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

In section V.B.5.a.(2) of this final rule, we discuss changes in the estimated burden for the information collections associated with the Quality Payment Program. The changes to the estimated burden and the information collections for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey, described in section V.B.5.b.(1) of this final rule, will be submitted to OMB for approval under control number 0938-1222 (CMS-10450). All other changes to burden and information collections for Quality Payment Program ICRs due to policy changes described in this section of the final rule, or the availability of updated data, will be submitted to OMB for approval under control number 0938-

1314 (CMS-10621). We did not propose changes to the virtual group election process or burden estimates, currently approved under OMB control number 0938-1343 (CMS-10652). (a) Summary of Annual Quality Payment Program Burden Estimates

We are finalizing our proposed changes to six Quality Payment Program ICRs due to policies finalized in this final rule. For these six ICRs (five under OMB control number 0938-1314 (CMS-10621) and one under OMB control number 0938-1222 (CMS-10450)), we also updated our burden assumptions based on the updated MIPS participation data. These updated data sources are described in section V.B 5.a.(4)(b) of this final rule. The following paragraphs in this section summarize these changes to our currently approved burden estimates. Detailed discussions per ICR begin in section XX of this final rule.

For ICRs under OMB control number 0938-1314 (CMS-10621), we estimate that the policies finalized in this final rule will result in 2,312 additional responses due to the availability of new MIPS Value Pathways (MVPs). This change reflects the number of historic traditional MIPS submissions we estimate will move to MVP reporting due to the availability of new MVPs and will need to complete a registration form that is not required with traditional MIPS submissions. Accordingly, we estimate the increase in MVP submissions and registrations, and resulting decrease in traditional MIPS submissions will result in an annual decrease of 6,798 hours and $840,757 (see total Policy Change in Tables D-A6, D-A7 and D-A8, respectively) beginning with the CY 2026 performance period/2028 MIPS payment year. In addition, we separately estimate changes to annual burden due to the availability of updated MIPS submission data for these five ICRs since our currently approved estimates will result in an additional annual burden decrease of 5,353 responses, 59,372 hours, and $7,119,526 (see total of Change Due to Updated Data in Tables D-A6, D-A7 and D-A8, respectively). Taken together, we estimate a total reduction of 3,041 responses, 66,169 hours, and $7,960,283 (see total of Total Change in Tables D-A6, D-A7 and D-A8, respectively). All time estimates in the referenced tables are rounded to the hour, and all cost estimates are rounded to the dollar. The change in total time and total cost in the referenced tables per ICR are described in section V.B.5.c. of this final rule and reflect the sum of changes due to policy provisions and newly available data before this rounding. Accordingly, the total change in time per ICR may not equal the sum of changes due to policy and data adjustments because of this rounding. The Total row estimate per table represents the sum of the component ICR rows in that table.

For the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey ICRs under OMB control number 0938-1222 (CMS- 10450) (see section V.B.5.b.(1) of this final rule), we estimate that the policy provisions in this final rule will result in an annual change of 0 responses, +10 hours, and +$1,077 (see total of Total Change in Tables D-A9, D-A10, and D-A11, respectively), beginning with the CY 2027 performance period/2029 MIPS payment year. [GRAPHIC] [TIFF OMITTED] TR05NO25.159

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(2) Summary of Changes for the Quality Payment Program: MIPS (a) MIPS ICRs With Changes Due to Policy Provisions

For the six ICRs detailed in Tables D-A6 through D-A13, we are finalizing our proposed burden changes based on policies finalized in this final rule as well as updated data available when preparing the CY 2026 PFS proposed rule. These discussions begin in section V.B.5.b. of this final rule. (b) MIPS ICRs With No Changes to Currently Approved Burden Estimates

In the CY 2026 PFS proposed rule (90 FR 32782), we did not propose to update our burden estimates for the following ICRs under OMB control number 0938-1314 (CMS-10621) because there were no proposed policies that affect our currently approved burden estimates, and we did not have updated available data by which to revise our currently approved burden estimates for respondents or hours: (1) Nomination of Improvement Activities; (2) Nomination of MVPs; (3) Opt-out of Performance Data Display on Compare Tools for Voluntary Participants; (4) Subgroup Registration; (5) Qualified Clinical Data Registry (QCDR) Full Self Nomination and other Requirements; (6) QCDR Simplified Self- Nomination and other Requirements; (7) Qualified Registry Full Self Nomination and other Requirements; (8) Qualified Registry Simplified Self Nomination and other Requirements; and (9) Third Party Intermediary Plan Audits. Additionally, we did not propose changes to our burden response and hour estimates for the following ICRs under OMB control number 0938-1222 (CMS-10450): (1) Beneficiary Responses to CAHPS for MIPS Survey; and (2) Group Registration for CAHPS for MIPS Survey. Lastly, we did not propose changes to our burden estimates for Registration for Virtual Groups under OMB control number 0938-1343 (CMS-10652). Where applicable, we discuss related policy provisions finalized in this final rule and the reasoning for not impacting our burden estimates per ICR, beginning in section V.B.5.b.(2) of this final rule.

(c) MIPS ICRs With Changes Due to Available Data

Separate from the policies finalized in section IV. of this final rule and ICRs described in Tables D-A6 through D-A11, we identified in the CY 2026 PFS proposed rule (90 FR 32782) that we are updating our burden estimates for the following ICRs for the CY 2026 performance period/2028 MIPS payment year due to the availability of updated data. Since the changes were not derived from policy provisions, we do not set out these changes in this final rule: (1) Call for Quality Measures; (2) Data Submission for the Improvement Activities Performance Category; (3) Data Submission for the Promoting Interoperability Performance Category; (4) Open Authorization (OAuth) Credentialing and Token Request Process; (5) Quality Payment Program Identity Management Application Process; and (6) Reweighting Applications for Promoting Interoperability and Other Performance Categories.

Where applicable, we discuss any related policies finalized in this final rule and our reasoning for why these policies do not impact our burden estimates per ICR, beginning in section V.B 5.d.(2) of this final rule. (d) New MIPS ICRs

The following changes will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).

In the CY 2026 PFS proposed rule (90 FR 32782 and 32783), we proposed to add a new ICR to reflect submissions for the Alternative Payment Model Performance Pathway (APP), due to the availability of updated data. The APP is an optional MIPS reporting and scoring pathway for MIPS eligible clinicians who are also participants in MIPS APMs, as defined at Sec. 414.1367. Our burden estimates for the APP focus on submissions by individuals, groups, or non-Shared Savings Program ACO APMs for the APP quality measure set. As there were no related policy provisions affecting these estimates, we did not detail the APP burden estimates in the CY 2026 PFS proposed rule.

We did not estimate burden for Shared Savings Program ACOs under the APP. Section 1899(e) of the Act provides that chapter 35 of title 44 U.S.C., which includes such provisions as the PRA, shall not apply to the Shared Savings Program. Additionally, we did not establish an ICR for the APP Plus quality measure set. In the CY 2025 PFS final rule (89 FR 98355 through 98371), we established the APP Plus as a new quality measure set designed for APP participants that expands the existing APP measure set and is mandatory for Shared Savings Program ACOs starting in the CY 2025 performance period/2027 MIPS payment year. We continued our assumption from the CY 2025 PFS final rule (89 FR 98549 and 98550) that MIPS eligible clinicians, groups, and APM Entities (excluding Shared Savings Program ACOs) will not elect to submit the APP Plus quality measure set. This assumption is because the APP Plus quality measure set has greater reporting requirements than the APP quality measure set. The APP Plus quality measure set for CY 2026 performance period/2028 MIPS payment year finalized in the CY 2025 PFS final rule (89 FR 98368) requires that MIPS eligible clinicians, groups, or non-Shared Savings Program ACOs actively report five quality measures (via the eCQM, MIPS CQM, and Part B Claims collection types as available per measure for non-Shared Savings Program ACOs per measure) instead of three quality measures in the APP quality measure set that are actively reported via the MIPS CQM, part B Claims and eCQM collection types, as available per measure for non-Shared Savings Program ACOs. We do not believe MIPS eligible clinicians, groups, and APM Entities who are not required to report the APP Plus quality measure set will elect to report APP Plus over APP quality measure set due to the increased data collection and submission requirements. (3) Summary of Changes for the Quality Payment Program: Advanced APMs

In the CY 2026 PFS proposed rule (90 FR 32783), we did not propose changes to the following ICRs due to policy provisions or the availability of updated submission data beyond the wage rate data described in section V.A. of this final rule: (1) Partial Qualifying Advanced APM (QP) Elections; (2) Other Payer Advanced APM Determinations: Payer-Initiated Process; (3) Other Payer Advanced APM Determinations: Eligible Clinician-Initiated Process; and (4) Submission of Data for QP Determinations under the All-Payer Combination Option. We discuss related policy provisions and why they do not impact our burden estimates in sections V.B 5.a.(4)(c) and VII.I.5.e.(2)(b) of this final rule. (4) Framework for Understanding the Burden of MIPS Data Submission and Data Considerations (a) Framework for Understanding the Burden of MIPS Data Submission

Across organizations permitted or required to submit data on behalf of clinicians, there can be variation across the types of data provided, and whether a clinician is a MIPS eligible clinician or other eligible clinician voluntarily submitting data, a MIPS APM participant, or an Advanced APM participant. MIPS eligible clinicians and other clinicians voluntarily submitting data to MIPS for the quality, Promoting Interoperability, and improvement activities performance categories may submit data as the following participation types: individual; group; virtual groups (available only for traditional MIPS); subgroups (available only for MVPs); and APM Entities. Eligible clinicians who attain Partial QP status may incur additional burden if they elect to participate in MIPS. MIPS eligible clinicians are not required to submit any additional data for the cost performance category, as CMS calculates performance on measures specified for this performance category based on claims-data.

Virtual groups are subject to the same data submission requirements as groups, and therefore, we will refer only to groups for the remainder of this section, unless otherwise noted.

For the aforementioned participation types, we assessed the same burden per reporting option and assumed from our available data that all non-Shared Savings Program ACO APM Entity submissions represent single Taxpayer Identification Number (TIN) APMs. We excluded performance category submissions by Shared Savings Program ACO APM Entities from our MIPS reporting estimates. Per section 1899(e) of the Act, the PRA does not apply to the Shared Savings Program. The regulatory impact analysis in section VII. of this final rule discusses impacts to the Shared Savings Program from provisions associated with this final rule.

There are three MIPS reporting options: traditional MIPS, MVPs, and the APP. In section V.B.5.c. of this final rule, we provide distinct estimates for the traditional MIPS and MVP reporting options for the quality performance category, focusing on changes to our currently approved burden estimates. We do not detail burden estimates for the Promoting Interoperability and improvement activities performance categories because we are not finalizing any updates to our burden estimates

associated with policy provisions of this final rule; for discussion of these provisions relative to burden implications, please see sections V.B.5.d. and V.B.5.e. of this final rule. As with the CY 2026 PFS proposed rule (90 FR 32783), we have not separately estimated burden for traditional MIPS and MVPs for the Promoting Interoperability and improvement activities performance categories. Traditional MIPS and MVPs require reporting on all Promoting Interoperability performance category objectives and measures. Traditional MIPS reporting for the improvement activities performance category typically requires attestation to two improvement activities; however, clinicians, groups, and virtual groups with a special status designation are only required to attest to one improvement activity. MVP participants are required to attest to one improvement activity regardless of special status. For additional details on historic burden assumptions for the improvement activities performance category, we refer readers to the CY 2025 PFS final rule (89 FR 98492). In the related collection of information request (OMB control number 0938-1314 (CMS-10621)), we aggregate submissions across all reporting options. For additional burden historic frameworks, we refer readers to the CY 2024 PFS final rule (88 FR 79422 through 79424) and the CY 2025 PFS proposed rule (89 FR 62111 through 62114). (b) Summary of Available MIPS Submission Data Sources

Where available, we incorporated updated data into our burden estimates beginning with the CY 2026 performance period/2028 MIPS payment year. These updates include submission data from the CY 2023 performance period/2025 MIPS payment year. To estimate QPs excluded from MIPS reporting requirements, we used the Advanced APM payment and patient percentages from the APM Participant List for the final snapshot for the 2023 QP Performance period.

The available CY 2023 performance period/2025 MIPS payment year data identifies performance category submissions by non-Shared Savings Program ACO APM Entities. We incorporated these estimates alongside our longstanding inclusion of individual, group, and virtual group data.

As detailed in section V.B.5.c.(6) of this final rule, we updated our assessment of estimated MVP quality performance category submissions and registrations. We assessed measure-level submission trends from the CY 2023 performance period/2025 MIPS payment year (87 FR 70650 through 70701) alongside the MVP inventory finalized in the CY 2025 PFS final rule Appendix 3 (89 FR 98972 through 99057), and the new MVPs finalized as proposed in section IV.A.4.a.(1) of this final rule. The CY 2023 performance period/2025 MIPS payment year submission data include MVP submissions and registration for the 12 MVPs available at that time for MIPS reporting. Due to the expanded MVP inventory (16 MVPs available for the CY 2024 performance period/2026 MIPS payment year (88 FR 79978 through 80047), 21 MVPs available for the CY 2025 performance period/2027 MIPS payment year (89 FR 98972 through 99057)), and 27 MVPs as finalized in this final rule for the CY 2026 performance period/2028 MIPs payment year, we anticipate increased MVP adoption for the CY 2026 performance period/2028 MIPS payment year and beyond. We estimated MVP submissions as a percentage of the total traditional MIPS and MVP submissions from the CY 2023 performance period/2025 MIPS payment year. For details on this analysis, we refer readers to section V.B.5.c.(6) of this final rule. (c) Additional Data Considerations

The accuracy of our estimates of the total burden for data submission for MIPS performance categories may be impacted by several primary factors. First, we are unable to predict with certainty who will be a QP for the CY 2026 performance period/2028 MIPS payment year and later years.

