared to $338 proposed and $205 current. Further, in order to maintain CDC Diabetes Prevention Recognition Program (DPRP) recognition status, which is required to be an MDPP supplier, certain levels of performance metrics (for example, weight loss) must be satisfied. There is no evidence that eliminating the second-year maintenance sessions, shortening the MDPP services period to 1 year, will have any negative effects on performance of the expanded model. (4) Effects on the Medicare Program (a) Estimated 10-Year Impact of MDPP Table 140 shows an updated estimate (in millions) for the impact on Medicare spending of two changes to the Medicare Diabetes Prevention Program (MDPP) to be implemented in 2022, with corrected assumptions.

Waiving the Medicare enrollment fee for all new MDPP suppliers. And Shortening the MDPP services period to 1 year and shifting all of the Ongoing Maintenance reimbursement amounts to year one. These estimates by the CMS Office of the Actuary do not consider waiving the Medicare enrollment fee as a direct cost and assume there will be an additional 500 beneficiaries per year participating in MDPP. The average payment for an MDPP participant will increase by $150.

While the maximum payment available to an MDPP supplier is only slightly greater than the maximum payment available under the original 2-year payment structure, the second year set of MDPP services have historically been far less utilized than the first year set of services. Therefore, eliminating the second-year payments has a minimal negative effect to the assumed costs of the expanded model. In the most recent year prior to the PHE, 747 Medicare FFS beneficiaries entered MDPP. Increasing the first-year payment amounts to suppliers and waiving the Medicare enrollment fee should increase access to MDPP, resulting in more utilization of the MDPP set of services.

Starting in 2022, we can assume that 750 beneficiaries will have entered the expanded model each year without including the finalized changes. After including these changes, we will now Start Printed Page 65633 assume 1,250 beneficiaries will enter the expanded model each year. This assumption has a high level of uncertainty and we revisit it in the Sensitivity Analysis section. Increasing the first year MDPP payment amounts should not negatively affect a supplier's performance (for example, participants' weight loss).

Almost all of the increases to the payment amounts are applied after the 4th core session. Even though most of the payment increases are not tied to weight loss achievement, in order to maintain CDC Diabetes Prevention Recognition Program recognition status, which is required to be an MDPP supplier, certain levels of performance metrics (for example, weight loss) must be satisfied. There is no evidence that eliminating the second-year maintenance sessions, shortening the MDPP services period to one year, will have any negative effects on performance of the expanded model. (b) Sensitivity Analysis Since the cost to suppliers for delivering the MDPP set of services is generally unknown, how utilization of the expanded model will be affected by the changes is highly uncertain.

Table 141 shows the 10-year impact estimates (in millions) for different levels of additional beneficiary participation as a result of the changes. Finally, higher projected savings are associated with increases in beneficiary participation, while no additional beneficiaries will result in an estimated cost. The financial impacts we provided for the previously proposed payment schedule changes included errors that impacted our estimates. Additional costs resulting from payment increases were not applied to the baseline participants.

The count of 1,742 participants used to estimate future baseline participation included Medicare Advantage beneficiaries, which should have been excluded. And since there were only 747 new FFS participants in the most recent year prior to the start of the PHE, our best estimate would have assumed 250 additional FFS participants per year resulting from the previously proposed changes. b. Alternatives Considered No alternatives were considered.

The 2-year MDPP service period has depressed interest in MDPP among would-be MDPP suppliers. These actions address stakeholder comments on the barriers to MDPP expanded model success. If we do not take action, we will not be able to scale MDPP as intended, impacting Medicare beneficiary access to this expanded model. Reducing the MDPP from a 24-to a 12-month services period, increasing the year 1 performance payments, and waiving the Medicare provider enrollment application fee not only better aligns the expanded model with the evidence that helped certify the DPP model test initially, but it will encourage eligible organizations to enroll as MDPP suppliers.

C. Impact on Beneficiaries This change will have a positive impact on eligible MDPP beneficiaries, as it better aligns with the CDC's National DPP, giving both the participants and the coaches similar messaging regarding this expanded model, regardless of payer. MDPP suppliers often offer the MDPP set of services to mixed cohorts, or classes with participants who are not eligible for MDPP, but who are enrolled in a National DPP cohort. Since MDPP generally follows the CDC's National DPP and aligns its expanded model with the CDC's DPRP Standards, it is confusing to participants, coaches, and staff when talking about a 2-year set of services to its eligible Medicare participants when the non-Medicare participants have a 1-year program.

Finally, reducing the MDPP service period from 2 years to 1 year allows more cohorts to start and finish MDPP during the expanded model initial period of performance, which is expected to end in March 2023. D. Estimating Regulatory Familiarization Costs Given that we tried to align this rule as much as possible with the CDC DPRP Standards, there should be minimal regulatory familiarization costs. This rule impacts only enrolled MDPP suppliers and eligible beneficiaries who Start Printed Page 65634 have started the MDPP expanded model or are interested in MDPP.

11. treatment Administration Services In section II.J.1. Of this final rule, we are finalizing that effective January 1, 2022, CMS will pay $30 per dose for the administration of the influenza, pneumococcal and hepatitis B zithromax treatments. In addition, CMS will maintain the current payment rate of $40 per dose for the administration of the buy antibiotics treatments through the end of the calendar year in which the ongoing PHE ends.

Effective January 1 of the year following the year in which the PHE ends, the payment rate for buy antibiotics treatment administration will be set at a rate to align with the payment rate for the administration of other Part B preventive treatments. We estimate that the policy to increase the administration cost for influenza/pneumococcal/HBV treatment services to $30 in 2022 will increase Medicare spending by roughly $250 million in CY 2022. This estimate doesn't reflect the impact of induced utilization of the treatment, or any offsetting savings resulting from averted hospitalizations for those who would now get the treatment. This policy may encourage more health care providers to offer these services or encourage those that already offer these services to proactively identify and vaccinate more beneficiaries compared to what they might under the lower rates, which would result in further additional treatment costs.

However, if more beneficiaries were vaccinated then Medicare costs associated with the treatment of influenza, pneumonia, and hepatitis B could be reduced. In order to offset the costs associated with this policy roughly 10-11K influenza-related hospitalizations would have to be averted. 12. Medicare Provider and Supplier Enrollment Changes—Provider Enrollment As explained in section III.N.

Of this final rule, we proposed changes to three of our existing revocation reasons. We proposed to expand § 424.535(a)(2) to permit revocation based on the OIG exclusion of administrative or management services personnel furnishing services payable by a Federal health care program, such as a billing specialist, accountant, or human resources specialist. We proposed to expand § 424.535(a)(13) to permit revocation of a physician's or other eligible professional's enrollment if he or she surrenders his/her Drug Enforcement Administration (DEA) certificate of registration in response to an order to show cause. We proposed to revise the factors in § 424.535(a)(8)(ii) (which permits revocation based on a pattern or practice of submitting non-compliant claims) to better enable CMS to target shorter periods of non-compliant billing.

We believe that all three of these changes will result in an increase in the number of revocations that CMS imposes. However, we believe this number will be rather small. We currently impose only a limited number of revocations under §§ 424.535(a)(2), (a)(13), and (a)(8)(ii). Accordingly, since our expansion of these three revocation reasons will be fairly modest, we do not foresee more than a very slight increase in revocations.

Table 143 outlines the number of revocations we estimate will ensue under our revocation expansions. These numbers only account for additional revocations stemming from our changes. Internal CMS data indicates that the average provider/supplier that will be affected by these regulatory expansions receives roughly $50,000 in Medicare payments each year. (We used a similar $50,000 annual payment estimate for our provider enrollment provisions in the CY 2020 PFS final rule) (84 FR 62568)).

Providers/suppliers revoked under our revocation expansions will thus not receive these payments. Hence, multiplying our $50,000 estimate by the revocation totals in Table 143 results in a projected transfer from these providers/suppliers to the Federal Government of $750,000 ($50,000 × 15 revocations). We did not receive public comments on these estimates and are therefore finalizing them as proposed. 13.

Provider/Supplier Medical Review Requirements—Prepayment and Post-Payment Reviews In section III.N.2. Of this final rule, we proposed to. (1) Define key terms including “additional documentation,” “additional documentation request,” “post-payment medical review,” and “prepayment medical review;” (2) codify contractors' authority to request additional documentation for prepayment and post-payment review within established timeframes. (3) codify timeframes for response to requests for documentation.

And (4) codify result of a failure to comply with prepayment or post-payment documentation request(s) by a provider or supplier, specifically denial of payment. We do not believe these provisions involve any additional impact or burden on providers, suppliers, or States. However, we welcomed feedback from stakeholders regarding the potential costs of these provisions. The regulations will incorporate already established key terms and definitions as well as processing requirements pertaining to prepayment and post-payment medical review into regulation.

Placing this information in regulation will improve provider and supplier understanding of the medical review process and their responsibilities in complying with our review contractor's requests. Further, the regulations represent no change to medical review requirements. As such, we did not anticipate any change in the number of prepayment medical reviews, post-payment medical reviews or the number of additional documentation requests made by contractors. We did not receive public comments on this provision, and therefore, we are finalizing as proposed.

Start Printed Page 65635 14. Effect of Modifications to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs) As discussed in section III.O of this final rule, we are finalizing our proposal to allow OTPs to continue to furnish the therapy and counseling portions of the weekly bundles, as well as any additional counseling or therapy that is billed using the add-on code, using audio-only telephone calls rather than via two-way interactive audio-video communication technology in cases where audio/video communication is not available to the beneficiary after the conclusion of the PHE for buy antibiotics, provided all other applicable requirements are met. We believe this change will facilitate broader access to these services for beneficiaries. We are also finalizing our proposal to require that when these services are furnished using audio-only technology, practitioners certify that they had the capacity to furnish the services using two-way audio/video communication technology, but instead, used audio-only technology because audio/video communication technology was not available to the beneficiary.

We believe the Part B cost impact of these final policies will be minimal, since payment for therapy and counseling is included in the bundled payment regardless of the modality used to deliver it and we do not expect that this provision will increase the frequency at which medically necessary counseling and therapy services are billed using the counseling and therapy add-on code (HCPCS code G2080). Additionally, as discussed in section III.O. Of this final rule, the FDA recently announced the approval of a new, higher dose naloxone hydrochloride nasal spray product used to treat opioid overdose and that the newly approved product delivers 8mg of naloxone. In the CY 2021 PFS final rule (85 FR 84683 through 84685), we finalized payment for HCPCS code G2215 (Take-home supply of nasal naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program).

List separately in addition to code for primary procedure). HCPCS code G2215 was priced based on an assumption of a typical case in which the beneficiary will be provided with a box of two 4mg nasal spray products. At the time of drafting the proposed rule, we did not yet have any available pricing information for this newly approved product. However, in order to be able to make payment to OTPs under Medicare for this product, we proposed to create a new G-code describing a take-home supply of this higher dose naloxone hydrochloride nasal spray product.

After considering the comments received, we are finalizing our proposal to establish a new code for a higher-dose of naloxone hydrochloride nasal spray. We will price this code as proposed. The drug component is based on the methodology at § 410.67(d)(2)(i) and the amount of the non-drug component of the code is based on the CY 2020 Medicare payment rate for CPT code 96161, as updated by the MEI. Based on utilization of the existing naloxone codes under the OTP benefit, we believe that the cost impact of finalizing this new code will be minimal.

15. Physician Self-Referral Update The physician self-referral law provisions are discussed in section III.P. Of this final rule. As discussed in section III.P.2.

Of this final rule, we are amending the provisions of § 411.354(c)(2) identifying unbroken chains of financial relationships that constitute “indirect compensation arrangements” to ensure that a longstanding prohibition on certain per unit of service-based compensation formulas for determining charges for the rental of office space and equipment remains within the ambit of the law. This provision, which was inadvertently omitted when the definition of “indirect compensation arrangement” was revised in the December 2, 2020 final rule entitled “Modernizing and Clarifying the Physician Self-Referral Regulations” (85 FR 77492), is necessary to protect against potential abuses such as overutilization and anti-competitive behavior. We believe that most parties have continued to comply with the regulatory provisions on per unit of service-based compensation formulas for the rental (or lease) of office space and equipment as they have done since the requirements became effective on October 1, 2009. We are also adding provisions to assist stakeholders in identifying the individual unit to be analyzed under the provisions of § 411.354(c)(2)(ii)(A)(2)(i) through (iv).

We believe that the clarity provided by these provisions will facilitate compliance without adding burden. As discussed in section III.P.3. Of this final rule, we are finalizing our proposal to permit the use of the exception for preventive screening tests and treatments at § 411.355(h) for buy antibiotics treatments during such period as the treatments are not subject to CMS-mandated frequency limits, provided that all other requirements of the exception are satisfied. We believe that this provision will ensure that the physician self-referral law will not impede the availability of critically important buy antibiotics treatments for Medicare and other patients.

As discussed in section III.P.4. Of this final rule, we are finalizing our proposal to publish the Code List for Certain Designated Health Services (Code List) solely on the CMS website. Commencing after the publication of the January 1, 2022 Code List in this final rule, the Code List will be updated annually and published on the CMS website at https://www.cms.gov/​Medicare/​Fraud-and-Abuse/​PhysicianSelfReferral/​List_​of_​Codes. No less than 30 consecutive calendar days prior to the effective date of a Code List update, we will provide advance notice of the updated Code List on the CMS website.

We will also provide for a 30-day public comment period for each update using www.regulations.gov, and publish instructions for submitting comments on the CMS website. We will address all public comments that we receive through this process on the CMS website. Finally, we are revising the definition of “List of CPT/HCPCS Codes” at § 411.351 by updating the URL that indicates where the Code List is published on the CMS website. We believe that these provisions will facilitate compliance with the physician self-referral law and allow easier access to the most up-to-date Code List.

16. Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug under a Prescription Drug Plan or an MA-PD Plan (section 2003 of the SUPPORT Act) In addition to the cost reflected in the Collection of Information section of this final rule, we expect that there will be an additional burden for CMS to award and work with a CMS contractor to develop a process for reviewing the PDE data to assess prescriber compliance with the regulatory provision and review and process prescriber attestations. Based on similar contracts, and conversations with the industry, in the CY 2022 PFS proposed rule, we estimated the costs of (A) development of operational strategy for the new program, (B) reviewing PDE data, and (C) prescriber case work. We solicited stakeholder feedback on our estimate and all our assumptions.

(A) Development of policy. We estimated that it would take our contractor a week of work, 40 hours, to develop the strategy for how the contractor will process the prescriber attestations. We estimated that it would take an operations manager and compliance officer working together at a combined hourly wage of $193.60/hr Start Printed Page 65636 ($120.90/hr + $72.70/hr) a full 40-hour work week to operationalize this aspect of it. Therefore, we estimated the aggregate cost to be $7,744 (40hr * $193.60/hr).

(B) Since systems already exist to collect the appropriate PDE data, in our proposed rule, we stated that our contractor would only have to review the data for compliance with the EPCS mandate. Therefore, we estimated that it would take 2 computer systems analysts each working at $95.22/hr, a week and a half of work, 60 hours. Therefore, the aggregate cost would be $5,713.20 (60 hr * $95.22/hr). (C) We estimated that it would take 4 administrative support workers each working at $36.82/hr, 60 hours to generate the letters and disseminate them to the appropriate prescriber, which means that it would cost our contractor $2,209.20/year (60 hr * $36.82/hr) in administrative support costs.

We estimated that it would be the full-time job of a customer service representative working at $37.02/hr to field prescriber inquiries about the disseminated letters. Thus, we estimated that our contractor would spend $77,001.60 ($37.02/hr * 40 * 52) on the salary of the customer service representative for this task. The aggregate impact for our contractor is 200 hours at a cost of $92,668. We solicited comment on the accuracy of this burden estimate and on any measures that CMS can take to decrease the impact of this provision, while maintaining its utility and implementing the statutory mandate.

We did not receive public comments on the burden estimates for this provision, and therefore, we are finalizing as proposed. 17. Open Payments a. Payment Context Field for Teaching Hospitals This provision is for a mandatory freeform text context field.

We have created this provision at the request of stakeholders, particularly after conversations with teaching hospitals. The teaching hospitals confirmed that the majority of their disputes arise because of a lack of information within the record and an inability to associate the payment to the correct area within their large organization, not the inaccuracy of the record itself. The benefit of this field is to give better context to the records attributed to teaching hospitals and thereby reduce the number of disputes. For this reason, we also believe it will increase goodwill between the program's stakeholders.

The cost is that reporting entities will need to collect an additional piece of information, which will increase burden. We do not believe this burden will be great because the volume of reported teaching hospital payments is much lower than the volume of physician covered recipient payments. In addition, we have created flexibility with this field so that the reporting entity can choose which piece of information is most appropriate and can be something that they already collect, such as a check number or name of the department in the hospital. B.

Optional Annual Recertification The optional annual recertification is at the request of reporting entities and will increase the availability of communication to CMS. The burden associated with this action is low because it will be a low-effort process only completed by the entities who choose to do so. C. Defining a Physician-Owned Distributorship Since the program began in 2013, we have heard feedback that physician-owned distributorship (PODs) should be better represented in the data because the conflict of interest potentially created by PODs is at the heart of the program.

We created this new definition due to the lack of an existing POD definition that would be appropriate for the program's needs. Although this is a new definition, it will only be a subset of the existing definitions of applicable manufacturer and applicable group purchasing organization. €œApplicable manufacturer—POD” and “Group purchasing organization—POD” are already “business type” choices when registering in the Open Payments system. Therefore, this definition will not alter existing regulations beyond requiring PODs to identify themselves as such.

D. Disallowing Record Deletion Without Reason We believe there is not currently language to prevent an applicable manufacturer or applicable group purchasing organization from submitting and attesting to records, then deleting the records to prevent publication. This action would be contrary to the spirit of transparency of the program. To help ensure compliance with this requirement, we are also adding a new field that will allow entities to communicate the reason for the deletion to CMS.

Since the entities will have attested to the accuracy and completeness of these records, we believe it is appropriate to confirm the reason for the deletion. We have not perceived the behavior of inappropriate deletions within the data and do not believe it will increase burden beyond the additional field when deleting a record. We are preemptively closing a potential loophole. E.

Disallow Publication Delays of General Payments The statute requires that delays are “made pursuant to product research or development agreements and clinical investigations” (1128G(c)(1)(E) of the Act). A small number of general payments are delayed annually, which we are unable to verify meet this requirement. Research payments contain the appropriate fields to ensure that the statutory provisions are being met. We do not believe that it will be a burden for the small number of general payments to either be reported as research payments or not delayed.

F. Short-Term Loans Short-term loans are not required to be reported, but they must be shorter than 91 days to meet the exception. This provision does not create burden because it only clarifies that those 90 days must be the cumulative total for a year, which is already outlined in subregulatory guidance. We do not anticipate that this will change reporting behavior but want to explain the exception more clearly within the text of the final rule.

G. Remove General Ownership Records Ownership records have special rules for reporting outlined in the statute (section 1128G(a)(2) of the Act), which are not included in the format for general records. However, there is currently a general record for reporting ownership and investment interest (Nature of Payment = 11). We anticipate a small burden for the approximately 92 reporting entities who have previously used the general nature of payment category in order to fill out the different fields in the ownership record.

This burden will allow the records to meet statutory mandates. H. Updated Contact Information Open Payments conducts regular compliance-related outreaches to reporting entities when it encounters data that may not meet program requirements. We have found that the two contacts provided by applicable manufacturers and group purchasing organizations often become obsolete, especially if a company has not updated its contact information during the recertification process.

It is crucial for the integrity of the data that we have the ability to contact entities in the case of Start Printed Page 65637 irregularities. Additionally, we believe that ensuring informal communications from CMS will reduce burden since it may prevent more formal compliance actions if the entity is unresponsive due to outdated contact information. However, we do not believe this is an issue for the majority of reporting entities, nor do we believe that keeping the contact information updated will create a large burden. 18.

Updates to the Quality Payment Program In section IV.A. Of this final rule, we include our finalized policies for the Quality Payment Program. In this section, we first present the overall and incremental impacts to the number of expected QPs and associated APM Incentive Payments. In the following sections, we estimate the overall and incremental impacts to the total MIPS eligible population and the payment impacts by practice size for the CY 2022 performance period/2024 MIPS payment year based on various finalized policies, including policies to modify MIPS eligibility, the MIPS final score and the performance threshold and additional performance threshold as discussed in sections IV.A.3.a., IV.A.3.d., IV.A.3.e., and IV.A.3.f.

Of this final rule. For the MIPS payment adjustment, we ran two RIA models. A baseline and a final policies model. The aim of the baseline model is to model the status of our population of clinicians for the CY 2022 performance period/2024 MIPS payment year if this final rule does not take effect.

It therefore reflects previously finalized policies for the CY 2022 performance period/2024 MIPS payment year. Select examples of the baseline policies scheduled to start in the CY 2022 performance period/2024 MIPS payment year include the removal of the Web Interface as a collection type and the change in the performance category weights. There was no defined performance threshold or additional performance threshold, so our baseline model assumed the performance threshold and additional performance threshold used for the previous period (CY 2021 performance period/2023 MIPS payment year). The aim of the final policies model is to estimate the incremental effect of the final policies for the CY 2022 performance period/2024 MIPS payment year on MIPS eligibility, MIPS final scores, and payment adjustments.

In other words, by comparing the difference between our baseline model and our final policies model we can estimate the incremental impact of finalizing the policies contained in this final rule. Select examples of the finalized policies include, the inclusion of new MIPS eligible clinician types, the inclusion of the Web Interface as a collection type, the change in performance threshold and additional performance threshold, and the changes to the complex patient bonus. Refer to section VI.F.18.e.(2) of this final rule for the detailed methods on how we integrated the policies into the baseline and final policies models. A.

Assessing Use of 2020 Data for Estimating Future MIPS Performance In the 2022 PFS proposed rule (86 FR 39546), we stated that the RIA used the 2019 MIPS performance period data because the data for the 2020 MIPS performance period were not available in time to incorporate into the proposed rule model. We noted we would evaluate whether it is appropriate to use the 2020 performance period data to predict performance in CY 2022 for the final rule and whether adjustments would need to be made if CY 2020 performance period data are used. We have already acknowledged some data from the CY 2020 performance period is not usable. For example, we have stated that based on our analysis of the 2020 performance period data, we could not reliably calculate scores for the cost measures that would adequately capture and reflect the performance of MIPS eligible clinicians.

As a result, we reweighted the cost performance category for all MIPS eligible clinicians for the CY 2020 MIPS performance period.[] Additionally, in section IV.A.3.f.(2) of this final rule, we noted we have final score data for the CY 2020 performance period/2022 MIPS payment year available to use in our assessment of whether to use the mean or median for the performance threshold, but the data for the CY 2020 performance period/2022 MIPS payment year may be subject to change as a result of the targeted review process. However, we have also indicated that for certain purposes 2020 performance period data could be beneficial too. As discussed in section IV.A.3.e.(1)(c)(ii) of this final rule, we believe 2020 performance period data is appropriate to use for historic benchmarks in part because it is the most recent available dataset and it reflects a performance period in which clinicians were facing the PHE. To evaluate whether the 2020 MIPS performance period data is appropriate to use to predict future performance, we considered whether the extreme and uncontrollable circumstances policy impacted submissions and data, and whether the buy antibiotics PHE impacted services provided (for example, quality measures, the number of MIPS eligible clinicians, claims).

For the 2020 performance year, we applied the MIPS automatic extreme and uncontrollable circumstances policy to all individual MIPS eligible clinicians and allowed for extreme and uncontrollable applications due to the buy antibiotics PHE ( https://qpp.cms.gov/​resources/​buy antibiotics19?. €‹py=​2020 ). Due to these extreme and uncontrollable circumstances policies, not all clinicians or groups may have submitted data for the 2020 MIPS performance period. When we evaluated whether the 2020 MIPS performance period data is appropriate to use to estimate 2022 MIPS performance period performance for MIPS eligible clinicians, we compared the 2020 MIPS performance period data to the 2019 MIPS performance period data on key metrics.

Overall, we observed a decrease in the number of MIPS eligible clinicians at the individual level who exceed the low-volume threshold. We also observed a decline in data submitted by individual and group. Finally, when examining actual scores and payment information for the 2020 performance period/2022 MIPS payment year compared to the 2019 performance period/2021 MIPS payment year, we found an increase in the number of MIPS eligible clinicians receiving a neutral score. However, our initial findings suggest the extreme and uncontrollable circumstances policy combined with the buy antibiotics PHE limit the data needed to simulate future MIPS eligible population and associated performance.

Therefore, this RIA uses the 2019 MIPS performance period submissions which were used for the CY 2021 PFS final rule RIA (85 FR 85011 through 85023) and CY 2022 PFS proposed rule RIA (86 FR 39545 through 39556). We note that the findings are specific for purposes of estimating future performance for the entire population of MIPS eligible clinicians. B. Estimated APM Incentive Payments to QPs in Advanced APMs and Other Payer Advanced APMs For payment years 2019 through 2024, through the Medicare Option, eligible clinicians with a sufficient percentage of Medicare Part B payments for covered professional services or Medicare patients through Advanced APMs will be QPs in the applicable QP performance period for a year.

These QPs will receive a lump-sum APM Incentive Payment equal to 5 percent of Start Printed Page 65638 their estimated aggregate paid amounts for Medicare covered professional services furnished during the calendar year immediately preceding the payment year. Beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the All-Payer Combination Option. The All-Payer Combination Option allows eligible clinicians to become QPs by meeting the QP payment amount or patient count threshold through a pair of calculations that assess a combination of both Medicare Part B covered professional services furnished or patients through Advanced APMs and services furnished or patients through Other Payer Advanced APMs. Eligible clinicians who become QPs for a year are not subject to MIPS reporting requirements and payment adjustments.

Eligible clinicians who do not become QPs but meet a lower threshold to become Partial QPs for the year may elect to report to MIPS and, if they elect to report, will then be scored under MIPS and receive a MIPS payment adjustment. Partial QPs are not eligible to receive the APM Incentive Payment. If an eligible clinician does not attain either QP or Partial QP status and does not meet any other exemption category, the eligible clinician will be subject to MIPS, will report to MIPS, and will receive the corresponding MIPS payment adjustment. Beginning in payment year 2026, the update to the PFS CF for services that are furnished by clinicians who achieve QP status for a year is 0.75 percent, while the update to the PFS CF for services that are furnished by clinicians who do not achieve QP status for a year is 0.25 percent.

In addition, MIPS eligible clinicians will receive positive, neutral, or negative MIPS payment adjustments to payment for their Part B PFS services in a payment year based on performance during a prior performance period. Although the statute establishes overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the 2024 MIPS payment year of the Quality Payment Program. Overall, we estimate that for the 2022 QP Performance Period between 225,000 and 290,000 eligible clinicians will become QPs. Therefore, they will be excluded them from MIPS and will qualify for the lump sum APM incentive payment in Payment Year 2024 based on 5 percent of their Part B paid amounts for covered professional services in the preceding year.

These paid amounts for QPs are estimated to be between approximately $12,000 million and $15,000 million in total for the 2022 performance year. The analysis for this final rule used the 2020 third snapshot participation file. We based APM Incentive Payment Amounts on paid amounts with service dates of January 1, through September 30, 2020. We multiplied the calculated amounts by 1.5 to approximate payment amounts for the full calendar year.

We estimate that the total lump sum APM Incentive Payments will be approximately $600-750 million for the 2024 Quality Payment Program payment year. In section VI.F.18.a. Of this final rule, we projected the number of eligible clinicians that will be QPs, and thus excluded from MIPS, using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs.

The projections reflect Advanced APMs that will be operating during the 2022 QP Performance Period as well as some Advanced APMs anticipated to be operational during the 2022 QP Performance Period. The projections also reflect an estimated number of eligible clinicians that will attain QP status through the All-Payer Combination Option. We note that the Kidney Care Choices Model and the Radiation Oncology model have been included in our analysis as we anticipate that the model will be Advanced APMs in 2022. Additionally, we anticipate that the Maryland Primary Care Program will not be an Advanced APMs in 2022.

The following APMs are expected to be Advanced APMs for the 2022 QP Performance Period. Bundled Payments for Care Improvement Advanced Model. Comprehensive Care for Joint Replacement Payment Model (CEHRT Track). Global and Professional Direct Contracting Model.

Kidney Care Choices Model (Kidney Care First. Professional Option and Global Option). Maryland Total Cost of Care Model (Care Redesign Program). Medicare Shared Savings Program (Basic Track Level E, and the ENHANCED Track).

Oncology Care Model (Two-Sided Risk Arrangements). Primary Care First (PCF) Model. Radiation Oncology model. And, Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative).

We used the Participation Lists and Affiliated Practitioner Lists, as applicable, (see 81 FR 77444 through 77445 for information on the APM Participant Lists and QP determinations) on the 2020 third snapshot participation file to estimate the number of QPs, total Part B paid amounts for covered professional services, and the aggregate total of APM Incentive Payments for the 2022 QP Performance Period. We examined the extent to which Advanced APM participants will meet the QP Thresholds of having at least 50 percent of their Part B covered professional services or at least 35 percent of their Medicare beneficiaries furnished Part B covered professional services through the APM Entity. C. Impact for the CY 2021 Performance Period/2023 MIPS Payment Year In section IV.A.3.e.(2)(a)(ii) of this final rule, we finalize our proposal to double the complex patient bonus, and to increase its cap to 10 points for the CY 2021 Performance Period/2023 MIPS Payment Year.

We expect this policy to result in an increase of 3 points in the median bonus thus increasing MIPS final scores at the median by 3 points. We do not know the effects of the PHE for buy antibiotics and its effect on MIPS performance in 2021, so we did not recreate the analysis and payment distributions with the updated bonus for the CY 2021 performance period/2023 MIPS payment year (85 FR 85012 through 85019). The increase in complex patient bonus points will result in smaller payment adjustments for three reasons. First, the resulting increase in final scores will reduce the budget neutral pool.

Second, the increase in complex patient bonus points will increase the number of clinicians with scores above the performance threshold or additional performance threshold, meaning more clinicians will share in the budget neutral pool and additional $500 million for exceptional performance and potentially lower the scaling factor that is applied to the MIPS payment adjustment and additional payment adjustment. Third, the average scores of those receiving a positive or additional adjustment will be higher, which means the adjustment rates for clinicians that have scores above the performance threshold or additional performance threshold will be lower. D. Estimated Number of Clinicians Eligible for MIPS Eligibility for the CY 2022 Performance Period/2024 MIPS Payment Year (1) Methodology To Assess MIPS Eligibility (a) Clinicians Included in the Model Prior To Applying the Low-Volume Threshold Exclusion To estimate the number of MIPS eligible clinicians for the CY 2022 performance period/2024 MIPS payment year and the effect of the final Start Printed Page 65639 policies in this final rule, we ran two models as described in section VI.F.18., a baseline model and final policies model.

For the baseline and final policies models, we used the same eligibility files and approach described in the CY 2021 PFS final rule (85 FR 85013) which resulted in the inclusion of 1.6 million clinicians who had PFS claims from October 1, 2018 to September 30, 2019, as well as additional clinicians associated with a group who had at least one PFS claim from October 1, 2019, through December 31, 2019. We used the same exclusion criteria to exclude clinicians from our MIPS eligibility assessment as described in the CY 2021 PFS final rule RIA (85 FR 85013) with the following model updates. (1) In both the baseline and final policies models, we excluded practitioners in Next Generation ACOs because the Next Generation ACO model ends in the CY 2021 MIPS performance period. (2) In both the baseline and final policies models, to determine which clinicians in the initial population of 1.6 million should be excluded as QPs, we used Advanced APM payment and patient percentages from the APM Participant List for the final snapshot date for the 2019 QP performance period.

We elected to use this data source because the APM participant list for the 2019 final snapshot can reliably be used for RIA projections. From this data, we calculated the QP and Partial QP determinations as described in section of IV.A.4.c.(1)(b) of this final rule for the 2022 QP performance period for both models. (3) In the final policies model, we included in our estimated MIPS eligible population for the CY 2022 performance period/2024 MIPS payment year clinical social workers and CNMs as finalized in section IV.A.3.a.(1) of this final rule. (4) In the final policies model, we are integrating the provision that starting with the CY 2022 MIPS performance period/2024 MIPS payment year, small practices, excluding virtual groups, must submit data as a group in any performance category to indicate that they wish to be scored as a group for Medicare Part B claims.

This affects eligibility because previously a single Medicare Part B claims submission, without any other submission, started a group score. Once a group score is created, a clinician who was individually excluded from MIPS for being under the low-volume threshold, may now be eligible if the group exceeds the low-volume threshold. This policy is described at section IV.A.3.a.(3) of this rule. (b) Assumptions Related To Applying the Low-Volume Threshold Exclusion The low-volume threshold policy may be applied at the individual (TIN/NPI) or group (TIN) levels based on how data are submitted including under the APM Entity level if the clinician is part of an APM Entity in a MIPS APM (hereafter, a MIPS APM Entity) that elects to submit to MIPS.

A clinician or group that exceeds at least one but not all three low-volume threshold criteria may become MIPS eligible by electing to opt-in and subsequently submitting data to MIPS, thereby getting measured on performance and receiving a MIPS payment adjustment. For the final policies model, we describe below the estimated MIPS eligibility status and the associated PFS allowed charges of clinicians in the initial population of 1.6 million clinicians. We present in section VI.F.18.d.(1)(c) the incremental impact of the final policies from the baseline model for the CY 2022 performance period/2024 MIPS payment year on the MIPS eligible clinician population and their associated PFS allowed charges. We applied the same assumptions presented in the CY 2021 PFS final rule RIA to apply the low-volume threshold and to understand whether clinicians participate as a group, virtual group, APM entity, or as individuals (85 FR 85013 through 85016), except for three modifications.

We assumed only individuals or APM TINs that exceeded the low-volume threshold will receive an APM Performance Pathway (APP) score consistent with the policy as finalized in the CY 2021 PFS final rule (85 FR 84897).[] We assumed APM TINs that qualified for opt-in and submitted data as a TIN will also be eligible. Finally, we did not consider clinicians in groups as MIPS eligible clinicians nor start a group score for clinicians in small practices with only Medicare Part B claims submissions to reflect the policy finalized at section IV.A.3.a.(3) of this rule. Table 144 summarizes our eligibility estimates for the final policies model. We identify approximately 212,000 clinicians [] as having “required eligibility” in Table 144.

These clinicians will be MIPS eligible because they exceed the low volume threshold as individuals and are not otherwise excluded. These clinicians may ultimately choose to participate in MIPS as an individual, group, virtual group or APM entity or to not participate. Regardless of how they participate they will be considered MIPS eligible. We estimate approximately 595,000 additional MIPS eligible clinicians will be eligible as “group eligibility” in Table 144.

These clinicians belong to an APM entity, group or virtual group that meets the low-volume threshold and submits to MIPS. If they were not associated with the group submission, these clinicians would not be eligible for MIPS. Finally, we estimate about 3,000 clinicians will be eligible through “opt-in eligibility” through the “opt-in” policy for a total MIPS eligible clinician population of approximately 810,000. This leads to an associated $67 billion allowed PFS charges estimated to be included in the CY 2022 performance period/2024 MIPS payment year.

Start Printed Page 65640 Furthermore, we estimate there will be approximately 412,000 clinicians as “Potentially MIPS eligible” in Table 144. These clinicians are not MIPS eligible but could be if their practice decides to participate or they elect to opt-in. These clinicians will be included as MIPS eligible in the unlikely scenario in which all group practices elect to submit data as a group, or clinicians in a group that does not submit are eligible to opt-into MIPS individually and choose to do so. This assumption is important because it quantifies the maximum number of MIPS eligible clinicians.

When this unlikely scenario is modeled, we estimate the MIPS eligible clinician population could be as high as 1.2 million clinicians. Finally, we estimate approximately 101,000 clinicians will not be MIPS eligible because they and their group are below the low-volume threshold on all three criteria and another approximately 304,000 will not be MIPS eligible because they are categorically excluded regardless of volume or submission activity. Eligibility among many clinicians is contingent on submission to MIPS as a Start Printed Page 65641 group, virtual group or election to opt-in, therefore we will not know the number of MIPS eligible clinicians who submit until the submission period for the 2022 MIPS performance period is closed. For this final policies model analysis, we use the estimated population of 809,593 MIPS eligible clinicians described above.

(c) Estimated Impact of the Final Policies on MIPS Eligibility and PFS Allowed Charges We illustrate in Table 145 how the final policies to add clinical social workers and CNMs as MIPS eligible clinician types and the policy to require small practices to submit data as a group for a group quality performance category score as finalized in sections IV.A.3.a.(1) and IV.A.3.a.(3) of this final rule affects the estimated number of MIPS eligible clinicians. The amended regulation text that we finalized in section IV.A.3.a.(2) of this final rule does not make modify how we assess eligibility in MIPS in our final policies model. The first row in Table 145 presents the estimates from the RIA baseline model with the number of individuals that will be MIPS eligible clinicians for the 2022 performance period/2024 MIPS payment year if this rule does not take effect. The second row presents estimates from the RIA final policies model with the incremental impact of adding the two new MIPS eligible clinician types on the number of MIPS eligible clinicians for the CY 2022 performance period/2024 MIPS payment year.

As shown in Table 145, the final policies lead to a small increase in the number of MIPS eligible clinicians (1.1 percent increase) and a minimal increase in the PFS allowed charges (0.1 percent increase) for the CY 2022 performance period/2024 MIPS payment year. e. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 2022 Performance Period/2024 MIPS Payment Year (1) Summary of Approach In sections IV.A.3.d., IV.A.3.e. And IV.A.3.f.

Of this final rule, we present several provisions which impact the measures and activities that impact the performance category scores, final score calculation, and the MIPS payment adjustment. We discuss these changes in more detail in section VI.F.18.e.(2). Of this RIA as we describe our methodology to estimate MIPS payments for the CY 2022 performance period/2024 MIPS payment year. We then present the impact of the overall final policies on the CY 2022 performance period/2024 MIPS payment year and then compare select metrics to the baseline model, which only incorporates previously finalized policies for the CY 2022 performance period/2024 MIPS payment year.

By comparing the baseline model to the final policies model, we can estimate the incremental impact of this rule's policies to the CY 2022 performance period/2024 MIPS payment year. The payment impact for a MIPS eligible clinician is based on the clinician's final score, and MIPS eligible clinicians can participate as an individual, group, virtual group, or APM Entity in the four MIPS performance categories. Quality, cost, improvement activities, and Promoting Interoperability. As discussed in section VI.F.18.

Of this final rule, we generally used data submitted for the 2019 performance period. For the cost performance category, we used the same data as the CY 2020 PFS final rule (84 FR 63169), which is primarily testing data for the cost measures. The estimated payment impacts presented in this final rule are averages by practice size weighted by Medicare utilization. The payment impact for a MIPS eligible clinician will vary from the average and will depend on the measure submissions, scores and their performance.

(2) Methodology To Assess Impact To estimate participation in MIPS for the CY 2022 performance period/2024 MIPS payment year for this final rule, we generally used 2019 MIPS performance period data for both the baseline and final policies models. Our baseline and final policies scoring models included the 801,013 and 809,593 estimated MIPS eligible clinicians, respectively, as described in section VI.F.18.d.(1) of this RIA. To estimate the impact of MIPS policies on MIPS eligible clinicians, we generally used the 2019 MIPS performance period submissions data, including data submitted for the quality, improvement activities, and Promoting Interoperability performance categories. We supplemented this information with 2019 data available for CAHPS for MIPS and CAHPS for ACOs, testing data for the revised total per capita cost measure and Medicare Spending Per Beneficiary (MSPB) clinician measures which were finalized in the CY 2020 PFS final rule (84 FR 62969 through 62977), testing data for the new episode cost measures, administrative claims data for the new quality performance category measures, and other data sets.[] We calculated a hypothetical final score for the 2022 performance period/2024 MIPS Start Printed Page 65642 payment year for the baseline and final policies scoring models for each MIPS eligible clinician using score estimates for quality, cost, Promoting Interoperability, and improvement activities performance categories, where each are described in detail in the following subsections.

(a) Methodology To Estimate the Quality Performance Category Score We estimated the quality performance category score using a methodology like the one described in the CY 2021 PFS final rule (85 FR 85016 through 85017) for baseline and final policy RIA models for the CY 2022 performance period/2024 MIPS payment year. For the baseline policies RIA model, which does not reflect the final policies for CY 2022 performance period/2024 MIPS payment year from this final rule, we made the following modifications to reflect the previously finalized policies for the CY 2022 performance period/2024 MIPS payment year for the quality performance category. As previously finalized in the CY 2021 PFS final rule (85 FR 84870 and 85 FR 84843), we removed the Web Interface as a collection type in MIPS and through the APP for the CY 2022 performance period/2024 MIPS payment year. Although the Web Interface is to be reinstated for groups for the CY 2022 performance period/2024 MIPS payment year and ACOs for CY 2022 performance period/2024 MIPS payment year through CY 2024 performance period/2026 MIPS payment year as discussed in sections IV.A.3.d.(1)(d) and IV.A.3.c.(2)(a), respectively, the baseline model is attempting to capture the CY 2022 performance period/2024 MIPS payment year as if this provision did not exist.

Therefore, the baseline model does not incorporate the Web Interface as a collection type for groups and ACOs. To estimate a quality performance category score for clinicians in groups who previously used the Web Interface as a collection type in 2019, we assumed these groups will use the other two other collection types (MIPS CQMs and eCQMs) available in the 2022 performance period/2024 MIPS payment year. We then applied the same methodology described in the CY 2021 PFS proposed rule when the removal of Web Interface as a collection type was previously proposed (85 FR 50387 through 50388) using 2019 MIPS submissions data. To estimate a quality performance category score for ACOs, we used the same methodology described in the CY 2021 PFS proposed rule when the Web Interface was not included in the APP (85 FR 50388).

• We used the published 2021 MIPS historical quality benchmarks file to identify measures subject to the topped out scoring cap that was finalized (82 FR 53721 through 53727).[] For the final policies model, we made the following modifications to the baseline model to reflect the new final policies for the 2022 performance period/2024 MIPS payment year for the quality performance category. As discussed in section IV.A.3.d.(1)(e) of this final rule, we finalized one new administrative claims measure for those for whom it is applicable. Clinician and Clinician Group Risk-standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions. To implement this policy in our final policies RIA model for the CY 2022 performance period/2024 MIPS payment year, we used testing data for this new administrative claims measure.

As discussed in section IV.A.3.d.(1)(c) of this final rule, we are finalizing our proposals with modification to maintain the data completeness criteria threshold of at least 70 percent for the CY 2021, CY 2022, and CY 2023 performance periods/2023, 2024, and 2025 MIPS payment years for QCDR measures, MIPS CQMs, or eCQMs. This is not a change from our baseline model assumptions. As discussed in section IV.A.3.d.(1)(e) of this final rule, we are finalizing our proposal to establish measure substantive change criteria. We did not make modifications to the final policies model for this policy.

We scored measures using the benchmarks described below. In section IV.A.3.d.(1)(g) of this final rule, we are finalizing several changes to the CAHPS for MIPS survey. We did not incorporate these changes into our model due to the lack of data. In Appendix 1 of this final rule, we added 4 new quality measures, removed 13 measures, and finalized 87 substantially modified measures.

Consistent with prior rules, (83 FR 50053), our RIA estimates assume that clinicians who reported Medicare Part B claims, eCQM, MIPS CQM and QCDR measures that are removed would find alternate measures. Therefore, we assign points to the measures that and included them in our scoring model. • As discussed in section IV.A.3.e.(1)(c)(ii) of this final rule, we did not finalize our proposal to use performance period benchmarks for the CY 2022 performance period in accordance with § 414.1380(b)(1)(ii) as opposed to a historical benchmark. For the final policies model, we utilized the most recent benchmark file.

The 2021 MIPS performance period historic benchmarks.[] However, the 2019 performance data we are using to estimate future performance includes data on measures that do not have a benchmark in the 2021 MIPS benchmark file (either because the measure was removed or because there were significant changes). If a benchmark was not available in the 2021 MIPS performance period historic benchmark file, then we supplemented the 2021 MIPS benchmark file with the benchmarks used for the CY 2019 performance period/2021 MIPS payment year. As discussed in section IV.A.3.e.(1)(c)(iii)(A) of this final rule, we are delaying our proposal to remove the 3-point floor for each measure that can be reliably scored against the benchmark and score the measure from 1 to 10 points until the CY 2023 performance period/2025 MIPS payment year. Similarly, we are delaying our proposal in section IV.A.3.e.(1)(c)(iii)(B) of this final rule to remove the special scoring policy of scoring 3 points for class 2 measures, except for clinicians in small practices until the CY 2023 performance period/2025 MIPS payment year.

Therefore, our RIA for the CY 2022 performance period/2024 MIPS payment year re-established the 3-point floor for class 1 measures and 3 points for class 2 measures. • As discussed in section IV.A.3.e.(1)(c)(iii)(B), we are finalizing our proposed policies for scoring new measures with modifications. For measures in their first two performance periods that meet data completeness and can be reliably scored against a benchmark (class 4a measures), we will assign a floor of 7 points for measures in their first year and a floor of 5 points for measures in their second year. For new measures in their first two performance periods that meet data completeness, but cannot be reliably scored against a benchmark because they lack a benchmark or do not meet case minimum in the program (class 4b measures), we will assign 7 points for measures in their first year and 5 points for measures in their second year.

We incorporated these scoring changes into our final policies model. Because we are using 2019 MIPS performance period Start Printed Page 65643 data, we assume that measures new to MIPS in 2019 are in their first year and measures new to MIPS in 2018 are in their second year. As discussed in sections IV.A.3.e.(1)(c)(vii) and IV.A.3.e.(1)(c)(viii) of this final rule, we finalized our proposal to remove measure bonus points for reporting high priority measures and for submitting with end-to-end electronic reporting beginning in the 2022 MIPS performance period. We incorporated these scoring changes into our final rule model for all MIPS collection types.

As discussed in section IV.A.3.d.(1)(d), we are extending the Web Interface measures for the CY 2022 performance period/2024 MIPS payment year for groups and virtual groups using the existing 10 CMS Web Interface measures. To estimate the impact of this policy, we used the same methodology described in the CY 2021 PFS final rule (85 FR 85016 through 85017) using 2019 MIPS submissions data. Finally, we will extend the CMS Web Interface as a means of reporting quality under the APM Performance Pathway for Shared Savings Program ACOs for the 2022 performance period/2024 MIPS payment year through the 2024 performance period/2026 MIPS payment years as described in section IV.A.3.c.(2)(a) of this final rule. Under the provision, Web Interface reporting will work in the same manner as for performance year 2021, where ACOs will have the option of reporting either the CMS Web Interface, the APP eCQM/MIPS CQM measure set, or both.

To estimate the impact of this policy, we used the same methodology described in the CY 2021 PFS final rule RIA (85 FR 85016 through 85017) when Web Interface was retained for the APP. (b) Methodology To Estimate the Cost Performance Category Score We estimated the cost performance category score using a similar methodology described in the CY 2020 PFS final rule (84 FR 63169) with the modifications to the baseline and the final policies RIA model described in this section. In the baseline model, we refined our methodology for developing benchmarks to better reflect the previously finalized policy in CY 2017 Quality Payment Program final rule (81 FR 77308 through 77309). We did not estimate cost improvement scoring that starts in the 2022 performance period/2024 MIPS payment year as previously finalized at § 414.1380(a)(1)(ii) and in the CY 2019 PFS final rule (83 FR 58956) since we did not have sufficient data to conduct improvement scoring, which requires 2 years of cost data to model.

In the final policies model, we modified the baseline model to incorporate the provision to add five new episode-based cost performance category measures in the CY 2022 performance period/2024 MIPS payment year as described in section IV.A.3.d.(2) of this final rule, by using claims data from January 1, 2019 to December 31, 2019. Cost measures were scored if the clinicians or groups met or exceeded the case volume. 10 episodes for Melanoma Resection to align with the reporting case minimum for procedural cost measures currently in use in MIPS, 20 episodes for Sepsis to align with the reporting case minimum for acute inpatient condition cost measures currently in use in MIPS, 20 episodes for Diabetes and Asthma/COPD as used in field testing for these chronic measures, and 20 episodes for Colon Resection. These new cost episode-based measures were calculated for both the TIN/NPI and the TIN.

(c) Methodology To Estimate the Facility-Based Measurement Scoring For the baseline model, we estimated the facility-based score using the scoring policies finalized in the CY 2018 Quality Payment Program final rule (82 FR 53763) and the methodology described in the CY 2020 PFS final rule (84 FR 63169). For the final policies model, we used the methodology for the CY 2022 performance period/2024 MIPS payment year as discussed in section IV.A.3.e.(2)(b)(v)(B) of this final rule. We proposed at § 414.1380(e)(vi) that beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology unless a clinician or group receives a higher MIPS final score through another MIPS submission. Therefore, if a MIPS eligible clinician or a group is eligible for facility-based measurement, but they participate in MIPS as an individual or group, we used the higher final score between the facility-based scoring and MIPS submission-based scoring.

(d) Methodology To Estimate the Promoting Interoperability Performance Category Score For the baseline model, we used the CY 2019 MIPS Promoting Interoperability performance period data submissions data to estimate CY 2022 MIPS performance for the Promoting Interoperability performance category. We made the following two modifications to the 2019 performance period scoring to reflect the previously finalized policy changes between the CY 2019 and CY 2021 performance periods. (1) We doubled the bonus points for clinicians who submitted the PDMP measure as described in section IV.A.3.d.(4)(c)(i) of this final rule. And (2) we did not incorporate the Verify Opioid Treatment Agreement measure data, a measure that was finalized in the CY 2019 performance period (83 FR 59807) but removed in the CY 2020 performance period (84 FR 62994).

We retained the PDMP bonus for the baseline model for continuity between the CY 2021 and 2022 performance periods and for consistency since bonuses for the quality performance category were retained for the baseline as well. Because we lacked data on who would adopt the finalized Health Information Exchange bi-directional exchange measure for the CY 2021 performance period we only used past reporting on the two existing Health Information Exchange Objective measures to estimate CY 2022 Promoting Interoperability performance. For the final policies model, we considered the following policy provisions as potential modifications to the baseline model. In section IV.A.3.d.(4)(c)(i) of this final rule, we finalized our proposal for the PDMP measure to remain optional and at 10 points.

Modifications were not made to reflect this policy in the final policies model since the baseline model already incorporated this policy. In section IV.A.3.d.(4)(c)(ii) of this final rule, we did not finalize our proposed modifications to the Provide Patients Electronic Access to Their Health Information measure. For this model, we did not make any modifications and continued to use the Provide Patients Electronic Access to Their Health Information measure that was submitted for the 2019 MIPS performance period. • In section IV.A.3.d.(4)(c)(iii) of this final rule, we finalized to require two of the measures associated with the Public Health and Clinical Data Exchange Objective, beginning with the CY 2022 performance period.

Immunization Registry Reporting. And Electronic Case Reporting. We also finalized in section IV.A.3.d.(4)(c)(iii) of this final rule to retain the Public Health Registry Reporting, Clinical Data Registry Reporting, and Syndromic Surveillance Reporting measures, and to make them optional and available for bonus points beginning with the CY 2022 performance period/2024 MIPS payment year. We did not model these policy changes because the Promoting Start Printed Page 65644 Interoperability data we used for this analysis is based on the CY 2019 performance period when a clinician was only required to report two of the possible 5 measures for the Public Health and Clinical Data Exchange Objective.

We believe incorporating this policy might artificially lower scores for the Public Health and Clinical Data Exchange Objective because there was no requirement to specifically report the Immunization Registry Reporting and Electronic Case Reporting measures in 2019. In section IV.A.3.d.(4)(d) of this final rule, we finalized the additional requirement that eligible clinicians must attest to conducting an annual assessment of the High Priority Guide of the SAFER Guides beginning with the 2022 performance period. This policy was not implemented in the final policies model as it does not affect eligibility or payment. We included this policy in our burden calculations in section V.B.8.g.(3) of this rule.

In section IV.A.3.d.(4)(g) of this final rule, we finalized changes to the attestation statements for information blocking. We did not include this policy in our model due to lack of information. In section IV.A.3.d.(4)(h)(i) of this final rule, we finalized beginning with the CY 2022 performance period/2024 MIPS payment year, we will no longer require an application for clinicians and small practices seeking to qualify for the small practice hardship exception and reweighting. We will assign a weight of zero only in the event a small practice did not submit any data for any of the measures specified for the Promoting Interoperability performance category.

This policy was implemented in the final policies model. In section IV.A.3.d.(4)(h)(ii) and IV.A.3.d.(4)(h)(iii) of this final rule, we finalized our proposal to continue the existing policy to reweight the Promoting Interoperability performance category for NPs, PAs, CRNAs, CNSs, physical therapists, occupational therapists, qualified speech-language pathologist, qualified audiologists, clinical psychologists, and registered dieticians or nutrition professionals for the CY 2022 performance period/2024 MIPS payment year. The baseline model already incorporated this policy. In section IV.A.3.d.(4)(h)(iv), we finalized that we will apply the same Promoting Interoperability reweighting policy we adopted previously for NPs, PAs, CNSs, CRNAs, and other types of MIPS eligible clinicians to clinical social workers.

This policy was implemented in the final policies model. (e) Methodology To Estimate the Improvement Activities Performance Category Score For the baseline model, we modeled the improvement activities performance category score based on CY 2019 performance period data and APM participation identified in section VI.F.18.d.(1) of this final rule. For clinicians and groups not participating in a MIPS APM, we used the CY 2019 submissions improvement activities score. We did not model the policy finalized for the CY 2020 performance period (84 FR 62980) to require a minimum threshold of 50 percent of clinicians in a group to complete an improvement activity for the group to receive credit since we did not have data to determine the proportion of clinicians in a group that completed the improvement activity.

We continued to apply the methodology described in the CY 2020 PFS final rule (84 FR 63170) to assign an improvement activities performance category score. For the APM participants identified in section VI.F.18.d.(1) of this final rule, we assigned an improvement activity performance category score of 100 percent. For the final policies model, we did not make modifications to the baseline model for the improvement activities changes finalized in section IV.A.3.d.(3) of this final rule. The final policies are (1) revise group reporting requirements for the 50 percent threshold to address subgroups.

(2) revise the timeframe for improvement activities nominated during a PHE. (3) revise the required criteria for improvement activity nominations received through the Annual Call for Activities. (4) suspend activities that raise possible safety concerns or become obsolete from the program when this occurrence happens outside of the rulemaking process. (5) add 7 new improvement activities, modify 15 existing improvement activities, and remove 6 previously adopted improvement activities.

(6) revise the “Drug Cost Transparency to include requirements for use of real-time benefit tools” improvement activity. And (7) add the buy antibiotics “Clinical Data Reporting with or without Clinical Trial” improvement activity. For policy 1, we lacked data to model the impact on improvement activities performance category. Policies 2 and 3 are related to the call for improvement activities which does not affect the improvement activities performance category scores.

Policies 4 through 7 address changes to specific improvement activities or the improvement activity inventory. We anticipate most clinicians performing improvement activities will continue to identify and report similar improvement activities from the inventory in future years. Please see section VI.F.18.g.(2)(f) of this final rule for additional details on the impact of these policy changes. (f) Methodology To Estimate the Complex Patient Bonus Points In section IV.A.3.e.(2)(a)(iii)(B) of this final rule, we will continue to apply the complex patient bonus, with updates, for the CY 2022 performance period/2024 MIPS payment year.

For the baseline model, we used the complex patient bonus information calculated for the 2019 performance period data for the CY 2022 performance period/2024 MIPS payment year, as was previously done in the CY 2021 PFS final rule (85 FR 85017). For the final policies model, we calculated the complex patient bonus using the calculation in section IV.A.3.e.(2)(a)(iii)(B) of this final rule for the CY 2022 performance period/2024 payment year. We finalized updates to the complex patient bonus for the CY 2022 performance period/2024 MIPS payment year and future MIPS performance periods/payment years to account for social and medical complexity, while still using our current established indicators of dual proportion and HCC risk scores, respectively. Consistent with the policy for the 2022 performance period, our final policies RIA model calculated and applied the separate risk indicator complex patient bonus components methodology with a single overall cap.

(g) Methodology To Estimate the Final Score We did not make changes for how we calculated the MIPS final score. Our baseline and final policies models assigned a final score for each TIN/NPI by multiplying each estimated performance category score by the corresponding performance category weight, adding the products together, multiplying the sum by 100 points, adding the complex patient bonus, and capping at 100 points. For the baseline model, we applied the performance category weights and redistribution weights finalized in the CY 2021 PFS final rule (85 FR 84913 through 84916). For the final policies model, we modified the redistribution policy for small practices as described in section IV.A.3.e.(2)(b)(iii)(A) of this final rule.

For both models, after adding any applicable bonus for complex patients, we reset any final scores that exceeded 100 points to equal 100 points. For Start Printed Page 65645 MIPS eligible clinicians who were assigned a weight of zero percent for any performance category, we redistributed the weights according to section IV.A.3.e.(2)(b)(ii) of this final rule. (h) Methodology To Estimate the MIPS Payment Adjustment For the baseline model, we applied the hierarchy as finalized in the CY 2021 PFS final rule (85 FR 84917 through 84919) to determine which final score should be used for the payment adjustment for each MIPS eligible clinician when more than one final score is available. For the final policies model, we applied the scoring hierarchy finalized in section IV.A.3.f.(5) of this final rule.

We then calculated the parameters of an exchange function in accordance with the statutory requirements related to the linear sliding scale, budget neutrality, minimum and maximum adjustment percentages, and additional payment adjustment for exceptional performance (§ 414.1405). For the baseline model, we applied the performance threshold and additional performance thresholds finalized for the CY 2021 performance period/2023 payment year (85 FR 84923), of 60 and 85, respectively. For the final policies model, we used the performance threshold of 75 points in section IV.A.3.f.(2) and the additional performance threshold of 89 points in section IV.A.3.f.(3). We used these resulting parameters to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the paid amount for covered professional services furnished by the MIPS eligible clinician.

As discussed in the CY 2021 PFS final rule RIA (85 FR 85013), we adjusted the paid amount of non-engaged clinicians to equal their proportion of paid amount prior to the PHE for buy antibiotics for the baseline and final policies models. (3) Impact of Payments by Practice Size As we shift from previous MIPS transition policies by removing bonuses from the quality performance category and increasing the performance threshold and the additional performance threshold, we observe large changes between the baseline model and final policies model. First, we observe an increase in the funds available for redistribution due to the increase in clinicians with final scores below the performance threshold. The baseline model estimates $428 million will be redistributed through BN and that $500 million will be distributed to MIPS eligible clinicians for exceptional performance.

The mean and median final scores for the baseline model are 78.13 and 82.59, respectively. Our final policies model estimates that $603 million will be redistributed through BN. For clinicians who meet or exceed the additional performance threshold, an additional $360 million was estimated to be distributed. The mean and median final scores for the final policies model are 75.21 and 79.59, respectively.

In the final policies model, the estimated bonus for exceptional performance is less than the $500 million of available funding because the maximum additional payment adjustment for clinicians with exceptional performance reached 10 percent. As finalized in the 2017 QPP final rule (81 FR 77339 through 77340), we stated the maximum additional payment adjustment would be 10 percent, which is established by the statute, and that it would be multiplied by a scaling factor that cannot exceed 1.0. We reached the maximum additional payment adjustment allowed of 10 percent because the additional performance threshold is higher, and fewer clinicians performed above this higher additional performance threshold while a greater percentage of clinicians performed below the additional performance threshold. As a result, fewer clinicians are estimated to share the funds available through the additional bonus for exceptional performance.

Second, we observe an increase in the maximum positive payment adjustment. The baseline model estimates the maximum positive MIPS payment adjustment based on the budget neutral pool at 1.5 percent and the maximum positive MIPS additional payment adjustment for exceptional performance at 5.1 percent, for a combined maximum payment adjustment of 6.6 percent. The final policies model estimates the maximum MIPS positive payment adjustment based on the budget neutral pool is 4.4 percent and the maximum positive additional MIPS payment adjustment for exceptional performance bonus at 10.0 percent for a combined maximum payment adjustment of 14.4 percent. Finally, we see narrower differences in performance across practice sizes due to the shift from MIPS transition policies.

Table 146 shows the overall impact of the payment adjustments by practice size and based on whether clinicians are expected to submit data to MIPS for the final policies model. In Table 147, we present the overall impact of the baseline and the final policies models among clinicians who submit data to assess the incremental impact of the final policies. The overall proportion of clinicians receiving a positive or neutral payment adjustment decreases from 91.7 percent to 66.8 percent with the implementation of the final policies that shift away from MIPS transition policies. In addition, we no longer observe a disproportionate number of clinicians in small practices receiving a negative payment adjustment when implementing the final policies.

For the CY 2022 performance period/2024 payment year, we have policies targeted towards small practices including special scoring policies to minimize burden and facilitate small practice participation in MIPS or APMs, which we describe in section VI.F.18.g.(2)(e) of this final rule. The intention of the final policies is to provide a more equitable participation process and reduce the disparity in performance between clinicians in large and small practices. These findings and final policies reflect movement away from the transition policies implemented during the early years of MIPS and how MIPS has shifted its focus to value rather than primarily on engagement. However, non-engagement by not submitting data to MIPS among clinicians in small practices is still a concern.

Among those who we estimate will not submit data to MIPS, 86 percent are in small practices (22,475 out of 26,180 clinicians who do not submit data). We intend to continue working with stakeholders to improve engagement in MIPS among clinicians in small practices. We want to highlight we are using 2019 MIPS performance period submissions data to simulate a 2022 MIPS performance period final score, and it is likely that there will be changes that we cannot account for at this time, including services and payments disrupted by the PHE for buy antibiotics or clinicians changing behavior in response to the performance thresholds increased for the CY 2022 performance period/2024 MIPS payment year to avoid a negative payment adjustment. It should also be noted that the estimated number of clinicians who do not submit data to MIPS may be an overestimate of non-engagement in MIPS for the CY 2022 performance period/2024 MIPS payment year.

This is because the PHE for buy antibiotics may have resulted in fewer clinicians submitting data to MIPS or more clinicians electing to apply for the extreme and uncontrollable circumstances policies due to the PHE for buy antibiotics for the 2019 MIPS performance period. Therefore, engagement levels in MIPS Start Printed Page 65646 for the CY 2022 performance period/2024 MIPS payment year may differ from these reported estimates. We also note this participation data is generally based off participation for the 2019 performance period, which is associated with the CY 2019 performance period/2021 MIPS payment year and had a performance threshold of 30 points, and that participation may change for the CY 2022 performance period/2024 MIPS payment year when the performance threshold is 75 points. Finally, the combined impact of negative and positive adjustments and the additional positive adjustments for exceptional performance as a percent of paid amount among those that do not submit data to MIPS on average was negative 8.5 percent.

It was not the maximum negative payment adjustment of 9 percent because some MIPS eligible clinicians that do not submit data to MIPS can still receive a MIPS final score that is greater than 1/4 of the performance threshold (and avoid the maximum negative adjustment as stipulated by section 1848(q)(6)(A)(iv)(II) of the Act [] ) if they have sufficient claims volume to measure performance for cost measures or quality administrative claim measure, which utilizes administrative claims data and does not require separate data submission to MIPS. Start Printed Page 65647 f. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 2023 Performance Period/2025 MIPS Payment Year We proposed for the CY 2023 MIPS Performance Period to begin transitioning to MIPS Value Pathways (MVPs) and introduce subgroup reporting in the CY 2023 MIPS performance period/2025 payment year. As described in section IV.A.3.b.(2)(c) of this final rule, the first step in the transition plan for MVPs and subgroup reporting is to be voluntary, where eventually MVPs and subgroups will become required.

Additionally, subgroups, if applicable, will have the option to report an APP. Since MVP and subgroup reporting will only begin in the CY 2023 performance period/2025 MIPS payment year, we do not have the data to report who will select MVPs and who will report through subgroups in the first year and how these clinicians will score. As discussed in section IV.A.3.b.(5) of this final rule, for MVP scoring policies, we evaluated all traditional MIPS scoring policies and maintained those that are required under section 1848(q)(2) of the Act such as requirements to measure achievement and improvement of the quality and cost of care. We noted MVPs offer incentives in terms of requiring fewer measures and activities tied to a specialty or medical condition which can offer clinicians a more cohesive experience and that we would continue to evaluating additional incentives that align with our scoring policies and the goals of MVPs in future rulemaking.

For this RIAs, we assume clinicians who elect to use MVPs and subgroups for reporting to MIPS will perform similarly to how they performed through traditional MIPS because the scoring policies are similar. We will revisit this assumption in future rulemaking as needed. As discussed in section V.B.8.e.(7)(a) of this final rule, for the purposes of estimating burden associated with the provision to implement MVP and subgroup reporting, we assume that 10 percent of MIPS eligible clinicians in the CY 2022 performance period/2024 MIPS payment year will report as MVP participants in the CY 2023 performance period/2025 MIPS payment year. In addition, we assume that there will be 20 subgroup reporters in the CY 2023 performance period/2025 MIPS payment year.

We anticipate a per respondent reduction of 3 hours and $412 dollars per CQM/QCDR quality submission, 3 hours and $336 per eCQM quality submission, and 5 hours and $717 per claims quality submission. Overall, we estimate a net reduction in burden of $7,463,145 in the quality performance category ICRs due to the introduction of MVP and subgroup reporting in the CY 2023 performance period/2025 MIPS payment year. We refer readers to section V.B.8.e.(7)(a)(iii) of this final rule for further discussion of our burden associated with MVPs and subgroups including the number of respondents. G.

Additional Impacts From Outside Payment Adjustments (1) Burden Overall In addition to policies affecting the payment adjustments, we proposed several policies that have an impact on burden in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. In section V.B.8 of Start Printed Page 65648 this final rule, we outline estimates of the costs of data collection that includes both the effect of policy updates and adjustments due to the use of updated data sources. For each provision included in this regulation which impacts our estimate of collection burden, the incremental burden for each is summarized in Table 148. We also provide additional burden discussions that we are not able to quantify.

As discussed in the section V.B.8 of this final rule, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. To provide the reader a better sense of the differences in burden between our CY 2022 and CY 2023 performance period/2024 and 2025 MIPS payment year estimates due to changes in policy, we are presenting our CY 2023 performance period/2025 MIPS payment year estimates in Table 148 in comparison to the CY 2022 performance period/2024 MIPS payment year estimate found in the CY 2021 PFS final rule. In Table 148, we are only including our CY 2023 performance period/2025 MIPS payment year estimates for the ICRs where our estimate is different from our CY 2022 performance period/2024 MIPS payment year estimate. Start Printed Page 65649 Start Printed Page 65650 (2) Additional Impacts to Clinicians (a) Web Interface As discussed in section IV.A.3.d.(1)(d) of this final rule, we finalized the proposal to continue the use of the CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians for the CY 2022 performance period/2024 MIPS payment year.

We are also sunsetting the CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians starting with the CY 2023 performance period/2025 MIPS payment year. As discussed in section IV.A.3.c.(2)(a), we are also extending the CMS Web Interface as a means of reporting quality under the APP for Shared Savings Program ACOs for the CY 2022 performance period/2024 MIPS payment year through the CY 2024 performance period/2025 MIPS payment year. We refer readers to sections V.B.8.e.(8) and V.B.8.e.(10) of this final rule for our discussion on the estimated burden associated with the extension of the CMS Web Interface collection type in CY 2022 performance period/2024 MIPS payment year and the sunset of the CMS Web Interface collection type in the CY 2023 performance period/2025 MIPS payment year (for those not using the APP). Additionally, we assume that the impacts associated with the sunset of CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians will remain the same as our discussion in the CY 2021 PFS final rule (85 FR 85020 through 85021).

(b) Administrative Claims Measure As discussed in section IV.A.3.d.(1)(e), we are adding one new administrative claims measures beginning in the CY 2022 performance period/2024 MIPS payment year and for future performance periods. Clinician and Clinician Group Risk-standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions. We acknowledge there are administrative burdens and related financial costs associated with each administrative claims measure that clinicians, groups, and organizations may choose to monitor. However, because these costs can vary significantly due to organizational size, number of administrative claims measures being reported, volume of clinicians reporting each measure, and the specific methods employed to improve performance, we are unable to provide an estimate of the financial impact each clinician, group, or organization may experience.

In summary, we are acknowledging that while there are no data submission requirements per § 414.1325(a)(2)(i) for administrative claim measures, there may be associated costs for clinicians and group practices to monitor new administrative claim measures. However, we are unable to quantify that impact. (c) Modifications to the Improvement Activities Inventory As discussed in section IV.A.3.d.(3)(c)(ii) of this final rule, we finalized the proposals to remove 7 previously adopted improvement activities, modify 15 existing improvement activities, and adopt 5 new improvement activities. We refer readers to Appendix 2 of this final rule for further details.

We do not believe these changes to the inventory will impact time or financial burden on stakeholders because MIPS eligible clinicians are still required to submit the same number of activities and the per response time for each activity is uniform. We do not expect these changes to the inventory to affect our currently approved information collection burden estimates in terms of neither the number of estimated respondents nor the burden per response. We anticipate most clinicians performing improvement activities, to comply with existing MIPS policies, will continue to perform the same activities under the policies in this final rule because previously finalized improvement activities continue to apply for the current and future years unless otherwise modified per rulemaking (82 FR 54175). Most of the improvement activities in the Inventory remain unchanged for the CY 2022 performance period/2024 MIPS payment year.

(d) Stakeholders Nominating Improvement Activities In section IV.A.3.d.(3)(c)(i)(B) of this rule, we finalized these proposals. (1) To revise the required criteria for improvement activity nominations received through the Annual Call for Activities. (2) changes to the timeline for improvement activities nomination during a PHE. And (3) to suspend Start Printed Page 65651 activities that become obsolete or impacted by clinical practice guideline changes from the program when this occurrence happens outside of the rulemaking process.

Regarding the provision to clarify the timeline for an improvement activity nominated during the PHE, we believe this provision will not affect our currently approved burden estimates since we believe that the number of nominations will not change, but it would make an activity available for reporting to clinicians in the same performance year it was intended to be implemented. In section IV.A.3.d.(3)(c)(i)(B)(aa) of this rule, we finalized the proposal that in order to implement a new improvement activity for a PHE during the same year as the nomination, the nomination will need to be received no later than January 5th of the nomination year to be included in a rule for notice-and-comment rulemaking during that fiscal or calendar year, a necessary precursor to implementation if it were to be finalized. As described in section V.B.8.j of this rule, we expect additional nominations may be received as a result of this provision, but we do not have any data with which to estimate what the additional number may be. As a result, we did not make any revisions to our currently approved burden estimate.

Regarding the provision to suspend activities that become obsolete or impacted by clinical practice guideline changes from the program when this occurrence happens outside of the rulemaking process, we do not anticipate additional burden for stakeholders because of the provision described above as the policy does not change requirements for the nomination of improvement activities. As described in section IV.A.3.d.(3)(c)(i)(B) of this rule, due to the provisions to add two new criteria and to increase the number of criteria stakeholders are required to meet when submitting an activity provision from a minimum of 1 to all 8 criteria, which includes the two new criteria, we proposed to revise our estimated annual information collection burden for nomination of improvement activities to 136 hours (31 nominations × 4.4 hr/nomination) at a cost of $20,355 (31 × [(2.8 hr × $114.24/hr) + (1.6 hr × $210.44/hr)]). (e) Impact on Small Practices As described in section VI.F.18.e.(3) of this final rule RIA, we found 85 percent of clinicians who did not submit data to MIPS were in small practices. However, the estimated number of MIPS eligible clinicians who do not submit data, including those in small practices, may be smaller in the CY 2022 performance period/2024 MIPS payment year since the submission window for the 2019 performance period was impacted by the start of the PHE for buy antibiotics.

CMS is committed to identifying flexibilities and options to help clinicians in small practices participate meaningfully and successfully in MIPS. Specifically, CMS finalized several policies to support clinicians in small practices once they engage with MIPS in the quality, improvement activities and Promoting Interoperability performance categories for the CY 2022 performance period/2024 MIPS payment year. Based on our RIA model findings described in section VI.F.18.e.(3) of this final rule, the final policies for the CY 2022 performance period/2024 payment year led to clinicians in small practices no longer disproportionately receiving negative payment adjustments compared to clinicians in larger sized practices. Therefore, the combination of the special scoring policies for clinicians in small practices is expected to positively affect this group of clinicians and will hopefully encourage and improve future engagement in MIPS among clinicians in small practices.

(f) Impact on Third Party Intermediaries In section IV.A.3.h. Of this rule, we finalized multiple changes to the third-party intermediary regulations at § 414.1400. Specifically, we finalized. (1) Reorganization and consolidation of § 414.1400 generally.

(2) an expansion of the general participation requirements of third-party intermediaries to third party intermediaries reporting to MIPS on behalf of APM Entities in order to align reporting requirements for all participants in MIPS. (3) a requirement that, beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. Health IT vendors must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. (4) to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year.

(5) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023. (6) a requirement that, beginning with the 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. (7) a requirement that, beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination, for CMS' approval, and may not change the plan once approved, without the prior approval of the agency. And (8) to add a rejection criterion to state that a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period.

Additionally, to provide further clarification of our current policy (84 FR 63070 through 63073), we finalized the proposal to state that if a QCDR measure owner is not approved during a given self-nomination period, any associated QCDR measures with that QCDR would also not be approved. With regard to the reorganization and consolidation of § 414.1400 generally, we do not anticipate this to require any additional effort for affected entities as the provision is to allow CMS to reorganize the existing information. For the requirements related to expanding the general participation requirements of third-party intermediaries to third party intermediaries reporting to MIPS on behalf of APM Entities in order to align reporting requirements for all participants in MIPS, we did not propose to revise our burden estimates as this requirement is not different from how third-party intermediaries currently submit data for the quality, improvement activities and Promoting Interoperability performance categories in MIPS on behalf of individual eligible clinicians and groups. As previously discussed in section IV.A.3.h.(2)(b)(ii) of this rule, we finalized the proposal to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year.

During the MVP Town Hall held in January 2021 (85 FR 74729), we heard from third-party intermediaries that they are confident that they can make the necessary updates to allow for subgroup reporting, if they have enough time. A few vendors suggested that we add Start Printed Page 65652 subgroup reporting to the existing CEHRT requirements. Given our provision described in section IV.A.3.b.(2)(d) of this rule to delay the implementation of subgroup reporting option to the CY 2023 performance period/2025 MIPS payment year, we assume that the delay will give these entities adequate time to make the necessary updates. We assume that there will be no additional burden that third-party intermediaries will incur to implement the subgroup reporting option.

We anticipate that there may be administrative burden associated with changes in workflows to their existing systems for submission of subgroup data for the CY 2023 performance period/2025 MIPS payment year. However, given that each of these entities and their information technology systems are unique, we are unable to quantify the burden for these entities to capture and submit data on behalf of clinicians who may choose to participate as subgroups. We do not anticipate a significant impact to QCDRs and qualified registries resulting from the finalized provision to require QCDRs and qualified registries to conduct an annual data validation audit and if one or more deficiencies or data errors are identified also conduct targeted audits. First, we are not revising our burden estimates because the finalized data validation requirements are like existing expectations which we have already accounted for the associated burden as stated in the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999).

Second, we believe that the requirements for conduct of the data validation audits are aligned with methods and procedures which stakeholders currently utilize. As discussed in section IV.A.3.h.(3)(a)(i) of this rule, due to the provision to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year to submit a participation plan as part of their self-nomination for CY 2023 performance period/2025 MIPS payment year, we refer readers to section V.B.8.c.(2) of this rule for details on the adjusted burden. As discussed in section V.B.8.c.(2) of this rule, we are not adjusting our burden estimates due to the provision related to two new rejection criteria for QCDR measures. (g) Assumptions &.

Limitations We note several limitations to our estimates of clinicians' MIPS eligibility and participation, negative MIPS payment adjustments, and positive payment adjustments for the CY 2022 performance year/2024 MIPS payment year. Due to the PHE for buy antibiotics, we are aware that there may be changes in health care delivery and billing patterns that will impact results for the CY 2022 performance year/2024 MIPS payment year that we are not able to model with our historic data sources. The scoring model results presented in this final rule assume that CY 2019 Quality Payment Program data submissions and performance are representative of CY 2022 Quality Payment Program data submissions and performance. The estimated performance for the CY 2022 performance year/2024 MIPS payment year using CY 2019 Quality Payment Program data may be underestimated because the performance threshold to avoid a negative payment adjustment for the 2019 MIPS performance period/2021 MIPS payment year was significantly lower (30 out of 100 points) than the performance threshold for the 2022 performance year/2024 payment year (75 out of 100).

We anticipate clinicians may participate more robustly by submitting more performance categories to meet the higher performance threshold to avoid a negative payment adjustment. In our MIPS eligible clinician assumptions, we assumed that clinicians who elected to opt-in in the CY 2019 Quality Payment Program and submitted data would continue to elect to opt-in in the CY 2022 performance year/2024 MIPS payment year. It is difficult to predict, based on 2019 data, whether clinicians will elect to opt-in to participate in MIPS with the CY 2022 performance year/2024 payment year finalized policies. In addition to the limitations described throughout the methodology sections, there are additional limitations to our estimates including.

(1) To the extent that there are year-to-year changes in the data submission, volume and mix of services provided by MIPS eligible clinicians, the actual impact on total Medicare revenues will be different from those shown in Table 144. And (2) due to updates in measure specifications and new measures, our cost performance is modeled using test data that does not always overlap with CY 2019 so we may not be capturing performance for clinicians or groups that change practices or TINs between when the testing data and the 2019 performance period. Due to the limitations described, there is considerable uncertainty around our estimates that is difficult to quantify. G.

Alternatives Considered This final rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our policies and, where relevant, alternatives that were considered. For purposes of the payment impact on PFS services of the policies contained in this final rule, we presented the estimated impact on total allowed charges by specialty. 1.

Alternatives Considered for Utilization Data in PFS Ratesetting As discussed earlier in this section II.C.1 (Changes in Relative Value Unit (RVU) Impacts), our estimates of changes in Medicare expenditures for PFS services compared payment rates for CY 2021 with payment rates for CY 2022 using CY 2020 Medicare utilization. As an alternative to using CY 2020 data, we considered using CY 2019 utilization data for the purposes of determining the CY 2022 RVUs, as well as in determining the CY 2022 BN adjustment and conversion factor. We considered using CY 2019 data due to the PHE for buy antibiotics, which has impacted the delivery of health care services over the past 18 months. Increases in remote delivery of services to reduce risk of exposure to both practitioner and patients, as well as postponement of elective procedures have resulted in a change to service utilization patterns across Medicare FFS payment systems.

Specific to the PFS, overall service utilization decreased by approximately 20 percent in CY 2020 compared to CY 2019, which caused us to question whether CY 2020 data is the best available data to use for CY 2022 ratesetting. In order to determine if lower overall utilization in CY 2020 would result in differential impacts on specialties and practitioners, we modeled the PFS ratesetting process using CY 2019 utilization data. We found that the use of CY 2020 as opposed to CY 2019 data in establishing payment rates had relatively little differential impacts on payment, despite the approximately 20 percent decrease in overall service utilization. Table 149 illustrates specialty-specific impacts for the proposed rule using CY 2019 data.

Start Printed Page 65653 Start Printed Page 65654 The majority of specialties experienced shifts of less than a percent when we used CY 2019 data, as opposed to CY 2020 data, as displayed in Table 136, as the basis for setting rates. Several specialties shifted by approximately one percent. We did not detect a pattern of specialties that were notably affected by the choice of claims data, either positively or negatively. While Pediatrics shifted from a 1 percent impact when we used CY 2020 claims data to a 5-payment impact when we used CY 2019 claims data, this shift is likely due to the smaller amount of allowed charges associated with the Pediatrics specialty.

We analyzed the percentage change in total RVUs per practitioner. Using CY 2019 utilization data, Total RVUs change between −1 percent and 1 percent for 53 percent of practitioners, representing more than 48 percent of the changes in Total RUs for all practitioners, similar to the results we found when using CY 2020 claims that we discussed in section II.C.1. Variations by specialty were also similar to the results we found using CY 2020 claims and are contained in the public use file that describes the percentage change in total RVUs per practitioner. Similar to the process described in section II.C.1.

Of this final rule, we used CY 2019 claims data to estimate the CY 2021 PFS CF to be 33.6184 which reflects a BN adjustment under section 1848(c)(2)(B)(ii)(II) of the Act, which we estimated to be −0.04 using CY 2019 data, the 0.00 percent update adjustment factor specified under section 1848(d)(19) of the Act, and the expiration of the 3.75 percent fee schedule payment increase for CY 2021 provided by the CAA. The anesthesia CF, which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments, would shift by a similar magnitude as the PFS CF. Thus, the estimated PFS CF and anesthesia CF using CY 2019 data is slightly higher compared to using claims data for CY 2020 with an estimated difference of 0.0336 (a little less than three and half cents). We note that the BN adjustment will be recalculated for the CY 2022 PFS final rule and the use of CY 2019 claims may or may not be higher than the use of CY 2020 claims based on which policies are ultimately finalized.

Comment. We received few comments on our Alternatives Considered for Utilization Data in PFS Ratesetting. One commenter stated that they supported the use of the alternate CY 2019 claims data because it resulted in a slight improvement (approximately 1 percent) in the impact of changes in RVUs for their specialty. A different commenter stated that practice patterns in CY 2020 were atypical as a result of the buy antibiotics zithromax and they believed that the use of 2019 claims data would be likely to more closely approximate overall PFS service utilization and costs in 2022.

Response. We continued to believe that the use of CY 2020 as opposed to CY 2019 data in establishing payment rates had relatively little differential impacts on payment, despite the approximately 20 percent decrease in overall service utilization. We found that the use of CY 2020 as opposed to CY 2019 data in establishing payment rates had little differential impact on payment at the specialty, service categories, and individual services levels. We also did not detect a pattern of specialties who were notably affected by the choice of claims data, either positively or negatively.

We received few comments on this alternative considered which we believe indicates support for our use of CY 2020 claims data from the majority of commenters. After consideration of the comments, we are finalizing our continued use of CY 2020 claims data instead of the potential alternative to use CY 2019 claims data for the purposes of determining the CY 2022 RVUs as well as in determining the CY 2022 BN adjustment and conversion factor. 2. Alternatives Considered for Split (or Shared) Visits In section II.F of this final rule, we codify our current policy allowing billing of certain “split” or “shared” E/M visits by a physician, when the visit is performed in part by both a physician and an NPP, who are in the same group and the physician performs a substantive portion of the visit.

We will codify in our regulations a definition of a split (or shared) visit as an E/M visit in the facility setting that is performed in part by both a physician and NPP who are in the same group, in accordance with applicable laws and regulations, such that the E/M visit could be billed by either the physician or the NPP if it were furnished independently by only one of them in the facility setting (rather than as a split (or shared) visit). The physician or NPP who performs the substantive portion of the split (or shared) visit will bill for the visit. We are also finalizing our proposed definition of substantive portion as more than half of the total time spent by the physician and NPP. We considered several alternative approaches.

First, we considered the option of disallowing split (or shared) visit billing beginning in CY 2022. Under this alternative, in settings where payment for “incident to” services is prohibited, physicians and NPPs would only be able to bill for visits they furnish in their entirety under their own NPI. Such a policy would be administratively simple, and reduce the likelihood of paying significantly more than the actual resource costs incurred. When physicians and practitioners furnish services in facility settings, they do not ordinarily incur the cost of clinical staff or other PE costs involved in furnishing the services.

When the physician bills for an E/M visit, in accordance with section 1833(a)(1)(N) of the Act, the Medicare Part B payment is equal to 80 percent of the payment basis under the PFS which, under section 1848(a)(1) of the Act, is the lesser of the actual charge or the full fee schedule Start Printed Page 65655 amount for the service. In contrast, if the NPP bills for it, in accordance with section 1833(a)(1)(O) of the Act, the Medicare Part B payment is equal to 80 percent of the lesser of the actual charge or 85 percent of the fee schedule rate. Because of this payment differential and the lower resource costs associated with E/M visits performed partly by a physician and partly by an NPP, it could be argued that the physician should not be able to bill for such a visit and be paid at the higher fee schedule amount. Our proposal was informed by our belief that longstanding clinical practice relies substantially upon shared visits between physicians and NPPs in facility settings.

To avoid the potential disruption in this common medical practice approach, we did not propose to disallow billing for split (or shared) visits. Comment. We received public comments confirming that it would be disruptive of current practice patterns to disallow split (or shared) visit billing. We did not receive public data indicating specifically how often split (or shared) visits occur.

Response. After consideration of the public comments, we are finalizing a policy to continue allowing billing of split (or shared) visits under specified conditions. We will require a modifier on claims for these types of visits, as proposed, to help inform future policy in this area. We also considered several alternatives for how to define the substantive portion of a split (or shared) visit.

We considered defining “substantive portion” as any face-to-face portion of the split (or shared) visit, consistent with our current definition. We did not believe it would be appropriate to consider just any portion of the visit—with or without direct patient contact— as a substantive portion. For instance, we did not believe it would be appropriate to consider a brief or trivial interaction, with or without direct patient contact, such as where the physician merely “pokes their head” into the room, to be a substantive portion of the visit. We did not believe it would be appropriate to permit a physician to bill for a visit if they do not substantially participate in the visit, given that physicians are paid under the PFS at a higher rate than NPPs.

Therefore, we proposed to define “substantive portion” as more than half of the total time spent by the physician or NPP. Another alternative we considered, but did not propose, was to utilize the medical decision making (MDM) to define substantive portion. We did not propose this approach because MDM is not easily attributed to a single physician or NPP when the work is shared, because MDM is not necessarily quantifiable and can depend on patient characteristics. We believed that time is a more precise factor than MDM to use as a basis for deciding which practitioner performs the substantive portion of the visit.

We believed that using the time spent by each practitioner furnishing the split (or shared) visit would provide a more precise metric than potentially finding a way to parse MDM between the physician and the NPP. We also considered defining substantive portion as performance of the history and/or physical exam, which are key components of certain E/M visits. Given recent changes in the CPT E/M Guidelines, history and physical exam are no longer necessarily included in all E/M visits, because for office/outpatient E/M visits, the visit level can now be selected based on either MDM or time, and history and exam are performed only as medically appropriate. Also, the CPT Editorial Panel is considering removing history and physical exam as key visit components for institutional visits, similar to the changes already made for office/outpatient E/M visits.

Accordingly, defining “substantive portion” as any key component including history or exam did not seem to be a viable approach. Lastly, we considered not defining substantive portion and instead leaving determinations regarding the substantive portion to MAC and/or medical review discretion. However, this approach would impose a significant burden on MACs to assess individual cases and could lead to too much regional variation in payment. We solicited public comment to help inform what we consider to be the “substantive portion” of a split (or shared) visit in institutional settings and assist us in consideration of our definition of “substantive portion”.

We received public comments to help inform what we consider to be the “substantive portion” of a split (or shared) visit in institutional settings and assist us in consideration of our definition of “substantive portion.” We refer readers to section II.F. Of this final rule with comment period for a complete discussion of the public comments on this topic and our responses, summarized below. Comment. The commenters agreed that the individual who performs the substantive portion should bill for the visit.

Approximately half of the commenters supported our proposal, believing that it was appropriate and would provide a clear rule. However, approximately half of the public comments recommended alternative definitions of substantive portion, including. A lower percentage of time (25 to 30 percent of the total time) (several comments). MDM (several comments).

Some portion of MDM (several comments). Choice of MDM or time, for example, based on whichever is used to select visit level (several comments). One of the three key components of history, exam, or MDM, at least until the AMA completes changes for E/M visit coding and the CPT E/M Guidelines that the commenters expect for 2023 (several comments). Some combination of the above, for example, more than half of the MDM or more than half of total time (several comments).

Working with the CPT Editorial Panel to develop a policy (several comments). These commenters were concerned about a perceived devaluation of the medical decision-making portion of visits, disruptions to current practice patterns, and administrative burdens associated with timing each of the practitioner's contribution to the visit. Response. Regarding recommendations to consider the substantive portion to be a lower percentage of time, having reviewed our current policy, we do not believe that the higher physician payment rate under the PFS should be made when a physician performs less than half of the visit, such as a quarter or a third of the total time or less than half of the MDM.

We do not think that MDM is necessarily the most critical or central component of E/M visits, and it is not the only service component being paid for. PFS payment rates incorporate and assume a certain amount of physician time per visit, reflected in the assigned RVUs and reflected annually in our physician time files. PFS payment rates reflect the typical amount of time spent on visits, and the Act requires us to reflect both time and intensity of work (physician and practitioner) in our payment rates. We do not believe this in any way devalues the unique education, training, experience, or expertise of physicians, but rather that both time and expertise are important and included in payment under the PFS.

We continue to believe that MDM cannot be readily attributed to only the physician or the NPP, or definitively divided between them. We believe the commenters overestimate the administrative burden Start Printed Page 65656 of tracking and attributing time, given the advent of EHRs and new E/M visit coding structures. However, we understand that an adjustment period may be needed to establish systems to track and attribute time for split (or shared) visits, especially since the coding for E/M visits in many facility settings will not use MDM or time to distinguish visit levels until 2023. Therefore, we are finalizing our definition of substantive portion for split (or shared) visits as proposed (more than half of the total time spent by the physician and NPP performing the split (or shared) visit) beginning January 1, 2023.

However, we are modifying our proposed policy for one transitional year. For CY 2022, except for critical care visits, the substantive portion will be defined as one of the three key components (history, exam, or MDM), or more than half of the total time spent by the physician and NPP performing the split (or shared) visit). In other words, for CY 2022, the practitioner who spends more than half of the total time, or performs the history, exam, or MDM can be considered to have performed the substantive portion and can bill for the split (or shared) E/M visit. We wish to be clear that practitioners can still use MDM to select visit level for the E/M split (or shared) visit, as proposed.

We also are clarifying that when one of the three key components is used as the substantive portion in CY 2022, the practitioner who bills the visit must perform that component in its entirety in order to bill (see section II.F.1.c.1. Of this final rule for a more detailed discussion). For visits that are already timed (that is, critical care services), the choice to use more than half of the total time, or performance of the history, exam, or MDM will not apply. For critical care visits, starting in CY 2022, the substantive portion will be more than half of the total time, as proposed.

We will continue to review and consider any future changes by the AMA/CPT Editorial Panel to the CPT E/M Guidelines for split (or shared) visits. We also intend to monitor the claims data for split (or shared) visits, to better understand how frequently practitioners use or rely upon this billing construct. We considered disallowing split (or shared) billing in critical care, SNF and nursing facility (NF) visits, as well as new patient and initial patient visits. We require certain SNF/NF visits to be provided entirely by a physician, but we believed we should allow split (or shared) visit billing for other visits that can be split (or shared) in these settings.

(We refer readers to our Conditions of Participation in 42 CFR 483.30 for information regarding the SNF/NF visits that are required to be performed in their entirety by a physician. That regulation requires that certain SNF/NF visits must be furnished directly and solely by a physician). However, we believed current clinical practice generally allows sharing of critical care visits by appropriately trained and qualified practitioners, and we solicited comment on this belief and this alternative considered. We proposed to allow split (or shared) visit billing in critical care because we believe the practice of medicine has evolved towards a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by clinicians in the same group in the facility setting.

Given this evolution in medical practice, the concerns that may have been present when we issued current policy may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care. There has also been an increase in alternative payment models that employ a more team-based approach to care. Comment.

We received many comments on our proposals for allowed settings of care, all in support of those proposals. Response. We thank the commenters for their support. After consideration of the public comments, we are finalizing as proposed.

We proposed to allow split (or shared) visits for both new and established patients as well as initial and subsequent visits. After conducting an internal review, including consulting our medical officers, we believed that the practice of medicine has evolved toward a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by practitioners in the same group in the facility setting. Given this evolution in medical practice, the concerns that may have been present when we issued the manual instructions may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care.

There has also been an increase in alternative payment models that employ a more team-based approach to care. In considering and reevaluating our policy, we saw no reason to preclude the physician or NPP from billing for split (or shared) visits for a new patient, in addition to an established patient, or for initial and subsequent split (or shared) visits. Therefore, we proposed to permit the physician or NPP to bill for split (or shared) visits for both new and established patients, as well as for initial and subsequent visits. We believed this approach is also consistent with the CPT E/M Guidelines for split (or shared) visits, which does not exclude these types of visits from being billed when furnished as split (or shared) services.

Comment. We received many comments on this proposal, all in support of it. Response. We thank the commenters for their support.

After consideration of public comments, we are finalizing as proposed. 3. Alternatives Considered for Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802, 414.806) This provision implements new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of the CAA (for the purposes of this section of this final rule, hereinafter is referred to as “section 401”). These new requirements will improve the accuracy of reported prices and limit the use of WAC-based pricing.

As discussed in section III.D.1. Of this final rule, section 1847A(c)(6)(A) of the Act incorporates the definition of manufacturer at section 1927(k)(5) of the Act, but permits the Secretary to exempt repackagers from the definition of manufacturer, as determined appropriate, for purposes of section 1847A(f)(2) of the Act. We considered whether to implement the flexibility afforded by the statute. However, implementing the flexibility afforded by the statute could potentially lead to a gap in the ASP reporting requirements, meaning that ASPs could be distorted to the extent that certain sales are carved out of the reporting requirement through the use of repackagers.

As discussed previously in this RIA, we are unable to quantitatively estimate the impacts of this provision. We welcomed comments on our approach, and on the alternative relative to. (1) The likely costs or savings (to manufacturers, beneficiaries, the government, and other stakeholders). And (2) any other related impacts of this provision.

Start Printed Page 65657 4. Alternatives Considered for the MDPP Expanded Model Emergency Policy For the MDPP Expanded Model Emergency Policy, no alternatives were considered. The 2-year MDPP service period has depressed interest in MDPP among would-be MDPP suppliers. These actions address stakeholder comments on the barriers to MDPP expanded model success.

If we do not take action, we will not be able to scale MDPP as intended, impacting Medicare beneficiary access to this program. Reducing the MDPP from a 24- to a 12-month services period, increasing the year 1 performance payments, and waiving the Medicare provider enrollment application fee not only better aligns the model with the evidence that helped certify the DPP model test initially, but it will encourage eligible organizations to enroll as MDPP suppliers. 5. Alternatives Considered for the Quality Payment Program We view the performance threshold as a critical factor affecting the distribution of payment adjustments in the Quality Payment Program.

We ran a separate final policies RIA model based on the actual mean for the CY 2019 performance period/2021 MIPS payment year with a performance threshold of 86 and an additional performance threshold of 92 points, which are potential values that may be used for the CY 2022 performance period/2024 MIPS payment year. The model with a performance threshold of 86 and additional performance threshold of 92 has the same mean and median final score as our policies RIA model since the performance threshold does not change the final score. We estimate that $ 907 million will be redistributed through BN. For clinicians who meet or exceed the additional performance threshold, an additional $241 million was distributed.

The maximum positive payment adjustment will be 18.2 percent prior to the maximum additional payment adjustment and 28.2 percent after considering the MIPS maximum positive payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 74.0 percent of MIPS eligible clinicians will receive a negative payment adjustment among those that submit data. We report the findings for the baseline model which describes the impact for the CY 2022 performance period/2024 MIPS payment year if this regulation did not exist. The baseline model has a final score mean of 78.13 and median of 82.59.

We estimate that $428 million will be redistributed through BN. There will be a maximum payment adjustment of 6.6 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 8.3 percent of MIPS eligible clinicians will receive a negative payment adjustment among those that submit data. H.

Impact on Beneficiaries We do not believe these provisions will have a negative impact on beneficiaries given overall PFS BN. 1. Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802, 414.806) Section 1927(b)(3)(A)(iii) of the Act requires manufacturers with a Medicaid drug rebate agreement to report ASP data consistent with the information required for such reporting at section 1847A of the Act. Some manufacturers without Medicaid drug rebate agreements voluntarily submit ASP data for their single source drugs or biologicals that are payable under Part B, however other manufacturers without Medicaid drug rebate agreements do not voluntarily submit such data.

Without manufacturer reported ASP data, CMS cannot calculate the ASP payment limit, and consequently, payment is typically based on Wholesale Acquisition Cost (WAC). Consistent with section 1847A(c)(3) of the Act and our regulations at § 414.804(a)(2), the ASP is net of price concessions. However, consistent with the definition of WAC at section 1847A(c)(6)(B) of the Act, the WAC is not net of price concessions and is thus nearly always, and sometimes significantly, higher than ASP. Drugs with payment allowances based on WAC may have greater “spreads” between acquisition costs and payment than drugs for which there is an ASP-based payment allowance, which, in turn, may.

(1) Incent the use of the drug based on its spread rather than on purely clinical considerations. (2) result in increased payments under Medicare Part B. And (3) result in increased beneficiary cost sharing. This provision implements new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of Division CC, Title IV of the CAA, 2021.

These new requirements will improve the accuracy of reported payment limits and limit the use of WAC-based pricing. For single source drugs, these changes may result in lower payment limits because, typically, the WAC plus 3 percent is higher than ASP plus 6 percent. This then translates to cost savings for both the government and beneficiaries, who will pay coinsurance on a lesser amount. However, for the reason stated earlier in this RIA (see section VI.G.4.

Of this final rule), we are unable to predict the magnitude of this effect. Similarly, payment limits for multiple source drugs could increase or decrease, and we are unable to predict the direction or magnitude of specific or aggregate effects at this time. 2. Determination of ASP for Certain Self-Administered Drug Products Although we are unable to quantify the total magnitude of the potential savings, these changes have the potential to substantially reduce program expenditures and beneficiary coinsurance.

The OIG's July 2020 report (discussed in section III.D.2. Of this final rule) determined that the inclusion of self-administered versions of certolizumab and abatacept in their respective volume-weighted, average ASPs, alone, has resulted in $173 million in additional Medicare beneficiary coinsurance between 2014 and 2018. The regulatory changes have the potential to result in decreased payment limits for identified billing and payment codes and could, in turn, substantially reduce beneficiary coinsurance. Since section 405 of Division CC, Title IV of the CAA, 2021 directs CMS to implement the statutory changes at section 1847A(g)(3) of the Act beginning on July 1, 2021, these potential savings may be observed within the year.

3. Medicare Diabetes Prevention Program Expanded Model Emergency Policy This change will have a positive impact on eligible MDPP beneficiaries, as it better aligns with the CDC's National DPP, giving both the participants and the coaches similar messaging around this program, regardless of payer. MDPP suppliers often offer the MDPP set of services to mixed cohorts, or classes with participants who are not eligible for MDPP, but who are enrolled in a National DPP cohort. Since MDPP generally follows the CDC's National DPP and aligns its program with the CDC's DPRP Standards, it is confusing to participants, coaches, and staff when talking about a 2-year program to its eligible Medicare participants when the non-Medicare participants have a 1-year program.

Finally, reducing the MDPP service period from 2 years to one (1) year allows more cohorts to start and finish MDPP during the expanded Start Printed Page 65658 model initial period of performance, which ends in March 2023. 4. Quality Payment Program There are several changes in this rule that are expected to have a positive effect on beneficiaries. In general, we believe that many of these changes, including the MVP and subgroup provisions, will lead to more meaningful and relevant data being available to beneficiaries on the type and scope of care provided by clinicians on the compare tool.

Additionally, beneficiaries could use the publicly reported information on clinician performance in subgroups to identify and choose clinicians in multispecialty groups relevant to their care needs. Consequently, we anticipate this will improve the quality and value of care provided to Medicare beneficiaries. For example, several of the new measures include patient-reported outcome-based measures, which may be used to help patients make more informed decisions about treatment options. Patient-reported outcome-based measures provide information on a patient's health status from the patient's point of view and may also provide valuable insights on factors such as quality of life, functional status, and overall disease experience, which may not otherwise be available through routine clinical data collection.

Patient-reported outcome-based measured are factors frequently of interest to patients when making decisions about treatment. K. Estimating Regulatory Familiarization Costs If regulations impose administrative costs on private entities, such as the time needed to read and interpret this rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assumed that the total number of unique commenters on this year's rule will be the number of reviewers of last year's rule.

We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters will review this year's rule in detail, and it is also possible that some reviewers will choose not to comment on the rule. For these reasons we thought that the number of commenters will be a fair estimate of the number of reviewers of last year's rule. We also recognized that different types of entities are in many cases affected by mutually exclusive sections of this rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule.

Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $114.24 per hour, including overhead and fringe benefits https://www.bls.gov/​oes/​current/​oes_​nat.htm. Assuming an average reading speed, we estimate that it will take approximately 8.0 hours for the staff to review half of this rule. For each facility that reviews the rule, the estimated cost is $913.92 (8.0 hours × $114.24). Therefore, we estimated that the total cost of reviewing this regulation is $32,380,186 ($885.92 × 35,430 reviewers on this year's proposed rule).

J. Accounting Statement As required by OMB Circular A-4 (available at http://www.whitehouse.gov/​omb/​circulars/​a004/​a-4.pdf ), in Tables 150 and 151 (Accounting Statements), we have prepared an accounting statement. This estimate includes growth in incurred benefits from CY 2021 to CY 2022 based on the FY 2022 President's Budget baseline. K.

Conclusion The analysis in the previous sections, together with the remainder of this preamble, provided an initial Regulatory Flexibility Analysis. The previous analysis, together with the preceding portion of this preamble, provides an RIA. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &.

Medicaid Services, approved this document on October 28, 2021. Start List of Subjects 42 CFR Part 403 Grant programs—healthHealth insuranceHospitalsIntergovernmental relationsMedicareReporting and recordkeeping requirements 42 CFR Part 405 Administrative practice and procedureDiseasesHealth facilitiesHealth insuranceHealth professionsMedical devicesMedicareReporting and recordkeeping requirementsRural areasX-rays 42 CFR Part 410 DiseasesHealth facilitiesHealth professionsLaboratoriesMedicareReporting and recordkeeping requirementsRural areasX-rays 42 CFR Part 411 DiseasesMedicareReporting and recordkeeping requirements 42 CFR Part 414 Administrative practice and procedureBiologicsDiseasesDrugsHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 415 Health facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 423 Administrative practice and procedureEmergency medical servicesHealth facilitiesHealth maintenance organizations (HMO)Health professionalsMedicarePenaltiesPrivacyReporting and recordkeeping requirements 42 CFR Part 424 Emergency medical servicesHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 425 Administrative practice and procedureHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1.

The authority citation for part 403 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, and 1395hh. End Authority Start Amendment Part2.

In § 403.902— End Amendment Part Start Amendment Parta. Amend the definition of “Ownership or investment interest” by adding paragraphs (3)(vi) and (vii). End Amendment Part Start Amendment Partb. Add a definition for “Physician-owned distributorship” in alphabetical order.

And End Amendment Part Start Amendment Partc. Revise the definition of “Short term medical supply or device loan”. End Amendment Part The additions and revision read as follows. Definitions.

* * * * * Ownership or investment interest * * * (3) * * * (vi) A titular ownership or investment interest that excludes the ability or right to receive the financial benefits of ownership or investment, including, but not limited to, the distribution of profits, dividends, proceeds of sale, or similar returns on investment. Or (vii) An interest in an entity that arises from an employee stock ownership plan (ESOP) that is qualified under section 401(a) of the Internal Revenue Code of 1986. * * * * * Physician-owned distributorship , for the purposes of determining the existence of a reportable ownership or investment interest under this subpart, means an entity that. (1) Meets the definition of an applicable manufacturer or applicable group purchasing organization as defined in this section, and (2) Meets at least one of the following two conditions.

(i) Has a minimum of 5 percent direct or indirect ownership or investment interest in the applicable manufacturer or applicable group purchasing organization held by a physician or a physician's immediate family member, or (ii) A physician or a physician's immediate family member receives compensation from the applicable manufacturer or group purchasing organization in the form of a commission, return on investment, profit sharing, profit distribution, or other remuneration directly or indirectly derived from the sale or distribution of devices by the applicable manufacturer or group purchasing organization in which the physician or physician's immediate family member has ownership. (3) This physician owned distributor definition does not apply for purposes of any other laws or regulations, including, but not limited to, section 1877 of the Act, the regulations at 42 CFR part 411, subpart J, section 1128B of the Act, or the regulations at 42 CFR 1001.952. * * * * * Short term medical supply or device loan means the loan of a covered device or a device under development, or the provision of a limited quantity of medical supplies for a short-term trial period, not to exceed a loan period of 90 cumulative days per calendar year or a quantity of 90 cumulative days of average daily use per calendar year, to permit evaluation of the device or medical supply by the covered recipient. * * * * * Start Amendment Part3.

Amend § 403.904 by adding paragraph (a)(3) to read as follows. End Amendment Part Reports of payments or other transfers of value to covered recipients. (a) * * * (3) An applicable manufacturer or applicable group purchasing organization that has reported payments or transfers of value under the scope of this section may not remove, delete, or alter any record/(s) unless an error is discovered in the information that had been furnished, or the record is otherwise believed to meet exceptions for reporting. * * * * * Start Amendment Part4.

Amend § 403.908 by revising paragraph (c)(3) and adding paragraph (c)(4) to read as follows. End Amendment Part Procedures for electronic submission of reports. * * * * * (c) * * * (3) During registration, applicable manufacturers and applicable group purchasing organizations must name two points of contact with appropriate contact information. These points of contact must be updated for 2 years following record submission.

(4) An applicable manufacturer or applicable group purchasing organization that meets the definition of physician-owned distributorship as defined in § 403.902 must identify its status as a physician-owned distributorship when registering or recertifying. * * * * * Start Part End Part Start Amendment Part5. The authority citation for part 405 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k). End Authority Start Amendment Part6. Amend § 405.902 by adding definitions for “Additional documentation”, “Additional documentation request (ADR)”, “Post-payment medical review”, and “Prepayment medical review” in alphabetical order to read as follows. End Amendment Part Start Printed Page 65660 Definitions.

* * * * * Additional documentation means any information requested by a contractor when conducting a prepayment review or post-payment review. Additional documentation request (ADR) means a contractor's initial documentation request in reviewing claims selected for prepayment review or post-payment review. * * * * * Post-payment medical review (or post-payment review) means a review that occurs after payment is made on the selected claim to determine whether the initial determination for payment was appropriate. Prepayment medical review (or prepayment review) means a review that occurs before an initial determination for payment is made on the selected claim to determine whether payment should be made.

