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 itive regional adjustment to the benchmark (for example, ACO spending is above their region’s expenditures) or a prior savings adjustment, since these ACOs are in their first agreement period. This early observation suggests that the HEBA is encouraging more participation in the Shared Savings Program, as intended, by high-cost ACOs 330 that may otherwise not have elected to apply and participate in the program and whose assigned beneficiary populations have the greatest potential to benefit from care coordination and quality improvement. Our initial analysis of the preliminary benchmarks suggests that these ACOs could see an approximate 1.36 percent increase in their benchmark compared to an approximate 2.29 percent for ACOs that received either a prior savings adjustment or positive regional adjustment. These figures are provisional as they rely on preliminary BY3 population data. Final figures will depend on the ACO’s final PY 2025 assigned population, which is not determined until financial reconciliation, consistent with § 425.662(b)(4). The regulatory impact analysis of the HEBA from the CY 2025 PFS final rule (89 FR 98523 through 98524) estimated 329 These benchmarks are pre financial reconciliation, consistent with § 425.662(b)(4). The regulatory impact analysis of the HEBA from the CY 2025 PFS final rule (89 FR 98523 through 98524) estimated 329 These benchmarks are preliminary because they are established at the start of an ACO’s agreement period and include incomplete data from benchmark year 3. 330 By ‘‘high-cost ACOs,’’ we refer in this rulemaking to those ACOs with spending above their region expenditures. that total net savings is projected to grow over ten years by approximately $260 million as a result of the HEBA attracting additional high-cost ACOs to join the program and creating savings for the Medicare program, ranging from $1.2 billion cost to a $2.2 billion savings at the 10th and 90th percentiles. (d) Expanding Participation The HEBA policy aligns with CMS’ aims of advancing prevention, wellness, and chronic disease management, while supporting the growth and expansion of the Shared Savings Program. Analysis reveals significant untapped potential to increase Shared Savings Program participation among practices currently not participating in the program, in particular among providers serving higher cost populations.331 We conducted an otential to increase Shared Savings Program participation among practices currently not participating in the program, in particular among providers serving higher cost populations.331 We conducted an analysis of Taxpayer Identification Numbers (TINs) associated with medical providers and/ or practices not part of ACOs participating in the Shared Savings Program during PY 2022. The analysis compared TINs that participated in the Shared Savings Program with those that did not. Results indicated that many non-participating TINs served a larger share of beneficiaries with disabled or aged/dual enrollment status and had greater presence in rural areas. The study also found that of all the TINs serving beneficiaries eligible to participate in a Shared Savings Program ACO, 84 percent (or 58,000 TINs) were not participating in the Shared Savings Program. By contrast, only about 11,000 TINs with at least one ACO-assigned beneficiary participated in a Shared Savings Program ACO. Among these non-participants, two-thirds were small practices that furnish care to 100 or fewer beneficiaries. The analysis also highlighted key differences between ACO participating and non-participating TINs in ter participants, two-thirds were small practices that furnish care to 100 or fewer beneficiaries. The analysis also highlighted key differences between ACO participating and non-participating TINs in terms of the population they served and their geographic distribution. We observed that TINs associated with medical providers and/ or practices not participating in Shared Savings Program ACOs are in regions with low Shared Savings Program ACO penetration and have a greater presence in rural areas. These practices serve larger shares of dual eligible and disabled beneficiaries and have higher spending per beneficiary driven primarily by inpatient and SNF expenditures. Encouraging participation in ACOs by practices serving these higher-cost 331 CMS, Press Release ‘‘Dr. Mehmet Oz Shares Vision for CMS’’ (April 10, 2025), available at https://www.cms.gov/newsroom/press-releases/dr- mehmet-oz-shares-vision-cms. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00341 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32692 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules beneficiari E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32692 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules beneficiaries remain crucial to the Shared Savings Program. Our internal analysis shows that Shared Savings Program ACOs have been successful in reducing inpatient and SNF spending. The HEBA accounts for a higher proportion of dual eligible and LIS beneficiaries, and therefore can strengthen the business case for providers that serve these populations to join and form ACOs and participate in the Shared Savings Program. The adjustment is particularly critical in rural areas where the CBO has identified high start-up costs as a significant barrier to ACOs formation.332 By enabling ACOs in rural and resource- limited areas to operate under more viable and realistic financial benchmarks, the HEBA policy aims to expand participation in the Shared Savings Program and increase the likelihood that these ACOs can succeed financially while delivering high-quality care. (2) Proposed Revisions We are proposing to update the language used to describe this adjustment to the benchmark to more accurately reflect can succeed financially while delivering high-quality care. (2) Proposed Revisions We are proposing to update the language used to describe this adjustment to the benchmark to more accurately reflect the populations served by the ACOs receiving the adjustment as discussed in section III.F.8.b.(1) of this proposed rule. This change reflects efforts to harmonize terminology across benchmark-related methodologies— regional and prior savings adjustments—where the titles explicitly reflect key features of their underlying methodology. The revision to ‘‘population adjustment’’ more accurately reflects the population of beneficiaries that are captured by this adjustment (ACO’s assigned beneficiaries who are enrolled in the Medicare Part D LIS or dually eligible for Medicare and Medicaid), as well as promote consistency in nomenclature across adjustment. Specifically, we propose to revise Shared Savings Program regulations that include references to ‘‘health equity benchmark adjustment’’ or HEBA to ‘‘population adjustment’’. We also propose to revise the term ‘‘HEBA scaler’’, which is a component in the calculation to ‘‘scaler’’. The naming changes would apply for performance year 2025 an EBA to ‘‘population adjustment’’. We also propose to revise the term ‘‘HEBA scaler’’, which is a component in the calculation to ‘‘scaler’’. The naming changes would apply for performance year 2025 and subsequent performance years. This proposal would revise only the terminology in the regulations. The calculation described in the regulations would be unchanged, if the proposed changes are finalized. This proposal, if 332 Congressional Budget Office (CBO), ‘‘Medicare Accountable Care Organizations: Past Performance and Future Directions,’’ April 2024, available at https://www.cbo.gov/system/files/2024-04/59879- Medicare-ACOs.pdf. finalized, would have a minimal impact on Shared Savings Program operations. CMS would only need to update the language used in historical benchmark reports and the assignment summary report, beginning with report deliveries occurring after the rule is finalized., and certain other programmatic materials, for example, the Medicare Shared Savings Program Assignment List Report and Assignment Summary Report User’s Guide, and the Medicare Shared Savings Program’s Shared Savings and Losses, Assignment and Quality Performance Standard Methodology Specifications ment List Report and Assignment Summary Report User’s Guide, and the Medicare Shared Savings Program’s Shared Savings and Losses, Assignment and Quality Performance Standard Methodology Specifications. These proposed revisions reflect changes to the terminology used in the regulations at §§ 425.652, 425.658, 425.662 and 425.672. No changes in the methodology currently used to calculate the health equity benchmark adjustment are being proposed. Specifically, we propose the following revisions to provisions of the regulation: • At § 425.652(a)(8)(ii)(A), we propose to remove the phrase ‘‘health equity benchmark adjustment (HEBA)’’ and add in its place the phrase ‘‘population adjustment’’. • At § 425.652 in paragraphs (a)(8)(ii)(B), (a)(8)(ii)(B)(2), (a)(9)(v),and (a)(9)(vi), we propose to remove the phrase ‘‘HEBA’’ and add in its place the phrase ‘‘population adjustment’’. • At § 425.652(a)(9)(v), we propose to remove the phrase ‘‘HEBA scaler used in calculating the HEBA at § 425.662(b)(2)’’ and add in its place the phrase ‘‘scaler used in calculating the population adjustment at § 425.662(b)(2)’’. • At § 425.658 in paragraph (d), we propose to remove the phrase ‘‘HEBA’’ and add in i 2)’’ and add in its place the phrase ‘‘scaler used in calculating the population adjustment at § 425.662(b)(2)’’. • At § 425.658 in paragraph (d), we propose to remove the phrase ‘‘HEBA’’ and add in its place the phrase ‘‘population adjustment’’. • At § 425.662, we propose to revise the section heading to read as follows: ‘‘Calculating the population adjustment to the historical benchmark.’’ • At § 425.662 we propose to revise paragraph (a) to read as follows: ‘‘General. For agreement periods beginning on January 1, 2025, and in subsequent years, CMS calculates the population adjustment to the historical benchmark’’. • At § 425.662 in paragraph (b) introductory text, we propose to remove the phrase ‘‘health equity benchmark adjustment’’ and add in its place the phrase ‘‘population adjustment’’. • At § 425.662 in paragraph (b)(2), and we propose to remove the phrase ‘‘Calculates the HEBA scaler’’ and add in its place the phrase ‘‘Calculates a scaler’’. • At § 425.662, we propose to revise paragraph (b)(3) to read as follows: ‘‘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 en se paragraph (b)(3) to read as follows: ‘‘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.’’ • At § 425.662, we propose to revise paragraph (b)(4) to read as follows: ‘‘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.’’ • At § 425.662 in paragraph (c), we propose to remove the phrase ‘‘HEBA’’ and add in its place the phrase ‘‘population adjustment’’. • At § 425.672 in paragraph (c)(2)(iv), we propose to remove th .’’ • At § 425.662 in paragraph (c), we propose to remove the phrase ‘‘HEBA’’ and add in its place the phrase ‘‘population adjustment’’. • At § 425.672 in paragraph (c)(2)(iv), we propose to remove the phrase ‘‘and calculating the HEBA scaler’’ and add in its place the phrase ‘‘and calculating the scaler’’. We seek public comments on this proposed change. 9. Shared Savings Program Quality Reporting Monitoring Provisions a. Overview In this section, we propose to revise our regulations at § 425.316(c)(2) related to monitoring of ACOs for compliance with the quality performance standards. Relatedly, we propose to revise § 425.224(b)(1)(ii)(A) related to reviewing applications for renewing and re-entering ACOs. The purpose of these proposed changes is to revise our regulations to ensure that ACOs continue to satisfy program requirements or to identify a pattern of noncompliance with ACOs meeting both the quality performance standard and the alternative quality performance standard. We believe these revisions would not significantly impact the program as currently implemented. b. Background In the CY 2021 PFS final rule (85 FR 84740 through 84743), we finalized changes to the Shared Sa ieve these revisions would not significantly impact the program as currently implemented. b. Background In the CY 2021 PFS final rule (85 FR 84740 through 84743), we finalized changes to the Shared Savings Program quality performance standard and quality reporting requirements for performance years beginning on January 1, 2021. The regulation we finalized at VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00342 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32693 § 425.316(c)(2) aligned the Shared Savings Program quality reporting requirements with the requirements that applied under the APP under the Quality Payment Program (85 FR 85039 and 85040). We have subsequently updated the quality performance standard and reporting requirements through rulemaking in the CYs 2022, 2023, 2024, and 2025 PFS final rules (86 FR 65255 through 65272, 87 FR 69860 through 69863, 88 FR 79112 through 79114, and 89 FR 98101 through 98132, respectively). In the CY 2023 PFS final rule (87 FR 70234), we finalized an alternative quality perf through 65272, 87 FR 69860 through 69863, 88 FR 79112 through 79114, and 89 FR 98101 through 98132, respectively). In the CY 2023 PFS final rule (87 FR 70234), we finalized an alternative quality performance standard at § 425.512(a)(4)(ii) and (a)(5)(ii) for performance year 2023 and subsequent performance years. Specifically, to meet the alternative quality performance standard for performance year 2025 and subsequent years as described at § 425.512(a)(5)(ii)(B), an ACO must report quality data on the APP Plus quality measure set established at § 414.1367 according to the method of submission established by CMS and achieve a quality performance score equivalent to or higher than the 10th percentile of the performance benchmark on at least one of the outcome measures in the APP Plus quality measure set. An ACO that does not meet the quality performance standard but does meet the alternative quality performance standard is eligible to share in savings on a sliding scale as described at §§ 425.605 and 425.610. Additionally, ACOs that do not meet both the quality performance standard and the alternative quality performance standard will not be eligible for shared savings and will have §§ 425.605 and 425.610. Additionally, ACOs that do not meet both the quality performance standard and the alternative quality performance standard will not be eligible for shared savings and will have a shared loss rate not exceeding 75 percent as described at § 425.610(f)(3)(ii) for performance year 2023 and subsequent performance years. The PHE for COVID–19 was in effect starting in January 2020 and expired on May 11, 2023.333 All Shared Savings Program ACOs were deemed affected by the PHE for COVID–19 under the program’s quality EUC policy for performance years 2022 and 2023 as defined at § 425.512(c) and were determined to have met the quality performance standard at § 425.512(a) (85 FR 84746). ACOs received a minimum quality performance score equal to the 30th percentile Merit-based Incentive 333 See Administration for Strategic Preparedness & Response website, Declarations of a Public Health Emergency webpage, at https://aspr.hhs.gov/legal/ PHE/pages/default.aspx (listing declarations of a public health emergency, among other information). See also U.S. Department of Health and Human Services website, COVID–19 Public Health Emergency webpage, available at https:// www.hhs.gov tions of a public health emergency, among other information). See also U.S. Department of Health and Human Services website, COVID–19 Public Health Emergency webpage, available at https:// www.hhs.gov/coronavirus/covid-19-public-health- emergency/index.html. Payment System (MIPS) Quality performance category score in PY 2022, and a score equal to the equivalent of the 40th percentile in PY 2023 across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. ACOs that were able to successfully report quality data received the higher of their own MIPS Quality performance category score (adjusted for health equity for performance year 2023, if applicable) or the applicable 30th percentile score. As such, all ACOs that qualified for shared savings for performance years 2022 and 2023 were eligible to receive the maximum sharing rate for their track (or performance level within a track) and, for performance year 2022, any shared losses determined to be owed to CMS using either a fixed (BASIC Track) or scaled loss rate (ENHANCED Track) were fully offset by the EUC policy and any shared losses determined for performance year 2023 were etermined to be owed to CMS using either a fixed (BASIC Track) or scaled loss rate (ENHANCED Track) were fully offset by the EUC policy and any shared losses determined for performance year 2023 were reduced by a least five-twelfths. To ensure that the ACO continues to satisfy Shared Savings Program requirements, CMS monitors and assesses the performance of ACOs, their ACO participants, and ACO providers/ suppliers. The monitoring policies at § 425.316(c) apply to compliance with quality performance standards. To identify ACOs that are not meeting the quality performance standards, we will review an ACO’s submission of quality measurement data at §§ 425.500 or 425.512. Currently, as specified