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 EBCM episodes related to ASM’s targeted chronic conditions from CY 2023 and Medicare FFS claims data. We reviewed these assumptions and determined them to be reasonable for the estimates. We simulated an ASM final score based on the methodology described in sections III.D.2.d and III.D.2.e of this proposed rule. For scoring the quality ASM performance category, we first made assumptions on who would report based on whether clinicians were engaged in the CY 2023 MIPS performance period/ 2025 MIPS payment year and submitted data. We believe that historical engagement and submission of data to MIPS would be an appropriate predictor of an ASM’s participant likelihood to submit data to meet ASM’s requirements. For clinicians we identified as engaged, we assumed the ASM participants would report all required quality measures (meeting data completeness requirements and case minimum requirements) as discussed in section III.D.2.d.(2). For ASM participants who were eligible for the 2023 MIPS performance period/2025 MIPS payment year, we generally assigned participants as engaged or not engaged based on their 2023 MIPS participation. We carved out an exception for clinicians who were labeled rformance period/2025 MIPS payment year, we generally assigned participants as engaged or not engaged based on their 2023 MIPS participation. We carved out an exception for clinicians who were labeled ‘‘not engaged’’ in MIPS but had MIPS final scores of 75 as we believe most of these clinicians received extreme and uncontrollable circumstances approval (which would result in a final score of 75 points equal to the MIPS performance threshold).429 For these participants, we cleared the engaged status flag. For ASM participants who did not have a populated engaged status flag (either because they were not eligible for CY 2023 MIPS performance period/2025 MIPS payment year or because we cleared their engaged status flag as described earlier), we randomly assigned engaged and not engaged flags, based on practice size, to mimic the proportion of ASM participants who were engaged and not engaged in the CY 2023 MIPS performance period/2025 MIPS payment year. This process resulted in all ASM participants receiving an engaged or not engaged assumption for the purpose of simulating a final score and payment adjustment. In calculating a quality ASM performance category score for engaged partic rticipants receiving an engaged or not engaged assumption for the purpose of simulating a final score and payment adjustment. In calculating a quality ASM performance category score for engaged participants (and we assumed participants would submit all quality measures meeting data completeness and case minimum requirements), we 429 We also excluded one participant, who was facility-based, who had a score greater than 75. did not have adequate historical MIPS performance data for the proposed measures in sections III.D.2.d.(2).(b) and III.D.2.d.(2).(c). Therefore, we randomly assigned measure achievement points for each proposed ASM measure. The values ranged from 1 to 10 based on decile benchmarks to simulate performance using benchmarks based on ASM participants only. We recognize that this method may not accurately assign performance for an individual. However, we believe it approximates the relative differences within a benchmark distribution and represents the best available approach given that most ASM participants that previously participated in MIPS did not submit the proposed quality ASM performance category measures in MIPS. For the ASM participants we identified as not e ach given that most ASM participants that previously participated in MIPS did not submit the proposed quality ASM performance category measures in MIPS. For the ASM participants we identified as not engaged and assumed would not submit quality measures, we assigned a score of zero for the quality ASM performance category. Ultimately, these non-engaged ASM participants received an ASM final score of zero in our model for not meeting the required minimum data submission requirements, as discussed in section III.D.2.e.(2). For the cost ASM performance category score proposed in section III.D.2.d.(3), we assigned measure achievement points and calculated a cost ASM performance category score using heart failure and low-back pain episode-based cost measure files based on CY 2023 administrative claims data. To simulate the improvement activity ASM performance category score and scoring adjustment that is proposed in section III.D.2.d.(4).(d), we relied on the same engagement assumptions that we used for the quality ASM performance category. We assumed that engaged ASM participants would also report all the required improvement activities. These ASM participants would have an improvement we used for the quality ASM performance category. We assumed that engaged ASM participants would also report all the required improvement activities. These ASM participants would have an improvement activities ASM performance category score of 100 percent and would not have any negative ASM improvement activities scoring adjustment. For ASM participants we identified as not engaged, we assigned an ASM performance category score of zero and an improvement activities ASM performance category scoring adjustment of negative 20 points. For the Promoting Interoperability ASM performance category, we calculated the Promoting Interoperability ASM performance category score and scoring adjustment discussed in section III.D.2.d.(5).(e) using proxies for the Promoting Interoperability ASM performance category score. Our primary proxy for VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00461 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 32812 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules the Promoting Interoperability ASM performance category score was to use the CY 2023 M 9 K S D n o d n o m m a h k 32812 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules the Promoting Interoperability ASM performance category score was to use the CY 2023 MIPS performance period/ 2025 MIPS payment year Promoting Interoperability performance category score where it was available. The Promoting Interoperability ASM performance category scoring adjustment was calculated using the formula discussed in III.D.2.e.(1). of this proposed rule. If an ASM participant was not eligible for the 2023 MIPS performance period/2025 MIPS payment year, we assumed that the Promoting Interoperability ASM performance category score would be 100, as over half of potential ASM participants that were eligible in the CY 2023 MIPS performance period/2025 MPS payment year and reported Promoting Interoperability information had a Promoting Interoperability performance category score of 100. ASM participants with a Promoting Interoperability ASM performance category score of 100 would not have a negative scoring adjustment for the Promoting Interoperability ASM performance category. For ASM participants who were in the CY 2023 MIPS performance period/2025 MIPS payment of 100 would not have a negative scoring adjustment for the Promoting Interoperability ASM performance category. For ASM participants who were in the CY 2023 MIPS performance period/2025 MIPS payment year but did not have a 2023 MIPS Promoting Interoperability performance category score because the performance category was reweighted, we assumed these participants may not have CEHRT and thus may not be able to report measures for the Promoting Interoperability ASM performance category. For these ASM participants, we assumed a Promoting Interoperability ASM performance category score of 0 which translates into a Promoting Interoperability ASM performance category scoring adjustment of negative 10 points. We anticipate that these clinicians could use CEHRT in the future and that we may be overestimating the number of ASM participants without CEHRT. Finally, we simulated a final score for each ASM participant using the formula proposed in section III.D.2.e. of this proposed rule. As described in this same section, we utilized scores for the quality and cost ASM performance categories and the scoring adjustments for the improvement activities and Promoting Interoperability ASM perform ribed in this same section, we utilized scores for the quality and cost ASM performance categories and the scoring adjustments for the improvement activities and Promoting Interoperability ASM performance categories. We also calculated a complex patient scoring adjustment, described in section III.D.2.e.(3). of this proposed rule, and applied a small practice scoring adjustment, described in section III.D.2.e.(4). of this proposed rule, using variables in the Quality Payment Program final eligibility file for the CY 2023 MIPS performance period/2025 MIPS payment year. As described earlier in this section, any ASM participants who we assumed would not be engaged, were assigned a final score of zero points. Using the simulated final scores for ASM participants, we simulated the resulting payment adjustments using the methods described in section III.D.2.f of this proposed rule. We used Medicare Part B paid amounts from claims for covered professional services in CY 2023 to calculate each ASM incentive pool. For each ASM cohort, we calculated the scaling factor and the resulting ASM payment adjustment factor and ASM payment multiplier for each ASM participant based on their final scor ASM incentive pool. For each ASM cohort, we calculated the scaling factor and the resulting ASM payment adjustment factor and ASM payment multiplier for each ASM participant based on their final score and the proposed logistic exchange function with a midpoint at the median final score for the applicable ASM cohort. We seek comments on our methods to estimate an ASM final score, ASM payment adjustment factor, and ASM payment multiplier for each ASM participant. (3) Medicare Estimates In this proposed rule, we summarize the estimated impact of ASM in Table 93. We estimate a net impact of $155.5 million in net savings to the Medicare program due to ASM from January 1, 2029 through December 31, 2033. The estimated impact reflects the proposed provisions described in this proposed rule. To summarize relevant proposed provisions, we propose a model test period covering five ASM performance years from January 1, 2027 through December 31, 2031 with payment adjustments occurring in corresponding ASM payment years from January 1, 2029 through December 31, 2033. As discussed earlier in this section of this proposed rule, we propose that ASM would operate in 25 percent of all CBSAs and metro ing ASM payment years from January 1, 2029 through December 31, 2033. As discussed earlier in this section of this proposed rule, we propose that ASM would operate in 25 percent of all CBSAs and metropolitan divisions. We also propose a payment methodology at § 512.750 under which ASM participants would be subject to a maximum risk level for each ASM payment year, which we propose would range from 9 percent to 12 percent over the ASM test period, and under which an ASM participant would receive an ASM payment adjustment factor based on their final score and the amount of each ASM incentive pool redistributed to each ASM cohort in the form of scaled payment adjustments. The estimated impact uses Medicare Part B paid amounts for covered professional services attributed to the simulated ASM participants in CY 2023 to determine the baseline spending. We trended the baseline spending in CY 2023 forward to the ASM payment years (CY 2029 through CY 2033) using the trend assumptions underlying the 2024 Medicare Trustees Report. We calculated the financial impact percentage as the downward ASM risk level (that is, the percentage of ASM participant spending at risk for each ASM participant f the 2024 Medicare Trustees Report. We calculated the financial impact percentage as the downward ASM risk level (that is, the percentage of ASM participant spending at risk for each ASM participant for a given ASM payment year) multiplied by 15 percent (that is, the average amount of the ASM incentive pool that would not be distributed to ASM participants in the form of payment adjustments). We applied this financial impact percentage to the trended baseline spending for each ASM payment year. The estimates in Table 93 do not account for behavioral effects that could occur as a result of implementing ASM. We refer readers to the sensitivity analysis later in this section of this proposed rule for further discussion on potential behavioral effects on spending as a result of ASM. Thus, we estimate that the Medicare program would save $155.5 million over ASM’s model test period. This estimate excludes changes in beneficiary cost sharing liability to the extent it is not a Federal outlay under the policy. 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 00462 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 1 under the policy. 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 00462 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32813 We welcome public comments on our estimated impact of ASM on the Medicare program. (i) Sensitivity Analysis ASM participants would receive payment adjustments based on their final scores. We expect these payment adjustments to incentivize participants to improve their ASM performance category scores, which could impact costs. The degree to which the participants would be incentivized to alter their behavior would depend on the magnitude of the payment adjustments, and the magnitude of the payment adjustment, including whether it is positive or negative, depends on the distribution of final scores used in the payment adjustment calculation. Since that distribution is unknown, we have not incorporated behavioral effects into the estimate. There is evidence that shows that delivering higher-value care could lead to savings for Medicare. For example, better adherence to clinical guidelines for heart behavioral effects into the estimate. There is evidence that shows that delivering higher-value care could lead to savings for Medicare. For example, better adherence to clinical guidelines for heart failure patients under ASM could reduce the number of hospitalizations that occur among ASM beneficiaries. Since hospitalizations and associated costs comprise a large share of total heart failure patient spending, such changes could reduce spending significantly. Similarly, improved adherence to clinical guidelines for low back pain could lead to lower rates of imaging service use, fewer invasive surgeries, and lower spending among ASM beneficiaries. However, it is unknown how well these changes in care patterns could ultimately be implemented. Alternatively, some of the quality measures used in determining final scores could motivate ASM participants to deliver more services than they would have absent the model. For example, preventive care and screening metrics for BMI and depression could incentivize participants to provide more care for some patients with low back pain, and metrics on controlling high blood pressure could have a similar effect. Another consideration is that ASM could incentivize participants to provide more care for some patients with low back pain, and metrics on controlling high blood pressure could have a similar effect. Another consideration is that ASM participants could react to negative payment adjustments with adverse behavior (for example, increasing coding intensity) to help offset revenue losses. To explore the potential financial impacts of these behavioral effects, we adjusted the original impact estimates under several illustrative scenarios using different amounts of behavioral effects, measured in percent change in spending. Table 94 shows estimated financial impacts on total Medicare Parts A and B spending from heart failure and low back pain episodes attributed to our simulated ASM participants based on the estimated behavioral effect levels. The estimated financial impacts presented in Table 94 present one set of assumptions on the behavioral effect on spending; the behavioral impact on spending could be larger in magnitude than the illustrative scenarios here. The resulting financial impact estimates (in millions of dollars) of each scenario in Table 94 represent the total estimated impact across ASM’s test period. 3 S than the illustrative scenarios here. The resulting financial impact estimates (in millions of dollars) of each scenario in Table 94 represent the total estimated impact across ASM’s test period. 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 We welcome public comments on our sensitivity analysis related to the estimated financial impacts of ASM. d. Effects on the Market There could be spillover effects in the non-Medicare market, because of the implementation of ASM. Testing changes in Medicare payment policy may have implications for non-Medicare payers. For example, non-Medicare patients may benefit if participating providers and suppliers introduce system-wide changes that improve the coordination and quality of health care. Other payers may also be developing payment models and may align their payment structures with CMS or may be waiting to utilize results from CMS’ evaluations of payment models. Because there is uncertainty whether and how this evidence applies to a test of these new payment models, our analyses assume that spillover effects on non- VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00463 Fmt 4701 Sfmt 4702 E:\FR\FM\16J ence applies to a test of these new payment models, our analyses assume that spillover effects on non- VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00463 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00464 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 32815 penetration in 2023 to construct a de facto counterfactual similar to the study in the December 2018 final rule. An alternate method, however, continues to show spending trends inversely correlated with ACO penetration over time. Roughly five percent of beneficiaries live in HRRs with ACO penetration consistently below the national average by 10 percentage points or more over the 2013 to 2023 time series (‘‘Lagging’’) while about 9 percent of beneficiaries live in HRRs with ACO penetration 10 percentage points or more above the national average over the same period (‘‘Leading’’). Relative to the 2011 base year immediately preceding the Shared Savings Program’s introduction, growth in average unadjust points or more above the national average over the same period (‘‘Leading’’). Relative to the 2011 base year immediately preceding the Shared Savings Program’s introduction, growth in average unadjusted per capita spending in 2023 for Lagging and Leading markets was 4.3 percent higher and 3.9 percent lower than the national average. The divergence in spending growth was even wider after HCC risk adjustment: 5.3 percent higher for Lagging markets and 4.6 percent lower for Leading markets. These market trends potentially overstate the impact that ACOs may have had on program spending in 2023. The portion of the difference in spending growth driven by risk adjustment may reflect efforts by ACOs to increase coding intensity. Leading markets may exhibit higher participation rates in CMMI models. ACO participation may naturally flock to markets with lower trend for exogenous reasons. Still, conservatively assuming only 35 percent of the unadjusted trend gap is causally related to Shared Savings Program ACOs would roughly validate the $5.2 billion gross savings indicated by comparing aggregate program benchmarks to actual ACO spending in 2023, and the roughly $2 billion in net savings to ngs Program ACOs would roughly validate the $5.2 billion gross savings indicated by comparing aggregate program benchmarks to actual ACO spending in 2023, and the roughly $2 billion in net savings to FFS Medicare. A more optimistic estimate, assuming Shared Savings Program ACOs were responsible for 50 percent of the risk-adjusted spending growth difference (mirroring assumptions used in the December 2018 final rule), would imply net savings roughly three times greater, or roughly $6 billion net savings for FFS Medicare. A study of benchmark performance for cohorts of ACOs that participated in both performance year 2022 and performance year 2023 (with related details in Table 95) reveals that the BASIC track is the primary driver of net savings (as measured by program benchmark target spending less actual spending and shared savings payments). Twenty-five ACOs moved from a one- sided model of the BASIC track (Level A or B) to a two-sided model of the BASIC track (Level C, D or E) over performance year 2022 to 2023 and showed the highest rates of net savings to the program at 2.4 percent of benchmark. One hundred six ACOs remained in two-sided models of the BASIC track (Levels C, D o erformance year 2022 to 2023 and showed the highest rates of net savings to the program at 2.4 percent of benchmark. One hundred six ACOs remained in two-sided models of the BASIC track (Levels C, D or E) over that same two-year period and reached 2.3 percent net savings. Both cohorts showed the lowest average unadjusted per capita spending trend over this two- year period at about 6 percent. One hundred thirty-nine ACOs remained in one-sided models of the BASIC track (Level A or B) over both years and saw net savings grow from 1.4 percent to 1.7 percent by 2023. The 135 ACOs that remained in the ENHANCED track over these 2 years showed 1.3 percent net savings in 2023, up slightly from 1.2 percent for 2022. Findings are compared for each cohort in the study in Table 95. 