Second, it is difficult to predict whether Partial QPs, who can elect to report to MIPS, will choose to participate in the CY 2026 performance period/2028 MIPS payment year or later years compared to the CY 2023 performance period/2025 MIPS payment year. Therefore, the actual number of Advanced APM participants and how they elect to submit data may differ from our estimates. However, we believe our estimates are the most appropriate given the available data. We refer readers to section VII.I.5.e.(2)(b) of this final rule for a discussion of the potential but unquantifiable burden implications on MIPS-related burden of the provisions to change QP determinations and remove the eligible clinician limit to the Medical Home Model, Aligned Other Payer Medical Home Model, and Medicaid Medical Home Model, finalized in section IV.B.5. of this final rule.

In section IV.B.5.d. of this final rule, we are finalizing our proposal to make a technical amendment to the language in Sec. 414.1455 that establishes Targeted Review for QPs. This provision revises the timeline but not the other established processes for requested a targeted review. We note that information collection requirements, such as targeted reviews, that are imposed after an administrative action are not subject to the PRA under 5 CFR 1320.4(a)(2). b. ICRs Regarding Third Party Intermediaries (1) CMS-Approved Survey Vendor Requirements

We refer readers to Sec. 414.1400(d) for the requirements for CMS- approved survey vendors that may submit data on the CAHPS for MIPS Survey. We refer readers to the CY 2024 PFS final rule (88 FR 79433 through 79434) and the CY 2025 PFS final rule (89 FR 98475) for recent burden discussions on this ICR. The following changes (associated with CAHPS survey vendors to submit data for eligible clinicians) will be submitted to OMB for approval under control number 0938-1222 (CMS- 10450). We will make the revised files available for public review under the standard non-rule PRA process which includes the publication of 60- and 30-day Federal Register notices, which are expected to publish in the CY 2026 performance period/2028 MIPS payment year.

As discussed in section IV.B.4.a.(5) of this final rule, we are finalizing our proposal to add a web administration mode to the current CAHPS for MIPS Survey administration in addition to the existing mail and phone options. Beginning with the CY 2027 performance period/2029 MIPS payment year, CMS-approved survey vendors are required to administer the CAHPS for MIPS Survey via a web-mail-phone protocol. During the 1-year implementation delay, we will update the survey administration requirements and associated materials.

For the CY 2027 performance period/2029 MIPS payment year, we proposed to increase the currently approved burden estimate of 10 hours to complete the vendor application by 1 hour for a total of 11 hours per application (90 FR 32784). The currently approved burden estimate for the vendor application includes completing the Vendor Attestation Statement, the Vendor Participation Form, and compiling documentation, including the quality assurance plan that demonstrates compliance with the Minimum Survey

Vendor Business Requirements. We estimate that it will take applicants an additional 0.5 hours to compile documentation related to the web mode and an additional 0.5 hours to develop a quality assurance plan related to web implementation. We assumed that our proposal to add a web administration mode to the current CAHPS for MIPS survey administration will not affect our currently approved estimate of 10 survey vendor applicants. We estimate an annual increase of 10 hours due to this proposed requirement (+1 hr/vendor x 10 vendors) at a cost of +$1,077 (10 hr x $107.66/hr for a computer systems analyst or equivalent). We have summarized the comments we received about the proposal to add the web administration mode in section XX of this final rule. We did not receive public comments about these burden estimates. [GRAPHIC] [TIFF OMITTED] TR05NO25.165

(2) Full and Simplified Self-Nomination for Qualified Clinical Data Registries and Qualified Registries

In section IV.A.4.a.(3) of this final rule, we are finalizing our proposal to provide additional flexibilities to allow third party intermediaries additional time to fully support finalized MVPs. The provision does not alter requirements related to the self-nomination process, therefore we did not propose revisions in the CY 2026 PFS proposed rule (90 FR 32784) to our currently approved responses and time per response for both the Full and Simplified Self-Nominations for Qualified Registries and Qualified Clinical Data Registries under OMB control number 0938-1314 (CMS-10621). c. ICRs Regarding Quality Data Submission (Sec. Sec. 414.1318, 414.1325, 414.1335, and 414.1365) (1) Changes to Quality Performance Category Submissions

As discussed in the CY 2026 PFS proposed rule (90 FR 32784 through 32786), we estimated the number of submissions for each collection type that require active reporting by individual clinicians, groups, subgroups (as applicable for MVP reporting), or non-Shared Savings Program ACO APM Entities. This includes Medicare Part B claims measures (individual clinicians only), MIPS Clinical Quality Measures (CQM) and QCDR measures, and electronic Clinical Quality Measures (eCQM). Notably, we did not assess burden for the quality administrative claims collection type, as CMS automatically calculates scores for individual clinicians, groups, subgroups (as applicable for MVP reporting), or non-Shared Savings Program ACO APM Entities that meet requirements to be scored. We assumed that the proposal to revise QP determinations, finalized with modification in section IV.B.5.b. of this final rule, does not affect MIPS performance category-level data submissions. For additional discussion of this assumption, we refer readers to section XX of this final rule.

Because MIPS eligible clinicians may submit data for multiple collection types for the quality performance category, the estimated numbers of individual clinicians, groups, subgroups (as applicable for MVP reporting), and non-Shared Savings Program ACO APM Entities to collect via the various collection types are not mutually exclusive and reflect the occurrence of individual clinicians, groups, subgroups (as applicable for MVP reporting) and non-Shared Savings Program ACO APM Entities that collected and submitted data via multiple collection types or reporting options during the CY 2023 performance period/2025 MIPS payment year. We describe our approach for each MIPS reporting option below. (a) Traditional MIPS

As described in the CY 2026 PFS proposed rule (90 FR 32785), we estimated the number of traditional MIPS submissions for the CY 2026 performance period/2028 MIPS payment year as the sum of estimated traditional MIPS and MVP quality performance submissions from the CY 2023 performance period/2025 MIPS payment year for each actively submitted collection type (Medicare Part B claims measures, MIPS CQMs and QCDR measures, and eCQMs) submitted by individual clinicians, groups, or non-Shared Savings Program APM Entities individual, less the estimated number of submissions we expect to submit MVPs. This analysis is described in section V.B.5.c.(6) of this final rule. (b) MVPs

As described in the CY 2026 PFS proposed rule (90 FR 32785), we estimated the number of MVP submissions for the CY 2026 performance period/2028 MIPS payment year as a percent of the total traditional MIPS and MVP submissions from the CY 2023 performance period/2025 MIPS payment year for each actively submitted collection type (Medicare Part B claims measures, MIPS CQMs and QCDR measures, and eCQMs) by individual clinicians, groups, or non-Shared Savings Program ACO APM Entities, and add our estimate of subgroup submissions described in section V.B.5.c.(6) of this final rule. We believe this approach to estimate MVP submissions as a function of historic traditional MIPS and MVP submissions, and not just MVP submissions from a given year, is appropriate to estimate future reporting behaviors because we expect increased adoption due to the annual expansion of and updates to the MVP inventory as summarized in section IV.A.4.a. of this final rule. This analysis is described in section V.B.5.c.(6) of this final rule. (c) APM Performance Pathway (APP)

We assumed the number of submissions per available collection type that is actively reported by clinicians, groups, or non-Shared Savings Program APM ACO Entities. We do not detail these estimates in this final rule as there are no changes due to policy provisions. (d) Factors Affecting Quality Performance Category Submission Estimates

Several factors drove our updates to the number of submissions for the Medicare Part B claims measures, MIPS CQMs and QCDR measures, and eCQMs,

as presented in the CY 2026 PFS proposed rule (90 FR 32785). First, we incorporated updated traditional MIPS and MVP submission data available for the CY 2023 performance period/2025 MIPS payment year. For the CY 2025 PFS final rule (89 FR 98475), our available submission data for the CY 2022 performance period/2024 MIPS payment year included only traditional MIPS submissions. We aggregated submissions for both traditional MIPS and MVPs by collection type and created a new baseline to which we applied our MVP participation estimates for the CY 2026 performance period/2028 MIPS payment year. Please see section V.B 5.a.(4) of this final rule for additional details on updates to available data.

Second, we proposed to updated our estimates for MVP participation for the CY 2026 performance period/2028 MIPS payment year. This updated estimate for MVP participation impacted our estimate of the number of estimated clinicians submitting quality data for traditional MIPS using each collection type. As detailed in section V.B.5.c.(6) of this final rule, we updated our estimates to account for the expected increase in MVP participation of 4 percentage points due to the finalized addition of six new MVPs in this final rule; we associated this incremental effect, all else equal, with policy provisions. With this approach, any increase to our expected MVP participation rate reduces the number of estimated submissions for each quality performance category collection type via traditional MIPS. Similarly, any decrease to our estimated MVP participation rate increases the number of estimated submissions for each quality performance category collection type via traditional MIPS. (e) Medicare Part B Claims Measure, MIPS CQMs/QCDR Measure, and eCQM Collection Types

Table D-A13 of this final rule identifies our methods to estimate the number of individual clinicians, groups, and non-Shared Savings Program ACO APM Entities that may submit data via each collection type in the CY 2026 performance period/2028 MIPS payment year, separating traditional MIPS and MVP estimates. As presented in the CY 2026 PFS proposed rule (90 FR 32785 through 32786), we identify estimated submissions per collection type from CY 2023 performance period/2025 MIPS payment year data (row a). We estimated that 14 percent of these quality performance category submissions may report via MVPs for the CY 2026 performance period/2028 MIPS payment year (row b). This 14 percent encompasses our estimate that 10 percent of submissions will report the MVPs previously finalized in the CY 2025 PFS final rule (row c), and that 4 percent of submissions will submit the new MVPs finalized in this final rule (row d). The basis of these assumptions is described in section V.B.5.c.(6) of this final rule.

In the following paragraphs, we discuss the impacts to the estimated number of submissions for traditional MIPS, aggregated across individual clinician, group, and non-Shared Savings Program APM Entity submissions where applicable per collection type. We discuss the impacts to the estimated number of submissions for MVPs in section V.B.5.c.(6) of this final rule. For each collection type, we assume there is one annual submission or response per respondent.

Medicare Part B Claims Measure Collection Type:

In the CY 2025 PFS final rule (89 FR 98479 through 98481), we estimated 12,197 submissions. For the CY 2026 performance period/2028 MIPS payment year we estimate 3,459 fewer submissions for this collection type via traditional MIPS due to the availability of updated submission data and assumptions. Additionally, we estimate that the six new MVPs finalized as proposed in section XX of this final rule will result in 388 fewer traditional MIPS submissions for this collection type, as the availability of new MVPs may lead clinicians who previously reported via traditional MIPS to report via MVPs. We estimate that there will be approximately 8,350 Medicare Part B claims measure collection type submissions for the CY 2026 performance period/ 2028 MIPS payment year submitted by individual clinicians. Taken together, we estimate a total decrease of 3,847 submissions (-388 submissions due to policy provisions + -3,459 submissions due to updated data). The net result is 8,350 submissions (12,197 currently approved submissions-3,847 submissions).

The aforementioned changes, as presented in the CY 2026 PFS proposed rule (90 FR 32785), apply to OMB control number 0938-1314 (CMS-10621). We did not receive public comment on these submission estimates and are finalizing these burden estimates as proposed. We calculated the impact of these updated submission estimates on total annual cost and total hours per participation option and collection type in section XX of this final rule.

MIPS CQM and QCDR Measure Collection Types:

In the CY 2025 PFS final rule (89 FR 98481 through 98483), we estimated 17,008 submissions. For the CY 2026 performance period/2028 MIPS payment year we estimate 1,209 more submissions for this collection type via traditional MIPS due to the availability of updated submission data and assumptions. Additionally, we estimate that the new MVPs finalized as proposed in section IV.A.4.a.(1) of this final rule will result in 810 fewer traditional MIPS submissions for this collection type, as the availability of new MVPs may lead clinicians who previously reported via traditional MIPS to report via MVPs. We estimate that there will be approximately 17,407 MIPS CQM/QCDR measure collection type submissions for the CY 2026 performance period/2028 MIPS payment year (11,266 individual clinicians + 6,132 groups + 9 non- Shared Savings Program ACO APM Entities). This is a total increase of 399 submissions (1,209 submissions due to updated data + -810 submissions due to policy provisions). The net result is 17,407 submissions (17,008 currently approved submissions + 399 submissions). Given the number of measures required for clinicians and groups is the same, we expect the burden to be the same for each respondent collecting data via MIPS CQMs or QCDR measures.