at § 425.316(c)(2)(i), if the ACO fails to meet the quality performance standard, we may take one or more of the actions prior to termination specified at § 425.216. As further specified at § 425.316(c)(2)(i), depending on the nature and severity of the noncompliance, we may forgo pre- termination actions and may immediately terminate the ACO’s participation agreement at § 425.218. While § 425.316(c)(2) addresses the quality performance standard, it fails to acknowledge the alternative quality actions and may immediately terminate the ACO’s participation agreement at § 425.218. While § 425.316(c)(2) addresses the quality performance standard, it fails to acknowledge the alternative quality performance standard. When we established the alternative quality performance standard in the CY 2023 PFS final rule, we inadvertently did not also propose to modify the corresponding monitoring policies at § 425.316(c)(2). Due to the quality EUC policies in effect until 2023, we did not encounter this discrepancy when monitoring ACO compliance with quality performance standards. c. Proposed Revisions We propose to add § 425.316(c)(3) to apply to performance years beginning on or after January 1, 2026. Under our proposal, if an ACO fails to meet both the quality performance standard and the alternative quality performance standard, as determined at § 425.512, we would be authorized to take one or more of the actions prior to termination as specified at § 425.216. Under the proposal, if an ACO is unable to meet the quality performance standard, then the ACO could still meet the alternative quality performance standard without CMS taking one of the prescribed actions prior to terminatio ACO is unable to meet the quality performance standard, then the ACO could still meet the alternative quality performance standard without CMS taking one of the prescribed actions prior to termination. However, if an ACO fails to meet both standards, then we believe it would be appropriate for CMS take one of the actions described at § 425.216 (provide a warning notice to the ACO, request a corrective action plan from the ACO, or place the ACO on a special monitoring plan) for noncompliance with the quality performance standards. We inadvertently did not modify the monitoring portion of the regulation, § 425.316(c), when we established the alternative quality performance standard in the CY 2023 PFS final rule and believe that it would be appropriate to revise the regulation at § 425.316(c) to be consistent with our longstanding practice to monitor ACOs for their compliance with our quality reporting and quality performance standard requirements. Specifically, we propose to add a new paragraph (c)(3) to § 425.316 to recognize that, for performance years beginning on or after January 1, 2026, if an ACO fails to meet both the quality performance standard and the alternative quality p aragraph (c)(3) to § 425.316 to recognize that, for performance years beginning on or after January 1, 2026, if an ACO fails to meet both the quality performance standard and the alternative quality performance standard, as determined at § 425.512, CMS may take one or more of the actions prior to termination specified at § 425.216. Additionally, in keeping with our established policies at § 425.316(c)(2)(ii), we propose to continue to terminate an ACO’s participation agreement if it: (1) fails to meet both the quality performance standard and alternative quality performance standard for 2 consecutive PYs within an agreement period; (2) fails to meet both the quality performance standard and alternative quality performance standard for any 3 performance years within an agreement period, regardless of whether the years are in consecutive order; (3) are a renewing ACO or re-entering ACO that fails to meet both the quality performance standard and 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 per or 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00343 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32694 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules failed quality performance during the previous agreement period; or (4) are a renewing ACO or re-entering ACO fails to meet both the quality performance standard and 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. As part of the Shared Savings Program application process, we identify applicant ACOs that have previously participated in the Shared Savings Program. If the applicant ACO has a history of noncompliance with the requirements of the Shared Savings Program, we may request the ACO demonstrate tha e previously participated in the Shared Savings Program. If the applicant ACO has a history of noncompliance with the requirements of the Shared Savings Program, we may request the ACO demonstrate that it has corrected the deficiencies that caused any noncompliance under their previous participation agreement (§ 425.224(b)(1)(iii)). The list of criteria we review for previous noncompliance includes, but is not limited to, whether the ACO demonstrated a pattern of failure to meet the quality performance standards, whether, for 2 PYs, the average per capita Medicare Parts A and B fee-for-service expenditures for the ACO’s assigned beneficiary population exceeded its updated benchmark, whether the ACO failed to repay shared losses in full within 90 days, whether the ACO failed to repay shared losses for any performance year while participating under a model authorized under section 1115A of the Act. In alignment with our proposal above, we also propose to modify § 425.224(b)(1)(ii)(A) to include the alternative quality performance standard. Specifically, we propose to modify § 425.224(b)(1)(ii)(A) to state that, as part of the factors we evaluate when determining whether to approve a include the alternative quality performance standard. Specifically, we propose to modify § 425.224(b)(1)(ii)(A) to state that, as part of the factors we evaluate when determining whether to approve a renewing ACO’s or re-entering ACO’s application, we will evaluate whether the ACO demonstrated a pattern of failure to meet the quality performance standard and alternative quality performance standard (if applicable), or met any of the criteria for termination at § 425.316(c)(1)(ii), (c)(2)(ii), or (c)(3)(ii). We seek comments on these proposals. G. Changes to the Regulations Associated With the Ambulance Fee Schedule 1. Ambulance Fee Schedule Background Section 1861(s)(7) of the Act establishes an ambulance service as a Medicare Part B service where the use of other methods of transportation is contraindicated by the individual’s condition, but only to the extent provided in regulations. Our regulations relating to coverage for ambulance services are set forth at 42 CFR part 410, subpart B. Since April 1, 2002, payment for ambulance services has been made under the ambulance fee schedule (AFS), which the Secretary established, as required by section 1834(l) of the Act, in 42 CFR part B. Since April 1, 2002, payment for ambulance services has been made under the ambulance fee schedule (AFS), which the Secretary established, as required by section 1834(l) of the Act, in 42 CFR part 414, subpart H. Payment for an ambulance service is made at the lesser of the actual billed amount or the AFS amount, which consists of a base rate for the level of service, a separate payment for mileage to the nearest appropriate facility, a geographic adjustment factor (GAF), and other applicable adjustment factors as set forth at section 1834(l) of the Act and § 414.610 of the regulations. In accordance with section 1834(l)(3) of the Act and § 414.610(f), the AFS rates are adjusted annually based on an inflation factor. (For a discussion about the ambulance inflation factor (AIF), please see CY 2011 PFS final rule (75 FR 73397). We stated in the CY 2011 PFS final rule that the AIF will be announced by instruction and on the CMS Web site. AIF transmittals are available on CMS’ website: https:// www.cms.gov/medicare/payment/fee- schedules/ambulance/afs-regulations- and-notices and in the Medicare Claims Processing Manual, Chapter 15, section 20.4). The AFS also incorporates two perm https:// www.cms.gov/medicare/payment/fee- schedules/ambulance/afs-regulations- and-notices and in the Medicare Claims Processing Manual, Chapter 15, section 20.4). The AFS also incorporates two permanent add-on payments in § 414.610(c)(5)(i) and three temporary add-on payments in § 414.610(c)(1)(ii) and (c)(5)(ii) to the base rate and/or mileage rate. 2. Ambulance Extender Provisions a. Amendment to Section 1834(l)(13) of the Act Section 146(a) of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110–275, enacted July 15, 2009) (MIPPA), amended section 1834(l)(13) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008, and before January 1, 2010, the ambulance fee schedule amounts for ground ambulance services shall be increased as follows: • For covered ground ambulance transports that originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 3 percent. • For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be incr ased by 3 percent. • For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 2 percent. The payment add-ons under section 1834(l)(13) of the Act have been extended several times. Section 3203 of the American Relief Act of 2025 (Pub. L. 118–158, December 21, 2024) extended these provisions through March 31, 2025. Most recently, section 2203 of the Full-Year Continuing Appropriations and Extensions Act, 2025 (Pub. L. 119–4, March 15, 2025) amended section 1834(l)(13) of the Act to extend the payment add-ons through September 30, 2025. Thus, these payment add-ons apply to covered ground ambulance transports furnished before October 1, 2025. We are proposing to revise § 414.610(c)(1)(ii) to conform the regulations to this statutory requirement. (For a discussion of past legislation extending section 1834(l)(13) of the Act, please see the CY 2014 PFS final rule with comment period (78 FR 74438 through 74439), the CY 2015 PFS final rule with comment period (79 FR 67743), the CY 2016 PFS final rule with comment period (80 FR 71071 through 71072), the CY 2019 with comment period (78 FR 74438 through 74439), the CY 2015 PFS final rule with comment period (79 FR 67743), the CY 2016 PFS final rule with comment period (80 FR 71071 through 71072), the CY 2019 PFS final rule with comment period (83 FR 59681 through 59682), and the CY 2024 PFS final rule with comment period (88 FR 79292– 79293)). This statutory requirement is self- implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase and does not require any substantive exercise of discretion on the part of the Secretary. b. Amendment to Section 1834(l)(12) of the Act Section 414(c) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108–173, December 8, 2003) added section 1834(l)(12) to the Act, which specified that, in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary’s in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary’s estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural county populations as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of rural county populations. Using the methodology specified in the July 1, 2004, interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00344 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32695 increase was applied to ground ambulance transports that originated in a ‘‘qualified rural area,’’ that is, to transports that originated in a rural area comprising the lowest 25th percentile of all rural populations arrayed by population den ransports that originated in a ‘‘qualified rural area,’’ that is, to transports that originated in a rural area comprising the lowest 25th percentile of all rural populations arrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of rural census tract). This rural bonus is sometimes referred to as the ‘‘Super Rural Bonus’’ and the qualified rural areas (also known as ‘‘super rural’’ areas) are identified during the claims process via the use of a data field included in the CMS-supplied ZIP code file. The Super Rural Bonus under section 1834(l)(12) of the Act has been extended several times. Section 3203 of the American Relief Act of 2025 extended this provision through March 31, 2025. Most recently, section 2203 of the Full- Year Continuing Appropriations and Extensions Act, 2025 amended section 1834(l)(12)(A) of the Act to extend this rural bonus through September 30, 2025. Therefore, we are continuing to apply the 22.6 percent rural bonus described in this section (in the same manner as in previous years) to ground ambulance services with dates of service before October 1, 2025, where transportation originates in a qualified rural area. Acco bed in this section (in the same manner as in previous years) to ground ambulance services with dates of service before October 1, 2025, where transportation originates in a qualified rural area. Accordingly, we are proposing to revise § 414.610(c)(5)(ii) to conform the regulations to this statutory requirement. (For a discussion of past legislation extending section 1834(l)(12) of the Act, please see the CY 2014 PFS final rule with comment period (78 FR 74439 through 74440), CY 2015 PFS final rule with comment period (79 FR 67743 through 67744), the CY 2016 PFS final rule with comment period (80 FR 71072), the CY 2019 PFS final rule with comment period (83 FR 59682) and the CY 2024 PFS final rule with comment period (88 FR 79293)). This statutory provision is self- implementing. It requires an extension of this rural bonus (which was previously established by the Secretary) through September 30, 2025, and does not require any substantive exercise of discretion on the part of the Secretary. IV. Updates to the Quality Payment Program A. CY 2026 Modifications to the Quality Payment Program Reporting and Data Submission 1. Executive Summary a. Overview This section of this proposed ru tary. IV. Updates to the Quality Payment Program A. CY 2026 Modifications to the Quality Payment Program Reporting and Data Submission 1. Executive Summary a. Overview This section of this proposed 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. 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 § 414.1305) 334 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 with respect to 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 § 414.1305). In calculating the final score, we must apply dif e four performance categories during a performance period to compute a final composite performance score (a ‘‘final score’’ as defined at § 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 § 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; 30 334 We note that the term MIPS eligible clinician is defined at § 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 § 414.1310(e). percent for the cost performance category; 25 percent for the Promoting Interoperability performance category; and 15 percent for the improvement activities performance category. Once calculated, each MIPS eligible clinician’s final score is compared to the performance threshold established in prior rulemaking for that performance peri rovement activities performance category. 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 with respect to 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 ligible 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 paymen 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, VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00345 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32696 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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. 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 par ncentive Payment. 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 proposed 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 pr y- 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 propose adding a new ‘‘Advancing Health and Wellness’’ subcategory within the improvement activities performance category. Through the proposals described in this proposed 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 enga y 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 propose 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 have 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 propose ending traditional MIPS in the future, at which point MVPs would become mandatory. That future date has not been determined and will be established through notice and comment rulemaking. We are issuing a request for information (RFI) to address the use of Fast Healthcare Interoperability Resources (FHIR)-based electronic clinical quality measures (eCQMs) in quality reporting and payment programs as discussed in s information (RFI) to address the use of Fast Healthcare Interoperability Resources (FHIR)-based electronic clinical quality measures (eCQMs) in quality reporting and payment programs as discussed in section IV.A.4.c. of this proposed rule. In section IV.A.3. of this proposed rule, we seek feedback on two 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 are seeking feedback on future use of well-being and nutrition measures in the Quality Payment Program. We are issuing three additional RFIs in section IV.A.4.d.