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 r this as an option as we continue to ensure that the performance threshold is truly reflective of MIPS eligible clinicians’ performance in MIPS. Due to several large programmatic changes (such as, transitioning to reporting MVPs and digital quality measures and potential introduction of ‘‘Core Elements’’ for selection of quality measures in MVPs) discussed further in sections IV.A.3.b. and IV.A.4.c. of this proposed rule, establishing the same performance threshold for the 2028, 2029, and 2030 payment years would allow us to provide stability and predictability to MIPS eligible clinicians as they adapt to and implement our policy changes for MIPS. As further discussed under section IV.B.2.b.(2) of this proposed rule, we are proposing to continue using the mean of the final scores for all MIPS eligible clinicians from the CY 2017 performance period/2019 MIPS payment year to establish the performance threshold as 75 points for the CY 2026 performance period/2028 MIPS payment year through the CY 2028 performance period/2030 MIPS payment year. We recognize that our proposal to establish the performance threshold for MIPS payment years 2028, 2029, and 2030 extends beyond the period for h the CY 2028 performance period/2030 MIPS payment year. We recognize that our proposal to establish the performance threshold for MIPS payment years 2028, 2029, and 2030 extends beyond the period for which we have established the mean methodology to determine the performance threshold. However, given the current statutory requirement, which allows us to reassess the methodology every three years, there is no requirement that prevents us from setting the methodology for a longer time frame. We plan to reassess the methodology in future rulemaking. For further information on our current performance threshold policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77333 through 77338), CY 2018 Quality Payment Program final rule (82 FR 53787 through 53792), CY 2019 PFS final rule (83 FR 59879 through 59883), CY 2020 PFS final rule (84 FR 63031 through 63037), CY 2021 PFS final rule (85 FR 84919 through 84923), CY 2022 PFS final rule (86 FR 65527 through 65532), CY 2023 PFS final rule (87 FR 70096 through 70100), CY 2024 PFS final rule (88 FR 79373 through 79380), and CY 2025 PFS final rule (89 FR 98448 through 98455). We codified the performance thresholds CY 2023 PFS final rule (87 FR 70096 through 70100), CY 2024 PFS final rule (88 FR 79373 through 79380), and CY 2025 PFS final rule (89 FR 98448 through 98455). We codified the performance thresholds for each of the first 9 years of MIPS at § 414.1405(b)(4) through (10). These performance thresholds are shown in Table 70. (2) Proposed Performance Threshold for the CY 2026 Performance Period/2028 MIPS Payment Year Through the CY 2028 Performance Period/2030 MIPS Payment Year We are proposing to use the mean of 75 points from the CY 2017 performance period/2019 MIPS payment year as it continues to be the most appropriate for establishing the performance threshold for the 2028, 2029, and 2030 MIPS payment years for several reasons. As further described in this section of the proposed rule, these reasons include providing stability and predictability for MIPS eligible clinicians, allowing MIPS eligible clinicians to gain experience with MVPs and other new MIPS policies, and continuing to support solo, small, and rural practices. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00413 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO upport solo, small, and rural practices. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00413 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00414 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00415 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32766 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules highest positive applicable percentage and resulting in the highest payment adjustment. However, there are two modifications to this linear sliding scale. First, as specified in section 1848(q)(6)(A)(iv)(II) of the Act, there is an exception for a final score between zero and one-fourth of the performance threshold (zero and 18.75 points based on the proposed performance threshold of 75 points for the CY 2026 performance period/2028 MIPS payment year). All MIPS eligible clinicians with a final score in this range will receive a negative MIPS payment adjustment factor equal to 9 perc points for the CY 2026 performance period/2028 MIPS payment year). All MIPS eligible clinicians with a final score in this range will receive a negative MIPS payment adjustment factor equal to 9 percent (the applicable percentage). Second, the linear sliding scale for the positive MIPS payment adjustment factor is adjusted by the scaling factor, which cannot be higher than 3.0, as required by section 1848(q)(6)(F)(i) of the Act. If the scaling factor is greater than zero and less than or equal to 1.0, then the MIPS payment adjustment factor for a final score of 100 will be less than or equal to 9 percent (the applicable percentage). If the scaling factor is above 1.0 but is less than or equal to 3.0, then the MIPS payment adjustment factor for a final score of 100 will be greater than 9 percent. Only those MIPS eligible clinicians with a final score equal to 75 points (the performance threshold proposed for the CY 2026 performance period/2028 MIPS payment year) will receive a neutral MIPS payment adjustment. Beginning with the CY 2023 performance period/2025 MIPS payment year, the additional MIPS payment adjustment for exceptional performance described in section 1848(q)(6)(C) of MIPS payment adjustment. Beginning with the CY 2023 performance period/2025 MIPS payment year, the additional MIPS payment adjustment for exceptional performance described in section 1848(q)(6)(C) of the Act is no longer available. For this reason, Figure 5 does not illustrate an additional adjustment factor for MIPS eligible clinicians with final scores at or above the additional performance threshold described in section 1848(q)(6)(D)(ii) of the Act. Table 72 illustrates the changes in payment adjustment based on the final policies from the CY 2025 PFS final rule (89 FR 98448 through 98455) for the CY 2025 performance period/2027 MIPS payment year and the proposed policies for the CY 2026 performance period/ 2028 MIPS payment year, as well as the applicable percent required by section 1848(q)(6)(B) of the Act. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00416 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00417 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / .SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00417 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00418 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32769 payment year, CMS-approved survey vendors would have to administer the CAHPS for MIPS Survey via a web-mail- phone protocol. We propose to codify this requirement at § 414.1400(d)(10). In addition, we propose to codify new requirements at §§ 414.1400(d)(3)(v)(A), 414.1400(d)(3)(vi)(A), and 414.1400(d)(3)(vii) to ensure an entity applying to become a CMS-approved survey vendor is capable of administering a web-mail-phone protocol prior to CMS approval. We note that, currently, an entity must apply to be a CMS-approved vendor on an annual basis, demonstrating they meet applicable requirements at § 414.1400. We propose to modify our requirements at § 414.1400(d)(3) to ensure an entity is prepared to administer the web-mail- on an annual basis, demonstrating they meet applicable requirements at § 414.1400. We propose to modify our requirements at § 414.1400(d)(3) to ensure an entity is prepared to administer the web-mail-phone protocol prior to CMS approval. Specifically, we propose that, beginning January 1, 2027, to be a CMS-approved survey vendor an entity must have sufficient experience, capability, and capacity to accurately report CAHPS data by demonstrating that they: (1) use equipment, software, computer programs, systems, and facilities that can send survey invitations via email that include a patient-specific hyperlink to a web survey, collect data via web, and track cases from web surveys through telephone follow-up activities (§ 414.1400(d)(3)(v)(A)); (2) employ a web survey administrator (§ 414.1400(d)(3)(vi)(A)); and (3) have at least 3 years of experience administering surveys in which web survey administration is followed by survey administration via mail survey or Computer Assisted Telephone Interview (CATI) (§ 414.1400(d)(3)(vii)). If this proposal is finalized, CMS would update the survey administration requirements and associated materials, including the survey vendor application, d ne Interview (CATI) (§ 414.1400(d)(3)(vii)). If this proposal is finalized, CMS would update the survey administration requirements and associated materials, including the survey vendor application, during the 1-year implementation delay. We note that entities seeking to, or that do, become a CMS-approved survey vendor would need to meet other applicable requirements in § 414.1400, including successfully completing CMS’ vendor training(s) as provided at § 414.1400(d)(5). We refer readers to section V.B.5.b. of this proposed rule for discussion on the burden estimates for this proposal. We request public comments on this proposal. (6) Proposal To Sunset Application Requirement at § 414.1400(d)(8) We propose to modify § 414.1400(d)(8) to sunset its requirement that, to apply to become a CMS-approved survey vendor, the entity must send an interim survey data file to CMS that establishes the entity’s ability to accurately report CAHPS data. Though this requirement was established to ensure accurate reporting, it is ultimately not feasible to implement because an entity cannot collect data until it is approved by CMS, and thus, the entity does not have any data to send to CMS prior to a accurate reporting, it is ultimately not feasible to implement because an entity cannot collect data until it is approved by CMS, and thus, the entity does not have any data to send to CMS prior to approval. Therefore, submission of a survey data file has not been used as a requirement for approval. We propose to sunset the requirement at § 414.1400(d)(8) so it is only effective from January 1, 2019 (when it was first finalized in the CY 2019 PFS final rule) through December 31, 2025. We propose that this requirement would no longer be in effect beginning with January 1, 2026. We request public comments on this proposal. 5. Advanced APMs a. Overview The Quality Payment Program provides incentives for eligible clinicians to engage in value-based, patient-centered care under Medicare Part B via MIPS and Advanced APMs. The structure of the Quality Payment Program enables us to advance accountability and encourage improvements in care. Our vision for increased clinician participation in Advanced APMs is aimed at integrating individuals’ clinical needs across a spectrum of providers and settings to improve patient care and population health. As we continue to make improvements to the Q dvanced APMs is aimed at integrating individuals’ clinical needs across a spectrum of providers and settings to improve patient care and population health. As we continue to make improvements to the Quality Payment Program, we seek to develop, propose, and implement policies that encourage broad and meaningful clinician participation, including by specialists, in Advanced APMs. In the CY 2025 PFS final rule, we anticipated that we would propose a comprehensive approach to QP determination in future rulemaking (89 FR 98464). In this section, we are proposing such a comprehensive approach, which includes two parts. First, we propose to add an individual level calculation to Qualifying APM Participant (QP) determinations, as set forth in proposed regulation text at §§ 414.1425(b)(3 and (c)(3), for all eligible clinicians participating in an Advanced APM, such that each eligible clinician would receive both APM Entity level calculation and an individual level calculation. Second, we are re-proposing to expand the scope of the services in the sixth criterion of the definition of ‘‘attribution-eligible beneficiary’’ at § 414.1305 to use covered professional services (section 1848(k)(3)(A -proposing to expand the scope of the services in the sixth criterion of the definition of ‘‘attribution-eligible beneficiary’’ at § 414.1305 to use covered professional services (section 1848(k)(3)(A) of the Act). We believe that, together, these proposals would modernize and improve the QP determination approach across Advanced APMs. In addition to the above proposals, we further propose to sunset our Advanced APM criterion at § 414.1415(c)(7), which currently limits Medical Home Model participants to 50 clinicians. Lastly, we propose to modify §§ 414.1455(a)(b)(3)(ii) and (b)(3)(vi) pertaining to the QP Targeted Review process to align with MIPS Targeted Review process set forth at § 414.1385 to ensure that the QP and MIPS Targeted Reviews occur concurrently. b. QP Determinations (1) General In the CY 2017 Quality Payment Program final rule (81 FR 77439 through 77445), we finalized our policy for QP determinations at § 414.1425. Currently, § 414.1425(b)(1) provides that, for the purposes of making QP determinations, an eligible clinician must be present on the Participation List of an APM Entity in an Advanced APM on one of the ‘‘snapshot dates’’ (March 31, June 30, or August 31 poses of making QP determinations, an eligible clinician must be present on the Participation List of an APM Entity in an Advanced APM on one of the ‘‘snapshot dates’’ (March 31, June 30, or August 31) for the QP Performance Period. An eligible clinician included on a Participation List on any such snapshot date is included in the APM Entity group even if that eligible clinician is not included on that Participation List at one of the prior- or later-listed dates. We perform QP determinations for eligible clinicians in an APM Entity group three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination snapshot dates. An eligible clinician can be determined to be a QP only if the eligible clinician appears on the Participation List on a snapshot date that we use to determine the APM Entity group and to make QP determinations at the APM Entity group level based on participation in the Advanced APM. For eligible clinicians who appear on a Participation List for more than one APM Entity, but who do not achieve QP status based on any APM Entity-level determinations, we make QP determinations at the indi ligible clinicians who appear on a Participation List for more than one APM Entity, but who do not achieve QP status based on any APM Entity-level determinations, we make QP determinations at the individual level as described in § 414.1425(c)(4). Likewise, for eligible clinicians on an Affiliated Practitioner list for an Advanced APM, we make QP determinations at the individual-level three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination snapshot dates as described in § 414.1425(b)(2). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00419 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32770 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules In the CY 2017 Quality Payment Program final rule (81 FR 77433 through 77440) we established a process to calculate Partial QP status at § 414.1425(d). While to date our Partial QP policies have impacted a small number of eligible clinicians, and thus we have not focused our discussion on this specific policy, we note that any change to QP 4.1425(d). While to date our Partial QP policies have impacted a small number of eligible clinicians, and thus we have not focused our discussion on this specific policy, we note that any change to QP determinations would likely require conforming changes to the policies for Partial QPs for consistency across the program. In the CY 2017 Quality Payment Program final rule (81 FR 77450 through 77457), we finalized the payment amount method and patient count method for calculation of Threshold Scores used for QP determinations under the Medicare option and codified these methods at § 414.1435(a) and (b), respectively. The payment amount method is based on payments for Medicare Part B covered professional services, including certain supplemental service payments, while the patient count method is based on numbers of patients. Both methods use the ratio of ‘‘Attributed beneficiaries’’ to ‘‘Attribution-eligible beneficiaries,’’ as these terms are defined at § 414.1305, as shown in Figure 6 below. If the Threshold Score (using either the payment amount or patient count method) calculated at the APM Entity or individual eligible clinician level, as applicable, meets or exceeds the relevant elow. If the Threshold Score (using either the payment amount or patient count method) calculated at the APM Entity or individual eligible clinician level, as applicable, meets or exceeds the relevant QP threshold described at § 414.1430(a), the relevant eligible clinician or clinicians (either the individual eligible clinician or all those on the APM Entity’s Participation List) achieve QP status for such year. Regulation at § 414.1435(b)(3) provides that a beneficiary may be counted only once in the numerator and denominator for a single APM Entity group, and at § 414.1435(b)(4) provides that a beneficiary may be counted multiple times in the numerator and denominator for multiple different APM Entity groups. In the CY 2021 PFS final rule (85 FR 84951 through 84952), we amended § 414.1435(c)(1)(i) to specify that beneficiaries who have been prospectively attributed to an APM Entity for a QP Performance Period are excluded from the attribution-eligible beneficiary count for any other APM Entity that is participating in an APM where that beneficiary would be ineligible to be added to the APM Entity’s attributed beneficiary list. An attributed beneficiary is a beneficiary attributed APM Entity that is participating in an APM where that beneficiary would be ineligible to be added to the APM Entity’s attributed beneficiary list. An attributed beneficiary is a beneficiary attributed to the APM Entity under the terms of the Advanced APM as indicated on the most recent available list of attributed beneficiaries at the time of a QP determination. There may be beneficiaries on the most recent available list who do not meet the criteria to be attribution-eligible beneficiaries because the QP performance period does not align with the Advanced APM’s performance period or attribution period, or for other reasons. There may also be cases where a beneficiary’s status changes, for example by enrolling in a Medicare Advantage Plan. As described in the CY 2017 Quality Payment Program final rule (81 FR 77451), attributed beneficiaries are a subset of attribution- eligible beneficiaries. Therefore, when calculating Threshold Scores for QP determinations, we exclude from the list of attributed beneficiaries any beneficiaries who do not meet the criteria to be attribution-eligible beneficiaries at that point in time. In the 414.1425(d). (2) Individual QP Determination When we in f attributed beneficiaries any beneficiaries who do not meet the criteria to be attribution-eligible beneficiaries at that point in time. In the 414.1425(d). (2) Individual QP Determination When we initially established our policy in the CY 2017 Quality Payment Program final rule (81 FR 77439 through 77445) to make most QP determinations at the APM Entity level, we believed it was the best approach at the time. However, we did not intend for the policy to create potentially conflicting incentives for an APM Entity between the goal for its eligible clinicians to achieve QP status under the Quality Payment Program and the goals of the Advanced APM(s) in which the APM Entity participates. In the CY 2024 proposed rule (88 FR 52618), we had proposed to address this issue by conducting all QP determinations at the individual level. However, commenters opposed this proposal, citing issues such as administrative burden for APM Entities tracking QP status and Partial QP status and elections at the individual level because of the implications for MIPS reporting. Many further believed that the change may have negative consequences for specialists, the opposite of our intent in making our prop the individual level because of the implications for MIPS reporting. Many further believed that the change may have negative consequences for specialists, the opposite of our intent in making our proposal. In light of comments received, we did not finalize our proposal (88 FR 79403). Since that time, we have continued to examine QP determinations with a desire to right- size the methodology to current and future Advanced APM design, remove barriers to participation, and conduct calculations fairly. Some commenters on our CY 2024 proposal recommended that we conduct QP determinations at both the APM Entity and individual levels (88 FR 79403). At the time, we indicated that we did not believe that this approach would sufficiently encourage more intensive Advanced APM participation by individual eligible clinicians. However, based on continued examination of QP determinations, including in the time since the publishing of the CY 2025 PFS final rule, we have recognized the importance of individual contribution, particularly for models that are condition-specific or focused on an episode of care. Clinicians in these models are particularly disadvantaged when, as is frequently the case, dividual contribution, particularly for models that are condition-specific or focused on an episode of care. Clinicians in these models are particularly disadvantaged when, as is frequently the case, their APM Entity fails to achieve QP status. Under our current policy, there is the potential that an eligible clinician who has fully engaged with an Advanced APM may still be unable to earn QP status because it is calculated at the APM Entity level as described at § 414.1425(c)(3). As we have noted earlier, under our current policy we conduct individual determinations, but we only do so in the following specific circumstances: For eligible clinicians who appear on a Participation List for more than one APM Entity, but who do not to achieve QP status based on any APM Entity-level determinations, we make QP determinations at the VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00420 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00421 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00421 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32772 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules We adopted the general rule with flexibility to apply alternative methods for this criterion to ensure that, for the Advanced APMs for which beneficiary attribution is based on services other than E/M services, the attributed beneficiary population is truly a subset of such Advanced APMs’ attribution- eligible beneficiary populations and, ultimately, so that our way of identifying beneficiaries for purposes of Threshold Score calculations for QP determinations would be appropriate for such Advanced APMs. That said, our thought when we developed these approaches was shaped by the form and nature of the Advanced APMs that existed at that time. We believed that, by affording sufficient flexibility within the program, we could both foster innovation in Advanced APMs and simplify our execution of the program. However, with our more narrowly defined default approach to beneficiary attribution (re within the program, we could both foster innovation in Advanced APMs and simplify our execution of the program. However, with our more narrowly defined default approach to beneficiary attribution (relying on claims for E/M services), we have increasingly needed to exercise the flexibility to identify an alternative approach to attribution eligibility for Advanced APMs that fell into the exception, which meant that we identified several individually tailored ways of performing the beneficiary attribution methodology for specific Advanced APMs. We anticipate that Advanced APMs will continue to evolve and use novel approaches to value- based care that may emphasize a broad range of covered professional services, and in that event the application of our current regulations may result in increased variability among the ways we define attribution-eligible beneficiary when making QP determinations. In the CY 2025 PFS proposed rule (89 FR 62098 through 62101), we proposed to amend the final criterion in the definition of ‘‘attribution-eligible beneficiary’’ at § 414.1305 to expand the scope of services used to covered professional services, indicating that we would conduct further analysi riterion in the definition of ‘‘attribution-eligible beneficiary’’ at § 414.1305 to expand the scope of services used to covered professional services, indicating that we would conduct further analysis. However, as further discussed in the CY 2025 PFS final rule (89 FR 98461 through 98465)-, we did not finalize this proposal. After continued examination, we are re-proposing to modify the sixth criterion of the definition of ‘‘attribution-eligible beneficiary’’ at § 414.1305 to include any beneficiary who has received a covered professional service furnished by the eligible clinician for whom we are making the QP determination, beginning with the 2026 QP Performance Period. In the CY 2025 proposed rule, we described how the proposed approach would result in a QP calculation that, by including beneficiaries receiving any covered professional service, more accurately reflect eligible clinicians’ actual participation in Advanced APMs, improve transparency and predictability of the determinations, be more operationally efficient than the current policy, and better align the QP determination methodology with the universe of services to which the Quality Payment Program (including MIPS an ations, be more operationally efficient than the current policy, and better align the QP determination methodology with the universe of services to which the Quality Payment Program (including MIPS and APMs) applies. In response to comments in the CY 2025 PFS final rule, we explained that changes in the composition of APM Entity Participation Lists, services furnished, and attributed beneficiaries all have significant effects on the number of projected versus actual QPs for a QP performance period, which complicates the ability to assess effects of methodological changes to QP determinations (89 FR 98461 through 98465). We also described how any methodology changes can lead to varied QP Threshold Scores for APM Entities within the same Advanced APM, and noted that because QP status is determined based on specific QP payment amount and QP patient count thresholds, only those changes in scores that result in an eligible clinician crossing over a QP threshold percentage contribute to the net estimated change in QP counts (89 FR 98461 through 98465). We further note that the QP thresholds have increased relative to previous years and, effective with the 2025 QP Performance Period are n net estimated change in QP counts (89 FR 98461 through 98465). We further note that the QP thresholds have increased relative to previous years and, effective with the 2025 QP Performance Period are now at 75 percent for the payment amount and 50 percent for the patient count. We note that this change, which occurs by statute, will be responsible for the largest quantitative effect on our QP predictions, largely by reducing the number of QPs relative to the previous, lower thresholds. As such, while the quantitative effects of our proposals may show small changes in the number of QPs relative to status quo, that status quo itself reflects this threshold level change to QP determinations, which is significant in its own right. In the CY 2025 PFS final rule (89 FR 98463 and 98464), we stated that we believed that our proposal was a better approach than the status quo, and we believed that it should likely be part of a comprehensive approach to QP determinations that would better reflect the current and future state of Advanced APMs. In response to public comments, we did not finalize at that time its proposal to revise the sixth criterion of the definition of ‘‘attribution-eligible b the current and future state of Advanced APMs. In response to public comments, we did not finalize at that time its proposal to revise the sixth criterion of the definition of ‘‘attribution-eligible beneficiary at § 414.1305. However, at the time we stated that we anticipated to propose a comprehensive approach to QP determination in future rulemaking, including a strategy to address the needs of condition-specific models, and that this proposal might be included as one element of such future proposals. (89 FR 98463 and 98464). CMS has further explored this issue and has determined that we could appropriately address the challenges we have described in this and prior rulemaking by allowing for the overall expansion of the QP determinations, in terms of both the level of the determination as discussed in section (2), and the services included in the QP determinations as discussed in this section. As we noted earlier in this proposed rule, in our discussion of the proposal to calculate QP status at the individual NPI level, primary care practitioners generally furnish a higher proportion of E/M services than do specialists with the same beneficiary, and as for the Threshold Score cal P status at the individual NPI level, primary care practitioners generally furnish a higher proportion of E/M services than do specialists with the same beneficiary, and as for the Threshold Score calculations described previously, the emphasis on E/M services in our beneficiary attribution policy may have inadvertently encouraged APM Entities to exclude specialists from their Participation Lists. Under our current policy, if one or more eligible clinicians on the APM Entity’s Participation List furnish covered professional services to a beneficiary but none of those services are among the E/ M services we use for attribution, that beneficiary would not be attribution- eligible, and therefore, would not be included in our QP determination calculation, even though the beneficiary is actually receiving covered professional services from an eligible clinician on the APM Entity’s Participation List. We are re-proposing to change the definition of ‘‘attribution-eligible beneficiary’’ at § 414.1305 so that, beginning with QP Performance Period 2026, a single definition using covered professional services would be applied regardless of the Advanced APMs in which the eligible clinician par 14.1305 so that, beginning with QP Performance Period 2026, a single definition using covered professional services would be applied regardless of the Advanced APMs in which the eligible clinician participates. We believe