The aforementioned changes, as presented in the CY 2026 PFS proposed rule (90 FR 32786), apply to OMB control number 0938-1314 (CMS-10621). We did not receive public comment on these submission estimates and are finalizing these burden estimates as proposed. We calculated the impact of these updated submission estimates on total annual cost and total hours per participation option and collection type in section XX of this final rule.

eCQM Collection Type:

In the CY 2025 PFS final rule (89 FR 98483 to 98485), we estimated 27,179 submissions. For the CY 2026 performance period/2028 MIPS payment year we estimate 2,129 fewer submissions for this collection type via traditional MIPS due to the availability of updated submission data and assumptions. Additionally, we estimate that the new MVPs finalized as proposed in section IV.A.4.a.(1) of this final rule will result in 1,114 fewer traditional MIPS submissions for this collection type, as the availability of new MVPs may lead clinicians who previously reported via traditional MIPS to report via MVP. We estimate that there will be approximately 23,936 eCQM collection type submissions for

the CY 2026 performance period/2028 MIPS payment year (approximately 18,282 individual clinicians + 5,647 groups + 7 non-Shared Savings Program ACO APM Entities). This is a total decrease of 3,243 submissions (-2,129 submissions due to updated data + -1,114 submissions due to policy provisions). The net result is 23,936 submissions (27,179 currently approved submissions-3,243 submissions).

The aforementioned changes, as presented in the CY 2026 PFS proposed rule (90 FR 32786), apply to OMB control number 0938-1314 (CMS-10621). We did not receive public comment on these submission estimates and are finalizing these burden estimates as proposed. We calculated the impact of these updated submission estimates on total annual cost and total hours per participation option and collection type in section XX of this final rule.

Consistent with the policy finalized in the CY 2018 Quality Payment Program final rule that for MIPS eligible clinicians who collect measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR measure collection types and submit more than the required number of measures (82 FR 53735 through 54736), we will score the clinician on the required measures with the highest assigned measure achievement points and thus, the same clinician may be counted as a respondent for more than one collection type. Therefore, our columns in Table D-A13 are not mutually exclusive. We assume that each response or submission per collection type for traditional MIPS includes six quality measures, and that each response or submission per collection type for MVPs includes four quality measures. [GRAPHIC] [TIFF OMITTED] TR05NO25.166

(2) Additional Burden Assumptions for the Quality Performance Category

For a discussion of the longstanding burden assumptions and any related limitations associated with the submission of quality performance category data, we refer readers to the CY 2025 PFS final rule (89 FR 98478 and 98479). We refer readers to the CY 2022 PFS final rule for details on MVP quality reporting requirements (86 FR 65411 through 65412).

As described in section IV.A.4.d.(1)(c)(iii) of this final rule, for the quality performance category, we are finalizing our proposal with modification to update the MIPS quality measure inventory; and are revising the definition of a high priority measure. As described in section IV.A.4.b.(2) of this final rule, we are finalizing our proposal to incorporate the updated versions of the MIPS quality measures used in the APP quality measure set. As these provisions do not affect the minimum reporting requirements for the quality performance category under traditional MIPS, MVPs, and the APP quality measure set, we did not propose burden changes for the Quality Payment Program (90 FR 32786). We refer readers to Table Group A of Appendix 1 for the finalized new measures; Table Group C of Appendix 1 for the finalized removed measures; and Table Groups D and DD of Appendix 1 for the finalized substantive changes to measures.

In sections V.B.5.c.(3), V.B.5.c.(4), and V.B.5.c.(5) of this final rule, we detail the estimated burden changes per collection type for traditional MIPS, and in section V.B.5.c.(6) for MVPs finalized in this rulemaking. As noted in section V.B.5.a.(4) of this final rule, we revised our estimates described in the CY 2025 PFS final rule due to: (1) the availability of updated performance category data; (2) the inclusion of data estimates for non-Shared Savings Program ACO APM Entities; and (3) the new MVPs. (3) Traditional MIPS Quality Data Submission by Clinicians: Medicare Part B Measure Collection Type

The following changes, as presented in the CY 2026 PFS proposed rule (90 FR 32787), will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).

The following estimates apply to requirements for the traditional MIPS reporting option and submissions by individual clinicians. For our most recent discussions of related burden, we refer readers to the CY 2024 PFS final rule (88 FR 70149 through 70151) and the CY 2025 PFS final rule (89 FR 98479 through 98481). As with the CY 2025 PFS final rule (89 FR 98479 through 98481), we acknowledge a range of times for computer system analysts to submit quality measure data (minimum, mean, and maximum burden estimates) for this collection type. We continue to apply the maximum burden in our total burden estimates. All changes to the number of quality performance category submissions as described in this section are relative to our currently approved estimate of 12,197 submissions detailed in the CY 2025 PFS final rule (89 FR 98479 through 98481).

Impact of Policy Provisions: We estimate a change of -388 submissions due to finalizing six new MVPs in this final rule. Multiplying the estimated change in submissions (-388) by the time per submission by labor category, we estimate a maximum total change of

minus 5,509.60 hours. All estimates encompass time to review measure specifications unless otherwise noted. This change of -5,509.60 hours incorporates the following estimates:

Minimum of -446.20 hours for computer system analysts (- 388 submissions x 1.15 hr/submission (0.15 hr to submit data and 1 hr to review measure specifications)).

Mean of -795.40 hours for computer system analysts (-388 submissions x 2.05 hr/submission (1.05 hr to submit data and 1 hr to review measure specifications)).

Maximum of -3,181.60 hours for computer system analysts (- 388 submissions x 8.2 hr/submission (7.2 hr to submit data and 1 hr to review measure specifications)).

-1,164 hours for medical and health service managers (-388 submissions x 3 hr/submission).

-388 hours for licensed practical nurses (LPNs) (-388 submissions x 1 hr/submission).

-388 hours for billing clerks (-388 submissions x 1 hr/ submission).

-388 hours for physicians (-388 submissions x 1 hr/ submission).

We estimate a maximum annual change of minus $655,228.02 [(- 3,181.602 hr x $107.66/hr = -$342,531.06 for computer system analysts) + (-1,164 hr x $132.44/hr = -$154,160.16 for medical and health service managers) + (-388 hr x $61.68/hr = -$23,931.84 for LPNs) + (-388 hr x $47.60/hr = -$18,468.80 for billing clerks) + (-388 hr x $299.32/hr = - $116,136.16 for physicians)].

Impact of Updated Data: We estimate an additional change of -3,459 submissions due to the availability of updated data and assumptions. Multiplying the estimated change in submissions (-3,459) by the time per submission identified by labor category in preceding list, we estimate a maximum total change of -49,117.808 hours. This change incorporates the following estimates:

Minimum of -3,997.85 hours for computer system analysts (- 3,459 submissions x 1.15 hr/submission).

Mean of -7,090.95 hours for computer system analysts (- 3,459 submissions x 2.05 hr/submission).

Maximum of -28,363.80 hours for computer system analysts (-3,459 submissions x 8.2 hr/submission).

-10,377 hours for medical and health service managers (- 3,459 submissions x 3 hr/submissions).

-3,459 hours for LPNs (-3,459 submissions x 1 hr/ submission).

-3,459 hours for billing clerks (-3,459 submissions x 1 hr/submission).

-3,459 hours for physicians (-3,459 submissions x 1 hr/ submission).

We estimate a maximum annual change of -$5,841,323.994 [(-28,363.80 hr x $107.66/hr = -$3,053,646.71 for computer system analysts) + (- 10,377 hr x $132.44/hr = -$1,374,329.88 for medical and health service managers) + (-3,459 hr x $61.68/hr = -$213,351.12 for LPNs) + (-3,459 hr x $47.60/hr = -$164,648.40 for billing clerks) + (-3,459 hr x $299.32/hr = -$1,035,347.88 for physicians)].

Total Impact: Taken together, we estimate that the changes in submissions due to policy provisions and newly available data will result in a change of minus 3,847 submissions (-388 due to policy provisions + -3,459 due to updated data), a maximum annual burden change of minus 54,627 hours (-5,509.60 hr due to policy provisions + - 49,117.80 hr due to updated data, rounded to the hour) and minus $6,496,552 (-$655,228.02 due to policy provisions + -$5,841,323.994 due to updated data). We estimate a total of 8,350 traditional MIPS submissions under the Medicare Part B collection type for the CY 2026 performance period/2028 MIPS payment year.

We did not receive public comments on our burden estimates and assumptions, and therefore, we are finalizing our burden estimates as proposed. (4) Traditional MIPS Quality Data Submission: MIPS CQM and QCDR Measure Collection Types

The following changes, as presented in the CY 2026 PFS proposed rule (90 FR 32787 through 32788), will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).

These estimates apply to requirements for the traditional MIPS reporting option and submissions by individual clinicians, groups, and non-Shared Savings Program ACO APM Entities. For our most recent discussions of related burden, we refer readers to the CY 2024 PFS final rule (88 FR 70149 through 70151) and the CY 2025 PFS final rule (89 FR 98479 through 98483). All estimates encompass time to review measure specifications unless otherwise noted. All changes to the number of quality performance category submissions described below are relative to our currently approved estimate of 17,008 submissions detailed in the CY 2025 PFS final rule (89 FR 98481 through 98483).

Impact of Policy Provision: We estimate a change of minus 810 submissions due to finalizing six new MVPs in this final rule. Multiplying the estimated change in submissions (-810) by the time per submission by labor category, we estimate a total change of -7,357.23 hours. This change of incorporates the following estimates: -3,307.23 hours for a computer system analyst (-810 submissions x 4.083 hr/ submission (3 hr to submit data; 1 hr to review measure specifications, and 5 minutes (0.083 hr) to authorize or instruct the qualified registry or QCDR to submit quality measure data on their behalf), - 1,620 hours for medical and health service managers (-810 submissions x 2 hr/submission), -810 hours for LPNs (-810 submissions x 1 hr/ submission), -810 hours for billing clerks (-810 submissions x 1 hr/ submission), and -810 hours for physicians (-810 submissions x 1 hr/ submission). We estimate an annual change of--$901,575.18 [(-3,307.23 hr x $107.66/hr = -$356,056.38 for computer systems analysts) + (-1,620 hr x $132.44/hr = -$214,552.80 for medical and health service managers) + (-810 hr x $61.68/hr = -$49,960.80 for LPNs) + (-810 hr x $47.60/hr = -$38,556.00 for billing clerks) + (- 810 hr x $299.32/hr = -$242,499.20 for physicians)].

Impact of Updated Data: Additionally, we estimate a change of +1,209 submissions due to the availability of updated data and assumptions. Multiplying the estimated change in submissions (+1,209) by the time per submission identified in the preceding paragraph by labor category, we estimate a total change of +10,981.35 hours. This change incorporates the following estimates: 4,936.347 hours for computer system analysts (+1,209 submissions x 4.083 hr/submission), 2,418 hours for medical and health service managers (+1,209 submissions x 2 hr/submission), 1,209 hours for LPNs (+1,209 submissions x 1 hr/ submission), 1,209 hours for billing clerks (+1,209 submissions x 1 hr/ submission), and 1,209 hours for physicians (+1,209 submissions x 1 hr/ submission). We estimate an annual change of +$1,345,684.44 [(+4,936.347 hr x $107.66/hr = $531,447.12 for computer system analysts) + (+2,418 hr x $132.44/hr = $320,239.92 for medical and health service managers) + (+1,209 hr x $61.68/hr = $74,571.12 for LPNs) + (+1,209 hr x $47.60/hr = $57,548.40 for billing clerks) + (+1,209 hr x $299.32/hr = $361,877.88 for physicians)].

Total Impact: Taken together, we estimate that the changes in submissions due to policy provisions

and newly available data will result in a change of +399 submissions (- 810 submissions due to policy provisions + 1,209 submissions due to updated data), an annual burden change of +3,624 hours (-7,357.23 hr due to policy provisions + 10,981.35 hr due to updated data, rounded to the hour) at a cost of +$444,109 (-$901,575.18 due to policy provisions + $1,345,684.44 due to updated data, rounded to the dollar). We estimate a total of 17,407 traditional MIPS submissions under the MIPS CQM/QCDR measure collection types for the CY 2026 performance period/ 2028 MIPS payment year (11,266 individual clinicians + 6,132 groups + 9 non-Shared Savings Program ACO APM Entities). We did not receive public comments on our burden estimates and assumptions, and therefore, we are finalizing our burden estimates as proposed. (5) Traditional MIPS Quality Data Submission: eCQM Collection Type

The following changes, as presented in the CY 2026 PFS proposed rule (90 FR 32788), will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).

These estimates apply to requirements for the traditional MIPS reporting option and submissions by individual clinicians, groups, and non-Shared Savings Program ACO APM Entities. For our most recent discussions of related burden, we refer readers to the CY 2024 PFS final rule (88 FR 79441 through 79442) and the CY 2025 PFS final rule (89 FR 98483 through 98485). All estimates encompass time to review measure specifications unless otherwise noted. All changes to submissions as described in this section are relative to our currently approved estimate of 27,179 submissions detailed in the CY 2025 PFS final rule (89 FR 98483 through 98485).