(4) of this proposed rule related to enhancing healthcare data quality and monitoring systems. These RFIs address: (1) potential future modifications to the Query of Prescription Drug Monitoring Program (PDMP) measure (2) potential modifications to the Promoting Interoperability performance category’s objectives and measures and (3) potential improvements to enhance health information MIPS eligible clinicians are exchanging across systems. These initiatives reflect our commitment to advancing interoperability, impro sures and (3) potential improvements to enhance health information MIPS eligible clinicians are exchanging across systems. These initiatives reflect our commitment to advancing interoperability, improving patient safety, and supporting the transition to value-based care through modern technology and standardized data exchange practices. (a) Transforming MIPS: MVP Strategy To support our goal of phasing out traditional MIPS and transitioning to MVP reporting, we are proposing policies, that if finalized, would encourage increased participation from specialists. Our proposals 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 proposing updates to two MVP subgroup policies as follows: (1) update the MVP group registration process to add the multispecialty self-attestation requirement; and (2) maintain the MVP group reporting option for multispecialty groups with a small practice designation. We are also seeking feedback via three RFIs. First, we are seeking feedback on the development of a subset of he MVP group reporting option for multispecialty groups with a small practice designation. We are also seeking feedback via three RFIs. First, we are seeking feedback on the development of a subset of key quality measures within each MVP, referred to as ‘‘Core Elements,’’ from which an MVP Participant would be required to report one Core Element that would highlight measures that represent the foundation and focus of an MVP and would better enable comparison of clinician performance. This would provide for more accurate comparisons of similar clinicians and would give patients the best information available about clinicians so they can make the most informed decisions about their care. Second, we are also seeking feedback on identifying Medicare Part B procedural billing codes that align with each MVP to encourage specialists to report the relevant MVP based on their use of the procedural billing codes. Third, we are seeking feedback on well- being and nutrition tools and measures that assess overall health, happiness, and satisfaction in life. (b) MIPS Value Pathways Development and Maintenance To continue moving the healthcare community toward value-based, high- quality, safe, an assess overall health, happiness, and satisfaction in life. (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 proposing six new MVPs around the following topics: Diagnostic Radiology, Interventional Radiology, Neuropsychology, Pathology, Podiatry, and Vascular Surgery. We are also proposing 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 have 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’’. When applicable, an ‘‘Advancing Health and Wellness’’ and/or ‘‘Experience of Care’’ clinical grouping is included for cross-cutting quality measures. This new stratified VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00346 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / l 15, 2025 Jkt 265001 PO 00000 Frm 00346 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32697 format offers a streamlined set of quality measures to aid clinicians in selecting the most clinically relevant measures applicable to their clinical area and identifies when quality and cost measures are linked. Finally, we are proposing to provide additional flexibilities to allow qualified clinical data registries (QCDRs) and qualified registries additional time to fully support finalized MVPs. Specifically, we are proposing to sunset the current requirement and modify § 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 proposing to modify the requirement at § 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 § 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 one year after finalization of the MVP. We are proposing to retain the remaining language currently set forth at § 414.1400(b)(1)(ii) without modification. (c) APM Performance Pathway We are proposing 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 section IV.A.4.b. of this proposed 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 are providing updates on our activities since prior RFIs and are seeking information from interested parties on a range of issues to better inform future proposals. More specifically, the RFI is s we are providing updates on our activities since prior RFIs and are seeking information from interested parties on a range of issues to better inform future proposals. More specifically, the RFI is seeking feedback, related to the digital quality measurement (dQM) transition, on the following: • What challenges providers and health information technology vendors anticipate during the transition. • What guidance may be required from CMS to support the transition. • Feedback on the stepwise approach to FHIR-based eCQM reporting. • What challenges Accountable Care Organizations (ACOs) specifically have with reporting via FHIR, to include challenges about aggregated data. • Any other implementation concerns. (e) MIPS Quality Performance Category For the CY 2026 performance period/ 2028 MIPS payment year, we are proposing 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 e 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 proposed rule, we are proposing to revise the definition of a ‘‘high priority measure’’ to remove health equity. (f) MIPS Cost Performance Category We are proposing to modify the Total Per Capita Cost (TPCC) measure beginning in the CY 2026 performance period/2028 MIPS payment year. We are also proposing 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 proposing to adopt a 2-year informational-only feedback period for newly implemented MIPS cost measures, which we are also proposing to codify at enance process for MIPS cost measures. Lastly, we are proposing to adopt a 2-year informational-only feedback period for newly implemented MIPS cost measures, which we are also proposing to codify at § 414.1380(b)(2). (g) MIPS Improvement Activities Performance Category We are proposing the following updates to the MIPS Improvement Activity Inventory beginning with the CY 2026 performance period/2028 MIPS payment year. First, we propose to add a new subcategory to the Improvement Activities performance category: Advancing Health and Wellness. Second, we propose to remove the Achieving Health Equity subcategory. Third, we propose to add three new improvement activities into two of our existing subcategories: (1) Population Management and (2) Patient Safety and Practice Assessment. Fourth, we propose to modify seven existing improvement activities currently specified for the performance category. Fifth, we propose 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 proposing several policies and measure updates for ance category. (h) MIPS Promoting Interoperability Performance Category Beginning with the CY 2026 performance period/2028 MIPS payment year, we are proposing several policies and measure updates for the MIPS Promoting Interoperability performance category. Specifically, for the MIPS Promoting Interoperability performance category, we are proposing to modify the Security Risk Analysis measure and the High Priority Practices Safety Assurance Factors for Electronic Health Record (EHR) Resilience (SAFER) Guide measure, and adopt one new optional bonus measure, the Public Health Reporting Using Trusted Exchange Framework and Common AgreementTM (TEFCATM) measure. Promoting Interoperability Program, we are proposing the following: • Adopt and codify at § 414.1380(b)(4)(iii) and § 495.24(f)(3), respectively, a measure suppression policy beginning with the CY 2026 performance period/2028 MIPS payment year and the EHR reporting period in CY 2026. • Suppress the Electronic Case Reporting measure by excluding the measure from scoring 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 by excluding the measure from scoring 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. Additionally, we include the following RFIs in section IV.A.4.d.(4) of this proposed rule. • RFI Regarding the Query of PDMP Measure seeks public comment on potential future modifications to the Query of PDMP measure that would transition the measure from attestation- based reporting to performance-based reporting and expand the types of drugs that apply to the measure to include all Schedule II drugs. • RFI Regarding performance-based measures seeks public comment on the potential modifications to the Promoting Interoperability performance category’s objectives and measures that would transition from attestation-based reporting to performance-based reporting. • RFI Regarding Data Quality seeks public comments on the improvements to enhance overall healthcare data quality, addressing current gaps in accuracy, completeness, and consistency of health information MIPS eligible clinicians are exchange across systems. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 000 ty, addressing current gaps in accuracy, completeness, and consistency of health information MIPS eligible clinicians are exchange across systems. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00347 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32698 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (i) MIPS Final Score Methodology (Scoring the Quality Performance Category) We are proposing 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 proposing a 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 proposing to modify the methodology for scoring the administrative claims-based measures within the quality performance cate k for the CY 2026 performance period/2028 MIPS payment year. Lastly, we are proposing 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 proposed administrative claims-based quality measure scoring methodology would be based on standard deviation, median, and an achievement point value derived from the performance threshold. (j) MIPS Payment Adjustment We are proposing to continue using the CY 2017 performance period/2019 MIPS payment year to establish the performance threshold. We are also proposing 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 proposing to codify at § 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 proposing to codify at § 41 ubmit 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 proposing to codify at § 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 proposing 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 proposing to codify this proposed requirement at § 414.1400(d)(10). In addition, we propose to modify our requirements at § 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 proposing to sunset one of the requirements to apply to become a CMS-approved survey vendor at § 414.1400(d)(8). (2) Advanced APM Proposals We are proposing to modify the methodology we use to calculate QP status at § 414.1425 to include an i s to apply to become a CMS-approved survey vendor at § 414.1400(d)(8). (2) Advanced APM Proposals We are proposing to modify the methodology we use to calculate QP status at § 414.1425 to include an individual calculation for all eligible clinicians in Advanced APMs. Additionally, we are proposing to use Covered Professional Services to identify beneficiaries, as described at § 414.1305 to define an Attribution- eligible beneficiary, in our calculations for all Advanced APMs. We are proposing to sunset our Advanced APM criterion at § 414.1415(c)(7), and § 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 proposing to modify the language at § 414.1455(b)(3)(ii) and § 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 § 414.1385(a)(2) and § 414.1385(a)(5). 2. Definitions At § 414.1305, we are proposing to revise the definition of the following terms: • High priority measure • Attribution-eligible beneficiary • Multispecialty group • M § 414.1385(a)(5). 2. Definitions At § 414.1305, we are proposing to revise the definition of the following terms: • High priority measure • Attribution-eligible beneficiary • Multispecialty group • MVP Participant • Single specialty group These terms and definitions are discussed in detail in the relevant sections of this proposed 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 2 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 proposing policies that would 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 proposed subgroup policies would continue the voluntary subgroup participation option for multispecialty group practices that qualify as small practices. Additionally, we seek 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 seek feedback on the consideration to identify Medicare Par asures within MVPs to better enable comparison of clinician performance and emphasize measures that reflect the core of a specialty. We also seek 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 §§ 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 § 414.1305. Beginning with the CY 2023 performance period/2025 MIPS payment year, an MVP participant means an individual MIP 65392 through 65394), we finalized the definition of an MVP participant at § 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00348 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32699 Entity that is assessed on an MVP in accordance with § 414.1365 for all MIPS performance categories. We also finalized at § 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 § 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 4). 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 § 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 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 § 414.1305 the definitions of a single specialty group and a multispecialty group. Specifically, a single specialty group means a group as defined at § 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 § 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 § 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 tha 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 this section, we propose 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 § 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 proposed rule, we previously finalized subgroup reporting requirements for multispecialty groups beginning in the CY 2026 ng the MIPS determination period. As discussed in section IV.A.3.a.(1) of this proposed 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 acknowledge 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 all 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 would 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/ 2817/2022Experienc orting 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, we propose to modify the definition of an MVP participant at § 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. Spe ups 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 propose to modify the definition of an MVP participant at § 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 § 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 seek comments on the above proposal to modify the MVP participant definition at § 414.1305 by adding the VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00349 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32700 Federal Register / 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00349 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32700 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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. (3) Proposal To Modify 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 § 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 diff he 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 proposed rule, we finalized at § 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 Par ved 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 re 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 be ode 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 id ures 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 acknowledge 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 dis t 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 proposed 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 propose 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 note that we are not proposing the self- attestation requirement for subgroups because under the current policy at ltispecialty group that meets the requirements of a small practice, respectively. We note that we are not proposing the self- attestation requirement for subgroups because under the current policy at § 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 section IV.A.3.a.