that this complements our proposal to add individual-level calculations to QP determinations. We are also concerned that retention of the current policy where E/M services are the default basis for attribution, and where special processes are required for Advanced APMs that use a different attribution basis, could result in a complex set of unique attribution approaches for Advanced APMs. We believe that this change would more appropriately recognize the Advanced APM participation of the eligible clinicians for whom these determinations are being made, particularly when considered in conjunction with the proposal to add an individual-level calculation to QP VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00422 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32773 determinations. We further believe tha 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32773 determinations. We further believe that this proposal would simplify and streamline QP determinations and address the challenges to Advanced APM participation reportedly faced by specialists who are less likely than primary care practitioners to provide E/ M services. We are proposing to modify the sixth criterion in the definition of ‘‘attribution-eligible beneficiary’’ at § 414.1305 to provide that, beginning with the 2026 QP Performance Period, an attribution-eligible beneficiary is a beneficiary who during the QP Performance Period has a minimum of one claim for any covered professional service furnished by an eligible clinician who is on the Participation List for the APM Entity at any determination date during the QP Performance Period. We seek public comments on this proposal. c. Medical Home Model 50 Eligible Clinician Limit In the CY 2017 Quality Payment Program final rule (81 FR 77428), we finalized a policy for the Medical Home Model nominal financial risk criterion to set a limit of 50 on the number of eligible Limit In the CY 2017 Quality Payment Program final rule (81 FR 77428), we finalized a policy for the Medical Home Model nominal financial risk criterion to set a limit of 50 on the number of eligible clinicians in an organization that participates as an Advanced APM through a Medical Home Model. In the CY 2023 PFS final rule (87 FR 70117), we amended § 414.1415(c)(7) to apply the 50 eligible clinician limit directly to the APM Entity participating in the Medical Home Model, and to no longer look to the parent organization for the APM Entity. Likewise, in the CY 2017 Quality Payment Program final rule (81 FR 77468) we finalized a policy at § 414.1420(d)(2) and (4) for the Medicaid Medical Home Model nominal financial risk criterion to set a limit of 50 on the number of eligible clinicians in an organization that participates as an Advanced APM through a Medical Home Model. In the CY 2020 PFS final rule (84 FR 63095) we finalized a proposed amendment at § 414.1420(d)(2) and (4) to include Aligned Other Payer Medical Home Models with the existing Medicaid Medical Home Model financial risk and nominal amount standards for Medicaid Medical Home Models. When we established the medical h de Aligned Other Payer Medical Home Models with the existing Medicaid Medical Home Model financial risk and nominal amount standards for Medicaid Medical Home Models. When we established the medical home model 50 eligible clinician limit in the CY 2017 Quality Payment Program final rule our stated intent was to encourage organizations capable of taking on significant downside risk to participate in Advanced Alternative Payment Models that met the ‘‘Generally applicable financial risk standard’’ at § 414.1415(c)(1) (81 FR 77430). Based on our experience operating the Quality Payment Program we note that participation in Advanced APMs has increased, and the necessity of the Medical Home Model 50 eligible clinician limit has lessened. Moreover, we expect that this policy could provide a barrier for participation in models that meet the Medical Home Model definition in the future. We are proposing to amend our policy at § 414.1415(c)(7) to provide that beginning with the 2026 QP Performance Period we would no longer apply the Medical Home Model 50 eligible clinician limit. Specifically, we propose to modify § 414.1415(c)(7) to sunset that provision and provide that it only applies from e Period we would no longer apply the Medical Home Model 50 eligible clinician limit. Specifically, we propose to modify § 414.1415(c)(7) to sunset that provision and provide that it only applies from the 2023 QP performance Period through the 2025 QP Performance Period. Additionally, we are proposing a conforming amendment to the Aligned Other Payer Medical Home Model and Medicaid Medical Home Model 50 eligible clinician limit at § 414.1420(d)(8) beginning in the 2026 performance period we would no longer apply the Medical Home Model 50 eligible clinician limit. We seek public comments on this proposal. d. Targeted Review of QP Determinations In the CY 2021 PFS final rule (85 FR 84952), we finalized a policy to provide an opportunity for eligible clinicians to bring to our attention potential clerical errors we may have made that could have resulted in the omission of an eligible clinician from a Participation List used for purposes of QP determinations, and for us to review and make corrections if warranted. We also finalized that, after the conclusion of the time period for targeted review, there would be no further review of our QP determination with respect to an eligible clin corrections if warranted. We also finalized that, after the conclusion of the time period for targeted review, there would be no further review of our QP determination with respect to an eligible clinician for the QP Performance Period (85 FR 84952). We noted that, consistent with section 1833(z)(4) of the Act, and as provided at § 414.1455(a), there is no right to administrative or judicial review at sections 1869 or 1878 of the Act, or otherwise, of the determination that an eligible clinician is a QP or Partial QP at § 414.1425, or of the determination of the amount of the APM Incentive Payment at § 414.1450. In the CY 2021 PFS final rule (85 FR 84953), we finalized our proposal to align the timing and procedures for this targeted review process with the MIPS targeted review process as codified at § 414.1385. We noted this alignment would reduce the likelihood of confusion and burden on eligible clinicians and APM Entities. In the CY 2024 PFS proposed rule (88 FR 79380 through 79382; 88 FR 79408), we modified the Targeted Review period for both MIPS and QPs such that we could meet our statutory obligation to apply the differentially higher QP conversion factor beginning on Janua ; 88 FR 79408), we modified the Targeted Review period for both MIPS and QPs such that we could meet our statutory obligation to apply the differentially higher QP conversion factor beginning on January 1 of each payment year beginning with CY 2026. When we made these updates, we also revised the language in § 414.1385 more generally, including a change from 30 days to 15 days between notification and a response at § 414.1385(a)(5), but we did not make corresponding changes to the QP Targeted Review regulation at § 414.1455. We recognize that the different language in the current versions of these two sections of regulation could make it appear that our intent is for the MIPS and QP Targeted Review periods to operate differently, and that in fact the inconsistencies could mean that the Targeted Review for both QPs and MIPS participants is not guaranteed to be aligned. Our intent for these Targeted Review periods to be aligned has not changed, and we do not want to give the impression that there is a misalignment between them. Accordingly, we are now proposing to modify the langauge at §§ 414.1455(b)(3)(ii) and 414.1455(b)(3)(vi) to make clear that the same timing requirements that hat there is a misalignment between them. Accordingly, we are now proposing to modify the langauge at §§ 414.1455(b)(3)(ii) and 414.1455(b)(3)(vi) to make clear that the same timing requirements that for MIPS Targeted Reviews that are currently specified in at §§ 414.1385(a)(2) and 414.1385(a)(5) also apply for purposes of QP Targeted Reviews. We seek comments on our proposal to modify the language at §§ 414.1455(b)(3)(ii) and 414.1455(b)(3)(vi) to the same timing requirements as that of MIPS Targeted Reviews specified at § 414.1385(a)(2) and 414.1385(a)(5). V. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), we are required to provide 60-day notice in the Federal Register and solicit public comment before a ‘‘collection of information’’ requirement (as defined under 5 CFR 1320.3(c) of the PRA’s implementing regulations) is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether a collection of information should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues: • The need for the information collection and i hether a collection of information should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of our agency. • The accuracy of our estimate of the information collection burden. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00423 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32774 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comments (see section VI. of this proposed rule) on each of the aforementioned issues for the following sections of this document that contain information collection requirements (ICRs). Comments, if received, will be responded to within the subsequent final rule. A. Wage Estimates To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ on requirements (ICRs). Comments, if received, will be responded to within the subsequent final rule. A. Wage Estimates To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ (BLS) May 2024 National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/ oes/2024/may/oes_nat.htm). In this regard, Tables 73 and 74 present BLS’ mean hourly wage, our estimated cost of fringe benefits and other indirect costs (calculated at 100 percent of salary), and our adjusted hourly wage. There are many sources of variance in the average cost estimates, both because fringe benefits and other indirect costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Therefore, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. We note that the May 2024 BLS data does not include median hourly wage rates for multiple physician occupation types listed in Table 74; in these cases, the BLS identifies that the median wage rate is equal to or greater than $115.00/ hr or $239,200 per year. BLS data for prior years, such as the M occupation types listed in Table 74; in these cases, the BLS identifies that the median wage rate is equal to or greater than $115.00/ hr or $239,200 per year. BLS data for prior years, such as the May 2022 and May 2023 data, provide similar notes for median wage rates for occupations that are above the same thresholds ($115.00/ hr or $239,200 per year for the May 2022 BLS data (https://www.bls.gov/oes/ 2022/may/oes_nat.htm) and May 2023 BLS data (https://www.bls.gov/oes/ 2023/may/oes_nat.htm)). Therefore, for consistency with previous years for estimating physician wage rates, we have continued to use mean hourly wage rates across our wage estimates. For our purposes, BLS’ May 2024 National Occupational Employment and Wage Estimates do not provide an occupation that we could use for ‘‘Physician’’ wage data. To estimate a Physician’s costs, we used an average conglomerate wage of $299.32/hr as demonstrated below in Table 74. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00424 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00425 Fmt 4701 d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00424 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00425 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00426 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32777 4. ICRs Regarding Manufacturers Reporting of Drug Pricing (§§ 414.802, 414.804, and 414.902) Pending our finalization of the following proposed provisions, the changes will submitted to OMB for review and approval under control number 0938–0921 (CMS–10110) using the standard PRA process. The process includes the publication of 60- and 30- day Federal Register notices that will provide the public with additional opportunities to review and comment on the changes. The following proposed changes will be submitted to OMB for review under control number 0938– 0921 (CMS–10110). a. Requiring Certain Manufacturers opportunities to review and comment on the changes. The following proposed changes will be submitted to OMB for review under control number 0938– 0921 (CMS–10110). a. Requiring Certain Manufacturers To Report Drug Pricing Information for Part B (§§ 414.802 and 414.902) In the CY 2022 PFS final rule, it was stated that the new provisions finalized in that rule at §§ 414.802 and 414.804 implemented new statutory requirements under sections 1847A and 1927 of the Act, as amended by section 401 of Division CC, Title IV of the CAA, 2021 (for the purposes of this section of this proposed rule, hereinafter is referred to as ‘‘section 401’’), which requires manufacturers without a Medicaid National Drug Rebate Agreement (NDRA) to report ASP information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological (86 FR 65560). In that final rule, we estimated that an additional 568 respondents had products for which they would be required to report ASP d s that are payable under Part B as a drug or biological (86 FR 65560). In that final rule, we estimated that an additional 568 respondents had products for which they would be required to report ASP data to CMS beginning January 1, 2022 (86 FR 65560), some of which are manufacturers of skin substitutes. Following the implementation of section 401, we estimated 500 respondents, 2,000 responses (500 respondents × 4 responses/yr), 26,000 hours (2,000 responses × 13 hr/ response). In section II.K. of this proposed rule, we are proposing that skin substitutes be paid as incident-to supplies, which are not required to be paid under section 1847A of the Act. Accordingly, if this proposal is finalized, manufacturers of skin substitutes will no longer be required to report ASP data to CMS. Instead, ASP data reporting for manufacturers of skin substitutes would become voluntary. The proposal to shift the payment of skin substitute manufactures to incident-to supplies would decrease the number of manufacturers that are required to report ASP data to CMS each quarter, ultimately decreasing the overall burden of ASP data reporting. Based on the most recent ASP data, 65 skin substitute manufactu manufacturers that are required to report ASP data to CMS each quarter, ultimately decreasing the overall burden of ASP data reporting. Based on the most recent ASP data, 65 skin substitute manufacturers are reporting ASP data. Under the proposal to pay for skin substitute products as incident-to supplies, the number of manufacturers required to report ASP data to CMS would decrease manufacturer burden by minus 65 respondents, minus 260 responses (¥65 respondents × 4 responses/yr), and minus 3,380 hours (¥260 responses × 13 hr/response) and minus $154,804 (¥3,380 hr × $45.80/ hr). 