* * * * * Start Amendment Part7. Add § 405.903 to read as follows. End Amendment Part Prepayment review. (a) A contractor may select a claim(s) for prepayment review.

(b) In conducting a prepayment review, a contractor may issue additional documentation requests to a provider or supplier. (1) A provider or supplier will be provided 45 calendar days to submit additional documentation in response to a contractor's request, except as stated in paragraph (b)(2) and (c) of this section. (2) A contractor may accept documentation received after 45-calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the contractor deems good cause in accepting the documentation.

(c) A provider or supplier will be provided 30 calendar days to submit additional documentation in response to a UPIC's request for additional documentation. A UPIC may accept documentation received after the 30 calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the UPIC deems good cause in accepting the documentation. (d) A contractor's prepayment review will result in an initial determination under § 405.920.

Start Amendment Part8. Add §§ 405.929 and 405.930 under the undesignated ceneter heading “Initial Determinations” in subpart I to read as follows. End Amendment Part Post-payment review. (a) A contractor may select a claim(s) for post-payment review, which is conducted under the reopening authority in § 405.980.

(b) In conducting a post-payment review, a contractor may issue an additional documentation request to a provider or supplier. (1) A provider or supplier will be provided 45 calendar days to submit additional documentation in response to a contractor's request, except as stated in paragraph (b)(2) and (c) of this section. (2) A contractor may accept documentation received after 45 calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the contractor deems good cause in accepting the documentation.

(c) A provider or supplier will be provided 30 calendar days to submit additional documentation in response to a UPIC's request for additional documentation. A UPIC may accept documentation received after 30 calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the UPIC deems good cause in accepting the documentation. (d) The outcome of a contractor's review will result in either no change to the initial determination or a revised determination under § 405.984.

Failure to respond to additional documentation request. If a contractor gives a provider or supplier notice and time to respond to an additional documentation request and the provider or supplier does not provide the additional documentation in a timely manner, the contractor has authority to deny the claim. Start Amendment Part9. Amend § 405.986 by revising the paragraph (a) subject heading to read as follows.

End Amendment Part Good cause for reopening. (a) Establishing good cause for reopening. * * * * * * * * Start Amendment Part10. Amend § 405.2411 by— End Amendment Part Start Amendment Parta.

Revising paragraph (b)(2). End Amendment Part Start Amendment Partb. Redesignating paragraph (b)(3) as (b)(4). And End Amendment Part Start Amendment Partc.

Adding a new paragraph (b)(3). End Amendment Part The revision and addition read as follows. Scope of benefits. * * * * * (b) * * * (2) Covered when furnished during a Part A stay in a skilled nursing facility only when provided by a physician, nurse practitioner, physician assistant, certified nurse midwife or clinical psychologist employed or under contract with the RHC or FQHC at the time the services are furnished.

(3) Inclusive of hospice attending physician services, and are covered when furnished during a patient's hospice election only when provided by an RHC/FQHC physician, nurse practitioner, or physician assistant designated by the patient as his or her attending physician and employed or under contract with the RHC or FQHC at the time the services are furnished. And * * * * * Start Amendment Part11. Amend § 405.2446 by revising paragraph (c) to read as follows. End Amendment Part Scope of services.

* * * * * (c) FQHC services are covered when provided in outpatient settings only, including a patient's place of residence, which may be a skilled nursing facility or a nursing facility, other institution used as a patient's home, or are hospice attending physician services furnished during a hospice election. * * * * * Start Amendment Part12. Amend § 405.2462— End Amendment Part Start Amendment Parta. By revising paragraphs (a) and (b).

End Amendment Part Start Amendment Partb. By redesignating paragraphs (c) through (g) as paragraphs (e) through (i), respectively. End Amendment Part Start Amendment Partc. By adding new paragraphs (c) and (d).

And End Amendment Part Start Amendment Partd. In newly redesignated paragraph (e) introductory text, by removing the reference “paragraph (d)” and adding in its place “paragraph (f)”. End Amendment Part The revisions and additions read as follows. Payment for RHC and FQHC services.

(a) Payment to independent RHCs that are authorized to bill under the reasonable cost system. (1) RHCs that are authorized to bill under the reasonable cost system are paid on the basis of an all-inclusive rate, subject to a payment limit per visit determined in paragraph (b) of this section, for each beneficiary visit for covered services. This rate is determined by the Medicare Administration Contractor (MAC), in accordance with this subpart and general instructions issued by CMS. (2) The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section.

Start Printed Page 65661 (b) RHC payment limit per visit. (1) In establishing limits on payment for rural health clinic services provided by rural health clinics the limit for services provided prior to April 1, 2021. (i) In 1988, after March 31, at $46 per visit. And (ii) In a subsequent year (before April 1, 2021), at the limit established for the previous year increased by the percentage increase in the Medicare Economic Index (MEI) (as defined in section 1842(i)(3) of the Act) applicable to primary care services (as defined in section 1842(i)(4) of the Act) furnished as of the first day of that year.

(2) In establishing limits on payment for rural health services furnished on or after April 1, 2021, by rural health clinics or any rural health clinic that is enrolled on or after January 1, 2021 under section 1866(j) of the Act), the limit for services provided. (i) In 2021, after March 31, at $100 per visit. (ii) In 2022, at $113 per visit. (iii) In 2023, at $126 per visit.

(iv) In 2024, at $139 per visit. (v) In 2025, at $152 per visit. (vi) In 2026, at $165 per visit. (vii) In 2027, at $178 per visit.

And (viii) In 2028, at $190 per visit. (ix) In a subsequent year, at the limit established for the previous year increased by the percentage increase in MEI applicable to primary care services furnished as of the first day of such year. (3) In establishing limits on payment for rural health services furnished on or after April 1, 2021, by provider-based rural health clinics as described in section (c)(4) of this part, the limit for services provided. (i) In 2021, after March 31, at an amount equal to the greater of.

(A) For rural health clinics that had an all-inclusive rate established for services furnished in 2020— ( 1 ) The all-inclusive rate applicable to the rural health clinic for services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021, or ( 2 ) The payment limit per visit applicable in paragraph (b)(2) of this section. (B) For rural health clinics that did not have an all-inclusive rate established for services furnished in 2020— ( 1 ) The all-inclusive rate applicable to the rural health clinic for services furnished in 2021, or ( 2 ) The payment limit per visit applicable in paragraph (b)(2) of this section. (ii) In a subsequent year, at an amount equal to the greater of. (A) The amount established under paragraph (b)(3)(i)(A) or (B) of this section, as applicable for the previous year, increased by the percentage increase in MEI applicable to primary care services furnished as of the first day of such subsequent year, or (B) The payment limit per visit applicable under paragraph (b)(2) of this section for such subsequent year.

(c) Payment to provider-based RHCs that are authorized to bill under the reasonable cost system. (1) An RHC that is authorized to bill under the reasonable cost system is paid in accordance with parts 405 and 413 of this subchapter, as applicable, if the RHC is— (i) An integral and subordinate part of a hospital, skilled nursing facility or home health agency participating in Medicare (that is, a provider of services). And (ii) Operated with other departments of the provider under common licensure, governance and professional supervision. (2) An RHC, described in paragraph (c)(1) of this section, is paid on the basis of an all-inclusive rate, subject to a payment limit per visit, described in paragraphs (b)(1) and (2) of this section, for each beneficiary visit for covered services when in a hospital with greater than 50 beds as determined in § 412.105(b) of this subchapter.

This all-inclusive rate is determined by the MAC, in accordance with this subpart and general instructions issued by CMS. The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section. (3) Prior to April 1, 2021, an RHC, described in paragraph (c)(1) of this section, is paid on the basis of an all-inclusive rate and is not subject to a payment limit per visit described in paragraphs (b)(1) and (2) of this section for each beneficiary visit for covered services when in a hospital with less than 50 beds as determined in § 412.105(b) of this subchapter. This all-inclusive rate is determined by the MAC, in accordance with this subpart and general instructions issued by CMS.

The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section. (4) On or after April 1, 2021, an RHC, described in paragraph (c)(1) of this section, is paid on the basis of an all-inclusive rate, subject to a payment limit per visit, described in paragraph (b)(3) of this section, for each beneficiary visit for covered services when it meets the specified qualifications in paragraph(d) of this section. This all-inclusive rate is determined by the MAC, in accordance with this subpart and general instructions issued by CMS. The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section.

(d) Specified qualifications. A provider-based rural health clinic must meet the following qualifications to have a payment limit per visit established in accordance with paragraph (b)(3) of this section. (1) As of December 31, 2020, was in a hospital with less than 50 beds (as determined in § 412.105(b) of this subchapter) and after December 31, 2020, in a hospital that continues to have less than 50 beds (not taking into account any increase in the number of beds pursuant to a waiver during the buy antibiotics Public Health Emergency (PHE)). And one of the following circumstances.

(i) As of December 31, 2020, was enrolled under section 1866(j) of the Act (including temporary enrollment during the buy antibiotics PHE). Or (ii) Submitted an application for enrollment under section 1866(j) of the Act (or a request for temporary enrollment during the buy antibiotics PHE) that was received not later than December 31, 2020. (2) [Reserved] * * * * * Start Amendment Part13. Amend § 405.2463 by revising paragraphs (a)(1)(i) introductory text and (b)(3) introductory text to read as follows.

End Amendment Part What constitutes a visit. (a) * * * (1) * * * (i) Face-to-face encounter (or, for mental health disorders only, an encounter that meets the requirements under paragraph (b)(3) of this section) between an RHC patient and one of the following. * * * * * (b) * * * (3) Visit—Mental health. A mental health visit is a face-to-face encounter or an encounter furnished using interactive, real-time, audio and video telecommunications technology or audio-only interactions in cases where the patient is not capable of, or does not consent to, the use of video technology for the purposes of diagnosis, evaluation or treatment of a mental health disorder, including an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary Start Printed Page 65662 is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record, between an RHC or FQHC patient and one of the following.

* * * * * Start Amendment Part14. Amend § 405.2466 by revising paragraph (b)(1)(iv) to read as follows. End Amendment Part Annual reconciliation. * * * * * (b) * * * (1) * * * (iv) For RHCs and FQHCs, payment for pneumococcal, influenza, and buy antibiotics treatment and their administration is 100 percent of Medicare reasonable cost.

* * * * * Start Amendment Part15. Amend § 405.2469 by revising paragraph (d) to read as follows. End Amendment Part FQHC supplemental payments. * * * * * (d) Per visit supplemental payment.

A supplemental payment required under this section is made to the FQHC when a covered face-to-face encounter or an encounter furnished using interactive, real-time, audio and video telecommunications technology or audio-only interactions in cases where beneficiaries do not wish to use or do not have access to devices that permit a two-way, audio/video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder occurs between a MA enrollee and a practitioner as set forth in § 405.2463. Additionally, there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record. Start Part End Part Start Amendment Part16. The authority citation for part 410 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd. End Authority Start Amendment Part17. Amend § 410.33 by— End Amendment Part Start Amendment Parta.

Revising paragraphs (c) and (g)(6)(i) and (ii). End Amendment Part Start Amendment Partb. Redesignating paragraphs (g)(8)(i) through (iii) as paragraphs (g)(8)(i)(A) through (C), respectively. And End Amendment Part Start Amendment Partc.

Adding paragraphs (g)(8)(i) introductory text and (g)(8)(ii). And End Amendment Part Start Amendment Partd. Revising paragraph (g)(9). End Amendment Part The revisions and additions read as follows.

Independent diagnostic testing facility. * * * * * (c) Nonphysician personnel. (1) Except as otherwise stated in paragraph (c)(2) of this section, any nonphysician personnel used by the IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropriate State health or education department. In the absence of a State licensing board, the technician must be certified by an appropriate national credentialing body.

The IDTF must maintain documentation available for review that these requirements are met. (2) For services that do not require direct or in-person beneficiary interaction, treatment, or testing, any nonphysician personnel used by the IDTF to perform the tests must meet all applicable State licensure requirements for doing so. If there are any applicable State licensure requirements, the IDTF must maintain documentation available for review that these requirements are met. * * * * * (g) * * * (6) * * * (i) Except as otherwise stated in paragraph (g)(6)(ii) of this section, have a comprehensive liability insurance policy of at least $300,000 per location that covers both the place of business and all customers and employees of the IDTF.

The policy must be carried by a nonrelative-owned company. Failure to maintain required insurance at all times will result in revocation of the IDTF's billing privileges retroactive to the date the insurance lapsed. IDTF suppliers are responsible for providing the contact information for the issuing insurance agent and the underwriter. In addition, the IDTF must— (A) Ensure that the insurance policy must remain in force at all times and provide coverage of at least $300,000 per incident.

And (B) Notify the CMS designated contractor in writing of any policy changes or cancellations. (ii) Paragraph (g)(6)(i) of this section does not apply to IDTFs that only perform services that do not require direct or in-person beneficiary interaction, treatment, or testing. * * * * * (8) * * * (i) Except as otherwise stated in paragraph (g)(8)(ii) of this section, answer, document, and maintain documentation of a beneficiary's written clinical complaint at the physical site of the IDTF. (For mobile IDTFs, this documentation would be stored at their home office.) This includes, but is not limited to, the following.

* * * * * (ii) Paragraph (g)(8)(i) of this section does not apply to IDTFs that only perform services that do not require direct or in-person beneficiary interaction, treatment, or testing. (9) Openly post these standards for review by patients and the public. (This requirement does not apply to IDTFs that only perform services that do not require direct or in-person beneficiary interaction, treatment, or testing.) * * * * * Start Amendment Part18. Amend § 410.37 by adding paragraph (j) to read as follows.

End Amendment Part Colorectal cancer screening tests. Conditions for and limitations on coverage. * * * * * (j) Expansion of coverage of colorectal cancer screening tests. Effective January 1, 2022, colorectal cancer screening tests include a planned screening flexible sigmoidoscopy or screening colonoscopy that involves the removal of tissue or other matter or other procedure furnished in connection with, as a result of, and in the same clinical encounter as the screening test.

Start Amendment Part19. Amend § 410.47— End Amendment Part Start Amendment Parta. In paragraph (a), by revising the definitions of “Individualized treatment plan”, “Medical director”, Outcomes assessment”, “Physician prescribed exercise”, “Psychosocial assessment”, and “Supervising physician”. End Amendment Part Start Amendment Partb.

By revising paragraphs (b) through (e). End Amendment Part Start Amendment Partc. By removing paragraph (f). And End Amendment Part Start Amendment Partd.

By redesignating paragraph (g) as paragraph (f). End Amendment Part The revisions read as follows. Start Printed Page 65663 Pulmonary rehabilitation program. Conditions of coverage.

(a) * * * Individualized treatment plan means a written plan tailored to each individual patient that includes all of the following. (i) A description of the individual's diagnosis. (ii) The type, amount, frequency, and duration of the items and services furnished under the plan. (iii) The goals set for the individual under the plan.

Medical director means the physician who oversees the pulmonary rehabilitation program at a particular site. Outcomes assessment means an evaluation of progress as it relates to the individual's rehabilitation which includes the following. (i) Evaluations, based on patient-centered outcomes, which must be measured by the physician or program staff at the beginning and end of the program. Evaluations measured by program staff must be considered by the physician in developing and/or reviewing individualized treatment plans.

(ii) Objective clinical measures of exercise performance and self-reported measures of shortness of breath and behavior. * * * * * Physician-prescribed exercise means aerobic exercise combined with other types of exercise (such as conditioning, breathing retraining, step, and strengthening) as determined to be appropriate for individual patients by a physician. Psychosocial assessment means an evaluation of an individual's mental and emotional functioning as it relates to the individual's rehabilitation or respiratory condition which includes an assessment of those aspects of an individual's family and home situation that affects the individual's rehabilitation treatment, and psychosocial evaluation of the individual's response to and rate of progress under the treatment plan. * * * * * Supervising physician means a physician that is immediately available and accessible for medical consultations and medical emergencies at all times items and services are being furnished to individuals under pulmonary rehabilitation programs.

(b) General rule —(1) Covered conditions. Medicare Part B covers pulmonary rehabilitation for beneficiaries. (i) With moderate to very severe COPD (defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease. (ii) Who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least four weeks.

(iii) Additional medical indications for coverage for pulmonary rehabilitation may be established through a national coverage determination (NCD). (2) Components. Pulmonary rehabilitation must include all of the following. (i) Physician-prescribed exercise during each pulmonary rehabilitation session.

(ii) Education or training that is closely and clearly related to the individual's care and treatment which is tailored to the individual's needs and assists in achievement of goals toward independence in activities of daily living, adaptation to limitations and improved quality of life. Education must include information on respiratory problem management and, if appropriate, brief smoking cessation counseling. (iii) Psychosocial assessment. (iv) Outcomes assessment.

(v) An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days. (3) Settings. (i) Medicare Part B pays for pulmonary rehabilitation in the following settings.

(A) A physician's office. (B) A hospital outpatient setting. (ii) All settings must have the following. (A) A physician immediately available and accessible for medical consultations and emergencies at all times when items and services are being furnished under the program.

This provision is satisfied if the physician meets the requirements for direct supervision for physician office services, at § 410.26 of this subpart. And for hospital outpatient services at § 410.27 of this subpart. (B) The necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary (for example, oxygen, cardiopulmonary resuscitation equipment, and defibrillator) to treat chronic respiratory disease. (c) Medical director standards.

The physician responsible for a pulmonary rehabilitation program is identified as the medical director. The medical director, in consultation with staff, is involved in directing the progress of individuals in the program and must possess all of the following. (1) Expertise in the management of individuals with respiratory pathophysiology. (2) Cardiopulmonary training in basic life support or advanced cardiac life support.

(3) Be licensed to practice medicine in the State in which the pulmonary rehabilitation program is offered. (d) Supervising physician standards. Physicians acting as the supervising physician must possess all of the following. (1) Expertise in the management of individuals with respiratory pathophysiology.

(2) Cardiopulmonary training in basic life support or advanced cardiac life support. (3) Be licensed to practice medicine in the State in which the pulmonary rehabilitation program is offered. (e) Limitations on coverage. The number of pulmonary rehabilitation sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare Administrative Contractor.

* * * * * Start Amendment Part20. Amend § 410.49— End Amendment Part Start Amendment Parta. In paragraph (a), by revising the definition of “Medical director”, revising paragraph (i) in the definition of “Outcomes assessment”, and revising the definition of “Physician-prescribed exercise”. And End Amendment Part Start Amendment Partb.

By revising paragraphs (b)(1) introductory text, (b)(2) introductory text, (b)(2)(ii), (b)(3)(i) introductory text, (d) introductory text, (e) introductory text, and (f). End Amendment Part The revisions read as follows. Cardiac rehabilitation program and intensive cardiac rehabilitation program. Conditions of coverage.

(a) * * * Medical director means the physician who oversees the cardiac rehabilitation or intensive cardiac rehabilitation program at a particular site. Outcomes assessment * * * (i) Evaluations, based on patient-centered outcomes, which must be measured by the physician or program staff at the beginning and end of the program. Evaluations measured by program staff must be considered by the physician in developing and/or reviewing individualized treatment plans. * * * * * Start Printed Page 65664 Physician-prescribed exercise means aerobic exercise combined with other types of exercise (such as strengthening and stretching) as determined to be appropriate for individual patients by a physician.

* * * * * (b) * * * (1) Covered conditions. Medicare Part B covers cardiac rehabilitation and intensive cardiac rehabilitation for beneficiaries who have experienced one or more of the following. * * * * * (2) Components. Cardiac rehabilitation and intensive cardiac rehabilitation must include all of the following.

* * * * * (ii) Cardiac risk factor modification, including education, counseling, and behavioral intervention, tailored to the individual's needs. * * * * * (3) * * * (i) Medicare Part B pays for cardiac rehabilitation and intensive cardiac rehabilitation in the following settings. * * * * * (d) Medical director standards. The physician responsible for a cardiac rehabilitation program or intensive cardiac rehabilitation program is identified as the medical director.

The medical director, in consultation with staff, is involved in directing the progress of individuals in the program and must possess all of the following. * * * * * (e) Supervising physician standards. Physicians acting as the supervising physician must possess all of the following. * * * * * (f) Limitations on coverage —(1) Cardiac rehabilitation.

The number of cardiac rehabilitation sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare Administrative Contractor. (2) Intensive cardiac rehabilitation. Intensive cardiac rehabilitation sessions are limited to 72 1-hour sessions (as defined in section 1848(b)(5) of the Act), up to 6 sessions per day, over a period of up to 18 weeks. Start Amendment Part21.

Amend § 410.59 by revising paragraph (a)(4)(iii)(B) and adding paragraphs (a)(4)(iv) and (v) to read as follows. End Amendment Part Outpatient occupational therapy services. Conditions. (a) * * * (4) * * * (iii) * * * (B) Except as provided in paragraph (a)(4)(iv) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service separately from the part furnished by the occupational therapist such that the minutes for that portion of a service (or unit of a service) furnished by the occupational therapist assistant exceed 10 percent of the total minutes for that service (or unit of a service).

(iv) Paragraph (a)(4)(iii)(B) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day when the occupational therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the occupational therapy assistant. (v) Where there are two remaining 15-minute units to bill of the same service, and the occupational therapist and occupational therapy assistant each provided between 9 and 14 minutes of the service with a total time of at least 23 minutes and no more than 28 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the occupational therapy assistant and one unit is billed without the prescribed modifier for the service provided by the occupational therapist. * * * * * Start Amendment Part22. Amend § 410.60 by revising paragraph (a)(4)(iii)(B) and adding paragraphs (a)(4)(iv) and (v) to read as follows.

End Amendment Part Outpatient physical therapy services. Conditions. (a) * * * (4) * * * (iii) * * * (B) Except as provided in paragraph (a)(4)(iv) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service separately from the part furnished by the physical therapist such that the minutes for that portion of a service (or unit of a service) furnished by the physical therapist assistant exceed 10 percent of the total minutes for that service (or unit of a service). (iv) Paragraph (a)(4)(iii)(B) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day, when the physical therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the physical therapist assistant.

(v) Where there are two remaining 15-minute units to bill of the same service, and the physical therapist and physical therapist assistant each provided between 9 and 14 minutes of the service with a total time of at least 23 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the physical therapist assistant and one unit is billed without the prescribed modifier for the service provided by the physical therapist. * * * * * Start Amendment Part23. Amend § 410.67— End Amendment Part Start Amendment Parta. In paragraph (b), by revising paragraphs (3) and (4) in the definition of “Opioid use disorder treatment service”.

End Amendment Part Start Amendment Partb. By revising paragraphs (d)(4)(ii) and (iii) and (d)(5). And End Amendment Part Start Amendment Partc. By adding paragraph (d)(6).

End Amendment Part The revisions and addition read as follows. Medicare coverage and payment of Opioid use disorder treatment services furnished by Opioid treatment programs. * * * * * (b) * * * Opioid use disorder treatment service * * * (3) Substance use counseling by a professional to the extent authorized under State law to furnish such services including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. During a Public Health Emergency, as defined in § 400.200 of this chapter, or for services furnished after the end of such emergency, in cases where audio/video communication technology is not available to the beneficiary, the counseling services may be furnished using audio-only telephone calls if all other applicable requirements are met.

(4) Individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law), including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. During a Public Health Emergency, as defined in § 400.200 of this chapter, or for services furnished after the end of such emergency, in cases where audio/video communication technology is not available to the beneficiary, the therapy Start Printed Page 65665 services may be furnished using audio-only telephone calls if all other applicable requirements are met. * * * * * (d) * * * (4) * * * (ii) The payment amounts for the non-drug component of the bundled payment for an episode of care, the adjustments for counseling or therapy, intake activities, periodic assessments, and the non-drug component of the adjustment for take-home supplies of opioid antagonist medications will be geographically adjusted using the Geographic Adjustment Factor described in § 414.26 of this subchapter. (iii) The payment amounts for the non-drug component of the bundled payment for an episode of care, the adjustments for counseling or therapy, intake activities, periodic assessments, and the non-drug component of the adjustment for take-home supplies of opioid antagonist medications will be updated annually using the Medicare Economic Index described in § 405.504(d) of this subchapter.

(5) Payment for medications delivered, administered or dispensed to a beneficiary as part of the bundled payment or an adjustment to the bundled payment under paragraph (d)(4)(i) of this section is considered a duplicative payment if a claim for delivery, administration or dispensing of the same medications for the same beneficiary on the same date of service was also separately paid under Medicare Part B or Part D. CMS will recoup the duplicative payment made to the opioid treatment program. (6) For purposes of the adjustment to the bundled payment under paragraph (d)(4)(i)(A) of this section, after the end of the Public Health Emergency as defined in § 400.200 of this chapter, when services are furnished using audio-only technology the practitioner must certify, in a form and manner specified by CMS, that they had the capacity to furnish the services using two-way, audio/video communication technology, but used audio-only technology because audio/video communication technology was not available to the beneficiary. * * * * * Start Amendment Part24.

Add § 410.72 to read as follows. End Amendment Part Registered dietitians' and nutrition professionals' services. (a) Definition. Registered dietitians and nutrition professionals.

Meet the qualifications at § 410.134. (b) Covered registered dietitian and nutrition professional services. Medicare Part B covers. (1) Coverage condition.

Medical nutrition therapy (MNT) services as defined at § 410.130 under the conditions of coverage at § 410.132. (2) Other services. Registered dietitians and nutrition professionals may also provide diabetes self-management (DSMT) services if they are or represent an accredited DSMT entity and have an order from a physician or qualified nonphysician practitioner who is treating the patient's diabetic condition. (3) Limits on MNT and DSMT.

(i) DSMT and MNT cannot be furnished to a patient on the same date of service, and (ii) MNT and DSMT services cannot be furnished incident to the professional services of a physician or nonphysician practitioner service. (c) Limitations. The following services are not registered dietitian or nutrition professional services for purposes of billing Medicare Part B. (1) Services furnished by a registered dietitian or nutrition professional to an inpatient of a Medicare-participating hospital.

(2) Services furnished by a registered dietitian or nutrition professional to an inpatient of a Medicare-participating SNF. (3) Services furnished by a registered dietitian or nutrition professional to a patient in a Medicare-participating ESRD facility in accordance with the limitation on coverage of MNT service listed at § 410.132(b)(1). (d) Professional services. Registered dietitians and nutrition professionals can be paid for professional services only when the services have been directly performed by them.

(e) Telehealth services. MNT and DSMT services may be provided as telehealth services (meeting the requirements in § 410.78) when registered dietitians or nutrition professionals act as distant site practitioners. (f) Restrictions. The services of a registered dietitian or nutrition professional are provided on an assignment-related basis, and a registered dietitian or nutrition professional may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55.

If a beneficiary has made payment for a service in excess of these limits, the registered dietitian or nutrition professional must refund the full amount of the impermissible charge to the beneficiary. Start Amendment Part25. Amend § 410.74 by revising paragraphs (a)(2)(v) and (d)(2) to read as follows. End Amendment Part Physician assistants' services.

(a) * * * (2) * * * (v) Prior to January 1, 2022, furnishes services that are billed by the employer of a physician assistant. And * * * * * (d) * * * (2) The services of a physician assistant are provided on an assignment-related basis, and the physician assistant may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the physician assistant must refund the full amount of the impermissible charge to the beneficiary. * * * * * Start Amendment Part26.

Amend § 410.75 by revising paragraph (e)(2) to read as follows. End Amendment Part Nurse practitioners' services. * * * * * (e) * * * (2) The services of a nurse practitioner are provided on an assignment-related basis, and the nurse practitioner may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the nurse practitioner must refund the full amount of the impermissible charge to the beneficiary.

* * * * * Start Amendment Part27. Amend § 410.76 by revising paragraph (e)(2) to read as follows. End Amendment Part Clinical nurse specialists' services. * * * * * (e) * * * (2) The services of a clinical nurse specialist are provided on an assignment-related basis, and the clinical nurse specialist may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55.

If a beneficiary has made payment for a service in excess of these limits, the clinical nurse specialist must refund the full amount of the impermissible charge to the beneficiary. * * * * * Start Amendment Part28. Amend § 410.77 by revising paragraph (d)(2) to read as follows. End Amendment Part Certified nurse-midwives' services.

Qualifications and conditions. * * * * * (d) * * * (2) The services of a certified nurse-midwife are provided on an assignment-related basis, and the certified nurse-midwife may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made Start Printed Page 65666 payment for a service in excess of these limits, the certified nurse-midwife must refund the full amount of the impermissible charge to the beneficiary. * * * * * Start Amendment Part29.

Amend 410.78 by revising paragraph (a)(3) and adding paragraphs (b)(3)(xiii) and (xiv) and (b)(4)(iv)(D) to read as follows. End Amendment Part Telehealth services. (a) * * * (3) Interactive telecommunications system means, except as otherwise provided in this paragraph, multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. For services furnished for purposes of diagnosis, evaluation, or treatment of a mental health disorder to a patient in their home, interactive telecommunications may include two-way, real-time audio-only communication technology if the distant site physician or practitioner is technically capable to use an interactive telecommunications system as defined in the previous sentence, but the patient is not capable of, or does not consent to, the use of video technology.

A modifier designated by CMS must be appended to the claim for services described in this paragraph to verify that these conditions have been met. * * * * * (b) * * * (3) * * * (xiii) A rural emergency hospital (as defined in section 1861(kkk)(2) of the Act), for services furnished on or after January 1, 2023. (xiv) The home of a beneficiary for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder for services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200 except as otherwise provided in this paragraph. Payment will not be made for a telehealth service furnished under this paragraph unless the following conditions are met.

(A) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service. (B) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, at least once within 12 months of each subsequent telehealth service described in this paragraph, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens associated with an in-person service outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reason(s) for this decision in the patient's medical record. (C) The requirements of paragraphs (b)(3)(xiv)(A) and (B) may be met by another physician or practitioner of the same specialty and subspecialty in the same group as the physician or practitioner who furnishes the telehealth service, if the physician or practitioner who furnishes the telehealth service described under this paragraph is not available. (4) * * * (iv) * * * (D) Services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200 for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder.

Payment will not be made for a telehealth service furnished under this paragraph unless the physician or practitioner has furnished an item or service in person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service and within 6 months of any subsequent telehealth service. * * * * * Start Amendment Part30. Amend § 410.79 by revising paragraphs (c)(1)(ii) and (e)(3)(v)(C) to read as follows. End Amendment Part Medicare Diabetes Prevention Program expanded model.

Conditions of coverage. * * * * * (c) * * * (1) * * * (ii) An MDPP beneficiary is eligible for the first ongoing maintenance session interval only if the beneficiary. (A) Starts his or her first core session on or before December 31, 2021. (B) Attends at least one in-person core maintenance session during the final core maintenance session interval.

And (C) Achieves or maintains the required minimum weight loss at a minimum of one in-person core maintenance session during the final core maintenance session interval. * * * * * (e) * * * (3) * * * (v) * * * (C) Beneficiaries who began the set of MDPP services between January 1, 2021 and December 31, 2021 and who are in the second year of the set of MDPP services as of the start of an applicable 1135 waiver event, whose in-person sessions are suspended due to the applicable 1135 waiver event, and who elect not to continue with MDPP services virtually can elect to attend ongoing maintenance sessions. And may restart the ongoing maintenance session interval in which they were participating at the start of the applicable 1135 waiver event or may resume with the most recent attendance session of record. * * * * * Start Amendment Part31.

Amend § 410.105 by revising paragraph (d)(3)(ii) and adding paragraphs (d)(3)(iii) and (iv) to read as follows. End Amendment Part Requirements for coverage of CORF services. * * * * * (d) * * * (3) * * * (ii) Except as provided in paragraph (d)(3)(iii) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service, separately from the part furnished by the physical or occupational therapist such that the minutes for that portion of a service (or unit of a service) exceed 10 percent of the total time for that service (or unit of a service). (iii) Paragraph (d)(3)(ii) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day when the physical or occupational therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the physical therapist assistant or occupational therapy assistant.

(iv) Where there are two remaining 15-minute units to bill of the same service and the physical therapist and the physical therapist assistant or the occupational therapist and the occupational therapy assistant, as applicable, each provided between 9 and 14 minutes, with a total time of at least 23 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the physical therapist assistant or occupational therapy assistant and one unit is billed without the prescribed modifier for the service provided by the Start Printed Page 65667 physical therapist or occupational therapist. Start Amendment Part32. Amend § 410.130 by revising the definition of “Chronic renal insufficiency” and removing the definition of “Treating physician”. End Amendment Part The revision reads as follows.

Definitions. * * * * * Chronic renal insufficiency means the stage of renal disease associated with a reduction in renal function not severe enough to require dialysis or transplantation (glomerular fiation rate [GFR] 15-59 ml/min/1.73m 2 ). * * * * * Start Amendment Part33. Amend § 410.132 by revising paragraphs (a), (b)(5), and (c) to read as follows.

End Amendment Part Medical nutrition therapy. (a) Conditions for coverage of MNT services. Medicare Part B pays for MNT services provided by a registered dietitian or nutrition professional as defined in § 410.134 when the beneficiary is referred for the service by a physician. (b) * * * (5) An exception to the maximum number of hours in paragraphs (b)(2), (3), and (4) of this section may be made when a physician determines that there is a change of diagnosis, medical condition, or treatment regimen related to diabetes or renal disease that requires a change in MNT during an episode of care.

(c) Referrals. Referral may only be made by a physician when the beneficiary has been diagnosed with diabetes or renal disease as defined in this subpart with documentation noted by a referring physician in the beneficiary's medical record. Start Amendment Part34. Amend § 410.150 by revising paragraph (b)(15) to read as follows.

End Amendment Part To whom payment is made. * * * * * (b) * * * (15)(i) Prior to January 1, 2022, to the qualified employer of a physician assistant for professional services furnished by the physician assistant and for services and supplies provided incident to his or her services. Payment is made to the employer of a physician assistant regardless of whether the physician assistant furnishes services under a W-2, employer-employee employment relationship, or whether the physician assistant is an independent contractor who receives a 1099 reflecting the relationship. Both types of relationships must conform to the appropriate guidelines provided by the Internal Revenue Service.

A qualified employer is not a group of physician assistants that incorporate to bill for their services. Payment is made only if no facility or other provider charges or is paid any amount for services furnished by a physician assistant. (ii) Effective on or after January 1, 2022, payment is made to a physician assistant for professional services furnished by a physician assistant in all settings in both rural and nonrural areas and for services and supplies furnished incident to those services. Payment is made only if no facility or other provider charges, or is paid, any amount for the furnishing of professional services of the physician assistant.

* * * * * Start Amendment Part35. Amend § 410.152 by revising paragraphs (l) introductory text and (l)(5) to read as follows. End Amendment Part Amounts of payment. * * * * * (l) Amount of payment.

Preventive services. Except as provided otherwise in this paragraph, Medicare Part B pays 100 percent of the Medicare payment amount established under the applicable payment methodology for the service furnished by a provider or supplier for the following preventive services. * * * * * (5) Colorectal cancer screening tests (excluding barium enemas). (i) For the colorectal cancer screening tests described in § 410.37(j), Medicare Part B pays at the specified percentage as follows.

(A) 80 percent for CY 2022. (B) 85 percent for CY 2023 through 2026. (C) 90 percent for 2027 through 2029. (D) 100 percent beginning January 1, 2030.

(ii) [Reserved] * * * * * Start Part End Part Start Amendment Part36. The authority citation for part 411 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn.

End Authority Start Amendment Part37. Amend § 411.351 by revising the definition of “List of CPT/HCPCS Codes” to read as follows. End Amendment Part Start Amendment Part38. Amend § 411.354 by revising paragraphs (c)(2)(ii)(A) through (C) to read as follows.

End Amendment Part Financial relationship, compensation, and ownership or investment interest. * * * * * (c) * * * (2)* * * (ii) * * * (A)( 1 ) The referring physician (or immediate family member) receives aggregate compensation from the person or entity in the chain with which the physician (or immediate family member) has a direct financial relationship that varies with the volume or value of referrals or other business generated by the referring physician for the entity furnishing the DHS. And ( 2 ) The amount of compensation that the physician (or immediate family member) receives per individual unit— ( i ) Is not fair market value for items or services actually provided. ( ii ) Could increase as the number or value of the physician's referrals to the entity furnishing DHS increases, or could decrease as the number or value of the physician's referrals to the entity decreases.

( iii ) Could increase as the amount or value of the other business generated by the physician for the entity furnishing DHS increases, or could decrease as the amount or value of the other business generated by the physician for the entity furnishing DHS decreases. Or ( iv ) Is payment for the lease of office space or equipment or for the use of premises or equipment. (B) For purposes of applying paragraph (c)(2)(ii)(A)( 2 ) of this section, the individual unit is. ( 1 ) Item, if the physician (or immediately family member) is compensated solely per item provided.

( 2 ) Service, if the physician (or immediate family member) is compensated solely per service provided, which includes arrangements where the “service” provided includes both items and services. ( 3 ) Time, if the conditions of paragraph (c)(2)(ii)(B)(1) or ( 2 ) of this section are not met. (C) If the financial relationship between the physician (or immediate family member) and the person or entity Start Printed Page 65668 in the chain with which the referring physician (or immediate family member) has a direct financial relationship is an ownership or investment interest, the nonownership or noninvestment interest closest to the referring physician (or immediate family member) is used to determine whether the aggregate compensation varies with the volume or value of referrals or other business generated by the referring physician for the entity furnishing the DHS and whether the amount of compensation that the physician (or immediate family member) receives per individual unit meets the conditions in paragraph (c)(2)(ii)(A)( 2 ) of this section. (For example, if a referring physician has an ownership interest in company A, which owns company B, which has a compensation arrangement with company C, which has a compensation arrangement with entity D that furnishes DHS, we would look to the aggregate compensation between company B and company C for purposes of this paragraph (c)(2)(ii).

* * * * * Start Amendment Part39. Amend § 411.355 by revising paragraph (h) to read as follows. End Amendment Part General exceptions to the referral prohibition related to both ownership/investment and compensation. * * * * * (h) Preventive screening tests and treatments.

(1) Preventive screening tests and treatments that meet the following conditions. (i) The preventive screening test or treatment is listed on the List of CPT/HCPCS Codes as a code to which the exception in this paragraph is applicable. (ii) The preventive screening test or treatment is covered by Medicare. (iii) The preventive screening test or treatment is subject to a CMS-mandated frequency limit.

(2) During such period as the treatment is not subject to a CMS-mandated frequency limit, paragraph (h)(1)(iii) of this section does not apply to a buy antibiotics treatment identified on the List of CPT/HCPCS Codes as a code to which the exception in this paragraph is applicable. * * * * * Start Part End Part Start Amendment Part40. The authority citation for part 414 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302, 1395hh, and 1395rr(b)(l). End Authority Start Amendment Part41. Amend § 414.64 by revising paragraph (a) to read as follows. End Amendment Part Payment for medical nutrition therapy.

(a) Payment under the physician fee schedule. Medicare payment for medical nutrition therapy is made under the physician fee schedule in accordance with subpart B of this part. Payment to nonphysician professionals, as specified in paragraph (b) of this section, is 80 percent (or 100 percent if such services are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual) of the lesser of the actual charges or 85 percent of the physician fee schedule amount. * * * * * Start Amendment Part42.

Amend § 414.84— End Amendment Part Start Amendment Parta. By revising paragraphs (b)(1)(i). End Amendment Part Start Amendment Partb. In paragraph (b)(1)(ii), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Partc. By revising paragraph (b)(2)(i). End Amendment Part Start Amendment Partd. In paragraph (b)(2)(ii), by removing the reference CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Parte. By revising paragraph (b)(3)(i). End Amendment Part Start Amendment Partf. In paragraph (b)(3)(ii), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Partg. By revising paragraph (b)(4)(i)(A). End Amendment Part Start Amendment Parth. In paragraph (b)(4)(i)(B), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Parti. By revising paragraph (b)(4)(ii)(A). End Amendment Part Start Amendment Parth. In paragraph (b)(4)(ii)(B), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

And End Amendment Part Start Amendment Partj. By revising paragraphs (b)(5), (b)(6)(i), (b)(7)(i) and (ii), and (c). End Amendment Part The revisions read as follows. Payment for MDPP Services.

* * * * * (b) * * * (1) * * * (i) For a first core session furnished January 1, 2022, through December 31, 2022 the amount is $35. * * * * * (2) * * * (i) For the fourth core session furnished January 1, 2022, through December 31, 2022 the amount is $105. * * * * * (3) * * * (i) For the ninth core session furnished January 1, 2022, through December 31, 2022 the amount is $175. * * * * * (4) * * * (i) * * * (A) For a second core maintenance session January 1, 2022, through December 31, 2022 the amount is $93.

* * * * * (ii) * * * (A) For a second core maintenance session January 1, 2022, through December 31, 2022 the amount is $75. * * * * * (5) Performance Goal 5. Attends two ongoing maintenance sessions and maintains the required minimum weight loss during an ongoing maintenance session interval. For an MDPP beneficiary who attends his or her first core session on or before December 31, 2021, CMS makes a performance payment to an MDPP supplier if an MDPP beneficiary attends two ongoing maintenance sessions during an ongoing maintenance session interval, achieves attendance at that second ongoing maintenance session upon attendance at an ongoing maintenance session furnished by that supplier, and achieves or maintains the required minimum weight loss as measured in-person during an ongoing maintenance session furnished during the applicable ongoing maintenance session interval.

CMS makes this performance payment to an MDPP supplier only once per MDPP beneficiary per ongoing maintenance session interval. The amount of this performance payment is determined as follows. (i) For a second ongoing maintenance session furnished in interval 1 (months 13-15 of the MDPP services period), January 1, 2022, through December 31, 2022, the amount is $52. (ii) For a second ongoing maintenance session furnished in interval 2 (months 16-18 of the MDPP services period), January 1, 2022, through December 31, 2022, the amount is $52.

(iii) For a second ongoing maintenance session furnished in interval 3 (months 19-21 of the MDPP services period), January 1, 2022, through December 31, 2022, the amount is $53. (iv) For a second ongoing maintenance session furnished in interval 4 (months 22-24 of the MDPP services period), January 1, 2022, through December 31, 2022 the amount is $53. (v) For a second ongoing maintenance session furnished during a subsequent year. The performance payment amount specified in this paragraph, adjusted as specified in paragraph (d) of this section.

(6) * * * (i) For a core session or core maintenance session, as applicable, furnished January 1, 2022, through December 31, 2022, the amount is $169. * * * * * (7) * * * (i) For a core session or core maintenance session, as applicable, Start Printed Page 65669 furnished January 1, 2022, through December 31, 2022, the amount is $35. (ii) For a core session or core maintenance session, as applicable, furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph, adjusted as specified in paragraph (d) of this section.

(c) Bridge payment. CMS makes a bridge payment to an MDPP supplier only for a core session or core maintenance session furnished to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier. An MDPP supplier that has previously been paid either a bridge payment or a performance payment for an MDPP beneficiary is not eligible to be paid a bridge payment for that beneficiary. A bridge payment is made only on an assignment-related basis in accordance with § 424.55 of this subchapter, and MDPP suppliers must accept the Medicare allowed charge as payment in full and may not bill or collect from the beneficiary any amount.

CMS will make a bridge payment only to an MDPP supplier that complies with all applicable enrollment and program requirements, and only for MDPP services furnished by an eligible coach, on or after his or her coach eligibility start date and, if applicable, before his or her coach eligibility end date. As a condition of payment, the MDPP supplier must report the NPI of the coach who furnished the session on the claim for the MDPP session. The amount of the bridge payment is determined as follows. (1) For core session or core maintenance session, as applicable, furnished January 1, 2022, through December 31, 2022, the amount is $35.

(2) For core session and core maintenance session, as applicable, furnished during a calendar year subsequent to CY 2022. The bridge payment amount specified in this paragraph, adjusted as specified in paragraph (d) of this section. * * * * * Start Amendment Part43. Amend § 414.626 by revising paragraphs (b)(1) and (f) to read as follows.

End Amendment Part Data reporting by ground ambulance organizations. * * * * * (b) * * * (1) Within 30 days of the date that CMS notifies a ground ambulance organization under paragraph (c)(3) of this section that it has selected the ground ambulance organization to report data under this section, the ground ambulance organization must select a data collection period that corresponds with its annual accounting period and provide the start date of that data collection period to CMS or its contractor. * * * * * (f) Public availability of data. Beginning in 2024, and at least once every 2 years thereafter, CMS will post on its website data that it collected under this section, including but not limited to summary statistics and ground ambulance organization characteristics.

* * * * * Start Amendment Part44. Amend § 414.802 by revising the definition of “Drug” to read as follows. End Amendment Part Definitions. * * * * * Drug means a drug or a biological, and for purposes of applying section 1847A(f) of the Act, includes an item, service, supply, or product that is payable under Medicare Part B as a drug or biological.

* * * * * Start Amendment Part45. Section 414.806 is revised to read as follows. End Amendment Part Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data. (a) Misrepresentation.

Section 1847A(d)(4)(A) of the Act specifies the penalties associated with misrepresentations in the reporting of the manufacturer's average sales price for a drug as defined at § 414.802. (b) Failure to provide timely information or the submission of false information. (1) For a manufacturer that has entered into and has in effect a rebate agreement under section 1927 of the Act, section 1927(b)(3)(C) of the Act specifies the penalties associated with a manufacturer's failure to submit timely information or the submission of false information. (2) For a manufacturer that has not entered into and does not have in effect a rebate agreement under section 1927 of the Act, sections 1847A(d)(4)(B) and (C) of the Act specify the penalties associated with a manufacturer's failure to submit timely information or the submission of false information.

Start Amendment Part46. Amend § 414.904 by adding paragraph (d)(4) to read as follows. End Amendment Part Average sales price as the basis for payment. * * * * * (d) * * * (4) Payment adjustment for certain drugs for which there is a self-administered version —(i) In general.

Except as provided in paragraphs (d)(4)(ii) and (iii) of this section, if the Inspector General identifies a drug or biological product in a study described in section 1847A(g)(1) of the Act, the Secretary must apply the payment limit for the applicable billing and payment code as specified in paragraph (d)(4)(iv) of this section, beginning with the first day of the second quarter after such study is publicly available. The methodology described in this paragraph will be recalculated each quarter thereafter, except when conditions described in paragraph (d)(4)(ii) are met. (ii) Exception. The adjustment described in paragraph (d)(4)(i) of this section does not apply to the payment limit for a billing and payment code for a quarter if, at the time that ASP calculations are finalized for such quarter, the drug in the dosage form described by the billing and payment code is included by the FDA on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act.

(iii) Special rule for certain billing and payment codes. Effective July 1, 2021, for a billing and payment code described under section 1847A(g)(3) of the Act, the payment limit for the applicable billing and payment code must be determined as described in paragraph (d)(4)(iv) of this section, and the exception specified at paragraph (d)(4)(ii) of this section does not apply. (iv) Lesser-of methodology. For purposes of this section, the payment limit is the lesser of.

(A) The payment limit determined under section 1847A of the Act for such billing and payment code if each National Drug Code for such product so identified under section 1847A(g)(1) of the Act were excluded from such determination. And (B) The payment limit otherwise determined under section 1847A of the Act for such billing and payment code without application of section 1847A(g) of the Act. (v) NDC changes. For an Inspector General-identified National Drug Code, as described under section 1847A(g)(1) or (3) of the Act, for which the manufacturer has redesignated the National Drug Code (without changes to the dosage form), the application of the lesser-of methodology described in this paragraph must use manufacturer-reported ASP data associated with the redesignated National Drug Code in the same manner as the one originally identified by the Inspector General.

* * * * * Start Amendment Part47. Amend § 414.1300 by revising paragraphs (a)(2) and (3) to read as follows. End Amendment Part Start Printed Page 65670 Basis and scope. (a) * * * (2) Section 1848(k)—Quality Reporting System.

(3) Section 1848(m)—Incentive Payments for Quality Reporting. * * * * * Start Amendment Part48. Amend § 414.1305— End Amendment Part Start Amendment Parta. By revising the definitions of “Collection type” and “Meaningful EHR user for MIPS”.

End Amendment Part Start Amendment Partb. In the definition of “MIPS determination period”, by revising paragraph (2). End Amendment Part Start Amendment Partc. In the definition of “MIPS eligible clinician”, by revising the introductory text, paragraph (2) introductory text, and adding paragraph (3).

End Amendment Part Start Amendment Partd. By adding the definitions of “Multispecialty group”, “MVP participant”, “Population health measure”, “QCDR measure”, “Single specialty group”, “Special status” and “Subgroup” in alphabetical order. And End Amendment Part Start Amendment Parte. By revising the definition of “Submission type”.

End Amendment Part The revisions and additions read as follows. Definitions. * * * * * Collection type means a set of quality measures with comparable specifications and data completeness criteria, as applicable, including, but not limited to. Electronic clinical quality measures (eCQMs).

MIPS clinical quality measures (MIPS CQMs). QCDR measures. Medicare Part B claims measures. CMS Web Interface measures (except as provided in paragraph (1) of this definition, for the CY 2017 through CY 2022 performance periods/2019 through 2024 MIPS payment years).

The CAHPS for MIPS survey. And administrative claims measures. (1) For the CY 2021 through CY 2024 performance periods/2023 through 2026 MIPS payment years, collection types include CMS Web Interface measures for APM Entities reporting through the APM Performance Pathway in accordance with § 414.1367. (2) [Reserved] * * * * * Meaningful EHR user for MIPS means a MIPS eligible clinician who possesses CEHRT, uses the functionality of CEHRT, reports on applicable objectives and measures specified for the Promoting Interoperability performance category for a performance period in the form and manner specified by CMS, does not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of CEHRT, and engages in activities related to supporting providers with the performance of CEHRT.

* * * * * MIPS determination period means. * * * (2) Subject to § 414.1310(b)(1)(iii), an individual eligible clinician, group, or APM Entity group that is identified as not exceeding the low-volume threshold or as having special status, as applicable, during the first segment of the MIPS determination period will be identified as such for the applicable MIPS payment year regardless of the results of the second segment of the MIPS determination period. An individual eligible clinician, group, or APM Entity group for which the unique billing TIN and NPI combination is established during the second segment of the MIPS determination period will be assessed based solely on the results of such segment. MIPS eligible clinician as identified by a unique billing TIN and NPI combination used to assess performance, means any of the following (except as excluded under § 414.1310(b)).

* * * * * (2) For the 2021 through 2023 MIPS payment years. * * * * * (3) For the 2024 MIPS payment year and future years. (i) A clinician described in paragraph (2) of this definition. (ii) A clinical social worker (as defined in section 1861(hh)(1) of the Act).

(ii) A certified nurse midwife (as defined in section 1861(gg)(2) of the Act). And (vii) A group that includes such clinicians. * * * * * Multispecialty group means a group that consists of two or more specialty types. MVP participant means an individual MIPS eligible clinician, multispecialty group, single-specialty group, subgroup, or APM Entity that is assessed on an MVP in accordance with § 414.1365 for all MIPS performance categories.

For the CY 2026 performance period/2028 MIPS payment year and future years, MVP Participant means an individual MIPS eligible clinician, single-specialty group, subgroup, or APM Entity that is assessed on an MVP in accordance with § 414.1365 for all MIPS performance categories. * * * * * Population health measure means a quality measure that indicates the quality of a population or cohort's overall health and well-being, such as access to care, clinical outcomes, coordination of care and community services, health behaviors, preventive care and screening, health equity, or utilization of health services. * * * * * QCDR measure means a quality measure that is submitted by a QCDR and approved by CMS under § 414.1400. QCDR measures consist of.

(1) Measures that are not included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year. And (2) Measures that are included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year, but have undergone substantive changes, as determined by CMS. * * * * * Single specialty group means a group that consists of one specialty type. * * * * * Special status means that a MIPS eligible clinician.

(1) Meets the definition of an ASC-based MIPS eligible clinician, facility-based MIPS eligible clinician, hospital-based MIPS eligible clinician, non-patient facing MIPS eligible clinician, or is in a small practice. Or (2) Is located in an HPSA or rural area. Subgroup means a subset of a group which contains at least one MIPS eligible clinician and is identified by a combination of the group TIN, subgroup identifier, and each eligible clinician's NPI. Submission type means the mechanism by which the submitter type submits data to CMS, including, but not limited to.

(1) Direct. (2) Log in and upload. (3) Log in and attest. (4) Medicare Part B claims.

And (5) CMS Web Interface (except as provided in paragraph (5)(i) of this definition, for the CY 2017 through CY 2022 performance periods/2019 through 2024 MIPS payment years). (i) For the CY 2021 through CY 2024 performance periods/2023 through 2026 MIPS payment years, submission types include the CMS Web Interface for APM Entities reporting through the APM Performance Pathway in accordance with § 414.1367. (ii) [Reserved] * * * * * Start Amendment Part49. Amend § 414.1310 by revising paragraph (e)(1) to read as follows.

End Amendment Part Applicability. * * * * * (e) * * * Start Printed Page 65671 (1) Except as provided under §§ 414.1315(a)(2), 414.1317(b), 414.1318(b), and 414.1370(f)(2) each MIPS eligible clinician in the group receives a final score based on the group's combined performance assessment. * * * * * Start Amendment Part50. Amend § 414.1317 by revising paragraph (b)(2) to read as follows.

End Amendment Part APM Entity groups. * * * * * (b) * * * (2) Performance category weights. The cost performance category weight is zero percent of the final score for an APM Entity. The performance category reweighting scenarios under § 414.1380(c)(2) apply to an APM Entity.

* * * * * Start Amendment Part51. Section 414.1318 is added to subpart O to read as follows. End Amendment Part Subgroups. (a) Eligibility and special status —(1) General.

Except as provided under paragraph (a)(2) of this section, for a MIPS payment year, determinations of meeting the low-volume threshold criteria and special status for subgroups are determined at the group level in accordance with §§ 414.1305 and 414.1310. (2) Exclusions. An individual eligible clinician or group that elects to participate in MIPS as a MIPS eligible clinician in accordance with § 414.1310(b)(1)(iii)(A) or (b)(2) is not eligible to participate in a subgroup. (b) Final score.

Except as provided under § 414.1317(b), each MIPS eligible clinician in the subgroup receives a final score based on the subgroup's combined performance assessment. (c) Subgroup reporting requirements. For individual eligible clinicians to participate in MIPS as a subgroup, all of the following requirements must be met. (1) Individual eligible clinicians that elect to participate in MIPS as a subgroup must aggregate their quality and improvement activities performance data across the subgroup's identifier.

(2) Individual eligible clinicians that elect to participate in MIPS as a subgroup will have their performance assessed at the subgroup level across all the MIPS performance categories based on an MVP in accordance with § 414.1365 and on the APM Performance Pathway in accordance with § 414.1367, as applicable. Subgroups that are MVP Participants must adhere to an election process described in § 414.1365(b). Start Amendment Part52. Amend § 414.1320 by— End Amendment Part Start Amendment Parta.

Redesignating paragraphs (d) through (g) as paragraphs (e) through (h), respectively. And End Amendment Part Start Amendment Partb. Adding a new paragraph (d). End Amendment Part The addition reads as follows.

MIPS performance period. * * * * * (d) For purposes of the CY 2020 performance period/2022 MIPS payment year, the performance period for. (1) The quality and cost performance categories are the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year. (2) The improvement activities performance categories are a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year.

* * * * * Start Amendment Part53. Amend § 414.1325 by revising paragraph (c)(1) to read follows. End Amendment Part Data submission requirements. * * * * * (c) * * * (1) For the quality performance category, the direct.

Login and upload. Medicare Part B claims (beginning with the CY 2019 MIPS performance period/2021 MIPS payment year, for small practices only). And CMS Web Interface (for groups consisting of 25 or more eligible clinicians, a third party intermediary submitting on behalf of a group) submission type. * * * * * Start Amendment Part54.

Amend § 414.1340 revising paragraphs (a)(3) and (b)(3) to read as follows. End Amendment Part Data completeness criteria for the quality performance category. (a) * * * (3) At least 70 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for MIPS payment years 2022, 2023, 2024, and 2025. * * * * * (b) * * * (3) At least 70 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment years 2022, 2023, 2024, and 2025.

* * * * * Start Amendment Part55. Amend § 414.1350 by revising paragraph (c)(4) and adding paragraph (c)(6) to read as follows. End Amendment Part Cost performance category. * * * * * (c) * * * (4) For the procedural episode-based measures specified beginning with the CY 2019 performance period/2021 MIPS payment year, the case minimum is 10, unless otherwise specified for individual measures.

Beginning with the CY 2022 performance period/2024 MIPS payment year, the case minimum for Colon and Rectal Resection procedural episode-based measure is 20 episodes. * * * * * (6) For the chronic condition episode-based measures specified beginning with the CY 2022 performance period/2024 MIPS payment year, the case minimum is 20. * * * * * Start Amendment Part56. Amend § 414.1360 by revising paragraph (a)(2) to read as follows.

End Amendment Part Data submission criteria for the improvement activities performance category. (a) * * * (2) Groups and virtual groups. Beginning with the 2022 performance year, each improvement activity for which groups and virtual groups submit a yes response in accordance with paragraph (a)(1) of this section must be performed by at least 50 percent of the NPIs that are billing under the group's TIN or virtual group's TINs or that are part of the subgroup, as applicable. And the NPIs must perform the same activity during any continuous 90-day period within the same performance year.

* * * * * Start Amendment Part57. Section 414.1365 is added to subpart O to read as follows. End Amendment Part MIPS Value Pathways. (a) General.

(1) Beginning with the CY 2023 MIPS performance period/2025 MIPS payment year, CMS uses MVPs included in the MIPS final inventory of MVPs established by CMS through rulemaking to assess performance for the quality, cost, improvement activities, and Promoting Interoperability performance categories. (2) [Reserved] (b) MVP/Subgroup registration. (1) To report an MVP, an MVP Participant must register for the MVP, and if applicable, as a subgroup during a period that begins on April 1 and ends on November 30 of the applicable CY performance period or a later date specified by CMS. To report the CAHPS for MIPS survey associated with an MVP, a group, subgroup or APM Entity must complete their registration by June 30 of such performance period or a later date specified by CMS.

Start Printed Page 65672 (2) At the time of registration, the MVP Participant must submit the following information, as applicable. (i) Each MVP Participant must select an MVP, 1 population health measure included in the MVP, and any outcomes-based administrative claims measure on which the MVP Participant intends to be scored. (ii) Each subgroup must submit a list of each TIN/NPI associated with the subgroup and a plain language name for the subgroup. (c) MVP reporting requirement s—(1) Quality.

Except as provided in paragraph (c)(1)(i) of this section, an MVP Participant must select and report, if applicable, 4 quality measures, including 1 outcome measure (or, if an outcome measure is not available, 1 high priority measure), included in the MVP, excluding the population health measure required under paragraph (c)(4)(ii) of this section. (i) Paragraph (c)(1) introductory text of this section does not apply to a small practice that reports on an MVP that includes fewer than 4 Medicare Part B claims measures, provided that the small practice reports each such measure that is applicable. (ii) [Reserved] (2) Cost. An MVP Participant is scored on the cost measures included in the MVP that they select and report.

(3) Improvement activities. An MVP Participant who reports an MVP, must report one of the following. (i) Two medium-weighted improvement activities. (ii) One high-weighted improvement activity.

(iii) Participation in a certified or recognized patient-centered medical home (PCMH) or comparable specialty practice, as described at § 414.1380(b)(3)(ii). (4) Foundational layer —(i) Promoting interoperability. An MVP Participant is required to meet the Promoting Interoperability performance category reporting requirements described at § 414.1375(b). (A) For the CY 2023 and 2024 performance periods/2025 and 2026 MIPS payment years, an MVP Participant that is a subgroup is required to submit its affiliated group's data for the Promoting Interoperability performance category.

(B) [Reserved] (ii) Population health measures. Each MVP Participant is scored on 1 population health measure in accordance with paragraph (d)(1) of this section. (d) MVP scoring —(1) General. An MVP Participant that is not an APM Entity is scored on measures and activities included in the MVP in accordance with paragraphs (d)(1) through (3) of this section.

An MVP Participant that is an APM Entity is scored on measures and activities included in the MVP in accordance with § 414.1317(b). (2) Performance standards. Unless otherwise indicated in this paragraph (d), the performance standards described at § 414.1380(a)(1)(i) through (iv) apply to the measures and activities included in the MVP. (3) Performance categories.

An MVP Participant is scored under MIPS in four performance categories. (i) Quality performance category. Except as provided in paragraphs (d)(3)(i)(A)(1) and (d)(3)(i)(B) of this section, the quality performance category score for MVP Participants is calculated in accordance with § 414.1380(b)(1) based on measures included in the MVP. (A) Population health measures.

Except as provided in paragraph (d)(3)(i)(A)( 1 ) of this section, each selected population health measure that does not have a benchmark or meet the case minimum requirement is excluded from the MVP participant's total measure achievement points and total available measure achievement points. ( 1 ) Subgroups are scored on each selected population health measure that does not have a benchmark or meet the case minimum requirement based on their affiliated group score, if available. If the subgroup's affiliated group score is not available, each such measure is excluded from the subgroup's total measure achievement points and total available measure achievement points. ( 2 ) [Reserved] (B) Outcomes-based administrative claims measures.

MVP Participants receive zero measure achievement points for each selected outcomes-based administrative claims measure that does not have a benchmark or meet the case minimum requirement. (ii) Cost performance category. The cost performance category score is calculated for an MVP Participant using the methodology at § 414.1380(b)(2)(i) through (v) and the cost measures included in the MVP that they select and report. (iii) Improvement activities performance category.

The improvement activities performance category score is calculated based on the submission of high- and medium-weighted improvement activities. MVP Participants will receive 20 points for each medium-weighted improvement activity and 40 points for each high-weighted improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325 or for participation in a certified or recognized patient-centered medical home (PCMH) or comparable specialty practice, as described at § 414.1380(b)(3)(ii). (iv) Promoting interoperability performance category. The Promoting Interoperability performance category score is calculated for an MVP Participant using the methodology at § 414.1380(b)(4), except as provided in paragraph (d)(3)(iv)(A) of this section.

(A) If a subgroup does not submit its affiliated group's data for the Promoting Interoperability performance category, the subgroup will receive a score of zero for the Promoting Interoperability performance category. (B) [Reserved] (e) Final score calculation. The final score is calculated for an MVP Participant using the methodology at § 414.1380(c), unless otherwise indicated in this paragraph (e). (1) MVP performance category weights.

For an MVP Participant that is not an APM Entity, the final score is calculated using the performance category weights described at § 414.1380(c)(1). For an MVP Participant that is an APM Entity, the final score is calculated using the performance category weights described at § 414.1317(b). (2) Reweighting MVP performance categories —(i) General reweighting. For an MVP Participant that is not an APM Entity, in accordance with paragraph (e)(2)(iii) of this section, a scoring weight different from the weights described at § 414.1380(c)(1) will be assigned to a performance category, and its weight as described at § 414.1380(c)(1) will be redistributed to another performance category or categories, in the circumstances described at § 414.1380(c)(2)(i)(A)(2) through (9) and § 414.1380(c)(2)(i)(C).

For an MVP Participant that is an APM Entity, the performance category weights will be redistributed in accordance with § 414.1317(b). (ii) Subgroups. For an MVP Participant that is a subgroup, any reweighting applied to its affiliated group will also be applied to the subgroup. In addition, if reweighting is not applied to the affiliated group, the subgroup may receive reweighting in the following circumstances independent of the affiliated group.

(A) A subgroup may submit an application to CMS demonstrating that it was subject to extreme and uncontrollable circumstances and receive reweighting in accordance with § 414.1380(c)(2)(i)(A)(6) and (c)(2)(i)(C)(2). In the event that a Start Printed Page 65673 subgroup submits data for a performance category, the scoring weight described at § 414.1380(c)(1) would be applied and its weight would not be redistributed. (B) A subgroup will receive reweighting if CMS determines, based on information known to the agency prior to the beginning of the relevant MIPS payment year, that data for the subgroup are inaccurate, unusable or otherwise compromised due to circumstances outside of the control of the subgroup and its agents, in accordance with § 414.1380(c)(2)(i)(A)(9) and (c)(2)(i)(C)(10). (iii) Reweighting scenarios.

For an MVP Participant that is not an APM Entity, a scoring weight different from the weights described at § 414.1380(c)(1) will be assigned to a performance category, and its weight as described at § 414.1380(c)(1) will be redistributed to another performance category or categories, in accordance with § 414.1380(c)(2)(ii). For an MVP Participant that is an APM Entity, the performance category weights will be redistributed in accordance with § 414.1317(b). (3) Facility-based scoring. If an MVP Participant, that is not an APM Entity, is eligible for facility-based scoring, a facility-based score also will be calculated in accordance with § 414.1380(e).

(4) Complex patient bonus. A complex patient bonus will be added to the final score for an MVP Participant in accordance with § 414.1380(c)(3). Start Amendment Part58. Amend § 414.1375— End Amendment Part Start Amendment Parta.

By revising paragraph (b)(2)(ii). End Amendment Part Start Amendment Partb. By revising the paragraph (b)(3) subject heading. End Amendment Part Start Amendment Partc.

By revising paragraph (b)(3)(ii) introductory text. And End Amendment Part Start Amendment Partc. Adding paragraph (b)(3)(iii). End Amendment Part The revisions and addition read as follows.

Promoting Interoperability (PI) performance category. * * * * * (b) * * * (2) * * * (ii) Beginning with the 2021 MIPS payment year. (A) Report that the MIPS eligible clinician completed the actions included in the Security Risk Analysis measure during the year in which the performance period occurs. (B) For each required measure, as applicable, report the numerator (of at least one) and denominator, or yes/no statement, or an exclusion for each measure that includes an option for an exclusion.

And (C) Beginning with the 2024 MIPS payment year, report that the MIPS eligible clinician completed the actions included in the SAFER Guides measure during the year in which the performance period occurs. (3) Engaging in activities related to supporting providers with the performance of CEHRT. Support for health information exchange and the prevention of information blocking. Actions to limit or restrict the compatibility or interoperability of CEHRT.

* * * * * * * * (ii) Support for health information exchange and the prevention of information blocking. For the 2019, 2020, 2021, 2022, and 2023 MIPS payment years, the MIPS eligible clinician must attest to CMS that he or she— * * * * * (iii) Actions to limit or restrict the compatibility or interoperability of CEHRT. Beginning with the 2024 MIPS payment year, the MIPS eligible clinician must attest to CMS that he or she— (A) Did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology. (B) [Reserved] Start Amendment Part59.

Amend § 414.1380 by— End Amendment Part Start Amendment Parta. Revising paragraphs (b)(1)(i) introductory text and(b)(1)(i)(A)( 1 ). End Amendment Part Start Amendment Partb. Adding paragraphs (b)(1)(i)(A)( 3 ) and (b)(1)(i)(C).

End Amendment Part Start Amendment Partc. Revising paragraphs (b)(1)(iii), (b)(1)(v)(A) introductory text, and (b)(1)(v)(B) introductory text. End Amendment Part Start Amendment Partd. Adding paragraph (b)(1)(v)(B)( 1 )( iii ).

End Amendment Part Start Amendment Parte. Revising paragraphs (b)(1)(vi)(C) introductory text, (b)(1)(vi)(C)( 4 ), (b)(1)(vi)(E), (b)(1)(vii) introductory text, (b)(1)(vii)(A), (b)(2)(iii) introductory text, and (b)(2)(v) introductory text. End Amendment Part Start Amendment Partf. Adding paragraphs (b)(2)(v)(A) and (B).

End Amendment Part Start Amendment Partg. Revising paragraph (b)(4)(ii) introductory text and (b)(4)(ii)(C). End Amendment Part Start Amendment Parth. Revising the table in paragraph (c) introductory text.

End Amendment Part Start Amendment Parti. Revising paragraph (c)(2)(i)(A)( 4 ). End Amendment Part Start Amendment Partj. Removing and reserving paragraph (c)(2)(i)(A)( 5 ).

End Amendment Part Start Amendment Partk. Revising paragraphs (c)(2)(i)(C)( 9 ), (c)(2)(ii)(A), and (c)(2)(ii)(F). End Amendment Part Start Amendment Partl. Adding paragraph (c)(2)(ii)(G).

And End Amendment Part Start Amendment Partm. Revising paragraphs (c)(3) and (e)(6)(iv) through (vi). End Amendment Part The revisions and additions read as follows. Scoring.

* * * * * (b) * * * (1) * * * (i) Measure achievement points. For the CY 2017 through 2021 performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340 and for each administrative claims-based measure that has a benchmark at paragraph (b)(1)(ii) of this section and meets the case minimum requirement at paragraph (b)(1)(iii) of this section. Except as provided under paragraph (b)(1)(i)(C) of this section, beginning with the CY 2023 performance period/2025 MIPS payment year, MIPS eligible clinicians receive between 1 and 10 measure achievement points (including partial points) for each such measure. The number of measure achievement points received for each such measure is determined based on the applicable benchmark decile category and the percentile distribution.

MIPS eligible clinicians receive zero measure achievement points for each measure required under § 414.1335 on which no data is submitted in accordance with § 414.1325. MIPS eligible clinicians that submit data in accordance with § 414.1325 on a greater number of measures than required under § 414.1335 are scored only on the required measures with the greatest number of measure achievement points. Beginning with the CY 2019 performance period/2021 MIPS payment year, MIPS eligible clinicians that submit data in accordance with § 414.1325 on a single measure via multiple collection types are scored only on the data submission with the greatest number of measure achievement points. (A) * * * ( 1 ) Except as provided in paragraphs (b)(1)(i)(A)( 2 ) and ( 3 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 3 measure achievement points for each submitted measure that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement.

Beginning with the CY 2022 performance period/2024 MIPS payment year, MIPS eligible clinicians other than small practices receive 0 measure achievement points Start Printed Page 65674 for each such measure, and small practices receive 3 measure achievement points for each such measure. * * * * * ( 3 ) Beginning with the CY 2023 performance period/2025 MIPS payment year, MIPS eligible clinicians receive 7 measure achievement points for each submitted measure in its first year in MIPS and 5 measure achievement points for each submitted measure in its second year in MIPS that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement. * * * * * (C) New measures. Beginning with the CY 2023 performance period/2025 MIPS payment year, for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340, a MIPS eligible clinician receives between 7 and 10 measure achievement points (including partial points) for each such measure in its first year in MIPS and between 5 and 10 measure achievement points for each such measure in its second year in MIPS.

* * * * * (iii) Minimum case requirements. Except as otherwise specified in the MIPS final list of quality measures described in § 414.1330(a)(1), the minimum case requirement is 20 cases. (v) * * * (A) High priority measures. Subject to paragraph (b)(1)(v)(A)( 1 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 2 measure bonus points for each outcome and patient experience measure and 1 measure bonus point for each other high priority measure.

Beginning with the 2021 MIPS payment year, MIPS eligible clinicians do not receive such measure bonus points for CMS Web Interface measures. * * * * * (B) End-to-end electronic reporting. Subject to paragraph (b)(1)(v)(B)( 1 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 1 measure bonus point for each measure (except claims-based measures) submitted with end-to-end electronic reporting for a quality measure under certain criteria determined by the Secretary. ( 1 ) * * * ( iii ) Beginning in the 2024 MIPS payment year, MIPS eligible clinicians will no longer receive measure bonus for submitting using end-to-end electronic reporting.

* * * * * (vi) * * * (C) The improvement percent score is assessed at the performance category level for the quality performance category and included in the calculation of the quality performance category score as described in paragraph (b)(1)(vii) of this section. * * * * * ( 4 ) Beginning with the CY 2018 performance period/2020 MIPS payment year, we will assume a quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year. * * * * * (E) For the purpose of improvement scoring methodology, the term “improvement percent score” means the score that represents improvement for the purposes of calculating the quality performance category score as described in paragraph (b)(1)(vii) of this section. * * * * * (vii) Quality performance category score.

A MIPS eligible clinician's quality performance category score is the sum of all the measure achievement points assigned for the measures required for the quality performance category criteria plus the measure bonus points in paragraph (b)(1)(v) of this section. The sum is divided by the sum of total available measure achievement points. The improvement percent score in paragraph (b)(1)(vi) of this section is added to that result. The quality performance category score cannot exceed 100 percentage points.

(A) For each measure that is submitted, if applicable, and impacted by significant changes or errors prior to the applicable data submission deadline at § 414.1325(e), performance is based on data for 9 consecutive months of the applicable CY performance period. If such data are not available or CMS determines that they may result in patient harm or misleading results, the measure is excluded from a MIPS eligible clinician's total measure achievement points and total available measure achievement points. For purposes of this paragraph (b)(1)(vii)(A), “significant changes or errors” means changes to or errors in a measure that are outside the control of the clinician and its agents and that CMS determines may result in patient harm or misleading results. Significant changes or errors include, but are not limited to, changes to codes (such as ICD-10, CPT, or HCPCS codes) or the active status of codes, the inadvertent omission of codes or inclusion of inactive or inaccurate codes, or changes to clinical guidelines or measure specifications.

CMS will publish on the CMS website a list of all measures scored under this paragraph (b)(1)(vii)(A) as soon as technically feasible, but by no later than the data submission deadline at § 414.1325(e)(1). * * * * * (2) * * * (iii) The cost performance category score is the sum of the following, not to exceed 100 percent. * * * * * (v) A cost performance category score is not calculated if a MIPS eligible clinician or group is not attributed any cost measures for the performance period because the clinician or group has not met the minimum case volume specified by CMS for any of the cost measures or a benchmark has not been created for any of the cost measures that would otherwise be attributed to the clinician or group. (A) Beginning with the 2024 MIPS payment year, if data used to calculate a score for a cost measure are impacted by significant changes during the performance period, such that calculating the cost measure score would lead to misleading or inaccurate results, then the affected cost measure is excluded from the MIPS eligible clinician's or group's cost performance category score.

For purposes of this paragraph (b)(2)(v)(A), “significant changes” are changes external to the care provided, and that CMS determines may lead to misleading or inaccurate results. Significant changes include, but are not limited to, rapid or unprecedented changes to service utilization, and will be empirically assessed by CMS to determine the extent to which the changes impact the calculation of a cost measure score that reflects clinician performance. (B) [Reserved] * * * * * (4) * * * (ii) Beginning with the 2019 performance period/2021 MIPS payment year, a MIPS eligible clinician's Promoting Interoperability performance category score equals the sum of the scores for each of the required measures and any applicable bonus scores, not to exceed 100 points. * * * * * Start Printed Page 65675 (C) Each optional measure is worth five or ten bonus points, as specified by CMS.

* * * * * (c) * * * Table 1 to Paragraph (c) Introductory TextFor the 2019 MIPS payment year:Final score = [(quality performance category score × quality performance category weight) + (cost performance category score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)], not to exceed 100 points.For the 2020 MIPS payment year:Final score = [(quality performance category score × quality performance category weight) + (cost performance category score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)] × 100 + [the complex patient bonus + the small practice bonus], not to exceed 100 points.Beginning with the 2021 MIPS payment year:Final score = [(quality performance category score × quality performance category weight) + (cost performance category score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)] × 100 + the complex patient bonus, not to exceed 100 points. * * * * * (2) * * * (i) * * * (A) * * * ( 4 ) For the Promoting Interoperability performance category. ( i ) For the 2021 through 2024 MIPS payment years, the MIPS eligible clinician is a physical therapist, occupational therapist, clinical psychologist, qualified audiologist, qualified speech-language pathologist, or a registered dietitian or nutrition professional. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.

( ii ) For the 2019 through 2024 MIPS payment years, the MIPS eligible clinician is a nurse practitioner, physician assistant, clinical nurse specialist, or certified registered nurse anesthetist. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. ( iii ) For the 2024 MIPS payment year, the MIPS eligible clinician is a clinical social worker. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.

* * * * * (C) * * * ( 9 ) For the 2020 MIPS payment year through the 2023 MIPS payment year the MIPS eligible clinician demonstrates through an application submitted to CMS that they are in a small practice as defined in § 414.1305, and overwhelming barriers prevent them from complying with the requirements for the Promoting Interoperability performance category. Beginning with the 2024 MIPS payment year the MIPS eligible clinician is in a small practice as defined in § 414.1305. * * * * * (ii) * * * (A) For the 2019 MIPS payment year. Table 2 to Paragraph (c)(2)(ii)(A)Performance category (%)Weighting for the 2019 MIPS payment year (%)Reweight scenario if no promoting interoperability performance category score (%)Reweight scenario if no quality performance category score (%)Reweight scenario if no improvement activities performance category score (%)Quality6085075Cost0000Improvement Activities1515500Promoting Interoperability2505025 * * * * * (F) Except as provided in paragraph (c)(2)(ii)(G) of this section, beginning with the 2024 MIPS payment year.

Table 7 to Paragraph (c)(2)(ii)(F)Reweighting scenarioQuality (%)Cost (%)Improvement activities (%)Promoting interoperability (%)No Reweighting Needed:Scores for all four performance categories30301525No Cost5501530Start Printed Page 65676No Promoting Interoperability5530150No Quality0301555No Improvement Activities4530025No Cost and no Promoting Interoperability850150No Cost and no Quality001585No Cost and no Improvement Activities700030No Promoting Interoperability and no Quality050500No Promoting Interoperability and no Improvement Activities703000No Quality and no Improvement Activities030070 (G) For small practices beginning with the 2024 MIPS payment year. Table 8 to Paragraph (c)(2)(ii)(G)Reweighting scenarioQuality (%)Cost (%)Improvement activities (%)Promoting interoperability (%)No Reweighting Needed:Scores for all four performance categories30301525No Cost5501530No Promoting Interoperability4030300No Quality0301555No Improvement Activities4530025No Cost and no Promoting Interoperability500500No Cost and no Quality001585No Cost and no Improvement Activities700030No Promoting Interoperability and no Quality050500No Promoting Interoperability and no Improvement Activities703000No Quality and no Improvement Activities030070 * * * * * (3) Complex patient bonus. For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, provided that a MIPS eligible clinician, group, virtual group or APM Entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus will be added to the final score for the MIPS payment year, as stated in paragraphs (c)(3)(i) through (iv) of this section. Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, provided that a MIPS eligible clinician, group, subgroup, virtual group or APM Entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus will be added to the final score for the MIPS payment year, if applicable, as described in paragraphs (c)(3)(v) through (viii) of this section.

(i) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, for MIPS eligible clinicians and groups, the complex patient bonus is calculated as follows. [The average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group] + [the dual eligible ratio × 5]. (ii) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, for APM Entities and virtual groups, the complex patient bonus is calculated as follows. [The beneficiary weighted average HCC risk score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation within the APM Entity or virtual group, respectively] + [the average dual eligible ratio for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively, × 5].

(iii) For the 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, the complex patient bonus cannot exceed 5.0 except as provided in paragraph (c)(3)(iv) of this section. (iv) For the 2022 and 2023 MIPS payment years and associated performance periods, the complex patient bonus is calculated pursuant to paragraphs (c)(3)(i) and (ii) of this section, and the resulting numerical value is then multiplied by 2.0. The complex patient bonus cannot exceed 10.0. (v) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the complex patient bonus is limited to MIPS eligible clinicians, groups, subgroups, APM Entities, and virtual groups with a risk indicator at or above the risk indicator calculated median.

To determine the median for the respective risk indicator (HCC and dual proportion), risk indicators associated with the final score assigned to a clinician from the most recent prior performance period, for all those who have submitted data for at least one MIPS performance category or are facility-based, are used. (vi) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, for MIPS eligible clinicians, groups, and subgroups, the complex patient bonus components are calculated as follows for the specific Start Printed Page 65677 risk indicators. Medical complex patient bonus component = 1.5 + 4 * associated HCC standardized score calculated with the average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group or subgroup. Social complex patient bonus component = 1.5 + 4 * associated dual proportion standardized score.

The components are added together to calculate one overall complex patient bonus. A standardized score for each risk indicator is determined based on the mean and standard deviation of the raw risk indicator score and provides a standardized measurement of how far each risk score is from the mean. (raw risk indicator score−risk indicator mean)/risk indicator standard deviation. (vii) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, for APM Entities and virtual groups, the complex patient bonus components are calculated as follows for the specific risk indicators.

Medical complex patient bonus component = 1.5 + 4 * the beneficiary weighted average HCC risk standardized score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation within the APM Entity or virtual group, respectively. Social complex patient bonus component = 1.5 + 4 * the average dual proportion standardized score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively. The components are added together to calculate one overall complex patient bonus. A standardized score for each risk indicator is determined based on the mean and standard deviation of the raw risk indicator score and provides a standardized measurement of how far each risk score is from the mean.

(raw risk indicator score−risk indicator mean)/risk indicator standard deviation. (viii) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the complex patient bonus cannot exceed 10.0 and cannot be below 0.0. * * * * * (e) * * * (6) * * * (iv) Quality. The quality performance category score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of this section and awarding a score associated with that same percentile performance in the MIPS quality performance category score for those MIPS-eligible clinicians who are not eligible to be scored using facility-based measurement for the MIPS payment year.

A clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS quality performance category (v) Cost. The cost performance category score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of this section and awarding a score associated with that same percentile performance in the MIPS cost performance category score for those MIPS eligible clinicians who are not eligible to be scored using facility-based measurement for the MIPS payment year. A clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS cost performance category. (A) Other cost measures.

MIPS eligible clinicians who are scored under facility-based measurement are not scored on cost measures described in paragraph (b)(2) of this section. (B) [Reserved] (vi) Use of score from facility-based measurement. The MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology described in paragraph (e)(6) of this section unless. (A) For the CY 2019 MIPS performance period/2021 MIPS payment year, through the CY 2021 MIPS performance period/2023 MIPS payment year, a clinician or group receives a higher combined MIPS quality and cost performance category score through another MIPS submission.

(B) Beginning with the CY 2022 MIPS performance period/2024 MIPS payment year, a clinician or group receives a higher MIPS final score through another MIPS submission. Start Amendment Part60. Amend § 414.1395 by revising paragraph (c) to read as follows. End Amendment Part Public reporting.

* * * * * (c) New measures and activities. (1) CMS does not publicly report any data on new quality or cost measure for the first 2 years in which it is in the program, after which CMS evaluates the measure to determine whether it is suitable for public reporting under paragraph (b) of this section. (2) CMS does not publicly report any MVP data on new improvement activity or Promoting Interoperability measure, objective, or activity included in an MVP for the first year in which it is included in the MVP. * * * * * Start Amendment Part61.

Revise § 414.1400 to read as follows. End Amendment Part Third party intermediaries. (a) General. (1) MIPS data may be submitted on behalf of a MIPS eligible clinician, group, virtual group, subgroup, or APM Entity by any of the following third party intermediaries.

(i) QCDR. (ii) Qualified registry. (iii) Health IT vendor. Or (iv) CMS-approved survey vendor.

(2) Third party intermediary approval criteria— (i) To be approved as a third party intermediary, an entity must agree to meet the applicable requirements of this section, including, but not limited to, the following. (A) A third party intermediary's principle place of business and retention of any data must be based in the U.S. (B) If the data is derived from CEHRT, a QCDR, qualified registry, or health IT vendor must be able to indicate its data source. (C) All data must be submitted in the form and manner specified by CMS.

(D) If the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS. (E) The third party intermediary must provide services throughout the entire performance period and applicable data submission period. (F) Prior to discontinuing services to any MIPS eligible clinician, group, virtual group, subgroup, or APM Entity during a performance period, the third party intermediary must support the transition of such MIPS eligible clinician, group, virtual group, subgroup, or APM Entity to an alternate third party intermediary, submitter type, or, for any measure on which data has been collected, collection type according to a CMS approved a transition plan. (ii) The determination of whether to approve an entity as a third party intermediary for a MIPS payment year may take into account.

(A) Whether the entity failed to comply with the requirements of this section for any prior MIPS payment year for which it was approved as third party intermediary. And (B) Whether the entity provided inaccurate information regarding the Start Printed Page 65678 requirements of this subpart to any eligible clinician. (iii) Beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner, and at the times, specified by CMS. (3) All data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group, virtual group, subgroup, or APM Entity must be certified by the third party intermediary as true, accurate, and complete to the best of its knowledge.

Such certification must be made in a form and manner and at such time as specified by CMS. (b) Additional requirements for QCDRs and qualified registries —(1) General. (i) Beginning with the CY 2021 performance period/2023 MIPS payment year, QCDRs and qualified registries must be able to submit data for all of the following MIPS performance categories. (A) Quality, except.

(1) The CAHPS for MIPS survey. And (2) For qualified registries, QCDR measures. (B) Improvement activities. And (C) Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless the third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)(4)(i) through (iii) or (c)(2)(i)(C)(1) through (7) or (c)(2)(i)(C)(9).

(ii) Beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. QCDRs and qualified registries may also support the APP. (2) Self-nomination. For the CY 2018 and 2019 performance periods/2020 and 2021 MIPS payment years, entities seeking to qualify as a QCDR or qualified registry must self-nominate September 1 until November 1 of the CY preceding the applicable performance period.

For the CY 2020 performance period/2022 MIPS payment year and future years, entities seeking to qualify as a QCDR or qualified registry must self-nominate during a 60-day period during the CY preceding the applicable performance period (beginning no earlier than July 1 and ending no later than September 1). Entities seeking to qualify as a QCDR or qualified registry for a performance period must provide all information required by CMS at the time of self-nomination and must provide any additional information requested by CMS during the review process. For the CY 2019 performance period/2021 MIPS payment year and future years, existing QCDRs and qualified registries that are in good standing may attest that certain aspects of their previous year's approved self-nomination have not changed and will be used for the applicable performance period. (3) Conditions for approval.

(i) Beginning with the CY 2020 performance period/2022 MIPS payment year, the QCDR or qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period. (ii) If an entity seeking to qualify as a QCDR or qualified registry uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period. (iii) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must provide performance feedback to their clinicians and groups at least 4 times a year, and provide specific feedback to their clinicians and groups on how they compare to other clinicians who have submitted data on a given measure within the QCDR or qualified registry.

Exceptions to this requirement may occur if the QCDR or qualified registry submits notification to CMS within the performance period promptly within the month of realization of the impending deficiency and provides sufficient rationale as to why they do not believe they would be able to meet this requirement (for example, if the QCDR does not receive the data from their clinician until the end of the performance period). (iv) Beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination for CMS' approval and may not change the plan once approved without the prior approval of the agency. (v) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct annual data validation audits in accordance with this paragraph (b)(3)(v). (A) The QCDR or qualified registry must conduct data validation for the payment year prior to submitting any data for that payment year to CMS for purposes of the MIPS program.

(B) The QCDR or qualified registry must conduct data validation on data for each performance category for which it will submit data, including if applicable the Quality, Improvement Activities, and Promoting Interoperability performance categories. (C) The QCDR or qualified registry must conduct data validation on data for each submitter type for which it will submit data, including MIPS eligible clinicians, groups, virtual groups, subgroups, APM entities, voluntary participants, and opt-in participants, if applicable. (D) The QCDR or qualified registry must use clinical documentation (provided by the clinicians they are submitting data for) to validate that the action or outcome measured actually occurred or was performed. (E) The QCDR or qualified registry must conduct each data validation audit using a sampling methodology that meets the following requirements.

(1) Uses a sample size of at least 3 percent of the TIN/NPIs for which the QCDR or qualified registry will submit data to CMS, except that if a 3 percent sample size would result in fewer than 10 TIN/NPIs, the QCDR or qualified registry must use a sample size of at least 10 TIN/NPIs, and if a 3 percent sample size would result in more than 50 TIN/NPIs, the QCDR or qualified registry may use a sample size of 50 TIN/NPIs. (2) Uses a sample that includes at least 25 percent of the patients of each TIN/NPI in the sample, except that the sample for each TIN/NPI must include a minimum of 5 patients and does not need to include more than 50 patients. (F) Each QCDR or qualified registry data validation audit must include the following. (1) Verification of the eligibility status of each eligible clinician, group, virtual group, subgroup, opt-in participant, and voluntary participant.

(2) Verification of the accuracy of TINs and NPIs. (3) Calculation of reporting and performance rates. (4) Verification that only the MIPS quality measures and QCDR measures, as applicable, that are relevant to the performance period will be used for MIPS submission. (G) In a form and manner and by a deadline specified by CMS, the QCDR or qualified registry must report the results of each data validation audit, including the overall data deficiencies or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or Start Printed Page 65679 error, and, how and when each deficiency or data error type was corrected.

(1) QCDRs and qualified registries must conduct validation on the data they intend to submit for the MIPS performance period and provide the results of the executed data validation plan by May 31st of the year following the performance period. (2) [Reserved] (vi) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct targeted audits in accordance with this paragraph (b)(3)(vi). (A) If a data validation audit under paragraph (b)(3)(v) of this section identifies one or more deficiency or data error, the QCDR or qualified registry must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year. (B) The QCDR or qualified registry must conduct any required targeted audits for the MIPS payment year and correct any deficiencies or data errors identified through such audit prior to the submission of data for that MIPS payment year.

(C) The QCDR or qualified registry must conduct the targeted audit using the sampling methodology that meets the requirements described in paragraph (b)(3)(iv)(E) of this section. The sample for the targeted audit must not include data from the sample used for the data validation audit in which the deficiency or data error was identified. (D) In a form and manner and by a deadline specified by CMS, the QCDR or qualified registry must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each deficiency or data error type was corrected. (vii) For the CY 2023 performance period/2025 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for any of the 2019 through 2023 MIPS payment years must submit a participation plan for CMS' approval.

The participation plan must include the QCDR and/or qualified registry's detailed plans about how the QCDR or qualified registry intends to encourage clinicians to submit MIPS data to CMS through the QCDR or qualified registry. (viii) Beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. This participation plan must include the QCDR's and/or qualified registry's detailed plans about how the QCDR or qualified registry intends to encourage clinicians to submit MIPS data to CMS through the QCDR or qualified registry. (4) QCDR measures for the quality performance category—(i) QCDR measure self-nomination requirements.

For the CY 2018 performance period/2020 MIPS payment year and future years, at the time of self-nomination an entity seeking to become a QCDR must submit the following information for any measure it intends to submit for the payment year. (A) For MIPS quality measures, the entity must submit specifications including the MIPS measure IDs and specialty-specific measure sets, as applicable. (B) For QCDR measures, the entity must submit for CMS-approval measure specifications including. Name/title of measures, NQF number (if NQF- endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms.

In addition, no later than 15 calendar days following CMS approval of any QCDR measure specifications, the entity must publicly post the measure specifications for that QCDR measure (including the CMS- assigned QCDR measure ID) and provide CMS with a link to where this information is posted. (ii) QCDR measure submission requirements. A QCDR must include the CMS-assigned QCDR measure ID when submitting data on any QCDR measure to CMS. (iii) QCDR measure approval criteria.

(A) QCDR measure requirements for approval are. ( 1 ) QCDR measures that are beyond the measure concept phase of development. ( 2 ) QCDR measures that address significant variation in performance. ( 3 ) Beginning with the CY 2022 performance period/2024 MIPS payment year, all QCDR measures must meet face validity.

To be approved for the CY 2023 performance period/2025 MIPS payment year, all QCDR measures must meet face validity for the initial MIPS payment year for which it is approved. For subsequent years after being initially approved, all QCDR measures must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination. ( i ) To be included in an MVP for the CY 2022 performance period/2024 MIPS payment year and future years, a QCDR measure must be fully tested. ( ii ) [Reserved] ( 4 ) Beginning with the CY 2022 performance period/2023 MIPS payment year, QCDRs are required to collect data on a QCDR measure, appropriate to the measure type, prior to submitting the QCDR measure for CMS consideration during the self-nomination period.

( 5 ) Beginning with the CY 2020 performance period/2022 MIPS payment year, CMS may provisionally approve the individual QCDR measures for 1 year with the condition that QCDRs address certain areas of duplication with other approved QCDR measures or MIPS quality measures in order to be considered for the program in subsequent years. If such areas of duplication are not addressed, CMS may reject the duplicative QCDR measure. (B) QCDR measure considerations for approval include, but are not limited to. ( 1 ) Measures that are outcome-based rather than clinical process measures.

( 2 ) Measures that address patient safety and adverse events. ( 3 ) Measures that identify appropriate use of diagnosis and therapeutics. ( 4 ) Measures that address the domain of care coordination. ( 5 ) Measures that address the domain for patient and caregiver experience.

( 6 ) Measures that address efficiency, cost, and resource use. ( 7 ) Beginning with the CY 2021 performance period/2023 MIPS payment year - ( i ) That QCDRs link their QCDR measures as feasible to at least one cost measure, improvement activity, or an MVP at the time of self-nomination. ( ii ) In cases where a QCDR measure does not have a clear link to a cost measure, improvement activity, or an MVP, CMS would consider exceptions if the potential QCDR measure otherwise meets the QCDR measure requirements and considerations. ( 8 ) Beginning with the CY 2020 performance period/2022 MIPS payment year CMS may consider the extent to which a QCDR measure is available to MIPS eligible clinicians reporting through QCDRs other than the QCDR measure owner for purposes of MIPS.

If CMS determines that a QCDR measure is not available to MIPS eligible clinicians, groups, and virtual groups reporting through other QCDRs, CMS may not approve the measure. ( 9 ) Greater consideration is given to measures for which QCDRs. Start Printed Page 65680 (i) Conducted an environmental scan of existing QCDR measures. MIPS quality measures.

Quality measures retired from the legacy Physician Quality Reporting System (PQRS) program. And ( ii ) Utilized the CMS Quality Measure Development Plan Annual Report and the Blueprint in the CMS Measures Management System to identify measurement gaps prior to measure development. ( 10 ) Beginning with the CY 2020 performance period/2022 MIPS payment year, CMS places greater preference on QCDR measures that meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods. Those that do not, may not continue to be approved.

( i ) Beginning with the CY 2020 performance period/2022 MIPS payment year, in instances where a QCDR believes the low-reported QCDR measure that did not meet benchmarking thresholds is still important and relevant to a specialist's practice, that the QCDR may develop and submit a QCDR measure participation plan for our consideration. This QCDR measure participation plan must include the QCDR's detailed plans and changes to encourage eligible clinicians and groups to submit data on the low-reported QCDR measure for purposes of the MIPS program. ( ii ) [Reserved] (C) Beginning with the CY 2021 performance period/2023 MIPS payment year, QCDR measures may be approved for 2 years, at CMS discretion by attaining approval status by meeting QCDR measure considerations and requirements. Upon annual review, CMS may revoke a QCDR measure's second year approval, if the QCDR measure is found to be.

Topped out. Duplicative of a more robust measure. Reflects an outdated clinical guideline. Or if the QCDR self-nominating the QCDR measure is no longer in good standing.

(iv) QCDR measure rejection criteria. Beginning with the CY 2020 performance period/2022 MIPS payment year, QCDR measure rejection considerations include, but are not limited to. (A) QCDR measures that are duplicative or identical to other QCDR measures or MIPS quality measures that are currently in the program. (B) QCDR measures that are duplicative or identical to MIPS quality measures that have been removed from MIPS through rulemaking.

(C) QCDR measures that are duplicative or identical to quality measures used under the legacy Physician Quality Reporting System (PQRS) program, which have been retired. (D) QCDR measures that meet the topped out definition as described at § 414.1305. (E) QCDR measures that are process-based, with consideration to whether the removal of the process measure impacts the number of measures available for a specific specialty. (F) Whether the QCDR measure has potential unintended consequences to a patient's care.

(G) Considerations and evaluation of the measure's performance data, to determine whether performance variance exists. (H) QCDR measures that split a single clinical practice or action into several QCDR measures. (I) QCDR measures that are “check-box” with no actionable quality action. (J) QCDR measures that do not meet the case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive years.

(K) QCDR measures with clinician attribution issues, where the quality action is not under the direct control of the reporting clinician. (L) QCDR measures that focus on rare events or “never events” in the measurement period. (M) QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. (N) If a QCDR measure owner is not approved or is not in good standing, any associated QCDR measures will not be approved.

(c) Additional requirements for Health IT vendors. (1) Beginning with the CY 2021 performance period/2023 MIPS payment year, health IT vendors must be able to submit data for the MIPS performance categories as follows. (i) Health IT vendors that support MVPs must be able to submit data for all of the MIPS performance categories. (A) Quality, except.

( 1 ) The CAHPS for MIPS survey. And ( 2 ) QCDR measures. (B) Improvement activities. And (C) Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless.

( 1 ) The third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 )( i ) through ( iii ) or (c)(2)(i)(C)( 1 ) through ( 7 ) or (c)(2)(i)(C)( 9 ). ( 2 ) [Reserved] (ii) Health IT vendors that do not support MVPs must be able to submit data for at least one of the MIPS performance categories described in paragraphs (c)(1)(i) of this section. (iii) Beginning with the CY 2023 performance period/2025 MIPS payment year, Health IT vendors must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. Health IT vendors may also support the APP.

(2) [Reserved] (d) Additional requirements for CMS-approved survey vendors. (1) CMS-approved survey vendors may submit data on the CAHPS for MIPS survey for the MIPS quality performance category. (2) Entities seeking to be a CMS-approved survey vendor for any MIPS performance period must submit a survey vendor application to CMS in a form and manner specified by CMS for each MIPS performance period for which it wishes to transmit such data. The application and any supplemental information requested by CMS must be submitted by deadlines specified by CMS.

For an entity to be a CMS-approved survey vendor, it must meet the following criteria. (3) The entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including. (i) At least 3 years of experience administering mixed-mode surveys (that is, surveys that employ multiple modes to collect date), including mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI). (ii) At least 3 years of experience administering surveys to a Medicare population.

(iii) At least 3 years of experience administering CAHPS surveys within the past 5 years. (iv) Experience administering surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available. (v) Use equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule call-backs to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities. And (vi) Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey.

Start Printed Page 65681 (4) The entity has certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data. (5) The entity has successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors. (6) The entity has submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts. (7) The entity has agreed to participate and cooperate, and has required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors.

(8) The entity has sent an interim survey data file to CMS that establishes the entity's ability to accurately report CAHPS data. (e) Remedial action and termination of third party intermediaries. (1) If CMS determines that a third party intermediary has ceased to meet one or more of the applicable criteria for approval, has submitted a false certification under paragraph (a)(3) of this section, or has submitted data that are inaccurate, unusable, or otherwise compromised, CMS may take one or more of the following remedial actions after providing written notice to the third party intermediary. (i) Require the third party intermediary to submit a corrective action plan (CAP) by a date specified by CMS.

The CAP must address the following issues, unless different or additional information is specified by CMS. (A) The issues that contributed to the non-compliance. (B) The impact to individual clinicians, groups, or virtual groups, regardless of whether they are participating in the program because they are MIPS eligible, voluntary participating, or opting in to participating in the MIPS program. (C) The corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved and will not recur in the future.

(D) The detailed timeline for achieving compliance with the applicable requirements. (ii) Publicly disclose the entity's data error rate on the CMS website until the data error rate falls below 3 percent. (2) CMS may immediately or with advance notice terminate the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the following reasons. (i) CMS has grounds to impose remedial action.

(ii) CMS has not received a CAP within the specified time-period or the CAP is not accepted by CMS. Or (iii) The third party intermediary fails to correct the deficiencies or data errors by the date specified by CMS. (3) Contains data inaccuracies affecting the third party intermediary's total clinicians may lead to remedial action/termination of the third party intermediary for future program year(s) based on CMS discretion. (4) For purposes of this paragraph (e), CMS may determine that submitted data are inaccurate, unusable, or otherwise compromised, including but not limited to, if the submitted data.

(i) Includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies. (ii) [Reserved] (f) Auditing of entities submitting MIPS data. Any third party intermediary must comply with the following procedures as a condition of its qualification and approval to participate in MIPS as a third party intermediary. (1) The entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data.

The contact information must include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email. (2) The entity must retain all data submitted to CMS for purposes of MIPS for 6 years from the end of the MIPS performance period. (3) For the purposes of auditing, CMS may request any records or data retained for the purposes of MIPS for up to 6 years from the end of the MIPS performance period. Start Amendment Part62.

Amend § 414.1405 by adding paragraphs (b)(9), (d)(7), and (g) to read as follows. End Amendment Part Payment. * * * * * (b) * * * (9) Pursuant to the methodology established at paragraph (g) of this section, the performance threshold for the 2024 MIPS payment year is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS payment year.

* * * * * (d) * * * (7) The additional performance threshold for the 2024 MIPS payment year is 89 points. * * * * * (g) Performance threshold methodology. For each of the 2024, 2025, and 2026 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible clinicians from a prior period as specified under paragraph (b) of this section. Start Amendment Part63.

Amend § 414.1430 by— End Amendment Part Start Amendment Parta. Revising paragraph (a)(1)(iii). End Amendment Part Start Amendment Partb. Adding paragraphs (a)(1)(iv).

End Amendment Part Start Amendment Partc. Removing the second occurrence of paragraph (a)(2)(ii). End Amendment Part Start Amendment Partd. Adding paragraphs (a)(2)(iii) and (iv).

And End Amendment Part Start Amendment Parte. Revising paragraphs (b)(1)(i)(A) and (B) and (b)(2)(i)(A) and (B). End Amendment Part The revisions and additions read as follows. Qualifying APM participant determination.

QP and partial QP thresholds. (a) * * * (1) * * * (iii) 2023 and 2024. 50 percent. (iv) 2025 and later.

75 percent. (2) * * * (iii) 2023 and 2024. 50 percent. (iv) 2025 and later.

75 percent. * * * * * (b) * * * (1) * * * (i) * * * (A) 2021 through 2024. 50 percent. (B) 2025 and later.

75 percent. * * * * * (2) * * * (i) * * * (A) 2021 through 2024. 35 percent. (B) 2025 and later.

50 percent. * * * * * Start Amendment Part64. Amend § 414.1450 by revising paragraph (c) introductory text to read as follows. End Amendment Part APM incentive payment.

* * * * * (c) APM Incentive Payment recipient. CMS will pay the APM Incentive Payment amount for a payment year to a solvent TIN or TINs associated with the QP, identified based on Medicare Part B claims submitted for covered professional services during the base period or payment year, according to this section. If no TIN or TINs with which the QP has an association can be identified at a step, CMS will move to the next and successive steps listed in paragraphs (c)(1) through (8) of this section until CMS identifies a TIN or TINs with which the QP is associated, and to which CMS will make the APM Start Printed Page 65682 Incentive Payment. If more than one TIN is identified at a step, the payment will be proportionately divided among the TINs according to the relative total paid amounts for Part B covered professional services paid to each TIN for services provided during the base year.

* * * * * Start Part End Part Start Amendment Part65. The authority citation for part 415 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh.

End Authority Start Amendment Part66. Section 415.140 is added to subpart D to read as follows. End Amendment Part Conditions for payment. Split (or shared) visits.

(a) Definitions. For purposes of this section, the following definitions apply. Facility setting for purposes of this section means institutional settings in which payment for services and supplies furnished incident to a physician or practitioner's professional services is prohibited under § 410.26(b)(1) of this subchapter. Split (or shared) visit means an evaluation and management (E/M) visit in the facility setting that is performed in part by both a physician and a nonphysician practitioner who are in the same group, in accordance with applicable law and regulations such that the service could be could be billed by either the physician or nonphysician practitioner if furnished independently by only one of them.

Substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit, except as otherwise provided in this paragraph. For visits other than critical care visits furnished in calendar year 2022, substantive portion means one of the three key components (history, exam or medical decision-making) or more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit. (b) Conditions of payment. For purposes of this section, the following conditions of payment apply.

(1) Substantive portion of split (or shared) visit. In general, payment is made to the physician or nonphysician practitioner who performs the substantive portion of the split (or shared) visit. (2) Medical record documentation. Documentation in the medical record must identify the physician and nonphysician practitioner who performed the visit.

The individual who performed the substantive portion of the visit (and therefore bills for the visit) must sign and date the medical record. (3) Claim modifier. The designated modifier must be included on the claim to identify that the service was a split (or shared) visit. Start Part End Part Start Amendment Part67.

The authority citation for part 423 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh. End Authority Start Amendment Part68.

Amend § 423.160 by revising paragraph (a)(5) to read as follows. End Amendment Part Standards for electronic prescribing. (a) * * * (5) Beginning on January 1, 2021, prescribers must, except in the circumstances described in paragraphs (a)(5)(i) through (iv) of this section, conduct prescribing for at least 70 percent of their Schedule II, III, IV, and V controlled substances that are Part D drugs electronically using the applicable standards in paragraph (b) of this section. Prescriptions written for a beneficiary in a long-term care facility will not be included in determining compliance until January 1, 2025.

Compliance actions against prescribers who do not meet the compliance threshold based on prescriptions written for a beneficiary in a long-term care facility will commence on or after January 1, 2025. Compliance actions against prescribers who do not meet the compliance threshold based on other prescriptions will commence on or after January 1, 2023. Prescribers will be exempt from this requirement in the following situations. (i) Prescriber and dispensing pharmacy are the same entity.

(ii) Prescriber issues 100 or fewer controlled substance prescriptions for Part D drugs per calendar year as determined using CMS claims data as of December 31st of the preceding year. (iii) Prescriber has an NCPDP database address in the geographic area of an emergency or disaster declared by a Federal, State, or local government entity. (iv) Prescriber has received a CMS-approved waiver because the prescriber is unable to conduct electronic prescribing of controlled substances (EPCS) due to circumstances beyond the prescriber's control. * * * * * Start Part End Part Start Amendment Part69.

The authority for part 424 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part70.

Amend § 424.205 by redesignating paragraphs (b)(5) and (6) as paragraphs (b)(6) and (7), respectively, and adding new paragraph (b)(5). End Amendment Part The addition reads as follows. Requirements for Medicare Diabetes Prevention Program suppliers. * * * * * (b) * * * (5) The Medicare provider enrollment application fee does not apply to all Medicare Diabetes Prevention Program (MDPP) suppliers that submit an enrollment application on or after January 1, 2022.

* * * * * Start Amendment Part71. Amend § 424.502 by revising the definition of “Institutional provider” to read as follows. End Amendment Part Definitions. * * * * * Institutional provider means any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and nonphysician practitioner organizations), CMS-855S, or an associated internet-based PECOS enrollment application.