Impact of Policy Provisions: We estimate a change of -1,114 submissions due to finalizing six new MVPs in this final rule. Multiplying the estimated change in submissions by the time per submission by labor category, we estimate a total change of -8,912 hours. This change incorporates the following estimates: -3,342 hours for computer system analysts (-1,114 submissions x 3 hr/submission (2 hr to submit data file and 1 hr to review measure specifications)), - 2,228 hours for medical and health service managers (-1,114 submissions x 2 hr/submission), -1,114 hours for LPNs (-1,114 submissions x 1 hr/ submission), -1,114 hours for billing clerks (-1,114 submissions x 1 hr/submission), and -1,114 hours for physicians (-1,114 submissions x 1 hr/submission). We estimate an annual change of -$1,110,056.44 [(-3,342 hr x $107.66/hr =-$359,799.72 for computer system analysts) + (-2,228 hr x $132.44/hr =-$295,076.32 for medical and health service managers) + (-1,114 hr x $61.68/hr =-$68,711.52 for LPNs) + (-1,114 hr x $47.60/ hr =-$53,026.40 for billing clerks) + (-1,114 hr x $299.32/hr =- $333,442.48 for physicians)].

Impact of Updated Data: Additionally, we estimate a change of - 2,129 submissions due to the availability of updated data and assumptions. Multiplying the estimated change in submissions (-2,129) by the time per submission identified in the preceding paragraph by labor category, we estimate a total change of -17,032 hours. This change incorporates the following estimates:-6,387 hours for computer system analysts (-2,129 submissions x 3 hr/submission), -4,258 hours for medical and health service managers (-2,129 submissions x 2 hr/ submission), -2,129 hours for LPNs (-2,129 submissions x 1 hr/ submission), -2,129 hours for billing clerks (-2,129 submissions x 1 hr/submission), and -2,129 hours for physicians (-2,129 submissions x 1 hr/submission). We estimate an annual change of -$2,121,463.34 [(-6,387 hr x $107.66/hr =-$687,624.42 for computer system analysts) + (-4,258 hr x $132.44/hr =-$563,929.52 for medical and health service managers) + (-2,129 hr x $61.68/hr =-$131,316.72 for LPNs) + (-2,129 hr x $47.60/ hr =-$101,340.40 for billing clerks) + (-2,129 hr x $299.32/hr =- $637,252.28 for physicians)].

Total Impact: Taken together, we estimate that the changes in submissions due to policy provisions and the availability of updated data will result in a change of -3,243 submissions (-1,114 due to policy provisions + -2,129 due to updated data), an annual burden change of -25,944 hours (-8,912 hr due to policy provisions + -17,032 hr due to updated data) at a cost of -$3,231,520 (-$1,110,056.44 due to policy provisions +-$2,121,463.34 due to updated data, rounded to the dollar). We estimate a total of 23,936 traditional MIPS submissions under the eCQM collection type for the CY 2026 performance period/2028 MIPS payment year (18,282 individual clinicians + 5,647 groups + 7 non- Shared Savings Program ACO APM Entities). We did not receive public comments on our burden estimates or assumptions, and therefore our finalizing our estimates as proposed. (6) ICRs Regarding Burden for MVP Reporting and Registration

The following changes, as presented in the CY 2026 PFS proposed rule (90 FR 32788 through 32791), will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).

In the CY 2022 PFS final rule, we finalized an option for clinicians choosing to report MVPs to participate through subgroups beginning with the CY 2023 performance period/2025 MIPS payment year (86 FR 65392 through 65394). We refer readers to the CY 2022 PFS final rule (86 FR 65590 through 65592), CY 2023 PFS final rule (87 FR 70155), CY 2024 PFS final rule (88 FR 79443), and CY 2025 PFS final rule (89 FR 98487) for our previously finalized burden assumptions and requirements for submitting quality performance category data for the MVP reporting option.

We refer readers to Appendix 3: MVP Inventory of this final rule for the updated format of the MVP tables. We do not anticipate that the new stratified update to the MVP format will affect the reporting burden, as it does not alter the composition of an MVP and does not affect the general minimum reporting requirements for each MVP.

In section IV.A.4.a. of this final rule, we are finalizing our proposal to update the MVP inventory in line with the MVP development criteria (85 FR 84849 through 84854). We are also finalizing our proposal to add six new MVPs to the MVP inventory for the CY 2026 performance period/2028 MIPS payment year.

In the CY 2025 PFS final rule (89 FR 98485 and 98486), we estimated that 10 percent of MIPS eligible clinicians from the CY 2022 performance period/2024 MIPS payment year will move from traditional MIPS reporting to MVP reporting for the CY 2025 performance period/2027 MIPS payment year. For details on prior approaches to estimating MVP reporting, we refer readers to the CY 2022 PFS final rule (86 FR 65588 through 65590), CY 2023 PFS final rule (87 FR 70155 and 70156), and CY 2024 PFS final rule (88 FR 79443 and 79444).

To estimate MVP submissions for the CY 2026 performance period/2028 MIPS payment year, we calculated the average quality measure submission rate for each of the new MVPs finalized in this final rule for the CY 2026 performance period/2028 MIPS payment year. For these analyses, we assessed measure submissions in the CY 2023 performance period/2025 MIPS payment year for clinicians with

relevant clinical specialties for each MVP. We considered quality reporting trends from all quality performance category reporting options (traditional MIPS, MVPs, and the APP), by clinicians, groups, subgroups, and non-Shared Savings Program ACO APM Entities. The total of these average quality measure submissions for all the MVPs finalized as proposed was equivalent to about 4 percent of the total quality performance category submissions in the CY 2023 performance period/2025 MIPS payment year. Adding this incremental change of 4 percentage points to the existing estimate of 10 percent for MVPs established in the CY 2025 PFS final rule (89 FR 98485 and 98486), we estimated that MVP reporting will account for 14 percent of MIPS quality performance category submissions for the CY 2026 performance period/2028 MIPS payment year.

Continuing our approach from the CY 2022 PFS final rule (86 FR 65589 and 65590), CY 2023 PFS final rule (87 FR 70155 and 701566), CY 2024 PFS final rule (88 FR 79443 and 79444), and CY 2025 PFS final rule (89 FR 98486), we assumed that number of MVP registrations will equal our estimated MVP quality submissions. (a) Burden for MVP Registration: Individuals, Groups, Subgroups, and APM Entities

The following changes, as presented in the CY 2026 PFS proposed rule (90 FR 32789), will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).

In section IV.A.3.a. of this final rule, we are finalizing our proposal to add a new self-attestation requirement to the MVP registration process requiring each group to attest whether it is either a single-specialty group or multispecialty group meeting the requirements of a small practice. We believe the associated impact of this provision will be minimal, and that this provision will not require the burden per registration to exceed the currently approved estimate of 15 minutes per registration. Therefore, we did not propose to revise the burden per MVP registration under OMB control number 0938-1314 (CMS-10621), and are not making any changes to the subgroup registration process under this control number. We refer readers to section IV.A.3.a. of this final rule for additional details on the MVP registration self-attestation requirement.

As described in section V.B.5.c.(6). of this final rule, we estimate that approximately 14 percent of the clinicians that participate in MIPS quality performance category reporting will submit data for the measures and activities in an MVP. For the CY 2026 performance period/2028 MIPS payment year, we assume that the total number of individual clinicians, groups, non-Shared Savings Program ACO APM Entities, and subgroups that will complete the MVP registration process is 8,110. All changes to the MVP registrations described below are relative to our currently approved estimate of 6,285 registrations detailed in the CY 2025 PFS final rule (89 FR 98486 and 98487).

We estimate that the finalized addition of six new MVPs will result in an increase of 2,312 MVP registrations. Using the currently approved estimate of 0.25/hr per registration, we estimate an annual burden change of +578.00 hours (+2,312 registrations x 0.25 hr/registration) at a cost of +$62,227.48 (+578 hr x $107.66/hr for a computer system analyst or equivalent). Additionally, we estimate that the availability of updated data will result in a change of -487 registrations. Using the currently approved estimate of 0.25 hr/registration, we estimate an annual change of -121.75 hours (-487 registrations x 0.25 hr/ registration) at a cost of -$13,107.61 (-121.75 hr x $107.66/hr for a computer system analyst or equivalent) due to the availability of updated data.

Taken together, we estimate that the anticipated changes due to policy provisions and the availability of updated data will result in a change of +1,825 registrations (2,312 registrations due to policy provisions + -487 registrations due to updated data), an annual burden change of +456 hr (578.00 hr due to policy provisions + -121.75 hr due to updated data, rounded to the hour) at a cost of +$49,120 (+$62,227.48 due to policy provisions + -$13,107.61 due to updated data, rounded to the dollar). We estimate a total of 8,110 MVP registrations for the CY 2026 performance period/2028 MIPS payment year.

We summarized comments received about the self-attestation proposal in section XX of this final rule and provided responses. We did not receive any comments about these on our burden estimates, and are finalizing the requirements and burden estimates as proposed. (b) Burden for Subgroup Registration

In the CY 2026 PFS proposed rule (90 FR 32789), we did not propose to revise burden for subgroup registration for the CY 2026 performance period/2028 MIPS payment year. We previously finalized a requirement for subgroup reporting for multispecialty groups choosing to report as an MVP Participant beginning in the CY 2026 performance period/2028 MIPS payment year (Sec. 414.1305; 86 FR 65394 through 65397). In section IV.A.3.a.(3) of this final rule, we are finalizing our proposal to update the MVP group registration process to add the self- attestation process for groups. If a group does not self-attest as a single specialty group or a multispecialty group meeting the requirements of a small practice during MVP registration, clinicians in the group cannot register as a group. Clinicians in such groups could register as subgroups to participate in MVP reporting. However, we did not propose to revise our subgroups' burden estimates because we are operationalizing previously finalized policies that will not impact the utilization of subgroups by groups and hence, will not change the way groups choose to organize clinicians in subgroups.

Additionally, we are finalizing our proposal to maintain the MVP group reporting option for multispecialty groups with a small practice designation in section IV.A.3.a.(3) of this final rule. Maintaining the MVP group reporting option will not impact the currently approved burden for subgroup registration because it will not change any requirements related to subgroup registration. As future performance year data becomes available to reflect subgroup reporting trends amid revisions to the MVP inventory, we will evaluate changes to our currently approved burden estimate under OMB control number 0938-1314 (CMS-10621). (c) Burden for MVP Quality Performance Category Submission

In the CY 2022 PFS final rule (86 FR 65411 through 65415), we finalized the reporting requirements for the MVP quality performance category at Sec. 414.1365(c)(1)(i). For prior discussions of our related burden estimates, please see the CY 2022 PFS final rule (86 FR 65590 through 65592), CY 2023 PFS final rule (87 FR 70157 through 70159), CY 2024 PFS final rule (88 FR 79444 through 79446), and CY 2025 PFS final rule (89 FR 98487 through 98490).

The following changes as proposed in the CY 2026 PFS proposed rule (90 FR 32790) will be submitted to OMB for approval under control number 0938-1314 (CMS-10621), relative to the currently approved burden estimates detailed in the CY 2025 PFS final rule (89 FR 98487 through 98490).

We estimate a change to the number of annual MVP quality performance category submissions per collection type

from our currently approved burden estimates, beginning with the CY 2026 performance period/2028 MIPS payment year. These estimates include the figures detailed in section V.B.5.c.(1)(e) of this final rule plus our currently approved estimate of 20 subgroup submissions (split evenly across the eCQM and MIPS CQM/QCDR measure collection types). These estimates aggregate individual clinician, group, subgroup, and non-Shared Savings Program ACO APM Entity submissions. All estimates encompass time to review measure specifications unless otherwise noted. (i) Medicare Part B Claims Measure Collection Type

All estimates below presume the maximum submission time. All changes to the estimated number of quality performance category submissions as described in this section are relative to our currently approved estimate of 1,355 submissions detailed in the CY 2025 PFS final rule (89 FR 98487 through 98490).

Impact of Policy Provisions: We estimate a change of +388 submissions due to the six new MVPs finalized in this final rule. Multiplying the estimated change in submissions (+388) by the time per submission by labor category, we estimate a total change of +3,662.72 hours. This change incorporates the following estimates: 2,118.48 hours for computer system analysts (+388 submissions x 5.46 hr/submission (4.8 hr to submit data + 0.66 hr to review measure specifications), 776 hours for medical and health service managers (+388 submissions x 2 hr/ submission), 256.08 hours for LPNs (+388 submissions x 0.66 hr/ submission), 256.08 hours for billing clerks (+388 submissions x 0.66 hr/submission), and 256.08 hours for physicians (+388 submissions x 0.66 hr/submission). We estimate an annual change of +$435,483.29 [(2,118.48 hr x $107.66/hr = $228,075.56 for computer system analysts) + (776 hr x $132.44/hr = $102,773.44 for medical and health service managers) + (256.08 hr x $61.68/hr = $15,795.01 for LPNs) + (256.08 hr x $47.60/hr = $12,189.41 for billing clerks) + (256.08 hr x $299.32/hr = $76,649.87 for physicians)].

