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

1. Executive Summary a. Overview

This section of this final rule outlines changes to the Quality Payment Program starting January 1, 2026, except as otherwise noted for specific provisions. We continue to move the Quality Payment Program forward, including focusing more on alignment between the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APM) tracks of participation, alignment with broader CMS initiatives, and new options for clinicians to participate in more meaningful ways. We aim to achieve continuous improvement in the quality of health care services provided to Medicare beneficiaries and other patients through the MIPS and Advanced APMs for the CY 2026 performance period/2028 MIPS payment year.

Authorized by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, April 16, 2015), the Quality Payment Program is a value-based payment program, by which the Medicare program rewards clinicians who provide high-value, high-quality care to their patients in a cost-efficient manner. There are two ways for clinicians who provide services under the Medicare program to participate in the Quality Payment Program: MIPS and Advanced APMs. The statutory requirements for the Quality Payment Program are set forth in section 1848(q) and (r) of the Act for MIPS and section 1833(z) of the Act for Advanced APMs.

For the MIPS participation track, MIPS eligible clinicians (defined at Sec. 414.1305) \428\ are subject to a MIPS payment adjustment (positive, neutral, or negative) based on their performance in four performance categories: cost, quality, improvement activities, and Promoting Interoperability. We assess each MIPS eligible clinician's total performance according to established performance standards for the applicable measures and activities specified in each of these four performance categories during a performance period to compute a final composite performance score (a “final score” as defined at Sec. 414.1305). In calculating the final score, we must apply different weights for the four performance categories, subject to certain exceptions, as set forth in section 1848(q)(5) of the Act and at Sec. 414.1380. Unless we assign a different scoring weight under these exceptions, for the CY 2026 performance period/2028 MIPS payment year, the scoring weights are as follows: 30 percent for the quality performance category; 30 percent for the cost performance category; 25 percent for the Promoting Interoperability performance category; and 15 percent for the improvement activities performance category.

\428\ We note that the term MIPS eligible clinician is defined at Sec. 414.1305 as including a group of at least one MIPS eligible clinician billing under a single tax identification number. We refer readers to our policies governing group reporting and scoring under MIPS as set forth at Sec. 414.1310(e).

Once calculated, each MIPS eligible clinician's final score is compared to the performance threshold established in prior rulemaking for that performance period to calculate the MIPS payment adjustment factor as specified in section 1848(q)(6) of the Act, such that the MIPS eligible clinician will receive in the applicable MIPS payment year: (1) a positive adjustment, if their final score exceeds the performance threshold; (2) a neutral adjustment, if their final score meets the performance threshold; or (3) a negative adjustment, if their final score is below the performance threshold. In calculating the MIPS payment adjustment factor for a MIPS eligible clinician, CMS accounts for scaling factor and budget neutrality requirements, as further specified in section 1848(q)(6) of the Act. CMS then applies the MIPS payment adjustment factor to amounts otherwise paid under Medicare Part B for covered professional services for the MIPS eligible clinician for the applicable MIPS payment year such that their payments for such covered professional services are increased, decreased, or not adjusted based on the MIPS eligible clinician's final score relative to the performance threshold.

Section 1848(q) of the Act sets forth other requirements applicable to MIPS, including opportunities for feedback and targeted review and public reporting of MIPS eligible clinicians' performance. Section 1848(r) of the Act sets forth more specific requirements for development of measures for the cost performance category under MIPS.

For the Advanced APM track, if an eligible clinician participates in an Advanced APM and achieves Qualifying APM Participant (QP) or Partial QP status, they are excluded from the MIPS reporting requirements and payment adjustment (though eligible clinicians who are Partial QPs may elect to participate in MIPS and be subject to the MIPS reporting requirements and payment adjustment). Under current law, eligible clinicians who are QPs for the 2024 performance period and beyond will receive an increased physician fee schedule update of 0.75 percent based on the QP conversion factor in the corresponding payment year. QPs will continue to be excluded from MIPS reporting and payment adjustments for the applicable year. We note that, historically, QPs received a lump sum APM Incentive Payment in the corresponding payment year, calculated as a specified percentage of the QP's paid claims for covered professional services from the base year. Under current law, payment year 2026 is the last year for these payments. Only legislation enacted by Congress can make changes to either the enhanced QP conversion factor updates or the APM Incentive Payment.

Active participation (or engaged clinicians) in the Quality Payment Program's MIPS track is defined as MIPS eligible clinicians who submitted at least one measure, attestation, or activity, or had this data submitted on their behalf. The percent of active participation has increased slightly to 94.02 percent in the eighth year (CY 2024 performance period/2026 MIPS payment year), with 488,937 engaged

MIPS eligible clinicians out of 520,012 total MIPS eligible clinicians (defined as those who received a MIPS final score). In the CY 2023 performance period/2025 MIPS payment year, 93.97 percent of MIPS eligible clinicians actively participated in MIPS, with 508,790 engaged MIPS eligible clinicians out of 541,421 total MIPS eligible clinicians. Therefore, the active participation rate in MIPS increased slightly between the CY 2023 and CY 2024 performance periods. In addition, 87.37 percent of MIPS eligible clinicians will receive a positive payment adjustment for the 2026 MIPS payment year based on their performance in the CY 2024 performance period. Please note that results for the CY 2024 performance period/2026 MIPS payment year described herein are subject to change as a result of the targeted review process, which began on September 9, 2025, and concludes 30 days after the release of MIPS payment adjustments. For more information on the targeted review process for the CY 2024 performance period/2026 MIPS payment year, please see our targeted review guide at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/3264/2024-Targeted-Review-User-Guide.pdf.

Regarding performance in Advanced APMs, for the CY 2024 QP Performance Period, 528,827 eligible clinicians (TIN-NPIs) earned Qualifying APM Participant (QP) status, while another 2,013 eligible clinicians earned partial QP status.

We plan to continue developing policies for the Quality Payment Program that more effectively reward high-quality of care for patients and increase opportunities for Advanced APM participation. We continue to implement MIPS Value Pathways (MVPs) to allow for a more cohesive participation experience by connecting activities and measures from the four MIPS performance categories that are relevant to a specialty, medical condition, or a particular population.

As we move into the ninth year of the Quality Payment Program, we will be implementing the updates set forth in this section of this final rule, encouraging continued improvement in clinicians' performance with each performance year and driving improved quality of health care through payment policy. b. Summary of Major Proposals (1) Transforming the Quality Payment Program

We continue to align with broader CMS initiatives, such as the Universal Foundation (https://www.cms.gov/medicare/quality/cms-national-quality-strategy/aligning-quality-measures-across-cms-universal-foundation) in an effort to promote the highest quality outcomes and safest care for all individuals. The Universal Foundation focuses on provider attention, reducing burden, prioritizing development and movement toward interoperable digital quality measures, allowing for comparisons across CMS programs, and helping to identify measurement gaps.

We are implementing meaningful improvements designed to strengthen healthcare delivery and advance patient outcomes. Through these efforts, we strive to create a healthcare system that not only responds to chronic disease but works proactively to prevent it. In alignment with our goal of promoting preventive care and fostering a more proactive approach to health management, we are finalizing a new “Advancing Health and Wellness” subcategory within the improvement activities performance category. Through the policies described in this final rule, we intend to transform and simplify MIPS, promote the use of connected measures and activities, continue rewarding clinicians for providing high value care, and use data-driven information to help all clinicians improve care and engage patients.

Separately, we are expanding our portfolio of available MVPs for the CY 2026 performance period/2028 MIPS payment year and remain committed to our goal of ensuring more meaningful participation in the Quality Payment Program through MVPs. We revised the format of each MVP to categorize the quality measures by clinical conditions or episodes of care. The new format offers a streamlined set of quality measures to aid clinicians in selecting the most clinically relevant measures. While traditional MIPS continues to be a reporting option, we intend to end traditional MIPS in the future, at which point MVPs would become mandatory. That future date has not been determined and will be established through the official notice and comment rulemaking process. (a) Transforming MIPS: MVP Strategy

To support our goal of phasing out traditional MIPS and transitioning to MVP reporting, we are finalizing policies that will encourage increased participation from specialists. Our policies seek to specify which groups fall under the multispecialty subgroups requirement that begins in CY 2026 through self-attestation and to maintain flexibility for multispecialty small practices to report MVPs as groups. Specifically, we are finalizing updates to two MVP subgroup policies as follows: (1) update the MVP group registration process to add the specialty self-attestation requirement; and (2) maintain the MVP group reporting option for multispecialty groups with a small practice designation.

