Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

42 CFR Part 405

Administrative practice and procedure, Diseases, Health facilities, Health professions, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, and X-rays.

42 CFR Part 410

Diseases, Health facilities, Health professions, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X- rays.

42 CFR Part 414

Administrative practice and procedure, Biologics, Diseases, Drugs, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 424

Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 425

Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 427

Administrative practice and procedure, Biologics, Inflation rebates, Medicare, Prescription drugs.

42 CFR Part 428

Administrative practice and procedure, Biologics, Inflation rebates, Medicare, Prescription drugs.

42 CFR Part 495

Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Health professions, Health records, Medicaid, Medicare, Penalties, Privacy, and Reporting and recordkeeping requirements.

42 CFR Part 512

Administrative practice and procedure, Health care, Health facilities, Health insurance, Intergovernmental relations, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 405-FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0 1. The authority citation for part 405 continues to read as follows:

Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).

0 2. Section 405.2401(b) is amended by adding the definition of “Direct Supervision” in alphabetical order to read as follows:

Sec. 405.2401 Scope and definitions.

* * * * *

(b) * * * * * * * *

Direct supervision means that the physician (or other supervising practitioner) must be present in the RHC or FQHC and immediately available to furnish assistance and direction throughout the performance of the service. It does not mean that the physician (or other supervising practitioner) must be present in the room when the service is performed. The presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology (excluding audio-only). * * * * * 0 3. Section 405.2463 is amended by revising paragraph (b)(3) to read as follows:

Sec. 405.2463 What constitutes a visit.

* * * * *

(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. On or after October 1, 2025, in the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, 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, between an RHC or FQHC patient and one of the following: * * * * *

0 4. Section 405.2464 is amended by-- 0 a. Revising paragraph (c)(2); 0 b. Adding paragraph (c)(8); and 0 c. Revising paragraph (e);

The revisions and addition read as follows:

Sec. 405.2464 Payment rate.

* * * * *

(c) * * * * * * * *

(2) For psychiatric collaborative care model (CoCM) services furnished between January 1, 2018, and December 31, 2025, payment is based on the average of the national non-facility PFS payment rate set for each psychiatric CoCM service and updated annually based on the PFS amounts. * * * * *

(8) For CoCM services furnished on or after January 1, 2026, payment is based on the PFS national non-facility payment rate. * * * * *

(e) Payment for communication technology-based and remote evaluation services.

(1) For communication technology-based and remote evaluation services furnished between January 1, 2019, and December 31, 2025, payment to RHCs and FQHCs is at the rate set for each of the RHC and FQHC payment codes for communication technology-based and remote evaluation services.

(2) For communication technology-based services furnished on or after January 1, 2026, payment to RHCs and FQHCs is based on the PFS national non-facility payment rate.

(3) For remote evaluation services furnished on or after January 1, 2026, payment to RHCs and FQHCs is based on the PFS national non- facility payment rate. * * * * *

Sec. 405.2469 [Amended]

0 6. Section 405.2469 is amended in paragraph (d) by removing the phrase “Additionally, beginning January 1, 2025,”” and adding in its place the phrase “On or after October 1, 2025,”.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0 7. The authority citation for part 410 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0 8. Section 410.15 is amended by revising paragraph (a), the definition for “First annual wellness visit providing personalized prevention plan services” and “Subsequent annual wellness visit providing personalized prevention plan services” to read as follows:

Sec. 410.15 Annual wellness visits providing Personalized Prevention Plan Services: Conditions for and limitations on coverage.

* * * * *

First annual wellness visit providing personalized prevention plan services * * *

(xiii) At the discretion of the health professional and beneficiary, furnish a Physical Activity and Nutrition Risk Assessment that is standardized and evidence-based. * * * * *

Subsequent annual wellness visit providing personalized prevention plan services * * *

(xi) At the discretion of the health professional and beneficiary, furnish a Physical Activity and Nutrition Risk Assessment that is standardized and evidence-based. * * * * *

0 9. Section 410.26 is amended by revising paragraphs (a)(2) and (c)(2) to read as follows:

Sec. 410.26 Services and supplies incident to a physician's professional services: Conditions.

(a) * * *

(2) Direct supervision means, except as provided in paragraphs (a)(2)(i) and (ii) of this section, the level of supervision by the physician (or other practitioner) of auxiliary personnel as defined in Sec. 410.32(b)(3)(ii). The presence of the physician (or other practitioner) required for direct supervision may include virtual presence through audio/video real-time communications technology (excluding audio-only) for services without a 010 or 090 global surgery indicator. * * * * *

(c) * * *

(2) Physical therapy, occupational therapy and speech-language pathology services provided incident to a physician's professional services are subject to the provisions established in Sec. Sec. 410.59(a)(3)(iii), 410.60(a)(3)(iii), and 410.62(a)(3)(iii).

0 10. Section 410.32 is amended by revising paragraph (b)(3)(ii) to read as follows:

Sec. 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

* * * * *

(b) * * *

(3) * * *

(ii) Direct supervision in the office setting means that the physician (or other supervising practitioner) must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the service. It does not mean that the physician (or other supervising practitioner) must be present in the room when the service is performed. The presence of the physician (or other practitioner) required for direct supervision may include virtual presence through audio/video real-time communications technology (excluding audio-only) for services without a 010 or 090 global surgery indicator. * * * * *

0 11. Section 410.62 is amended by revising paragraph (a) to read as follows:

Sec. 410.62 Outpatient speech-language pathology services: Conditions and exclusions.

(a) Basic rule. Except as specified in paragraph (a)(3)(iii) of this section, Medicare Part B pays for outpatient speech-language pathology services only if they are furnished by an individual who meets the qualifications for a speech-language pathologist in Sec. 484.115 of this chapter and only under the following conditions: * * * * *

0 12. Section 410.79 is amended-- 0 a. In paragraph (b) by-- 0 i. Revising the definitions of “Extended flexibilities period” and “Online;” 0 ii. Adding the definitions of “Live Coach interaction,” “Online delivery period” and “Online session;” in alphabetical order. 0 b. Revising paragraphs (c)(1)(ii) and (e)(3)(iii)(C); and 0 c. Adding paragraph (f).

The revisions and additions read as follows:

Sec. 410.79 Medicare Diabetes Prevention Program expanded model: Conditions of coverage.

* * * * *

(b) * * *

Extended flexibilities period refers to the 6-year period (January 1, 2024 to December 31, 2029) for the Extended flexibilities to apply. * * * * *

Live Coach interaction refers to the bi-directional communication between the Coach and beneficiary. * * * * *

Online means sessions that are delivered 100 percent through the internet via phone, tablet, or laptop in an asynchronous (non-live) classroom where participants are experiencing the content on their own time without a live (including non-artificial intelligence (AI)) Coach teaching the content.

Online delivery period refers to the 4-year period (January 1, 2026 to December 31, 2029) to test an asynchronous delivery modality of the Set of MDPP services. During this time, MDPP suppliers may deliver the Set of MDPP services through the Online modality.

Online session refers to an MDPP session that is not furnished in person or via distance learning and that is furnished in a manner consistent with the DPRP standards for Online sessions. * * * * *

(c) * * *

(1) * * *

(ii) Weight measurements used to determine the achievement or maintenance of the required minimum weight loss must be taken in person by an MDPP supplier during an MDPP session or reflected in the beneficiary's medical record dated within 5 calendar days of the MDPP session.

(e) * * *

(3) * * *

(iii) * * *

(C) Self-reported weight measurements from the digital scale of the MDPP beneficiary. Self-reported weights must be obtained during live, synchronous Online video technology, such as video chatting or video conferencing, wherein the MDPP Coach observes the beneficiary weighing themselves and views the weight indicated on the digital scale, or the MDPP supplier receives two date-stamped photos or a video recording of the beneficiary's weight, with the beneficiary visible on the scale, submitted by the MDPP beneficiary to the MDPP supplier. Photo or video must clearly document the weight of the MDPP beneficiary as it appears on the digital scale on the date associated with the billable MDPP session. If choosing to submit two photos, one photo must show the beneficiary's weight on the digital scale, the second photo must show the beneficiary visible in their home or other reasonable location outside of an in-person delivery site, and both photos must be date- stamped. * * * * *

(d) * * *

(1) An MDPP supplier may offer a make-up session to an MDPP beneficiary who missed a regularly scheduled session. MDPP make-up sessions may only use In-person, Distance learning, or Online delivery. If an MDPP supplier offers one or more make-up sessions to an MDPP beneficiary, each session must be furnished in accordance with the following requirements:

(i) * * *

(ii) * * *

(iii) * * * * * * * *

(f) MDPP Online delivery.

(1) Notwithstanding paragraphs (a) through (e) of this section, the policies described in this paragraph (f) apply during the Online delivery period.

(2) During the Online delivery period, MDPP suppliers are not required to maintain in-person delivery capabilities of the Set of MDPP services, as applicable during the Online delivery period.

(i) Online sessions must be furnished in a manner consistent with the DPRP Standards regarding program format, Coach interaction, and program intensity and duration to qualify for payment. Online sessions must be delivered 100 percent through the internet via phone, tablet, or laptop in an asynchronous (non-live) classroom where participants are experiencing the content on their own time without a live (including non-artificial intelligence (AI) Coach teaching the content.

(A) Live Coach interaction must be offered to each participant during weeks when the beneficiary has engaged with content. Emails and text messages can count toward the requirements for Live Coach interaction if there is bi-directional communication (that is, organizations may not simply send out an announcement via text or email and count that as live Coach interaction; the beneficiary must have the ability to respond to and get support from the live Coach) between the Coach and participant. Chat bots and AI forums do not count as live Coach interaction. Coaches are required to track participant engagement and completion of online modules. Proactive outreach must be used to encourage Online session completion and beneficiary weight reporting.

(1) MDPP suppliers may not require that beneficiaries initiate interactions with the Coach and MDPP suppliers may not use AI or Machine Learning (ML) to replace Live Coach interaction.

(2) [Reserved]

(B) Beneficiaries must submit weight measurements on the date in which the Online session is completed. MDPP suppliers must ensure safeguards are in place to ensure the accuracy of beneficiary weight measurements.

(C) For MDPP beneficiaries, MDPP suppliers may not bill for Online Sessions as well as In-Person or Virtual Sessions during the Online delivery period. The Set of MDPP services must be delivered to individual beneficiaries as Online sessions or fully synchronously (that is, In-person, Distance learning, or In-person with a distance learning component), inclusive of make-up sessions.