* * * * * Start Amendment Part72. Amend § 424.530 by revising paragraphs (a)(2) introductory text and (a)(11)(i) to read as follows. End Amendment Part Denial of enrollment in the Medicare program. (a) * * * (2) Provider or supplier conduct.

The provider or supplier, or any owner, managing employee, authorized or delegated official, medical director, supervising physician, or other health care or administrative or management services personnel furnishing services payable by a Federal health care program, of the provider or supplier is— * * * * * (11) * * * (i) A physician or other eligible professional's Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause. * * * * * Start Amendment Part73. Amend § 424.535 by revising paragraphs (a)(2) introductory text, Start Printed Page 65683 (a)(8)(ii), (a)(13)(i), and (e) to read as follows. End Amendment Part Revocation of enrollment in the Medicare program.

(a) * * * (2) Provider or supplier conduct. The provider or supplier, or any owner, managing employee, authorized or delegated official, medical director, supervising physician, or other health care or administrative or management services personnel furnishing services payable by a Federal health care program, of the provider or supplier is— * * * * * (8) * * * (ii) CMS determines that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements. In making this determination, CMS considers, as appropriate or applicable, the following. (A) The percentage of submitted claims that were denied during the period under consideration.

(B) Whether the provider or supplier has any history of final adverse actions and the nature of any such actions. (C) The type of billing non-compliance and the specific facts surrounding said non-compliance (to the extent this can be determined). (D) Any other information regarding the provider or supplier's specific circumstances that CMS deems relevant to its determination. * * * * * (13) * * * (i) A physician or other eligible professional's Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause.

* * * * * (e) Reversal of revocation. If the revocation was due to adverse activity (sanction, exclusion, or felony) against the provider's or supplier's owner, managing employee, authorized or delegated official, medical director, supervising physician, or other health care or administrative or management services personnel furnishing services payable by a Federal health care program, the revocation may be reversed if the provider or supplier terminates and submits proof that it has terminated its business relationship with that individual within 30 days of the revocation notification. * * * * * Start Amendment Part74. Amend § 424.545 in paragraph (b) by removing the reference “§ 405.374” and adding in its place the reference “§ 424.546”.

End Amendment Part Start Amendment Part75. Add § 424.546 to read as follows. End Amendment Part Deactivation rebuttals. (a) Rebuttal submittal period.

(1) If a provider or supplier receives written notice from CMS or its contractor that the provider's or supplier's billing privileges are to be or have been deactivated under § 424.540, the provider or supplier has 15 calendar days from the date of the written notice to submit a rebuttal to CMS as permitted under § 424.545(b). (2) CMS may, at its discretion, extend the 15-day time-period referenced in paragraph (a)(1) of this section. (b) Rebuttal requirements. A rebuttal submitted pursuant to this section and § 424.545(b) must.

(1) Be in writing. (2) Specify the facts or issues about which the provider or supplier disagrees with the deactivation's imposition and/or the effective date, and the reasons for disagreement. (3) Submit all documentation the provider or supplier wants CMS to consider in its review of the deactivation. (4) Be submitted in the form of a letter that is signed and dated by the individual supplier (if enrolled as an individual physician or nonphysician practitioner), the authorized official or delegated official (as those terms are defined in 42 CFR 424.502), or a legal representative (as defined in 42 CFR 498.10).

If the legal representative is an attorney, the attorney must include a statement that he or she has the authority to represent the provider or supplier. This statement is sufficient to constitute notice of such authority. If the legal representative is not an attorney, the provider or supplier must file with CMS written notice of the appointment of a representative. This notice of appointment must be signed and dated by, as applicable, the individual supplier, the authorized official or delegated official, or a legal representative.

(c) Waiver of rebuttal rights. The provider's or supplier's failure to submit a rebuttal that is both timely under paragraph (a) of this section and fully compliant with all of the requirements of paragraph (b) of this section constitutes a waiver of all rebuttal rights under this section and § 424.545(b). (d) CMS review. Upon receipt of a timely and compliant deactivation rebuttal, CMS reviews the rebuttal to determine whether the imposition of the deactivation and/or the designated effective date are correct.

(e) Imposition. Nothing in this section or in § 424.545(b) requires CMS to delay the imposition of a deactivation pending the completion of the review described in paragraph (d) of this section. (f) Initial determination. A determination made under this section is not an initial determination under § 498.3(b) of this chapter and therefore not appealable.

Start Part End Part Start Amendment Part76. The authority citation for part 425 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

End Authority Start Amendment Part77. Amend § 425.116 by revising paragraph (c) to read as follows. End Amendment Part Agreements with ACO participants and ACO providers/suppliers. * * * * * (c) Submission of agreements.

The ACO must submit an executed ACO participant agreement for each ACO participant that it requests to add to its list of ACO participants in accordance with § 425.118. The agreements may be submitted in the form and manner set forth in § 425.204(c)(6) or as otherwise specified by CMS. Start Amendment Part78. Amend § 425.204 by revising paragraphs (b), (c)(6), (f)(4)(ii)(A) and (B), (f)(4)(iii) introductory text, and (f)(4)(iii)(A) and adding paragraph (f)(4)(v) to read as follows.

End Amendment Part Content of the application. * * * * * (b) Prior participation. Upon request by CMS during the application cycle, the ACO must submit information regarding prior participation in the Medicare Shared Savings Program by the ACO, its ACO participants, or its ACO providers/suppliers, including such information as may be necessary for CMS to determine whether to approve an ACO's application in accordance with § 425.224(b). (c) * * * (6) Upon request by CMS during the application cycle or at any point during an agreement period, the ACO must submit documents demonstrating that its ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to ACO activities are required to comply with the requirements of the Shared Savings Program.

Upon such a request, the evidence to be submitted must include, without limitation, sample or form agreements and, in the case of ACO participant agreements, the first and signature page(s) of each executed ACO participant agreement. Start Printed Page 65684 CMS may request all pages of an executed ACO participant agreement to confirm that it conforms to the sample form agreement submitted by the ACO. The ACO must certify that all of its ACO participant agreements comply with the requirements of this part. * * * * * (f) * * * (4) * * * (ii) * * * (A) One-half percent of the total per capita Medicare Parts A and B fee-for-service expenditures for the ACO's assigned beneficiaries, based on expenditures and the number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available.

(B) One percent of the total Medicare Parts A and B fee-for-service revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available, and based on the ACO's number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available. (iii) CMS recalculates the ACO's repayment mechanism amount for the second and each subsequent performance year in the agreement period in accordance with paragraph (f)(4)(ii) of this section based on the certified ACO participant list for the relevant performance year, except that the number of assigned beneficiaries used in the calculations is the number of beneficiaries assigned to the ACO at the beginning of the relevant performance year under § 425.400(a)(2)(i) (for ACOs under preliminary prospective assignment with retrospective reconciliation) or § 425.400(a)(3)(i) (for ACOs under prospective assignment). (A) If the recalculated repayment mechanism amount exceeds the existing repayment mechanism amount by at least $1,000,000, CMS notifies the ACO in writing that the amount of its repayment mechanism must be increased to the recalculated repayment mechanism amount. * * * * * (v)(A) An ACO that established a repayment mechanism to support its participation in a two-sided model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, may elect to decrease the amount of its repayment mechanism if the repayment mechanism amount for performance year 2022, as recalculated pursuant to paragraph (f)(4)(iii) of this section, is less than the existing repayment mechanism amount.

(B) CMS will notify the ACO in writing if the ACO may elect to decrease the amount of its repayment mechanism pursuant to this paragraph (f)(4)(v). The ACO must submit such election, and revised repayment mechanism documentation, in a form and manner and by a deadline specified by CMS. CMS will review the revised repayment mechanism documentation and may reject the election if the repayment mechanism documentation does not comply with the requirements of this paragraph (f). * * * * * Start Amendment Part79.

Amend § 425.312 by revising paragraph (a)(2)(ii) and adding paragraph (a)(2)(iii) to read as follows. End Amendment Part Beneficiary notifications. (a) * * * (2) * * * (ii) In the case of an ACO that has selected preliminary prospective assignment with retrospective reconciliation, by the ACO or ACO participant providing each fee-for-service beneficiary with a standardized written notice prior to or at the first primary care visit of the performance year in the form and manner specified by CMS. (iii) In the case of an ACO that has selected prospective assignment, by the ACO or ACO participant providing each prospectively assigned beneficiary with a standardized written notice prior to or at the first primary care visit of the performance year in the form and manner specified by CMS.

* * * * * Start Amendment Part80. Amend § 425.400 by— End Amendment Part Start Amendment Parta. Revising paragraph (c)(1)(v) introductory text. End Amendment Part Start Amendment Partb.

Adding paragraph (c)(1)(vi). And End Amendment Part Start Amendment Partc. Revising paragraphs (c)(2)(i) introductory text, (c)(2)(i)(A)(2), and (c)(2)(ii). End Amendment Part The revisions and addition read as follows.

General. * * * * * (c) * * * (1) * * * (v) For the performance year starting on January 1, 2021. * * * * * (vi) For the performance year starting on January 1, 2022, and subsequent performance years as follows. (A) CPT codes.

( 1 ) 96160 and 96161 (codes for administration of health risk assessment). ( 2 ) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). ( 3 ) 99304 through 99318 (codes for professional services furnished in a nursing facility. Professional services or services reported on an FQHC or RHC claim identified by these codes are excluded when furnished in a SNF).

( 4 ) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit). ( 5 ) 99341 through 99350 (codes for evaluation and management services furnished in a patient's home for claims identified by place of service modifier 12). ( 6 ) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure. When the base code is also a primary care service code under this paragraph (c)(1)(vi)).

( 7 ) 99421, 99422, and 99423 (codes for online digital evaluation and management). ( 8 ) 99424, 99425, 99426, and 99427 (codes for principal care management services). ( 9 ) 99437, 99487, 99489, 99490 and 99491 (codes for chronic care management). ( 10 ) 99439 (code for non-complex chronic care management).

( 11 ) 99483 (code for assessment of and care planning for patients with cognitive impairment). ( 12 ) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services). ( 13 ) 99495 and 99496 (codes for transitional care management services). ( 14 ) 99497 and 99498 (codes for advance care planning.

Services identified by these codes furnished in an inpatient setting are excluded). (B) HCPCS codes. ( 1 ) G0402 (code for the Welcome to Medicare visit). ( 2 ) G0438 and G0439 (codes for the annual wellness visits).

( 3 ) G0442 (code for alcohol misuse screening service). ( 4 ) G0443 (code for alcohol misuse counseling service). ( 5 ) G0444 (code for annual depression screening service). ( 6 ) G0463 (code for services furnished in ETA hospitals).

( 7 ) G0506 (code for chronic care management). ( 8 ) G2010 (code for the remote evaluation of patient video/images). ( 9 ) G2012 and G2252 (codes for virtual check-in). ( 10 ) G2058 (code for non-complex chronic care management).

( 11 ) G2064 and G2065 (codes for principal care management services). ( 12 ) G2212 (code for prolonged office or other outpatient visit for the evaluation and management of a patient). Start Printed Page 65685 ( 13 ) G2214 (code for psychiatric collaborative care model). (C) Primary care service codes include any CPT code identified by CMS that directly replaces a CPT code specified in paragraph (c)(1)(vi)(A) of this section or a HCPCS code specified in paragraph (c)(1)(vi)(B) of this section, when the assignment window (as defined in § 425.20) for a benchmark or performance year includes any day on or after the effective date of the replacement code for payment purposes under FFS Medicare.

(2)(i) Except as otherwise specified in paragraph (c)(2)(i)(A)(2) of this section, when the assignment window (as defined in § 425.20) for a benchmark or performance year includes any month(s) during the buy antibiotics Public Health Emergency defined in § 400.200 of this chapter, in determining beneficiary assignment, we use the primary care service codes identified in paragraph (c)(1) of this section, and additional primary care service codes as follows. (A) * * * (2) 99441, 99442, and 99443 (codes for telephone evaluation and management services). These codes are used in determining beneficiary assignment as specified in paragraphs (c)(2)(i) and (ii) of this section and until they are no longer payable under Medicare fee-for-service payment policies as specified under section 1834(m) of the Act and §§ 410.78 and 414.65 of this subchapter. * * * * * (ii) Except as otherwise specified in paragraph (c)(2)(i)(A)(2) of this section, the additional primary care service codes specified in paragraph (c)(2)(i) of this section are applicable to all months of the assignment window (as defined in § 425.20), when the assignment window includes any month(s) during the buy antibiotics Public Health Emergency defined in § 400.200 of this chapter.

Start Amendment Part81. Amend § 425.512 by— End Amendment Part Start Amendment Parta. Revising paragraphs (a)(2) and (3). End Amendment Part Start Amendment Partb.

Redesignating paragraph (a)(4) as paragraph (a)(5). End Amendment Part Start Amendment Partc. Adding a new paragraph (a)(4). End Amendment Part Start Amendment Partd.

Revising newly redesignated paragraph (a)(5). And End Amendment Part Start Amendment Parte. Revising paragraphs (b)(2)(i) and (ii) and (b)(3)(i) and (ii). End Amendment Part The revisions and addition read as follows.

Determining the ACO quality performance standard for performance years beginning on or after January 1, 2021. (a) * * * (2) For the first performance year of an ACO's first agreement period under the Shared Savings Program. If the ACO reports data via the APP and meets the data completeness requirement at § 414.1340 of this subchapter and the case minimum requirement at § 414.1380 of this subchapter on the measures specified in this paragraph (a)(2) for the applicable performance year, the ACO will meet the quality performance standard. (i) For performance years 2022, 2023, and 2024.

The ten CMS Web Interface measures or the three eCQMs/MIPS CQMs, and the CAHPS for MIPS survey. (ii) For performance year 2025 and subsequent performance years. The three eCQMs/MIPS CQMs and the CAHPS for MIPS survey. (3) For performance year 2021.

(i) Except as specified in paragraph (a)(2) of this section, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367 of this subchapter, according to the method of submission established by CMS and achieving a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. (ii) If an ACO does not report any of the ten CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for MIPS survey under the APP, the ACO will not meet the quality performance standard. (4) For performance years 2022 and 2023. (i) Except as specified in paragraph (a)(2) of this section, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367 of this subchapter according to the method of submission established by CMS and either.

(A) Achieving a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, or (B) If the ACO reports the three eCQMs/MIPS CQMs in the APP measure set, meeting the data completeness requirement at § 414.1340 of this subchapter and the case minimum requirement at § 414.1380 of this subchapter for all three eCQMs/MIPS CQMs, achieving a quality performance score equivalent to or higher than the 10th percentile of the performance benchmark on at least one of the four outcome measures in the APP measure set and a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least one of the remaining five measures in the APP measure set. (ii) If an ACO does not report any of the ten CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for MIPS survey under the APP, the ACO will not meet the quality performance standard. (5) For performance year 2024 and subsequent performance years. (i) Except as specified in paragraph (a)(2) of this section, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367 of this subchapter, according to the method of submission established by CMS and achieving a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring.

(ii) If an ACO does not report any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for MIPS survey under the APP, the ACO will not meet the quality performance standard. (b) * * * (2) * * * (i) For performance years 2021, 2022, and 2023, the ACO's minimum quality performance score is set to the equivalent of the 30th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. (ii) For performance year 2024 and subsequent performance years, the ACO's minimum quality performance score is set to the equivalent of the 40th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. (3) * * * (i) For performance years 2021, 2022, and 2023, CMS will use the higher of the ACO's quality performance score or the equivalent of the 30th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year.

(ii) For performance year 2024 and subsequent performance years, CMS will use the higher of the ACO's quality performance score or the equivalent of the 40th percentile MIPS Quality performance category score across all MIPS Quality performance category Start Printed Page 65686 scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. * * * * * Start Signature Xavier Becerra, Secretary, Department of Health and Human Services. End Signature The following appendices will not appear in the Code of Federal Regulations. 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2021-23972 Filed 11-2-21. 8:45 am]BILLING CODE 4120-01-PStratis Health Announces National Virtual Quality Improvement Mentors for Critical Access HospitalsStratis Health announced twelve critical access hospital (CAH) staff who will serve for two years as national Virtual Quality Improvement Mentors through an initiative that broadly transfers knowledge from leading CAH quality improvement staff to others across the country. The initiative is organized through Rural Quality Improvement Technical Assistance (RQITA), a program of Stratis Health supported by the Federal Office of Rural Health Policy (FORHP).These twelve outstanding mentors were selected from a pool of candidates across the country who were nominated by their respective state Flex programs as quality improvement leaders. They each successfully report and use data to support quality improvement activities in their small rural hospitals.

They represent the diversity of CAHs across the nation, with varying rural locations, service lines, and patient volumes, which average 4.16 to 15 patients per day and 2,322 to 13,681 emergency room visits annually.“Our first Virtual Quality Improvement Mentor cohort shared so many notable examples of how they successfully advanced quality in their critical access hospitals,” said Janelle Shearer, Stratis Health program manager. €œWe are excited to build on that success with this new group of QI leaders.”“Critical access hospital” is a Centers for Medicare &. Medicaid Services (CMS) designation given to eligible rural hospitals, with 25 beds or less, to reduce the financial vulnerability and improve access to health care by keeping essential services in rural communities.Of the 1,353 CAHs across the U.S., more than 1,330 were participating in FORHP’s Medicare Beneficiary Quality Improvement Project (MBQIP) at the end of 2020.The new Virtual Quality Improvement Mentors are:Gloria Barth, Harrison County Hospital, Corydon, INCaryn Bommersbach, Carris Health – Redwood, Redwood Falls, MNKatherine Bryant, Covington County Hospital, Collins, MSCara Cruz, Carson Valley Medical Center, Gardnerville, NVMarilyn Denno, Community Memorial Hospital, Cloquet, MNStacey Karvoski, Wallowa Memorial Hospital, Enterprise, ORJenifer Monzo, McKenzie Health System, Sandusky, MIElly Shaw, Knoxville Hospital &. Clinics, Knoxville, IATammy Suchy, TriCounty Health Care, Wadena, MNKatrina “Kitty” Strowbridge, Clark Fork Valley Hospital, Plains, MTTammy Sudtelgte, Floyd Valley Healthcare, LeMars, IALinda Webb, Pulaski Memorial Hospital, Winamac, INThe Virtual Quality Improvement Mentors will add to the examples and advice of their predecessors on addressing common quality improvement challenges that occur in CAHs.

RQITA will capture these strategies, tips, and ideas to disseminate them broadly to others serving in CAH quality roles, including through the RQITA newsletter MBQIP Monthly and the Quality Time. Sharing PIE (performance improvement experience) recorded conversation series..

Start Preamble Start Printed Page 65524 (iv) MIPS Reweighting Based on Extreme and Uncontrollable Circumstances (A) MIPS Applications for Reweighting for the CY 2021 Performance Period/2023 MIPS Payment Year Based on Extreme and Uncontrollable Circumstances We anticipate that the national PHE for buy antibiotics will http://dsdtips.com/de6-de9-de9c-california-quarterly-unemployment-filing-with-mas-90-mas-200/ continue through CY 2021 where to buy zithromax over the counter. Therefore, we remind clinicians that the application-based extreme and uncontrollable circumstances policy, as described in § 414.1380(c)(2)(i)(A)( 6 ) and (c)(2)(i)(C)( 2 ), will be available for the CY 2021 performance period/2023 MIPS payment year (85 FR 84916 through 84917). Please refer to where to buy zithromax over the counter https://qpp.cms.gov/​about/​buy antibiotics19?. €‹py=​2021 for details.

The application allows clinicians, groups, and virtual groups significantly impacted by the PHE where to buy zithromax over the counter for buy antibiotics to request reweighting for any or all MIPS performance categories. Under this policy, if a clinician, group, or virtual group submits a reweighting application and also submits data for a performance category for which an application was submitted, the data submission will override the application, and the clinician, group, or virtual group will be scored on the data submitted. Additionally, if an application is submitted for one performance category only, and data is submitted for the other 2 performance categories, only the performance category for which the application was submitted will be reweighted and the other performance categories will be scored. We believe this approach maintains a balance of encouraging participation in the Quality Payment Program while still providing for flexibility in weighting the performance categories for those who where to buy zithromax over the counter have been affected by the national PHE for buy antibiotics.

Please refer to https://qpp.cms.gov/​about/​buy antibiotics19?. €‹py=​2021 for where to buy zithromax over the counter more information. (B) MIPS Reweighting Based on Extreme and Uncontrollable Circumstances. Automatic and Application-Based Policies Clarification Under the application-based extreme and uncontrollable circumstances policy codified at §  414.1380(c)(2)(i)(A)( 6 ) for the quality, cost, and improvement activities performance categories and at § 414.1380(c)(2)(i)(C)( 2 ) for the promoting interoperability performance category, clinicians who are subject to extreme and uncontrollable circumstances may submit an application to CMS to request reweighting of a performance category or categories.

We also established an automatic extreme and uncontrollable circumstances policy at § 414.1380(c)(2)(i)(A)( 8 ) where to buy zithromax over the counter for the quality, cost, and improvement activities performance categories and at § 414.1380(c)(2)(i)(C)( 3 ) for the promoting interoperability performance category, under which we automatically reweight the performance categories for clinicians who are located in an area affected by extreme and uncontrollable circumstances as identified by us. Based on stakeholder inquiries, we recognize not all stakeholders understand how individual MIPS eligible clinicians who are eligible for reweighting under the automatic extreme and uncontrollable circumstances policy and who also submit an application for reweighting based on extreme and uncontrollable circumstances are affected by the intersection of these policies. Currently, under both the application-based and automatic extreme and uncontrollable circumstances policies, if a MIPS eligible clinician who is located in an area affected by extreme and uncontrollable circumstances as identified by CMS submits data for any of the MIPS performance categories by the applicable submission deadline for the MIPS performance period, they will be scored on each performance category for which they submit where to buy zithromax over the counter data, and the performance category will not be reweighted to zero percent in the final score. Under the automatic extreme and uncontrollable circumstances policy, the other performance categories for which data was not submitted will remain reweighted to zero percent (82 FR 53898, 83 FR 59874).

Additionally, as described in the CY 2019 PFS final rule (83 FR 59874), under the automatic extreme and uncontrollable circumstances where to buy zithromax over the counter policy, a MIPS eligible clinician who is located in an area affected by extreme and uncontrollable circumstances as identified by CMS will Start Printed Page 65525 not be scored on the cost performance category. As we stated in the CY 2019 PFS final rule (83 FR 59874), if a MIPS eligible clinician is located in an affected area, we would assume the clinician does not have sufficient cost measures applicable to him or her and assign a weight of zero percent to that category in the final score, even if we receive administrative claims data that will enable us to calculate the cost measures for that clinician. The following example is intended to illustrate the intersection of the automatic and application-based extreme and uncontrollable circumstances policies. A MIPS eligible clinician who is located in an area affected by extreme and uncontrollable circumstances as identified by CMS and eligible for the automatic extreme and uncontrollable circumstances policy submits an where to buy zithromax over the counter application for reweighting based on extreme and uncontrollable circumstances.

The application requests reweighting for the Promoting Interoperability performance category, and the clinician submits data for the quality and improvement activities performance categories. The clinician will be where to buy zithromax over the counter scored on the quality and improvement activities performance categories because they submitted data for those categories. The cost performance category is reweighted to zero percent under the automatic extreme and uncontrollable circumstances policy, as discussed above. And the Promoting Interoperability performance category is also reweighted to zero percent under the automatic extreme and uncontrollable circumstances policy.

The application where to buy zithromax over the counter for reweighting was not needed in this example to reweight the Promoting Interoperability performance category. Please refer to https://qpp.cms.gov/​about/​buy antibiotics19?. €‹py=​2021 for where to buy zithromax over the counter more information. (v) Redistributing Performance Category Weights for Facility-Based Measurement (A) Background In the CY 2018 Quality Payment Program final rule, we established facility-based measurement under section 1848(q)(2)(C)(ii) of the Act which provides that the Secretary may use measures used for payment systems other than for physicians, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories (82 FR 53752 through 53767).

Scoring under facility-based where to buy zithromax over the counter measurement was available for clinicians beginning with the CY 2019 performance period/2021 MIPS payment year. We established facility-based measurement to better align incentives between facilities and the MIPS eligible clinicians who provide services there (82 FR 53753). For more background on facility-based measurement, we refer readers to both the CY 2018 Quality Payment Program final rule (82 FR 53752 through 53767) and the CY 2019 PFS final rule (83 FR 59856 through 59867). (B) Redistribution of Performance Category Weights Under Facility-Based Measurement where to buy zithromax over the counter In the CY 2019 PFS final rule, we established that clinicians and groups would not need to elect or opt-in to facility-based measurement, but instead we would automatically apply facility-based measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement and who would benefit by having a higher combined quality and cost performance category score (83 FR 59863).

In this same final rule, we finalized policies for redistributing weight among the performance categories for the CY 2019 performance period/2021 MIPS payment year under § 414.1380(c)(2)(ii)(C). Under those redistribution policies, if the cost performance category is reweighted to zero percent of the final score, its weight is redistributed entirely to the quality performance category, unless the quality performance category is reweighted to zero percent, in which where to buy zithromax over the counter case the quality and cost performance category weights would be redistributed to the improvement activities and Promoting Interoperability performance categories. A clinician or group could have the weight of the cost performance category redistributed because they did not meet the case minimum for any of the measures in the cost performance category. Because facility-based measurement always includes both the quality and cost performance categories, it is possible a clinician or group would be scored on the cost performance category under facility-based measurement but not outside of facility-based measurement.

There are two common scenarios for a facility-based clinician or group which could occur in the where to buy zithromax over the counter CY 2019 performance period/2021 MIPS payment year. In the first scenario, a facility-based clinician or group meets the case minimum for at least one cost performance category measure and receives a cost performance category percent score as defined at § 414.1380(b)(2). The respective quality and cost scores will be multiplied by the available points in the quality performance category (45 points) and the available points where to buy zithromax over the counter in the cost performance category (15 points) to determine the combined contribution of the quality performance category and the cost performance category to the final score out of the available 60 points. In the second scenario, a facility-based clinician or group does not meet the case minimum for any cost performance category measure and the cost performance category weight is redistributed to the quality performance category so the quality performance category score alone determines the score out of the available 60 points.

Table 65 shows where to buy zithromax over the counter these two scenarios. Start Printed Page 65526 In the CY 2020 PFS final rule, we established a redistribution policy for the CY 2020 performance period/2022 MIPS payment year at § 414.1380(c)(2)(ii)(D), for scenarios when the cost performance category weight is redistributed to the Promoting Interoperability performance category, as well as to the quality performance category (84 FR 63028). Under this policy, the weights of the combined quality and cost performance categories could be different for a clinician or group under facility-based measurement and outside of facility-based measurement in circumstances in which the clinician or group was not scored on the cost performance category outside of facility-based measurement but was scored on all other performance categories. Table 66 shows the scenario in which the combined weights of the quality and cost performance categories differ if cost is included, which occurs when the cost performance category is where to buy zithromax over the counter redistributed, and all other categories are scored.

We established similar redistribution policies for CY 2021 performance period/2023 MIPS payment year and CY 2022 performance period/2024 MIPS payment year at § 414.1380(c)(2)(ii)(E) and (F) in that same rule (84 FR 63029 through 63031), which also described situations where the combined weight of the cost and quality performance categories was not always consistent. For more on the background and proposed policies related to redistribution of performance where to buy zithromax over the counter categories, please see section IV.A.3.e.(2)(b)(iii) of this final rule. Based on inquires we received from clinicians who were eligible for facility-based measurement, we believe our policy for determining the combined quality and cost performance category scores via facility-based measurement and outside of facility-based measurement is not ideal because it could result in a facility-based clinician or group receiving a lower final score than they would otherwise receive outside of facility-based measurement. We considered whether this more complex consideration of the scores and the weights in the performance categories necessitated a reconsideration of an opt-in requirement for facility-based measurement.

However, we believe that establishing such a requirement would create administrative burden where to buy zithromax over the counter for clinicians and groups. Instead of adding an opt-in requirement, we proposed a new policy to determine the MIPS final score for clinicians and groups who are eligible for facility-based measurement. We proposed at § 414.1380(e)(6)(vi)(B) that beginning with the CY 2022 performance period/2024 MIPS payment year, the MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology unless a clinician or group receives a higher MIPS final score through another MIPS submission where to buy zithromax over the counter. Under this proposed policy, we will calculate two final scores for clinicians and groups who are facility-based.

One score will be based on the clinician or group's performance and the weights of the performance categories if facility-based measurement did not apply, and the other will be based on the application of facility-based measurement. The example below shows how this proposed policy will apply for a facility-based group that did not meet the case minimum for any of the cost measures but was where to buy zithromax over the counter scored on all other performance categories. As a result of this policy, the group in this example will receive a final score on the basis of their performance outside of facility-based measurement because they have obtained a higher final score through the combination of their submitted quality measures, submitted improvement activities and submitted promoting interoperability measures. We solicited comments on this proposal where to buy zithromax over the counter.

We received public comments on the redistribution of performance category weights under facility-based measurement. The following is a summary of the where to buy zithromax over the counter comments we received and our responses. Comment. A few commenters supported CMS' proposal to take the higher of the two scores when Start Printed Page 65527 determining the final score for facility-based eligible clinicians and groups.

One commenter suggested that where to buy zithromax over the counter CMS adopt this policy starting from CY 2021 performance period/2023 MIPS payment year. Response. We thank the commenters for their support and feedback and note that, as mentioned in the 2021 Facility-Based Measurement Quick Start Guide, because the FY 2022 total performance score from the Hospital Value-Based Purchasing Program will be unavailable, we will not be able to calculate MIPS facility-based scores for the CY 2021 MIPS performance period/2023 MIPS where to buy zithromax over the counter payment year.[] Please refer to https://qpp-cm-prod-content.s3.amazonaws.com/​uploads/​1293/​2021%20MIPS%20Facility%20Based%20Quick%20Start%20Guide.pdf for more information. After consideration of public comments, we finalize the proposal at § 414.1380(e)(6)(vi)(B) that beginning with the CY 2022 performance period/2024 MIPS payment year, the MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology unless a clinician or group receives a higher MIPS final score through another MIPS submission.

F. MIPS Payment Adjustments (1) Background For our previously established policies regarding the final score used to determine MIPS payment adjustments we refer readers to the CY 2021 PFS final rule (85 FR 84917 through 84926), CY 2020 PFS final rule (84 FR 63031 through 63045), CY 2019 PFS final rule (83 FR 59878 through 59894), CY 2018 Quality Payment Program final rule (82 FR 53785 through 53799) and CY 2017 Quality Payment Program final rule (81 FR 77329 through where to buy zithromax over the counter 77343). In the CY 2022 PFS proposed rule (86 FR 39453 through 39458), we proposed. (1) To select the where to buy zithromax over the counter mean as our methodology for calculating the performance threshold.

(2) to establish the performance threshold for the 2024 MIPS payment year using 2019 MIPS payment year data. (3) to establish the additional performance threshold for exceptional performance for the where to buy zithromax over the counter 2024 MIPS payment year. And (4) to update the scoring hierarchy to include subgroups. In addition, we are including information about our timing for providing MIPS performance feedback to clinicians for the performance period in 2020.

(2) Establishing the Performance Threshold Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, the Secretary shall compute a performance threshold with respect to which the final where to buy zithromax over the counter scores of MIPS eligible clinicians are compared for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, and which may be reassessed every 3 years) of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act included a special rule for the initial 2 years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act where to buy zithromax over the counter and an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act, each of which shall be based on a period prior to the performance period and take into account data available for performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary. Section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 (Pub.

L. 115-123, February where to buy zithromax over the counter 9, 2018) amended section 1848(q)(6)(D)(iii) of the Act to extend the special rule to apply for the initial 5 years of MIPS instead of only the initial 2 years of MIPS. In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which includes an additional special rule for the third, fourth, and fifth years of MIPS (the 2021 through 2023 MIPS payment years). This additional special rule provides, for purposes of determining the MIPS payment adjustment factors where to buy zithromax over the counter under section 1848(q)(6)(A) of the Act, in addition to the requirements specified in section 1848(q)(6)(D)(iii) of the Act, the Secretary shall increase the performance threshold for each of the third, fourth, and fifth years to ensure a gradual and incremental transition to the performance threshold described in section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) with respect to the sixth year (the 2024 MIPS payment year) to which the MIPS applies.

We have applied these special rules for the past 5 years to provide for a gradual and incremental transition to the year 6 performance threshold. For further information on established performance threshold policies we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77333 through where to buy zithromax over the counter 77338), CY 2018 Quality Payment Program (82 FR 53787 through 53794), CY 2019 PFS final rule (83 FR 59880 through 59883), the CY 2020 PFS final rule (84 FR 63031 through 63037), and the CY 2021 PFS final rule (85 FR 84919 through 84923). We codified the performance thresholds for each of the first 5 years of MIPS at § 414.1405(b)(4), (5), (6), (7), and (8) as presented in Table 68. Start Printed Page 65528 In the CY 2020 PFS final rule (84 FR 63031 through 63037) at § 414.1405(b)(7) and (8), we finalized the performance thresholds for the 2022 and 2023 MIPS payment years at 45 and 60 points, respectively, an increase of 15 points each year until the 2024 MIPS payment year, for which we estimated that the performance threshold would be 74.01 points.

We believe that this approach effectively provided for a gradual and incremental transition where to buy zithromax over the counter to the performance threshold we had estimated for the 2024 MIPS payment year, as required by the statute. Beginning with the 2024 MIPS payment year, section 1848(q)(6)(D)(i) of the Act requires the performance threshold to be the mean or median (as selected by the Secretary) of the final scores for all MIPS eligible clinicians with respect to a prior period specified by the Secretary. That section also where to buy zithromax over the counter provides that the Secretary may reassess the selection of the mean or median every 3 years. Thus, we considered whether to use the mean or median as the methodology for determining the performance threshold.

We will use this methodology to determine a performance threshold for each of the following 3 years. The 2024 MIPS payment year, where to buy zithromax over the counter 2025 MIPS payment year, and 2026 MIPS payment year. We would then reassess and establish the methodology (mean or median) that we will use for each of the next 3 years (2027 MIPS payment year, 2028 MIPS payment year, and 2029 MIPS payment year). At the time of drafting of this final rule, we have final score data from the CY 2017 performance period/2019 MIPS payment year through the CY 2020 performance period/2022 where to buy zithromax over the counter MIPS payment year available to use in our assessment of whether to use the mean or median as our methodology for the next 3 years.

At this time, however, the targeted review process (see § 414.1385) for the CY 2020 performance period/2022 MIPS payment year has not yet concluded, and the data for the CY 2020 performance period/2022 MIPS payment year may be subject to change as a result of targeted review which began on August 2, 2021, and will conclude on November 29, 2021, at 8:00 p.m., eastern standard time. For more information on the targeted review process, see our announcement sent to our list where to buy zithromax over the counter serve on September 27th, 2021 available at https://qpp-cm-prod-content.s3.amazonaws.com/​uploads/​1631/​2020%20Scoring%20Updates_​EUC%20Reweighting%20Requests%20Extension_​Listserv.pdf. We do not believe it would be appropriate to consider mean and median final scores from the CY 2020 performance period/2022 MIPS payment year for purposes of establishing the performance threshold for the 2024 MIPS payment year in this final rule when those scores may be subject to change as a result of the targeted review process. Furthermore, we are not utilizing final scores from the CY 2020 performance period/2022 MIPS payment for the creation of our regulatory impact analysis model.

For a detailed discussion of the RIA methodology, including where to buy zithromax over the counter the basis of our decision to not use CY 2020 performance period/2022 MIPS payment year data, please see section VI.F.18.a of this final rule. From our review of the data available to us, we have identified the mean and median final scores for each of the 2019 through 2021 MIPS payment years, as shown in Table 69. These six values represent the prior year mean and median final scores that we considered for the 2024 MIPS payment year performance threshold where to buy zithromax over the counter. As shown in Table 69, using the median final score gives a possible range of performance thresholds from 89.71 points to 99.63 points.

Given our performance threshold of 60 points in year 5, these values would result in an increase of 29.71 points to 39.63 points for year 6. Selecting the median of final scores as our methodology would, at a minimum, nearly double the where to buy zithromax over the counter annual increase in the performance threshold of 15 points that we had from year 2 to year 5 of the program. Section 1848(q)(6)(D)(iv) of the Act required that we increase the performance threshold for each of the third, fourth, and fifth years of MIPS to ensure a gradual and incremental transition to the performance threshold we estimated with respect to the sixth year of MIPS. In prior rules we estimated the where to buy zithromax over the counter year six Start Printed Page 65529 performance threshold to be 74.01 points and used this estimate to determine how to gradually raise the performance threshold (83 FR 59881, 84 FR 63032, 84 FR 40802).

Although section 1848(q)(6)(D)(iv) of the Act does not require this approach for the sixth year and subsequent years of MIPS, we believe that it is appropriate to set the performance threshold at a level that is in line with our previous estimates for year 6. We believe that continuing the gradual and incremental increase into year 6 would provide consistency to our stakeholders. After evaluating the possible values shown in Table 69, we believe that using the mean as our methodology where to buy zithromax over the counter would continue this approach. Using the mean final score as the methodology would yield a possible range of performance thresholds from 74.65 points to 85.61 points (rounded to 75 points and 86 points respectively).

Given our performance threshold of 60 points in year 5, these values would result in an increase of 15 points to 26 points where to buy zithromax over the counter for year 6. Given these values and our annual performance threshold increases of 15 points for years 2 to 5 of the program, 75 is the value that is most consistent with the gradual and incremental approach that we have elected to continue. Therefore, we proposed at § 414.1405(g) that for each of the 2024, 2025, and 2026 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible where to buy zithromax over the counter clinicians from a prior period as specified under § 414.1405(b). This methodology will be used for MIPS payment years 2024 through 2026 of the program after which we will reassess the methodology for MIPS payment years 2027 through 2029.

In addition to selecting the methodology (mean or median), section 1848(q)(6)(D)(i) of the Act also requires us to specify a prior period from which we will use the final scores for all MIPS eligible clinicians to calculate the mean or median. As shown in Table 69, the mean final scores are 74.65, 87, and 85.61 points for MIPS payment where to buy zithromax over the counter years 2019 through 2021 respectively. In previous rules (83 FR 59881, 84 FR 63032), we used the MIPS payment year 2019 mean final score to estimate a performance threshold of 74.01 points for year 6 of the program. Our data have been updated to reflect completed targeted reviews since the time we made this estimate, and the mean final score for the 2019 MIPS payment year is now 74.65 points where to buy zithromax over the counter (see Table 69).

This value would be an increase of almost exactly 15 points from the MIPS payment year 2023 performance threshold of 60 points, which is identical to the increases of the previous 3 years and consistent with our intention to continue the gradual and incremental approach that has been utilized in prior years. After reviewing the available final score data, we proposed at § 414.1405(b)(9) to use the MIPS payment year 2019 as the prior period and the rounded mean final score of 75 points as the year 6 performance threshold. When we establish the performance threshold for future MIPS payment years in future rulemaking, we will reassess using the mean final score for MIPS payment year 2019 as mean where to buy zithromax over the counter final scores for subsequent years become available. We solicited comments on these proposals, as well as the alternative methodology of the median that we considered but did not propose.

Additionally, we solicited comments on calculating the performance threshold using an alternative year's final scores that we considered but did not propose where to buy zithromax over the counter. We received public comments on establishing the performance threshold. The following where to buy zithromax over the counter is a summary of the comments we received and our responses. Comment.

One commenter requested that CMS not roll back or reduce the performance threshold from its current value with the transition to MVPs in future years. The commenter believes that the extended phase in of the performance threshold under traditional MIPS was not necessary and had the unintended consequence of clinicians not where to buy zithromax over the counter taking MIPS as seriously as they should have. The commenter also stated that any phase-in does not advance the goals of transitioning to value-based care. Response where to buy zithromax over the counter.

In future years of the program we will evaluate the data available to us and select a performance threshold in accordance with the requirements of the statute. The gradual and incremental increase in the performance threshold gave clinicians time to anticipate the transition to the statutorily mandated methodology for the performance threshold beginning in year six. The CY 2022 performance period/2024 where to buy zithromax over the counter MIPS payment year is the first year of the program where CMS does not have additional flexibilities and must set the performance threshold at the mean or median of a prior year's final scores, thus ending the performance threshold transition period. While we agree with the commenter that further phase in of the performance threshold is not needed, it is possible the performance threshold numerical value for a future year could be lower than the numerical value for the CY 2022 performance period/2024 MIPS payment year, depending on the final score data available.

Comment where to buy zithromax over the counter. One commenter believes that data from the CY 2019 performance period/2021 MIPS payment year is a better basis for creating performance thresholds than the CY 2017 performance period/2019 MIPS payment year. The commenter believes that the entire structure of the program as where to buy zithromax over the counter far as scoring was very different in 2017 and that 2019 offers a more accurate picture compared to 2017. Response.

We understand that the program has undergone modifications since the CY 2017 performance period/2019 MIPS payment year. However, we have where to buy zithromax over the counter previously stated our intent to use a gradual and incremental approach to raising the performance threshold. For reference, the mean and median final scores for CY 2019 performance period/2021 MIPS payment year are 85.61 and 92.30 respectively and would represent an increase in the performance threshold of 25.61 or 32.3 points. We raised the performance threshold 12 points from CY 2017 performance period/2019 where to buy zithromax over the counter MIPS payment year to CY 2018 performance period/2020 MIPS payment year and raised the performance threshold 15 points in each subsequent year.

We believe that raising the performance threshold 15 points in CY 2022 performance period/2024 MIPS payment year is consistent with our gradual and incremental approach. We recognize that clinicians are facing ongoing difficulties due to the PHE, and we believe that choosing the lowest performance threshold value available to us would gradually increase the performance threshold while minimizing disruption to clinicians during this emergency. Comment where to buy zithromax over the counter. Several commenters supported setting the performance threshold at 75 and using the mean from a prior performance period.

Some commenters stated the 15-point increase aligns with the gradual increase over the last where to buy zithromax over the counter 4 years. One commenter stated it was an attainable goal. A few commenters stated this meant having a larger budget neutral pool to redistribute funds, but one commenter requested more information about impact to their specialty. One commenter supported that it was where to buy zithromax over the counter the lowest of the possible options.

Response. We thank the commenters for their support for setting the performance threshold for the CY 2022 performance period/2024 MIPS payment year at 75 points, for noting that the 15-point increase is the same magnitude as where to buy zithromax over the counter the change in prior years, and for noting that the performance threshold selected was the lowest of the Start Printed Page 65530 possible options. Overall information on prior year's final scores can be found in the corresponding Quality Payment Program Experience Report and specialty specific information can be found in the Public Use File in the QPP resource library ( https://qpp.cms.gov/​resources/​resource-library ). Comment where to buy zithromax over the counter.

A few commenters expressed concern with the proposed performance threshold, specifically for small practices. A few commenters requested setting a separate performance threshold for small practices at a value such as 60, or setting the performance threshold for other practices higher at 85 points. Response where to buy zithromax over the counter. We appreciate this feedback from commenters.

However, as we previously discussed, the statute requires where to buy zithromax over the counter us to set the performance threshold at the mean or median of a prior period's final scores, and we do not have the statutory authority to establish a separate performance threshold for small practices. We also note that CMS does not have the authority to waive the statutory requirements for setting the performance threshold using our extreme and uncontrollable circumstances policies or section 1135 of the Act. We encourage the commenters to look at our estimates of how our proposed policies will affect the payment adjustments, broken down by practice size, for the MIPS 2024 payment year in our regulatory impact analysis (see section VI.F.18.e of this final rule). As shown in where to buy zithromax over the counter the impact analysis, we project the discrepancy in payment adjustments between large and small practices to shrink as a cumulative result of our policies, including raising the performance threshold.

Comment. Many commenters opposed the proposed performance threshold where to buy zithromax over the counter and recommended that CMS lower the performance threshold. Most of these commenters requested that CMS explore ways to use its authority to adjust the performance threshold beginning with the CY 2022 performance period/2024 MIPS payment year. Commenters specifically requested that CMS consider emergency authorities under the PHE such as the section 1135 waiver authority or its Extreme and Uncontrollable where to buy zithromax over the counter Circumstances policy.

Commenters noted the stress of the continuing zithromax on practices. That the proposed performance threshold of 75 points represents a significant increase from the 30 points in 2019 or 45 points for 2020. A few commenters acknowledged that CMS has chosen the lowest value possible (75 points), but the commenters believe that positive payment adjustments will become more difficult to obtain, especially as the where to buy zithromax over the counter buy antibiotics zithromax continues. One commenter expressed concern that clinicians may become frustrated and lose motivation to engage with the MIPS program.

Another commenter stated that the steep increases in the performance threshold assumes that practices will not only perform, as well as they did before buy antibiotics but where to buy zithromax over the counter that they will be able to perform better than before. Some commenters stated that CMS should establish a transitional policy that recognizes the impact of the buy antibiotics PHE. One commenter appreciated the flexibilities that CMS has put in place during the zithromax and urges CMS not to flip a switch in 2022 as if the past 3 years have been business as usual. A few commenters suggested lower performance threshold levels, including 60, where to buy zithromax over the counter 50 and 45.

One commenter requested that CMS delay the increase to the performance threshold until the implementation of MVPs. Response where to buy zithromax over the counter. We understand the commenters concern about the stress the PHE is putting on practices. However, we do not have the authority to set the performance threshold for MIPS payment year 2024 at a value other than the mean or median of where to buy zithromax over the counter the final scores with respect to a prior period, as required by section 1848(q)(6)(D)(i) of the Act.

We agree that positive payment adjustments could be more difficult to obtain with a higher performance threshold and are actively working to keep clinicians engaged with the introduction of MVPs which provide a streamlined way for clinicians to participate in the program with a set of measures that are relevant to their practice. We understand that the performance threshold of 75 represents a steep increase from the pre-zithromax performance threshold of 45 points, which was applicable for the CY 2019 performance period/2021 MIPS payment year. For the past 4 years we have where to buy zithromax over the counter finalized increases of 15 points. We increased the performance threshold from 15 to 30 between the CY 2018 and 2019 performance periods/2020 and 2021 MIPS payment years, from 30 to 45 between the CY 2019 and 2020 performance periods/2021 and 2022 MIPS payment years, and from 45 to 60 between the CY 2020 and 2021 performance periods/2022 and 2023 MIPS payment years.

We acknowledge the where to buy zithromax over the counter commenter's concern that this increase assumes that clinicians will not only perform, as well as they did before buy antibiotics but that they will be able to perform better than before. We note that the proposed increase of 15 points is the same as the increase in the previous 3 years and was based on a gradual and incremental approach to setting the performance threshold. As discussed previously, we are statutorily required to set the performance threshold for the 2024 MIPS payment year at the mean or median of the final scores with respect to a prior period, and we do not have the flexibility to choose other values. We appreciate the commenter's suggestion to where to buy zithromax over the counter adopt a transitional policy for the performance threshold due to the PHE but reiterate that we do not have the flexibility to do so due to the statutory requirements discussed previously.

We also note that CMS does not have the authority to waive the statutory requirements for setting the performance threshold under section 1135 of the Act. Comment where to buy zithromax over the counter. A few commenters opposed the proposed performance threshold for specialty related or practice related reasons. A few commenters were specifically concerned about groups or where to buy zithromax over the counter specialties that can only be measured on two performance categories.

One commenter expressed their opinion that setting the performance threshold at the mean or median of prior final scores of all MIPS eligible clinicians in a prior period was an unfair standard for their specialty because they are limited in their ability to report under the Promoting Interoperability performance category. They stated this limitation gives them fewer opportunities to amass points. Another commenter stated where to buy zithromax over the counter that their group was unable to report Promoting Interoperability performance category measures and would be reweighted in a manner that would increase their cost category weight. A different commenter stated that they have a limited number of quality measures that they can report.

As a result, they stated that for groups such as theirs that have limited measures and a high-weighted quality category, CMS now requires 100 percent quality to meet the performance threshold or otherwise they would where to buy zithromax over the counter receive a negative MIPS payment adjustment. One commenter expressed concern that CRNAs cannot report 6 of the measures in the MIPS Anesthesia Measure set because they do not provide relevant services. The commenter suggested CMS should address how specialties such as anesthesia can meet the performance threshold, perhaps through the use of CAHPS data or by allowing them to report additional Improvement Activities. Response where to buy zithromax over the counter.

We understand that different specialties sometimes face challenges with not being able to report Start Printed Page 65531 measures and activities for every performance category. We agree where to buy zithromax over the counter that the final scores of these clinicians may be based on fewer categories than they would be for a clinician reporting all 4 performance categories. However, we remind clinicians that even if their final score is based on fewer than 4 performance categories they still have the ability to score anywhere from 0 to 100 points for their final score, just as a clinician reporting all 4 performance categories would. In this way, we do not believe that a performance threshold of 75 points is disadvantageous to clinicians reporting fewer than 4 performance categories.

As stated below, we also encourage clinicians that do not have enough quality measures relevant to their scope of practice to work with their specialty societies to provide recommendations during the where to buy zithromax over the counter specialty measure set solicitation process and to consider reporting a relevant MVP when one becomes available. We note, for the commenter who stated that not being able to report Promoting Interoperability would cause their group to be reweighted in a manner that would increase their cost category weight, that the cost category weight would only increase if a group was reweighted for the Promoting Interoperability and Quality performance categories. If a group is reweighted for the Promoting Interoperability where to buy zithromax over the counter performance category only, the cost category weight remains at 30 percent. We believe the commenter who stated that they have a limited number of quality measures that they can report is referring to the possibility that if the weight of other performance categories is redistributed to the quality category, a clinician may need to achieve a high score in quality in order to exceed the proposed performance threshold of 75 points.

We understand where to buy zithromax over the counter that some clinicians may not have 6 measures in the Quality performance category that are relevant to their practice. To address this, we have our eligible measure applicability policy within the quality performance category to reduce the denominator of required measures for the MIPS CQM and Medicare Part B claims collection types, in the event that a clinician has less than 6 applicable measures to report. In this way, clinicians can be scored on the quality measures that are relevant to their scope of practice. For more information on the eligible measure applicability policy please see the CY 2017 through CY 2019 where to buy zithromax over the counter PFS final rules (81 FR 77290 through 77291, 82 FR 53750 through 53732).

For the commenter's concerns on the specialty measures available, we solicit stakeholder recommendations for new specialty measure sets and revisions to existing specialty sets on an annual basis. We urge stakeholders to work with their specialty societies to provide recommendations during the specialty measure set solicitation process (for where to buy zithromax over the counter more information please see the QPP resource library at http://www.qpp.cms.gov ). We are also developing MIPS Value Pathways (MVPs) to provide clinicians with a simplified method to report measures that are relevant to their practice and we encourage them to report an MVP when one that is relevant to their scope of practice is available. We thank the commenter for their suggestion to expand the use of CAHPS or to allow clinicians to report additional improvement activities if they cannot report 6 quality measures.

Comment where to buy zithromax over the counter. Many commenters expressed concern that the proposal to increase the performance threshold to 75 points would increase the number of clinicians receiving a negative payment adjustment and decrease the number of clinicians with positive or neutral adjustments. Many commenters also stated their concern that the increase in the performance threshold comes where to buy zithromax over the counter with several proposed policies to remove bonuses and floors for quality measures and proposals to change quality data completeness which may lower the MIPS final score. A few commenters requested that CMS reconsider the reporting and scoring policies, delay the scoring policies, or gradually phase in the scoring changes, especially if CMS finalized the proposed performance threshold.

One commenter specifically where to buy zithromax over the counter requested continuing current scoring for an additional year. A few commenters noted the difficulty of achieving the performance threshold now compared to a few years ago because of the scoring changes. A few commenters noted the cost of participating in MIPS versus the potential incentive. One commenter cited a study on the cost to participate in MIPS and expressed concern that where to buy zithromax over the counter clinicians would still get negative MIPS payment adjustment after these costs due to a premature increase in the performance threshold following 3 years of flexibilities due to the buy antibiotics PHE.

Response. We acknowledge the commenters concerns regarding the increased burden on clinicians due to the buy antibiotics PHE and agree that the statutory formula for determining the performance threshold beginning with the 2024 MIPS payment year could lead to additional clinicians where to buy zithromax over the counter receiving a negative payment adjustment. The MIPS is a budget neutral program and is designed in the statute to balance the positive payment adjustments of clinicians who score above the performance threshold against the negative payment adjustments of clinicians whose scores are below the performance threshold. We encourage the commenter to look at our estimates of how our proposed policies will affect the payment adjustments for the MIPS 2024 payment year in our regulatory impact analysis (see section VI.F.18.e of this final rule).

In light of the continuing burden of the PHE we are making changes to some scoring flexibility proposals including postponing the removal of the where to buy zithromax over the counter 3-point scoring floor on quality measures and keeping the data completeness threshold at 70 percent (see section IV.A.3.e.(1)(c)(iii)(B) of this final rule). We are also introducing some new flexibilities including a 7-point floor for scoring new measures in their first year and a 5-point floor in their second year (see section IV.A.3.e.(1)(c)(iii)(B) of this final rule). Comment where to buy zithromax over the counter. A few commenters discussed refinements for the performance threshold methodology.

One commenter suggested CMS determine what the mean or median of where to buy zithromax over the counter “raw” or “achievement” final performance scores would be and use that figure to set the 2022 threshold. The commenter stated that CMS only uses the base quality measure score, absent any bonus points, to determine improvement scoring in the Quality category. Therefore, the commenter stated that method could be used in setting the performance threshold as well. Another commenter recommended that where to buy zithromax over the counter CMS evaluate balancing the reported data from 2019, 2020, and 2021 to control for self-selection bias since the commenter believed MIPS reporting has been fundamentally voluntary for these performance periods.

One commenter asked what the agency's intent is with respect to performance thresholds and quality benchmark data going forward given that CY 2022 performance period/2024 MIPS payment year benchmarks will be based on CY 2022 performance period data while CY 2024 performance period/2026 MIPS payment year benchmarks appear to revert to performance period 2017 data. The commenter noted the performance threshold is based on CY 2017 performance period data while benchmarks where to buy zithromax over the counter are proposed to be based on CY 2022 performance period data. Response. We appreciate the commenter's suggestion to use a “raw” or “achievement” score to set the performance threshold.

We interpret the Start Printed Page 65532 suggestion of “raw” or “achievement” scores to mean removing any performance category bonuses, final where to buy zithromax over the counter score bonuses or improvement scoring. We note section 1848(q)(6)(D)(i) of the Act requires us to set the performance threshold using composite performance scores, which we refer to as the final score as defined under § 414.1305 (81 FR 77319 through 77320). We do not believe that the statute allows us to use “raw” or “achievement” where to buy zithromax over the counter scores when setting the performance threshold. We thank the commenter for the suggestion of balancing the scores from 2019, 2020, and 2021 but reiterate that the statute requires us to choose the mean or median from a prior period and does not allow us to balance scores from multiple years.

We refer the commenter to section IV.A.3.e(1)(c)(ii) of this final rule, where we are not finalizing our proposal to use performance period benchmarks and instead we will continue to use historic quality benchmarks for the CY 2022 performance period/2024 MIPS payment year will be based on CY 2020 performance period data. In regards where to buy zithromax over the counter to the comment on using 2017 data for purposes of the CY 2024 performance period/2026 MIPS payment year benchmarks, we note that we have not yet made any proposals on quality benchmarks for the CY 2024 performance period/2026 MIPS payment year. Comment. One commenter supported the larger size of positive payment adjustments where to buy zithromax over the counter that a higher performance threshold would cause due to a greater quantity of money being redistributed through BN, but requested more information on the impact to specialties and practices.

The commenter stated that this information will give societies a stronger argument for their membership as to why clinicians should continue to participate in MIPS. Response where to buy zithromax over the counter. We encourage the commenter to read our projections of the impact of the Quality Payment Program Finalized policies on payment adjustments for MIPS payment year 2024 in our Regulatory Impact Analysis (see section VI.F.18.e of this final rule). We also note that CMS publishes a Quality Payment Program Experience Report and Public Use File at https://qpp.cms.gov/​resources/​resource-library.

A detailed breakdown of a prior year's scores can be found in the QPP Experience Report and specialty specific information can be found in where to buy zithromax over the counter the Public Use File. After consideration of public comments, we are finalizing our proposal at § 414.1405(g) that for each of the 2024, 2025, and 2026 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible clinicians from a prior period as specified under § 414.1405(b). We are also finalizing our proposal at § 414.1405(b)(9) to use the MIPS payment year 2019 as the where to buy zithromax over the counter prior period and the rounded mean final score of 75 points as the year 6 performance threshold. (3) Additional Performance Threshold for Exceptional Performance Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to compute, for each year of the MIPS (beginning with the 2019 MIPS payment year and ending with the 2024 MIPS payment year), an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors for exceptional performance under section 1848(q)(6)(C) of the Act.

For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold. (1) The threshold shall be the score that is equal to the 25th percentile of the range of possible final scores above the performance threshold determined under where to buy zithromax over the counter section 1848(q)(6)(D)(i) of the Act. Or (2) the threshold shall be the score that is equal to the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act. Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician with a final score at or where to buy zithromax over the counter above the additional performance threshold will receive an additional MIPS payment adjustment factor and may share in the $500 million of funding available for the year under section 1848(q)(6)(F)(iv) of the Act.

We note that under section 1848(q)(6)(F)(iv) of the Act, funding is available for additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act only through the 2024 MIPS payment year, which is the sixth year of the MIPS program. In the CY 2020 PFS final rule (84 FR 63037 through where to buy zithromax over the counter 63040), we used the special rule under section 1848(q)(6)(D)(iii) of the Act to set the additional performance threshold at 85 points for the 2022 and 2023 MIPS payment years. We note that the special rule under section 1848(q)(6)(D)(iii) of the Act applies only to the initial 5 years of MIPS, so we cannot use that rule to establish the additional performance threshold for the 2024 MIPS payment year. As noted above, under section 1848(q)(6)(D)(ii) of the Act, we may set the additional performance threshold at either.

(1) The 25th percentile of the range of possible final scores above the where to buy zithromax over the counter performance threshold, or (2) the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act. In the CY 2022 PFS proposed rule (86 FR 39453), for illustrative purposes, we referenced the possible additional performance thresholds shown in Table 70. Note that mean or median refers to where to buy zithromax over the counter the methodology for calculation of the performance threshold. As can be seen in Table 70, the potential values for the additional performance threshold range from a low of 81.26 to a high of 100.

However, to remain consistent with our gradual and incremental approach, we proposed to use the mean as our methodology for setting the performance threshold during the next 3 years and Start Printed Page 65533 we proposed to use the final score data from MIPS payment year 2019. We are where to buy zithromax over the counter finalizing these proposals in section IV.A.3.f.2 of this final rule. The selection of the mean for the methodology and final score data from the 2019 MIPS payment year leaves us with the options in the first column of Table 70 for where we can set the additional performance threshold. With a performance threshold of 75 points for the 2024 MIPS payment year based on final scores for the 2019 MIPS payment where to buy zithromax over the counter year, the calculation methods in section 1848(q)(6)(D)(ii) of the Act give us two possible options for where we can set the additional performance threshold for MIPS payment year 2024.

The first calculation method (described in section 1848(q)(6)(D)(ii)(I) of the Act), using the range of possible final scores above the proposed performance threshold for the 2024 MIPS payment year, yields a value of 81.26 points (the 25th percentile of the range of 75.01 to 100). The calculation is as where to buy zithromax over the counter follows. 75.01 + [(100−75.01) * 0.25] = 81.26. The second calculation method (described in section 1848(q)(6)(D)(ii)(II) of the Act), the 25th percentile of the actual final scores for the 2019 MIPS payment year at or above the proposed performance threshold for the 2024 MIPS payment year, yields a value of 88.94.

For the second calculation method, we will where to buy zithromax over the counter apply the 25th percentile calculation of (n+1)p/100 to the 2019 MIPS payment year final score data that are at or above 75. We considered using each of these methods, but we do not believe that it would be appropriate to lower the additional performance threshold to 81.26 points from its present value of 85 points. Maintaining or increasing the additional performance threshold will serve as a greater incentive to clinicians to continue to improve their performance on the MIPS measures and activities where to buy zithromax over the counter and to achieve exceptional performance. We believe that an additional performance threshold of 88.94 points rounded to 89 points is appropriate.

This is an increase of 4 points from the prior year, which we believe is a gradual increase. Therefore, using the second calculation method where to buy zithromax over the counter described above, we proposed at § 414.1405(d)(7) to set the additional performance threshold for the 2024 MIPS payment year at 89 points. We solicited comments on these proposals, as well as the alternative additional performance thresholds listed that we considered but did not propose. We received where to buy zithromax over the counter public comments on the additional performance threshold for exceptional performance.

The following is a summary of the comments we received and our responses. Comment where to buy zithromax over the counter. A few commenters expressed concern about the exceptional performance funding under section 1848(q)(6)(F)(iv) of the Act ending after the CY 2022 performance period/2024 MIPS payment year. One commenter believes that eliminating this funding is contradictory to the mission of the Quality Payment Program as it provides an additional incentive for improving performance.

A few commenters expressed concerns about the cost of participating in MIPS and where to buy zithromax over the counter that the majority of the MIPS adjustment has been funded from the exceptional performance funding under section 1848(q)(6)(F)(iv) of the Act rather than from negative payment adjustments. Some commenters requested that CMS work with Congress to extend the funding. Response where to buy zithromax over the counter. We acknowledge the commenters' concern about the exceptional performance funding under section 1848(q)(6)(F)(iv) of the Act ending after the CY 2022 performance period/2024 MIPS payment year.

We acknowledge that in previous years the additional performance threshold has funded a large portion of positive MIPS payment adjustments. However, we point the commenter to where to buy zithromax over the counter our Regulatory Impact Analysis (see section VI.F.18.e of this final rule) where we estimate that positive MIPS payment adjustments funded by BN will be much higher than in previous years. Comment. A few commenters suggested that CMS should consider using the section 1135 waiver authority it has under the PHE or its Extreme and Uncontrollable Circumstances policy to waive the statutory requirement to where to buy zithromax over the counter set the additional performance threshold at either.

(1) The 25th percentile of the range of possible final scores above the performance threshold, or (2) the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold with respect to the prior period described in section 1848(q)(6)(D)(i) of the Act, and instead keep the additional performance threshold at 85 points in 2022. Response. We note that CMS does not have the authority to waive the statutory requirements for where to buy zithromax over the counter setting the additional performance threshold using our extreme and uncontrollable circumstances policies or section 1135 of the Act. Comment.

One commenter acknowledged the two statutory options CMS presented for the where to buy zithromax over the counter additional performance threshold (81.26 and 88.94), but urged CMS to use PHE authorities to maintain the additional performance threshold at 85 points instead of 89 points. The commenter stated that it gives clinicians a final opportunity to qualify for this funding and takes into account the unusual operational and clinical circumstances present during the buy antibiotics zithromax. Response where to buy zithromax over the counter. We agree with the commenter that there have been unusual operational and clinical circumstances for clinicians during the buy antibiotics zithromax.

However, we are not aware of any PHE authorities available to CMS that would allow us to set the additional performance threshold for the 2024 MIPS payment year at any value other than those resulting from the calculation methods described in section 1848(q)(6)(D)(ii) of the Act. Comment where to buy zithromax over the counter. A few commenters supported the additional performance threshold. One commenter where to buy zithromax over the counter stated that the increase to the additional performance threshold increases the difficulty but still makes the additional positive payment adjustment an attainable goal.

Response. We thank the commenters for their support. Comment where to buy zithromax over the counter. A few commenters supported a lower additional performance threshold.

Some commenters requested that CMS where to buy zithromax over the counter select the option of 81 points rather than the proposed 89 points to account for loss of score potential due to removal of bonus points in the quality performance category and the increased weight of the cost performance category. One commenter noted that CMS has the latitude to select 81 points as it meets the 25th percentile of possible scores and believes that the lower additional performance threshold will incentivize a greater number of clinicians. The commenter also noted that choosing a lower additional performance threshold will allow CMS to where to buy zithromax over the counter both reward top performers in MIPS and incentivize more of them by setting reasonable thresholds to reward them for their performance. Other commenters requested keeping the additional performance threshold at 85 points.

Response. We established the where to buy zithromax over the counter additional performance threshold at 85 points for the 2022 and 2023 MIPS payment years in the CY 2020 PFS final rule (84 FR 63037 through 63040). We do not believe that it is appropriate to set the additional performance threshold at a lower value (81 points) than it was set at for the CY 2020 performance period/2022 MIPS payment year nor do we have the authority to keep the additional Start Printed Page 65534 performance threshold at 85 points as was requested by the commenter. We believe that 89 points is an appropriate value to incentivize the highest performing clinicians, given that the where to buy zithromax over the counter threshold has been 85 points for the past 2 years.

After consideration of public comments, we are finalizing the proposal at § 414.1405(d)(7) to set the additional performance threshold for the 2024 MIPS payment year at 89 points. (4) Example of Adjustment Factors Figure A provides an illustrative example of how various final scores will be converted to a MIPS payment adjustment factor and potentially an additional MIPS payment adjustment factor, using the statutory formula and based on our finalized policies for the 2024 MIPS payment year. In Figure A, the performance threshold is set at where to buy zithromax over the counter 75 points. The applicable percentage is 9 percent for the 2024 MIPS payment year.

The MIPS payment adjustment factor is determined on a linear sliding scale from zero to where to buy zithromax over the counter 100, with zero being the lowest possible score which receives the negative applicable percentage (negative 9 percent for the 2024 MIPS payment year) and resulting in the lowest payment adjustment, and 100 being the highest possible score which receives the highest positive applicable percentage and resulting in the highest payment adjustment. However, there are two modifications to this linear sliding scale. First there is an exception for a final score between zero and one-fourth of the performance threshold (zero where to buy zithromax over the counter and 18.75 points based on the performance threshold of 75 points for the 2024 MIPS payment year). All MIPS eligible clinicians with a final score in this range will receive the lowest negative applicable percentage (negative 9 percent for the 2024 MIPS payment year).

Second, the linear sliding scale line for the positive MIPS payment adjustment factor is adjusted by the scaling factor, which cannot be higher than 3.0. If the scaling factor is where to buy zithromax over the counter greater than zero and less than or equal to 1.0, then the MIPS payment adjustment factor for a final score of 100 will be less than or equal to 9 percent. If the scaling factor is above 1.0 but is less than or equal to 3.0, then the MIPS payment adjustment factor for a final score of 100 will be greater than 9 percent. Only those MIPS eligible clinicians where to buy zithromax over the counter with a final score equal to 75 points (which is the finalized performance threshold) will receive a neutral MIPS payment adjustment.

Because the performance threshold is 75 points, we anticipate that more clinicians will receive a positive adjustment than a negative adjustment and that the scaling factor will be less than 1 and the MIPS payment adjustment factor for each MIPS eligible clinician with a final score of 100 points will be less than 9 percent. Start Printed Page 65535 Table 71 illustrates the changes in payment adjustment based on the final policies from the CY 2021 PFS final rule (85 FR 84923 through 84925) for the 2023 MIPS payment year and the final policies for the 2024 MIPS payment year, as well as the applicable percent required by section 1848(q)(6)(B) of the Act. Start Printed Page 65536 (5) Final Score Hierarchy Used in Payment Adjustment Calculation In the CY 2021 PFS final rule (85 where to buy zithromax over the counter FR 84917 through 84919), we modified the final score hierarchy that applies when more than one final score is associated with a TIN/NPI, as displayed in Table 72. Beginning with the CY 2021 performance period/2023 MIPS payment year, if a TIN/NPI has a virtual group final score associated with it, we use the virtual group final score to determine the MIPS payment adjustment.

If a TIN/NPI does not have where to buy zithromax over the counter a virtual group final score associated with it, we use the highest available final score associated with the TIN/NPI to determine the MIPS payment adjustment. Start Printed Page 65537 In the CY 2022 PFS proposed rule (86 FR 39457), we proposed policies applicable to subgroups, including a definition of a subgroup at § 414.1305 as a subset of a group which contains at least one MIPS eligible clinician and is identified by a combination of the group TIN, subgroup identifier, and each eligible clinician's NPI. Each clinician in a subgroup where to buy zithromax over the counter would be identifiable by a unique TIN/NPI combination just as in any MIPS group or APM Entity. In addition, a clinician, group, subgroup, or APM Entity could choose more than one MIPS reporting option for a performance period.

A clinician, group, subgroup, or APM Entity could choose to report through MVPs, traditional MIPS, and/or the APP (assuming they are eligible for each of these reporting options) for a performance period. As a result, there could be more than one final score for a clinician, group, where to buy zithromax over the counter subgroup, or APM Entity for a performance period from MVPs, traditional MIPS, and/or the APP. Therefore, we proposed to update the scoring hierarchy to include subgroups and to specify that the scoring hierarchy would apply with respect to any available final score that is associated with a TIN/NPI from MVPs, traditional MIPS, and/or the APP. The proposed updated scoring hierarchy where to buy zithromax over the counter can be seen in Table 73.

We solicited comments on this proposal. We received public comments on the proposed updated scoring hierarchy. The following is a summary of the comments we received and where to buy zithromax over the counter our responses. Comment.

A few commenters requested clarification on the scoring hierarchy where to buy zithromax over the counter. One commenter expressed concerns with the modified hierarchy, citing the complexity of adding subgroups to MIPS and concerns about allowing ACO clinicians to report outside the ACO. The commenter recommended that to reduce complexity, ACO performance should be evaluated at the ACO level for MIPS evaluations. Another commenter noted confusion about where to buy zithromax over the counter how payment adjustments would be calculated and applied for clinicians reporting an MVP as part of a subgroup.

Response. We acknowledge where to buy zithromax over the counter the commenters concern about the complexity of the scoring hierarchy for ACO reporters. However, we disagree with the recommendation that ACOs only be evaluated at the ACO level. CMS is introducing subgroups to collect data at a where to buy zithromax over the counter more granular level that will be more useful for beneficiaries to use to make informed healthcare decisions.

Having data at the subgroup level will allow beneficiaries to evaluate performance data, especially performance data about specialists, that is more closely related to the actual clinicians the beneficiaries may see for their medical care. We also note that subgroup scores will not be rolled up to the ACO level. If a TIN reports as a subgroup, the subgroup score would only be applicable to the NPIs where to buy zithromax over the counter in the subgroup. Comment.

A few commenters supported the proposed scoring where to buy zithromax over the counter hierarchy. Commenters appreciated CMS' intent to select the highest final score achieved for a TIN/NPI across the QPP pathways for individual, group subgroup or APM entity. Response. We thank where to buy zithromax over the counter the commenter for their support.

Comment. One commenter asked CMS to confirm that a MIPS eligible clinician that participates in MVPs via multiple subgroups would receive the highest final score that can be attributed to their TIN/NPI combination from any reporting option (traditional MIPS, APP where to buy zithromax over the counter reporting, or any MVP subgroup reporting) and participation option (as an individual, group, subgroup, or APM Entity (with the exception of virtual groups). Response. The commenter is correct that, with the exception of virtual groups, a MIPS eligible clinician will receive the highest final score that can be attributed to where to buy zithromax over the counter their TIN/NPI combination from the listed reporting options (traditional MIPS, APP, or MVPs) and participation options (individual, group, subgroup, or APM entity).

After consideration of public comments, we are finalizing the proposed updated scoring hierarchy as proposed. G. Review and Correction of MIPS Final Score (1) Feedback and Information To Improve Performance Under section 1848(q)(12)(A)(i) of the Act, we are at a minimum required to provide MIPS eligible clinicians with timely (such as quarterly) confidential feedback on their performance under the quality and cost performance categories beginning July where to buy zithromax over the counter 1, 2017, and we have discretion to provide such feedback regarding the improvement activities and Promoting Interoperability performance categories. In the CY 2018 Quality Payment Program final rule (82 FR 53799 through 53801), we finalized that on an annual basis, beginning July 1, 2018, performance feedback will be provided to MIPS eligible clinicians and groups for the quality and cost performance categories, and if technically feasible, for the improvement activities and advancing care information (now called the Promoting Interoperability) performance categories.

On July 1, where to buy zithromax over the counter 2018, we provided the first performance feedback for the Quality Payment Program. The second performance feedback was provided on July 1, 2019. In the CY 2021 PFS proposed rule (85 FR 50321), we noted that we aim to provide performance feedback on or around July 1 of each year, but due to the PHE and buy antibiotics, we estimated that we would provide performance feedback for the performance period in 2019 in late July Start Printed Page 65538 or early August of 2020. The third performance feedback (for the CY 2019 where to buy zithromax over the counter performance period) was provided on August 5, 2020.

In the proposed rule, we noted that similar to the CY 2019 performance period, due to the PHE for buy antibiotics, we may provide performance feedback for the CY 2020 performance period after July 1, 2021. Although we aim to provide performance feedback on or where to buy zithromax over the counter around July 1 of each year, it is possible that the release date could be later than July 1 depending on the circumstances. We provided performance feedback for the CY 2020 performance period on August 2 and September 27, 2021. We direct readers to qpp.cms.gov for more information where to buy zithromax over the counter.

h. Third Party Intermediaries We refer readers to §§ 414.1305 and 414.1400, the CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390), the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819), the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS final rule (84 FR 63049 through 63080), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (85 FR 84926 through 84947) for our previously established policies regarding third party intermediaries. As discussed in the CY where to buy zithromax over the counter 2022 PFS proposed rule (86 FR 39458), we proposed to make several changes. (1) Reorganization and consolidation of § 414.1400 generally.

(2) new third where to buy zithromax over the counter party intermediaries general requirements. (3) new requirements specific to both QCDRs and qualified registries. (4) new requirements specific to only QCDRs. And (5) where to buy zithromax over the counter remedial action and termination of third parties.

(1) Reorganization and Consolidation of § 414.1400 Generally We recognize that many of our policies for third party intermediaries are similar or verbatim, and yet in prior rules, we have described them separately. To minimize where to buy zithromax over the counter the lengthiness and burden of reading our policies, we proposed to consolidate our regulatory text under § 414.1400. To be clear, our proposed updates would not change previously finalized requirements for third party intermediaries, but would bring more clarity and simplicity to the regulatory text. These changes are discussed by topic in more detail below.

We also where to buy zithromax over the counter note that in several places at § 414.1400 the regulation text was only updated to reflect both the applicable MIPS performance period/MIPS payment year. (a) Reorganization for Requirements Related to MIPS Performance Categories That Must Be Supported by Third Party Intermediaries We previously established in the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364), further revised in the Quality Payment Program provisions in the CY 2019 and CY 2020 PFS final rules ((83 FR 60088 and 84 FR 63049 through 63052, respectively), and further clarified our requirements for QCDRs, qualified registries, and health IT vendors with regards to submitting data for the purposes of the MIPS program in the Quality Payment Program provisions in the CY 2021 PFS final rule. Our current policy, codified at § 414.1400(a)(2), states that, beginning with the CY 2021 performance period/2023 MIPS where to buy zithromax over the counter payment year, QCDRs and qualified registries must be able to submit data for all of the following MIPS performance categories, and Health IT vendors must be able to submit data for at least one of the following MIPS performance categories. Except as provided under paragraph (a)(2)(ii), QCDRs, qualified registries, and health IT vendors must be able to submit data for all of the following MIPS performance categories.

Quality, where to buy zithromax over the counter except. ++ The CAHPS for MIPS survey. And ++ For qualified registries and Health IT vendors, QCDR measures. Improvement activities where to buy zithromax over the counter.

And • Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT. However, a where to buy zithromax over the counter third party intermediary may be excepted from this requirement if its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 ) or ( 5 ) or (c)(2)(i)(C)( 1 ) through ( 7 ) or (c)(2)(i)(C)(9)). ++ Health IT vendors that do not support MIPS Value Pathways must be able to submit data for at least one of the MIPS performance categories described in paragraphs (a)(2)(i)(A) through (C) of this section. ++ Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT.

However, a third party intermediary may be excepted from this requirement if its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 ) or ( 5 ) or § 414.1380(c)(2)(i)(C)( 1 ) through ( 7 ) or § 414.1380(c)(2)(i)(C)( 9 where to buy zithromax over the counter )). In an effort to simplify, we proposed reorganizing the existing language at § 414.1400(a)(2). Specifically, we proposed where to buy zithromax over the counter providing updates to separately identify and provide clarity to data submission requirements since data requirements vary based on third party intermediary type and to provide clarification to exceptions to Promoting Interoperability for virtual groups and subgroups. We proposed the following updates.

To revise and redesignate existing paragraph at § 414.1400(a)(2) through (a)(2)(i) to proposed where to buy zithromax over the counter paragraphs § 414.1400(b)(1)(i) and (c)(1) through (c)(1)(i) to state the following. To state at proposed § 414.1400(b)(1)(i), beginning with the CY 2021 performance period/2023 MIPS payment year, QCDRs and qualified registries must be able to submit data for all of the following MIPS performance categories. Quality, except. ++ The CAHPS for where to buy zithromax over the counter MIPS survey.

And ++ For qualified registries, QCDR measures. Improvement where to buy zithromax over the counter activities. And Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless. ++ The third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 )( i ) through ( iii ) or (c)(2)(i)(C)( 1 ) through (7) or (c)(2)(i)(C)( 9 )).

To state at proposed § 414.1400(c)(1), beginning with the CY 2021 performance period/2023 MIPS payment year, health IT vendors must be able to submit data for the MIPS where to buy zithromax over the counter performance categories as follows. To state at proposed § 414.1400(c)(1)(i) through (c)(1)(i)(B), health IT vendors that support MVPs must be able to submit data for all of the MIPS performance categories. Quality, except where to buy zithromax over the counter. ++ The CAHPS for MIPS survey.

And ++ QCDR measures where to buy zithromax over the counter. Improvement activities. And To revise and redesignate existing paragraph at § 414.1400(a)(2)(iii) to proposed paragraph § 414.1400(c)(1)(i)(C) state, Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless. ++ The third party intermediary's MIPS eligible where to buy zithromax over the counter clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 )( i ) through ( iii ) or (c)(2)(i)(C)( 1 ) through ( 7 ) or (c)(2)(i)(C)( 9 ).

• To revise and redesignate existing paragraph at § 414.1400(a)(2)(ii) to proposed paragraph § 414.1400(c)(1)(ii) to state, health IT vendors that do not support MVPs must be able to submit data for at least one of the MIPS Start Printed Page 65539 performance categories described in paragraphs (c)(1)(i) through (iii) of this section. We proposed where to buy zithromax over the counter to create a new requirement at § 414.1400(c)(1)(iii) for health IT vendors to support MVPs. For more information on this proposal, please refer to section “proposed new requirement for third party intermediaries to support MVPs and the APP” at section IV.A.3.h.(2)(b)(i) of this final rule. To move the current Health IT vendor requirements from paragraphs §§ 414.1400(a)(2)(ii) through (iii) and (d) to a new paragraph applicable to Health IT vendor requirements at § 414.1400(c).

This will separately identify and provide clarity to data submission requirements specific where to buy zithromax over the counter to Health IT vendors. To move the current CMS-approved survey vendor requirements from paragraphs (a)(3) and (e) to a new paragraph applicable to CMS-approved survey vendor requirements at § 414.1400(d). We proposed to the redesignate paragraph (a)(3) current requirements to paragraph (d)(1) CMS-approved survey vendors may submit data on where to buy zithromax over the counter the CAHPS for MIPS survey for the MIPS quality performance category. For the current requirements at paragraph (e), we proposed to move up those requirements to paragraph (d)(2).

To redesignate paragraph (a)(4) as paragraph (a)(2) where to buy zithromax over the counter. To redesignate paragraph (a)(5) as paragraph (a)(3). We solicited public comments on our proposals. We did where to buy zithromax over the counter not receive public comments on these proposals, and therefore, we are finalizing them as proposed.

(b) Reorganization for Requirements Related QCDR and Qualified Registries Self-Nomination We proposed to consolidate and redesignate the existing language at § 414.1400(b)(1) and (c)(1) to proposed § 414.1400(b)(2) to reference both QCDR and qualified registries. We proposed this consolidation to provide clarity and alignment with the where to buy zithromax over the counter aforementioned proposals and consolidate the duplicative criteria of QCDRs and qualified registries. As discussed below, we also proposed to consolidate and redesignate the performance feedback requirements previously at existing § 414.1400(b)(1) and (c)(1) to § 414.1400(b)(3)(iii). We proposed to state at § 414.1400(b)(2), Self-nomination.

For the CY 2018 and 2019 performance periods/2020 and 2021 MIPS payment where to buy zithromax over the counter years, entities seeking to qualify as a QCDR or qualified registry must self-nominate September 1 until November 1 of the CY preceding the applicable performance period. For the CY 2020 performance period/2022 MIPS payment year and future years, entities seeking to qualify as a QCDR or qualified registry must self-nominate during a 60-day period during the CY preceding the applicable performance period (beginning no earlier than July 1 and ending no later than September 1). Entities seeking to qualify as a QCDR or qualified registry for a performance period must provide all information required by CMS at the time of self-nomination and must provide where to buy zithromax over the counter any additional information requested by CMS during the review process. For the CY 2019 performance period/2021 MIPS payment year and future years, existing QCDRs and qualified registries that are in good standing may attest that certain aspects of their previous year's approved self-nomination have not changed and will be used for the applicable performance period.

We also proposed removing the last two sentences of existing § 414.1400(b)(1), which are duplicative with existing § 414.1400(b)(3)(iii). We proposed consolidating where to buy zithromax over the counter this language with existing paragraph (b)(3)(iii). We solicited public comments on our proposals. The following is a where to buy zithromax over the counter summary of the comments we received and our responses.

Comment. One commenter suggested that we refine the QCDR option under MIPS to streamline the where to buy zithromax over the counter self-nomination process, and to provide better incentives for organizations, including medical associations, to continue to invest in their QCDRs and develop new, meaningful measures for specialists to use for MIPS reporting and other clinical and research purposes. Response. We thank the commenter for their suggestion.

We may consider where to buy zithromax over the counter it for future rulemaking. Comment. One commenter expressed support for the updates that CMS has made to the QCDR and qualified registry where to buy zithromax over the counter self-nomination process, including the development of the measure submission portal at QualityPaymentProgram.cms.gov. Response.

We thank the commenter for their support. After consideration of public comments, we are finalizing these where to buy zithromax over the counter policies as proposed. (c) Reorganization for Requirements Related to QCDR and Qualified Registries Conditions for Approval We refer readers to existing § 414.1400(b)(2) for QCDR conditions for approval and existing § 414.1400(c)(2) for qualified registries conditions for approval. In this final rule, we proposed the following in order to better organize, consolidate the duplicative criteria where to buy zithromax over the counter of QCDRs and qualified registries, and refer to both “QCDR and qualified registry” instead of one or the other.

• We proposed to redesignate existing paragraph (b)(2) to proposed paragraph (b)(3) and to revise the paragraph heading as, Conditions for approval. We also proposed to update the reference to both QCDR and qualified registry in where to buy zithromax over the counter proposed paragraph (b)(3). We proposed to revise to include both QCDR and qualified registry and redesignate existing paragraph (b)(2)(i) to proposed paragraph (b)(3)(i). We proposed to revise and redesignate existing paragraph (b)(2)(ii) to paragraph (b)(3)(ii).

We also proposed where to buy zithromax over the counter to extend our policy for collaboration. For more information on this proposal, please refer to section “collaboration of entities to become a QCDR and proposal to extend policy for collaboration of entities to become a qualified registry” at section IV.A.3.h.(3)(a)(ii) of this final rule. As discussed above, we proposed to consolidate where to buy zithromax over the counter and redesignate the performance feedback requirements previously at existing § 414.1400(b)(1) and (c)(1) to § 414.1400(b)(3)(iii). Furthermore, to consolidate similar performance feedback requirements, we also proposed to revise and redesignate existing paragraph (b)(2)(iii) to paragraph (b)(3)(iii) to state, beginning with the CY 2021 performance period/2023 MIPS payment year, require the QCDR or qualified registry must to provide performance feedback to their clinicians and groups at least 4 times a year, and provide specific feedback to their clinicians and groups on how they compare to other clinicians who have submitted data on a given measure within the QCDR or qualified registry.

Exceptions to this requirement may occur if the QCDR or qualified registry submits notification to CMS within the reporting period promptly within the month of realization of the impending deficiency and provides sufficient rationale as to why they do not believe they would be able to meet this requirement (for example, if the QCDR does not receive the data from their clinician until the end of the performance period). • We proposed to consolidate and redesignate paragraphs (b)(2)(iv) and (c)(2)(iii) in their entirety, into a new paragraph (b)(3)(v), and to correct a typographical error in which the where to buy zithromax over the counter word “MIPS” was omitted in the first sentence. Start Printed Page 65540 We proposed to consolidate and redesignate paragraphs (b)(2)(v) and (c)(3)(iv), in their entirety, into a new paragraph (b)(3)(vi). We where to buy zithromax over the counter solicited public comments on our proposals.

We did not receive public comments on these proposals, and therefore, we are finalizing them as proposed. (d) Reorganization for Requirements Related to QCDR Measures (i) Reorganization for Requirements Related to QCDR Measures for the Quality Performance Category We refer readers to existing language at § 414.1400(b)(3) for QCDR measures for the where to buy zithromax over the counter quality performance category. We currently define “QCDR measure” at existing § 414.1400(b)(3). We recognize that the QCDR measure definition is referred to throughout our policies and that it is not specific to § 414.1400(b)(3) or third party intermediaries.

Therefore, to provide further clarity and to where to buy zithromax over the counter better align with the current policy, we proposed moving the QCDR measure definition to the definitions section at § 414.1305. We also proposed the following revisions to better organize regulation text at § 414.1400(b)(4) and to update cross-references to correspond to the new section numbers as reflected in this final rule. We proposed to redesignate paragraphs (b)(3)(i), where to buy zithromax over the counter (b)(3)(i)(A), and (b)(3)(i)(B) to definitions at § 414.1305. We proposed to revise and redesignate existing paragraph (b)(3)(ii) to proposed paragraph (b)(4)(i) to state, for the CY 2018 performance period/2020 MIPS payment year and future years, at the time of self-nomination an entity seeking to become a QCDR must submit the following information for any measure it intends to submit for the payment year.

++ For MIPS quality measures, the entity must submit specifications including the MIPS measure IDs and specialty-specific measure sets, as applicable. + For QCDR measures, the entity must where to buy zithromax over the counter submit for CMS-approval measure specifications including. Name/title of measures, NQF number (if NQF- endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. In addition, no later than 15 calendar days following CMS approval of any QCDR measure specifications, the entity must publicly post the measure specifications for that QCDR measure (including the CMS- assigned QCDR measure ID) and provide CMS where to buy zithromax over the counter with a link to where this information is posted.

We also proposed adding a header to state, “QCDR measure self-nomination requirements”. We believe adding a heading will help readers clearly distinguish QCDR measure self-nomination requirements. We proposed moving existing where to buy zithromax over the counter paragraph (b)(3)(iii) in its entirety to proposed paragraph (b)(4)(ii) and adding a header to state, “QCDR measure submission requirements”. We believe adding a heading will help readers clearly distinguish QCDR measure submission requirements.

• We proposed moving existing paragraphs (b)(3)(v) through (v)(C)( 1 ) in its entirety, to proposed paragraphs (b)(4)(iii) through (b)(4)(iii)(A)( 3 where to buy zithromax over the counter ). • We proposed to revise and redesignate existing paragraph at (b)(3)(v)(C)( 2 ) to paragraph (b)(4)(iii)(A)( 3 )( i ) to state, to be included in an MVP for the CY 2022 performance period/2024 MIPS payment year and future years, a QCDR measure must be fully tested. We proposed moving existing where to buy zithromax over the counter paragraph (b)(3)(vii) in its entirety, to paragraph (b)(4)(iv). (ii) Reorganization for Requirements Related to QCDR Measure Approval Criteria We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375) and the Quality Payment Program provisions in the CY 2020 PFS final rule (84 FR 63059), where we finalized existing § 414.1400(b)(3)(v).

At § 414.1400, we proposed to reorganize and make minor updates to the existing requirements at paragraph (b)(3)(v) to proposed paragraph (b)(4)(iii). We proposed to reorganize the where to buy zithromax over the counter existing requirements so that QCDR measure approval at paragraph (b)(3)(v) is discussed before QCDR measure considerations at paragraph (b)(3)(iv). Therefore, we proposed the following revisions. To revise and redesignate existing paragraph (b)(3)(v) “QCDR measure requirement for approval include” to where to buy zithromax over the counter proposed paragraph (b)(4)(iii) and add a heading to state, “QCDR measure approval criteria”.

We believe adding a heading will help readers clearly distinguish QCDR measure approval criteria. We also proposed to include the following updates. ++ Move existing paragraph (b)(3)(v) to proposed revised paragraph (b)(4)(iii)(A) to state, QCDR measure requirements for where to buy zithromax over the counter approval are. ++ Move existing paragraph (b)(3)(v)(A) in its entirety to proposed paragraph (b)(4)(iii)(A)( 1 ).

++ Move existing where to buy zithromax over the counter paragraph (b)(3)(v)(B) in its entirety to proposed paragraph (b)(4)(iii)(A)( 2 ). ++ Revise existing paragraphs (b)(3)(v)(C) and (b)(3)(v)(C)( 1 ) to proposed paragraph (b)(4)(iii)(A)( 3 ) to state, beginning with the CY 2022 performance period/2024 MIPS payment year, all QCDR measures must meet face validity. To be where to buy zithromax over the counter approved for the CY 2023 performance period/2025 MIPS payment year, all QCDR measures must be must meet face validity for the initial MIPS payment year for which it is approved. For subsequent years after being initially approved, all QCDR measures must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination.

++ Move existing paragraph (b)(3)(v)(C)( 2 ) in its entirety to proposed paragraph (b)(4)(iii)(A)( 3 )( i ). ++ Move existing where to buy zithromax over the counter paragraph (b)(3)(v)(D) in its entirety to proposed paragraph (b)(4)(iii)(A)( 4 ). ++ Move existing paragraph (b)(3)(v)(E) in its entirety to proposed paragraph (b)(4)(iii)(A)( 5 ). We where to buy zithromax over the counter solicited public comment on our proposals.

The following is a summary of the comments we received and our responses. Comment. A few commenters supported the measure requirement for face validity testing of measures and stated it should where to buy zithromax over the counter be extended for future years. One commenter noted particular concern for the face validity testing requirement, as the testing process is arduous and funding, staff, and other resources have been significantly reduced due to the PHE for buy antibiotics.

A few commenters suggested that CMS delay the deadline for full QCDR measure testing to 2023 or later due to the impact of buy antibiotics on providers where to buy zithromax over the counter and registries. Another commenter suggested that CMS limit the face validity testing requirement, stating that because the buy antibiotics extreme and uncontrollable circumstances exception decreased the number of groups reporting to MIPS through QCDRs, the face validity testing requirement should be limited to the first 2 years for which measures are approved or until 2 years after the end of the buy antibiotics PHE. Several commenters expressed concerns with QCDR measure testing requirements and where to buy zithromax over the counter pointed to the significant burden of these requirements. One commenter expressed the belief that a barrier to use of QCDR measures is the requirement that they be fully tested, which is Start Printed Page 65541 extremely burdensome for QCDR measure owners.

Another commenter asked for clarification as to what constitutes acceptable measure testing. Commenters requested that CMS develop a transparent and where to buy zithromax over the counter consistent process for evaluating QCDR testing approaches and results. Commenters noted that failure to ease the QCDR requirements may result in interested parties opting to not participate in the QCDR program. Response where to buy zithromax over the counter.

We note that we did not propose to substantively modify the measure requirement for face validity and testing in the proposed rule, such as to delay these requirements. The existing requirement (85 FR 84939) at § 414.1400(b)(3)(v)(C)( 1 ) states that, for a QCDR measure to approved for the CY 2022 performance period/2024 MIPS payment year it must meet face validity. To be approved for the CY 2023 performance period/2025 MIPS payment year and for each subsequent year, a where to buy zithromax over the counter QCDR measure must meet face validity for the initial MIPS payment year for which it is approved. Separately, paragraph (b)(3)(v)(C) provides that, beginning with the CY 2022 performance period/2024 MIPS payment year, a QCDR measure must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination.

In addition, paragraph (b)(3)(v)(C)( 1 ) requires that, for each subsequent year, for which a QCDR measure is approved, it where to buy zithromax over the counter must be fully tested. We intended our proposed reorganization of these standards at paragraph (b)(4)(B)(iii)( 3 ) to track these existing requirements. In regards to what constitutes acceptable testing and the burden associated with, and possible delay of such testing, we refer readers to where to buy zithromax over the counter our discussion of this and related issues in past rules (85 FR 27594 through 27595. 85 FR 84940.

85 FR 84926. 85 FR 84936 where to buy zithromax over the counter. 84 FR 63066. 84 FR 63065 through where to buy zithromax over the counter 63067.

83 FR 59901 through 59902. 82 FR 53805 through 53806) and guidance documents, including the current CMS Measures Management System Blueprint for additional guidance in measure testing at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​MMS/​Downloads/​Blueprint.pdf. Although we did not address any changes to the QCDR measure testing requirement at § 414.1400(b)(3)(v)(C)( 1 ) in the CY 2022 PFS proposed rule, based on public comments received on our where to buy zithromax over the counter proposals, we are considering proposing in next year's rulemaking to further delay this requirement for traditional MIPS until the CY 2024 performance period/2026 MIPS payment year, instead of the CY 2023 performance period/2025 MIPS payment year as previously finalized. We clarify that this delay would not modify the existing requirement at paragraph (b)(3)(v)(C)( 2 ), to be included in an MIPS Value Pathway for the 2024 MIPS payment year and future years, a QCDR measure must be fully tested.

Comment where to buy zithromax over the counter. One commenter suggested that CMS provide more meaningful credit/incentivization for measure testing participation given the difficulty to motivate practices to engage in measure testing. The commenter suggested an improvement activity credit for measure testing given the difficulty to motivate practices to engage in measure testing. Response where to buy zithromax over the counter.

We thank the commenter for their suggestion. We may consider where to buy zithromax over the counter it for future rulemaking. We encourage the commenter to visit the 2021 Improvement Activities Inventory for additional guidance on improvement activities that focus on QCDR participation at https://qpp-cm-prodcontent.s3.amazonaws.com/​uploads/​1189/​2021%20Improvement%20Activities%20List.zip. After consideration of where to buy zithromax over the counter public comments, we are finalizing these policies as proposed.

(iii) Reorganization for Requirements Related to QCDR Measure Considerations for Approval We refer readers to the Quality Payment Program provisions in the CY 2019 PFS final rule (84 FR 63198 through 63199), where we finalized existing § 414.1400(b)(3)(iv) “QCDR measure considerations for approval.” We proposed to reorganize and make minor updates to the language at existing paragraph (b)(3)(iv) to paragraph (b)(4)(iii)(B). We proposed to reorganize the existing requirements so that QCDR measure approval at paragraph (b)(3)(v) is discussed before QCDR measure considerations at paragraph (b)(3)(iv). We also where to buy zithromax over the counter proposed to redesignate existing paragraph (b)(3)(vi) to paragraph (b)(4)(iii)(C). Specifically, we proposed the following revisions.

To revise and redesignate existing paragraph (b)(3)(iv) “QCDR where to buy zithromax over the counter measure considerations for approval include” to paragraph (b)(4)(iii)(B) “QCDR measure considerations for approval include, but are not limited to”. • Move existing paragraphs (b)(3)(iv)(A) in its entirety to paragraph (b)(4)(iii)(B)( 1 ). • Move existing paragraph (b)(3)(iv)(B) in its entirety to paragraph (b)(4)(iii)(B)( 2 ). • Move existing paragraph (b)(3)(iv)(C) in its entirety to where to buy zithromax over the counter paragraph (b)(4)(iii)(B)( 3 ).

• Move existing paragraph (b)(3)(iv)(D) in its entirety to paragraph (b)(4)(iii)(B)( 4 ). • Move existing where to buy zithromax over the counter paragraph (b)(3)(iv)(E) in its entirety to paragraph (b)(4)(iii)(B)( 5 ). • Move existing paragraph (b)(3)(iv)(F) in its entirety to paragraph (b)(4)(iii)(B)( 6 ). • Move existing paragraph (b)(3)(iv)(G) in its entirety to paragraph (b)(4)(iii)(B)( 7 ) where to buy zithromax over the counter.

• Revise and consolidate existing paragraph (b)(3)(iv)(G)( 1 ) to paragraph (b)(4)(iii)(B)( 7 )( i ) to state that QCDR link their QCDR measures as feasible to at least one cost measure, improvement activity, or an MVP at the time of self-nomination. • Revise and redesignate existing paragraph (b)(3)(iv)(G)( 2 ) to paragraph (b)(4)(iii)(B)( 7 )( ii ) to state that in cases where a QCDR measure does not have a clear link to a cost measure, improvement activity, or an MVP, CMS would consider exceptions if the potential QCDR measure otherwise meets the QCDR measure requirements and considerations. • Move existing paragraph (b)(3)(iv)(H) in its entirety to paragraph (b)(4)(iii)(B)( where to buy zithromax over the counter 8 ). • Move existing paragraph (b)(3)(iv)(I) in its entirety to paragraph (b)(4)(iii)(B)( 9 ).

• Revise and redesignate existing paragraph (b)(3)(iv)(J) to paragraph (b)(4)(iii)(B)( 10 ) to where to buy zithromax over the counter state beginning with the CY 2020 performance period/2022 MIPS payment year, CMS places greater preference on QCDR measures that meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods. Those that do not, may not continue to be approved. • Move existing paragraph (b)(3)(iv)(J)( 1 ) in its entirety to paragraph (b)(4)(iii)(B)( 10 )( i ). • Move existing paragraph (b)(3)(iv)(J)( 2 ) to paragraph reserve (b)(4)(iii)(B)( where to buy zithromax over the counter 10 )( ii ).

Move existing paragraph (b)(3)(vi) in its entirety to paragraph (b)(4)(iii)(C). We solicited public comments on our proposals where to buy zithromax over the counter. The following is a summary of the comments we received and our responses. Comment where to buy zithromax over the counter.

The commenter suggested that we assess whether the limit on the number of QCDR measures available (30 measures) should be revised. Response. We thank the commenter for where to buy zithromax over the counter their suggestion. We may consider it for future rulemaking.

Start Printed Page 65542 After consideration of public comments, we are finalizing where to buy zithromax over the counter these policies as proposed. (iv) QCDR Measure Rejection Criteria We refer readers to the existing requirements at § 414.1400(b)(3)(vii). We proposed reorganizing existing requirements at paragraph (b)(3)(vii) to proposed paragraph (b)(4)(iv). Therefore, we proposed the following where to buy zithromax over the counter revisions.

• To revise and redesignate existing paragraph (b)(3)(vii) “QCDR measure rejection criteria” to paragraph (b)(4)(iv) and add a heading to state, QCDR measure rejection criteria. We believe adding a where to buy zithromax over the counter heading will help readers clearly distinguish measure rejection criteria. We also proposed to include the following updates. • To move existing paragraph where to buy zithromax over the counter (b)(3)(vii) to proposed paragraph (b)(4)(iv) to state, QCDR measure rejection criteria.

Beginning with the CY 2020 performance period/2022 MIPS payment year, QCDR measure rejection considerations include, but are not limited to. Move existing paragraphs (b)(3)(vii)(A) through (L) in their entirety to (b)(4)(iv)(A) through (L). We solicited where to buy zithromax over the counter public comments on our proposals. We did not receive public comments on these proposals, and therefore, we are finalizing them as proposed.

(e) Reorganization for Requirements Related to Remedial Action and Termination of Third Party Intermediaries We refer readers to § 414.1400(f), the CY 2017 where to buy zithromax over the counter Quality Payment Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 through 59910), the CY 2020 PFS final rule (84 FR 63077 through 63080), and the CY 2021 PFS final rule (85 FR 84930 through 84937) for previously finalized policies for remedial action and termination of third party intermediaries. With the proposed updates being made at § 414.1400, we proposed to redesignate the following sections. We proposed to redesignate current paragraph (f) as paragraph (e) and to update cross-references to correspond to the new section numbers as reflected in this final rule. We also where to buy zithromax over the counter proposed to redesignate current paragraph (g) as paragraph (f) and to update cross-references to correspond to the new section numbers as reflected in this final rule.

We solicited public comments on these proposals. We did not receive public comments on these proposals, and where to buy zithromax over the counter therefore, we are finalizing them as proposed. (2) Third Party Intermediaries General Requirements We refer readers to previously established § 414.1400(a) and the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364), and as further revised in the CY 2019 PFS final rule (83 FR 60088), CY 2020 PFS final rule (84 FR 63049 through 63052), CY 2021 PFS final rule (85 FR 84926 through 84947) for our established policy regarding third party intermediaries general requirements. In the CY 2022 PFS proposed rule, we proposed two changes for third party intermediaries.

(1) Third where to buy zithromax over the counter party intermediary submissions for APM Entities. And (2) MIPS performance categories that must be supported by third party intermediaries. We also solicited comment on third party intermediaries where to buy zithromax over the counter that derive data from CEHRT. These proposals and the request for comments are discussed in more detail below.

(a) Third Party Intermediary Submissions for APM Entities As finalized in the Quality Payment Program provisions in the CY 2021 PFS final rule (85 FR 84895), APM Entities now have the option of where to buy zithromax over the counter reporting to MIPS on behalf of the MIPS eligible clinicians participating in their APM Entity. They have the option of reporting to traditional MIPS or via the APP (85 FR 84859). APM Entities have historically used Third Party Intermediaries for submitting their quality measures to their APMs, rather than to MIPS, however, these third party intermediaries now have the opportunity to submit these data for purposes of MIPS. In the CY 2022 PFS proposed rule, we proposed to add APM Entities to § 414.1400(a)(1), expanding the general participation requirements of third party intermediaries to third party intermediaries where to buy zithromax over the counter reporting to MIPS on behalf of APM Entities in order to align reporting requirements for all participants in MIPS.

We note that the Promoting Interoperability performance category is scored for APM Entities based on data submitted by the participant MIPS eligible clinicians and groups as described at § 414.1317(b)(1), and therefore, would not be required to be submitted by the third party intermediary on behalf of the APM Entity. We solicited comments on where to buy zithromax over the counter this proposal. We did not receive public comments on this proposal, and therefore, we are finalizing it as proposed. (b) MIPS Performance Categories That Must Be Supported by Third Party Intermediaries We refer readers to previously established § 414.1400(a)(2) and the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364), and as further revised in the CY 2019 PFS final rule (83 FR 60088), CY 2020 PFS final rule (84 FR 63049 through 63052), CY 2021 PFS final rule (85 FR 84926 through 84947) for our established policy regarding the types of MIPS data that third party intermediaries may submit.

In the CY 2022 PFS proposed rule, we proposed new requirements in alignment with our proposals in sections IV.A.3.b.(2)(c), IV.A.3.b.(4)(e) and IV.A.3.b.(3)(e) of this final rule to adopt where to buy zithromax over the counter MVPs and subgroups. (i) New Requirement for Third Party Intermediaries To Support MVPs and the APP As described in the Quality Payment Program provisions finalized in the CY 2021 PFS final rule (85 FR 84849), MVPs should include measures and activities from the quality, cost, improvement activities, and Promoting Interoperability performance categories. As described in section IV.A.3.b.(2)(c)(i) of this final rule, we discussed our proposals related to furthering our transition to MIPS Value Pathways (MVPs) where to buy zithromax over the counter. As MVPs are implemented, proposed beginning with the CY 2023 performance period/2025 MIPS payment year, we also proposed the methods in which an MVP participant may report on an MVP or the APP.

Since QCDRs, qualified registries, and health IT vendors are required under existing § 414.1400(a)(1) to submit data for quality, improvement activities, and promoting interoperability, we believe they would have the experience needed where to buy zithromax over the counter to support MVP and APP reporting. Therefore, we proposed to create a new requirement at § 414.1400(b)(1)(ii) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. QCDRs and qualified registries may also support the APP. Additionally, we proposed to create a new requirement at paragraph § 414.1400(c)(1)(iii) to state that beginning with the CY 2023 performance period/2025 MIPS payment year, Health IT vendors must support MVPs that are applicable to the Start where to buy zithromax over the counter Printed Page 65543 MVP participants on whose behalf they submit MIPS data.

Health IT vendors may also support the APP. Based off historical participation, we are aware that some third party intermediaries where to buy zithromax over the counter (QCDRs and qualified registries) support a single specialty or subspecialty, while others support multiple specialties. Therefore, we believe that it is not appropriate to expect that all third party intermediaries are able to support all MVPs that are implemented in the program. Rather, the third party intermediaries should identify and support MVPs that are relevant to the clinicians and groups they support.

We do not believe that CMS-approved survey vendors will be able to support MVP reporting, because they are historically limited, in that they where to buy zithromax over the counter only support the CAHPS for MIPS Survey Measure. As discussed in section IV.A.3.b.(2)(c) of this final rule, MVPs will start with the CY 2023 performance period/2025 MIPS payment year. We believe this delay in implementation will allow third where to buy zithromax over the counter party intermediaries sufficient time for programming and system preparation for MVP reporting success. We solicited comments on our proposals.

The following where to buy zithromax over the counter is a summary of the comments we received and our responses. Comment. One commenter supported third party intermediaries only reporting on the MVPs that reflect their participant needs but suggested third-party intermediaries be able to choose which MVPs they wish to support. The commenter expressed where to buy zithromax over the counter concerns about MVPs being arbitrarily assigned to third-party intermediaries.

One commenter noted that supporting an entire MVP is very different from supporting the inclusion of specific QCDR measures in an MVP and could carry much more burden for the registry and sought clarification of whether CMS will assign specific MVPs to a QCDR or qualified registry. Response where to buy zithromax over the counter. We thank the commenter for their support. At this time, CMS does not intend on assigning specific MVPs to a third party intermediary.