We also solicited feedback via three RFIs related to MVPs to address: (1) potential Core Elements MVP reporting requirements; and (2) functions utilizing Medicare procedural codes to further facilitate more MVP specialty reporting. Additionally, we solicited feedback on the future use of well-being and nutrition measures in the Quality Payment Program. We appreciate the feedback received on these requests for information which may inform future rulemaking. (b) MIPS Value Pathways Development and Maintenance

To continue moving the healthcare community toward value-based, high-quality, safe, and cost-efficient care, we are finalizing six new MVPs around the following topics: Diagnostic Radiology, Interventional Radiology, Neuropsychology, Pathology, Podiatry, and Vascular Surgery.

We are also finalizing MVP maintenance updates to our MVP inventory that are aligned with the MVP development criteria and take into consideration feedback from interested parties we have received through the maintenance process. Additionally, we updated the format of the MVP tables to stratify quality measures by clinical conditions and/or episodes of care for each MVP identified as “Clinical Groupings”.

Finally, we are finalizing our proposal to provide additional flexibilities to allow qualified clinical data registries (QCDRs) and qualified registries additional time to fully support finalized MVPs. Specifically, we are finalizing our proposal to sunset the current requirement and modify Sec. [thinsp]414.1400(b)(1)(ii) to state that QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data through CY 2025 performance period/2027 MIPS payment year. We are also finalizing our proposal to modify the requirement at Sec. [thinsp]414.1400(b)(1)(ii) to provide that, 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. We are finalizing our proposal to

retain the remaining language currently set forth at Sec. 414.1400(b)(1)(ii) without modification. (c) APM Performance Pathway

We are finalizing our proposal to update some quality measures in the APM Performance Pathway (APP), original quality measure set and the APP Plus quality measure set to reflect our proposed changes to measures specified for the quality performance category as discussed in section IV.A.4.b. of this final rule. (d) Fast Healthcare Interoperability Resources (FHIR) Request for Information

We want to engage interested parties, ahead of future policy decisions, on the timeline and measure development of FHIR-based eCQMs in quality reporting and payment programs. In this RFI, we provided updates on our activities since prior RFIs and solicited information from interested parties on a range of issues. We appreciate the feedback received on this RFI which may inform future rulemaking. (e) MIPS Quality Performance Category

For the CY 2026 performance period/2028 MIPS payment year, we are finalizing our proposal to establish a measure set inventory of 190 MIPS quality measures, of which 187 are available in traditional MIPS and three are available only for utilization in MVPs.

The proposed measure removals focus on process measures, measures reaching extremely topped-out status or the end of the topped-out measure lifecycle, measures no longer aligned with clinical guidelines and measures the steward would no longer maintain. The measure additions focus on measuring outcomes and increasing the number of eCQMs. Substantive changes to measures would ensure the measures included in MIPS continue to be meaningful and drive improvements in quality of care.

Additionally, as discussed in section IV.A.4.d.(1).(b). of this final rule, we are revising the definition of a “high priority measure” to remove health equity. (f) MIPS Cost Performance Category

We are finalizing our proposal to modify the Total Per Capita Cost (TPCC) measure beginning in the CY 2026 performance period/2028 MIPS payment year. We are also finalizing our proposal to update the operational list of care episodes and patient condition groups and codes to reflect coding changes identified through our annual maintenance process for MIPS cost measures. Lastly, we are finalizing our proposal to adopt a 2-year informational-only feedback period for new MIPS cost measures, which we are also codifying at Sec. [thinsp]414.1380(b)(2). (g) MIPS Improvement Activities Performance Category

We are finalizing the following updates to the MIPS Improvement Activity Inventory beginning with the CY 2026 performance period/2028 MIPS payment year. First, we are finalizing our proposal to add a new subcategory to the Improvement Activities performance category: Advancing Health and Wellness. Second, we are finalizing our proposal to remove the Achieving Health Equity subcategory. Third, we are finalizing our proposal to add three new improvement activities into two of our existing subcategories: (1) Population Management; and (2) Patient Safety and Practice Assessment. Fourth, we are finalizing our proposal to modify seven existing improvement activities currently specified for the performance category. Fifth, we are finalizing our proposal to remove eight improvement activities currently specified for the performance category. (h) MIPS Promoting Interoperability Performance Category

Beginning with the CY 2026 performance period/2028 MIPS payment year, we are finalizing several policies and measure updates for the MIPS Promoting Interoperability performance category. Specifically, for the MIPS Promoting Interoperability performance category, we are finalizing the following proposals as proposed:

Modification to the Security Risk Analysis measure;

Modification to the High Priority Practices Safety Assurance Factors for Electronic Health Record (EHR) Resilience (SAFER) Guide measure; and

Adoption of one new optional bonus measure, the Public Health Reporting Using Trusted Exchange Framework and Common Agreement\TM\ (TEFCA\TM\) measure.

Amendment to rectify an incongruency in regulation at Sec. 414.1380(b)(4)(ii)(C) to provide that, beginning with the CY 2026 performance period/2028 MIPS payment year, 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 five bonus points for the MIPS Promoting Interoperability performance category.

For the Promoting Interoperability Program and the MIPS Promoting Interoperability performance category, we are finalizing with modification the following proposals:

Adoption of a measure suppression policy beginning with the CY 2026 performance period/2028 MIPS payment year and the EHR reporting period in CY 2026 that will not assess the performance of a suppressed measure and will allow MIPS eligible clinicians, eligible hospitals, and CAHs to receive the maximum available points for a measure or full credit for a measure; and

Suppression of the Electronic Case Reporting measure for MIPS eligible clinicians for the CY 2025 performance period/2027 MIPS payment year and eligible hospitals and critical access hospitals for the EHR reporting period in CY 2025. MIPS eligible clinicians, eligible hospitals, and CAHs reporting the suppressed Electronic Case Reporting measure will be able to receive full credit for the measure under the Public Health and Clinical Data Exchange objective.

Additionally, in the CY 2026 PFS proposed rule (90 FR 32747 through 32751), we solicited public comment on the following RFIs:

Query of Prescription Drug Monitoring Program (PDMP) Measure;

RFI Regarding Performance-Based Measures; and

RFI Regarding Data Quality.

We appreciate the feedback received on these RFIs, which may inform future rulemaking. (i) MIPS Final Score Methodology (Scoring the Quality Performance Category)

We are finalizing our proposal to update our approach for identifying measures impacted by limited measure choice to apply the analysis and criteria finalized in the CY 2025 PFS final rule (89 FR 98432 and 98433) to MVPs, in addition to specialty measure sets. MVPs, similar to specialty measure sets, contain a limited set of quality measures for a clinician to choose from. We are also finalizing our proposed list of topped-out measures impacted by limited measure choice and subject to the defined topped-out measure benchmark for the CY 2026 performance period/2028 MIPS payment year.

Lastly, we are finalizing our proposal to modify the methodology for scoring the administrative claims-based measures within the quality performance category beginning with the 2025 performance period/2027 MIPS payment year. The modification to the administrative claims-based quality measure scoring methodology will be based on standard deviation, median,

and an achievement point value derived from the performance threshold. (j) MIPS Payment Adjustment

We are finalizing our proposal to continue using the CY 2017 performance period/2019 MIPS payment year to establish a performance threshold of 75 points for the CY 2026 performance period/2028 MIPS payment year through the CY 2028 performance period/2030 MIPS payment year. (k) Third Party Intermediaries

We are finalizing our proposal to codify at Sec. 414.1400(d)(9) a policy we previously finalized in the CY 2025 PFS final rule to require CMS-approved survey vendors to submit a range of the cost of their services with their application beginning with the CY 2026 performance period/2028 MIPS payment year (89 FR 98459 and 98460). We are also finalizing our proposal to codify at Sec. 414.1400(d)(3)(iv)(A) a policy previously finalized in the CY 2024 PFS final rule to require an entity to administer the CAHPS for MIPS Survey Spanish translation to Spanish-preferring patients (88 FR 79332 through 79334).

We are finalizing our proposal to require that, beginning with the CY 2027 performance period/2029 MIPS payment year, CMS-approved survey vendors would have to administer the CAHPS for MIPS Survey via a web- mail-phone protocol. We are finalizing our proposal to codify this requirement at Sec. 414.1400(d)(10). In addition, we are finalizing our proposal to modify the requirements at Sec. 414.1400(d)(3) for an entity applying to become a CMS-approved survey vendor to ensure the entity is capable of administering a web-mail-phone protocol prior to CMS approval. Lastly, we are finalizing our proposal to sunset one of the requirements to apply to become a CMS-approved survey vendor at Sec. 414.1400(d)(8). (2) Advanced APM Proposals

We are finalizing our proposal to modify the methodology we use to calculate QP status at Sec. 414.1425 to include an individual calculation for all eligible clinicians in Advanced APMs. Additionally, we are finalizing with modification, our proposal to use Covered Professional Services to identify beneficiaries, as described at Sec. 414.1305 to define Covered professional service attribution-eligible beneficiaries and evaluation and management (E/M) attribution eligible beneficiaries in our calculations for all Advanced APMs.