(D) MDPP suppliers must ensure that MDPP beneficiaries engage with and understand the content of each Online session. MDPP suppliers may use one or more of the following to ensure engagement and understanding: videos/presentations, email, video conferencing; knowledge checks (multiple choice or short answer); participant contributions to group discussions on a community board; or beneficiary responses to the Coach via email, text message, or in-app messaging.

(ii) [Reserved] * * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0 13. The authority citation for part 414 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0 14. Section 414.84 is amended by-- 0 a. Revising paragraphs (b)(1) introductory text and (b)(2) introductory text; 0 b. Redesignating paragraphs (c)(3) and (c)(4) as paragraphs (c)(4) and (c)(5); 0 c. Adding new paragraph (c)(3); and 0 d. Revising newly redesignated paragraph (c)(4)(ii).

The revisions and addition read as follows:

Sec. 414.84 Payment for MDPP services.

* * * * *

(b) * * *

(1) Performance Goal 1: Achieves the required minimum 5-percent weight loss. CMS makes a performance payment to an MDPP supplier for an MDPP beneficiary who achieves the required minimum weight loss as measured in accordance with Sec. 410.79(c)(ii) or described in Sec. 410.79(e)(3)(iii) during a core session or core maintenance session furnished by that supplier. The amount of this performance payment is determined as follows: * * * * *

(2) Performance Goal 2: Achieves 9-percent weight loss. CMS makes a performance payment to an MDPP supplier for an MDPP beneficiary who achieves at least a 9-percent weight loss as measured in accordance with Sec. 410.79(c)(ii) or described in Sec. 410.79(e)(3)(iii) during a core session or core maintenance session furnished by that supplier. The amount of this performance payment is determined as follows: * * * * *

(c) * * *

(3) For the duration of Online delivery described in Sec. 410.79(f), the Online HCPCS G-code applies for any Set of MDPP services that are delivered Online, as described in Sec. 410.79(b).

(4) Medicare pays for up to 22 sessions in a 12-month period. The amount of this payment is determined as follows:

(i) * * *

(ii) For a core session or core maintenance session furnished January 1, 2026 through December 31, 2026, $18.

(5) Current Procedural Terminology (CPT) Modifier 76 (repeat services by same physician) must be appended to any claim for G9886, G9887, or G9871 to identify a MDPP make-up session that was held on the same day as a regularly scheduled MDPP session. * * * * *

Sec. 414.610 Basis of payment.

0 15. Section 414.610 is amended by-- 0 a. Revising paragraph (c)(1)(ii) introductory text; and 0 b. In paragraph (c)(5)(ii) removing the date “December 31, 2024” and adding in its place the date “September 30, 2025”. * * * * *

(c) * * *

(1) * * *

(ii) For services furnished during the period July 1, 2008 through September 30, 2025, ambulance services originating in. * * * * *

0 16. Section 414.802 is amended by-- 0 a. Adding a definition of biological in alphabetical order; 0 b. Adding the definition of bundled arrangement in alphabetical order; and

These additions and revision read as follows:

Sec. 414.802 Definitions.

* * * * *

Biological means a product licensed under section 351 of the Public Health Service Act.

Bundled arrangement means an arrangement regardless of physical

packaging under which the rebate, discount, or other price concession is conditioned upon the purchase of the same drug or biological or other drugs or biologicals or another product or some other performance requirement (for example, the achievement of market share, inclusion or tier placement on a formulary), or where the resulting discounts or other price concessions are greater than those which would have been available had the bundled drugs or biologicals been purchased separately or outside the bundled arrangement. * * * * *

0 17. Section 414.804 is amended by-- 0 a. Adding paragraphs (a)(2)(iii) and (iv); and 0 b. Revising paragraph (a)(5).

The additions and revision read as follows:

Sec. [thinsp]414.804 Basis of payment.

(a) * * *

(2) * * * * * * * *

(iii) The discounts in a bundled arrangement as defined at Sec. 414.802, including those discounts resulting from a contingent arrangement, are allocated proportionately to the dollar value of the units of all drugs or products sold under the bundled arrangement.

(iv) For bundled arrangements where multiple drugs are discounted, the aggregate value of all the discounts in the bundled arrangement must be proportionally allocated across all the drugs or products in the bundle. * * * * *

(5) Submission requirements. Manufacturers must submit the following to CMS within 30 days of the close of the quarter: The manufacturer's average sales price must be calculated by the manufacturer every calendar quarter and submitted to CMS within 30 days of the close of the quarter. The first quarter submission must be submitted by April 30, 2004. Subsequent reports are due not later than 30 days after the last day of each calendar quarter.

(i) The manufacturer's average sales price, which must be calculated by the manufacturer every calendar quarter. The first quarter submission must be submitted by April 30, 2004.

(ii) Effective January 1, 2026, reasonable assumptions for calculations of the manufacturer's ASP, consistent with the general requirements and intent of the Act, Federal regulations, and its customary business practices including documentation of the methodology used to determine fair market value.

(iii) Effective January 1, 2026, certification letter from the recipient of a bona fide service fee as evidence that the fee is not passed on in whole or in part to a client or customer of the recipient of the fee, whether or not the entity takes title to the drug. * * * * *

0 18. Section 414.902 is amended by adding the definition of “biological” in alphabetical order to read as follows:

Sec. 414.902 Definitions.

* * * * *

Biological means a product licensed under section 351 of the Public Health Service Act. * * * * *

0 19. Section 414.1305 is amended by-- 0 a. Revising paragraph (6) of the definition for “Attribution-eligible beneficiary”; 0 b. Adding the definitions “Covered professional service attribution- eligible beneficiary” and “E/M attribution-eligible beneficiary”. 0 c. In the definition of “high priority measure”, the phrase “care coordination, opioid, or health equity-related quality measure.” is removed and added in its place is the phrase “care coordination or opioid-related quality measure.”; 0 d. Revising the definitions of “Multispecialty group”, “MVP participant”, and “Single specialty group.

The revisions read as follows:

Sec. 414.1305 Definitions.

Attribution-eligible beneficiary means a beneficiary who, through the 2025 QP Performance Period:

(1) Is not enrolled in Medicare Advantage or a Medicare cost plan;

(2) Does not have Medicare as a secondary payer;

(3) Is enrolled in both Medicare Parts A and B;

(4) Is at least 18 years of age;

(5) Is a United States resident; and

(6) Has a minimum of one claim for evaluation and management services furnished by an eligible clinician who is in the APM Entity for any period during the QP Performance Period or, for an Advanced APM that does not base attribution on evaluation and management services and for which attributed beneficiaries are not a subset of the attribution-eligible beneficiary population based on the requirement to have at least one claim for evaluation and management services furnished by an eligible clinician who is in the APM Entity for any period during the QP Performance Period, the attribution basis determined by CMS based upon the methodology the Advanced APM uses for attribution, which may include a combination of evaluation and management and other services. * * * * *

Covered professional service attribution-eligible beneficiary means a beneficiary who, starting with the 2026 QP Performance Period:

(1) Is not enrolled in Medicare Advantage or a Medicare cost plan;

(2) Does not have Medicare as a secondary payer;

(3) Is enrolled in both Medicare Parts A and B;

(4) Is at least 18 years of age;

(5) Is a United States resident; and

(6) Has a minimum of one claim for a Covered Professional Service furnished by an eligible clinician who is in the APM Entity for any period during the QP Performance Period. * * * * *

E/M attribution-eligible beneficiary means a beneficiary who, starting with the 2026 QP Performance Period:

(1) Is not enrolled in Medicare Advantage or a Medicare cost plan;

(2) Does not have Medicare as a secondary payer;

(3) Is enrolled in both Medicare Parts A and B;

(4) Is at least 18 years of age;

(5) Is a United States resident; and

(6) Has a minimum of one claim for evaluation and management services furnished by an eligible clinician who is in the APM Entity for any period during the QP Performance Period. * * * * *

Multispecialty group means a group as defined at Sec. 414.1305 that consists of clinicians in two or more specialty types or clinicians involved in multiple foci of care.

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 Sec. 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, multispecialty group that meets the requirements of a small practice, subgroup, or APM Entity that is assessed on an MVP in accordance with Sec. 414.1365 for all MIPS performance categories. * * * * *

Single specialty group means a group that consists of one specialty type or consists of clinicians involved in a single focus of care. * * * * *

0 19. Section 414.1305 is amended by-- 0 a. Revising paragraph (6) of the definition for “Attribution-eligible beneficiary”;

0 b. In the definition of “high priority measure”, removing the phrase “care coordination, opioid, or health equity-related quality measure.” and adding in its place the phrase “care coordination or opioid-related quality measure”; and 0 c. Revising the definitions of “Multispecialty group”, “MVP participant”, and “Single specialty group.

The revisions read as follows:

Sec. 414.1305 Definitions.

Attribution-eligible beneficiary * * * * *

(6) Has a minimum of one claim for any covered professional service furnished by an eligible clinician who is on the Participation List for an Advanced APM Entity at any determination date during the QP Performance Period. * * * * *

Multispecialty group means a group that consists of clinicians in two or more specialty types or clinicians involved in multiple foci of care.

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 Sec. 414.1365 for all MIPS performance categories. For the CY 2026 performance period/2028 MIPS payment year and subsequent years, MVP Participant means an individual MIPS eligible clinician, single-specialty group, multispecialty group that meets the requirements of a small practice, subgroup, or APM Entity that is assessed on an MVP in accordance with Sec. 414.1365 for all MIPS performance categories. * * * * *

Single specialty group means a group that consists of clinicians in one specialty type or clinicians involved in a single focus of care. * * * * *

0 20. Section 414.1355 is amended by revising paragraph (c)(7) to read as follows:

Sec. 414.1355 Improvement activities performance category

* * * * *

(c) * * *

(7) Advancing health and wellness, such as MIPS eligible clinicians demonstrating involvement in preventive care and health promotion. * * * * *

0 21. Section 414.1365 is amended by adding paragraph (b)(2)(iv) to read as follows:

Sec. 414.1365 MIPS Value Pathways.

* * * * *

(b) * * *

(2) * * *

(iv) Self-attestation requirement. Beginning with the CY 2026 performance period/2028 MIPS payment year, to report an MVP, a group must attest to being either a single-specialty group or a multispecialty group that meets the requirements of a small practice. * * * * *

0 22. Section 414.1380 is amended by-- 0 a. Revising paragraphs (b)(1)(i) introductory text, (b)(1)(ii)(D), and (b)(2)(iii) introductory text; 0 c. Adding paragraph (b)(2)(vi); 0 d. Revising paragraph (b)(4)(ii)(C); and 0 e. Adding paragraph (b)(4)(iii).