(2) of this proposed rule, we are proposing to expand the definition of MVP Participant to include multispecialty groups meeting the requirements of small practices. Under this proposal, a VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00350 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32701 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 consis les 32701 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 anticipate the group practice would 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 propose 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 o y 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, we are proposing 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 tha e 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 are proposing 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 would need to attest either as a single specialty group or a multispecialty group that meets the requirements of a small practice during MVP registration. We propose to codify this proposal at § 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 discussed above in this section of the proposed rule, at this time, we are unable to utilize claims data for designating a group as either a single specialty group or a multispecialty group. Therefore, we propose to make conforming changes and revise the current definitions of a single specialty ims data for designating a group as either a single specialty group or a multispecialty group. Therefore, we propose to make conforming changes and revise the current definitions of a single specialty group and a multispecialty group at § 414.1305. We propose to revise the definition of a single specialty group at § 414.1305 to mean a group that consists of clinicians in one specialty type or clinicians involved in a single focus of care. We propose to revise the definition of a multispecialty group at § 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 seek public comments on the above proposal to update the MVP group registration by adding a self- attestation requirement. We also seek comment on our 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 proposed rule for discussion on the burden estimates for these proposals. 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 mates for these proposals. 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 are considering 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. Spe nt choice of care. We are considering 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. Specifically, we are considering a policy to require an MVP Participant to select one quality measure from a subset of quality measures in each MVP, referred to as ‘‘Core Elements.’’ MVP Participants would select the other three required quality measures and would still have to meet existing MVP reporting requirements. This policy aims to emphasize and increase reporting on select quality measures that are most important to clinicians and patients and reflect care that is at the crux of the MVP’s applicable specialty, medical condition, or episode of care. Core Elements could be, but would not necessarily be, outcomes measures. Core Elements would highlight measures that represent the foundation and essence of an MVP. The resulting standardized reporting would lead to more directly comparable clinician data on a subset of key quality measures within an MVP that constitute critical elements within that specialty which will better enable patients to compare the care provided to patients, em clinician data on a subset of key quality measures within an MVP that constitute critical elements within that specialty which will better enable patients to compare the care provided to patients, emphasize a crucial subset of quality measures, and may also drive quality and outcome improvement. The quality measures identified as Core Elements for an MVP would be meaningful and reflect the critical care elements for each MVP’s relevant specialty, medical condition or episode of care. We may also consider Core Elements from the Adult Universal Foundation quality measures or the MVP’s Advancing Health and Wellness quality measures subcategory, when possible. If we propose implementing Core Elements in MVPs, we would propose Core Elements for existing MVPs via notice and comment rulemaking. When new MVPs are proposed, we would identify the MVP’s Core Elements at that time through notice and comment rulemaking. Given the existing quality measure gaps for certain specialists and subspecialists, there may be clinicians for whom there would not be an applicable and available Core Element. We are considering proposing the Core Elements policy in the CY 2027 PFS proposed rule and proposing ists, there may be clinicians for whom there would not be an applicable and available Core Element. We are considering proposing the Core Elements policy in the CY 2027 PFS proposed rule and proposing the policy for implementation prior to the sunset of traditional MIPS. In the CY 2025 PFS proposed rule, we discussed that we anticipate we may be ready to fully transition to MVPs by the CY 2029 performance period/2031 MIPS payment year (89 FR 62012). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00351 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32702 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules RFI Questions We request public comment on the following questions related to MVP Core Elements: • One of the key goals of Core Elements is to provide patients with enough information across different clinicians to compare specialist performance on foundational measures within a clinical area. Are there other ways to ensure MVP reporting results provide comparative performance data for patients on critical measures? • Core Elements will be selected based on clinical r ithin a clinical area. Are there other ways to ensure MVP reporting results provide comparative performance data for patients on critical measures? • Core Elements will be selected based on clinical relevance, but for consistency across MVPs, we are considering a set number of Core Elements for all MVPs. We are also considering setting the number of Core Elements in an MVP based on a percentage of the total number of quality measures in an MVP. For example, we may consider a policy that identifies 25 percent of an MVP’s quality measures as Core Elements, such that an MVP with 12 quality measures would have three Core Elements measures to choose from. We request feedback on the ideal number or percentage of Core Elements in MVPs. • One of our concerns is that Core Elements specified for a few collection types, such as electronic clinical quality measures (eCQMs) or Qualified Clinical Data Registry (QCDR) measures, would limit clinician choice and may unintentionally force clinicians to report via intermediaries. One possible solution would be to include Core Elements with several different collection types, when possible, to provide clinicians with some choice of collection type. Ar report via intermediaries. One possible solution would be to include Core Elements with several different collection types, when possible, to provide clinicians with some choice of collection type. Are there other flexibilities or options that could reduce this limitation? • We are considering policies to increase the likelihood that clinicians have an applicable and available Core Element. We request feedback on ways to include measures that are applicable for more clinicians, such as including cross-cutting and broadly applicable measures. We also request feedback on ways to avoid disadvantaging clinicians without an applicable Core Element, such as attesting to no applicable and available Core Element. • As we consider which measures should be used as Core Elements, we are interested in receiving feedback on specific measures that should or should not be considered for the Core Elements requirement, including measures in the proposed Advancing Health and Wellness quality measures clinical grouping, as discussed in section IV.A.4.a.(2) of this proposed rule, or Adult Universal Foundation quality measures. • We request feedback on our goal to consider the Core Elements policy for inical grouping, as discussed in section IV.A.4.a.(2) of this proposed rule, or Adult Universal Foundation quality measures. • We request feedback on our goal to consider the Core Elements policy for proposal in the CY 2027 PFS proposed rule. • We understand the Core Elements requirement places a new restriction on MVP reporting. We request feedback on whether the Core Elements reporting requirement would impact your decision to report an MVP while traditional MIPS remains a reporting option. Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subj ning to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the PRA. c. Medicare Procedural Codes Request for Information (RFI) Alongside the proposed subgroup policies and the RFI on MVP Core Elements requirements in sections IV.A.3.a and IV.A.3.b. of this proposed rule, we are considering utilizing Medicare procedural codes to further facilitate more MVP specialty reporting and to encourage and potentially require specialists to report an MVP applicable to their specialty or scope of care. In the CY 2022 PFS final rule, we finalized the MVP reporting option for MIPS eligible clinicians beginning in the CY 2023 performance period/2025 MIPS payment year (86 FR 65392 through 65394). 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. B evant 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 MIPS 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 from MIPS eligible clinicians and groups. Currently, MVP Participants may select any MVP to report. We recognize that a policy to assign clinicians to a particular MVP would limit the ability for clinicians to choose an MVP and therefore limit the measures they can select to report. However, it is important to ensure that clinicians report an MVP that is relevant to their specialty or scope of care to make performance measurement more clinically relevant for specialists and inform patient choice of care with meaningful and comparative clinician performance data. Therefore, we are considering a potential future policy to requir more clinically relevant for specialists and inform patient choice of care with meaningful and comparative clinician performance data. Therefore, we are considering a potential future policy to require clinicians to report a specific MVP based on the procedural codes that they bill. Furthermore, there may be measures within an MVP that are more relevant to an individual specialist based on the types of services they perform, so we are further considering requiring specialists to report specific measures within an MVP. See section IV.A.3.b. of this proposed rule for discussion of the Core Elements RFI. Efforts were made in the CY 2025 PFS final rule to further the goal of using quality measurement to advance specific types of care. For example, we introduced the Advanced Primary Care Management (APCM) services (89 FR 97858 through 97906) coding and payment. APCM includes a performance measurement requirement for clinicians furnishing APCM services to assess clinicians on primary care quality, total cost of care, and meaningful use of CEHRT. The performance measurement requirements can be met for practitioners who are MIPS eligible clinicians by registering for and reporting the Valu ality, total cost of care, and meaningful use of CEHRT. The performance measurement requirements can be met for practitioners who are MIPS eligible clinicians by registering for and reporting the Value in Primary Care MVP. A practitioner who is part of a TIN participating in a Shared Savings Program ACO or REACH ACO, or in a Making Care Primary or a Primary Care First practice satisfies this requirement by virtue of meeting requirements under the Shared Savings Program, CMS Innovation Center ACO REACH, Making Care Primary, or Primary Care First models (89 FR 97879 through 97894). In section III.D. of this proposed rule, the Innovation Center is proposing to test a mandatory model that focuses on high-volume, high-cost chronic- conditions and directly engages specialists in value-based payment. Specifically, the Ambulatory Specialty Model (ASM) is proposing the identification of a physician’s specialty type using the specialty code on the VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00352 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 20 O 00000 Frm 00352 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32703 Medicare Part B claims data, in conjunction with a minimum volume of episodes triggered for the relevant condition-specific episode-based cost measure to identify specialists to include in the model. We refer readers to section III.D. of this rule for additional details on the model requirements and correlation to the existing MVP framework. The frameworks used in APCM, where practitioners who are MIPS eligible clinicians must register for and report the Value in Primary Care MVP for the performance year in which they bill for APCM services (89 FR 97893 and 97894), and the proposed ASM in section III.D. of this proposed rule where procedural codes from Medicare Part B claims data would attribute clinicians to MVPs via cost measures, may be useful tools for increasing specialty reporting in MVPs and ultimately improving quality performance measurement. We are considering an approach that would identify relevant procedural codes for each MVP, where applicable, a ing specialty reporting in MVPs and ultimately improving quality performance measurement. We are considering an approach that would identify relevant procedural codes for each MVP, where applicable, and then identify clinicians to report that MVP based on their billing of those procedural codes. We would prioritize linking MVPs with high-utilization and high-cost procedures. For example, quality measures in the Improving Care for Lower Extremity Joint Repair MVP such as 350: Total Knee or Hip Replacement: Shared Decision-Making: Trial of Conservative (Non-surgical) Therapy and 351: Total Knee or Hip Replacement: Venous Thromboembolic and Cardiovascular Risk Evaluation would be relevant for clinicians who perform hip replacement surgery and bill hip replacement surgery procedural codes. We therefore may connect the hip replacement surgery procedural codes to the Improving Care for Lower Extremity Joint Repair MVP and the relevant quality measures to encourage clinicians to report measures that are relevant to their scope of care, such as these RFI Questions. We request public comment on the following questions related to the use of Medicare procedural codes to suggest or assign MVPs es that are relevant to their scope of care, such as these RFI Questions. We request public comment on the following questions related to the use of Medicare procedural codes to suggest or assign MVPs: • If we do not suggest or assign MVPs to clinicians, how else can we encourage specialty reporting of relevant MVPs based on the scope of care provided? • What data sources should we consider using to assign clinicians to an MVP? To appropriately determine the relevance of the measures and activities in an MVP to the scope of care provided by the clinicians, we are considering using procedural billing codes from Medicare Part B claims data. We refer readers to section IV.A.3.a.(3) of this proposed rule for a discussion of our concerns for using Medicare Part B claims data to identify the specialty composition of a group. • The MIPS determination period is used to determine MIPS eligibility and, as defined at § 414.1305, begins the calendar year, 2 years prior to the applicable performance period. Would it be appropriate to align with that timeline and use the procedural billing codes from Medicare Part B claims data from 2 years prior to the performance year in which a clinician woul e period. Would it be appropriate to align with that timeline and use the procedural billing codes from Medicare Part B claims data from 2 years prior to the performance year in which a clinician would report the particular MVP? • We are considering setting a volume threshold that clinicians must meet to be assigned to a particular MVP. For example, we may consider a threshold of 20 cases in order to be assigned to the MVP, given the case minimum requirement of 20 cases for most measures. What would be an appropriate volume threshold for the procedural billing codes? • If we suggest or require the reporting of a particular MVP, we would limit clinicians’ current flexibility to choose an MVP. Additionally, it would take time for CMS to identify effective approaches to operationalize this concept. Given these constraints, how long would clinicians need to prepare for a suggested MVP based on Medicare Part B claims data? How long would clinicians need to prepare for a required MVP based on Medicare Part B claims data? Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 C n Medicare Part B claims data? Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the PRA. d. Well-Being and Nutrition Measures Request for Information (RFI) We are seeking 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.335 This comprehensive approach emphasizes person-centered care by promoting the well-b es mental and physical health while emphasizing preventative care to proactively address potential health issues.335 This comprehensive approach emphasizes person-centered care by promoting the well-being of patients and family members. We are seeking 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. We would like to receive input and comments on the applicability of tools and constructs that assess for the integration of complementary and integrative health, skill building, and self-care. Please provide feedback on the relevant aspects of well-being for the QPP. We refer readers to section IV.A.4.a.