As described where to buy zithromax over the counter in the CY 2022 PFS proposed rule (86 FR 39462), we proposed at § 414.1400(b)(1)(ii) and (c)(1)(iii) that QCDRs, qualified registries, and Health IT vendors must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. We refer readers to Appendix 3 of this final rule, where discuss the MVPs being finalized beginning with the CY 2023 performance period/CY 2025 MIPS payment year, around the clinical topics of stroke care, heart disease, rheumatology, chronic conditions, emergency medicine, anesthesia, and lower extremity joint repair. QCDRs, qualified registries, and Health IT vendors that support MVP participants, who work in the aforementioned clinical areas will be required to support these MVPs, as applicable where to buy zithromax over the counter. Furthermore, we expect that QCDRs, qualified registries, and Health IT vendors who support MVPs would support all measures and activities, across the quality, PI, and improvement activities performance category that are included in the MVP (cost measures and population health measures are calculated by CMS and do not require data submission by a third party intermediary or a clinician).

The expectation that the QCDR and qualified registry support measures and activities across all three performance categories is not new, as these third party intermediaries are currently required to do so. We believe allowing QCDRs to where to buy zithromax over the counter only support specific QCDR measures in an MVP creates undue burden on the MVP Participant who would need to find other means to complete MVP reporting requirements. This may deter clinicians from utilizing a third party intermediary. For the time being, CMS does not intend where to buy zithromax over the counter on assigning specific MVPs to a third party intermediary.

It is required for QCDRs, qualified registries, and Health IT vendors to identify (CMS approved) MVPs that are relevant to the clinicians they support and report on those. Comment where to buy zithromax over the counter. One commenter supported third party intermediaries supporting MVPs but requested clarification on whether a QCDR would be responsible for validating an MVP participant's performance on population health measures and/or providing “enhanced” performance feedback, including performance data comparing the performance of similar clinicians who report on the same MVP. Response.

Third party intermediaries will not be expected to validate the performance on the current population health measures, since they are administrative claims-based and do where to buy zithromax over the counter not require external data submission. The responsibility of identifying the population health measure that should be calculated will fall to the MVP participant to determine at the time of MVP registration. CMS calculates these measures based on administrative claims where to buy zithromax over the counter data. In the CY 2022 PFS proposed rule (86 FR 39383), we describe our proposal to include comparative performance feedback within the annual performance feedback that CMS currently provides under traditional MIPS.

While CMS intends to provide this enhanced feedback through our existing performance feedback processes, QCDRs and qualified registries will still be required to provide clinicians they support with performance feedback as described at § 414.1400(b)(iii) and (c)(ii), regardless of whether the clinician chooses to report through traditional MIPS or an MVP. Comment where to buy zithromax over the counter. One commenter suggested that CMS mandate that EHR vendors support the quality measures in MVPs, otherwise clinicians would be forced to join multiple registries with the cost exceeding the maximum penalty. Response where to buy zithromax over the counter.

To clarify, health IT vendors (such as EHRs), QCDRs, and qualified registries who support MVPs are required to support all measures and activities available in the MVP across the quality, improvement activities, and promoting interoperability performance categories. The exceptions to this requirement are where to buy zithromax over the counter the cost measures and population health measures, which do not require external data submission to be calculated. In addition, some MVPs may include QCDR measures, which are only reportable through a QCDR. In instances where QCDR measures are included in an MVP, a qualified registry or health IT vendor will be expected to support all other quality measures included within the MVP.

Comment where to buy zithromax over the counter. One commenter expressed concerns about layering another auditing requirement on QCDRs and qualified registries when MVPs are finalized as this could increase regulatory complexity and result in added work and burden without making a significant difference in the quality of data submitted. One commenter where to buy zithromax over the counter requested that CMS add more detail in future requirements for third-party intermediaries to validate data submitted by MVP participants. Response.

We disagree with the commenter. QCDRs and qualified registries are currently required to where to buy zithromax over the counter conduct data validation on data that is submitted to CMS for purposes of the MIPS program, to ensure the data is true, accurate, and complete. We refer readers to section IV.A.3.h.(3)(a)(iii) of this final rule for a detailed discussion of those requirements. The current data where to buy zithromax over the counter validation requirements that are utilized in traditional MIPS, will also be applied to MVP submissions.

MVPs are considered a method of reporting under MIPS, but is nonetheless a part of the program. Therefore, the requirements and expectations where to buy zithromax over the counter remain the same— QCDRs and qualified registries must conduct data validation on data submitted to CMS for purposes of the MIPS program, regardless of whether Start Printed Page 65544 the data is submitted under traditional MIPS or through an MVP. In the future, data validation information that is covered in the Self-Nomination Toolkit for QCDRs and qualified registries available at https://qpp-cm-prod-content.s3.amazonaws.com/​uploads/​1083/​2021%20Self-Nomination%20Toolkit%20for%20QCDRs%20and%20Qualified%20Registries.zip will also include MVPs. Comment.

One commenter requested clarification on whether where to buy zithromax over the counter QCDRs and qualified registries are required or permitted to support the APP, stating that the preamble states this is a requirement while the regulatory text says that QCDRs and qualified registries may support the APP. The commenter opposed a requirement for QCDRs and qualified registries to support the APP. Response where to buy zithromax over the counter. In the CY 2021 PFS final rule (85 FR 84859), we discussed that APM Entities have the option of reporting to MIPS on behalf of the MIPS eligible clinicians participating in their APM Entity.

Additionally, there is an option of reporting to traditional MIPS or via the APP. Furthermore, in the proposed rule (86 FR 39462), we proposed to add APM Entities to § 414.1400(a)(1), where to buy zithromax over the counter expanding the general participation requirements of third party intermediaries to third party intermediaries reporting to MIPS on behalf of APM Entities in order to align reporting requirements for all. We want to note that QCDRs and qualified registries would not be required to support the APP, but may do so. If QCDRs and qualified registries would like to support the APP, they would need to meet where to buy zithromax over the counter all of the other requirements of being a QCDR or qualified registry reporting to MIPS (with the exception of PI reporting, which has some exceptions) as described above.

After consideration of public comments, we are finalizing these policies as proposed. (ii) Requirements for All Third Party Intermediaries To Support Subgroup Reporting As proposed where to buy zithromax over the counter in section IV.A.3.b.(3) of this final rule, subgroup reporting would allow clinicians in multispecialty practices to participate in MIPS more meaningfully. Since subgroups would be implemented concurrently with MVPs, it is important that third party intermediaries have the capability to support subgroup reporting of MVPs. As described above, we believe QCDRs, qualified registries, and health IT vendors would have the capacity to support MVP and APP reporting.

In the CY 2022 PFS proposed rule, we proposed to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with where to buy zithromax over the counter the CY 2023 performance period/2025 MIPS payment year. Therefore, we proposed to revise § 414.1400(a)(1) to state that MIPS data may be submitted on behalf of a MIPS eligible clinician, group, virtual group, subgroup or APM Entity by any of the following third party intermediaries. QCDR. Qualified registry.

Health IT vendor. Or CMS-approved survey vendor. We believe it is imperative for all third party intermediaries to be able to support subgroup reporting as we envision that to be the future of the program. While the CAHPS for MIPS survey vendors cannot support MVPs or the APP, we believe they can support the reporting of the CAHPS for MIPS measure within an MVP and the APP, if a subgroup decides to report on that measure.

Due to the limited experience, CAHPS for MIPS survey vendors have in quality reporting, we do not believe it is feasible for them to support MVP reporting since MVP reporting would require experience with reporting across the performance categories and the use of several collection types for quality reporting. However, there may be instances where the CAHPS for MIPS survey measure may be included in an MVP. For example, in the Optimizing Chronic Conditions Management MVP, as described in Appendix 3. MVP Inventory, of this final rule.

In such instances, if groups or subgroups would like to report this measure, they should be able to utilize a CAHPS for MIPS survey vendor to do so. We believe it is important that all third party intermediaries support subgroup reporting in order to support meaningful quality reporting. We understand that there may be a level of burden to third party intermediaries that are required in supporting subgroup reporting by requiring them to support another clinician type. However, we believe that requiring third party intermediaries to support subgroup reporting will allow for clinicians to participate in a manner that is more meaningful.

We noted in section IV.A.3.b.(4)(f)(ii)(D) of this final rule, subgroups would have to register through the MVP participant registration process. Third party intermediaries would need to be able to track the subgroup identifiers and support the data submission process accordingly. We solicited comments on our proposal. The following is a summary of the comments we received and our responses.

Comment. A few commenters expressed concern regarding the burden for registries to identify and validate subgroup reporting. Response. To clarify, as discussed in section IV.A.3.b.(4)(f)(ii)(D) of this final rule, subgroups must self-identify and register through a registration process in order to be considered a subgroup.

The subgroup would need to register directly through the MVP registration process, that is done separately and not through a third party intermediary. Therefore, we believe there is no burden to registries to identify the subgroups. As MVP participants such as subgroups enroll to use the services of a registry, the subgroup will share with the registry their CMS-assigned identifier and a list of participants within that subgroup. The registry will need to submit the subgroup identifier information with the subgroup's data at the time of submission.

We understand there may be concerns in scenarios in which subgroups inadvertently provide an incorrect subgroup identifier to the registry. We will take that into consideration for future rulemaking, as we determine whether there are additional system safeguards, such as a system rejection of an incorrect identifier can be implemented to limit the occurrence of such issues. With regards to data validation, all QCDRs and qualified registries will continue to be held to the data validation requirements that currently exist, regardless of whether a clinician or group decides to participate in MVP reporting or traditional MIPS reporting. While we understand there is a level of burden associated with data validation, we believe the benefit outweighs the burden to ensure that all data submitted to CMS is true, accurate, and complete.

Comment. One commenter suggested that CMS delay its proposal requiring third party intermediaries to support subgroup reporting to allow more time for registries to implement reporting processes. Several commenters expressed concern that subgroup reporting will impose a large increase in burden on registries, particularly with respect to how registries validate NPIs. A few commenters expressed concern that QCDRs may lack the capacity to support subgroup reporting.

Response. We disagree with the need for further delay. We intentionally proposed MVPs and subgroup reporting with a delayed implementation to account for the time that clinicians, third party intermediaries, and healthcare organizations would need to prepare to operationalize MVP and subgroup reporting. We believe the availability of subgroup reporting Start Printed Page 65545 should go hand-in-hand with the implementation of MVPs, and therefore, should be jointly available beginning with the CY 2023 performance period/2025 MIPS payment year.

The delayed implementation should provide third party intermediaries sufficient time for system and operation preparations for subgroup reporting. In addition, we do not believe that subgroup reporting will impose a large increase in burden to registries. We refer readers to section IV.A.3.b.(3) of this final rule, for further discussion of validation requirements. Subgroups are derived from their affiliated TINs who would have otherwise reported traditional MIPS through a registry.

After consideration of public comments, we are finalizing this policy as proposed. (c) Request for Comment on Third Party Intermediaries That Derive Data From CEHRT For third party intermediaries that will be submitting quality measure data on behalf of MIPS eligible clinicians, we believe that EHR systems will be able to provide measure results for a set of providers that are part of a subgroup where required for subgroup reporting. We note that the existing CEHRT definition for eligible clinicians at § 414.1305 includes the 45 CFR 170.315(c)(4) “Clinical quality measures—filter” as an optional element. This criterion requires health IT to be able to filter CQM results at both patient and aggregate levels.

Moreover, a Health IT Module must be able to filter by a single proposed data element (for example, provider type) or a combination of any of the data elements). Historically, the “Clinical quality measures—filter” at 45 CFR 170.315(c)(4)” (CQM-filter) criterion has been applicable for certified health IT modules supporting quality measurement for participants in certain APMs. We believe technology certified to this optional criterion could support subgroup reporting via third party intermediaries that derive data from CEHRT by ensuring that an EHR can produce CQM results filtered for a specific group of provider NPIs that are part of a subgroup. These filtered CQM results could then be shared with a third party intermediary, which provides this data for reporting to CMS.

However, we also believe health IT developers are offering non-certified functionality that can effectively support reporting of measure results for a subgroup. As a result, we did not propose any changes at this time to the language in the CEHRT definition for eligible clinicians regarding the “optional” status of technology certified to the CQM-filter criterion. We are interested in general feedback from stakeholders on the current capabilities of third party intermediaries that derive data from CEHRT to successfully receive and transmit data to CMS for CQMs based on subgroups. Capabilities of EHR systems to support subgroup reporting, including reporting facilitated by third party intermediaries, and whether requiring the adoption of technology certified to the CQM-filter criterion would help to support subgroup reporting.

And challenges which entities may face in meeting requirements to report on subgroups when deriving data from CEHRT. We solicited feedback on this topic. Comment. A few commenters responded to CMS' request for information regarding CEHRT and third party intermediaries.

One commenter urged CMS to establish clear expectations and guidelines to ensure data security and to define roles and responsibilities for data validation and data cleaning. Another commenter recommended that CMS consider making the CQM filter criterion mandatory for CEHRT because, otherwise, organizations would likely be required to contract with qualified registries/QCDRs to submit MIPS data. Another commenter disagreed, stating that as a developer of CEHRT that provides CQM functionality, they do not believe that the CQM-filer criterion is necessary. Response.

We thank commenters for the feedback received through this request for information. We may consider this information to inform future rulemaking. (3) New Requirements for Both Qualified Clinical Data Registries (QCDRs) and Qualified Registries (a) Background We refer readers to §§ 414.1305 and 414.1400, the CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390), the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819), the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS final rule (84 FR 63049 through 63080), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (85 FR 84926 through 84947) for our previously established policies regarding QCDRs and qualified registries. In the CY 2022 PFS proposed rule, we proposed several changes for both QCDRs and qualified registries.

(1) New requirement for approved QCDRs and qualified registries that have not submitted performance data. (2) collaboration of entities to become a QCDR and qualified registry. And (3) data validation audit and targeted audit requirements. These proposals are discussed in more detail below.

(i) New Requirement for Approved QCDRs and Qualified Registries That Have Not Submitted Performance Data We require that both QCDRs and qualified registries must have a minimum of 25 participants signed up by the prior performance period at existing § 414.1400(b)(2) and (c)(2). We refer readers to CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390), the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819), the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS final rule (84 FR 63049 through 63080), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (85 FR 84926 through 84947). We identified a number of QCDRs and qualified registries that have continued to self-nominate to become a third party intermediary for the MIPS program, but have not submitted clinician, group or virtual group data to CMS. As the MIPS program continues to mature, we wish to reduce the number of vendors that self-nominate to become a qualified vendor, but do not actively participate in the MIPS program.

We believe that maintaining these vendors who do not actively participate does not provide a benefit to the MIPS program, rather it creates stakeholder confusion by including these vendors in our qualified postings. We proposed a two-tiered approach to solve this issue. First, we proposed to create a new requirement at § 414.1400(b)(3)(vii) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023. Exceptions to this requirement may occur if data is received for the CY 2021 performance period/2023 MIPS payment year.

Under this scenario, QCDRs and qualified registries would not need to submit a participation plan for CY 2023 of the self-nomination period. If they do not submit data, their participation plan must be submitted as part of self-nomination for CY 2023 and must be accepted by CMS to continue to be an approved QCDR or qualified registry. Start Printed Page 65546 Secondly, we proposed to codify a new requirement at paragraph (b)(3)(viii) to state, beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. For example, for the CY 2024 performance period/2026 MIPS payment year, vendors will be required to have submitted performance data for the CY 2021 and 2022 performance periods/2023 and 2024 MIPS payment years.

Under this proposal, the participation plan must explain the QCDR's or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third party intermediary on behalf of clinicians or groups. The vendor must also explain why they should still be allowed to participate as a qualified vendor. We note that this proposed participation plan was modeled off of the current requirement for QCDR measure participation at existing § 414.1400(b)(3)(iv)(J)( 1 ) (redesignated to proposed paragraph (b)(4)(iii)(B)(10)( i )). We solicited comments on this proposal.

The following is a summary of the comments we received and our responses. Comment. A few commenters disagreed with the proposal to require a participation plan for approved QCDRs that did not submit data for 2 years preceding the applicable self-nomination period. One commenter stated that the buy antibiotics PHE reduced reporting by eligible clinicians to QCDRs.

Response. While we are sympathetic and acknowledge that the impact the PHE may have had on reduced reporting, we note that we are proposing an incremental approach to assess QCDR data reporting. This includes the first proposal which would apply to any QCDR or qualified registry that has not submitted data to CMS since the inception of MIPS (CY 2017). We believe a QCDR should have been able to report data to CMS for years preceding CY 2021.

Specifically, we believe a QCDR should have been able to report data to CMS for CY 2019. If a QCDR was new in CY 2020 and did not submit data to CMS, the QCDR still has CY 2021 to report for clinicians which in turn, satisfies this requirement. Furthermore, the proposal provides QCDRs and qualified registries the opportunity to submit participation plans, which could support the decision to allow a QCDR or qualified registry to continue their MIPS participation. This plan would outline possible reasons for low/no reporting to CMS and the efforts the QCDR plans to take to further encourage their clinicians to submit data to CMS.

Some examples include but are not limited to. A reduction in associated fees, improvement of an EHR interface to reduce data extraction burden, expansion of the numbers/types of measures the QCDR chooses to report, etc. As such, this proposal would not immediately remove a QCDR or qualified registry from participating as a third party intermediary. As discussed above, we want to reduce the number of vendors that self-nominate to become a qualified vendor, but do not actively participate in the MIPS program.

We believe that maintaining these vendors who do not actively participate does not provide a benefit to the MIPS program. We note that our goal is to decrease the operational burden on CMS and those vendors who do not submit MIPS data to CMS. CMS would decrease its operational burden by not having to go through the vetting process of these entities or monitor program compliance during the year. Additionally, we believe that we can better utilize the resources used for vendors that do not submit MIPS data elsewhere to improve the MIPS program.

Furthermore, vendors who choose not to submit MIPS data to CMS are depriving CMS of data that would benefit the MIPS program. Lastly, vendors who do not submit data will decrease their burden in the long-term by not self-nominating year after year. Comment. One commenter disagreed with the proposal for QCDRs and qualified registries who do not submit data 2 years preceding the applicable self-nomination period to submit a participation plan at the time of self-nomination.

The commenter noted that CMS would also require the participation plan to include moving users over to submit their MIPS data through the qualified registry. The commenter expressed concern that this policy would create significant demand on QCDRs specifically, due to the already cumbersome Eligible Measure Applicability (EMA) process required for qualified registries. The commenter currently uses both the qualified registry and QCDR to collect data, however, the commenter only submits the data to CMS through the QCDR. Response.

We disagree with the commenter's interpretation of this policy. The intention of the participation plan requirement is to explain the QCDR's or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third party intermediary on behalf of clinicians or group and to explain why they should still be allowed to participate as a qualified vendor. The participation plan will not require moving users over to submit their MIPS data through the qualified registry and that this policy would create significant demand on QCDRs. We note that during the CY 2019 MIPS performance period, the Eligible Measure Applicability (EMA) process was updated to be applicable to collection types (that is, EMA applies to Part B Claims measures and MIPS clinical quality measures (CQMs) but does not apply to electronic clinical quality measures (eCQMs), QCDR measures, or Web Interface) rather than third party intermediaries.

As such, EMA does not apply to QCDRs and qualified registries as an entity, rather it could apply to MIPS CQMs that the QCDR or qualified registry is approved to support. We encourage third party intermediaries to participate as a QCDR if they intend to self-nominate their own QCDR measures or use another QCDR's measures (with permission from the QCDR who owns the measure) or as a qualified registry if they plan to support their clients through the reporting of CQMs or eCQMs only. After consideration of public comments, we are finalizing these policies as proposed. (ii) Collaboration of Entities To Become a QCDR and Proposal To Extend Policy for Collaboration of Entities To Become a Qualified Registry (A) Background In the CY 2017 Quality Payment Program final rule (81 FR 77377), we finalized to allow collaboration of entities to become a QCDR based on our experience with the qualifying entities wishing to become QCDRs for performance periods.

We stated that we believed our previously finalized policy supporting entity collaboration should be continued under MIPS. Therefore, we discussed that an entity that may not meet the criteria of a QCDR solely on its own, but could do so in conjunction with another entity and would be eligible for qualification through collaboration with another entity. Additionally, we finalized at § 414.1400(b)(2)(ii), specifically for QCDRs, that if the entity uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the Start Printed Page 65547 responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period.

For example, an entity, such as a specialty society, that needs technical support may partner with an outside entity such as a health IT vendor to qualify as a QCDR. While entities, such as QCDRs, Health IT vendors, and qualified registries, can collaborate with external organizations, those entities could only do so to meet requirements to be a QCDR. We did not explicitly create a policy for entities to collaborate to meet the requirements to be a qualified registry. (B) Proposal To Extend to Qualified Registries We believe we should extend the previously finalized policy to apply to entities that wish to collaborate to become a qualified registry as well because extending this policy to qualified registries would also help smaller specialty societies that may not have the resources on their own to become a qualified registry.

This will allow those societies to be able to partner with other entities to meet the definition of a qualified registry. Therefore, in the CY 2022 PFS proposed rule, we proposed to revise and redesignate existing paragraph (b)(2)(ii) to new paragraph (b)(3)(ii) to state, if the entity seeking to qualify as a QCDR or qualified registry uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period. For example, an entity, such as a specialty society, that needs technical support may partner with an outside entity such as a health IT vendor to qualify as a qualified registry.

We solicited comments on this proposal. We did not receive public comments on this proposal, and therefore, we are finalizing it as proposed. (iii) Data Validation Audit and Targeted Audit Requirements (A) Information Required at the Time of Self-Nomination In the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367. 81 FR 77383 through 77384) we discussed our expectation for QCDRs and qualified registries to conduct validation on the data they intend to submit for the MIPS performance period.

We also discussed that the full self-nomination process would require the following. A submission of basic information, a description of the process the QCDR and qualified registry will use for completion of a targeted audit of a subset of data prior to submission, the provision of a data validation plan along with the results of the executed data validation plan by May 31 of the year following the performance period. Additionally, in the Quality Payment Program provisions in the CY 2021 PFS final rule (85 FR 84930 through 84937. 85 FR 84944 through 84947) at existing § 414.1400(b)(2)(iv) and (v), and (c)(2)(iii) and (iv), we finalized the data validation audit requirements as condition for approval.

While we did finalize the requirements for the data validation audits as condition for approval, we did not codify the requirements for QCDR and qualified registries to submit data validation plan during self-nomination along with the results of the executed data validation plan by May 31 of the year following the performance period. In order to provide clarification and to better align with the previously finalized policy (81 FR 77366 through 77367. 81 FR 77383 through 77384), we proposed to codify the following revisions. As stated in previous polices (81 FR 77366 through 77367;81 FR 77383 through 77384), QCDRs and qualified registries are required to submit the results of their data validation plan to CMS by May 31 of the year following the performance period.

Therefore, we proposed to codify at § 414.1400(b)(3)(v)(G)( 1 ) to state that QCDRs and qualified registries must conduct validation on the data they intend to submit for the applicable MIPS performance period, and provide the results of the executed data validation plan by May 31st of the year following the performance period. Furthermore, QCDRs and qualified registries are required to submit their data validation plan explaining their process of data validation submission annually during self-nomination, and it must be approved by CMS for before use. To provide further clarity and to better align with the existing policy (81 FR 77366 through 77367. 81 FR 77383 through 77384), we also proposed to codify a new requirement at § 414.1400(b)(3)(iv) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination, for CMS' approval, and may not change the plan once approved, without the prior approval of the agency.

As discussed above we proposed to codify at § 414.1400(b)(3)(iv) to provide further clarity to better align with previous policies. Therefore, we proposed to reorganize at § 414.1400(b)(2)(iv) though (viii) to better align with the above changes. We proposed with the following revisions. We proposed to revise and redesignate existing paragraph (b)(2)(iv) to paragraph (b)(3)(v) to state, that beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct annual data validation audits in accordance with this paragraph (b)(3)(v).

We proposed to revise and redesignate existing paragraph (b)(2)(iv)(A) to paragraph (b)(3)(vi)(A) to state that, if a data validation audit under paragraph (b)(3)(v) identifies one or more deficiency or data error, the QCDR or qualified registry must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year. We proposed to revise and redesignate existing paragraph (b)(2)(v) to paragraph (b)(3)(vi) to state that beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct targeted audits in accordance with this paragraph (b)(3)(vi). We proposed to revise and redesignate paragraph (b)(2)(vi) to paragraph (b)(3)(vii), to state for the CY 2023 performance period/2025 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for any of the CY 2017 through 2021 performance periods/2019 through 2023 MIPS payment years must submit a participation plan for CMS' approval. This participation plan must include the QCDR's detailed plans and changes to encourage eligible clinicians and groups to submit data on the low-reported QCDR measure for purposes of the MIPS program.

• We proposed to revise and redesignate existing paragraph (b)(2)(vii) to paragraph (b)(4)(viii) to state that beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. Start Printed Page 65548 The following is a summary of the comments we received and our responses. Comment. Several commenters expressed concerns about the “overly burdensome” nature and significant cost of the CMS data validation audit requirements for third party intermediaries.

One commenter expressed concerns with the randomized auditing resulting in an unintended consequence of increasing burden on small and mid-sized group practices because of the low number of participants reporting via the qualified registry as individuals. One commenter stated that the audit requirements are duplicative, unnecessary, and do not enhance data quality and validity because QCDRs already have rigorous internal data and quality standards. A few commenters stated that clinicians and registries were impacted by the buy antibiotics zithromax, specifically that dozens of audits were conducted and QCDRs and qualified registries have encountered practices struggling to collect and report data while a majority of their time and effort has been spent on responding to the buy antibiotics zithromax. Response.

While we understand that data validation requires a level of effort, time, and cost by the QCDRs and qualified registries, we disagree that this causes undue burden. While we acknowledge and appreciate the efforts and participation of all group practices of varying sizes including small and mid-sized groups, we believe it is important to hold all practices to the same standards for data validation audits to ensure that all data submitted is true, accurate, and complete. As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367. 81 FR 77383 through 77384), we expect that QCDRs and qualified registries would conduct validation on the data they intend on submitting for the MIPS performance period and provide the results of the data validation to CMS in the form of a data validation execution report by May 31st of the year following the performance period.

As noted in the CY 2017 PFS final rule (81 FR 77366 through 77367), we believe it is necessary to establish a requirement that QCDRs conduct data validation to ensure they are actively monitoring the data they submit to CMS for purposes of a pay-for-performance program. We also believe it is important for QCDRs to validate the data that they intend to submit to us for purposes of the MIPS program to ensure that the data submitted is true, accurate, and complete (85 FR 84936). We disagree that audit requirements are duplicative, unnecessary, and do not enhance data quality and validity because QCDRs already have rigorous internal data and quality standards. While we appreciate that many QCDRs already have rigorous internal data and quality standards, we are not asking QCDRs to duplicate work.

If QCDRs have their own auditing requirements, they can use the same auditing process or combine the efforts to reduce duplication as long as they meet the data validation requirements specified by the regulation at a minimum (81 FR 77366 through 77367. 81 FR 77383 through 77384). For example, if a QCDR already audits 10 percent of their data prior to submission for all performance categories, this would meet the 3 percent portion of the data validation requirement. Additionally, despite our requirements to have validation audits, each year there are still some QCDRs that submit inaccurate data.

As payment adjustments increase, this could adversely affect a practice with respect to their payment because these payment calculations were based on inaccurate data submitted to CMS. Furthermore, while we do acknowledge that the impact of the PHE for buy antibiotics may have affected some providers and registries ability to conduct audits due to practices struggling to collect and report data due to majority of their time and effort being spent on responding to the buy antibiotics zithromax, as stated above, we believe it is important to enforce the requirements for data validation audits to ensure all data submitted is true, accurate, and complete. We will continue to assess the implications of the PHE for buy antibiotics and will consider whether to make any policy changes in future rulemaking. Comment.

One commenter expressed that NCQA data validation alleviates the burden on health plans having to perform their own audit of data received from an HIE and on providers from having to respond to data requests from health plans. This commenter suggested that CMS leverage NCQA processes for data validation. Response. We thank the commenter for their suggestion.

We may consider it for future rulemaking. After consideration of public comments, we are finalizing these policies as proposed. (4) New Requirements Specific to QCDRs (a) Background We refer readers to § 414.1400(b), the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375), the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814), the CY 2019 PFS final rule (83 FR 59900 through 59906), the CY 2020 PFS final rule (84 FR 63058 through 63074), the May 8th buy antibiotics IFC (85 FR 27594 through 27595), and the CY 2021 PFS final rule (84937 through 84944) for where we previously finalized standards and criteria for QCDRs, specifically QCDR measure requirements. In this section, we proposed to update policies related to QCDR measure rejections.

(b) QCDR Measures (i) QCDR Measure Rejections (A) New QCDR Measure Rejection Criteria We refer readers to the Quality Payment Program provisions in the CY 2020 PFS final rule (84 FR 63070 through 63073) at § 414.1400(b)(3)(vii) where we have previously adopted QCDR measure rejection criteria. In the CY 2022 PFS proposed rule, we proposed to add two new criteria. (1) QCDR does not have permission to use a QCDR measure. And (2) QCDR not approved or not in good standing.

These are discussed in more detail below in this section. (aa) QCDR Does Not Have Permission To Use a QCDR Measure In the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814), we discussed that beginning with the 2018 performance period and for future program years, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. We noted that the QCDR measure owner (QCDR vendor) would still own and maintain the QCDR measure, but would allow other QCDRs to utilize their measure with proper notification. We intended for this policy to help reduce the number of QCDR measures that are similar in concept or clinical topic, or duplicative of other QCDR measures that are being approved.

Additionally, in the Quality Payment Program provisions in the CY 2020 PFS final rule (84 FR 63070 through 63073) at § 414.1400(b)(3)(vii), we finalized the QCDR measure rejection criteria considerations. We noted that these considerations would help to ensure that QCDR measures are meaningful and measurable. Although we finalized the QCDR measure rejection criteria, we did not codify that QCDRs may seek permission from another QCDR to use an existing measure that is owned by another QCDR. In order to provide further clarity to the existing policies (82 FR 53813 through 53814.

84 FR Start Printed Page 65549 63070 through 63073), we proposed to codify a new requirement and add a rejection criterion at § 414.1400(b)(4)(iv)(M) to state, a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. We solicited comments on this proposal. The following is a summary of the comments we received and our responses. Comment.

A few commenters supported the proposal to add the rejection criterion that “A QCDR does not have permission to use QCDR measure owned by another QCDR for the applicable performance period” because CMS currently allows QCDRs to seek permission from another QCDR to report on an existing measure that is owned by the other QCDR, and because if a QCDR would like to use an existing QCDR measure that is owned by another QCDR, it must obtain permission from the QCDR measure owner that it can use the measure for the performance period and include proof of such permission in its self-nomination application. Response. We thank the commenters for their support. After consideration of public comments, we are finalizing this policy as proposed.

(bb) QCDR Not Approved or Not in Good Standing Additionally, if a QCDR measure owner is not approved or is not in good standing, any QCDR measures associated with that QCDR would also not be approved. We believe it is important to have an approved QCDR measure owner for all approved QCDR measures. This would ensure that there is active involvement by the QCDR measure owner so that any potential measure issues can be mitigated during the specified MIPS performance period. For example, any mid-year guideline changes or measure questions would need to be immediately clarified to avoid negative impacts to clinicians such as the inability to construct a benchmark due to an error in the measure specifications.

Therefore, we proposed to codify another rejection criterion at § 414.1400(b)(4)(iv)(N) to state that, if a QCDR measure owner is not approved during a given self-nomination period, any associated QCDR measures with that QCDR would also not be approved. We solicited comments on this proposal. We have received inquiries from stakeholders on what can be done in circumstances when an active QCDR wishes to use an inactive QCDR's measure. We are interested in feedback from stakeholders on what should be done in such circumstances.

For example, what should happen if “QCDR A” is using “QCDR B's” measures in a given performance period and “QCDR B” is terminated mid performance period?. Alternatively, what if “QCDR A” is using a measure from “QCDR B” and “QCDR B” decides not to self-nominate for the subsequent performance period?. While “QCDR A” could partner with “QCDR B” as described at § 414.1400(b)(3)(ii), are there other policy options we should consider to minimize impact to the MIPS eligible clinician who has selected the QCDR measure for reporting?. We solicited comments on the above circumstances.

The following is a summary of the comments we received and our responses. Comment. A few commenters disagreed with the proposal to add a rejection criterion requiring permission to use an inactive QCDR's measures. One commenter stated that there is no evidence that inactive QCDRs are withholding access to these measures.

The commenter noted the ability of QCDRs to license measures allows QCDRs to ensure the appropriate use of their measures and incentivizes organizations to invest in developing new and improved measures. The commenter suggested that CMS should continue its policy that allows active or inactive QCDR measure owners to choose to license their measures only to QCDRs that have the experience and expertise to properly implement a measure in a particular specialty. Therefore, there is no reason to change CMS' current policy under which an active QCDR that wishes to use an inactive QCDR's measure can approach the inactive QCDR and the two QCDRs can negotiate an agreement regarding the transfer of ownership if the active QCDR has the appropriate experience and expertise in QCDR measure development. In the event that such agreement cannot be reached between the two parties, the inactive QCDR can decline to license rights to the QCDR measure.

One commenter suggested that CMS require that either there be an agreement between the two QCDRs to transfer ownership of the measure or that the initial QCDR should maintain their measures and license it to other QCDRs. Response. We thank the commenters for their comments and suggestions. We clarify that if a QCDR measure owner is not approved or is not in good standing, any QCDR measures owned or maintained with that QCDR would also not be approved.

We disagree that the proposal to add a rejection criterion requiring permission to use an inactive QCDR's measures is not supported by evidence that inactive QCDRs are withholding access to these measures. We note that there have been instances where active QCDRs have inquired about using QCDR measures of inactive QCDR measure stewards. We also disagree that this policy is not needed. We believe it is imperative that all QCDR measures in the MIPS program have an active QCDR measure steward to provide ongoing maintenance and updates to QCDR measures.

For example, recently, a QCDR who shares their measures with several other QCDRs discovered multiples discrepancies, including risk adjustment calculation issues. If they had not been an active QCDR and performing quality assurance on these QCDR measures, this issue would likely not have been discovered and resolved. We do agree that the ability of QCDRs to license measures allows QCDRs to ensure the appropriate use of their measures and incentivizes organizations to invest in developing new and improved measures. We also agree that active or inactive QCDR measure owners may choose to license their measures only to QCDRs that have the experience and expertise to properly implement a measure in a particular specialty.

Furthermore, this process is consistent with what CMS requires for all other measures available for all clinicians to report in the MIPS program (the non-QCDR measures). That is, every measure in the program needs an active measure steward that agrees to support and maintain the measure. A non-active QCDR cannot be compelled to meet this requirement. In this context, we interpret the commenter's reference to a “policy under which an active QCDR that wishes to use an inactive QCDR's measure can approach the inactive QCDR and the two QCDRs can negotiate an agreement regarding the transfer of ownership”, to apply to our statements regarding QCDR licensing as discussed in the CY 2018 PFS final rule (82 FR 53813).

There we noted that, beginning with the 2018 performance period and for future program years, a QCDR vendor may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. While we thank the commenter for the suggestion to require the transfer of ownership of a measure from an inactive QCDR to an active QCDR or that the inactive QCDR should maintain the measure and license it to active QCDRs, we note that such approaches are beyond the scope of our regulations, which in this case is limited to approval and disapproval criteria for QCDRs and Start Printed Page 65550 QCDR measures. We are considering building out additional policies to ensure that all QCDR measures that are used/owned are properly maintained throughout the performance period. After consideration of public comments, we are finalizing this policy as proposed.

(5) Remedial Action and Termination of Third Party Intermediaries We refer readers to § 414.1400(f), the CY 2017 Quality Payment Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 through 59910), the CY 2020 PFS final rule (84 FR 63077 through 63080), and the CY 2021 PFS final rule (85 FR 84930 through 84937) for previously finalized policies for remedial action and termination of third party intermediaries. In the Quality Payment Program provisions in the CY 2019 PFS final rule (83 FR 59908 through 59910), we discussed that the threshold for “inaccurate, unusable or otherwise compromised” may be met if the submitted data includes TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies that affect more 3 percent of the total number of MIPS eligible clinicians or groups for which data was submitted by the third party intermediary. We proposed to update the existing language at § 414.1400(f)(3)(ii) to broadly explain that it is up CMS' discretion on whether third party intermediaries' inaccuracies may lead to possible remedial action or termination. As discussed earlier, we proposed consolidating and redesignating the existing language at § 414.1400(f) as paragraph (e) and § 414.1400(g) as paragraph (f) to provide clarity and alignment with the aforementioned proposals to consolidate the duplicative criteria of QCDRs and qualified registries.

Therefore, we proposed to revise and redesignate existing language at § 414.1400(f)(3)(ii) to paragraph (e)(3) to state, contains data inaccuracies affecting the third party intermediary's total clinicians may lead to remedial action/termination of the third party intermediary for future program year(s) based on CMS discretion. We did not receive public comments on this policy, and therefore, we are finalizing it as proposed. I. Public Reporting on the Compare Tools Hosted by the U.S.

Department of Health &. Human Services (HHS) In the CY 2022 PFS proposed rule, we proposed to amend § 414.1395(c) to add a 1-year delay of publicly reporting new improvement activities and Promoting Interoperability measures and attestations reported via MVP. We also proposed a one-time, 1-year delay to subgroup-level public reporting, such that subgroup-level public reporting will begin with CY 2024 performance information available in 2025, and each year thereafter, on the Compare Tools hosted by the U.S. Department of Health and Human Services (HHS), referred to as “compare tool” throughout this final rule, available at https://www.medicare.gov/​care-compare/​ and data.medicare.gov, as technically feasible.

We proposed to add facility affiliations, beyond the hospital affiliations currently displayed on individual profile pages. Additional facility affiliations would include. Inpatient rehabilitation facilities (IRFs). Long-term care hospitals (LTCHs).

Skilled nursing facilities (SNFs). Inpatient psychiatric facilities (IPFs). Home health agencies (HHAs). Hospices.

And dialysis facilities. Finally, we solicited comments on publicly reporting utilization data on clinician and group profile pages (86 FR 39466 through 39469). For previous discussions on public reporting, we refer readers to the CY 2016 PFS final rule (80 FR 71116 through 71123), the CY 2017 Quality Payment Program final rule (81 FR 77390 through 77399), the CY 2018 Quality Payment Program final rule (82 FR 53819 through 53832), the CY 2019 PFS final rule (83 FR 59910 through 59915), the CY 2020 PFS final rule (84 FR 63080 through 63083), the CY 2021 PFS final rule (85 FR 84947 through 85 FR 84948) and the Care Compare. Doctors and Clinicians Initiative Page at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Compare-DAC.

(1) MVP and Subgroup Public Reporting The introduction of MVPs and subgroup reporting provides for new types of performance information that are available for public reporting, provided they meet the established public reporting standards at § 414.1395(b). In consideration of our MVP and subgroup performance information public reporting proposals, we wish to remind readers that all submitted MIPS performance information is available for public reporting (81 FR 77395 through 77397). Additionally, we previously finalized at § 414.1395(c) that, for each program year, CMS does not publicly report any first-year measures for the first 2 years, meaning any measure in its first 2 years of use in the quality and cost performance categories. We also note that MIPS performance category and composite final scores for MIPS eligible clinicians participating in MVPs will continue to be publicly reported as required under section 1848(q)(A)(i)(I) of the Act and finalized at § 414.1395(a)(1)(i).

We believe delaying public reporting of certain MVP and subgroup performance information provides a catalyst to encourage clinician participation in MVPs and subgroups while they familiarize themselves with these options. For this reason, we proposed, for individuals, groups, and subgroups reporting via MVP, to add a 1-year delay for publicly reporting new improvement activities and Promoting Interoperability measures and attestations, as technically feasible. This means that new improvement activities and Promoting Interoperability measures and attestations would be available for public reporting at their inception in traditional MIPS, but we would delay public reporting of new improvement activities and Promoting Interoperability measures and attestations by 1 year after inception for those reporting via MVP. We note that improvement activities and Promoting Interoperability measures and attestations that have already been in MIPS for more than 1 year and become newly available as part of an MVP would be available for public reporting in the first year the MVP is in the program.

That is, non-first year improvement activities and Promoting Interoperability measures and attestations that are newly part of an MVP would be available for public reporting in the first year the MVP is in the program (86 FR 39466 through 39467). Table 74 further clarifies when this 1-year delay would apply. Start Printed Page 65551 We recognized that under this proposal, we would be further delaying the release of performance information for improvement activities and Promoting Interoperability measures and attestations reported via MVP. Because of this, as a potential incentive, we also considered whether to delay public reporting of quality and cost measure information reported via MVP by 1 additional year, for a total of 3 years.

We solicited comments on our proposal to delay public reporting of new improvement activities and Promoting Interoperability measures and attestations reported via MVP by 1 year, as well as any feedback on alternate approaches we should consider spurring clinicians to report performance data on MVPs while making performance data available for patients on the compare tool. We proposed to amend this MVP public reporting policy at § 414.1395(c)(2) to state CMS does not publicly report any MVP data on new improvement activities or Promoting Interoperability measure, objective, or activity included in an MVP for the first year in which it is included in the MVP. We also proposed to amend § 414.1395(c)(1) to state that CMS does not publicly report any data on new quality or cost measure for the first 2 years in which it is in the program, after which CMS evaluates the measure to determine whether it is suitable for public reporting under § 414.1395(b). Currently, § 414.1395(c) refers to these quality and cost measures as “first year measures”.

We proposed to change “first year measures” to “new measures” (86 FR 39467). The introduction of MVPs and subgroup reporting in MIPS provides for new types of performance information that are available for public reporting, provided they meet the public reporting standards. Currently, we display information on profile pages at the individual clinician and group level, since this is the level of information we provide for and at which patients and caregivers search for on the compare tool. To ensure that patients and caregivers have access to subgroup performance information, we proposed creating a separate workflow from the established ones for individuals and groups, since we only display information at the level at which it was publicly reported (86 FR 39467).

That is, we only publicly report individual-level performance information on individual clinician profile pages and group-level performance information on group profile pages. We do not publicly report group-level performance information on individual profile pages or individual-level information on group profile pages, as doing so would not be truly representative of either the group's or individual's own performance, and we do not want to mislead website users. Instead, we would link from the individual or group profile page to the corresponding subgroup performance information. That is, we proposed to create a subgroup public reporting workflow, in which we would indicate with plain language on an individual profile page that the clinician reports performance information as part of a subgroup or on a group profile page that the group has subgroups for purposes of performance information and then link to that subgroup's performance information.

Future user testing would determine how to best display and put in plain language subgroup performance information. Subgroup performance information will also be available on http://data.medicare.gov/​. Subgroups represent a new type of reporting for MIPS, that is available for clinicians reporting on MVPs or via the APP. For this reason, we also proposed to delay all subgroup-level public reporting for 1 year, including measures, activities and attestations across the quality, cost, improvement activities, and Promoting Interoperability performance categories in order to encourage clinician participation in subgroups without the risk of displaying subgroup performance information as clinicians familiarize themselves with the option of subgroup reporting.

This would only be a one-time delay in public reporting of subgroup-level information. That is, we would not publicly report any CY 2023 subgroup-level measure, attestation, or activity performance information. This information would be available for public reporting beginning with CY 2024 performance period/2026 MIPS payment year. We would publicly report CY 2024 performance period/2026 MIPS payment year subgroup information and for each performance period thereafter if the information meets our established public reporting standards.

Since we are moving toward more granular level performance information, we believe delaying subgroup public reporting by 1 year provides an incentive for subgroup participation and experience. As an alternative, we also considered a 1-year public reporting delay of performance information for all new subgroups each performance year, as technically feasible. For example, subgroups that begin in CY 2023 are not eligible for public reporting until CY 2024, subgroups that begin in CY 2024 are not eligible for public reporting until CY 2025, and so on for each subsequent year. Another alternative we considered was to publicly report all subgroup performance information without delay and provide new subgroups the opportunity to opt-out, during the preview period, of having their performance information publicly reported for their first year.

Some subgroups may want to have their performance information publicly reported and having an overall 1-year delay may be a disincentive to subgroup participation. We solicited comments on these considerations. We noted that MIPS performance category and composite final scores for MIPS eligible clinicians participating in MVPs will continue to be publicly reported for those participating in subgroups, as required under section 1848(q)(A)(i)(I) of the Act and finalized at § 414.1395(a)(1)(i), and will not be delayed by 1 year for public reporting. We also solicited comments on additional factors that we should consider as we look to expand the availability of MVP and subgroup data on the compare tools.

For example, Start Printed Page 65552 should there be a certain threshold of MVPs available, or clinicians participating in MVPs prior to public reporting?. For public reporting of subgroups, are there factors we should consider to make this information usable to the patient but reflective of the subgroups characteristics and composition?. Should we test an indicator of MVP participation for compare tool profile pages to see if this is useful information for patients making healthcare decisions?. We solicited comments on this proposal and additional ways public reporting may encourage MVP participation.

The following is a summary of the comments we received and our responses. Comments. Several commenters supported the proposal to delay, by 1 year, the public reporting of new improvement activities and Promoting Interoperability measures attestations reported through MVPs. One commenter requested clarification as to why new Promoting Interoperability measures and attestations would be delayed only for MVP participants.

While some commenters supported the delay, they recommended extending the delay beyond 1 year. Two commenters stated a concern that delaying public reporting for MVPs and not traditional MIPS may be confusing for patients. One of the commenters recommended adding a note to profile pages explaining why there may not be performance information. The same commenter also recommended that instead of delaying public reporting for MVPs, CMS should allow MVP participants to opt-out of public reporting for their first year.

Another commenter recommended beginning public reporting MVP performance information only once MVP reporting becomes mandatory. Response. We agree with most commenters that a 1-year delay of new improvement activities and Promoting Interoperability measures and attestations is an appropriate way to incentivize participation in MVPs. We also want to clarify that we proposed this 1-year delay as an incentive because new quality and cost measures already have a delay in public reporting for the first 2 years of use for clinicians in traditional MIPS.

This delay is for new improvement activities and Promoting Interoperability measures, objectives, and activities in all MVPs whether they are new or existing MVPs. We appreciate the recommendations to extend the delay beyond 1 year, to allow MVP participants to opt-out of public reporting in their first year, and to only publicly report performance information reported via MVPs once MVP reporting becomes mandatory. We do believe that a 1-year delay is enough time to allow clinicians to familiarize themselves with MVPs as we do not want to further delay valid performance information that consumers can use to make informed healthcare decisions. It is for this same reason that we do not want to have MVP participants opt-out of public reporting or to delay public reporting of performance information reported via MVPs until MVP reporting becomes mandatory.

We also want to clarify that performance information available via MVPs is the same as the performance information available in traditional MIPS and that we are required to publicly report performance information submitted by MIPS eligible clinicians. We do not believe that a delay for MVP participants and not traditional MIPS will be confusing to website users. Under traditional MIPS, we delay public reporting of new quality and cost measures by 2 years, and this has not caused any confusion to date. We also clarify that improvement activities and Promoting Interoperability measures and attestations that are already in traditional MIPS will be available for public reporting without any 1-year delay.

After consideration of public comments, we are finalizing this policy as proposed. Comment. Several commenters supported the one time, 1-year delay of subgroup public reporting, such that subgroup public reporting will begin with the availability of CY 2024 performance period/2026 MIPS payment year performance information. One commenter recommended extending the delay to 3 years.

Response. We agree that a one-time 1-year delay is enough time for participants to familiarize themselves with this subgroup-level reporting. We also clarify that CY 2023 performance period/2025 MIPS payment year subgroup-level measure, attestation, or activity performance information across all MIPS performance categories would not be available for public reporting. We would begin publicly reporting subgroup-level performance information with CY 2024 performance period/2026 MIPS payment year, which would be available for public reporting in CY 2025.

After consideration of the public comments, we are finalizing this policy as proposed. After consideration of all of the public comments received on MVP and subgroup public reporting, we are finalizing all policies in this section as proposed. We did not receive any public comments on the proposal to create a separate subgroup workflow, and therefore, are finalizing it as proposed. (2) Publicly Reporting APM Performance Pathway Information In the CY 2021 Quality Payment Program final rule, we finalized to establish an APM performance pathway (APP) beginning in the 2021 MIPS performance year.

This is an optional MIPS reporting and scoring pathway for MIPS eligible clinicians who participate in MIPS APMs. We also note that since APP participants are MIPS eligible clinicians, their MIPS performance category and composite final scores will be publicly reported as required under section 1848(q)(A)(i)(I) of the Act and finalized at § 414.1395(a)(1)(i). In the CY 2017 Quality Payment Program final rule, we finalized, as technically feasible, to use ACO profile pages as a guide to publicly reporting more APM data (81 FR 77398). Currently, groups who participate in an ACO have an indicator showing their participation, as well as a link to the ACO profile page with available performance information.

User testing has shown that website users find the ACO information meaningful and displayed in a user-friendly way. For this reason, we plan to continue this approach for APM performance information, including that which comes in via the APP, as technically feasible. We also solicited comments on alternative ways to publicly report performance information reporting via APPs and additional considerations to publicly reporting this information (86 FR 39467). We did not receive public comments on alternative ways to publicly report performance information reported via APPs or any additional considerations to publicly reporting this information.

(3) Facility Affiliations Compare tool profile pages for clinicians currently provide demographic information, including names, addresses, phone numbers, medical specialties, APM affiliations, Medicare assignment status, board certifications, education and residency, gender, and group and hospital affiliations. User testing consistently shows that Medicare patients and caregivers find value in these types of information. For hospital affiliations, website users have consistently noted the importance of understanding up front the relationships clinicians may have with facilities where they perform services when searching for a clinician. Specifically, patients and caregivers have noted during user testing that hospital affiliation is important to them, Start Printed Page 65553 since they may be looking for a clinician to perform a procedure at a hospital or want to know the hospitals a clinician could potentially admit them if needed.

Linking from the clinician profile page to their affiliated hospital page has provided a seamless experience for patients and caregivers, as they do not need to separately search for clinicians and hospitals. Rather, they can navigate to a hospital profile page directly from the clinician's profile page. With these user testing findings in mind, and because the Compare Tools include information on a number of other types of facilities beyond hospitals, we believe it would benefit patients and caregivers to also be able to navigate from clinician profile pages to profile pages for other types of facilities such as. IRFs.

Hospices. And dialysis facilities (86 FR 39468). Expanding the types of clinician-facility affiliations, beyond hospital affiliation, publicly reported would allow us to provide additional information about clinicians with or without any hospital affiliation but who are affiliated with other types of facilities. User testing with patients and caregivers has shown that facility affiliations not only for hospitals but also for IRFs, LTCHs, SNFs, IPFs, HHAs, hospices, and dialysis facilities would be helpful to their healthcare decision-making.

Specifically, we proposed adding affiliations to clinician profile pages for each of the following types of facilities, pending the results of user testing, as applicable and technically feasible. IRFs. LTCHs. SNFs.

IPFs. HHAs. Hospices. And dialysis facilities.

User testing will determine how to best display these affiliations on compare tool clinician profile pages. To determine clinician affiliations to these facilities, we would use claims data the same way we do to display the hospital affiliations currently available on clinician profile pages (77 FR 69165). We build the clinician-hospital affiliations based on observing a clinician practicing at a given hospital caring for at least three different Medicare patients on three different dates of service in the preceding 6 months, as documented in Medicare claims. We would use similar criteria for determining additional facility affiliations.

Clinicians can email the Quality Payment Program Service Center at http://www.QPP@cms.hhs.gov if they believe their facility affiliations are displayed incorrectly. We solicited comments on the proposal to add affiliations to clinician profile pages for each of the following types of facilities and link to the specific facility's page on the compare tool. IRFs. LTCHs.

And dialysis facilities. Further, we also solicited comment on whether there should be a limit on the number of procedures done or conditions treated at a given facility to determine clinician-facility affiliations. The following is a summary of the comments we received and our responses. Comments.

Several commenters supported adding facility affiliations beyond hospital affiliations to clinician profile pages on the compare tools. Specifically, these commenters supported the addition of affiliations for all facilities proposed, including IRFs, LTCHs, SNFs, IPFs, HHAs, hospices, and dialysis facilities. One commenter also recommended including clinicians' role as SNF medical directors on their profile pages. A few commenters noted concern, with two of these commenters opposing the proposal, related to the threshold for determining facility affiliations and how CMS would handle a clinician with multiple affiliations.

These commenters believed that the three different Medicare patients on three different dates of service in the preceding 6 months threshold may be too low for determining facility affiliations. One of the commenters recommended CMS conduct user testing to determine how consumers react when a clinician is affiliated with multiple facilities or with a facility that has poor quality ratings. Another commenter requested clarification on how we plan to obtain and verify facility affiliation and noted concern about location and specialty accuracy. Response.

We agree with commenters that adding affiliations to facilities beyond hospitals, on clinician profile pages, will aid patients in making healthcare decisions. We currently do not have a mechanism or source of data for verifying medical director or other healthcare administrative roles in SNFs or other types of care settings. Rather, if the clinician has filed a claim, it is because that clinician is actively treating patients and furnishing healthcare services, even if they also have an administrative role. We would not have information to report for a medical director or other healthcare administrator unless they have filed a claim.

We understand the commenters concern and will explore alternative data sources that are found to be reliable. Regarding the concern about a clinician having multiple affiliations, we have user tested clinician profile pages that display multiple facility affiliations and have found that if a clinician has multiple affiliations, beneficiaries and their caregivers consider it important for them to know when making healthcare decisions. We also want to note that the threshold for determining facility affiliations has been reliable for determining the hospital affiliations that are currently on clinician profile pages, which is why we proposed using this threshold for the additional facility affiliations. We will continue to monitor this process as we expand using our currently methodology to affiliate other settings of care to clinicians.

In response to questions regarding how we plan to obtain and verify facility affiliation, we plan to determine additional facility affiliations by using claims data in the same way we determine the hospital affiliations currently on clinician profile pages. This analysis includes reviewing claims for clinicians practicing at a given facility caring for at least three different Medicare patients on three different dates of service in the preceding 6 months, as documented in Medicare claims. Clinicians can email the Quality Payment Program Service Center at http://www.QPP@cms.hhs.gov with the correct information if they believe their facility affiliations are displayed incorrectly, as they do today for hospital affiliation. We would then manually edit the affiliation on the website.

This manual edit would remain in effect for 6 months only. To ensure a more permanent change, clinicians must update their information in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS). For more information, clinicians can visit the Care Compare. Doctors and Clinicians Initiative Page at https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Compare-DAC.

Regarding the accuracy of clinician specialty and location, we note that this information is obtained from the PECOS. We rely on clinicians to ensure that their information in PECOS is up to date to ensure the most accurate information is publicly reported. After consideration of public comments, we are finalizing this policy as proposed. (4) Utilization Data Request for Information Under section 104(e) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), beginning with 2016, the Secretary is required to integrate utilization data information on Start Printed Page 65554 Physician Compare.[] To satisfy section 104(e) of the MACRA, we previously implemented a policy to begin to include utilization data in a downloadable format in late 2017 using the most currently available data, and previously finalized that the specific codes to be included will be determined via data analysis and reported at the eligible clinician level (80 FR 71130).

We finalized to continue to include utilization data in the downloadable database (81 FR 77398). This information continues to be available today on www.data.cms.gov/​provider-data. To date, we have gathered utilization data for procedures from physician/supplier Medicare Part B non-institutional claims on certain services and procedures and published it in the public use file (PUF) file entitled “Physician and Other Supplier Data.” These data are useful to the healthcare industry, healthcare researchers, and other stakeholders who can accurately interpret these data and use them in meaningful analyses. However, this information is presented in a technical way that is not easily accessible or usable by patients, who do not frequently visit data.cms.gov or understand medical procedure coding.

This information also does not provide detail on the specific conditions clinicians treat, though in select cases it may be inferred by the clinicians and researchers reviewing this information. Section 10331(b)(3) of the Affordable Care Act requires that for public reporting, to the extent practicable, to include processes to assure that the data made available provides a robust and accurate portrayal of a clinician's performance. In our efforts to continue to provide patients and caregivers with meaningful information to make informed healthcare decisions, we believe utilization data may also have a place on clinician and group profile pages, if presented in a consumer-friendly way. We envision utilization data on patient-facing profile pages providing two main areas of benefit.

The first is allowing for more granular clinician searches, so that patients not only find specific types of clinicians but also those clinicians experienced in performing specific types of procedures and/or treating specific conditions. The second is providing categories of utilization data in a more plain language display that is usable to patients and their caregivers. In summary, utilization data could provide information to Medicare patients and their caregivers on the specific diagnoses clinicians treat and the frequency with which certain services or procedures are performed by a clinician or group and/or which types of clinicians do not provide certain services. For example, someone with severe arthritis of the knee may want to search for an orthopedic surgeon who specifically does knee replacements.

The way the clinician search works currently would only show results for “orthopedic surgeons” generally. That is, the patient would not see which of these clinicians specialize in this procedure, and likely would need to spend time calling clinicians to ascertain more detail. This could similarly be the case for finding a clinician who focuses on treatment of a certain condition. We believe indicating which clinicians focus on certain procedures or conditions would relieve some of this patient burden, as it would yield more specific search results.

There are a number of factors that could influence how procedure- and condition-specific information is determined, which is why we solicited comments on this topic in several areas. For display purposes, we may wish to apply a minimum experience level, such as the number of times a clinician performed a procedure or treated a condition, before a clinician profile is annotated to indicate experience with the condition or procedure. Regarding the methods in which we would identify clinician volume of procedures conducted or treat specific conditions, we would need to set a threshold for making these assertions. We have considered several options.

The threshold could be based on the number of times a clinician has performed a procedure or treated a condition within a certain time-period, or the proportion of the clinician's practice that is represented by the procedure or condition. Alternatively, thresholds may be devised based on ranking clinicians compared to their peers (specialty and geography may be considered when defining peers) in volume of procedures performed or frequency with which they treat each condition. We note also that these approaches utilize Medicare claims data only. That is, these data would not include procedures performed or conditions treated for patients who have other types of insurance, since this information is not available.

We also acknowledge that this utilization data only represents the care provided to Medicare beneficiaries and clinicians offer care to those with other forms of insurance. This disclaimer could be added to any data that may be publicly reported. We solicited comments on these approaches and whether there are any additional ones we should consider. Additionally, because the Compare Tools utilize a location-based search, national or local thresholds may be appropriate.

For example, clinicians in urban centers may specialize in a small number of procedures that they perform on a weekly basis, while a clinician in a rural area might be the most experienced at a given procedure, but not have comparable volume to the urban clinician who practices a very narrow scope. We solicited comments on these considerations, as well as if there are others. We also solicited comments on the potential types of utilization data that, if publicly reported, could help Medicare patients and their caregivers make informed healthcare decisions, as well as on technical considerations for presenting a specific affiliation between clinicians and diagnoses and/or procedures. Specifically, we solicited comments on.

The types of conditions and procedures that would most benefit patients' clinician searches. Important features and considerations for clinician searches by conditions or procedures. The lookback period for Medicare claims in order to identify a clinician's volume of procedures balancing frequency with recent experience (for example, 6 months, 1 year, 2 years). Clinician specialties or conditions with special considerations (for example, non-patient facing clinicians).

The maximum number of conditions treated or procedures performed to display on a given clinicians profile page. And Methods to set a threshold of treatment volume to display that a clinician commonly performs a procedure or treats a condition. For example, the threshold could be. (1) The number of times a clinician treated a condition or performed a procedure.

(2) the total scope that a condition or treatment represents in a clinician's practice. Or (3) the clinician's rank—either overall among all clinicians or among a subset of clinicians—in the number of times that clinician treated a condition or performed a procedure. Any other factors or considerations not listed above. We received public comments on considerations for publicly reporting utilization data.

We thank the commenters' feedback and will take these comments into consideration in future years. Start Printed Page 65555 4. Overview of the APM Incentive (a) Overview Under the Quality Payment Program, eligible clinicians who are Qualifying APM Participants (QPs) for a year are eligible to receive an APM Incentive Payment in the corresponding payment year for payment years 2019 through 2024. In the CY 2017 Quality Payment Program final rule (81 FR 77480 through 77489), we finalized at § 414.1450(d) that this payment is made based on the clinician's QP status in the QP Performance Period that is 2 years prior (for example, the 2021 payment will correspond to the 2019 performance year), and at § 414.1450(b)(1) that the payment is equal to 5 percent of the estimated aggregate payments for covered professional services in the base period (the year between the QP performance and payment years).

We also finalized at § 414.1450(c)(1) (82 FR 31729) that the APM Incentive Payment will go to the TIN associated with the Advanced APM Entity through which an eligible clinician becomes a QP during the QP Performance Period. In 2019, our first year of making APM Incentive Payments, we learned that the amount of time between the QP Performance Period (during which QP status is attained) and the QP payment year (during which APM Incentive Payments are issued) creates challenges to disbursing the payment for some QPs in a routine and efficient manner, for example for QPs who may have changed practices in the interim. Consistent with section 1833(z) of the Act, QP status is determined for, and connected to, an eligible clinician (identified by their NPI) for the QP payment year based on their Advanced APM participation during the QP Performance Period. In the proposed rule, we stated that we do not believe that changes in a QP's practice or TIN in the interim year between the QP determination and the QP payment year should affect a QP's ability to receive the APM Incentive Payment.

To address some of the unanticipated challenges we encountered in disbursing the APM Incentive Payments, in the CY 2021 PFS final rule, we finalized a hierarchy, codified at § 414.1450, that, based on our experience and lessons learned in making payments in 2019, provides more ways to identify an appropriate TIN to which we can make the APM Incentive Payment when a QP has experienced changes in their practice or TIN since the performance year in which they attained QP status. (c) APM Incentive Payment Recipient In the 2021 PFS final rule (85 FR 84472), we revised our approach to identifying the TIN or TINs to which we make the APM Incentive Payment and established a process that enables QPs to provide CMS with updated enrollment information that could be used to complete the payment in the event our approach does not yield an appropriate TIN or TINs to which to send their APM Incentive Payments. The process for those QPs to update their information, as well as a preliminary list of NPIs to whom it may be applicable, is included in a public notice published annually in the Federal Register. We explained in the CY 2021 PFS final rule that the revised approach would involve looking at a QP's relationship with TINs at different, specified periods in time, as well as considering the relationships such TINs have with certain APM Entities and Advanced APMs.

We stated that we believe this revised approach enables us to more appropriately identify TINs with which QPs currently have relationships to receive other Medicare payments, and through which the QPs likely would anticipate receiving their APM Incentive Payments. We noted that, when the QP is no longer affiliated with the TIN through which they achieved QP status, this approach will prioritize identifying an alternate TIN with which the QP is affiliated at the time the APM Incentive Payment is made, and to which it is appropriate to make the payment. The approach we adopted also serves to reduce uncertainty for QPs as they anticipate the APM Incentive Payments, as well as potential delays in our ability to make their payments. To improve and expand the ways we identify the TIN(s) to which we make the APM Incentive Payment for a QP in a timely and efficient manner, we finalized a policy to sequentially apply a decision hierarchy and codified the hierarchy in § 414.1450(c).

We apply the hierarchy by beginning at the first step, and if we are unable to identify one or more TINs with which the QP has a current affiliation at this step, we move to the next and successive steps of the hierarchy until we do identify one or more TINs with which the QP is affiliated. As discussed in the CY 2021 PFS final rule, if we identify more than one TIN at the applicable step in the hierarchy, we divide the APM Incentive Payment proportionally between the QP's TINs based on the relative paid amount for Part B covered professional services that are billed through each of the TINs. We proposed to clarify that, when we divide the APM Incentive Payment between two or more TINs, we apportion the APM Incentive Payment among TINs based on the share of total payments for covered professional services made to each TIN in the same base year that we use to calculate the APM Incentive Payment for the year. To calculate the APM Incentive Payment, we sum the total estimated aggregate payments for covered professional services for a QP for the base year, which is based on claims submitted for covered professional services, as codified at § 414.1450(b)(1) through (3).

We proposed to codify this policy at § 414.1450(c). In the course of making APM Incentive Payments during CY 2020 PFS final rule, we explored the possibility of expanding our search at each step of the hierarchy at § 414.450(c) to identify potential payee TINs that are associated with the QP during the QP payment year. Based on our findings, we stated we believe expanding our search in this way would enable us to make payments earlier in the calendar year and reduce the number of QP NPIs for whom we cannot identify a payee TIN using our hierarchy, and thus, rely on our public notice to request additional information. Therefore, we proposed to revise the hierarchy at § 414.1450(c) so that, using the criterion described in each step of our current regulation, we would first seek to identify a TIN associated with the QP during the base year, and if no such TIN is identified in the base year, we would then seek to identify a TIN associated with the QP during the payment year.

We have found in many instances that there are changes in enrollment information in PECOS for a QP over the span of 2 years between the QP performance period and payment year. By using enrollment information for the QP during the payment year, we are more likely to identify an appropriate TIN to which to make the APM Incentive Payment hierarchy. Under the proposal, applying the steps in the APM Incentive Payment hierarchy, we would make the APM Incentive Payment to one or more solvent TINs associated with the QP, identified by paid Medicare Part B claims for covered professional services and associated PECOS enrollment information during the base period. And if no such TIN is identified, we will make the payment to such TINs associated with the QP during the payment year.

We proposed to codify this policy in the regulation at § 414.1450(c). If no such TIN or TINs can be identified at a particular step, we will Start Printed Page 65556 move to the next and successive steps listed in § 414.1450(c)(1) through (8) until we identify one or more solvent TINs with which the QP is associated, and then would make the APM Incentive Payment to any such TIN(s). If more than one TIN is identified at a step based on paid claims during the applicable year either the base year or payment year, as we explain earlier and proposed to codify in the regulation under § 414.1450(c), would divide the APM Incentive Payment proportionately among such TINs according to the relative total paid amounts for Part B covered professional services to each TIN in same the base year we use to calculate the APM Incentive Payment. We proposed, for each step in the APM Incentive Payment decision hierarchy, we would first search for a payment TIN or TINs associated with the QP during the base period.

If no such TIN is found during the base year, we would search for any TIN or TINs that are similarly situated with respect to the criterion at that step in the hierarchy and associated with the QP during the payment year. If such a TIN or TINs are found, we would make the APM Incentive Payment to such TIN or TINs. We will continue at each step in the hierarchy to first attempt to identify the relevant base year TIN or TINs associated with the QP because, as noted in the proposed rule, we believe such TINs are more likely to be associated with the APM Entity through which the QP attained their QP status during the QP performance period. However, if no such TIN is found in the base year, we would proceed at that step to search for a TIN or TINs with which the QP is associated in the payment year.

We explained that we believe this approach creates the greatest opportunity to identify and pay an appropriate TIN as efficiently and early as possible during the payment year. The proposed change would maintain the current hierarchy while adding a sub-step at each level in which we would conduct our search based on more current enrollment information. The proposed change would allow for the identification of an appropriate TIN or TINs at each step by first checking the base year, and then checking the payment year before moving on to the next step in the process. We stated we believe that by maintaining the current hierarchy we would continue to incent Advanced APM participation by prioritizing making payments to TINs affiliated with Advanced APMs, even if they are not in the same Advanced APM Entity through which QP status originally was achieved.

For example, we stated that we anticipate that many eligible clinicians who earned QP status in 2020 through a practice participating in the CPC+ model will join the new Primary Care First (PCF) model in 2022. In the event the eligible clinician's CPC+ participant TIN is no longer active, our proposed modification to the hierarchy would enable us to pay the APM Incentive Payment to a TIN participating in the PCF model in 2022. We stated that we continue to believe it would be appropriate to first identify the relevant base year TIN or TINs at each step in of the hierarchy because we believe those TINs are more likely to be associated with the APM Entity through which the QP attained their QP status during the QPs performance period. However, if no TIN is found in the base year, we would proceed to identify any TINs associated with the QP in the payment year, and then use the same process for the subsequent steps in the hierarchy until we identify one or more TINs associated with the QP at a particular step for a particular year (base year or payment year).

We explained that we believe this approach will be a more efficient and expeditious way to identify a TIN or TINs to which to make the APM Incentive Payment for QPs. We solicited comments on this proposal to amend our APM Incentive Payment decision hierarchy to include an additional attempt to identify and pay, at each step, one or more solvent TINs associated with the QP during the payment year when no such TIN is identified for the QP in the base year. We received several comments on this proposal. Comment.

We received many public comments in support of this approach to identifying payee TINs during the payment year. Response. We thank commenters for their support of this policy. Comment.

We received two public comments advocating that the APM Incentive Payment should be paid directly to the ACO or APM Entity. Response. We disagree with this comment for several reasons. First, the APM Incentive Payment is not earned by the APM Entity in the way a shared savings payment may be earned by the ACO under the Shared Savings Program.

Although QP determinations are in some cases are made at the APM Entity group level, QP status is conferred on an individual eligible clinician. As a result, the individual QP is excluded from the MIPS reporting and payment adjustment requirements, and it is the QP who earns the APM incentive payment. Therefore, the payment is disbursed for the eligible clinician who is a QP to a TIN that is affiliated with the QP, even in instances where the QP is no longer affiliated with the APM Entity. The payment is designed as an incentive in lieu of the pursuance of a MIPS payment adjustment.

CMS makes the APM Incentive Payment to one or more TINs to which the QP has reassigned their billing rights. Thus, the QP and TIN may resolve between themselves the handling of the APM Incentive Payment. Some APM Entities are the same as the Medicare enrolled TIN to which QPs have reassigned their Medicare payment rights, and to which we would make the APM Incentive Payment. Other APM Entities, such as ACOs, are not.

For these reasons, we do not make the APM Incentive Payment directly to an ACO, and we do not believe it would be appropriate to do so. Comment. One commenter suggested that we should allow QPs to individually identify their preferred payee TIN to receive the APM Incentive Payment. Response.

It would not be practically feasible for every QP to individually identify a recipient TIN for the QP incentive payment. Our experience working with PECOS and other voluntary systems, including our annual public notice, indicate that requiring individual eligible clinicians to elect a recipient TIN for the incentive payment could cause significant delays in completing the payments. These delays would be of such duration that CMS would likely miss the statutory deadline of December 31 of the payment year in which we are required to have completed these payments. Further, some QPs might never complete the prerequisite step, which would make it difficult if not impossible to disburse APM Incentive Payments for them.

Moreover, eligible clinicians are not without an opportunity to indicate to CMS the TINs with which they have current billing arrangements. In fact, all Medicare enrolled eligible clinicians are required to update their billing information, including reassignments within the PECOS system within a specified timeframe. By ensuring PECOS is updated at all times, eligible clinicians have an opportunity to ensure that if they become QPs for a year, the APM Incentive Payment will be received by a TIN to which they have reassigned their billing rights. We believe it is both appropriate and efficient for clinicians to use the longstanding and required processes that are in place to update their billing information, which enables us to identify one or more appropriate TINs to which to make the APM Incentive Payment.

Finally, we have established in regulations a payment decision Start Printed Page 65557 hierarchy that specifies how we will identify the TIN or TINs to which we will distribute the APM Incentive Payment. One of the main purposes for establishing this hierarchy and for updating it this year is to provide predictability for eligible clinicians regarding the APM Incentive Payment disbursements. After consideration of the public comments, we are finalizing our proposed update to the APM Incentive Payment decision hierarchy, and amending our regulation at § 415.1415(c), as proposed. C.

Advanced APMs 1. Qualifying APM Participant Determination a. General Overview In the CY 2017 Quality Payment Program final rule (81 FR 77439 through 77445), we finalized our policy at § 414.1425(b) for Qualifying APM Participant (QP) determinations. For the purposes of making QP determinations, an eligible clinician must be present on the Participation List of an APM Entity in an Advanced APM on one of the “snapshot dates” (March 31, June 30, or August 31) for the QP Performance Period.

An eligible clinician included on a Participation List on any one of such dates is included in the APM Entity group even if that eligible clinician is not included on that Participation List at one of the prior- or later-listed dates. We perform QP determinations for the eligible clinicians in an APM entity group three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP snapshot dates. An eligible clinician can be determined to be a QP only if the eligible clinician appears on the Participation List on a snapshot date that we use to determine the APM Entity group and to make QP determinations at the APM Entity group level based on participation in the Advanced APM. For eligible clinicians who appear on a Participation List in more than one APM Entity, but do not to achieve QP status based on any APM Entity level determinations, we make QP determinations at the individual level as described in § 414.1425(c)(4).

Likewise, for eligible clinicians on an Affiliated Practitioner list for an Advanced APM we make QP determinations at the individual level three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination snapshot dates as described in § 414.1425(b)(2). B. QP Thresholds and Partial QP Thresholds Section 1833(z)(2)(B) of the Act describes the thresholds for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year. The Medicare Option, based on Part B payments for covered professional services or counts of patients furnished covered professional services under Part B, has been applicable since payment year 2019.

The All-Payer Combination Option, which uses the Medicare Option, as well as an eligible clinician's participation in Other Payer Advanced APMs, is applicable beginning in the payment year 2021. In the CY 2017 Quality Payment Program final rule (81 FR 77433 through 77439) we finalized our policy for the Medicare Option as codified at § 414.1430(a) and for the All-Payer Option at § 414.1430(b). Section 114 of Division CC of the CCA amended section 1833(z)(2)(B) of the Act with regard to payment years 2023 and 2024 (which correspond respectively to performance years 2021 and 2022), by freezing for such years the applicable payment amount and patient count thresholds for an eligible clinician to achieve QP status. Specifically, the CAA amended section 1833(z)(2)(B) of the Act to continue the QP payment amount thresholds that apply in payment years 2021 and 2022 to payment years 2023 and 2024.

Additionally, the CAA amended section 1833(z)(2)(D) of the Act to require that, for payment years 2023 and 2024, the Secretary use the same percentage criteria for the QP patient count threshold that are applied in payment year 2022. As such, the Medicare Option QP thresholds for payment years 2023 and 2024 (performance years 2021 and 2022) will remain at 50 percent for the payment amount method and 35 percent for the patient count method. The CAA also amended section 1848(q)(1)(C)(iii) of the Act to extend through payment year 2024 the Partial QP thresholds that are established for payment years 2021 and 2022. Therefore, the Partial QP thresholds for payment years 2023 and 2024 (performance years 2021 and 2022) will remain at 40 percent for the payment amount method and 25 percent for the patient count method.

For performance years beginning with 2023 (corresponding to payment years beginning with 2025) the statute prescribes the QP thresholds for the payment amount method, and the QP thresholds we established for the patient count method at § 414.1430 will take effect. Specifically, for performance years beginning with 2023, the Medicare Option QP thresholds will be 75 percent for the payment amount method and 50 percent for the patient count method. The Partial QP thresholds under the Medicare Option will be 50 percent for the payment amount method and 35 percent for the patient count method. Under the All-Payer Combination Option, the QP thresholds for performance years 2021 and 2022 (corresponding to payment years 2023 and 2024) will be 50 percent for the payment amount method and 35 percent for the patient count method.

The Partial QP thresholds for performance years 2021 and 2022 will be 40 percent for the payment amount method and 25 percent for the patient count method. In order to become a QP through the All-Payer Combination Option, eligible clinicians must first meet certain threshold percentages under the Medicare Option. For performance years 2021 and later (corresponding to payment year 2023 and later), the minimum Medicare Option threshold an eligible clinician must meet for the All-Payer Combination Option is 25 percent for the payment amount method or 20 percent under the patient count method. Start Printed Page 65558 Although we included proposed amendments to our regulation at § 414.1430(a)(1) and (2) in the CY 2022 PFS proposed rule to reflect the changes made by the CAA to the QP and Partial QP Thresholds under the Medicare Option payment amount method, we inadvertently neglected to discuss those proposed amendments in the preamble.

Additionally, we inadvertenly did not include proposed regulation text at § 414.1430(a)(3) or (4) to reflect the amendments made by the CAA to the QP and Partial QP thresholds under the Medicare Option patient count method. Or to the regulation text at § 414.1430(b) to reflect amendments to the All Payer Option payment amount and patient count QP and Partial QP thresholds. However, we believe it is preferable to revise the regulation text to consistently and accurately reflect the statutory threshold percentages for each year in accordance with the CAA amendments for both the Medicare Option and All Payer Option and for both the payment amount and patient count methods for each of the options. Therefore, we are finalizing the proposed amendments to § 414.1430(a)(1) and (2) and making amendments to § 414.1430(a)(3) and (4).

And § 414.1430(b)(1) through (4) to reflect the applicable statutory threshold percentages as amended by the CAA. We received four public comments, all in support of the statutory changes to the QP and Partial QP threshold levels. We thank the commenters for their input and will implement the amendments made by the CAA as discussed and revise the regulation at § 414.1430 as proposed. V.

Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ), we are required to publish a 60-day notice in the Federal Register and solicit public comment before a “collection of information” requirement is submitted to the Office of Management and Budget (OMB) for review and approval. For the purposes of the PRA and this section of the preamble, collection of information is defined under 5 CFR 1320.3(c) of OMB's implementing regulations.

To fairly evaluate whether an information collection should be approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our burden estimates. The quality, utility, and clarity of the information to be collected.

Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques. We solicited public comment on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements. A. Wage Estimates To derive average costs, we used data from the U.S.

Bureau of Labor Statistics' May 2020 National Occupational Employment and Wage Estimates for all salary estimates ( http://www.bls.gov/​oes/​current/​oes_​nat.htm ). In this regard, Table 76 presents the mean hourly wage, the cost of fringe benefits and overhead (calculated at 100 percent of salary), and the adjusted hourly wage. Start Printed Page 65559 For the CY 2019 and CY 2020 PFS final rules, we used the BLS wage for “Physicians and Surgeons” (occupation code 29-1060) to estimate the cost for Physicians. In BLS' most recent set of occupational wage rates (dated May 2020) they have discontinued this occupation in their wage data.

As a result, in order to estimate the burden for Physicians, similar to the estimates in the CY 2021 PFS final rule (85 FR 84958), we are using a rate of $217.32/hr which is the average of the following BLS occupations and adjusted wage estimates. As indicated, we adjusted BLS' hourly wage estimates by a factor of 100 percent to obtain the adjusted hourly wage estimate. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of Start Printed Page 65560 estimating these costs vary widely from study to study. Nonetheless, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

B. Information Collection Requirements (ICRs) 1. ICRs Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802 and 414.806) The following provisions will be subject to the standard PRA process under OMB control number 0938-0921 (CMS-10110). The standard PRA process includes the publication of 60- and 30-day Federal Register notices that will provide the public with opportunities for public review and comment.

We expect to publish the 60-day notice shortly after the publication of this final rule. The new provisions at §§ 414.802 and 414.806 will implement new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of Division CC, Title IV of the CAA, 2021 (for the purposes of this section of this final rule, hereinafter is referred to as “section 401”), which requires manufacturers without a Medicaid drug rebate agreement to report ASP information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological. Specifically, to implement the new reporting requirements for manufacturers without Medicaid drug rebate agreements, we proposed to modify. (1) The definition of drug at § 414.802.

And (2) the regulations describing civil money penalties at § 414.806. The new requirements will improve the accuracy of reported payment limits and limit the use of WAC-based pricing. For the purposes of section 401's new reporting requirements, for manufacturers without Medicaid drug rebate agreements, confidentiality requirements appear in section 1847A(f)(2)(D) of the Act which states that the ASP data are confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs or biologicals by such manufacturer or wholesaler, except—as the Secretary determines to be necessary to carry out section 1847A of the Act (including the determination and implementation of the payment amount), or to carry out section 1847B of the Act. To permit the Comptroller General of the United States to review the information provided.

To permit the Director of the Congressional Budget Office to review the information provided. To permit the MedPAC to review the information provided. And to permit the Medicaid and CHIP Payment and Access Commission to review the information provided. For manufacturers with Medicaid drug rebate agreements, confidentiality requirements appear in section 1927(b)(3)(D) of the Act which states that the ASP data are confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler, prices charged for drugs by such manufacturer or wholesaler, except—in relevant part, as the Secretary determines to be necessary to carry out section 1847A of the Act (including the determination of the payment amount), or to carry our section 1847B of the Act, to permit the Comptroller General to review the information provided, to permit the Director of the Congressional Budget Office to review the information provided, and to permit the Executive Director of the Medicare Payment Advisory Commission (MedPAC) and the Executive Director of the Medicaid and CHIP Payment and Access Commission to review the information provided.

The burden associated with these requirements is the time and effort required by manufacturers of drugs and biologicals payable under Medicare Part B to prepare and submit the required ASP data to CMS. We have previously estimated the burden associated with ASP reporting requirements for manufacturers with Medicaid drug rebate agreements. Because section 401 extends the ASP reporting requirements to manufacturers without Medicaid drug rebate agreements, we are updating our burden estimates to account for the additional manufacturers who will now be required to report ASP data to us. As described in section III.D.1.

Of this final rule, in considering whether to exclude repackagers from the reporting requirements at section 1847A(f)(2) of the Act, we conducted analyses to estimate. (1) The proportion of repackaged products in our existing ASP data. (2) the number of new ASP submissions we can expect as a result of the new reporting requirements under section 401. And (3) the proportion of those (new) submissions that involve repackaged products.

Based on our existing ASP data, 547 manufacturers (respondents) report ASP data to us. Of these, 331 respondents have products for which they are required to submit ASP data, and 216 respondents have products for which they currently submit ASP data voluntarily, but will now be required to do so under section 1847A(f)(2) of the Act. (331 + 216 = 547) We also estimate that under the new reporting requirements of section 401, a total of 568 respondents have products for which they will now be required to report ASP data to us. The 568 includes the 216 respondents (above) and 361 respondents who have products (identified by us) for which they will now be required to submit ASP data under section 1847A(f)(2) of the Act and did not previously voluntarily submit these data to us.

There were 9 respondents who voluntarily submitted ASP data for some, but not all, of their products identified in our analysis. (216 + 361−9 overlap = 568) We estimate a total of 740 respondents will report ASP data to us. This includes the 547 respondents who currently submit ASP data to us (voluntarily, or as currently required), and the 361 respondents who have products (identified by us) for which they will now be required to submit ASP data under section 1847A(f)(2) of the Act and did not previously voluntarily submit these data to us. However, there were 168 respondents who currently are required to submit ASP data to us, or who voluntarily submit ASP data to us, for whom we identified additional products that they did not previously submit ASP data, and will now be required to submit ASP data for these additional products under the new reporting requirements of section 401.

(547 + 361−168 overlap = 740) These respondents submit ASP data four times per year for a total of 2,960 submissions (740 respondents × 4 submissions/year). Based on our experience with ASP data reporting, we continue to estimate that the time associated with reporting, record keeping, and third-party disclosure for ASP data reporting is 13 hours. 10 hours to review instructions and search existing data resources and 3 hours to gather the data, compile the data, submit via electronic media and upload to the automated system. This estimate includes labor costs for respondents to extract data from their information systems and to compile and submit the ASP data, including signature, to CMS via the internet-based automated system and electronic media.

This estimate also includes the cost of the compact disc (CD) and overnight mail service used to report the data, Start Printed Page 65561 time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. Based on these analyses and assumptions, we estimate an annual burden of 38,480 hours (2,960 submissions/yr × 13 hours per response) at a cost of $1,495,332.80 (38,480 hr × $38.86/hr), rounding to $1,495,333. We solicited comment on the likely costs or savings manufacturers from this provision. We did not receive public comments on the analyses or the estimates.

We are finalizing the definition of the term “drug” at § 414.802 as proposed. 2. ICRs Regarding the Medicare Shared Savings Program (Sections VI.F.8.a. And b.) Section 1899(e) of the Act provides that chapter 35 of title 44 U.S.C., which includes such provisions as the PRA, shall not apply to the Shared Savings Program.

Accordingly, we are not setting out burden under the authority of the PRA. Please refer to sections VI.F.8.a. And b. Of this final rule for a discussion of the impacts associated with this rule's changes to the Shared Savings Program's quality reporting requirements, quality performance standard, beneficiary assignment methodology, repayment mechanism requirements, requirements for disclosure of prior participation in the Shared Savings Program by the ACO, ACO participants, and ACO providers/suppliers, requirements for ACOs to submit sample ACO participant agreements and executed ACO participant agreements to CMS, and beneficiary notification requirements.

3. ICRs Regarding the Medicare Ground Ambulance Data Collection System (§ 414.626) Section 1834(l)(17) of the Act requires that the Secretary develop a ground ambulance data collection system that collects cost, revenue, utilization, and other information determined appropriate by the Secretary with respect to providers of services and suppliers of ground ambulance services (ground ambulance organizations). Section 1834(l)(17)(I) of the Act states that the PRA does not apply to the collection of information required under section 1834(l)(17) of the Act. Accordingly, this collection of information section does not set out any burden for the proposed provisions that we are finalizing in this final rule.

Please see section VI. Of this final rule for a discussion of the estimated impacts. We received no public comments on the collection of information requirements for the Medicare Ground Ambulance Data Collection System. We are finalizing as proposed.

4. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) Expanded Model (§§ 410.79, 414.84, 424.205, and 424.502) In section III.L. Of this final rule, we finalize policies necessary to shorten the Medicare Diabetes Prevention Program (MDPP) services period to one (1) year on a prospective basis, amend and update the amount of the performance payments for the Core Sessions and Core Maintenance Sessions, and make changes to eliminate the ongoing maintenance phase for MDPP beneficiaries who start MDPP set of services on or after January 1, 2022. In addition, we are finalizing a provision to waive the provider enrollment Medicare application fee for all organizations enrolling in Medicare as MDPP suppliers during the MDPP expanded model on or after January 1, 2022.

We expect the finalized policies will increase the number of eligible organizations willing to enroll as MDPP suppliers. We also anticipate that the shortened service period will make MDPP more marketable to beneficiaries in that their time commitment is reduced and less intimidating with a 12-month vs. 24-month service period. We anticipate the shortened MDPP services period will reduce the recordkeeping burden for suppliers.

Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the MDPP expanded model, from the provisions of the PRA. Accordingly, this collection of information section does not set out any burden for the provisions. Please see section VI. Of this final rule for a discussion of the estimated impacts.

5. ICRs for Prepayment and Post-Payment Definitions, Documentation Request Timeframes, and Payment Denials for Noncompliance With Documentation Requests (§§ 405.902, 405.903, 405.929, and 405.930) In section III.N.2. Of this final rule, we proposed to. (1) Define key terms including “additional documentation,” “additional documentation request,” “post-payment medical review,” and “prepayment medical review;” (2) codify contractors' authority to request additional documentation for prepayment and post-payment review within established timeframes.

(3) codify timeframes for response to requests for documentation. (4) codify result of a failure to comply with prepayment or post-payment documentation request(s) by a provider or supplier, specifically denial of payment. The codification of contractor authority to request additional documentation for post-payment reviews, associated timeframes, and resulting denials for failure to comply with these requests is not subject to the PRA per 5 CFR 1320.3(h)(9). The request for additional documentation will be on a case-by-case basis using non-standardized follow-up questions.

With regard to the (1) definitions for “additional documentation” and “additional documentation request,” “post-payment medical review,” and “prepayment medical review;” (2) the codification of contractor authority to Start Printed Page 65562 request additional documentation for pre-payment reviews. (3) the associated provider and supplier timeframes for providing additional documentation from the pre-payment reviews. And (4) possible denials for failure to comply with these requests, we do not expect that these proposals will affect our information collection burden estimates because these policies do not require providers or suppliers to submit any more documentation to CMS than what is already approved by OMB under control number 0938-0969 (CMS-10417). The regulations simply codify certain requirements by clarifying definitions, timeframes, and results for noncompliance.

We did not receive public comments on this provision, and therefore, we are finalizing as proposed. 6. ICRs Regarding the Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan (§ 423.160(a)) Pending our finalization of the following provisions, the changes will be subject to the standard PRA process under OMB control number 0938-1396 (CMS-10755) to give stakeholders optimal opportunity to comment on our burden for this provision, given how dynamic the burden for EPCS is. The standard PRA process includes the publication of 60- and 30-day Federal Register notices that will provide the public with opportunities for public review and comment.

We expect to publish the 60-day notice shortly after the publication of the final rule. The purpose of this provision is to continue to implement section 2003 of the SUPPORT for Patients and Communities Act, which requires that the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program beginning January 1, 2021, subject to any exceptions, which HHS may specify. We refer readers to the CY 2021 PFS final rule (85 FR 84472) for our previously finalized requirements and burden for the first phase of implementing this statutory mandate, which required prescribers to use the NCPDP SCRIPT 2017071 standard for Electronic Prescription for Controlled Substances (EPCS) prescription transmissions. The purpose of this final rule is to delay the date for CMS to begin taking compliance actions, implement certain exceptions to the mandate, and implement a compliance threshold.

In the CY 2021 PFS final rule, we estimated that the one-time burden to implement this provision would be 828,750 hours (165,750 prescribers * 6 hr) at a cost of $36,418,590 (994,500 hr * $36.62/hr). We arrived at the estimate of 165,750 prescribers having to implement EPCS based on taking the 425,000 Part D prescriber practices, and decreasing that amount by 60 percent to account for the 60 percent of prescriber practices that likely already had EPCS in place by January 1, 2021. Based on our current PDE data, we estimate that 70 percent of Part D prescribers already conduct EPCS,[] which would leave 30 percent of Part D prescribers that would have to implement EPCS, if we did not propose any exceptions to this mandate. We also proposed that prescribers writing prescriptions for beneficiaries in long term care facilities will have an extension for those prescriptions until January 1, 2025 along with the following exceptions to the EPCS mandate.

(1) For prescriptions issued when the prescriber and dispensing pharmacy are the same entity. (2) cases where prescribers issue only a small number of Part D. (3) cases where a prescriber's NCPDP database address is in a geographic service area of an emergency or disaster declared by a Federal, State or local government entity. And (4) cases where a prescriber has received a CMS-approved waiver.

These exceptions will result in fewer prescribers being required to conduct EPCS. Based on our PDE data, we believe that these exceptions will substantially decrease the number of prescribers having to implement EPCS as a result of this regulation. We have listed the exceptions and the estimated number of prescribers falling under each exception in Table 79.[] We do not anticipate that our proposal to include a compliance threshold of 70 percent will have any material effect on the impact of this provision. The reason for this is that based on our PDE data and conversations with prescribers, we believe that the 30 percent or less of the time that prescribers are not e-prescribing is because they are unable to e-prescribe, so they would have applied for a waiver.

Although there are sometimes scenarios where beneficiaries may request that their prescriptions not be transmitted electronically, it appears as though those circumstances are not enough to make a material impact, since beneficiaries often change their views when they are given countervailing reasons that the prescriptions should be transmitted via EPCS. Start Printed Page 65563 Table 79 gives our estimate of the number of prescribers affected by our exceptions broken down by the type of exception. As shown in Table 79, we estimate that our exceptions will exempt approximately 582,664 prescribers from the EPCS requirement, which consistutes approximately 38 percent of prescribers, since there are an estimated 1,548,221 Part D prescribers [] (582,664/1,548,221). Since the number of exempted prescribers from this mandate far exceeds the number of prescribers who currently do not e-prescribe controlled substances in Part D, we do not expect that the total number of Part D prescribers who electronically prescribe controlled substances will increase following our implementation of this mandate.

As a result, we do not believe there will be a measurable impact to the prescriber community as a whole, once this provision is finalized. However, for individual prescribers who have to implement this mandate, we expect that the implementation costs will be the same amounts that we finalized in the CY 2021 PFS final rule. Based on the modeling that we have seen, we have found that EHR companies provide the initial set-up of e-prescribing software free of charge, provided the prescribers pay the per transaction cost of $1.88 mentioned in the CY 2021 PFS final rule. Based on the comments received on our CY 2021 PFS proposed rule, we understand that implementing EPCS can lead to technological glitches, and then fixing those issues.

We understand that the EHR companies remedy the issues free of charge. However, we also understand that such fixes take time away from the medical office staff. We estimate that such fixes would take the staff approximately 1 extra hour from the estimate given in our CY 2020 PFS proposed rule, when averaged across all prescribers. As a result, we have changed our one-time burden estimate of e-prescribing set-up from 5 hours to 6 hours per provider, which means a total of 994,500 hours (165,750 prescribers * 6 hr) at a cost of $36,617,490 (994,500 hr * $36.82/hr), since we anticipate that this work will be completed by an Administrative Support Worker.

In this regard, the impact of this rule is plus 1 hour per response, plus 165,750 hours (165,750 prescribers × 1 hr/response), and $6,102,915 (165,750 hr × $36.82/hr). We proposed that prescribers have the ability to apply for a waiver from the EPCS requirement, should they be facing circumstances beyond their control that prevent them from e-prescribing, and these circumstances are not the result of a natural disaster or emergency. Due to the high prevalence of EPCS, the miniscule compliance actions that we proposed for non-compliance, and the number of prescribers that we expect to exempt from the mandate, we only expect to receive about 100 attestations per year. Although we proposed certain fields be in this attestation, these were minimal, and there was no accompanying documentation required.

(Note, as outlined in section II.Q. Of this final rule, to meet the standard for a waiver, prescribers must provide documentation showing the existence of a circumstance beyond their control and that such a circumstance prevents them from conducting EPCS.) We expect that each attestation will take 10 minutes (0.1667 hr) for a prescriber at $217.32/hr to complete. In aggregate, CMS estimates an annual burden for filling out attestations of 16.67 hours (100 attestations × 0.1667 hr) at a cost of $3,622.72 (16.67 hr × $217.32/hr). In addition, we solicit comment on any other potential information collection implications.

We received no comments on our proposed burden estimates and assumptions, and have finalized our provision as proposed. As a result, we are finalizing our burden estimates and assumptions as proposed. Start Printed Page 65564 7. ICRs Regarding Open Payments Provisions Included in the CY 2022 PFS (42 CFR Part 403) The following requirement and burden changes will be submitted to OMB for approval under control number 0938-1237 (CMS-10495).

The following estimates burden changes to the Open Payments final rule at §§ 403.900 through 403.914 in this final rule. A. Payment Context Field for Teaching Hospitals The mandatory context field is a new requirement for reporting entities submitting and attesting to records that are attributed to teaching hospitals only. The field will be freeform text entry.

We estimate that for each applicable manufacturer and applicable group purchasing organization (GPO), the inclusion of this field for collection and reporting activities will average an additional 6 total hours. The applicable instrument for these activities in the current PRA package is the “General-Research-Ownership Submission Data Elements”. At the support staff cost per FTE of $42.40/hr, this will increase costs by $254.40 (6 hr × $42.40/hr) per applicable manufacturer or applicable GPO submitting teaching hospital records. However, because we anticipate fewer disputes due to this field, we believe it will decrease dispute resolution by 2 total hours for support staff at $42.40/hr respectively, reducing costs by $84.80 (2 hr × $42.40/hr) per applicable manufacturer and applicable GPO.

This results in a net increase in burden for each applicable manufacturer and applicable GPO submitting teaching hospital records of $169.60 ($254.40−$84.80). In Program Year (PY) 2019, 794 applicable manufacturers and applicable GPOs submitted at least one teaching hospital record, meaning the increase in burden will be a total of 3,176 hours (4 hours × 794 reporting entities) at a cost of $42./40/hr or a total of $134,662.40 (3,176 × $42.40). In addition, we estimate this will reduce teaching hospital dispute resolution estimates by 2 hours per support staff FTE at $37.82/hr or $75.64 (2 hr × $37.82/hr) per teaching hospital with records attributed to them. In PY 2019, 1,202 hospitals had record attributed to them, so for teaching hospitals we estimate a total burden reduction of 2,404 hours at a cost of $90,919.28 (2,404 × $75.64).

In aggregate, we estimate an annual burden of 772 hours (3,176−2,404) at a cost of $43,743.12 ($134,662.40−$90,919.28). B. Optional Annual Recertification The annual recertification is voluntary for applicable manufacturers or applicable group purchasing organizations. We approximate that 15 percent of applicable manufacturers and group purchasing organizations, or 240 reporting entities (0.15 [1,595 applicable manufacturers and applicable GPOs]) will complete and submit the proposed optional annual recertification.

We anticipate that it will be a simple check box form to be included in the AM (Attestation) and GPO (Attestation) Annual IC Requirement and the “Attestation and Assumptions Screen Shots” Instrument in the existing PRA package. We estimate that it will take 0.5 hours at $42.40/hr for support staff to complete and submit the recertification. In aggregate, we estimate an added annual burden of 120 hours (240 entities × 0.5 hr/response) at a cost of $5,088 (120 hr × $42.40/hr). C.

Defining a Physician-Owned Distributorship (42 CFR 403.902) The new definition is not subject to the PRA since it will not revise, add, or remove any collection of information requirements or burden. D. Disallowing Record Deletion Without Reason (§ 403.904(a)(3)) This provision clarifies that entities are not permitted to delete records without reason once their timeliness, completeness, and accuracy has been attested to. In order to ensure compliance with this requirement, a freeform text dialogue box will be added to the system when records are deleted that asks the applicable manufacturer or GPO to input a reason for the deletion.

This will be included in the AM (Data collection and submission) and Applicable GPO (Data Collection and Submission) IC requirements and the “Open Payments User Guide” Instrument in the existing PRA package. We anticipate that this will take an average of 2 hours at $42.40/hr to input a reason for the deletion. In aggregate, we estimate an added annual burden of 80 hours (40 applicable manufacturers or GPOs deleting records annually × 2 hr/response) at a cost of $3,392 (80 hr × $42.40/hr). E.

Disallow Publication Delays of General Payments A very small number of general payments are delayed from publication by reporting entities every year, and these records will simply either be reported as research records instead, or not delayed at all. Therefore, we anticipate a negligible burden for this provision. F. Short Term Loans (§ 403.902) This provision is merely a clarification of an existing requirement in regulation text.

The purpose of this language is to clarify that the exemption for short-term loans from reporting requirements only applies for loans of less than 91 cumulative days per calendar year. In other words, multiple short-term loans in a calendar year will still meet reporting requirements if they add up to 91 days or greater. We do not believe this provision will change reporting behavior, and therefore do not anticipate an increase in burden. G.

Remove General Ownership Records Currently the Open Payments system allows for a reporting entity to submit either a general record with a nature of payment category of ownership, or an ownership and investment interest record. For Program Years 2015-2019, approximately 92 applicable Start Printed Page 65565 manufacturers and GPOs reported records with the nature of payment category of ownership. Since reporting these general records as ownership records will require the addition of two additional pieces of information, we anticipate that it will take these 92 entities an additional 3 hours at $42.40/hr to report the two extra fields. In aggregate, we estimate an added annual burden of 276 hours (92 entities × 3 hr/response) at a cost of $11,702 (276 hr × $42.40/hr).

This will be included in the AM (Data collection and submission) and Applicable GPO (Data Collection and Submission) IC requirements and the “Open Payments User Guide” Instrument in the existing PRA package. h. Updated Contact Information (§ 403.908(c)(3)) This provision creates a requirement for reporting entities to keep their contact information up to date with CMS. The ability to communicate with a reporting entity is important because CMS may need to contact the entity in the case of perceived issues with the records.

Applicable manufacturers and applicable GPOs will only be required to update their contact information if the two contacts provided become obsolete due to a change in the organization. This will also only apply to entities that do not have records to report for 2 years after a program year in which they reported. Therefore, we anticipate that it will only affect approximately 30 applicable manufacturers and applicable group purchasing organizations. We estimate that it will take 0.5 hours at $42.40/hr to update the contact information.

In aggregate, we estimate an added annual burden of 15 hours (30 entities × 0.5 hr/response) at a cost of $636 (15 hr × $42.40/hr). This will be included in the AM (Data collection and submission) and Applicable GPO (Data Collection and Submission) IC requirements and the “Open Payments User Guide” Instrument in the existing PRA package. I. Summary 8.

The Quality Payment Program (QPP) (42 CFR Part 414 and Section IV. Of This Final Rule) The following QPP-specific ICRs reflect this final rule's policy changes as well as adjustments to the policies that have been finalized in the CY 2017 and 2018 Quality Payment Program final rules (81 FR 77008 and 82 FR 53568, respectively), the CY 2019, CY 2020, and CY 2021 PFS final rules (83 FR 59452, 84 FR 62568 and 85 FR 84472, respectively). A. Background (1) ICRs Associated With MIPS and Advanced APMs There is a series of ICRs associated with the Quality Payment Program, including for MIPS and Advanced APMs.

The MIPS ICRs consist of. Registration for virtual groups (see section V.B.8.b of this final rule). QCDR self-nomination applications and other requirements (see section V.B.8.c.(2) of this final rule). Qualified registry self-nomination applications and other requirements (see section V.B.8.c.(3) of this final rule).

CAHPS survey vendor applications (see section V.B.8.c.(4) of this final rule). Health IT vendors (see section V.B.8.c.(5) of this final rule). Open Authorization credentialing and token request process (see section V.B.8.d of this final rule). Quality Payment Program Identity Management Application Process (see section V.B.8.e.(3) of this final rule).

Quality performance category data submission by Medicare Part B claims collection type (see section V.B.8.e.(4) of this final rule), QCDR and MIPS CQM collection type (see section V.B.8.e.(5) of this final rule), eCQM collection type (see section V.B.8.e.(6) of this final rule), MVP Quality submission (see section V.B.8.e.(7)(a)(iii) of this final rule), and CMS Web Interface collection type (see section V.B.8.e.(8) of this final rule). CAHPS for MIPS survey beneficiary participation (see section V.B.8.e.(9) of this final rule). Group registration for CMS Web Interface (see section V.B.8.e.(10) of this final rule). Group registration for CAHPS for MIPS survey (see section V.B.8.e.(11) of this final rule).

MVP registration (see section V.B.8.e.(7)(a)(i) of this final rule). Subgroups registration (see section V.B.8.e.(7)(a)(ii) of this final rule). All for quality measures (see section V.B.8.f of this final rule). Reweighting applications for Promoting Interoperability and other performance categories (see section V.B.8.g.(2) of this final rule).

Promoting Interoperability performance category data submission (see section V.B.8.g.(3) of this final rule). Call for Promoting Interoperability measures (see section V.B.8.h of this final rule). Improvement activities performance category data submission (see section V.B.8.i of this final rule). Nomination of improvement activities (see section V.B.8.j of this final rule).

Nomination of MVPs (see section Start Printed Page 65566 V.B.8.k of this final rule). And opt-out of Physician Compare for voluntary participants (see section V.B.8.o of this final rule). The ICRs for Advanced APMs consist of. Partial Qualifying APM Participant (QP) election (section V.B.8.m of this final rule).

Other Payer Advanced APM identification. Payer Initiated and Eligible Clinician Initiated Processes (sections V.B.8.n.(1) and V.B.8.n.(2) of this final rule). And submission of data for QP determinations under the All-Payer Combination Option (section V.B.8.n.(3) of this final rule). (2) Summary of Quality Payment Program Changes.

MIPS We have included the change in estimated burden for the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years due to the finalized policies and information collections in this final rule. The finalized policies in this rule impact the burden estimates for the CY 2022 and CY 2023 MIPS performance periods/2024 and 2025 MIPS payment years. However, our currently approved burden estimates for the CY 2021 performance period (85 FR 84958 through 84998) approved by OMB on May 28, 2021, included estimated burden due to finalized policies and assumptions for the CY 2021 and CY 2022 performance periods/2023 and 2024 MIPS payment years. The currently approved estimated burden for the package does not include the CY 2023 performance period/2025 MIPS payment year.

To understand the burden implications of the policies finalized in this final rule relative to the current package that was approved by OMB on May 28, 2021. We have subtracted the burden for the policies and information collections set forth for the CY 2021 performance period/2023 MIPS payment year in the CY 2021 PFS final rule (see Table 128). We have revised our burden estimates for the CY 2022 performance period/2024 MIPS payment year due to the finalized policies in this rule and changes for continuing the policies and information collections set forth in the CY 2021 PFS final rule into the CY 2022 performance period/2024 MIPS payment year (see Table 129). We are setting forth new burden for the CY 2023 performance period/2025 MIPS payment year (see Table 130), meaning that there will be no currently approved figures for these estimates.

In the CY 2022 PFS proposed rule (86 FR 39479 through 39528), we compared our proposed burden estimates for the CY 2022 and 2023 performance periods/2024 and 2025 MIPS payment years to the CY 2022 performance period/2024 MIPS payment year in the CY 2021 PFS final rule (85 FR 84994). We believe that using the approach described above for the final rule will help readers easily understand and follow the changes in the estimated burden due to the policies and assumptions in the CY 2022 PFS final rule relative to the currently approved burden. The following nine MIPS ICRs show changes in burden due to the finalized policies in this rule. (1) QCDR self-nomination applications.

(2) Qualified Registry self-nomination applications. (3) Quality performance category data submission by QCDR and MIPS CQM collection type. (4) Quality performance category data submission by eCQM collection type. (5) Group registration for CMS Web Interface.

(6) CMS Web Interface submission burden. (7) Reweighting applications for Promoting Interoperability and other performance categories. (8) Promoting Interoperability performance category data submission. And (9) Nomination of improvement activities.

In aggregate, we estimate the finalized policies will result in a net increase in burden of 3,805 hours and $358,305 for the CY 2022 performance period/2024 MIPS payment year. The remaining changes to our currently approved burden estimates are adjustments due to the revised burden assumptions based on the updated data available at the time of publication of this final rule. We have also added 3 new ICRs (MVP Registration, MVP Quality Submissions, and Subgroups Registration) for the associated burden related to the policies for implementation of MVPs and subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. The MVP and subgroup registration ICRs reflect the burden associated with the MVP and subgroup registration requirements described in section IV.A.3.b(4)(f) of this rule.

The MVP quality submission ICR reflects the change in burden associated with the requirements for the quality performance category of MVPs described in section IV.A.3.b(4)(d)(ii) of this rule. With these new ICRs and the other policy changes discussed for the CY 2022 performance period/2024 MIPS payment year, we estimate the finalized policies will result in a net increase in burden of 1,383,049 hours and $139,501,770 for the CY 2023 performance period/2025 MIPS payment year. As discussed above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimates for comparison. We are not making any changes or adjustments to the following ICRs.

Registration for virtual groups. CAHPS survey vendor applications. Quality Payment Program Identity Management Application Process. Group registration for CAHPS for MIPS survey.

CAHPS for MIPS survey beneficiary participation. Open Authorization (OAuth) Credentialing and Token Request Process. Nomination of MVPs and call for Promoting Interoperability measures. See section V.B.8.