Impact of Updated Data: Additionally, we estimate a change of -384 submissions due to the availability of updated data and assumptions. Multiplying the estimated change in submissions (-384) by the time per submission by labor category, we estimate a total change of -3,624.96 hours. This change incorporates the following estimates, and applies the annual time per labor category identified in the preceding paragraph: -2,096.64 hours for computer system analysts (-384 submissions x 5.46 hr/submission), -768 hours for medical and health service managers (-384 submissions x 2 hr/submission), -253.44 hours for LPNs (-384 submissions x 0.66 hr/submission), -253.44 hours for billing clerks (-384 submissions x 0.66 hr/submission), and -253.44 hours for physicians (-384 submissions x 0.66 hr/submission). We estimate an annual change of -$430,993.76 [(-2,096.64 hr x $107.66/hr =-$225,724.26 for computer system analysts) + (-768 hr x $132.44/hr =- $101,713.92 for medical and health service managers) + (-253.44 hr x $61.68/hr =-$15,632.18 for LPNs) + (-253.44 hr x $47.60/hr =-$12,063.74 for billing clerks) + (-253.44 hr x $299.32/hr =-$75,859.66 for physicians)].

Total Impact: Taken together, we estimate that the changes in submissions due to policy provisions and newly available data will result in a change of +4 submission (+388 submissions due to policy provisions + -384 submissions due to updated data), an annual burden change of +38 hours (3,662.72 hr due to policy provisions + -3,624.96 hr due to updated data, rounded to the hour) at a cost of +$4,490 ($435,483.29 due to policy provisions + -430,993.76 due to updated data, rounded to the dollar). We estimate a total of 1,359 MVP submissions under the Medicare Part B claims measure collection type for the CY 2026 performance period/2028 MIPS payment year. We did not receive public comments on our burden estimates and assumptions for this collection type, and therefore, we are finalizing our burden estimates as proposed. (ii) MIPS CQM/QCDR Measure Collection Type

All changes to the estimated number of quality performance category submissions described later in this section are relative to our currently approved estimate of 1,900 submissions detailed in the CY 2025 PFS final rule (89 FR 98487 through 98490).

Impact of Policy Provisions: We estimate a change of +810 submissions due to the six new MVPs finalized in this final rule. Multiplying the estimated change in submissions (+810) by the time per submission by labor category, we estimate a total change of +4,835.70 hours. All estimates encompass time to review measure specifications unless otherwise noted. This change incorporates the following estimates: 2,154.60 hours for computer system analysts (+810 submissions x 2.66 hr/submission (2 hr to submit data and 0.66 hr to review measure specifications)), 1,077.30 hours for medical and health service managers (+810 submissions x 1.33 hr/submission), 534.60 hours for LPNs (+810 submissions x 0.66 hr/submission), 534.60 hours for billing clerks (+810 submissions x 0.66 hr/submission), and 534.60 hours for physicians (+810 submissions x 0.66 hr/submission). We estimate an annual change of $593,079.41 [(2,154.60 hr x $107.66/hr = $231,964.24 for computer system analysts) + (1,077.30 hr x $132.44/hr = $142,677.61 for medical and health service managers) + (534.60 hr x $61.68/hr = $32,974.13 for LPNs) + (534.60 hr x $47.60/hr = $25,446.96 for billing clerks) + (534.60 hr x $299.32/hr = $160,016.47 for physicians)].

Impact of Updated Data: Additionally, we estimate a change of +134 submissions due to the availability of updated data and assumptions. Multiplying the estimated change in submissions (+134) by the time per submission by labor category, we estimate a total change of +799.98 hours. This change incorporates the following estimates, and applies the annual time per labor category identified in the preceding paragraph: +356.44 hours for computer system analysts (+134 submissions x 2.66 hr/submission), 178.22 hours for medical and health service managers (+134 submissions x 1.33 hr/submission), 88.44 hours for LPNs (+134 submissions x 0.66 hr/submission), 88.44 hours for billing clerks (+134 submissions x 0.66 hr/submission), and 88.44 hours for physicians (+134 submissions x 0.66 hr/submission). We estimate an annual change of $98,114.37 [(356.44 hr x $107.66/hr = $38,374.33 for computer system analysts) + (178.22 hr x $132.44/hr = $23,603.46 for medical and health service managers) + (88.44 hr x $61.68/hr = $5,454.98 for LPNs) + (88.44 hr x $47.60/hr = $4,209.74 for billing clerks) + (88.44 hr x $299.32/hr = $26,471.86 for physicians)].

Total Impact: Taken together, we estimate that the changes in submissions due to policy provisions and newly available data will result in a change of +944 submissions (810 due to policy provisions + 134 due to updated data), an annual burden change of 5,636 hours (4,835.70 hr due to policy provisions + 799.98 hr due to updated data, rounded to the hour) at a cost of +$691,194 ($593,079.41 due to policy provisions + 98,114.37 due to updated data, rounded to the dollar). We estimate a total of 2,844 MVP submissions under the MIPS CQM/

QCDR measure collection types for the CY 2026 performance period/2028 MIPS payment year (10 subgroups + 1,834 individuals + 999 groups + 1 non-Shared Savings Program APM ACO entity).

We did not receive public comments on our burden estimates and assumptions for this collection type, and therefore, we are finalizing our burden estimates as proposed. (iii) eCQM Collection Type

All changes to the estimated number of quality performance category submissions as described in this section are relative to our currently approved estimate of 3,030 submissions detailed in the CY 2025 PFS final rule (89 FR 98487 through 98490).

Impact of Policy Provisions: We estimate a change of +1,114 submissions due to the six new MVPs finalized in this final rule. Multiplying the estimated change in submissions (+1,114) by the time per submission by labor category, we estimate a total change of +5,904.20 hours. All estimates incorporate time to review measure specifications unless otherwise noted. This change incorporates the following estimates: 2,216.86 hr for computer system analysts (+1,114 submissions x 1.99 hr/submission (1.33 hr to submit data file and 0.66 hr to review measure specifications)), 1,481.62 hr for medical and health service managers (+1,114 submissions x 1.33 hr/submission), 735.24 hr for LPNs (+1,114 submissions x 0.66 hr/submission), 735.24 hr for billing clerks (+1,114 submissions x 0.66 hr/submission), and 735.24 hr for physicians (1,114 submissions x 0.66 hr/submission). We estimate an annual change of +$735,311.96 [(2,216.86 hr x $107.66/hr = $238,667.15 for computer system analysts) + (1,481.62 hr x $132.44/hr = $196,225.75 for medical and health service managers) + 735.24 hr x $61.68/hr = $45,349.60 for LPNs) + (735.24 hr x $47.60/hr = $34,997.42 for billing clerks) + (735.24 hr x $299.32/hr = $220,072.04 for physicians)].

Impact of Updated Data: Additionally, we estimate a change of -237 submissions due to the availability of updated data and assumptions. Multiplying the estimated change in submissions (-237) by the time per submission by labor category, we estimate a total change of -1,256.10 hours. This change incorporates the following estimates, and applies the annual time per labor category identified in the preceding paragraph: -471.63 hr for computer system analysts (-237 submissions x 1.99 hr/submission) + -315.21 hr for medical and health service managers (-237 submissions x 1.33 hr/submission) + -156.42 hr for LPNs (-237 submissions x 0.66 hr/submission) +-156.42 hr for billing clerks (-237 submissions x 0.66 hr/submission) + -156.42 hr for physicians (- 237 submissions x 0.66 hr/submission). We estimate an annual change of -$156,435.31 [(-471.63 hr x $107.66/hr =-$50,775.69 for computer systems analysts) + (-315.21 hr x $132.44/hr =-$41,746.41 for medical and health service managers) + (-156.42 hr x $61.68/hr =-$9,647.99 for LPNs) + (-156.42 hr x $47.60/hr =-$7,445.59 for billing clerks) + (- 156.42 hr x $299.32/hr =-$46,819.63 for physicians)].

Total Impact: Taken together, we estimate that the changes in submissions due to policy provisions and newly available data will result in a change of +877 submissions (1,114 due to policy provisions + -237 due to updated data), an annual burden change of +4,648 hours (5,904.20 hr due to policy provisions + -1,256.10 hr due to updated data, rounded to the hour) at a cost of -$578,877 ($735,311.96 due to policy provisions + -$156,435.31 due to updated data, rounded to the hour). We estimate a total of 3,907 MVP submissions using the eCQM collection type for the CY 2026 performance period/2028 MIPS payment year (10 subgroups + 2,977 individuals + 919 groups + 1 non-Shared Savings Program APM ACO entity).

We did not receive public comments on our burden estimates, and therefore, we are finalizing our burden estimates as proposed. (iv) Summation of Medicare Part B Claims Measure, MIPS CQM/QCDR Measure, and eCQM Collection Types

Across the quality performance category collection types for MVPs, we estimate that policy provisions will result in a total change of +2,312 submissions (388 Medicare Part B claims measure submissions + 810 MIPS CQM/QCDR measure submissions + 1,114 eCQM submissions), an annual burden change of +14,402.62 hours (3,662.72 hr for Medicare Part B claims measure submissions + 4,835.70 hr for MIPS CQM/QCDR measure submissions + 5,904.20 hr for eCQM submissions) at a cost of +$1,763,874.66 ($435,483.29 for Medicare Part B claims measure submissions + $593,079.41 for MIPS CQM/QCDR measure submissions + $735,311.96 for eCQM submissions).

Additionally, we estimate that updated data and assumption will result in a total change of -487 submissions (-384 Medicare Part B claims measure submissions + 134 MIPS CQM/QCDR measure submissions + - 237 eCQM submissions), an annual burden change of -4,081.08 hours (- 3,624.96 hr for Medicare Part B claims measure submissions + 799.98 hr for MIPS CQM/QCDR measure submissions + -1,256.10 hr for eCQM submissions) at a cost of--$489,314.70 (-$430,993.76 for Medicare Part B claims measure submissions + $98,114.37 for MIPS CQM/QCDR measure submissions +-$156,435.31 for eCQM submissions).

Taken together, we estimate that the change in submissions due to finalized policy provisions and newly available data will result in a change of +1,825 submissions (+2,312 submissions due to policy provisions + -487 submissions due to updated data), an annual burden change of +10,322 hours (+14,402.62 hr due to policy provisions + - 4,081.08 hr due to updated data, rounded to the hour) at a cost of +$1,274,560 (+$1,763,874.66 due to policy provisions + -$489,314.70 due to updated data, rounded to the dollar). We estimate a total of 8,110 MVP submissions under the Medicare Part B claims measure, MIPS CQM/QCDR measure, and eCQM collection types for the CY 2026 performance period/ 2028 MIPS payment year (20 subgroups + 6,170 individuals +1,918 groups + 2 non-Shared Savings Program ACO APM entities).

We did not receive public comments on our burden estimates and assumptions, and therefore, we are finalizing our burden estimates as proposed. (7) Beneficiary Responses to CAHPS for MIPS Survey

In section IV.B.4.a.(5) of this final rule, we are finalizing our proposal to update the CAHPS for MIPS Survey measure by changing from a mail-web protocol to a web-mail-phone protocol. As we were unable to estimate the incremental change in submissions above our currently approved estimates, we did not propose to change our currently approved estimates under OMB control number 0938-1222 (CMS-10450) (90 FR 32791 and 32792). We proposed to continue our currently approved estimate of response time per survey of 0.2183 hours (13.1 minutes), as we did not propose revisions to the survey questions. We did not receive public comments on our burden assumptions. (8) Group Registration for CAHPS for MIPS Survey

In section IV.B.4.a.(5) of this final rule, we are finalizing our proposal to update the CAHPS for MIPS Survey measure by changing from a mail-web

protocol to a web-mail-phone protocol. We do not anticipate that the provision will affect the number of groups registering for the CAHPS for MIPS Survey, nor will it affect the time to complete each group registration. In the CY 2026 PFS proposed rule (90 FR 32792), we did not propose changes to the requirements and burden estimates currently approved by OMB under control number 0938-1222 (CMS-10450). We did not receive public comments on our burden assumptions. d. ICRs Regarding Reporting the Promoting Interoperability Performance Category (1) Background

We refer readers to Sec. 414.1375 for our previously established policies regarding reporting for the Promoting Interoperability performance category. We also refer readers to Sec. 414.1305 for the definition of attestation, Sec. 414.1325 for data submission requirements, and Sec. Sec. 414.1380(b)(4) and 414.1365(d)(3)(iv) for Promoting Interoperability performance category scoring. For historic assumptions on reporting requirements for the Promoting Interoperability performance category, we refer readers to the CY 2024 PFS final rule (88 FR 79449 through 79451). As identified in section V.B.4., we do not estimate MIPS reporting burden due to requirements of the Shared Savings Program in the collection of information pages. (2) Submitting Promoting Interoperability Data

In the following paragraphs, we outline the policy changes to the MIPS Promoting Interoperability performance category reporting requirements finalized in section IV.A.4.d.(4) of this final rule and our assumptions as to why such policies do not affect burden. For the first three policies finalized in this final rule, there are similar policies for the Medicare Promoting Interoperability Program in the Fiscal Year (FY) 2026 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment Systems (IPPS/LTCH PPS) final rule (90 FR 37045 through 37056). Our burden assumptions for policies affecting the MIPS Promoting Interoperability performance category are consistent with the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18414 and 18415) and FY 2026 IPPS/ LTCH PPS final rule (90 FR 37199).