We are finalizing our proposal to sunset our Advanced APM criterion at Sec. 414.1415(c)(7), and Sec. 414.1420, which currently sets a limit on the number of clinicians belonging to an APM Entity participating in a Medical Home Model.

We are also finalizing our proposal to modify the language at Sec. 414.1455(b)(3)(ii) and Sec. 414.1455(b)(3)(vi) that establishes Targeted Review for QPs to ensure that the Targeted Review timeline described in such section is the same timeline as that established for MIPS Targeted Reviews specified at Sec. 414.1385(a)(2) and Sec. 414.1385(a)(5). 2. Definitions

At Sec. 414.1305, we are finalizing our proposals to revise definitions of the following terms:

High priority measure

Attribution-eligible beneficiary

Covered professional service attribution-eligible beneficiary

E/M attribution eligible beneficiary

Multispecialty group

MVP Participant

Single specialty group

These terms and definitions are discussed in detail in the relevant sections of this final rule. 3. Transforming the Quality Payment Program

Section 1848(q)(1)(D) of the Act requires that the Secretary establish and apply a process that includes features of the provisions of section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group practice reporting for the quality performance category and provides that the Secretary may establish such a process for the other three MIPS performance categories. Section 1848(q)(1)(D)(ii) of the Act requires that the process we establish and apply under section 1848(q)(1)(D)(i) of the Act, to the extent practicable, must reflect the range of items and services provided by the MIPS eligible clinicians within the group practice. In accordance with the statute, in the CY 2022 PFS final rule, we finalized the MIPS Value Pathways (MVP) reporting option for MIPS eligible clinicians beginning in the CY 2023 performance period/2025 MIPS payment year (86 FR 65392 through 65394). To support CMS' goal of phasing out traditional MIPS and transitioning to MVP reporting, we are finalizing policies that will enable groups to self-identify their specialty composition and submit MVP data that appropriately reflects the diverse range of services provided by the clinicians within the group. These policies would also help groups in assessing whether they would need to participate as subgroups, based on the scope of care provided by the clinicians within a group. Additionally, the subgroup policies will continue the voluntary subgroup participation option for multispecialty group practices that qualify as small practices. Additionally, we solicited feedback on developing a subset of key quality measures within MVPs to better enable comparison of clinician performance and emphasize measures that reflect the core of a specialty. We also solicited feedback on the consideration to identify Medicare Part B procedural billing codes that align with each MVP, and to encourage, or potentially require, specialists to report the relevant MVP based on their use of the procedural billing codes. a. Subgroup Reporting (1) Background

In the CY 2022 PFS final rule, we finalized the option for MIPS eligible clinicians to participate as subgroups for reporting MVPs beginning in the CY 2023 performance period/2025 MIPS payment year (86 FR 65392 through 65394). We refer readers to regulations at Sec. Sec. 414.1305, 414.1318, and 414.1365 and the CY 2022 PFS final rule (86 FR 65398 through 65405), the CY 2023 PFS final rule (87 FR 70038 through 70045), and the CY 2024 PFS final rule (88 FR 79323 through 79328) for additional details on previously finalized subgroup policies.

In the CY 2022 PFS final rule (86 FR 65392 through 65394), we finalized the definition of an MVP participant at Sec. 414.1305. Beginning with the CY 2023 performance period/2025 MIPS payment year, an 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. We also finalized at Sec. 414.1305 that, beginning with the CY 2026 performance period/2028 MIPS payment year, an MVP Participant means an individual MIPS eligible clinician, single- specialty group, subgroup, or APM Entity that is assessed on an MVP in accordance with Sec. 414.1365 for all MIPS performance categories (86 FR 65392 through 65394). We excluded “multispecialty group” from the MVP participant definition beginning with the CY 2026 performance period/2028 MIPS payment year and replaced the term with “subgroup” to account for the requirement for multispecialty groups to divide into subgroups if they choose to report MVPs.

Under the MVP Participant definition codified at Sec. 414.1305, multispecialty groups and single specialty groups may report as groups or choose to form subgroups to report MVPs for the CY 2023 performance period/2025 MIPS payment year through the CY 2025 performance period/ 2027 MIPS payment year. Beginning with the CY 2026 MIPS performance period/2028 MIPS payment year, multispecialty groups will no longer be able to report MVP as a single group. This will mean that if a multispecialty group would like to report an MVP, beginning with the CY 2026 MIPS performance period/2028 MIPS payment year, MIPS eligible clinicians in multispecialty groups must divide into and report as subgroup or report as an individual to report an MVP. Alternatively, MIPS eligible clinicians in multispecialty groups may continue to participate in traditional MIPS reporting. In the CY 2023 PFS final rule (87 FR 70038 through 70040), we finalized at Sec. 414.1305 the definitions of a single specialty group and a multispecialty group. Specifically, a single specialty group means a group as defined at Sec. 414.1305 consisting of one specialty type, as determined by CMS using Medicare Part B claims. A multispecialty group means a group as defined at Sec. 414.1305 consisting of two or more specialty types, as determined by CMS using Medicare Part B claims.

In the CY 2022 PFS final rule (86 FR 65415 through 65418), we also established a registration process at Sec. 414.1365(b) for clinicians who choose to participate in MVP reporting. Under this policy, an MVP participant must register between April 1 and November 30 of the applicable calendar year performance period, or a later date specified by CMS. An MVP participant that elects to report the CAHPS for MIPS Survey associated with an MVP must complete their registration by June 30 of the applicable performance period. Section 414.1365(b)(2)(i) further provides that the MVP participant must select an MVP they intend to report and may select an outcomes-based administrative claims measure if available in the selected MVP (86 FR 65416 through 65417). We refer readers to the CY 2022 PFS final rule (86 FR 65415 through 65418) for additional details on MVP and subgroup registration requirements.

In the CY 2026 PFS proposed rule (90 FR 32699 through 32701), we proposed to: (1) maintain the MVP group reporting option for multispecialty groups with a small practice designation; and (2) modify the MVP group registration process to add the self-attestation requirement. (2) Maintain the MVP Group Reporting Option for Small Practices

At Sec. 414.1305, beginning with the CY 2019 performance period/ 2021 MIPS payment year, we define a small practice to mean a TIN consisting of 15 or fewer eligible clinicians during the MIPS determination period. As discussed in section IV.A.3.a.(1) of this final rule, we previously finalized subgroup reporting requirements for multispecialty groups beginning in the CY 2026 performance period/2028 MIPS payment year (86 FR 39360). Under this policy, a multispecialty group designated as a small practice (with 15 or fewer eligible clinicians) will not be allowed to participate as a single group in MVP reporting. If clinicians in such groups would like to participate in MVP reporting, beginning in the CY 2026 performance period/2028 MIPS payment year, such groups will currently need to divide into subgroups. Alternatively, clinicians in these groups could participate as individuals in MVP reporting or continue to report at the group level in traditional MIPS reporting.

We acknowledged that, like large groups, small practices could be classified as a single specialty or multispecialty groups. However, we do not believe there are additional benefits to require a small practice of 15 or fewer clinicians to further divide into smaller subgroups as we anticipate that multiple subgroups within a small practice could choose to report the same set of measures within the same MVP. Historically, we have received feedback from MIPS eligible clinicians in small practices expressing concerns regarding the lack of adequate resources for these clinicians to meet MIPS reporting requirements. Additionally, we are concerned that requiring small practices to divide into smaller subgroups could negatively impact small practices as the subgroups may not meet the established case minimums for the quality measures in the selected MVP, resulting in lower scores. We recognize the challenges for small group practices to allocate the resources needed to administer quality reporting requirements. We are concerned that if we require multispecialty groups that qualify as small practices to divide and report as subgroups, these practices will avoid participating in MVP reporting and continue to participate in traditional MIPS reporting. Based on the 2022 Quality Payment Program Experience Report (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2817/2022ExperienceReport.pdf), there is a decrease in MIPS participation from clinicians in small practices from the CY 2021 performance period/2023 MIPS payment year to the CY 2022 performance period/2024 MIPS payment year. Given that we intend to sunset traditional MIPS in a future year, we want to adopt policies which would reduce barriers for small group practices to transition to MVP reporting. Therefore, it would be beneficial to continue the MVP group reporting option for small practices regardless of the specialty composition of the clinicians within the small practices.