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k b. Average Sales Price: Price Concessions and Bona Fide Service Fees (§§ 414.802 and 414.804) In section III.A of this proposed rule, we are proposing revisions to § 414.804(a)(5) to add additional submission requirements for the reporting of ASP data. Specifically, the submission requirement is being expanded to include (1) reasonable assumptions for calculating the manufacturer’s ASP as described at § 414.804 and (2) warranty or certification letter from the recipient of a fee from a manufacturer as evidence that a fee was not le assumptions for calculating the manufacturer’s ASP as described at § 414.804 and (2) warranty or certification letter from the recipient of a fee from a manufacturer as evidence that a fee was not passed on as a price concession in accordance with the proposed revised definition of bona fide service fee at § 414.802 and submission requirements at § 414.804. Currently, in the absence of specific guidance in the Act or Federal regulations, the manufacturer may make VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00427 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00428 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00429 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32780 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00430 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 2 R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00430 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00431 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00432 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00433 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32784 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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 da efore, 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 proposed rule for a discussion of the potential but unquantifiable burden implications on MIPS-related burden of the proposals 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, presented in section IV.B.5. of this proposed rule. In section IV.B.5.d. of this proposed rule, we are proposing to make a technical amendment to the language in § 414.1455 that establishes Targeted Review for QPs. This proposal would revise 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 § 414.1400(d) for the requirements ion 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 § 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 proposed changes (associated with CAHPS survey vendors to submit data for eligible clinicians) will be submitted to OMB for review 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 proposed rule, we are proposing 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 surve on 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 would administer the CAHPS for MIPS Survey via a web-mail-phone protocol. During the 1-year implementation delay, we would update the survey administration requirements and associated materials. For the CY 2027 performance period/ 2029 MIPS payment year, we are proposing 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. 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 would 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 assume that our proposal to add a web administration mod compile documentation related to the web mode and an additional 0.5 hours to develop a quality assurance plan related to web implementation. We assume that our proposal to add a web administration mode to the current CAHPS for MIPS survey administration would 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 × 10 vendors) at a cost of +$1,077 (10 hr × $107.66/hr for a computer systems analyst or equivalent). (2) Full and Simplified Self Nomination for Qualified Clinical Data Registries and Qualified Registries c. ICRs Regarding Quality Data Submission (§§ 414.1318, 414.1325, 414.1335, and 414.1365) In section IV.A.4.a.(3) of this proposed rule, we are proposing to provide additional flexibilities to allow third party intermediaries additional time to fully support finalized MVPs. As this proposal does not alter requirements related to the self- nomination process, we are not proposing revisions 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 ot proposing revisions 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). (1) Changes to Quality Performance Category Submissions In this section, we estimate the number of submissions for each collection type that requires 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 do 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 assume that the proposal to revise QP determinations in section IV.B.5.b. would not affect MIPS performance category-level data submissions. Because MIPS eligible clinicians may submit da e scored. We assume that the proposal to revise QP determinations in section IV.B.5.b. would not affect MIPS performance category-level data submissions. 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00434 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00435 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32786 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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 collection type via traditional MIPS due to the availability of updated submission data and assumptions. Additionally, we e ormance period/2028 MIPS payment year we estimate 1,209 more submissions for collection type via traditional MIPS due to the availability of updated submission data and assumptions. Additionally, we estimate that the new MVPs proposed in section IV.A.4.a.(1) of this proposed rule would result in 810 fewer traditional MIPS submissions for this collection type, as the proposed availability of new MVPS could lead clinicians who previously reported via traditional MIPS to report via MVPs. We estimate that there would 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 proposed 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 proposed changes a f 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 proposed changes apply to OMB control number 0938–1314 (CMS–10621). 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 that the new MVPs proposed in section IV.A.4.a.(1) of this proposed rule would result in 1,114 fewer traditional MIPS submissions for this collection type, as the proposed availability of new MVPS could lead clinicians who previously reported via traditional MIPS to report via MVP. We estimate that there would 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 d/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 proposed policy provisions). The net result is 23,936 submissions (27,179 currently approved submissions¥3,243 submissions). The aforementioned proposed changes apply to OMB control number 0938–1314 (CMS–10621). 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 86 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 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. (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 proposed rule, for the quality performance category, we are proposing to update the MIPS quality measure inventory for the CY 2026 performance period/2028 MIPS payment year; and revise the definition of a high priority measure. As described in section IV.A.4.b.(2) of this proposed rule, we are proposing to incorporate the updated versions of the MIPS quality measures used in the APP quality measure set. As these proposals would not affect the minimum reporting requirements for the q we are proposing to incorporate the updated versions of the MIPS quality measures used in the APP quality measure set. As these proposals would not affect the minimum reporting requirements for the quality performance category under traditional MIPS, MVPs, and the APP quality measure set, we do not anticipate burden changes for the Quality Payment Program. We refer readers to Table Group A of Appendix 1 for the proposed new measures; Table Group C of Appendix 1 for the proposed removed measures; and Table Group D of Appendix 1 for the proposed substantive changes to measures. In sections V.B.5.c.(3), V.B.5.c.(4), and V.B.5.c.(5) of this proposed rule, we VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00436 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00437 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32788 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules ¥$901,575.18 [(¥3,307.23 hr × $107.66/hr = ¥$356,056.38 for computer systems 4 1 S 7 W 9 K S D n o d n o m m a h k 32788 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules ¥$901,575.18 [(¥3,307.23 hr × $107.66/hr = ¥$356,056.38 for computer systems analysts) + (¥1,620 hr × $132.44/hr = ¥$214,552.80 for medical and health service managers) + (¥810 hr × $61.68/hr = ¥$49,960.80 for LPNs) + (¥810 hr × $47.60/hr = ¥$38,556.00 for billing clerks) + (¥810 hr × $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 × 4.083 hr/submission), 2,418 hours for medical and health service managers (+1,209 submissions × 2 hr/submission), 1,209 hours for LPNs (+1,209 submissions × 1 hr/submission), 1,209 hours for billing clerks (+1,209 submissions × 1 hr/submission), and 1,209 hours for physicians (+1,209 submissions × 1 h ubmission), 1,209 hours for LPNs (+1,209 submissions × 1 hr/submission), 1,209 hours for billing clerks (+1,209 submissions × 1 hr/submission), and 1,209 hours for physicians (+1,209 submissions × 1 hr/submission). We estimate an annual change of +$1,345,684.44 [(+4,936.347 hr × $107.66/hr = $531,447.12 for computer system analysts) + (+2,418 hr × $132.44/ hr = $320,239.92 for medical and health service managers) + (+1,209 hr × $61.68/ hr = $74,571.12 for LPNs) + (+1,209 hr × $47.60/hr = $57,548.40 for billing clerks) + (+1,209 hr × $299.32/hr = $361,877.88 for physicians)]. Total Impact: Taken together, we estimate that the changes in submissions due to policy proposals and newly available data would result in a change of +399 submissions (¥810 submissions due to policy proposals + 1,209 submissions due to updated data), an annual burden change of +3,624 hours (¥7,357.23 hr due to policy proposals + 10,981.35 hr due to updated data, rounded to the hour) at a cost of +$444,109 (¥$901,575.18 due to policy proposals + $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 f 75.18 due to policy proposals + $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 invite public comments on our estimates and assumptions. (5) Traditional MIPS Quality Data Submission: eCQM Collection Type The following proposed changes will be submitted to OMB for review 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 described below are relative to our currently approved estimate of 27,179 submissions detailed in the CY 2025 PFS final rule (89 F ure specifications unless otherwise noted. All changes to submissions described below 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 Proposals: We estimate a change of ¥1,114 submissions due to the proposal of additional MVPs in this proposed 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 × 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 × 2 hr/submission), ¥1,114 hours for LPNs (¥1,114 submissions × 1 hr/ submission), ¥1,114 hours for billing clerks (¥1,114 submissions × 1 hr/ submission), and ¥1,114 hours for physicians (¥1,114 submissions × 1 hr/ submission). We estimate an annual change of ¥$1,110,056.44 [(¥3,342 hr × $107.66/hr = ¥$359,799.72 for computer system analysts) + (¥2,228 hr × $132.44/hr =¥$295,076.32 for medical and health service managers) + ( e estimate an annual change of ¥$1,110,056.44 [(¥3,342 hr × $107.66/hr = ¥$359,799.72 for computer system analysts) + (¥2,228 hr × $132.44/hr =¥$295,076.32 for medical and health service managers) + (¥1,114 hr × $61.68/hr = ¥$68,711.52 for LPNs) + (¥1,114 hr × $47.60/hr = ¥$53,026.40 for billing clerks) + (¥1,114 hr × $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 × 3 hr/submission), ¥4,258 hours for medical and health service managers (¥2,129 submissions × 2 hr/ submission), ¥2,129 hours for LPNs (¥2,129 submissions × 1 hr/ submission), ¥2,129 hours for billing clerks (¥2,129 submissions × 1 hr/ submission), and ¥2,129 hours for physicians (¥2,129 submissions × 1 hr/ submission). We estimate an annual change of ¥$2,121,463.34 [(¥6,387 hr × $107.66/hr =¥$68 g clerks (¥2,129 submissions × 1 hr/ submission), and ¥2,129 hours for physicians (¥2,129 submissions × 1 hr/ submission). We estimate an annual change of ¥$2,121,463.34 [(¥6,387 hr × $107.66/hr =¥$687,624.42 for computer system analysts) + (¥4,258 hr × $132.44/hr = ¥$563,929.52 for medical and health service managers) + (¥2,129 hr × $61.68/hr = ¥$131,316.72 for LPNs) + (¥2,129 hr × $47.60/hr = ¥$101,340.40 for billing clerks) + (¥2,129 hr × $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 would result in a change of ¥3,243 submissions (¥1,114 due to policy proposals + ¥2,129 due to updated data), an annual burden change of ¥25,944 hours (¥8,912 hr due to policy proposals + ¥17,032 hr due to updated data) at a cost of ¥$3,231,520 (¥$1,110,056.44 due to policy proposals +¥$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 6 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 invite public comments on our estimates and assumptions. (6) ICRs Regarding Burden for MVP Reporting and Registration The following proposed changes will be submitted to OMB for review 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 proposed rule for updates to the format of the MVP tables. We do not anticipate that the new stratified update to the MVP format would a g option. We refer readers to Appendix 3: MVP Inventory of this proposed rule for updates to the format of the MVP tables. We do not anticipate that the new stratified update to the MVP format would affect reporting burden, as it does not alter the composition of an MVP and VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00438 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32789 does not affect the general minimum reporting requirements for each MVP. In section IV.A.4.a. of this proposed rule, we are proposing MVP maintenance updates to our MVP inventory that are aligned with the MVP development criteria (85 FR 84849 through 84854). We are also proposing to add 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 would move from traditional MIPS reporting to MVP reporting for the CY 2025 performance period/2027 MI 10 percent of MIPS eligible clinicians from the CY 2022 performance period/2024 MIPS payment year would 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 newly proposed MVPs 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 proposed MVPs was equivalent to about 4 percent by clinicians, groups, subgroups, and non- Shared Savings Program ACO APM Entities. The total of these average quality measure submissions for all the proposed MVPs 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 estimate 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 assume that number of MVP registrations would equal our estimated MVP quality submissions. (a) Burden for MVP Registration: Individuals, Groups, Subgroups, and APM Entities In section IV.A.3.a. of this proposed rule, we are proposing to add a new self- attestation requirement to the MVP registration process requiring each group iduals, Groups, Subgroups, and APM Entities In section IV.A.3.a. of this proposed rule, we are proposing 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 proposal would be minimal, and that this proposal would not require the burden per registration to exceed the currently approved estimate of 15 minutes per registration. Therefore, we are not proposing to revise the burden per MVP registration under OMB control number 0938–1314 (CMS–10621). We refer readers to section IV.A.3.a. of this proposed rule for additional details on the self-attestation requirement. As described in section V.B.5.c.