First, beginning with the CY 2026 performance period/2028 MIPS payment year we are finalizing our proposal to modify the Security Risk Analysis measure to require MIPS eligible clinicians to submit a second attestation (“Yes” or “No”) to having conducted security risk management activities as required under the HIPAA Security Rule implementation specification for risk management (codified at 45 CFR 164.308(a)(1)(ii)(B)). This attestation is in addition to the current requirement under the measure for MIPS eligible clinicians to attest “Yes” to having conducted or reviewed a security risk analysis as required under the HIPAA Security Rule. In the CY 2026 PFS proposed rule (90 FR 32792), we did not propose to update the currently approved time per MIPS Promoting Interoperability performance category submission due to the additional attestation, as we believe the currently approved burden of 2.7 hours per MIPS Promoting Interoperability performance category submission is sufficient to absorb the negligible effort of the additional attestation included as a component of the Security Risk Analysis measure.

Second, beginning with the CY 2026 performance period/2028 MIPS payment year, we are finalizing our proposal to modify the High Priority Practices Safety Assurance Factors for EHR Resilience (SAFER) Guide measure by specifying that MIPS eligible clinicians use the version of the SAFER Guides published in January 2025. In the CY 2026 PFS proposed rule (90 FR 32792), we did not propose to revise our burden estimates because the modification of the measure does not alter the core requirement to attest “Yes” or “No.”

Third, beginning with the CY 2026 performance period/2028 MIPS payment year, we are finalizing our proposal to establish the new optional bonus measure Public Health Reporting under Trusted Exchange Framework and Common Agreement (TEFCA). We did not propose to update our burden estimates in the CY 2026 PFS proposed rule (90 FR 32792) because the measure submission is optional and we cannot predict which MIPS eligible clinicians will elect to report this measure and how they will participate in MIPS (individual, group, virtual group, subgroup, or APM Entity (excluding Shared Savings Program Accountable Care Organizations (ACOs)) level). For further discussion regarding the three aforementioned policies, we refer readers to section IV.A.4.d.(4) of this final rule.

In sections IV.A.4.d.(4)(f) and IV.A.4.d.(4)(g) of this final rule, we are finalizing the following: (1) establish a measure suppression policy for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program; and (2) suppress the Electronic Case Reporting measure for the CY 2025 performance period/ 2027 MIPS payment year for the MIPS Promoting Interoperability performance category and the EHR reporting period in CY 2025 for the Medicare Promoting Interoperability Program. For further discussion regarding such policies, we refer readers to sections IV.A.4.d.(4)(f) and IV.A.4.d.(4)(g) of this final rule. The suppression of a measure only pertains to a measure not being assessed for performance, and thus, MIPS eligible clinicians, eligible hospitals, and CAHs will continue to be required to report the measure. In the CY 2026 PFS proposed rule (90 FR 32792), we did not propose to revise our burden estimates because the measure suppression policy does not impact reporting requirements of the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program.

We summarized the comments received regarding the aforementioned proposals in section XX of this final rule. We did not receive public comment on the burden assumptions for submitting Promoting Interoperability data, and are finalizing our requirements and burden estimates as proposed.

Independent of the aforementioned policies, we proposed to update the currently approved burden estimates for the number of total submissions for the MIPS Promoting Interoperability performance category due to the availability of updated data from the CY 2023 performance period/2025 MIPS payment year (90 FR 32792). Additionally, we increased the time per MIPS Promoting Interoperability performance category submission by 30 seconds (0.083 hour) to account for the addition of the Electronic Prior Authorization measure under the Health Information Exchange objective for the MIPS Promoting Interoperability performance category beginning with the CY 2027 performance period/2029 MIPS payment year. Such measure was established in the CMS Interoperability and Prior Authorization final rule published in the Federal Register on February 8, 2024 (89 FR 8758). In this final rule, we do not outline the burden estimate updates in this collection of information section due to the burden estimates not being affected by the policy provisions in this final rule. The applicable burden changes will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).

We refer readers to Sec. Sec. 414.1355 and 414.1365(c)(3) for our previously established policies regarding reporting for the improvement activities performance category. We also refer readers to Sec. 414.1305 for the definition of attestation, Sec. 414.1360 for data submission requirements, and Sec. Sec. 414.1380(b)(3) and 414.1365(d)(3)(iii) for improvement activities performance category scoring. For historic assumptions on reporting requirements for the improvement activities performance category, we refer readers to the CY 2024 PFS final rule (88 FR 79454 and 79455).

In section IV.A.4.d.(3)(b) of this final rule, we are finalizing our proposed changes to the Improvement Activities Inventory for the CY 2026 performance period/2028 MIPS payment year and future years. Consistent with our assumptions in the CY 2023 PFS final rule (87 FR 70211), the CY 2024 PFS final rule (88 FR 79519), and the CY 2025 PFS final rule (89 FR 98492), we believe clinicians performing improvement activities will continue to perform the same activities because previously finalized improvement activities continue to apply for the current and future years unless otherwise modified via rulemaking (82 FR 54175). We did not receive public comment on these burden assumptions.

We refer readers to section VII.I.5.e.(2)(a) of this final rule for additional discussion. Independent of these policies, we are updating the number of submissions due to the availability of updated submission data from the CY 2023 performance period/2025 MIPS payment year. While not scored in this rule, the non-policy changes will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). f. ICRs Regarding the Cost Performance Category (Sec. 414.1350)

The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process (OMB control number 0938-1197; CMS-1500 and CMS-1490S) is used to collect data on cost measures from MIPS eligible clinicians. MIPS eligible clinicians are not required to provide any documentation by Compact Disc or hardcopy. The following policies finalized in section IV.A.4.d.(2) of this final rule will not result in the need to add or revise or delete any claims data fields: (1) modify the Total Per Capita Cost (TPCC) measure beginning in the CY 2026 performance period/2028 MIPS payment year; (2) update the operational list of care episode and patient condition groups and codes to reflect coding changes identified through annual maintenance of MIPS cost measures; and (3) adopt an informational-only feedback period of 2 years for new MIPS cost measures. Consequently, we are not making any changes under the aforementioned OMB control number.

In this final rule, we finalized payment and policy changes under the Medicare PFS. Our proposed policies in this rulemaking specifically address: changes to the PFS; and other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, the relative value of services, and changes in the statute; updates and refinements to Medicare Shared Savings Program (Shared Savings Program) requirements; updates to the Quality Payment Program (MIPS and Advanced APMs); changes to payment policies for

drugs and biologicals products paid under Medicare Part B, other changes to Medicare Part B payment policies for Rural Health Clinics and Federally Qualified Health Centers, and changes to the regulations associated with the Ambulance Fee Schedule. The policies reflect CMS' stewardship of the Medicare program and overarching policy objectives for ensuring equitable beneficiary access to appropriate and quality medical care. 1. Statutory Provisions a. Medicare Prescription Drug Inflation Rebate Program

Section III.I. of this final rule finalized regulations to implement provisions of the Inflation Reduction Act of 2022 (IRA) that establish the Medicare Prescription Drug Inflation Rebate Program. Sections 11101 and 11102 of the Inflation Reduction Act of 2022 (IRA) (Pub. L. 117-169, enacted August 16, 2022) established requirements under which drug manufacturers must pay inflation rebates if they raise their prices for certain drugs payable under Part B and/or covered under Part D faster than the rate of inflation. Specifically, section 11101 of the IRA amended section 1847A of the Social Security Act (the Act) by adding new subsection (i) which establishes a requirement for drug manufacturers to pay rebates into the Federal Supplementary Medical Insurance Trust Fund for Part B rebatable drugs for each calendar quarter beginning on or after January 1, 2023, if the specified amount, as determined under section 1847A(i)(3)(A)(ii) of the Act, exceeds the inflation-adjusted payment amount, which is calculated as set forth in section 1847A(i)(3)(C) of the Act. The IRA also provides for an adjustment to the beneficiary coinsurance amount in cases where the price of a Part B rebatable drug increases faster than the rate of inflation such that the beneficiary coinsurance is calculated based on the lower inflation-adjusted payment amount instead of the applicable payment amount. Section 1847A(i)(2) of the Act defines a “Part B rebatable drug,” in part, as a single source drug or biological product (as defined in section 1847A(c)(6)(D) of the Act), including a biosimilar biological product (as defined in section 1847A(c)(6)(H) of the Act), but excluding a qualifying biosimilar biological product (as defined in section 1847A(b)(8)(B)(iii) of the Act) for which payment is made under Part B.

Section 11102 of the IRA added section 1860D-14B of the Act, which requires drug manufacturers to pay rebates into the Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund for each 12-month applicable period, starting with the applicable period that began on October 1, 2022, for Part D rebatable drugs if the annual manufacturer price (AnMP) of such drug, which is calculated as set forth in section 1860D-14B(b)(2) of the Act, exceeds the inflation-adjusted payment amount, which is calculated as set forth in section 1860D-14B(b)(3) of the Act. Section 1860D- 14B(g)(1)(A) of the Act defines a “Part D rebatable drug,” in part, as a drug or biological described at section 1860D-14B(g)(1)(C) of the Act that is a “covered Part D drug” as that term is defined in section 1860D-2(e) of the Act. The definition of a Part D rebatable drug includes drugs approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic (FD&C) Act, drugs approved under an abbreviated new drug application under section 505(j) of the FD&C Act that meet certain sole source criteria described at sections 1860D-14B(g)(1)(C)(ii)(I) through (IV) of the Act, and biologicals licensed under section 351 of the Public Health Service Act, including biosimilars. b. Quality Payment Program

This final rule is also necessary to make changes to the Quality Payment Program to move the program forward to focus more on measurement efforts, refine how clinicians would be able to participate in a more meaningful way through the Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs), and highlight the value of participating in Advanced Alternative Payment Models (APMs). Authorized by MACRA, the Quality Payment Program is a value-based payment program that includes two participation tracks: MIPS and Advanced APMs. MIPS eligible clinicians are subject to a MIPS payment adjustment based on their performance in four performance categories: cost, quality, improvement activities, and Promoting Interoperability. We continue to move the Quality Payment Program forward, including focusing more on alignment between the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APM) tracks of participation, alignment with broader CMS initiatives, and new options for clinicians to participate in more meaningful ways. We aim to achieve continuous improvement in the quality of health care services provided to Medicare beneficiaries and other patients through the MIPS and Advanced APMs for the CY 2026 performance period/2028 MIPS payment year. 2. Discretionary Provisions a. Drugs and Biological Products Paid Under Medicare Part B

In section III.A.1. of this final rule, as part of our continued implementation of section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117-58, November 15, 2021) (IIJA), which amended section 1847A of the Act to require manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drug (hereinafter, refundable drug), we discuss two applications received for increased applicable percentage.

In section III.A.2 of this final rule, we discuss the calculation of manufacturer's Average Sales Price (ASP) related to price concessions and bona fide service fees (BFSFs). Regarding the proposals we made for price concessions, we finalized adding a definition of bundled arrangement at Sec. [thinsp]414.802 to specify how certain financial benefits, including rebates, discounts or other price concessions, are conditional upon certain requirements being met. We also finalized adding paragraphs at Sec. [thinsp]414.804(a)(2) to provide manufacturers with additional guidance on how to allocate discounts under bundled arrangements.

We also finalized several evidence requirements changes for BFSFs at Sec. 414.804. Specifically, we finalized revisions at Sec. 414.804(a)(5) that manufacturers are required to provide sufficient evidence that the BFSF is not passed on in whole or in part to a client or customer of an entity, whether or not the entity takes title to the drug by providing documentation (such as a certification or warranty from the recipient of the fee). In addition, we finalized to revise Sec. 414.804(a)(5) to add data submission requirements. Under this revision, manufacturers will be required to submit reasonable assumptions for calculations of the manufacturer's ASP, including documentation of the fair market value methodology for BFSF contracts.

In section III.A.3. of this final rule, we finalized that preparatory procedures for patient-specific cell or tissue procurement required for manufacturing an autologous cell-based immunotherapy or gene therapy be included in the payment of the product itself. However, we are not finalizing the proposal to require manufacturers, beginning January 1, 2026 (that is, data reflecting sales beginning on that date), to include manufacturer-paid

preparatory procedures for such procurement in the calculation of the manufacturer's ASP. Instead, we conclude that such payments may be treated as BFSFs when the four-part test at Sec. 414.802 is satisfied. b. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

In section III.B.2. of this final rule, we finalized changes to the furnishing of Advance Primary Care Management (APCM) services in RHCs and FQHCs. We finalized to adopt add-on codes for APCM that will facilitate billing for Behavioral Health Integration (BHI) and Psychiatric Collaborative Care Model (CoCM) services when RHCs and FQHCs are providing advanced primary care. We also finalized to require RHCs and FQHCs to report the individual codes that make up the CoCM HCPCS code, G0512. We also finalized to require RHCs and FQHCs to report the individual codes that make up the communications technology- based services (CTBS), HCPCS code G0071 as well. In addition, we finalized to revise Sec. 405.2464(c) and (e) to reflect our proposal on payment of CoCM and CTBS services for RHCs and FQHCs. We also finalized to adopt services that are established and paid under the PFS and designated as care management services as care coordination services for purposes of separate payment for RHCs and FQHCs.