Of this final rule for a summary of the ICRs, the overall burden estimates, and a summary of the assumption and data changes affecting each ICR. The accuracy of our estimates of the total burden for data submission under the quality, Promoting Interoperability, and improvement activities performance categories may be impacted by two primary factors. First, we are unable to predict with absolute certainty who will be a QP for the CY 2022 performance period/2024 MIPS payment year. New eligible clinician participants in Advanced APMs who become QPs will be excluded from MIPS reporting requirements and payment adjustments, and as such, are unlikely to report under MIPS.

While some current Advanced APM participants may end participation such that the APM Entity's eligible clinicians may not be QPs for a year based on § 414.1425(c)(5), and thus be required to report under MIPS. Second, it is difficult to predict what Partial QPs, who can elect whether to report to MIPS, will do in the CY 2022 performance period/2024 MIPS payment year compared to the CY 2019 performance period/2021 MIPS payment year, and therefore, the actual number of Advanced APM participants and how they elect to submit data may be different than our estimates. However, we believe our estimates are the most appropriate given the available data. Additionally, we will continue to update our estimates annually as data becomes available.

In the 2022 PFS proposed rule (86 FR 39480), we discussed a recent JAMA article (Khullar, et al., 2021) [] which included new data on the burden involved in submitting data for the Quality Payment Program. We have chosen not to include this data in our estimates because of the small sample size included (30 TINs, half of which are APM participants, which we do not include in our estimates). In addition, the article did not indicate the time Start Printed Page 65567 spent per activity involved in submissions for MIPS, so we are unable to determine if the totals in the article represent only the activities relevant for regulatory burden or separate the totals for the individual ICRs. We solicited comment on our assumptions for estimating the burden for clinicians submitting data for the Quality Payment Program.

We did not receive public comments regarding our burden estimates for clinicians submitting data in the Quality Payment Program. We are finalizing to not include the data from the above referenced article in our assumptions. We made updates to our figures to correct a few technical errors that we observed in the CY 2022 PFS proposed rule. (3) Summary of Quality Payment Program Changes.

Advanced APMs For these ICRs (identified above under, “ICRs Associated with MIPS and Advanced APMs”), the changes to currently approved burden estimates are adjustments based on updated projections for the CY 2022 performance period/2024 MIPS payment year. We did not implement any changes to the Other Payer Advanced APM identification. Eligible Clinician Initiated Process and submission of Data for QP determinations under the All-Payer Combination Option ICRs. (4) Framework for Understanding the Burden of MIPS Data Submission Because of the wide range of information collection requirements under MIPS, Table 82 presents a framework for understanding how the organizations permitted or required to submit data on behalf of clinicians vary across the types of data, and whether the clinician is a MIPS eligible clinician or other eligible clinician voluntarily submitting data, MIPS APM participant, or an Advanced APM participant.

As shown in the first row of Table 82, MIPS eligible clinicians and other clinicians voluntarily submitting data will submit data either as individuals, groups, or virtual groups for the quality, Promoting Interoperability, and improvement activities performance categories. Note that virtual groups are subject to the same data submission requirements as groups, and therefore, we will refer only to groups for the remainder of this section unless otherwise noted. We want to note that we have included subgroups to Table 82 due to the introduction of subgroups for clinicians choosing to report MVPs or the APP in the CY 2023 performance period/2025 MIPS payment year described in section IV.A.3.b.(2)(d)(ii) of this final rule. Because MIPS eligible clinicians are not required to submit any additional information for assessment under the cost performance category, the administrative claims data used for the cost performance category is not represented in Table 82.

For MIPS eligible clinicians participating in MIPS APMs, the organizations submitting data on behalf of MIPS eligible clinicians will vary between performance categories and, in some instances, between MIPS APMs. As discussed in section IV.A.3.c. Of this final rule, for clinicians in APM Entities, the APM Performance Pathway is available for both ACO and non-ACOs to submit quality data. Due to data limitations and our inability to determine who will use the APM Performance Pathway versus the traditional MIPS submission mechanism for the CY 2022 performance period/2024 MIPS payment year, we assume ACO APM Entities will submit data through the APM Performance Pathway, using the CMS Web Interface option, and non-ACO APM Entities will participate through traditional MIPS, thereby submitting as an individual or group rather than as an entity.

We also want to note that as finalized in section IV.A.3.d.(1)(d) of this final rule, we are finalizing to extend the CMS Web Interface as a collection type beyond the CY 2022 performance period/2024 MIPS payment year for clinicians participating in the Shared Savings Program. Per section 1899 of the Act (42 U.S.C. 1395jjj), submissions received from eligible clinicians in ACOs are not included in burden estimates for this final rule because quality data submissions to fulfill requirements of the Shared Savings Program are not subject to the PRA. For the Promoting Interoperability performance category, group TINs may submit data on behalf of eligible clinicians in MIPS APMs, or eligible clinicians in MIPS APMs may submit data individually.

For the improvement activities performance category, we will assume no reporting burden for MIPS APM participants. In the CY 2017 PFS final rule, we described that for MIPS APMs, we compare the requirements of the specific MIPS APM with the list of activities in the improvement activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians (81 FR 77185). Although the policy allows for the submission of additional improvement activities if a MIPS APM receives less than the maximum improvement activities performance category score, to date all MIPS APM have qualified for the maximum improvement activities score. Therefore, we assume that no additional submission will be needed.

Eligible clinicians who attain Partial QP status may incur additional burden if they elect to participate in MIPS, which is discussed in more detail in the CY 2018 PFS final rule (82 FR 53841 through 53844). Start Printed Page 65568 The policies finalized in the CY 2017 and CY 2018 Quality Payment Program final rules, the CY 2019, CY 2020, and CY 2021 PFS final rules, and continued in this final rule create some additional data collection requirements not listed in Table 82. These additional data collections, some of which are currently approved by OMB under the control numbers 0938-1314 (Quality Payment Program, CMS-10621) and 0938-1222 (CAHPS for MIPS, CMS-10450), are as follows. Additional ICRs Related to MIPS Third-Party Intermediaries (See Section V.B.8.c) • Self-nomination of new and returning QCDRs (81 FR 77507 through 77508, 82 FR 53906 through 53908, and Start Printed Page 65569 83 FR 59998 through 60000) (OMB 0938-1314).

Self-nomination of new and returning registries (81 FR 77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59997 through 59998) (OMB 0938-1314). Approval process for new and returning CAHPS for MIPS survey vendors (82 FR 53908) (OMB 0938-1222). Open Authorization Credentialing and Token Request Process (New) (OMB 0938-1314) (see section V.B.8.d). Additional ICRs Related to the Data Submission and the Quality Performance Category (See Section V.B.8.e) Additional ICRs Related to the Promoting Interoperability Performance Category (See Section V.B.8.g) Reweighting Applications for Promoting Interoperability and other performance categories (82 FR 53918 and 83 FR 60011 through 60012) (OMB 0938-1314).

Additional ICRs Related to Call for New MIPS Measures and Activities (See Sections V.B.8.f, V.B.8.h, V.B.8.j. And V.B.8.k) Nomination of improvement activities (82 FR 53922 and 83 FR 60017 through 60018) (OMB 0938-1314). Call for new Promoting Interoperability measures (83 FR 60014 through 60015) (OMB 0938-1314). Call for MIPS quality measures (83 FR 60010 through 60011) (OMB 0938-1314).

Nomination of MVPs (OMB 0938-1314). Additional ICRs Related to MIPS (See Section V.B.8.o) Opt out of performance data display on Physician Compare for voluntary reporters under MIPS (82 FR 53924 through 53925 and 83 FR 60022) (OMB 0938-1314). Additional ICRs Related to APMs (See Sections V.B.8.m and V.B.8.n) Partial QP Election (81 FR 77512 through 77513, 82 FR 53922 through 53923, and 83 FR 60018 through 60019) (OMB 0938-1314). Other Payer Advanced APM determinations.

Payer Initiated Process (82 FR 53923 through 53924 and 83 FR 60019 through 60020) (OMB 0938-1314). Other Payer Advanced APM determinations. Eligible Clinician Initiated Process (82 FR 53924 and 83 FR 60020) (OMB 0938-1314). Submission of Data for All-Payer QP Determinations (83 FR 60021) (OMB 0938-1314).

b. ICRs Regarding the Virtual Group Election (§ 414.1315) This rule is not implementing any new or revised collection of information requirements or burden related to the virtual group election. The virtual group election requirements and burden are currently approved by OMB under control number 0938-1343 (CMS-10652). Consequently, we are not making any changes to the virtual group election process under that control number.

C. ICRs Regarding Third-Party Intermediaries (§ 414.1400) The finalized requirements and burden associated with this rule's data submission changes related to qualified registries and QCDRs will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). In section IV.A.3.h. Of this rule, we are finalizing policies related to the third-party intermediary regulations at § 414.1400.

Specifically, we are finalizing. (1) Requirement for third-party intermediaries to submit MIPS data for APM Entities. (2) requirement for QCDRs and qualified registries to support MVPs, QCDRs and qualified registries may also support the APP. (3) requirement for all QCDRs and qualified registries to support subgroup reporting.

(4) requirements for approved QCDRs and qualified registries that have not submitted performance data. And (5) new QCDR measure rejection criteria. The burden associated with each of these topics is discussed separately below for qualified registries, QCDRs, and survey vendors. (1) Background Under MIPS, the quality, Promoting Interoperability, and improvement activities performance category data may be submitted via relevant third-party intermediaries, such as qualified registries, QCDRs, and health IT vendors.

Data on the CAHPS for MIPS survey, which counts as either one quality performance category measure, or towards an improvement activity, can be submitted via CMS-approved survey vendors. Entities seeking approval to submit data on behalf of clinicians as a qualified registry, QCDR, or survey vendor must complete a self-nomination process annually.[] The processes for self-nomination for entities seeking approval as qualified registries and QCDRs are similar with the exception that QCDRs have the option to nominate QCDR measures for approval for the reporting of quality performance category data. Therefore, differences between QCDRs and qualified registry self-nomination are associated with the preparation of QCDR measures for approval. (2) QCDR Self-Nomination Applications As described below, in this rule we are adjusting the number of self-nomination applications based on current data (from 82 to 84), change the number of QCDR measures submitted for consideration by each QCDR at the time of self-nomination (from 2 to 12), and adjust the average time required to submit information for each QCDR measure (from 2.5 hours to 0.75 hours).

(a) Self-Nomination Process and Other Requirements In section IV.A.3.h.(1) of this rule, we are reorganizing and consolidating § 414.1400 generally. We assume that this provision does not change the existing requirements for third-party intermediaries during the self-nomination process. Therefore, we are not revising our burden estimates related to these provisions. We refer readers to § 414.1400 which states that QCDRs interested in submitting MIPS data to us on behalf of a MIPS eligible clinician, group, or virtual group will need to complete a self-nomination process to be considered for approval to do so.

We also refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77507 through 77508), CY 2018 Quality Payment Program final rule (82 FR 53906 through 53908), CY 2019 PFS final rule (83 FR 59998 through 60000), the CY 2020 PFS final rule (84 FR 63116 through 63121) and the CY 2021 PFS final rule (85 FR 84964 through 84969) for our previously finalized requirements and burden for self-nomination of QCDRs and nomination of QCDR measures. In section IV.A.3.h.(2)(a) of this rule, we are finalizing to add APM Entities to § 414.1400(a)(1), and expand the general participation requirements of third-party intermediaries, to third-party intermediaries reporting to MIPS on behalf of APM Entities reporting to MIPS in order to align reporting requirements for all participants in Start Printed Page 65570 MIPS. We are also finalizing that beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support the APP, and MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. As finalized in the CY 2017 PFS final rule, third-party intermediaries currently support MIPS data submission on behalf of eligible clinicians (81 FR 77016).

APM Entities have historically used third party intermediaries for submitting their quality measures to their APMs. Additionally, QCDRs, qualified registries and health IT vendors are required under existing § 414.1400(a)(1) to submit data for the quality, improvement activities, and Promoting Interoperability performance categories in MIPS. Therefore, we anticipate no additional steps being added to the self-nomination process as a result of this provision for third-party intermediaries to submit MIPS data on behalf of APM Entities, and to support measures and activities in MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. For this final rule, we assume that there will be no impact on the time required for QCDRs to complete either the simplified or full self-nomination process because of the above provisions.

Additionally, we are finalizing to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year. We anticipate that at the time of self-nomination, QCDRs would be using a checkbox to indicate their compliance for the requirement to support data submission for subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. We assume that this will not impact the overall time estimated for QCDRs to submit their information at the time of self-nomination. Therefore, as discussed in the CY 2022 PFS proposed rule (86 FR 84965) we did not make any adjustments in the time required for QCDRs during the simplified or full self-nomination process because of this provision.

However, we anticipate that third-party intermediaries will need to make administrative changes to their existing workflows for submission of MVPs and APP data for clinicians participating as subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. We refer readers to section VI.F.18.g(2)(f) of this final rule where we discuss our impact analysis. In section IV.A.3.h.(3)(a)(iii) of this rule, to provide further clarity and to better align with the existing policy (81 FR 77366 through 77367. 81 FR 77383 through 77384), we are finalizing to codify that QCDRs, and qualified registries must conduct validation on the data they intend to submit for the applicable MIPS performance period and provide the results of the executed data validation plan by May 31st of the year following the performance period.

Additionally, we are finalizing to codify a new requirement at § 414.1400(b)(3)(iv) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination, for CMS' approval, and may not change the plan once approved, without the prior approval of the agency. We anticipate that this provision does not make any changes to the existing data validation requirements for QCDRs and qualified registries. Through this provision, we are codifying the finalized policies related to data validation for QCDRs and qualified registries in previous rules. In the CY 2022 PFS proposed rule (86 FR 39483), we did not revise our burden estimates as a result of the above provision because the associated burden was captured in the CY 2017 PFS final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999) and submitted to OMB for approval under control number 0938-1314 (CMS-10621).

In section IV.A.3.h(3)(a)(i) of this final rule, we are finalizing new requirements for approved QCDRs and qualified registries that have not submitted performance data. First, we are finalizing to create a new requirement at § 414.1400(b)(3)(vii) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023. If the QCDRs and qualified registries did not submit data, their participation plan must be submitted as part of self-nomination for the 2023 self-nomination period and must be accepted by CMS to continue to be an approved QCDR or qualified registry. We are also finalizing to codify a new requirement at paragraph § 414.1400(b)(3)(viii) to state that, beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval.

Under this provision, the participation plan must explain the QCDR and/or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third-party intermediary on behalf of clinicians or groups. The vendor must also explain why they should still be allowed to participate as a qualified vendor. Based on our review of the existing list of approved QCDRs that did not submit performance data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year), we estimate that approximately 10 QCDRs will submit participation plans for the CY 2022 and the CY 2023 self-nomination periods. Similar to our assumptions for submission of a Corrective Action Plan (CAP) in the CY 2021 PFS final rule (85 FR 84968), we anticipate that the effort involved in developing a participation plan including the policies specified in this rule and submitting it to CMS is likely to be no more than 3 hours for a computer systems analyst at a rate of $95.22/hr.

For the CY 2022 performance period/2024 MIPS payment year, we estimate an annual burden of 30 hours (3 hr × 10 participation plans) at a cost of $2,857 (30 hr × $95.22/hr) for QCDRs that will need to develop and submit a participation plan. In section IV.A.3.h.(4) of this rule, we are finalizing to codify new requirements that if a QCDR measure owner is not an approved active QCDR for a given self-nomination period, that QCDR measure will not be available for use. Additionally, we are finalizing to codify a new requirement in section IV.A.3.h.(4)(a)(i)(A) of this rule and add a rejection criterion at § 414.1400(b)(4)(iv)(M) to state, a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. It was finalized in the CY 2018 PFS final rule (82 FR 53813) that beginning with the CY 2018 performance period/2020 MIPS payment year, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR.

Additionally, in the CY 2020 PFS final rule (84 FR 63070 through 63073), we finalized the QCDR measure rejection criteria considerations. Specifically, we stated that all previously approved QCDR measures and new QCDR measures would be reviewed on an annual basis (as a part of the QCDR measure review Start Printed Page 65571 process that occurs after the self-nomination period closes on September 1st) to determine whether they are appropriate for the program. In the CY 2020 PFS final rule, we indicated to stakeholders that as information becomes available in future years, we will revisit our assumptions to better reflect the impact of these requirements on QCDRs and the quantity of measures annually (84 FR 63118 through 63119). As discussed in the CY 2019 PFS final rule (83 FR 60000) and CY 2020 PFS final rule (84 FR 63118), we are not accounting for QCDR measure licensing costs as part of our burden estimate.

Based on the number of QCDR measures submitted at the time of self-nomination for the CY 2021 performance period/2023 MIPS payment year, we assume that 82 QCDRs will submit 984 measures for consideration in the CY 2022 performance period/2024 MIPS payment year, approximately 12 measures per QCDR, on average. We anticipate that out of the 984 measures, 820 measures will be existing or borrowed measures, approximately 10 measures submitted per QCDR self-nomination application. The remaining 104 measures will be new measures, approximately 2 measures on average per QCDR. Using the above assumption that each QCDR submitting measures for approval during the self-nomination process will submit approximately 12 measures (10 existing or borrowed measures + 2 new measures), we estimate an increase of 10 measures from the currently approved estimate of 2 measures per QCDR.

The estimated increase in the total number of measures submitted by a QCDR at the time of self-nomination is due to the inclusion of the existing or borrowed QCDR measures in our assumptions. Additionally, we anticipate that less information is needed for a QCDR to submit an existing or borrowed measure for approval, therefore, we estimate that the time needed for a QCDR to submit an existing or borrowed measure is 0.5 hours, independent of the selection of the simplified or full self-nomination process. Consistent with our assumption in the CY 2020 PFS final rule (84 FR 63119), we continue to estimate that each QCDR will require 2 hours to submit a new QCDR measures for approval, independent of the selection of the simplified or full self-nomination process. To account for the difference in the time for submission of new vs existing QCDR measures for approval, we are using the weighted average to estimate the time required for QCDR measure submission at the time of self-nomination.

Therefore, we assume that the weighted average of the time required for each QCDR to submit a new or existing or borrowed measure for approval during the self-nomination process is 0.75 hours [((2 new measures × 2 hours) + (10 existing or borrowed measures × 0.5 hours))/total # of measures (12)]. Based on the above assumptions, we are finalizing to revise our estimates in the amount of time required for a QCDR to submit measures during the self-nomination process from a total of 2 hours to approximately 0.75 hours, a decrease of 1.75 hours from the currently approved estimated burden per QCDR measure submission. In the CY 2019 PFS final rule, we estimated that it would take 0.5 hours and 3 hours for a QCDR to submit all the required information during the simplified and full self-nomination process, respectively (83 FR 59999). Based on our experience with the amount of time needed for QCDRs during the 2020 self-nomination period, we assume that the estimated time of 3 hours per QCDR for a full self-nomination process is an overestimate and therefore, are adjusting our estimated time required for the QCDR full-self-nomination process to 2.5 hours, a decrease of 0.5 hours.

We are not making any adjustments in the amount of time needed for simplified self-nomination process. For this final rule, we are adjusting the number of QCDRs that submitted applications for self-nomination from 90 to 84 based on the actual number of applications received during the CY 2021 self-nomination period for the CY 2022 performance period/2024 MIPS payment year, an increase of two applications from the currently approved estimate of 82. This is a decrease of 6 from the estimate of 90 provided in the CY 2022 PFS proposed rule (86 FR 39484). For QCDRs that submit measures as part of their self-nomination process, while simultaneously accounting for the estimated increase in the number of existing or borrowed QCDR measures submitted with the self-nomination application and the decrease in the estimated time for the QCDR full-nomination process, we are finalizing to revise our estimated time for the QCDR self-nomination process to a minimum of 9.5 hours [0.5 hours for the simplified self-nomination process + (12 measures × 0.75 hr/measure for QCDR measure submission)] and a maximum of 11.5 hours [2.5 hours for the full self-nomination process + (12 measures × 0.75 hr/measure for QCDR measure submission)], an increase of 4 hours at a cost of $ 380.88 (4 hr × $95.22/hr) and 3.5 hours at a cost of $333.27 (3.5 hr × $95.22/hr) from the currently approved burden per respondent estimate in the CY 2021 PFS final rule (85 FR 84965).

Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84967), based on updated data for the number of QCDR applications submitted during the CY 2020 self-nomination period, we are adjusting our estimate that 18 QCDRs will submit targeted audits for the CY 2022 performance period/2024 MIPS payment year, an increase of 1 from the currently approved estimate of 17 targeted audits in the CY 2021 PFS final rule (85 FR 84965). This is a decrease of 2 compared to our estimate of 20 targeted audits in the CY 2022 PFS proposed rule (86 FR 39484). Using the currently approved unchanged burden per respondent estimate, the estimated burden associated with QCDRs completing targeted audits will range from 90 hours (18 audits × 5 hr/audit) at a cost of $8,570 (18 audits × $476.10/audit) for the simplified self-nomination process to 180 hours (18 audits × 10 hr/audit) at a cost of $17,140 (18 audits × $952.20/audit) for the full self-nomination process (see Table 68 for the cost per audit). We assume that this would adjust our burden estimates for targeted audits by +5 hours (+1 respondents × 5 hr/audit) at a cost of $476 (5 hrs × $95.22/hr) and +10 hours (+1 respondents × 10 hr/audit) at a cost of $952 (10 hrs × $95.22/hr) for the simplified and full self-nomination process, respectively.

Based on the assumptions discussed in this section, we provide an estimate of the total annual burden associated with a QCDR self-nominating to be considered “qualified” to submit quality measures results and numerator and denominator data on behalf of MIPS eligible clinicians. As shown in Table 83, we assume that the staff involved in the QCDR self-nomination process will continue to be computer systems analysts or their equivalent, who have an average labor rate of $95.22/hr. Using the change in the number of respondents and the estimated time per respondent for QCDRs that submit measures for approval during the self-nomination process, the annual burden for the simplified and full-self nomination process will range from 798 hours (84 QCDRs × 9.5 hr) to 966 hours (84 QCDRs × 11.5 hr) at a cost ranging from $75,986 (798 hr × $95.22/hr) and $91,983 (966 hr × $95.22/hr), respectively. As shown in Table 83, combined with our adjusted estimate of annual burden for targeted audits and the burden for submission of participation plans, we are finalizing to revise our estimated Start Printed Page 65572 burden for the QCDR self-nomination process, ranging from 918 hours [798 hr (84 QCDRs × 9.5 hr) + 90 hr (18 audits × 5 hr) + 30 hr (10 participation plans × 3 hr)] at a cost of $87,413 [$75,986 (798 hr × $95.22/hr) + $8,570 (18 audits × $476.10/audit) + $2,857 (30 hr × $95.22/hr)] for a simplified self-nomination process to 1,176 hours [966 hr (84 QCDRs × 11.5 hr) + 180 hr (18 audits × 10 hr) + 30 hr (10 participation plans × 3 hr)] at a cost of $111,980 [$91,983 (966 hr × $95.22/hr) + $17,140 (18 audits × $952.20/audit) + $2,857 (30 hr × $95.22/hr)] for the full self-nomination process.

As shown in Table 84, for the CY 2022 performance period/2024 MIPS payment year, independent of the change to our per response time estimate, the estimated increase in 2 respondents from the currently approved 82 respondents to 84 results in an increase of between +19 hours (+2 respondents × 9.5 hrs/respondent for the simplified self-nomination process) and +23 hours (+ 2 respondents × 11.5 hrs/respondent for the full self-nomination process) at a cost of between +$1,809 (+2 respondents × $904.60/respondent for the simplified self-nomination process) and +$2,190 (+2 respondents × $1,095.03/respondent for the full self-nomination process) (see Table 83 for the cost per QCDR). Accounting for the change in time required for the QCDR self-nomination process results in an adjustment of between +328 hours (82 respondents × +4 hr for the simplified self-nomination process or also referred to as minimum burden) at a cost + $31,232 [82 respondents × $380.88 (+4 hr × $95.22/hr)/respondent) and +287 hours (82 respondents × 3.5 hr for the full self-nomination process or also referred to as maximum burden) at a cost of and +$27,328 (82 respondents × $333.27 (+3.5 hr × $95.22/hr)/respondent). The reason for the increase in minimum burden compared to the maximum burden is due to an increase in the change in the number of hours required for the simplified self-nomination process compared to the increase in the number of hours for the full self-nomination process. In aggregate, when these impacts are combined with the estimate for targeted audits and participation plans discussed above, the net impact ranges between + 382 hours [19 hr (+2 respondents × 9.5 hrs/respondent) + 5 hr (+1 targeted audit × 5 hrs/audit) + 30 hr (10 participation plans × 3 hr/plan) + 328 hr (82 respondents × 4 hr)] at a cost of $36,374 ($1,809 + $476 + $2,857 + $31,232) for the simplified self-nomination process (also referred to as minimum burden) and +350 hours [23 hr (+2 respondents × 11.5 hrs/respondent) + 10 hr (+1 targeted audits × 10 hrs/audit) + 30 hr (10 participation plans × 3 hr/plan) + 287 hr (+82 respondents × 3.5 hr)] at a cost of $33,328 [$2,190 (+2 respondents × $1,095.03/respondent + $952 (10 hr × $95.22/hr) + $2,857 (30 hr × $95.22/hr) + $27,328 (82 respondents × $333.27/respondent)] for the full self-nomination process (also referred to as maximum burden) for the CY 2022 performance period/2024 MIPS payment year.

As discussed above in this section of the rule, we are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year. Therefore, we estimate the total change in burden for the QCDR self-nomination process would be 918 hours at a cost of $87,413 for the simplified self-nomination process (also referred to as minimum burden) and 1,176 hours at a cost of $111,980 for the full self-nomination process (also referred to as maximum burden). For the purposes of calculating estimated change in burden in Tables 128, 129, and 130 of this final rule, we use only the maximum burden estimate. Start Printed Page 65573 (b) QCDR Measure Requirements In the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814), we discussed that beginning with the CY 2018 performance period/2020 MIPS payment year and for future program years, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR.

Additionally, in the CY 2020 Quality Payment Program rule (84 FR 63070 through 63073) we finalized the QCDR measure rejection criteria considerations. In section IV.A.3.h.(4)(a)(i)(A)(aa) of this rule, we are finalizing to codify a new requirement and add a rejection criterion that a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. Additionally, we are finalizing to codify new requirements that if a QCDR measure owner is not an approved active QCDR for a given self-nomination period, that QCDR measure will not be available for use. The inactive QCDR measure owner has the option to transfer ownership of the QCDR measure to an active QCDR or agree upon terms set forth with the active QCDR allowing co-ownership of the QCDR measure.

We refer readers to section IV.A.3.h.(4)(a)(i)(A) of this rule for additional details on the finalized policies for transfer of ownership of QCDR measures. This provision is to codify the existing requirements for the QCDR self-nomination process. We are not adjusting our burden estimates as result of this provision because we assume that this does not change the requirements, or the time required for a QCDR to submit information for a QCDR measure at the time of self-nomination. Additionally, we are finalizing to codify another rejection criterion at § 414.1400(b)(4)(iv)(N) to state that, if a QCDR measure owner is not approved during a given self-nomination period, any associated QCDR measures with that QCDR will also not be approved.

We are not revising our burden estimates as a result of the above provision because we assume that there will not be additional requirements for QCDRs to submit at the time of self-nomination. This is part of the measure specification requirements for QCDRs which submit measures for approval during the self-nomination process. (3) Qualified Registry Self-Nomination Process and Other Requirements The requirements and burden associated with this rule's data submission changes related to qualified registries will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to § 414.1400 which states that qualified registries interested in submitting MIPS data to us on behalf of MIPS eligible clinicians, groups, or virtual groups need to complete a self-nomination process to be considered for approval to do so.

We also refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77507 through 77508), CY 2018 Quality Payment Program final rule (82 FR 53906 through 53908), CY 2019 PFS final rule (83 FR 59997 through 59998), CY 2020 PFS final rule (84 FR 63114 through 63116) and the CY 2021 PFS final rule (85 FR 84967 through 85 FR 84969) for our previously finalized requirements and burden for self-nomination of qualified registries. In section IV.A.3.h.(1) of this rule, we are finalizing reorganization and consolidation of § 414.1400 generally. We assume that this provision does not change the existing requirements for third-party intermediaries during the self-nomination process. Therefore, we did not revise our burden estimates related to these provisions.

In section IV.A.3.h.(2)(a) of this rule, we are finalizing to add APM Entities to § 414.1400(a)(1), expanding the general participation requirements of third-party intermediaries, to third party intermediaries reporting to MIPS on behalf of APM Entities reporting to MIPS to align reporting requirements for all participants in MIPS. We are also finalizing that beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support APP, and MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. As finalized in the CY 2017 PFS final rule, third-party intermediaries currently support MIPS data submission on behalf of eligible clinicians (81 FR 77016). APM Entities have historically used third party intermediaries for submitting their quality measures to their APMs.

Additionally, QCDRs, qualified registries and health IT vendors are required under existing § 414.1400(a)(1) to submit data for the quality, improvement activities, and promoting interoperability performance categories in MIPS. Similar to our discussion for QCDRs above, we anticipate no additional steps being added to the qualified registry self-nomination process as a result of this provision for third-party intermediaries to submit MIPS data on behalf of APM Entities, and to support measures and activities in MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. For this final rule, we assume that there will be no impact on the time required for qualified registries to complete either the simplified or full Start Printed Page 65574 self-nomination process because of the above provisions. Additionally, we are finalizing to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year.

We anticipate that at the time of self-nomination, qualified registries would be using a checkbox to indicate their compliance for the requirement to support data submission for subgroups beginning with the CY 2023 performance period/2025 MIPS payment year. We assume that this would not impact the overall time estimated for qualified registries to submit their information at the time of self-nomination. Therefore, we are not making any adjustments in the time required for qualified registries during the simplified or full self-nomination process because of this provision. However, we anticipate that third-party intermediaries would need to make administrative changes to their existing workflows for submission of MVPs and APP data for clinicians participating as subgroups beginning with the CY 2023 performance period/2025 MIPS payment year.

We refer readers to section VI.F.18.g.(2)(f) of this rule where we discuss our impact analysis. For this final rule, we are adjusting the number of qualified registries that submitted applications for self-nomination from 210 to 147 based on the number of applications received during the CY 2021 self-nomination period for the CY 2022 performance period/2024 MIPS payment year, a decrease of 36 applications from the currently approved estimate of 183. This is also a decrease of 63 from the estimate of 210 provided in the CY 2022 PFS proposed rule (86 FR 39487). Therefore, we are revising our estimates for this information collection related to the qualified registry self-nomination process.

We are not making any new adjustments to the estimated burden per respondent as a result of this updated data. Based on our estimates in the CY 2021 PFS final rule (85 FR 84967) and the updated data received for the number of qualified registries that submitted self-nomination applications, we are adjusting the estimated number of qualified registries that will submit targeted audits for the CY 2022 performance period/2024 MIPS payment year. Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84967) and based on the updated data received from the CY 2021 self-nomination period, we are adjusting our estimate that 46 qualified registries will be required to conduct targeted audits, a decrease of 10 from the currently approved estimate of 56 in the CY 2021 PFS final rule (85 FR 84965). Therefore, we estimate the total impact associated with qualified registries completing targeted audits will range from 230 hours (46 registries × 5 hours/audit) at a cost of $21,901 (46 registries × $476.10/audit) to 460 hours (46 registries × 10 hours/audit) at a cost of $43,801 (46 registries × $952.20/audit) for the simplified and full self-nomination process, respectively (see Table 83 for the cost per audit).

We assume that this would adjust our burden estimates for targeted audits by −50 hours (−10 respondents × 5 hr/audit) at a cost of −$4,761 (−50 hrs × $95.22/hr) and + −100 hours (−10 respondents × 10 hr/audit) at a cost of −$9,522 (−100 hrs × $95.22/hr) for the simplified and full self-nomination process, respectively. Using our currently approved time per response estimate of 3 hours, the resulting adjustment in burden for QCDRs and qualified registries to submit CAPs is 30 hours (10 respondents × 3 hrs/respondent) at a cost of $2,857 (30 hours × $95.22/hr). In section IV.A.3.h.(3)(a)(i) of this final rule, we are finalizing new requirements for approved QCDRs and qualified registries that have not submitted performance data. First, we are finalizing to create a new requirement at paragraph at § 414.1400(b)(3)(vii) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023.

Exceptions to this requirement may occur if data is received for the CY 2021 performance period/2023 MIPS payment year. Under this scenario, QCDRs and qualified registries will not need to submit a participation plan for the CY 2023 self-nomination process. If the QCDRs and qualified registries did not submit data, their participation plan must be submitted as part of self-nomination for the CY 2023 MIPS self-nomination period and must be accepted by CMS to continue to be an approved QCDR or qualified registry. We are also finalizing to codify a new requirement that, beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval.

Under this provision, the participation plan must explain the QCDR and/or qualified registry's detailed plans about how the vendor intends to encourage clinicians to submit MIPS data to CMS through the third-party intermediary on behalf of clinicians or groups. The vendor must also explain why they should still be allowed to participate as a qualified vendor. Based on our review of the existing list of approved qualified registries that did not submit performance data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year), we estimate that 19 qualified registries would submit participation plans for the CY 2023 self-nomination period. Similar to our assumptions used for submission of a CAP in the CY 2021 PFS final rule (85 FR 84968), we anticipate that the effort involved in developing a participation plan including the policies specified in this rule and submitting it to CMS is likely to be no more than 3 hours for a computer systems analyst at a rate of $95.22/hr.

For the CY 2023 performance period/2025 MIPS payment year, we estimate an annual burden of 57 hours (3 hr × 19 participation plans) at a cost of $5,428 (57 hr × $95.22/hr) for qualified registries to develop and submit a participation plan. As stated above, based on the number of self-nominations received for the CY 2022 performance period/2024 MIPS payment year, we are finalizing to adjust the estimated number of qualified registries that will self-nominate for the CY 2022 self-nomination period to 147, a decrease of 36 from the currently approved estimate of 183 in the CY 2021 PFS final rule (85 FR 84969). In the CY 2019 PFS final rule, we estimated that it would take 3 hours for a qualified registry to submit all the required information during the full self-nomination process (83 FR 59998). Based on our experience with the self-nomination process, we believe that the number of fields needed to be submitted for a qualified registry are fewer than those needed for a QCDR.

We assume that our previous assumption of 3 hours is an overestimate. Therefore, we are adjusting the estimated time required for a qualified registry submitting a full-self-nomination process to 2 hours, a decrease of 1 hour. We assume that the staff involved in the qualified registry self-nomination process will continue to be computer systems analysts or their equivalent, who have an average labor rate of $95.22/hr. Using the change in estimated burden per respondent time, associated with the self-nomination process range from a minimum of 0.5 hours to a maximum of 2 hours, we Start Printed Page 65575 estimate that the annual burden would range from 74 hours (147 qualified registries × 0.5 hr) to 294 hours (147 qualified registries × 2 hr) at a cost ranging from $7,046 (74 hr × $95.22/hr) and $27,995 (294 hr × $95.22/hr), respectively (see Table 85).

Both the minimum and maximum burden shown in Table 85 reflect the adjustments to the number of respondents due to availability of more recent data. Combined with our estimates of burden associated with completing targeted audits and developing and submitting participation plans and corrective action plans, our total burden estimate ranges from 391 hours [74 hr (147 qualified registries × 0.5 hr) + 57 hr (+19 participation plans × 3 hr/plan) + 230 hr (46 targeted audits × 5 hours/audit) + 30 hr (10 CAPs × 3 hr) at a cost of $37,232 [$7,046 (74 hr × $95.22/hr) + $5,428 (57 hr × $95.22/hr) + $21,901 (46 registries × $476.10/audit) + $2,857 (30 hours × $95.22/hr)] to 841 hours [294 hr (147 qualified registries × 2 hr) + 57 hr (+19 participation plans × 3 hr/plan) + 460 hr (46 targeted audits × 10 hours/audit) + 30 hr (10 CAPs × 3 hr)] at a cost of $80,081 [$27,995 (294 hr × $95.22/hr) + $5,428 (57 hr × $95.22/hr) + $43,801 (46 registries × $952.20/audit) + $2,857 (30 hours × $95.22/hr) for the simple self-nomination process (see minimum burden in Table 85) and full self-nomination process (see maximum burden in Table 85) respectively. Based on the assumptions discussed in this section, we provide an estimate of the total annual burden associated with a qualified registry self-nominating to be considered “qualified” to submit quality measures results and numerator and denominator data on MIPS eligible clinicians. As shown in Table 86, for the CY 2022 performance period/2024 MIPS payment year, independent of the change to our per response time estimate, the estimated decrease in 36 respondents from the currently approved 183 respondents to 147 results in a change of −18 hours (−36 respondents × 0.5 hrs/respondent) at a cost of −$1,714 (−18 hours × $95.22/hr) for the simplified self-nomination process and a change of −72 hours (−36 respondents × 2 hrs/respondent) at a cost of −$6,856 (−72 hours × $95.22/hr).

Accounting for the change in time required for the qualified registry self-nomination process results in an adjustment of 0 hours for the simplified self-nomination process and −183 hours (183 respondents × −1 hours) at a cost of −$17,425 (−183 hours × $95.22/hr) for the full self-nomination process. When the above impacts are combined with the estimates for targeted audits, participation plans and corrective action plans discussed above, the net impact ranges between −11 hours [−18 hr (−36 respondents × 0.5 hrs/respondent) + 0 hr +−50 hr (−10 audits × 5 hr/audit) + 57 hr (+19 participation plans × 3 hr/plan) + 0 hr)] at a cost of −$1,046 [(−$1,713 (−18 hours × $95.22/hr) + $0 +−$4,761 (−50 hrs × $95.22/hr) + $5,428 (+57 hr × $95.22/hr) + $0)] for the simplified self-nomination process and −298 hours [(−72 hr (−36 respondents × 2 hrs/respondent) + −183 hr (183 respondents × −1 hours) + −100 hr (−10 audits × 10 hr/audit) + 57 hr (+19 participation plans × 3 hr) + 0 hr)] at a cost of −$28,375 [(−$6,856 (−72 hours × $95.22/hr)−$17,425 (−183 hours × $95.22/hr)−$9,522 (−100 hrs × $95.22/hr) + $5,428 (+57 hr × $95.22/hr) + $0)] for the full self-nomination process for the CY 2022 performance period/2024 MIPS payment year. As discussed above in this section of the rule, we are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year. Therefore, we estimate the total change in burden for the qualified registry self-nomination process would be 391 hours at a cost of $37,232 for the simplified self-nomination process and 841 hours at a cost of $80,081 for the full self-nomination process.

For the purposes of calculating estimated change in burden in Tables 128, 129, and 130 of this final Start Printed Page 65576 rule, we use only the maximum burden estimate. We received public comments for our burden estimates related to QCDRs and qualified registries. The following is a summary of the public comments received for the Quality Payment Program ICRs regarding the burden estimates for QCDR and qualified registries. Comment.

One commenter did not agree with CMS burden estimates for audits conducted by QCDRs and qualified registries and shared their belief that the time required for a QCDR was two to three-fold more than CMS estimates. The commenter shared their concern that our estimate does not accurately represent the total amount of time it takes for a QCDR or qualified registry to conduct data audits. Response. We would like to clarify that our burden estimates provided for the QCDR and qualified registry self-nomination process are not intended to capture the holistic total annual time for a QCDR or a qualified registry to participate in MIPS.

Our burden estimate of 9.5 hours to 11.5 hours for the QCDR and 0.5 hours to 2 hours for the qualified registry self-nomination process specifically includes the estimated time it takes for a QCDR or qualified registry to populate and submit a self-nomination form and QCDR measures, if applicable. These burden estimates do not include any time needed to comply with third-party intermediary requirements outside of the self-nomination process. We believe our burden estimate is a reasonable average across all respondents based on our review of the nomination process, the information required to complete the nomination form, and the criteria required to self-nominate as a QCDR or registry. After consideration of public comments, we are not making any changes to our estimates of the time required for the QCDR and qualified registry self-nomination process.

(4) Survey Vendor Requirements In section IV.A.3.h(2)(b)(ii) of this rule, we are finalizing to require CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year. Because of this provision, we anticipate no additional steps being added to the requirements for CAHPS for MIPS survey vendors to submit a participation form and assume there would be no impact on the time required for the survey vendors. Therefore, we are not making any adjustments in the time required for CAHPS survey vendors to submit their information because of this provision. The requirements and burden for CAHPS survey vendors to submit data for eligible clinicians are currently approved by OMB under control number 0938-1222 (CMS-10450).

Consequently, we are not making any changes to the CAHPS for MIPS Survey vendor information collection request under that control number. (5) Health IT Vendors In section IV.A.3.h.(2)(b) of this rule, we are finalizing to create a new requirement at paragraph § 414.1400(c)(1)(iii) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, health IT vendors must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. Health IT vendors may also support the APP. Additionally, we are finalizing to require health IT vendors to support subgroup reporting beginning with the CY 2023 performance period/2025 MIPS payment year.

We do not anticipate any requirement or burden changes as it relates to the support of reporting data. As stated in the CY 2019 PFS final rule (83 FR 59998), health IT vendors are not included in the burden estimates for MIPS. D. ICR Regarding Open Authorization (OAuth) Credentialing and Token Request Process This rule is not implementing new or revised collection of information requirements or burden related to the identity management application process.

The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the identity management application process under that control number. E. ICRs Regarding Quality Data Submission (§§ 414.1318, 414.1325, 414.1335, and 414.1365) (1) Background We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77502 through 77503), CY 2018 Quality Payment Program final rule (82 FR 53908 through 53912), CY 2019 PFS final rule (83 FR 60000 through 60003), CY 2020 PFS final rule (84 FR 63121 through 63124), and the CY 2021 PFS final rule (85 FR 84970 through 84974) for our previously finalized requirements for data submission for the quality performance category.

Under our current policies, two groups of clinicians must submit quality data under MIPS. Those who submit as MIPS eligible clinicians and those who submit data voluntarily but are not subject to MIPS payment adjustments. Clinicians are ineligible for MIPS payment adjustments if they are newly Start Printed Page 65577 enrolled to Medicare. Are QPs.

Are partial QPs who elect to not participate in MIPS. Are not one of the clinician types included in the definition for MIPS eligible clinician. Or do not exceed the low-volume threshold as an individual or as a group. (2) Changes and Adjustments to Quality Performance Category Respondents To determine which QPs should be excluded from MIPS, we used the Advanced APM payment and patient percentages from the APM Participant List for the final snapshot date for the 2019 QP performance period.

From this data, we calculated the QP determinations as described in the Qualifying APM Participant (QP) definition at § 414.1305 for the CY 2022 performance period/2024 MIPS payment year. Due to data limitations, we could not identify specific clinicians who have not yet enrolled in APMs, but who may become QPs in the future CY 2022 performance period/2024 MIPS payment year (and therefore will no longer need to submit data to MIPS). Hence, our model may underestimate or overestimate the number of respondents. In the CY 2019 PFS final rule, we finalized limiting the Medicare Part B claims collection type to small practices beginning with the CY 2019 performance period/2021 MIPS payment year and allowing clinicians in small practices to report Medicare Part B claims as a group or as individuals (83 FR 59752).

As in the CY 2021 PFS final rule, we continue to use CY 2019 performance period/2021 MIPS payment year data to estimate the number of respondents in the CY 2022 PFS final rule. There may be an undercount in submissions due to the PHE for buy antibiotics, because of the automatic extreme and uncontrollable circumstances policy, and application-based policy that allowed clinicians to elect not to submit during the submission period for the CY 2019 performance period/2021 MIPS payment year that we are using to inform our burden estimates. Despite this limitation, we believe the data from the CY 2019 performance period/2021 MIPS payment year is still the best data source available as it most accurately reflects the impacts of policies finalized in previous rules and trends toward increased group reporting. In section IV.A.3.d.(1)(d) of this rule, we are finalizing to continue the CMS Web Interface measures as a collection type for the CY 2022 performance period/2024 MIPS payment year.

Additionally, we are finalizing to sunset the CMS Web Interface measures as a collection type/submission type starting with the CY 2023 performance period/2025 MIPS payment year. In the CY 2021 PFS final rule (85 FR 84981), we finalized the sunset of CMS Web Interface as a collection type for the CY 2022 performance period/2024 MIPS payment year. We refer readers to the CY 2021 PFS final rule for discussion on our assumptions for the CY 2022 performance period/2024 MIPS payment year, where we estimated a burden of zero due to our assumption that all Web Interface respondents will alternately utilize either the MIPS CQM and QCDR or eCQM collection types. Based on the number of groups that submitted quality performance data via the CMS Web Interface in the CY 2019 performance period/2021 MIPS payment year, we are not able to ascertain what alternative collection type(s) the groups would elect.

In order to estimate the number of groups that will select each of these collection types, we first clustered the number of groups which submitted data via the CMS Web Interface collection type during the CY 2019 performance period/2021 MIPS payment year by practice size (between 25 and 49 clinicians, between 50 and 99 clinicians, etc.). Then, for each cluster, we allocated these groups to each of the MIPS CQM and QCDR and eCQM collection types based on the percent of TINs that submitted MIPS data via these two collection types. For example, of the 1,629 TINs with a practice size of 25 to 49 clinicians which submitted data for the CY 2019 performance period/2021 MIPS payment year, 1,066 (65 percent) submitted data via the MIPS CQM and QCDR collection type and 563 (35 percent) submitted data via the eCQM collection type. We applied these percentages to the 7 TINs with a practice size of 25 to 49 clinicians which submitted data via the CMS Web Interface collection type for the CY 2019 performance period/2021 MIPS payment year to estimate that 4 (7 TINs × 0.56) would elect to submit data via the MIPS CQM and QCDR collection type and the remaining 3 (7 TINs × 0.44) would elect to submit data via the eCQM collection type.

In total, beginning with the CY 2023 performance period/2025 MIPS payment year, we estimate that 64 of the 114 groups that submitted data via the CMS Web Interface collection type for the CY 2019 performance period/2021 MIPS payment year will submit quality data via the MIPS CQM and QCDR collection type and 50 groups will now submit quality data via the eCQM collection type. We note that 114 groups are an increase of 114 from our currently approved estimate of 0 groups in the CY 2022 performance period/2024 MIPS payment year. We also performed this analysis to determine the number of clinicians that will be affected and will need to submit quality data via an alternate collection type beginning with the CY 2023 performance period/2025 MIPS payment year. In total, of the estimated 45,599 individual clinicians affected by this provision, we estimate that 11,432 will submit quality data as part of a group via the MIPS CQM and QCDR collection type and 34,167 will submit quality data as part of a group via the eCQM collection type.

These estimates are reflected in Tables 90 and 92 and the associated changes in burden are reflected in Tables 91 and 93. In aggregate, as discussed in section V.B.8.p. Of this final rule, we estimate the provision to sunset the CMS Web Interface measures as a collection type/submission type will result in a net decrease in quality performance data reporting burden while acknowledging the additional financial impacts on clinicians as discussed in section VI.F.18.g.(2)(a) of the Regulatory Impact Analysis. We assume that 100 percent of ACO APM Entities will submit quality data to CMS as required under their models.

While we do not believe there is additional reporting for ACO APM entities, consistent with assumptions used in the CY 2020 and CY 2021 PFS final rules (84 FR 63122 and 85 FR 84972), we include all quality data voluntarily submitted by MIPS APM participants at the individual or TIN-level in our respondent estimates. As stated in section V.B.8.e.(2) of this final rule, we assume non-ACO APM Entities will participate through traditional MIPS and submit as an individual or group rather than as an entity. To estimate who will be a MIPS APM participant in the CY 2022 performance period/2024 MIPS payment year, we used the Advanced APM payment and patient percentages from the APM Participant List for the final snapshot date for the 2019 QP performance period. We elected to use this data source because the overlap with the data submissions for the CY 2019 performance period/2021 MIPS payment year enabled the exclusion of Partial QPs that elected to not participate in MIPS and required fewer assumptions as to who is a QP or not.

Based on this information, if we determine that a MIPS eligible clinician will not be scored as a MIPS APM, then their reporting assumption is based on their reporting as a group or individual Start Printed Page 65578 for the CY 2019 performance period/2021 MIPS payment year. Our burden estimates for the quality performance category do not include the burden for the quality data that APM Entities submit to fulfill the requirements of their APMs. The burden is excluded from this collection of information section but is discussed in the regulatory impact analysis section of this final rule because sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 1315a(d)(3), respectively) state that the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models tested under section 1115A of the Act (or section 3021 of the Affordable Care Act) are not subject to the PRA.[] Tables 84, 85, and 86 explain our revised estimates of the number of organizations (including groups, virtual groups, and individual MIPS eligible clinicians) submitting data on behalf of clinicians segregated by collection type.

Table 87 provides our estimated counts of clinicians that will submit quality performance category data as MIPS individual clinicians or groups in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years based on data from the CY 2019 performance period/2021 MIPS payment year. For the CY 2022 performance period/2024 MIPS payment year, respondents will have the option to submit quality performance category data via Medicare Part B claims, direct, and log in and upload submission types, and Web Interface. For the CY 2023 performance period/2025 MIPS payment year, respondents will no longer have the option to submit quality performance category data via the Web Interface. We estimate the burden for collecting data via collection type.

Medicare Part B claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface. We believe that, while estimating burden by submission type may be better aligned with the way clinicians participate with the Quality Payment Program, it is more important to reduce confusion and enable greater transparency by maintaining consistency with previous rulemaking. For the CY 2023 performance period/2025 MIPS payment year, we are finalizing in section IV.A.3.b.(2)(c) of this rule that clinicians in MIPS will have the option to submit measures and activities in MVPs. We refer readers to section IV.A.3.b.(4)(d) of this rule for additional details on the reporting requirements for MVPs.

For the quality performance category of MVPs, we assume that MVP Participants will choose to report via the Medicare Part B claims, QCDR, MIPS CQMs, and eCQMs collection type. Table 99 of this rule includes the estimated burden for collecting data for the quality performance category of MVPs. As shown in Table 87, using participation data from the CY 2019 performance period/2021 MIPS payment year, combined with the estimate of QPs for the CY 2022 performance period/2024 MIPS payment year, we estimate a total of 625,703 clinicians will submit quality data as individuals or groups in each of the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years, a decrease of 25,811 clinicians when compared to our estimate of 651,514 clinicians in the CY 2021 PFS final rule (85 FR 84972). For the CY 2022 performance period/2024 payment year, we estimate 28,252 clinicians will submit data as individuals for the Medicare Part B claims collection type.

279,247 clinicians will submit data as individuals or as part of groups for the MIPS CQM and QCDR collection type. 273,819 clinicians will submit data as individuals or as part of groups via eCQM collection types. And 44,385 clinicians will submit as part of groups via the CMS Web Interface. Compared to the CY 2022 performance period/2024 MIPS payment year burden estimated in the CY 2021 PFS final rule (85 FR 84972), these are decreases from the estimates of 29,273, 295,941, and 326,300 for Medicare Part B claims, MIPS CQM and QCDR, eCQM, and an increase of 44,385 for the CMS Web Interface collection types, respectively.

These adjustments are due to the availability of updated data from the CY 2019 performance period/2021 MIPS payment year and the delay in sunsetting the CMS Web Interface from the CY 2022 performance period/2024 MIPS payment year to the CY 2023 performance period/2025 MIPS payment year. For the CY 2023 performance period/2025 MIPS payment year, we estimate 25,427 clinicians will submit data as individuals for the Medicare Part B claims collection type. 288,637 clinicians will submit data as individuals or as part of groups for the MIPS CQM and QCDR collection type. 311,326 clinicians will submit data as individuals or as part of groups via the eCQM collection type.

Table 87 provides estimates of the number of clinicians to collect quality measures data via each collection type, regardless of whether they decide to submit as individual clinicians or as part of groups. Because our burden estimates for quality data submission assume that burden is reduced when clinicians elect to submit as part of a group, we also separately estimate the expected number of clinicians to submit as individuals or part of groups. Start Printed Page 65579 Because MIPS eligible clinicians may submit data for multiple collection types for a single performance category, the estimated numbers of individual clinicians and groups to collect via the various collection types are not mutually exclusive and reflect the occurrence of individual clinicians or groups that collected data via multiple collection types during the CY 2019 performance period/2021 MIPS payment year. We captured the burden of any eligible clinician that may have historically collected via multiple collection types, as we assume they will continue to collect via multiple collection types and that our MIPS scoring methodology will take the highest score where the same measure is submitted via multiple collection types.

Table 88 uses methods similar to those described to estimate the number of clinicians that will submit data as individual clinicians via each collection type in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. For the CY 2022 performance period/2024 MIPS payment year, we estimate that approximately 28,252 clinicians will submit data as individuals using the Medicare Part B claims collection type. Approximately 40,507 clinicians will submit data as individuals using MIPS CQM and QCDR collection type. And approximately 40,446 clinicians will submit data as individuals using eCQMs collection type.

Based on performance data from the CY 2019 performance period/2021 MIPS payment year, these are decreases of −1,021, −833, and −1,809 respondents from the currently approved estimates of 29,273, 41,340, and 42,255 for the Medicare Part B claims, MIPS CQM and QCDR, and eCQM collection types, respectively. As shown in Table 88, for the CY 2023 performance period/2025 MIPS payment year, we estimate that approximately 25,427 clinicians will submit data as individuals using the Medicare Part B claims collection type. Approximately 36,456 clinicians will submit data as individuals using MIPS CQM and QCDR collection type. And approximately 36,401 clinicians will submit data as individuals using eCQMs collection type.

As stated above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. Start Printed Page 65580 Consistent with the policy finalized in the CY 2018 Quality Payment Program final rule that for MIPS eligible clinicians who collect measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection types and submit more than the required number of measures (82 FR 53735 through 54736), we will score the clinician on the required measures with the highest assigned measure achievement points and thus, the same clinician may be counted as a respondent for more than one collection type. Therefore, our columns in Table 88 are not mutually exclusive. Table 89 provides our estimated counts of groups or virtual groups that will submit quality data on behalf of clinicians for each collection type in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years.

We assume that clinicians that submitted quality data as groups in the CY 2019 performance period/2021 MIPS payment year will continue to submit quality data either as groups or virtual groups for the same collection types as they did as a group or TIN within a virtual group for the CY 2022 and 2023 performance periods/2024 and 2025 MIPS payment years. Specifically, for the CY 2022 performance period/2024 MIPS payment year we estimate that 11,529 groups and virtual groups will submit data for the MIPS CQM and QCDR collection type on behalf of 243,169 clinicians. 8,127 groups and virtual groups will submit for eCQM collection types on behalf of 249,878 eligible clinicians. And 114 groups will submit data via the CMS Web Interface on behalf of 44,385 clinicians.

These are decreases of −75 and −93 respondents from the currently approved estimates of 11,604, and 8,220 groups and virtual groups for the MIPS CQM and QCDR and eCQM collection types, and an increase of +114 groups from the currently approved estimates of 0 groups for the CMS Web Interface collection types, respectively. As shown in Table 89, for the CY 2023 performance period/2025 MIPS payment year we estimate that 10,434 groups and virtual groups will submit data for the MIPS CQM and QCDR collection type on behalf of 313,038 clinicians and 7,359 groups and virtual groups will submit for eCQM collection types on behalf of 339,109 eligible clinicians. As stated above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. The reason for the difference in estimated number of respondents from the estimates for the CY 2022 performance period/2024 MIPS payment year described above, is due to the sunset of the CMS Web Interface as a collection type and the implementation of MVPs beginning with the CY 2023 performance period/2025 MIPS payment year.

As the data does not exist for APM performance pathway or MIPS quality measures for non-ACO APM entities, we assume non-ACO APM Entities will participate through traditional MIPS and base our estimates on submissions received in the CY 2019 performance period/2021 MIPS payment year. Start Printed Page 65581 The burden associated with the submission of quality performance category data have some limitations. We believe it is difficult to quantify the burden accurately because clinicians and groups may have different processes for integrating quality data submission into their practices' workflows. Moreover, the time needed for a clinician to review quality measures and other information, select measures applicable to their patients and the services they furnish, and incorporate the use of quality measures into the practice workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician's practice and by the collection type.

For example, clinicians submitting data via the Medicare Part B claims collection type need to integrate the capture of quality data codes for each encounter whereas clinicians submitting via the eCQM collection types may have quality measures automated as part of their EHR implementation. We believe the burden associated with submitting quality measures data will vary depending on the collection type selected by the clinician, group, or third-party. As such, we separately estimated the burden for clinicians, groups, and third parties to submit quality measures data by the collection type used. For the purposes of our burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and eCQM collection types, we also assume that, on average, each clinician or group will submit 6 quality measures.

For the CY 2023 performance period/2025 MIPS payment year we refer readers to section IV.A.3.b.(4)(d) of the rule for the changes related to MVP and subgroup reporting requirements. In terms of the quality measures available for clinicians and groups to report for the CY 2022 performance period/2024 MIPS payment year, we are finalizing that the total number of quality measures will be 200. The new MIPS quality measures finalized for inclusion in MIPS for the CY 2022 performance period/2024 MIPS payment year and future years are found in Table Group A of Appendix 1. MIPS quality measures with substantive changes can be found in Table Group D of Appendix 1.

And MIPS quality measures finalized for removal can be found in Table Group C of Appendix 1. These measures are stratified by collection type in Table 90, as well as counts of new, removed, and substantively changed measures. Start Printed Page 65582 For the CY 2022 performance period/2024 MIPS payment year, we are finalizing a net reduction of 9 quality measures across all collection types compared to the 209 measures finalized for the CY 2021 performance period/2023 MIPS payment year (85 FR 84974). Specifically, as discussed in section IV.A.3.d.(1)(e) of this rule, we are finalizing to add 1 new administrative claims outcome measure, remove 13 quality measures, and make substantive updates to 87 quality measures.

We do not anticipate that our provision to remove these measures will increase or decrease the reporting burden on clinicians and groups as respondents generally are still required to submit quality data for 6 measures. For the change in associated burden related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99 of this section. (3) Quality Payment Program Identity Management Application Process This rule is not implementing any new or revised collection of information requirements or burden related to the identity management application process. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621).

Consequently, we are not making any changes to the identity management application process under that control number. (4) Quality Data Submission by Clinicians. Medicare Part B Claims-Based Collection Type This rule is not implementing any new or revised collection of information requirements related to the submission of Medicare Part B claims data for the quality performance category. However, we are adjusting our currently approved burden estimates based on more recent data.

For the change in associated burden related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99 of this section. The following burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77501 through 77504), CY 2018 Quality Payment Program final rule (82 FR 53912), CY 2019 PFS final rule (83 FR 60004 through 60005), CY 2020 PFS final rule (84 FR 63124 through 63126) and the CY 2021 PFS final rule (85 FR 84975 through 84976) for our previously finalized requirements and burden for quality data submission via the Medicare Part B claims collection type. As noted in Table 88, based on data from the CY 2019 performance period/2021 MIPS payment year, we assume that 28,252 individual clinicians will collect and submit quality data via the Medicare Part B claims collection type.

In this rule, we are finalizing to adjust the number of Medicare Part B claims respondents from the currently approved estimate of 29,273 to 28,252 (a decrease of 1,021) based on more recent data and our methodology of accounting only for clinicians in small practices who submitted such claims data in the CY 2019 performance period/2021 MIPS payment year rather than all clinicians who submitted quality data codes to us for the Medicare Part B claims collection type. As shown in Table 91, consistent with our currently approved per response time figures, we estimate that the burden of quality data submission using Medicare Part B claims will range from 0.15 hours (9 minutes) for a computer systems analyst at a cost of $14.28 (0.15 hr × $95.22/hr) to 7.2 hours for a computer systems analyst at a cost of $685.58 (7.2 hr × $95.22/hr). The burden will involve becoming familiar with MIPS quality measure specifications. Consistent with our currently approved per response time figures, we believe that the start-up cost for a clinician's practice to review measure specifications is 7 hours, consisting of 3 hours at $114.24/hr for a medical and health services manager, 1 hour at $217.32/hr for a physician, 1 hour at $48.16/hr for an LPN, 1 hour at $95.22/hr for a computer systems analyst, and 1 hour at $40.02/hr for a billing and posting clerk.

We are not revising our currently approved per response time estimates. As shown in Table 91, considering both data submission and start-up requirements for our adjusted number of clinicians, the estimated time (per clinician) ranges from a minimum of 7.15 hours (0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this regard the total annual time for the CY 2022 performance period/2024 MIPS payment year ranges from 202,002 hours (7.15 hr × 28,252 clinicians) to 401,178 hours (14.2 hr × 28,252 clinicians). The estimated annual cost (per clinician) ranges from $758 [(0.15 hr × $95.22/hr) + (3 hr × $114.24/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr) + (1 hr × $217.32/hr)] to a maximum of $1,429.02 [(7.2 hr × $95.22/hr) + (3 hr × $114.24/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr) + (1 hr × $217.32/hr)].

The total annual cost for the CY 2022 performance period/2024 MIPS payment year ranges from a minimum of $21,407,105 (28,252 clinicians × $758) Start Printed Page 65583 to a maximum of $40,372,673 (28,252 clinicians × $1,429.02). As shown in Table 91, for purposes of calculating total burden associated with the Claims collection type for the CY 2023 performance period/2025 MIPS payment year only the maximum burden is used. The decrease in the number of annual respondents results in an estimated total annual time of 361,063 hours (14.2 hr × 25,427 clinicians) for the CY 2023 performance period/2025 MIPS payment year. Using the currently approved unchanged estimate for cost per respondent, the total annual cost for the CY 2023 performance period/2025 MIPS payment year is $36,335,692 (25,427 clinicians × $1,429.02 per respondent).

Table 91 summarizes our estimated range of total annual burden associated with clinicians submitting quality data via Medicare Part B claims for both the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. As shown in Table 91, using the unchanged currently approved hours per respondent, we estimate that the burden per respondent for quality data submission using the Medicare Part B Claims collection type will range from $758 to $1,429.02. The decrease in number of respondents from 29,273 to 28,252 results in a total adjustment of between −7,300 hours (−1,021 respondents × 7.15 hr/respondent) at a cost of −$773,918 (−1,021 respondents × $758/respondent) and −14,498 hours (−1,021 respondents × 14.2 hr/respondent) at a cost of −$1,459,029 (−1,021 respondents × $1,429.02/respondent). For purposes of calculating total burden associated with this final rule as shown in Tables 125, 126, 127, and 128, only the maximum burden is used.

As shown in Table 92, for purposes of calculating total burden associated the CY 2023 performance period/2025 MIPS payment year only the maximum burden is used. We are setting forth our CY 2023 performance period/2025 MIPS payment year estimate as new burden, which results in an increase of 361,063 hours (25,427 respondents × 14.2 hr/respondent) at a cost of $36,355,692 (25,427 respondents × $1,429/respondent). Start Printed Page 65584 (5) Quality Data Submission by Individuals and Groups Using MIPS CQM and QCDR Collection Types The following requirement and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77504 through 77505), CY 2018 Quality Payment Program final rule (82 FR 53912 through 53914), CY 2019 PFS final rule (83 FR 60005 through 60006), CY 2020 PFS final rule (84 FR 63127 through 63128), CY 2021 PFS final rule (85 FR 84977 through 84979) for our previously finalized requirements and burden for quality data submission via the MIPS CQM and QCDR collection types.

For the change in associated burden for quality data submission related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99. As noted in Tables 84, 85, and 86, and based on data from the CY 2019 performance period/2021 MIPS payment year, for the CY 2022 performance period/2024 MIPS payment year, we assume that 279,247 clinicians will submit quality data as individuals or groups using MIPS CQM or QCDR collection types. 52,036 clinicians will submit as individuals and the remaining 279,223 clinicians will submit as members of 11,527 groups and virtual groups. This is an increase of 10,696 individuals and a decrease of 32 groups from the estimates of 41,340 individuals and the 11,559 groups provided in the CY 2021 PFS final rule (85 FR 84977).

Given that the number of measures required for clinicians and groups is the same, we expect the burden to be the same for each respondent collecting data via MIPS CQM or QCDR, whether the clinician is participating in MIPS as an individual or group. Under the MIPS CQM and QCDR collection types, the individual clinician or group may either submit the quality measures data directly to us, log in and upload a file, or utilize a third-party intermediary to submit the data to us on the clinician's or group's behalf. We estimate that the burden associated with the QCDR collection type is similar to the burden associated with the MIPS CQM collection type. Therefore, we discuss the burden for both together below.

For MIPS CQM and QCDR collection types, we estimate an additional time for respondents (individual clinicians and groups) to become familiar with MIPS quality measure specifications and, in some cases, specialty measure sets and QCDR measures. Therefore, we believe that the burden for an individual clinician or group to review measure specifications and submit quality data is total of 9 hours at a cost of $922.76 per response. This consists of 3 hours at $95.22/hr for a computer systems analyst (or their equivalent) to submit quality data along with 2 hours at $114.24/hr for a medical and health services manager, 1 hour at $95.22/hr for a computer systems analyst, 1 hour at $48.16/hr for an LPN, 1 hour at $40.02/hr for a billing clerk, and 1 hour at $217.32/hr for a physician to review measure specifications. Additionally, clinicians and groups who do not submit data directly will need to authorize or instruct the qualified registry or QCDR to submit quality measures' results and numerator and denominator data on quality measures to us on their behalf.

We estimate that the time and effort associated with authorizing or instructing the quality registry or QCDR to submit this data will be approximately 5 minutes (0.083 hours) at $95.22/hr for a computer systems analyst at a cost of $7.90 (0.083 hr × $95.22/hr). Overall, we estimate 9.083 hr/response (3 hr + 2 hr + 1 hr + 1 hr + 1 hr + 1 hr + 0.083 hr) at a cost of $922.76/response [(3 hr × $95.22/hr) + (2 hr × $114.24/hr) + (1 hr × $217.32/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr) + (0.083 hr × $95.22/hr)]. For the CY 2022 performance period/2024 MIPS payment year, in aggregate, we estimate a burden of 472,643 hours [9.083 hr/response × (40,507 clinicians submitting as individuals + 11,527 groups submitting via QCDR or MIPS CQM on behalf of individual clinicians or 52,036 responses)] at a cost of $ $48,016,739 (52,036 responses × $922.76/response). For the CY 2023 performance period/2025 MIPS payment year, in aggregate, we estimate a burden of 425,902 hours [9.083 hr/response × (36,456 clinicians submitting as individuals + 10,434 groups submitting via QCDR or MIPS CQM on behalf of individual clinicians or 46,890 responses)] at a cost of $43,268,216 (46,890 responses × $922.76/response).

Based on these assumptions, we have estimated in Start Printed Page 65585 Table 93 the burden for these submissions. As shown in Table 94, using the unchanged currently approved hours per respondent burden estimate, the decrease of 913 respondents from 52,944 to 52,036 for the CY 2022 performance period/2024 MIPS payment year results in a decrease of −8,247 hours (−908 respondents × 9.083 hr/respondent) and −$837,866 (908 respondents × $922.76/respondent). We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 425,902 hours (46,890 respondents × 9.083 hr/respondent) and $43,268,216 (46,890 respondents × $922.76/respondents). Start Printed Page 65586 (6) Quality Data Submission by Clinicians and Groups.

ECQM Collection Type The following requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77505 through 77506), CY 2018 Quality Payment Program final rule (82 FR 53914 through 53915), CY 2019 PFS final rule (83 FR 60006 through 60007), CY 2020 PFS final rule (84 FR 63128 through 63130) and the CY 2021 PFS final rule (85 FR 84979 through 84980) for our previously finalized requirements and burden for quality data submission via the eCQM collection types. For the change in associated burden for quality data submission related to the provisions introducing MVP and subgroup reporting beginning in the CY 2023 performance period/2025 MIPS payment year, we refer readers to Table 99 of this section. Based on CY 2019 performance period/2021 MIPS payment year data, for the CY 2022 performance period/2024 MIPS payment year, we assume that 322,392 clinicians will elect to use the eCQM collection type.

40,446 clinicians are expected to submit eCQMs as individuals. And 8,127 groups and virtual groups are expected to submit eCQMs on behalf of the remaining 273,819 clinicians. This is a decrease of 2,109 individuals and 27 groups from the estimates of 42,555 individuals and 8,154 groups provided in the CY 2021 PFS final rule (85 FR 84979). We expect the burden to be the same for each respondent using the eCQM collection type, whether the clinician is participating in MIPS as an individual or group.

Under the eCQM collection type, the individual clinician or group may either submit the quality measures data directly to us from their eCQM, log in and upload a file, or utilize a third-party intermediary to derive data from their CEHRT and submit it to us on the clinician's or group's behalf. To prepare for the eCQM collection type, the clinician or group must review the quality measures on which we will be accepting MIPS data extracted from eCQMs, select the appropriate quality measures, extract the necessary clinical data from their CEHRT, and submit the necessary data to a QCDR/qualified registry or use a health IT vendor to submit the data on behalf of the clinician or group. We assume the burden for collecting quality measures data via eCQM is similar for clinicians and groups who submit their data directly to us from their CEHRT and clinicians and groups who use a health IT vendor to submit the data on their behalf. This includes extracting the necessary clinical data from their CEHRT and submitting the necessary data to a QCDR/qualified registry.

We estimate that it will take no more than 2 hours at $95.22/hr for a computer systems analyst to submit the actual data file. The burden will also involve becoming familiar with MIPS quality measure specifications. In this regard, we estimate it will take 6 hours for a clinician or group to review measure specifications. Of that time, we estimate 2 hours at $114.24/hr for a medical and health services manager, 1 hour at $217.32/hr for a physician, 1 hour at $95.22/hr for a computer systems analyst, 1 hour at $48.16/hr for an LPN, and 1 hour at $40.02/hr for a billing clerk.

Overall, we estimate a cost of $812.76/response [(2 hr × $95.22/hr) + (2 hr × $114.24/hr) + (1 hr × $217.32/hr) + (1 hr × $95.22/hr) + (1 hr × $48.16/hr) + (1 hr × $40.02/hr)]. For the CY 2022 performance period/2024 MIPS payment year, in aggregate, we estimate a burden of 388,584 hours [8 hr × 48.573 (40,446 clinicians + 8,127 groups and virtual groups)] at a cost of $39,812,374 (48,573 responses × $819.64/response). For the CY 2023 performance period/2025 MIPS payment year, in aggregate, we estimate a burden of 350,186 hours [8 hr × 43,773 (36,401 clinicians + 7,372 groups and virtual groups)] at a cost of $35,878,102 (43,773 responses × $819.64/response). Based on these assumptions, we have estimated in Table 95 the burden for these submissions.

Start Printed Page 65587 As shown in Table 96, using the unchanged currently approved hours per respondent burden estimate, the decrease of 1,902 respondents from 50,475 to 48,573 for the CY 2022 performance period/2024 MIPS payment year results in a total difference of ×15,216 hours at a cost of ×$1,558,955. For CY 2023 performance period/2025 MIPS payment year, we are setting forth our estimate as new burden, which represents an increase of 350,184 hours (43,773 respondents × 8 hr/respondent) and $35,878,102 (43,773 respondents × $819.64/respondent). Start Printed Page 65588 (7) ICRs Regarding Burden for MVP Reporting Section IV.A.3.b.(2)(d) of this rule describes provisions related to implementing MVPs beginning with the CY 2023 performance period/2025 MIPS payment year. The MVPs will include the Promoting Interoperability performance category as a foundational element and incorporate population health claims-based measures, as feasible, along with the relevant measures and activities in the quality, cost, and improvement activities performance categories.

For the CY 2023 performance period/2025 MIPS payment year, we are finalizing an inventory of seven MVPs included in Appendix 3. MVP Inventory of this rule to assess performance across MVPs for the quality, cost, improvement activities, and Promoting Interoperability performance categories. Additionally, in section IV.A.3.b.(2)(b)(i) of this rule, we are finalizing to use the term “MVP Participant” to refer to clinicians who will choose to participate in MIPS for reporting MVPs. The following new ICRs reflect the burden associated with the first year of data collection related to the implementation of MVPs and subgroup reporting in the CY 2023 performance period/2025 MIPS payment year as described in section IV.A.3.b.(2)(c) of this rule.

The requirements and burden associated with the implementation of MVPs and subgroups will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). While MVP respondents report on all performance categories, we believe that for purposes of data submission, the burden for clinicians submitting information for the Promoting Interoperability and improvement activities performance categories of MVPs will be consistent with the currently approved estimated burden per respondent for clinicians submitting data for these performance categories in traditional MIPS. We acknowledge that clinicians participating through MVPs will have fewer requirements to meet for the improvement activity performance category as discussed in section IV.A.3.b.(4)(d)(iv) of this final rule. We assume that these requirement changes will not significantly lower the burden for clinicians reporting MVPs.

Therefore, we will not add additional ICRs to capture the burden for the Promoting Interoperability and Improvement Activity performance categories. For this rule, we are finalizing to create a separate ICR for estimating the burden associated with data submission for the Quality performance category of MVPs. We considered whether we should have a separate ICR to estimate burden for submission of measures and activities in the Promoting Interoperability performance category of MVPs. Based on our assumption above that the burden for clinicians submitting information for these performance categories of MVPs will be consistent with the currently approved estimated burden per respondent for clinicians submitting data in traditional MIPS, we anticipate that the separate ICRs will not be of value to clinicians.

We solicited comment on our proposal to distinctly estimate burden only for data submission in the Quality performance category of MVPs and whether we should revise the MVP submission ICR to include all the four MIPS performance categories and whether our assumptions on Promoting Interoperability and Improvement Activities should be modified for MVPs. We did not receive public comments on this provision. We are finalizing as proposed. (a) Burden for MVP Quality Submission In section IV.A.3.b.(4)(d)(ii) of this rule, we are finalizing to implement voluntary MVP reporting beginning with the CY 2023 performance period/2025 MIPS payment year.

Therefore, clinicians participating in MIPS will have the option to voluntarily submit data using MVPs starting with the CY 2023 performance period/2025 MIPS payment year. While we recognize the implementation of MVPs in MIPS will result in a burden for registration, we also assume that MVP reporting will result in a decline in burden for MVP participants due to the finalized changes in the MVP reporting requirements described in section IV.A.3.b.(4)(d) of this rule. We anticipate that the clinicians choosing to participate in MIPS for reporting MVPs will need to select from a reduced inventory of measures and activities for the quality and improvement activities performance categories. This reduction in burden is described in the quality, improvement activities and Promoting Interoperability performance categories sections below.

For the ICRs related to MVP participants, we used the MIPS submission data from the CY 2019 performance period/2021 MIPS payment year. Based on our review of the inventory of 7 MVPs in Appendix 3. MVP Inventory of this rule and the existing submission trends in MIPS for the measures and activities included in these MVPs, we anticipate that 10 percent of the clinicians who participate in traditional MIPS in the CY 2022 performance period/2024 MIPS payment year will report MVPs in the CY 2023 performance period/2025 MIPS payment year. Given that MVPs are new, voluntary, and represent a Start Printed Page 65589 reduction in burden per response, we believe that we should be conservative in estimating the number of clinicians submitting through MVPs during the initial year.

Given that MVPs are a new mechanism available for clinicians, we believe that initial participation numbers will be relatively low. In an effort to be conservative in our estimate of burden reduction due to MVP reporting and reflect the anticipate low uptake by clinicians in the first year of MVP availability, we assume that a total of 10 percent of MIPS submitters will become MVP participants in the CY 2023 performance period/2025 MIPS payment year. As described in section IV.A.3.b.(2)(c)(ii) of this rule, beginning with the CY 2023 performance period/2025 MIPS payment year, we are finalizing voluntary subgroup reporting within MIPS limited to clinicians reporting the MVP or the APP. We recognize the implementation of subgroups for clinicians to participate in MVP and APP reporting in MIPS will result in additional burden.

However, we believe that subgroup participation option will allow clinicians in certain specialties and subspecialties to report on measures and activities meaningful to the scope of care provided. We anticipate that public reporting of subgroup performance information will allow patients to identify clinicians in multispecialty groups that are representative of the care specific to their clinical condition. Clinician participation in subgroups is new to MIPS and we do not have any historical participation data to estimate the submission burden for clinicians who will choose to participate as subgroups for reporting the MVP or the APP. We refer readers to section IV.A.3.b.(3) of this final rule for details on the provisions related to subgroup composition.

We anticipate that the subgroup reporting option will increase reporting and allow clinicians in specialties to report on measures and activities meaningful to their practice. Due to the delay in implementation of subgroup reporting in the CY 2023 performance period/2025 MIPS payment year, we anticipate that there is an adequate amount of time for clinicians that historically participate in MIPS to determine if they will be able to participate as subgroups for reporting on the measures and activities in an MVP. However, due to the limited number of MVPs available for clinicians to choose, the additional burden involved in reporting, and also given the voluntary option to participate as subgroups for reporting the MVPs or the APP, we anticipate that a relatively small number of clinicians will choose to participate as subgroups in the CY 2023 performance period/2025 MIPS payment year. Therefore, we assume there will be 20 subgroups reporters in the CY 2023 performance period/2025 MIPS payment year.

We assume that more clinicians will choose to participate as subgroups in future years. We solicited comment on our MVP and subgroup reporting assumptions for the CY 2023 performance period/2025 MIPS payment year. We received public comments on our MVP and subgroup reporting assumptions for the CY 2023 MIPS performance period/2025 MIPS payment year. The following is a summary of the comments we received and our responses.

Comment. One commenter stated that our estimate that 10 percent of eligible clinicians would report as MVP participants in the first year of implementation is low. The commenter shared their belief that the number of MVP participants would be higher because of the reduced reporting burden associated with MVP reporting. Response.

We thank the commenter for their feedback. We acknowledge the commenter's concern that our assumptions for MVP reporting are low. We agree with the commenter that MVP reporting is associated with a reduction in reporting burden. However, we believe that our estimates are appropriate because there would be a limited number of MVPs available for all clinicians during the CY 2023 performance period/2025 MIPS payment year.

We expect that there would be increased participation in MVP reporting as more MVPs become available for clinicians in future years. We plan to revise our estimates for future years as more data becomes available. After consideration of public comments, we are finalizing our proposed estimate for the number of MIPS eligible clinicians that would participate in MVP reporting during the CY 2023 performance period/2025 MIPS payment year. (i) Burden for MVP Registration.

Individuals, Groups and APM Entities Beginning with the CY 2023 performance period/2025 MIPS payment year, we are finalizing that clinicians interested in participating in MIPS through MVP reporting would be required to complete an annual registration process described in section IV.A.3.b.(4)(f) of this rule. At the time of registration, MVP participants would need to select a specific MVP, a population health measure and if administrative claims measures are included in the selected MVP, the MVP participants would also need to choose an applicable administrative claims measure in the MVP. We refer readers to section IV.A.3.b.(4)(f) of this rule for additional details on MVP registration requirements. Due to the delay in implementation of MVPs to the CY 2023 performance period/2025 MIPS payment year, we anticipate that there is an adequate amount of time for clinicians that historically participate in MIPS to determine if the measures and activities in an MVP are applicable to the scope of care provided.

In Table 97, we estimate that the registration process for clinicians choosing to submit MIPS data for the measures and the activities in an MVP would require 0.25 hours of a computer systems analyst's time, similar to the currently approved burden of group registration process for CMS Web Interface finalized in the CY 2021 PFS final rule (85 FR 84983) for the CY 2023 performance period/2025 MIPS payment year. We assume that the staff involved in the MVP registration process will mainly be computer systems analysts or their equivalent, who have an average labor cost of $95.22/hour. As discussed above, based on data from the CY 2019 performance period/2021 MIPS payment year, we assume that approximately 10 percent of the clinicians that currently participate in MIPS would submit data for the measures and activities in an MVP. Note that we apply this 10 percent calculation after adding the clinicians who begin submitting though the CQM and eCQM collection types due to the sunset of Web Interface in the CY 2023 performance period/2025 MIPS payment year.

For the CY 2023 performance period/2025 MIPS payment year, we assume that a total of 25,798 submissions will be received for the measures and activities included in MVPs. This total includes our estimate of 20 subgroup reporters that would also be reporting MVPs in addition to MVP reporters who currently participate in MIPS. Therefore, we assume that the total number of individual clinicians, groups, subgroups and APM Entities to complete the MVP registration process is 12,917. We estimate that the total cost to clinicians participating as individuals and groups associated with the MVP registration process would be approximately $307,465.

Table 97 includes our burden assumptions related to the MVP registration process for clinicians participating in MIPS for Start Printed Page 65590 reporting MVPs as individuals, groups, subgroups, and APM Entities. (ii) Burden for Subgroup Registration We are finalizing the proposal to add a separate ICR to estimate the burden associated with subgroup registration to capture the subgroup registration requirements in section IV.A.3.b.(4)(f)(ii)(D) of this rule. In section IV.A.3.b.(3)(b)(ii) of this rule, we finalized the definition of a subgroup at § 414.1305 as a subset of a group, as identified by a combination of the group TIN, the subgroup identifier, and each eligible clinician's NPI. In addition to the burden for MVP registration process described above, clinicians who choose to form subgroups for reporting the MVPs or the APP will need to submit a list of each TIN/NPI associated with the subgroup and a plain language name for the subgroup in a manner specified by CMS, described in section IV.A.3.b.(4)(f)(ii)(D) of this rule.

As discussed above, we estimate that clinicians will choose to form 20 subgroups for reporting the measures and activities in MVPs. Additionally, we estimate that clinicians who choose to participate as subgroups for reporting MVPs will require a minimum of 0.5 hours per subgroup respondent to submit the finalized requirements for subgroup registration. We assume that the staff involved in the subgroup registration process will mainly be computer systems analysts or their equivalent, who have an average labor cost of $95.22/hr. We assume that all subgroups would report MVPs, the burden associated with subgroup quality reporting will be included with the MVP quality reporting ICR.

The burden associated with subgroup submissions for Promoting Interoperability and improvement activities will be included with those ICRs. (iii) Burden for MVP Quality Performance Category Submission In the CY 2017 PFS final rule (81 FR 77100 through 77114), we established the submission criteria for quality measures (excluding the CMS Web Interface measures and the CAHPS for MIPS survey measure) at § 414.1335, which requires a MIPS eligible clinician, group, or virtual group that is reporting on Qualified Clinical Data Registry (QCDR) measures, MIPS clinical quality measures (MIPS CQMs), electronic CQMs (eCQMs), or Medicare Part B claims measures to submit data on at least six measures, including at least one outcome measure. As discussed in section IV.A.3.b.(4)(d)(ii) of this final rule, we finalized the proposal that except as provided in paragraph Start Printed Page 65591 § 414.1365(c)(1)(i), an MVP Participant must select and report 4 quality measures, including 1 outcome measure (or, if an outcome measure is not available, 1 high priority measure, included in the MVP. The decrease in the number of required measures in the quality performance category from 6 to 4 is a two-thirds reduction in the number of measures needed for eligible clinicians to submit data for the quality performance category in MVPs described in Appendix 3.

MVP Inventory of this final rule. Therefore, we estimate that the time for submitting the measures in the MVP quality performance category would, on average, take two-thirds of the currently approved burden per respondent for the quality performance category as it does to complete a MIPS quality submission through the CQM, eCQM, and Claims submission types. As described above in this section of the final rule, we estimate that 10 percent of the clinicians who participated in MIPS for the CY 2019 performance period/2021 MIPS payment year would submit data for the quality performance category of MVPs beginning with the CY 2023 performance period/2025 MIPS payment year. We anticipate that there would be 20 subgroups reporters in the CY 2023 performance period/2025 MIPS payment year.

As shown in Table 99, we estimate that approximately 2,825 clinicians would submit data for the MVP quality performance category using the Medicare Part B claims collection type. Approximately 5,210 clinicians and 10 subgroups would submit data using MIPS CQM and QCDR collection type. And approximately 4,862 clinicians and 10 subgroups would submit data using eCQMs collection type. We want to note that we used the same methodologies used in sections V.B.8.e.(4), V.B.8.e.(5) and V.B.8.e.(6) to estimate the quality submission burden for each collection type.

As shown in Table 99, for the clinicians and subgroups submitting data for the MVP quality performance category, we estimate a burden of 26,670 hours (9.44 hr × 2,825 clinicians) at a cost of $2,691,329 (2,825 respondents × 952.68/respondent) for the Medicare Part B claims collection type, 31,163 hours [5.97 hr × 5,220 (5,210 + 10)] at a cost of $3,211,216 (5,220 × 615.18/respondent) for the MIPS CQM and QCDR collection type, and 25,822 hours [5.3 hr × 4,872 (4,862 + 10) respondents] at a cost of $2,662,191 (4,872 × 546.43/respondent) for the eCQM collection types. Start Printed Page 65592 (8) Quality Data Submission via CMS Web Interface The finalized requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). Background In the CY 2021 PFS final rule, we finalized our policy to sunset the CMS Web Interface measures as a collection type/submission type starting with the CY 2022 performance period/2024 MIPS payment year. As a result of this provision, for the CY 2022 performance period/2024 MIPS payment year, we estimated a burden of zero due to our assumption that all Web Interface respondents will alternately utilize either the MIPS CQM and QCDR or eCQM collection types (85 FR 84981).

In section IV.A.3.d.(1)(d) of this rule, we are finalizing to continue the CMS Web Interface measures as a collection type for the CY 2022 performance period/2024 MIPS payment year. Additionally, we are finalizing to sunset the CMS Web Interface measures as a collection type for the CY 2023 performance period/2025 MIPS payment year. For this final rule, we estimate burden for the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. For the CY 2022 performance period/2024 MIPS payment year, we assume that 114 groups will submit quality data via the CMS Web Interface based on the number of groups who completed 100 percent of reporting quality data via the Web Interface in the CY 2019 performance period/2021 MIPS payment year.

This is an increase of 114 groups from the currently approved number of 0 groups provided in the CY 2021 PFS final rule (85 FR 84981 due to the provision to continue with the CMS Web Interface as a collection type for the CY 2022 performance period/2024 MIPS payment year. We estimate that 44,385 clinicians will submit as part of groups via this method, an increase of 44,385 from our currently approved estimate of 0 clinicians. The estimated burden associated with the group submission requirements is the time and effort associated with submitting data on a sample of the organization's beneficiaries that is Start Printed Page 65593 prepopulated in the CMS Web Interface. Our burden estimate for submission includes the time (61 hours and 40 minutes or 61.67 hours) needed for each group to populate data fields in the web interface with information on approximately 248 eligible assigned Medicare beneficiaries and submit the data (we will partially pre-populate the CMS Web Interface with claims data from their Medicare Part A and B beneficiaries).

The patient data either can be manually entered, uploaded into the CMS Web Interface via a standard file format, which can be populated by CEHRT, or submitted directly. Each group must provide data on 248 eligible assigned Medicare beneficiaries (or all eligible assigned Medicare beneficiaries if the pool of eligible assigned beneficiaries is less than 248) for each measure. In aggregate, we estimate a burden for the CY 2022 performance period/2024 MIPS payment year of 7,030 hours (114 groups × 61.67 hr) at a cost of $669,433 (114 groups × $5,872.21/group). For the CY 2023 performance period/2025 MIPS payment year, we are finalizing to revise our estimated burden to zero due to our assumption that with the finalized policy to sunset the CMS Web Interface as a collection type, all Web Interface respondents will alternately utilize either the MIPS CQM and QCDR or eCQM collection types.

Based on the assumptions discussed in this section, Table 100 summarizes the finalized estimated burden for groups submitting to MIPS via the CMS Web Interface. (9) Beneficiary Responses to CAHPS for MIPS Survey This rule is not implementing any new or revised collection of information requirements or burden related to the CAHPS for MIPS survey. The CAHPS for MIPS survey requirements and burden are currently approved by OMB under control number 0938-1222 (CMS-10450). Consequently, we are not making any changes to the CAHPS for MIPS Survey process under that control number.

(10) Group Registration for CMS Web Interface The finalized requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). In the CY 2021 PFS final rule, we finalized to sunset the CMS Web Interface measures as a collection type/submission type starting with the CY 2022 performance period/2024 MIPS payment year. As a result, we estimated that there will be zero hours and $0 burden for group registration for the CMS Web Interface for the CY 2022 performance period/2024 MIPS payment year (85 FR 84984). As discussed in section IV.A.3.d.(1)(d) of this final rule, we are finalizing to continue the CMS Web Interface measures as a collection type for the CY 2022 performance period/2024 MIPS payment year.

We are also finalizing to sunset the CMS Web Interface as a collection type starting with the CY 2023 performance period/2025 MIPS payment year. Start Printed Page 65594 Groups interested in participating in MIPS using the CMS Web Interface for the first time must complete an online registration process. After first time registration, groups will only need to opt out if they are not going to continue to submit via the CMS Web Interface. In Table 102, we estimate that the registration process for groups under MIPS involves approximately 0.25 hours at $95.22/hr for a computer systems analyst (or their equivalent) to register the group.

Because we are finalizing to sunset the CMS Web Interface beginning with the CY 2023 performance period/2025 MIPS payment year, it is possible that fewer groups will elect to register to submit quality data for the first time in the performance year prior to the collection type/submission type no longer being available. However, we currently have no data with which to estimate what the associated reduction may be. Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84983), we continue to assume that approximately 90 groups will elect to use the CMS Web Interface for the first time during the CY 2022 performance period/2025 MIPS payment year based on the estimated number of new registrations during the CY 2021 performance period/2023 MIPS payment year. As shown in Table 102, we estimate a burden of 23 hours (90 new registrations × 0.25 hr/registration) at a cost of $2,190 (22.5 hr × $95.22/hr).

As shown in Table 103, the estimated increase in the number of groups registering for the CMS Web Interface collection type to submit the MIPS data and the estimated increase in burden per respondent results in adjustment to the total time burden of +23 hours (+90 respondents × 0.25 hr/respondent) at a cost of $2,190 for the CY 2022 performance period/2024 MIPS payment year. For the CY 2023 performance period/2025 MIPS payment year, our finalized burden estimate is zero hours and $0. (11) Group Registration for CAHPS for MIPS Survey This rule is not implementing any new or revised collection of information requirements or burden related to the group registration for the CAHPS for MIPS Survey. The CAHPS for MIPS survey requirements and burden are currently approved by OMB under control number 0938-1222 (CMS-10450).

Consequently, we are not making any changes to the CAHPS for MIPS Survey registration process under that control number. F. ICRs Regarding the Call for MIPS Quality Measures This rule is not implementing any new or revised collection of information requirements or burden related to the call for MIPS quality measures. However, outside of the rulemaking process we replaced the existing tool for stakeholders beginning with the 2021 Annual Call for Measures.

As described below, to account for the updated tool (MERIT), we are finalizing to revise our currently approved burden estimates. The updated tool and revised burden will be submitted to OMB under control number 0938-1314 (CMS-10621). Beginning with the 2021 Annual Call for Measures, we replaced the customary Office of the National Coordinator (ONC) Issue Tracking System Jira platform that stakeholders Start Printed Page 65595 used to submit candidate quality measure specifications and all supporting data files for CMS review with the MUC Entry/Review Information Tool (MERIT). For the ONC Issue Tracking System Jira platform used by stakeholders, the approved estimated time for a practice administrator to identify, propose, and link to a quality measure is 0.9 hours and for a clinician to identify, propose, link to quality measure, and complete the Peer Review Journal Article form is 4.6 hours (0.6 hours to identify, propose, and link to quality measure (84 FR 63132) and 4 hours to complete the Peer Review Journal Article Form (84 FR 63133), with a total estimated time of 5.5 hours per quality measure submission.

Based on the stakeholder experience with the updated tool and additional information collected at the time of submission, we estimate that it will add approximately 1.5 hours for the practice administrator at $114.24/hr and 0.5 hours at $217.32/hr for a clinician to identify, propose, and link the quality measure, and reduce approximately 2 hours at $217.32/hr for a clinician to complete the Peer Review Journal Article Form, resulting in a new estimated time of 2.4 hours for a practice administrator and 3.1 hours for a clinician, and an unchanged total estimated time of 5.5 hours per quality measure submission. In order to account for the implementation of the MERIT tool starting with the 2021 Annual Call for Measures, we are revising the estimated time required for a practice administrator to identify, propose, and link to a quality measure to 2.4 hours (from 0.9 hr) and a clinician to identify, propose, link to quality measure, and complete the Peer Review Journal Article Form to 3.1 hours (from 4.6 hr), resulting in a total estimated time of 5.5 hours per quality measure submission. Based on the number of submissions received during the CY 2020 Call for Quality Measures process, we anticipate receiving the same number of 28 submissions during the CY 2021 Call for Quality Measures process (84 FR 63132). Although the total estimated time of 5.5 hours for completing a quality measure submission using the MERIT tool (see Table 104) is the same estimated time as the ONC Issue Tracking System Jira platform, we need to account for the changes to the individual components of the estimated time required by a practice administrator and clinician using the MERIT tool.

Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84984), we estimate an annual burden of 154 hours (28 submissions × 5.5 hr/measure). Thus, we are finalizing to adjust our estimated annual burden from $30,197 (28 submissions × [(0.9 hr × $110.74/hr) + (4.6 hr × $212.78/hr)) to $26,541 (28 measures × [(2.4 hr × $114.24/hr) + (3.1 hr × $217.32/hr)]) a difference of −$4,329 for the CY 2022 performance period/2024 MIPS payment year. As shown in Table 105, using our currently approved burden estimates, the redistribution of the estimated time needed for the clinician and practice administrator as discussed above, we are estimating an adjustment of 0 hours at a cost of −$4,329 for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of $26,541 (28 measures × $947.89/respondent).

Start Printed Page 65596 g. ICRs Regarding Promoting Interoperability Data (§§ 414.1375 and 414.1380) (1) Background For the CY 2022 performance period/2024 MIPS payment year, clinicians and groups can submit Promoting Interoperability data through direct, log in and upload, or log in and attest submission types. With the exception of submitters who elect to use the log in and attest submission type for the Promoting Interoperability performance category, which is not available for the quality performance category, we anticipate that individuals and groups will use the same data submission type for both of these performance categories and that the clinicians, practice managers, and computer systems analysts involved in supporting the quality data submission will also support the Promoting Interoperability data submission process. The following burden estimates show only incremental hours required above and beyond the time already accounted for in the quality data submission process.

Although this analysis assesses burden by performance category and submission type, we emphasize that MIPS is a consolidated program and submission analysis, and decisions are expected to be made for the program as a whole. (2) Reweighting Applications for Promoting Interoperability and Other Performance Categories The finalized requirements and burden associated with this rule's data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53918 through 53919), CY 2019 PFS final rule (83 FR 60011 through 60012), CY 2020 PFS final rule (84 FR 63134 through 63135), and the CY 2021 PFS final rule (85 FR 84984 through 84985) for our previously finalized requirements and burden for reweighting applications for Promoting Interoperability and other performance categories. As established in the CY 2017 and CY 2018 Quality Payment Program final rules, MIPS eligible clinicians who meet the criteria for a significant hardship or other type of exception may submit an application requesting a zero percent weighting for the Promoting Interoperability, quality, cost, and/or improvement activities performance categories under specific circumstances (81 FR 77240 through 77243, 82 FR 53680 through 53686, and 82 FR 53783 through 53785).

Respondents who apply for a reweighting of the quality, cost, and/or improvement activities performance categories have the option of applying for reweighting of the Promoting Interoperability performance category on the same online form. We assume that respondents applying for a reweighting of the Promoting Interoperability performance category due to extreme and uncontrollable circumstances will also request a reweighting of at least one of the other performance categories simultaneously and not submit multiple reweighting applications. Table 106 summarizes the burden for clinicians to apply for reweighting of the Promoting Interoperability performance category to zero percent due to a significant hardship exception or as a result of a decertification of an EHR. Based on the number of reweighting applications received by March, 2021 for the CY 2020 performance period/2022 MIPS payment year, we assume 20,192 respondents (eligible clinicians or groups) will submit a request to reweight the Promoting Interoperability performance category to zero percent due to a significant hardship or EHR decertification and an additional 22,635 respondents will submit a request to reweight one or more of the quality, cost, Promoting Interoperability, or improvement activities performance categories due to an extreme or uncontrollable circumstance.

For the CY 2022 performance period/2024 MIPS payment year, we estimate that a total of 42,797 reweighting applications will be submitted. This is a decrease of 9,302 respondents compared to our currently approved estimate of 52,099 respondents (85 FR 84984). This decrease is likely due to the provision in section IV.A.3.e.(2)(b)(iv)(A) of this rule to automatically reweight the Promoting Interoperability performance category for small practices who previously had to apply for reweighting. For the CY 2020 performance period/2024 MIPS payment year, 13,894 respondents requested reweighting due to significant hardship for small practices.

Similar to the data used to estimate the number of respondents in the CY 2021 PFS final rule, our respondent estimate includes a significant number of applications submitted as a result of a data issue CMS was made aware of and is specific to a single third-party intermediary. While we do not anticipate similar data issues to occur in each performance period, we do believe future similar incidents may occur and are electing to use this data without adjustment to reflect this belief. Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84984), our respondent estimate does not include reweighting Start Printed Page 65597 applications submitted during the extended period ending November 29, 2021 due to the PHE for buy antibiotics, as we do not believe it would be an accurate basis of future estimates for reweighting application submissions. We assume that, out of our total respondent count of 42,797 above, we estimate that 22,605 respondents (eligible clinicians or groups) will submit a request for reweighting the Promoting Interoperability performance category to zero percent due to extreme and uncontrollable circumstances, insufficient internet connectivity, lack of control over the availability of CEHRT, or as a result of a decertification of an EHR.

In the CY 2021 PFS final rule (85 FR 84984) we discussed that, beginning with the CY 2019 performance period/2021 MIPS payment year, APM Entities may submit an extreme and uncontrollable circumstances exception application for all four performance categories and applicable to all MIPS eligible clinicians in the APM Entity group. As discussed in this section of this final rule, due to data limitations and our inability to determine who will use the APP versus the traditional MIPS submission mechanism for the CY 2022 performance period/2024 MIPS payment year, we assume ACO APM Entities will submit data through the APP and non-ACO APM Entities will participate through traditional MIPS, thereby submitting as an individual or group rather than as an entity. Therefore, we limited our analysis to ACOs that were eligible for an exception due to extreme and uncontrollable circumstances during the CY 2020 performance period/2022 MIPS payment year and elected not to report quality data. Based on this data, we estimate that 30 APM Entities will submit an extreme and uncontrollable circumstances exception application for the CY 2022 performance period/2024 MIPS payment year.

Combined with our aforementioned estimate of 42,797 eligible clinicians and groups, the total estimated number of respondents for the CY 2022 performance period/2024 MIPS payment year is 42,827. Consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84984-84985), we continue to estimate it will take 0.25 hours for a computer system analyst to complete and submit the application. As shown in Table 106, we estimate an annual burden of 10,707 hours (42,827 applications × 0.25 hr/application) and $1,019,521 (10,707 hr × $95.22/hr). As shown in Table 107, using our currently approved burden estimates, the decrease in the estimated number of respondents (from 52,099 to 42,827 respondents) results in an adjustment of minus 2,318 hours (9,272 respondents × 0.25 hr/respondent) and minus $220,720 for the CY 2022 performance period/2024 MIPS payment year.

We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 10,707 hours (42,827 respondents × 0.25 hr/respondent) and $1,019,521 (10,707 hours × $95.22/respondents). Start Printed Page 65598 (3) Submitting Promoting Interoperability Data The requirements and burden associated with this rule's data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77509 through 77511), CY 2018 Quality Payment Program final rule (82 FR 53919 through 53920), CY 2019 PFS final rule (83 FR 60013 through 60014), CY 2020 PFS final rule (84 FR 63135 through 63137), and the CY 2021 PFS final rule (85 FR 84985 through 84987) for our previously finalized requirements and burden for submission of data for the Promoting Interoperability performance category. In section IV.A.3.d.(4)(d)(ii) of this final rule, we are finalizing the additional requirement that MIPS eligible clinicians must attest to conducting an annual assessment of the High Priority Guides of the SAFER Guides beginning with the CY 2022 performance period/2024 MIPS payment year.

Clinicians will complete this attestation by checking a box when they submit their Promoting Interoperability performance category data. We estimate that this requirement will add an additional minute to the current estimated time it takes to complete the submission of Promoting Interoperability data. In the CY 2022 PFS proposed rule, we assumed no change in estimates as result of the proposal to modify the Provide Patients Electronic Access to Their Health Information measure to require MIPS eligible clinicians to ensure that patient health information remains available to the patient (or patient-authorized representative) to access indefinitely (86 FR 39509). As discussed in section IV.

Of this final rule, this policy is not being finalized as proposed at this time. As shown in Table 108, based on data from the CY 2019 performance period/2021 MIPS payment year, we estimate that a total of 51,647 respondents consisting of 40,172 individual MIPS eligible clinicians and 11,475 groups and virtual groups will submit Promoting Interoperability data. Since our CY 2021 PFS final rule estimated 53,636 respondents, this represents a decrease of 1,989 respondents (51,647 respondents −53,636 active respondents). We assume that MIPS eligible clinicians previously scored under the APM scoring standard, as described in the CY 2020 PFS final rule, will continue to submit Promoting Interoperability data (84 FR 63006) in a similar way through the APP.

As a result, we do not anticipate any change in burden. Each MIPS eligible clinician in an APM Entity reports data for the Promoting Interoperability performance category through either their group TIN or individual reporting. Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 U.S.C.

1315a, respectively) state that the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models are not subject to the PRA. However, in the CY 2019 PFS final rule, we established that MIPS eligible clinicians who participate in the Shared Savings Program are no longer limited to reporting for the Promoting Interoperability performance category through their ACO participant TIN (83 FR 59822 through 59823). Burden estimates for this final rule assume group TIN-level reporting as we believe this is the most reasonable assumption for the Shared Savings Program, which requires that ACOs include full TINs as ACO participants. Start Printed Page 65599 As discussed in section IV.A.3.b.(2)(c)(ii) of this final rule, we will be introducing subgroup reporting in CY 2023 performance period/2025 MIPS payment year.

As we discussed above in this section of the final rule, we estimate that there will be 20 subgroup submissions in CY 2023 performance period/2025 MIPS payment year, each of which will have burden related to the submission of Promoting Interoperability data. We have included this burden in Table 109. With the inclusion of the additional minute (0.02 hr) to attest to conducting an annual assessment of the High Priority Guides of the SAFER Guides, we are adjusting our estimate of the time required for an individual or group to submit Promoting Interoperability data from 2.67 hours to 2.69 hours (2.67 hr + 0.02 hr). As shown in Table 110, the total burden estimate for submitting data on the specified Promoting Interoperability objectives and measures is estimated to be 138,930 hours (51,647 respondents × 2.69 incremental hours for a computer analyst's time above and beyond the physician, medical and health services manager, and computer system's analyst time required to submit quality data) and $13,228,915 (138,930 hr × $95.22/hr)).

As shown in Table 111, with the introduction of subgroup reporting in CY 2023 performance period/2025 MIPS payment year, the total burden for submitting data on the specified Promoting Interoperability objectives and measures is estimated to be 138,984 hours (51,667 respondents × 2.69 incremental hours for a computer analyst's time above and beyond the physician, medical and health services manager, and computer system's analyst time required to submit quality data) and $13,234,078 (138,984 hr × $95.22/hr)). Start Printed Page 65600 Table 112, using our updated per respondent burden estimate (+0.02 hr/response), the decrease in number of respondents and SAFER guide attestation requirement results in a total adjustment of −4,278 hours at a cost of −$407,351 for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 138,984 hours (51,667 respondents × 2.69 incremental hours for a computer analyst's time above and beyond the physician, medical and health services manager, and computer system's analyst time required to submit quality data) and $13,234,078 (138,984 hours × $95.22/hour). h.

ICRs Regarding the Nomination of Promoting Interoperability (PI) Measures This rule is not implementing any new or revised collection of information requirements or burden related to the nomination of Promoting Interoperability measures. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the process for nomination of Promoting Interoperability measures under that control number. I.

ICR Regarding Improvement Activities Submission (§§ 414.1305, 414.1355, 414.1360, and 414.1365) The finalized requirements and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77511 through 77512), CY 2018 Quality Payment Program final rule (82 FR 53920 through 53922), CY 2019 PFS final rule (83 FR 60015 through 60017), CY 2020 PFS final rule (84 FR 63138 through 63140) and the CY 2021 PFS final rule (85 FR 84987 through 84989) for our previously finalized requirements and burden for submission of data for the improvement activities performance category. In section IV.A.3.d.(3) of this rule, we are finalizing to. (1) Revise group reporting requirements for the 50 percent threshold to address subgroups.

(2) add 7 new improvement activities, modify 15 existing improvement activities, and remove 6 previously adopted improvement activities for the CY 2022 performance period/2024 MIPS payment year and future years. (3) revise the “Drug Cost Transparency to include requirements for use of real-time benefit tools” improvement activity. And (4) add the buy antibiotics “Clinical Data Reporting with or without Clinical Trial” improvement activity for CY 2022 performance period/2024 MIPS payment year and future years. Additionally, we are finalizing to adjust our currently approved burden estimates based on more recent data.

Specifically, we are finalizing to revise § 414.1360(a)(2) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, each improvement activity for which groups and virtual Start Printed Page 65601 groups submit a yes response in accordance with paragraph (a)(1) of this section must be performed by at least 50 percent of the NPIs that are billing under the group's TIN or virtual group's TINs or that are part of the subgroup, as applicable. And the NPIs must perform the same activity during any continuous 90-day period within the same performance year. In section IV.A.3.d.(3)(b) of this rule, we discussed stakeholder requests through the Quality Payment Program help desk to apply the 50 percent threshold to a portion of clinicians in a group. We anticipate that clinicians will find applicable and meaningful activities specific to practice size, specialty, or practice setting.

Therefore, we assume that the provision to apply the 50 percent minimum threshold to clinicians who submit for the improvement activity performance category as part of groups, virtual groups, or choose to participate as subgroups beginning with the CY 2023 performance period/2025 MIPS payment year will not present additional complexity or burden. We do not believe the changes to the improvement activities inventory will impact time or financial burden on stakeholders because MIPS eligible clinicians are still required to submit the same number of activities and the per response time for each activity is uniform. Therefore, we are not adjusting the estimated time of 5 minutes (per response) currently approved for improvement activities submission. As represented in Table 113, based on data from the CY 2019 performance period/2021 MIPS payment year, we estimate that a total of 81,562 respondents consisting of 63,845 individual clinicians and 17,717 groups will submit improvement activities during the CY 2022 performance period/2024 MIPS payment year.