(6). of this proposed rule, we estimate that approximately 14 percent of the clinicians that participate in MIPS quality performance category reporting would 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 s nd 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 would 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 proposal of new MVPs, if finalized, would 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 × 0.25 hr/ registration) at a cost of +$62,227.48 (+578 hr × $107.66/hr for a computer system analyst or equivalent). Additionally, we estimate that the availability of updated data would result in a change of ¥487 submissions. Using the currently approved estimate of 0.25 hr/registration, we estimate an annual change of ¥121.75 hours (¥487 registrations × 0.25 hr/registration) at a cost of ¥$13,107.61 (¥122 hr × $107.66/hr for a computer system analyst or equivalent) due to the avail , we estimate an annual change of ¥121.75 hours (¥487 registrations × 0.25 hr/registration) at a cost of ¥$13,107.61 (¥122 hr × $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 would result in a change of +1,825 registrations (2,312 registrations due to policy proposals + ¥487 registrations due to updated data), an annual burden change of +456 hr (578.00 hr due to policy proposals + ¥121.75 hr due to updated data, rounded to the hour) at a cost of +$49,120 (+$62,227.48 due to policy proposals + ¥$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 invite public comments on our estimates and assumptions. (b) Burden for Subgroup Registration We are not proposing to revise burden for subgroup registration for the CY 2026 performance period/2028 MIPS payment year based on policy proposals in section IV. of this proposed rule. We previously finalized a requirement for subgroup reporting for multispecialty groups Y 2026 performance period/2028 MIPS payment year based on policy proposals in section IV. of this proposed rule. 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 (§ 414.1305; 86 FR 65394 through 65397). In section IV.A.3.a.(3) of this proposed rule, we are proposing 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 are not revising the subgroups’ burden relevant to this proposal because we are operationalizing previously finalized policies that would not impact the utilization of subgroups by groups and hence, would not change the way groups choose to organize clinicians in subgroups. Additionally, we are proposing to maintain the MVP group reporting option for multispecialty groups with a small and hence, would not change the way groups choose to organize clinicians in subgroups. Additionally, we are proposing to maintain the MVP group reporting option for multispecialty groups with a small practice designation in section IV.A.3.a.(3) of this proposed rule. Maintaining the MVP group reporting option would not impact the currently approved burden for subgroup registration because it would 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 would evaluate changes to our currently approved burden estimate under OMB control number 0938–1314 (CMS– 10621). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00439 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32790 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (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 § 414.1365(c)(1)(i) ality 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 § 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 proposed changes will be submitted to OMB for review 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 proposed 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 B.5.c.(1)(e) of this proposed 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 described below 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 Proposals: We estimate a change of +388 submissions due to the proposal of additional MVPs in this proposed 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 × 5.46 hr/ submission (4.8 hr to submit data + 0.66 hr to review measure specificati rs. This change incorporates the following estimates: 2,118.48 hours for computer system analysts (+388 submissions × 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 × 2 hr/submission), 256.08 hours for LPNs (+388 submissions × 0.66 hr/ submission), 256.08 hours for billing clerks (+388 submissions × 0.66 hr/ submission), and 256.08 hours for physicians (+388 submissions × 0.66 hr/ submission). We estimate an annual change of +$435,483.29 [(2,118.48 hr × $107.66/hr = $228,075.56 for computer system analysts) + (776 hr × $132.44/hr = $102,773.44 for medical and health service managers) + (256.08 hr × $61.68/ hr = $15,795.01 for LPNs) + (256.08 hr × $47.60/hr = $12,189.41 for billing clerks) + (256.08 hr × $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, an 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 × 5.46 hr/ submission), ¥768 hours for medical and health service managers (¥384 submissions × 2 hr/submission), ¥253.44 hours for LPNs (¥384 submissions × 0.66 hr/submission), ¥253.44 hours for billing clerks (¥384 submissions × 0.66 hr/submission), and ¥253.44 hours for physicians (¥384 submissions × 0.66 hr/submission). We estimate an annual change of ¥$430,993.76 [(¥2,096.64 hr × $107.66/hr = ¥$225,724.26 for computer system analysts) + (¥768 hr × $132.44/hr = ¥$101,713.92 for medical and health service managers) + (¥253.44 hr × $61.68/hr = ¥$15,632.18 for LPNs) + (¥253.44 hr × $47.60/hr = ¥$12,063.74 for billing clerks) + (¥253.44 hr × $299.32/hr = ¥$75,859.66 for physicians)]. Total Impact: Taken together, we estimate that the changes in submissions due to policy proposals and newly available data would result in a change of +4 submiss .32/hr = ¥$75,859.66 for physicians)]. Total Impact: Taken together, we estimate that the changes in submissions due to policy proposals and newly available data would result in a change of +4 submission (+388 submissions due to policy proposals + ¥384 submissions due to updated data), an annual burden change of +38 hours (3,662.72 hr due to policy proposals + ¥3,624.96 hr due to updated data, rounded to the hour) at a cost of +$4,490 ($435,483.29 due to policy proposals + ¥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 invite public comments on our estimates and assumptions. (ii) MIPS CQM/QCDR Measure Collection Type All changes to the estimated number of quality performance category submissions described below 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 Proposals: We estimate a change of +810 submissions due to the proposal of additional MVPs in this proposed rule. Multiplying the estimated change in s le (89 FR 98487 through 98490). Impact of Policy Proposals: We estimate a change of +810 submissions due to the proposal of additional MVPs in this proposed 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 × 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 × 1.33 hr/ submission), 534.60 hours for LPNs (+810 submissions × 0.66 hr/ submission), 534.60 hours for billing clerks (+810 submissions × 0.66 hr/ submission), and 534.60 hours for physicians (+810 submissions × 0.66 hr/ submission). We estimate an annual change of $593,079.41 [(2,154.60 hr × $107.66/hr = $231,964.24 for computer system analysts) + (1,077.30 hr × $132.44/hr = $142,677.61 for medical and health service managers) + (534.60 hr × $61.68/hr = $32,974.13 for LPNs) + (534.60 hr × $47.60/hr = $25,446.96 for bill puter system analysts) + (1,077.30 hr × $132.44/hr = $142,677.61 for medical and health service managers) + (534.60 hr × $61.68/hr = $32,974.13 for LPNs) + (534.60 hr × $47.60/hr = $25,446.96 for billing clerks) + (534.60 hr × $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 × 2.66 hr/ submission), 178.22 hours for medical and health service managers (+134 submissions × 1.33 hr/submission), 88.44 hours for LPNs (+134 submissions × 0.66 hr/submission), 88.44 hours for billing clerks (+134 submissions × 0.66 hr/submission), and 88.44 hours for physicians (+134 submissions × 0.66 hr/ submission). We estimate an annual VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00440 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM and 88.44 hours for physicians (+134 submissions × 0.66 hr/ submission). We estimate an annual VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00440 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32791 change of $98,114.37 [(356.44 hr × $107.66/hr = $38,374.33 for computer system analysts) + (178.22 hr × $132.44/ hr = $23,603.46 for medical and health service managers) + (88.44 hr × $61.68/ hr = $5,454.98 for LPNs) + (88.44 hr × $47.60/hr = $4,209.74 for billing clerks) + (88.44 hr × $299.32/hr = $26,471.86 for physicians)]. Total Impact: Taken together, we estimate that the changes in submissions due to policy proposals and newly available data would result in a change of +944 submissions (810 due to policy proposals + 134 due to updated data), an annual burden change of 5,636 hours (4,835.70 hr due to policy proposals + 799.98 hr due to updated data, rounded to the hour) at a cost of +$691,194 ($593,079.41 due to policy proposals + 98,114.37 due to updated data, rounded to the dollar). We estimate a total of 2,844 + 799.98 hr due to updated data, rounded to the hour) at a cost of +$691,194 ($593,079.41 due to policy proposals + 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 invite public comments on our assumptions and estimates. (iii) eCQM Collection Type All changes to the estimated number of quality performance category submissions described below 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 Proposals: We estimate a change of +1,114 submissions due to the proposal of additional MVPs in this proposed 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 analyst ge 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 × 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 × 1.33 hr/submission), 735.24 hr for LPNs (+1,114 submissions × 0.66 hr/submission), 735.24 hr for billing clerks (+1,114 submissions × 0.66 hr/submission), and 735.24 hr for physicians (1,114 submissions × 0.66 hr/submission). We estimate an annual change of +$735,311.96 [(2,216.86 hr × $107.66/hr = $238,667.15 for computer system analysts) + (1,481.62 hr × $132.44/hr = $196,225.75 for medical and health service managers) + 735.24 hr × $61.68/hr = $45,349.60 for LPNs) + (735.24 hr × $47.60/hr = $34,997.42 for billing clerks) + (735.24 hr × $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 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 × 1.99 hr/ submission) + ¥315.21 hr for medical and health service managers (¥237 submissions × 1.33 hr/submission) + ¥156.42 hr for LPNs (¥237 submissions × 0.66 hr/submission) +¥156.42 hr for billing clerks (¥237 submissions × 0.66 hr/submission) + ¥156.42 hr for physicians (¥237 submissions × 0.66 hr/submission). We estimate an annual change of ¥$156,435.31 [(¥471.63 hr × $107.66/ hr = ¥$50,775.69 for computer systems analysts) + (¥315.21 hr × $132.44/hr = ¥$41,746.41 for medical and health service managers) + (¥156.42 hr × $61.68/hr = ¥$9,647.99 for LPNs) + (¥156.42 hr × $47.60/hr = ¥$7,445.59 for billing clerks) + (¥156.42 hr × $299.32/hr = ¥$46,819.63 for physicians)]. Total Impact: Taken together, we estimate that the chang hr = ¥$9,647.99 for LPNs) + (¥156.42 hr × $47.60/hr = ¥$7,445.59 for billing clerks) + (¥156.42 hr × $299.32/hr = ¥$46,819.63 for physicians)]. Total Impact: Taken together, we estimate that the changes in submissions due to policy proposals and newly available data would result in a change of +877 submissions (1,114 due to policy proposals + ¥237 due to updated data), an annual burden change of +4,648 hours (5,904.20 hr due to policy proposals + ¥1,256.10 hr due to updated data, rounded to the hour) at a cost of ¥$578,877 ($735,311.96 due to policy proposals + ¥$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 invite public comments on our estimates and assumptions. (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 proposals would result in a total change of +2,312 submissions (388 Medicare Part B claims measur ction Types Across the quality performance category collection types for MVPs, we estimate that policy proposals would 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 would 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 submissio 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 proposed policy provisions and newly available data would result in a change of +1,825 submissions (+2,312 submissions due to policy proposals + ¥487 submissions due to updated data), an annual burden change of +10,322 hours (+14,402.62 hr due to policy proposals + ¥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 proposals + ¥$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 invite public comments on our estimates and assumptions. (7) Beneficiary Responses to CAHPS for MIPS Survey In section IV.B.4.a.(5) of this proposed rul n- Shared Savings Program ACO APM entities). We invite public comments on our estimates and assumptions. (7) Beneficiary Responses to CAHPS for MIPS Survey In section IV.B.4.a.(5) of this proposed rule, we are proposing to update the CAHPS for MIPS Survey measure by changing from a mail-web protocol to a web-mail-phone protocol. As we are unable to estimate the incremental increase in submissions above our currently approved estimates, we are not proposing to increase our currently approved estimates under OMB control number 0938–1222 (CMS–10450). Additionally, we are proposing to VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00441 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32792 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules continue our currently approved estimate of response time per survey of 0.2183 hours (13.1 minutes), as we are not proposing revisions to the survey questions. We invite public comments on these assumptions. (8) Group Registration for CAHPS for MIPS Survey In section IV.B.4.a.(5) of this proposed rule, we are proposing to update the CAH the survey questions. We invite public comments on these assumptions. (8) Group Registration for CAHPS for MIPS Survey In section IV.B.4.a.(5) of this proposed rule, we are proposing 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 this proposal would affect the number of groups registering for the CAHPS for MIPS Survey, nor affect the time to complete each group registration. Therefore, we are not proposing any changes to the requirements and burden estimates that are currently approved by OMB under control number 0938–1222 (CMS– 10450). d. ICRs Regarding Reporting the Promoting Interoperability Performance Category (1) Background We refer readers to § 414.1375 for our previously established policies regarding reporting for the Promoting Interoperability performance category. We also refer readers to § 414.1305 for the definition of attestation, § 414.1325 for data submission requirements, and §§ 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 cate 14.1380(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 proposed changes to the MIPS Promoting Interoperability performance category reporting requirements identified in section IV.A.4.d.