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 00465 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00466 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00467 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O 25 Jkt 265001 PO 00000 Frm 00466 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00467 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 H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00468 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 32819 Beginning with QP Performance Period 2019 (payment year 2021), in addition to the Medicare Option, the All-Payer Combination Option also affords eligible clinicians an opportunity at QP status. The All-Payer Combination Option allows eligible clinicians to become QPs by assessing a combination of both Medicare Part B covered professional services furnished or patients through Advanced APMs and services furnished or patients through Other Payer Advanced APMs. Eligible clinicians who become QPs for a given QP Performance Period are not subject to MIPS reporting requirements and payment adjustments for the contemporaneous MIPS performance period/payment Ms. Eligible clinicians who become QPs for a given QP Performance Period are not subject to MIPS reporting requirements and payment adjustments for the contemporaneous MIPS performance period/payment year. Eligible clinicians who do not become QPs but who meet a lower threshold requirement to become Partial QPs for the year may elect whether or not to report to MIPS. If they elect to report, they are scored in and receive a payment adjustment under MIPS. Partial QPs are not eligible to receive the APM Incentive Payment. If an eligible clinician does not attain either QP or Partial QP status and is not excluded from MIPS on another basis, the eligible clinician will be subject to the MIPS reporting requirements and will receive the corresponding MIPS payment adjustment. Separately from the APM Incentive Payment, beginning in payment year 2026, there are two separate PFS CFs— one for eligible clinicians who are QPs for the year (the qualifying APM CF), and the other for all non-QP eligible clinicians and other suppliers paid under the PFS (the non-qualifying APM CF). The update to the qualifying APM CF for a year is 0.75 percent, whereas the update to the non-qualifying APM CF for a le clinicians and other suppliers paid under the PFS (the non-qualifying APM CF). The update to the qualifying APM CF for a year is 0.75 percent, whereas the update to the non-qualifying APM CF for a year is 0.25 percent. For payment year 2026, under current law, both an APM Incentive Payment and the qualifying APM CF will apply. This means that eligible clinicians who attained QP status for QP Performance Period 2024 will receive a lump-sum payment of 1.88 percent of their 2025 covered professional services paid claims as described above, and additionally their 2026 covered professional services claims will be paid using the physician fee schedule rates that are established using the 0.75 percent QP APM CF. In addition, the thresholds to achieve QP status beginning in the 2026 QP Performance Period (2028 payment year) will increase from 50 percent to 75 percent for the payment amount, and from 35 percent to 50 percent for the patient count. Overall, we estimated that for the 2026 QP Performance Period, between 375,000 and 482,200 eligible clinicians will become QPs, and therefore will be excluded from MIPS reporting requirements and payment adjustments. In addition, the thresholds erformance Period, between 375,000 and 482,200 eligible clinicians will become QPs, and therefore will be excluded from MIPS reporting requirements and payment adjustments. In addition, the thresholds to achieve QP status beginning in the 2026 QP Performance Period will increase to 75 percent for the payment amount, and 50 percent for the patient count. Overall, we estimated that for the 2026 QP Performance Period, between 375,000 and 482,200 eligible clinicians will become QPs, and therefore be excluded from MIPS reporting requirements and payment adjustments. In section IV.A.4.m.(2) of the CY2026 PFS proposed rule, we proposed to modify the definition of ‘‘attribution- eligible beneficiary’’ to include any beneficiary who has received a covered professional service furnished by the eligible clinician (NPI) for whom we are making the QP determination. However, we are not finalizing this proposal and therefore no impact of this policy is included in the estimated number of QPs provided above. We projected the number of eligible clinicians who will be QPs, and thus excluded from MIPS, using several sources of information. First, the projections are anchored in the most recently avai above. We projected the number of eligible clinicians who will be QPs, and thus excluded from MIPS, using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs. The projections reflect Advanced APMs that will be operating during the 2026 QP Performance Period, as well as some Advanced APMs anticipated to be operational during the 2026 QP Performance Period. The projections also reflect an estimated number of eligible clinicians who will attain QP status through the All-Payer Combination Option. The following APMs are expected to be Advanced APMs for the 2026 QP Performance Period: • ACO REACH Model (formerly Global and Professional Direct Contracting) Model; • States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model • Enhancing Oncology Model (EOM); • Kidney Care Choices Model (Comprehensive Kidney Care Contracting Options, Professional Option and Global Option); • Medicare Shared Savings Program (Level E of the BASIC Track and the ENHANCED Track); and • Transforming Episode Accountability Model (TEAM) We used the Participation Lists and Affiliated Practitioner Lists, as appli Savings Program (Level E of the BASIC Track and the ENHANCED Track); and • Transforming Episode Accountability Model (TEAM) We used the Participation Lists and Affiliated Practitioner Lists, as applicable (see § 414.1425(a) for information on the APM Participant Lists used for QP determinations) for the 2024 QP performance period third snapshot QP determination date to estimate the number of QPs for the 2026 QP Performance Period. For models starting in the 2026 QP Performance Period we estimated performance based on projected participation. We examined the extent to which Advanced APM participants will meet the QP Thresholds of having at least 75 percent of their Part B covered professional services or at least 50 percent of their Medicare beneficiaries were attribution eligible through the APM Entity. c. Estimated Number of MIPS Eligible Clinicians in the CY 2026 Performance Period/2028 MIPS Payment Year (1) Initial Population of Clinicians Included in the RIA Baseline and Proposed Policies Models For this proposed rule, we applied the same assumptions as in the CY 2025 PFS final rule (89 FR 98532) to estimate our initial population of clinicians using 2023 performance data. Spe Policies Models For this proposed rule, we applied the same assumptions as in the CY 2025 PFS final rule (89 FR 98532) to estimate our initial population of clinicians using 2023 performance data. Specifically, we used the CY 2023 final reconciled eligibility determination file, same as the 2022 file described in the CY 2025 PFS final rule (88 FR 79505). This file reconciles eligibility from two determination periods and aligns with the CY 2023 performance period submissions data on which we based this model. Our analysis included 1,889,733 clinicians with PFS claims in this initial population. This initial population of clinicians was used to determine eligibility using the methodology described in the following sections. (2) Estimated Number of MIPS Eligible Clinicians After Applying Eligibility Assumptions (a) Methods and Assumptions Used To Estimate Eligibility After identifying the clinician population with PFS claims, we applied the same eligibility assumptions and determination process described in the CY 2025 PFS final rule (89 FR 97710). We are not proposing any modifications to MIPS eligibility requirements and the same eligibility assumptions apply to both the baseline a process described in the CY 2025 PFS final rule (89 FR 97710). We are not proposing any modifications to MIPS eligibility requirements and the same eligibility assumptions apply to both the baseline and proposed policies model. For our impact analysis model, we established the ‘‘required eligibility’’ category, which means the clinician exceeds the low-volume threshold in all 3 criteria (§§ 414.1305 and 414.1310(b)(1)(iii)) and is subject to a MIPS payment adjustment. We based this estimate on the CY 2023 performance period data described in this section of this proposed rule, which includes the 3 low volume criteria. Within the eligible clinicians, we divided them into two groups- VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00469 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 32820 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules clinicians who report MIPS data and clinicians who do not report MIPS data. Our next two eligibility assumptions concern clinicians in groups, who may voluntarily participate in MIPS, but are not required to participate. First, we esti clinicians who do not report MIPS data. Our next two eligibility assumptions concern clinicians in groups, who may voluntarily participate in MIPS, but are not required to participate. First, we estimate group eligibility. These are the clinicians who have a group submission, and their group exceeds the low-volume threshold in all 3 criteria. Next, we apply our opt-in eligibility assumptions. Individuals or groups who exceed the low-volume threshold in at least 1 criterion, but not all 3, may elect to opt in. Based on the number of individuals who opted in to MIPS for the CY 2023 performance period/2025 MIPS payment year, our model estimates that these clinicians will continue to opt in to MIPS. After applying the process outlined in this section of this proposed rule, we then estimate the number of ‘‘Potentially MIPS Eligible’’ clinicians. These clinicians are not included in our total number of MIPS eligible clinicians. These clinicians are potentially eligible; however, they do not choose to report to MIPS. Finally, we estimated the number of clinicians who are neither MIPS eligible nor potentially MIPS eligible. First, we estimated the number of clinicians who are below all 3 choose to report to MIPS. Finally, we estimated the number of clinicians who are neither MIPS eligible nor potentially MIPS eligible. First, we estimated the number of clinicians who are below all 3 low-volume criteria (both as an individual and as a group) using the CY 2023 performance data as outlined in this section of this proposed rule. Next, we estimated the number of QPs (not MIPS eligible). Also in this proposed rule, we estimated a range of QPs. For the purposes of our impact analysis, we estimate a specific number of QPs because a specific number of clinicians is needed to simulate the impacts of our proposed policies on participation, final scores, and payment adjustments. Finally, we estimate the number of clinicians who are excluded for other reasons, for example, they are in a clinician type that is not MIPS eligible or newly enrolled in Medicare. After applying these assumptions to our initial population, we estimate that there will be 607,419 MIPS eligible clinicians with ∼$51.84 billion in allowed charges in CY2026. (b) MIPS Eligibility Estimates For the impact analysis, we use the estimated population of 607,419 MIPS eligible clinicians described previously in th ith ∼$51.84 billion in allowed charges in CY2026. (b) MIPS Eligibility Estimates For the impact analysis, we use the estimated population of 607,419 MIPS eligible clinicians described previously in this section of this proposed rule. Table 99 summarizes our eligibility estimates for the policies model after applying our assumptions outlined in this section of this proposed rule. 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 00470 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32821 BILLING CODE 4120–01–C d. Modeling Approach and Methods for MIPs Value Pathways (MVPs) and Traditional MIPS (1) Summary of Approach In this proposed rule, we present several proposals that impact the measures and activities, the performance category scores, final scores, and MIPS payment adjustments for MIPS eligible clinicians. In section VII.I.5.d(3). of this proposed rule, we outline these changes in more detail and describe our methodology to estimate MIPS payment adjustments for the CY 2026 performance period/2 inicians. In section VII.I.5.d(3). of this proposed rule, we outline these changes in more detail and describe our methodology to estimate MIPS payment adjustments for the CY 2026 performance period/2028 MIPS payment year. We then present the impact of the policies in the CY 2026 performance period/2028 MIPS payment year and compare select metrics to the baseline model. By comparing model outputs in the baseline model to the proposed policies model, we are able to observe the impact of the policies for the CY 2026 performance period/2028 MIPS payment year. MIPS eligible clinicians’ final scores are calculated based on the clinicians’ performance on measures and activities specified under the four MIPS performance categories: quality, cost, improvement activities, and Promoting Interoperability. MIPS eligible clinicians can participate in the four MIPS performance categories as an individual, group, virtual group, APM Entity and via traditional MIPS, the APM Performance Pathway (APP), or MVP reporting options. MIPS APM participants can participate in the APP VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00471 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P r MVP reporting options. MIPS APM participants can participate in the APP VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00471 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 00472 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 32823 category score as described in the CY 2025 PFS final rule (89 FR 79508) including alignment with the clarification provided regarding IA automatic weighting for APM participants (89 FR 79366). In section IV.A.4.d.(3).(b). of this proposed rule, we propose to amend § 414.1355(c)(7) by adding a new subcategory, ‘‘Advancing Health and Wellness’’ (AHW), to replace the ‘‘Achieving Health Equity’’ subcategory.’’ We proposed adding three new Improvement Activities while removing eight existing ones. However, the three new measures were not included in the RIA model because we lack historical benchmark data to estimate their potential impact. Additionally, the eight e removing eight existing ones. However, the three new measures were not included in the RIA model because we lack historical benchmark data to estimate their potential impact. Additionally, the eight measures being removed were also excluded from the RIA model, as the models cannot predict how clinicians will alter their behavior once these measures are removed. (e) Methodology To Estimate the Complex Patient Bonus Points This proposed rule does not include proposals to modify the complex patient bonus. Therefore, for the baseline and proposed policies RIA model, we used the previously established method to calculate the complex patient bonus as described in the CY 2022 PFS final rule (86 FR 64996). (f) Methodology To Estimate the Final Score We are not proposing any changes to how we calculate the MIPS final score. Our baseline and proposed policies models assigned a final score for each TIN/NPI by multiplying each estimated performance category score by the corresponding performance category weight, adding the products together, multiplying the sum by 100 points, adding the complex patient bonus, and capping at 100 points. For both models, after adding any applicable complex pat category weight, adding the products together, multiplying the sum by 100 points, adding the complex patient bonus, and capping at 100 points. For both models, after adding any applicable complex patient bonus, we reset any final scores that exceeded 100 points to equal 100 points. For MIPS eligible clinicians who were assigned a weight of zero percent for any performance category, we redistributed the weights according to § 414.1380(c). For the purposes of this model, if a MIPS eligible clinician was approved for reweighting of one or more performance category to zero percent of their final score, and the category’s weight redistributed to other performance category(ies), for the CY 2023 performance period/2025 MIPS payment year (which was the data source used in our model) in accordance with our reweighting policies under § 414.1380(c)(2), then we continue to apply that reweighting in our model by assigning them a neutral score equal to the performance threshold if all categories were reweighted or assigning the applicable weights to the categories which were reweighted. Although it is unlikely (but possible) that the exact same clinicians will apply for and receive reweighting re reweighted or assigning the applicable weights to the categories which were reweighted. Although it is unlikely (but possible) that the exact same clinicians will apply for and receive reweighting in both the CY 2023 performance period/2025 MIPS payment year (which our data is based on) and the CY 2026 performance period/2028 MIPS payment year (which we are simulating), we believe that this assumption accurately reflects future clinician behavior for two reasons. First, while the exact same MIPS eligible clinicians may not receive reweighting in 2 different years, we believe that this assumption allows us to quantify the impact of the reweighting on a population level. In other words, even if the same clinicians do not apply for and receive reweighting in these 2 different years, the absolute number of reweighting and the characteristics of practices that receive reweighting are likely to remain similar. Secondly, if we were to not assign reweighting to those MIPS eligible clinicians, many of them would receive a very low final score because they did not submit data for one or more performance categories during the year in which they received reweighting. We do not believe that s, many of them would receive a very low final score because they did not submit data for one or more performance categories during the year in which they received reweighting. We do not believe that it is a realistic assumption that, in the absence of reweighting, those clinicians will continue not to submit data. For these reasons, we assume that clinicians who received reweighting in the CY 2023 performance period/2025 MIPS payment year are also approved for reweighting in the CY 2026 performance period/2028 MIPS payment year. These clinicians are assigned a score of the performance threshold (75) in our model because this corresponds with a neutral (0 percent) payment adjustment. (g) Methodology To Estimate the MIPS Payment Adjustment For the baseline and proposed policies models, we applied the hierarchy as finalized in the CY 2023 PFS final rule (86 FR 65536 through 65537) to determine which final score should be used for the payment adjustment for each MIPS eligible clinician when more than one final score is available. We then calculate the parameters of an exchange function in accordance with the statutory requirements related to the linear sliding scale, budget neutrality en more than one final score is available. We then calculate the parameters of an exchange function in accordance with the statutory requirements related to the linear sliding scale, budget neutrality, and minimum and maximum adjustment percentages. For the baseline model, we apply the performance threshold of 75 points finalized in the CY 2025 PFS final rule. In section IV.B.2.b.(2) of this proposed rule, we are proposing to again set the performance threshold at 75. Therefore, for both the baseline and proposed policies models we used a performance threshold of 75 to calculate the exchange function used for MIPS payment adjustments. We note that the results of this exchange are not identical between the baseline and proposed policies models. This is due to the scaling factor used to determine positive adjustments is dependent on the total dollar amount of negative payment adjustments and those adjustments differ as final scores are not identical between both models. For both the baseline and proposed policies models, we use these resulting parameters to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the allowed charges for covered line and proposed policies models, we use these resulting parameters to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the allowed charges for covered professional services furnished by the MIPS eligible clinician. (4) Simulation Results and Projected Impact to MIPS Eligible Clinicians Based on the methodology described in section VII.I.5.d.(3). of the proposed rule, we create a baseline and proposed policies simulation. Using this simulation, we estimate the impact of the policies of this proposed rule. (a) Impact on Clinician Eligibility In section VII.E.17.c.(2). of this proposed rule, we noted that we do not modify clinician eligibility and therefore there is no difference in the total number of MIPS eligible clinicians between our models. (b) Impact on Clinician’s Final Scores Table 100 shows the median final score by practice size and the percentage of MIPS eligible clinicians of each practice size with a positive, neutral, or negative adjustment. BILLING CODE 4120–01–P VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00473 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 ative adjustment. BILLING CODE 4120–01–P VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00473 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 32824 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules The overall median final score is 87.96 in our baseline model and 89.47 in our proposed policies model, a slight increase for all practice sizes. There is a slight increase in the percentage of clinicians receiving a positive payment adjustment, we project that, overall, 83.61 percent of MIPS eligible clinicians will receive a positive adjustment in our baseline model, and 84.04 percent of MIPS eligible clinicians will receive a positive adjustment in our policies model. This slight increase is largely due to our proposed policies in the quality category, including the change to the administrative claims based quality measure scoring methodology and the updated topped out measure policy discussed in section IV.B.1.a.(2). of this proposed rule. Table 101 shows the median quality category score for MIPS eligible clinicians who are scored on the quality performance category f ure policy discussed in section IV.B.1.a.(2). of this proposed rule. Table 101 shows the median quality category score for MIPS eligible clinicians who are scored on the quality performance category for our baseline and proposed policies model. There is a noticeable difference in median quality category scores between our two models. This is true across almost all practice sizes, except for solo practitioners. The overall median quality category score is 78.78 in our baseline model and 83.76 in our policies model. 