(2) of this proposed rule for discussion of the proposed Advancing Health and Wellness quality measure clinical grouping in MVPs. Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from th ork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the PRA. 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 n ers 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 335 Well-Being Concepts. (2017). CDC Archives. Available at: https://www.naspa.org/images/ uploads/kcs/WHPL_Canon_WB_WellBeing_ Concepts___HRQOL___CDC_2017.pdf. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00353 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32704 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules aim to gradually develop new MVPs that are relevant and meaningful for MIPS eligible clinicians. In this proposed rule, we are proposing to adopt the following six new MVPs: • Diagnostic Radiology; • Interventional Radiology; • Neuropsychology; • Pathology; • Podiatry; and • Vascular Surgery. We refer readers to Appendix 3: MVP Inventory, in this proposed rule for a detailed description of each proposed new MVP. We continue to encourage interested parties to utilize our established pre- rulema efer readers to Appendix 3: MVP Inventory, in this proposed rule for a detailed description of each proposed new MVP. 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 Disea ; • 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 8004 , 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 this proposed rule, we are proposing 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 f ns, 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 have 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 refer readers to Appendix 3: MVP Inventory of this proposed rule for the proposed modifications and detailed descriptions to the previously finalized MVPs. We also refer readers to section V.B.5.c.(6)(a) of this proposed rule for discussion on the burden estimates for these proposals. (3) Third Party Intermediaries Support of MVPs We refer readers to our regulation at § 414.1400 and section IV.B.4. of this proposed rule for more detailed discussion regarding our previously finalized requirements for third party inte ort of MVPs We refer readers to our regulation at § 414.1400 and section IV.B.4. of this proposed 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 § 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 § 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 acknowledge that some QCDRs and qualified registries may have difficulties programming new MVP that are applicable to their MIPS eligible clinicians for the first year of the MVP’s implementation. We acknowledge 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 one year to January of the next year). We have heard concerns from QCDRs and qualified registries regarding feasibility of meeting this requirement at § 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, we are proposing to modify the language currently set forth at § 414.1400(b)(1)(ii). As discussed previously, § 414.1400(b)(1)(ii) currently provides that, beginning with the C n MIPS. On these bases, we are proposing to modify the language currently set forth at § 414.1400(b)(1)(ii). As discussed previously, § 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. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00354 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32705 We are proposing to modify § 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 one year after finalization of the MVP in accordance with the current requirement. We are also proposing to sunset the current requirement as of the end of the CY 2025 performance period/ 2027 MIPS payment year. We are proposing to retain the remaining language curr ent requirement. We are also proposing to sunset the current requirement as of the end of the CY 2025 performance period/ 2027 MIPS payment year. We are proposing to retain the remaining language currently set forth at § 414.1400(b)(1)(ii) without modification. This proposed modification will provide QCDRs and qualified registries with one 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 invite comments on our proposal. 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 § 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 § 414.1305 (MIPS APM participants) (§ 414.1367(a)). The APP provides a predictable and consistent MIPS reporting option to reduce reporting burden for, and encourage continued APM participation by, in § 414.1305 (MIPS APM participants) (§ 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 he 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 § 414.1380(b)(1)(iv) in the event that a measure in the APP quality measure s APP, we established in the CY 2021 PFS final rule (85 FR 84907) that we would not apply the quality measure scoring cap at § 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 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 proposed rule, we are proposing 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 ality 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 MI red 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 53, 54, and 55 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 proposed rule, we note that we are proposing changes to the following measures that are part of the APP Plus quality measure set: VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00355 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32706 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules • Breast Cancer Screening (Quality ID: 112). • Colorectal Cancer Screen P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32706 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules • 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 the Tables 54, 55, 56, and 57. 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 proposed 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. BILLING CODE 4120–01–P 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 2650 e MIPS measures for use in the APP quality measure sets. BILLING CODE 4120–01–P 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00356 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00357 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00358 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00359 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00360 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00361 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32712 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules for quality measurement and reporting would be addressed through future notice-and-comment rulemaking, as necessary. (2) Approach to eCQM Re ol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules for quality measurement and reporting would be addressed through future notice-and-comment rulemaking, as necessary. (2) Approach to eCQM Reporting Using FHIR in CMS Quality Programs In this section, we describe the current state and request input on key components of the ongoing dQM transition related to FHIR-based eCQMs for the Medicare Shared Savings Program and the MIPS quality performance category. These components include: (1) FHIR-based eCQM conversion progress; (2) Data standardization for quality measurement and reporting; (3) The timeline under consideration for FHIR-based eCQM reporting; (4) Measure development and reporting tools; and (5) FHIR Reporting and Data Aggregation for ACOs. (a) eCQM FHIR Conversion Activities Currently, Medicare Shared Savings Program Accountable Care Organizations (ACOs) and eligible clinicians participating in MIPS can report eCQMs for their quality reporting. Electronic health record (EHR) and other health IT systems certified under the ONC Health IT Certification Program use patient data to calculate the results for each eCQM based upon the measure specifications for the eCQM.351 EHR) and other health IT systems certified under the ONC Health IT Certification Program use patient data to calculate the results for each eCQM based upon the measure specifications for the eCQM.351 An important initial step in our dQM strategy is to ensure current eCQMs are specified using the FHIR standard and allow these measures to be calculated consistently using standardized data represented in FHIR. Standardized digital data can support multiple use cases, including quality measurement, quality improvement efforts, clinical decision support, research, and public health. The eCQMs currently use structured data defined by the Quality Data Model (QDM) and measure logic in Clinical Quality Language to evaluate a clinician’s, provider’s, facility’s, or organization’s performance on a measure concept.352 As we move to FHIR-based eCQMs, we continue to convert current eCQMs (authored using the QDM) to eCQMs authored using the HL7 FHIR® Quality Improvement Core (QI-Core) IG, updating to new versions as appropriate. We are conducting advanced validation of FHIR data exchange through ongoing HL7 Connectathons and integrated systems testing, leveraging and refining IGs to enhance inter new versions as appropriate. We are conducting advanced validation of FHIR data exchange through ongoing HL7 Connectathons and integrated systems testing, leveraging and refining IGs to enhance interoperability and data 351 https://ecqi.healthit.gov/sites/default/files/ eCQM-Basics-508.pdf. standardization.353 While new eCQMs continue to be developed, proposed, and adopted in existing CMS programs, we are working with measure developers to ensure existing eCQMs are converted to FHIR and that new eCQMs are also natively developed in FHIR. In the future, we are considering a requirement that all quality measures proposed for addition to CMS programs be specified in FHIR. We are also considering requirements to include FHIR-based specifications for measures developed by Qualified Clinical Data Registries (QCDRs). Additional information and updates regarding eCQMs and the dQM transition can be found on the Electronic Clinical Quality Improvement (eCQI) Resource Center website, available at: https:// ecqi.healthit.gov/dqm?qt-tabs_ dqm=dqm-strategic-roadmap. We continue to explore potential applications of the FHIR standard to the reporting and use of different types of quality measurem t: https:// ecqi.healthit.gov/dqm?qt-tabs_ dqm=dqm-strategic-roadmap. We continue to explore potential applications of the FHIR standard to the reporting and use of different types of quality measurement data. We seek feedback on the following questions: • Are there specific eCQMs or components of existing eCQMs that you anticipate presenting particular challenges in specifying in FHIR? • Are there gaps in the QI-Core IG that are likely to impact our ability to effectively specify current CMS eCQMs in FHIR? • What supplementary activities would encourage additional engagement in FHIR testing activities (such as Connectathons) that support the development of current and future IGs to advance adoption and use of FHIR- based eCQMs? (b) Data Standardization for Quality Measurement and Reporting We are continuing to collaborate with ONC as it develops a certification approach to enable reporting of FHIR- based eCQMs using technology certified under the ONC Health IT Certification Program. This approach aims to repurpose and harmonize existing FHIR requirements in the ONC Health IT Certification Program whenever possible.354 It also aims to incorporate industry-developed standards for th his approach aims to repurpose and harmonize existing FHIR requirements in the ONC Health IT Certification Program whenever possible.354 It also aims to incorporate industry-developed standards for the exchange of quality measurement data using FHIR. 353 Summaries are available and more information on the most recent Connectathon is available at: https://confluence.hl7.org/spaces/FHIR/pages/ 281218287/2025+-+01+Clinical+Reasoning. 354 See 45 CFR 170.315(g)(10)—Standardized API In this section, we discuss the standards and other artifacts which CMS and ONC are evaluating to serve as the basis for new health IT certification criteria supporting FHIR-based quality measurement and reporting. New health IT certification criteria for quality measurement and reporting could include requirements for certified Health IT Modules to support the consistent capture and exchange of quality data using FHIR APIs. New criteria could also support standardized reporting rules to ensure successful submission of quality measure data for the Medicare Shared Savings Program and the MIPS quality performance category. A key artifact CMS and ASTP are reviewing as part of this approach is the QI-Core IG, whi ion of quality measure data for the Medicare Shared Savings Program and the MIPS quality performance category. A key artifact CMS and ASTP are reviewing as part of this approach is the QI-Core IG, which defines a set of FHIR profiles within a common logic model for clinical quality measurement and clinical decision support intended for use for multiple use cases across domains.355 As described previously, this IG is used to represent the data elements necessary to support current eCQMs. The QI-Core IG builds on the HL7 FHIR® US Core IG (US Core IG) which is currently referenced under the ONC Health IT Certification Program and implements the USCDI in FHIR. The US Core IG is incorporated in the ‘‘Standardized API for patient and population services’’ health IT certification criterion 356 and is widely implemented across certified health IT systems. Accordingly, we anticipate that developers implementing the QI-Core IG will be able to leverage existing work from implementing the US Core IG. QI- Core is expected to evolve over time to reflect subsequent versions of the US Core IG. For example, QI-Core 6.0 builds upon US Core version 6.1.0, which provides consensus-based capabilities a IG. QI- Core is expected to evolve over time to reflect subsequent versions of the US Core IG. For example, QI-Core 6.0 builds upon US Core version 6.1.0, which provides consensus-based capabilities aligned with USCDI version 3 (v3) data elements for FHIR APIs. In the HTI–1 final rule (89 FR 1196), ONC finalized the expiration of USCDI v1 on January 1, 2026, and adopted USCDI v3 as the new baseline version of USCDI after USCDI v1 expires. We are also supporting ASTP in their work to advance alignment between the QI-Core IG and the USCDI+ Quality data element list, which incorporates additional data elements beyond USCDI. We have collaborated with ASTP around the development of USCDI+ Quality as an extension to USCDI to improve healthcare interoperability across quality programs, establishing a consistent baseline of harmonized data 352 https://ecqi.healthit.gov/sites/default/files/ Digital%20Quality%20Measurement%20eCQMs% 20reference%20brief_508ed.pdf. for patient and population services FHIR certification in the ONC Health IT Certification program. 355 https://hl7.org/fhir/us/qicore/index.html. 356 45 CFR 170.315(g)(10). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm es FHIR certification in the ONC Health IT Certification program. 355 https://hl7.org/fhir/us/qicore/index.html. 356 45 CFR 170.315(g)(10). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00362 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32713 elements for a wide range of quality measurement use cases.357 Specifically for CMS programs, USCDI+ Quality includes the data elements to support program-specific measures.358 We are also considering the Data Exchange for Quality Measures (DEQM) IG 359 as part of the framework supporting the transition to FHIR-based eCQMs, in particular for supporting FHIR-based reporting to CMS. The DEQM IG provides a framework that defines conformance profiles and guidance to enable the exchange of quality information and enable FHIR- based quality measure reporting. It is based upon other related work in the FHIR and quality measure realm, including the US Core IG, the Healthcare Effectiveness Data and Information Set (HEDIS) IG, and Quality Reporting Document Architecture (QRDA) Category ated work in the FHIR and quality measure realm, including the US Core IG, the Healthcare Effectiveness Data and Information Set (HEDIS) IG, and Quality Reporting Document Architecture (QRDA) Category I and III reporting specifications. We are considering the use of the DEQM IG with quality measures specified in accordance with QI-Core. To facilitate the exchange of significant volumes of data to support quality measurement, we are also evaluating the use of HL7 FHIR ® Bulk Data 360 including analysis of: Potential enhancements to support the use of Bulk paired with the QI Core IG and potential use of Bulk paired with the DEQM IG.361 The existing Bulk Data Access IG defines a standardized, FHIR- based approach for exporting bulk data from a FHIR server to an authenticated and authorized client. ONC has adopted the Bulk Data Access IG STU 1, version 1.0.0, published on August 8, 2019 (hereafter referred to as version 1), and has incorporated it into the ONC Health IT Certification Program.362 The Bulk Data Access IG has recently seen considerable revisions and enhancements over version 1 from the HL7 standards community. A new version of the Bulk Data Access IG, planned to be ballot am.362 The Bulk Data Access IG has recently seen considerable revisions and enhancements over version 1 from the HL7 standards community. A new version of the Bulk Data Access IG, planned to be balloted in 2025, is expected to introduce new features such as the capacity to organize output by patient and criteria-based cohort creation, which could significantly 357 https://www.healthit.gov/topic/ interoperability/uscdi-plus. 358 For more information about the USCDI+ Quality data element list please visithttps:// uscdiplus.healthit.gov/. 