(4) of this proposed rule and our assumptions as to why such proposals would not affect burden. For the first three policy proposals, there are similar proposed policies for the Medicare Promoting Interoperability Program in the CY 2026 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment Systems (IPPS/ LTCH PPS) proposed rule (90 FR 18355 through 18361). Our burden assumptions for proposals in this proposed rule affecting the MIPS Promoting Interoperability pe ital Prospective Payment Systems (IPPS/ LTCH PPS) proposed rule (90 FR 18355 through 18361). Our burden assumptions for proposals in this proposed rule affecting the MIPS Promoting Interoperability performance category are consistent with the CY 2026 IPPS/LTCH PPS proposed rule (90 FR 18414 and 18415). First, beginning with the CY 2026 performance period/2028 MIPS payment year we are proposing 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 would be 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. We are not proposing 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 Interoperabil ed 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 proposed additional attestation that would be included as a component of the Security Risk Analysis measure. Second, beginning with the CY 2026 performance period/2028 MIPS payment year, we are proposing 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. We are not proposing to modify our burden estimates because the proposed 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 proposing to establish the new optional bonus measure Public Health Reporting under Trusted Exchange Framework and Common Agreement (TEFCA). We are not proposing to update the burden estimates because the measure submission is optional and we can measure Public Health Reporting under Trusted Exchange Framework and Common Agreement (TEFCA). We are not proposing to update the burden estimates because the measure submission is optional and we cannot predict which MIPS eligible clinicians would elect to report this measure and how they would 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 policy proposals, we refer readers to section IV.A.4.d.(4) of this proposed rule. In sections IV.A.4.d.(4)(f) and IV.A.4.d.(4)(g) of this proposed rule, we are also proposing to: (1) establish a measure suppression policy for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, in which an identified suppressed measure would not be included in scoring calculations; and (2) suppress the Electronic Case Reporting measure from scoring calculations 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 Pro scoring calculations 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 proposals, we refer readers to sections IV.A.4.d.(4)(f) and IV.A.4.d.(4)(g) of this proposed rule. The exclusion of a measure would only apply to how we score such a measure, and thus MIPS eligible clinicians, eligible hospitals, and CAHs would continue to be required to report the measure. We are not proposing any changes to the burden estimates due to the proposed measure exclusion policy not impacting burden estimates for meeting the requirements of the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program. Independent of the aforementioned policy proposals, we are proposing 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. Additionally, we intend to increase the time MIPS Promoting Interoperability performance category due to the availability of updated data from the CY 2023 performance period/ 2025 MIPS payment year. Additionally, we intend to increase the time per MIPS Promoting Interoperability performance category submission by 30 seconds (0.083 hour) in order 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 proposed 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 proposals in this proposed rule. The applicable burden changes will be submitted to OMB for review under control number 0938–1314 (CMS–10621). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00442 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D l number 0938–1314 (CMS–10621). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00442 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32793 e. ICRs Regarding Reporting for the Improvement Activities Performance Category We refer readers to §§ 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 § 414.1305 for the definition of attestation, § 414.1360 for data submission requirements, and §§ 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 proposed rule, we are proposing 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 (8 e proposing 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, to comply with previously finalized MIPS policies, 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 refer readers to section VII.I.5.e.(2)(a) of this proposed rule for additional discussion. Independent of these policy proposals, 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 review under control number 0938– 1314 (CMS–10621). f. ICRs Regarding the Cost Performance Category (§ 414.1350) The cost performance category relies on administrative claims data. The Medicare Parts A and B claims su rol number 0938– 1314 (CMS–10621). f. ICRs Regarding the Cost Performance Category (§ 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 policy proposals in section IV.A.4.d.(2) of this proposed rule would 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 proposing changes under the aforementioned OMB control number. C. Summary of Proposed Annual Burden Estimates Table 85 sets out the burden for this rulemaking’s proposed provisions that are we are not proposing changes under the aforementioned OMB control number. C. Summary of Proposed Annual Burden Estimates Table 85 sets out the burden for this rulemaking’s proposed provisions that are subject to the PRA. It does not score burden adjustments that are strictly based on updated data and are unrelated to any of this rule’s proposed provisions. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k D. Submission of PRA-Related Comments We have submitted a copy of this proposed rule to OMB for its review of the rule’s information collection requirements. The requirements are not effective until they have been approved by OMB. To obtain copies of the supporting statement and any related forms for the proposed collections discussed previously, please visit the CMS website VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00443 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00444 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32795 pro mt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32795 providing documentation (such as a certification or warranty from the recipient of the fee). In addition, we are proposing to revise § 414.804(a)(5) to add data submission requirements. Under this revision, manufacturers would be required to submit reasonable assumptions for calculations of the manufacturer’s ASP. Lastly, we are proposing some specific, non- exhaustive examples of BFSFs and how they should be considered in the calculation of manufacturer’s ASP. In section III.A.3. of this proposed rule, we propose that preparatory procedures for tissue procurement required for manufacturing an autologous cell-based immunotherapy or gene therapy be included in the payment of the product itself. In addition, we propose that, beginning January 1, 2026 (that is, data reflecting sales beginning on that date), any preparatory procedures for tissue procurement required for manufacturing an autologous cell-based immunotherapy or gene therapy that are paid by the manufacturer be included in the ca that date), any preparatory procedures for tissue procurement required for manufacturing an autologous cell-based immunotherapy or gene therapy that are paid by the manufacturer be included in the calculation of the manufacturer’s ASP. b. RHCs and FQHCs In section III.B.2. of this proposed rule, we are proposing changes to the furnishing of Advance Primary Care Management (APCM) services in RHCs and FQHCs. We are proposing to adopt add-on codes for APCM that would facilitate billing for Behavioral Health Integration (BHI) and Psychiatric Collaborative Care Model (CoCM) services when RHCs and FQHCs are providing advanced primary care. We are also proposing to require RHCs and FQHCs to report the individual codes that make up the CoCM HCPCS code, G0512. We are also proposing 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 are proposing to revise § 405.2464(c) and (e) to reflect our proposal on payment of CoCM and CTBS services for RHCs and FQHCs. We are also proposing to adopt services that are established and paid under the PFS and designated as care management servi eflect our proposal on payment of CoCM and CTBS services for RHCs and FQHCs. We are also proposing 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. We believe this proposal would improve transparency and efficiency for RHCs and FQHCs since their designation as care management services goes through notice and comment rulemaking. In addition, we are seeking comment on whether the proposed process to align the care coordination services with the care management services paid under the PFS is sustainable moving forward or is there a more effective approach for adopting new care coordination codes established under the PFS as care management codes that would improve transparency and efficiency for RHCs and FQHCs. In section III.B.3. of this proposed rule, we are proposing the 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 are also proposing, on a temporary basis, to facilitate payment for non-behavioral and visual interactive telecommunications for the direct supervision permanently for all. RHC and FQHC services. We are also proposing, 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 would 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. c. Ambulatory Specialty Model (ASM) In section III.D of the preamble of this proposed rule, we discuss the proposed 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 bene lity 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 would 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, would produce scores and subsequent paymen et of relevant performance measures they are required to report; and (2) among clinicians furnishing similar sets of services for similar chronic conditions, would produce scores and subsequent payment adjustments that are more reflective of clinician performance. A more targeted approach to measurement would 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 would 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.D.1 of this proposed rule for more information on our research and rationale for ASM. d. Effects of Proposals c conditions, all while achieving net savings to Medicare. We refer readers to section III.D.1 of this proposed rule for more information on our research and rationale for ASM. d. Effects of Proposals Relating to the Medicare Diabetes Prevention Program Expanded Model 1. Effects on Beneficiaries We propose 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) rage 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00445 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32796 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules to 22 sessions using a Centers for Disease Control and Prevention (CDC) approved National Diabetes Prevention Program (National DPP) curriculum.421 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 2024.422 The CY 2021 PFS final rule allowed for increased virtual delivery of MDPP during the PHE for COVID–19 (85 FR 84830). Improvem 4 CDC DPRP Standards replaced the 2021 CDC DPRP Standards in June 2024.422 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 learnin PP 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 are proposing 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 421 https://www.cdc.gov/diabetes/prevention/ resources/curriculum.html. 422 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/D 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. 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, we are proposing 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 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 feedba f the MDPP session. 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) on the same date as their MDPP session. This proposed flexibility may promote safe and consistent collection of weight for MDPP sessions while encouraging model participation. Additionally, we propose 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 in 410.79(e)(3)(iii)(c) which state that the photo or video must c utside of an in- person delivery site while maintaining program integrity through existing date- stamped photo requirements described in 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 propose 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 suppli verage 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] 423 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 propose 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 fy 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.424 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. We propose edits throughout § 414.84 by revising paragraphs (b)(1) 423 H.R. 7856 (118th): PREVENT DIABETES Act, https://www.govtrack.us/congress/bills/118/hr7856/ text. 424 RTI International. Evaluation of the Medicare Diabetes Prevention Program. March 2025. https:// 23 H.R. 7856 (118th): PREVENT DIABETES Act, https://www.govtrack.us/congress/bills/118/hr7856/ text. 424 RTI International. Evaluation of the Medicare Diabetes Prevention Program. March 2025. https:// www.cms.gov/priorities/innovation/data-and- reports/2025/mdpp-finalevalrpt. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00446 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32797 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 propose 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 propose 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 s (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 propose amending § 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; § 424.205(f)(2)(i) to include the online modality among acceptable session types for session documentation; and § 424.205(f)(5) to update requirements for achieving five and nine percent weight loss measured in accordance with § 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 t ulemaking. 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 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 am er 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.425 However, only 330 (26 percent) of these eligible in- person organizations are participating in MDPP.426 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. 3. Payment for MDPP Services Regulations at § 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 anticipate that the inclusion of asynchronous, Online delivery will have minimal impact on total payment for MDPP services, as current performance payments for 5 percent 425 Centers for Disease Control and Prevention. Diabetes P n of asynchronous, Online delivery will have minimal impact on total payment for MDPP services, as current performance payments for 5 percent 425 Centers for Disease Control and Prevention. Diabetes Prevention Recognition Program Application. Registry of All Recognized Organizations. https://dprp.cdc.gov/Registry. 426 Medicare Provider Enrollment, Chain, and Ownership System (PECOS), Centers for Medicare & Medicaid Services | CMS (.gov), accessed May 1, 2025). 