The revisions and additions read as follows:

Sec. 414.1380 Scoring.

* * * * *

(b) * * *

(1) * * *

(i) Measure achievement points. For the CY 2017 through 2022 performance periods/2019 through 2024 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under Sec. 414.1335 on which data is submitted in accordance with Sec. 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 Sec. 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. Except as specified otherwise under paragraph (b)(1)(ii) of this section, 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 Sec. 414.1335 on which no data is submitted in accordance with Sec. 414.1325. MIPS eligible clinicians that submit data in accordance with Sec. 414.1325 on a greater number of measures than required under Sec. 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 Sec. 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.

(ii) * * *

(D) Administrative claims-based quality measure benchmark.

(1) Beginning with the CY 2023 performance period/2025 MIPS payment year, CMS calculates a benchmark for an administrative claims quality measure using the performance on the measures during the current performance period.

(2) Beginning with the CY 2025 performance period/2027 MIPS payment year, for each administrative claims-based quality measure, CMS determines 10 benchmark ranges based on the median performance rate of all MIPS eligible clinicians scored on the measure, plus or minus standard deviations.

(i) CMS awards achievement points based on which benchmark range a MIPS eligible clinician's performance rate for an administrative claims-based quality measure corresponds; and

(ii) CMS awards achievement points equivalent to 10 percent of the performance threshold for a MIPS eligible clinician whose performance rate is equal to the median performance for all MIPS eligible clinicians scored on the measure.

(2) * * *

(iii) Excluding cost measure scores calculated for informational- only purposes as provided in paragraph (b)(2)(vi) of this section, the cost performance category score is the sum of the following, not to exceed 100 percent: * * * * *

(vi) Beginning with the 2028 MIPS payment year, CMS calculates a score for each new cost measure in accordance with the scoring policy set forth in this paragraph (b)(2) of this section for informational- only purposes during the measure's informational-only feedback period.

(A) For the purposes of this paragraph (b)(2)(vi) of this section, the following terms have the following meanings.

(1) New cost measure means a measure that CMS has newly specified for the MIPS cost performance category for a performance period under Sec. 414.1350 beginning with the 2028 MIPS payment year. This term excludes any cost measures that CMS has

specified for the MIPS cost performance category prior to the 2028 MIPS payment year or CMS modifies at any time.

(2) Informational-only feedback period means a 2-year period beginning with the first day of the first performance period and ending with the final day of the second performance period for the two applicable MIPS payment years for which CMS initially has specified the new cost measure.

(B) During a new cost measure's informational-only feedback period, CMS does not include any scores for the new cost measure calculated for informational-only purposes under paragraph (b)(2)(vi) of this section in CMS's calculation of a MIPS eligible clinician's cost performance category score under paragraph (b)(2)(iii) of this section or a MIPS eligible clinician's MIPS final score under paragraph (c) of this section.

(C) During a new cost measure's informational-only feedback period, CMS confidentially provides each MIPS eligible clinician their measure score under paragraph (b)(2)(vi) of this section for informational-only purposes. CMS also provides performance feedback to the MIPS eligible clinician in accordance with section 1848(q)(12) of the Act.

(D) Upon completion of a new cost measure's informational-only feedback period, CMS includes its calculation of any scores for the cost measure in CMS's calculation of a MIPS eligible clinician's cost performance category score under paragraph (b)(2)(iii) of this section and a MIPS eligible clinician's MIPS final score under paragraph (c) of this section.

(3) * * *

(4) * * *

(ii) * * *

(C)(1) For the 2019 performance period/2021 MIPS payment year through the 2022 performance period/2024 MIPS payment year, each optional measure is worth 5 or 10 bonus points, as specified by CMS.

(2) For the 2023 performance period/2025 MIPS payment year and subsequent years, each optional measure is worth 5 bonus points, as specified by CMS.

(3) Beginning with the CY 2026 performance period/2028 MIPS payment years, the total number of bonus points available to be earned when reporting one bonus measure, more than one bonus measure, or all bonus measures is a total of 5 bonus points.

(iii) Beginning with the CY 2026 performance period/2028 MIPS payment year, if certain circumstances occur that impact CMS' assessment of the performance of MIPS eligible clinicians on a measure specified for the Promoting Interoperability performance category under Sec. 414.1375(b), CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS' assessment of performance while allocating the maximum points available or providing full credit for the affected measure as long as the affected measure is reported, resulting in a suppressed measure contributing to the Promoting Interoperability performance category objective score under paragraph (b)(4) of this section; or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. CMS determines whether certain circumstances exist warranting suppression of a measure based on CMS' consideration of one or more of the following factors:

(A) The nature, breadth, and duration of the circumstances' effect on MIPS eligible clinicians' ability to fulfill the measure requirement.

(B) The availability of certified health IT modules to fulfill the measure.

(C) The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance.

(D) Out-of-date or conflicting technical standards.

(E) Technical and operational capacity of required partners.

(F) Other factors as determined by CMS. * * * * *

0 23. Section 414.1400 is amended by-- 0 a. Revising paragraph (b)(1)(ii); 0 b. In paragraph (d)(3) introductory text, removing the phrase “including:” and adding in its place the phrase “including all of the following:”; 0 c. Revising paragraph (d)(3)(i); 0 d. In paragraphs (d)(3)(ii) and (iii), removing the “;” and adding in its place “.”; 0 e. Redesignating paragraphs (d)(3)(iv) through (vi) as paragraphs (d)(3)(iv) through (vi) introductory text; 0 f. Adding paragraphs (d)(3)(iv)(A) and (B), (d)(3)(v)(A) and (B), (d)(3)(vi)(A) and (B), and (d)(3)(vii). 0 g. Revising paragraph (d)(8); and 0 h. Adding paragraphs (d)(9) and (d)(10).

The revisions and additions read as follows:

Sec. 414.1400 Third party intermediaries.

* * * * *

(b) * * *

(1) * * *

(ii)(A) Beginning with the CY 2023 performance period/2025 MIPS payment year through the CY 2025 performance period/2027 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data.

(B) Beginning with the CY 2026 performance period/2028 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data no later than 1 year after finalization of the MVP in accordance with the current requirement.

(1) QCDRs and qualified registries may also support the APP.

(2) A QCDR or qualified registry must support all measures and activities included in the MVP with the following exceptions:

(i) If an MVP is intended for reporting by multiple specialties, a QCDR or a qualified registry are required to report those measures pertinent to the specialty of its MIPS eligible clinicians.

(ii) If an MVP includes a QCDR measure, it is not required to be reported by a QCDR other than the measure owner. * * * * *

(d) * * *

(3) * * *

(i) At least 3 years of experience administering surveys in which mail survey administration is followed by survey administration via Computer Assisted Telephone Interview (CATI);

(iv) * * *

(A) Beginning January 1, 2024, in addition to administering the survey in English, entities must administer the Spanish survey translation to Spanish-preferring patients using the procedures detailed in subregulatory guidance to standardize the CAHPS data collection process for MIPS and to make sure the survey data collected across survey vendors are comparable within the program or model;.

(B) [Reserved]

(v) * * *

(A) Beginning January 1, 2027, use equipment, software, computer programs, systems, and facilities that can send survey invitations via email that include a patient-specific hyperlink to a web survey, collect data via web, and track cases from web surveys through telephone follow-up activities.

(B) [Reserved]

(vi) * * *

(A) Beginning January 1, 2027, employ a web survey administrator.

(B) [Reserved]

(vii) Beginning January 1, 2027, at least 3 years of experience administering surveys in which web

survey administration is followed by survey administration via mail survey or Computer Assisted Telephone Interview (CATI). * * * * *

(8) From January 1, 2019 through December 31, 2025, the entity has sent an interim survey data file to CMS that establishes the entity's ability to accurately report CAHPS data.

(9) Beginning with January 1, 2026, the entity seeking to be a CMS- approved survey vendor must include on its application the range of costs of its third-party intermediary services.

(10) Beginning with the CY 2027 performance period/2029 MIPS payment year, the CMS-approved survey vendor must administer the survey via a web-mail-phone protocol. * * * * *

0 24. Section 414.1405 amended by adding paragraph (b)(10)(ii) to read as follows:

Sec. 414.1405 Payment.

* * * * *

(b) * * *

(10) * * *

(i) * * *

(ii) The performance threshold for the 2028 through 2030 MIPS payment years is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS payment year. * * * * *

Sec. 414.1415 [Amended]

0 25. Section 414.1415 is amended in paragraph (c)(7) by removing the phrase “2023 QP Performance Period, notwithstanding” and adding in its place the phrase “2023 QP Performance Period and ending with the 2025 QP Performance Period, notwithstanding”.

Sec. 414.1420 [Amended]

0 26. Section 414.1420 is amended in paragraph (d)(8) by removing the phrase “2023 QP Performance Period, notwithstanding” and adding in its place the phrase “2023 QP Performance Period and ending with the 2025 QP Performance Period, notwithstanding”. * * * * *

0 27. Section 414.1425 is amended by--

(a) Adding paragraph (b)(3); and

(b) Revising paragraphs (c)(3), (c)(4), (d)(1), and (2).

The addition and revisions read as follows:

Sec. 414.1425 Qualifying APM participant determination: In general.

* * * * *

(b) * * *

(3) For QP Performance Periods beginning with 2026, except for paragraphs (b)(1) and (b)(2) of this section and as set forth in Sec. 414.1440, for purposes of the QP determinations, CMS performs QP determinations for the eligible clinicians three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination dates: March 31, June 30, and August 31. An eligible clinician can be determined to be a QP only if the eligible clinician appears on the Participation List on a date (March 31, June 30, or August 31) CMS uses based on participation in the Advanced APM.

(c) * * *

(3) An eligible clinician is a QP for a year under the Medicare Option if--

(i) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, the eligible clinician is in an APM Entity group that achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(a)(1) and (3). An eligible clinician is a QP for the year under the All-Payer Combination Option if the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(b)(1) and (3).

(ii) Beginning with the CY 2026 QP Performance Period, the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(a)(1) and (3). An eligible clinician is a QP for the year under the All-Payer Combination Option if the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(b)(1) and (3).

(4) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, notwithstanding paragraph (c)(3) of this section, an eligible clinician is a QP for a year if--

(i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the QP payment amount threshold or the QP patient count threshold, or the eligible clinician is an Affiliated Practitioner; and

(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the QP payment amount threshold or the QP patient count threshold. * * * * *

(d) * * *

(1) An eligible clinician is a Partial QP for a year under the Medicare Option if:

(i) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, the eligible clinician is in an APM Entity group that achieves Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(a)(2) and (4). An eligible clinician is a Partial QP for the year under the All-Payer Combination Option if the eligible clinician achieves individually, or as part of an APM Entity group, a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(b)(2) and (4).