For the above reasons, in the CY 2026 PFS proposed rule (90 FR 32698 through 32699) we proposed to modify the definition of an MVP participant at Sec. 414.1305 to provide that multispecialty groups that meet the requirements of a small practice may be MVP participants. Because multispecialty groups that meet the requirements of a small practice would meet the definition of an MVP participant, they would, unlike other multispecialty groups, be permitted to report an MVP as a single group. Specifically, we proposed to modify the definition of an MVP participant at Sec. 414.1305 to provide that, 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. Under this proposal, to utilize the MVP reporting option, a multispecialty group that meets the requirements of a small practice would not be required to divide and report as subgroups, although it could still do so if it chooses.

We solicited comments on the above proposal to modify the MVP participant definition at Sec. 414.1305 by adding the term “multispecialty group that meets the requirements of a small practice” to maintain the MVP group reporting option for groups with a small practice designation. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposal to revise the definition of an MVP participant allowing a multispecialty group that meets the requirements of a small practice to participate as a group in MVP reporting and stated their belief that it reduces the administrative burden on small practices while sustaining engagement in MVPs.

Response: We thank the commenters for their support.

Comment: Several commenters recommended extending the MVP group reporting flexibility available for multispecialty small practices to multispecialty groups with 16 or more clinicians. Specifically, the commenters suggested maintaining the MVP group reporting option for all multispecialty group practices. The commenters expressed concern that the challenges related to subgroup participation, such as increased reporting burden and difficulties in meeting the case minimums for quality measures exist for all multispecialty group practices, regardless of the group size.

Response: We appreciate the commenters' recommendation to extend the MVP group reporting flexibility to multispecialty group practices of all sizes and not just multispecialty small practices. We implemented subgroup reporting for MVPs based on consistent feedback received from multispecialty group practices recommending we offer a participation option for a multispecialty group practice to report MIPS measures and activities that comprehensively capture the diverse range of services provided by the clinicians in a group. While we are certain that the increased reporting associated with required subgroups will be beneficial to the public by allowing more reporting on specialists in multispecialty practices, we recognize the need to balance that against administrative burden for smaller practices with limited resources. We have previously adopted similar flexibilities exclusively for small practices, such as bonus points and reduced reporting requirements for small practices participating in MIPS due to limited resources and infrastructure support for clinicians in these practices. We anticipate that multispecialty group practices that do not meet the requirements of small practices may have the ability to select an MVP with relevant quality measures due to the expanded range of services provided by the clinicians within the group which would allow them to meet case minimums. Additionally, we anticipate that clinicians in multispecialty groups that do not qualify as a small practice would benefit from participating as subgroups as it allows clinicians involved in multiple foci of care to report on the measures relevant to the scope of care provided. We refer readers to the CY 2022 PFS final rule (86 FR 65392 through 65394) for additional details on the discussion regarding the previously finalized MVP participant definition.

Comment: A commenter recommended CMS continue offering support for small practices and ensuring that the requirement excluding small practices does not impact the overall performance of small practices participating in MVP reporting. Another commenter requested CMS to monitor the implementation of this policy to ensure that it achieves its intended purpose of reducing reporting burden without compromising the validity of performance measurement.

Response: Under the proposed policy, multispecialty groups that qualify as small practices may continue to use the MVP group reporting option and may choose to participate as subgroups. As a result, we expect multispecialty small practices to choose their participation options, as an individual, group, or subgroup, in MVP reporting to align with their practice needs. Therefore, we do not anticipate negative impacts on MVP scores for small practices because of this policy. Clinicians may also seek support via the Quality Payment Program Help Desk at [email protected]. We will continue to monitor the effects of this policy on small practices for any unintended consequences and will provide additional support as needed.

After consideration of public comments, we are finalizing to modify the definition of an MVP participant at Sec. 414.1305 as proposed to provide that, 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. Under this policy, to utilize the MVP reporting option, a multispecialty group that meets the requirements of a small practice would not be required to divide and report as subgroups, although it could still do so if it chooses. (3) Update the MVP Group Registration Process

Beginning in the CY 2026 performance period/2028 MIPS payment year, to implement the subgroup reporting requirement for multispecialty groups as previously discussed, we would need to determine the specialty composition of a group as a single specialty or multispecialty group as defined at Sec. 414.1305. Currently in the Quality Payment Program, we assign specialty type for MIPS eligible clinicians at the individual clinician (or TIN-NPI) level and not collectively at the group (or TIN) level. As discussed in the CY 2023 PFS final rule (87 FR 70039), we currently use the Medicare Provider Enrollment, Chain, and Ownership System (PECOS) and Medicare Part B claims data to identify clinician specialty for different purposes. For public reporting purposes, we rely on PECOS as the primary data source, and for purposes of MIPS eligibility determination, we use both PECOS and claims data. Additionally, we use the information on claims to identify clinician specialty when attributing some of the measures in the cost and quality performance categories.

As discussed above in section IV.A.3.a.(1) of this final rule, we finalized at Sec. 414.1305 in the CY 2023 PFS final rule (87 FR 70038 through 70040) the definition of a single specialty group as a group consisting of one specialty type, and the definition of a multispecialty group as a group consisting of two or more specialty types, as determined by CMS using Medicare Part B claims. In the CY 2023 PFS final rule (87 FR 70039 through 70040), we received mixed feedback from commenters on the proposal to utilize claims data for identifying specialty composition of a group. Many were concerned that the specialty information indicated on Medicare Part B claims is not an accurate representation of the actual care provided by the various clinicians in a multispecialty group. A few commenters recommended the use of a specialty attestation process during subgroup registration instead of using the claims data. In responding to the comments received regarding the recommendation to consider a specialty attestation process, we explained our intent was to provide group specialty designations either as a single specialty or multispecialty group in advance of the MVP registration process, allowing group practices to make changes in their administrative workflows accordingly (87 FR70040).

To operationalize the previously finalized definitions of a single specialty and multispecialty group and to implement the previously finalized CY 2026 subgroup reporting requirement for multispecialty group practices, we considered utilizing claims data to assign these specialty designations to group practices. After further analyzing the claims data, we recognize and agree there are additional nuances to consider in using the claims analysis to accurately identify the specialty composition of a group.

For example, the claims data may not reflect the care provided by certain clinician types in a group, such as nurse practitioners (NPs), and physician assistants (PAs). The NPs and PAs that

are part of group practices could be involved in more than one clinical focus and the specialty information on claims for these clinicians reflects their educational credentials rather than the type of care provided.

We recognize there could be instances when a group practice consists of clinicians across multiple specialty types but provides care in a single clinical area. We are also concerned that using the individual clinician (or NPI) level specialty code information available from the claims data to collectively designate a group as either a single specialty or multispecialty would inadvertently misrepresent the specialty composition of a group because of the way clinician specialty is reflected on claims. For example, claims data would indicate that a group practice, focused on providing cardiovascular care for patients and consisting of internists, cardiologists, NPs, and PAs, meets our definition of a multispecialty group. If we use claims data to implement the previously finalized definitions of single specialty and multispecialty groups, this group providing cardiovascular care would be designated as a multispecialty group and will be required to form subgroups for reporting an MVP beginning in the CY 2026 performance period/2028 MIPS payment year. Given the single clinical focus of care provided by all the clinicians in such group practice, we anticipate the multiple subgroups within such group would choose to report the measures and activities in the Advancing Care for Heart Disease MVP, resulting in redundant data submissions. In such instances, we acknowledge utilizing the claims data would result in CMS incorrectly identifying a group's specialty composition as a single specialty or a multispecialty group.

Additionally, we acknowledged that the composition of groups may not be constant due to several factors unrelated to MVP policies (for example, clinician turnover and acquisitions or consolidation of practices). In instances when the overall composition of a group changes due to clinician turnover, consolidation of practices, or other reasons, the specialty designations provided by CMS may not fully capture the changes in the group composition during a performance period. Therefore, we are unable to utilize the claims data at this time to evaluate the specialty composition of a group or to designate a group practice as either a single specialty or a multispecialty group. We recognize we need to conduct a thorough analysis of the claims data to pursue an effective and sophisticated approach for assessing the feasibility of appropriately assigning specialty designations to groups. Please see our discussion in section IV.A.3.c. of this final rule for language associated with the Medicare Procedural Codes Request for Information (RFI), where we discuss potential alternative approaches for utilizing Medicare Part B claims to identify clinician specialties within a group for considering policies encouraging MIPS eligible clinicians to report an MVP aligned with the scope of care provided.