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 GXXXX. The proposed GXXXX 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 are proposing that for each MDPP beneficiary, son, group, 60 minutes, and G9887, behavioral counseling for diabetes prevention, distance learning, 60 minutes are delivered synchronously. Therefore, we are proposing 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. In order 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 n-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 The following table shows the estimated impact (in millions) on Medicare spending for allowing asynchronous, online delivery of the MDPP benefit: 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00447 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32798 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (b) Assumptions/Notes • While we propose 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 assumptio t 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 were 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 above impacts assume 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 enrol ted 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 benefit from the supplier and beneficiary sides, utilizat those receiving the email, about 86,000 recipients followed the link. With little information about the potential interest in the asynchronous 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 four years of the asynchronous test. • To evaluate the reduction in diabetes rates, the effectiveness of the 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 The following table shows projected 10-year financial impacts (in millions) of delivering the asynchronous online benefit from 2026–2029 at various levels of effectiveness with respect to the in- person benefit. It also provides the first year in which the accumulated savings is greater than the performance payments. As indicated in the table, 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 P s, 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 rulemaking as much as possible with the CDC DPRP Standards, there should be minimal regulatory familiarization costs. This rulemaking impacts only enrolled MDPP suppliers and eligible beneficiaries who have started MDPP or are interested in enrolling in MDPP. We invite public comments on our regulatory impact analysis for our MDPP proposal. e. Medicare Shared Savings Program In section III.F. of this proposed rule, we are proposing modifications to the Shared Savings Program regulations to allow for timely improvements to program policies and operations. The proposed changes to the Shared Savings Program include the following. We are proposing 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00448 Fmt 4701 Sfmt 4702 E:\FR\FM\ ck’s glide path (if eligible), for a maximum of 5 performance years instead of 7 performance years. Under VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00448 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00449 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32800 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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 proposed 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 ed 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 603 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 tri ions 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 th ether 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 proposed 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. C. Executive Order 14192, ‘‘Unleashing Prosperity Through Deregulation’’ Executive Order 14192, titled ‘‘Unleashing Prosperity Through Deregulation’’ was issued on January 31, 2025, and requires that ‘‘any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the eli sperity Through Deregulation’’ was issued on January 31, 2025, and requires that ‘‘any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.’’ D. Changes in Relative Value Unit (RVU) Impacts 1. Resource-Based Work, PE, and MP RVUs Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of Medicare Part B expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality. Our estimates of changes in Medicare expenditures for PFS services compare payment rates for CY 2025 with payment rates for CY 2026 using CY 2024 Medicare utilization. The payment impacts described in this rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and will depend on the mix of services they furnish. The average percentage change in total revenues will be less than the impact displayed h for an individual practitioner could vary from the average and will depend on the mix of services they furnish. The average percentage change in total revenues will be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and non-Medicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical diagnostic laboratory tests that are paid under the Clinical Laboratory Fee Schedule (CLFS). As required by section 1848(d)(1)(A) of the Act, beginning in CY 2026, there will be two separate conversion factors (CFs): one for items and services furnished by a qualifying APM participant as defined in section 1833(z)(2) of the Act (referred to as the qualifying APM conversion factor) and another for other items and services (referred to as the nonqualifying APM conversion factor), equal to the respective conversion factor for the previous year (or, for CY 2026, equal to the single conversion factor for CY 2025) multiplied by th ed to as the nonqualifying APM conversion factor), equal to the respective conversion factor for the previous year (or, for CY 2026, equal to the single conversion factor for CY 2025) multiplied by the update established under section 1848(d)(20) of the Act for such respective conversion factor for such year. As specified by section 1848(d)(20) of the Act, the update to the qualifying APM conversion factor for CY 2026 is 0.75 percent while the update to the nonqualifying APM conversion factor for CY 2026 is 0.25 percent. To calculate the estimated CY 2026 PFS conversion factors, we took the CY 2025 conversion factor and multiplied it by the budget neutrality adjustment required as described in the preceding paragraphs, then multiplied by the qualifying APM and nonqualifying APM updates specified by section 1848(d)(20) of the Act, then applied the one-year increase of 2.50 percent for CY 2026 established by statute. We estimate the CY 2026 PFS qualifying APM CF to be 33.5875 which reflects a 0.55 percent positive budget neutrality adjustment required under section 1848(c)(2)(B)(ii)(II) of the Act and the 0.75 percent update adjustment factor specified under section 1848(d)(20) of th cts a 0.55 percent positive budget neutrality adjustment required under section 1848(c)(2)(B)(ii)(II) of the Act and the 0.75 percent update adjustment factor specified under section 1848(d)(20) of the Act. We estimate the CY 2026 PFS nonqualifying APM CF to be 33.4209 which reflects a 0.55 percent positive budget neutrality adjustment required under section 1848(c)(2)(B)(ii)(II) of the Act and the 0.25 percent update adjustment factor specified under section 1848(d)(20) of the Act. We estimate the CY 2026 anesthesia qualifying APM CF to be 20.6754 and the CY 2026 anesthesia nonqualifying APM CF to be 20.5728, reflecting the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments. BILLING CODE 4120–01–P VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00450 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32801 BILLING CODE 4120–01–C Table 92 shows the impact on PFS payment for physicians’ services based on the proposed policies included in this rule. To the extent that there are year- / Proposed Rules 32801 BILLING CODE 4120–01–C Table 92 shows the impact on PFS payment for physicians’ services based on the proposed policies included in this rule. To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues will be different from those shown in Table 92 (CY 2026 PFS Estimated Impact on Total Allowed Charges by Specialty). In recent years, we have received requests from interested parties to provide more granular information that separates the specialty-specific impacts by site of service. These interested parties have presented us with high- level information suggesting that Medicare payment policies are directly responsible for consolidating privately owned physician practices and freestanding supplier facilities into larger health systems. Their concerns highlight a need to update the information under the PFS to account for current trends in healthcare delivery, especially concerning independent versus facility-based practices. We published an RFI in the CY 2023 PFS proposed rule to gather feedback on this issue and refer readers to the discussion in the CY 2023 PFS lly concerning independent versus facility-based practices. We published an RFI in the CY 2023 PFS proposed rule to gather feedback on this issue and refer readers to the discussion in the CY 2023 PFS final rule (87 FR 69429 through 69438). As part of our holistic review of how best to update our data and offer interested parties additional information that addresses some of the concerns raised, we have recently improved our current suite of public use files (PUFs) by including a new file that shows estimated specialty payment impacts at a more granular level, specifically by showing ranges of impact for practitioners within a specialty. This file is available on the CMS website under downloads for the CY 2026 PFS proposed rule at https:// www.cms.gov/Medicare/Medicare-Fee- for-Service-Payment/ PhysicianFeeSched/PFS-Federal- Regulation-Notices.html. Some of the proposed policies in this rule are estimated to have significant differential effects depending on the site of service, especially the proposed changes to the allocation of indirect PE in the facility setting. Therefore, we are publishing the impact tables including a VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 F ally the proposed changes to the allocation of indirect PE in the facility setting. Therefore, we are publishing the impact tables including a VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00451 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G H P G H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00452 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32803 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00453 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00454 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00455 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00456 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 202 00000 Frm 00456 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32807 The proposed efficiency adjustment for CY 2026 is calculated as the sum of the final productivity adjustments used in the Medicare Economic Index (MEI) for the prior five years (2021 through 2025). The MEI is a measure of input price inflation faced by physicians and practitioners furnishing physicians’ services such as physician’s own time, non-physician employees’ compensation, office rent, medical equipment, and more. The MEI productivity adjustment reflects the most recent historical estimate of the 10- year moving average growth of private nonfarm business total factor productivity, as calculated by the Bureau of Labor Statistics. Every year, the productivity adjustment is calculated by the CMS Office of the Actuary (OACT) based on the most recent historical data published by BLS at the time of the PFS final rule. Beginning in CY 2026, we are proposing a 5-year look-back period to calculate the initial efficiency adjustment. See section II.E.2.b of this ru ata published by BLS at the time of the PFS final rule. Beginning in CY 2026, we are proposing a 5-year look-back period to calculate the initial efficiency adjustment. See section II.E.2.b of this rule for more information on the proposed methodology. This calculation results in a proposed efficiency adjustment of 2.5 percent for CY 2026. Generally, specialties that bill more often for timed codes, such as family practice, clinical psychologists, clinical social workers, geriatrics, and psychiatry would likely see an increase in RVUs; while specialties that bill more often for procedures, diagnostic imaging, and radiology services (such as radiation oncology, radiology, and some surgical specialties), would likely see a decrease in RVUs. This proposed efficiency adjustment will decrease the work RVU for many services across most specialty types to reflect the efficiency gains that have taken place over time. Since this proposal will reduce the work RVU for affected services, we project that there will be a net increase to the conversion factor as required under our budget neutrality provisions. We estimate that almost all specialties will experience no more than +1 or ¥1 percent c t that there will be a net increase to the conversion factor as required under our budget neutrality provisions. We estimate that almost all specialties will experience no more than +1 or ¥1 percent change in RVUs as a result of this proposed policy, although the effect on individual services may be greater. d. Estimated Impacts Related to the Proposed Site of Service Payment Differential In section II.B. of this proposed rule, we are proposing to, for each service valued in the facility setting, reduce the portion of the facility PE RVUs allocated based on work RVUs to half the amount allocated to non-facility PE RVUs for CY 2026. Overall, specialties that practice primarily in the non-facility setting will see an increase in PE RVUs as a result of this redistribution. Specialties that perform services primarily in the facility setting will see a decrease in PE RVUs as a result of the proposed reduction to facility indirect PE. Overall, this proposed methodology change to indirect PE allocation would not affect the conversion factor, as all changes in valuation would be contained within the development of PE RVUs and redistribute PE RVUs from the facility to the non-facility setti allocation would not affect the conversion factor, as all changes in valuation would be contained within the development of PE RVUs and redistribute PE RVUs from the facility to the non-facility setting. E. Impact of Changes Related to Telehealth Services We are proposing the addition of several codes to the Medicare Telehealth Services List, including HCPCS codes G0473 and G0545, and CPT codes 90849, 92622, and 92623. We are also proposing to remove HCPCS code G0136 from the Medicare Telehealth Services List. We are proposing certain telecommunications technology-related flexibilities, including that we will continue to use a definition of direct supervision that allows ‘‘immediate availability’’ of the supervising practitioner using real-time audio and video interactive telecommunications for services without a 010 or 090 global period indicator. We are also proposing to eliminate the telehealth frequency limitations for subsequent nursing facility and inpatient hospital visits. While we note that certain other Medicare telehealth flexibilities related to the Public Health Emergency (PHE) for the Coronavirus Disease 2019 (COVID–19) (PHE for COVID–19) PHE for COVID–19 are expiring e we note that certain other Medicare telehealth flexibilities related to the Public Health Emergency (PHE) for the Coronavirus Disease 2019 (COVID–19) (PHE for COVID–19) PHE for COVID–19 are expiring, including the removal of statutory geographic and location limitations for most Medicare telehealth services, the beneficiary’s