Since our currently approved burden sets out 79,927 respondents, this represents an increase of 1,635 respondents (81,562 respondents−79,927 active respondents). This is an increase of 1,242 individuals and 393 groups from the estimates of 62,603 individuals and 17,324 groups provided in the CY 2021 PFS final rule (85 FR 50362). As discussed in sections V.B.8.e. And V.B.8.g.(3) of this final rule regarding our estimate of clinicians and groups submitting data for the quality and Promoting Interoperability performance categories, we are finalizing to update our estimates for the number of clinicians and groups that will submit improvement activities data based on projections of the number of eligible clinicians that were not QPs or participating in an ACO in the CY 2019 performance period/2021 MIPS payment year but will be QPs in the CY 2022 performance period/2024 MIPS payment year, and will therefore not be required to submit improvement activities data.

As discussed in section IV.A.3.b.(2)(c)(ii) of this final rule, we are finalizing subgroup reporting in the CY 2023 performance period/2025 MIPS payment year. As we discussed in section V.B.8.e.(7)(a) of this final rule, we estimate that there will be 20 subgroup reporters in the CY 2023 performance period/2025 MIPS payment year, each of which will have burden related to the submission of improvement activities. We have included this burden in Table 114. Start Printed Page 65602 Consistent with the CY 2021 PFS final rule, we continue to estimate that the per response time required per individual or group is 5 minutes for a computer system analyst to submit by logging in and manually attesting that certain activities were performed in the form and manner specified by CMS with a set of authenticated credentials (84 FR 63140).

As shown in Table 115, we estimate an annual burden of 6,770 hours (81,562 responses × 0.083 hr) at a cost of $644,639 (6,770 hr × $95.22/hr)) for the CY 2022 performance period/2024 MIPS payment year. As shown in Table 116, with the introduction of subgroup reporting in the CY 2023 performance period/2025 MIPS payment year, we estimate an annual burden of 6,771 hours (81,582 responses × 0.083 hr) and $644,735 (6,771 hr × $95.22/hr). Start Printed Page 65603 As shown in Table 117, using our unchanged currently approved per respondent burden estimate, the increase in the number of respondents results in an adjustment of 109 hours at a cost of $10,379 (109 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 6,771 hours (81,582 responses × 0.083 hr) at a cost of $644,735 (6,771 hr × $95.22/hr).

j. ICRs Regarding the Nomination of Improvement Activities (§ 414.1360) The requirements and burden associated with this rule's data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53922), CY 2019 PFS final rule (83 FR 60017 through 60018), CY 2020 PFS final rule (84 FR 63141) and the CY 2021 PFS final rule (85 FR 84989 through 85 FR 84990) for our previously finalized requirements and information collection burden for the nomination of improvement activities. In section IV.A.3.d.(3)(c)(i)(B) of this rule, we are finalizing.

(1) To revise the required criteria for improvement activity nominations received through the Annual Call for Activities. (2) changes to the timeline for improvement activities nomination during a PHE. And (3) to suspend activities that become obsolete or impacted by clinical practice guideline changes from the program when this occurrence happens outside of the rulemaking process. In section IV.A.3.d.(3)(c)(i)(B)(cc) of this rule, we are finalizing 2 new criteria that beginning with the CY 2022 Annual Call for Activities MIPS improvement activities.

(1) Should not duplicate other improvement activities in the Inventory. And (2) should drive improvements that go beyond purely common clinical practices. Additionally, we are finalizing to increase the number of criteria stakeholders are required to meet when submitting an activity provision from a minimum of 1 to all 8 criteria, which includes the two new provision criteria. We believe that this provision will provide clearer guidance to stakeholders when submitting a nomination for an improvement activity.

In the CY 2021 PFS final rule, we estimated that it would require 0.6 hours for a medical and health services manager or equivalent and 0.4 hours for a physician to link the nominated improvement activity to existing and related cost and quality measures (85 FR 84989). Given that our current approved estimated time per respondent to nominate an improvement activity is 3 hours (1.8 hours for a medical and health services manager or equivalent and 1.2 hours for a physician), we assume that the new requirement to meet all 8 criteria will require approximately 1 hour at $114.24/hr for a medical and health services manager to identify and submit an activity and 0.4 hours at a rate of $217.32/hr for a clinician to review each activity. Combined with our currently approved burden estimate, we are finalizing to revise our estimate to 2.8 hours at $114.24/hr for a medical and health services manager or equivalent and 1.6 hours at $217.32/hr for a physician to nominate an improvement activity. This represents a change of +1 Start Printed Page 65604 hours (2.8 hr − 1.8 hr) for a medical and health services manager or equivalent and +0.4 hours (2 hr − 1.6 hr) for a physician and an overall increase of 1.4 hours.

We considered whether we should double our estimates for nomination of an improvement activity to 6 hours. Since only 2 of the required 8 criteria are new, we assume that stakeholders are familiar with the existing criteria and will not need additional time to review but will need the additional time to verify and confirm if the considered activity meets all the 8 criteria. We solicited comment on our estimate to revise the time for nomination of an improvement activity to 4.4 hours and if there are additional burden implications that we should consider for above provisions to revise the criteria. We did not receive public comments on the proposed burden estimates for this information collection.

We are finalizing as proposed. The burden estimates have not been updated from the CY 2021 PFS proposed rule (86 FR 39514 through 39516). In the CY 2021 PFS final rule, we finalized an exception stating that during the PHE, stakeholders can nominate improvement activities outside of the established Annual Call for Activities timeframe (85 FR 84989). Instead of only accepting nominations and modifications submitted February 1st through July 1 each year, we would accept nominations for the duration of the PHE as long as the improvement activity is still relevant.

No other aspects of the Annual Call for Activities process would be affected (for example, criteria for nominating improvement activities, considerations for selection of improvement activities, or weighting policies would all still apply). In section IV.A.3.d.(3)(c)(i)(B)(aa) of this rule, we are finalizing to clarify that in order to implement a new improvement activity for a PHE during the same year as the nomination, the nomination will need to be received no later than January 5th of the nomination year to be included in a rule for notice-and-comment rulemaking during that fiscal or calendar year, a necessary precursor to implementation if it were to be finalized, as described above. We believe this provision will not affect our currently approved burden estimates since we assume that the number of nominations will not change, but it will make an activity available for reporting to clinicians in the same performance year it was intended to be implemented. Similar to our assumptions in the CY 2021 PFS final rule (85 FR 84989), we expect additional nominations may be received as a result of this change.

However, we do not have any data with which to estimate what the additional number may be. As a result, we are not making any changes our currently approved burden estimate. In section IV.A.3.d.(3)(c)(i)(C)(aa) of this rule, we are finalizing that beginning with the CY 2022 performance period/2024 MIPS payment year, for each improvement activity that is in the Inventory, if applicable, and impacted by significant changes or errors prior to the applicable data submission deadline, it will be removed from the program as soon as possible. In the CY 2020 PFS final rule (84 FR 62988 through 62990), we finalized the factors for consideration in removing improvement activities.

Following the publication of the CY 2021 PFS proposed rule, the improvement activities team became aware that clinicians could no longer complete the activity from April 1 through December 31, 2020, because one of the improvement activities in the Inventory had expired on March 31, 2020. We do not anticipate any burden for stakeholders because of the above provision as described, the policy does not change requirements for the nomination of improvement activities. This provision will help avoid stakeholder confusion and ensure the accuracy of the available activities in the Inventory. Therefore, we are not making any changes to our estimated burden due to the above policy.

Additionally, consistent with our assumptions in the CY 2021 PFS final rule (85 FR 84990) we continue to use our currently approved assumption that we will receive 31 nominations of new or modified activities which will be evaluated for the Improvement Activities Under Consideration (IAUC) list for possible inclusion in the CY 2023 Improvement Activities Inventory as we believe this estimate is more realistic than basing our estimate on the number of nominations received during the 2021 Annual Call for Activities. As shown in Table 118, accounting for the change in burden per respondent estimate due to the provision to require all the 8 criteria for nomination of an improvement activity as described above in this section, we are adjusting our estimated annual information collection burden to 136 hours (31 nominations × 4.4 hr/nomination) at a cost of $20,695 (31 × [(2.8 hr × $114.24/hr) + (1.6 hr × $217.32/hr)]). Start Printed Page 65605 As shown in Table 119, using our unchanged estimate of the number of activities nominated, the increase in the burden per nomination results in a change of 43 hours (31 nominations × 1.4 hr/nomination) at a cost of $6,492 (31 activities × [(1 hr × $114.24/hr) + (0.4 hr × $217.32/hr)]) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 136 hours (31 nominations × 4.4 hr) at a cost of $20,695 (31 × [(2.8 hr × $114.24/hr) + (1.6 hr × $217.32/hr)]).

k. Nomination of MVPs This rule is not implementing any new or revised collection of information requirements or burden related to the nomination of MVPs for inclusion in the Quality Payment Program. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the MVP nomination process under that control number.

L. ICRs Regarding the Cost Performance Category (§ 414.1350) The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process (OMB control number 0938-1197. CMS-1500 and CMS-1490S) is used to collect data on cost measures from MIPS eligible clinicians.

MIPS eligible clinicians are not required to provide any documentation by CD or hardcopy. Moreover, the policies in this rule do not result in the need to add or revise or delete any claims data fields. Consequently, we are not making any changes to this information collection under that control number. M.

ICRs Regarding Partial QP Elections (§§ 414.1310(b) and 414.1430) This rule is not implementing any new or revised collection of information requirements related to the Partial QP Elections to participate in MIPS as a MIPS eligible clinician. However, we are finalizing to adjust our currently approved burden estimates based on updated projections for the CY 2022 performance period/2024 MIPS payment year. The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). As shown in Table 120, based on our predictive QP analysis for the 2022 QP performance period/2024 MIPS payment year, which accounts for historical response rates in the CY 2020 performance period/2022 MIPS payment year, we are revising our estimate that 150 APM Entities and 100 eligible clinicians (representing approximately 9,000 Partial QPs) will make the election to participate as a Partial QP in MIPS, a total of 250 elections which is a decrease of 50 from the 300 elections that are currently approved by OMB under the aforementioned control number.

We continue to estimate it will take the APM Entity representative or eligible clinician 15 minutes (0.25 hr) to make this election. In aggregate, we are revising our estimated annual burden to 63 hours (250 respondents × 0.25 hr/election) and $5,999 (63 hr × $95.22/hr). Start Printed Page 65606 As shown in Table 121, using our unchanged currently approved per respondent burden estimate (85 FR 84991), the decrease in the number of Partial QP elections results in an adjustment of 12.5 hours (−50 elections × 0.25 hr) at a cost of −$1,191 (−12.5 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 63 hours (250 respondents × 0.25 hr/election) at a cost of $5,999 (63 hr × $95.22/hr).

n. ICRs Regarding Other Payer Advanced APM Determinations. Payer-Initiated Process (§ 414.1445) and Eligible Clinician Initiated Process (§ 414.1445) The following burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). (1) Payer Initiated Process (§ 414.1445) This rule is not implementing any new or revised collection of information requirements related to the Payer-Initiated Process.

However, we are adjusting our currently approved burden estimates based on updated projections for the CY 2022 performance period/2024 MIPS payment year. As shown in Table 122, based on the actual number of requests received in the 2020 QP performance period, we are revising our estimate that for the 2023 QP performance period, 15 payer-initiated requests for Other Payer Advanced APM determinations will be submitted (6 Medicaid payers, 6 Medicare Advantage Organizations, and 3 remaining other payers), a decrease of 65 from the 80 total requests currently approved by OMB under the aforementioned control number. We continue to estimate it will take 10 hours for a computer system analyst per arrangement submission. We are revising our estimated annual burden to 150 hours (15 submissions × 10 hr/submission) and $14,283 (150 hr × $95.22/hr).

As shown in Table 123, using our unchanged currently approved per respondent burden estimate (85 FR 84992), the decrease in the number of payer-initiated requests from 800 to 150 results in an adjustment of −650 hours (−65 requests × 10 hr) at a cost of −$61,893 (−650 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 150 hours (15 requests × 10 hr) at a cost of $14,283 (150 hr × $95.22/hr). Start Printed Page 65607 (2) Eligible Clinician Initiated Process (§ 414.1445) This rule is not implementing any new or revised collection of information requirements or burden related to the Eligible-Clinician Initiated Process. As described below, we are adjusting our currently approved burden estimates based on updated projections for the CY 2022 performance period/2024 MIPS payment year.

As mentioned above, the new and adjusted burden will be submitted to OMB for approval. As shown in Table 124, based on the actual number of requests received in the 2020 QP performance period, we estimate that in CY 2022 for the 2023 QP performance period, 15 Eligible-Clinician Initiated request for Other Payer Advanced APM determinations will be submitted, a decrease of 135 from the 150 total requests currently approved by OMB under the aforementioned control number. We continue to estimate it will take 10 hours for a computer system analyst per arrangement submission. We are adjusting our estimated annual burden to 150 hours (15 submissions × 10 hr/submission) and $14,283 (150 hr × $95.22/hr).

As shown in Table 125, using our unchanged currently approved per respondent burden estimate (85 FR 84993), the decrease in the number of eligible clinician-initiated requests from 150 to 15 results in an adjustment of −1,350 hours (−135 requests × 10 hr) at a cost of −$128,547 (−1,350 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 150 hours (15 submissions × 10 hr/submission) at a cost of $14,283 (150 hr × $95.22/hr). Start Printed Page 65608 (3) Submission of Data for QP Determinations Under the All-Payer Combination Option (§ 414.1440) This rule is not implementing any new or revised collection of information requirements related to the Submission of Data for QP Determinations under the All-Payer Combination Option. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621).

Consequently, we are not making any changes under that control number. O. ICRs Regarding Voluntary Participants Election To Opt-Out of Performance Data Display on Physician Compare (§ 414.1395) This rule is not implementing any new or revised collection of information requirements related to the election by voluntary participants to opt-out of public reporting on Physician Compare. As described below, we are adjusting our currently approved burden estimates based on data from the CY 2019 performance period/2021 MIPS payment year.

The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53924 through 53925), CY 2019 PFS final rule (83 FR 60022), CY 2020 PFS final rule (84 FR 63145 through 63146) and the CY 2021 PFS final rule (85 FR 84993) for our previously finalized requirements and burden for voluntary participants to opt-out of public reporting on Physician Compare. In the CY 2021 PFS final rule (85 FR 84993), we estimated that 10 percent of the clinicians and groups who voluntarily participate in MIPS would opt out of public reporting. Based on the number of opt-out eligible clinicians that chose to opt-out of public reporting in the CY 2019 performance period/2021 MIPS payment year, we are revising our estimates.

We anticipate that 0.1 percent of the total clinicians and groups who will voluntarily participate in the CY 2022 performance period/2024 MIPS payment year will also elect not to participate in public reporting. This results in a total of 38 (0.001 × 37,934 voluntary MIPS participants) clinicians and groups, a decrease of 3,448 from the currently approved estimate of 3,486. Voluntary MIPS participants are clinicians that are not QPs and are expected to be excluded from MIPS after applying the eligibility requirements set out in the CY 2019 PFS final rule but have elected to submit data to MIPS. As discussed in the RIA section of the CY 2019 PFS final rule, we continue to estimate that 33 percent of clinicians that exceed one (1) of the low-volume criteria, but not all three (3), will elect to opt-in to MIPS, become MIPS eligible, and no longer be considered a voluntary reporter (83 FR 60050).

Table 126 shows that for these voluntary participants, we continue to estimate it will take 0.25 hours for a computer system analyst to submit a request to opt-out. In aggregate, we estimate an annual burden of 10 hours (38 requests × 0.25 hr/request) and $952 (10 hr × $95.22/hr). Start Printed Page 65609 As shown in Table 127, using our unchanged currently approved per respondent burden estimate, the decrease of 3,448 opt outs by voluntary participants results in an adjustment of −862 hours (−3,448 requests × 0.25 hr) at a cost of $−82,079 (−862 hr × $95.22/hr) for the CY 2022 performance period/2024 MIPS payment year. We are setting forth new burden estimates for the CY 2023 performance period/2025 MIPS payment year, which results in an increase of 10 hours (38 requests × 0.25 hr/request) at a cost of $952 (10 hr × $95.22/hr).

p. Summary of Annual Quality Payment Program Burden Estimates Table 128 summarizes this final rule's total burden estimates for the Quality Payment Program for the CY 2021, CY 2022 and CY 2023 performance periods/2023, 2024, and 2025 MIPS payment years. As discussed earlier, for this final rule, we are subtracting the currently approved burden for the CY 2021 performance period/2023 MIPS payment year. As shown in table 128, this represents a decrease in burden of 1,479,672 hours and $144,576,960.

In the CY 2021 PFS final rule, the total estimated burden for the CY 2022 MIPS performance period/2024 MIPS payment year was 1,473,741 hours at a cost of $144,034,968 (85 FR 84994). Accounting for updated wage rates and the subset of all Quality Payment Program ICRs discussed in this rule compared to the CY 2021 PFS final rule, the total estimated annual burden of continuing policies and information set forth in the CY 2021 PFS final rule into the CY 2022 performance period/2024 MIPS payment year is 1,468,566 hours at a cost of $148,078,846. These represent a decrease of 5,175 hours and an increase of $4,043,878. To understand the burden implications of the policies in this rule, we provide an estimate of the total burden associated with continuing the policies and information collections set forth in the CY 2021 PFS final rule into the CY 2022 performance period/2024 MIPS payment year.

This burden estimate of 1,424,586 hours at a cost of $143,651,994 reflects the availability of more accurate data to account for all potential respondents and submissions across all the performance categories and more accurately reflect the exclusion of QPs from all MIPS performance categories, a decrease of 43,980 hours and $4,426,813. This burden estimate is lower than the burden approved for information collection related to the CY 2021 PFS final rule due to updated data and assumptions. Our total burden estimate for the CY 2022 performance period/2024 MIPS payment year is 1,428,391 hours and $144,014,757, which represents a decrease of 40,175 hours and $4,068,418 from the CY 2021 PFS final rule. The difference of +3,805 hours (43,980 hours−40,175 hours) and +$358,395 ($4,426,813−$4,068,418) between this estimate and the total burden shown in Table 128 is the increase in burden associated with impacts of the policies for the CY 2022 performance period/2024 MIPS payment year, which includes the re-introduction of the CMS Web Interface measures as a collection type/submission type.

Table 128 also offers a comparison between the total currently approved estimated burden from the CY 2021 PFS final rule and our estimated burden for the CY 2023 performance period/2025 MIPS payment year. As discussed above, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. Our total burden estimate for the CY 2023 MIPS performance period/2025 MIPS payment year is 1,383,049 hours and $139,501,770. We have included Table 128 to assist in understanding these differences.

Note that the difference between the burden estimates for the CY 2022 and 2023 MIPS performance periods/2024 and 2025 MIPS payment years is entirely due to the policies to introduce MVP and subgroup reporting and sunset the CMS Web Interface measures as a collection type/submission type beginning in the CY 2023 MIPS performance period/2025 MIPS payment year. Start Printed Page 65610 Start Printed Page 65611 Start Printed Page 65612 Start Printed Page 65613 Table 131 represents averages for the estimated changes in burden for the CY 2021, 2022, and 2023 performance periods/2023, 2024, and 2025 MIPS payment years. Table 132 provides the reasons for changes in the estimated burden for information collections in the Quality Payment Program segment of this final rule. We have divided the reasons for our change in burden into those related to new policies and those related to adjustments in burden from continued Quality Payment Program Year 5 policies that reflect updated data and revised methods.

Start Printed Page 65614 Start Printed Page 65615 Start Printed Page 65616 C. Summary of Annual Burden Estimates for Changes Start Printed Page 65617 VI. Regulatory Impact Analysis A. Statement of Need In this final rule, we are finalizing payment and policy changes under the Medicare PFS and required statutory changes under the Consolidated Appropriations Act, 2021 and sections 2003 and 2005 of the SUPPORT for Patients and Communities Act of 2018.

We also are finalizing changes to payment policy and other related policies for Medicare Part B. In addition, this final rule will make modest revisions to certain Medicare provider and supplier enrollment regulatory provisions and add already existing provider and supplier requirements pertaining to prepayment and post-payment review activities. This final rule is necessary to make policy changes under Medicare FFS and to address various provider and supplier enrollment issues. Therefore, we included a detailed Regulatory Impact Analysis (RIA) to assess all costs and benefits of available regulatory alternatives and explain the selection of these regulatory approaches that we believe adhere to statutory requirements and, to the extent feasible, maximize net benefits B.

Overall Impact We examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub.

L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

An RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimated, as discussed in this section, that the PFS provisions included in this final rule will redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we prepared an RIA that, to the best of our ability, presents the costs and benefits of the rulemaking.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, practitioners and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details, see the SBA's website at http://www.sba.gov/​content/​table-small-business-size-standards (refer to the 620000 series)).

Individuals and States are not included in the definition of a small entity. The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. Start Printed Page 65618 The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.

Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this final rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. Medicare does not pay rural hospitals for their services under the PFS. Rather, the PFS pays for physicians' services, which can be furnished by physicians and NPPs in a variety of settings, including rural hospitals.

We did not prepare an analysis for section 1102(b) of the Act because we determined, and the Secretary certified, that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on State, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158 million. This final rule will impose no mandates on State, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. Since this final rule does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. We prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this final rule.

Details the costs and benefits of the rule. Analyzes alternatives. And presents the measures we will use to minimize the burden on small entities. As indicated elsewhere in this final rule, we discussed a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services, and to implement provisions of the statute.

We provide information for each of the policy changes in the relevant sections of this final rule. We are unaware of any relevant Federal rules that duplicate, overlap, or conflict with this final rule. The relevant sections of this final rule contain a description of significant alternatives if applicable. C.

Changes in Relative Value Unit (RVU) Impacts 1. Resource-Based Work, PE, and MP RVUs Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve BN. Our estimates of changes in Medicare expenditures for PFS services compared payment rates for CY 2021 with payment rates for CY 2022 using CY 2020 Medicare utilization.

The payment impacts described in this final rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and will depend on the mix of services he or she furnishes. The average percentage change in total revenues will be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and non-Medicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems.

For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are paid under the Clinical Laboratory Fee Schedule (CLFS). The PFS update adjustment factor for CY 2022, as specified in section 1848(d)(19) of the Act, is 0.00 percent before applying other adjustments. In addition, section 101 of Division N of the CAA provided a 3.75 percent increase in PFS payment amounts for services furnished on or after January 1, 2021, and before January 1, 2022 and required that the increase shall not be taken into account in determining PFS payment rates for subsequent years. The expiration of this 3.75 percent increase in payment amounts will result in the CY 2022 conversion factor being calculated as though the 3.75 percent increase for the CY 2021 conversion factor had never been applied.

To calculate the CY 2022 PFS conversion factor (CF), we took the CY 2021 conversion factor without the 1-year 3.75 percent increase provided by the CAA and multiplied it by the BN adjustment required as described in the preceding paragraphs. We estimate the CY 2022 PFS CF to be 33.5983 which reflects the BN adjustment under section 1848(c)(2)(B)(ii)(II) of the Act, the 0.00 percent update adjustment factor specified under section 1848(d)(19) of the Act, and the expiration of the 3.75 percent increase for services furnished in CY 2021, as provided in the CAA. We estimate the CY 2022 anesthesia CF to be 20.9343 which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments. Start Printed Page 65619 Table 136 shows the payment impact of the policies contained in this final rule on PFS services.

To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues will be different from those shown in Table 136 (CY 2022 PFS Estimated Impact on Total Allowed Charges by Specialty). The following is an explanation of the information represented in Table 136. • Column A (Specialty). Identifies the specialty for which data are shown.

• Column B (Allowed Charges). The aggregate estimated PFS allowed charges for the specialty based on CY 2020 utilization and CY 2021 rates. That is, allowed charges are the PFS amounts for covered services and include coinsurance and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty.

• Column C (Impact of Work RVU Changes). This column shows the estimated CY 2022 impact on total allowed charges of the changes in the work RVUs, including the impact of changes due to potentially misvalued codes. • Column D (Impact of PE RVU Changes). This column shows the estimated CY 2022 impact on total allowed charges of the changes in the PE RVUs.

• Column E (Impact of MP RVU Changes). This column shows the estimated CY 2022 impact on total allowed charges of the changes in the MP RVUs. • Column F (Combined Impact). This column shows the estimated CY 2022 combined impact on total allowed charges of all the changes in the previous columns.

Column F may not equal the sum of columns C, D, and E due to rounding. Start Printed Page 65620 Start Printed Page 65621 2. CY 2021 PFS Impact Discussion a. Changes in RVUs The most widespread specialty impacts of the RVU changes are generally related to the changes to RVUs for specific services resulting from the misvalued code initiative, including RVUs for new and revised codes.

The estimated impacts for some specialties, including diagnostic testing facilities, portable x-ray, podiatry, hand surgery, and geriatrics, reflect increases relative to other physician specialties. These increases can be attributed largely to the update to clinical labor pricing as the services that these specialties furnish involve a higher proportion of clinical labor cost that is reflected in their PE RVUs. These increases are also due to increases in value for particular services after considering the recommendations from the American Medical Association (AMA)'s Relative Value Scale Update Committee (RUC), and CMS review and increased payments resulting from updates to supply and equipment pricing. The estimated impacts for several specialties, including interventional radiology, vascular surgery, radiation oncology, and cardiology, reflect decreases in payments relative to payment to other physician specialties which are largely the result of the redistributive effects of the clinical labor pricing update.

The services furnished by these specialties involve proportionally higher supply or equipment item costs, and therefore are affected negatively by the updates to clinical labor pricing. Since PE is budget neutralized within itself, increased pricing for clinical labor holds a corresponding relative decrease for other components of PE such as supplies and equipment. These decreases are also due to the revaluation of individual procedures based on reviews by the AMA RUC and CMS, as well as decreases resulting from the continued phase-in implementation of the previously finalized updates to supply and equipment pricing. The estimated impacts also reflect decreases due to continued implementation of previously finalized code-level reductions that are being phased in over several years.

For independent laboratories, it is important to note that these entities receive approximately 83 percent of their Medicare revenues from services that are paid under the CLFS. As a result, the estimated 2 percent decrease for CY 2021 is only applicable to approximately 17 percent of the Medicare payment to these entities. We often receive comments regarding the changes in RVUs displayed on the specialty impact table (Table 136), including comments received in response to the valuations. We remind stakeholders that although the estimated impacts are displayed at the specialty level, typically the changes are driven by the valuation of a relatively small number of new and/or potentially misvalued codes.

The percentage changes in Table 136 are based upon aggregate estimated PFS allowed charges summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty, and compared to the same summed total from the previous calendar year. Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty. To illustrate how impacts can vary within specialties, we created a public use file that models the expected percentage change in total RVUs per practitioner. Using CY 2020 utilization data, Total RVUs change between −1 percent and 1 percent for more than 90 percent of practitioners, representing more than 81 percent of the changes in Total RVUs for all practitioners, with variation by specialty.

Many specialties, such as chiropractic, clinical social worker, family practice, internal medicine and emergency medicine, exhibit little variation in changes in total RVUs per practitioner. For these specialties, more than 90 percent of these practitioners will experience a change in Total RVUs between −1 percent and 1 percent. Other specialties exhibit more variation in changes in total RVUs per practitioner. For example, for diagnostic testing facilities, 39 percent of IDTFs will experience a 2 percent or more decrease in Total RVUs, but these suppliers represent only 33 percent of Total RVUs for this specialty.

Meanwhile, one percent of IDTFs will experience 10 percent or more increases in Total RVUs and these suppliers account for 33 percent of Total RVUs for this specialty. We also note the code level RVU changes are available in the Addendum B public use file that we make available with each rule. Many commenters requested that CMS maintain the 3.75 percent increase in PFS payment amounts that was specified under section 101 of the CAA for services furnished during CY 2021. We remind commenters that this increase was provided through a time-limited amendment to the statute, which CMS does not have legal authority to alter.

The expiration of this 3.75 percent increase in payment amounts will result in the CY 2022 conversion factor being calculated as though the 3.75 percent increase for the CY 2021 conversion factor had never been applied. Several commenters requested clarification regarding whether the specialty impacts displayed in Table 136 reflected the expiration of the 3.75 percent CAA provision for CY 2022. We can clarify for the commenters that the specialty impacts displayed in Table 136 reflect changes that take place within the pool of total RVUs. The specialty impacts table therefore includes any changes in spending which result from finalized policies within BN (such as the revaluation of E/M codes in CY 2021 or the clinical labor Start Printed Page 65622 pricing update in CY 2022) but does not include any changes in spending which result from finalized policies outside of BN.

The expiration of the 3.75 percent CAA provision for CY 2022 is a statutory change that takes place outside of BN, and therefore, is not captured in the specialty impacts displayed in Table 136. b. Impact Column F of Table 136 displays the estimated CY 2022 impact on total allowed charges, by specialty, of all the RVU changes. A table showing the estimated impact of all of the changes on total payments for selected high volume procedures is available under “downloads” on the CY 2022 PFS final rule website at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysisianFeeSched/​.

We selected these procedures for sake of illustration from among the procedures most commonly furnished by a broad spectrum of specialties. The change in both facility rates and the nonfacility rates are shown. For an explanation of facility and nonfacility PE, we refer readers to Addendum A on the CMS website at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysisianFeeSched/​. D.

Effect of Changes Related to Telehealth Services Before the PHE for buy antibiotics, approximately 15,000 FFS Medicare beneficiaries received a Medicare telemedicine service each week. According to a report prepared by the Assistant Secretary for Planning and Evaluation (ASPE),[] in the last week of April 2020, nearly 1.7 million beneficiaries received telehealth services. By April 2020, nearly half of all Medicare primary care visits were telehealth encounters, a level consistent with health care encounters more broadly. There are approximately 271 services currently included on the list of Medicare telehealth services, including more than 165 that were added on a temporary basis during the PHE for buy antibiotics (including service categories such as emergency department visits, initial inpatient and nursing facility visits, and discharge day management services) that are covered through the end of the PHE.

Preliminary data show that between mid-March and mid-October 2020, over 24.5 million out of 63 million Medicare beneficiaries and enrollees have received a Medicare telemedicine service during the PHE. It is important to note that preliminary data reflect that the largest increases in services furnished via telehealth communications systems, by beneficiary access/volume, were for services that were already on the Medicare telehealth services list before the PHE. As discussed in section II.D. Of this final rule, we are finalizing our proposal to amend the regulatory definition of interactive telecommunications system for purposes of Medicare telehealth services to include audio-only communication technology under certain circumstances for mental health services furnished to established patients in their homes.

We anticipate that this policy will increase utilization of Medicare telehealth mental health services relative to utilization that will occur without the change. The estimated cost impact on overall Medicare services is unclear, though these changes will largely maintain current policies and access to the specific mental health services that are available to beneficiaries during the PHE. By requiring that a modifier be appended to the claim to identify that the service was furnished via audio-only communication technology, we will be able to closely monitor utilization and address any potential concerns regarding overutilization through future rulemaking. Comment.

Commenters were very supportive of our proposal to allow for mental health services to be furnished using audio-only communications technology. A few commenters, while supportive of the use of audio-only communications technology during the PHE, urged CMS to further study and evaluate the safety and effectiveness of the audio-only modality for various levels of care and treatments to determine appropriateness of continuing payment after the PHE expires. Commenters supported the proposal to create a service-level modifier to identify mental health telehealth visits “furnished to a beneficiary in their home using audio-only communications technology.” Response. We are finalizing creation of a service-level modifier that would identify mental health telehealth services furnished to a beneficiary in their home using audio-only communications technology.

We anticipate that our policy of allowing mental health services to be furnished using audio-only communications technology this will have a positive impact on access to care for mental health services and contribute to overall health equity. Section 123 of the CAA removed the geographic and site of service restrictions for telehealth services furnished for the purpose of diagnosis, evaluation, or treatment of a mental health disorder, and required as a condition of payment for these telehealth services furnished in the patient's home that a physician or practitioner furnish an in-person, non-telehealth service to a beneficiary within 6 months prior to the first time the physician or practitioner furnishes a telehealth service to the beneficiary, and thereafter, at intervals as specified by the Secretary. Section 125 of the CAA created a new Medicare provider type—the rural emergency hospital, effective beginning in CY 2023—and added rural emergency hospitals to the list of eligible telehealth originating sites at section 1834(m)(4)(C)(ii) of the Act. As discussed in section II.D.

Of this final rule, we will require, as a condition of payment for a telehealth service described in section 1834(m)(7) of the Act, that the billing physician or practitioner must have furnished an in-person, non-telehealth service to the beneficiary within the 6-month period before the date of service of a telehealth service as specified in section 1834(m)(7)(B)(i) of the Act, and proposed in this final rule that an in-person, non-telehealth service to the beneficiary must occur at 12-month intervals for subsequent care, with the possibility for exceptions that must be documented by the practitioner in the medical record. We solicited comment on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service, and we are finalizing a policy to allow this. Given that the removal of the geographic and site of service restrictions for telehealth will expand the availability of mental health services, we anticipate that utilization of these mental health services will be comparable to observed utilization for mental health services during the buy antibiotics PHE. We received public comments on whether the required in-person, non-telehealth service could also be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service.

The following is a summary of the comments we received and our responses. Comment. Many commenters agreed with the alternative policy we considered to allow the required in- Start Printed Page 65623 person, non-telehealth service to be furnished by another physician or practitioner of the same specialty and subspecialty in the same group as the practitioner who furnishes the mental health telehealth services to the beneficiary if the practitioner who furnishes the telehealth services is unavailable. Response.

We are adopting the alternative policy discussed in the proposed rule to allow a clinician's colleague in the same subspecialty in the same group to furnish the in-person, non-telehealth service to the beneficiary if the original practitioner is unavailable. This is also consistent with longstanding policy, which defines an established patient as an individual who receives professional services from the physician/NPP or another physician of the same specialty and subspecialty who belongs to the same group within the previous 3 years, for purposes of billing for E/M services. While the language in the CAA states that the physician or practitioner furnishing the in-person, non-telehealth service must be the same person as the practitioner furnishing the telehealth service, we believe this policy would be consistent with statutory requirements, because we have historically treated the billing practitioner and other practitioners of the same specialty or subspecialty in the same group as if they were the same individual. After consideration of public comments, we are finalizing our alternative policy that a practitioner in the same subspecialty and the same group may furnish the in-person, non-telehealth service to the same beneficiary, if the original practitioner is unavailable.

With regard to our policy to retain all services added to the Medicare telehealth services list on a Category 3 basis until the end of CY 2023, we believe the establishment of this certain end date will provide clarity to the stakeholder community but will have a negligible impact on PFS expenditures. For example, services that have already been added to the permanent telehealth services list are furnished via telehealth, on average, less than 0.1 percent of the time they are reported. Further, although data is still being collected, in our initial review of the data, we have not noticed an increase in the overall utilization trend for these services suggesting that practitioners may be furnishing these services via telehealth as replacement for in person encounters. The statutory conditions on payment for Medicare telehealth services under section 1834(m) of the Act, such as the originating site requirements related to geographic location and site of service, have limited increases in telehealth service utilization outside of the PHE for buy antibiotics.

However, we believe there is value in allowing physicians to furnish services added to the Medicare telehealth services list on a Category 3 basis, and for patients to receive broader access to this care through telehealth, through the end of CY 2023 in order to ease the transition from the PHE. Additionally, for services added to the Medicare telehealth list on a Category 3 basis, outside of the circumstances of the PHE for buy antibiotics, all of the statutory restrictions under section 1834(m) of the Act will also apply to these services. Therefore, we do not anticipate any significant increase in utilization. E.

Effect of Changes Related to Services Furnished in Whole or in Part by PTAs and OTAs As discussed in section II.H.1., we are finalizing proposed revisions to the current de minimis policy for services furnished in whole or in part by PTAs/OTAs that we finalized in CY 2020 PFS final rule (84 FR 62702 through 62708) under which the CQ or CO modifier applies when the PTA or OTA furnished more than 10 percent of a service or a 15-minute unit of service. Beginning January 1, 2022, CMS will apply a 15 percent reduction to the payment amount for a physical or occupational therapy service when the CQ/CO modifier is applied to the service. Our revision to the de minimis policy will allow the PT/OT to bill without the CQ/CO modifier for the final 15-minute unit (in a multi-unit billing scenario) when the PT/OT meets the billing threshold of 8 minutes, which is when the minutes are greater than the midpoint (7.5 minutes) of the 15-minute unit, regardless of any minutes provided by the PTA/OTA for that final unit. Under the policy we are finalizing, the PT/OT services will not be discounted as the result of any “left-over” minutes provided by the PTA/OTA when the therapist provides enough minutes on his or her own to meet the billing threshold amount.

In these scenarios, the PTA's/OTA's minutes are considered immaterial for the purposes of billing. For example, if the PT/OT provided 23 minutes of a 15-minute service and the PTA/OTA provided another 20 minutes of the same service—three units of service can be billed for the 43 total minutes (38 minutes through 52 minutes). Here, one full 15-minute unit of service is billed without the CQ/CO modifier for the PT/OT service with 8 minutes remaining, and one full unit of service is billed with the CQ/CO modifier for the service provided by the PTA/OTA with 5 minutes remaining. Under the policy, the third unit is billed without the CQ/CO modifier because the 8 minutes provided by the PT/OT meets the billing threshold amount.

However, under our current de minimis policy, the 5 minutes provided by the PTA/OTA is more than 10 percent (it is 38 percent of the total service−PTA/OTA minutes divided by the total of PTA/OTA + PT/OT minutes. 5 divided by 13 = 38 percent) meaning the CQ/CO modifier is applied to the third and final unit of service. Under our current de minimis policy, under which the CQ/CO modifier is applied whenever the PTA/OTA provides more than 10 percent of a service whether or not the PT/OT furnishes enough of the service to bill for it without the portion furnished by the PTA/OTA, stakeholders have expressed concern that the PT/OT has a financial incentive not to have the PTA/OTA provide any additional minutes, regardless of the individual patient's needs, when those minutes of service lead to a reduced payment for a unit of a service. There may be a cost implication to this policy as fewer billing scenarios may result in application of the CQ/CO modifiers and consequent payment reduction.

However, we believe that basing our policy on a “midpoint rule” in which the PT/OT provides enough minutes on their own (8 or more minutes) to bill for the final unit of a billing scenario could eliminate the PT's/OT's financial incentive to not provide appropriate therapy to an individual patient when it is furnished by the PTA/OTA. On the other hand, if we were to continue with our de minimis standard to apply to all billing scenarios for PTA/OTA services that exceed the 10 percent standard, we are uncertain how to gauge the order zithromax online uk overall costs of this policy because of the possible altered PT/OT behavioral change that is due to the financial incentives built into that policy as discussed above. F. Other Provisions of the Regulation 1.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) In section III.A. Of this final rule, we make multiple provisions related to RHCs and FQHCs. In terms of estimated impacts to the Medicare program, Payment for Attending Physician Services Furnished by RHCs or FQHCs to Hospice Patients as required by section 132 of the CAA, 2021 and Concurrent Billing for CCM and Start Printed Page 65624 Transitional Care Management TCM Services for RHCs and FQHCs will have negligible impact to Medicare spending. Section 130 requires that all independent RHCs are now subject to the per-visit limit (which is also referred to as “cap”) and phases in an increase in the statutory payment cap over an 8-year period.

The cap in CY 2021, for services furnished after March 31, is set at $100 per visit, then at $126 per visit in 2022. At $139 per visit in 2023. At $152 per visit in 2024. At $152 per visit in 2025.

At $165 per visit in 2026. At $178 per visit in 2027. And at $190 per visit in 2028. Beyond 2028, the limit is updated by the applicable Medicare Economic Index (MEI).

This provision also controls the annual rate of growth in payments to certain provider-based RHCs whose payments are currently higher than the payment limit. Each year, but for services provided after March 31 in 2021, the payment limit shall be set at the greater of. (1) The RHC per visit amount from the prior year, increased by the percentage increase in the applicable MEI. And (2) the cap limits applicable to each year as described above.

In order to be eligible for this “grandfathering” policy, the RHC must have been based in a hospital with fewer than 50 beds and enrolled in Medicare as of December 31, 2019. Section 2 of Public Law 117-7, enacted on April 14, 2021, made technical corrections to section 130. First, for an RHC that is hospital-based and whose parent hospital has fewer than 50 beds, the date by which the RHC must be Medicare-certified, in order to be grandfathered, was changed from December 31, 2019 to December 31, 2020. Next, a clinic that is owned by a hospital with fewer than 50 beds and that submitted certain applications (received by Medicare) for certification as a Medicare RHC prior to the end of 2020 can be grandfathered, and its clinic-specific cap is to be set based on its 2021 cost per visit.

Lastly, a grandfathered RHC must continue to be owned by a hospital with fewer than 50 beds. If the parent hospital exceeds 50 beds, the RHC will lose its grandfathered status. Table 137 are the FY estimates (in millions) for the impact of section 130, which improves payments to RHCs. These providers are currently paid an all-inclusive rate (AIR) for all medically necessary medical and mental health services, and qualified preventive health services furnished on the same day (with some exceptions).

The AIR is subject to a payment limit, except for certain provider-based RHCs that have an exception to the payment limit. The RHC payment limit per visit for CY 2021 is $87.52, which is 1.4 percent higher than the CY 2020 payment limit of $86.31. In section III.B. Of this final rule, we discuss that we proposed to revise the regulatory requirement that an RHC or FQHC mental health visit must be a face-to-face (that is, in person) encounter between an RHC or FQHC patient and an RHC or FQHC practitioner to also include encounters furnished through interactive, real-time telecommunications technology, but only when furnishing services for the purposes of diagnosis, evaluation, or treatment of a mental health disorder.

According to our analysis of Medicare Part B claims data for services furnished via Medicare telehealth under the PFS during the PHE, use of telehealth for many professional services spiked in utilization around April 2020 and diminished over time, but not to pre-zithromax levels. In contrast, Medicare claims data suggests that for mental health services both permanently and temporarily added to the Medicare Telehealth list, subsequent to April 2020, the trend is toward maintaining a steady state of usage over time. Given the expanded availability of mental health services at RHCs and FQHCs, we do anticipate that this policy will increase spending. However, we are not certain of the magnitude of this increase, since it is not clear at this time how or whether trends related to utilization of communication technology during the PHE will continue after such a time that the PHE were to end.

While the estimated cost impact of this provision is unclear, the requirement that a modifier be appended to the claim to identify that the service was furnished via audio-only communication technology will allow us to closely monitor utilization and address any potential concerns regarding overutilization through future rulemaking. 2. Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802 and 414.806) This provision implements new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of the CAA (for the purposes of this section of this final rule, hereinafter is referred to as “section 401”). These new requirements will improve the accuracy of reported payment limits and limit the use of WAC-based pricing.

As described in section III.D.1. Of this final rule, in considering whether to exclude repackagers from the reporting requirements at section 1847A(f)(2) of the Act, we conducted two analyses to estimate. (1) The proportion of repackaged products in our existing ASP data. (2) the number of new ASP submissions we can expect as a result of the new reporting requirements under section 401.

And (3) the proportion of those (new) submissions that involve repackaged products. Additionally, while we believe it will impact reporting volume and payment limits under section 1847A of the Act for many billing and payment codes, we are unable to estimate the magnitude of these effects for the following reasons. We estimate. (1) 361 non-reporting manufacturers (of either single source or multiple source drugs) will now be required to report ASP data under section 1847A(f)(2) of the Act.

And (2) 6114 products payable under Part B that these non-reporting manufacturers sell. However, we do not know which Healthcare Common Procedure Coding System (HCPCS) code payment limits will be impacted by these 6114 products, nor do we know the sales volume of these 6114 products. Because this information is used to calculate volume-weighted ASP payment limits, we are unable to quantitatively estimate the economic impacts of this provision (that is, the likely costs or savings) on beneficiaries, the government, and other Start Printed Page 65625 stakeholders. (We note that the economic impacts on manufacturers, as a result of the information collection requirements of this provision is discussed in section V.

Of this final rule.) For single source drugs, these changes may result in lower payment limits because, typically, the WAC-based pricing is higher than ASP plus 6 percent. This then translates to cost savings for both the government and beneficiaries, who will pay coinsurance on a lesser amount. However, for the reason stated previously, we are unable to predict the magnitude of this effect. Similarly, payment limits for multiple source drugs could increase or decrease, and we are unable to predict the direction or magnitude of specific or aggregate effects at this time.

We do not anticipate that this provision of this final rule will necessitate the revision of existing Medicaid Drug Rebate Agreements. We welcomed comment on (1) the likely costs or savings to beneficiaries, the government, and other stakeholders and (2) other related impacts of this provision. We received public comments on the likely costs or savings to beneficiaries, the government, and other stakeholders, and other related impacts of this provision. The following is a summary of the comments we received and our responses.

Comment. One commenter suggested that CMS exclude repackagers from the proposed ASP reporting requirements. They stated that requiring all repackagers to report would likely be duplicative and increase the burden on all parties without providing tangible benefit. They recommend repackagers who already report ASP data continue to do so, but that CMS not require repackagers, as a group, to be subject to the reporting requirements at this time.

Response. We are not persuaded that repackagers should be excluded at this time. In order to maintain consistency and integrity of the ASP data for those manufacturers with and without Medicaid drug rebate agreements, and for operational reasons, we do not believe it is appropriate to exclude repackagers from the ASP reporting requirements. If warranted, we could revisit this in future rulemaking.

Comment. One commenter concluded that CMS' analysis and proposal not to exclude repackagers without a rebate agreement from reporting ASP data is reasonable. The commenter stated given that repackagers with a rebate agreement are required to report ASP data, it is reasonable not to exclude repackagers without a rebate agreement from the requirements of section 401. They added that having ASP data from repackagers with and without rebate agreements could also permit future analysis of the effect of repackagers' ASP submissions on Medicare Part B payment rates.

Response. We agree it is reasonable not to exclude repackagers without a Medicaid drug rebate agreement and thank the commenter for their feedback. After consideration of public comments, we are finalizing as proposed. 3.

Determination of ASP for Certain Self-Administered Drug Products a. Anticipated Effects This provision implements new statutory requirements under section 1847A(g) of the Act, as amended by section 405 of the CAA 2021, (for the purposes of this section of this final rule, hereinafter is referred to as “section 405”). As identified by the OIG studies discussed in section III.D.2. Of this final rule, the CMS payment-limit determination under section 1847A of the Act includes all versions of a product marketed under a single FDA approval, and consistent with section 1847A(b)(5) of the Act, the payment-limit determination does not exclude products based on packaging.

Thus, the volume-weighted, average-ASP determination can include self-administered versions that may lead to increased program and beneficiary costs because of distorted ASP-based payment limits. In particular, the OIG studies identified two billing and payment codes that included self-administered NDCs. The OIG study determined that as a result of the inclusion of these NDCs in the calculation of the ASP payment limit, Medicare payment amounts remained inflated in 2017 and 2018, causing the program and its beneficiaries to pay an additional $497 million during this period. Since 2014, current payment methodology has resulted in an additional $173 million in Medicare beneficiary coinsurance for these two NDCs.

(See OIG's July 2020 report titled, “Loophole in Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds of Millions of Dollars,” available at https://oig.hhs.gov/​oei/​reports/​OEI-BL-20-00100.asp. ) Implementation of the regulatory changes has the potential to result in decreased payment limits for identified billing and payment codes that could, in turn, substantially reduce Medicare and beneficiary expenditures, as described in the OIG study. Since section 1847A(g)(3) of the Act requires CMS to implement the required payment changes beginning on July 1, 2021, these potential savings may be observed within the year. By adding sections 1847A(g)(1) and (2) of the Act, section 405 also directs the OIG to conduct future studies with same or similar methodologies to those in the July 2020 report and directs CMS to apply the lesser of payment methodology to the applicable billing and payment codes.

This has the potential to result in additional savings to the program and beneficiaries if additional products are identified by these periodic OIG studies. B. Expected Benefits Codifying the provisions set forth by section 405 will permit to CMS to apply the lesser of payment methodology at section 1847(g)(2) of the Act to billing and payment codes identified by future OIG studies (described in section III.D.2. Of this final rule).

This provision addresses distorted payment limits for these products and may result in payment amounts that are better aligned with versions of these products that are payable under Part B (for example, versions that are usually not self-administered). Although we are unable to quantify the total magnitude of the potential savings, these changes have the potential to substantially reduce program expenditures and beneficiary coinsurance. 4. Appropriate Use Criteria Section 1834(q)(2) of the Act, as added by section 218(b) of the Protecting Access to Medicare Act (PAMA), established a program to promote the use of appropriate use criteria (AUC) for applicable imaging services furnished in an applicable setting.

In the CY 2019 PFS final rule (83 FR 59452), we performed an RIA for this program. In this final rule, we are finalizing our proposal to begin the payment penalty phase of the program on the later of January 1, 2023 or the January 1 of the year after the year in which the PHE for buy antibiotics ends. Because, under our provisions, the payment penalty phase will be further delayed, we are updating the estimates for incremental changes from the RIA from the CY 2019 PFS final rule. Since we did not propose new policy requirements nor do we have sufficient reason to change any of the assumptions made in the RIA finalized in the CY 2019 PFS (83 FR 60034 through 60044), we are only updating the analysis to reflect 2019 Medicare claims data (updated from 2014).

We identify four incremental changes from the CY 2019 Start Printed Page 65626 PFS final rule estimates due to updated claims data. (1) Impact of required AUC consultations by ordering professionals. (2) impact to Medicare beneficiaries. (3) process efficiencies to potentially offset the estimated burden on Medicare beneficiaries.

And (4) impact on transmitting orders for advanced diagnostic imaging services. Each of these incremental changes results in a lower estimate. a. Impact of Required AUC Consultations by Ordering Professionals As discussed in detail in the CY 2019 PFS final rule (83 FR 60035 through 60037), the annual impact estimate of consultations by ordering professionals was $70,001,700.

In our estimates, we calculated the burden for auxiliary personnel to consult AUC under the direction of an ordering professional and the burden for ordering professionals to perform the consultation directly. We estimated that 90 percent of consultations will be performed by a medical assistant (occupation code 31-9092) and 10 percent of consultations will be performed by a general practitioner (occupation code 29-1062). We estimated that 43,181,818, 2-minute consultations occur annually. Using 2019 Medicare claims data as our basis for the analysis, we proposed to change the methodology used to determine the volume of consultations and proposed to use more granular data that will reduce potential double-counting of advanced diagnostic imaging services.

For example, an imaging service furnished in an outpatient hospital department could have two claims associated with that service. There could be a claim from the facility and a claim from the physician that interprets that imaging service. In the CY 2019 RIA (83 FR 60034 through 60044) we were concerned that the estimate of 43,181,818 consultations may be an overestimate because it took into account total claims. For this CY 2022 RIA, we proposed to change the method of counting the total number of advanced diagnostic imaging services that will be furnished under the AUC program which will correspond to the total number of consultations.

Using the Integrated Data Repository we identified Medicare claims using the following parameters. (1) 2019 date of service. (2) claim lines containing one of the procedure codes identified in CR10481 and CR11268 at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Transmittals/​2018Downloads/​R2040OTN.pdf and https://www.cms.gov/​files/​document/​r2404otn.pdf, respectively. And (3) claims types of outpatient or practitioner.

Claims were then separated based on the setting in which the imaging service was furnished and further by claim type. Using only services billed on the professional claim type, the total number of claim lines containing one of the identified procedure codes was included to total 30,359,901 advanced diagnostic imaging services estimated to be subject to the AUC program. By using this combination, we believe we can reduce the risk of double-counting services to obtain a more accurate estimate of total number of diagnostic imaging services subject to the AUC program. Therefore, this analysis will use the estimate of 30,359,901 AUC consultations.

Using the May 2020 BLS mean hourly wages, we update our estimates for a medical assistant (occupation code 31-9092) with mean hourly wage of $17.75 and 100 percent fringe benefits for 90 percent of consultations (910,797 hours) to be $30,511,701 (910,797 hours × $33.50/hour). The occupation for general practitioner is no longer listed on the BLS so, instead, we update our estimate using the occupation code for general internal medicine physician (29-1216) with mean hourly wage of $101.42 and 100 percent fringe benefits for 10 percent of consultations (101,200 hours) to be $20,527,408 (101,200 hours × $202.84/hour). The updated total annual estimated impact of consultations is $51,039,109, for an incremental change (reduction) of $18,962,591. B.

Impact to Medicare Beneficiaries In the CY 2019 PFS final rule, we estimated that the additional 2-minute consultation would impact the Medicare beneficiary when their advanced diagnostic imaging service is ordered by the ordering professional by introducing additional time to their office visit. For this update, we used the updated number of consultations calculated above from claims data, as well as the May 2020 BLS mean hourly wage. To estimate this annual cost, we multiplied the annual burden of 1,011,997 hours by the BLS occupation code that represents all occupations in the BLS (00-0000) as mean hourly wage plus 100 percent fringe ($54.14/hr) for a total estimate of $54,789,518 per year for an incremental change (reduction) of $13,211,482. We also estimated that, over time, process efficiencies may be implemented.

We assumed that 50 percent of practices implemented an improvement process that streamlined AUC consultation so Medicare beneficiaries spent the same amount of time in the physician's office regardless of whether an advanced diagnostic imaging service was ordered. The updated estimate that such an improvement process could offset the estimated burden on Medicare beneficiaries by $27,394,759 annually for an incremental change (reduction) of $6,605,741. C. Impact on Transmitting Orders for Advanced Diagnostic Imaging Services In the CY 2019 PFS final rule, we estimated that including AUC consultation information on the order for an advanced diagnostic imaging service to the furnishing professional or facility is estimated as the additional 5 minutes spent by a medical secretary (occupation code 43-6013).

To update this estimate, we use the May 2020 mean hourly wage of $18.75 plus 100 percent fringe benefits to transmit the order for the advanced diagnostic imaging service. In aggregate, we assumed in the CY 2019 PFS final rule that 40,000,000 advanced diagnostic imaging services are ordered annually. We proposed to update that number to match the total number of AUC consultations proposed earlier in this RIA to 30,359,901, so the updated total annual burden to communicate additional information in the order is estimated as $94,495,192 ($18.75/hr × 2 × 0.083 hr × 30,359,901 orders) for an incremental change (reduction) of $20,044,808. D.

Impact on Furnishing Professionals and Facilities As described in the CY 2019 PFS final rule, we identified an estimated 174,064 furnishing professionals (comprising radiologists, ASCs, IDTFs and hospitals) and assumed that every identified furnishing professional will choose to update their processes for the purposes of the AUC program in the same way by purchasing an automated solution to report AUC consultation information which was estimated to cost $10,000 for each furnishing professional. We update this cost to account for inflation and therefore the updated estimated cost is $10,636.07 ($10,000 adjusted for inflation to 2021 dollars) for a total estimated one-time update cost of $1,851,356,888.48 (174,064 × $10,636.07). E. Appropriate Use Criteria for Advanced Diagnostic Imaging Services As described in the CY 2019 PFS final rule, we assumed that there may be some savings to the Medicare program due to the AUC program requirements and potential decreases in inappropriate utilization of advanced diagnostic imaging services.

This assumption was based on literature describing prior Start Printed Page 65627 experiences with clinical decision support in a pilot project conducted in Minnesota, a retrospective cohort study on evidence-based clinical decision support for lumbar MRI, brain MR and sinus CT and local implementation of clinical decision support, and we estimated that savings may account for $700,000,000 savings per year. f. Summary of Delay-Attributable Changes and Discounted Rates Table 138 summarizes the substantive changes from the CY 2019 PFS final rule to the CY 2022 PFS final rule impact estimates. The effect of a 3-year delay is approximated by applying 3 years' worth of discounting at 7 percent or 3 percent discount rates (Circular A-4, https://www.whitehouse.gov/​sites/​whitehouse.gov/​files/​omb/​assets/​regulatory_​matters_​pdf/​a-4.pdf ).

5. Removal of Selected National Coverage Determinations (NCDs) We proposed to remove two older NCDs that no longer contain clinically pertinent and current information or that involve items or services that are used infrequently by beneficiaries. Generally, proactively removing obsolete or unnecessary NCDs removes barriers to innovation and reduces burden for stakeholders and CMS. The two NCDs fall into two impact categories.

First, eliminating an NCD for items and services that were previously covered means that the item or service will no longer be automatically covered by Medicare. Instead, the coverage determinations for those items and services will be made by Medicare Administrative Contractors (MACs). Second, if the previous national coverage determination barred coverage for an item or service under title XVIII, MACs will now be able to cover the item or service if the MAC determines that such action is appropriate under the statute. We believe that allowing local contractor flexibility in these cases better serves the needs of the Medicare program and its beneficiaries since we believe the future utilization for items and services within these policies will be limited, each affecting less than one percent of the Medicare FFS population.

For the one NCD where NCD removal changes coverage from limited national coverage to MAC discretion, claims data from 2019 shows that less than one percent of the Medicare population is affected. Specifically, NCD 180.2 Enteral and Parenteral Nutrition Therapy provided coverage with limitations. Where in 2019 CMS paid 1,643,739 Medicare FFS claims for 83,551 unique beneficiaries totaling CMS payments of $356,228,606. While we have claims data available for 2020, the data shows a decrease in claims, unique beneficiaries and total amount paid by CMS.

We believe this may be due in part to the buy antibiotics zithromax. However, we do not have any information to be able to say that conclusively. The change could be due to other factors not examined here. We estimate there will be de minimis change to 2022 payments, compared to 2019 or 2020 because, as discussed in section III.F.

Of the final rule, local contractors have finalized two LCDs, effective for dates of service on or after September 5, 2021 that will continue to provide parenteral and enteral nutrition coverage for Medicare beneficiaries, after removal of NCD 180.2. Therefore, we believe that removing this NCD will not result in significant changes to payments. For the one non-covered NCD to be eliminated, Positron Emission Tomography (PET) Scans under NCD 220.6, we did not expect to find historical claims data for the non-oncologic uses of PET at issue. We broadly noncover non-oncologic indications of PET, in other words, we required that every non-oncologic indication for PET must have its own NCD in order to receive coverage.

Because this NCD provides for noncoverage on non-oncologic indications, we do not have accurate claims data to estimate total impact. However, based on the service, we expect future claims to affect less than one percent of Medicare FFS beneficiaries. As discussed in section III.F. Of this final rule, the NCD allows coverage for diagnostic PET imaging for oncologic uses not already determined by an NCD, to be made at the discretion of local MACs.

We believe that extending local contractor discretion for non-oncologic indications of PET provides an immediate avenue to potential coverage in appropriate Start Printed Page 65628 candidates and provides a framework that better serves the needs of the Medicare program and its beneficiaries. For clarity, we did not propose to change any other subsections of 220.6. Thus, the NCDs listed at 220.6.1 through 220.6.20 will not be changed by this provision. 6.

Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation As discussed in section III.H., Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR), of this final rule, we proposed largely conforming changes throughout §§ 410.47 (PR) and 410.49 (CR/ICR). These changes are intended to ensure consistency and accuracy in terminology, definitions and requirements where appropriate across PR and CR/ICR conditions of coverage. Specific to PR, we proposed to remove the requirement for direct physician-patient contact related to the periodic review of the patient's treatment plan because such interaction within the PR program is not necessary for all patients and can be specified, as needed, in individualized treatment plans (ITPs). We also proposed to add coverage of PR for beneficiaries who were hospitalized with a buy antibiotics diagnosis and experience persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospital discharge.

After considering public comments and additional clinical evidence, we are finalizing the revisions to improve consistency and accuracy across PR and CR/ICR conditions of coverage as proposed. We are also finalizing the removal of the PR requirement for direct physician-patient contact. We are expanding upon our proposal to cover PR for beneficiaries who were hospitalized with a buy antibiotics diagnosis and experience persistent symptoms, including respiratory dysfunction, for at least 4 weeks after hospital discharge. We are removing the proposed hospitalization requirement and finalizing coverage of PR for beneficiaries who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least 4 weeks.

We did not receive public comments on the proposed impact so we use the same methodology in estimating the impact of the final expansion of coverage for PR below. In assessing the impact of these provisions, we note that the expansion of PR coverage may increase utilization. Based on the low utilization rate discussed below, we do not believe the other revisions will significantly impact utilization and the Medicare program. To estimate the potential increase from the expansion of coverage for PR, we searched the literature for articles that evaluated the utilization rate of PR for the currently eligible diagnosis of chronic obstructive pulmonary disease (COPD) in order to determine the historical utilization trends of this service.

Nishi et al. (2016) investigated the number of Medicare beneficiaries with COPD who received PR from January 1, 2003 to December 31, 2012. Their results included both individuals who had experienced hospitalizations for COPD and those who were outpatients only. The number of unique patients with COPD who initially participated in PR during the study period was 2.6 percent in 2003 (before conditions of coverage at § 410.47 were established) and 2.88 percent in 2012 (after conditions of coverage at § 410.47 were established).[] In 2019, Spitzer, et al.

Published an article based on Medicare claims data from 2012, finding that 2.7 percent of eligible Medicare beneficiaries received PR within 12 months of hospitalization with COPD.[] Using claims data from FFS Medicare beneficiaries hospitalized for COPD in 2014, Lindenauer et al. (2020) reported that only 3 percent initiated PR within 1 year of their hospital discharge.[] Taken together, this data informs us that utilization of PR in the Medicare population is very low, and that the majority of patients who avail themselves of this service do so, post hospitalization. There are limitations to applying this data to identify the utilization rate of PR to the conditions of coverage specified at § 410.47. Most notably, some of these studies included patients whose services were billed with non-PR respiratory therapy codes (G0237, G0238 and G0239), instead of only patients whose services were billed with the PR code (G0424).

But the authors also limited patient inclusion to those with a principal or secondary COPD diagnosis, so we believe this suggests that 3 percent is an upper bound for the utilization of PR currently in Medicare beneficiaries. Given that participation in PR has remained steady for many years, we do not expect this pattern to change. As such, for the purposes of this analysis, we assume that 3 percent of eligible beneficiaries under the expansion of coverage (beneficiaries who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least 4 weeks) will participate in PR. To identify the eligible beneficiaries under our provision, we first identify the number of beneficiaries who had buy antibiotics using the Preliminary Medicare buy antibiotics Data Snapshot.[] At the time of writing, the Snapshot included data from January 1, 2020 to July 24, 2021, and identified 4,656,553 total buy antibiotics cases for Medicare beneficiaries.

Using Medicare FFS data from February 24, 2020 to September 27, 2020 as compared to the same time frame in 2015 through 2019, Tarazi et al. (2021) found that the buy antibiotics related mortality rate, defined as death within 60 days of buy antibiotics diagnosis, was 17.5 percent.[] To calculate the number of beneficiaries that survive buy antibiotics to be eligible for PR under our coverage expansion, we reduced 4,656,553 by 17.5 percent (814,897) to 3,841,656 beneficiaries. A paper published by the Tony Blair Institute for Global Change [] states that the buy antibiotics Symptom Study led by King's College London indicated that about 10 percent of survey participants reported symptoms (including shortness of breath and other symptoms like fatigue, headache and loss of smell) beyond a four-week recovery period. Using this information, we estimate that the patient population we are expanding PR coverage to, those who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least 4 weeks, to be 384,166 beneficiaries (3,841,656 × 0.10).

Based on our assumption of utilization above, 3 percent, for the newly covered patient population, we estimate 11,525 Start Printed Page 65629 beneficiaries will receive PR (384,166 × 0.03). Medicare covers PR for a maximum of 72 sessions. Using 2018 and 2019 Medicare claims data from the Chronic Conditions Data Warehouse (CCW), beneficiaries on average completed 14 sessions of PR. If we assume patients eligible based on our expansion of coverage will participate, on average, in the same number of sessions, we estimate the expansion of coverage will increase PR utilization by 161,350 sessions annually (11,525 beneficiaries × 14 average sessions completed per beneficiary).

Claims for PR are submitted using CPT code G0424. Our analysis of Medicare claims data indicates that 97.54 percent of PR sessions are billed under the Hospital OPPS at $55.66 (national average price) for an estimated total of $8,759,815 (161,350 PR sessions × 0.9754 × $55.66). The remaining 2.46 percent of PR sessions are billed under the PFS, with 2.12 percent of PR sessions furnished in a physician's office which has a national average price of $30.36 and 0.34 percent billed by a physician when PR was furnished in a HOPD which has a national average price of $13.96. Taken together, the estimated total for this remaining 2.46 percent of PR sessions is $111,508 ((161,350 PR sessions × 0.0212 × $30.36) + (161,350 PR sessions x 0.0034 × $13.96)).

We estimate the total added cost to the Medicare program of this expansion of coverage to be $8,871,323 ($8,759,815 + $111,508) annually during and immediately following the PHE for buy antibiotics. The impact of our final rule increases the final estimate by $6,709,876 which reflects the larger patient population that will be eligible for PR. Removing the proposed hospitalization requirement increased the number of eligible beneficiaries by 290,555. As buy antibiotics cases decline, we expect the annual impact to decrease because eligible patient populations will likely decrease.

However, we are unable to estimate the longer term impact of our provisions due to the unpredictable nature of the PHE and the lack of long term data on buy antibiotics. 7. Medical Nutrition Therapy As discussed in section III.I., Medical Nutrition Therapy (MNT), of this final rule, we proposed to remove the restriction that patients only be referred to MNT by the treating physician and update the glomerular fiation rate (GFR) eligibility for patients with chronic kidney disease. We do not anticipate any significant increase in utilization of MNT services resulting from our revisions.

Despite various policy changes that could have improved use, such as increasing payment via adding work RVUs to MNT codes in 2006, approving MNT for telehealth coverage in 2005 and including registered dieticians (RDs) and nutrition professionals as telehealth distant site providers, and waiving out-of-pocket costs to beneficiaries, MNT participation remains under 2 percent of eligible beneficiaries. Based on an analysis of Medicare claims data from 2018, 2019, 2020, we identify the utilization rate of MNT services among eligible beneficiaries to be between 1.5 and 1.8 percent. Although MNT is covered by many State Medicaid programs and private insurers, use is low in the US.[] The Academy of Nutrition and Dietetics recognizes that research specific to the underuse of MNT services is scant.[] Anecdotal reports and related research on diabetes self-management training point to a multitude of reasons why utilization of the MNT services benefit have remained low. These potential barriers include lack of awareness of MNT by patients and clinicians, inconsistent coverage for MNT services by non-Medicare payers, patient travel and time issues to receive the services and lack of availability of services from RDs who may perceive the process of Medicare enrollment/insurance credentialing and billing as being burdensome and complex.[] Of about 100,000 RDs in the US, only 1,589 submitted Medicare FFS MNT claims in 2017.

One study revealed that less than half of RDs providing MNT services in an ambulatory care setting indicated they were not Medicare providers due to reasons such as perceived low reimbursement rates, not providing MNT to Medicare eligible patients, not knowing how to become a Medicare provider, and providing MNT to Medicare patients for diagnoses not covered by Medicare.[] Our revisions may increase beneficiary access to the MNT benefit and reduce primary care physician burden since we proposed that referrals can come from other physicians and not only from the physician treating the patient for their diabetes or kidney disease. Although, as discussed above, we do not expect the changes to make a significant impact on the Medicare program. We do not anticipate increased administrative burden as documentation in the medical record of any referred service is already a part of discharge planning in the hospital setting. The changes to the GFR requirements are to conform our regulation to updated clinical standards and also do not pose a significant change.

8. Medicare Shared Savings Program a. Modifications to the Shared Savings Program Quality Reporting Requirements Under the APP and the Quality Performance Standard In section IV.A.3.d.(1)(d) of this final rule, we are extending the use of the CMS Web Interface as a collection type for the Quality Payment Program for performance years 2022, 2023, and 2024 for Shared Savings Program ACOs reporting under the APP. In section III.J.1.c.

Of this final rule, we are finalizing that in order for ACOs to meet the quality reporting requirements under the Shared Savings Program for performance year 2022 and subsequent performance years, ACOs must meet the following requirements. For performance years 2022, 2023, and 2024. An ACO must report on either. (a) The ten CMS Web Interface measures and administer a CAHPS for MIPS survey and CMS will calculate the two claims-based measures included under the APP, or (b) The three eCQMs/MIPS CQMs and administer a CAHPS for MIPS survey and CMS will calculate the two claims-based measures included under the APP.

If an ACO chooses to report the three eCQMs/MIPS CQMs, its performance on all three eCQMs/MIPS CQMs will be used for purposes of MIPS scoring under the APP. If an ACO decides to report both the ten CMS Web Interface measures and the three eCQMs/MIPS CQMs, it will receive the higher of the Start Printed Page 65630 two quality scores for purposes of the MIPS Quality performance category. For performance year 2025 and subsequent years. The ACO must report the three eCQMs/MIPS CQMs and administer a CAHPS for MIPS survey and CMS will calculate the two claims-based measures included under the APP.

Absent the related provision analyzed below to reduce the quality performance standard for PY 2023 to the 30th percentile MIPS Quality performance category score, the changes to the quality reporting requirements, including the accommodation to continue the availability of the CMS Web Interface as a reporting mechanism under the APP will likely provide an easier path for a meaningful subset of ACOs that would otherwise have faced difficulty meeting the quality performance threshold previously established in rulemaking for PY 2023. However, we estimate that nearly all such ACOs would already have met the lower 30th percentile performance standard in PY 2023 without the additional reporting flexibility. Of the relatively few, remaining ACOs that we estimate would have failed to meet the lower 30th percentile performance standard without the additional reporting flexibility, we estimate that about half (on average) will meet the quality performance standard as a result of the quality reporting flexibility adopted in this final rule, and thereby further increase shared savings payments to ACOs by about $20 million in PY 2023. In section III.J.1.d.

Of this final rule, we are finalizing, with modifications, the proposal to freeze the quality performance standard at the 30th percentile across all MIPS Quality performance category scores for performance year 2023, and to establish incentives to encourage ACOs to begin the transition to eCQM/MIPS CQM reporting in performance year 2022 and performance year 2023. The quality performance standard will increase to the 40th percentile across all MIPS Quality performance category scores for performance years 2024 and subsequent performance years. The quality performance standard is the minimum performance level ACOs must achieve in order to share in any savings earned, avoid maximum shared losses under certain payment tracks, and avoid quality-related compliance actions. We are finalizing that, with the exception of an ACO in the first performance year of its first agreement period, an ACO will meet the quality performance standard under the Shared Savings Program by reporting quality data via the APP established under § 414.1367 according the method of submission established by CMS and for.

Performance years 2022 and 2023. ++ Achieving a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, or ++ If the ACO reports the three eCQMs/MIPS CQMs, meeting the data completeness requirement at § 414.1340 and the case minimum requirement at § 414.1380 for all three measures, and achieves a quality performance score equivalent to or higher than the 10th percentile of the performance benchmark on at least 1 of the 4 outcome measures in the APP measure set and a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least 1 of the 5 remaining measures in the APP measure set. Consequently, the ACO would be required to meet the performance benchmark on either 2 outcome measures (one measure at the 10th percentile and the other at the 30th percentile), or 1 outcome measure at the 10th percentile and any other measure in the APP measure set at the 30th percentile. If the ACO (1) does not report any of the 10 CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and (2) does not administer a CAHPS for MIPS survey, the ACO would not meet the quality performance standard.

Performance year 2024 and subsequent performance years. Achieving a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. If the ACO (1) does not report any of the 10 CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and (2) does not administer a CAHPS for MIPS survey, the ACO would not meet the quality performance standard. Our analysis of quality performance data reported by ACOs for performance years starting during 2019 indicates that about 20 percent of ACOs would have failed a quality performance standard defined as the 40th percentile across all MIPS Quality performance category scores.

There is significant uncertainty whether PY 2023 will play out similarly to the baseline data. The fraction of ACOs that would ultimately fail to meet a higher standard in PY 2023 could change significantly if the universe of MIPS Quality performance category scores improves relative to ACOs' quality performance scores, or alternatively if ACOs, particularly ACOs at risk of failing, respond to the increased quality performance standard by boosting their performance. Utilizing a Monte Carlo approach, assuming that the simulated poor performing ACOs have a 50 percent chance of improving their quality performance beyond the 40th percentile, if CMS kept the quality performance standard at the 40th percentile, then the cost of reducing to the 30th percentile in 2023 will be $190 million (range $10 million to $370 million). There is a wide range because slight changes in quality scoring at the low end of the distribution could render the 40th percentile more or less of an effective point of discrimination among ACOs earning shared savings.

B. Modifications to Other Shared Savings Program Requirements We do not anticipate a material aggregate impact for the other changes we are finalizing as proposed related to the Shared Savings Program, specifically. Revisions to the definition of primary care services used in the Shared Savings Program's beneficiary assignment methodology (section III.J.2. Of this final rule).

Revisions to the repayment mechanism arrangement policy, including changes to the calculation and recalculation of repayment mechanism amounts (section III.J.3. Of this final rule). Revision of the requirements concerning disclosure of prior participation in the Shared Savings Program by the ACO, ACO participants, and ACO providers/suppliers, and revisions to Shared Savings Program requirements to reduce the frequency and circumstances under which ACOs submit sample ACO participant agreements and executed ACO participant agreements to CMS (section III.J.4. Of this final rule).

And revisions to the beneficiary notification requirement as it applies to ACOs under prospective assignment and ACOs under preliminary prospective assignment with retrospective reconciliation (section III.J.5. Of this final rule). However, as we note in section III.J.3. Of this final rule, lower required repayment mechanism amounts could reduce costs for ACOs in fees charged by financial institutions for letters of credit and by insurance companies for surety bonds.

We estimate that such relief, in total for all participating ACOs, could be worth $2 to $4 million annually under the approach we are finalizing (assuming a reduction of approximately $196 million in repayment mechanism amounts, in aggregate). Start Printed Page 65631 We also note that the revisions we are finalizing to the definition of primary care services used in the assignment methodology may have differing effects on a subset of participating ACOs, for example, by leading a beneficiary to be assigned to a competing ACO, for a small subset of beneficiaries. We do not anticipate such ACO-level changes will result in a net impact on program spending overall. 9.

Medicare Ground Ambulance Data Collection System In section III.K. Of this final rule, we finalized our proposed changes to the Medicare Ground Ambulance Data Collection System including the proposed change to the data collection period and data reporting period for selected ground ambulance organizations in year 3, proposed revisions to the timeline for when the payment reduction for failure to report will begin and when the data will be publicly available, and proposed revisions to the Medicare Ground Ambulance Data Collection Instrument. We stated in the proposed rule that while we believed that these changes and clarifications will be well received by the ground ambulance stakeholders, we did not believe that these changes will have any substantive impact on the cost or time associated with completing the Medicare Ground Ambulance Data Collection Instrument. We also noted in the proposed rule that the overall length of the Medicare Ground Ambulance Data Collection Instrument would be the same as previously finalized (84 FR 62888) with these changes.

Additionally, some of the instructions which we proposed to add were intended to improve clarity and may therefore reduce the time the ground ambulance organizations spend addressing the questions. We did not receive any public comments on our estimated impact on the cost or time associated with completing the Medicare Ground Ambulance Data Collection Instrument. As we discussed in section III.K of this final rule, we are finalizing our proposed changes to the Medicare Ground Ambulance Data Collection System. 10.

Medicare Diabetes Prevention Program Expanded Model a. Effects of Provisions Relating to the Medicare Diabetes Prevention Program Expanded Model (1) Effects on Beneficiaries We proposed to modify certain Medicare Diabetes Prevention Program (MDPP) expanded model policies to. (1) Allow CMS to remove the ongoing maintenance phase (months 13-24) of the MDPP set of services for those beneficiaries who started their first core session on or after January 1, 2022. (2) update the performance payments for the MDPP set of services in the core and core maintenance performance periods.

And (3) waive the Medicare provider enrollment application fee for all organizations enrolling as MDPP suppliers on a prospective basis. These changes will have a positive impact on beneficiaries' health by increasing the capacity of MDPP eligible organizations to enroll in Medicare as MDPP suppliers and increasing access to the MDPP set of services for beneficiaries. Eligible beneficiaries receive these services as preventive services, which require no copays or cost sharing. These changes address MDPP supplier and beneficiary needs based upon all available monitoring and evaluation data.

The changes are also responsive respond to stakeholder comments. (2) Effects on the Market Currently, more than 1,000 organizations nationally are eligible to become MDPP suppliers based on their preliminary or full CDC Diabetes Prevention Recognition Program (DPRP) status. However, only 27 percent of eligible organizations are participating in MDPP. We anticipate that the removal of the second year of the MDPP set of services will make MDPP attractive and feasible to more MDPP eligible organizations.

Not only does a 12-month MDPP services period align with that of the CDC's National DPP and the DPP model test, our data show that only 10 percent of enrolled MDPP participants continue with the Ongoing Maintenance phase sessions (Year 2), and the majority are reaching their weight loss milestone within the first 6 months of the set of MDPP services. Stakeholders report that the second year of MDPP, or the ongoing maintenance phase, is cost prohibitive due to the costs to retain beneficiaries in year 2 of the expanded model as well as the costs to deliver an additional year of the expanded model that is not supported by the CDC National DPP curriculum. The CDC's National DPP curriculum supports a 1-year program and suppliers have found it difficult to extrapolate the curriculum to a second year. Additionally, MDPP suppliers commented that they have an increasingly difficult time making the business case for MDPP given the costs associated with the ongoing maintenance phase and the low performance payments associated with the second year.

Given the low volume of participants continuing in the second year of MDPP, delivering the MDPP ongoing maintenance period creates an undue burden to MDPP suppliers. The cost to offer and deliver the sessions to a small cohort of individuals outweigh the maximum payments available from Medicare. Stakeholders have consistently commented that CMS should shorten the MDPP expanded model to 1 year, with payment levels at least equivalent to the levels provided in the DPP model test. For example, during the DPP model test, suppliers were paid an average of $462 per beneficiary for the 1-year model test.

The second year has made delivering MDPP both financially unattractive and unstainable for many of the current and eligible MDPP suppliers. Suppliers have reported that it is very difficult to engage and retain beneficiaries in a second year, and the reimbursement levels for a second year are inadequate to cover supplier costs. We proposed to shorten the MDPP service period to 1 year and increase the performance payments in the first year. These changes respond to stakeholder feedback and may alleviate some of the difficulty retaining MDPP participants during the core maintenance phase of the expanded model.

(3) Burden Related to Information Collection Requirements—No impact (a) Supplier Standards MDPP suppliers may encounter the Medicare enrollment fee during the following Medicare provider enrollment transactions. Initial enrollment. Revalidation (every 5 years for MDPP). Or the addition of a new practice location.

The provider/supplier enrollment fee for Calendar Year 2021 is $599. Although MDPP suppliers may submit a written request to CMS for a hardship exception to the application fee in accordance with § 424.514, many will not qualify and the hardship application process will simply add more burden on the organization. We have heard from the CDC as well as other stakeholders that the enrollment fee is a potential barrier to eligible MDPP suppliers who will not otherwise enroll in Medicare except for MDPP. Approximately 39 percent of our current suppliers are non-traditional suppliers that serve their local communities and play a critical role in enrolling more diverse, equitable, and inclusive cohorts of Medicare beneficiaries to MDPP.

These non-traditional suppliers include, but are not limited to YMCAs, county health departments, community health centers, and non-profit organizations that focus on health education, and otherwise will neither enroll nor be able Start Printed Page 65632 to enroll as a Medicare supplier at all if it were not for MDPP. They often serve as trusted sources of health information for their communities. However, they also represent a large number of eligible organizations who have not enrolled in Medicare as MDPP suppliers. We anticipate that waiving the enrollment fee on a prospective basis along with the other programmatic adjustments are likely to result in more MDPP suppliers, increased beneficiary access to MDPP services, and an ongoing reduction of the incidence of diabetes in eligible Medicare beneficiaries, in both urban and rural communities.

In April 2020, CMS waived all provider enrollment application fees as part of the buy antibiotics Emergency Declaration Blanket Waivers for Health Care Providers. As a result, we saw an increase in MDPP supplier enrollment. We believe that granting a waiver of the fee for MDPP suppliers to extend beyond the buy antibiotics Emergency Declaration Blanket Waiver, along with the other change to MDPP, may stimulate MDPP supplier enrollment and enhance the MDPP evaluation. We proposed waiving the Medicare provider enrollment fee beyond buy antibiotics Emergency Declaration Blanket Waivers for Health Care Providers because the enrollment fee creates a potential barrier to MDPP supplier enrollment, beneficiary access to the program, and subsequently, our ability to evaluate MDPP.

Specifically, we proposed, to waive the enrollment fee as described in section 1866(j)(2)(C)(i) and (ii) of the Act during the MDPP expanded model test phase. (b) Payment for MDPP Services Our regulations at § 414.84 specify the payments MDPP suppliers may be eligible to receive, payments for furnishing MDPP services, and meeting performance targets related to beneficiary weight loss and/or attendance. MDPP suppliers are paid by CMS by submitting claims for MDPP beneficiaries using claim form CMS-1500 ( https://www.cms.gov/​Medicare/​CMS-Forms/​CMS-Forms/​Downloads/​CMS1500.pdf ). As a condition for payment, claims submitted by MDPP suppliers must be for services furnished to eligible beneficiaries in accordance with § 414.84(b) and (c).

We have streamlined the performance payments so that they are easier to understand and suppliers receive larger payments for participants reaching attendance and weight loss performance-based milestones. For example, the attendance-based performance payments are based on a standardized per-session rate, paid after the 1st, 4th, and 9th sessions attended during the core sessions interval, and after attending the two (2) sessions during each of the core maintenance intervals. We have redistributed all the Year 2 ongoing maintenance sessions phase performance payments to certain core and core maintenance session performance payments in Year 1. As finalized, the maximum payment of $705 over a 1-year service period is $1 more than the current maximum payment of $704 under the original 2-year payment structure.

We believe eliminating the second year and its associated payments while increasing the first-year payments will result in a more financially sustainable expanded model. Increasing the first year MDPP payment amounts should not negatively affect a supplier's performance (for example, participants' weight loss). As finalized, we increased the per session payments to $35, with suppliers receiving $53 more per beneficiary who attends the 4th core session compared to current payments and $27 more than proposed. We increased the attendance-based payments in response to stakeholder comments and maintained the 5 percent weight loss payments.

Although some of the largest payments to suppliers are still driven by weight loss achievement, the maximum payment for attendance only is finalized at $455 compared to $338 proposed and $205 current. Further, in order to maintain CDC Diabetes Prevention Recognition Program (DPRP) recognition status, which is required to be an MDPP supplier, certain levels of performance metrics (for example, weight loss) must be satisfied. There is no evidence that eliminating the second-year maintenance sessions, shortening the MDPP services period to 1 year, will have any negative effects on performance of the expanded model. (4) Effects on the Medicare Program (a) Estimated 10-Year Impact of MDPP Table 140 shows an updated estimate (in millions) for the impact on Medicare spending of two changes to the Medicare Diabetes Prevention Program (MDPP) to be implemented in 2022, with corrected assumptions.

Waiving the Medicare enrollment fee for all new MDPP suppliers. And Shortening the MDPP services period to 1 year and shifting all of the Ongoing Maintenance reimbursement amounts to year one. These estimates by the CMS Office of the Actuary do not consider waiving the Medicare enrollment fee as a direct cost and assume there will be an additional 500 beneficiaries per year participating in MDPP. The average payment for an MDPP participant will increase by $150.

While the maximum payment available to an MDPP supplier is only slightly greater than the maximum payment available under the original 2-year payment structure, the second year set of MDPP services have historically been far less utilized than the first year set of services. Therefore, eliminating the second-year payments has a minimal negative effect to the assumed costs of the expanded model. In the most recent year prior to the PHE, 747 Medicare FFS beneficiaries entered MDPP. Increasing the first-year payment amounts to suppliers and waiving the Medicare enrollment fee should increase access to MDPP, resulting in more utilization of the MDPP set of services.

Starting in 2022, we can assume that 750 beneficiaries will have entered the expanded model each year without including the finalized changes. After including these changes, we will now Start Printed Page 65633 assume 1,250 beneficiaries will enter the expanded model each year. This assumption has a high level of uncertainty and we revisit it in the Sensitivity Analysis section. Increasing the first year MDPP payment amounts should not negatively affect a supplier's performance (for example, participants' weight loss).

Almost all of the increases to the payment amounts are applied after the 4th core session. Even though most of the payment increases are not tied to weight loss achievement, in order to maintain CDC Diabetes Prevention Recognition Program recognition status, which is required to be an MDPP supplier, certain levels of performance metrics (for example, weight loss) must be satisfied. There is no evidence that eliminating the second-year maintenance sessions, shortening the MDPP services period to one year, will have any negative effects on performance of the expanded model. (b) Sensitivity Analysis Since the cost to suppliers for delivering the MDPP set of services is generally unknown, how utilization of the expanded model will be affected by the changes is highly uncertain.

Table 141 shows the 10-year impact estimates (in millions) for different levels of additional beneficiary participation as a result of the changes. Finally, higher projected savings are associated with increases in beneficiary participation, while no additional beneficiaries will result in an estimated cost. The financial impacts we provided for the previously proposed payment schedule changes included errors that impacted our estimates. Additional costs resulting from payment increases were not applied to the baseline participants.

The count of 1,742 participants used to estimate future baseline participation included Medicare Advantage beneficiaries, which should have been excluded. And since there were only 747 new FFS participants in the most recent year prior to the start of the PHE, our best estimate would have assumed 250 additional FFS participants per year resulting from the previously proposed changes. b. Alternatives Considered No alternatives were considered.

The 2-year MDPP service period has depressed interest in MDPP among would-be MDPP suppliers. These actions address stakeholder comments on the barriers to MDPP expanded model success. If we do not take action, we will not be able to scale MDPP as intended, impacting Medicare beneficiary access to this expanded model. Reducing the MDPP from a 24-to a 12-month services period, increasing the year 1 performance payments, and waiving the Medicare provider enrollment application fee not only better aligns the expanded model with the evidence that helped certify the DPP model test initially, but it will encourage eligible organizations to enroll as MDPP suppliers.

C. Impact on Beneficiaries This change will have a positive impact on eligible MDPP beneficiaries, as it better aligns with the CDC's National DPP, giving both the participants and the coaches similar messaging regarding this expanded model, regardless of payer. MDPP suppliers often offer the MDPP set of services to mixed cohorts, or classes with participants who are not eligible for MDPP, but who are enrolled in a National DPP cohort. Since MDPP generally follows the CDC's National DPP and aligns its expanded model with the CDC's DPRP Standards, it is confusing to participants, coaches, and staff when talking about a 2-year set of services to its eligible Medicare participants when the non-Medicare participants have a 1-year program.

Finally, reducing the MDPP service period from 2 years to 1 year allows more cohorts to start and finish MDPP during the expanded model initial period of performance, which is expected to end in March 2023. D. Estimating Regulatory Familiarization Costs Given that we tried to align this rule as much as possible with the CDC DPRP Standards, there should be minimal regulatory familiarization costs. This rule impacts only enrolled MDPP suppliers and eligible beneficiaries who Start Printed Page 65634 have started the MDPP expanded model or are interested in MDPP.

11. treatment Administration Services In section II.J.1. Of this final rule, we are finalizing that effective January 1, 2022, CMS will pay $30 per dose for the administration of the influenza, pneumococcal and hepatitis B zithromax treatments. In addition, CMS will maintain the current payment rate of $40 per dose for the administration of the buy antibiotics treatments through the end of the calendar year in which the ongoing PHE ends.

Effective January 1 of the year following the year in which the PHE ends, the payment rate for buy antibiotics treatment administration will be set at a rate to align with the payment rate for the administration of other Part B preventive treatments. We estimate that the policy to increase the administration cost for influenza/pneumococcal/HBV treatment services to $30 in 2022 will increase Medicare spending by roughly $250 million in CY 2022. This estimate doesn't reflect the impact of induced utilization of the treatment, or any offsetting savings resulting from averted hospitalizations for those who would now get the treatment. This policy may encourage more health care providers to offer these services or encourage those that already offer these services to proactively identify and vaccinate more beneficiaries compared to what they might under the lower rates, which would result in further additional treatment costs.

However, if more beneficiaries were vaccinated then Medicare costs associated with the treatment of influenza, pneumonia, and hepatitis B could be reduced. In order to offset the costs associated with this policy roughly 10-11K influenza-related hospitalizations would have to be averted. 12. Medicare Provider and Supplier Enrollment Changes—Provider Enrollment As explained in section III.N.

Of this final rule, we proposed changes to three of our existing revocation reasons. We proposed to expand § 424.535(a)(2) to permit revocation based on the OIG exclusion of administrative or management services personnel furnishing services payable by a Federal health care program, such as a billing specialist, accountant, or human resources specialist. We proposed to expand § 424.535(a)(13) to permit revocation of a physician's or other eligible professional's enrollment if he or she surrenders his/her Drug Enforcement Administration (DEA) certificate of registration in response to an order to show cause. We proposed to revise the factors in § 424.535(a)(8)(ii) (which permits revocation based on a pattern or practice of submitting non-compliant claims) to better enable CMS to target shorter periods of non-compliant billing.

We believe that all three of these changes will result in an increase in the number of revocations that CMS imposes. However, we believe this number will be rather small. We currently impose only a limited number of revocations under §§ 424.535(a)(2), (a)(13), and (a)(8)(ii). Accordingly, since our expansion of these three revocation reasons will be fairly modest, we do not foresee more than a very slight increase in revocations.

Table 143 outlines the number of revocations we estimate will ensue under our revocation expansions. These numbers only account for additional revocations stemming from our changes. Internal CMS data indicates that the average provider/supplier that will be affected by these regulatory expansions receives roughly $50,000 in Medicare payments each year. (We used a similar $50,000 annual payment estimate for our provider enrollment provisions in the CY 2020 PFS final rule) (84 FR 62568)).

Providers/suppliers revoked under our revocation expansions will thus not receive these payments. Hence, multiplying our $50,000 estimate by the revocation totals in Table 143 results in a projected transfer from these providers/suppliers to the Federal Government of $750,000 ($50,000 × 15 revocations). We did not receive public comments on these estimates and are therefore finalizing them as proposed. 13.

Provider/Supplier Medical Review Requirements—Prepayment and Post-Payment Reviews In section III.N.2. Of this final rule, we proposed to. (1) Define key terms including “additional documentation,” “additional documentation request,” “post-payment medical review,” and “prepayment medical review;” (2) codify contractors' authority to request additional documentation for prepayment and post-payment review within established timeframes. (3) codify timeframes for response to requests for documentation.

And (4) codify result of a failure to comply with prepayment or post-payment documentation request(s) by a provider or supplier, specifically denial of payment. We do not believe these provisions involve any additional impact or burden on providers, suppliers, or States. However, we welcomed feedback from stakeholders regarding the potential costs of these provisions. The regulations will incorporate already established key terms and definitions as well as processing requirements pertaining to prepayment and post-payment medical review into regulation.

Placing this information in regulation will improve provider and supplier understanding of the medical review process and their responsibilities in complying with our review contractor's requests. Further, the regulations represent no change to medical review requirements. As such, we did not anticipate any change in the number of prepayment medical reviews, post-payment medical reviews or the number of additional documentation requests made by contractors. We did not receive public comments on this provision, and therefore, we are finalizing as proposed.

Start Printed Page 65635 14. Effect of Modifications to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs) As discussed in section III.O of this final rule, we are finalizing our proposal to allow OTPs to continue to furnish the therapy and counseling portions of the weekly bundles, as well as any additional counseling or therapy that is billed using the add-on code, using audio-only telephone calls rather than via two-way interactive audio-video communication technology in cases where audio/video communication is not available to the beneficiary after the conclusion of the PHE for buy antibiotics, provided all other applicable requirements are met. We believe this change will facilitate broader access to these services for beneficiaries. We are also finalizing our proposal to require that when these services are furnished using audio-only technology, practitioners certify that they had the capacity to furnish the services using two-way audio/video communication technology, but instead, used audio-only technology because audio/video communication technology was not available to the beneficiary.

We believe the Part B cost impact of these final policies will be minimal, since payment for therapy and counseling is included in the bundled payment regardless of the modality used to deliver it and we do not expect that this provision will increase the frequency at which medically necessary counseling and therapy services are billed using the counseling and therapy add-on code (HCPCS code G2080). Additionally, as discussed in section III.O. Of this final rule, the FDA recently announced the approval of a new, higher dose naloxone hydrochloride nasal spray product used to treat opioid overdose and that the newly approved product delivers 8mg of naloxone. In the CY 2021 PFS final rule (85 FR 84683 through 84685), we finalized payment for HCPCS code G2215 (Take-home supply of nasal naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program).

List separately in addition to code for primary procedure). HCPCS code G2215 was priced based on an assumption of a typical case in which the beneficiary will be provided with a box of two 4mg nasal spray products. At the time of drafting the proposed rule, we did not yet have any available pricing information for this newly approved product. However, in order to be able to make payment to OTPs under Medicare for this product, we proposed to create a new G-code describing a take-home supply of this higher dose naloxone hydrochloride nasal spray product.

After considering the comments received, we are finalizing our proposal to establish a new code for a higher-dose of naloxone hydrochloride nasal spray. We will price this code as proposed. The drug component is based on the methodology at § 410.67(d)(2)(i) and the amount of the non-drug component of the code is based on the CY 2020 Medicare payment rate for CPT code 96161, as updated by the MEI. Based on utilization of the existing naloxone codes under the OTP benefit, we believe that the cost impact of finalizing this new code will be minimal.

15. Physician Self-Referral Update The physician self-referral law provisions are discussed in section III.P. Of this final rule. As discussed in section III.P.2.

Of this final rule, we are amending the provisions of § 411.354(c)(2) identifying unbroken chains of financial relationships that constitute “indirect compensation arrangements” to ensure that a longstanding prohibition on certain per unit of service-based compensation formulas for determining charges for the rental of office space and equipment remains within the ambit of the law. This provision, which was inadvertently omitted when the definition of “indirect compensation arrangement” was revised in the December 2, 2020 final rule entitled “Modernizing and Clarifying the Physician Self-Referral Regulations” (85 FR 77492), is necessary to protect against potential abuses such as overutilization and anti-competitive behavior. We believe that most parties have continued to comply with the regulatory provisions on per unit of service-based compensation formulas for the rental (or lease) of office space and equipment as they have done since the requirements became effective on October 1, 2009. We are also adding provisions to assist stakeholders in identifying the individual unit to be analyzed under the provisions of § 411.354(c)(2)(ii)(A)(2)(i) through (iv).

We believe that the clarity provided by these provisions will facilitate compliance without adding burden. As discussed in section III.P.3. Of this final rule, we are finalizing our proposal to permit the use of the exception for preventive screening tests and treatments at § 411.355(h) for buy antibiotics treatments during such period as the treatments are not subject to CMS-mandated frequency limits, provided that all other requirements of the exception are satisfied. We believe that this provision will ensure that the physician self-referral law will not impede the availability of critically important buy antibiotics treatments for Medicare and other patients.

As discussed in section III.P.4. Of this final rule, we are finalizing our proposal to publish the Code List for Certain Designated Health Services (Code List) solely on the CMS website. Commencing after the publication of the January 1, 2022 Code List in this final rule, the Code List will be updated annually and published on the CMS website at https://www.cms.gov/​Medicare/​Fraud-and-Abuse/​PhysicianSelfReferral/​List_​of_​Codes. No less than 30 consecutive calendar days prior to the effective date of a Code List update, we will provide advance notice of the updated Code List on the CMS website.

We will also provide for a 30-day public comment period for each update using www.regulations.gov, and publish instructions for submitting comments on the CMS website. We will address all public comments that we receive through this process on the CMS website. Finally, we are revising the definition of “List of CPT/HCPCS Codes” at § 411.351 by updating the URL that indicates where the Code List is published on the CMS website. We believe that these provisions will facilitate compliance with the physician self-referral law and allow easier access to the most up-to-date Code List.

16. Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug under a Prescription Drug Plan or an MA-PD Plan (section 2003 of the SUPPORT Act) In addition to the cost reflected in the Collection of Information section of this final rule, we expect that there will be an additional burden for CMS to award and work with a CMS contractor to develop a process for reviewing the PDE data to assess prescriber compliance with the regulatory provision and review and process prescriber attestations. Based on similar contracts, and conversations with the industry, in the CY 2022 PFS proposed rule, we estimated the costs of (A) development of operational strategy for the new program, (B) reviewing PDE data, and (C) prescriber case work. We solicited stakeholder feedback on our estimate and all our assumptions.

(A) Development of policy. We estimated that it would take our contractor a week of work, 40 hours, to develop the strategy for how the contractor will process the prescriber attestations. We estimated that it would take an operations manager and compliance officer working together at a combined hourly wage of $193.60/hr Start Printed Page 65636 ($120.90/hr + $72.70/hr) a full 40-hour work week to operationalize this aspect of it. Therefore, we estimated the aggregate cost to be $7,744 (40hr * $193.60/hr).

(B) Since systems already exist to collect the appropriate PDE data, in our proposed rule, we stated that our contractor would only have to review the data for compliance with the EPCS mandate. Therefore, we estimated that it would take 2 computer systems analysts each working at $95.22/hr, a week and a half of work, 60 hours. Therefore, the aggregate cost would be $5,713.20 (60 hr * $95.22/hr). (C) We estimated that it would take 4 administrative support workers each working at $36.82/hr, 60 hours to generate the letters and disseminate them to the appropriate prescriber, which means that it would cost our contractor $2,209.20/year (60 hr * $36.82/hr) in administrative support costs.

We estimated that it would be the full-time job of a customer service representative working at $37.02/hr to field prescriber inquiries about the disseminated letters. Thus, we estimated that our contractor would spend $77,001.60 ($37.02/hr * 40 * 52) on the salary of the customer service representative for this task. The aggregate impact for our contractor is 200 hours at a cost of $92,668. We solicited comment on the accuracy of this burden estimate and on any measures that CMS can take to decrease the impact of this provision, while maintaining its utility and implementing the statutory mandate.

We did not receive public comments on the burden estimates for this provision, and therefore, we are finalizing as proposed. 17. Open Payments a. Payment Context Field for Teaching Hospitals This provision is for a mandatory freeform text context field.

We have created this provision at the request of stakeholders, particularly after conversations with teaching hospitals. The teaching hospitals confirmed that the majority of their disputes arise because of a lack of information within the record and an inability to associate the payment to the correct area within their large organization, not the inaccuracy of the record itself. The benefit of this field is to give better context to the records attributed to teaching hospitals and thereby reduce the number of disputes. For this reason, we also believe it will increase goodwill between the program's stakeholders.

The cost is that reporting entities will need to collect an additional piece of information, which will increase burden. We do not believe this burden will be great because the volume of reported teaching hospital payments is much lower than the volume of physician covered recipient payments. In addition, we have created flexibility with this field so that the reporting entity can choose which piece of information is most appropriate and can be something that they already collect, such as a check number or name of the department in the hospital. B.

Optional Annual Recertification The optional annual recertification is at the request of reporting entities and will increase the availability of communication to CMS. The burden associated with this action is low because it will be a low-effort process only completed by the entities who choose to do so. C. Defining a Physician-Owned Distributorship Since the program began in 2013, we have heard feedback that physician-owned distributorship (PODs) should be better represented in the data because the conflict of interest potentially created by PODs is at the heart of the program.

We created this new definition due to the lack of an existing POD definition that would be appropriate for the program's needs. Although this is a new definition, it will only be a subset of the existing definitions of applicable manufacturer and applicable group purchasing organization. €œApplicable manufacturer—POD” and “Group purchasing organization—POD” are already “business type” choices when registering in the Open Payments system. Therefore, this definition will not alter existing regulations beyond requiring PODs to identify themselves as such.

D. Disallowing Record Deletion Without Reason We believe there is not currently language to prevent an applicable manufacturer or applicable group purchasing organization from submitting and attesting to records, then deleting the records to prevent publication. This action would be contrary to the spirit of transparency of the program. To help ensure compliance with this requirement, we are also adding a new field that will allow entities to communicate the reason for the deletion to CMS.

Since the entities will have attested to the accuracy and completeness of these records, we believe it is appropriate to confirm the reason for the deletion. We have not perceived the behavior of inappropriate deletions within the data and do not believe it will increase burden beyond the additional field when deleting a record. We are preemptively closing a potential loophole. E.

Disallow Publication Delays of General Payments The statute requires that delays are “made pursuant to product research or development agreements and clinical investigations” (1128G(c)(1)(E) of the Act). A small number of general payments are delayed annually, which we are unable to verify meet this requirement. Research payments contain the appropriate fields to ensure that the statutory provisions are being met. We do not believe that it will be a burden for the small number of general payments to either be reported as research payments or not delayed.

F. Short-Term Loans Short-term loans are not required to be reported, but they must be shorter than 91 days to meet the exception. This provision does not create burden because it only clarifies that those 90 days must be the cumulative total for a year, which is already outlined in subregulatory guidance. We do not anticipate that this will change reporting behavior but want to explain the exception more clearly within the text of the final rule.

G. Remove General Ownership Records Ownership records have special rules for reporting outlined in the statute (section 1128G(a)(2) of the Act), which are not included in the format for general records. However, there is currently a general record for reporting ownership and investment interest (Nature of Payment = 11). We anticipate a small burden for the approximately 92 reporting entities who have previously used the general nature of payment category in order to fill out the different fields in the ownership record.

This burden will allow the records to meet statutory mandates. H. Updated Contact Information Open Payments conducts regular compliance-related outreaches to reporting entities when it encounters data that may not meet program requirements. We have found that the two contacts provided by applicable manufacturers and group purchasing organizations often become obsolete, especially if a company has not updated its contact information during the recertification process.

It is crucial for the integrity of the data that we have the ability to contact entities in the case of Start Printed Page 65637 irregularities. Additionally, we believe that ensuring informal communications from CMS will reduce burden since it may prevent more formal compliance actions if the entity is unresponsive due to outdated contact information. However, we do not believe this is an issue for the majority of reporting entities, nor do we believe that keeping the contact information updated will create a large burden. 18.

Updates to the Quality Payment Program In section IV.A. Of this final rule, we include our finalized policies for the Quality Payment Program. In this section, we first present the overall and incremental impacts to the number of expected QPs and associated APM Incentive Payments. In the following sections, we estimate the overall and incremental impacts to the total MIPS eligible population and the payment impacts by practice size for the CY 2022 performance period/2024 MIPS payment year based on various finalized policies, including policies to modify MIPS eligibility, the MIPS final score and the performance threshold and additional performance threshold as discussed in sections IV.A.3.a., IV.A.3.d., IV.A.3.e., and IV.A.3.f.

Of this final rule. For the MIPS payment adjustment, we ran two RIA models. A baseline and a final policies model. The aim of the baseline model is to model the status of our population of clinicians for the CY 2022 performance period/2024 MIPS payment year if this final rule does not take effect.

It therefore reflects previously finalized policies for the CY 2022 performance period/2024 MIPS payment year. Select examples of the baseline policies scheduled to start in the CY 2022 performance period/2024 MIPS payment year include the removal of the Web Interface as a collection type and the change in the performance category weights. There was no defined performance threshold or additional performance threshold, so our baseline model assumed the performance threshold and additional performance threshold used for the previous period (CY 2021 performance period/2023 MIPS payment year). The aim of the final policies model is to estimate the incremental effect of the final policies for the CY 2022 performance period/2024 MIPS payment year on MIPS eligibility, MIPS final scores, and payment adjustments.

In other words, by comparing the difference between our baseline model and our final policies model we can estimate the incremental impact of finalizing the policies contained in this final rule. Select examples of the finalized policies include, the inclusion of new MIPS eligible clinician types, the inclusion of the Web Interface as a collection type, the change in performance threshold and additional performance threshold, and the changes to the complex patient bonus. Refer to section VI.F.18.e.(2) of this final rule for the detailed methods on how we integrated the policies into the baseline and final policies models. A.

Assessing Use of 2020 Data for Estimating Future MIPS Performance In the 2022 PFS proposed rule (86 FR 39546), we stated that the RIA used the 2019 MIPS performance period data because the data for the 2020 MIPS performance period were not available in time to incorporate into the proposed rule model. We noted we would evaluate whether it is appropriate to use the 2020 performance period data to predict performance in CY 2022 for the final rule and whether adjustments would need to be made if CY 2020 performance period data are used. We have already acknowledged some data from the CY 2020 performance period is not usable. For example, we have stated that based on our analysis of the 2020 performance period data, we could not reliably calculate scores for the cost measures that would adequately capture and reflect the performance of MIPS eligible clinicians.

As a result, we reweighted the cost performance category for all MIPS eligible clinicians for the CY 2020 MIPS performance period.[] Additionally, in section IV.A.3.f.(2) of this final rule, we noted we have final score data for the CY 2020 performance period/2022 MIPS payment year available to use in our assessment of whether to use the mean or median for the performance threshold, but the data for the CY 2020 performance period/2022 MIPS payment year may be subject to change as a result of the targeted review process. However, we have also indicated that for certain purposes 2020 performance period data could be beneficial too. As discussed in section IV.A.3.e.(1)(c)(ii) of this final rule, we believe 2020 performance period data is appropriate to use for historic benchmarks in part because it is the most recent available dataset and it reflects a performance period in which clinicians were facing the PHE. To evaluate whether the 2020 MIPS performance period data is appropriate to use to predict future performance, we considered whether the extreme and uncontrollable circumstances policy impacted submissions and data, and whether the buy antibiotics PHE impacted services provided (for example, quality measures, the number of MIPS eligible clinicians, claims).

For the 2020 performance year, we applied the MIPS automatic extreme and uncontrollable circumstances policy to all individual MIPS eligible clinicians and allowed for extreme and uncontrollable applications due to the buy antibiotics PHE ( https://qpp.cms.gov/​resources/​buy antibiotics19?. €‹py=​2020 ). Due to these extreme and uncontrollable circumstances policies, not all clinicians or groups may have submitted data for the 2020 MIPS performance period. When we evaluated whether the 2020 MIPS performance period data is appropriate to use to estimate 2022 MIPS performance period performance for MIPS eligible clinicians, we compared the 2020 MIPS performance period data to the 2019 MIPS performance period data on key metrics.