In lieu of using the claims data for designating a group as either a single specialty or a multispecialty group, we proposed that to report an MVP, a group practice which is either a single-specialty group or a multispecialty group that meets the requirements of a small practice, would be required to attest to its designation as a group that meets the requirements of a single specialty group, or a multispecialty group that meets the requirements of a small practice, respectively. We noted that we did not propose the self-attestation requirement for subgroups because under the current policy at Sec. 414.1365(b), subgroup registration is an additional step in the MVP registration process for multispecialty groups choosing to report an MVP. We refer readers to the CY 2022 and CY 2023 PFS final rules (86 FR 65415 through 65418 and 87 FR 70040 through 70041) for previously finalized MVP subgroup registration requirements.

In the CY 2026 PFS proposed rule (90 FR 32699 through 32700), we proposed to expand the definition of MVP Participant to include multispecialty groups meeting the requirements of small practices. Under this proposal, a multispecialty group practice consisting of 15 or fewer clinicians that chooses to report an MVP would be exempt from the requirement to participate as subgroups. For a group practice consisting of 16 or more clinicians, and the clinicians within the group are involved in a single focus of care, we anticipated the group practice will attest as a single specialty group and register as a single group for MVP reporting. If a group practice consists of 16 or more clinicians and the clinicians within the group are involved in multiple foci of care, the group practice cannot register for MVP reporting as a single group. MIPS eligible clinicians in such groups would need to divide into subgroups or if applicable, participate as individuals for reporting an MVP.

To align with the proposed self-attestation process during MVP registration as a mechanism for identifying the group specialty composition, we proposed modifying the definitions of a single specialty group and a multispecialty group. These proposed updates and the self-attestation requirement for groups participating in MVP reporting would enable group practices to assess their need for participation as subgroups based on the scope of care provided by the clinicians within the group. Additionally, the proposed updates would allow either a single-specialty group or a multispecialty group that meets the requirements of a small practice to self-identify themselves and report the MVP as a single group. This proposed process would also alleviate the concerns associated with determining a group's specialty composition due to inaccurate representation of the clinician specialty information on the claims data.

For the above reasons, to implement the previously finalized subgroup reporting requirement for multispecialty group practices beginning with CY 2026 performance period/2028 MIPS payment year and to operationalize the definitions of a single specialty and multispecialty group, in the CY 2026 PFS proposed rule (90 FR 32698 and 32699), we proposed updates to the previously finalized MVP registration process to include the addition of a self-attestation process for groups to identify themselves as either a single specialty group or a multispecialty group that meets the requirements of a small practice. Specifically, we proposed that, beginning with the CY 2026 performance period/2028 MIPS payment year, a group practice registering for MVP reporting that intends to participate as a single group will need to attest either as a single specialty group or a multispecialty group that meets the requirements of a small practice during MVP registration.

In the CY 2026 PFS proposed rule (90 FR 32701), we proposed to codify the proposal at Sec. 414.1365(b)(2)(iv), providing that, 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. As previously discussed, in this section of the final rule, we are unable to utilize claims data for designating a group as either a single specialty group or a multispecialty group. Therefore, we proposed to make conforming changes and revise the current definitions of a single specialty group and a multispecialty group at Sec. 414.1305. We proposed to revise the definition of a single specialty group at Sec. 414.1305 to mean a group that consists

of clinicians in one specialty type or clinicians involved in a single focus of care. We proposed to revise the definition of a multispecialty group at Sec. 414.1305 to mean a group that consists of clinicians in two or more specialty types or clinicians involved in multiple foci of care.

We solicited public comments on the proposal to update the MVP group registration by adding a self-attestation requirement. We also solicited comments on conforming proposals to update the definitions of a single specialty group and a multispecialty group. We refer readers to section V.B.5.c.(6).(b). of this final rule for discussion on the burden estimates for these proposals. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposed modification to the MVP group registration process, which would allow group practices to self-attest to their specialty composition and align MVP reporting accordingly. The commenters appreciated CMS acknowledging the limitations of utilizing PECOS and Medicare Part B claims data to designate a group as either a single specialty or a small multi- specialty group. Several commenters believe that the proposal promotes flexibility and reduces administrative burdens while enabling practices to more accurately represent their care delivery structure.

Response: We thank the commenters for their support.

Comment: A commenter recommended CMS implement the self-attestation process for groups of all sizes, and not just multispecialty groups that meet the requirements of a small practice, noting concerns that lack of a self-attestation process would require a multispecialty group to further divide into subgroups.

Response: We acknowledge the commenter's concern regarding implementing the self-attestation requirement only for multispecialty groups that meet the requirements of a small practice. We would like to clarify that the self-attestation process would be available for group practices of all sizes to self-identify whether they are considered as a single specialty or a multispecialty group. Under this policy finalized in section XX of this final rule, only group practices that attest as a single specialty group may register as a single group for reporting an MVP. Groups with 16 or more clinicians (that are not small practices) that do not attest as a single specialty group would be considered as a multispecialty group and would not be allowed to register as a single group for reporting an MVP. Such groups choosing to report an MVP would need to divide into subgroups or participate as individuals.

Comment: A few commenters recommended CMS implement additional safeguards for the specialty self-attestation process to avoid inaccurate specialty attestations and provide additional guidance on auditing and validating group self-attestation statements.

Response: We appreciate the commenters' recommendations to implement additional safeguards to prevent inaccurate use of the self- attestation process and to clarify auditing and validation requirements. We expect group practices to use the self-attestation process to accurately identify a group's specialty composition to the extent feasible. We also note that we will apply the existing data validation and auditing requirements described under Sec. 414.1390 for auditing subgroups. We will also continue to monitor the use of the self-attestation process by groups and as needed, provide additional guidance specific to auditing and validating subgroups in the future.

Comment: A commenter recommended that in addition to the self- attestation process, CMS also consider specialty volume within a group practice that self-attests as a multispecialty group, allowing the group to report the MVP relevant to the predominant specialty instead of dividing into subgroups.

Response: We appreciate the commenter's recommendation to consider specialty volume within a group practice that self-attests as a multispecialty group and to allow group reporting of the MVP relevant to the predominant specialty. Under the proposed self-attestation process, a group consisting of clinicians across multiple specialty types would only need to attest as either a single specialty or a multispecialty group. We do not require groups attesting as a single specialty or a multispecialty to provide details on individual clinician specialties. Identifying the predominant specialty volume would require groups to submit additional information, such as clinician specialty type and the clinical area of care, which would increase the burden and complexity of the self-attestation process. Furthermore, the predominant specialty volume within a group practice may fluctuate due to changes in the groups' composition as a result of clinician turnover or practice mergers. We have not implemented stringent restrictions on the composition of a subgroup, allowing group practices to organize clinicians into subgroups based on the scope of care provided. For example, a multispecialty cardiology group practice, consisting of cardiologists and internists in which majority of the clinicians are cardiologists. The cardiologists in this group could form one subgroup to report the Advancing Care for Heart Disease MVP, while the internists could form a second subgroup or report as individuals.

Comment: A commenter did not support the proposed self-attestation process and stated their belief that it would increase administrative burden for clinicians and vendors.

Response: We acknowledge the commenter's concerns regarding the administrative burden for clinicians and vendors associated with the proposed addition of the self-attestation requirement to the MVP group registration process. The self-attestation process will only require a multispecialty group practice to select whether they consider their group to be a single specialty group or a multispecialty group, adding no additional burden to the existing estimated burden for MVP registration. We refer readers to section XX of this final rule for additional details on the burden related to MVP registration. Furthermore, for multispecialty groups providing a single focus of care, the addition of self-attestation requirement will allow such groups to report an MVP as a group instead of dividing into subgroups.

Comment: Many commenters supported the proposed changes to the definitions of a single specialty and a multispecialty.

Response: We thank the commenters for their support.

Comment: Many commenters urged CMS to further clarify the proposed definitions and more accurately capture the intent of the proposal, ensuring the definitions are mutually exclusive and emphasizing the differences in the focus of care, thus ensuring multispecialty groups with a single focus of care would not need to form subgroups for reporting an MVP. Specifically, several commenters recommended that CMS make modifications to the proposed definitions to more accurately capture the emphasis on the focus of care rather than the distinct number of specialty types within a group. A few commenters requested CMS to issue subregulatory guidance for assisting group practices to apply the definitions during the self-attestation process.