(ii) Beginning with the CY 2026 QP Performance Period, the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(a)(2) and (4). An eligible clinician is a Partial QP for the year under the All-Payer Combination Option if the eligible clinician achieves individually, or as part of an APM Entity group, a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in Sec. 414.1430(b)(2) and (4).

(2) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, notwithstanding paragraph (d)(1) of this section, an eligible clinician is a Partial QP for a year if--

(i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the corresponding QP or Partial QP threshold, or the eligible clinician is an Affiliated Practitioner; and

(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the corresponding Partial QP Threshold. * * * * *

0 28. Section 414.1435 is revised to read as follows:

Sec. 414.1435 Qualifying APM participant determination: Medicare option.

* * * * *

(a) Payment amount method. For QP performance periods through 2025, the Threshold Score for an APM Entity or eligible clinician is calculated as a percent by dividing the value described under paragraph (a)(1) of this section by the value described under paragraph (a)(2) of this section.

(1) Numerator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to attributed beneficiaries during the QP Performance Period.

(2) Denominator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to all attribution-eligible beneficiaries during the QP Performance Period.

(3) Claims and adjustments. In the calculations under paragraphs (a)(1) and (2) of this section, CMS compiles claims and treats claims adjustments, supplemental service payments, and alternative payment methods in the same manner as described in Sec. 414.1450.

(b) Patient count method. For QP performance periods through 2025, the Threshold Score for each eligible clinician in an APM Entity group is calculated as a percent under the patient count method by dividing the value described under paragraph (b)(1) of this section by the value described under paragraph (b)(2) of this section.

(1) Numerator. The number of attributed beneficiaries to whom the APM Entity group furnishes Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally- Qualified Health Center (FQHC) during the QP Performance Period.

(2) Denominator. The number of attribution-eligible beneficiaries to whom the APM Entity group or eligible clinician furnish Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally-Qualified Health Center (FQHC) during the QP Performance Period.

(3) Unique beneficiaries. For each APM Entity group, a unique Medicare beneficiary is counted no more than one time for the numerator and no more than one time for the denominator.

(4) Beneficiaries count multiple times. Based on attribution under the terms of an Advanced APM, a single Medicare beneficiary may be counted in the numerator or denominator for multiple different APM Entity groups.

(2) When operationally feasible, this attributed beneficiary list will be the final beneficiary list used for reconciliation purposes in the Advanced APM.

(3) When it is not operationally feasible to use the final attributed beneficiary list, the attributed beneficiary list will be taken from the Advanced APM's most recently available attributed beneficiary list at the end of the QP Performance Period.

(c) Covered Professional Service Payment amount method. Starting with the 2026 QP performance period, the Threshold Score for an APM Entity or eligible clinician is calculated as a percent by dividing the value described under paragraph (c)(1) of this section by the value described under paragraph (c)(2) of this section.

(1) Numerator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to attributed beneficiaries during the QP Performance Period.

(2) Denominator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to all Covered Professional Service attribution-eligible beneficiaries during the QP Performance Period.

(3) Claims and adjustments. In the calculations under paragraphs (c)(1) and (2) of this section, CMS compiles claims and treats claims adjustments, supplemental service payments, and alternative payment methods in the same manner as described in Sec. 414.1450.

(d) Covered Professional Service Patient count method. Starting with the 2026 QP performance period the Threshold Score for each eligible clinician in an APM Entity group is calculated as a percent under the patient count method by dividing the value described under paragraph (e)(1) of this section by the value described under paragraph (d)(2) of this section.

(1) Numerator. The number of attributed beneficiaries to whom the APM Entity group furnishes Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally- Qualified Health Center (FQHC) during the QP Performance Period.

(2) Denominator. The number of Covered Professional Service attribution-eligible beneficiaries to whom the APM Entity group or eligible clinician furnish Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally- Qualified Health Center (FQHC) during the QP Performance Period.

(3) Unique beneficiaries. For each APM Entity group, a unique Medicare beneficiary is counted no more than one time for the numerator and no more than one time for the denominator.

(4) Beneficiaries count multiple times. Based on attribution under the terms of an Advanced APM, a single Medicare beneficiary may be counted in the numerator or denominator for multiple different APM Entity groups.

(e) E/M Payment amount method. Starting with the 2026 QP performance period, the Threshold Score for an APM Entity or eligible clinician is calculated as a percent by dividing the value described under paragraph (e)(1) of this section by the value described under paragraph (e)(2) of this section.

(1) Numerator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to attributed beneficiaries during the QP Performance Period.

(2) Denominator. The aggregate of payments for Medicare Part B covered professional services furnished by the APM Entity group to all E/M attribution-eligible beneficiaries during the QP Performance Period.

(3) Claims and adjustments. In the calculations under paragraphs (e)(1) and (2) of this section, CMS compiles claims and treats claims adjustments, supplemental service payments, and alternative payment methods in the same manner as described in Sec. 414.1450.

(f) E/M Patient count method. Starting with the 2026 QP performance period, the Threshold Score for each eligible clinician in an APM Entity group is calculated as a percent under the patient count method by dividing the value described under paragraph (f)(1) of this section by the value described under paragraph (f)(2) of this section.

(1) Numerator. The number of attributed beneficiaries to whom the APM Entity group furnishes Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally- Qualified Health Center (FQHC) during the QP Performance Period.

(2) Denominator. The number of E/M attribution-eligible beneficiaries to whom the APM Entity group or eligible clinician furnish Medicare Part B covered professional services or services by a Rural Health Clinic (RHC) or Federally-Qualified Health Center (FQHC) during the QP Performance Period.

(3) Unique beneficiaries. For each APM Entity group, a unique Medicare beneficiary is counted no more than one time for the numerator and no more than one time for the denominator.

(4) Beneficiaries count multiple times. Based on attribution under the terms of an Advanced APM, a single Medicare beneficiary may be counted in the numerator or denominator for multiple different APM Entity groups.

(g) Attribution.

(1) Attributed beneficiaries are determined from each Advanced APM Entity's attributed beneficiary lists generated by each Advanced APM's specific attribution methodology except as set forth in paragraph (g)(1) of this section.

(i) Beneficiaries who have been prospectively attributed to an APM Entity for a QP Performance Period will be excluded from the attribution-eligible beneficiary count for any other APM Entity that is participating in an APM where that beneficiary would be ineligible to be added to the APM Entity's attributed beneficiary list.

(ii) [Reserved]

(2) When operationally feasible, this attributed beneficiary list will be the final beneficiary list used for reconciliation purposes in the Advanced APM.

(3) When it is not operationally feasible to use the final attributed beneficiary list, the attributed beneficiary list will be taken from the Advanced APM's most recently available attributed beneficiary list at the end of the QP Performance Period.

(h) Use of methods. CMS calculates Threshold Scores for an APM Entity or eligible clinician as provided by Sec. 414.1425(b) under all payment amount and patient count methods for each QP Performance Period. CMS then assigns to the eligible clinicians included in the APM Entity group or to the eligible clinician the score that results in the greater QP status. QP status is greater than Partial QP status, and Partial QP status is greater than no QP status. * * * * *

0 29. Section 414.1455 is amended by revising paragraph (b)(3)(ii) and (vi) to read as follows:

Sec. 414.1455 Limitation on review.

* * * * *

(b) * * *

(3) * * *

(ii) All requests for targeted review must be submitted during the targeted review request submission period as described at Sec. 414.1385(a)(2). The targeted review request submission period may be extended as specified by CMS. * * * * *

(vi) A request for targeted review may include additional information in support of the request at the time it is submitted. CMS may also request additional information from the requestor. If CMS requests additional information relating to the eligible clinician or the APM Entity group that is the subject of a request for targeted review, responsive information must be provided and received by CMS within 15 days of the request. If CMS does not receive a timely response to a request for additional information, CMS may make a final decision on the targeted review request based on the information available. * * * * *

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0 30. The authority citation for part 424 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0 31. Section 424.205 amended by revising paragraphs (c)(10), (f)(2)(i), and (f)(5) to read as follows:

Sec. 424.205 Requirements for Medicare Diabetes Prevention Program suppliers.

* * * * *

(c) * * *

(10) Except as allowed under paragraph (d)(8) of this section, the MDPP supplier must offer an MDPP beneficiary no fewer than all of the following:

(i) 16 in-person, distance learning, or Online core sessions no more frequently than weekly for the first 6 months of the MDPP services period, which begins on the date of attendance at the first core session.

(ii) One in-person, distance learning, or Online core maintenance session each month during months 7 through 12 (6 months total) of the MDPP services period. * * * * *

(f) * * *

(1) * * *

(ii) Basic beneficiary information for each MDPP beneficiary in attendance, including but not limited to beneficiary name, MBI, and age. * * * * *

(2) * * *

(i) Documentation of the type of session (in-person, distance learning, or Online). * * * * *

(5) The MDPP supplier's records must include an attestation from the MDPP supplier that, as applicable, the MDPP beneficiary for which it is submitting a claim--

(i) Has achieved required minimum weight loss as measured in accordance with Sec. 410.79(e)(3)(iii) of this chapter during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under Sec. 414.84(b)(1) of this chapter.

(ii) Has achieved required minimum weight loss as measured in accordance with Sec. 410.79(c)(ii) during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under Sec. 414.84(b)(1) of this chapter.

(iii) Has achieved at least a 9-percent weight loss percentage as measured in accordance with Sec. 410.79(e)(3)(iii) of this chapter during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under Sec. 414.84(b)(2) of this chapter.

(iv) Has achieved at least a 9-percent weight loss percentage as measured in in accordance with Sec. 410.79(c)(ii) during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under Sec. 414.84(b)(2) of this chapter. * * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0 32. The authority citation for part 425 continues to read as follows:

Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

0 33. Section 425.20 is amended by revising paragraph (1)(ii) in the definition of “Beneficiary eligible for Medicare CQMs” to read as follows:

Sec. 425.20 Definitions.

* * * * *

Beneficiary eligible for Medicare CQMs * * *

(1) * * *

(ii)(A) For performance year 2024, had at least one claim with a date of service during the measurement period from an ACO professional who is a primary care physician or who has one of the specialty designations included in Sec. 425.402(c), or who is a physician assistant, nurse practitioner, or clinical nurse specialist.