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 00474 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00475 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 H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00476 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00477 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00478 Fmt 4701 Sfmt 4702 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00477 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00478 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00479 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 00480 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00481 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00482 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00483 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 00484 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 32835 Superficial Radiation Treatment services. As we considered the mos 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 32835 Superficial Radiation Treatment services. As we considered the most accurate approach to developing PE RVUs for these code families, an alternative we considered was the following approach: Step 1: Estimate the share of direct costs for all services in the radiology- therapeutic cost center using the hospital cost reports. Step 2: For each service in an APC, calculate the weighted geometric mean of the OPPS total costs. The weights are PFS non-facility volume. Step 3: Multiply the result of step 2 by the result of step 1. We did not select this alternative because the use of cost report data to calculate the share of direct costs may reflect an imprecise accounting of direct costs. In addition, the percentage of direct costs is imprecise for a particular service. We are therefore unable to confirm the precision of the estimate of the direct costs for these services, which is a necessary step in this calculation. We refer the reader to the RAND Corporation (‘‘RAND’’) report prepared for CMS, entitled Practice Expense Methodology and Data Collection Re se services, which is a necessary step in this calculation. We refer the reader to the RAND Corporation (‘‘RAND’’) report prepared for CMS, entitled Practice Expense Methodology and Data Collection Research and Analysis, available at https://www.rand.org/pubs/research_ reports/RR2166.html.432 2. Alternatives Considered for Adjusting RVUs To Match PE Share in the American Medical Association’s (AMA) Physician Practice Information (PPI) and Clinician Practice Information (CPI) Surveys As discussed in section II.B. of this proposed rule, ‘‘(5) PE RVU Methodology,’’ Steps 3, 10, and 18, and ‘‘3. Adjusting RVUs To Match PE Share of the Medicare Economic Index (MEI)’’, we hold the work RVUs constant and adjust the PE RVUs, MP RVUs, and CF to produce the appropriate balance in RVUs among the PFS components and payment rates for individual services, that is, that the total RVUs on the PFS are proportioned to approximately 51 percent work RVUs, 45 percent PE RVUs, and 4 percent MP RVUs. As the Medicare Economic Index (MEI) cost shares are updated, we would typically propose to modify steps 3 and 10 described in section II.B. of this proposed rule to adjust the aggregate pools of PE costs (d Medicare Economic Index (MEI) cost shares are updated, we would typically propose to modify steps 3 and 10 described in section II.B. of this proposed rule to adjust the aggregate pools of PE costs (direct PE in step 3 and indirect PE in step 10) in proportion to the change in the PE share in the 432 Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al. ‘‘Practice Expense Methodology and Data Collection Research and Analysis.’’ RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/ RR2166.html. updated MEI cost share weights, as previously described in the CY 2014 PFS final rule (78 FR 74236 and 74237), and to recalibrate the relativity adjustment that we apply in step 18 described in section II.B. of this proposed rule. The most recent recalibration was done for the CY 2014 RVUs. Of note, although we did not propose to for CY 2023, we considered using the rebased and revised 2017- based MEI cost share weights to adjust the aggregate pools of PE RVUs and the relativity adjustment to reflect more recent data, shifting over a 4-year transition to reach the proportions of work, PE, and MP EI cost share weights to adjust the aggregate pools of PE RVUs and the relativity adjustment to reflect more recent data, shifting over a 4-year transition to reach the proportions of work, PE, and MP. We refer readers to a detailed discussion of this alternative considered in sections II.B. and V.I. of the CY 2023 PFS final rule (87 FR 69414 through 69415 and 70212 through 70217) for awareness regarding potential future rulemaking. As an alternative to adjusting the aggregate pools of direct and indirect PE costs and using a relativity adjustment based on the currently used 2006-based MEI, we considered 3 different alternatives related to the weights from the American Medical Association’s (AMA) Physician Practice Information (PPI) and Clinician Practice Information (CPI) Surveys, as discussed in detail in section II.B. of this proposed rule, for purposes of adjusting the RVUs to match PE share from the surveys for CY 2026: • Full implementation of the updated PPI and CPI Survey PE/HR data, while maintaining the current cost shares (2006-based MEI) (to allow for isolated comparison to the CY 2025 Final Rule impacts). • Full implementation of the updated shares, as reported by the data, while maintaining the current cost shares (2006-based MEI) (to allow for isolated comparison to the CY 2025 Final Rule impacts). • Full implementation of the updated shares, as reported by the AMA, while maintaining the current PE/HR data (to allow for isolated comparison to the CY 2025 Final Rule impacts). • Full implementation of updated shares, weighted by Medicare RVUs, while maintaining the current PE/HR data (to allow for isolated comparison to the CY 2025 Final Rule impacts). Likely due in part to lower-than- expected response rates, more Medicare specialties were grouped together in the updated PPI and CPI Survey data than the original PPI Survey. The AMA and Mathematica’s decision to group together more specialties is a consequential decision alone, therefore, we are displaying the estimated specialty-level impacts that would result from mapping the current PE/HR data to the updated specialty groupings reported in the new PPI and CPI Surveys. To do so, we calculated direct and indirect PE/HR values using the existing data (which primarily come from the 2007–08 PPI Survey) and volume-weighted averages of these existing PE/HR values within each of the new specialty gr ect and indirect PE/HR values using the existing data (which primarily come from the 2007–08 PPI Survey) and volume-weighted averages of these existing PE/HR values within each of the new specialty groupings. While this is not an alternative we considered implementing, we believe it is important to display the redistributive impacts of mapping the old PE/HR information to the new specialty groupings for interested parties to consider. For purposes of displaying impacts for these alternatives considered, we used the estimated impacts from the CY 2025 PFS final rule as a base and comparison rather than the proposed CY 2026 impacts due to the significant redistributive impacts of the policy proposals for CY 2026. We believe that displaying these alternatives considered relative to CY 2025 provides a more stable base to isolate changes related to the alternatives themselves and allows the public to meaningfully comment on the alternatives considered, as opposed to the interaction of these alternatives with the redistributions attributable to the CY 2026 policy proposals. Table 108 illustrates the estimated specialty-specific impacts under each alternative considered, relative to the CY alternatives with the redistributions attributable to the CY 2026 policy proposals. Table 108 illustrates the estimated specialty-specific impacts under each alternative considered, relative to the CY 2025 PFS final rule estimated impacts as a baseline. The following is an explanation of the information represented in Table 108. • Column A (Specialty): Identifies the specialty for which data are shown. • Column B (Setting): Identifies the facility or nonfacility setting for which data are shown. • Column C (Allowed Charges): The aggregate estimated PFS allowed charges for the specialty based on CY 2023 utilization and CY 2024 rates. Reminder: CY 2025 Estimated Impacts are used as a baseline for these alternatives considered, therefore, this column matches Column C of Table 111 in the CY 2025 PFS final rule (89 FR 98503 through 98507). • Column D (Combined Impact): This column shows the estimated CY 2025 combined impact on total allowed charges of all the changes finalized for CY 2025. Reminder: this column matches Column D of Table 111 in the CY 2025 PFS final rule (89 FR 98503 through 98507). • Column E (Combined Impact): This column shows the estimated CY 2025 combined impact on Reminder: this column matches Column D of Table 111 in the CY 2025 PFS final rule (89 FR 98503 through 98507). • Column E (Combined Impact): This column shows the estimated CY 2025 combined impact on total allowed charges that would result from mapping the current PE/HR data to the updated specialty groupings reported in the new PPI and CPI Surveys. • Column F (Combined Impact): This column shows the estimated CY 2025 combined impact on total allowed charges that would result if we VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00485 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 32836 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules implemented the new PE/HR data from the new PPI and CPI Surveys. Because these changes are solely within practice expense, there would be no impact to the estimated conversion factor and would result only in the redistribution of PE RVUs. • Column G (Combined Impact): This column shows the estimated CY 2025 combined impact on total allowed charges that would result if we implemented updated cost share weights as reported by the AMA, to • Column G (Combined Impact): This column shows the estimated CY 2025 combined impact on total allowed charges that would result if we implemented updated cost share weights as reported by the AMA, to adjust the RVUs to match the PE share from the surveys, relative to the impacts for the CY 2025 PFS final rule, while maintaining the current PE/HR data. This results in changes to the work RVU pool, and therefore, yields a different estimated conversion factor. • Column H (Combined Impact): This column shows the estimated CY 2025 combined impact on total allowed charges that would result if we implemented updated cost share weights derived by CMS from the AMA’s PPI and CPI Surveys, weighted by Medicare RVUs, to adjust the RVUs to match the PE share from the surveys, relative to the impacts for the CY 2025 PFS final rule, while maintaining the current PE/HR data. This results in changes to the work RVU pool, and therefore, yields a different estimated conversion factor. 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 00486 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No 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 00486 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32837 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 00487 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00488 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00489 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00490 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 00491 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 32842 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Secondly, we combined the PPI and CPI Survey data and weighted the data by RVU 1 S 7 W 9 K S D n o d n o m m a h k 32842 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Secondly, we combined the PPI and CPI Survey data and weighted the data by RVUs to develop a combined PPI and CPI Survey ‘‘All’’ line, analogous to the AMA’s PPI Survey results ‘‘All’’ line,434 which was not provided for the CPI Survey data.435 We then used the calculated direct and indirect totals from the PPI and CPI Survey data (weighted them by total RVUs) for each PE GPCI element based on the proposed mapping for the 4 PE GPCI components above to derive new weights for each of the 4 PE GPCI components, as shown below in Table 110. We welcome comments on the weights displayed above in Table 110, and any alternative methodologies to weight and or map the PPI and CPI Survey data to derive weights used to weight the four components of the PE GPCI for possible consideration in future rulemaking. Because any alternative derivation or weighting methodology for the PPI and CPI Survey data would result in different shares than displayed above, we do not believe that displaying the resulting CY 2026 PE GPCI based on these shares would be beneficial until we provide o and CPI Survey data would result in different shares than displayed above, we do not believe that displaying the resulting CY 2026 PE GPCI based on these shares would be beneficial until we provide opportunity for the public to comment on this methodology. Additionally, because CY 2026 is a GPCI update, there would be a confounding effect of these updated shares due to the implementation of updated data required for a triennial GPCI update. 4. Alternatives Considered for Changes Related to Medicare Part B Payment for Skin Substitutes When Used During a Covered Application Procedure in the Non-Facility Setting As discussed in detail in section II.K.D. of this proposed rule, starting January 1, 2026, we are proposing to pay for the provision of certain groups of skin substitute products used during a covered application procedure (CPT codes 15271 through 15278) as supplies. These skin substitutes will be paid as incident-to supplies under the PFS in the non-facility setting in accordance with section 1861(s)(2)(A) of the Act. While costs associated with supplies are usually bundled into the PE RVUs for particular services in non-facility settings, these products have been paid separ e with section 1861(s)(2)(A) of the Act. While costs associated with supplies are usually bundled into the PE RVUs for particular services in non-facility settings, these products have been paid separately for many years in the non- 434 https://www.ama-assn.org/system/files/table- 435 https://www.ama-assn.org/system/files/table- 1-results-from-ppi.pdf. 1-results-from-cpi-final.pdf. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00492 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 H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00493 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 32844 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules to administer the survey, coupled with the tendency of MIPS groups to choose measures they will perform well on. Additionally, ACOs showed improvement for nine of the ten CMS Web Interface measures and statistically significant improvement for seven out of the ten measures, in performance year 2023 relative to performance year 2022 (as shown in Tabl for nine of the ten CMS Web Interface measures and statistically significant improvement for seven out of the ten measures, in performance year 2023 relative to performance year 2022 (as shown in Table 112). 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 00494 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00495 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 00496 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 H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00497 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 32848 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules i. Revising the definitions of ‘‘Extended flexibilities period’’ and ‘‘Online;’’ ii. Adding the definitions of ‘‘Live Coach interaction,’’ ‘‘Online No. 134 / Wednesday, July 16, 2025 / Proposed Rules i. Revising the definitions of ‘‘Extended flexibilities period’’ and ‘‘Online;’’ ii. Adding the definitions of ‘‘Live Coach interaction,’’ ‘‘Online delivery period’’ and ‘‘Online session;’’ in alphabetical order. ■ b. Revising paragraphs (c)(1)(ii) and (e)(3)(iii)(C); and ■ c. Adding paragraph (f). The revisions and additions read as follows: § 410.79 Medicare Diabetes Prevention Program expanded model: Conditions of coverage. * * * (b) * * * Extended flexibilities period refers to * * the 6-year period (January 1, 2024 to December 31, 2029) for the Extended flexibilities to apply. * * * * * * Live Coach interaction refers to the bi- directional communication between the Coach and beneficiary. * * * * Online means sessions that are delivered 100 percent through the internet via phone, tablet, or laptop in an asynchronous (non-live) classroom where participants are experiencing the content on their own time without a live (including non-artificial intelligence (AI)) Coach teaching the content. Online delivery period refers to the 4- year period (January 1, 2026 to December 31, 2029) to test an asynchronous delivery modality of the n-artificial intelligence (AI)) Coach teaching the content. Online delivery period refers to the 4- year period (January 1, 2026 to December 31, 2029) to test an asynchronous delivery modality of the set of MDPP services. During this time, MDPP suppliers may deliver the Set of MDPP services through the online modality. Online session refers to an MDPP session that is not furnished in person or via distance learning and that is furnished in a manner consistent with the DPRP standards for online sessions. * * * (c) * * * (1) * * * (ii)Weight measurements used to * * determine the achievement or maintenance of the required minimum weight loss must be taken in person by an MDPP supplier during an MDPP session or reflected in the beneficiary’s medical record dated within two (2) days of the MDPP session. (e) * * * (3) * * * (iii) * * * (C) Self-reported weight measurements from the digital scale of the MDPP beneficiary. Self-reported weights must be obtained during live, synchronous online video technology, such as video chatting or video conferencing, wherein the MDPP coach observes the beneficiary weighing themselves and views the weight indicated on the digital scale, or the MDPP sup video technology, such as video chatting or video conferencing, wherein the MDPP coach observes the beneficiary weighing themselves and views the weight indicated on the digital scale, or the MDPP supplier receives two date- stamped photos or a video recording of the beneficiary’s weight, with the beneficiary visible on the scale, submitted by the MDPP beneficiary to the MDPP supplier. Photo or video must clearly document the weight of the MDPP beneficiary as it appears on the digital scale on the date associated with the billable MDPP session. If choosing to submit two photos, one photo must show the beneficiary’s weight on the digital scale, the second photo must show the beneficiary visible in their home or other reasonable location outside of an in-person delivery site, and both photos must be date-stamped. * * * * * (f) MDPP online delivery. (1) Notwithstanding paragraphs (a) through (e) of this section, the policies described in this paragraph (f) apply during the online delivery period. (2) During the online delivery period, MDPP suppliers are not required to maintain in-person delivery capabilities of the set of MDPP services, as applicable during the online delivery period period. (2) During the online delivery period, MDPP suppliers are not required to maintain in-person delivery capabilities of the set of MDPP services, as applicable during the online delivery period. (i) Online sessions must be furnished in a manner consistent with the DPRP Standards regarding program format, coach interaction, and program intensity and duration to qualify for payment. Online sessions must be delivered 100 percent through the internet via phone, tablet, or laptop in an asynchronous (non-live) classroom where participants are experiencing the content on their own time without a live (including non- artificial intelligence (AI) Coach teaching the content. (A) Live Coach interaction must be offered to each participant during weeks when the beneficiary has engaged with content. E-mails and text messages can count toward the requirements for Live Coach interaction if there is bi- directional communication (that is, organizations may not simply send out an announcement via text or e-mail and count that as live Coach interaction; the beneficiary must have the ability to respond to and get support from the live Coach) between the Coach and participant. Chat bots and AI f text or e-mail and count that as live Coach interaction; the beneficiary must have the ability to respond to and get support from the live Coach) between the Coach and participant. Chat bots and AI forums do not count as live Coach interaction. Coaches are required to track participant engagement and completion of online modules. Proactive outreach must be used to encourage Online session completion and beneficiary weight reporting. (1) MDPP suppliers may not require that beneficiaries initiate interactions with the Coach and MDPP suppliers may not use AI or Machine Learning (ML) to replace Live Coach interaction. (B) Beneficiaries must submit weight measurements on the date in which the Online session is completed. MDPP suppliers must ensure safeguards are in place to ensure the accuracy of beneficiary weight measurements. (C) For MDPP beneficiaries, MDPP suppliers may not bill for Online Sessions as well as In-Person or Virtual Sessions during the Online delivery period. The Set of MDPP services must be delivered to individual beneficiaries as Online sessions or fully synchronously (that is, In-person, Distance learning, or In-person with a distance learning component). (D) MDPP MDPP services must be delivered to individual beneficiaries as Online sessions or fully synchronously (that is, In-person, Distance learning, or In-person with a distance learning component). (D) MDPP suppliers must ensure that MDPP beneficiaries engage with and understand the content of each Online session. MDPP suppliers may use one or more of the following to ensure engagement and understanding: videos/ presentations, email, video conferencing; knowledge checks (multiple choice or short answer); participant contributions to group discussions on a community board; or beneficiary responses to the Coach via email, text message, or in-app messaging. (ii) [Reserved] * * * * * PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES ■ 13. The authority citation for part 414 continues to read as follows: Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l). ■ 14. Section 414.84 is amended by— ■ a. Revising paragraphs (b)(1) introductory text and (b)(2) introductory text; ■ b. Redesignating paragraphs (c)(3) and (c)(4) as paragraphs (c)(4) and (c)(5); ■ c. Adding new paragraph (c)(3); and ■ d. Revising newly redesignated paragraph (c)(4)(ii). The revisions and addition read as follo ting paragraphs (c)(3) and (c)(4) as paragraphs (c)(4) and (c)(5); ■ c. Adding new paragraph (c)(3); and ■ d. Revising newly redesignated paragraph (c)(4)(ii). The revisions and addition read as follows: § 414.84 Payment for MDPP services. * * * * (b) * * * (1) Performance Goal 1: Achieves the * required minimum 5-percent weight loss. CMS makes a performance payment to an MDPP supplier for an MDPP beneficiary who achieves the required minimum weight loss as measured in accordance with § 410.79(c)(ii) or described in § 410.79(e)(3)(iii) during a core session or core maintenance session furnished VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00498 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 32849 by that supplier. The amount of this performance payment is determined as follows: * * * * * (2) Performance Goal 2: Achieves 9- percent weight loss. CMS makes a performance payment to an MDPP supplier for an MDPP beneficiary who achieves at least a 9-percent weight loss as measured in accordance with § 410.79(c)(ii) o ieves 9- percent weight loss. CMS makes a performance payment to an MDPP supplier for an MDPP beneficiary who achieves at least a 9-percent weight loss as measured in accordance with § 410.79(c)(ii) or described in § 410.79(e)(3)(iii) during a core session or core maintenance session furnished by that supplier. The amount of this performance payment is determined as follows: * * * (c) * * * (3) For the duration of online delivery * * described in § 410.79(f), the online HCPCS G-code applies for any Set of MDPP services that are delivered online, as described in § 410.79(b). (4) Medicare pays for up to 22 sessions in a 12-month period. The amount of this