Response: We appreciate the commenters' support for the proposed definitions of a single specialty and

multispecialty group. We acknowledge the recommendations to further clarify the proposed definitions by emphasizing the focus of care provided by the clinicians in a group practice rather than the number of specialty type. We note that the intent of the proposed definitions is to emphasize the focus of care provided by the clinicians within a group, rather than the number of distinct specialty types. To further clarify, a group composed of clinicians with a single specialty type would attest as a single specialty group. Alternatively, a group with clinicians in two or more specialty types, who share a single focus of care, and not involved in multiple foci of care, would attest as a single specialty group and collectively participate as a group in MVP reporting. We will consider the commenters' recommendation to provide subregulatory guidance to assist group practices to apply these definitions and appropriately identify their specialty composition. We will include additional guidance in educational resources and materials shared with clinicians and other interested parties participating in MVP reporting to further clarify the relevance of these to MVPs.

After consideration of public comments, we are finalizing the proposal at Sec. 414.1365(b)(2)(iv) without modification, providing that, 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. We are also finalizing the proposed conforming changes to revise the current definitions of a single specialty group and a multispecialty group at Sec. 414.1305. We are finalizing, as proposed, to revise the definition of a single specialty group at Sec. 414.1305 to mean a group that consists of clinicians in one specialty type or clinicians involved in a single focus of care. We are also finalizing, as proposed, to revise the definition of a multispecialty group at Sec. 414.1305 to mean a group that consists of clinicians in two or more specialty types or clinicians involved in multiple foci of care. b. Core Elements Request for Information (RFI)

One of the goals of the transition from traditional MIPS to MVPs is to provide patients with comparative clinician performance data to make better assessments of the care provided to patients by requiring clinicians within an MVP to report on the same group of measures. While MVPs were designed to reduce the burden of measure selection by narrowing the scope of large, unaligned inventories, some MVPs still have a large selection of measures to accommodate the variety of clinicians who may choose to report that MVP. The MVPs finalized for the CY 2025 performance period/2027 MIPS payment year contain an average of 14 quality measures for MVP Participants to select from, ranging from 8 to 24 quality measures in each MVP (89 FR 98972 through 99056). Given this degree of measure volume, we are concerned that MVP reporting may not produce sufficient comparative performance data on standardized measures to support patient choice of care.

We considered policies to ensure more direct comparability by requiring the reporting of a subset of measures within an MVP that are meaningful for clinicians and patients. In the CY 2026 PFS proposed rule (90 FR 32701 and 32702) we issued an RFI to solicit feedback on a policy to require an MVP Participant to report one of the four required quality measure from a subset of quality measures in each MVP, referred to as “Core Elements,” that reflect care that is at the crux of the MVP's applicable specialty, medical condition, or episode of care. Specifically, we requested feedback on alternative approaches to achieving the goals of the Core Elements policy, the ideal number of Core Elements in an MVP, appropriate measures and collection types for Core Elements, the timeline for proposing the Core Elements policy, and potential implications for MVP reporting. Please note, this was an RFI only. We appreciate the feedback we received in response to this comment solicitation. We may consider this information to inform future rulemaking. c. Medicare Procedural Codes Request for Information (RFI)

In the CY 2022 PFS final rule (86 FR 65392 through 65394), we finalized the MVP reporting option for MIPS eligible clinicians beginning in the CY 2023 performance period/2025 MIPS payment year. To advance our goal of phasing out traditional MIPS and fully transitioning to MVP reporting, we continue to develop and maintain MVPs that are meaningful and relevant to the clinicians currently participating in MIPS. For the CY 2025 performance period, there are 21 MVPs available, covering the services provided by a wide range of clinician specialty types. Based on internal data, we received over 2,000 MVP registrations (including groups, individual clinicians, and subgroups) for the CY 2024 performance period/2026 MIPS payment year. Exploring approaches to utilize Medicare procedural billing codes for appropriately identifying MVPs relevant to a clinician specialty type could further increase MVP participation, ensure that clinicians report an MVP that is relevant to their scope of care to make performance measurements more clinically relevant for specialists, and inform patient choice of care with meaningful and comparative clinician performance data.

In the CY 2026 PFS proposed rule (90 FR 32702 and 32703) we issued an RFI to solicit feedback on encouraging and potentially requiring specialists to report a relevant MVP based on their use of procedural billing codes from Medicare Part B claims data. Specifically, we solicited feedback on alternative approaches to encourage specialty reporting of relevant MVPs, the appropriate data sources, volume threshold, and determination period to assign clinicians to an MVP, and clinician readiness to report an MVP assigned according to Medicare Part B claims data. Please note, this was an RFI only. We appreciate the feedback we received in response to this comment solicitation. We may consider this information to inform future rulemaking. d. Well-Being and Nutrition Measures Request for Information (RFI)

In the CY 2026 PFS proposed rule (90 FR 32703) we issued an RFI to solicit input on well-being and nutrition measures for future years in the QPP. Well-being is a comprehensive approach to disease prevention and health promotion, as it integrates mental and physical health while emphasizing preventative care to proactively address potential health issues.\429\ This comprehensive approach emphasizes person-centered care by promoting the well-being of patients and family members. Specifically, we solicited comments on tools and measures that assess overall health, happiness, and satisfaction in life that could include aspects of emotional well-being, social connections, purpose, and fulfillment; the applicability of tools and constructs that assess the integration of complementary and integrative health, skill building, and self-care; and relevant aspects of well-being for the Quality Payment Program. Please note, this was an RFI only. We appreciate the feedback we received in response to this comment solicitation. We may consider

this information to inform future rulemaking.

\429\ Well-Being Concepts. (2017). CDC Archives. Available at: https://www.naspa.org/images/uploads/kcs/WHPL_Canon_WB_WellBeing_Concepts___HRQOL___CDC_2017.pdf.

4. QPP Reporting and Data Submission a. CY 2026 MVP Development and Maintenance (1) Development of New MIPS Value Pathways (MVPs)

In the CY 2023 PFS final rule (87 FR 70035 through 70037), we finalized modifications to the MVP development process to broaden opportunities for the general public to provide feedback on new candidate MVPs prior to the notice and comment rulemaking process. We refer readers to the Quality Payment Program website to review the public feedback we received for each 2026 MVP candidate (https://qpp.cms.gov/mips/candidate-feedback).

Through our development processes for new MVPs (85 FR 84849 through 84856; 87 FR 70035 through 70037), we aim to gradually develop new MVPs that are relevant and meaningful for MIPS eligible clinicians. In the CY 2026 PFS proposed rule (90 FR 33182 through 33204), we proposed adopting the following six new MVPs:

Diagnostic Radiology;

Interventional Radiology;

Neuropsychology;

Pathology;

Podiatry; and

Vascular Surgery.

We refer readers to Appendix 3: MVP Inventory, of this final rule for discussion of the proposed new MVPs, the public comments received, and our responses.

We continue to encourage interested parties to utilize our established pre-rulemaking processes to develop and submit candidate quality and cost measures relevant to their specialty. Furthermore, we continue to develop MVPs based on needs and priorities, as described in the MVP Needs and Priorities document (https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1803/MIPS%20Value%20Pathways%20(MVPs)%20Development%20Resources.zip). (2) MVP Maintenance Updates to Previously Finalized MVPs

Between the CY 2022 PFS final rule (86 FR 65998 through 66031) and the CY 2023 PFS final rule (87 FR 70037), we finalized the following 12 MVPs to be available for reporting beginning with the CY 2023 performance period/2025 MIPS payment year:

Adopting Best Practices and Promoting Patient Safety within Emergency Medicine;

Advancing Cancer Care;

Advancing Care for Heart Disease;

Advancing Rheumatology Patient Care;

Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes;

Improving Care for Lower Extremity Joint Repair;

Optimizing Chronic Disease Management;

Optimal Care for Kidney Health;

Optimal Care for Neurological Conditions;

Patient Safety and Support of Positive Experiences with Anesthesia;

Promoting Wellness; and

Supportive Care for Cognitive-Based Neurological Conditions.

In the CY 2024 PFS final rule (88 FR 79978 through 80047), we consolidated Promoting Wellness and Optimizing Chronic Disease Management MVPs into a single primary care MVP titled “Value in Primary Care MVP” as well as finalized the following five additional MVPs to be available for reporting beginning with the CY 2024 performance period/2026 MIPS payment year:

Focusing on Women's Health;

Prevention and Treatment of Infectious Disorders Including Hepatitis C and Human Immunodeficiency Virus (HIV);

Quality Care for the Treatment of Ear, Nose, and Throat Disorders;

Quality Care in Mental Health and Substance Use Disorder; and

Rehabilitative Support for Musculoskeletal Care.