(B) For performance year 2025 and subsequent performance years, had at least one primary care service with a date of service during the applicable performance year from an ACO professional who is a primary care physician or who has one of the

specialty designations included in Sec. 425.402(c), or who is a physician assistant, nurse practitioner, or clinical nurse specialist. * * * * *

0 34. Section 425.110 is amended by revising paragraph (a)(2) and adding paragraph (a)(3) to read as follows:

Sec. 425.110 Number of ACO professionals and beneficiaries.

(a) * * *

(2) For agreement periods beginning before January 1, 2027, CMS deems an ACO to have initially satisfied the requirement to have at least 5,000 assigned beneficiaries as specified in paragraph (a)(1) of this section if 5,000 or more beneficiaries are historically assigned to the ACO participants in each of the 3 benchmark years, as calculated using the assignment methodology set forth in subpart E of this part. In the case of the third benchmark year, CMS uses the most recent data available to estimate the number of assigned beneficiaries.

(3) For agreement periods beginning on or after January 1, 2027, CMS determines whether an ACO has 5,000 or more beneficiaries historically assigned to the ACO participants in each of the 3 benchmark years, as calculated using the assignment methodology set forth in subpart E of this part. In the case of the third benchmark year, CMS uses the most recent data available to estimate the number of assigned beneficiaries.

(i) CMS deems an ACO to have initially satisfied the requirement to have at least 5,000 assigned beneficiaries as specified in paragraph (a)(1) of this section if 5,000 or more beneficiaries are historically assigned to the ACO participants in the third benchmark year.

(ii) If an ACO has fewer than 5,000 assigned beneficiaries in either the first benchmark year, the second benchmark year, or both, the ACO may only participate under the BASIC track in accordance with Sec. 425.600(h)(3). * * * * *

0 35. Section 425.118 is amended by-- 0 a. Redesignating paragraph (b)(3) as paragraph (b)(4); 0 b. Adding new paragraph (b)(3); and 0 c. In newly redesignated paragraph (b)(4) adding paragraph (b)(4)(iii).

The additions read as follows:

Sec. 425.118 Required reporting of ACO participants and ACO providers/suppliers.

* * * * *

(b) * * *

(3) Change of ownership for ACO participant. No later than 30 days after an ACO participant has undergone a change of ownership that has resulted in a change to its Medicare enrolled TIN, whereby the surviving Medicare enrolled TIN has no Medicare billing claims history, the ACO must submit a change request to CMS.

(i) The change request and supporting documentation must be submitted in the form and manner specified by CMS.

(ii)(A) CMS has sole discretion to approve the change request.

(B) If CMS approves the change request, the ACO participant TIN is updated in the ACO participant list in the form and manner specified by CMS.

(4) * * *

(iii) In alignment with changes approved under paragraph (b)(3) of this section, CMS adjusts the ACO's assignment, performance year financial calculations, and the requirement that the ACO submit quality data under Sec. 425.508 and Sec. 425.510 on behalf of eligible professionals that bill under the TIN of an ACO participant. When processed during applicable Quality Payment Program snapshot dates for the relevant Performance Period, the adjustment includes the surviving Medicare enrolled TIN with no Medicare billing claims history on the ACO participant list as the change becomes effective during the performance year. * * * * *

0 36. Section 425.224 is amended by revising paragraph (b)(1)(ii)(A) to read as follows:

Sec. 425.224 Application procedures for renewing ACOs and re-entering ACOs.

* * * * *

(b) * * *

(1) * * *

(ii) * * *

(A) Whether the ACO demonstrated a pattern of failure to meet both the quality performance standard and alternative quality performance standard (if applicable) or met any of the criteria for termination under Sec. 425.316(c)(1)(ii), (c)(2)(ii), or (c)(3)(ii). * * * * *

0 37. Section 425.316 is amended by revising paragraph (c)(2) introductory text and adding paragraph (c)(3) to read as follows:

Sec. 425.316 Monitoring of ACOs.

* * * * *

(c) * * *

(2) For performance years beginning on or after January 1, 2021 and before January 1, 2026. * * * * *

(3) For performance years beginning on or after January 1, 2026.

(i) If the ACO fails to meet both the quality performance standard and the alternative quality performance standard, CMS may take one or more of the actions prior to termination specified in Sec. 425.216. Depending on the nature and severity of the noncompliance, CMS may forgo pre-termination actions and may immediately terminate the ACO's participation agreement under Sec. 425.218.

(ii) CMS terminates an ACO's participation agreement under any of the following circumstances:

(A) The ACO fails to meet both the quality performance standard and the alternative quality performance standard for 2 consecutive performance years within an agreement period.

(B) The ACO fails to meet both the quality performance standard and the alternative quality performance standard for any 3 performance years within an agreement period, regardless of whether the years are in consecutive order.

(C) A renewing ACO or re-entering ACO fails to meet both the quality performance standard and the alternative quality performance standard for the last performance year of the ACO's previous agreement period and this occurrence was either the second consecutive performance year of failed quality performance or the third nonconsecutive performance year of failed quality performance during the previous agreement period.

(D) A renewing ACO or re-entering ACO fails to meet both the quality performance standard and the alternative quality performance standard for 2 consecutive performance years across 2 agreement periods, specifically the last performance year of the ACO's previous agreement period and the first performance year of the ACO's new agreement period. * * * * *

0 38. Section 425.400 is amended by revising paragraph (c)(1)(ix) introductory text and adding paragraph (c)(1)(x) to read as follows:

Sec. 425.400 General.

* * * * *

(c) * * *

(1) * * *

(ix) For the performance year starting on January 1, 2025, as follows: * * * * *

(x) For the performance year starting on January 1, 2026, and subsequent performance years as follows:

(A) CPT codes:

(1) 96160 and 96161 (codes for administration of health risk assessment).

(2) 96202 and 96203 (codes for caregiver behavior management training).

(3) 97550, 97551, and 97552 (codes for caregiver training services).

(4) 98016 (code for virtual check-in).

(5) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient).

(6) 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 skilled nursing facility (SNF)).

(7) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit).

(8) 99341 through 99350 (codes for evaluation and management services furnished in a patient's home).

(9) 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)(x)).

(10) 99406 and 99407 (codes for smoking and tobacco-use cessation counseling services).

(11) 99421, 99422, and 99423 (codes for online digital evaluation and management).

(12) 99424, 99425, 99426, and 99427 (codes for principal care management services).

(13) 99437, 99487, 99489, 99490 and 99491 (codes for chronic care management).

(14) 99439 (code for non-complex chronic care management).

(15) 99452 (code for interprofessional consultation service).

(16) 99483 (code for assessment of and care planning for patients with cognitive impairment).

(17) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services).

(18) 99495 and 99496 (codes for transitional care management services).

(19) 99497 and 99498 (codes for advance care planning; services identified by these codes furnished in an inpatient setting are excluded).

(B) HCPCS codes:

(1) G0019 and G0022 (codes for community health integration services).

(2) G0023 and G0024 (codes for principal illness navigation services).

(3) G0101 (code for cervical or vaginal cancer screening).

(4) G0136 (code for physical activity and nutritional assessment services).

(5) G0317, G0318, and G2212 (codes for prolonged office or other outpatient visit for the evaluation and management of a patient).

(6) G0402 (code for the Welcome to Medicare visit).

(7) G0438 and G0439 (codes for the annual wellness visits).

(8) G0442 (code for alcohol misuse screening service).

(9) G0443 (code for alcohol misuse counseling service).

(10) G0444 (code for annual depression screening service).

(11) G0463 (code for services furnished in electing teaching amendment (ETA) hospitals).

(12) G0506 (code for chronic care management).

(13) G0537 and G0538 (codes for cardiovascular risk assessment and risk management services).

(14) G0539 and G0540 (codes for individual behavior management/ modification caregiver training services).

(15) G0541, G0542, and G0543 (codes for direct care caregiver training services).

(16) G0544 (code for post-discharge telephonic follow-up contacts intervention).

(17) G0556, G0557, and G0558 (codes for advanced primary care management services).

(18) G0560 (code for safety planning interventions).

(19) G0568 and G0569 (codes for behavioral health integration add- on when furnished with advanced primary care management services).

(20) G0570 (code for psychiatric collaborative care model add-on when furnished with advanced primary care management services).

(21) G2010 (code for the remote evaluation of patient video/ images).

(22) G2012 and G2252 (codes for virtual check-in).

(23) G2058 (code for non-complex chronic care management).

(24) G2064 and G2065 (codes for principal care management services).

(25) G2086, G2087, and G2088 (codes for office-based opioid use disorder services).

(26) G2211 (code for visit complexity inherent to evaluation and management services add-on).

(27) G2214 (code for psychiatric collaborative care model).

(28) G3002 and G3003 (codes for chronic pain management).

(C) Primary care service codes include any CPT code identified by CMS that directly replaces a CPT code specified in paragraph (c)(1)(x)(A) of this section or a HCPCS code specified in paragraph (c)(1)(x)(B) of this section, when the assignment window or expanded window for assignment (as defined in Sec. 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. * * * * *

0 39. Section 425.512 is amended by-- 0 a. In paragraph (a)(3)(i), removing the phrase “quality performance score” and adding in its place the phrase “quality score”; 0 b. In paragraphs (a)(4)(i)(A), (a)(5)(i)(A)(1), (a)(5)(i)(B)(1), (a)(5)(i)(C)(1), and (a)(7), removing the phrase “health equity adjusted quality performance score” and adding in its place the phrase “quality score”; 0 c. Revising and republishing paragraph (b); 0 d. Revising paragraph (c)(1) introductory text; 0 e. Adding paragraph (c)(1)(iii); 0 f. In paragraphs (c)(2)(i), (c)(2)(ii), and (c)(3)(i), removing the phrase “quality performance score” and adding in its place the phrase “quality score”; and 0 g. In paragraphs (c)(3)(ii), (c)(3)(iii), and (c)(3)(iv), removing the phrase “health equity adjusted quality performance score” and adding in its place the phrase “quality score”.

The revisions and addition read as follows:

Sec. 425.512 Determining the ACO quality performance standard for performance years beginning on or after January 1, 2021.

* * * * *

(b) Calculation of an adjustment to an ACO's quality score for performance years 2023 through 2025--

(1) For performance year 2023. For an ACO that reports the three eCQMs/MIPS CQMs in the APP quality measure set, meeting the data completeness requirement at Sec. 414.1340 of this subchapter for all three eCQMs/MIPS CQMs, and administers the CAHPS for MIPS survey, CMS calculates the ACO's quality score as the sum of the ACO's MIPS Quality performance category score for all measures in the APP quality measure set and the ACO's population and income adjustment bonus points calculated in accordance with paragraph (b)(4) of this section. The sum of these values may not exceed 100 percent.