payment is determined as follows: (i) * * * (ii) For a core session or core * * * * maintenance session furnished January 1, 2026 through December 31, 2026, $18. * ■ 15. Section 414.610 is amended by— ■ a. Revising paragraph (c)(1)(ii) introductory text; and ■ b. In paragraph (c)(5)(ii) removing the date ‘‘December 31, 2024’’ and adding in its place the date ‘‘September 30, 2025’’. * * § 414.610 Basis of payment. * * * (c) * * * (1) * * * (ii) For services furnished during the period July 1, 2008 through September 30, 2025, ambulanc in its place the date ‘‘September 30, 2025’’. * * § 414.610 Basis of payment. * * * (c) * * * (1) * * * (ii) For services furnished during the period July 1, 2008 through September 30, 2025, ambulance services originating in. * ■ 16. Section 414.802 is amended by— ■ a. Adding a definition of biological in alphabetical order; ■ b. Revising the definition of Bona fide service fees; ■ c. Adding the definition of bundled arrangement in alphabetical order; and These additions and revision read as * * * * follows: § 414.802 Definitions. * * * * * Biological means a product licensed under section 351 of the Public Health Service Act. Bona fide service fees means fees paid by a manufacturer to an entity, that must meet all of the following characteristics: (1) Represent fair market value as determined according to methods in paragraph (1)(i) or (ii) of this paragraph. Fair market value analyses for service arrangements that are ongoing must be updated at a frequency no less than the renewal frequency of the agreement. (i) For fees paid by a manufacturer to an entity that do not vary directly with the amount of drug sold or price of a manufacturer’s drug, fair market value must be determin requency of the agreement. (i) For fees paid by a manufacturer to an entity that do not vary directly with the amount of drug sold or price of a manufacturer’s drug, fair market value must be determined either based on comparable market transactions that generally reflect current market conditions or the cost of the service plus a reasonable markup to the total cost. (ii) For fees paid by a manufacturer to an entity that vary directly with the amount of drug sold or price of a manufacturer’s drug, the fair market value must be determined by using the cost of the service and adding a reasonable markup to the total cost. If any material portion of cost data is not available, manufacturers should follow a market-based approach based on verifiable market data until such time as sufficient cost data becomes available. The fair market value assessment must be conducted by an independent third- party valuator. (2) For a bona fide, itemized service actually performed on behalf of the manufacturer. (3) For a service that the manufacturer would otherwise perform (or contract for) in the absence of the service arrangement. (4) The fee must not be passed on in whole or in part to an affiliate, rer. (3) For a service that the manufacturer would otherwise perform (or contract for) in the absence of the service arrangement. (4) The fee must not be passed on in whole or in part to an affiliate, client, or customer of an entity whether or not the entity takes title to the drug. Bundled arrangement means an arrangement regardless of physical packaging under which the rebate, discount, or other price concession is conditioned upon the purchase of the same drug or biological or other drugs or biologicals or another product or some other performance requirement (for example, the achievement of market share, inclusion or tier placement on a formulary, purchasing patterns, prior purchases), or where the resulting discounts or other price concessions are greater than those which would have been available had the bundled drugs or biologicals been purchased separately or outside the bundled arrangement. * * * * * Drug means a drug or a biological, and for purposes of applying section 1847A(f) of the Act, includes an item, service, supply, or product that is payable under Medicare Part B as a drug or biological. * * * ■ 17. Section 414.804 is amended by— * * ■ a. Adding paragraphs (a)( A(f) of the Act, includes an item, service, supply, or product that is payable under Medicare Part B as a drug or biological. * * * ■ 17. Section 414.804 is amended by— * * ■ a. Adding paragraphs (a)(2)(i)(f), (iii) and (iv); and ■ b. Revising paragraph (a)(5). The additions and revision read as follows: § 414.804 Basis of payment. (a) * * * (2) * * * (i) * * * (F) Fees paid by a manufacturer to an * * entity that vary directly with the amount of the manufacturer’s drug sold or price of a manufacturer’s drug unless it meets the definition of bona fide service fee under § 414.802. * * (iii) The discounts in a bundled arrangement as defined at § 414.802, including those discounts resulting from a contingent arrangement, are allocated proportionately to the dollar value of the units of all drugs or products sold under the bundled arrangement. * (iv) For bundled arrangements where * * * multiple drugs are discounted, the aggregate value of all the discounts in the bundled arrangement must be proportionally allocated across all the drugs or products in the bundle. * * (5) Submission requirements. Manufacturers must submit the following to CMS within 30 days of the close of the quarter: be proportionally allocated across all the drugs or products in the bundle. * * (5) Submission requirements. Manufacturers must submit the following to CMS within 30 days of the close of the quarter: The manufacturer’s average sales price must be calculated by the manufacturer every calendar quarter and submitted to CMS within 30 days of the close of the quarter. The first quarter submission must be submitted by April 30, 2004. Subsequent reports are due not later than 30 days after the last day of each calendar quarter. (i) The manufacturer’s average sales price, which must be calculated by the manufacturer every calendar quarter. The first quarter submission must be submitted by April 30, 2004. (ii) Effective January 1, 2026, reasonable assumptions for calculations of the manufacturer’s ASP, consistent with the general requirements and intent of the Act, Federal regulations, and its customary business practices including documentation of the methodology used to determine fair market value and periodic reviews of fair market value. (iii) Effective January 1, 2026, certification letter from the recipient of a bona fide service fee (as defined under § 414.802) as evidence that the f value and periodic reviews of fair market value. (iii) Effective January 1, 2026, certification letter from the recipient of a bona fide service fee (as defined under § 414.802) as evidence that the fee is not passed on in whole or in part to an affiliate, client or customer of the recipient of the fee, whether or not the entity takes title to the drug. * * * * * VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00499 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 32850 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules ■ 18. Section 414.902 is amended by adding the definition of ‘‘biological’’ in alphabetical order to read as follows: § 414.902 Definitions. * * * * * * * Biological means a product licensed under section 351 of the Public Health Service Act. * * * ■ 19. Section 414.1305 is amended by— ■ a. Revising paragraph (6) of the definition for ‘‘Attribution-eligible beneficiary’’; and ■ b. Revising the definitions of ‘‘Multispecialty group’’, ‘‘MVP participant’’, and ‘‘Single specialty group. The revisions read as follows: § 414.1305 Definitions. Attribution-elig beneficiary’’; and ■ b. Revising the definitions of ‘‘Multispecialty group’’, ‘‘MVP participant’’, and ‘‘Single specialty group. The revisions read as follows: § 414.1305 Definitions. Attribution-eligible beneficiary * * * (6) Has a minimum of one claim for any covered professional service furnished by an eligible clinician who is on the Participation List for an Advanced APM Entity at any determination date during the QP Performance Period. * * * * * Multispecialty group means a group as defined at § 414.1305 that consists of clinicians in two or more specialty types or clinicians involved in multiple foci of care. MVP participant means an individual MIPS eligible clinician, multispecialty group, single-specialty group, subgroup, or APM Entity that is assessed on an MVP in accordance with § 414.1365 for all MIPS performance categories. For the CY 2026 performance period/2028 MIPS payment year and future years, MVP Participant means an individual MIPS eligible clinician, single-specialty group, multispecialty group that meets the requirements of a small practice, subgroup, or APM Entity that is assessed on an MVP in accordance with § 414.1365 for all MIPS performance categories. * ty 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. * * * * * Single specialty group means a group that consists of one specialty type or consists of clinicians involved in a single focus of care. * ■ 20. Section 414.1355 is amended by revising paragraph (c)(7) to read as follows: * * * * § 414.1355 Improvement activities performance category * * * (c) * * * (7) Advancing health and wellness, * * such as MIPS eligible clinicians demonstrating involvement in preventive care and health promotion. * ■ 21. Section 414.1365 is amended by adding paragraph (b)(2)(iv) to read as follows: * * * * § 414.1365 MIPS Value Pathways. * * * (b) * * * (2) * * * (iv) Self-attestation requirement. * * Beginning with the CY 2026 performance period/2028 MIPS payment year, a group registering for MVP reporting at the group level must attest to being either a single-specialty group or a multispecialty group that meets the requirements of a small practice, as defined at § 414.1305. * * ■ 22. Section 414.1380 is amended by— ■ a. Revising paragraphs (b)(1)(i) intr e-specialty group or a multispecialty group that meets the requirements of a small practice, as defined at § 414.1305. * * ■ 22. Section 414.1380 is amended by— ■ a. Revising paragraphs (b)(1)(i) introductory text, (b)(1)(ii)(D), and (b)(2)(iii) introductory text; ■ c. Adding paragraph (b)(2)(vi); ■ d. Revising paragraph (b)(4)(ii)(C); and ■ e. Adding paragraph (b)(4)(iii). * * * The revisions and additions read as follows: § 414.1380 Scoring. * * * * * (b) * * * (1) * * * (i) Measure achievement points. For the CY 2017 through 2022 performance periods/2019 through 2024 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340 and for each administrative claims- based measure that has a benchmark at paragraph (b)(1)(ii) of this section and meets the case minimum requirement at paragraph (b)(1)(iii) of this section. (A) Except d for each administrative claims- based measure that has a benchmark at paragraph (b)(1)(ii) of this section and meets the case minimum requirement at paragraph (b)(1)(iii) of this section. (A) Except as provided under paragraph (b)(1)(i)(C) of this section, beginning with the CY 2023 performance period/2025 MIPS payment year, MIPS eligible clinicians receive between 1 and 10 measure achievement points (including partial points) for each such measure. (B) Except as specified otherwise under paragraph (b)(1)(ii) of this section, the number of measure achievement points received for each such measure is determined based on the applicable benchmark decile category and the percentile distribution. MIPS eligible clinicians receive zero measure achievement points for each measure required under § 414.1335 on which no data is submitted in accordance with § 414.1325. MIPS eligible clinicians that submit data in accordance with § 414.1325 on a greater number of measures than required under § 414.1335 are scored only on the required measures with the greatest number of measure achievement points. (C) Beginning with the CY 2019 performance period/2021 MIPS payment year, MIPS eligible clinicia 4.1335 are scored only on the required measures with the greatest number of measure achievement points. (C) Beginning with the CY 2019 performance period/2021 MIPS payment year, MIPS eligible clinicians that submit data in accordance with § 414.1325 on a single measure via multiple collection types are scored only on the data submission with the greatest number of measure achievement points. (ii) * * * (D) Beginning with the CY 2023 performance period/2025 MIPS payment year, CMS calculates a benchmark for an administrative claims quality measure using the performance on the measures during the current performance period. (E) Beginning with the CY 2025 performance period/2027 MIPS payment year, for each administrative claims-based quality measure, CMS determines 10 benchmark ranges based on the median performance rate of all MIPS eligible clinicians scored on the measure, plus or minus standard deviations. (1) CMS awards achievement points based on which benchmark range a MIPS eligible clinician’s performance rate for an administrative claims-based quality measure corresponds; and (2) CMS awards achievement points equivalent to 10 percent of the performance threshold for a MIPS elig clinician’s performance rate for an administrative claims-based quality measure corresponds; and (2) CMS awards achievement points equivalent to 10 percent of the performance threshold for a MIPS eligible clinician whose performance rate is equal to the median performance for all MIPS eligible clinicians scored on the measure. (2) * * * (iii) Excluding cost measure scores calculated for informational-only purposes as provided in paragraph (b)(2)(vi) of this section, the cost performance category score is the sum of the following, not to exceed 100 percent: * * * * * (vi) Beginning with the 2028 MIPS payment year, CMS calculates a score for each new cost measure in accordance with the scoring policy set forth in this paragraph (b)(2) of this section for informational-only purposes during the measure’s informational-only feedback period. (A) For the purposes of this paragraph (b)(2)(vi) of this section, the following terms have the following meanings. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00500 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, Jkt 265001 PO 00000 Frm 00500 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 32851 (1) New cost measure means a measure that CMS has newly specified for the MIPS cost performance category for a performance period under § 414.1350 beginning with the 2028 MIPS payment year. This term excludes any cost measures that CMS has specified for the MIPS cost performance category prior to the 2028 MIPS payment year or CMS modifies at any time. (2) Informational-only feedback period means a 2-year period beginning with the first day of the first performance period and ending with the final day of the second performance period for the two applicable MIPS payment years for which CMS initially has specified the new cost measure. (B) During a new cost measure’s informational-only feedback period, CMS does not include any scores for the new cost measure calculated for informational-only purposes under paragraph (b)(2)(vi) of this section in CMS’s calculation of a MIPS eligible clinician’s cost performance category score under paragraph (b)(2)(iii ure calculated for informational-only purposes under paragraph (b)(2)(vi) of this section in CMS’s calculation of a MIPS eligible clinician’s cost performance category score under paragraph (b)(2)(iii) of this section or a MIPS eligible clinician’s MIPS final score under paragraph (c) of this section. (C) During a new cost measure’s informational-only feedback period, CMS confidentially provides each MIPS eligible clinician their measure score under paragraph (b)(2)(vi) of this section for informational-only purposes. CMS also provides performance feedback to the MIPS eligible clinician in accordance with section 1848(q)(12) of the Act. (D) Upon completion of a new cost measure’s informational-only feedback period, CMS includes its calculation of any scores for the cost measure in CMS’s calculation of a MIPS eligible clinician’s cost performance category score under paragraph (b)(2)(iii) of this section and a MIPS eligible clinician’s MIPS final score under paragraph (c) of this section. (3) * * * (4) * * * (ii) * * * (C)(1) For the 2019 performance period/2021 MIPS payment year through the 2022 performance period/ 2024 MIPS payment year, each optional measure is worth 5 or 10 bonu n. (3) * * * (4) * * * (ii) * * * (C)(1) For the 2019 performance period/2021 MIPS payment year through the 2022 performance period/ 2024 MIPS payment year, each optional measure is worth 5 or 10 bonus points, as specified by CMS. (2) For the 2023 performance period/ 2025 MIPS payment year and subsequent years, each optional measure is worth 5 bonus points, as specified by CMS. (3) Beginning with the CY 2026 performance period/2028 MIPS payment years, the total number of bonus points available to be earned when reporting one bonus measure, more than one bonus measure, or all bonus measures is a total of 5 bonus points. (iii) Beginning with the CY 2026 performance period/2028 MIPS payment year, if certain circumstances occur that impact CMS’s assessment of the performance of MIPS eligible clinicians on a measure specified for the Promoting Interoperability performance category under § 414.1375(b), CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS’s calculation of the Promoting Interoperability performance category objective score under paragraph (b)(4) of this section or excluding it from the determination of a meaningful EHR user if the affecte calculation of the Promoting Interoperability performance category objective score under paragraph (b)(4) of this section or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. CMS determines whether certain circumstances exist warranting suppression of a measure based on CMS’s consideration of one or more of the following factors: (A) The nature, breadth, and duration of the circumstances’ effect on MIPS eligible clinicians’ ability to fulfill the measure requirement. (B) The availability of certified health IT modules to fulfill the measure. (C) The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance. (D) Out-of-date or conflicting technical standards. (E) Technical and operational capacity of required partners. (F) Other factors as determined by * * * * CMS. * ■ 23. Section 414.1400 is amended by— ■ a. Revising paragraph (b)(1)(ii); ■ b. In paragraph (d)(3) introductory text, removing the phrase ‘‘including:’’ and adding in its place the phrase ‘‘including all of the following:’’; ■ c. Revising paragraph (d)(3)(i); ■ d. (1)(ii); ■ b. In paragraph (d)(3) introductory text, removing the phrase ‘‘including:’’ and adding in its place the phrase ‘‘including all of the following:’’; ■ c. Revising paragraph (d)(3)(i); ■ d. In paragraphs (d)(3)(ii) and (iii), removing the ‘‘;’’ and adding in its place ‘‘.’’; ■ e. Redesignating paragraphs (d)(3)(iv) through (vi) as paragraphs (d)(3)(iv) through (vi) introductory text; f. Adding paragraphs (d)(3)(iv)(A) and (B), (d)(3)(v)(A) and (B), (d)(3)(vi)(A) and (B), and (d)(3)(vii). ■ g. Revising paragraph (d)(8); and ■ h. Adding paragraphs (d)(9) and (d)(10). The revisions and additions read as follows: § 414.1400 Third party intermediaries. * * * * * (b) * * * (1) * * * (ii)(A) Beginning with the CY 2023 performance period/2025 MIPS payment year through the CY 2025 performance period/2027 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data. (B) Beginning with the CY 2026 performance period/2028 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data no later than 1 year after fi rformance period/2028 MIPS payment year, QCDRs and qualified registries must support MVPs that are applicable to the MVP participant on whose behalf they submit MIPS data no later than 1 year after finalization of the MVP in accordance with the current requirement. (1) QCDRs and qualified registries may also support the APP. (2) A QCDR or qualified registry must support all measures and activities included in the MVP with the following exceptions: (i) If an MVP is intended for reporting by multiple specialties, a QCDR or a qualified registry are required to report those measures pertinent to the specialty of its MIPS eligible clinicians. (ii) If an MVP includes a QCDR * * measure, it is not required to be reported by a QCDR other than the measure owner. * * * (d) * * * (3) * * * (i) At least 3 years of experience administering surveys in which mail survey administration is followed by survey administration via Computer Assisted Telephone Interview (CATI); (iv) * * * (A) Beginning January 1, 2024, in addition to administering the survey in English, entities must administer the Spanish survey translation to Spanish- preferring patients using the procedures detailed in subregulatory g ry 1, 2024, in addition to administering the survey in English, entities must administer the Spanish survey translation to Spanish- preferring patients using the procedures detailed in subregulatory guidance to standardize the CAHPS data collection process for MIPS and to make sure the survey data collected across survey vendors are comparable within the program or model;. (B) [Reserved] (v) * * * (A) Beginning January 1, 2027, use equipment, software, computer programs, systems, and facilities that can send survey invitations via email that include a patient-specific hyperlink to a web survey, collect data via web, and track cases from web surveys through telephone follow-up activities. (B) [Reserved] (vi) * * * (A) Beginning January 1, 2027, employment of a web survey administrator. (B) [Reserved] VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00501 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 ■ 32852 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (vii) Beginning January 1, 2027, at (3) For QP Performance Periods least 3 years of experience administering surv 32852 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (vii) Beginning January 1, 2027, at (3) For QP Performance Periods least 3 years of experience administering surveys in which web survey administration is followed by survey administration via mail survey or Computer Assisted Telephone Interview (CATI). * * * * * (8) From January 1, 2019 through December 31, 2025, the entity has sent an interim survey data file to CMS that establishes the entity’s ability to accurately report CAHPS data. (9) Beginning with January 1, 2026, the entity seeking to be a CMS-approved survey vendor must include on its application the range of costs of its third-party intermediary services. (10) Beginning with the CY 2027 performance period/2029 MIPS payment year, the CMS-approved survey vendor must administer the survey via a web-mail-phone protocol. * * ■ 24. Section 414.1405 amended by adding paragraph (b)(10)(ii) to read as follows: * * * § 414.1405 Payment. * * * * * (b) * * * (10) * * * (i) * * * (ii) The performance threshold for the 2028 through 2030 MIPS payment years is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS pa b) * * * (10) * * * (i) * * * (ii) The performance threshold for the 2028 through 2030 MIPS payment years is 75 points. The prior period used to determine the performance threshold is the 2019 MIPS payment year. * * * * * § 414.1415 [Amended] ■ 25. Section 414.1415 is amended in paragraph (c)(7) by removing the phrase ‘‘2023 QP Performance Period, notwithstanding’’ and adding in its place the phrase ‘‘2023 QP Performance Period and ending with the 2025 QP Performance Period, notwithstanding’’. § 414.1420 [Amended] ■ 26. Section 414.1420 is amended in paragraph (d)(8) by removing the phrase ‘‘2023 QP Performance Period, notwithstanding’’ and adding in its place the phrase ‘‘2023 QP Performance Period and ending with the 2025 QP Performance Period, notwithstanding’’. * ■ 27. Section 414.1425 is amended by— * * * * (a) Adding paragraph (b)(3); and (b) Revising paragraphs (c)(3), (c)(4), (d)(1) and (2). The addition and revisions read as follows: § 414.1425 Qualifying APM participant determination: In general. * * * * (b) * * * * beginning with 2026, except for paragraphs (b)(1) and (b)(2) of this section and as set forth in § 414.1440, for purposes of the QP determinations, CMS perfor mination: In general. * * * * (b) * * * * beginning with 2026, except for paragraphs (b)(1) and (b)(2) of this section and as set forth in § 414.1440, for purposes of the QP determinations, CMS performs QP determinations for the eligible clinicians three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination dates: March 31, June 30, and August 31. An eligible clinician can be determined to be a QP only if the eligible clinician appears on the Participation List on a date (March 31, June 30, or August 31) CMS uses based on participation in the Advanced APM. (c) * * * (3) An eligible clinician is a QP for a year under the Medicare Option if: (i) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, the eligible clinician is in an APM Entity group that achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in § 414.1430(a)(1) and (3). An eligible clinician is a QP for the year under the All-Payer Combination Option if the eligible clinician nt count threshold for that QP Performance Period as described in § 414.1430(a)(1) and (3). An eligible clinician is a QP for the year under the All-Payer Combination Option if the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in § 414.1430(b)(1) and (3). (ii) Beginning with the CY 2026 QP Performance Period, the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in § 414.1430(a)(1) and (3). An eligible clinician is a QP for the year under the All-Payer Combination Option if the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period as described in § 414.1430(b)(1) and (3). (4) Starting with the CY 2017 QP Performance Period and ending with the C ayment amount threshold or QP patient count threshold for that QP Performance Period as described in § 414.1430(b)(1) and (3). (4) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, notwithstanding paragraph (c)(3) of this section, an eligible clinician is a QP for a year if— (i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the QP payment amount threshold or the QP patient count threshold, or the eligible clinician is an Affiliated Practitioner; and (ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the QP payment amount threshold or the QP patient count threshold. * * * (d) * * * (1) An eligible clinician is a Partial QP for a year under the Medicare Option if: * * (i) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, the eligible clinician is in an APM Entity group that achieves Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Pe gible clinician is in an APM Entity group that achieves Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in § 414.1430(a)(2) and (4). An eligible clinician is a Partial QP for the year under the All-Payer Combination Option if the eligible clinician achieves individually, or as part of an APM Entity group, a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in § 414.1430(b)(2) and (4). (ii) Beginning with the CY 2026 QP Performance Period, the eligible clinician individually, or as part of an APM Entity group, achieves a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in § 414.1430(a)(2) and (4). An eligible clinician is a Partial QP for the year under the All-Payer Combination Option if the eligible clinician achieves individually, or as part of an APM Entity group, a Threshold Score that meets or exceeds the cor is a Partial QP for the year under the All-Payer Combination Option if the eligible clinician achieves individually, or as part of an APM Entity group, a Threshold Score that meets or exceeds the corresponding Partial QP payment amount threshold or Partial QP patient count threshold for that QP Performance Period as described in § 414.1430(b)(2) and (4). (2) Starting with the CY 2017 QP Performance Period and ending with the CY 2025 QP Performance Period, notwithstanding paragraph (d)(1) of this section, an eligible clinician is a Partial QP for a year if— (i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the corresponding QP or Partial QP threshold, or the eligible clinician is an Affiliated Practitioner; and (ii) CMS determines that the eligible clinician individually achieves a VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00502 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 32853 Threshold Score that meets .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 32853 Threshold Score that meets or exceeds the corresponding Partial QP Threshold. * ■ 28. Section 414.1455 is amended by revising paragraph (b)(3)(ii) and (vi) to read as follows: * * * * * * § 414.1455 Limitation on review. * * * (b) * * * (3) * * * (ii) All requests for targeted review must be submitted during the targeted review request submission period as described at § 414.1385(a)(2). The targeted review request submission period may be extended as specified by CMS. * * * * * (vi) A request for targeted review may include additional information in support of the request at the time it is submitted. CMS may also request additional information from the requestor. If CMS requests additional information relating to the eligible clinician or the APM Entity group that is the subject of a request for targeted review, responsive information must be provided and received by CMS within 15 days of the request. If CMS does not receive a timely response to a request for additional information, CMS may make a final decisio sponsive information must be provided and received by CMS within 15 days of the request. If CMS does not receive a timely response to a request for additional information, CMS may make a final decision on the targeted review request based on the information available. * * * * * PART 424—CONDITIONS FOR MEDICARE PAYMENT ■ 29. The authority citation for part 424 continues to read as follows: Authority: 42 U.S.C. 1302 and 1395hh. ■ 30. Section 424.205 is amended by revising paragraphs (c)(10), (f)(2)(i), and (f)(5) to read as follows: * * § 424.205 Requirements for Medicare Diabetes Prevention Program suppliers. * * * (c) * * * (10) Except as allowed under paragraph (d)(8) of this section, the MDPP supplier must offer an MDPP beneficiary no fewer than all of the following: (i) 16 in-person, distance learning, or online core sessions no more frequently than weekly for the first 6 months of the MDPP services period, which begins on the date of attendance at the first such core session. (ii) One in-person, distance learning, or online core maintenance session each month during months 7 through 12 (6 months total) of the MDPP services period. * * * * * (f) * * * (1) * * * (ii) Basic benefi One in-person, distance learning, or online core maintenance session each month during months 7 through 12 (6 months total) of the MDPP services period. * * * * * (f) * * * (1) * * * (ii) Basic beneficiary information for each MDPP beneficiary in attendance, including but not limited to beneficiary name, MBI, and age. * * * (2) * * * (i) Documentation of the type of * * session (in-person, distance learning, or online). * * * * * (5) The MDPP supplier’s records must include an attestation from the MDPP supplier that, as applicable, the MDPP beneficiary for which it is submitting a claim— (i) Has achieved required minimum weight loss as measured in accordance with § 410.79(e)(3)(iii) of this chapter during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(1) of this chapter. (ii) Has achieved required minimum weight loss as measured in accordance with § 410.79(c)(ii) during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(1) of this chapter. (iii) Has achieved at least a 9-percent weight loss percentage maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(1) of this chapter. (iii) Has achieved at least a 9-percent weight loss percentage as measured in accordance with § 410.79(e)(3)(iii) of this chapter during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(2) of this chapter. (iv) Has achieved at least a 9-percent weight loss percentage as measured in accordance with § 410.79(c)(ii) during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(2) of this chapter. * * * * * PART 425—MEDICARE SHARED SAVINGS PROGRAM ■ 31. The authority citation for part 425 continues to read as follows: Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj. ■ 32. Section 425.20 is amended by revising paragraph (1)(ii) in the definition of ‘‘Beneficiary eligible for Medicare CQMs’’ to read as follows: § 425.20 Definitions. * * * * * Beneficiary eligible for Medicare CQMs * * * (1) * * * (ii)(A) For performance year 2024, had at least one claim with a date of serv Medicare CQMs’’ to read as follows: § 425.20 Definitions. * * * * * Beneficiary eligible for Medicare CQMs * * * (1) * * * (ii)(A) For performance year 2024, had at least one claim with a date of service during the measurement period from an ACO professional who is a primary care physician or who has one of the specialty designations included in § 425.402(c), or who is a physician assistant, nurse practitioner, or clinical nurse specialist. (B) For performance year 2025 and subsequent performance years, had at least one primary care service with a date of service during the applicable performance year from an ACO professional who is a primary care physician or who has one of the specialty designations included in § 425.402(c), or who is a physician assistant, nurse practitioner, or clinical nurse specialist. * * ■ 33. Section 425.110 is amended by revising paragraph (a)(2) and adding paragraph (a)(3) to read as follows: * * * § 425.110 Number of ACO professionals and beneficiaries. (a) * * * (2) For agreement periods beginning before January 1, 2027, CMS deems an ACO to have initially satisfied the requirement to have at least 5,000 assigned beneficiaries as specified in paragraph * * * (2) For agreement periods beginning before January 1, 2027, CMS deems an ACO to have initially satisfied the requirement to have at least 5,000 assigned beneficiaries as specified in paragraph (a)(1) of this section if 5,000 or more beneficiaries are historically assigned to the ACO participants in each of the 3 benchmark years, as calculated using the assignment methodology set forth in subpart E of this part. In the case of the third benchmark year, CMS uses the most recent data available to estimate the number of assigned beneficiaries. (3) For agreement periods beginning on or after January 1, 2027, CMS determines whether an ACO has 5,000 or more beneficiaries historically assigned to the ACO participants in each of the 3 benchmark years, as calculated using the assignment methodology set forth in subpart E of this part. CMS uses the most recent data available to estimate the number of assigned beneficiaries in the third benchmark year. (i) CMS deems an ACO to have initially satisfied the requirement to have at least 5,000 assigned beneficiaries as specified in paragraph (a)(1) of this section if 5,000 or more beneficiaries are historically assigned to the ACO participan satisfied the requirement to have at least 5,000 assigned beneficiaries as specified in paragraph (a)(1) of this section if 5,000 or more beneficiaries are historically assigned to the ACO participants in the third benchmark year. (ii) If an ACO has fewer than 5,000 assigned beneficiaries in either the first benchmark year, the second benchmark year, or both, the ACO may only participate under the BASIC track in accordance with § 425.600(h)(3). * * ■ 34. Section 425.118 is amended by— * * * VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00503 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 32854 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules ■ a. Redesignating paragraph (b)(3) as paragraph (b)(4); ■ b. Adding new paragraph (b)(3); and ■ c. In newly redesignated paragraph (b)(4) adding paragraph (b)(4)(iii). The additions read as follows: * * § 425.118 Required reporting of ACO participants and ACO providers/suppliers. * * * (b) * * * (3) Change of ownership for ACO participant. No later than 30 days after an ACO participant has undergone a change of ownership tha ing of ACO participants and ACO providers/suppliers. * * * (b) * * * (3) Change of ownership for ACO participant. No later than 30 days after an ACO participant has undergone a change of ownership that has resulted in a change to its Medicare enrolled TIN, whereby the surviving Medicare enrolled TIN has no Medicare billing claims history, the ACO must submit a change request to CMS. (i) The change request and supporting documentation must be submitted in the form and manner specified by CMS. (ii)(A) CMS has sole discretion to approve the change request. (B) If CMS approves the change request, the ACO participant TIN is updated in the ACO participant list in the form and manner specified by CMS. (4) * * * (iii) In alignment with changes approved under paragraph (b)(3) of this section, CMS adjusts the ACO’s assignment, performance year financial calculations, and the requirement that the ACO submit quality data under § 425.508 and § 425.510 on behalf of eligible professionals that bill under the TIN of an ACO participant. When processed during applicable Quality Payment Program snapshot dates for the relevant Performance Period, the adjustment includes the surviving Medicare enrolled nder the TIN of an ACO participant. When processed during applicable Quality Payment Program snapshot dates for the relevant Performance Period, the adjustment includes the surviving Medicare enrolled TIN with no Medicare billing claims history on the ACO participant list as the change becomes effective during the performance year. * * ■ 35. Section 425.224 is amended by revising paragraph (b)(1)(ii)(A) to read as follows: * * * § 425.224 Application procedures for renewing ACOs and re-entering ACOs. * * * * (b) * * * (1) * * * (ii) * * * (A) Whether the ACO demonstrated a * pattern of failure to meet both the quality performance standard and alternative quality performance standard (if applicable) or met any of the criteria for termination under § 425.316(c)(1)(ii), (c)(2)(ii), or (c)(3)(ii). * * ■ 36. Section 425.316 is amended by revising paragraph (c)(2) introductory * * * text and adding paragraph (c)(3) to read as follows: * * § 425.316 Monitoring of ACOs. * * * (c) * * * (2) For performance years beginning on or after January 1, 2021 and before January 1, 2026. * * * * * (3) For performance years beginning on or after January 1, 2026. (i) If the ACO fails to meet both the qu performance years beginning on or after January 1, 2021 and before January 1, 2026. * * * * * (3) For performance years beginning on or after January 1, 2026. (i) If the ACO fails to meet both the quality performance standard and the alternative quality performance standard, CMS may take one or more of the actions prior to termination specified in § 425.216. Depending on the nature and severity of the noncompliance, CMS may forgo pre- termination actions and may immediately terminate the ACO’s participation agreement under § 425.218. (ii) CMS terminates an ACO’s participation agreement under any of the following circumstances: (A) The ACO fails to meet both the quality performance standard and the alternative quality performance standard for 2 consecutive performance years within an agreement period. (B) The ACO fails to meet both the quality performance standard and the alternative quality performance standard for any 3 performance years within an agreement period, regardless of whether the years are in consecutive order. (C) A renewing ACO or re-entering ACO fails to meet both the quality performance standard and the alternative quality performance standard for the last performa her the years are in consecutive order. (C) A renewing ACO or re-entering ACO fails to meet both the quality performance standard and the alternative quality performance standard for the last performance year of the ACO’s previous agreement period and this occurrence was either the second consecutive performance year of failed quality performance or the third nonconsecutive performance year of failed quality performance during the previous agreement period. (D) A renewing ACO or re-entering ACO fails to meet both the quality performance standard and the alternative quality performance standard for 2 consecutive performance years across 2 agreement periods, specifically the last performance year of the ACO’s previous agreement period and the first performance year of the ACO’s new agreement period. * * ■ 37. Section 425.400 is amended by revising paragraph (c)(1)(ix) introductory text and adding paragraph (c)(1)(x) to read as follows: * * * § 425.400 General. * * * * * (c) * * * (1) * * * (ix) For the performance year starting on January 1, 2025, as follows: * * * * * (x) For the performance year starting on January 1, 2026, and subsequent performance years as follows: (A) CPT codes * (ix) For the performance year starting on January 1, 2025, as follows: * * * * * (x) For the performance year starting on January 1, 2026, and subsequent performance years as follows: (A) CPT codes: (1) 96160 and 96161 (codes for administration of health risk assessment). (2) 96202 and 96203 (codes for caregiver behavior management training). (3) 97550, 97551, and 97552 (codes for caregiver training services). (4) 98016 (code for virtual check-in). (5) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). (6) 99304 through 99318 (codes for professional services furnished in a nursing facility; professional services or services reported on an FQHC or RHC claim identified by these codes are excluded when furnished in a skilled nursing facility (SNF)). (7) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit). (8) 99341 through 99350 (codes for evaluation and management services furnished in a patient’s home). (9) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure; when the base code is al patient’s home). (9) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure; when the base code is also a primary care service code under this paragraph (c)(1)(x)). (10) 99406 and 99407 (codes for smoking and tobacco-use cessation counseling services). (11) 99421, 99422, and 99423 (codes for online digital evaluation and management). (12) 99424, 99425, 99426, and 99427 (codes for principal care management services). (13) 99437, 99487, 99489, 99490 and 99491 (codes for chronic care management). (14) 99439 (code for non-complex chronic care management). (15) 99452 (code for interprofessional consultation service). (16) 99483 (code for assessment of and care planning for patients with cognitive impairment). (17) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services). (18) 99495 and 99496 (codes for transitional care management services). (19) 99497 and 99498 (codes for advance care planning; services VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00504 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 for advance care planning; services VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00504 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 32855 identified by these codes furnished in an inpatient setting are excluded). (B) HCPCS codes: (1) G0019 and G0022 (codes for community health integration services). (2) G0023 and G0024 (codes for principal illness navigation services). (3) G0101 (code for cervical or vaginal cancer screening). (4) G0317, G0318, and G2212 (codes for prolonged office or other outpatient visit for the evaluation and management of a patient). (5) G0402 (code for the Welcome to Medicare visit). (6) G0438 and G0439 (codes for the annual wellness visits). (7) G0442 (code for alcohol misuse screening service). (8) G0443 (code for alcohol misuse counseling service). (9) G0444 (code for annual depression screening service). (10) G0463 (code for services furnished in electing teaching amendment (ETA) hospitals). (11) G0506 (code for chronic care management). (12) G0537 and G0538 (codes for cardiovascular ri ning service). (10) G0463 (code for services furnished in electing teaching amendment (ETA) hospitals). (11) G0506 (code for chronic care management). (12) G0537 and G0538 (codes for cardiovascular risk assessment and risk management services). (13) G0539 and G0540 (codes for individual behavior management/ modification caregiver training services). (14) G0541, G0542, and G0543 (codes for direct care caregiver training services). (15) G0544 (code for post-discharge telephonic follow-up contacts intervention). (16) G0556, G0557, and G0558 (codes for advanced primary care management services). (17) G0560 (code for safety planning interventions). (18) G2010 (code for the remote evaluation of patient video/images). (19) G2012 and G2252 (codes for virtual check-in). (20) G2058 (code for non-complex chronic care management). (21) G2064 and G2065 (codes for principal care management services). (22) G2086, G2087, and G2088 (codes for office-based opioid use disorder services). (23) G2211 (code for visit complexity inherent to evaluation and management services add-on). (24) G2214 (code for psychiatric collaborative care model). (25) G3002 and G3003 (codes for chronic pain management). (26) for visit complexity inherent to evaluation and management services add-on). (24) G2214 (code for psychiatric collaborative care model). (25) G3002 and G3003 (codes for chronic pain management). (26) GPCM1 and GPCM2 (codes for behavioral health integration add-on when furnished with advanced primary care management services). (27) GPCM3 (code for psychiatric collaborative care model add-on when furnished with advanced primary care management services). (C) Primary care service codes include * * * * any CPT code identified by CMS that directly replaces a CPT code specified in paragraph (c)(1)(x)(A) of this section or a HCPCS code specified in paragraph (c)(1)(x)(B) of this section, when the assignment window or expanded window for assignment (as defined in § 425.20) for a benchmark or performance year includes any day on or after the effective date of the replacement code for payment purposes under FFS Medicare. * ■ 38. Section 425.512 is amended by— ■ a. In paragraph (a)(3)(i), removing the phrase ‘‘quality performance score’’ and adding in its place the phrase ‘‘quality score’’; ■ b. In paragraphs (a)(4)(i)(A), (a)(5)(i)(A)(1), (a)(5)(i)(B)(1), (a)(5)(i)(C)(1), and (a)(7), removi ng the phrase ‘‘quality performance score’’ and adding in its place the phrase ‘‘quality score’’; ■ b. In paragraphs (a)(4)(i)(A), (a)(5)(i)(A)(1), (a)(5)(i)(B)(1), (a)(5)(i)(C)(1), and (a)(7), removing the phrase ‘‘health equity adjusted quality performance score’’ and adding in its place the phrase ‘‘quality score’’; ■ c. Revising and