In section III.B.3. of this final rule, we finalized to adopt the definition “immediate availability” as including real-time audio and visual interactive telecommunications for the direct supervision permanently for all RHC and FQHC services. We also finalized, on a temporary basis, to facilitate payment for non-behavioral health visits furnished via telecommunication technology using a payment methodology based upon payment rates that are similar to the national average payment rates for comparable telehealth services under the PFS. RHCs and FQHCs will continue to bill for RHC and FQHC services furnished using telecommunication technology services by reporting HCPCS code G2025 on the claim through December 31, 2026. We also finalized that, beginning October 1, 2025, there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12- month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record. c. Ambulatory Specialty Model (ASM)

In section III.C of this final rule, we discuss the finalized provisions of the mandatory alternative payment model called the Ambulatory Specialty Model (ASM) which would be tested under the authority at section 1115A of the Act. Section 1115A of the Act authorizes the testing of innovative payment and service delivery models that preserve or enhance the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program (CHIP) beneficiaries while reducing program expenditures.

Health care is becoming more fragmented as Medicare beneficiaries are increasingly seeing a greater number of specialists on a more regular basis. We believe there are opportunities to improve coordination between specialists and primary care providers (PCPs) and increase beneficiary engagement in care decisions, particularly with respect to preventing the onset and progression of chronic disease. ASM will test whether rewarding select specialists that furnish a high volume of services related to heart failure or low back pain based on measures of quality, cost, care coordination, and Promoting Interoperability results in enhanced quality of care and reduced costs through more effective upstream chronic condition management for ASM's targeted chronic conditions. We expect that a more targeted approach where clinicians are evaluated: (1) on a set of relevant performance measures they are required to report; and (2) among clinicians furnishing similar sets of services for similar chronic conditions, will produce scores and subsequent payment adjustments that are more reflective of clinician performance. A more targeted approach to measurement will also offer more insight into how clinical decisions and processes, such as care coordination, affect patient outcomes. We believe this insight is necessary to support and incentivize accountable care, increasing beneficiary access to coordinated specialty care.

We believe that ASM's meaningful comparisons of performance to similar specialists furnishing a substantial volume of services related to ASM's targeted chronic conditions when matched with a payment methodology that creates impactful Medicare Part B payment adjustments will encourage quality improvements in specialty care and meaningful engagement with primary care clinicians to both prevent and manage the onset of chronic conditions, all while achieving net savings to Medicare.

We refer readers to section III.C.1 of this final rule for more information on our research and rationale for ASM, as well as our finalized provisions. d. Effects of Proposals Being Finalized Relating to the Medicare Diabetes Prevention Program Expanded Model 1. Effects on Beneficiaries

We proposed to modify certain Medicare Diabetes Prevention Program (MDPP) expanded model policies to: (1) address barriers related to weight collection requirements by clarifying that 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 completion of the MDPP session; (2) allow beneficiaries to self-report weight from a reasonable location outside of an in-person delivery site; (3) extend the flexibilities allowed during the PHE for COVID-19 through December 31, 2029; (4) test the addition of coverage of asynchronous, Online delivery of MDPP through December 31, 2029; (5) clarify that MDPP suppliers are not required to maintain In-person delivery capability through December 31, 2029; and (6) introduce a new Healthcare Common Procedure Coding System (HCPCS) G-code and payment for Online sessions.

MDPP is a non-pharmacological behavioral intervention consisting of up to 22 sessions using a Centers for Disease Control and Prevention (CDC) approved National Diabetes Prevention Program (National DPP) curriculum.\473\ CDC administers a national quality assurance program recognizing eligible organizations that furnish the National DPP through its evidence-based DPRP Standards, which are updated every 3 years. The 2024 CDC DPRP Standards replaced the 2021 CDC DPRP Standards in June 2024.\474\

\473\ https://www.cdc.gov/diabetes/prevention/resources/curriculum.html.

\474\ Centers for Disease Control and Prevention Diabetes Prevention Recognition Program. Standards and Operating Procedures. Requirements for CDC Recognition. June 2024. https://nationaldppcsc.cdc.gov/s/article/DPRP-Standards-and-Operating-Procedures.

The CY 2021 PFS final rule allowed for increased virtual delivery of MDPP during the PHE for COVID-19 (85 FR 84830). Improvements to MDPP in the CY 2024 final rule included a simplified payment structure to allow for fee-for-service (FFS) payments for beneficiary attendance, while retaining the performance-based payments for diabetes risk reduction (that is, weight loss) (88 FR 79241) and an extension of PHE flexibilities to deliver some or all MDPP sessions via distance learning, until December 31, 2027 (88 FR 79241). Another PHE flexibility extended through the CY 2024 PFS final rule was for MDPP suppliers to obtain weight measurements for beneficiaries using one of the following options through December 31, 2027: (1) via digital technology, such as scales that transmit weights securely via wireless or cellular transmission; or (2) via self-reported weight measurements from the at-home digital scale of the MDPP beneficiary (88 FR 79243). The CY 2025 PFS expanded this flexibility by allowing beneficiaries with the choice to submit one or two (2) photos for self-reporting weight for an MDPP Distance learning session (89 FR 98047). Finally, to align with 2024 CDC DPRP Standards, the CY 2025 PFS final rule (89 FR 98045) updated the MDPP definition of “Online” to align with the 2024 CDC DPRP definition for this delivery modality. However, while the CY 2025 PFS final rule updated the MDPP definition for Online, only In- person, Distance learning (synchronous), and In-person with a distance learning component remained accepted delivery modalities for MDPP in CY 2025.

We proposed to revise the definitions of “Extended flexibilities period” and “Online” and add definitions for three new terms for MDPP, including “Live Coach interaction,” “Online delivery period,” and “Online session.” These changes will extend virtual delivery flexibilities through December 31, 2029, describe accepted delivery modes for MDPP by including Online (asynchronous) delivery, and further align MDPP terminology with CDC DPRP Standards. These proposed changes aim to remove access barriers for beneficiaries and provide MDPP suppliers with more delivery offerings in response to comments regarding the increasing demand for virtual participation options.

Through the CY 2026 PFS (90 FR 32593 through 32597), we proposed to clarify that 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 completion of the MDPP session. Beneficiaries may also choose to report weight measurements according to the CY 2025 PFS policies regarding beneficiary weight self-reported measurements and virtual weight collection (89 FR 98045), which allow beneficiaries to self-report their weights by providing one or 2 (two) date-stamped photo(s) 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. Beneficiaries who participate in MDPP do not currently have the option to submit medical record data as proof of weight. This proposed change is in response to MDPP supplier feedback that the current weight collection requirements discourage individuals with mobility concerns from participating in MDPP due to risk of injury while self-reporting weight from home. For example, some beneficiaries may need to obtain weight at a medical office using a special scale (for example, wheelchair scale). This flexibility may promote safe and consistent collection of weight for MDPP sessions while encouraging model participation. After consideration of public comments indicating that the proposed 2 day timeframe was overly restrictive, we are finalizing the changes to the provision at Sec. 410.79 (c)(1)(ii) to allow for weight measurements used to determine the achievement or maintenance of the required minimum weight loss to be based on weight documented in the beneficiary's medical record with an updated timeframe of five (5) calendar days, which provides sufficient flexibility while maintaining clear separation between sessions.

Additionally, we proposed to revise weight collection requirements for MDPP in response to comments regarding increased flexibility for MDPP beneficiaries who may be traveling or unable to obtain weight measurements at home. This change allows beneficiaries to self-report weight from a reasonable location outside of an In-person delivery site while maintaining program integrity through existing date-stamped photo requirements described at Sec. 410.79(e)(3)(iii)(c) which state that the photo or video must clearly document the weight of the MDPP beneficiary as it appears on their digital scaled on the date associated with the billable MDPP session. The current weight collection requirements state that beneficiaries self-report weight by submitting date-stamped photo(s) or video of the beneficiary's weight on the scale with the beneficiary visible in their home. This limits beneficiaries from participating by reporting weight from other reasonable locations outside of an in-person delivery site or home, such as a medical office, or hotel if the beneficiary is on vacation but otherwise able to participate in MDPP sessions. This proposed change is expected to remove barriers to weight collection and provide flexibilities that may increase session attendance.

We proposed to test the addition of coverage of an asynchronous, Online delivery modality during the Online delivery period (until December 31, 2029). This change will allow virtual-only organizations to enroll in Medicare as MDPP suppliers, streamline the process to allow for greater delivery of Online sessions, and promote alignment with the 2024 CDC DPRP Standards, which support asynchronous delivery. To date, MDPP suppliers have commented that the exclusion of the asynchronous modality significantly limits program participation among Medicare beneficiaries. Advocacy group members pursued legislation that would require CMS to open the MDPP to suppliers of asynchronous, Online MDPP programs through the PREVENT DIABETES Act [H.R. 7856] \475\ in April 2024. Although this bill was not enacted into law, suppliers continue to encourage CMS to meet the demand for asynchronous delivery of MDPP. To facilitate the ability of MDPP suppliers to deliver the program through an asynchronous, Online delivery modality, we proposed to clarify that MDPP suppliers are not required to maintain the ability to deliver the program In-person during the Online delivery period. This will allow for virtual-only organizations to enroll in Medicare as MDPP suppliers and streamline the process to allow for greater asynchronous delivery. Additionally, beneficiary focus groups indicate that among beneficiaries who participate in MDPP via Distance learning or In-person with a distance learning component (hybrid), most expressed their satisfaction by citing the flexibility the choices provided when faced with challenges such as inclement weather or travel restrictions that made

in-person participation difficult.\476\ This extended flexibility is expected to promote beneficiary access to the Set of MDPP services, since suppliers may deliver the set of MDPP services to beneficiaries across State lines, reaching beneficiaries who do not live near an In- person delivery site. Upon further review of existing regulations, we have determined that current requirements for make-up sessions do not adequately address Online delivery. Make-up sessions for Online delivery were referenced in the CY 2026 PFS proposed rule (90 FR 32593) at Sec. 410.79 (f)(2)(i)(C), which states the Set of MDPP services, inclusive of make-up sessions, must be delivered to individual beneficiaries fully synchronously (that is, In-person, Distance learning, or In-person with a distance learning component) or fully asynchronously (that is, Online). Therefore, we are finalizing additional updates to ensure regulatory clarity for make-up sessions offered through Online delivery by revising existing requirements at Sec. 410.79(d)(1), which state “an MDPP supplier may offer a make-up session to an MDPP beneficiary who missed a regularly scheduled session. MDPP make-up sessions may only use in-person or distance learning delivery.” We are revising this language to indicate that Online delivery is also an accepted delivery modality for make-up sessions by specifically stating that “an MDPP supplier may offer a make-up session to an MDPP beneficiary who missed a regularly scheduled session. MDPP make-up sessions may only be used in-person, distance learning, or Online delivery.” We would like to reiterate that the Set of MDPP services, inclusive of make-up sessions, must be delivered to individual beneficiaries fully synchronously (that is, In-person, Distance learning, or In-person with a distance learning component) or fully asynchronously (that is, Online). Therefore, a supplier may not offer an Online make up session to a beneficiary who is participating in MDPP through In-person, Distance learning, or In-person with a distance learning component delivery.

\475\ H.R. 7856 (118th): PREVENT DIABETES Act, https://www.govtrack.us/congress/bills/118/hr7856/text.

\476\ RTI International. Evaluation of the Medicare Diabetes Prevention Program. March 2025. https://www.cms.gov/priorities/innovation/data-and-reports/2025/mdpp-finalevalrpt.

We proposed edits throughout Sec. 414.84 by revising paragraphs (b)(1) introductory text and (b)(2) introductory text to update language to include all accepted MDPP delivery modes for performance goals in which beneficiaries achieve weight loss milestones. We also proposed adding paragraph (c)(3) to describe the proposed payment for Online delivery, including the inclusion of a new HCPCS G-code for the Set of MDPP services delivered Online. Finally, we proposed redesignating paragraphs (c)(3) and (c)(4) as paragraphs (c)(4) and (c)(5) respectively and revising the redesignated paragraph (c)(4)(ii) to include a payment rate for a core session or core maintenance session furnished Online during the Online delivery period.

Lastly, we proposed amending Sec. 424.205(c)(10) to allow the minimum number of required MDPP core sessions and core maintenance sessions to be delivered Online during the Online delivery period; Sec. 424.205(f)(2)(i) to include the Online delivery modality among acceptable session types for session documentation; and Sec. 424.205(f)(5) to update requirements for achieving 5 and 9 percent weight loss measured in accordance with Sec. 410.79(c)(ii). Overall, these modifications address MDPP supplier and beneficiary needs based upon available monitoring and evaluation data received to date, feedback from existing MDPP suppliers, and feedback from beneficiary focus groups. The proposed changes are also in response to comments from interested parties made through public comments in response to prior rulemaking. These proposed changes are aimed towards increasing access and participation in this prevention-focused program, empowering beneficiaries, and promoting further alignment between MDPP and the CDC DPRP Standards.