(2) For performance year 2024. For an ACO that reports the three eCQMs/MIPS CQMs/Medicare CQMs in the APP quality measure set, meeting the data completeness requirement at Sec. 414.1340 of this subchapter for all three eCQMs/MIPS CQMs/Medicare CQMs, and administers the CAHPS for MIPS survey (except as specified in Sec. 414.1380(b)(1)(vii)(B) of this subchapter), CMS calculates the ACO's quality score as the sum of the ACO's

MIPS Quality performance category score for all measures in the APP quality measure set and the ACO's population and income adjustment bonus points calculated in accordance with paragraph (b)(4) of this section. The sum of these values may not exceed 100 percent.

(3) For performance year 2025. For an ACO that reports all of the required measures in the APP Plus quality measure set, meeting the data completeness requirement at Sec. 414.1340 of this subchapter for all of the required measures in the APP Plus quality measure set, and administers the CAHPS for MIPS survey (except as specified in Sec. 414.1380(b)(1)(vii)(B) of this subchapter), CMS calculates the ACO's quality score as the sum of the ACO's MIPS Quality performance category score for all measures in the APP Plus quality measure set and the ACO's population and income adjustment bonus points calculated in accordance with paragraph (b)(4) of this section. The sum of these values may not exceed 100 percent.

(4) Calculation of ACO's population and income adjustment bonus points. CMS calculates the ACO's bonus points as follows:

(i) For each measure that an ACO is required to report for the applicable performance year, CMS groups an ACO's performance into the top, middle, or bottom third of ACO measure performers by reporting mechanism.

(ii) CMS assigns values to the ACO for its performance on each measure as follows:

(A) Values of four, two, or zero for each measure for which the ACO's performance places it in the top, middle, or bottom third of ACO measure performers, respectively.

(B) Values of zero for each measure that CMS does not evaluate because the measure is unscored or the ACO does not meet the case minimum or the minimum sample size for the measure.

(iii) CMS sums the values assigned to the ACO according to paragraph (b)(4)(ii) of this section, to calculate the ACO's measure performance scaler.

(iv) CMS calculates a multiplier for the ACO.

(A) (1) CMS determines the proportion ranging from zero to one of the ACO's assigned beneficiary population for the performance year based on the highest of either of the following:

(i) The proportion of the ACO's assigned beneficiaries residing in a census block group with an Area Deprivation Index (ADI) national percentile rank of at least 85. An ACO's assigned beneficiaries without an available numeric ADI national percentile rank are excluded from the calculation of the proportion of the ACO's assigned beneficiaries residing in a census block group with an ADI national percentile rank of at least 85.

(ii) The proportion of the ACO's assigned beneficiaries who are enrolled in the Medicare Part D low-income subsidy (LIS); or are dually eligible for Medicare and Medicaid.

(2) CMS calculates the proportions specified in paragraph (b)(4)(iv)(A)(1)(ii) of this section as follows:

(i) For performance year 2023, the proportion of the ACO's assigned beneficiaries who are enrolled in the Medicare Part D LIS or are dually eligible for Medicare and Medicaid divided by the total number of the ACO's assigned beneficiaries' person years.

(ii) For performance years 2024 and 2025, the proportion of the ACO's assigned beneficiaries with any months enrolled in the Medicare Part D LIS or are dually eligible for Medicare and Medicaid divided by the total number of the ACO's assigned beneficiaries.

(B) If the proportion determined in accordance with paragraph (b)(4)(iv)(A) of this section is lower than 20 percent, the ACO is ineligible for bonus points.

(v) Except as specified in paragraph (b)(4)(iv)(B) of this section, CMS calculates the ACO's bonus points as the product of the measure performance scaler determined under paragraph (b)(4)(iii) of this section and the multiplier determined under paragraph (b)(4)(iv) of this section. If the product of these values is greater than 10, the value of the ACO's bonus points is set equal to 10.

(5) Use of ACO's quality score. The ACO's quality score, determined in accordance with paragraphs (b)(1) through (4) of this section, is used as follows:

(i) In determining whether the ACO meets the quality performance standard as specified under paragraphs (a)(4)(i)(A), (a)(5)(i)(A)(1), (a)(5)(i)(B), and (a)(7) of this section.

(ii) In determining the final sharing rate for calculating shared savings payments under the BASIC track in accordance with Sec. 425.605(d), and under the ENHANCED track in accordance with Sec. 425.610(d), for an ACO that meets the alternative quality performance standard by meeting the criteria specified in paragraph (a)(4)(ii) or (a)(5)(ii) of this section.

(iii) In determining the shared loss rate for calculating shared losses under the ENHANCED track in accordance with Sec. 425.610(f), for an ACO that meets the quality performance standard established in paragraphs (a)(2), (a)(4)(i), and (a)(5)(i) of this section or the alternative quality performance standard established in paragraph (a)(4)(ii) or (a)(5)(ii) of this section.

(iv) In determining the quality score for an ACO affected by extreme and uncontrollable circumstances as described in paragraphs (c)(3)(ii) through (iv) of this section (as applicable).

(c) * * *

(1) CMS determines the ACO was affected by an extreme and uncontrollable circumstance based on any of the following: * * * * *

(iii) For performance year 2025 and subsequent performance years, the ACO, as defined at Sec. 425.20, is affected by an extreme and uncontrollable circumstance due to a cyberattack, including ransomware/ malware, as determined by the Quality Payment Program. * * * * *

0 40. Section 425.600 is amended by-- 0 a. In paragraph (a)(4)(i)(C)(1), removing the phrase “paragraph (g)(1) of this section” and adding in its place the phrase “paragraphs (g)(1) or (h)(1) of this section”; 0 b. In paragraph (a)(4)(i)(C)(2)(iii), removing the phrase “paragraph (h)(2)(i) of this section” and adding in its place the phrase “paragraph (i)(2)(i) of this section”; 0 c. In paragraph (a)(4)(ii), removing the phrase “paragraph (d) or paragraph (g)(2) of this section” and adding in its place the phrase “paragraphs (d), (g)(2) or (h) of this section”; 0 d. Revising paragraph (g) introductory text; 0 e. Redesignating paragraph (h) as paragraph (i); and 0 f. Adding new paragraph (h).

The revision and addition read as follows:

Sec. 425.600 Selection of risk model.

* * * * *

(g) For agreement periods beginning on or after January 1, 2024 and before January 1, 2027, CMS determines an ACO's eligibility for the Shared Savings Program participation options specified in paragraph (a) of this section as follows: * * * * *

(h) For agreement periods beginning on or after January 1, 2027, CMS determines an ACO's eligibility for the Shared Savings Program participation options specified in paragraph (a) of this section as follows:

(1) If an ACO is determined to be inexperienced with performance- based risk Medicare ACO initiatives, the ACO

may enter either the BASIC track's glide path at any of the levels of risk and potential reward under paragraphs (a)(4)(i)(A)(1) through (5) of this section, or the ENHANCED track under paragraph (a)(3) of this section, except as otherwise specified in paragraph (h)(3) of this section.

(i) An ACO that is inexperienced with performance-based risk Medicare ACO initiatives may participate under the BASIC track's glide path for a maximum of one agreement period, as specified in paragraph (a)(4)(i)(C) of this section.

(ii) An ACO that enters an agreement period under the BASIC track's glide path at any of the levels of risk and potential reward available under paragraphs (a)(4)(i)(A)(1) through (5) of this section is deemed to have completed one agreement period under the BASIC track's glide path. For the purpose of determining the ACO's prior participation in the BASIC track's glide path, CMS considers whether the ACO satisfies either of the following:

(A) The ACO is the same legal entity as a current or previous ACO that previously entered into a participation agreement for participation in the BASIC track's glide path.

(B) For a new ACO identified as a re-entering ACO, the ACO in which the majority of the new ACO's participants were participating previously entered into a participation agreement for participation in the BASIC track's glide path.

(iii) An ACO determined to be inexperienced with performance-based risk Medicare ACO initiatives but is not eligible to enter the BASIC track's glide path, in accordance with this paragraph, may enter BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period, or the ENHANCED track under paragraph (a)(3) of this section, except as otherwise specified in paragraph (h)(3) of this section.

(2) If an ACO is determined to be experienced with performance- based risk Medicare ACO initiatives, the ACO may enter either the BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period, or the ENHANCED track under paragraph (a)(3) of this section, except as otherwise specified in paragraph (h)(3) of this section.

(3) If an ACO is determined to have fewer than 5,000 assigned beneficiaries in either the first benchmark year, the second benchmark year, or both, in accordance with Sec. 425.110(a)(3), the ACO may only enter the BASIC track. The ACO may enter a level of risk and potential reward under the BASIC track in accordance with the requirements of this paragraph, as follows:

(i) An ACO determined to be inexperienced with performance-based risk Medicare ACO initiatives may enter the BASIC track's glide path at any of the levels of risk and potential reward available under paragraphs (a)(4)(i)(A)(1) through (5) of this section (if eligible in accordance with paragraph (h)(1) of this section), or BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period.

(ii) An ACO determined to be experienced with performance-based risk Medicare ACO initiatives may enter BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period. * * * * *

0 41. Section 425.605 is amended by-- 0 a. In paragraph (b)(2)(ii)(E), removing the reference “Sec. 425.600(h)(2)” and adding in its place the reference “Sec. 425.600(i)(2)”; 0 b. In paragraph (d)(1) introductory text, removing the references “Sec. 425.600(d) or Sec. 425.600(g)” and adding in its place the references “Sec. 425.600(d), (g), or (h)”; 0 c. In paragraphs (d)(1)(i)(A)(3)(ii), (d)(1)(i)(A)(4)(ii), (d)(1)(ii)(A)(3)(ii), (d)(1)(ii)(A)(4)(ii), (d)(1)(iii)(A)(3)(ii), (d)(1)(iii)(A)(4)(ii), (d)(1)(iv)(A)(3)(ii), (d)(1)(iv)(A)(4)(ii), (d)(1)(v)(A)(3)(ii), and (d)(1)(v)(A)(4)(ii), removing the phrase “health equity adjusted quality performance score calculated according to Sec. 425.512(b)” and adding in its place the phrase “quality score calculated according to Sec. 425.512”; 0 d. Revising paragraph (d)(2); 0 e. Adding paragraph (f)(2)(ii); 0 f. Revising paragraph (f)(3) introductory text; 0 g. Removing the punctuation “; and” at the end of paragraph (f)(3)(i) and adding in its place a period; 0 h. Adding paragraph (f)(3)(iii); 0 i. Redesignating paragraph (f)(4) as paragraph (f)(5); 0 j. Adding new paragraph (f)(4); and 0 k. Adding paragraphs (h)(1)(v) and (i).