Overall, we observed a decrease in the number of MIPS eligible clinicians at the individual level who exceed the low-volume threshold. We also observed a decline in data submitted by individual and group. Finally, when examining actual scores and payment information for the 2020 performance period/2022 MIPS payment year compared to the 2019 performance period/2021 MIPS payment year, we found an increase in the number of MIPS eligible clinicians receiving a neutral score. However, our initial findings suggest the extreme and uncontrollable circumstances policy combined with the buy antibiotics PHE limit the data needed to simulate future MIPS eligible population and associated performance.

Therefore, this RIA uses the 2019 MIPS performance period submissions which were used for the CY 2021 PFS final rule RIA (85 FR 85011 through 85023) and CY 2022 PFS proposed rule RIA (86 FR 39545 through 39556). We note that the findings are specific for purposes of estimating future performance for the entire population of MIPS eligible clinicians. B. Estimated APM Incentive Payments to QPs in Advanced APMs and Other Payer Advanced APMs For payment years 2019 through 2024, through the Medicare Option, eligible clinicians with a sufficient percentage of Medicare Part B payments for covered professional services or Medicare patients through Advanced APMs will be QPs in the applicable QP performance period for a year.

These QPs will receive a lump-sum APM Incentive Payment equal to 5 percent of Start Printed Page 65638 their estimated aggregate paid amounts for Medicare covered professional services furnished during the calendar year immediately preceding the payment year. Beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the All-Payer Combination Option. The All-Payer Combination Option allows eligible clinicians to become QPs by meeting the QP payment amount or patient count threshold through a pair of calculations that assess a combination of both Medicare Part B covered professional services furnished or patients through Advanced APMs and services furnished or patients through Other Payer Advanced APMs. Eligible clinicians who become QPs for a year are not subject to MIPS reporting requirements and payment adjustments.

Eligible clinicians who do not become QPs but meet a lower threshold to become Partial QPs for the year may elect to report to MIPS and, if they elect to report, will then be scored under MIPS and receive a MIPS payment adjustment. Partial QPs are not eligible to receive the APM Incentive Payment. If an eligible clinician does not attain either QP or Partial QP status and does not meet any other exemption category, the eligible clinician will be subject to MIPS, will report to MIPS, and will receive the corresponding MIPS payment adjustment. Beginning in payment year 2026, the update to the PFS CF for services that are furnished by clinicians who achieve QP status for a year is 0.75 percent, while the update to the PFS CF for services that are furnished by clinicians who do not achieve QP status for a year is 0.25 percent.

In addition, MIPS eligible clinicians will receive positive, neutral, or negative MIPS payment adjustments to payment for their Part B PFS services in a payment year based on performance during a prior performance period. Although the statute establishes overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the 2024 MIPS payment year of the Quality Payment Program. Overall, we estimate that for the 2022 QP Performance Period between 225,000 and 290,000 eligible clinicians will become QPs. Therefore, they will be excluded them from MIPS and will qualify for the lump sum APM incentive payment in Payment Year 2024 based on 5 percent of their Part B paid amounts for covered professional services in the preceding year.

These paid amounts for QPs are estimated to be between approximately $12,000 million and $15,000 million in total for the 2022 performance year. The analysis for this final rule used the 2020 third snapshot participation file. We based APM Incentive Payment Amounts on paid amounts with service dates of January 1, through September 30, 2020. We multiplied the calculated amounts by 1.5 to approximate payment amounts for the full calendar year.

We estimate that the total lump sum APM Incentive Payments will be approximately $600-750 million for the 2024 Quality Payment Program payment year. In section VI.F.18.a. Of this final rule, we projected the number of eligible clinicians that will be QPs, and thus excluded from MIPS, using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs.

The projections reflect Advanced APMs that will be operating during the 2022 QP Performance Period as well as some Advanced APMs anticipated to be operational during the 2022 QP Performance Period. The projections also reflect an estimated number of eligible clinicians that will attain QP status through the All-Payer Combination Option. We note that the Kidney Care Choices Model and the Radiation Oncology model have been included in our analysis as we anticipate that the model will be Advanced APMs in 2022. Additionally, we anticipate that the Maryland Primary Care Program will not be an Advanced APMs in 2022.

The following APMs are expected to be Advanced APMs for the 2022 QP Performance Period. Bundled Payments for Care Improvement Advanced Model. Comprehensive Care for Joint Replacement Payment Model (CEHRT Track). Global and Professional Direct Contracting Model.

Kidney Care Choices Model (Kidney Care First. Professional Option and Global Option). Maryland Total Cost of Care Model (Care Redesign Program). Medicare Shared Savings Program (Basic Track Level E, and the ENHANCED Track).

Oncology Care Model (Two-Sided Risk Arrangements). Primary Care First (PCF) Model. Radiation Oncology model. And, Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative).

We used the Participation Lists and Affiliated Practitioner Lists, as applicable, (see 81 FR 77444 through 77445 for information on the APM Participant Lists and QP determinations) on the 2020 third snapshot participation file to estimate the number of QPs, total Part B paid amounts for covered professional services, and the aggregate total of APM Incentive Payments for the 2022 QP Performance Period. We examined the extent to which Advanced APM participants will meet the QP Thresholds of having at least 50 percent of their Part B covered professional services or at least 35 percent of their Medicare beneficiaries furnished Part B covered professional services through the APM Entity. C. Impact for the CY 2021 Performance Period/2023 MIPS Payment Year In section IV.A.3.e.(2)(a)(ii) of this final rule, we finalize our proposal to double the complex patient bonus, and to increase its cap to 10 points for the CY 2021 Performance Period/2023 MIPS Payment Year.

We expect this policy to result in an increase of 3 points in the median bonus thus increasing MIPS final scores at the median by 3 points. We do not know the effects of the PHE for buy antibiotics and its effect on MIPS performance in 2021, so we did not recreate the analysis and payment distributions with the updated bonus for the CY 2021 performance period/2023 MIPS payment year (85 FR 85012 through 85019). The increase in complex patient bonus points will result in smaller payment adjustments for three reasons. First, the resulting increase in final scores will reduce the budget neutral pool.

Second, the increase in complex patient bonus points will increase the number of clinicians with scores above the performance threshold or additional performance threshold, meaning more clinicians will share in the budget neutral pool and additional $500 million for exceptional performance and potentially lower the scaling factor that is applied to the MIPS payment adjustment and additional payment adjustment. Third, the average scores of those receiving a positive or additional adjustment will be higher, which means the adjustment rates for clinicians that have scores above the performance threshold or additional performance threshold will be lower. D. Estimated Number of Clinicians Eligible for MIPS Eligibility for the CY 2022 Performance Period/2024 MIPS Payment Year (1) Methodology To Assess MIPS Eligibility (a) Clinicians Included in the Model Prior To Applying the Low-Volume Threshold Exclusion To estimate the number of MIPS eligible clinicians for the CY 2022 performance period/2024 MIPS payment year and the effect of the final Start Printed Page 65639 policies in this final rule, we ran two models as described in section VI.F.18., a baseline model and final policies model.

For the baseline and final policies models, we used the same eligibility files and approach described in the CY 2021 PFS final rule (85 FR 85013) which resulted in the inclusion of 1.6 million clinicians who had PFS claims from October 1, 2018 to September 30, 2019, as well as additional clinicians associated with a group who had at least one PFS claim from October 1, 2019, through December 31, 2019. We used the same exclusion criteria to exclude clinicians from our MIPS eligibility assessment as described in the CY 2021 PFS final rule RIA (85 FR 85013) with the following model updates. (1) In both the baseline and final policies models, we excluded practitioners in Next Generation ACOs because the Next Generation ACO model ends in the CY 2021 MIPS performance period. (2) In both the baseline and final policies models, to determine which clinicians in the initial population of 1.6 million should be excluded as QPs, we used Advanced APM payment and patient percentages from the APM Participant List for the final snapshot date for the 2019 QP performance period.

We elected to use this data source because the APM participant list for the 2019 final snapshot can reliably be used for RIA projections. From this data, we calculated the QP and Partial QP determinations as described in section of IV.A.4.c.(1)(b) of this final rule for the 2022 QP performance period for both models. (3) In the final policies model, we included in our estimated MIPS eligible population for the CY 2022 performance period/2024 MIPS payment year clinical social workers and CNMs as finalized in section IV.A.3.a.(1) of this final rule. (4) In the final policies model, we are integrating the provision that starting with the CY 2022 MIPS performance period/2024 MIPS payment year, small practices, excluding virtual groups, must submit data as a group in any performance category to indicate that they wish to be scored as a group for Medicare Part B claims.

This affects eligibility because previously a single Medicare Part B claims submission, without any other submission, started a group score. Once a group score is created, a clinician who was individually excluded from MIPS for being under the low-volume threshold, may now be eligible if the group exceeds the low-volume threshold. This policy is described at section IV.A.3.a.(3) of this rule. (b) Assumptions Related To Applying the Low-Volume Threshold Exclusion The low-volume threshold policy may be applied at the individual (TIN/NPI) or group (TIN) levels based on how data are submitted including under the APM Entity level if the clinician is part of an APM Entity in a MIPS APM (hereafter, a MIPS APM Entity) that elects to submit to MIPS.

A clinician or group that exceeds at least one but not all three low-volume threshold criteria may become MIPS eligible by electing to opt-in and subsequently submitting data to MIPS, thereby getting measured on performance and receiving a MIPS payment adjustment. For the final policies model, we describe below the estimated MIPS eligibility status and the associated PFS allowed charges of clinicians in the initial population of 1.6 million clinicians. We present in section VI.F.18.d.(1)(c) the incremental impact of the final policies from the baseline model for the CY 2022 performance period/2024 MIPS payment year on the MIPS eligible clinician population and their associated PFS allowed charges. We applied the same assumptions presented in the CY 2021 PFS final rule RIA to apply the low-volume threshold and to understand whether clinicians participate as a group, virtual group, APM entity, or as individuals (85 FR 85013 through 85016), except for three modifications.

We assumed only individuals or APM TINs that exceeded the low-volume threshold will receive an APM Performance Pathway (APP) score consistent with the policy as finalized in the CY 2021 PFS final rule (85 FR 84897).[] We assumed APM TINs that qualified for opt-in and submitted data as a TIN will also be eligible. Finally, we did not consider clinicians in groups as MIPS eligible clinicians nor start a group score for clinicians in small practices with only Medicare Part B claims submissions to reflect the policy finalized at section IV.A.3.a.(3) of this rule. Table 144 summarizes our eligibility estimates for the final policies model. We identify approximately 212,000 clinicians [] as having “required eligibility” in Table 144.

These clinicians will be MIPS eligible because they exceed the low volume threshold as individuals and are not otherwise excluded. These clinicians may ultimately choose to participate in MIPS as an individual, group, virtual group or APM entity or to not participate. Regardless of how they participate they will be considered MIPS eligible. We estimate approximately 595,000 additional MIPS eligible clinicians will be eligible as “group eligibility” in Table 144.

These clinicians belong to an APM entity, group or virtual group that meets the low-volume threshold and submits to MIPS. If they were not associated with the group submission, these clinicians would not be eligible for MIPS. Finally, we estimate about 3,000 clinicians will be eligible through “opt-in eligibility” through the “opt-in” policy for a total MIPS eligible clinician population of approximately 810,000. This leads to an associated $67 billion allowed PFS charges estimated to be included in the CY 2022 performance period/2024 MIPS payment year.

Start Printed Page 65640 Furthermore, we estimate there will be approximately 412,000 clinicians as “Potentially MIPS eligible” in Table 144. These clinicians are not MIPS eligible but could be if their practice decides to participate or they elect to opt-in. These clinicians will be included as MIPS eligible in the unlikely scenario in which all group practices elect to submit data as a group, or clinicians in a group that does not submit are eligible to opt-into MIPS individually and choose to do so. This assumption is important because it quantifies the maximum number of MIPS eligible clinicians.

When this unlikely scenario is modeled, we estimate the MIPS eligible clinician population could be as high as 1.2 million clinicians. Finally, we estimate approximately 101,000 clinicians will not be MIPS eligible because they and their group are below the low-volume threshold on all three criteria and another approximately 304,000 will not be MIPS eligible because they are categorically excluded regardless of volume or submission activity. Eligibility among many clinicians is contingent on submission to MIPS as a Start Printed Page 65641 group, virtual group or election to opt-in, therefore we will not know the number of MIPS eligible clinicians who submit until the submission period for the 2022 MIPS performance period is closed. For this final policies model analysis, we use the estimated population of 809,593 MIPS eligible clinicians described above.

(c) Estimated Impact of the Final Policies on MIPS Eligibility and PFS Allowed Charges We illustrate in Table 145 how the final policies to add clinical social workers and CNMs as MIPS eligible clinician types and the policy to require small practices to submit data as a group for a group quality performance category score as finalized in sections IV.A.3.a.(1) and IV.A.3.a.(3) of this final rule affects the estimated number of MIPS eligible clinicians. The amended regulation text that we finalized in section IV.A.3.a.(2) of this final rule does not make modify how we assess eligibility in MIPS in our final policies model. The first row in Table 145 presents the estimates from the RIA baseline model with the number of individuals that will be MIPS eligible clinicians for the 2022 performance period/2024 MIPS payment year if this rule does not take effect. The second row presents estimates from the RIA final policies model with the incremental impact of adding the two new MIPS eligible clinician types on the number of MIPS eligible clinicians for the CY 2022 performance period/2024 MIPS payment year.

As shown in Table 145, the final policies lead to a small increase in the number of MIPS eligible clinicians (1.1 percent increase) and a minimal increase in the PFS allowed charges (0.1 percent increase) for the CY 2022 performance period/2024 MIPS payment year. e. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 2022 Performance Period/2024 MIPS Payment Year (1) Summary of Approach In sections IV.A.3.d., IV.A.3.e. And IV.A.3.f.

Of this final rule, we present several provisions which impact the measures and activities that impact the performance category scores, final score calculation, and the MIPS payment adjustment. We discuss these changes in more detail in section VI.F.18.e.(2). Of this RIA as we describe our methodology to estimate MIPS payments for the CY 2022 performance period/2024 MIPS payment year. We then present the impact of the overall final policies on the CY 2022 performance period/2024 MIPS payment year and then compare select metrics to the baseline model, which only incorporates previously finalized policies for the CY 2022 performance period/2024 MIPS payment year.

By comparing the baseline model to the final policies model, we can estimate the incremental impact of this rule's policies to the CY 2022 performance period/2024 MIPS payment year. The payment impact for a MIPS eligible clinician is based on the clinician's final score, and MIPS eligible clinicians can participate as an individual, group, virtual group, or APM Entity in the four MIPS performance categories. Quality, cost, improvement activities, and Promoting Interoperability. As discussed in section VI.F.18.

Of this final rule, we generally used data submitted for the 2019 performance period. For the cost performance category, we used the same data as the CY 2020 PFS final rule (84 FR 63169), which is primarily testing data for the cost measures. The estimated payment impacts presented in this final rule are averages by practice size weighted by Medicare utilization. The payment impact for a MIPS eligible clinician will vary from the average and will depend on the measure submissions, scores and their performance.

(2) Methodology To Assess Impact To estimate participation in MIPS for the CY 2022 performance period/2024 MIPS payment year for this final rule, we generally used 2019 MIPS performance period data for both the baseline and final policies models. Our baseline and final policies scoring models included the 801,013 and 809,593 estimated MIPS eligible clinicians, respectively, as described in section VI.F.18.d.(1) of this RIA. To estimate the impact of MIPS policies on MIPS eligible clinicians, we generally used the 2019 MIPS performance period submissions data, including data submitted for the quality, improvement activities, and Promoting Interoperability performance categories. We supplemented this information with 2019 data available for CAHPS for MIPS and CAHPS for ACOs, testing data for the revised total per capita cost measure and Medicare Spending Per Beneficiary (MSPB) clinician measures which were finalized in the CY 2020 PFS final rule (84 FR 62969 through 62977), testing data for the new episode cost measures, administrative claims data for the new quality performance category measures, and other data sets.[] We calculated a hypothetical final score for the 2022 performance period/2024 MIPS Start Printed Page 65642 payment year for the baseline and final policies scoring models for each MIPS eligible clinician using score estimates for quality, cost, Promoting Interoperability, and improvement activities performance categories, where each are described in detail in the following subsections.

(a) Methodology To Estimate the Quality Performance Category Score We estimated the quality performance category score using a methodology like the one described in the CY 2021 PFS final rule (85 FR 85016 through 85017) for baseline and final policy RIA models for the CY 2022 performance period/2024 MIPS payment year. For the baseline policies RIA model, which does not reflect the final policies for CY 2022 performance period/2024 MIPS payment year from this final rule, we made the following modifications to reflect the previously finalized policies for the CY 2022 performance period/2024 MIPS payment year for the quality performance category. As previously finalized in the CY 2021 PFS final rule (85 FR 84870 and 85 FR 84843), we removed the Web Interface as a collection type in MIPS and through the APP for the CY 2022 performance period/2024 MIPS payment year. Although the Web Interface is to be reinstated for groups for the CY 2022 performance period/2024 MIPS payment year and ACOs for CY 2022 performance period/2024 MIPS payment year through CY 2024 performance period/2026 MIPS payment year as discussed in sections IV.A.3.d.(1)(d) and IV.A.3.c.(2)(a), respectively, the baseline model is attempting to capture the CY 2022 performance period/2024 MIPS payment year as if this provision did not exist.

Therefore, the baseline model does not incorporate the Web Interface as a collection type for groups and ACOs. To estimate a quality performance category score for clinicians in groups who previously used the Web Interface as a collection type in 2019, we assumed these groups will use the other two other collection types (MIPS CQMs and eCQMs) available in the 2022 performance period/2024 MIPS payment year. We then applied the same methodology described in the CY 2021 PFS proposed rule when the removal of Web Interface as a collection type was previously proposed (85 FR 50387 through 50388) using 2019 MIPS submissions data. To estimate a quality performance category score for ACOs, we used the same methodology described in the CY 2021 PFS proposed rule when the Web Interface was not included in the APP (85 FR 50388).

• We used the published 2021 MIPS historical quality benchmarks file to identify measures subject to the topped out scoring cap that was finalized (82 FR 53721 through 53727).[] For the final policies model, we made the following modifications to the baseline model to reflect the new final policies for the 2022 performance period/2024 MIPS payment year for the quality performance category. As discussed in section IV.A.3.d.(1)(e) of this final rule, we finalized one new administrative claims measure for those for whom it is applicable. Clinician and Clinician Group Risk-standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions. To implement this policy in our final policies RIA model for the CY 2022 performance period/2024 MIPS payment year, we used testing data for this new administrative claims measure.

As discussed in section IV.A.3.d.(1)(c) of this final rule, we are finalizing our proposals with modification to maintain the data completeness criteria threshold of at least 70 percent for the CY 2021, CY 2022, and CY 2023 performance periods/2023, 2024, and 2025 MIPS payment years for QCDR measures, MIPS CQMs, or eCQMs. This is not a change from our baseline model assumptions. As discussed in section IV.A.3.d.(1)(e) of this final rule, we are finalizing our proposal to establish measure substantive change criteria. We did not make modifications to the final policies model for this policy.

We scored measures using the benchmarks described below. In section IV.A.3.d.(1)(g) of this final rule, we are finalizing several changes to the CAHPS for MIPS survey. We did not incorporate these changes into our model due to the lack of data. In Appendix 1 of this final rule, we added 4 new quality measures, removed 13 measures, and finalized 87 substantially modified measures.

Consistent with prior rules, (83 FR 50053), our RIA estimates assume that clinicians who reported Medicare Part B claims, eCQM, MIPS CQM and QCDR measures that are removed would find alternate measures. Therefore, we assign points to the measures that and included them in our scoring model. • As discussed in section IV.A.3.e.(1)(c)(ii) of this final rule, we did not finalize our proposal to use performance period benchmarks for the CY 2022 performance period in accordance with § 414.1380(b)(1)(ii) as opposed to a historical benchmark. For the final policies model, we utilized the most recent benchmark file.

The 2021 MIPS performance period historic benchmarks.[] However, the 2019 performance data we are using to estimate future performance includes data on measures that do not have a benchmark in the 2021 MIPS benchmark file (either because the measure was removed or because there were significant changes). If a benchmark was not available in the 2021 MIPS performance period historic benchmark file, then we supplemented the 2021 MIPS benchmark file with the benchmarks used for the CY 2019 performance period/2021 MIPS payment year. As discussed in section IV.A.3.e.(1)(c)(iii)(A) of this final rule, we are delaying our proposal to remove the 3-point floor for each measure that can be reliably scored against the benchmark and score the measure from 1 to 10 points until the CY 2023 performance period/2025 MIPS payment year. Similarly, we are delaying our proposal in section IV.A.3.e.(1)(c)(iii)(B) of this final rule to remove the special scoring policy of scoring 3 points for class 2 measures, except for clinicians in small practices until the CY 2023 performance period/2025 MIPS payment year.

Therefore, our RIA for the CY 2022 performance period/2024 MIPS payment year re-established the 3-point floor for class 1 measures and 3 points for class 2 measures. • As discussed in section IV.A.3.e.(1)(c)(iii)(B), we are finalizing our proposed policies for scoring new measures with modifications. For measures in their first two performance periods that meet data completeness and can be reliably scored against a benchmark (class 4a measures), we will assign a floor of 7 points for measures in their first year and a floor of 5 points for measures in their second year. For new measures in their first two performance periods that meet data completeness, but cannot be reliably scored against a benchmark because they lack a benchmark or do not meet case minimum in the program (class 4b measures), we will assign 7 points for measures in their first year and 5 points for measures in their second year.

We incorporated these scoring changes into our final policies model. Because we are using 2019 MIPS performance period Start Printed Page 65643 data, we assume that measures new to MIPS in 2019 are in their first year and measures new to MIPS in 2018 are in their second year. As discussed in sections IV.A.3.e.(1)(c)(vii) and IV.A.3.e.(1)(c)(viii) of this final rule, we finalized our proposal to remove measure bonus points for reporting high priority measures and for submitting with end-to-end electronic reporting beginning in the 2022 MIPS performance period. We incorporated these scoring changes into our final rule model for all MIPS collection types.

As discussed in section IV.A.3.d.(1)(d), we are extending the Web Interface measures for the CY 2022 performance period/2024 MIPS payment year for groups and virtual groups using the existing 10 CMS Web Interface measures. To estimate the impact of this policy, we used the same methodology described in the CY 2021 PFS final rule (85 FR 85016 through 85017) using 2019 MIPS submissions data. Finally, we will extend the CMS Web Interface as a means of reporting quality under the APM Performance Pathway for Shared Savings Program ACOs for the 2022 performance period/2024 MIPS payment year through the 2024 performance period/2026 MIPS payment years as described in section IV.A.3.c.(2)(a) of this final rule. Under the provision, Web Interface reporting will work in the same manner as for performance year 2021, where ACOs will have the option of reporting either the CMS Web Interface, the APP eCQM/MIPS CQM measure set, or both.

To estimate the impact of this policy, we used the same methodology described in the CY 2021 PFS final rule RIA (85 FR 85016 through 85017) when Web Interface was retained for the APP. (b) Methodology To Estimate the Cost Performance Category Score We estimated the cost performance category score using a similar methodology described in the CY 2020 PFS final rule (84 FR 63169) with the modifications to the baseline and the final policies RIA model described in this section. In the baseline model, we refined our methodology for developing benchmarks to better reflect the previously finalized policy in CY 2017 Quality Payment Program final rule (81 FR 77308 through 77309). We did not estimate cost improvement scoring that starts in the 2022 performance period/2024 MIPS payment year as previously finalized at § 414.1380(a)(1)(ii) and in the CY 2019 PFS final rule (83 FR 58956) since we did not have sufficient data to conduct improvement scoring, which requires 2 years of cost data to model.

In the final policies model, we modified the baseline model to incorporate the provision to add five new episode-based cost performance category measures in the CY 2022 performance period/2024 MIPS payment year as described in section IV.A.3.d.(2) of this final rule, by using claims data from January 1, 2019 to December 31, 2019. Cost measures were scored if the clinicians or groups met or exceeded the case volume. 10 episodes for Melanoma Resection to align with the reporting case minimum for procedural cost measures currently in use in MIPS, 20 episodes for Sepsis to align with the reporting case minimum for acute inpatient condition cost measures currently in use in MIPS, 20 episodes for Diabetes and Asthma/COPD as used in field testing for these chronic measures, and 20 episodes for Colon Resection. These new cost episode-based measures were calculated for both the TIN/NPI and the TIN.

(c) Methodology To Estimate the Facility-Based Measurement Scoring For the baseline model, we estimated the facility-based score using the scoring policies finalized in the CY 2018 Quality Payment Program final rule (82 FR 53763) and the methodology described in the CY 2020 PFS final rule (84 FR 63169). For the final policies model, we used the methodology for the CY 2022 performance period/2024 MIPS payment year as discussed in section IV.A.3.e.(2)(b)(v)(B) of this final rule. We proposed at § 414.1380(e)(vi) that beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology unless a clinician or group receives a higher MIPS final score through another MIPS submission. Therefore, if a MIPS eligible clinician or a group is eligible for facility-based measurement, but they participate in MIPS as an individual or group, we used the higher final score between the facility-based scoring and MIPS submission-based scoring.

(d) Methodology To Estimate the Promoting Interoperability Performance Category Score For the baseline model, we used the CY 2019 MIPS Promoting Interoperability performance period data submissions data to estimate CY 2022 MIPS performance for the Promoting Interoperability performance category. We made the following two modifications to the 2019 performance period scoring to reflect the previously finalized policy changes between the CY 2019 and CY 2021 performance periods. (1) We doubled the bonus points for clinicians who submitted the PDMP measure as described in section IV.A.3.d.(4)(c)(i) of this final rule. And (2) we did not incorporate the Verify Opioid Treatment Agreement measure data, a measure that was finalized in the CY 2019 performance period (83 FR 59807) but removed in the CY 2020 performance period (84 FR 62994).

We retained the PDMP bonus for the baseline model for continuity between the CY 2021 and 2022 performance periods and for consistency since bonuses for the quality performance category were retained for the baseline as well. Because we lacked data on who would adopt the finalized Health Information Exchange bi-directional exchange measure for the CY 2021 performance period we only used past reporting on the two existing Health Information Exchange Objective measures to estimate CY 2022 Promoting Interoperability performance. For the final policies model, we considered the following policy provisions as potential modifications to the baseline model. In section IV.A.3.d.(4)(c)(i) of this final rule, we finalized our proposal for the PDMP measure to remain optional and at 10 points.

Modifications were not made to reflect this policy in the final policies model since the baseline model already incorporated this policy. In section IV.A.3.d.(4)(c)(ii) of this final rule, we did not finalize our proposed modifications to the Provide Patients Electronic Access to Their Health Information measure. For this model, we did not make any modifications and continued to use the Provide Patients Electronic Access to Their Health Information measure that was submitted for the 2019 MIPS performance period. • In section IV.A.3.d.(4)(c)(iii) of this final rule, we finalized to require two of the measures associated with the Public Health and Clinical Data Exchange Objective, beginning with the CY 2022 performance period.

Immunization Registry Reporting. And Electronic Case Reporting. We also finalized in section IV.A.3.d.(4)(c)(iii) of this final rule to retain the Public Health Registry Reporting, Clinical Data Registry Reporting, and Syndromic Surveillance Reporting measures, and to make them optional and available for bonus points beginning with the CY 2022 performance period/2024 MIPS payment year. We did not model these policy changes because the Promoting Start Printed Page 65644 Interoperability data we used for this analysis is based on the CY 2019 performance period when a clinician was only required to report two of the possible 5 measures for the Public Health and Clinical Data Exchange Objective.

We believe incorporating this policy might artificially lower scores for the Public Health and Clinical Data Exchange Objective because there was no requirement to specifically report the Immunization Registry Reporting and Electronic Case Reporting measures in 2019. In section IV.A.3.d.(4)(d) of this final rule, we finalized the additional requirement that eligible clinicians must attest to conducting an annual assessment of the High Priority Guide of the SAFER Guides beginning with the 2022 performance period. This policy was not implemented in the final policies model as it does not affect eligibility or payment. We included this policy in our burden calculations in section V.B.8.g.(3) of this rule.

In section IV.A.3.d.(4)(g) of this final rule, we finalized changes to the attestation statements for information blocking. We did not include this policy in our model due to lack of information. In section IV.A.3.d.(4)(h)(i) of this final rule, we finalized beginning with the CY 2022 performance period/2024 MIPS payment year, we will no longer require an application for clinicians and small practices seeking to qualify for the small practice hardship exception and reweighting. We will assign a weight of zero only in the event a small practice did not submit any data for any of the measures specified for the Promoting Interoperability performance category.

This policy was implemented in the final policies model. In section IV.A.3.d.(4)(h)(ii) and IV.A.3.d.(4)(h)(iii) of this final rule, we finalized our proposal to continue the existing policy to reweight the Promoting Interoperability performance category for NPs, PAs, CRNAs, CNSs, physical therapists, occupational therapists, qualified speech-language pathologist, qualified audiologists, clinical psychologists, and registered dieticians or nutrition professionals for the CY 2022 performance period/2024 MIPS payment year. The baseline model already incorporated this policy. In section IV.A.3.d.(4)(h)(iv), we finalized that we will apply the same Promoting Interoperability reweighting policy we adopted previously for NPs, PAs, CNSs, CRNAs, and other types of MIPS eligible clinicians to clinical social workers.

This policy was implemented in the final policies model. (e) Methodology To Estimate the Improvement Activities Performance Category Score For the baseline model, we modeled the improvement activities performance category score based on CY 2019 performance period data and APM participation identified in section VI.F.18.d.(1) of this final rule. For clinicians and groups not participating in a MIPS APM, we used the CY 2019 submissions improvement activities score. We did not model the policy finalized for the CY 2020 performance period (84 FR 62980) to require a minimum threshold of 50 percent of clinicians in a group to complete an improvement activity for the group to receive credit since we did not have data to determine the proportion of clinicians in a group that completed the improvement activity.

We continued to apply the methodology described in the CY 2020 PFS final rule (84 FR 63170) to assign an improvement activities performance category score. For the APM participants identified in section VI.F.18.d.(1) of this final rule, we assigned an improvement activity performance category score of 100 percent. For the final policies model, we did not make modifications to the baseline model for the improvement activities changes finalized in section IV.A.3.d.(3) of this final rule. The final policies are (1) revise group reporting requirements for the 50 percent threshold to address subgroups.

(2) revise the timeframe for improvement activities nominated during a PHE. (3) revise the required criteria for improvement activity nominations received through the Annual Call for Activities. (4) suspend activities that raise possible safety concerns or become obsolete from the program when this occurrence happens outside of the rulemaking process. (5) add 7 new improvement activities, modify 15 existing improvement activities, and remove 6 previously adopted improvement activities.

(6) revise the “Drug Cost Transparency to include requirements for use of real-time benefit tools” improvement activity. And (7) add the buy antibiotics “Clinical Data Reporting with or without Clinical Trial” improvement activity. For policy 1, we lacked data to model the impact on improvement activities performance category. Policies 2 and 3 are related to the call for improvement activities which does not affect the improvement activities performance category scores.

Policies 4 through 7 address changes to specific improvement activities or the improvement activity inventory. We anticipate most clinicians performing improvement activities will continue to identify and report similar improvement activities from the inventory in future years. Please see section VI.F.18.g.(2)(f) of this final rule for additional details on the impact of these policy changes. (f) Methodology To Estimate the Complex Patient Bonus Points In section IV.A.3.e.(2)(a)(iii)(B) of this final rule, we will continue to apply the complex patient bonus, with updates, for the CY 2022 performance period/2024 MIPS payment year.

For the baseline model, we used the complex patient bonus information calculated for the 2019 performance period data for the CY 2022 performance period/2024 MIPS payment year, as was previously done in the CY 2021 PFS final rule (85 FR 85017). For the final policies model, we calculated the complex patient bonus using the calculation in section IV.A.3.e.(2)(a)(iii)(B) of this final rule for the CY 2022 performance period/2024 payment year. We finalized updates to the complex patient bonus for the CY 2022 performance period/2024 MIPS payment year and future MIPS performance periods/payment years to account for social and medical complexity, while still using our current established indicators of dual proportion and HCC risk scores, respectively. Consistent with the policy for the 2022 performance period, our final policies RIA model calculated and applied the separate risk indicator complex patient bonus components methodology with a single overall cap.

(g) Methodology To Estimate the Final Score We did not make changes for how we calculated the MIPS final score. Our baseline and final policies models assigned a final score for each TIN/NPI by multiplying each estimated performance category score by the corresponding performance category weight, adding the products together, multiplying the sum by 100 points, adding the complex patient bonus, and capping at 100 points. For the baseline model, we applied the performance category weights and redistribution weights finalized in the CY 2021 PFS final rule (85 FR 84913 through 84916). For the final policies model, we modified the redistribution policy for small practices as described in section IV.A.3.e.(2)(b)(iii)(A) of this final rule.

For both models, after adding any applicable bonus for complex patients, we reset any final scores that exceeded 100 points to equal 100 points. For Start Printed Page 65645 MIPS eligible clinicians who were assigned a weight of zero percent for any performance category, we redistributed the weights according to section IV.A.3.e.(2)(b)(ii) of this final rule. (h) Methodology To Estimate the MIPS Payment Adjustment For the baseline model, we applied the hierarchy as finalized in the CY 2021 PFS final rule (85 FR 84917 through 84919) to determine which final score should be used for the payment adjustment for each MIPS eligible clinician when more than one final score is available. For the final policies model, we applied the scoring hierarchy finalized in section IV.A.3.f.(5) of this final rule.

We then calculated the parameters of an exchange function in accordance with the statutory requirements related to the linear sliding scale, budget neutrality, minimum and maximum adjustment percentages, and additional payment adjustment for exceptional performance (§ 414.1405). For the baseline model, we applied the performance threshold and additional performance thresholds finalized for the CY 2021 performance period/2023 payment year (85 FR 84923), of 60 and 85, respectively. For the final policies model, we used the performance threshold of 75 points in section IV.A.3.f.(2) and the additional performance threshold of 89 points in section IV.A.3.f.(3). We used these resulting parameters to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the paid amount for covered professional services furnished by the MIPS eligible clinician.

As discussed in the CY 2021 PFS final rule RIA (85 FR 85013), we adjusted the paid amount of non-engaged clinicians to equal their proportion of paid amount prior to the PHE for buy antibiotics for the baseline and final policies models. (3) Impact of Payments by Practice Size As we shift from previous MIPS transition policies by removing bonuses from the quality performance category and increasing the performance threshold and the additional performance threshold, we observe large changes between the baseline model and final policies model. First, we observe an increase in the funds available for redistribution due to the increase in clinicians with final scores below the performance threshold. The baseline model estimates $428 million will be redistributed through BN and that $500 million will be distributed to MIPS eligible clinicians for exceptional performance.

The mean and median final scores for the baseline model are 78.13 and 82.59, respectively. Our final policies model estimates that $603 million will be redistributed through BN. For clinicians who meet or exceed the additional performance threshold, an additional $360 million was estimated to be distributed. The mean and median final scores for the final policies model are 75.21 and 79.59, respectively.

In the final policies model, the estimated bonus for exceptional performance is less than the $500 million of available funding because the maximum additional payment adjustment for clinicians with exceptional performance reached 10 percent. As finalized in the 2017 QPP final rule (81 FR 77339 through 77340), we stated the maximum additional payment adjustment would be 10 percent, which is established by the statute, and that it would be multiplied by a scaling factor that cannot exceed 1.0. We reached the maximum additional payment adjustment allowed of 10 percent because the additional performance threshold is higher, and fewer clinicians performed above this higher additional performance threshold while a greater percentage of clinicians performed below the additional performance threshold. As a result, fewer clinicians are estimated to share the funds available through the additional bonus for exceptional performance.

Second, we observe an increase in the maximum positive payment adjustment. The baseline model estimates the maximum positive MIPS payment adjustment based on the budget neutral pool at 1.5 percent and the maximum positive MIPS additional payment adjustment for exceptional performance at 5.1 percent, for a combined maximum payment adjustment of 6.6 percent. The final policies model estimates the maximum MIPS positive payment adjustment based on the budget neutral pool is 4.4 percent and the maximum positive additional MIPS payment adjustment for exceptional performance bonus at 10.0 percent for a combined maximum payment adjustment of 14.4 percent. Finally, we see narrower differences in performance across practice sizes due to the shift from MIPS transition policies.

Table 146 shows the overall impact of the payment adjustments by practice size and based on whether clinicians are expected to submit data to MIPS for the final policies model. In Table 147, we present the overall impact of the baseline and the final policies models among clinicians who submit data to assess the incremental impact of the final policies. The overall proportion of clinicians receiving a positive or neutral payment adjustment decreases from 91.7 percent to 66.8 percent with the implementation of the final policies that shift away from MIPS transition policies. In addition, we no longer observe a disproportionate number of clinicians in small practices receiving a negative payment adjustment when implementing the final policies.

For the CY 2022 performance period/2024 payment year, we have policies targeted towards small practices including special scoring policies to minimize burden and facilitate small practice participation in MIPS or APMs, which we describe in section VI.F.18.g.(2)(e) of this final rule. The intention of the final policies is to provide a more equitable participation process and reduce the disparity in performance between clinicians in large and small practices. These findings and final policies reflect movement away from the transition policies implemented during the early years of MIPS and how MIPS has shifted its focus to value rather than primarily on engagement. However, non-engagement by not submitting data to MIPS among clinicians in small practices is still a concern.

Among those who we estimate will not submit data to MIPS, 86 percent are in small practices (22,475 out of 26,180 clinicians who do not submit data). We intend to continue working with stakeholders to improve engagement in MIPS among clinicians in small practices. We want to highlight we are using 2019 MIPS performance period submissions data to simulate a 2022 MIPS performance period final score, and it is likely that there will be changes that we cannot account for at this time, including services and payments disrupted by the PHE for buy antibiotics or clinicians changing behavior in response to the performance thresholds increased for the CY 2022 performance period/2024 MIPS payment year to avoid a negative payment adjustment. It should also be noted that the estimated number of clinicians who do not submit data to MIPS may be an overestimate of non-engagement in MIPS for the CY 2022 performance period/2024 MIPS payment year.

This is because the PHE for buy antibiotics may have resulted in fewer clinicians submitting data to MIPS or more clinicians electing to apply for the extreme and uncontrollable circumstances policies due to the PHE for buy antibiotics for the 2019 MIPS performance period. Therefore, engagement levels in MIPS Start Printed Page 65646 for the CY 2022 performance period/2024 MIPS payment year may differ from these reported estimates. We also note this participation data is generally based off participation for the 2019 performance period, which is associated with the CY 2019 performance period/2021 MIPS payment year and had a performance threshold of 30 points, and that participation may change for the CY 2022 performance period/2024 MIPS payment year when the performance threshold is 75 points. Finally, the combined impact of negative and positive adjustments and the additional positive adjustments for exceptional performance as a percent of paid amount among those that do not submit data to MIPS on average was negative 8.5 percent.

It was not the maximum negative payment adjustment of 9 percent because some MIPS eligible clinicians that do not submit data to MIPS can still receive a MIPS final score that is greater than 1/4 of the performance threshold (and avoid the maximum negative adjustment as stipulated by section 1848(q)(6)(A)(iv)(II) of the Act [] ) if they have sufficient claims volume to measure performance for cost measures or quality administrative claim measure, which utilizes administrative claims data and does not require separate data submission to MIPS. Start Printed Page 65647 f. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 2023 Performance Period/2025 MIPS Payment Year We proposed for the CY 2023 MIPS Performance Period to begin transitioning to MIPS Value Pathways (MVPs) and introduce subgroup reporting in the CY 2023 MIPS performance period/2025 payment year. As described in section IV.A.3.b.(2)(c) of this final rule, the first step in the transition plan for MVPs and subgroup reporting is to be voluntary, where eventually MVPs and subgroups will become required.

Additionally, subgroups, if applicable, will have the option to report an APP. Since MVP and subgroup reporting will only begin in the CY 2023 performance period/2025 MIPS payment year, we do not have the data to report who will select MVPs and who will report through subgroups in the first year and how these clinicians will score. As discussed in section IV.A.3.b.(5) of this final rule, for MVP scoring policies, we evaluated all traditional MIPS scoring policies and maintained those that are required under section 1848(q)(2) of the Act such as requirements to measure achievement and improvement of the quality and cost of care. We noted MVPs offer incentives in terms of requiring fewer measures and activities tied to a specialty or medical condition which can offer clinicians a more cohesive experience and that we would continue to evaluating additional incentives that align with our scoring policies and the goals of MVPs in future rulemaking.

For this RIAs, we assume clinicians who elect to use MVPs and subgroups for reporting to MIPS will perform similarly to how they performed through traditional MIPS because the scoring policies are similar. We will revisit this assumption in future rulemaking as needed. As discussed in section V.B.8.e.(7)(a) of this final rule, for the purposes of estimating burden associated with the provision to implement MVP and subgroup reporting, we assume that 10 percent of MIPS eligible clinicians in the CY 2022 performance period/2024 MIPS payment year will report as MVP participants in the CY 2023 performance period/2025 MIPS payment year. In addition, we assume that there will be 20 subgroup reporters in the CY 2023 performance period/2025 MIPS payment year.

We anticipate a per respondent reduction of 3 hours and $412 dollars per CQM/QCDR quality submission, 3 hours and $336 per eCQM quality submission, and 5 hours and $717 per claims quality submission. Overall, we estimate a net reduction in burden of $7,463,145 in the quality performance category ICRs due to the introduction of MVP and subgroup reporting in the CY 2023 performance period/2025 MIPS payment year. We refer readers to section V.B.8.e.(7)(a)(iii) of this final rule for further discussion of our burden associated with MVPs and subgroups including the number of respondents. G.

Additional Impacts From Outside Payment Adjustments (1) Burden Overall In addition to policies affecting the payment adjustments, we proposed several policies that have an impact on burden in the CY 2022 and CY 2023 performance periods/2024 and 2025 MIPS payment years. In section V.B.8 of Start Printed Page 65648 this final rule, we outline estimates of the costs of data collection that includes both the effect of policy updates and adjustments due to the use of updated data sources. For each provision included in this regulation which impacts our estimate of collection burden, the incremental burden for each is summarized in Table 148. We also provide additional burden discussions that we are not able to quantify.

As discussed in the section V.B.8 of this final rule, we are setting forth our estimates for the CY 2023 performance period/2025 MIPS payment year as new burden with no currently approved estimate. To provide the reader a better sense of the differences in burden between our CY 2022 and CY 2023 performance period/2024 and 2025 MIPS payment year estimates due to changes in policy, we are presenting our CY 2023 performance period/2025 MIPS payment year estimates in Table 148 in comparison to the CY 2022 performance period/2024 MIPS payment year estimate found in the CY 2021 PFS final rule. In Table 148, we are only including our CY 2023 performance period/2025 MIPS payment year estimates for the ICRs where our estimate is different from our CY 2022 performance period/2024 MIPS payment year estimate. Start Printed Page 65649 Start Printed Page 65650 (2) Additional Impacts to Clinicians (a) Web Interface As discussed in section IV.A.3.d.(1)(d) of this final rule, we finalized the proposal to continue the use of the CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians for the CY 2022 performance period/2024 MIPS payment year.

We are also sunsetting the CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians starting with the CY 2023 performance period/2025 MIPS payment year. As discussed in section IV.A.3.c.(2)(a), we are also extending the CMS Web Interface as a means of reporting quality under the APP for Shared Savings Program ACOs for the CY 2022 performance period/2024 MIPS payment year through the CY 2024 performance period/2025 MIPS payment year. We refer readers to sections V.B.8.e.(8) and V.B.8.e.(10) of this final rule for our discussion on the estimated burden associated with the extension of the CMS Web Interface collection type in CY 2022 performance period/2024 MIPS payment year and the sunset of the CMS Web Interface collection type in the CY 2023 performance period/2025 MIPS payment year (for those not using the APP). Additionally, we assume that the impacts associated with the sunset of CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians will remain the same as our discussion in the CY 2021 PFS final rule (85 FR 85020 through 85021).

(b) Administrative Claims Measure As discussed in section IV.A.3.d.(1)(e), we are adding one new administrative claims measures beginning in the CY 2022 performance period/2024 MIPS payment year and for future performance periods. Clinician and Clinician Group Risk-standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions. We acknowledge there are administrative burdens and related financial costs associated with each administrative claims measure that clinicians, groups, and organizations may choose to monitor. However, because these costs can vary significantly due to organizational size, number of administrative claims measures being reported, volume of clinicians reporting each measure, and the specific methods employed to improve performance, we are unable to provide an estimate of the financial impact each clinician, group, or organization may experience.

In summary, we are acknowledging that while there are no data submission requirements per § 414.1325(a)(2)(i) for administrative claim measures, there may be associated costs for clinicians and group practices to monitor new administrative claim measures. However, we are unable to quantify that impact. (c) Modifications to the Improvement Activities Inventory As discussed in section IV.A.3.d.(3)(c)(ii) of this final rule, we finalized the proposals to remove 7 previously adopted improvement activities, modify 15 existing improvement activities, and adopt 5 new improvement activities. We refer readers to Appendix 2 of this final rule for further details.

We do not believe these changes to the inventory will impact time or financial burden on stakeholders because MIPS eligible clinicians are still required to submit the same number of activities and the per response time for each activity is uniform. We do not expect these changes to the inventory to affect our currently approved information collection burden estimates in terms of neither the number of estimated respondents nor the burden per response. We anticipate most clinicians performing improvement activities, to comply with existing MIPS policies, will continue to perform the same activities under the policies in this final rule because previously finalized improvement activities continue to apply for the current and future years unless otherwise modified per rulemaking (82 FR 54175). Most of the improvement activities in the Inventory remain unchanged for the CY 2022 performance period/2024 MIPS payment year.

(d) Stakeholders Nominating Improvement Activities In section IV.A.3.d.(3)(c)(i)(B) of this rule, we finalized these proposals. (1) To revise the required criteria for improvement activity nominations received through the Annual Call for Activities. (2) changes to the timeline for improvement activities nomination during a PHE. And (3) to suspend Start Printed Page 65651 activities that become obsolete or impacted by clinical practice guideline changes from the program when this occurrence happens outside of the rulemaking process.

Regarding the provision to clarify the timeline for an improvement activity nominated during the PHE, we believe this provision will not affect our currently approved burden estimates since we believe that the number of nominations will not change, but it would make an activity available for reporting to clinicians in the same performance year it was intended to be implemented. In section IV.A.3.d.(3)(c)(i)(B)(aa) of this rule, we finalized the proposal that in order to implement a new improvement activity for a PHE during the same year as the nomination, the nomination will need to be received no later than January 5th of the nomination year to be included in a rule for notice-and-comment rulemaking during that fiscal or calendar year, a necessary precursor to implementation if it were to be finalized. As described in section V.B.8.j of this rule, we expect additional nominations may be received as a result of this provision, but we do not have any data with which to estimate what the additional number may be. As a result, we did not make any revisions to our currently approved burden estimate.

Regarding the provision to suspend activities that become obsolete or impacted by clinical practice guideline changes from the program when this occurrence happens outside of the rulemaking process, we do not anticipate additional burden for stakeholders because of the provision described above as the policy does not change requirements for the nomination of improvement activities. As described in section IV.A.3.d.(3)(c)(i)(B) of this rule, due to the provisions to add two new criteria and to increase the number of criteria stakeholders are required to meet when submitting an activity provision from a minimum of 1 to all 8 criteria, which includes the two new criteria, we proposed to revise our estimated annual information collection burden for nomination of improvement activities to 136 hours (31 nominations × 4.4 hr/nomination) at a cost of $20,355 (31 × [(2.8 hr × $114.24/hr) + (1.6 hr × $210.44/hr)]). (e) Impact on Small Practices As described in section VI.F.18.e.(3) of this final rule RIA, we found 85 percent of clinicians who did not submit data to MIPS were in small practices. However, the estimated number of MIPS eligible clinicians who do not submit data, including those in small practices, may be smaller in the CY 2022 performance period/2024 MIPS payment year since the submission window for the 2019 performance period was impacted by the start of the PHE for buy antibiotics.

CMS is committed to identifying flexibilities and options to help clinicians in small practices participate meaningfully and successfully in MIPS. Specifically, CMS finalized several policies to support clinicians in small practices once they engage with MIPS in the quality, improvement activities and Promoting Interoperability performance categories for the CY 2022 performance period/2024 MIPS payment year. Based on our RIA model findings described in section VI.F.18.e.(3) of this final rule, the final policies for the CY 2022 performance period/2024 payment year led to clinicians in small practices no longer disproportionately receiving negative payment adjustments compared to clinicians in larger sized practices. Therefore, the combination of the special scoring policies for clinicians in small practices is expected to positively affect this group of clinicians and will hopefully encourage and improve future engagement in MIPS among clinicians in small practices.

(f) Impact on Third Party Intermediaries In section IV.A.3.h. Of this rule, we finalized multiple changes to the third-party intermediary regulations at § 414.1400. Specifically, we finalized. (1) Reorganization and consolidation of § 414.1400 generally.

(2) an expansion of the general participation requirements of third-party intermediaries to third party intermediaries reporting to MIPS on behalf of APM Entities in order to align reporting requirements for all participants in MIPS. (3) a requirement that, beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. Health IT vendors must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. (4) to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year.

(5) to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the 2020 performance period/2022 MIPS payment year, to submit a participation plan as part of their self-nomination for CY 2023. (6) a requirement that, beginning with the 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. (7) a requirement that, beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination, for CMS' approval, and may not change the plan once approved, without the prior approval of the agency. And (8) to add a rejection criterion to state that a QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period.

Additionally, to provide further clarification of our current policy (84 FR 63070 through 63073), we finalized the proposal to state that if a QCDR measure owner is not approved during a given self-nomination period, any associated QCDR measures with that QCDR would also not be approved. With regard to the reorganization and consolidation of § 414.1400 generally, we do not anticipate this to require any additional effort for affected entities as the provision is to allow CMS to reorganize the existing information. For the requirements related to expanding the general participation requirements of third-party intermediaries to third party intermediaries reporting to MIPS on behalf of APM Entities in order to align reporting requirements for all participants in MIPS, we did not propose to revise our burden estimates as this requirement is not different from how third-party intermediaries currently submit data for the quality, improvement activities and Promoting Interoperability performance categories in MIPS on behalf of individual eligible clinicians and groups. As previously discussed in section IV.A.3.h.(2)(b)(ii) of this rule, we finalized the proposal to require QCDRs, qualified registries, health IT vendors, and CAHPS for MIPS survey vendors to support subgroup reporting, beginning with the CY 2023 performance period/2025 MIPS payment year.

During the MVP Town Hall held in January 2021 (85 FR 74729), we heard from third-party intermediaries that they are confident that they can make the necessary updates to allow for subgroup reporting, if they have enough time. A few vendors suggested that we add Start Printed Page 65652 subgroup reporting to the existing CEHRT requirements. Given our provision described in section IV.A.3.b.(2)(d) of this rule to delay the implementation of subgroup reporting option to the CY 2023 performance period/2025 MIPS payment year, we assume that the delay will give these entities adequate time to make the necessary updates. We assume that there will be no additional burden that third-party intermediaries will incur to implement the subgroup reporting option.

We anticipate that there may be administrative burden associated with changes in workflows to their existing systems for submission of subgroup data for the CY 2023 performance period/2025 MIPS payment year. However, given that each of these entities and their information technology systems are unique, we are unable to quantify the burden for these entities to capture and submit data on behalf of clinicians who may choose to participate as subgroups. We do not anticipate a significant impact to QCDRs and qualified registries resulting from the finalized provision to require QCDRs and qualified registries to conduct an annual data validation audit and if one or more deficiencies or data errors are identified also conduct targeted audits. First, we are not revising our burden estimates because the finalized data validation requirements are like existing expectations which we have already accounted for the associated burden as stated in the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999).

Second, we believe that the requirements for conduct of the data validation audits are aligned with methods and procedures which stakeholders currently utilize. As discussed in section IV.A.3.h.(3)(a)(i) of this rule, due to the provision to require QCDRs and qualified registries that have never submitted data since the inception of MIPS (CY 2017 performance period/2019 MIPS payment year) through the CY 2020 performance period/2022 MIPS payment year to submit a participation plan as part of their self-nomination for CY 2023 performance period/2025 MIPS payment year, we refer readers to section V.B.8.c.(2) of this rule for details on the adjusted burden. As discussed in section V.B.8.c.(2) of this rule, we are not adjusting our burden estimates due to the provision related to two new rejection criteria for QCDR measures. (g) Assumptions &.

Limitations We note several limitations to our estimates of clinicians' MIPS eligibility and participation, negative MIPS payment adjustments, and positive payment adjustments for the CY 2022 performance year/2024 MIPS payment year. Due to the PHE for buy antibiotics, we are aware that there may be changes in health care delivery and billing patterns that will impact results for the CY 2022 performance year/2024 MIPS payment year that we are not able to model with our historic data sources. The scoring model results presented in this final rule assume that CY 2019 Quality Payment Program data submissions and performance are representative of CY 2022 Quality Payment Program data submissions and performance. The estimated performance for the CY 2022 performance year/2024 MIPS payment year using CY 2019 Quality Payment Program data may be underestimated because the performance threshold to avoid a negative payment adjustment for the 2019 MIPS performance period/2021 MIPS payment year was significantly lower (30 out of 100 points) than the performance threshold for the 2022 performance year/2024 payment year (75 out of 100).

We anticipate clinicians may participate more robustly by submitting more performance categories to meet the higher performance threshold to avoid a negative payment adjustment. In our MIPS eligible clinician assumptions, we assumed that clinicians who elected to opt-in in the CY 2019 Quality Payment Program and submitted data would continue to elect to opt-in in the CY 2022 performance year/2024 MIPS payment year. It is difficult to predict, based on 2019 data, whether clinicians will elect to opt-in to participate in MIPS with the CY 2022 performance year/2024 payment year finalized policies. In addition to the limitations described throughout the methodology sections, there are additional limitations to our estimates including.

(1) To the extent that there are year-to-year changes in the data submission, volume and mix of services provided by MIPS eligible clinicians, the actual impact on total Medicare revenues will be different from those shown in Table 144. And (2) due to updates in measure specifications and new measures, our cost performance is modeled using test data that does not always overlap with CY 2019 so we may not be capturing performance for clinicians or groups that change practices or TINs between when the testing data and the 2019 performance period. Due to the limitations described, there is considerable uncertainty around our estimates that is difficult to quantify. G.

Alternatives Considered This final rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our policies and, where relevant, alternatives that were considered. For purposes of the payment impact on PFS services of the policies contained in this final rule, we presented the estimated impact on total allowed charges by specialty. 1.

Alternatives Considered for Utilization Data in PFS Ratesetting As discussed earlier in this section II.C.1 (Changes in Relative Value Unit (RVU) Impacts), our estimates of changes in Medicare expenditures for PFS services compared payment rates for CY 2021 with payment rates for CY 2022 using CY 2020 Medicare utilization. As an alternative to using CY 2020 data, we considered using CY 2019 utilization data for the purposes of determining the CY 2022 RVUs, as well as in determining the CY 2022 BN adjustment and conversion factor. We considered using CY 2019 data due to the PHE for buy antibiotics, which has impacted the delivery of health care services over the past 18 months. Increases in remote delivery of services to reduce risk of exposure to both practitioner and patients, as well as postponement of elective procedures have resulted in a change to service utilization patterns across Medicare FFS payment systems.

Specific to the PFS, overall service utilization decreased by approximately 20 percent in CY 2020 compared to CY 2019, which caused us to question whether CY 2020 data is the best available data to use for CY 2022 ratesetting. In order to determine if lower overall utilization in CY 2020 would result in differential impacts on specialties and practitioners, we modeled the PFS ratesetting process using CY 2019 utilization data. We found that the use of CY 2020 as opposed to CY 2019 data in establishing payment rates had relatively little differential impacts on payment, despite the approximately 20 percent decrease in overall service utilization. Table 149 illustrates specialty-specific impacts for the proposed rule using CY 2019 data.

Start Printed Page 65653 Start Printed Page 65654 The majority of specialties experienced shifts of less than a percent when we used CY 2019 data, as opposed to CY 2020 data, as displayed in Table 136, as the basis for setting rates. Several specialties shifted by approximately one percent. We did not detect a pattern of specialties that were notably affected by the choice of claims data, either positively or negatively. While Pediatrics shifted from a 1 percent impact when we used CY 2020 claims data to a 5-payment impact when we used CY 2019 claims data, this shift is likely due to the smaller amount of allowed charges associated with the Pediatrics specialty.

We analyzed the percentage change in total RVUs per practitioner. Using CY 2019 utilization data, Total RVUs change between −1 percent and 1 percent for 53 percent of practitioners, representing more than 48 percent of the changes in Total RUs for all practitioners, similar to the results we found when using CY 2020 claims that we discussed in section II.C.1. Variations by specialty were also similar to the results we found using CY 2020 claims and are contained in the public use file that describes the percentage change in total RVUs per practitioner. Similar to the process described in section II.C.1.

Of this final rule, we used CY 2019 claims data to estimate the CY 2021 PFS CF to be 33.6184 which reflects a BN adjustment under section 1848(c)(2)(B)(ii)(II) of the Act, which we estimated to be −0.04 using CY 2019 data, the 0.00 percent update adjustment factor specified under section 1848(d)(19) of the Act, and the expiration of the 3.75 percent fee schedule payment increase for CY 2021 provided by the CAA. The anesthesia CF, which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments, would shift by a similar magnitude as the PFS CF. Thus, the estimated PFS CF and anesthesia CF using CY 2019 data is slightly higher compared to using claims data for CY 2020 with an estimated difference of 0.0336 (a little less than three and half cents). We note that the BN adjustment will be recalculated for the CY 2022 PFS final rule and the use of CY 2019 claims may or may not be higher than the use of CY 2020 claims based on which policies are ultimately finalized.

Comment. We received few comments on our Alternatives Considered for Utilization Data in PFS Ratesetting. One commenter stated that they supported the use of the alternate CY 2019 claims data because it resulted in a slight improvement (approximately 1 percent) in the impact of changes in RVUs for their specialty. A different commenter stated that practice patterns in CY 2020 were atypical as a result of the buy antibiotics zithromax and they believed that the use of 2019 claims data would be likely to more closely approximate overall PFS service utilization and costs in 2022.

Response. We continued to believe that the use of CY 2020 as opposed to CY 2019 data in establishing payment rates had relatively little differential impacts on payment, despite the approximately 20 percent decrease in overall service utilization. We found that the use of CY 2020 as opposed to CY 2019 data in establishing payment rates had little differential impact on payment at the specialty, service categories, and individual services levels. We also did not detect a pattern of specialties who were notably affected by the choice of claims data, either positively or negatively.

We received few comments on this alternative considered which we believe indicates support for our use of CY 2020 claims data from the majority of commenters. After consideration of the comments, we are finalizing our continued use of CY 2020 claims data instead of the potential alternative to use CY 2019 claims data for the purposes of determining the CY 2022 RVUs as well as in determining the CY 2022 BN adjustment and conversion factor. 2. Alternatives Considered for Split (or Shared) Visits In section II.F of this final rule, we codify our current policy allowing billing of certain “split” or “shared” E/M visits by a physician, when the visit is performed in part by both a physician and an NPP, who are in the same group and the physician performs a substantive portion of the visit.

We will codify in our regulations a definition of a split (or shared) visit as an E/M visit in the facility setting that is performed in part by both a physician and NPP who are in the same group, in accordance with applicable laws and regulations, such that the E/M visit could be billed by either the physician or the NPP if it were furnished independently by only one of them in the facility setting (rather than as a split (or shared) visit). The physician or NPP who performs the substantive portion of the split (or shared) visit will bill for the visit. We are also finalizing our proposed definition of substantive portion as more than half of the total time spent by the physician and NPP. We considered several alternative approaches.

First, we considered the option of disallowing split (or shared) visit billing beginning in CY 2022. Under this alternative, in settings where payment for “incident to” services is prohibited, physicians and NPPs would only be able to bill for visits they furnish in their entirety under their own NPI. Such a policy would be administratively simple, and reduce the likelihood of paying significantly more than the actual resource costs incurred. When physicians and practitioners furnish services in facility settings, they do not ordinarily incur the cost of clinical staff or other PE costs involved in furnishing the services.

When the physician bills for an E/M visit, in accordance with section 1833(a)(1)(N) of the Act, the Medicare Part B payment is equal to 80 percent of the payment basis under the PFS which, under section 1848(a)(1) of the Act, is the lesser of the actual charge or the full fee schedule Start Printed Page 65655 amount for the service. In contrast, if the NPP bills for it, in accordance with section 1833(a)(1)(O) of the Act, the Medicare Part B payment is equal to 80 percent of the lesser of the actual charge or 85 percent of the fee schedule rate. Because of this payment differential and the lower resource costs associated with E/M visits performed partly by a physician and partly by an NPP, it could be argued that the physician should not be able to bill for such a visit and be paid at the higher fee schedule amount. Our proposal was informed by our belief that longstanding clinical practice relies substantially upon shared visits between physicians and NPPs in facility settings.

To avoid the potential disruption in this common medical practice approach, we did not propose to disallow billing for split (or shared) visits. Comment. We received public comments confirming that it would be disruptive of current practice patterns to disallow split (or shared) visit billing. We did not receive public data indicating specifically how often split (or shared) visits occur.

Response. After consideration of the public comments, we are finalizing a policy to continue allowing billing of split (or shared) visits under specified conditions. We will require a modifier on claims for these types of visits, as proposed, to help inform future policy in this area. We also considered several alternatives for how to define the substantive portion of a split (or shared) visit.

We considered defining “substantive portion” as any face-to-face portion of the split (or shared) visit, consistent with our current definition. We did not believe it would be appropriate to consider just any portion of the visit—with or without direct patient contact— as a substantive portion. For instance, we did not believe it would be appropriate to consider a brief or trivial interaction, with or without direct patient contact, such as where the physician merely “pokes their head” into the room, to be a substantive portion of the visit. We did not believe it would be appropriate to permit a physician to bill for a visit if they do not substantially participate in the visit, given that physicians are paid under the PFS at a higher rate than NPPs.

Therefore, we proposed to define “substantive portion” as more than half of the total time spent by the physician or NPP. Another alternative we considered, but did not propose, was to utilize the medical decision making (MDM) to define substantive portion. We did not propose this approach because MDM is not easily attributed to a single physician or NPP when the work is shared, because MDM is not necessarily quantifiable and can depend on patient characteristics. We believed that time is a more precise factor than MDM to use as a basis for deciding which practitioner performs the substantive portion of the visit.

We believed that using the time spent by each practitioner furnishing the split (or shared) visit would provide a more precise metric than potentially finding a way to parse MDM between the physician and the NPP. We also considered defining substantive portion as performance of the history and/or physical exam, which are key components of certain E/M visits. Given recent changes in the CPT E/M Guidelines, history and physical exam are no longer necessarily included in all E/M visits, because for office/outpatient E/M visits, the visit level can now be selected based on either MDM or time, and history and exam are performed only as medically appropriate. Also, the CPT Editorial Panel is considering removing history and physical exam as key visit components for institutional visits, similar to the changes already made for office/outpatient E/M visits.

Accordingly, defining “substantive portion” as any key component including history or exam did not seem to be a viable approach. Lastly, we considered not defining substantive portion and instead leaving determinations regarding the substantive portion to MAC and/or medical review discretion. However, this approach would impose a significant burden on MACs to assess individual cases and could lead to too much regional variation in payment. We solicited public comment to help inform what we consider to be the “substantive portion” of a split (or shared) visit in institutional settings and assist us in consideration of our definition of “substantive portion”.

We received public comments to help inform what we consider to be the “substantive portion” of a split (or shared) visit in institutional settings and assist us in consideration of our definition of “substantive portion.” We refer readers to section II.F. Of this final rule with comment period for a complete discussion of the public comments on this topic and our responses, summarized below. Comment. The commenters agreed that the individual who performs the substantive portion should bill for the visit.

Approximately half of the commenters supported our proposal, believing that it was appropriate and would provide a clear rule. However, approximately half of the public comments recommended alternative definitions of substantive portion, including. A lower percentage of time (25 to 30 percent of the total time) (several comments). MDM (several comments).

Some portion of MDM (several comments). Choice of MDM or time, for example, based on whichever is used to select visit level (several comments). One of the three key components of history, exam, or MDM, at least until the AMA completes changes for E/M visit coding and the CPT E/M Guidelines that the commenters expect for 2023 (several comments). Some combination of the above, for example, more than half of the MDM or more than half of total time (several comments).

Working with the CPT Editorial Panel to develop a policy (several comments). These commenters were concerned about a perceived devaluation of the medical decision-making portion of visits, disruptions to current practice patterns, and administrative burdens associated with timing each of the practitioner's contribution to the visit. Response. Regarding recommendations to consider the substantive portion to be a lower percentage of time, having reviewed our current policy, we do not believe that the higher physician payment rate under the PFS should be made when a physician performs less than half of the visit, such as a quarter or a third of the total time or less than half of the MDM.

We do not think that MDM is necessarily the most critical or central component of E/M visits, and it is not the only service component being paid for. PFS payment rates incorporate and assume a certain amount of physician time per visit, reflected in the assigned RVUs and reflected annually in our physician time files. PFS payment rates reflect the typical amount of time spent on visits, and the Act requires us to reflect both time and intensity of work (physician and practitioner) in our payment rates. We do not believe this in any way devalues the unique education, training, experience, or expertise of physicians, but rather that both time and expertise are important and included in payment under the PFS.

We continue to believe that MDM cannot be readily attributed to only the physician or the NPP, or definitively divided between them. We believe the commenters overestimate the administrative burden Start Printed Page 65656 of tracking and attributing time, given the advent of EHRs and new E/M visit coding structures. However, we understand that an adjustment period may be needed to establish systems to track and attribute time for split (or shared) visits, especially since the coding for E/M visits in many facility settings will not use MDM or time to distinguish visit levels until 2023. Therefore, we are finalizing our definition of substantive portion for split (or shared) visits as proposed (more than half of the total time spent by the physician and NPP performing the split (or shared) visit) beginning January 1, 2023.

However, we are modifying our proposed policy for one transitional year. For CY 2022, except for critical care visits, the substantive portion will be defined as one of the three key components (history, exam, or MDM), or more than half of the total time spent by the physician and NPP performing the split (or shared) visit). In other words, for CY 2022, the practitioner who spends more than half of the total time, or performs the history, exam, or MDM can be considered to have performed the substantive portion and can bill for the split (or shared) E/M visit. We wish to be clear that practitioners can still use MDM to select visit level for the E/M split (or shared) visit, as proposed.

We also are clarifying that when one of the three key components is used as the substantive portion in CY 2022, the practitioner who bills the visit must perform that component in its entirety in order to bill (see section II.F.1.c.1. Of this final rule for a more detailed discussion). For visits that are already timed (that is, critical care services), the choice to use more than half of the total time, or performance of the history, exam, or MDM will not apply. For critical care visits, starting in CY 2022, the substantive portion will be more than half of the total time, as proposed.

We will continue to review and consider any future changes by the AMA/CPT Editorial Panel to the CPT E/M Guidelines for split (or shared) visits. We also intend to monitor the claims data for split (or shared) visits, to better understand how frequently practitioners use or rely upon this billing construct. We considered disallowing split (or shared) billing in critical care, SNF and nursing facility (NF) visits, as well as new patient and initial patient visits. We require certain SNF/NF visits to be provided entirely by a physician, but we believed we should allow split (or shared) visit billing for other visits that can be split (or shared) in these settings.

(We refer readers to our Conditions of Participation in 42 CFR 483.30 for information regarding the SNF/NF visits that are required to be performed in their entirety by a physician. That regulation requires that certain SNF/NF visits must be furnished directly and solely by a physician). However, we believed current clinical practice generally allows sharing of critical care visits by appropriately trained and qualified practitioners, and we solicited comment on this belief and this alternative considered. We proposed to allow split (or shared) visit billing in critical care because we believe the practice of medicine has evolved towards a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by clinicians in the same group in the facility setting.

Given this evolution in medical practice, the concerns that may have been present when we issued current policy may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care. There has also been an increase in alternative payment models that employ a more team-based approach to care. Comment.

We received many comments on our proposals for allowed settings of care, all in support of those proposals. Response. We thank the commenters for their support. After consideration of the public comments, we are finalizing as proposed.

We proposed to allow split (or shared) visits for both new and established patients as well as initial and subsequent visits. After conducting an internal review, including consulting our medical officers, we believed that the practice of medicine has evolved toward a more team-based approach to care, and greater integration in the practice of physicians and NPPs, particularly when care is furnished by practitioners in the same group in the facility setting. Given this evolution in medical practice, the concerns that may have been present when we issued the manual instructions may no longer be as relevant. We understand that there have been changes in the practice of medicine over the past several years, some facilitated by the advent of EHRs and other systems, toward a more team-based approach to care.

There has also been an increase in alternative payment models that employ a more team-based approach to care. In considering and reevaluating our policy, we saw no reason to preclude the physician or NPP from billing for split (or shared) visits for a new patient, in addition to an established patient, or for initial and subsequent split (or shared) visits. Therefore, we proposed to permit the physician or NPP to bill for split (or shared) visits for both new and established patients, as well as for initial and subsequent visits. We believed this approach is also consistent with the CPT E/M Guidelines for split (or shared) visits, which does not exclude these types of visits from being billed when furnished as split (or shared) services.

Comment. We received many comments on this proposal, all in support of it. Response. We thank the commenters for their support.

After consideration of public comments, we are finalizing as proposed. 3. Alternatives Considered for Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802, 414.806) This provision implements new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of the CAA (for the purposes of this section of this final rule, hereinafter is referred to as “section 401”). These new requirements will improve the accuracy of reported prices and limit the use of WAC-based pricing.

As discussed in section III.D.1. Of this final rule, section 1847A(c)(6)(A) of the Act incorporates the definition of manufacturer at section 1927(k)(5) of the Act, but permits the Secretary to exempt repackagers from the definition of manufacturer, as determined appropriate, for purposes of section 1847A(f)(2) of the Act. We considered whether to implement the flexibility afforded by the statute. However, implementing the flexibility afforded by the statute could potentially lead to a gap in the ASP reporting requirements, meaning that ASPs could be distorted to the extent that certain sales are carved out of the reporting requirement through the use of repackagers.

As discussed previously in this RIA, we are unable to quantitatively estimate the impacts of this provision. We welcomed comments on our approach, and on the alternative relative to. (1) The likely costs or savings (to manufacturers, beneficiaries, the government, and other stakeholders). And (2) any other related impacts of this provision.

Start Printed Page 65657 4. Alternatives Considered for the MDPP Expanded Model Emergency Policy For the MDPP Expanded Model Emergency Policy, no alternatives were considered. The 2-year MDPP service period has depressed interest in MDPP among would-be MDPP suppliers. These actions address stakeholder comments on the barriers to MDPP expanded model success.

If we do not take action, we will not be able to scale MDPP as intended, impacting Medicare beneficiary access to this program. Reducing the MDPP from a 24- to a 12-month services period, increasing the year 1 performance payments, and waiving the Medicare provider enrollment application fee not only better aligns the model with the evidence that helped certify the DPP model test initially, but it will encourage eligible organizations to enroll as MDPP suppliers. 5. Alternatives Considered for the Quality Payment Program We view the performance threshold as a critical factor affecting the distribution of payment adjustments in the Quality Payment Program.

We ran a separate final policies RIA model based on the actual mean for the CY 2019 performance period/2021 MIPS payment year with a performance threshold of 86 and an additional performance threshold of 92 points, which are potential values that may be used for the CY 2022 performance period/2024 MIPS payment year. The model with a performance threshold of 86 and additional performance threshold of 92 has the same mean and median final score as our policies RIA model since the performance threshold does not change the final score. We estimate that $ 907 million will be redistributed through BN. For clinicians who meet or exceed the additional performance threshold, an additional $241 million was distributed.

The maximum positive payment adjustment will be 18.2 percent prior to the maximum additional payment adjustment and 28.2 percent after considering the MIPS maximum positive payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 74.0 percent of MIPS eligible clinicians will receive a negative payment adjustment among those that submit data. We report the findings for the baseline model which describes the impact for the CY 2022 performance period/2024 MIPS payment year if this regulation did not exist. The baseline model has a final score mean of 78.13 and median of 82.59.

We estimate that $428 million will be redistributed through BN. There will be a maximum payment adjustment of 6.6 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 8.3 percent of MIPS eligible clinicians will receive a negative payment adjustment among those that submit data. H.

Impact on Beneficiaries We do not believe these provisions will have a negative impact on beneficiaries given overall PFS BN. 1. Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802, 414.806) Section 1927(b)(3)(A)(iii) of the Act requires manufacturers with a Medicaid drug rebate agreement to report ASP data consistent with the information required for such reporting at section 1847A of the Act. Some manufacturers without Medicaid drug rebate agreements voluntarily submit ASP data for their single source drugs or biologicals that are payable under Part B, however other manufacturers without Medicaid drug rebate agreements do not voluntarily submit such data.

Without manufacturer reported ASP data, CMS cannot calculate the ASP payment limit, and consequently, payment is typically based on Wholesale Acquisition Cost (WAC). Consistent with section 1847A(c)(3) of the Act and our regulations at § 414.804(a)(2), the ASP is net of price concessions. However, consistent with the definition of WAC at section 1847A(c)(6)(B) of the Act, the WAC is not net of price concessions and is thus nearly always, and sometimes significantly, higher than ASP. Drugs with payment allowances based on WAC may have greater “spreads” between acquisition costs and payment than drugs for which there is an ASP-based payment allowance, which, in turn, may.

(1) Incent the use of the drug based on its spread rather than on purely clinical considerations. (2) result in increased payments under Medicare Part B. And (3) result in increased beneficiary cost sharing. This provision implements new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of Division CC, Title IV of the CAA, 2021.

These new requirements will improve the accuracy of reported payment limits and limit the use of WAC-based pricing. For single source drugs, these changes may result in lower payment limits because, typically, the WAC plus 3 percent is higher than ASP plus 6 percent. This then translates to cost savings for both the government and beneficiaries, who will pay coinsurance on a lesser amount. However, for the reason stated earlier in this RIA (see section VI.G.4.

Of this final rule), we are unable to predict the magnitude of this effect. Similarly, payment limits for multiple source drugs could increase or decrease, and we are unable to predict the direction or magnitude of specific or aggregate effects at this time. 2. Determination of ASP for Certain Self-Administered Drug Products Although we are unable to quantify the total magnitude of the potential savings, these changes have the potential to substantially reduce program expenditures and beneficiary coinsurance.

The OIG's July 2020 report (discussed in section III.D.2. Of this final rule) determined that the inclusion of self-administered versions of certolizumab and abatacept in their respective volume-weighted, average ASPs, alone, has resulted in $173 million in additional Medicare beneficiary coinsurance between 2014 and 2018. The regulatory changes have the potential to result in decreased payment limits for identified billing and payment codes and could, in turn, substantially reduce beneficiary coinsurance. Since section 405 of Division CC, Title IV of the CAA, 2021 directs CMS to implement the statutory changes at section 1847A(g)(3) of the Act beginning on July 1, 2021, these potential savings may be observed within the year.

3. Medicare Diabetes Prevention Program Expanded Model Emergency Policy This change will have a positive impact on eligible MDPP beneficiaries, as it better aligns with the CDC's National DPP, giving both the participants and the coaches similar messaging around this program, regardless of payer. MDPP suppliers often offer the MDPP set of services to mixed cohorts, or classes with participants who are not eligible for MDPP, but who are enrolled in a National DPP cohort. Since MDPP generally follows the CDC's National DPP and aligns its program with the CDC's DPRP Standards, it is confusing to participants, coaches, and staff when talking about a 2-year program to its eligible Medicare participants when the non-Medicare participants have a 1-year program.

Finally, reducing the MDPP service period from 2 years to one (1) year allows more cohorts to start and finish MDPP during the expanded Start Printed Page 65658 model initial period of performance, which ends in March 2023. 4. Quality Payment Program There are several changes in this rule that are expected to have a positive effect on beneficiaries. In general, we believe that many of these changes, including the MVP and subgroup provisions, will lead to more meaningful and relevant data being available to beneficiaries on the type and scope of care provided by clinicians on the compare tool.

Additionally, beneficiaries could use the publicly reported information on clinician performance in subgroups to identify and choose clinicians in multispecialty groups relevant to their care needs. Consequently, we anticipate this will improve the quality and value of care provided to Medicare beneficiaries. For example, several of the new measures include patient-reported outcome-based measures, which may be used to help patients make more informed decisions about treatment options. Patient-reported outcome-based measures provide information on a patient's health status from the patient's point of view and may also provide valuable insights on factors such as quality of life, functional status, and overall disease experience, which may not otherwise be available through routine clinical data collection.

Patient-reported outcome-based measured are factors frequently of interest to patients when making decisions about treatment. K. Estimating Regulatory Familiarization Costs If regulations impose administrative costs on private entities, such as the time needed to read and interpret this rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assumed that the total number of unique commenters on this year's rule will be the number of reviewers of last year's rule.

We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters will review this year's rule in detail, and it is also possible that some reviewers will choose not to comment on the rule. For these reasons we thought that the number of commenters will be a fair estimate of the number of reviewers of last year's rule. We also recognized that different types of entities are in many cases affected by mutually exclusive sections of this rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule.

Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $114.24 per hour, including overhead and fringe benefits https://www.bls.gov/​oes/​current/​oes_​nat.htm. Assuming an average reading speed, we estimate that it will take approximately 8.0 hours for the staff to review half of this rule. For each facility that reviews the rule, the estimated cost is $913.92 (8.0 hours × $114.24). Therefore, we estimated that the total cost of reviewing this regulation is $32,380,186 ($885.92 × 35,430 reviewers on this year's proposed rule).

J. Accounting Statement As required by OMB Circular A-4 (available at http://www.whitehouse.gov/​omb/​circulars/​a004/​a-4.pdf ), in Tables 150 and 151 (Accounting Statements), we have prepared an accounting statement. This estimate includes growth in incurred benefits from CY 2021 to CY 2022 based on the FY 2022 President's Budget baseline. K.

Conclusion The analysis in the previous sections, together with the remainder of this preamble, provided an initial Regulatory Flexibility Analysis. The previous analysis, together with the preceding portion of this preamble, provides an RIA. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &.

Medicaid Services, approved this document on October 28, 2021. Start List of Subjects 42 CFR Part 403 Grant programs—healthHealth insuranceHospitalsIntergovernmental relationsMedicareReporting and recordkeeping requirements 42 CFR Part 405 Administrative practice and procedureDiseasesHealth facilitiesHealth insuranceHealth professionsMedical devicesMedicareReporting and recordkeeping requirementsRural areasX-rays 42 CFR Part 410 DiseasesHealth facilitiesHealth professionsLaboratoriesMedicareReporting and recordkeeping requirementsRural areasX-rays 42 CFR Part 411 DiseasesMedicareReporting and recordkeeping requirements 42 CFR Part 414 Administrative practice and procedureBiologicsDiseasesDrugsHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 415 Health facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 423 Administrative practice and procedureEmergency medical servicesHealth facilitiesHealth maintenance organizations (HMO)Health professionalsMedicarePenaltiesPrivacyReporting and recordkeeping requirements 42 CFR Part 424 Emergency medical servicesHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements 42 CFR Part 425 Administrative practice and procedureHealth facilitiesHealth professionsMedicareReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services amends 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1.

The authority citation for part 403 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, and 1395hh. End Authority Start Amendment Part2.

In § 403.902— End Amendment Part Start Amendment Parta. Amend the definition of “Ownership or investment interest” by adding paragraphs (3)(vi) and (vii). End Amendment Part Start Amendment Partb. Add a definition for “Physician-owned distributorship” in alphabetical order.

And End Amendment Part Start Amendment Partc. Revise the definition of “Short term medical supply or device loan”. End Amendment Part The additions and revision read as follows. Definitions.

* * * * * Ownership or investment interest * * * (3) * * * (vi) A titular ownership or investment interest that excludes the ability or right to receive the financial benefits of ownership or investment, including, but not limited to, the distribution of profits, dividends, proceeds of sale, or similar returns on investment. Or (vii) An interest in an entity that arises from an employee stock ownership plan (ESOP) that is qualified under section 401(a) of the Internal Revenue Code of 1986. * * * * * Physician-owned distributorship , for the purposes of determining the existence of a reportable ownership or investment interest under this subpart, means an entity that. (1) Meets the definition of an applicable manufacturer or applicable group purchasing organization as defined in this section, and (2) Meets at least one of the following two conditions.

(i) Has a minimum of 5 percent direct or indirect ownership or investment interest in the applicable manufacturer or applicable group purchasing organization held by a physician or a physician's immediate family member, or (ii) A physician or a physician's immediate family member receives compensation from the applicable manufacturer or group purchasing organization in the form of a commission, return on investment, profit sharing, profit distribution, or other remuneration directly or indirectly derived from the sale or distribution of devices by the applicable manufacturer or group purchasing organization in which the physician or physician's immediate family member has ownership. (3) This physician owned distributor definition does not apply for purposes of any other laws or regulations, including, but not limited to, section 1877 of the Act, the regulations at 42 CFR part 411, subpart J, section 1128B of the Act, or the regulations at 42 CFR 1001.952. * * * * * Short term medical supply or device loan means the loan of a covered device or a device under development, or the provision of a limited quantity of medical supplies for a short-term trial period, not to exceed a loan period of 90 cumulative days per calendar year or a quantity of 90 cumulative days of average daily use per calendar year, to permit evaluation of the device or medical supply by the covered recipient. * * * * * Start Amendment Part3.

Amend § 403.904 by adding paragraph (a)(3) to read as follows. End Amendment Part Reports of payments or other transfers of value to covered recipients. (a) * * * (3) An applicable manufacturer or applicable group purchasing organization that has reported payments or transfers of value under the scope of this section may not remove, delete, or alter any record/(s) unless an error is discovered in the information that had been furnished, or the record is otherwise believed to meet exceptions for reporting. * * * * * Start Amendment Part4.

Amend § 403.908 by revising paragraph (c)(3) and adding paragraph (c)(4) to read as follows. End Amendment Part Procedures for electronic submission of reports. * * * * * (c) * * * (3) During registration, applicable manufacturers and applicable group purchasing organizations must name two points of contact with appropriate contact information. These points of contact must be updated for 2 years following record submission.

(4) An applicable manufacturer or applicable group purchasing organization that meets the definition of physician-owned distributorship as defined in § 403.902 must identify its status as a physician-owned distributorship when registering or recertifying. * * * * * Start Part End Part Start Amendment Part5. The authority citation for part 405 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k). End Authority Start Amendment Part6. Amend § 405.902 by adding definitions for “Additional documentation”, “Additional documentation request (ADR)”, “Post-payment medical review”, and “Prepayment medical review” in alphabetical order to read as follows. End Amendment Part Start Printed Page 65660 Definitions.

* * * * * Additional documentation means any information requested by a contractor when conducting a prepayment review or post-payment review. Additional documentation request (ADR) means a contractor's initial documentation request in reviewing claims selected for prepayment review or post-payment review. * * * * * Post-payment medical review (or post-payment review) means a review that occurs after payment is made on the selected claim to determine whether the initial determination for payment was appropriate. Prepayment medical review (or prepayment review) means a review that occurs before an initial determination for payment is made on the selected claim to determine whether payment should be made.

* * * * * Start Amendment Part7. Add § 405.903 to read as follows. End Amendment Part Prepayment review. (a) A contractor may select a claim(s) for prepayment review.

(b) In conducting a prepayment review, a contractor may issue additional documentation requests to a provider or supplier. (1) A provider or supplier will be provided 45 calendar days to submit additional documentation in response to a contractor's request, except as stated in paragraph (b)(2) and (c) of this section. (2) A contractor may accept documentation received after 45-calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the contractor deems good cause in accepting the documentation.

(c) A provider or supplier will be provided 30 calendar days to submit additional documentation in response to a UPIC's request for additional documentation. A UPIC may accept documentation received after the 30 calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the UPIC deems good cause in accepting the documentation. (d) A contractor's prepayment review will result in an initial determination under § 405.920.

Start Amendment Part8. Add §§ 405.929 and 405.930 under the undesignated ceneter heading “Initial Determinations” in subpart I to read as follows. End Amendment Part Post-payment review. (a) A contractor may select a claim(s) for post-payment review, which is conducted under the reopening authority in § 405.980.

(b) In conducting a post-payment review, a contractor may issue an additional documentation request to a provider or supplier. (1) A provider or supplier will be provided 45 calendar days to submit additional documentation in response to a contractor's request, except as stated in paragraph (b)(2) and (c) of this section. (2) A contractor may accept documentation received after 45 calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the contractor deems good cause in accepting the documentation.

(c) A provider or supplier will be provided 30 calendar days to submit additional documentation in response to a UPIC's request for additional documentation. A UPIC may accept documentation received after 30 calendar days for good cause. Good cause means situations such as natural disasters, interruptions in business practices, or other extenuating circumstances that the UPIC deems good cause in accepting the documentation. (d) The outcome of a contractor's review will result in either no change to the initial determination or a revised determination under § 405.984.

Failure to respond to additional documentation request. If a contractor gives a provider or supplier notice and time to respond to an additional documentation request and the provider or supplier does not provide the additional documentation in a timely manner, the contractor has authority to deny the claim. Start Amendment Part9. Amend § 405.986 by revising the paragraph (a) subject heading to read as follows.

End Amendment Part Good cause for reopening. (a) Establishing good cause for reopening. * * * * * * * * Start Amendment Part10. Amend § 405.2411 by— End Amendment Part Start Amendment Parta.

Revising paragraph (b)(2). End Amendment Part Start Amendment Partb. Redesignating paragraph (b)(3) as (b)(4). And End Amendment Part Start Amendment Partc.

Adding a new paragraph (b)(3). End Amendment Part The revision and addition read as follows. Scope of benefits. * * * * * (b) * * * (2) Covered when furnished during a Part A stay in a skilled nursing facility only when provided by a physician, nurse practitioner, physician assistant, certified nurse midwife or clinical psychologist employed or under contract with the RHC or FQHC at the time the services are furnished.

(3) Inclusive of hospice attending physician services, and are covered when furnished during a patient's hospice election only when provided by an RHC/FQHC physician, nurse practitioner, or physician assistant designated by the patient as his or her attending physician and employed or under contract with the RHC or FQHC at the time the services are furnished. And * * * * * Start Amendment Part11. Amend § 405.2446 by revising paragraph (c) to read as follows. End Amendment Part Scope of services.

* * * * * (c) FQHC services are covered when provided in outpatient settings only, including a patient's place of residence, which may be a skilled nursing facility or a nursing facility, other institution used as a patient's home, or are hospice attending physician services furnished during a hospice election. * * * * * Start Amendment Part12. Amend § 405.2462— End Amendment Part Start Amendment Parta. By revising paragraphs (a) and (b).

End Amendment Part Start Amendment Partb. By redesignating paragraphs (c) through (g) as paragraphs (e) through (i), respectively. End Amendment Part Start Amendment Partc. By adding new paragraphs (c) and (d).

And End Amendment Part Start Amendment Partd. In newly redesignated paragraph (e) introductory text, by removing the reference “paragraph (d)” and adding in its place “paragraph (f)”. End Amendment Part The revisions and additions read as follows. Payment for RHC and FQHC services.

(a) Payment to independent RHCs that are authorized to bill under the reasonable cost system. (1) RHCs that are authorized to bill under the reasonable cost system are paid on the basis of an all-inclusive rate, subject to a payment limit per visit determined in paragraph (b) of this section, for each beneficiary visit for covered services. This rate is determined by the Medicare Administration Contractor (MAC), in accordance with this subpart and general instructions issued by CMS. (2) The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section.

Start Printed Page 65661 (b) RHC payment limit per visit. (1) In establishing limits on payment for rural health clinic services provided by rural health clinics the limit for services provided prior to April 1, 2021. (i) In 1988, after March 31, at $46 per visit. And (ii) In a subsequent year (before April 1, 2021), at the limit established for the previous year increased by the percentage increase in the Medicare Economic Index (MEI) (as defined in section 1842(i)(3) of the Act) applicable to primary care services (as defined in section 1842(i)(4) of the Act) furnished as of the first day of that year.

(2) In establishing limits on payment for rural health services furnished on or after April 1, 2021, by rural health clinics or any rural health clinic that is enrolled on or after January 1, 2021 under section 1866(j) of the Act), the limit for services provided. (i) In 2021, after March 31, at $100 per visit. (ii) In 2022, at $113 per visit. (iii) In 2023, at $126 per visit.

(iv) In 2024, at $139 per visit. (v) In 2025, at $152 per visit. (vi) In 2026, at $165 per visit. (vii) In 2027, at $178 per visit.

And (viii) In 2028, at $190 per visit. (ix) In a subsequent year, at the limit established for the previous year increased by the percentage increase in MEI applicable to primary care services furnished as of the first day of such year. (3) In establishing limits on payment for rural health services furnished on or after April 1, 2021, by provider-based rural health clinics as described in section (c)(4) of this part, the limit for services provided. (i) In 2021, after March 31, at an amount equal to the greater of.

(A) For rural health clinics that had an all-inclusive rate established for services furnished in 2020— ( 1 ) The all-inclusive rate applicable to the rural health clinic for services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021, or ( 2 ) The payment limit per visit applicable in paragraph (b)(2) of this section. (B) For rural health clinics that did not have an all-inclusive rate established for services furnished in 2020— ( 1 ) The all-inclusive rate applicable to the rural health clinic for services furnished in 2021, or ( 2 ) The payment limit per visit applicable in paragraph (b)(2) of this section. (ii) In a subsequent year, at an amount equal to the greater of. (A) The amount established under paragraph (b)(3)(i)(A) or (B) of this section, as applicable for the previous year, increased by the percentage increase in MEI applicable to primary care services furnished as of the first day of such subsequent year, or (B) The payment limit per visit applicable under paragraph (b)(2) of this section for such subsequent year.

(c) Payment to provider-based RHCs that are authorized to bill under the reasonable cost system. (1) An RHC that is authorized to bill under the reasonable cost system is paid in accordance with parts 405 and 413 of this subchapter, as applicable, if the RHC is— (i) An integral and subordinate part of a hospital, skilled nursing facility or home health agency participating in Medicare (that is, a provider of services). And (ii) Operated with other departments of the provider under common licensure, governance and professional supervision. (2) An RHC, described in paragraph (c)(1) of this section, is paid on the basis of an all-inclusive rate, subject to a payment limit per visit, described in paragraphs (b)(1) and (2) of this section, for each beneficiary visit for covered services when in a hospital with greater than 50 beds as determined in § 412.105(b) of this subchapter.

This all-inclusive rate is determined by the MAC, in accordance with this subpart and general instructions issued by CMS. The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section. (3) Prior to April 1, 2021, an RHC, described in paragraph (c)(1) of this section, is paid on the basis of an all-inclusive rate and is not subject to a payment limit per visit described in paragraphs (b)(1) and (2) of this section for each beneficiary visit for covered services when in a hospital with less than 50 beds as determined in § 412.105(b) of this subchapter. This all-inclusive rate is determined by the MAC, in accordance with this subpart and general instructions issued by CMS.

The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section. (4) On or after April 1, 2021, an RHC, described in paragraph (c)(1) of this section, is paid on the basis of an all-inclusive rate, subject to a payment limit per visit, described in paragraph (b)(3) of this section, for each beneficiary visit for covered services when it meets the specified qualifications in paragraph(d) of this section. This all-inclusive rate is determined by the MAC, in accordance with this subpart and general instructions issued by CMS. The amount payable by the MAC for a visit is determined in accordance with paragraphs (i)(1) and (2) of this section.

(d) Specified qualifications. A provider-based rural health clinic must meet the following qualifications to have a payment limit per visit established in accordance with paragraph (b)(3) of this section. (1) As of December 31, 2020, was in a hospital with less than 50 beds (as determined in § 412.105(b) of this subchapter) and after December 31, 2020, in a hospital that continues to have less than 50 beds (not taking into account any increase in the number of beds pursuant to a waiver during the buy antibiotics Public Health Emergency (PHE)). And one of the following circumstances.

(i) As of December 31, 2020, was enrolled under section 1866(j) of the Act (including temporary enrollment during the buy antibiotics PHE). Or (ii) Submitted an application for enrollment under section 1866(j) of the Act (or a request for temporary enrollment during the buy antibiotics PHE) that was received not later than December 31, 2020. (2) [Reserved] * * * * * Start Amendment Part13. Amend § 405.2463 by revising paragraphs (a)(1)(i) introductory text and (b)(3) introductory text to read as follows.

End Amendment Part What constitutes a visit. (a) * * * (1) * * * (i) Face-to-face encounter (or, for mental health disorders only, an encounter that meets the requirements under paragraph (b)(3) of this section) between an RHC patient and one of the following. * * * * * (b) * * * (3) Visit—Mental health. A mental health visit is a face-to-face encounter or an encounter furnished using interactive, real-time, audio and video telecommunications technology or audio-only interactions in cases where the patient is not capable of, or does not consent to, the use of video technology for the purposes of diagnosis, evaluation or treatment of a mental health disorder, including an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary Start Printed Page 65662 is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record, between an RHC or FQHC patient and one of the following.

* * * * * Start Amendment Part14. Amend § 405.2466 by revising paragraph (b)(1)(iv) to read as follows. End Amendment Part Annual reconciliation. * * * * * (b) * * * (1) * * * (iv) For RHCs and FQHCs, payment for pneumococcal, influenza, and buy antibiotics treatment and their administration is 100 percent of Medicare reasonable cost.

* * * * * Start Amendment Part15. Amend § 405.2469 by revising paragraph (d) to read as follows. End Amendment Part FQHC supplemental payments. * * * * * (d) Per visit supplemental payment.

A supplemental payment required under this section is made to the FQHC when a covered face-to-face encounter or an encounter furnished using interactive, real-time, audio and video telecommunications technology or audio-only interactions in cases where beneficiaries do not wish to use or do not have access to devices that permit a two-way, audio/video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder occurs between a MA enrollee and a practitioner as set forth in § 405.2463. Additionally, there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record. Start Part End Part Start Amendment Part16. The authority citation for part 410 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd. End Authority Start Amendment Part17. Amend § 410.33 by— End Amendment Part Start Amendment Parta.

Revising paragraphs (c) and (g)(6)(i) and (ii). End Amendment Part Start Amendment Partb. Redesignating paragraphs (g)(8)(i) through (iii) as paragraphs (g)(8)(i)(A) through (C), respectively. And End Amendment Part Start Amendment Partc.

Adding paragraphs (g)(8)(i) introductory text and (g)(8)(ii). And End Amendment Part Start Amendment Partd. Revising paragraph (g)(9). End Amendment Part The revisions and additions read as follows.

Independent diagnostic testing facility. * * * * * (c) Nonphysician personnel. (1) Except as otherwise stated in paragraph (c)(2) of this section, any nonphysician personnel used by the IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropriate State health or education department. In the absence of a State licensing board, the technician must be certified by an appropriate national credentialing body.

The IDTF must maintain documentation available for review that these requirements are met. (2) For services that do not require direct or in-person beneficiary interaction, treatment, or testing, any nonphysician personnel used by the IDTF to perform the tests must meet all applicable State licensure requirements for doing so. If there are any applicable State licensure requirements, the IDTF must maintain documentation available for review that these requirements are met. * * * * * (g) * * * (6) * * * (i) Except as otherwise stated in paragraph (g)(6)(ii) of this section, have a comprehensive liability insurance policy of at least $300,000 per location that covers both the place of business and all customers and employees of the IDTF.

The policy must be carried by a nonrelative-owned company. Failure to maintain required insurance at all times will result in revocation of the IDTF's billing privileges retroactive to the date the insurance lapsed. IDTF suppliers are responsible for providing the contact information for the issuing insurance agent and the underwriter. In addition, the IDTF must— (A) Ensure that the insurance policy must remain in force at all times and provide coverage of at least $300,000 per incident.

And (B) Notify the CMS designated contractor in writing of any policy changes or cancellations. (ii) Paragraph (g)(6)(i) of this section does not apply to IDTFs that only perform services that do not require direct or in-person beneficiary interaction, treatment, or testing. * * * * * (8) * * * (i) Except as otherwise stated in paragraph (g)(8)(ii) of this section, answer, document, and maintain documentation of a beneficiary's written clinical complaint at the physical site of the IDTF. (For mobile IDTFs, this documentation would be stored at their home office.) This includes, but is not limited to, the following.

* * * * * (ii) Paragraph (g)(8)(i) of this section does not apply to IDTFs that only perform services that do not require direct or in-person beneficiary interaction, treatment, or testing. (9) Openly post these standards for review by patients and the public. (This requirement does not apply to IDTFs that only perform services that do not require direct or in-person beneficiary interaction, treatment, or testing.) * * * * * Start Amendment Part18. Amend § 410.37 by adding paragraph (j) to read as follows.

End Amendment Part Colorectal cancer screening tests. Conditions for and limitations on coverage. * * * * * (j) Expansion of coverage of colorectal cancer screening tests. Effective January 1, 2022, colorectal cancer screening tests include a planned screening flexible sigmoidoscopy or screening colonoscopy that involves the removal of tissue or other matter or other procedure furnished in connection with, as a result of, and in the same clinical encounter as the screening test.

Start Amendment Part19. Amend § 410.47— End Amendment Part Start Amendment Parta. In paragraph (a), by revising the definitions of “Individualized treatment plan”, “Medical director”, Outcomes assessment”, “Physician prescribed exercise”, “Psychosocial assessment”, and “Supervising physician”. End Amendment Part Start Amendment Partb.

By revising paragraphs (b) through (e). End Amendment Part Start Amendment Partc. By removing paragraph (f). And End Amendment Part Start Amendment Partd.

By redesignating paragraph (g) as paragraph (f). End Amendment Part The revisions read as follows. Start Printed Page 65663 Pulmonary rehabilitation program. Conditions of coverage.

(a) * * * Individualized treatment plan means a written plan tailored to each individual patient that includes all of the following. (i) A description of the individual's diagnosis. (ii) The type, amount, frequency, and duration of the items and services furnished under the plan. (iii) The goals set for the individual under the plan.

Medical director means the physician who oversees the pulmonary rehabilitation program at a particular site. Outcomes assessment means an evaluation of progress as it relates to the individual's rehabilitation which includes the following. (i) Evaluations, based on patient-centered outcomes, which must be measured by the physician or program staff at the beginning and end of the program. Evaluations measured by program staff must be considered by the physician in developing and/or reviewing individualized treatment plans.

(ii) Objective clinical measures of exercise performance and self-reported measures of shortness of breath and behavior. * * * * * Physician-prescribed exercise means aerobic exercise combined with other types of exercise (such as conditioning, breathing retraining, step, and strengthening) as determined to be appropriate for individual patients by a physician. Psychosocial assessment means an evaluation of an individual's mental and emotional functioning as it relates to the individual's rehabilitation or respiratory condition which includes an assessment of those aspects of an individual's family and home situation that affects the individual's rehabilitation treatment, and psychosocial evaluation of the individual's response to and rate of progress under the treatment plan. * * * * * Supervising physician means a physician that is immediately available and accessible for medical consultations and medical emergencies at all times items and services are being furnished to individuals under pulmonary rehabilitation programs.

(b) General rule —(1) Covered conditions. Medicare Part B covers pulmonary rehabilitation for beneficiaries. (i) With moderate to very severe COPD (defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease. (ii) Who have had confirmed or suspected buy antibiotics and experience persistent symptoms that include respiratory dysfunction for at least four weeks.

(iii) Additional medical indications for coverage for pulmonary rehabilitation may be established through a national coverage determination (NCD). (2) Components. Pulmonary rehabilitation must include all of the following. (i) Physician-prescribed exercise during each pulmonary rehabilitation session.

(ii) Education or training that is closely and clearly related to the individual's care and treatment which is tailored to the individual's needs and assists in achievement of goals toward independence in activities of daily living, adaptation to limitations and improved quality of life. Education must include information on respiratory problem management and, if appropriate, brief smoking cessation counseling. (iii) Psychosocial assessment. (iv) Outcomes assessment.

(v) An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days. (3) Settings. (i) Medicare Part B pays for pulmonary rehabilitation in the following settings.

(A) A physician's office. (B) A hospital outpatient setting. (ii) All settings must have the following. (A) A physician immediately available and accessible for medical consultations and emergencies at all times when items and services are being furnished under the program.

This provision is satisfied if the physician meets the requirements for direct supervision for physician office services, at § 410.26 of this subpart. And for hospital outpatient services at § 410.27 of this subpart. (B) The necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary (for example, oxygen, cardiopulmonary resuscitation equipment, and defibrillator) to treat chronic respiratory disease. (c) Medical director standards.

The physician responsible for a pulmonary rehabilitation program is identified as the medical director. The medical director, in consultation with staff, is involved in directing the progress of individuals in the program and must possess all of the following. (1) Expertise in the management of individuals with respiratory pathophysiology. (2) Cardiopulmonary training in basic life support or advanced cardiac life support.

(3) Be licensed to practice medicine in the State in which the pulmonary rehabilitation program is offered. (d) Supervising physician standards. Physicians acting as the supervising physician must possess all of the following. (1) Expertise in the management of individuals with respiratory pathophysiology.

(2) Cardiopulmonary training in basic life support or advanced cardiac life support. (3) Be licensed to practice medicine in the State in which the pulmonary rehabilitation program is offered. (e) Limitations on coverage. The number of pulmonary rehabilitation sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare Administrative Contractor.

* * * * * Start Amendment Part20. Amend § 410.49— End Amendment Part Start Amendment Parta. In paragraph (a), by revising the definition of “Medical director”, revising paragraph (i) in the definition of “Outcomes assessment”, and revising the definition of “Physician-prescribed exercise”. And End Amendment Part Start Amendment Partb.

By revising paragraphs (b)(1) introductory text, (b)(2) introductory text, (b)(2)(ii), (b)(3)(i) introductory text, (d) introductory text, (e) introductory text, and (f). End Amendment Part The revisions read as follows. Cardiac rehabilitation program and intensive cardiac rehabilitation program. Conditions of coverage.

(a) * * * Medical director means the physician who oversees the cardiac rehabilitation or intensive cardiac rehabilitation program at a particular site. Outcomes assessment * * * (i) Evaluations, based on patient-centered outcomes, which must be measured by the physician or program staff at the beginning and end of the program. Evaluations measured by program staff must be considered by the physician in developing and/or reviewing individualized treatment plans. * * * * * Start Printed Page 65664 Physician-prescribed exercise means aerobic exercise combined with other types of exercise (such as strengthening and stretching) as determined to be appropriate for individual patients by a physician.

* * * * * (b) * * * (1) Covered conditions. Medicare Part B covers cardiac rehabilitation and intensive cardiac rehabilitation for beneficiaries who have experienced one or more of the following. * * * * * (2) Components. Cardiac rehabilitation and intensive cardiac rehabilitation must include all of the following.

* * * * * (ii) Cardiac risk factor modification, including education, counseling, and behavioral intervention, tailored to the individual's needs. * * * * * (3) * * * (i) Medicare Part B pays for cardiac rehabilitation and intensive cardiac rehabilitation in the following settings. * * * * * (d) Medical director standards. The physician responsible for a cardiac rehabilitation program or intensive cardiac rehabilitation program is identified as the medical director.

The medical director, in consultation with staff, is involved in directing the progress of individuals in the program and must possess all of the following. * * * * * (e) Supervising physician standards. Physicians acting as the supervising physician must possess all of the following. * * * * * (f) Limitations on coverage —(1) Cardiac rehabilitation.

The number of cardiac rehabilitation sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare Administrative Contractor. (2) Intensive cardiac rehabilitation. Intensive cardiac rehabilitation sessions are limited to 72 1-hour sessions (as defined in section 1848(b)(5) of the Act), up to 6 sessions per day, over a period of up to 18 weeks. Start Amendment Part21.

Amend § 410.59 by revising paragraph (a)(4)(iii)(B) and adding paragraphs (a)(4)(iv) and (v) to read as follows. End Amendment Part Outpatient occupational therapy services. Conditions. (a) * * * (4) * * * (iii) * * * (B) Except as provided in paragraph (a)(4)(iv) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service separately from the part furnished by the occupational therapist such that the minutes for that portion of a service (or unit of a service) furnished by the occupational therapist assistant exceed 10 percent of the total minutes for that service (or unit of a service).

(iv) Paragraph (a)(4)(iii)(B) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day when the occupational therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the occupational therapy assistant. (v) Where there are two remaining 15-minute units to bill of the same service, and the occupational therapist and occupational therapy assistant each provided between 9 and 14 minutes of the service with a total time of at least 23 minutes and no more than 28 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the occupational therapy assistant and one unit is billed without the prescribed modifier for the service provided by the occupational therapist. * * * * * Start Amendment Part22. Amend § 410.60 by revising paragraph (a)(4)(iii)(B) and adding paragraphs (a)(4)(iv) and (v) to read as follows.

End Amendment Part Outpatient physical therapy services. Conditions. (a) * * * (4) * * * (iii) * * * (B) Except as provided in paragraph (a)(4)(iv) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service separately from the part furnished by the physical therapist such that the minutes for that portion of a service (or unit of a service) furnished by the physical therapist assistant exceed 10 percent of the total minutes for that service (or unit of a service). (iv) Paragraph (a)(4)(iii)(B) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day, when the physical therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the physical therapist assistant.

(v) Where there are two remaining 15-minute units to bill of the same service, and the physical therapist and physical therapist assistant each provided between 9 and 14 minutes of the service with a total time of at least 23 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the physical therapist assistant and one unit is billed without the prescribed modifier for the service provided by the physical therapist. * * * * * Start Amendment Part23. Amend § 410.67— End Amendment Part Start Amendment Parta. In paragraph (b), by revising paragraphs (3) and (4) in the definition of “Opioid use disorder treatment service”.