In the CY 2025 PFS final rule (88 FR 79978 through 80047), we consolidated Optimal Care for Patients with Episodic Neurological Conditions and the Supportive Care for Neurodegenerative Conditions MVPs into a single neurological MVP titled “Quality Care for Patients with Neurological Conditions MVP” as well as finalized the following six additional MVPs to be available for reporting beginning with the CY 2025 performance period/2027 MIPS payment year:

Complete Ophthalmologic Care;

Dermatological Care;

Gastroenterology Care;

Pulmonology Care; and

Surgical Care.

In the CY 2026 PFS proposed rule (90 FR 33205 through 33257), we proposed modifications to all 21 previously finalized MVPs with the addition and removal of measures and improvement activities based on the MVP development criteria we previously established (85 FR 84849 through 84854). Through these modifications, we can expand upon the clinical concepts, advance health and wellness, address maintenance requests from the public, and remove measures and activities that would either be finalized for removal from their respective MIPS Inventory or replaced by more robust measures or activities.

Additionally, we updated the format of the MVP tables to stratify quality measures by clinical conditions and/or episodes of care for each MVP. The new format does not change the measures and activities included in the MVP. It is intended to provide a more user-friendly format for MIPS eligible clinicians when choosing the measures and activities most applicable to their practice.

We received public comments on these updates. The following is a summary of the comments we received and our responses.

Comment: A commenter expressed concerns about the inconsistent inclusion of the “advancing health and wellness” and “experience of care” clinical groupings in MVPs and noted the rule did not clearly explain how these determinations were made.

Response: We updated the format of the MVP tables to stratify quality measures by clinical conditions and/or episodes of care for each MVP to provide a more user-friendly format for MIPS eligible clinicians when choosing the measures and activities most applicable to their practice. As there are no reporting requirements based upon clinical groupings, the methodology for determining the structure and inclusion of each grouping was not explicitly stated. The Advancing Health and Wellness clinical grouping represents an administration priority that should be in the forefront of all care. These measures represent broadly applicable concepts that would be relevant to all clinicians who may report the MVP and are important for the overall health and wellbeing of each patient. The Experience of Care bucket includes measures representing broadly applicable assessments capturing the patient voice, experience of care, and/or shared decision making that would be relevant to all clinicians who may report the MVP. Both the Advancing Health and Wellness and Experience of Care clinical groupings contain measures that, due to their broadly applicable nature, could be included in other clinical groupings within the MVP. However, for clarity, we chose to list each measure once using the clinical grouping that was the most appropriate based upon different factors, such as the MVP topic, targeted specialties/subspecialties, denominator eligible patient populations, and purpose of measure inclusion.

In addition, we received public comments on the proposed maintenance updates to previously finalized MVPs. We refer readers to Appendix 3: MVP Inventory of this final rule for the proposed modifications to the previously finalized MVPs, the public comments received, and our responses. We also refer readers to section V.B.5.c.(6)(a) of this final rule for discussion on the burden estimates for these proposals. (3) Third Party Intermediaries Support of MVPs

We refer readers to our regulation at Sec. 414.1400 and section IV.B.4. of this final rule for more detailed discussion regarding our previously finalized requirements for third party intermediaries to submit data on behalf of MIPS eligible clinicians for certain MIPS performance categories. In the CY 2022 PFS final rule (86 FR 65542 through 65544), we finalized a new requirement at Sec. [thinsp]414.1400(b)(1)(ii) to state that, beginning with the CY 2023 performance period/2025 MIPS payment year, qualified clinical data registries (QCDRs) and qualified registries (as these terms are defined at Sec. 414.1305) must support MVPs that are applicable to the MVP participants on whose behalf they submit MIPS data. This regulatory provision does not specifically address by when the QCDRs and qualified registries must support the MVPs. However, since finalizing this policy in the CY 2022 PFS final rule, QCDRs and qualified registries have been expected to be ready to support each newly finalized MVP that are applicable to their MIPS eligible clinicians for the first year of the MVP's implementation.

We acknowledged that some QCDRs and qualified registries may have difficulties programming new measures and preparing their systems to support MVP reporting within the brief timeframe from when we typically issue the PFS final rule and its effective date, which only allows 2 months for implementation (typically from November of 1 year to January of the next year). We heard concerns from QCDRs and qualified registries regarding feasibility of meeting this requirement at Sec. 414.1400(b)(1)(ii), such as the cost of implementing registry measures and working with other parties who may charge for QCDR measure use. QCDRs and qualified registries that are not ready to support applicable MVPs risk termination as they would not be in compliance with the requirement to support all applicable MVPs. Withdrawal and termination would also result in the removal of QCDR measures implemented in MIPS.

On these bases, in the CY 2026 PFS proposed rule (90 FR 32704 through 32705), we proposed to modify the language currently set forth at Sec. 414.1400(b)(1)(ii). As discussed previously, Sec. 414.1400(b)(1)(ii) currently provides that, beginning with the CY 2023 performance period/2025 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. We proposed to modify Sec. [thinsp]414.1400(b)(1)(ii) to provide that, 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. We also proposed to sunset the current requirement as of the end of the CY 2025 performance period/2027 MIPS payment year. We proposed to retain the remaining language currently set forth at Sec. 414.1400(b)(1)(ii) without modification.

This proposed modification will provide QCDRs and qualified registries with 1 year following the effective date of the final rule for programming and system preparation for MVP reporting success and reduce potential of withdrawal or termination.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposal to provide additional time for QCDRs and qualified registries to implement and fully support new MVPs. Commenters appreciated CMS' recognition of some of the technical and logistical challenges involved in adapting systems to support new reporting requirements and stated their belief that this delay will allow for improved implementation. A commenter recommended that CMS urge QCDRs and qualified registries not to use this extended timeline to delay, but rather to complete any necessary modifications by the earliest practicable convenience. The commenter believes this would allow MIPS participants to utilize these reporting methods as soon as available, as well as make completion, testing, and usability likely to be complete before the 1-year mark.

Response: We thank commenters for their support and feedback.

Comment: Several commenters urged CMS to adopt a minimum 24-month timeframe for QCDRs, qualified registries, and certified EHRs to fully support new MVPs, citing the need for sufficient development, testing, certification, and deployment, in addition to allowing clinicians time to engage and onboard with intermediaries. A commenter believes a timeframe less than 24 months increases the likelihood of fragmented implementations, higher costs, and unintended disruptions to clinicians, all which oppose CMS' broader goals of reducing provider burden and supporting safe, effective clinical decision-making. Another commenter indicated that many intermediaries do not support all MVPs, forcing practices to engage multiple intermediaries, which increases costs, resource demands, and coordination challenges due to differing data submission processes and reporting formats.

Response: A 12-month timeframe should be sufficient time for development, testing, certification, and deployment, in addition to allowing clinicians time to engage and onboard with intermediaries. Each MVP goes through a multi-year process before inclusion within MIPS, during which time QCDRs, qualified registries, and certified EHRs can begin planning based on applicability. In addition, MVP candidates are posted for public comment a year prior to being finalized within MIPS. As specified in the CY 2022 PFS final rule (86 FR 65542 through 65544) and codified at Sec. [thinsp]414.1400(b)(1)(ii), all intermediaries are required to support the MVPs applicable to their users, which should decrease the need to engage multiple intermediaries.

Comment: A few commenters were concerned about the current requirement for third party intermediaries to support all measures within an MVP. A commenter believes it should be up to the QCDR to determine which MVPs and quality measures they plan to support. Another commenter requested clarification on whether QCDRs and qualified registries must support MVP measures that are general in nature rather than specialty-specific. This commenter stated that requiring support for such “generic” measures would impose unnecessary burden without meaningful benefit, and recommended flexibility for QCDRs and qualified registries to determine whether broadly applicable measures add value for their clinicians. Similarly, other commenters stated concerns about supporting non-specialty-specific measures within MVPs, with a commenter recommending exemptions or opt-outs for registries unable to support certain measures. In addition, a

few commenters requested that each MVP include at least four measures per collection type to reduce development costs, lower physician burden, and still maintain measure variety and relevance.

In contrast, a few commenters recommended stronger requirements, stating that a loophole currently allows intermediaries to bypass the expectation of supporting all MVP measures if they do not collect data for a given measure through the exceptions. The commenters believe this undermined the integrity of MVP reporting and created inconsistencies in clinician access to measures, and recommended CMS consider requiring documented justification for exceptions. The commenters also noted that many EHR vendors lack support for key data elements required by MIPS measures, preventing clinicians from selecting certain measures.