The revisions and additions read as follows:

Sec. 425.605 Calculation of shared savings and losses under the BASIC track.

* * * * *

(d) * * *

(2) If the ACO enters the BASIC track at Level E as specified under Sec. 425.600(d), (g), or (h), the level of risk and reward specified in paragraph (d)(1)(v) of this section applies to all performance years of an ACO's agreement period. * * * * *

(f) * * *

(2) * * *

(ii) For performance year 2025 and subsequent performance years, for an ACO as defined at Sec. 425.20 that is determined to be affected by an extreme and uncontrollable circumstance due to a cyberattack, including ransomware/malware, for any month of the performance year that is affected, CMS considers 100 percent of the ACO's assigned beneficiaries to reside in an affected area.

(3) CMS applies determinations made under the Quality Payment Program with respect to all of the following (as applicable): * * * * *

(iii) The time period during which the ACO was affected by a cyberattack, including ransomware/malware.

(4) CMS determines the time period during which an ACO is affected by a cyberattack, including ransomware/malware, as follows:

(i) CMS uses the start and end date indicated on an ACO's application to the Quality Payment Program for an extreme and uncontrollable circumstance exception due to a cyberattack, including ransomware/malware, or the start date indicated on the application and an end date subsequently provided by the ACO in the form and manner as specified by CMS.

(ii) Except as specified in paragraph (f)(4)(iii) of this section, if no end date is indicated on the ACO's application or otherwise provided to CMS in a form and manner specified by CMS, described in paragraph (f)(4)(i) of this section, CMS applies a 90-day duration for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance.

(iii) If the start date indicated on the ACO's application described in paragraph (f)(4)(i) of this section is less than 90 days before the end of the performance year and no end date is indicated on the ACO's application or otherwise provided to CMS in the form and manner specified by CMS, described in paragraph (f)(4)(i) of this section, CMS applies an end date of December 31st of the performance year for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance. * * * * *

(h) * * *

(1) * * *

(v) For agreement periods beginning on or after January 1, 2027, the ACO has at least 5,000 assigned beneficiaries in each of the ACO's benchmark years. * * * * *

(i) Calculation of performance payment limit and loss recoupment limit.

(1) The performance payment limit is a percentage of the ACO's updated benchmark, as determined under Sec. 425.601 or Sec. 425.652.

(i) CMS calculates the performance payment limit as follows, except as specified in paragraph (i)(1)(ii) of this section:

(A) Calculates the value for total benchmark expenditures as the product of an ACO's per capita updated benchmark expenditures for the performance year and an ACO's assigned beneficiary person years for the performance year.

(B) Calculates the product of the percentage specified in paragraph (d)(1)(i)(B)(2), (d)(1)(ii)(B)(2), (d)(1)(iii)(B)(2), (d)(1)(iv)(B)(2), and (d)(1)(v)(B)(2) of this section, as applicable, and the ACO's total benchmark expenditures calculated according to paragraph (i)(1)(i)(A) of this section.

(ii) For agreement periods beginning on or after January 1, 2027, if the ACO has fewer than 5,000 assigned beneficiaries in benchmark year (BY) 1, BY2 or BY3, in conducting financial reconciliation for each performance year, CMS determines whether to apply an alternative performance payment limit, rather than the performance payment limit specified in paragraph (d)(1)(i)(B)(2), (d)(1)(ii)(B)(2), (d)(1)(iii)(B)(2), (d)(1)(iv)(B)(2), and (d)(1)(v)(B)(2) of this section, as applicable, as follows:

(A) CMS calculates the value for total benchmark expenditures as the product of an ACO's per capita updated benchmark expenditures for the performance year and an ACO's assigned beneficiary person years for the benchmark year with the lowest number of assigned beneficiaries.

(B) CMS calculates the product of the percentage specified in paragraph (d)(1)(i)(B)(2), (d)(1)(ii)(B)(2), (d)(1)(iii)(B)(2), (d)(1)(iv)(B)(2), and (d)(1)(v)(B)(2) of this section, as applicable, and the ACO's total benchmark expenditures calculated according to paragraph (i)(1)(ii)(A) of this section.

(C) The performance payment limit is set to the lesser of the amount calculated under paragraph (i)(1)(i)(B) of this section and the alternative amount calculated under paragraph (i)(1)(ii)(B) of this section.

(2) The loss recoupment limit is a percentage of total Medicare Parts A and B fee-for-service revenue of the ACO participants in the ACO (revenue-based loss recoupment limit) not to exceed a percentage of the ACO's updated benchmark as determined under Sec. 425.601 or Sec. 425.652 (benchmark-based loss recoupment limit).

(i) CMS calculates the benchmark-based loss recoupment limit as follows, except as specified in paragraph (i)(2)(ii) of this section:

(A) Calculates the value for total benchmark expenditures as the product of an ACO's per capita updated benchmark expenditures for the performance year and an ACO's assigned beneficiary person years for the performance year.

(B) Calculates the product of the percentage used to calculate the benchmark-based loss recoupment limit specified in paragraph (d)(1)(iii)(D)(2), (d)(1)(iv)(D)(2), and (d)(1)(v)(D)(2) of this section, as applicable, and the ACO's total benchmark expenditures calculated according to paragraph (i)(2)(i)(A) of this section.

(ii) For agreement periods beginning on or after January 1, 2027, if the ACO has fewer than 5,000 assigned beneficiaries in BY1, BY2 or BY3, in conducting financial reconciliation for each performance year, CMS determines whether to apply an alternative loss recoupment limit, as follows:

(A) CMS calculates an alternative benchmark-based loss recoupment limit:

(1) CMS calculates the value for total benchmark expenditures as the product of an ACO's per capita updated benchmark expenditures for the performance year and an ACO's assigned beneficiary person years for the benchmark year with the lowest number of assigned beneficiaries.

(2) CMS calculates the product of the percentage used to calculate the benchmark-based loss recoupment limit specified in paragraph (d)(1)(iii)(D)(2), (d)(1)(iv)(D)(2), and (d)(1)(v)(D)(2) of this section, as applicable, and the ACO's total benchmark expenditures calculated according to paragraph (i)(2)(ii)(A)(1) of this section.

(B) The loss recoupment limit is set to the revenue-based loss recoupment limit specified in paragraph (d)(1)(iii)(D)(1), (d)(1)(iv)(D)(1), or (d)(1)(v)(D)(1) of this section, as applicable, not to exceed the lower of the benchmark-based loss recoupment limit amount calculated under paragraph (i)(2)(i)(B) of this section or the alternative benchmark-based loss recoupment limit amount calculated under paragraph (i)(2)(ii)(A)(2) of this section.

0 42. Section 425.610 is amended by-- 0 a. In paragraphs (d)(3)(ii), (d)(4)(ii), (f)(3)(i)(A), and (f)(4)(i)(A), removing the phrase “health equity adjusted quality performance score calculated according to Sec. 425.512(b)” and adding in its place the phrase “quality score calculated according to Sec. 425.512”; 0 b. Adding paragraph (i)(2)(ii); 0 c. Revising paragraph (i)(3) introductory text; 0 d. Removing the punctuation “; and” at the end of paragraph (i)(3)(i) and adding in its place a period; 0 e. Adding paragraph (i)(3)(iii); 0 f. Redesignating paragraph (i)(4) as paragraph (i)(5); and 0 g. Adding new paragraphs (i)(4) and (l).

The revisions and additions read as follows:

Sec. 425.610 Calculation of shared savings and losses under the ENHANCED track.

* * * * *

(i) * * *

(2) * * *

(ii) For performance year 2025 and subsequent performance years, for an ACO as defined at Sec. 425.20 that is determined to be affected by an extreme and uncontrollable circumstance due to a cyberattack, including ransomware/malware, for any month of the performance year that is affected, CMS considers 100 percent of the ACO's assigned beneficiaries to reside in an affected area.

(3) CMS applies determinations made under the Quality Payment Program with respect to all of the following (as applicable): * * * * *

(iii) The time period during which the ACO was affected by a cyberattack, including ransomware/malware.

(4) CMS determines the time period during which an ACO is affected by a cyberattack, including ransomware/malware, as follows:

(i) CMS uses the start and end date indicated on an ACO's application to the Quality Payment Program for an extreme and uncontrollable circumstance exception due to a cyberattack, including ransomware/malware, or the start date indicated on the application and an end date subsequently provided by the ACO in the form and manner as specified by CMS.

(ii) Except as specified in paragraph (i)(4)(iii) of this section, if no end date is indicated on the ACO's application or otherwise provided to CMS in a form and manner specified by CMS, described in paragraph (i)(4)(i) of this section, CMS applies a 90-day duration for purposes of determining the time period during which the ACO was

affected by the extreme and uncontrollable circumstance.

(iii) If the start date indicated on the ACO's application described in paragraph (i)(4)(i) of this section is less than 90 days before the end of the performance year and no end date is indicated on the ACO's application or otherwise provided to CMS in the form and manner specified by CMS, described in paragraph (i)(4)(i) of this section, CMS applies an end date of December 31st of the performance year for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance. * * * * *

(l) Calculation of performance payment limit and loss recoupment limit.

(1) The performance payment limit and the loss recoupment limit are a percentage of the ACO's updated benchmark.

(2) CMS calculates the performance payment limit and loss recoupment limit as follows, except as specified in paragraph (l)(3) of this section:

(i) Calculates the value for total benchmark expenditures as the product of an ACO's per capita updated benchmark expenditures for the performance year and an ACO's assigned beneficiary person years for the performance year.

(ii) Calculates the product of the percentage used to calculate the performance payment limit specified in paragraph (e)(2) of this section or the loss recoupment limit specified in paragraph (g) of this section and the ACO's total benchmark expenditures calculated according to paragraph (l)(2)(i) of this section.

(3) For agreement periods beginning on or after January 1, 2027, if the ACO has fewer than 5,000 assigned beneficiaries in BY1, BY2 or BY3, in conducting financial reconciliation for each performance year, CMS determines whether to apply an alternative performance payment limit or alternative loss recoupment limit, rather than the performance payment limit specified in paragraph (e)(2) of this section or the loss recoupment limit specified in paragraph (g) of this section, as follows:

(i) CMS calculates the value for total benchmark expenditures as the product of an ACO's per capita updated benchmark expenditures for the performance year and an ACO's assigned beneficiary person years for the benchmark year with the lowest number of assigned beneficiaries.