End Amendment Part Start Amendment Partb. By revising paragraphs (d)(4)(ii) and (iii) and (d)(5). And End Amendment Part Start Amendment Partc. By adding paragraph (d)(6).

End Amendment Part The revisions and addition read as follows. Medicare coverage and payment of Opioid use disorder treatment services furnished by Opioid treatment programs. * * * * * (b) * * * Opioid use disorder treatment service * * * (3) Substance use counseling by a professional to the extent authorized under State law to furnish such services including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. During a Public Health Emergency, as defined in § 400.200 of this chapter, or for services furnished after the end of such emergency, in cases where audio/video communication technology is not available to the beneficiary, the counseling services may be furnished using audio-only telephone calls if all other applicable requirements are met.

(4) Individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law), including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. During a Public Health Emergency, as defined in § 400.200 of this chapter, or for services furnished after the end of such emergency, in cases where audio/video communication technology is not available to the beneficiary, the therapy Start Printed Page 65665 services may be furnished using audio-only telephone calls if all other applicable requirements are met. * * * * * (d) * * * (4) * * * (ii) The payment amounts for the non-drug component of the bundled payment for an episode of care, the adjustments for counseling or therapy, intake activities, periodic assessments, and the non-drug component of the adjustment for take-home supplies of opioid antagonist medications will be geographically adjusted using the Geographic Adjustment Factor described in § 414.26 of this subchapter. (iii) The payment amounts for the non-drug component of the bundled payment for an episode of care, the adjustments for counseling or therapy, intake activities, periodic assessments, and the non-drug component of the adjustment for take-home supplies of opioid antagonist medications will be updated annually using the Medicare Economic Index described in § 405.504(d) of this subchapter.

(5) Payment for medications delivered, administered or dispensed to a beneficiary as part of the bundled payment or an adjustment to the bundled payment under paragraph (d)(4)(i) of this section is considered a duplicative payment if a claim for delivery, administration or dispensing of the same medications for the same beneficiary on the same date of service was also separately paid under Medicare Part B or Part D. CMS will recoup the duplicative payment made to the opioid treatment program. (6) For purposes of the adjustment to the bundled payment under paragraph (d)(4)(i)(A) of this section, after the end of the Public Health Emergency as defined in § 400.200 of this chapter, when services are furnished using audio-only technology the practitioner must certify, in a form and manner specified by CMS, that they had the capacity to furnish the services using two-way, audio/video communication technology, but used audio-only technology because audio/video communication technology was not available to the beneficiary. * * * * * Start Amendment Part24.

Add § 410.72 to read as follows. End Amendment Part Registered dietitians' and nutrition professionals' services. (a) Definition. Registered dietitians and nutrition professionals.

Meet the qualifications at § 410.134. (b) Covered registered dietitian and nutrition professional services. Medicare Part B covers. (1) Coverage condition.

Medical nutrition therapy (MNT) services as defined at § 410.130 under the conditions of coverage at § 410.132. (2) Other services. Registered dietitians and nutrition professionals may also provide diabetes self-management (DSMT) services if they are or represent an accredited DSMT entity and have an order from a physician or qualified nonphysician practitioner who is treating the patient's diabetic condition. (3) Limits on MNT and DSMT.

(i) DSMT and MNT cannot be furnished to a patient on the same date of service, and (ii) MNT and DSMT services cannot be furnished incident to the professional services of a physician or nonphysician practitioner service. (c) Limitations. The following services are not registered dietitian or nutrition professional services for purposes of billing Medicare Part B. (1) Services furnished by a registered dietitian or nutrition professional to an inpatient of a Medicare-participating hospital.

(2) Services furnished by a registered dietitian or nutrition professional to an inpatient of a Medicare-participating SNF. (3) Services furnished by a registered dietitian or nutrition professional to a patient in a Medicare-participating ESRD facility in accordance with the limitation on coverage of MNT service listed at § 410.132(b)(1). (d) Professional services. Registered dietitians and nutrition professionals can be paid for professional services only when the services have been directly performed by them.

(e) Telehealth services. MNT and DSMT services may be provided as telehealth services (meeting the requirements in § 410.78) when registered dietitians or nutrition professionals act as distant site practitioners. (f) Restrictions. The services of a registered dietitian or nutrition professional are provided on an assignment-related basis, and a registered dietitian or nutrition professional may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55.

If a beneficiary has made payment for a service in excess of these limits, the registered dietitian or nutrition professional must refund the full amount of the impermissible charge to the beneficiary. Start Amendment Part25. Amend § 410.74 by revising paragraphs (a)(2)(v) and (d)(2) to read as follows. End Amendment Part Physician assistants' services.

(a) * * * (2) * * * (v) Prior to January 1, 2022, furnishes services that are billed by the employer of a physician assistant. And * * * * * (d) * * * (2) The services of a physician assistant are provided on an assignment-related basis, and the physician assistant may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the physician assistant must refund the full amount of the impermissible charge to the beneficiary. * * * * * Start Amendment Part26.

Amend § 410.75 by revising paragraph (e)(2) to read as follows. End Amendment Part Nurse practitioners' services. * * * * * (e) * * * (2) The services of a nurse practitioner are provided on an assignment-related basis, and the nurse practitioner may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made payment for a service in excess of these limits, the nurse practitioner must refund the full amount of the impermissible charge to the beneficiary.

* * * * * Start Amendment Part27. Amend § 410.76 by revising paragraph (e)(2) to read as follows. End Amendment Part Clinical nurse specialists' services. * * * * * (e) * * * (2) The services of a clinical nurse specialist are provided on an assignment-related basis, and the clinical nurse specialist may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55.

If a beneficiary has made payment for a service in excess of these limits, the clinical nurse specialist must refund the full amount of the impermissible charge to the beneficiary. * * * * * Start Amendment Part28. Amend § 410.77 by revising paragraph (d)(2) to read as follows. End Amendment Part Certified nurse-midwives' services.

Qualifications and conditions. * * * * * (d) * * * (2) The services of a certified nurse-midwife are provided on an assignment-related basis, and the certified nurse-midwife may not charge a beneficiary in excess of the amounts permitted under 42 CFR 424.55. If a beneficiary has made Start Printed Page 65666 payment for a service in excess of these limits, the certified nurse-midwife must refund the full amount of the impermissible charge to the beneficiary. * * * * * Start Amendment Part29.

Amend 410.78 by revising paragraph (a)(3) and adding paragraphs (b)(3)(xiii) and (xiv) and (b)(4)(iv)(D) to read as follows. End Amendment Part Telehealth services. (a) * * * (3) Interactive telecommunications system means, except as otherwise provided in this paragraph, multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. For services furnished for purposes of diagnosis, evaluation, or treatment of a mental health disorder to a patient in their home, interactive telecommunications may include two-way, real-time audio-only communication technology if the distant site physician or practitioner is technically capable to use an interactive telecommunications system as defined in the previous sentence, but the patient is not capable of, or does not consent to, the use of video technology.

A modifier designated by CMS must be appended to the claim for services described in this paragraph to verify that these conditions have been met. * * * * * (b) * * * (3) * * * (xiii) A rural emergency hospital (as defined in section 1861(kkk)(2) of the Act), for services furnished on or after January 1, 2023. (xiv) The home of a beneficiary for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder for services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200 except as otherwise provided in this paragraph. Payment will not be made for a telehealth service furnished under this paragraph unless the following conditions are met.

(A) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service. (B) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, at least once within 12 months of each subsequent telehealth service described in this paragraph, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens associated with an in-person service outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reason(s) for this decision in the patient's medical record. (C) The requirements of paragraphs (b)(3)(xiv)(A) and (B) may be met by another physician or practitioner of the same specialty and subspecialty in the same group as the physician or practitioner who furnishes the telehealth service, if the physician or practitioner who furnishes the telehealth service described under this paragraph is not available. (4) * * * (iv) * * * (D) Services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200 for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder.

Payment will not be made for a telehealth service furnished under this paragraph unless the physician or practitioner has furnished an item or service in person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service and within 6 months of any subsequent telehealth service. * * * * * Start Amendment Part30. Amend § 410.79 by revising paragraphs (c)(1)(ii) and (e)(3)(v)(C) to read as follows. End Amendment Part Medicare Diabetes Prevention Program expanded model.

Conditions of coverage. * * * * * (c) * * * (1) * * * (ii) An MDPP beneficiary is eligible for the first ongoing maintenance session interval only if the beneficiary. (A) Starts his or her first core session on or before December 31, 2021. (B) Attends at least one in-person core maintenance session during the final core maintenance session interval.

And (C) Achieves or maintains the required minimum weight loss at a minimum of one in-person core maintenance session during the final core maintenance session interval. * * * * * (e) * * * (3) * * * (v) * * * (C) Beneficiaries who began the set of MDPP services between January 1, 2021 and December 31, 2021 and who are in the second year of the set of MDPP services as of the start of an applicable 1135 waiver event, whose in-person sessions are suspended due to the applicable 1135 waiver event, and who elect not to continue with MDPP services virtually can elect to attend ongoing maintenance sessions. And may restart the ongoing maintenance session interval in which they were participating at the start of the applicable 1135 waiver event or may resume with the most recent attendance session of record. * * * * * Start Amendment Part31.

Amend § 410.105 by revising paragraph (d)(3)(ii) and adding paragraphs (d)(3)(iii) and (iv) to read as follows. End Amendment Part Requirements for coverage of CORF services. * * * * * (d) * * * (3) * * * (ii) Except as provided in paragraph (d)(3)(iii) of this section, furnishes a portion of a service, or in the case of a 15-minute (or other time interval) timed code, a portion of a unit of service, separately from the part furnished by the physical or occupational therapist such that the minutes for that portion of a service (or unit of a service) exceed 10 percent of the total time for that service (or unit of a service). (iii) Paragraph (d)(3)(ii) of this section does not apply when determining whether the prescribed modifier applies to the last 15-minute unit of a service billed for a patient on a treatment day when the physical or occupational therapist provides more than the midpoint of a 15-minute timed code, that is, 8 or more minutes, regardless of any minutes for the same service furnished by the physical therapist assistant or occupational therapy assistant.

(iv) Where there are two remaining 15-minute units to bill of the same service and the physical therapist and the physical therapist assistant or the occupational therapist and the occupational therapy assistant, as applicable, each provided between 9 and 14 minutes, with a total time of at least 23 minutes, one unit of the service is billed with the prescribed modifier for the minutes furnished by the physical therapist assistant or occupational therapy assistant and one unit is billed without the prescribed modifier for the service provided by the Start Printed Page 65667 physical therapist or occupational therapist. Start Amendment Part32. Amend § 410.130 by revising the definition of “Chronic renal insufficiency” and removing the definition of “Treating physician”. End Amendment Part The revision reads as follows.

Definitions. * * * * * Chronic renal insufficiency means the stage of renal disease associated with a reduction in renal function not severe enough to require dialysis or transplantation (glomerular fiation rate [GFR] 15-59 ml/min/1.73m 2 ). * * * * * Start Amendment Part33. Amend § 410.132 by revising paragraphs (a), (b)(5), and (c) to read as follows.

End Amendment Part Medical nutrition therapy. (a) Conditions for coverage of MNT services. Medicare Part B pays for MNT services provided by a registered dietitian or nutrition professional as defined in § 410.134 when the beneficiary is referred for the service by a physician. (b) * * * (5) An exception to the maximum number of hours in paragraphs (b)(2), (3), and (4) of this section may be made when a physician determines that there is a change of diagnosis, medical condition, or treatment regimen related to diabetes or renal disease that requires a change in MNT during an episode of care.

(c) Referrals. Referral may only be made by a physician when the beneficiary has been diagnosed with diabetes or renal disease as defined in this subpart with documentation noted by a referring physician in the beneficiary's medical record. Start Amendment Part34. Amend § 410.150 by revising paragraph (b)(15) to read as follows.

End Amendment Part To whom payment is made. * * * * * (b) * * * (15)(i) Prior to January 1, 2022, to the qualified employer of a physician assistant for professional services furnished by the physician assistant and for services and supplies provided incident to his or her services. Payment is made to the employer of a physician assistant regardless of whether the physician assistant furnishes services under a W-2, employer-employee employment relationship, or whether the physician assistant is an independent contractor who receives a 1099 reflecting the relationship. Both types of relationships must conform to the appropriate guidelines provided by the Internal Revenue Service.

A qualified employer is not a group of physician assistants that incorporate to bill for their services. Payment is made only if no facility or other provider charges or is paid any amount for services furnished by a physician assistant. (ii) Effective on or after January 1, 2022, payment is made to a physician assistant for professional services furnished by a physician assistant in all settings in both rural and nonrural areas and for services and supplies furnished incident to those services. Payment is made only if no facility or other provider charges, or is paid, any amount for the furnishing of professional services of the physician assistant.

* * * * * Start Amendment Part35. Amend § 410.152 by revising paragraphs (l) introductory text and (l)(5) to read as follows. End Amendment Part Amounts of payment. * * * * * (l) Amount of payment.

Preventive services. Except as provided otherwise in this paragraph, Medicare Part B pays 100 percent of the Medicare payment amount established under the applicable payment methodology for the service furnished by a provider or supplier for the following preventive services. * * * * * (5) Colorectal cancer screening tests (excluding barium enemas). (i) For the colorectal cancer screening tests described in § 410.37(j), Medicare Part B pays at the specified percentage as follows.

(A) 80 percent for CY 2022. (B) 85 percent for CY 2023 through 2026. (C) 90 percent for 2027 through 2029. (D) 100 percent beginning January 1, 2030.

(ii) [Reserved] * * * * * Start Part End Part Start Amendment Part36. The authority citation for part 411 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn.

End Authority Start Amendment Part37. Amend § 411.351 by revising the definition of “List of CPT/HCPCS Codes” to read as follows. End Amendment Part Start Amendment Part38. Amend § 411.354 by revising paragraphs (c)(2)(ii)(A) through (C) to read as follows.

End Amendment Part Financial relationship, compensation, and ownership or investment interest. * * * * * (c) * * * (2)* * * (ii) * * * (A)( 1 ) The referring physician (or immediate family member) receives aggregate compensation from the person or entity in the chain with which the physician (or immediate family member) has a direct financial relationship that varies with the volume or value of referrals or other business generated by the referring physician for the entity furnishing the DHS. And ( 2 ) The amount of compensation that the physician (or immediate family member) receives per individual unit— ( i ) Is not fair market value for items or services actually provided. ( ii ) Could increase as the number or value of the physician's referrals to the entity furnishing DHS increases, or could decrease as the number or value of the physician's referrals to the entity decreases.

( iii ) Could increase as the amount or value of the other business generated by the physician for the entity furnishing DHS increases, or could decrease as the amount or value of the other business generated by the physician for the entity furnishing DHS decreases. Or ( iv ) Is payment for the lease of office space or equipment or for the use of premises or equipment. (B) For purposes of applying paragraph (c)(2)(ii)(A)( 2 ) of this section, the individual unit is. ( 1 ) Item, if the physician (or immediately family member) is compensated solely per item provided.

( 2 ) Service, if the physician (or immediate family member) is compensated solely per service provided, which includes arrangements where the “service” provided includes both items and services. ( 3 ) Time, if the conditions of paragraph (c)(2)(ii)(B)(1) or ( 2 ) of this section are not met. (C) If the financial relationship between the physician (or immediate family member) and the person or entity Start Printed Page 65668 in the chain with which the referring physician (or immediate family member) has a direct financial relationship is an ownership or investment interest, the nonownership or noninvestment interest closest to the referring physician (or immediate family member) is used to determine whether the aggregate compensation varies with the volume or value of referrals or other business generated by the referring physician for the entity furnishing the DHS and whether the amount of compensation that the physician (or immediate family member) receives per individual unit meets the conditions in paragraph (c)(2)(ii)(A)( 2 ) of this section. (For example, if a referring physician has an ownership interest in company A, which owns company B, which has a compensation arrangement with company C, which has a compensation arrangement with entity D that furnishes DHS, we would look to the aggregate compensation between company B and company C for purposes of this paragraph (c)(2)(ii).

* * * * * Start Amendment Part39. Amend § 411.355 by revising paragraph (h) to read as follows. End Amendment Part General exceptions to the referral prohibition related to both ownership/investment and compensation. * * * * * (h) Preventive screening tests and treatments.

(1) Preventive screening tests and treatments that meet the following conditions. (i) The preventive screening test or treatment is listed on the List of CPT/HCPCS Codes as a code to which the exception in this paragraph is applicable. (ii) The preventive screening test or treatment is covered by Medicare. (iii) The preventive screening test or treatment is subject to a CMS-mandated frequency limit.

(2) During such period as the treatment is not subject to a CMS-mandated frequency limit, paragraph (h)(1)(iii) of this section does not apply to a buy antibiotics treatment identified on the List of CPT/HCPCS Codes as a code to which the exception in this paragraph is applicable. * * * * * Start Part End Part Start Amendment Part40. The authority citation for part 414 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302, 1395hh, and 1395rr(b)(l). End Authority Start Amendment Part41. Amend § 414.64 by revising paragraph (a) to read as follows. End Amendment Part Payment for medical nutrition therapy.

(a) Payment under the physician fee schedule. Medicare payment for medical nutrition therapy is made under the physician fee schedule in accordance with subpart B of this part. Payment to nonphysician professionals, as specified in paragraph (b) of this section, is 80 percent (or 100 percent if such services are recommended with a grade of A or B by the United States Preventive Services Task Force for any indication or population and are appropriate for the individual) of the lesser of the actual charges or 85 percent of the physician fee schedule amount. * * * * * Start Amendment Part42.

Amend § 414.84— End Amendment Part Start Amendment Parta. By revising paragraphs (b)(1)(i). End Amendment Part Start Amendment Partb. In paragraph (b)(1)(ii), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Partc. By revising paragraph (b)(2)(i). End Amendment Part Start Amendment Partd. In paragraph (b)(2)(ii), by removing the reference CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Parte. By revising paragraph (b)(3)(i). End Amendment Part Start Amendment Partf. In paragraph (b)(3)(ii), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Partg. By revising paragraph (b)(4)(i)(A). End Amendment Part Start Amendment Parth. In paragraph (b)(4)(i)(B), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

End Amendment Part Start Amendment Parti. By revising paragraph (b)(4)(ii)(A). End Amendment Part Start Amendment Parth. In paragraph (b)(4)(ii)(B), by removing the reference “CY 2018” and adding in its place the reference “CY 2022”.

And End Amendment Part Start Amendment Partj. By revising paragraphs (b)(5), (b)(6)(i), (b)(7)(i) and (ii), and (c). End Amendment Part The revisions read as follows. Payment for MDPP Services.

* * * * * (b) * * * (1) * * * (i) For a first core session furnished January 1, 2022, through December 31, 2022 the amount is $35. * * * * * (2) * * * (i) For the fourth core session furnished January 1, 2022, through December 31, 2022 the amount is $105. * * * * * (3) * * * (i) For the ninth core session furnished January 1, 2022, through December 31, 2022 the amount is $175. * * * * * (4) * * * (i) * * * (A) For a second core maintenance session January 1, 2022, through December 31, 2022 the amount is $93.

* * * * * (ii) * * * (A) For a second core maintenance session January 1, 2022, through December 31, 2022 the amount is $75. * * * * * (5) Performance Goal 5. Attends two ongoing maintenance sessions and maintains the required minimum weight loss during an ongoing maintenance session interval. For an MDPP beneficiary who attends his or her first core session on or before December 31, 2021, CMS makes a performance payment to an MDPP supplier if an MDPP beneficiary attends two ongoing maintenance sessions during an ongoing maintenance session interval, achieves attendance at that second ongoing maintenance session upon attendance at an ongoing maintenance session furnished by that supplier, and achieves or maintains the required minimum weight loss as measured in-person during an ongoing maintenance session furnished during the applicable ongoing maintenance session interval.

CMS makes this performance payment to an MDPP supplier only once per MDPP beneficiary per ongoing maintenance session interval. The amount of this performance payment is determined as follows. (i) For a second ongoing maintenance session furnished in interval 1 (months 13-15 of the MDPP services period), January 1, 2022, through December 31, 2022, the amount is $52. (ii) For a second ongoing maintenance session furnished in interval 2 (months 16-18 of the MDPP services period), January 1, 2022, through December 31, 2022, the amount is $52.

(iii) For a second ongoing maintenance session furnished in interval 3 (months 19-21 of the MDPP services period), January 1, 2022, through December 31, 2022, the amount is $53. (iv) For a second ongoing maintenance session furnished in interval 4 (months 22-24 of the MDPP services period), January 1, 2022, through December 31, 2022 the amount is $53. (v) For a second ongoing maintenance session furnished during a subsequent year. The performance payment amount specified in this paragraph, adjusted as specified in paragraph (d) of this section.

(6) * * * (i) For a core session or core maintenance session, as applicable, furnished January 1, 2022, through December 31, 2022, the amount is $169. * * * * * (7) * * * (i) For a core session or core maintenance session, as applicable, Start Printed Page 65669 furnished January 1, 2022, through December 31, 2022, the amount is $35. (ii) For a core session or core maintenance session, as applicable, furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph, adjusted as specified in paragraph (d) of this section.

(c) Bridge payment. CMS makes a bridge payment to an MDPP supplier only for a core session or core maintenance session furnished to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier. An MDPP supplier that has previously been paid either a bridge payment or a performance payment for an MDPP beneficiary is not eligible to be paid a bridge payment for that beneficiary. A bridge payment is made only on an assignment-related basis in accordance with § 424.55 of this subchapter, and MDPP suppliers must accept the Medicare allowed charge as payment in full and may not bill or collect from the beneficiary any amount.

CMS will make a bridge payment only to an MDPP supplier that complies with all applicable enrollment and program requirements, and only for MDPP services furnished by an eligible coach, on or after his or her coach eligibility start date and, if applicable, before his or her coach eligibility end date. As a condition of payment, the MDPP supplier must report the NPI of the coach who furnished the session on the claim for the MDPP session. The amount of the bridge payment is determined as follows. (1) For core session or core maintenance session, as applicable, furnished January 1, 2022, through December 31, 2022, the amount is $35.

(2) For core session and core maintenance session, as applicable, furnished during a calendar year subsequent to CY 2022. The bridge payment amount specified in this paragraph, adjusted as specified in paragraph (d) of this section. * * * * * Start Amendment Part43. Amend § 414.626 by revising paragraphs (b)(1) and (f) to read as follows.

End Amendment Part Data reporting by ground ambulance organizations. * * * * * (b) * * * (1) Within 30 days of the date that CMS notifies a ground ambulance organization under paragraph (c)(3) of this section that it has selected the ground ambulance organization to report data under this section, the ground ambulance organization must select a data collection period that corresponds with its annual accounting period and provide the start date of that data collection period to CMS or its contractor. * * * * * (f) Public availability of data. Beginning in 2024, and at least once every 2 years thereafter, CMS will post on its website data that it collected under this section, including but not limited to summary statistics and ground ambulance organization characteristics.

* * * * * Start Amendment Part44. Amend § 414.802 by revising the definition of “Drug” to read as follows. End Amendment Part Definitions. * * * * * Drug means a drug or a biological, and for purposes of applying section 1847A(f) of the Act, includes an item, service, supply, or product that is payable under Medicare Part B as a drug or biological.

* * * * * Start Amendment Part45. Section 414.806 is revised to read as follows. End Amendment Part Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data. (a) Misrepresentation.

Section 1847A(d)(4)(A) of the Act specifies the penalties associated with misrepresentations in the reporting of the manufacturer's average sales price for a drug as defined at § 414.802. (b) Failure to provide timely information or the submission of false information. (1) For a manufacturer that has entered into and has in effect a rebate agreement under section 1927 of the Act, section 1927(b)(3)(C) of the Act specifies the penalties associated with a manufacturer's failure to submit timely information or the submission of false information. (2) For a manufacturer that has not entered into and does not have in effect a rebate agreement under section 1927 of the Act, sections 1847A(d)(4)(B) and (C) of the Act specify the penalties associated with a manufacturer's failure to submit timely information or the submission of false information.

Start Amendment Part46. Amend § 414.904 by adding paragraph (d)(4) to read as follows. End Amendment Part Average sales price as the basis for payment. * * * * * (d) * * * (4) Payment adjustment for certain drugs for which there is a self-administered version —(i) In general.

Except as provided in paragraphs (d)(4)(ii) and (iii) of this section, if the Inspector General identifies a drug or biological product in a study described in section 1847A(g)(1) of the Act, the Secretary must apply the payment limit for the applicable billing and payment code as specified in paragraph (d)(4)(iv) of this section, beginning with the first day of the second quarter after such study is publicly available. The methodology described in this paragraph will be recalculated each quarter thereafter, except when conditions described in paragraph (d)(4)(ii) are met. (ii) Exception. The adjustment described in paragraph (d)(4)(i) of this section does not apply to the payment limit for a billing and payment code for a quarter if, at the time that ASP calculations are finalized for such quarter, the drug in the dosage form described by the billing and payment code is included by the FDA on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act.

(iii) Special rule for certain billing and payment codes. Effective July 1, 2021, for a billing and payment code described under section 1847A(g)(3) of the Act, the payment limit for the applicable billing and payment code must be determined as described in paragraph (d)(4)(iv) of this section, and the exception specified at paragraph (d)(4)(ii) of this section does not apply. (iv) Lesser-of methodology. For purposes of this section, the payment limit is the lesser of.

(A) The payment limit determined under section 1847A of the Act for such billing and payment code if each National Drug Code for such product so identified under section 1847A(g)(1) of the Act were excluded from such determination. And (B) The payment limit otherwise determined under section 1847A of the Act for such billing and payment code without application of section 1847A(g) of the Act. (v) NDC changes. For an Inspector General-identified National Drug Code, as described under section 1847A(g)(1) or (3) of the Act, for which the manufacturer has redesignated the National Drug Code (without changes to the dosage form), the application of the lesser-of methodology described in this paragraph must use manufacturer-reported ASP data associated with the redesignated National Drug Code in the same manner as the one originally identified by the Inspector General.

* * * * * Start Amendment Part47. Amend § 414.1300 by revising paragraphs (a)(2) and (3) to read as follows. End Amendment Part Start Printed Page 65670 Basis and scope. (a) * * * (2) Section 1848(k)—Quality Reporting System.

(3) Section 1848(m)—Incentive Payments for Quality Reporting. * * * * * Start Amendment Part48. Amend § 414.1305— End Amendment Part Start Amendment Parta. By revising the definitions of “Collection type” and “Meaningful EHR user for MIPS”.

End Amendment Part Start Amendment Partb. In the definition of “MIPS determination period”, by revising paragraph (2). End Amendment Part Start Amendment Partc. In the definition of “MIPS eligible clinician”, by revising the introductory text, paragraph (2) introductory text, and adding paragraph (3).

End Amendment Part Start Amendment Partd. By adding the definitions of “Multispecialty group”, “MVP participant”, “Population health measure”, “QCDR measure”, “Single specialty group”, “Special status” and “Subgroup” in alphabetical order. And End Amendment Part Start Amendment Parte. By revising the definition of “Submission type”.

End Amendment Part The revisions and additions read as follows. Definitions. * * * * * Collection type means a set of quality measures with comparable specifications and data completeness criteria, as applicable, including, but not limited to. Electronic clinical quality measures (eCQMs).

MIPS clinical quality measures (MIPS CQMs). QCDR measures. Medicare Part B claims measures. CMS Web Interface measures (except as provided in paragraph (1) of this definition, for the CY 2017 through CY 2022 performance periods/2019 through 2024 MIPS payment years).

The CAHPS for MIPS survey. And administrative claims measures. (1) For the CY 2021 through CY 2024 performance periods/2023 through 2026 MIPS payment years, collection types include CMS Web Interface measures for APM Entities reporting through the APM Performance Pathway in accordance with § 414.1367. (2) [Reserved] * * * * * Meaningful EHR user for MIPS means a MIPS eligible clinician who possesses CEHRT, uses the functionality of CEHRT, reports on applicable objectives and measures specified for the Promoting Interoperability performance category for a performance period in the form and manner specified by CMS, does not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of CEHRT, and engages in activities related to supporting providers with the performance of CEHRT.

* * * * * MIPS determination period means. * * * (2) Subject to § 414.1310(b)(1)(iii), an individual eligible clinician, group, or APM Entity group that is identified as not exceeding the low-volume threshold or as having special status, as applicable, during the first segment of the MIPS determination period will be identified as such for the applicable MIPS payment year regardless of the results of the second segment of the MIPS determination period. An individual eligible clinician, group, or APM Entity group for which the unique billing TIN and NPI combination is established during the second segment of the MIPS determination period will be assessed based solely on the results of such segment. MIPS eligible clinician as identified by a unique billing TIN and NPI combination used to assess performance, means any of the following (except as excluded under § 414.1310(b)).

* * * * * (2) For the 2021 through 2023 MIPS payment years. * * * * * (3) For the 2024 MIPS payment year and future years. (i) A clinician described in paragraph (2) of this definition. (ii) A clinical social worker (as defined in section 1861(hh)(1) of the Act).

(ii) A certified nurse midwife (as defined in section 1861(gg)(2) of the Act). And (vii) A group that includes such clinicians. * * * * * Multispecialty group means a group that consists of two or more specialty types. MVP participant means an individual MIPS eligible clinician, multispecialty group, single-specialty group, subgroup, or APM Entity that is assessed on an MVP in accordance with § 414.1365 for all MIPS performance categories.

For the CY 2026 performance period/2028 MIPS payment year and future years, MVP Participant means an individual MIPS eligible clinician, single-specialty group, subgroup, or APM Entity that is assessed on an MVP in accordance with § 414.1365 for all MIPS performance categories. * * * * * Population health measure means a quality measure that indicates the quality of a population or cohort's overall health and well-being, such as access to care, clinical outcomes, coordination of care and community services, health behaviors, preventive care and screening, health equity, or utilization of health services. * * * * * QCDR measure means a quality measure that is submitted by a QCDR and approved by CMS under § 414.1400. QCDR measures consist of.

(1) Measures that are not included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year. And (2) Measures that are included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year, but have undergone substantive changes, as determined by CMS. * * * * * Single specialty group means a group that consists of one specialty type. * * * * * Special status means that a MIPS eligible clinician.

(1) Meets the definition of an ASC-based MIPS eligible clinician, facility-based MIPS eligible clinician, hospital-based MIPS eligible clinician, non-patient facing MIPS eligible clinician, or is in a small practice. Or (2) Is located in an HPSA or rural area. Subgroup means a subset of a group which contains at least one MIPS eligible clinician and is identified by a combination of the group TIN, subgroup identifier, and each eligible clinician's NPI. Submission type means the mechanism by which the submitter type submits data to CMS, including, but not limited to.

(1) Direct. (2) Log in and upload. (3) Log in and attest. (4) Medicare Part B claims.

And (5) CMS Web Interface (except as provided in paragraph (5)(i) of this definition, for the CY 2017 through CY 2022 performance periods/2019 through 2024 MIPS payment years). (i) For the CY 2021 through CY 2024 performance periods/2023 through 2026 MIPS payment years, submission types include the CMS Web Interface for APM Entities reporting through the APM Performance Pathway in accordance with § 414.1367. (ii) [Reserved] * * * * * Start Amendment Part49. Amend § 414.1310 by revising paragraph (e)(1) to read as follows.

End Amendment Part Applicability. * * * * * (e) * * * Start Printed Page 65671 (1) Except as provided under §§ 414.1315(a)(2), 414.1317(b), 414.1318(b), and 414.1370(f)(2) each MIPS eligible clinician in the group receives a final score based on the group's combined performance assessment. * * * * * Start Amendment Part50. Amend § 414.1317 by revising paragraph (b)(2) to read as follows.

End Amendment Part APM Entity groups. * * * * * (b) * * * (2) Performance category weights. The cost performance category weight is zero percent of the final score for an APM Entity. The performance category reweighting scenarios under § 414.1380(c)(2) apply to an APM Entity.

* * * * * Start Amendment Part51. Section 414.1318 is added to subpart O to read as follows. End Amendment Part Subgroups. (a) Eligibility and special status —(1) General.

Except as provided under paragraph (a)(2) of this section, for a MIPS payment year, determinations of meeting the low-volume threshold criteria and special status for subgroups are determined at the group level in accordance with §§ 414.1305 and 414.1310. (2) Exclusions. An individual eligible clinician or group that elects to participate in MIPS as a MIPS eligible clinician in accordance with § 414.1310(b)(1)(iii)(A) or (b)(2) is not eligible to participate in a subgroup. (b) Final score.

Except as provided under § 414.1317(b), each MIPS eligible clinician in the subgroup receives a final score based on the subgroup's combined performance assessment. (c) Subgroup reporting requirements. For individual eligible clinicians to participate in MIPS as a subgroup, all of the following requirements must be met. (1) Individual eligible clinicians that elect to participate in MIPS as a subgroup must aggregate their quality and improvement activities performance data across the subgroup's identifier.

(2) Individual eligible clinicians that elect to participate in MIPS as a subgroup will have their performance assessed at the subgroup level across all the MIPS performance categories based on an MVP in accordance with § 414.1365 and on the APM Performance Pathway in accordance with § 414.1367, as applicable. Subgroups that are MVP Participants must adhere to an election process described in § 414.1365(b). Start Amendment Part52. Amend § 414.1320 by— End Amendment Part Start Amendment Parta.

Redesignating paragraphs (d) through (g) as paragraphs (e) through (h), respectively. And End Amendment Part Start Amendment Partb. Adding a new paragraph (d). End Amendment Part The addition reads as follows.

MIPS performance period. * * * * * (d) For purposes of the CY 2020 performance period/2022 MIPS payment year, the performance period for. (1) The quality and cost performance categories are the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year. (2) The improvement activities performance categories are a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year.

* * * * * Start Amendment Part53. Amend § 414.1325 by revising paragraph (c)(1) to read follows. End Amendment Part Data submission requirements. * * * * * (c) * * * (1) For the quality performance category, the direct.

Login and upload. Medicare Part B claims (beginning with the CY 2019 MIPS performance period/2021 MIPS payment year, for small practices only). And CMS Web Interface (for groups consisting of 25 or more eligible clinicians, a third party intermediary submitting on behalf of a group) submission type. * * * * * Start Amendment Part54.

Amend § 414.1340 revising paragraphs (a)(3) and (b)(3) to read as follows. End Amendment Part Data completeness criteria for the quality performance category. (a) * * * (3) At least 70 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for MIPS payment years 2022, 2023, 2024, and 2025. * * * * * (b) * * * (3) At least 70 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment years 2022, 2023, 2024, and 2025.

* * * * * Start Amendment Part55. Amend § 414.1350 by revising paragraph (c)(4) and adding paragraph (c)(6) to read as follows. End Amendment Part Cost performance category. * * * * * (c) * * * (4) For the procedural episode-based measures specified beginning with the CY 2019 performance period/2021 MIPS payment year, the case minimum is 10, unless otherwise specified for individual measures.

Beginning with the CY 2022 performance period/2024 MIPS payment year, the case minimum for Colon and Rectal Resection procedural episode-based measure is 20 episodes. * * * * * (6) For the chronic condition episode-based measures specified beginning with the CY 2022 performance period/2024 MIPS payment year, the case minimum is 20. * * * * * Start Amendment Part56. Amend § 414.1360 by revising paragraph (a)(2) to read as follows.

End Amendment Part Data submission criteria for the improvement activities performance category. (a) * * * (2) Groups and virtual groups. Beginning with the 2022 performance year, each improvement activity for which groups and virtual groups submit a yes response in accordance with paragraph (a)(1) of this section must be performed by at least 50 percent of the NPIs that are billing under the group's TIN or virtual group's TINs or that are part of the subgroup, as applicable. And the NPIs must perform the same activity during any continuous 90-day period within the same performance year.

* * * * * Start Amendment Part57. Section 414.1365 is added to subpart O to read as follows. End Amendment Part MIPS Value Pathways. (a) General.

(1) Beginning with the CY 2023 MIPS performance period/2025 MIPS payment year, CMS uses MVPs included in the MIPS final inventory of MVPs established by CMS through rulemaking to assess performance for the quality, cost, improvement activities, and Promoting Interoperability performance categories. (2) [Reserved] (b) MVP/Subgroup registration. (1) To report an MVP, an MVP Participant must register for the MVP, and if applicable, as a subgroup during a period that begins on April 1 and ends on November 30 of the applicable CY performance period or a later date specified by CMS. To report the CAHPS for MIPS survey associated with an MVP, a group, subgroup or APM Entity must complete their registration by June 30 of such performance period or a later date specified by CMS.

Start Printed Page 65672 (2) At the time of registration, the MVP Participant must submit the following information, as applicable. (i) Each MVP Participant must select an MVP, 1 population health measure included in the MVP, and any outcomes-based administrative claims measure on which the MVP Participant intends to be scored. (ii) Each subgroup must submit a list of each TIN/NPI associated with the subgroup and a plain language name for the subgroup. (c) MVP reporting requirement s—(1) Quality.

Except as provided in paragraph (c)(1)(i) of this section, an MVP Participant must select and report, if applicable, 4 quality measures, including 1 outcome measure (or, if an outcome measure is not available, 1 high priority measure), included in the MVP, excluding the population health measure required under paragraph (c)(4)(ii) of this section. (i) Paragraph (c)(1) introductory text of this section does not apply to a small practice that reports on an MVP that includes fewer than 4 Medicare Part B claims measures, provided that the small practice reports each such measure that is applicable. (ii) [Reserved] (2) Cost. An MVP Participant is scored on the cost measures included in the MVP that they select and report.

(3) Improvement activities. An MVP Participant who reports an MVP, must report one of the following. (i) Two medium-weighted improvement activities. (ii) One high-weighted improvement activity.

(iii) Participation in a certified or recognized patient-centered medical home (PCMH) or comparable specialty practice, as described at § 414.1380(b)(3)(ii). (4) Foundational layer —(i) Promoting interoperability. An MVP Participant is required to meet the Promoting Interoperability performance category reporting requirements described at § 414.1375(b). (A) For the CY 2023 and 2024 performance periods/2025 and 2026 MIPS payment years, an MVP Participant that is a subgroup is required to submit its affiliated group's data for the Promoting Interoperability performance category.

(B) [Reserved] (ii) Population health measures. Each MVP Participant is scored on 1 population health measure in accordance with paragraph (d)(1) of this section. (d) MVP scoring —(1) General. An MVP Participant that is not an APM Entity is scored on measures and activities included in the MVP in accordance with paragraphs (d)(1) through (3) of this section.

An MVP Participant that is an APM Entity is scored on measures and activities included in the MVP in accordance with § 414.1317(b). (2) Performance standards. Unless otherwise indicated in this paragraph (d), the performance standards described at § 414.1380(a)(1)(i) through (iv) apply to the measures and activities included in the MVP. (3) Performance categories.

An MVP Participant is scored under MIPS in four performance categories. (i) Quality performance category. Except as provided in paragraphs (d)(3)(i)(A)(1) and (d)(3)(i)(B) of this section, the quality performance category score for MVP Participants is calculated in accordance with § 414.1380(b)(1) based on measures included in the MVP. (A) Population health measures.

Except as provided in paragraph (d)(3)(i)(A)( 1 ) of this section, each selected population health measure that does not have a benchmark or meet the case minimum requirement is excluded from the MVP participant's total measure achievement points and total available measure achievement points. ( 1 ) Subgroups are scored on each selected population health measure that does not have a benchmark or meet the case minimum requirement based on their affiliated group score, if available. If the subgroup's affiliated group score is not available, each such measure is excluded from the subgroup's total measure achievement points and total available measure achievement points. ( 2 ) [Reserved] (B) Outcomes-based administrative claims measures.

MVP Participants receive zero measure achievement points for each selected outcomes-based administrative claims measure that does not have a benchmark or meet the case minimum requirement. (ii) Cost performance category. The cost performance category score is calculated for an MVP Participant using the methodology at § 414.1380(b)(2)(i) through (v) and the cost measures included in the MVP that they select and report. (iii) Improvement activities performance category.

The improvement activities performance category score is calculated based on the submission of high- and medium-weighted improvement activities. MVP Participants will receive 20 points for each medium-weighted improvement activity and 40 points for each high-weighted improvement activity required under § 414.1360 on which data is submitted in accordance with § 414.1325 or for participation in a certified or recognized patient-centered medical home (PCMH) or comparable specialty practice, as described at § 414.1380(b)(3)(ii). (iv) Promoting interoperability performance category. The Promoting Interoperability performance category score is calculated for an MVP Participant using the methodology at § 414.1380(b)(4), except as provided in paragraph (d)(3)(iv)(A) of this section.

(A) If a subgroup does not submit its affiliated group's data for the Promoting Interoperability performance category, the subgroup will receive a score of zero for the Promoting Interoperability performance category. (B) [Reserved] (e) Final score calculation. The final score is calculated for an MVP Participant using the methodology at § 414.1380(c), unless otherwise indicated in this paragraph (e). (1) MVP performance category weights.

For an MVP Participant that is not an APM Entity, the final score is calculated using the performance category weights described at § 414.1380(c)(1). For an MVP Participant that is an APM Entity, the final score is calculated using the performance category weights described at § 414.1317(b). (2) Reweighting MVP performance categories —(i) General reweighting. For an MVP Participant that is not an APM Entity, in accordance with paragraph (e)(2)(iii) of this section, a scoring weight different from the weights described at § 414.1380(c)(1) will be assigned to a performance category, and its weight as described at § 414.1380(c)(1) will be redistributed to another performance category or categories, in the circumstances described at § 414.1380(c)(2)(i)(A)(2) through (9) and § 414.1380(c)(2)(i)(C).

For an MVP Participant that is an APM Entity, the performance category weights will be redistributed in accordance with § 414.1317(b). (ii) Subgroups. For an MVP Participant that is a subgroup, any reweighting applied to its affiliated group will also be applied to the subgroup. In addition, if reweighting is not applied to the affiliated group, the subgroup may receive reweighting in the following circumstances independent of the affiliated group.

(A) A subgroup may submit an application to CMS demonstrating that it was subject to extreme and uncontrollable circumstances and receive reweighting in accordance with § 414.1380(c)(2)(i)(A)(6) and (c)(2)(i)(C)(2). In the event that a Start Printed Page 65673 subgroup submits data for a performance category, the scoring weight described at § 414.1380(c)(1) would be applied and its weight would not be redistributed. (B) A subgroup will receive reweighting if CMS determines, based on information known to the agency prior to the beginning of the relevant MIPS payment year, that data for the subgroup are inaccurate, unusable or otherwise compromised due to circumstances outside of the control of the subgroup and its agents, in accordance with § 414.1380(c)(2)(i)(A)(9) and (c)(2)(i)(C)(10). (iii) Reweighting scenarios.

For an MVP Participant that is not an APM Entity, a scoring weight different from the weights described at § 414.1380(c)(1) will be assigned to a performance category, and its weight as described at § 414.1380(c)(1) will be redistributed to another performance category or categories, in accordance with § 414.1380(c)(2)(ii). For an MVP Participant that is an APM Entity, the performance category weights will be redistributed in accordance with § 414.1317(b). (3) Facility-based scoring. If an MVP Participant, that is not an APM Entity, is eligible for facility-based scoring, a facility-based score also will be calculated in accordance with § 414.1380(e).

(4) Complex patient bonus. A complex patient bonus will be added to the final score for an MVP Participant in accordance with § 414.1380(c)(3). Start Amendment Part58. Amend § 414.1375— End Amendment Part Start Amendment Parta.

By revising paragraph (b)(2)(ii). End Amendment Part Start Amendment Partb. By revising the paragraph (b)(3) subject heading. End Amendment Part Start Amendment Partc.

By revising paragraph (b)(3)(ii) introductory text. And End Amendment Part Start Amendment Partc. Adding paragraph (b)(3)(iii). End Amendment Part The revisions and addition read as follows.

Promoting Interoperability (PI) performance category. * * * * * (b) * * * (2) * * * (ii) Beginning with the 2021 MIPS payment year. (A) Report that the MIPS eligible clinician completed the actions included in the Security Risk Analysis measure during the year in which the performance period occurs. (B) For each required measure, as applicable, report the numerator (of at least one) and denominator, or yes/no statement, or an exclusion for each measure that includes an option for an exclusion.

And (C) Beginning with the 2024 MIPS payment year, report that the MIPS eligible clinician completed the actions included in the SAFER Guides measure during the year in which the performance period occurs. (3) Engaging in activities related to supporting providers with the performance of CEHRT. Support for health information exchange and the prevention of information blocking. Actions to limit or restrict the compatibility or interoperability of CEHRT.

* * * * * * * * (ii) Support for health information exchange and the prevention of information blocking. For the 2019, 2020, 2021, 2022, and 2023 MIPS payment years, the MIPS eligible clinician must attest to CMS that he or she— * * * * * (iii) Actions to limit or restrict the compatibility or interoperability of CEHRT. Beginning with the 2024 MIPS payment year, the MIPS eligible clinician must attest to CMS that he or she— (A) Did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology. (B) [Reserved] Start Amendment Part59.

Amend § 414.1380 by— End Amendment Part Start Amendment Parta. Revising paragraphs (b)(1)(i) introductory text and(b)(1)(i)(A)( 1 ). End Amendment Part Start Amendment Partb. Adding paragraphs (b)(1)(i)(A)( 3 ) and (b)(1)(i)(C).

End Amendment Part Start Amendment Partc. Revising paragraphs (b)(1)(iii), (b)(1)(v)(A) introductory text, and (b)(1)(v)(B) introductory text. End Amendment Part Start Amendment Partd. Adding paragraph (b)(1)(v)(B)( 1 )( iii ).

End Amendment Part Start Amendment Parte. Revising paragraphs (b)(1)(vi)(C) introductory text, (b)(1)(vi)(C)( 4 ), (b)(1)(vi)(E), (b)(1)(vii) introductory text, (b)(1)(vii)(A), (b)(2)(iii) introductory text, and (b)(2)(v) introductory text. End Amendment Part Start Amendment Partf. Adding paragraphs (b)(2)(v)(A) and (B).

End Amendment Part Start Amendment Partg. Revising paragraph (b)(4)(ii) introductory text and (b)(4)(ii)(C). End Amendment Part Start Amendment Parth. Revising the table in paragraph (c) introductory text.

End Amendment Part Start Amendment Parti. Revising paragraph (c)(2)(i)(A)( 4 ). End Amendment Part Start Amendment Partj. Removing and reserving paragraph (c)(2)(i)(A)( 5 ).

End Amendment Part Start Amendment Partk. Revising paragraphs (c)(2)(i)(C)( 9 ), (c)(2)(ii)(A), and (c)(2)(ii)(F). End Amendment Part Start Amendment Partl. Adding paragraph (c)(2)(ii)(G).

And End Amendment Part Start Amendment Partm. Revising paragraphs (c)(3) and (e)(6)(iv) through (vi). End Amendment Part The revisions and additions read as follows. Scoring.

* * * * * (b) * * * (1) * * * (i) Measure achievement points. For the CY 2017 through 2021 performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340 and for each administrative claims-based measure that has a benchmark at paragraph (b)(1)(ii) of this section and meets the case minimum requirement at paragraph (b)(1)(iii) of this section. Except as provided under paragraph (b)(1)(i)(C) of this section, beginning with the CY 2023 performance period/2025 MIPS payment year, MIPS eligible clinicians receive between 1 and 10 measure achievement points (including partial points) for each such measure. The number of measure achievement points received for each such measure is determined based on the applicable benchmark decile category and the percentile distribution.

MIPS eligible clinicians receive zero measure achievement points for each measure required under § 414.1335 on which no data is submitted in accordance with § 414.1325. MIPS eligible clinicians that submit data in accordance with § 414.1325 on a greater number of measures than required under § 414.1335 are scored only on the required measures with the greatest number of measure achievement points. Beginning with the CY 2019 performance period/2021 MIPS payment year, MIPS eligible clinicians that submit data in accordance with § 414.1325 on a single measure via multiple collection types are scored only on the data submission with the greatest number of measure achievement points. (A) * * * ( 1 ) Except as provided in paragraphs (b)(1)(i)(A)( 2 ) and ( 3 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 3 measure achievement points for each submitted measure that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement.

Beginning with the CY 2022 performance period/2024 MIPS payment year, MIPS eligible clinicians other than small practices receive 0 measure achievement points Start Printed Page 65674 for each such measure, and small practices receive 3 measure achievement points for each such measure. * * * * * ( 3 ) Beginning with the CY 2023 performance period/2025 MIPS payment year, MIPS eligible clinicians receive 7 measure achievement points for each submitted measure in its first year in MIPS and 5 measure achievement points for each submitted measure in its second year in MIPS that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement. * * * * * (C) New measures. Beginning with the CY 2023 performance period/2025 MIPS payment year, for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340, a MIPS eligible clinician receives between 7 and 10 measure achievement points (including partial points) for each such measure in its first year in MIPS and between 5 and 10 measure achievement points for each such measure in its second year in MIPS.

* * * * * (iii) Minimum case requirements. Except as otherwise specified in the MIPS final list of quality measures described in § 414.1330(a)(1), the minimum case requirement is 20 cases. (v) * * * (A) High priority measures. Subject to paragraph (b)(1)(v)(A)( 1 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 2 measure bonus points for each outcome and patient experience measure and 1 measure bonus point for each other high priority measure.

Beginning with the 2021 MIPS payment year, MIPS eligible clinicians do not receive such measure bonus points for CMS Web Interface measures. * * * * * (B) End-to-end electronic reporting. Subject to paragraph (b)(1)(v)(B)( 1 ) of this section, for the CY 2017 through 2021 MIPS performance periods/2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 1 measure bonus point for each measure (except claims-based measures) submitted with end-to-end electronic reporting for a quality measure under certain criteria determined by the Secretary. ( 1 ) * * * ( iii ) Beginning in the 2024 MIPS payment year, MIPS eligible clinicians will no longer receive measure bonus for submitting using end-to-end electronic reporting.

* * * * * (vi) * * * (C) The improvement percent score is assessed at the performance category level for the quality performance category and included in the calculation of the quality performance category score as described in paragraph (b)(1)(vii) of this section. * * * * * ( 4 ) Beginning with the CY 2018 performance period/2020 MIPS payment year, we will assume a quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year. * * * * * (E) For the purpose of improvement scoring methodology, the term “improvement percent score” means the score that represents improvement for the purposes of calculating the quality performance category score as described in paragraph (b)(1)(vii) of this section. * * * * * (vii) Quality performance category score.

A MIPS eligible clinician's quality performance category score is the sum of all the measure achievement points assigned for the measures required for the quality performance category criteria plus the measure bonus points in paragraph (b)(1)(v) of this section. The sum is divided by the sum of total available measure achievement points. The improvement percent score in paragraph (b)(1)(vi) of this section is added to that result. The quality performance category score cannot exceed 100 percentage points.

(A) For each measure that is submitted, if applicable, and impacted by significant changes or errors prior to the applicable data submission deadline at § 414.1325(e), performance is based on data for 9 consecutive months of the applicable CY performance period. If such data are not available or CMS determines that they may result in patient harm or misleading results, the measure is excluded from a MIPS eligible clinician's total measure achievement points and total available measure achievement points. For purposes of this paragraph (b)(1)(vii)(A), “significant changes or errors” means changes to or errors in a measure that are outside the control of the clinician and its agents and that CMS determines may result in patient harm or misleading results. Significant changes or errors include, but are not limited to, changes to codes (such as ICD-10, CPT, or HCPCS codes) or the active status of codes, the inadvertent omission of codes or inclusion of inactive or inaccurate codes, or changes to clinical guidelines or measure specifications.

CMS will publish on the CMS website a list of all measures scored under this paragraph (b)(1)(vii)(A) as soon as technically feasible, but by no later than the data submission deadline at § 414.1325(e)(1). * * * * * (2) * * * (iii) The cost performance category score is the sum of the following, not to exceed 100 percent. * * * * * (v) A cost performance category score is not calculated if a MIPS eligible clinician or group is not attributed any cost measures for the performance period because the clinician or group has not met the minimum case volume specified by CMS for any of the cost measures or a benchmark has not been created for any of the cost measures that would otherwise be attributed to the clinician or group. (A) Beginning with the 2024 MIPS payment year, if data used to calculate a score for a cost measure are impacted by significant changes during the performance period, such that calculating the cost measure score would lead to misleading or inaccurate results, then the affected cost measure is excluded from the MIPS eligible clinician's or group's cost performance category score.

For purposes of this paragraph (b)(2)(v)(A), “significant changes” are changes external to the care provided, and that CMS determines may lead to misleading or inaccurate results. Significant changes include, but are not limited to, rapid or unprecedented changes to service utilization, and will be empirically assessed by CMS to determine the extent to which the changes impact the calculation of a cost measure score that reflects clinician performance. (B) [Reserved] * * * * * (4) * * * (ii) Beginning with the 2019 performance period/2021 MIPS payment year, a MIPS eligible clinician's Promoting Interoperability performance category score equals the sum of the scores for each of the required measures and any applicable bonus scores, not to exceed 100 points. * * * * * Start Printed Page 65675 (C) Each optional measure is worth five or ten bonus points, as specified by CMS.

* * * * * (c) * * * Table 1 to Paragraph (c) Introductory TextFor the 2019 MIPS payment year:Final score = [(quality performance category score × quality performance category weight) + (cost performance category score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)], not to exceed 100 points.For the 2020 MIPS payment year:Final score = [(quality performance category score × quality performance category weight) + (cost performance category score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)] × 100 + [the complex patient bonus + the small practice bonus], not to exceed 100 points.Beginning with the 2021 MIPS payment year:Final score = [(quality performance category score × quality performance category weight) + (cost performance category score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (Promoting Interoperability performance category score × Promoting Interoperability performance category weight)] × 100 + the complex patient bonus, not to exceed 100 points. * * * * * (2) * * * (i) * * * (A) * * * ( 4 ) For the Promoting Interoperability performance category. ( i ) For the 2021 through 2024 MIPS payment years, the MIPS eligible clinician is a physical therapist, occupational therapist, clinical psychologist, qualified audiologist, qualified speech-language pathologist, or a registered dietitian or nutrition professional. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.

( ii ) For the 2019 through 2024 MIPS payment years, the MIPS eligible clinician is a nurse practitioner, physician assistant, clinical nurse specialist, or certified registered nurse anesthetist. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed. ( iii ) For the 2024 MIPS payment year, the MIPS eligible clinician is a clinical social worker. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.

* * * * * (C) * * * ( 9 ) For the 2020 MIPS payment year through the 2023 MIPS payment year the MIPS eligible clinician demonstrates through an application submitted to CMS that they are in a small practice as defined in § 414.1305, and overwhelming barriers prevent them from complying with the requirements for the Promoting Interoperability performance category. Beginning with the 2024 MIPS payment year the MIPS eligible clinician is in a small practice as defined in § 414.1305. * * * * * (ii) * * * (A) For the 2019 MIPS payment year. Table 2 to Paragraph (c)(2)(ii)(A)Performance category (%)Weighting for the 2019 MIPS payment year (%)Reweight scenario if no promoting interoperability performance category score (%)Reweight scenario if no quality performance category score (%)Reweight scenario if no improvement activities performance category score (%)Quality6085075Cost0000Improvement Activities1515500Promoting Interoperability2505025 * * * * * (F) Except as provided in paragraph (c)(2)(ii)(G) of this section, beginning with the 2024 MIPS payment year.

Table 7 to Paragraph (c)(2)(ii)(F)Reweighting scenarioQuality (%)Cost (%)Improvement activities (%)Promoting interoperability (%)No Reweighting Needed:Scores for all four performance categories30301525No Cost5501530Start Printed Page 65676No Promoting Interoperability5530150No Quality0301555No Improvement Activities4530025No Cost and no Promoting Interoperability850150No Cost and no Quality001585No Cost and no Improvement Activities700030No Promoting Interoperability and no Quality050500No Promoting Interoperability and no Improvement Activities703000No Quality and no Improvement Activities030070 (G) For small practices beginning with the 2024 MIPS payment year. Table 8 to Paragraph (c)(2)(ii)(G)Reweighting scenarioQuality (%)Cost (%)Improvement activities (%)Promoting interoperability (%)No Reweighting Needed:Scores for all four performance categories30301525No Cost5501530No Promoting Interoperability4030300No Quality0301555No Improvement Activities4530025No Cost and no Promoting Interoperability500500No Cost and no Quality001585No Cost and no Improvement Activities700030No Promoting Interoperability and no Quality050500No Promoting Interoperability and no Improvement Activities703000No Quality and no Improvement Activities030070 * * * * * (3) Complex patient bonus. For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, provided that a MIPS eligible clinician, group, virtual group or APM Entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus will be added to the final score for the MIPS payment year, as stated in paragraphs (c)(3)(i) through (iv) of this section. Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, provided that a MIPS eligible clinician, group, subgroup, virtual group or APM Entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus will be added to the final score for the MIPS payment year, if applicable, as described in paragraphs (c)(3)(v) through (viii) of this section.

(i) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, for MIPS eligible clinicians and groups, the complex patient bonus is calculated as follows. [The average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group] + [the dual eligible ratio × 5]. (ii) For the CY 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, for APM Entities and virtual groups, the complex patient bonus is calculated as follows. [The beneficiary weighted average HCC risk score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation within the APM Entity or virtual group, respectively] + [the average dual eligible ratio for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively, × 5].

(iii) For the 2020, 2021, 2022, and 2023 MIPS payment years and associated performance periods, the complex patient bonus cannot exceed 5.0 except as provided in paragraph (c)(3)(iv) of this section. (iv) For the 2022 and 2023 MIPS payment years and associated performance periods, the complex patient bonus is calculated pursuant to paragraphs (c)(3)(i) and (ii) of this section, and the resulting numerical value is then multiplied by 2.0. The complex patient bonus cannot exceed 10.0. (v) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the complex patient bonus is limited to MIPS eligible clinicians, groups, subgroups, APM Entities, and virtual groups with a risk indicator at or above the risk indicator calculated median.

To determine the median for the respective risk indicator (HCC and dual proportion), risk indicators associated with the final score assigned to a clinician from the most recent prior performance period, for all those who have submitted data for at least one MIPS performance category or are facility-based, are used. (vi) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, for MIPS eligible clinicians, groups, and subgroups, the complex patient bonus components are calculated as follows for the specific Start Printed Page 65677 risk indicators. Medical complex patient bonus component = 1.5 + 4 * associated HCC standardized score calculated with the average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group or subgroup. Social complex patient bonus component = 1.5 + 4 * associated dual proportion standardized score.

The components are added together to calculate one overall complex patient bonus. A standardized score for each risk indicator is determined based on the mean and standard deviation of the raw risk indicator score and provides a standardized measurement of how far each risk score is from the mean. (raw risk indicator score−risk indicator mean)/risk indicator standard deviation. (vii) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, for APM Entities and virtual groups, the complex patient bonus components are calculated as follows for the specific risk indicators.

Medical complex patient bonus component = 1.5 + 4 * the beneficiary weighted average HCC risk standardized score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation within the APM Entity or virtual group, respectively. Social complex patient bonus component = 1.5 + 4 * the average dual proportion standardized score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively. The components are added together to calculate one overall complex patient bonus. A standardized score for each risk indicator is determined based on the mean and standard deviation of the raw risk indicator score and provides a standardized measurement of how far each risk score is from the mean.

(raw risk indicator score−risk indicator mean)/risk indicator standard deviation. (viii) Beginning with the CY 2022 MIPS performance period/CY 2024 MIPS payment year, the complex patient bonus cannot exceed 10.0 and cannot be below 0.0. * * * * * (e) * * * (6) * * * (iv) Quality. The quality performance category score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of this section and awarding a score associated with that same percentile performance in the MIPS quality performance category score for those MIPS-eligible clinicians who are not eligible to be scored using facility-based measurement for the MIPS payment year.

A clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS quality performance category (v) Cost. The cost performance category score is established by determining the percentile performance of the facility in the value-based purchasing program for the specified year as described in paragraph (e)(1) of this section and awarding a score associated with that same percentile performance in the MIPS cost performance category score for those MIPS eligible clinicians who are not eligible to be scored using facility-based measurement for the MIPS payment year. A clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS cost performance category. (A) Other cost measures.

MIPS eligible clinicians who are scored under facility-based measurement are not scored on cost measures described in paragraph (b)(2) of this section. (B) [Reserved] (vi) Use of score from facility-based measurement. The MIPS quality and cost performance category scores will be based on the facility-based measurement scoring methodology described in paragraph (e)(6) of this section unless. (A) For the CY 2019 MIPS performance period/2021 MIPS payment year, through the CY 2021 MIPS performance period/2023 MIPS payment year, a clinician or group receives a higher combined MIPS quality and cost performance category score through another MIPS submission.

(B) Beginning with the CY 2022 MIPS performance period/2024 MIPS payment year, a clinician or group receives a higher MIPS final score through another MIPS submission. Start Amendment Part60. Amend § 414.1395 by revising paragraph (c) to read as follows. End Amendment Part Public reporting.

* * * * * (c) New measures and activities. (1) CMS does not publicly report any data on new quality or cost measure for the first 2 years in which it is in the program, after which CMS evaluates the measure to determine whether it is suitable for public reporting under paragraph (b) of this section. (2) CMS does not publicly report any MVP data on new improvement activity or Promoting Interoperability measure, objective, or activity included in an MVP for the first year in which it is included in the MVP. * * * * * Start Amendment Part61.

Revise § 414.1400 to read as follows. End Amendment Part Third party intermediaries. (a) General. (1) MIPS data may be submitted on behalf of a MIPS eligible clinician, group, virtual group, subgroup, or APM Entity by any of the following third party intermediaries.

(i) QCDR. (ii) Qualified registry. (iii) Health IT vendor. Or (iv) CMS-approved survey vendor.

(2) Third party intermediary approval criteria— (i) To be approved as a third party intermediary, an entity must agree to meet the applicable requirements of this section, including, but not limited to, the following. (A) A third party intermediary's principle place of business and retention of any data must be based in the U.S. (B) If the data is derived from CEHRT, a QCDR, qualified registry, or health IT vendor must be able to indicate its data source. (C) All data must be submitted in the form and manner specified by CMS.

(D) If the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS. (E) The third party intermediary must provide services throughout the entire performance period and applicable data submission period. (F) Prior to discontinuing services to any MIPS eligible clinician, group, virtual group, subgroup, or APM Entity during a performance period, the third party intermediary must support the transition of such MIPS eligible clinician, group, virtual group, subgroup, or APM Entity to an alternate third party intermediary, submitter type, or, for any measure on which data has been collected, collection type according to a CMS approved a transition plan. (ii) The determination of whether to approve an entity as a third party intermediary for a MIPS payment year may take into account.

(A) Whether the entity failed to comply with the requirements of this section for any prior MIPS payment year for which it was approved as third party intermediary. And (B) Whether the entity provided inaccurate information regarding the Start Printed Page 65678 requirements of this subpart to any eligible clinician. (iii) Beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner, and at the times, specified by CMS. (3) All data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group, virtual group, subgroup, or APM Entity must be certified by the third party intermediary as true, accurate, and complete to the best of its knowledge.

Such certification must be made in a form and manner and at such time as specified by CMS. (b) Additional requirements for QCDRs and qualified registries —(1) General. (i) Beginning with the CY 2021 performance period/2023 MIPS payment year, QCDRs and qualified registries must be able to submit data for all of the following MIPS performance categories. (A) Quality, except.

(1) The CAHPS for MIPS survey. And (2) For qualified registries, QCDR measures. (B) Improvement activities. And (C) Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless the third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)(4)(i) through (iii) or (c)(2)(i)(C)(1) through (7) or (c)(2)(i)(C)(9).

(ii) Beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. QCDRs and qualified registries may also support the APP. (2) Self-nomination. For the CY 2018 and 2019 performance periods/2020 and 2021 MIPS payment years, entities seeking to qualify as a QCDR or qualified registry must self-nominate September 1 until November 1 of the CY preceding the applicable performance period.

For the CY 2020 performance period/2022 MIPS payment year and future years, entities seeking to qualify as a QCDR or qualified registry must self-nominate during a 60-day period during the CY preceding the applicable performance period (beginning no earlier than July 1 and ending no later than September 1). Entities seeking to qualify as a QCDR or qualified registry for a performance period must provide all information required by CMS at the time of self-nomination and must provide any additional information requested by CMS during the review process. For the CY 2019 performance period/2021 MIPS payment year and future years, existing QCDRs and qualified registries that are in good standing may attest that certain aspects of their previous year's approved self-nomination have not changed and will be used for the applicable performance period. (3) Conditions for approval.

(i) Beginning with the CY 2020 performance period/2022 MIPS payment year, the QCDR or qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period. (ii) If an entity seeking to qualify as a QCDR or qualified registry uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period. (iii) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must provide performance feedback to their clinicians and groups at least 4 times a year, and provide specific feedback to their clinicians and groups on how they compare to other clinicians who have submitted data on a given measure within the QCDR or qualified registry.

Exceptions to this requirement may occur if the QCDR or qualified registry submits notification to CMS within the performance period promptly within the month of realization of the impending deficiency and provides sufficient rationale as to why they do not believe they would be able to meet this requirement (for example, if the QCDR does not receive the data from their clinician until the end of the performance period). (iv) Beginning with the CY 2023 performance period/2025 MIPS payment year, the QCDR or qualified registry must submit a data validation plan annually, at the time of self-nomination for CMS' approval and may not change the plan once approved without the prior approval of the agency. (v) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct annual data validation audits in accordance with this paragraph (b)(3)(v). (A) The QCDR or qualified registry must conduct data validation for the payment year prior to submitting any data for that payment year to CMS for purposes of the MIPS program.

(B) The QCDR or qualified registry must conduct data validation on data for each performance category for which it will submit data, including if applicable the Quality, Improvement Activities, and Promoting Interoperability performance categories. (C) The QCDR or qualified registry must conduct data validation on data for each submitter type for which it will submit data, including MIPS eligible clinicians, groups, virtual groups, subgroups, APM entities, voluntary participants, and opt-in participants, if applicable. (D) The QCDR or qualified registry must use clinical documentation (provided by the clinicians they are submitting data for) to validate that the action or outcome measured actually occurred or was performed. (E) The QCDR or qualified registry must conduct each data validation audit using a sampling methodology that meets the following requirements.

(1) Uses a sample size of at least 3 percent of the TIN/NPIs for which the QCDR or qualified registry will submit data to CMS, except that if a 3 percent sample size would result in fewer than 10 TIN/NPIs, the QCDR or qualified registry must use a sample size of at least 10 TIN/NPIs, and if a 3 percent sample size would result in more than 50 TIN/NPIs, the QCDR or qualified registry may use a sample size of 50 TIN/NPIs. (2) Uses a sample that includes at least 25 percent of the patients of each TIN/NPI in the sample, except that the sample for each TIN/NPI must include a minimum of 5 patients and does not need to include more than 50 patients. (F) Each QCDR or qualified registry data validation audit must include the following. (1) Verification of the eligibility status of each eligible clinician, group, virtual group, subgroup, opt-in participant, and voluntary participant.

(2) Verification of the accuracy of TINs and NPIs. (3) Calculation of reporting and performance rates. (4) Verification that only the MIPS quality measures and QCDR measures, as applicable, that are relevant to the performance period will be used for MIPS submission. (G) In a form and manner and by a deadline specified by CMS, the QCDR or qualified registry must report the results of each data validation audit, including the overall data deficiencies or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or Start Printed Page 65679 error, and, how and when each deficiency or data error type was corrected.

(1) QCDRs and qualified registries must conduct validation on the data they intend to submit for the MIPS performance period and provide the results of the executed data validation plan by May 31st of the year following the performance period. (2) [Reserved] (vi) Beginning with the CY 2021 performance period/2023 MIPS payment year, the QCDR or qualified registry must conduct targeted audits in accordance with this paragraph (b)(3)(vi). (A) If a data validation audit under paragraph (b)(3)(v) of this section identifies one or more deficiency or data error, the QCDR or qualified registry must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year. (B) The QCDR or qualified registry must conduct any required targeted audits for the MIPS payment year and correct any deficiencies or data errors identified through such audit prior to the submission of data for that MIPS payment year.

(C) The QCDR or qualified registry must conduct the targeted audit using the sampling methodology that meets the requirements described in paragraph (b)(3)(iv)(E) of this section. The sample for the targeted audit must not include data from the sample used for the data validation audit in which the deficiency or data error was identified. (D) In a form and manner and by a deadline specified by CMS, the QCDR or qualified registry must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each deficiency or data error type was corrected. (vii) For the CY 2023 performance period/2025 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for any of the 2019 through 2023 MIPS payment years must submit a participation plan for CMS' approval.

The participation plan must include the QCDR and/or qualified registry's detailed plans about how the QCDR or qualified registry intends to encourage clinicians to submit MIPS data to CMS through the QCDR or qualified registry. (viii) Beginning with the CY 2024 performance period/2026 MIPS payment year, a QCDR or qualified registry that was approved but did not submit any MIPS data for either of the 2 years preceding the applicable self-nomination period must submit a participation plan for CMS' approval. This participation plan must include the QCDR's and/or qualified registry's detailed plans about how the QCDR or qualified registry intends to encourage clinicians to submit MIPS data to CMS through the QCDR or qualified registry. (4) QCDR measures for the quality performance category—(i) QCDR measure self-nomination requirements.

For the CY 2018 performance period/2020 MIPS payment year and future years, at the time of self-nomination an entity seeking to become a QCDR must submit the following information for any measure it intends to submit for the payment year. (A) For MIPS quality measures, the entity must submit specifications including the MIPS measure IDs and specialty-specific measure sets, as applicable. (B) For QCDR measures, the entity must submit for CMS-approval measure specifications including. Name/title of measures, NQF number (if NQF- endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms.

In addition, no later than 15 calendar days following CMS approval of any QCDR measure specifications, the entity must publicly post the measure specifications for that QCDR measure (including the CMS- assigned QCDR measure ID) and provide CMS with a link to where this information is posted. (ii) QCDR measure submission requirements. A QCDR must include the CMS-assigned QCDR measure ID when submitting data on any QCDR measure to CMS. (iii) QCDR measure approval criteria.

(A) QCDR measure requirements for approval are. ( 1 ) QCDR measures that are beyond the measure concept phase of development. ( 2 ) QCDR measures that address significant variation in performance. ( 3 ) Beginning with the CY 2022 performance period/2024 MIPS payment year, all QCDR measures must meet face validity.

To be approved for the CY 2023 performance period/2025 MIPS payment year, all QCDR measures must meet face validity for the initial MIPS payment year for which it is approved. For subsequent years after being initially approved, all QCDR measures must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination. ( i ) To be included in an MVP for the CY 2022 performance period/2024 MIPS payment year and future years, a QCDR measure must be fully tested. ( ii ) [Reserved] ( 4 ) Beginning with the CY 2022 performance period/2023 MIPS payment year, QCDRs are required to collect data on a QCDR measure, appropriate to the measure type, prior to submitting the QCDR measure for CMS consideration during the self-nomination period.

( 5 ) Beginning with the CY 2020 performance period/2022 MIPS payment year, CMS may provisionally approve the individual QCDR measures for 1 year with the condition that QCDRs address certain areas of duplication with other approved QCDR measures or MIPS quality measures in order to be considered for the program in subsequent years. If such areas of duplication are not addressed, CMS may reject the duplicative QCDR measure. (B) QCDR measure considerations for approval include, but are not limited to. ( 1 ) Measures that are outcome-based rather than clinical process measures.

( 2 ) Measures that address patient safety and adverse events. ( 3 ) Measures that identify appropriate use of diagnosis and therapeutics. ( 4 ) Measures that address the domain of care coordination. ( 5 ) Measures that address the domain for patient and caregiver experience.

( 6 ) Measures that address efficiency, cost, and resource use. ( 7 ) Beginning with the CY 2021 performance period/2023 MIPS payment year - ( i ) That QCDRs link their QCDR measures as feasible to at least one cost measure, improvement activity, or an MVP at the time of self-nomination. ( ii ) In cases where a QCDR measure does not have a clear link to a cost measure, improvement activity, or an MVP, CMS would consider exceptions if the potential QCDR measure otherwise meets the QCDR measure requirements and considerations. ( 8 ) Beginning with the CY 2020 performance period/2022 MIPS payment year CMS may consider the extent to which a QCDR measure is available to MIPS eligible clinicians reporting through QCDRs other than the QCDR measure owner for purposes of MIPS.

If CMS determines that a QCDR measure is not available to MIPS eligible clinicians, groups, and virtual groups reporting through other QCDRs, CMS may not approve the measure. ( 9 ) Greater consideration is given to measures for which QCDRs. Start Printed Page 65680 (i) Conducted an environmental scan of existing QCDR measures. MIPS quality measures.

Quality measures retired from the legacy Physician Quality Reporting System (PQRS) program. And ( ii ) Utilized the CMS Quality Measure Development Plan Annual Report and the Blueprint in the CMS Measures Management System to identify measurement gaps prior to measure development. ( 10 ) Beginning with the CY 2020 performance period/2022 MIPS payment year, CMS places greater preference on QCDR measures that meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods. Those that do not, may not continue to be approved.

( i ) Beginning with the CY 2020 performance period/2022 MIPS payment year, in instances where a QCDR believes the low-reported QCDR measure that did not meet benchmarking thresholds is still important and relevant to a specialist's practice, that the QCDR may develop and submit a QCDR measure participation plan for our consideration. This QCDR measure participation plan must include the QCDR's detailed plans and changes to encourage eligible clinicians and groups to submit data on the low-reported QCDR measure for purposes of the MIPS program. ( ii ) [Reserved] (C) Beginning with the CY 2021 performance period/2023 MIPS payment year, QCDR measures may be approved for 2 years, at CMS discretion by attaining approval status by meeting QCDR measure considerations and requirements. Upon annual review, CMS may revoke a QCDR measure's second year approval, if the QCDR measure is found to be.

Topped out. Duplicative of a more robust measure. Reflects an outdated clinical guideline. Or if the QCDR self-nominating the QCDR measure is no longer in good standing.

(iv) QCDR measure rejection criteria. Beginning with the CY 2020 performance period/2022 MIPS payment year, QCDR measure rejection considerations include, but are not limited to. (A) QCDR measures that are duplicative or identical to other QCDR measures or MIPS quality measures that are currently in the program. (B) QCDR measures that are duplicative or identical to MIPS quality measures that have been removed from MIPS through rulemaking.

(C) QCDR measures that are duplicative or identical to quality measures used under the legacy Physician Quality Reporting System (PQRS) program, which have been retired. (D) QCDR measures that meet the topped out definition as described at § 414.1305. (E) QCDR measures that are process-based, with consideration to whether the removal of the process measure impacts the number of measures available for a specific specialty. (F) Whether the QCDR measure has potential unintended consequences to a patient's care.

(G) Considerations and evaluation of the measure's performance data, to determine whether performance variance exists. (H) QCDR measures that split a single clinical practice or action into several QCDR measures. (I) QCDR measures that are “check-box” with no actionable quality action. (J) QCDR measures that do not meet the case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive years.

(K) QCDR measures with clinician attribution issues, where the quality action is not under the direct control of the reporting clinician. (L) QCDR measures that focus on rare events or “never events” in the measurement period. (M) QCDR does not have permission to use a QCDR measure owned by another QCDR for the applicable performance period. (N) If a QCDR measure owner is not approved or is not in good standing, any associated QCDR measures will not be approved.

(c) Additional requirements for Health IT vendors. (1) Beginning with the CY 2021 performance period/2023 MIPS payment year, health IT vendors must be able to submit data for the MIPS performance categories as follows. (i) Health IT vendors that support MVPs must be able to submit data for all of the MIPS performance categories. (A) Quality, except.

( 1 ) The CAHPS for MIPS survey. And ( 2 ) QCDR measures. (B) Improvement activities. And (C) Promoting Interoperability, if the eligible clinician, group, virtual group, or subgroup is using CEHRT, unless.

( 1 ) The third party intermediary's MIPS eligible clinicians, groups, virtual groups, or subgroups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)( 4 )( i ) through ( iii ) or (c)(2)(i)(C)( 1 ) through ( 7 ) or (c)(2)(i)(C)( 9 ). ( 2 ) [Reserved] (ii) Health IT vendors that do not support MVPs must be able to submit data for at least one of the MIPS performance categories described in paragraphs (c)(1)(i) of this section. (iii) Beginning with the CY 2023 performance period/2025 MIPS payment year, Health IT vendors must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. Health IT vendors may also support the APP.

(2) [Reserved] (d) Additional requirements for CMS-approved survey vendors. (1) CMS-approved survey vendors may submit data on the CAHPS for MIPS survey for the MIPS quality performance category. (2) Entities seeking to be a CMS-approved survey vendor for any MIPS performance period must submit a survey vendor application to CMS in a form and manner specified by CMS for each MIPS performance period for which it wishes to transmit such data. The application and any supplemental information requested by CMS must be submitted by deadlines specified by CMS.

For an entity to be a CMS-approved survey vendor, it must meet the following criteria. (3) The entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including. (i) At least 3 years of experience administering mixed-mode surveys (that is, surveys that employ multiple modes to collect date), including mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI). (ii) At least 3 years of experience administering surveys to a Medicare population.

(iii) At least 3 years of experience administering CAHPS surveys within the past 5 years. (iv) Experience administering surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available. (v) Use equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule call-backs to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities. And (vi) Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey.

Start Printed Page 65681 (4) The entity has certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data. (5) The entity has successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors. (6) The entity has submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts. (7) The entity has agreed to participate and cooperate, and has required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors.

(8) The entity has sent an interim survey data file to CMS that establishes the entity's ability to accurately report CAHPS data. (e) Remedial action and termination of third party intermediaries. (1) If CMS determines that a third party intermediary has ceased to meet one or more of the applicable criteria for approval, has submitted a false certification under paragraph (a)(3) of this section, or has submitted data that are inaccurate, unusable, or otherwise compromised, CMS may take one or more of the following remedial actions after providing written notice to the third party intermediary. (i) Require the third party intermediary to submit a corrective action plan (CAP) by a date specified by CMS.

The CAP must address the following issues, unless different or additional information is specified by CMS. (A) The issues that contributed to the non-compliance. (B) The impact to individual clinicians, groups, or virtual groups, regardless of whether they are participating in the program because they are MIPS eligible, voluntary participating, or opting in to participating in the MIPS program. (C) The corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved and will not recur in the future.

(D) The detailed timeline for achieving compliance with the applicable requirements. (ii) Publicly disclose the entity's data error rate on the CMS website until the data error rate falls below 3 percent. (2) CMS may immediately or with advance notice terminate the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the following reasons. (i) CMS has grounds to impose remedial action.

(ii) CMS has not received a CAP within the specified time-period or the CAP is not accepted by CMS. Or (iii) The third party intermediary fails to correct the deficiencies or data errors by the date specified by CMS. (3) Contains data inaccuracies affecting the third party intermediary's total clinicians may lead to remedial action/termination of the third party intermediary for future program year(s) based on CMS discretion. (4) For purposes of this paragraph (e), CMS may determine that submitted data are inaccurate, unusable, or otherwise compromised, including but not limited to, if the submitted data.

(i) Includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies. (ii) [Reserved] (f) Auditing of entities submitting MIPS data. Any third party intermediary must comply with the following procedures as a condition of its qualification and approval to participate in MIPS as a third party intermediary. (1) The entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data.

The contact information must include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email. (2) The entity must retain all data submitted to CMS for purposes of MIPS for 6 years from the end of the MIPS performance period. (3) For the purposes of auditing, CMS may request any records or data retained for the purposes of MIPS for up to 6 years from the end of the MIPS performance period. Start Amendment Part62.

Amend § 414.1405 by adding paragraphs (b)(9), (d)(7), and (g) to read as follows. End Amendment Part Payment. * * * * * (b) * * * (9) Pursuant to the methodology established at paragraph (g) of this section, the performance threshold for the 2024 MIPS payment year is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS payment year.

* * * * * (d) * * * (7) The additional performance threshold for the 2024 MIPS payment year is 89 points. * * * * * (g) Performance threshold methodology. For each of the 2024, 2025, and 2026 MIPS payment years, the performance threshold is the mean of the final scores for all MIPS eligible clinicians from a prior period as specified under paragraph (b) of this section. Start Amendment Part63.

Amend § 414.1430 by— End Amendment Part Start Amendment Parta. Revising paragraph (a)(1)(iii). End Amendment Part Start Amendment Partb. Adding paragraphs (a)(1)(iv).

End Amendment Part Start Amendment Partc. Removing the second occurrence of paragraph (a)(2)(ii). End Amendment Part Start Amendment Partd. Adding paragraphs (a)(2)(iii) and (iv).

And End Amendment Part Start Amendment Parte. Revising paragraphs (b)(1)(i)(A) and (B) and (b)(2)(i)(A) and (B). End Amendment Part The revisions and additions read as follows. Qualifying APM participant determination.

QP and partial QP thresholds. (a) * * * (1) * * * (iii) 2023 and 2024. 50 percent. (iv) 2025 and later.

75 percent. (2) * * * (iii) 2023 and 2024. 50 percent. (iv) 2025 and later.

75 percent. * * * * * (b) * * * (1) * * * (i) * * * (A) 2021 through 2024. 50 percent. (B) 2025 and later.

75 percent. * * * * * (2) * * * (i) * * * (A) 2021 through 2024. 35 percent. (B) 2025 and later.

50 percent. * * * * * Start Amendment Part64. Amend § 414.1450 by revising paragraph (c) introductory text to read as follows. End Amendment Part APM incentive payment.

* * * * * (c) APM Incentive Payment recipient. CMS will pay the APM Incentive Payment amount for a payment year to a solvent TIN or TINs associated with the QP, identified based on Medicare Part B claims submitted for covered professional services during the base period or payment year, according to this section. If no TIN or TINs with which the QP has an association can be identified at a step, CMS will move to the next and successive steps listed in paragraphs (c)(1) through (8) of this section until CMS identifies a TIN or TINs with which the QP is associated, and to which CMS will make the APM Start Printed Page 65682 Incentive Payment. If more than one TIN is identified at a step, the payment will be proportionately divided among the TINs according to the relative total paid amounts for Part B covered professional services paid to each TIN for services provided during the base year.

* * * * * Start Part End Part Start Amendment Part65. The authority citation for part 415 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh.

End Authority Start Amendment Part66. Section 415.140 is added to subpart D to read as follows. End Amendment Part Conditions for payment. Split (or shared) visits.

(a) Definitions. For purposes of this section, the following definitions apply. Facility setting for purposes of this section means institutional settings in which payment for services and supplies furnished incident to a physician or practitioner's professional services is prohibited under § 410.26(b)(1) of this subchapter. Split (or shared) visit means an evaluation and management (E/M) visit in the facility setting that is performed in part by both a physician and a nonphysician practitioner who are in the same group, in accordance with applicable law and regulations such that the service could be could be billed by either the physician or nonphysician practitioner if furnished independently by only one of them.

Substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit, except as otherwise provided in this paragraph. For visits other than critical care visits furnished in calendar year 2022, substantive portion means one of the three key components (history, exam or medical decision-making) or more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit. (b) Conditions of payment. For purposes of this section, the following conditions of payment apply.

(1) Substantive portion of split (or shared) visit. In general, payment is made to the physician or nonphysician practitioner who performs the substantive portion of the split (or shared) visit. (2) Medical record documentation. Documentation in the medical record must identify the physician and nonphysician practitioner who performed the visit.

The individual who performed the substantive portion of the visit (and therefore bills for the visit) must sign and date the medical record. (3) Claim modifier. The designated modifier must be included on the claim to identify that the service was a split (or shared) visit. Start Part End Part Start Amendment Part67.

The authority citation for part 423 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh. End Authority Start Amendment Part68.

Amend § 423.160 by revising paragraph (a)(5) to read as follows. End Amendment Part Standards for electronic prescribing. (a) * * * (5) Beginning on January 1, 2021, prescribers must, except in the circumstances described in paragraphs (a)(5)(i) through (iv) of this section, conduct prescribing for at least 70 percent of their Schedule II, III, IV, and V controlled substances that are Part D drugs electronically using the applicable standards in paragraph (b) of this section. Prescriptions written for a beneficiary in a long-term care facility will not be included in determining compliance until January 1, 2025.

Compliance actions against prescribers who do not meet the compliance threshold based on prescriptions written for a beneficiary in a long-term care facility will commence on or after January 1, 2025. Compliance actions against prescribers who do not meet the compliance threshold based on other prescriptions will commence on or after January 1, 2023. Prescribers will be exempt from this requirement in the following situations. (i) Prescriber and dispensing pharmacy are the same entity.

(ii) Prescriber issues 100 or fewer controlled substance prescriptions for Part D drugs per calendar year as determined using CMS claims data as of December 31st of the preceding year. (iii) Prescriber has an NCPDP database address in the geographic area of an emergency or disaster declared by a Federal, State, or local government entity. (iv) Prescriber has received a CMS-approved waiver because the prescriber is unable to conduct electronic prescribing of controlled substances (EPCS) due to circumstances beyond the prescriber's control. * * * * * Start Part End Part Start Amendment Part69.

The authority for part 424 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part70.

Amend § 424.205 by redesignating paragraphs (b)(5) and (6) as paragraphs (b)(6) and (7), respectively, and adding new paragraph (b)(5). End Amendment Part The addition reads as follows. Requirements for Medicare Diabetes Prevention Program suppliers. * * * * * (b) * * * (5) The Medicare provider enrollment application fee does not apply to all Medicare Diabetes Prevention Program (MDPP) suppliers that submit an enrollment application on or after January 1, 2022.

* * * * * Start Amendment Part71. Amend § 424.502 by revising the definition of “Institutional provider” to read as follows. End Amendment Part Definitions. * * * * * Institutional provider means any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and nonphysician practitioner organizations), CMS-855S, or an associated internet-based PECOS enrollment application.

* * * * * Start Amendment Part72. Amend § 424.530 by revising paragraphs (a)(2) introductory text and (a)(11)(i) to read as follows. End Amendment Part Denial of enrollment in the Medicare program. (a) * * * (2) Provider or supplier conduct.

The provider or supplier, or any owner, managing employee, authorized or delegated official, medical director, supervising physician, or other health care or administrative or management services personnel furnishing services payable by a Federal health care program, of the provider or supplier is— * * * * * (11) * * * (i) A physician or other eligible professional's Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause. * * * * * Start Amendment Part73. Amend § 424.535 by revising paragraphs (a)(2) introductory text, Start Printed Page 65683 (a)(8)(ii), (a)(13)(i), and (e) to read as follows. End Amendment Part Revocation of enrollment in the Medicare program.

(a) * * * (2) Provider or supplier conduct. The provider or supplier, or any owner, managing employee, authorized or delegated official, medical director, supervising physician, or other health care or administrative or management services personnel furnishing services payable by a Federal health care program, of the provider or supplier is— * * * * * (8) * * * (ii) CMS determines that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements. In making this determination, CMS considers, as appropriate or applicable, the following. (A) The percentage of submitted claims that were denied during the period under consideration.

(B) Whether the provider or supplier has any history of final adverse actions and the nature of any such actions. (C) The type of billing non-compliance and the specific facts surrounding said non-compliance (to the extent this can be determined). (D) Any other information regarding the provider or supplier's specific circumstances that CMS deems relevant to its determination. * * * * * (13) * * * (i) A physician or other eligible professional's Drug Enforcement Administration (DEA) Certificate of Registration to dispense a controlled substance is currently suspended or revoked or is surrendered in response to an order to show cause.

* * * * * (e) Reversal of revocation. If the revocation was due to adverse activity (sanction, exclusion, or felony) against the provider's or supplier's owner, managing employee, authorized or delegated official, medical director, supervising physician, or other health care or administrative or management services personnel furnishing services payable by a Federal health care program, the revocation may be reversed if the provider or supplier terminates and submits proof that it has terminated its business relationship with that individual within 30 days of the revocation notification. * * * * * Start Amendment Part74. Amend § 424.545 in paragraph (b) by removing the reference “§ 405.374” and adding in its place the reference “§ 424.546”.

End Amendment Part Start Amendment Part75. Add § 424.546 to read as follows. End Amendment Part Deactivation rebuttals. (a) Rebuttal submittal period.

(1) If a provider or supplier receives written notice from CMS or its contractor that the provider's or supplier's billing privileges are to be or have been deactivated under § 424.540, the provider or supplier has 15 calendar days from the date of the written notice to submit a rebuttal to CMS as permitted under § 424.545(b). (2) CMS may, at its discretion, extend the 15-day time-period referenced in paragraph (a)(1) of this section. (b) Rebuttal requirements. A rebuttal submitted pursuant to this section and § 424.545(b) must.

(1) Be in writing. (2) Specify the facts or issues about which the provider or supplier disagrees with the deactivation's imposition and/or the effective date, and the reasons for disagreement. (3) Submit all documentation the provider or supplier wants CMS to consider in its review of the deactivation. (4) Be submitted in the form of a letter that is signed and dated by the individual supplier (if enrolled as an individual physician or nonphysician practitioner), the authorized official or delegated official (as those terms are defined in 42 CFR 424.502), or a legal representative (as defined in 42 CFR 498.10).

If the legal representative is an attorney, the attorney must include a statement that he or she has the authority to represent the provider or supplier. This statement is sufficient to constitute notice of such authority. If the legal representative is not an attorney, the provider or supplier must file with CMS written notice of the appointment of a representative. This notice of appointment must be signed and dated by, as applicable, the individual supplier, the authorized official or delegated official, or a legal representative.

(c) Waiver of rebuttal rights. The provider's or supplier's failure to submit a rebuttal that is both timely under paragraph (a) of this section and fully compliant with all of the requirements of paragraph (b) of this section constitutes a waiver of all rebuttal rights under this section and § 424.545(b). (d) CMS review. Upon receipt of a timely and compliant deactivation rebuttal, CMS reviews the rebuttal to determine whether the imposition of the deactivation and/or the designated effective date are correct.

(e) Imposition. Nothing in this section or in § 424.545(b) requires CMS to delay the imposition of a deactivation pending the completion of the review described in paragraph (d) of this section. (f) Initial determination. A determination made under this section is not an initial determination under § 498.3(b) of this chapter and therefore not appealable.

Start Part End Part Start Amendment Part76. The authority citation for part 425 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

End Authority Start Amendment Part77. Amend § 425.116 by revising paragraph (c) to read as follows. End Amendment Part Agreements with ACO participants and ACO providers/suppliers. * * * * * (c) Submission of agreements.

The ACO must submit an executed ACO participant agreement for each ACO participant that it requests to add to its list of ACO participants in accordance with § 425.118. The agreements may be submitted in the form and manner set forth in § 425.204(c)(6) or as otherwise specified by CMS. Start Amendment Part78. Amend § 425.204 by revising paragraphs (b), (c)(6), (f)(4)(ii)(A) and (B), (f)(4)(iii) introductory text, and (f)(4)(iii)(A) and adding paragraph (f)(4)(v) to read as follows.

End Amendment Part Content of the application. * * * * * (b) Prior participation. Upon request by CMS during the application cycle, the ACO must submit information regarding prior participation in the Medicare Shared Savings Program by the ACO, its ACO participants, or its ACO providers/suppliers, including such information as may be necessary for CMS to determine whether to approve an ACO's application in accordance with § 425.224(b). (c) * * * (6) Upon request by CMS during the application cycle or at any point during an agreement period, the ACO must submit documents demonstrating that its ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to ACO activities are required to comply with the requirements of the Shared Savings Program.

Upon such a request, the evidence to be submitted must include, without limitation, sample or form agreements and, in the case of ACO participant agreements, the first and signature page(s) of each executed ACO participant agreement. Start Printed Page 65684 CMS may request all pages of an executed ACO participant agreement to confirm that it conforms to the sample form agreement submitted by the ACO. The ACO must certify that all of its ACO participant agreements comply with the requirements of this part. * * * * * (f) * * * (4) * * * (ii) * * * (A) One-half percent of the total per capita Medicare Parts A and B fee-for-service expenditures for the ACO's assigned beneficiaries, based on expenditures and the number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available.

(B) One percent of the total Medicare Parts A and B fee-for-service revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available, and based on the ACO's number of assigned beneficiaries for the most recent calendar year for which 12 months of data are available. (iii) CMS recalculates the ACO's repayment mechanism amount for the second and each subsequent performance year in the agreement period in accordance with paragraph (f)(4)(ii) of this section based on the certified ACO participant list for the relevant performance year, except that the number of assigned beneficiaries used in the calculations is the number of beneficiaries assigned to the ACO at the beginning of the relevant performance year under § 425.400(a)(2)(i) (for ACOs under preliminary prospective assignment with retrospective reconciliation) or § 425.400(a)(3)(i) (for ACOs under prospective assignment). (A) If the recalculated repayment mechanism amount exceeds the existing repayment mechanism amount by at least $1,000,000, CMS notifies the ACO in writing that the amount of its repayment mechanism must be increased to the recalculated repayment mechanism amount. * * * * * (v)(A) An ACO that established a repayment mechanism to support its participation in a two-sided model beginning on July 1, 2019, January 1, 2020, or January 1, 2021, may elect to decrease the amount of its repayment mechanism if the repayment mechanism amount for performance year 2022, as recalculated pursuant to paragraph (f)(4)(iii) of this section, is less than the existing repayment mechanism amount.

(B) CMS will notify the ACO in writing if the ACO may elect to decrease the amount of its repayment mechanism pursuant to this paragraph (f)(4)(v). The ACO must submit such election, and revised repayment mechanism documentation, in a form and manner and by a deadline specified by CMS. CMS will review the revised repayment mechanism documentation and may reject the election if the repayment mechanism documentation does not comply with the requirements of this paragraph (f). * * * * * Start Amendment Part79.

Amend § 425.312 by revising paragraph (a)(2)(ii) and adding paragraph (a)(2)(iii) to read as follows. End Amendment Part Beneficiary notifications. (a) * * * (2) * * * (ii) In the case of an ACO that has selected preliminary prospective assignment with retrospective reconciliation, by the ACO or ACO participant providing each fee-for-service beneficiary with a standardized written notice prior to or at the first primary care visit of the performance year in the form and manner specified by CMS. (iii) In the case of an ACO that has selected prospective assignment, by the ACO or ACO participant providing each prospectively assigned beneficiary with a standardized written notice prior to or at the first primary care visit of the performance year in the form and manner specified by CMS.

* * * * * Start Amendment Part80. Amend § 425.400 by— End Amendment Part Start Amendment Parta. Revising paragraph (c)(1)(v) introductory text. End Amendment Part Start Amendment Partb.

Adding paragraph (c)(1)(vi). And End Amendment Part Start Amendment Partc. Revising paragraphs (c)(2)(i) introductory text, (c)(2)(i)(A)(2), and (c)(2)(ii). End Amendment Part The revisions and addition read as follows.

General. * * * * * (c) * * * (1) * * * (v) For the performance year starting on January 1, 2021. * * * * * (vi) For the performance year starting on January 1, 2022, and subsequent performance years as follows. (A) CPT codes.

( 1 ) 96160 and 96161 (codes for administration of health risk assessment). ( 2 ) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). ( 3 ) 99304 through 99318 (codes for professional services furnished in a nursing facility. Professional services or services reported on an FQHC or RHC claim identified by these codes are excluded when furnished in a SNF).

( 4 ) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit). ( 5 ) 99341 through 99350 (codes for evaluation and management services furnished in a patient's home for claims identified by place of service modifier 12). ( 6 ) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure. When the base code is also a primary care service code under this paragraph (c)(1)(vi)).

( 7 ) 99421, 99422, and 99423 (codes for online digital evaluation and management). ( 8 ) 99424, 99425, 99426, and 99427 (codes for principal care management services). ( 9 ) 99437, 99487, 99489, 99490 and 99491 (codes for chronic care management). ( 10 ) 99439 (code for non-complex chronic care management).

( 11 ) 99483 (code for assessment of and care planning for patients with cognitive impairment). ( 12 ) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services). ( 13 ) 99495 and 99496 (codes for transitional care management services). ( 14 ) 99497 and 99498 (codes for advance care planning.

Services identified by these codes furnished in an inpatient setting are excluded). (B) HCPCS codes. ( 1 ) G0402 (code for the Welcome to Medicare visit). ( 2 ) G0438 and G0439 (codes for the annual wellness visits).

( 3 ) G0442 (code for alcohol misuse screening service). ( 4 ) G0443 (code for alcohol misuse counseling service). ( 5 ) G0444 (code for annual depression screening service). ( 6 ) G0463 (code for services furnished in ETA hospitals).

( 7 ) G0506 (code for chronic care management). ( 8 ) G2010 (code for the remote evaluation of patient video/images). ( 9 ) G2012 and G2252 (codes for virtual check-in). ( 10 ) G2058 (code for non-complex chronic care management).

( 11 ) G2064 and G2065 (codes for principal care management services). ( 12 ) G2212 (code for prolonged office or other outpatient visit for the evaluation and management of a patient). Start Printed Page 65685 ( 13 ) G2214 (code for psychiatric collaborative care model). (C) Primary care service codes include any CPT code identified by CMS that directly replaces a CPT code specified in paragraph (c)(1)(vi)(A) of this section or a HCPCS code specified in paragraph (c)(1)(vi)(B) of this section, when the assignment window (as defined in § 425.20) for a benchmark or performance year includes any day on or after the effective date of the replacement code for payment purposes under FFS Medicare.

(2)(i) Except as otherwise specified in paragraph (c)(2)(i)(A)(2) of this section, when the assignment window (as defined in § 425.20) for a benchmark or performance year includes any month(s) during the buy antibiotics Public Health Emergency defined in § 400.200 of this chapter, in determining beneficiary assignment, we use the primary care service codes identified in paragraph (c)(1) of this section, and additional primary care service codes as follows. (A) * * * (2) 99441, 99442, and 99443 (codes for telephone evaluation and management services). These codes are used in determining beneficiary assignment as specified in paragraphs (c)(2)(i) and (ii) of this section and until they are no longer payable under Medicare fee-for-service payment policies as specified under section 1834(m) of the Act and §§ 410.78 and 414.65 of this subchapter. * * * * * (ii) Except as otherwise specified in paragraph (c)(2)(i)(A)(2) of this section, the additional primary care service codes specified in paragraph (c)(2)(i) of this section are applicable to all months of the assignment window (as defined in § 425.20), when the assignment window includes any month(s) during the buy antibiotics Public Health Emergency defined in § 400.200 of this chapter.

Start Amendment Part81. Amend § 425.512 by— End Amendment Part Start Amendment Parta. Revising paragraphs (a)(2) and (3). End Amendment Part Start Amendment Partb.

Redesignating paragraph (a)(4) as paragraph (a)(5). End Amendment Part Start Amendment Partc. Adding a new paragraph (a)(4). End Amendment Part Start Amendment Partd.

Revising newly redesignated paragraph (a)(5). And End Amendment Part Start Amendment Parte. Revising paragraphs (b)(2)(i) and (ii) and (b)(3)(i) and (ii). End Amendment Part The revisions and addition read as follows.

Determining the ACO quality performance standard for performance years beginning on or after January 1, 2021. (a) * * * (2) For the first performance year of an ACO's first agreement period under the Shared Savings Program. If the ACO reports data via the APP and meets the data completeness requirement at § 414.1340 of this subchapter and the case minimum requirement at § 414.1380 of this subchapter on the measures specified in this paragraph (a)(2) for the applicable performance year, the ACO will meet the quality performance standard. (i) For performance years 2022, 2023, and 2024.

The ten CMS Web Interface measures or the three eCQMs/MIPS CQMs, and the CAHPS for MIPS survey. (ii) For performance year 2025 and subsequent performance years. The three eCQMs/MIPS CQMs and the CAHPS for MIPS survey. (3) For performance year 2021.

(i) Except as specified in paragraph (a)(2) of this section, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367 of this subchapter, according to the method of submission established by CMS and achieving a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. (ii) If an ACO does not report any of the ten CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for MIPS survey under the APP, the ACO will not meet the quality performance standard. (4) For performance years 2022 and 2023. (i) Except as specified in paragraph (a)(2) of this section, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367 of this subchapter according to the method of submission established by CMS and either.

(A) Achieving a quality performance score that is equivalent to or higher than the 30th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, or (B) If the ACO reports the three eCQMs/MIPS CQMs in the APP measure set, meeting the data completeness requirement at § 414.1340 of this subchapter and the case minimum requirement at § 414.1380 of this subchapter for all three eCQMs/MIPS CQMs, achieving a quality performance score equivalent to or higher than the 10th percentile of the performance benchmark on at least one of the four outcome measures in the APP measure set and a quality performance score equivalent to or higher than the 30th percentile of the performance benchmark on at least one of the remaining five measures in the APP measure set. (ii) If an ACO does not report any of the ten CMS Web Interface measures or any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for MIPS survey under the APP, the ACO will not meet the quality performance standard. (5) For performance year 2024 and subsequent performance years. (i) Except as specified in paragraph (a)(2) of this section, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367 of this subchapter, according to the method of submission established by CMS and achieving a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring.

(ii) If an ACO does not report any of the three eCQMs/MIPS CQMs and does not administer a CAHPS for MIPS survey under the APP, the ACO will not meet the quality performance standard. (b) * * * (2) * * * (i) For performance years 2021, 2022, and 2023, the ACO's minimum quality performance score is set to the equivalent of the 30th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. (ii) For performance year 2024 and subsequent performance years, the ACO's minimum quality performance score is set to the equivalent of the 40th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. (3) * * * (i) For performance years 2021, 2022, and 2023, CMS will use the higher of the ACO's quality performance score or the equivalent of the 30th percentile MIPS Quality performance category score across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year.

(ii) For performance year 2024 and subsequent performance years, CMS will use the higher of the ACO's quality performance score or the equivalent of the 40th percentile MIPS Quality performance category score across all MIPS Quality performance category Start Printed Page 65686 scores, excluding entities/providers eligible for facility-based scoring, for the relevant performance year. * * * * * Start Signature Xavier Becerra, Secretary, Department of Health and Human Services. End Signature The following appendices will not appear in the Code of Federal Regulations. 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CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-P[FR Doc.

2021-23972 Filed 11-2-21. 8:45 am]BILLING CODE 4120-01-PStratis Health Announces National Virtual Quality Improvement Mentors for Critical Access HospitalsStratis Health announced twelve critical access hospital (CAH) staff who will serve for two years as national Virtual Quality Improvement Mentors through an initiative that broadly transfers knowledge from leading CAH quality improvement staff to others across the country. The initiative is organized through Rural Quality Improvement Technical Assistance (RQITA), a program of Stratis Health supported by the Federal Office of Rural Health Policy (FORHP).These twelve outstanding mentors were selected from a pool of candidates across the country who were nominated by their respective state Flex programs as quality improvement leaders. They each successfully report and use data to support quality improvement activities in their small rural hospitals.

They represent the diversity of CAHs across the nation, with varying rural locations, service lines, and patient volumes, which average 4.16 to 15 patients per day and 2,322 to 13,681 emergency room visits annually.“Our first Virtual Quality Improvement Mentor cohort shared so many notable examples of how they successfully advanced quality in their critical access hospitals,” said Janelle Shearer, Stratis Health program manager. €œWe are excited to build on that success with this new group of QI leaders.”“Critical access hospital” is a Centers for Medicare &. Medicaid Services (CMS) designation given to eligible rural hospitals, with 25 beds or less, to reduce the financial vulnerability and improve access to health care by keeping essential services in rural communities.Of the 1,353 CAHs across the U.S., more than 1,330 were participating in FORHP’s Medicare Beneficiary Quality Improvement Project (MBQIP) at the end of 2020.The new Virtual Quality Improvement Mentors are:Gloria Barth, Harrison County Hospital, Corydon, INCaryn Bommersbach, Carris Health – Redwood, Redwood Falls, MNKatherine Bryant, Covington County Hospital, Collins, MSCara Cruz, Carson Valley Medical Center, Gardnerville, NVMarilyn Denno, Community Memorial Hospital, Cloquet, MNStacey Karvoski, Wallowa Memorial Hospital, Enterprise, ORJenifer Monzo, McKenzie Health System, Sandusky, MIElly Shaw, Knoxville Hospital &. Clinics, Knoxville, IATammy Suchy, TriCounty Health Care, Wadena, MNKatrina “Kitty” Strowbridge, Clark Fork Valley Hospital, Plains, MTTammy Sudtelgte, Floyd Valley Healthcare, LeMars, IALinda Webb, Pulaski Memorial Hospital, Winamac, INThe Virtual Quality Improvement Mentors will add to the examples and advice of their predecessors on addressing common quality improvement challenges that occur in CAHs.

RQITA will capture these strategies, tips, and ideas to disseminate them broadly to others serving in CAH quality roles, including through the RQITA newsletter MBQIP Monthly and the Quality Time. Sharing PIE (performance improvement experience) recorded conversation series..

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Department of Labor’s Occupational Safety and Health Administration today announced the award of more than $11.6 million in grants to 93 nonprofit organizations nationwide to fund education and training on hazard recognition and prevention, and on rights of workers to safe workplaces and the responsibilities of employers to provide them. Derived from the Susan Harwood Workplace Safety and Health Training program, the grants awarded by OSHA in fiscal year 2021 are in the Targeted Topic Training, Training where to buy zithromax over the counter and Educational Materials Development, and Capacity Building categories. The grants are a critical part of OSHA’s effort to educate workers and assist employers. OSHA awards these grants to nonprofit organizations, including community and faith-based where to buy zithromax over the counter groups, employer associations, labor unions, joint labor-management associations, colleges and universities. Target trainees include small-business employers and underserved vulnerable workers in high-hazard industries.

The grants honor the late Susan Harwood, former director of where to buy zithromax over the counter OSHA’s Office of Risk Assessment. In a 17-year career with the agency, she helped develop federal standards to protect workers from bloodborne pathogens, cotton dust, benzene, formaldehyde, asbestos and lead in construction. Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees where to buy zithromax over the counter. OSHA’s role is to help ensure these conditions for America’s workers by setting and enforcing standards and providing training, education, and assistance. Learn more where to buy zithromax over the counter about OSHA.

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