Response: We will take the suggestions into consideration. To clarify, we do not assign specific MVPs to third party intermediaries. The third party intermediaries should identify and support MVPs that are relevant and applicable to the clinicians and groups they support. We expect that QCDRs and qualified registries who support MVPs will support all measures and activities that are included in the MVP as required at Sec. 414.1400(b)(1)(ii). We acknowledge that broadly applicable measures may not always be the most meaningful measures to report for a specific clinician. However, we have to account for MIPS eligible clinicians with narrowed scopes of care or case-mix, which makes it difficult for them to meet the four measure requirement for MVP reporting when there are no broadly applicable measures available. This may be due to insufficient denominator eligible cases or that the quality action being assessed is not within their scope of care; therefore, the specialized measures may not be applicable or appropriate for them to report. We include broadly applicable measures to ensure these clinicians can still meet MVP reporting requirements. In addition, there are clinical concepts that are important regardless of specialty and these measures allow for the capture of those for comparison across multiple specialties. We require that all measures within an MVP are available for reporting to ensure clinician choice, MVPs are being implemented as consistently as possible, and measure adoption is not hindered.

We strive to maintain the integrity of MVP reporting and clinician access to measures and appreciate the feedback. While we acknowledge the concern regarding the exceptions, currently we do not require intermediaries to provide justification if an exception is applicable. We may consider stronger requirements for the justification for exceptions in future rulemaking. We also acknowledge the concern that some EHR vendors lack support for key data elements required by MIPS measures. EHR vendors that self-nominate as a QCDR or qualified registry are required to support all measures, though not all collection types, and activities available in the MVP that are applicable to its eligible clinicians.

We continue to encourage the development of quality measures across multiple collection types through our established pre-rulemaking processes, as we are limited to the current quality measure inventory. We encourage commenters to reach out to measure stewards to expand collection types for possible future implementation.

After consideration of public comments, we are finalizing our proposal to modify the requirement for QCDR and qualified registries support for MVPs as proposed. b. APM Performance Pathway (1) Overview

In the CY 2021 PFS final rule (85 FR 84859 through 84866), we finalized the APM Performance Pathway (APP) at Sec. 414.1367 beginning with the CY 2021 performance period/2023 MIPS payment year. The APP was designed as a reporting and scoring pathway available only to MIPS eligible clinicians identified on the Participation List or Affiliated Practitioner List of an APM Entity participating in a MIPS APM as defined in Sec. 414.1305 (MIPS APM participants) (Sec. 414.1367(a)). The APP provides a predictable and consistent MIPS reporting option to reduce reporting burden for, and encourage continued APM participation by, these clinicians. We also established in the APM Performance Pathway for Shared Savings Program ACOs providing that, beginning with the Shared Savings Program performance year 2021 (CY 2021 performance period/2023 MIPS payment year), ACOs were required to report quality data for purposes of the Shared Savings Program via the APP (42 CFR 425.512(a)(3); 85 FR 84722).

In that same rule, we finalized a quality measure set (85 FR 84860 and 84861) for purposes of quality performance category scoring for the APP. For those MIPS eligible clinicians, groups, or APM Entities for whom a given measure is unavailable due to the size of the available patient population or who are otherwise unable to meet the minimum case threshold for a measure, we established that such measure would be removed from the quality performance category score for such MIPS eligible clinician, group, or APM Entity (85 FR 84861).

In the CY 2025 PFS final rule (89 FR 98562), we finalized a second, optional quality measure set within the APP, called the APP Plus quality measure set, to align with the Universal Foundation measure set. The measure set currently includes the current APP quality measures and 2 additional quality measures from the Adult Universal Foundation measure set. As discussed in the CY 2025 PFS final rule, we intend to incrementally add the remaining 3 Adult Universal Foundation measures by the CY 2028 performance period/2030 MIPS payment year. We also finalized a 1-year delay to the CY 2026 performance year/2027 MIPS payment year in the incorporation of the Clinician and Clinician Group Risk-standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions (Quality ID #484) measure.

Further, for MIPS eligible clinicians, groups, and APM Entities reporting through the APP, we established in the CY 2021 PFS final rule (85 FR 84907) that we would not apply the quality measure scoring cap at Sec. 414.1380(b)(1)(iv) in the event that a measure in the APP quality measure set is determined to be topped out. Because the APP quality measure set is fixed, we noted that it would not be appropriate to limit the maximum quality performance category score available to APP reporters. Should an APP quality measure be determined to be topped out, we would at that time consider amending the APP quality measure set through future rulemaking, if appropriate.

In the CY 2024 PFS final rule (88 FR 79329), we established the Medicare Clinical Quality Measure for Accountable Care Organizations Participating in the Medicare Shared Savings Program (Medicare CQM) collection type in the APP quality measure set and finalized that the Medicare CQM collection type would be available to only ACOs participating in the Shared Savings Program. (2) Updates to Quality Measures in the APP and APP Plus Quality Measure Sets

In the CY 2021 PFS final rule, we adopted the original APP quality measure set (85 FR 84860 and 84861). Table 52 contains the original APP quality measure set. In the CY 2025 PFS final rule, we finalized a phased approach to establish the APP Plus

quality measure set over four years (89 FR 62024), including by incorporating into the APP Plus quality measure set the measures from the original APP quality measure set.

To conform with changes to the MIPS quality measure inventory, as set forth in Table Group DD and Table Group C of this final rule, we proposed to incorporate the updated versions of MIPS quality measures used in the APP quality measure set. We refer to readers the proposed revisions to the following MIPS measures:

Preventive Care and Screening: Screening for Depression and Follow-up Plan (Quality ID: 134)

Clinician and Clinician Group Risk-Standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions (Quality ID: 484). Because the APP is a reporting pathway within MIPS, all of the quality measures offered through the APP are the MIPS versions of the measures. As such, we generally take the approach of adopting changes to APP and APP Plus quality measures to conform with changes to the same measures within MIPS as a whole.

In the CY 2025 PFS final rule, we finalized a phased approach to establish the APP Plus quality measure set over 4 years (89 FR 62024). As finalized, the APP Plus quality measure set currently consists of all the measures currently within the APP quality measure set (5 Adult Universal Foundation measures and a separate quality measure) plus 1 additional measure from the Adult Universal Foundation measure set, with the intention of incrementally incorporating the remaining measures from the Adult Universal Foundation measure set by the CY 2028 performance year/2030 MIPS payment year. We finalized this incremental approach in part to allow for both the eCQM and, for Shared Savings ACOs, Medicare CQM collection types to be developed and become available.

We refer readers to Table 52 for the APP quality measure set beginning with the CY 2025 performance period/2027 MIPS payment year. The APP Plus quality measure sets for the CY 2026, 2027, and 2028 performance periods and subsequent performance periods are displayed in Tables C-BC1, C-BC2, and C-BC3 respectively.

Because the APP is a feature within MIPS and therefore the quality measures used within the APP and APP Plus quality measure sets are all MIPS measures, any updates CMS applies to MIPS measures also are incorporated into the APP and APP Plus quality measure sets, accordingly. As set forth in Table Group DD and Table Group C of this final rule, we proposed the following changes to and the removals of the following measures that are part of the APP Plus quality measure set:

Breast Cancer Screening (Quality ID: 112)

Colorectal Cancer Screening (Quality ID: 113)

Preventive Care and Screening: Screening for Depression and Follow-up Plan (Quality ID: 134; eCQM collection type only)

Clinician and Clinician Group Risk-Standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions (Quality ID:484)

Screening for Social Drivers of Health (Quality ID: 487)

These changes have been reflected in Tables C-BC1, C-BC2, C-BC3, and C-BC4. For further discussion and rationale for the proposed modification or removal of these measures is provided at Table Group DD and Table Group C of this final rule. Again, because the APP is a reporting pathway within MIPS, all of the quality measures offered through the APP are the MIPS versions of such measures, and we generally take the approach of adopting updates made to the MIPS measures for use in the APP quality measure sets.

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We received public comments on our proposals to conform with changes to the MIPS quality measure inventory, as set forth in Table Group DD and Table Group C of this final rule. The following is a summary of the comments we received and our responses. For responses to specific measures, we have addressed it in section X.XX of this final rule.

Comment: Many commenters expressed support for the CMS proposal, highlighting its potential to reduce burden by aligning changes to quality measures along with the broader program.

Response: We appreciate the commenters for their support. To maintain internal consistency of the measures used within the APP and APP Plus quality measure sets with MIPS overall, we are finalizing the updates to the APP and APP Plus measure sets as proposed.