republishing paragraph (b); ■ d. Revising paragraph (c)(1) introductory text; ■ e. Adding paragraph (c)(1)(iii); f. In paragraphs (c)(2)(i), (c)(2)(ii), and (c)(3)(i), removing the phrase ‘‘quality performance score’’ and adding in its place the phrase ‘‘quality score’’; and ■ g. In paragraphs (c)(3)(ii), (c)(3)(iii), and (c)(3)(iv), removing the phrase ‘‘health equity adjusted quality performance score’’ and adding in its place the phrase ‘‘quality score’’. The revisions and addition read as follows: § 425.512 Determining the ACO quality performance standard for performance years beginning on or after January 1, 2021. * * * * * (b) Calculation of an adjustment to an ACO’s quality score for performance years 2023 and 2024— (1) For performance year 2023. For an ACO that reports the three eCQMs/MIPS CQMs in the APP quality measure set, meeting the dat justment to an ACO’s quality score for performance years 2023 and 2024— (1) For performance year 2023. For an ACO that reports the three eCQMs/MIPS CQMs in the APP quality measure set, meeting the data completeness requirement at § 414.1340 of this subchapter for all three eCQMs/MIPS CQMs, and administers the CAHPS for MIPS survey, CMS calculates the ACO’s quality score as the sum of the ACO’s MIPS quality performance category score for all measures in the APP quality measure set and the ACO’s population and income adjustment bonus points calculated in accordance with paragraph (b)(3) of this section. The sum of these values may not exceed 100 percent. (2) For performance year 2024. For an ACO that reports the three eCQMs/MIPS CQMs/Medicare CQMs in the APP quality measure set, meeting the data completeness requirement at § 414.1340 of this subchapter for all three eCQMs/ MIPS CQMs/Medicare CQMs, and administers the CAHPS for MIPS survey (except as specified in § 414.1380(b)(1)(vii)(B) of this subchapter), CMS calculates the ACO’s quality score as the sum of the ACO’s MIPS quality performance category score for all measures in the APP quality measure set and the ACO’s population and of this subchapter), CMS calculates the ACO’s quality score as the sum of the ACO’s MIPS quality performance category score for all measures in the APP quality measure set and the ACO’s population and income adjustment bonus points calculated in accordance with paragraph (b)(3) of this section. The sum of these values may not exceed 100 percent. (3) Calculation of ACO’s population and income adjustment bonus points. CMS calculates the ACO’s bonus points as follows: (i) For each measure that an ACO is required to report for the applicable performance year, CMS groups an ACO’s performance into the top, middle, or bottom third of ACO measure performers by reporting mechanism. (ii) CMS assigns values to the ACO for its performance on each measure as follows: (A) Values of four, two, or zero for each measure for which the ACO’s performance places it in the top, middle, or bottom third of ACO measure performers, respectively. (B) Values of zero for each measure that CMS does not evaluate because the measure is unscored or the ACO does not meet the case minimum or the minimum sample size for the measure. (iii) CMS sums the values assigned to the ACO according to paragraph (b)(3)(ii) of th ause the measure is unscored or the ACO does not meet the case minimum or the minimum sample size for the measure. (iii) CMS sums the values assigned to the ACO according to paragraph (b)(3)(ii) of this section, to calculate the ACO’s measure performance scaler. (iv) CMS calculates a multiplier for the ACO. (A) (1) CMS determines the proportion ranging from zero to one of the ACO’s assigned beneficiary population for the performance year based on the highest of either of the following: (i) The proportion of the ACO’s assigned beneficiaries residing in a census block group with an Area Deprivation Index (ADI) national percentile rank of at least 85. An ACO’s assigned beneficiaries without an available numeric ADI national percentile rank are excluded from the calculation of the proportion of the ACO’s assigned beneficiaries residing in a census block group with an ADI national percentile rank of at least 85. (ii) The proportion of the ACO’s assigned beneficiaries who are enrolled in the Medicare Part D low-income subsidy (LIS); or are dually eligible for Medicare and Medicaid. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00505 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16 Medicare Part D low-income subsidy (LIS); or are dually eligible for Medicare and Medicaid. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00505 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 ■ 32856 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (2) CMS calculates the proportions specified in paragraph (b)(3)(iv)(A)(1)(ii) of this section as follows: (i) For performance year 2023, the proportion of the ACO’s assigned beneficiaries who are enrolled in the Medicare Part D LIS or are dually eligible for Medicare and Medicaid divided by the total number of the ACO’s assigned beneficiaries’ person years. (ii) For performance year 2024, the proportion of the ACO’s assigned beneficiaries with any months enrolled in LIS or dually eligible for Medicare and Medicaid divided by the total number of the ACO’s assigned beneficiaries. (B) If the proportion determined in accordance with paragraph (b)(3)(iv)(A) of this section is lower than 20 percent, the ACO is ineligible for bonus points. (v) Except as specified in paragraph (b)(3)(iv)(B) of this section, CMS calculates the e with paragraph (b)(3)(iv)(A) of this section is lower than 20 percent, the ACO is ineligible for bonus points. (v) Except as specified in paragraph (b)(3)(iv)(B) of this section, CMS calculates the ACO’s bonus points as the product of the measure performance scaler determined under paragraph (b)(3)(iii) of this section and the multiplier determined under paragraph (b)(3)(iv) of this section. If the product of these values is greater than 10, the value of the ACO’s bonus points is set equal to 10. (4) Use of ACO’s quality score. The ACO’s quality score, determined in accordance with paragraphs (b)(1) through (3) of this section, is used as follows: (i) In determining whether the ACO meets the quality performance standard as specified under paragraphs (a)(4)(i)(A), (a)(5)(i)(A)(1), (a)(5)(i)(B), and (a)(7) of this section. (ii) In determining the final sharing rate for calculating shared savings payments under the BASIC track in accordance with § 425.605(d), and under the ENHANCED track in accordance with § 425.610(d), for an ACO that meets the alternative quality performance standard by meeting the criteria specified in paragraph (a)(4)(ii) or (a)(5)(ii) of this section. (iii) In k in accordance with § 425.610(d), for an ACO that meets the alternative quality performance standard by meeting the criteria specified in paragraph (a)(4)(ii) or (a)(5)(ii) of this section. (iii) In determining the shared loss rate for calculating shared losses under the ENHANCED track in accordance with § 425.610(f), for an ACO that meets the quality performance standard established in paragraphs (a)(2), (a)(4)(i), and (a)(5)(i) of this section or the alternative quality performance standard established in paragraph (a)(4)(ii) or (a)(5)(ii) of this section. (iv) In determining the quality score for an ACO affected by extreme and uncontrollable circumstances as described in paragraphs (c)(3)(ii) and (iii) of this section. (c) * * * (1) CMS determines the ACO was affected by an extreme and uncontrollable circumstance based on any of the following: * * * * * * * * * (iii) For performance year 2025 and subsequent performance years, the ACO, as defined at § 425.20, is affected by an extreme and uncontrollable circumstance due to a cyberattack, including ransomware/malware, as determined by the Quality Payment Program. * ■ 39. Section 425.600 is amended by— ■ a. In paragraph (a)(4)(i)( me and uncontrollable circumstance due to a cyberattack, including ransomware/malware, as determined by the Quality Payment Program. * ■ 39. Section 425.600 is amended by— ■ a. In paragraph (a)(4)(i)(C)(1), removing the phrase ‘‘paragraph (g)(1) of this section’’ and adding in its place the phrase ‘‘paragraphs (g)(1) or (h)(1) of this section’’; ■ b. In paragraph (a)(4)(i)(C)(2)(iii), removing the phrase ‘‘paragraph (h)(2)(i) of this section’’ and adding in its place the phrase ‘‘paragraph (i)(2)(i) of this section’’; ■ c. In paragraph (a)(4)(ii), removing the phrase ‘‘paragraph (d) or paragraph (g)(2) of this section’’ and adding in its place the phrase ‘‘paragraphs (d), (g)(2) or (h) of this section’’; ■ d. Revising paragraph (g) introductory text; ■ e. Redesignating paragraph (h) as paragraph (i); and f. Adding new paragraph (h). The revision and addition read as follows: § 425.600 Selection of risk model. * * * * * (g) For agreement periods beginning on or after January 1, 2024 and before January 1, 2027, CMS determines an ACO’s eligibility for the Shared Savings Program participation options specified in paragraph (a) of this section as follows: * * * * * (h) For agreement per before January 1, 2027, CMS determines an ACO’s eligibility for the Shared Savings Program participation options specified in paragraph (a) of this section as follows: * * * * * (h) For agreement periods beginning on or after January 1, 2027, CMS determines an ACO’s eligibility for the Shared Savings Program participation options specified in paragraph (a) of this section as follows: (1) If an ACO is determined to be inexperienced with performance-based risk Medicare ACO initiatives, the ACO may enter either the BASIC track’s glide path at any of the levels of risk and potential reward under paragraphs (a)(4)(i)(A)(1) through (5) of this section, or the ENHANCED track under paragraph (a)(3) of this section, except as otherwise specified in paragraph (h)(3) of this section. (i) An ACO that is inexperienced with performance-based risk Medicare ACO initiatives may participate under the BASIC track’s glide path for a maximum of one agreement period, as specified in paragraph (a)(4)(i)(C) of this section. (ii) An ACO that enters an agreement period under the BASIC track’s glide path at any of the levels of risk and potential reward available under paragraphs (a)(4)(i)(A)(1) through (5) of this section. (ii) An ACO that enters an agreement period under the BASIC track’s glide path at any of the levels of risk and potential reward available under paragraphs (a)(4)(i)(A)(1) through (5) of this section is deemed to have completed one agreement period under the BASIC track’s glide path. For the purpose of determining the ACO’s prior participation in the BASIC track’s glide path, CMS considers whether the ACO satisfies either of the following: (A) The ACO is the same legal entity as a current or previous ACO that previously entered into a participation agreement for participation in the BASIC track’s glide path. (B) For a new ACO identified as a re- entering ACO, the ACO in which the majority of the new ACO’s participants were participating previously entered into a participation agreement for participation in the BASIC track’s glide path. (iii) An ACO determined to be inexperienced with performance-based risk Medicare ACO initiatives but is not eligible to enter the BASIC track’s glide path, in accordance with this paragraph, may enter BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period, or the ENHANCED track’s glide path, in accordance with this paragraph, may enter BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period, or the ENHANCED track under paragraph (a)(3) of this section, except as otherwise specified in paragraph (h)(3) of this section. (2) If an ACO is determined to be experienced with performance-based risk Medicare ACO initiatives, the ACO may enter either the BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period, or the ENHANCED track under paragraph (a)(3) of this section, except as otherwise specified in paragraph (h)(3) of this section. (3) If an ACO is determined to have fewer than 5,000 assigned beneficiaries in either the first benchmark year, the second benchmark year, or both, in accordance with § 425.110(a)(3), the ACO may only enter the BASIC track. The ACO may enter a level of risk and potential reward under the BASIC track in accordance with the requirements of this paragraph, as follows: (i) An ACO determined to be inexperienced with performance-based risk Medicare ACO initiatives may enter the BASIC track’s glide path at any dance with the requirements of this paragraph, as follows: (i) An ACO determined to be inexperienced with performance-based risk Medicare ACO initiatives may enter the BASIC track’s glide path at any of the levels of risk and potential reward available under paragraphs (a)(4)(i)(A)(1) through (5) of this section (if eligible in accordance with paragraph (h)(1) of this section), or BASIC track Level E under paragraph (a)(4)(i)(A)(5) VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00506 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 32857 of this section for all performance years of the agreement period. assigned beneficiaries to reside in an affected area. specified in paragraph (i)(1)(ii) of this section: (ii) An ACO determined to be (3) CMS applies determinations made (A) Calculates the value for total * * * experienced with performance-based risk Medicare ACO initiatives may enter BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period. * * ■ 40. Sectio d with performance-based risk Medicare ACO initiatives may enter BASIC track Level E under paragraph (a)(4)(i)(A)(5) of this section for all performance years of the agreement period. * * ■ 40. Section 425.605 is amended by— ■ a. In paragraph (b)(2)(ii)(E), removing the reference ‘‘§ 425.600(h)(2)’’ and adding in its place the reference ‘‘§ 425.600(i)(2)’’; ■ b. In paragraph (d)(1) introductory text, removing the references ‘‘§ 425.600(d) or § 425.600(g)’’ and adding in its place the references ‘‘§ 425.600(d), (g), or (h)’’; ■ c. In paragraphs (d)(1)(i)(A)(3)(ii), (d)(1)(i)(A)(4)(ii), (d)(1)(ii)(A)(3)(ii), (d)(1)(ii)(A)(4)(ii), (d)(1)(iii)(A)(3)(ii), (d)(1)(iii)(A)(4)(ii), (d)(1)(iv)(A)(3)(ii), (d)(1)(iv)(A)(4)(ii), (d)(1)(v)(A)(3)(ii), and (d)(1)(v)(A)(4)(ii), removing the phrase ‘‘health equity adjusted quality performance score calculated according to § 425.512(b)’’ and adding in its place the phrase ‘‘quality score calculated according to § 425.512’’; ■ d. Revising paragraph (d)(2); ■ e. Adding paragraph (f)(2)(ii); f. Revising paragraph (f)(3) introductory text; ■ g. Removing the punctuation ‘‘; and’’ at the end of paragraph (f)(3)(i) and adding in its place a period; ■ h. Add ; ■ e. Adding paragraph (f)(2)(ii); f. Revising paragraph (f)(3) introductory text; ■ g. Removing the punctuation ‘‘; and’’ at the end of paragraph (f)(3)(i) and adding in its place a period; ■ h. Adding paragraph (f)(3)(iii); i. Redesignating paragraph (f)(4) as paragraph (f)(5); j. Adding new paragraph (f)(4); and ■ k. Adding paragraphs (h)(1)(v) and (i). The revisions and additions read as follows: § 425.605 Calculation of shared savings and losses under the BASIC track. * * * (d) * * * (2) If the ACO enters the BASIC track * * * * at Level E as specified under § 425.600(d), (g), or (h), the level of risk and reward specified in paragraph (d)(1)(v) of this section applies to all performance years of an ACO’s agreement period. * * * (f) * * * (2) * * * (ii) For performance year 2025 and subsequent performance years, for an ACO as defined at § 425.20 that is determined to be affected by an extreme and uncontrollable circumstance due to a cyberattack, including ransomware/ malware, for any month of the performance year that is affected, CMS considers 100 percent of the ACO’s under the Quality Payment Program with respect to all of the following (as applicable): * * * * * (iii) The any month of the performance year that is affected, CMS considers 100 percent of the ACO’s under the Quality Payment Program with respect to all of the following (as applicable): * * * * * (iii) The time period during which the ACO was affected by a cyberattack, including ransomware/malware. (4) CMS determines the time period during which an ACO is affected by a cyberattack, including ransomware/ malware, as follows: (i) CMS uses the start and end date indicated on an ACO’s application to the Quality Payment Program for an extreme and uncontrollable circumstance exception due to a cyberattack, including ransomware/ malware, or the start date indicated on the application and an end date subsequently provided by the ACO in the form and manner as specified by CMS. (ii) Except as specified in paragraph (f)(4)(iii) of this section, if no end date is indicated on the ACO’s application or otherwise provided to CMS in a form and manner specified by CMS, described in paragraph (f)(4)(i) of this section, CMS applies a 90-day duration for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance. (iii) If the start date indicated s section, CMS applies a 90-day duration for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance. (iii) If the start date indicated on the ACO’s application described in paragraph (f)(4)(i) of this section is less than 90 days before the end of the performance year and no end date is indicated on the ACO’s application or otherwise provided to CMS in the form and manner specified by CMS, described in paragraph (f)(4)(i) of this section, CMS applies an end date of December 31st of the performance year for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance. * * * (h) * * * (1) * * * (v) For agreement periods beginning on or after January 1, 2027, the ACO has at least 5,000 assigned beneficiaries in each of the ACO’s benchmark years. * * (i) Calculation of performance payment limit and loss recoupment limit. * * * * * (1) The performance payment limit is a percentage of the ACO’s updated benchmark, as determined under § 425.601 or § 425.652. (i) CMS calculates the performance payment limit as follows, except as benchmark expenditures as the product s a percentage of the ACO’s updated benchmark, as determined under § 425.601 or § 425.652. (i) CMS calculates the performance payment limit as follows, except as benchmark expenditures as the product of an ACO’s per capita updated benchmark expenditures for the performance year and an ACO’s assigned beneficiary person years for the performance year. (B) Calculates the product of the percentage specified in paragraph (d)(1)(i)(B)(2), (d)(1)(ii)(B)(2), (d)(1)(iii)(B)(2), (d)(1)(iv)(B)(2), and (d)(1)(v)(B)(2) of this section, as applicable, and the ACO’s total benchmark expenditures calculated according to paragraph (i)(1)(i)(A) of this section. (ii) For agreement periods beginning on or after January 1, 2027, if the ACO has fewer than 5,000 assigned beneficiaries in benchmark year (BY) 1, BY2 or BY3, in conducting financial reconciliation for each performance year, CMS determines whether to apply an alternative performance payment limit, rather than the performance payment limit specified in paragraph (d)(1)(i)(B)(2), (d)(1)(ii)(B)(2), (d)(1)(iii)(B)(2), (d)(1)(iv)(B)(2), and (d)(1)(v)(B)(2) of this section, as applicable, as follows: (A) CMS calculates the value for total benchmark d in paragraph (d)(1)(i)(B)(2), (d)(1)(ii)(B)(2), (d)(1)(iii)(B)(2), (d)(1)(iv)(B)(2), and (d)(1)(v)(B)(2) of this section, as applicable, as follows: (A) CMS calculates the value for total benchmark expenditures as the product of an ACO’s per capita updated benchmark expenditures for the performance year and an ACO’s assigned beneficiary person years for the benchmark year with the lowest number of assigned beneficiaries. (B) CMS calculates the product of the percentage specified in paragraph (d)(1)(i)(B)(2), (d)(1)(ii)(B)(2), (d)(1)(iii)(B)(2), (d)(1)(iv)(B)(2), and (d)(1)(v)(B)(2) of this section, as applicable, and the ACO’s total benchmark expenditures calculated according to paragraph (i)(1)(ii)(A) of this section. (C) The performance payment limit is set to the lesser of the amount calculated under paragraph (i)(1)(i)(B) of this section and the alternative amount calculated under paragraph (i)(1)(ii)(B) of this section. (2) The loss recoupment limit is a percentage of total Medicare Parts A and B fee-for-service revenue of the ACO participants in the ACO (revenue-based loss recoupment limit) not to exceed a percentage of the ACO’s updated benchmark as determined under § 425. care Parts A and B fee-for-service revenue of the ACO participants in the ACO (revenue-based loss recoupment limit) not to exceed a percentage of the ACO’s updated benchmark as determined under § 425.601 or § 425.652 (benchmark- based loss recoupment limit). (i) CMS calculates the benchmark- based loss recoupment limit as follows, except as specified in paragraph (i)(2)(ii) of this section: VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00507 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 ■ ■ ■ 32858 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (A) Calculates the value for total benchmark expenditures as the product of an ACO’s per capita updated benchmark expenditures for the performance year and an ACO’s assigned beneficiary person years for the performance year. (B) Calculates the product of the percentage used to calculate the benchmark-based loss recoupment limit specified in paragraph (d)(1)(iii)(D)(2), (d)(1)(iv)(D)(2), and (d)(1)(v)(D)(2) of this section, as applicable, and the ACO’s total benchmark expenditures calculated according to paragraph (i)(2)( mit specified in paragraph (d)(1)(iii)(D)(2), (d)(1)(iv)(D)(2), and (d)(1)(v)(D)(2) of this section, as applicable, and the ACO’s total benchmark expenditures calculated according to paragraph (i)(2)(i)(A) of this section. (ii) For agreement periods beginning on or after January 1, 2027, if the ACO has fewer than 5,000 assigned beneficiaries in BY1, BY2 or BY3, in conducting financial reconciliation for each performance year, CMS determines whether to apply an alternative loss recoupment limit, as follows: (A) CMS calculates an alternative benchmark-based loss recoupment limit: (1) CMS calculates the value for total benchmark expenditures as the product of an ACO’s per capita updated benchmark expenditures for the performance year and an ACO’s assigned beneficiary person years for the benchmark year with the lowest number of assigned beneficiaries. (2) CMS calculates the product of the percentage used to calculate the benchmark-based loss recoupment limit specified in paragraph (d)(1)(iii)(D)(2), (d)(1)(iv)(D)(2), and (d)(1)(v)(D)(2) of this section, as applicable, and the ACO’s total benchmark expenditures calculated according to paragraph (i)(2)(ii)(A)(1) of this section. (B) The iii)(D)(2), (d)(1)(iv)(D)(2), and (d)(1)(v)(D)(2) of this section, as applicable, and the ACO’s total benchmark expenditures calculated according to paragraph (i)(2)(ii)(A)(1) of this section. (B) The loss recoupment limit is set to the revenue-based loss recoupment limit specified in paragraph (d)(1)(iii)(D)(1), (d)(1)(iv)(D)(1), or (d)(1)(v)(D)(1) of this section, as applicable, not to exceed the lower of the benchmark-based loss recoupment limit amount calculated under paragraph (i)(2)(i)(B) of this section or the alternative benchmark- based loss recoupment limit amount calculated under paragraph (i)(2)(ii)(A)(2) of