(ii) CMS calculates the product of the percentage used to calculate the performance payment limit specified in paragraph (e)(2) of this section or the loss recoupment limit specified in paragraph (g) of this section and the ACO's total benchmark expenditures calculated according to paragraph (l)(3)(i) of this section.

(iii) The performance payment limit or loss recoupment limit is set to the lesser of the amount calculated under paragraph (l)(2)(ii) of this section or the alternative amount calculated under paragraph (l)(3)(ii) of this section.

0 43. Section 425.612 is amended by revising paragraph (a)(1)(i)(B) to read as follows:

Sec. 425.612 Waivers of payment rules or other Medicare requirements.

(a) * * *

(1) * * *

(i) * * *

(B)(1) A list of SNFs, including the Medicare-enrolled TIN and the CCN, with whom the ACO will partner along with executed written SNF affiliate agreements between the ACO and each listed SNF.

(2) An ACO must notify CMS no later than 30 days after the change of ownership of a SNF affiliate, identified in accordance with paragraph (a)(1)(i)(B)(1) of this section, that has resulted in a change to the Medicare enrolled TIN of the SNF affiliate. Such notice and supporting documentation must be submitted in the form and manner specified by CMS. * * * * *

Sec. 425.652 [Amended]

0 44. Section 425.652 is amended by-- 0 a. In paragraph (a)(8)(ii)(A), removing the phrase “health equity benchmark adjustment (HEBA)” and adding in its place the phrase “population adjustment”; 0 b. In paragraphs (a)(8)(ii)(B) introductory text, (a)(8)(ii)(B)(2), and (a)(9)(vi), removing the phrase “HEBA” and adding in its place the phrase “population adjustment”; and 0 c. In paragraph (a)(9)(v), removing the phrase “HEBA scaler used in calculating the HEBA under Sec. 425.662(b)(2)” and adding in its place the phrase “scaler used in calculating the population adjustment under Sec. 425.662(b)(2)”.

Sec. 425.658 [Amended]

0 45. Section 425.658 is amended in paragraph (d) by removing the phrase “HEBA” and adding in its place the phrase “population adjustment”.

0 45. Section 425.662 is amended by-- 0 a. Revising the section heading and paragraph (a); 0 b. In paragraph (b) introductory text, removing the phrase “health equity benchmark adjustment” and adding in its place the phrase “population adjustment”; 0 c. In paragraph (b)(2), removing the phrase “Calculates the HEBA scaler” and adding in its place the phrase “Calculates a scaler”; and 0 d. Revising paragraphs (b)(3), (b)(4), and (c).

The revisions read as follows:

Sec. 425.662 Calculating the population adjustment to the historical benchmark.

(a) General. For agreement periods beginning on January 1, 2025, and in subsequent years, CMS calculates the population adjustment to the historical benchmark.

(b) * * *

(3) Determines the ACO's eligibility for the population adjustment based on the proportion of the ACO's assigned beneficiaries for the performance year who are enrolled in the Medicare Part D low-income subsidy (LIS) or dually eligible for Medicare and Medicaid. An ACO is only eligible for the population adjustment if this proportion is greater than or equal to 15 percent. An ACO with a proportion less than 15 percent is ineligible to receive the population adjustment.

(4) Calculates the population adjustment. If the ACO is eligible for the population adjustment as determined in paragraph (b)(3) of this section, the adjustment is equal to the product of the scaler calculated in paragraph (b)(2) of this section and the proportion of the ACO's assigned beneficiaries for the performance year who are enrolled in the Medicare Part D LIS or dually eligible for Medicare and Medicaid.

(c) Applicability of the population adjustment. CMS compares the population adjustment determined in paragraph (b)(4) of this section with the regional adjustment, expressed as a single value as described in Sec. 425.656(d), and the per capita prior savings adjustment determined in Sec. 425.658(c), if any, to determine the adjustment, if any, that will be applied to the ACO's benchmark in accordance with Sec. 425.652(a)(8)(ii).

Sec. 425.672 [Amended]

0 47. Section 425.672 is amended in paragraph (c)(2)(iv) by removing the phrase “and calculating the HEBA scaler” and adding in its place the phrase “and calculating the scaler”.

PART 427--MEDICARE PART B DRUG INFLATION REBATE PROGRAM

0 48. The authority citation for part 427 continues to read as follows:

Authority: 42 U.S.C. 1395w-3a(i), 1302, and 1395hh.

0 49. Section 427.20 is amended by removing the definition of “Billing and payment code FDA approval or licensure date”.

0 50. Section 427.302 is amended by-- 0 a. Revising paragraphs (c) introductory text and (c)(5); 0 b. Adding paragraph (c)(6); and 0 c. Revising paragraphs (d)(1).

The revisions and addition to read as follows:

Sec. 427.302 Calculation of the per unit Part B rebate amount.

* * * * *

(c) Identification of the payment amount benchmark quarter. For each Part B rebatable drug, CMS identifies the applicable payment amount benchmark quarter as set forth in paragraphs (c)(1) through (3) of this section, as applicable, subject to paragraphs (c)(4) through (6) of this section, using the earliest first marketed date of any NDC ever marketed under any FDA application under which any NDCs that have ever been assigned to the billing and payment code as of the applicable calendar quarter have been marketed, and using the earliest approval or licensure date of any FDA application under which any NDCs that have ever been assigned to the billing and payment code as of the applicable calendar quarter have been marketed. * * * * *

(5) If the data needed to calculate the payment amount in the payment amount benchmark quarter described in and determined under Sec. 427.302(d)(1) are not available, CMS uses the third full calendar quarter after a drug is assigned a billing and payment code as the payment amount benchmark quarter, no earlier than the calendar quarter beginning July 1, 2021, or the third full calendar quarter after the drug's first marketed date, whichever is later.

(6) For a Part B rebatable drug that is a selected drug (as defined in section 1192(c) of the Act) with respect to a price applicability period (as defined in section 1191(b)(2) of the Act), in the case of a Part B rebatable drug that is no longer considered to be a selected drug, for each applicable quarter beginning after the price applicability period with respect to the drug, the payment amount benchmark quarter is the calendar quarter beginning January 1 of the last year during the price applicability period with respect to the selected drug.

(d) * * *

(1) For a Part B rebatable drug, subject to paragraphs (d)(1)(i) and (ii) of this section and except as provided in paragraph (d)(2) of this section, CMS identifies the payment amount in the payment amount benchmark quarter using the published payment limit for the billing and payment code for the applicable payment amount benchmark quarter.

(i) If a published payment limit is not available for the applicable payment amount benchmark quarter, CMS calculates the payment amount in the payment amount benchmark quarter using positive ASP or positive WAC data from the ASP Data Collection System.

(ii) If a published payment limit is not available and neither positive ASP nor positive WAC data are available in the ASP Data Collection System, CMS calculates the payment amount in the payment amount benchmark quarter using WAC data from other public sources. * * * * *

0 51. Section 427.501 is amended by adding paragraph (c)(3) to read as follows:

Sec. 427.501 Rebate Reports and reconciliation.

* * * * *

(c) * * *

(3) The manufacturer's rebate amount due is reported as a dollar amount rounded to the nearest cent. * * * * *

0 52. Section 427.502 is amended by revising paragraph (c)(1)(ii) to read as follows:

Sec. 427.502 Rebate Reports for applicable calendar quarters in calendar years 2023 and 2024.

* * * * *

(c) * * *

(1) * * *

(ii) Within 9 months after issuance of the single Rebate Report, CMS performs one regular reconciliation for the applicable calendar quarters in calendar year 2024 in order to include revisions to the information used, determined under Sec. 427.501(b)(1), to calculate the rebate amount. The reconciliation is as determined under Sec. 427.501(d) inclusive of a preliminary reconciliation and a report with the reconciled rebate amount.

PART 428--MEDICARE PART D DRUG INFLATION REBATE PROGRAM

0 53. The authority citation for part 428 continues to read as follows:

Authority: 42 U.S.C. 1395w-114b, 1302, and 1395hh.

0 54. Section 428.401 is amended by adding paragraph (c)(3) to read as follows:

Sec. 428.401 Rebate Reports and reconciliation.

* * * * *

(c) * * *

(3) The manufacturer's rebate amount due is reported as a dollar amount rounded to the nearest cent.

Sec. 428.402 [Amended]

0 55. Section 428.402 is amended by-- 0 a. In paragraph (c)(1)(ii), removing the phrase “will be reconciled 21 months” and adding in its place the phrase “is reconciled within 21 months”; and 0 b. In paragraph (c)(2)(ii) removing the phrase “will be reconciled 9 months after the Rebate Report and 33 months after” and adding in its place the phrase “within 9 months after the Rebate Report and within 33 months after”.

Sec. 428.405 [Amended]

0 56. Section 428.405 is amended in paragraph (a)(1) introductory text by removing the phrase “30 calendar days” and adding in its place the phrase “30th calendar day”.

PART 495--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0 58. The authority citation for part 495 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0 59. Section 495.24 by adding paragraph (f)(3) to read as follows:

Sec. 495.24 Stage 3 meaningful use objectives and measures for EPs, eligible hospitals and CAHs for 2019 and subsequent years.

* * * * *

(f) * * *

(3) Beginning with the EHR reporting period in CY 2026, if certain circumstances occur that impact CMS's assessment of the performance of eligible hospitals and CAHs on a measure selected as described in paragraph (f)(1)(i)(A) of this section, CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS' assessment of performance while allocating the maximum points available or providing full credit for the affected measure as long as the affected measure is reported, resulting in a suppressed measure contributing to the Medicare Promoting Interoperability Program objective score in paragraph (f)(1)(i)(D) of this section; or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. CMS determines whether certain circumstances exist warranting suppression of a measure based on CMS' consideration of one or more of the following factors:

(i) The nature, breadth, and duration of the circumstance's effect on eligible hospitals' and CAHs' ability to fulfill the measure requirement.

(ii) The availability of certified health IT modules to fulfill the measure.

(iii) The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance.

(iv) Out-of-date or conflicting technical standards.

(v) Technical and operational capacity of required partners.

(vi) Other factors as determined by CMS. * * * * *

PART 512--STANDARD PROVISIONS FOR MANDATORY INNOVATION CENTER MODELS AND SPECIFIC PROVISIONS FOR THE RADIATION ONCOLOGY MODEL AND THE END-STAGE RENAL DISEASE TREATMENT CHOICES MODEL

0 60. The authority citation for part 512 continues to read as follows:

Authority: 42 U.S.C. 1302, 1315a, and 1395hh.

0 61. Adding subparts F and G to part 512 to read as follows: Subpart F--[Reserved] Subpart G--Ambulatory Specialty Model (ASM)