359 https://build.fhir.org/ig/HL7/davinci-deqm/. 360 https://hl7.org/fhir/uv/bulkdata/. 361 https://hl7.org/fhir/us/davinci-deqm/ OperationDefinition-bulk-submit-data.html. 362 ONC has adopted the Bulk Data Access IG, version 1, in 45 CFR 170.215, and has incorporated this IG into the ONC Health IT Certification Program as part of the ‘‘Standardized API for patient and population services’’ certification criterion in 45 CFR 170.315(g)(10). enhance the quality reporting use case for the IG.363 The HL7 community will also continue to prepare additional enhancements to the Bulk Data Access IG throughout 2025, with the Argonaut Project announcing Bulk Im ality reporting use case for the IG.363 The HL7 community will also continue to prepare additional enhancements to the Bulk Data Access IG throughout 2025, with the Argonaut Project announcing Bulk Import as a 2025 project.364 Bulk Import is already being used by AHA in their UDS+ IG,365 and has the potential to enhance the quality reporting use case more broadly. It defines a standardized mechanism for data submitters to upload or submit their Bulk FHIR data to a receiving system when they have their Bulk FHIR data ready to submit, rather than having to reactively respond to a Bulk FHIR export request initiated by a receiving system. We seek feedback on the following questions: • Can you share any experiences or challenges reviewing, implementing, or testing the QI-Core, DEQM, or Bulk FHIR standards, including any experiences or challenges unique to Bulk FHIR Import versus Bulk FHIR Export? • Are there any deficiencies or gaps in the DEQM IG that must be addressed before it can potentially be used for reporting to CMS on eCQMs using FHIR APIs? • Are there additional baseline requirements or capabilities that need to be considered before FHIR-based eCQMs could be reported to CMS us ially be used for reporting to CMS on eCQMs using FHIR APIs? • Are there additional baseline requirements or capabilities that need to be considered before FHIR-based eCQMs could be reported to CMS using Bulk FHIR? • Are there additional supports or enhancements that CMS should consider for the QI Core, DEQM, or Bulk FHIR IGs that would support quality measurement and reporting beyond the CMS eCQMs or potential dQMs? (c) Timeline Under Consideration for FHIR-Based eCQM Reporting As we noted in the FY 2023 IPPS/ LTCH PPS proposed rule (87 FR 49183), we are considering proposing a transition period during which healthcare providers that satisfy quality reporting requirements by using the eCQM collection type may report using either QDM- or FHIR-based eCQMs. For MIPS and other programs that use the eCQM collection type, we are considering a similar transition for the eCQM collection type to FHIR, instead of QDM-based eCQMs. This period would provide time for providers and clinicians participating in CMS programs, health IT developers, and 363 See Argonaut Bulk Optimize project: https:// confluence.hl7.org/spaces/AP/pages/227213555/ Bulk+Optimize. 364 https://confluence.hl7.org/spaces/ cipating in CMS programs, health IT developers, and 363 See Argonaut Bulk Optimize project: https:// confluence.hl7.org/spaces/AP/pages/227213555/ Bulk+Optimize. 364 https://confluence.hl7.org/spaces/AP/pages/ 325453837/Bulk+Import. 365 https://www.fhir.org/guides/hrsa/uds-plus/ OperationDefinition-import.html. CMS to engage in learning to optimize systems and processes. During this period, participants that have chosen to satisfy applicable quality reporting requirements by reporting eCQMs would be able to choose to submit either QDM-based or FHIR-based eCQMs to meet respective reporting requirements. For instance, participants who are implementing updated certified health IT and gaining experience with FHIR- based eCQMs could continue submitting QRDA files to meet program requirements, while those who are ready to report FHIR-based eCQMs would be able to do so, for a specified period. For the purposes of this RFI, we refer to this concept as the ‘‘reporting options’’ period. As a note, while MIPS eligible clinicians have the option to satisfy quality reporting requirements by reporting an eCQM, it is currently not required within MIPS. We are not proposing to limit any collection e, while MIPS eligible clinicians have the option to satisfy quality reporting requirements by reporting an eCQM, it is currently not required within MIPS. We are not proposing to limit any collection types for MIPS eligible clinicians to report quality measures for the quality performance category. We acknowledge that participants in the identified CMS programs may proceed with updating certified health IT and implementing dQMs at different speeds. Hence, we are considering the reporting options period to provide additional time for clinicians who elect to report the eCQM collection type, in advance of any future proposal to require FHIR-based reporting for eCQMs. We are considering at least a two-year reporting options period before any future proposal to require only FHIR-based reporting for eCQMs. Note that any updates to specific program requirements related to providing data for quality measurement and reporting would be addressed through future notice-and-comment rulemaking, as necessary. We seek feedback on the following questions: • Would a minimum of 24 months from the effective date of a FHIR-based eCQM reporting option using ONC Health IT Certification Program criteria necessary. We seek feedback on the following questions: • Would a minimum of 24 months from the effective date of a FHIR-based eCQM reporting option using ONC Health IT Certification Program criteria to support quality program submission provide sufficient time for implementation (including measure specification review, certified health IT updates, workflow changes, training, and testing)? • What resources or guidance could CMS provide to assist with the transition to submission of FHIR-based eCQM data? • What challenges, if any, do you anticipate with the reporting timeline of FHIR-based eCQMs (beginning with at least a 2-year reporting options period VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00363 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32714 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules before any future proposal to require FHIR-based reporting)? (e) FHIR Reporting and Data Aggregation for ACOs • What resources, guidance, or other support could we provide to encourage and facilitate the early adoption and reporting of FHIR-based eCQMs during the d FHIR Reporting and Data Aggregation for ACOs • What resources, guidance, or other support could we provide to encourage and facilitate the early adoption and reporting of FHIR-based eCQMs during the data submission period? (d) Measure Development and Reporting Tools We develop and maintain tools and resources to assist measure developers in the different stages of the Measure Lifecycle.366 The Measure Authoring Development Integrated Environment (MADiE) is a free software tool that supports the eCQM development and testing process through dynamic authoring and testing within a single application.367 MADiE supports QI-Core profile-informed authoring, testing, and verification of the behavior of FHIR- based eCQMs.368 We encourage measure developers to continue using this environment for the development of FHIR-based eCQMs. In the FY 2023 IPPS/LTCH PPS final rule (87 FR 49183), we described plans to modernize programmatic data receiving systems through a unified CMS FHIR receiving system that would provide a single point of data receipt for quality reporting programs. We may also consider separate FHIR receiving systems for some programs initially as the shift to FHIR across CMS progr that would provide a single point of data receipt for quality reporting programs. We may also consider separate FHIR receiving systems for some programs initially as the shift to FHIR across CMS programs will be incremental. We will provide information on the form and manner for reporting for each program in respective notice-and-comment rulemaking, as necessary. Our vision remains to ultimately develop and implement a single point of data receipt via a unified CMS FHIR receiving system. In the CMS Digital Quality Measurement Strategic Roadmap, we noted the development of a FHIR-based measure calculation tool (MCT).369 After further consideration and testing, we have decided not to advance the MCT as previously described. We seek feedback on the following questions: • What capabilities would be most useful for CMS to support in a FHIR- based eCQM reporting model? • What additional concerns, if any, should CMS take into consideration when developing FHIR-based reporting requirements for systems receiving quality data? 366 https://mmshub.cms.gov/cms-tools. 367 https://www.emeasuretool.cms.gov/. 368 Ibid. 369 https://ecqi.healthit.gov/dqm?qt-tabs_ dqm=dqm-strategic-roadmap. As finaliz systems receiving quality data? 366 https://mmshub.cms.gov/cms-tools. 367 https://www.emeasuretool.cms.gov/. 368 Ibid. 369 https://ecqi.healthit.gov/dqm?qt-tabs_ dqm=dqm-strategic-roadmap. As finalized in the CY 2025 PFS final rule, Shared Savings Program ACOs are required to report the Alternative Payment Model (APM) Performance Pathway (APP) Plus quality measure set beginning with the 2025 performance year (89 FR 98105). For the 2025 performance year, ACOs will be required to report four measures using one of the three collection types: eCQMs, MIPS Clinical Quality Measure (CQM), or Medicare CQM. We finalized the incremental increase in the number of measures required with each subsequent performance year (89 FR 98105), sunsetting the MIPS CQM collection type beginning with the CY 2027 performance period/2029 MIPS payment year (89 FR 98111). As ACOs bring together health care providers using disparate EHR systems from which data is extracted and aggregated, they have encountered challenges with aggregating, deduplicating, and matching all patient data required under the eCQM and MIPS CQM quality measure collection types. We released a document that describes eCQM and MIPS CQM re llenges with aggregating, deduplicating, and matching all patient data required under the eCQM and MIPS CQM quality measure collection types. We released a document that describes eCQM and MIPS CQM reporting scenarios specific to Shared Savings Program ACOs and that provides guidance on patient matching and data aggregation, and how MIPS data completeness policy applies to an ACOs eligible and matched patient population, available here: https:// www.cms.gov/files/document/medicare- shared-savings-program-reporting-mips- cqms-and-ecqms-alternative-payment- model-performance.pdf. While the number of ACOs reporting eCQMs and MIPS CQMs has grown, uptake has been slow. In 2021, 12 ACOs reported using either eCQMs or MIPS CQMs. The number using these collection types increased to 37 ACOs in 2022, and 73 ACOs in 2023. We have provided reporting incentives specific to eCQMs and MIPS CQMs to encourage the adoption of eCQMs and MIPS CQMs (89 FR 98123). We are interested in how a transition to FHIR-based reporting of eCQMs could help to mitigate the burden ACOs may experience related to aggregating quality data from multiple practices and multiple EHR systems. We note that any updates to spec IR-based reporting of eCQMs could help to mitigate the burden ACOs may experience related to aggregating quality data from multiple practices and multiple EHR systems. We note that any updates to specific program requirements related to providing data for quality measurement and reporting requirements would be addressed through future notice-and-comment rulemaking, as necessary. We seek feedback on the following questions: • What types of technical support, guidance, and resources would be most beneficial for ACOs in the implementation of FHIR-based eCQMs? • Are you presently ready and able to report eCQM data using FHIR? Are there any challenges you anticipate facing in transitioning to these reporting methods? • What changes need to be made to health IT functionality, including EHRs, to better support efforts to aggregate data from multiple settings or health IT systems, including EHRs, to enable ACOs to successfully report eCQMs using FHIR? • For ACOs developing the infrastructure needed to aggregate data from multiple settings and health IT systems, including EHRs, what are the estimated costs and timelines that your ACO has identified for implementing capabilities necessary to eeded to aggregate data from multiple settings and health IT systems, including EHRs, what are the estimated costs and timelines that your ACO has identified for implementing capabilities necessary to perform this data aggregation? Where applicable, please provide appropriate context. • What changes could be made to the available eCQMs and eCQM specifications to better support the efficacy and relevance of applicable measures for ACOs reporting from multiple settings? • What feedback do you have, if any, on ACO experience reporting aggregate quality measure data using the Data Exchange for Quality Measures (DEQM) IG? • What feedback do you have, if any, on ACO experience using Bulk FHIR? • What feedback do you have, if any, on ACO experience using the QI Core IG? • What challenges, if any, do you anticipate for eligible clinicians, group practices, and ACOs transitioning to FHIR-based eCQMs within the anticipated reporting options timeline? (3) General Solicitation of Comments In conjunction with the previous questions, we are also seeking input on the following: • Specific to FHIR-based quality reporting, are there any additional factors, or considerations to account for, that may nction with the previous questions, we are also seeking input on the following: • Specific to FHIR-based quality reporting, are there any additional factors, or considerations to account for, that may help reduce reporting burden across entities? Are there any areas CMS should consider that would help reduce burden for reporting quality beyond the scope of CMS eCQMs or potential dQMs? • Would the ability to reuse or repurpose technology, standards, data elements, and/or specifications reduce burden for healthcare providers in measuring and reporting quality overall? • The Trusted Exchange Framework and Common AgreementTM (TEFCATM) framework supports nationwide health information exchange by connecting VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00364 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32715 health information networks (HINs) across the country.370 Additionally, TEFCA facilitates FHIR exchange by requiring Qualified HINs (QHINs) to perform patient discovery for those querying for data and providing data ion networks (HINs) across the country.370 Additionally, TEFCA facilitates FHIR exchange by requiring Qualified HINs (QHINs) to perform patient discovery for those querying for data and providing data holders with FHIR endpoints to enable point-to-point exchange via FHIR APIs. How could this initiative potentially support exchange of FHIR-based quality measures consistent with the FHIR Roadmap (available here: https:// rce.sequoiaproject.org/three-year-fhir- roadmap-for-tefca/)? How might TEFCA enable the use of data for secondary uses such as treatment and research? Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, f, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the PRA. f. MIPS Performance Category Measures and Activities (1) Quality Performance Category (a) Background Section 1848(q)(1)(A)(i) and (ii) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to certain specified performance standards and, using such methodology, to provide for a final score for each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act provides that the Secretary must use the quality performance category in determining each MIPS eligible clinician’s final score, and section 1848(q)(2)(B)(i) of the Act describes the measures that must be specified under the quality performance category. We refer readers to §§ 414.1330 through 414.1340 and the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77097 through 77162 and 82 FR 53626 through 53641, respectively), and the CY 2019, CY 370 eaders to §§ 414.1330 through 414.1340 and the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77097 through 77162 and 82 FR 53626 through 53641, respectively), and the CY 2019, CY 370 For more information about TEFCA, see https://www.healthit.gov/topic/interoperability/ policy/trusted-exchange-framework-and-common- agreement-tefca. 