this section. ■ 41. Section 425.610 is amended by— ■ a. In paragraphs (d)(3)(ii), (d)(4)(ii), (f)(3)(i)(A), and (f)(4)(i)(A), removing the phrase ‘‘health equity adjusted quality performance score calculated according to § 425.512(b)’’ and adding in its place the phrase ‘‘quality score calculated according to § 425.512’’; ■ b. Adding paragraph (i)(2)(ii); ■ c. Revising paragraph (i)(3) introductory text; ■ d. Removing the punctuation ‘‘; and’’ at the end of paragraph (i)(3)(i) and adding in its place a period; ■ e. Adding paragraph (i)(3)(iii); f. Redesignating para paragraph (i)(3) introductory text; ■ d. Removing the punctuation ‘‘; and’’ at the end of paragraph (i)(3)(i) and adding in its place a period; ■ e. Adding paragraph (i)(3)(iii); f. Redesignating paragraph (i)(4) as paragraph (i)(5); and ■ g. Adding new paragraphs (i)(4) and (l). The revisions and additions read as follows: * * § 425.610 Calculation of shared savings and losses under the ENHANCED track. * * * (i) * * * (2) * * * (ii) For performance year 2025 and subsequent performance years, for an ACO as defined at § 425.20 that is determined to be affected by an extreme and uncontrollable circumstance due to a cyberattack, including ransomware/ malware, for any month of the performance year that is affected, CMS considers 100 percent of the ACO’s assigned beneficiaries to reside in an affected area. (3) CMS applies determinations made under the Quality Payment Program with respect to all of the following (as applicable): * * * * * (iii) The time period during which the ACO was affected by a cyberattack, including ransomware/malware. (4) CMS determines the time period during which an ACO is affected by a cyberattack, including ransomware/ malware, as follows: (i) CMS uses the sta ted by a cyberattack, including ransomware/malware. (4) CMS determines the time period during which an ACO is affected by a cyberattack, including ransomware/ malware, as follows: (i) CMS uses the start and end date indicated on an ACO’s application to the Quality Payment Program for an extreme and uncontrollable circumstance exception due to a cyberattack, including ransomware/ malware, or the start date indicated on the application and an end date subsequently provided by the ACO in the form and manner as specified by CMS. (ii) Except as specified in paragraph (i)(4)(iii) of this section, if no end date is indicated on the ACO’s application or otherwise provided to CMS in a form and manner specified by CMS, described in paragraph (i)(4)(i) of this section, CMS applies a 90-day duration for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance. (iii) If the start date indicated on the ACO’s application described in paragraph (i)(4)(i) of this section is less than 90 days before the end of the performance year and no end date is indicated on the ACO’s application or otherwise provided to CMS in the form and manner s agraph (i)(4)(i) of this section is less than 90 days before the end of the performance year and no end date is indicated on the ACO’s application or otherwise provided to CMS in the form and manner specified by CMS, described in paragraph (i)(4)(i) of this section, CMS applies an end date of December 31st of the performance year for purposes of determining the time period during which the ACO was affected by the extreme and uncontrollable circumstance. * * (l) Calculation of performance payment limit and loss recoupment limit. * * * (1) The performance payment limit and the loss recoupment limit are a percentage of the ACO’s updated benchmark. (2) CMS calculates the performance payment limit and loss recoupment limit as follows, except as specified in paragraph (l)(3) of this section: (i) Calculates the value for total benchmark expenditures as the product of an ACO’s per capita updated benchmark expenditures for the performance year and an ACO’s assigned beneficiary person years for the performance year. (ii) Calculates the product of the percentage used to calculate the performance payment limit specified in paragraph (e)(2) of this section or the loss recoupment limit specified the performance year. (ii) Calculates the product of the percentage used to calculate the performance payment limit specified in paragraph (e)(2) of this section or the loss recoupment limit specified in paragraph (g) of this section and the ACO’s total benchmark expenditures calculated according to paragraph (l)(2)(i) of this section. (3) For agreement periods beginning on or after January 1, 2027, if the ACO has fewer than 5,000 assigned beneficiaries in BY1, BY2 or BY3, in conducting financial reconciliation for each performance year, CMS determines whether to apply an alternative performance payment limit or alternative loss recoupment limit, rather than the performance payment limit specified in paragraph (e)(2) of this section or the loss recoupment limit specified in paragraph (g) of this section, as follows: (i) CMS calculates the value for total benchmark expenditures as the product of an ACO’s per capita updated benchmark expenditures for the performance year and an ACO’s assigned beneficiary person years for the benchmark year with the lowest number of assigned beneficiaries. (ii) CMS calculates the product of the percentage used to calculate the performance payment limi igned beneficiary person years for the benchmark year with the lowest number of assigned beneficiaries. (ii) CMS calculates the product of the percentage used to calculate the performance payment limit specified in paragraph (e)(2) of this section or the loss recoupment limit specified in paragraph (g) of this section and the ACO’s total benchmark expenditures calculated according to paragraph (l)(3)(i) of this section. (iii) The performance payment limit or loss recoupment limit is set equal to the lesser of the amount calculated under paragraph (l)(2)(ii) of this section or the alternative amount calculated under paragraph (l)(3)(ii) of this section. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00508 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 32859 ■ 42. Section 425.612 is amended by revising paragraph (a)(1)(i)(B) to read as follows: § 425.612 Waivers of payment rules or other Medicare requirements. (a) * * * (1) * * * (i) * * * (B)(1) A list of SNFs, including the Medicare-enrolled TIN and the CCN, with w )(B) to read as follows: § 425.612 Waivers of payment rules or other Medicare requirements. (a) * * * (1) * * * (i) * * * (B)(1) A list of SNFs, including the Medicare-enrolled TIN and the CCN, with whom the ACO will partner along with executed written SNF affiliate agreements between the ACO and each listed SNF. (2) An ACO must notify CMS no later than 30 days after the change of ownership of a SNF affiliate, identified in accordance with paragraph (a)(1)(i)(B)(1) of this section, that has resulted in a change to the Medicare enrolled TIN of the SNF affiliate. Such notice and supporting documentation must be submitted in the form and manner specified by CMS. * * * * * § 425.652 [Amended] ■ 43. Section 425.652 is amended by— ■ a. In paragraph (a)(8)(ii)(A), removing the phrase ‘‘health equity benchmark adjustment (HEBA)’’ and adding in its place the phrase ‘‘population adjustment’’; ■ b. In paragraphs (a)(8)(ii)(B) introductory text, (a)(8)(ii)(B)(2), (a)(9)(v), and (a)(9)(vi), removing the phrase ‘‘HEBA’’ and adding in its place the phrase ‘‘population adjustment’’; and ■ c. In paragraph (a)(9)(v), removing the phrase ‘‘HEBA scaler used in calculating the HEBA under § 425.662(b)(2 g the phrase ‘‘HEBA’’ and adding in its place the phrase ‘‘population adjustment’’; and ■ c. In paragraph (a)(9)(v), removing the phrase ‘‘HEBA scaler used in calculating the HEBA under § 425.662(b)(2)’’ and adding in its place the phrase ‘‘scaler used in calculating the population adjustment under § 425.662(b)(2)’’. § 425.658 [Amended] ■ 44. Section 425.658 is amended in paragraph (d) by removing the phrase ‘‘HEBA’’ and adding in its place the phrase ‘‘population adjustment’’. ■ 45. Section 425.662 is amended by— ■ a. Revising the section heading and paragraph (a); ■ b. In paragraph (b) introductory text, removing the phrase ‘‘health equity benchmark adjustment’’ and adding in its place the phrase ‘‘population adjustment’’; ■ c. In paragraph (b)(2), removing the phrase ‘‘Calculates the HEBA scaler’’ and adding in its place the phrase ‘‘Calculates a scaler’’; and ■ d. Revising paragraphs (b)(3), (b)(4), and (c). The revisions read as follows: § 425.662 Calculating the population adjustment to the historical benchmark. (a) General. For agreement periods beginning on January 1, 2025, and in subsequent years, CMS calculates the population adjustment to the historical benchmark. (b) * ment to the historical benchmark. (a) General. For agreement periods beginning on January 1, 2025, and in subsequent years, CMS calculates the population adjustment to the historical benchmark. (b) * * * (3) Determines the ACO’s eligibility for the population adjustment based on the proportion of the ACO’s assigned beneficiaries for the performance year who are enrolled in the Medicare Part D low-income subsidy (LIS) or dually eligible for Medicare and Medicaid. An ACO is only eligible for the population adjustment if this proportion is greater than or equal to 15 percent. An ACO with a proportion less than 15 percent is ineligible to receive the population adjustment. (4) Calculates the population adjustment. If the ACO is eligible for the population adjustment as determined in paragraph (b)(3) of this section, the adjustment is equal to the product of the scaler calculated in paragraph (b)(2) of this section and the proportion of the ACO’s assigned beneficiaries for the performance year who are enrolled in the Medicare Part D LIS or dually eligible for Medicare and Medicaid. (c) Applicability of the population adjustment. CMS compares the population adjustment determined in parag ear who are enrolled in the Medicare Part D LIS or dually eligible for Medicare and Medicaid. (c) Applicability of the population adjustment. CMS compares the population adjustment determined in paragraph (b)(4) of this section with the regional adjustment, expressed as a single value as described in § 425.656(d), and the per capita prior savings adjustment determined in § 425.658(c), if any, to determine the adjustment, if any, that will be applied to the ACO’s benchmark in accordance with § 425.652(a)(8)(ii). * * * * * § 425.672 [Amended] ■ 46. Section 425.672 is amended in paragraph (c)(2)(iv) by removing the phrase ‘‘and calculating the HEBA scaler’’ and adding in its place the phrase ‘‘and calculating the scaler’’. PART 427—MEDICARE PART B DRUG INFLATION REBATE PROGRAM ■ 47. The authority citation for part 427 continues to read as follows: Authority: 42 U.S.C. 1395w–3a(i), 1302, and 1395hh. ■ 48. Section 427.20 is amended by removing the definition of ‘‘Billing and payment code FDA approval or licensure date’’. ■ 49. Section 427.302 is amended by revising paragraphs (c) introductory text, (c)(5), (c)(6), (d)(1)(i) and (ii) to read as follows. § 427.302 Calculation of the per u A approval or licensure date’’. ■ 49. Section 427.302 is amended by revising paragraphs (c) introductory text, (c)(5), (c)(6), (d)(1)(i) and (ii) to read as follows. § 427.302 Calculation of the per unit Part B rebate amount. * * * * * (c) Identification of the payment amount benchmark quarter. For each Part B rebatable drug, CMS identifies the applicable payment amount benchmark quarter as set forth in paragraphs (c)(1) through (6) of this section, as applicable, subject to paragraphs (c)(4) and (6) of this section, using the earliest first marketed date of any NDC ever marketed under any FDA application under which any NDCs that have ever been assigned to the billing and payment code as of the applicable calendar quarter have been marketed, and using the earliest approval or licensure date of any FDA application under which any NDCs that have ever been assigned to the billing and payment code as of the applicable calendar quarter have been marketed. (5) If the data needed to calculate the payment amount in the payment amount benchmark quarter described in and determined under § 427.302(d)(1) are not available, CMS uses the third full calendar quarter after a drug is assigned a bi e the payment amount in the payment amount benchmark quarter described in and determined under § 427.302(d)(1) are not available, CMS uses the third full calendar quarter after a drug is assigned a billing and payment code as the payment amount benchmark quarter, no earlier than the calendar quarter beginning July 1, 2021, or the third full calendar quarter after such drug’s first marketed date, whichever is later. (6) For a Part B rebatable drug that is a selected drug (as defined in section 1192(c) of the Act) with respect to a price applicability period (as defined in section 1191(b)(2) of the Act), in the case such Part B rebatable drug is no longer considered to be a selected drug, for each applicable quarter beginning after the price applicability period with respect to such drug, the payment amount benchmark quarter is the calendar quarter beginning January 1 of the last year during such price applicability period with respect to such selected drug. (d) * * * (1) For a Part B rebatable drug, subject to paragraphs (d)(1)(i) and (ii) of this section and except as provided in paragraph (d)(2) of this section, CMS identifies the payment amount in the payment amount benchmark qua batable drug, subject to paragraphs (d)(1)(i) and (ii) of this section and except as provided in paragraph (d)(2) of this section, CMS identifies the payment amount in the payment amount benchmark quarter using the published payment limit for the billing and payment code for the applicable payment amount benchmark quarter. (i) If a published payment limit is not available for the applicable payment amount benchmark quarter, CMS calculates the payment amount in the payment amount benchmark quarter using positive ASP or positive WAC VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00509 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 32860 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules data from the ASP Data Collection System. (ii) If a published payment limit is not available and neither positive ASP nor positive WAC data are available in the ASP Data Collection System, CMS calculates the payment amount in the payment amount benchmark quarter using WAC data from other public sources. * * ■ 50. Section 427.501 is amended by adding paragraph (c)(3) to read as follows: CMS calculates the payment amount in the payment amount benchmark quarter using WAC data from other public sources. * * ■ 50. Section 427.501 is amended by adding paragraph (c)(3) to read as follows: * * * § 427.501 Rebate Reports and reconciliation. * * * (c) * * * (3) The manufacturer’s rebate amount * * due is reported as a dollar amount rounded to the nearest cent. ■ 51. Section 427.502 is amended by revising paragraph (c)(1)(ii) to read as follows: * * § 427.502 Rebate Reports for applicable calendar quarters in calendar years 2023 and 2024. * * * (c) * * * (1) * * * (i) * * * (ii) Within 9 months after issuance of the single Rebate Report, CMS performs one regular reconciliation for the applicable calendar quarters in calendar year 2024 in order to include revisions to the information used, determined under § 427.501(b)(1), to calculate the rebate amount. Such reconciliation is as determined under § 427.501(d) inclusive of a preliminary reconciliation and a report with the reconciled rebate amount. PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM ■ 52. The authority citation for part 428 continues to read as follows: Authority: 42 U.S.C. 1395w–114b, 1302, and 1395hh. ■ iled rebate amount. PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM ■ 52. The authority citation for part 428 continues to read as follows: Authority: 42 U.S.C. 1395w–114b, 1302, and 1395hh. ■ 53. Section 428.401 is amended by adding paragraph (c)(3) to read as follows: § 428.401 Rebate Reports and reconciliation. * * * (c) * * * (1) * * * (2) * * * (3) The manufacturer’s rebate amount * * due is reported as a dollar amount rounded to the nearest cent. ■ 54. Section 428.402 is amended by revising paragraphs (c)(1)(ii) and (c)(2)(ii) to read as follows: § 428.402 Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023. * * * (c) * * * (1) * * * (i) * * * (ii) The rebate amount is reconciled * * within 21 months after the Rebate Report set forth in paragraph (c)(1) of this section is issued to include the information set forth in § 428.401(d)(1)(i)(A) through (G). (2) * * * (i) * * * (ii) The rebate amount is reconciled within 9 months after the Rebate Report and within 33 months after the Rebate Report specified in paragraph (b)(2) of this section is issued to include the information determined under § 428.401(d)(1)(i)(A) through (G). ■ 55. Sectio Report and within 33 months after the Rebate Report specified in paragraph (b)(2) of this section is issued to include the information determined under § 428.401(d)(1)(i)(A) through (G). ■ 55. Section 428.405(a)(1) is amended to read as follows: § 428.405 Deadline and process for payment of rebate amount. (a) * * * (1) Upon receipt of a rebate amount, payment is due no later than 11:59 p.m. Pacific Time (PT) on the 30th calendar day after the date of receipt of information regarding the rebate amount on— PART 495—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES ■ 56. The authority citation for part 495 continues to read as follows: Authority: 42 U.S.C. 1302 and 1395hh. ■ 57. Section 495.24 by adding paragraph (f)(3) to read as follows: § 495.24 Stage 3 meaningful use objectives and measures for EPs, eligible hospitals and CAHs for 2019 and subsequent years. * * * (f) * * * (3) Beginning with the EHR reporting * * period in CY 2026, if certain circumstances occur that impact CMS’s assessment of the performance of eligible hospitals and CAHs on a measure selected as described in paragraph (f)(1)(i)(A) of this section, CMS may, in its sole discretion, suppress the affected measur assessment of the performance of eligible hospitals and CAHs on a measure selected as described in paragraph (f)(1)(i)(A) of this section, CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS’s calculation of the objective score in paragraph (f)(1)(i)(D) of this section or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. CMS determines whether certain circumstances exist warranting suppression of a measure based on CMS’s consideration of one or more of the following factors: (i) The nature, breadth, and duration of the circumstance’s effect on eligible hospitals’ and CAHs’ ability to fulfill the measure requirement. (ii) The availability of certified health IT modules to fulfill the measure. (iii) The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance. (iv) Out-of-date or conflicting technical standards. (v) Technical and operational capacity of required partners. (vi) Other factors as determined by CMS. * ■ 58. The authority citation for part 512 continues to read as follows: * * * * ical standards. (v) Technical and operational capacity of required partners. (vi) Other factors as determined by CMS. * ■ 58. The authority citation for part 512 continues to read as follows: * * * * Authority: 42 U.S.C. 1302, 1315a, and 1395hh. ■ 59. Adding subparts F and G to part 512 to read as follows: Subpart F—[Reserved] Subpart G—Ambulatory Specialty Model (ASM) General 512.700 Basis and scope. 512.705 Definitions. 512.710 Participant eligibility and selection. Performance Categories and Scoring 512.715 Overview of performance assessment. 512.720 Data submission requirements. 512.725 Quality ASM performance category. 512.730 Cost ASM performance category. 512.735 Improvement activities ASM performance category. 512.740 Promoting Interoperability ASM performance category. 512.745 Final scoring. Payment and Timely Error Notice Process 512.750 Payment adjustment. 512.755 Timely error notice. Data Sharing, Waivers, Safe Harbor, and Compliance 512.760 Data sharing with ASM participants. 512.765 Application of the CMS-sponsored model arrangements and patient incentives safe harbor. 512.770 ASM beneficiary incentives. 512.771 Collaborative care arrangements. 512.775 Medicare progra ts. 512.765 Application of the CMS-sponsored model arrangements and patient incentives safe harbor. 512.770 ASM beneficiary incentives. 512.771 Collaborative care arrangements. 512.775 Medicare program waivers. 512.780 Extreme and uncontrollable circumstances. Subpart G—Ambulatory Specialty Model (ASM) § 512.700 Basis and scope of subpart. (a) Basis. This subpart implements the test of the Ambulatory Specialty Model (ASM) under section 1115A of the Act. (b) Scope. This subpart sets forth the following: (1) The method for selecting ASM participants. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00510 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 32861 (2) The methodology for ASM participant performance assessment and scoring for purposes of the improvement activities ASM performance category, quality ASM performance category, cost ASM performance category, and Promoting Interoperability ASM performance category, including beneficiary inclusion and episode-based cost measures. (3) Data submission for applicable ASM p egory, cost ASM performance category, and Promoting Interoperability ASM performance category, including beneficiary inclusion and episode-based cost measures. (3) Data submission for applicable ASM performance categories. (4) The schedule and methodologies for payment adjustments. (5) Appeals process. (6) Data sharing with ASM participants. (7) ASM beneficiary incentives. (8) Collaborative care arrangements. (9) Application of the CMS-sponsored model arrangements and patient incentives safe harbor. (10) Medicare program waivers. (11) Except as specifically noted in this subpart, the regulations under this subpart do not affect the applicability of other provisions affecting providers and suppliers under Medicare fee for service, including the applicability of provisions regarding payment, coverage, or program integrity. (c) Applicability. Except as otherwise specified in this subpart, ASM participants are subject to the standard provisions for Innovation Center models specified in subpart A of this part 512 and in subpart K of part 403 of this chapter. § 512.705 Definitions. For purposes of this part, the terms in this part have the same meanings as 42 CFR §§ 512.110 and 414.1300 part A of this part 512 and in subpart K of part 403 of this chapter. § 512.705 Definitions. For purposes of this part, the terms in this part have the same meanings as 42 CFR §§ 512.110 and 414.1300 unless otherwise stated. ASM beneficiary means a Medicare FFS beneficiary who is being treated by an ASM participant for a targeted chronic condition. ASM cohort means a group of ASM participants who treat the same ASM targeted chronic condition, specifically the ASM heart failure cohort and the ASM back pain cohort. ASM data sharing agreement means an agreement between the ASM participant, and CMS that includes the terms and conditions for any beneficiary-identifiable data being shared with the ASM participant under § 512.760(e). ASM heart failure cohort refers to all ASM heart failure participants. ASM low back pain cohort refers to all ASM low back pain participants. ASM heart failure participant means an ASM participant who meets the ASM participant eligibility criteria related to heart failure. ASM incentive pool means a fixed percentage of the total amount of Medicare Part B covered professional services claims paid to ASM participants with final scores within an ASM cohort durin t failure. ASM incentive pool means a fixed percentage of the total amount of Medicare Part B covered professional services claims paid to ASM participants with final scores within an ASM cohort during an ASM performance year that would be distributed in the form of scaled payment adjustments during an ASM payment year. CMS calculates an ASM incentive pool for each ASM cohort for each ASM payment year as described at § 512.750(c)(1)(iii). ASM low back pain participant means an ASM participant who meets the ASM participant eligibility criteria related to low back pain. ASM participant means an individual clinician who, for at least one ASM performance year, satisfies the ASM participant eligibility criteria and has been selected for participation in the model as described at § 512.710(g). ASM participant eligibility criteria means the set of criteria defined at § 512.710(b) that CMS uses to determine whether a clinician is selected to participate in ASM. ASM payment adjustment factor means a percent value based on an ASM participant’s final score as described at § 512.750(c)(1) that CMS uses in calculating adjustments to the ASM participant’s Medicare Part B payments for covered pro ans a percent value based on an ASM participant’s final score as described at § 512.750(c)(1) that CMS uses in calculating adjustments to the ASM participant’s Medicare Part B payments for covered professional services during an ASM payment year. ASM payment multiplier means the numerical value equal to 1 plus the ASM payment adjustment factor determined for an ASM participant for an applicable ASM payment year as described at § 512.750(c). ASM payment year means a calendar year in which CMS applies the ASM payment multiplier to Medicare Part B payments based on the final score achieved by that ASM participant for the ASM performance year 2 years prior. ASM performance category means a group of applicable measures or activities used to assess ASM participant’s performance on quality, cost, improvement activities, or Promoting Interoperability. ASM performance category score means the assessment of each ASM participant’s performance on the applicable measures and activities for a performance category during an ASM performance year based on the performance standards described at §§ 512.715, 512.725, 512.730, 512.735, and 512.740. ASM performance report means the notification that CMS mance category during an ASM performance year based on the performance standards described at §§ 512.715, 512.725, 512.730, 512.735, and 512.740. ASM performance report means the notification that CMS provides to the ASM participant for each ASM performance year, which contains the information specified at § 512.745(b). ASM performance year means a 12- month period beginning on January 1 and ending on December 31 of each year during the first 5 calendar years of ASM test period. ASM redistribution percentage means a percentage of Medicare Part B covered professional services payments to ASM participants during an ASM performance year that CMS distributes in the form of payment adjustment to ASM participants during an ASM payment year as described at § 512.750(c)(1)(iii). ASM risk level the magnitude of the maximum positive or negative net payment adjustment percentage to which an ASM participant would be subject to during an ASM payment year as described at § 512.750(c)(1)(i). ASM targeted chronic condition means a medical condition that is a core focus of ASM; that is, heart failure or low back pain. ASM test period means the 7-year period from January 1, 2027, to December 31, 203 eted chronic condition means a medical condition that is a core focus of ASM; that is, heart failure or low back pain. ASM test period means the 7-year period from January 1, 2027, to December 31, 2033, that includes all ASM performance years and ASM payment years. ASTP/ONC stands for the Assistant Secretary for Technology Policy/Office of the National Coordinator on Health Information Technology. CY means calendar year. CEHRT stands for Certified Electronic Health Records Technology that meets the requirements set forth in § 414.1305 of this chapter, except all instances of references to Merit-based Incentive Payment System (MIPS) are to be replaced with references to ASM. Clinician has the same meaning as ‘‘eligible professional’’ as defined in section 1848(k)(3) of the Act, as identified by a unique TIN and NPI combination. CMS EHR Certification ID means the identification number that represents the combination of Certified Health Information Technology that is owned and used by providers and hospitals to provide care to their patients and is generated by the Certified Health IT Product List. Collaborative care arrangement means an arrangement that meets all of the requirements viders and hospitals to provide care to their patients and is generated by the Certified Health IT Product List. Collaborative care arrangement means an arrangement that meets all of the requirements set forth in § 512.771. Core Based Statistical Area (CBSA) means a statistical geographic area, based on the definition as identified by the Office of Management and Budget in the OMB Bulletin 23–01 issued on July 21, 2023, with a population of at least 10,000, which consists of a county or counties anchored by at least one core (urbanized area or urban cluster), plus adjacent counties having a high degree of social and economic integration with the core (as measured through commuting ties with the counties containing the core). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00511 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 32862 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Covered entity has the meaning set forth at 45 CFR 160.103. Covered professional services means ‘‘covered services’’ and has the meaning set forth in § 512.110 of this chapter. CQM stands for ed Rules Covered entity has the meaning set forth at 45 CFR 160.103. Covered professional services means ‘‘covered services’’ and has the meaning set forth in § 512.110 of this chapter. CQM stands for Clinical Quality Measures. Days means calendar days unless otherwise specified by CMS. Dually eligible Medicare beneficiary means a beneficiary enrolled in both Medicare and full Medicaid benefits. eCQM stands for Electronic Clinical Quality Measures. EBCM stands for episode-based cost measure and means the standardized Medicare-allowed cost for the items and services furnished to a patient during an episode of care, based on FFS claims and Medicare Part D claims data. EHR stands for Electronic Health Record and means a ‘‘Base EHR,’’ as defined at 45 CFR 170.102. Exchange function means the function used to translate an ASM participant’s final score into an ASM payment adjustment factor as described at § 512.750(c)(1)(ii). Episode means all the relevant health care services a patient receives during a specified period for the treatment of a physical or behavioral health condition. FFS stands for fee-for-service. Final score means a composite assessment (using a scoring scale of zero t ives during a specified period for the treatment of a physical or behavioral health condition. FFS stands for fee-for-service. Final score means a composite assessment (using a scoring scale of zero to 100) for each ASM participant for an ASM performance year determined using the methodology for assessing the total performance of an ASM participant according to performance standards for applicable measures and activities for each ASM performance category as described in § 512.745. HCC risk score stands for Hierarchical Condition Category risk score and means the risk score assigned to a Medicare beneficiary pursuant to the HCC risk adjustment model established by CMS under section 1853(a)(1) of the Act. Health-related social need means an unmet, adverse social condition that can contribute to poor health outcomes and is a result of underlying social determinants of health, which refer to the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. Improvement activities mean activities relating to care coordination, integration of specialty and primary car that affect a wide range of health, functioning, and quality-of-life outcomes and risks. Improvement activities mean activities relating to care coordination, integration of specialty and primary care, and addressing health-related social needs of patients. Mandatory geographic area means a CBSA or metropolitan division as defined by the Office of Management and Budget and selected by CMS under the terms of § 512.710(f). Meaningful EHR user means an ASM participant who possesses CEHRT, uses the functionality of CEHRT, reports on applicable objectives and measures specified for the Promoting Interoperability ASM performance category for a performance period in the form and manner specified by CMS, does not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of CEHRT, and engages in activities related to supporting providers with the performance of CEHRT. Measure achievement points mean numerical values assigned to an ASM participant’s reported performance data, that CMS uses to calculate an ASM performance category score. Metropolitan division means—(1) A county or group of counties (or equivalent entitie ed to an ASM participant’s reported performance data, that CMS uses to calculate an ASM performance category score. Metropolitan division means—(1) A county or group of counties (or equivalent entities) delineated within a larger metropolitan statistical area, provided that the larger metropolitan statistical area contains a single core with a population of at least 2.5 million and other criteria are met; and (2) Consists of one or more main or secondary counties that represent an employment center or centers, plus adjacent counties associated with the main/secondary county or counties through commuting ties. Metropolitan statistical area means the county or counties (or equivalent entities) associated with at least one urban area of at least 50,000 population, plus adjacent counties having a high degree of social and economic integration with the core as measured through commuting ties. MIPS stands for the Merit-based Incentive Payment System. NPI stands for National Provider Identifier. ONC–ACB stands for ONC-Authorized Certification Bodies. Physician has the meaning set forth in section 1861(r) of the Act. Primary care services has the meaning set forth in section 1842(i)(4) of er. ONC–ACB stands for ONC-Authorized Certification Bodies. Physician has the meaning set forth in section 1861(r) of the Act. Primary care services has the meaning set forth in section 1842(i)(4) of the Act. Risk indicator refers to hierarchical condition category (HCC) risk scores under the HCC risk adjustment model established by CMS under section 1853(a)(1) of the Act or the proportion of beneficiaries with dual eligible status used in calculating the complex patient scoring adjustment as defined at § 512.745(a)(3). SAFER stands for Safety Assurance Factors for EHR Resilience. Scaling factor means a numerical value calculated by CMS to ensure that the total estimated payment adjustments in an ASM payment year are equal to the ASM incentive pool for the applicable ASM payment year as described at § 512.750(c)(1)(iv). Small practice means a practice consisting of 15 or fewer clinicians at the time we identify ASM participants for an ASM performance year as described at § 512.710(g). Specialty type means a medical specialty as determined by the specialty code indicated on the plurality of a clinician’s Medicare Part B claims. Solo practitioner means a practice consisting of 1 clin Specialty type means a medical specialty as determined by the specialty code indicated on the plurality of a clinician’s Medicare Part B claims. Solo practitioner means a practice consisting of 1 clinician at the time we identify ASM participants for an ASM performance year as described at § 512.710(g). Submission type means the mechanism by which the ASM submitter submits data to CMS in the form and manner specified by CMS, including, but not limited to all of the following: (1) Direct. (2) Log in and upload. (3) Log in and attest. Third-party intermediary has the meaning set forth in § 414.1305 of this chapter. TIN stands for Taxpayer Identification Number. Topped out measure has the meaning of either topped out process measure or topped out non-process measure set forth in § 414.1305 of this chapter. U.S. Territories has the meaning set forth in § 512.110 of this chapter. § 512.710 Participant eligibility and selection. (a) Mandatory ASM participation. (1) Unless otherwise specified, any clinician who meets all ASM participant eligibility criteria as specified in paragraph (b) of this section and furnishes covered services that begin on or after January 1 and end on or before De , any clinician who meets all ASM participant eligibility criteria as specified in paragraph (b) of this section and furnishes covered services that begin on or after January 1 and end on or before December 31 of any applicable ASM performance year within the ASM test period is considered an ASM participant for the duration of the model. (i) 2027 ASM performance year: ASM participants are measured for performance and exempted from MIPS participation, if applicable, during CY 2027; report and are scored during CY 2028; and receive payment adjustments for CY 2027 performance in CY 2029; (ii) 2028 ASM performance year: ASM participants meeting ASM eligibility criteria for the 2028 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2028; report and are scored during CY 2029; and receive payment adjustments for CY 2028 performance in CY 2030; (iii) 2029 ASM performance year: ASM participants meeting ASM VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00512 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 / Wedn 2025 Jkt 265001 PO 00000 Frm 00512 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 32863 eligibility criteria for the 2029 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2029; report and are scored during CY 2030; and receive payment adjustments for CY 2029 performance in CY 2031; (iv) 2030 ASM performance year: ASM participants meeting ASM eligibility criteria for the 2030 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2030; report and are scored during CY 2031; and receive payment adjustments for CY 2030 performance in CY 2032; and (v) 2031 ASM performance year: ASM participants meeting ASM eligibility criteria for the 2031 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2031; report and are scored during CY 2032; and receive payment adjustments for CY 2031 performance in CY 2033. (2) For any ASM performance year within the ASM test period that a applicable, during CY 2031; report and are scored during CY 2032; and receive payment adjustments for CY 2031 performance in CY 2033. (2) For any ASM performance year within the ASM test period that an ASM participant does not meet the criteria for mandatory participation set forth in this section, such ASM participant is not subject, for the applicable ASM performance year, to §§ 512.715, 512.720, 512.745, and 512.750. The ASM participant is no longer eligible for the waivers as described at § 512.775 and is instead subject to MIPS reporting obligations, if applicable. (b) ASM participant eligibility criteria. CMS uses the following set of criteria to determine whether a clinician is an ASM participant: (1) Is a clinician who bills claims under the Medicare Physician Fee Schedule. (2) Is identified by TIN/NPI as a selected specialty type as described at paragraph (d) of this section. (3) Meets the EBCM episode volume threshold applicable to an ASM targeted chronic condition as described at paragraph (e) of this section. (4) Is located in one of the mandatory geographic areas selected in accordance with paragraph (f) of this section. (c) Participant exclusion due to change in TIN d ed at paragraph (e) of this section. (4) Is located in one of the mandatory geographic areas selected in accordance with paragraph (f) of this section. (c) Participant exclusion due to change in TIN during an ASM performance year. (1) An ASM participant who stops assigning billing rights to the TIN used to identify the ASM participant and begins assigning billing rights to a new TIN during an applicable ASM performance year must notify CMS of the change in a form and manner determined by CMS within 30 days of such change. performance year is not subject, for the applicable ASM performance year, to §§ 512.715, 512.720, 512.745, and 512.750. The ASM participant is no longer eligible for the waivers as described at § 512.775 and is instead subject to MIPS reporting obligations, if applicable. (d) Specialty type. ASM participants have one of the following Medicare Part B specialty codes indicated on the plurality of their Medicare Part B claims: (1) Heart failure specialty type— (i) Cardiology. (ii) [Reserved] (2) Low back pain specialty type— (i) Anesthesiology. (ii) Interventional Pain Management. (iii) Neurosurgery. (iv) Orthopedic Surgery. (v) Pain Management. (vi) Physical Medicin logy. (ii) [Reserved] (2) Low back pain specialty type— (i) Anesthesiology. (ii) Interventional Pain Management. (iii) Neurosurgery. (iv) Orthopedic Surgery. (v) Pain Management. (vi) Physical Medicine and Rehabilitation. (e) EBCM episode volume. To determine if a clinician meets the ASM participant eligibility criterion defined in paragraph (b)(1)(iii) of this section, CMS uses the volume of EBCM episodes related to ASM targeted chronic conditions that are attributed to a clinician using the applicable EBCM specifications and attribution methodology. (1) Heart failure EBCM. Clinicians who have a specialty designation type described at § 512.710(d)(1) and 20 or more heart failure EBCM episodes attributed in accordance with the heart failure episode-based cost measure as specified under MIPS during the calendar year 2 years prior to the applicable ASM performance year meet the ASM participant eligibility criterion defined in paragraph (b)(1)(iii) of this section. (2) Low back pain EBCM. Clinicians who have a specialty designation type described at § 512.710(d)(2) and 20 or more low back pain EBCM episodes attributed in accordance with the low back pain episode-based cost measure as Clinicians who have a specialty designation type described at § 512.710(d)(2) and 20 or more low back pain EBCM episodes attributed in accordance with the low back pain episode-based cost measure as specified under MIPS during the calendar year 2 years prior to the applicable ASM performance year meet the ASM participant eligibility criterion defined in paragraph (b)(1)(iii) of this section. (f) Mandatory geographic areas. CMS uses a stratified random sampling methodology described in paragraphs (f)(2) and (f)(3) of this section to select CBSA and metropolitan divisions (in cases where CBSA divide large metropolitan statistical areas into metropolitan divisions) from which CMS identifies clinicians for participation in ASM. (2) An ASM participant who notifies CMS of a change in TIN during an ASM (1) Exclusions. CMS excludes from the selection of CBSAs and metropolitan divisions applicable areas that meet any of the following criteria: (i) Areas that did not have at least one attributed episode between January 1, 2024 and December 31, 2024 for each of the episode-based cost measures described in paragraph (e) of this section and used in the ASM participant eligibility criteria desc d episode between January 1, 2024 and December 31, 2024 for each of the episode-based cost measures described in paragraph (e) of this section and used in the ASM participant eligibility criteria described in paragraph (b) of this section. (ii) Areas located entirely in U.S. Territories. (2) CBSA and metropolitan division stratification process. Prior to sampling CBSAs and metropolitan divisions, CMS stratifies CBSAs and metropolitan divisions, excluding those described in paragraph (f)(1) of this section, into six mutually exclusive strata based on three CBSA/metropolitan division-level characteristics (average total Part A and Part B episode spending, volume of eligible episodes, and metropolitan division status) as follows. ‘‘Average total episode spending’’ as the term is used below, is measured using the average total Part A and Part B episode spending using claims data from January 1, 2024 to December 31, 2024 relating to heart failure and low back pain episodes, as specified under the episode-based cost measures described in § 512.710(e). Values below the median are characterized as ‘‘Low’’ average total episode spending. Values at or above the median are characterized as ‘‘ er the episode-based cost measures described in § 512.710(e). Values below the median are characterized as ‘‘Low’’ average total episode spending. Values at or above the median are characterized as ‘‘High’’ average total spending. ‘‘Eligible episode volume’’ as the term is used below, is measured as the total count of eligible heart failure and low back pain episodes, as specified under the episode-based cost measures described in § 512.710(e), in a CBSA between January 1, 2024 and December 31, 2024. CMS categorizes CBSAs with values below the median as ‘‘Low;’’ CBSAs at-or-above the median and below the 95th percentile as ‘‘High;’’ and CBSAs at-or-above the 95th percentile as ‘‘Very High.’’. (i) CBSAs with ‘‘Low’’ average total episode spending and ‘‘Low’’ eligible episode volume. (ii) CBSAs with ‘‘Low’’ average total episode spending and ‘‘High’’ eligible episode volume. (iii) CBSAs with ‘‘High’’ average total episode spending (as defined below) and ‘‘Low’’ eligible episode volume. (iv) Eligible CBSAs with ‘‘High’’ average total episode spending and ‘‘High’’ eligible episode volume. (v) Eligible CBSAs with ‘‘Very High’’ eligible episode volume. (vi) Eligible metropolitan division iv) Eligible CBSAs with ‘‘High’’ average total episode spending and ‘‘High’’ eligible episode volume. (v) Eligible CBSAs with ‘‘Very High’’ eligible episode volume. (vi) Eligible metropolitan divisions. (3) Sampling of CBSAs and metropolitan divisions. CMS selects approximately 40 percent of CBSAs and metropolitan divisions from each VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00513 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 32864 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules stratum to select the mandatory geographic areas. If 40 percent of a given stratum does not result in a whole number of CBSAs or metropolitan divisions, CMS rounds up to the next whole number to ensure that at least 40 percent of areas from each stratum are selected. (4) Assignment of CBSA or metropolitan division code to clinicians. CMS assigns a CBSA or a metropolitan division code to every TIN/NPI with attributed EBCM episodes related to ASM targeted chronic conditions for the applicable calendar year as described in paragraph (e) of this section to determine ASM participation eli