The policy changes proposed for MDPP in the CY 2026 PFS (90 FR 32593) are expected to have a significant impact on beneficiaries' access to MDPP services. Aligning with 2024 CDC DPRP Standards for MDPP delivery modes may help expand beneficiary access and increase the number of MDPP eligible organizations that enroll in Medicare as MDPP suppliers. Additionally, the proposed changes to weight collection requirements and the inclusion of Online delivery will increase flexibility for both MDPP suppliers and beneficiaries and may help increase access for beneficiaries who lack transportation or live in geographic areas without access to an In-person delivery site. 2. Effects on the Market

We anticipate that the policy changes proposed in this rulemaking are likely to result in a greater number of MDPP suppliers and increased beneficiary access to the Set of MDPP services. We anticipate that our proposal will result in the delayed onset and reduction of the incidence of diabetes among eligible Medicare beneficiaries.

As of May 2025, there are approximately 1,253 nationally recognized In-person organizations that are eligible to become MDPP suppliers based on their preliminary or full CDC Diabetes DPRP status.\477\ However, only 330 (26 percent) of these eligible In-person organizations are participating in MDPP.\478\ Aligning with CDC DPRP delivery modes, particularly allowing asynchronous, Online delivery, is expected to help increase recruitment of new DPRP organizations, MDPP suppliers, and beneficiaries.

\477\ Centers for Disease Control and Prevention. Diabetes Prevention Recognition Program Application. Registry of All Recognized Organizations. https://dprp.cdc.gov/Registry.

\478\ Medicare Provider Enrollment, Chain, and Ownership System (PECOS), Centers for Medicare & Medicaid Services CMS (.gov), accessed May 1, 2025).

Regulations at Sec. 414.84 specify that MDPP suppliers may be eligible to receive payments for furnishing MDPP services and meeting performance targets related to MDPP beneficiary weight loss and attendance.

We anticipated that the inclusion of asynchronous, Online delivery will have minimal impact on total payment for MDPP services, as current performance payments for 5 percent weight loss achieved from baseline weight (G9880) and 9 percent weight loss achieved from baseline weight (G9881) will remain the same regardless of delivery modality for MDPP. For each beneficiary, MDPP suppliers must either bill claims with G9886, G9887, a combination of G9886 and G9887, or G9871. The proposed G9871 for behavioral counseling for diabetes prevention, online, 60 minutes ($18) is for the Set of MDPP services delivered Online, asynchronously. The existing G9886, behavioral counseling for diabetes prevention, in-person, group, 60 minutes, and G9887, behavioral counseling for diabetes prevention, distance learning, 60 minutes are delivered synchronously. Therefore, we proposed that for each MDPP beneficiary, suppliers may not bill for the Set of MDPP services that were delivered through a combination of synchronous and asynchronous delivery modalities, inclusive of make-up sessions. To evaluate the efficacy of the Online delivery modality during the Online Delivery Period, beneficiary outcomes from synchronous (that is, In-person, Distance learning, or In-person with a Distance learning component)

delivery of the Set of MDPP services must be compared to beneficiary outcomes from asynchronous (that is, Online), therefore, these modalities must be delivered separately for individual beneficiaries in order to evaluate whether Online results, including weight loss, are similar to In-person and Distance learning delivery modalities.

The total maximum payment per beneficiary for MDPP for In-person or Distance learning delivery will remain unchanged by our proposals. The total maximum payment per beneficiary for Online delivery of MDPP will be $619. 4. Effects on the Medicare Program (a) Estimated 10-Year Impact of MDPP

Table D-B1 shows the estimated impact (in millions) on Medicare spending for allowing asynchronous, Online delivery of the MDPP benefit: [GRAPHIC] [TIFF OMITTED] TR05NO25.168

(b) Assumptions/Notes

While we proposed several changes to the existing MDPP expanded model for CY 2026, these changes should not lead to significantly different impacts on Medicare spending. The previous table provides projected impacts to Medicare fee for service spending resulting from allowing asynchronous, Online, delivery of MDPP without requiring providers to maintain an In-person delivery option.

The assumed annual cost of diabetes from the initial certification of MDPP was trended forward using USPCC FFS PMPM spending assumptions included in the 2024 Trustees Report.

Average per beneficiary MDPP payments for the asynchronous, Online delivery was assumed to be less than the In-person or Distance Learning benefit due to the reduced payment rate for session attendance. In 2025, the maximum total payment for completion of MDPP with weight loss is $795. The proposed maximum payment for the asynchronous, Online, delivery of MDPP is $619. Average per beneficiary MDPP payments were trended forward using a projected annual increase of 2.4 percent, consistent with the long-range CPI-U assumption included in the 2024 Trustees Report.

The previous listed impact assumes that there are 15,000 new beneficiaries in 2026; 25,000 new beneficiaries in 2027; tapering off to 5,000 new beneficiaries in years 2028 and 2029. It is anticipated that the number of new beneficiaries in 2026 and 2027 may be higher due to pent up demand for the Online delivery modality. Additionally, it may take up to 90 days for approval of a Medicare enrollment application for those organizations newly enrolling as MDPP suppliers with an Online organization code, leading to lower uptake of the model in 2026 compared to 2027. There is a high degree of uncertainty with respect to the potential utilization of the asynchronous benefit. The CMS Office of Communications (OC) sends emails to a distribution list made up of potential MDPP participants twice every year. The emails contain a link to a website where more information relating to MDPP is available. OC reviews Medicare fee for service claims data to exclude beneficiaries that would be ineligible to participate in MDPP (ESRD patients or beneficiaries with a diabetes diagnosis) to develop the distribution list. In the last email distribution, approximately 11.8 million emails were sent. Of those receiving the email, about 86,000 recipients followed the link. With little information about the potential interest in the asynchronous, Online benefit from the supplier and beneficiary sides, utilization was assumed to be up to 20 percent in the first year and up to just over half of the number of email recipients who followed the email link during the 4 years of the asynchronous test.

To evaluate the reduction in diabetes rates, the effectiveness of asynchronous, Online benefit is assumed to be equal to that of the in-person benefit. This assumption is revisited in the sensitivity analysis section. (c) Sensitivity Analysis

Table D-B2 shows projected 10-year financial impacts (in millions) of delivering the asynchronous Online benefit from 2026 to 2029 at various levels of effectiveness with respect to the In-person benefit. It also provides the first year in which the accumulated savings are greater than the performance payments. [GRAPHIC] [TIFF OMITTED] TR05NO25.169

As indicated in Table D-B2, asynchronous, Online delivery of MDPP services is estimated to produce savings over the next 10 years even when it is 50 percent as effective as the In-person delivery.

As for the Medicare Diabetes Prevention Program, given that we tried to align this final rule as much as possible with the CDC DPRP Standards, there should be minimal regulatory familiarization costs. This rule impacts

only enrolled MDPP suppliers and eligible beneficiaries who have started MDPP or are interested in enrolling in MDPP.

We solicited comments on the regulatory impact analysis for this proposal.

We did not receive public comments on the regulatory impact analysis for this provision, and therefore, we are finalizing as proposed. e. Medicare Shared Savings Program

In section III.F. of this final rule, we are finalizing modifications to the Shared Savings Program regulations to allow for timely improvements to program policies and operations. The changes to the Shared Savings Program include the following.

We are finalizing our proposed changes to limit participation in a one-sided model to an ACO's first agreement period under the BASIC track's glide path (if eligible), for a maximum of 5 performance years instead of 7 performance years. Under the policies being finalized, ACOs inexperienced with performance-based risk Medicare ACO initiatives (defined at Sec. 425.20) will progress more rapidly to higher levels of risk and potential reward under Level E of the BASIC track or the ENHANCED track (if eligible), compared to existing policies. These changes apply to agreement periods beginning on or after January 1, 2027.

We are also finalizing our proposed modifications to the Shared Savings Program eligibility and financial reconciliation requirements in connection with the statutory requirement that ACOs have at least 5,000 assigned Medicare FFS beneficiaries to: (1) require ACOs applying to enter a new agreement period beginning on or after January 1, 2027, to have at least 5,000 assigned beneficiaries in benchmark year (BY) 3, while allowing an ACO to have fewer than 5,000 assigned beneficiaries in BY1, BY2, or both; (2) establish safeguards to reduce the risk that ACOs owe shared losses payments, or are owed shared savings payments by the program, based on normal variation in beneficiary expenditures by (i) requiring that an ACO applying to enter a new agreement period that has fewer than 5,000 assigned beneficiaries in BY1, BY2, or both, may only enter the BASIC track, and (ii) capping shared savings or shared losses at a lesser amount if an ACO, at any time during the agreement period, has fewer than 5,000 assigned beneficiaries in any of the three BYs; as well as (3) exclude ACOs that fall below 5,000 assigned beneficiaries in any benchmark year from being eligible to leverage existing policies that provide certain low revenue ACOs participating in the BASIC track with increased opportunities to share in savings.

We are finalizing our proposed changes to the Shared Savings Program's quality performance standard and other quality reporting requirements, including to: (1) revise the definition of a beneficiary eligible for Medicare CQMs at Sec. 425.20 for performance year 2025 and subsequent performance years so that the population identified for reporting within the Medicare CQM collection type will have greater overlap with the beneficiaries that are assignable to an ACO; (2) update the APP Plus quality measure set for Shared Savings Program ACOs including the removal of Quality ID: 487 Screening for Social Drivers of Health; and (3) implement a web-mail-phone protocol and discontinue the mail-phone protocol for the CAHPS for MIPS Survey beginning with 2027. We are finalizing with modifications our proposal to remove the health equity adjustment applied to an ACO's quality score and to revise the terminology used to describe the health equity adjustment and other related terms; specifically, we are removing the health equity adjustment applied to an ACO's quality score beginning in performance year 2026 and we are revising the terminology used to describe the health equity adjustment and other related terms for performance years 2023 through 2025.

We are finalizing our proposed changes to expand the application of the Shared Savings Program's quality and finance extreme and uncontrollable circumstances (EUC) policies to an ACO that is affected by an EUC due to a cyberattack, including ransomware/malware, as determined by the Quality Payment Program, for performance year 2025 and subsequent performance years.

We are finalizing our proposed changes to other programmatic areas, including: changes to Shared Savings Program eligibility requirements and change request procedures to: (1) require ACOs that experience certain ACO participant CHOWs outside of the change request cycle to update their certified ACO participant list to reflect such ACO participant's CHOW; and (2) require ACOs to submit changes which occur during the performance year to the ACO's SNF affiliate list, if a SNF affiliate undergoes a CHOW resulting in a new TIN. We are finalizing our proposed updates to the beneficiary assignment methodology to revise the definition of primary care services to align with payment policy changes and include, among other services for the purposes of beneficiary assignment, new behavioral health integration and psychiatric collaborative care model add-on services when these services are furnished with advanced primary care management services. We are finalizing our proposed changes to the Shared Savings Program's regulations specifying the financial benchmarking methodology applicable for agreement periods beginning on January 1, 2025, and in subsequent years, to rename the “health equity benchmark adjustment” (HEBA) the “population adjustment.” Finally, we are finalizing our proposed changes to revise the Shared Savings Program's quality reporting monitoring policies. f. Changes to the Regulations Associated With the Ambulance Fee Schedule

As outlined in section III.G. of this final rule, section 3203 of the American Relief Act of 2025 and most recently, section 2203 of the Full-Year Continuing Appropriations and Extensions Act, 2025 amended section 1834(l)(12)(A) and (l)(13) of the Act to extend the payment add-ons sets forth in those subsections through September 30, 2025. The ambulance extender provisions are enacted through legislation that is self-implementing. We proposed only to revise dates at Sec. 414.610(c)(1)(ii) and (c)(5)(ii) to conform the regulations to these self-implementing statutory requirements.

We have examined the impacts of this final rule as required by Executive Order 12866, Regulatory Planning and Review (September 30, 1993), Executive Order 14192, “Unleashing Prosperity Through Deregulation”; the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354); section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4); and Executive Order 13132, Federalism (August 4, 1999).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

A regulatory impact analysis (RIA) must be prepared for regulatory actions that are significant under section 3(f)(1) of Executive Order 12866. Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is significant per

section 3(f)(1)). Accordingly, we have prepared an RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, practitioners, and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details, see the SBA's website at https://www.sba.gov/document/support-table-size-standards (refer to the 620000 series).) Individuals and States are not included in the definition of a small entity.

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

Approximately 95 percent of practitioners, other suppliers, and providers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this final rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. Medicare does not pay rural hospitals for their services under the PFS; rather, Medicare payment is made under the PFS for physicians' services, which can be furnished by physicians and NPPs in a variety of settings, including rural hospitals. We did not prepare an analysis for section 1102(b) of the Act because we determined, and the Secretary certified, that this rulemaking will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on State, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2025, that threshold is approximately $187 million. This rule will impose no mandates on State, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. Since this rulemaking does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.

We prepared the following analysis, which, together with the information provided in the rest of this rule, meets all assessment requirements. The analysis explains the rationale for and purposes of this rule; details the costs and benefits of this rulemaking; analyzes alternatives; and presents the measures we will use to minimize the burden on small entities. As indicated elsewhere in this rule, we discussed various changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services and to implement provisions of the statute. We provide information for each policy change in the relevant sections of this final rule. We are unaware of any relevant Federal rules that duplicate, overlap, or conflict with this rule. The relevant sections of this rulemaking describe significant alternatives we considered, if applicable.