2020, CY 2021, CY 2022, CY 2023, CY 2024, and CY 2025 PFS final rules (83 FR 59754 through 59765, 84 FR 63949 through 62959, 85 FR 84866 through 84877, 86 FR 65431 through 65445, 87 FR 70047 through 70055, 88 FR 79329 through 79338, and 89 FR 98373 through 98375 respectively) for a description of previously established policies and statutory basis for policies regarding the quality performance category. In the CY 2026 PFS proposed rule, we are proposing to: • Amend the definition of the term ‘‘high priority measure’’ to remove references to health equity at § 414.1305. • Modify the MIPS quality measure set as described in Appendix 1 of this proposed rule, including the addition of new measures, updates to specialty sets, removal of existing measures, and substantive changes to existing measures. (b) High Priority Measure Definition The Me roposed rule, including the addition of new measures, updates to specialty sets, removal of existing measures, and substantive changes to existing measures. (b) High Priority Measure Definition The Meaningful Measures Initiative provides for the identification of high priority areas for quality measurement and quality improvement, which identifies the core quality of care issues that advances our work to improve patient outcomes (83 FR 59719). To further identify priority areas for MIPS quality measurement, we defined the term high priority measure at § 414.1305, beginning with the CY 2019 performance period/2021 MIPS payment year, as an outcome (including intermediate-outcome and patient- reported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure (83 FR 59761). In the 2023 PFS final rule (87 FR 70047 through 70049), we finalized an amended definition of the term ‘‘high priority measure’’ to include quality measurement pertaining to health equity. We also codified this revised definition at § 414.1305 beginning with the CY 2023 performance period/2025 MIPS payment year (87 FR 70047 through 70048).In the C easurement pertaining to health equity. We also codified this revised definition at § 414.1305 beginning with the CY 2023 performance period/2025 MIPS payment year (87 FR 70047 through 70048).In the CY 2023 PFS final rule (87 FR 70047), we noted significant and persistent inequities in healthcare outcomes exist in the United States and that we are committed to developing innovative solutions that support access to high quality care and promote health equity, including the exploration of solutions to measure health equity within MIPS. Consequently, we stated that we believed it was imperative to include quality measures pertaining to health equity as high priority measures in order to incentivize the adoption of health equity measures by MIPS eligible clinicians. In the 2023 PFS final rule (87 FR 70049) we defined health equity as ‘‘the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identify, socioeconomic status, geography, preferred language, and other factors that affect access to care and health outcomes.’’ This definition ce, ethnicity, disability, sexual orientation, gender identify, socioeconomic status, geography, preferred language, and other factors that affect access to care and health outcomes.’’ This definition was adopted during the Public Health Emergency (PHE) for COVID–19. At the time we believed that adding the term health equity to our definition of a high priority measure was the best way to address health disparities exacerbated by the pandemic. On September 12, 2023, Health and Human Services (HHS) announced the end of the Federal PHE for COVID–19 in a statement effective May 11, 2023. 371 Now that the PHE has ended, we believe that these disparities are best addressed through other mechanisms. We believe that our definition of ‘‘health equity’’ was confusing and that health disparities are best addressed through efforts to improve overall healthcare quality for all beneficiaries. In section IV.A.3.d of this proposed rule, we requested public input to identify measures around well- being and nutrition as high priority area for quality measurement and quality improvement. Therefore, we propose to remove quality measurement pertaining to health equity from the definition of the term ‘ g and nutrition as high priority area for quality measurement and quality improvement. Therefore, we propose to remove quality measurement pertaining to health equity from the definition of the term ‘‘high priority measure’’ Specifically, we are amending the definition of the term high priority measure at § 414.1305 to mean an outcome (including intermediate- outcome and patient-reported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure beginning with the CY 2026 performance period/CY 2028 MIPS payment year. (c) Selection of Quality Measures (i) Addition of New Quality Measures (A) Pre-Rulemaking Process Prior to introducing a new MIPS quality measure in a proposed rule, we receive public input on measures through the pre-rulemaking process (referred to as the Pre-Rulemaking Measure Review (PRMR)) established in accordance with section 1890A of the Act. Although section 1848(q)(2)(D)(viii) of the Act provides that the pre- rulemaking process under section 1890A of the Act is not required to 371 Available at https://www.hhs.gov/coronavirus/ covid-19-public-health-emergency/index.html. VerDate Sep 2014 23:2 that the pre- rulemaking process under section 1890A of the Act is not required to 371 Available at https://www.hhs.gov/coronavirus/ covid-19-public-health-emergency/index.html. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00365 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32716 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules apply to the selection of MIPS quality measures, we have found that the pre- rulemaking process provides a comprehensive review of measures from multi-stakeholder workgroups and have accordingly elected for such measures to be reviewed utilizing the PRMR process (87 FR 70048). Under the established PRMR process (additional information regarding the PRMR process is available at https://p4qm.org/PRMR), CMS has contracted with a Consensus-Based Entity (CBE), which is responsible for convening a multi-stakeholder panel comprised of clinicians, patients, measure experts, and health information technology specialists to provide input on measures CMS is considering for use in Medicare. The pre-rulemaking process begins with CMS’s publication of atients, measure experts, and health information technology specialists to provide input on measures CMS is considering for use in Medicare. The pre-rulemaking process begins with CMS’s publication of measures under consideration for use in Medicare (the MUC List). Each measure on the MUC List is reviewed by one of several committees convened by the PQM for the purpose of providing multi- stakeholder input to the Secretary. The PRMR process includes opportunities for public comments through a 21-day public comment period, as well as public listening sessions. The PQM posts the compiled comments and listening session inputs received during the public comment period and the listening sessions within 5 days of the close of the public comment period. More details regarding the PRMR process may be found in the PQM Guidebook of Policies and Procedures for Pre-Rulemaking Measure Review and Measure Set Review. The final vote of a multistakeholder committee convened by the CBE may result in the following disposition of a measure: recommended, recommended with conditions, do not recommend, or no consensus. A ‘‘no consensus’’ recommendation signals continued disagreement among the committee d following disposition of a measure: recommended, recommended with conditions, do not recommend, or no consensus. A ‘‘no consensus’’ recommendation signals continued disagreement among the committee despite being presented with perspectives from public comments, committee member feedback and discussion, and highlights the multi- faceted assessments of quality measures. Quality measures that are considered for potential implementation in MIPS starting with CY 2026 performance period/CY 2028 payment year period were included on the 2024 Measures Under Consideration (MUC) List (available at https://mmshub.cms.gov/ sites/default/files/2024-MUC-List.xlsx). The new MIPS quality measures finalized, as proposed, are described in Table Group A of Appendix 1 of this proposed rule. There may be cases in which the CBE does not recommend a measure to move forward to the rulemaking process and eventual implementation due to a measure not being endorsed by the CBE or other CBE, but we go forth with proposing a measure. We note that section 1848(q)(2)(D)(iii)(v)(III) of the Act does not preclude the Secretary from proposing and implementing measures that are not endorsed by a CBE as long as the me roposing a measure. We note that section 1848(q)(2)(D)(iii)(v)(III) of the Act does not preclude the Secretary from proposing and implementing measures that are not endorsed by a CBE as long as the measure is evidence-based. (ii) Removal of Quality Measures In the CY 2025 PFS final rule, we codified previously established criteria for the removal of MIPS quality measures from the MIPS quality measure inventory at § 414.1330. In the CY 2017 Quality Payment Program final rule (81 FR 77136 through 77137), we established the following criteria for measure removal to include: If the Secretary determines that the MIPS quality measure is no longer meaningful, such as MIPS quality measures that are topped out; and, if a measure steward is no longer able to maintain the quality measure. In the CY 2019 PFS final rule (83 FR 59763), we expanded the criteria for measure removal to include MIPS quality measures that reached an extremely topped out status (for example, a measure with an average mean performance within the 98th to 100th percentile range); the MIPS quality measure may be proposed for removal in the next rulemaking cycle, regardless of whether or not it is in the midst of the toppe performance within the 98th to 100th percentile range); the MIPS quality measure may be proposed for removal in the next rulemaking cycle, regardless of whether or not it is in the midst of the topped-out measure lifecycle, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made, after taking into account any other relevant factors. Also, in the CY 2019 PFS final rule (83 FR 59764), we established other criteria for measure removal, specifically MIPS quality measures that are: duplicative; not maintained or updated to reflect current clinical guidelines, which are not reflective of a clinician’s scope of practice; and low- bar, standard of care process measures. As described in the CY 2019 PFS final rule (83 FR 59765), we established an approach to incrementally remove process measures where prior to removal, consideration will be given to, but will not be limited to the following: • Whether the removal of the process measure impacts the number of measures available for a specific specialty. • Whether the MIPS quality measure addresses a priority area highlighted in the Measure Development Plan: https:/ the process measure impacts the number of measures available for a specific specialty. • Whether the MIPS quality measure addresses a priority area highlighted in the Measure Development Plan: https:// www.cms.gov/Medicare/Quality- Payment-Program/Measure- Development/ Measuredevelopment.html. • Whether the MIPS quality measure promotes positive outcomes in patients. • Considerations and evaluation of the measure’s performance data. • Whether the MIPS quality measure is designated as high priority or not. • Whether the MIPS quality measure has reached extremely topped out status within the 98th to 100th percentile range, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made. In the CY 2020 PFS final rule (84 FR 62958 through 62959), we expanded the criteria for measure removal to include MIPS quality measures that do not meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods and not available for MIPS quality reporting by or on behalf of all MIPS eligible clinicians. For MIPS quality measures that do not meet case minimum an rogram for 2 consecutive CY performance periods and not available for MIPS quality reporting by or on behalf of all MIPS eligible clinicians. For MIPS quality measures that do not meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods, we noted that we will factor in other considerations (such as, but not limited to: The robustness of the measure; whether it addresses a measurement gap; if the measure is a patient-reported outcome; and consideration of the MIPS quality measure in developing MVPs) prior to determining whether to remove the MIPS quality measure. (iii) Inventory of Quality Measures Section 1848(q)(2)(D)(i) of the Act requires the Secretary, through notice and comment rulemaking, to establish an annual final list of quality measures from which MIPS eligible clinicians may choose for the purpose of assessment under MIPS. Section 1848(q)(2)(D)(i)(II) of the Act requires that the Secretary annually update the list by removing measures from the list, as appropriate; adding new measures to the list, as appropriate; and determining whether measures that have undergone substantive changes should be update the list by removing measures from the list, as appropriate; adding new measures to the list, as appropriate; and determining whether measures that have undergone substantive changes should be included on the updated list. Previously finalized MIPS quality measures can be found in the CY 2025 PFS final rule (89 FR 98599 through 98954), CY 2024 PFS final rule (88 FR 79556 through 79964), CY 2023 PFS final rule (87 FR 70250 through 70633), CY 2022 PFS final rule (86 FR 65687 through 65968), CY 2021 PFS final rule (85 FR 85045 through 85377), CY 2020 PFS final rule (84 FR 63205 through 63513), CY 2019 PFS final rule (83 FR 60097 through 60285), CY 2018 Quality VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00366 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32717 Payment Program final rule (82 FR 53966 through 54174), and CY 2017 Quality Payment Program final rule (81 FR 77558 through 77816). We are proposing changes to the MIPS quality measure inventory, as set forth in Appendix 1 of this proposed rule, includ 4), and CY 2017 Quality Payment Program final rule (81 FR 77558 through 77816). We are proposing changes to the MIPS quality measure inventory, as set forth in Appendix 1 of this proposed rule, including the following: the addition of new measures; updates to specialty sets (that is, creation of new specialty sets; addition and/or removal of measures; and substantive changes to existing measures within specialty sets); removal of existing measures; and substantive changes to existing measures. For the CY 2026 performance period, we are proposing an inventory of 190 MIPS quality measures. The new MIPS quality measures that we are proposing to include in MIPS for the CY 2026 performance period/CY 2028 payment year and future years can be found in Table Group A of Appendix 1 of this proposed rule. For the CY 2026 performance period, we are proposing 5 new MIPS quality measures, which include 3 high priority measures, one of which is also patient-reported outcome measures. On January 4, 2025, we announced that we will be accepting recommendations for potential new specialty measure sets or revisions to existing specialty measure sets for year 10 (CY 2017 performance period/2019 MIPS pa 25, we announced that we will be accepting recommendations for potential new specialty measure sets or revisions to existing specialty measure sets for year 10 (CY 2017 performance period/2019 MIPS payment year through CY 2026 performance period/2028 MIPS payment year) of MIPS under the Quality Payment Program.372 The recommendations we received were based on the MIPS quality measures finalized in the CY 2025 PFS final rule and the 2024 MUC List; the recommendations include the addition or removal of current MIPS quality measures from existing specialty sets, and/or the creation of new specialty sets. All specialty set recommendations submitted for consideration were assessed and vetted, and as a result, the recommendations that we agree with are proposed in this proposed rule. We proposed modifications to existing specialty sets as described in Table Group B of Appendix 1 of this proposed rule. Modifications to specialty sets include the addition of new measures and/or existing measures within the MIPS quality measure inventory, removal of measures, and/or substantive changes to previously finalized 372 Message to the Quality Payment Program listserv on January 4, 2025, entitled ‘ es within the MIPS quality measure inventory, removal of measures, and/or substantive changes to previously finalized 372 Message to the Quality Payment Program listserv on January 4, 2025, entitled ‘‘The Centers for Medicare & Medicaid Services (CMS) is Soliciting Stakeholder Recommendations for Potential Consideration of New Specialty Measure Sets and/or Revisions to the Existing Specialty Measure Sets for the 2026 Performance Year of the Merit-based Incentive Payment System (MIPS).’’ measures. Specialty and subspecialty sets are not inclusive of every specialty or subspecialty. We develop and maintain specialty measure sets to assist MIPS eligible clinicians with selecting quality measures that are most relevant to their scope of practice. In addition to establishing new individual MIPS quality measures and modifying existing specialty sets as described in Tables Group A and Group B of Appendix 1 of this proposed rule, we referred readers to Table Group C of Appendix 1 of this PFS proposed rule for a list of MIPS quality measures proposed for removal and applicable rationale for each measure. In the 2025 PFS final rule (89 FR 98388), we codified previously finalized removal crit roposed rule for a list of MIPS quality measures proposed for removal and applicable rationale for each measure. In the 2025 PFS final rule (89 FR 98388), we codified previously finalized removal criteria for MIPS quality measures at 42 CFR 414.1330(c). Of the 10 MIPS quality measures proposed for removal, 1 MIPS quality measure is being proposed for removal at the measure steward’s request and is not aligned with current clinical guidelines), 4 MIPS quality measures are extremely topped out, 1 MIPS quality measure has reached the topped-out lifecycle, 1 MIPS quality measure is no longer able to be maintained by the measure steward, and 3 are process measures. For a detailed discussion of our rational for the removal of these measures please see Table Group C of Appendix 1 of this proposed rule. We have continuously communicated to interested parties our desire to reduce the number of process measures within the MIPS quality measure set (see, for example, 83 FR 59763 through 59765). The proposal to remove the MIPS quality measures described in Table Group C of Appendix 1 of this proposed rule would lead to a more parsimonious inventory of meaningful, robust measures in the program. e proposal to remove the MIPS quality measures described in Table Group C of Appendix 1 of this proposed rule would lead to a more parsimonious inventory of meaningful, robust measures in the program. Also, in Appendix 1 of this proposed rule, we are proposing substantive changes to 42 MIPS quality measures, which can be found in Table Group D of this proposed rule. We have previously established criteria that would apply when we are considering making substantive changes to a quality measure (81 FR 77137, and 86 FR 65441 through 65442). On an annual basis, we review the established MIPS quality measure inventory to consider updates to the measures. Possible updates to measures may be minor or substantive. The proposed inventory of 190 MIPS quality measures includes 187 MIPS quality measure available for utilization in traditional MIPS and MVPs, and 3 MIPS quality measures available only for utilization in MVPs (as finalized in the CY 2024 PFS final rule (88 FR 79897 through 77902)). In CY 2026 PFS proposed rule, we are proposing to modify the quality performance category measure inventory, a set of 190 MIPS quality measures for the CY 2026 performance period, which includes the fo n CY 2026 PFS proposed rule, we are proposing to modify the quality performance category measure inventory, a set of 190 MIPS quality measures for the CY 2026 performance period, which includes the following: • Implementation of 5 new MIPS quality measures including 3 high priority measures one of which is a patient reported outcome measure; • Removal of 10 MIPS quality measures: 1 quality measure at the measure steward’s request due to not being aligned with current clinical guidelines, 4 quality measures are extremely topped out, 1 quality measure has reached the end of the topped-out lifecycle, 1 measure where the measure steward is no longer able to maintain the quality measure, 3 process measures , and; • Substantive changes to 42 MIPS quality measures. We refer readers to Table Groups A through DD of Appendix 1 of this proposed rule for a summary of the new measures proposed, the measures proposed for removal, and the substantive changes proposed. We seek public comments on these proposals. (2) Cost Performance Category (a) Background Section 1848(q)(2)(A)(ii) of the Act includes resource use as a performance category under MIPS. We refer to this performance category as the c proposals. (2) Cost Performance Category (a) Background Section 1848(q)(2)(A)(ii) of the Act includes resource use as a performance category under MIPS. We refer to this performance category as the cost performance category. As required by sections 1848(q)(2) and (5) of the Act, the four performance categories of MIPS are used in determining the MIPS final score for each MIPS eligible clinician. In general, MIPS eligible clinicians are evaluated under all four of the MIPS performance categories, including the cost performance category. Section 1848(q)(2)(B)(ii) of the Act provides that, for the cost performance category, the measurement of resource use (that is, cost) for such period must be in accordance with section 1848(p)(3) of the Act, using the methodology under section 1848(r) as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Medicare Part D. Section 1848(p)(3) of the Act provides that costs shall be evaluated, to the extent practicable, based on a composite of appropriate measures of costs established by the Secretary that eliminate the effect of geographic adjustments in payment rates, and take into account risk factors (such as socio sed on a composite of appropriate measures of costs established by the Secretary that eliminate the effect of geographic adjustments in payment rates, and take into account risk factors (such as socioeconomic and demographic characteristics, ethnicity, and health status of individuals) and other factors determined appropriate by the Secretary. Section 1848(r) of the Act VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00367 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32718 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules specifies a series of steps and activities for the Secretary to undertake to involve physicians, practitioners, and other interested parties in enhancing the infrastructure for cost measurement, including for purposes of MIPS and Advanced APMs under section 1833(z) of the Act. We are proposing the following updates to the cost performance category beginning with the CY 2026 performance period/2028 MIPS payment year: • Modify the MIPS cost measure inventory as described in Appendix X of this rule; • Update the operational list of care episode and p inning with the CY 2026 performance period/2028 MIPS payment year: • Modify the MIPS cost measure inventory as described in Appendix X of this rule; • Update the operational list of care episode and patient condition groups and codes to reflect changes to service and diagnosis codes that define care episodes and patient condition groups, as identified through the annual maintenance of episode-based measures; and • Adopt a 2-year informational-only feedback period for new cost measures, where a measure would not impact MIPS cost performance category scores, final scores, or payment adjustments until the third year it is implemented. For a description of the statutory authority for and existing policies pertaining to the cost performance category, we refer readers to §§ 414.1350 and 414.1380(b)(2) and the CY 2017 Quality Payment Program final rule (81 FR 77162 through 77177), CY 2018 Quality Payment Program final rule (82 FR 53641 through 53648), CY 2019 PFS final rule (83 FR 59765 through 59776), CY 2020 PFS final rule (84 FR 62959 through 62979), CY 2021 PFS final rule (85 FR 84877 through 84881), CY 2022 PFS final rule (86 FR 65445 through 65461), CY 2023 PFS final rule (87 FR 700 gh 59776), CY 2020 PFS final rule (84 FR 62959 through 62979), CY 2021 PFS final rule (85 FR 84877 through 84881), CY 2022 PFS final rule (86 FR 65445 through 65461), CY 2023 PFS final rule (87 FR 70055 through 70057), CY 2024 PFS final rule (88 FR 79339 through 79349), and CY 2025 PFS final rule (89 FR 98390 through 98408). More details on the proposals in this section, which we invite comments on, are provided in section IV.A.4.d.(2)(b) through section IV.A.4.d.(2).(d). of this proposed rule. We also refer readers to section V.B.5.c. of this proposed rule for discussion on the burden estimates for these proposals. (b) Selection of Cost Measures In accordance with our statutory authority as described in section IV.A.4.d.(2)(a) of this proposed rule and our regulation at § 414.1350(a), we specify cost measures for a performance period to assess the performance of MIPS eligible clinicians on the cost performance category. We consider adoption of cost measures to support the transition from traditional MIPS to MVPs by allowing new MVPs to be created and enhancing existing MVPs. Additionally, adopting cost measures also increases the cost coverage of care episode and patient condition rom traditional MIPS to MVPs by allowing new MVPs to be created and enhancing existing MVPs. Additionally, adopting cost measures also increases the cost coverage of care episode and patient condition groups, moving closer towards the statutory goal of covering 50 percent of expenditures under Medicare Parts A and B, as specified under section 1848(r)(2)(i)(I) of the Act. In the CY 2022 PFS final rule (86 FR 65455 through 65459), we established common standards to ensure consistency across episode-based measures being considered for potential use in MIPS. Specifically, the CY 2022 PFS final rule requires that any episode- based measure for the cost performance category include the following: (1) episode definition based on trigger codes that determine the patient cohort; (2) attribution; (3) service assignment; (4) exclusions; and (5) risk adjustment. Additionally, in the CY 2025 PFS final rule (89 FR 98405), we codified removal criteria for the removal of MIPS cost measures from the MIPS cost measure inventory at § 414.1350. We may remove a cost measure from MIPS based on one or more of the following factors, provided however that we may retain a cost measure that meets one or mor IPS cost measure inventory at § 414.1350. We may remove a cost measure from MIPS based on one or more of the following factors, provided however that we may retain a cost measure that meets one or more of the following factors if we determine the benefit of retaining the measure outweighs the benefit of removing it. • It is not feasible to implement the measure specifications. • A measure steward is no longer able to maintain the cost measure. • The implementation costs or negative unintended consequences associated with a cost measure outweigh the benefit of its continued use in the MIPS cost performance category. • The measure specifications do not reflect current clinical practice or guidelines. • The availability of a more applicable measure, including a measure that applies across settings, applies across populations, or is more proximal in time to desired patient outcomes for the particular topic. We are not proposing to adopt any new measures for the CY 2026 performance period/2028 MIPS payment year. We are also not proposing to remove any measures for the CY 2026 performance period/2028 MIPS payment year. (c) Inventory of Cost Measures As discussed previously, we specify co 028 MIPS payment year. We are also not proposing to remove any measures for the CY 2026 performance period/2028 MIPS payment year. (c) Inventory of Cost Measures As discussed previously, we specify cost measures for a performance period to assess the performance of MIPS eligible clinicians on the cost performance category. While the requirement to annually issue a list of final measures as set forth in section 1848(q)(2)(D)(i) of the Act only applies to quality measures adopted for the MIPS quality performance category, we have applied some of these requirements for cost measures. Section 1848(q)(2)(D)(i) of the Act requires the Secretary, through notice and comment rulemaking, to establish an annual final list of quality measures from which MIPS eligible clinicians may choose for the purpose of assessment under MIPS. Section 1848(q)(2)(D)(i)(II) of the Act requires that the Secretary annually update the list of quality measures by removing measures from the list, as appropriate; adding new measures to the list, as appropriate; and determining whether measures that have undergone substantive changes should be included on the updated list. In the CY 2022 PFS final rule, we stated th g new measures to the list, as appropriate; and determining whether measures that have undergone substantive changes should be included on the updated list. In the CY 2022 PFS final rule, we stated that section 1848(q)(2)(D)(i)(II)(cc) of the Act, which requires all substantive changes to quality measures to be proposed and identified through notice-and-comment rulemaking, also should apply to cost measures (86 FR 65459). On an annual basis, we review the established MIPS cost measure inventory to consider updates to the measures identified through measure maintenance reviews. The CMS Measure Maintenance System (MMS) provides additional information about measure maintenance review processes and best practices (https:// mmshub.cms.gov/measure-lifecycle/ measure-use/maintenance/overview). Possible updates to measures may be minor or substantive. In the CY 2022 PFS final rule, we finalized several criteria for determining whether a proposed change to a cost measure would be substantive beginning with the CY 2022 performance period/2024 MIPS payment year (86 FR 65459 and 65460). Section 1848(r)(10) of the Act provides that the pre-rulemaking requirements set forth in sections 1890(b)(7 ginning with the CY 2022 performance period/2024 MIPS payment year (86 FR 65459 and 65460). Section 1848(r)(10) of the Act provides that the pre-rulemaking requirements set forth in sections 1890(b)(7) and 1890A of the Act do not apply to our development of MIPS cost measures under section 1848(r) of the Act. Historically, we have subjected existing cost measures for which we are considering substantive changes to the pre-rulemaking process required by section 1890A of the Act prior to notice- and-comment rulemaking. There are currently 35 cost measures in the cost performance category for the CY 2025 performance period/2027 MIPS payment year, comprising 33 episode- based measures covering a range of conditions and procedures and 2 population-based measures. Previously finalized MIPS cost measures can be found in the CY 2018 Quality Payment VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00368 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32719 Program final rule (82 FR 53641 through 53648), CY 2019 PFS final rule (8 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32719 Program final rule (82 FR 53641 through 53648), CY 2019 PFS final rule (83 FR 59765 through 59776), CY 2020 PFS final rule (84 FR 62959 through 62979), CY 2021 PFS final rule (85 FR 84877 through 84881), CY 2022 PFS final rule (86 FR 65445 through 65461), CY 2023 PFS final rule (87 FR 70055 through 70057), CY 2024 PFS final rule (88 FR 79339 through 79349), and CY 2025 PFS final rule (89 FR 98390 through 98408). We are neither proposing any new MIPS cost measures nor proposing to remove any MIPS cost measures for the CY 2026 performance period/2028 MIPS payment year. We are proposing substantive changes to the Total Per Capita Cost (TPCC) measure, one of the 2 population-based measures, which can be found in Table Group A of Appendix X of this proposed rule, beginning with the CY 2026 performance period/2028 MIPS payment year. We invite comments on the proposal in this section. (d) Proposed Revisions to the Operational List of Care Episode and Patient Condition Groups and Codes Generally, to calculate MIPS eligible clinicians’ performance on cost measures, in this section. (d) Proposed Revisions to the Operational List of Care Episode and Patient Condition Groups and Codes Generally, to calculate MIPS eligible clinicians’ performance on cost measures, we use codes from claims data to identify and apply each cost measure’s specifications, which govern the attribution, scope, and calculation of the cost measure. We are proposing revisions to the operational list of care episode and patient condition groups and codes to reflect to reflect coding changes due to annual measure maintenance of implemented cost measures. This section of this proposed rule provides context on the statutory requirements for care episode and patient condition groups and proposes changes to the operational list. Section 1848(r) of the Act specifies a series of steps and activities for the Secretary to undertake to involve physicians, practitioners, and other interested parties in enhancing the infrastructure for cost measurement, including for purposes of MIPS and Advanced APMs under section 1833(z) of the Act. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups, and provi Advanced APMs under section 1833(z) of the Act. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups, and provides for care episode and patient condition groups to account for a target of an estimated one-half of expenditures under Medicare Parts A and B (with this target increasing over time as appropriate). Sections 1848(r)(2)(E) through (G) of the Act require the Secretary to post on the CMS website a draft list of care episode and patient condition groups and codes for solicitation of input from interested parties, and subsequently, post an operational list of such groups and codes. Section 1848(r)(2)(H) of the Act requires that not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list of care episode and patient condition codes as the Secretary determines may be appropriate, and that these revisions may be based on experience, new information developed under section 1848(n)(9)(A) of the Act, and input from physician specialty societies and other interested parties. For more information about past revisions to the oper