home continues to be a permissible originating site for certain types of services including those furnished for the diagnosis, evaluation, or treatment of a mental health disorder, including a Substance Use Disorder (SUD), and for monthly End Stage Renal Disease (ESRD) related clinical assessments described in section 1881(b)(3)(B). However, expiration of certain flexibilities for Medicare telehealth services is not expected to impact broader utilization of these services because reasonable and necessary services for the diagnosis or treatment of an illness or injury continue to be covered. Despite the fact that some services will no longer be furnished under telehealth, we expect that they will continue to be furnished in-person. We therefore anticipate that our provisions will result in continued utilization of services that can be furnished as Medicare te lehealth, we expect that they will continue to be furnished in-person. We therefore anticipate that our provisions will result in continued utilization of services that can be furnished as Medicare telehealth services during CY 2026 at levels comparable to observed utilization of these services during CY 2025. F. Other Provisions of the Proposed Rule 1. Impact of Changes Related to Medicare Part B Payment for Skin Substitutes When Used During a Covered Application Procedure Under the PFS in the Non-Facility Setting As discussed in detail in section II.K.D. of this proposed rule, starting January 1, 2026, we are proposing to pay for the provision of certain groups of skin substitute products used during a covered application procedure (CPT codes 15271 through 15278) as supplies. These skin substitutes will be paid as incident-to supplies under the PFS in the non-facility setting in accordance with section 1861(s)(2)(A) of the Act. While costs associated with supplies are usually bundled into the PE RVUs for particular services in non-facility settings, these products have been paid separately for many years in the non- facility setting, where the majority of these products are curre into the PE RVUs for particular services in non-facility settings, these products have been paid separately for many years in the non- facility setting, where the majority of these products are currently used. As discussed in detail in section II.K. of this proposed rule, in light of our careful review of the applicable statutory provisions governing products paid under the ASP methodology under 1847A of the Act, the different FDA regulatory frameworks used for these products, and the skyrocketing increase in Medicare spending for such products, we are proposing to pay separately for specific skin substitute products (other than products licensed under section 351 of the PHS Act, which will continue to be paid as biologicals under the ASP methodology in section 1847A of the Act) that are eligible for Medicare coverage during a covered application procedure in the non-facility setting as incident-to supplies in accordance with section 1861(s)(2)(A) of the Act. To reflect relevant product characteristics, we propose to group skin substitutes that are not drugs or biologicals (that is, biological products licensed under section 351 of the PHS Act) using three CMS payment categories b ct characteristics, we propose to group skin substitutes that are not drugs or biologicals (that is, biological products licensed under section 351 of the PHS Act) using three CMS payment categories based on FDA regulatory pathways (PMAs, 510(k)s, and 361 HCT/Ps) to set payment rates. We believe that our proposal to pay for these supplies as incident-to supplies under the PFS, valued in groups by how the products are used, better aligns payment with the resources involved in the provision of these incident-to supplies during a covered application procedure and will generate payment stability over time. We estimate that VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00457 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32808 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules under this proposal, which assumes a single rate of approximately $125.38 for CY 2026, there would be an estimated savings of $9.4 billion. Because the resources involved in provision of these supplies were not previously incorporated into RVUs under the PFS, the costs are not accounted for when we be an estimated savings of $9.4 billion. Because the resources involved in provision of these supplies were not previously incorporated into RVUs under the PFS, the costs are not accounted for when we compare the RVUs for physicians’ services from 1 year to the next. In other words, changes in payment rates for these particular codes will be incorporated into PFS relativity once we use claims data from 2026, should the policy be finalized. Under the usual methodology, that means that changes in rates for these services between CY 2027 and CY 2028 would have an impact on the development of PE RVUs for other services. Over time, we anticipate that our proposal will continue to result in significant overall price reductions since grouped valuation instead of product-specific pricing should result in downward pricing pressure in the market. Additionally, we do not anticipate an impact to beneficiaries’ access to appropriate care. 2. Drugs and Biological Products Paid Under Medicare Part B a. Requiring Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded Amounts Section 90004 of the Infrastructure Investment and Jobs Act a. Requiring Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded Amounts Section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117– 58, November 15, 2021) 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. The refund amount is either as noted in section 1847A(b)(1)(B) of the Act in the case of a single source drug or biological or as noted in section 1847A(b)(1)(C) of the Act in the case of a biosimilar biological product, multiplied by the amount of discarded drug that exceeds an applicable percentage, which is required to be at least 10 percent, of total charges (subject to certain exclusions) for the drug in a given calendar quarter. In the CY 2023, 2024, and 2025 PFS final rules, we finalized several policies to implement the provision. in December of 2024, CMS sent discarded drug refund reports for CY 2023 ‘‘new refund quarters,’’ as defined at § 414.902. The total refunds owed for these quarters in amounts to over $139 million, which was deposited into the Suppleme arded drug refund reports for CY 2023 ‘‘new refund quarters,’’ as defined at § 414.902. The total refunds owed for these quarters in amounts to over $139 million, which was deposited into the Supplementary Medical Insurance (SMI) trust fund, as required by law. In section III.A.1 of this proposed rule, we discuss two applications (CMS 10835, OMB 0938– 1435) for increased applicable percentage which will have no impact on Medicare spending. b. Average Sales Price: Price Concessions and Bona Fide Service Fees (§§ 414.804 and 414.802) In section III.A.2 of this proposed rule, we are proposing clarifications to two aspects of the calculation of manufacturer’s Average Sales Price (ASP), including price concessions and bona fide service fees (BFSFs). Both price concessions and BFSFs have direct implications on the manufacturer’s ASP. For example, if a manufacturer currently classifies an amount paid to an entity to be a bona fide service fee but must reclassify the amount as a price concession under these proposed changes, the manufacturer’s ASP would theoretically decrease. The resulting payment limit for the drug, typically ASP plus six percent, would also decrease. The opposite would on under these proposed changes, the manufacturer’s ASP would theoretically decrease. The resulting payment limit for the drug, typically ASP plus six percent, would also decrease. The opposite would also be true; that is, if a manufacturer considers an amount paid to an entity a price concession but then determines the amount to be a bona fide service fee, the manufacturer’s ASP would increase. Therefore, we anticipate that these proposals may have an impact on Medicare spending. The reclassification of certain fees could increase or decrease the ASP for such drugs. We anticipate that the proposed policy would likely result in more amounts to be considered price concessions (instead of BFSFs) resulting in decreases in ASP. If this occurs, there would be decreased spending on affected drugs. However, since details of arrangements and terms that manufacturers have with other entities are often not known to CMS, we are not able to quantify the possible changes in the payment limits for separately paid drugs under Medicare Part B as under these proposals. c. Impacts Related to Autologous Cell- Based Immunotherapy and Gene Therapy Payment In section III.A.4. of this proposed rule, we p eparately paid drugs under Medicare Part B as under these proposals. c. Impacts Related to Autologous Cell- Based Immunotherapy and Gene Therapy Payment In section III.A.4. of this proposed rule, we propose that preparatory procedures for tissue procurement required for manufacturing an autologous cell-based immunotherapy or gene therapy be included in the payment of the product itself. Since the payment for preparatory procedures is an extension of current policy for a subset of these products, Chimeric Antigen Receptor (CAR) T-cell therapies, and these products are furnished to very few beneficiaries, we do not anticipate the proposed policy to have a significant financial impact. In addition, we propose that, beginning January 1, 2026 (that is, data reflecting sales beginning on that date), any preparatory procedures for tissue procurement required for manufacturing an autologous cell-based immunotherapy or gene therapy that are paid by the manufacturer be included in the calculation of the manufacturer’s ASP. Because we have little information about how manufacturers currently factor in the cost of tissue procurement into pricing these products, we cannot predict the exact fina n of the manufacturer’s ASP. Because we have little information about how manufacturers currently factor in the cost of tissue procurement into pricing these products, we cannot predict the exact financial impact on Medicare payment. However, given that the cost of tissue procurement is typically a very small fraction of the overall cost of the product, we anticipate that any financial impact will not be substantial. 3. Impacts Related to Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) In section III.B.2. of this proposed rule, to continue alignment with the PFS and goals associated with APCM services, we propose to adopt the add- on codes for APCM that would facilitate billing for BHI and CoCM services when RHCs and FQHCs are providing advanced primary care. We are also proposing to require RHCs and FQHCs to report individual codes that make up HCPCS code G0512. We are also proposing to require RHCs and FQHCs to report the individual codes that make up the communications technology- based services (CTBS), HCPCS code G0071. In addition, we are proposing to revise § 405.2464(c) and (e) to reflect our proposal on payment of CoCM and CTBS services for RHCs a ommunications technology- based services (CTBS), HCPCS code G0071. In addition, we are proposing to revise § 405.2464(c) and (e) to reflect our proposal on payment of CoCM and CTBS services for RHCs and FQHCs. We are also proposing 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 terms of estimated impacts to the Medicare program, we believe that the proposals discussed in section III.B.2 of this proposed rule will have a negligible impact on Medicare spending. In section III.B.3 of this proposed rule, we are proposing the policy 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 are also proposing, 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 would VerDate n 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 would VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00458 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32809 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 believe these RHC/FQHC proposals related to telecommunication technology will have a negligible impact on Medicare spending. 4. Ambulatory Specialty Model (ASM) a. Scale of the Model As we discuss in sections III.D.2.c.(4) and III.D. l of this proposed rule, there is no one-size-fits-all approach to designing, implementing, and evaluating Innovation Center models. Each payment and service delivery model tested by the Innovation Center is unique in its goals, and thus its design. Models vary in size to accommodate various design features and satisfy a variety s. Each payment and service delivery model tested by the Innovation Center is unique in its goals, and thus its design. Models vary in size to accommodate various design features and satisfy a variety of priorities. Decisions made regarding the features and design of the model strongly influence the extent to which the evaluation will be able to accurately assess the effect of a given model test and produce clear and replicable results. The Innovation Center conducts analyses to determine the ideal number of participants for each model for evaluation purposes. This analysis considers a variety of factors including the target population (for example, Medicare beneficiaries with select chronic conditions), model eligibility (for example, participant eligibility criteria for inclusion in the model), participant enrollment strategy (for example, mandatory versus voluntary) and, the need to test effects on subgroups. Model size can also be influenced by the type and size of hypothesized effect on beneficiary outcomes, such as quality of care, or the target level of model savings. The smaller the expected impact a model is hypothesized to achieve, the larger a model needs to be for CMS t ect on beneficiary outcomes, such as quality of care, or the target level of model savings. The smaller the expected impact a model is hypothesized to achieve, the larger a model needs to be for CMS to have confidence in the observed impacts. An insufficient number of participants increases the risk that the evaluation will be imprecise in detecting the true effect of a model, potentially leading, for example, to a false negative or false positive result. The goal is to design a model that is sufficiently large to achieve adequate precision but not so large as to waste CMS’s limited resources. These decisions affect the quality of evidence CMS can present regarding the impacts of a model on quality of care, utilization, and spending. In the case of ASM, in this proposed rule we have determined the sample size necessary for a minimum estimated savings impact of 3.5 percent. While savings higher than 3.5 percent would require a smaller sample size from an evaluation perspective, if we were to reduce the size of ASM and if the actual savings are at or just below the 3.5 percent level, then we would increase the risk of being unable to detect whether ASM resulted in savings. As propose re to reduce the size of ASM and if the actual savings are at or just below the 3.5 percent level, then we would increase the risk of being unable to detect whether ASM resulted in savings. As proposed, we expect that ASM would include approximately 25 percent of all CBSAs and metropolitan divisions. As proposed at § 512.710(f), a CBSA or metropolitan division must have at least one clinician of the required specialty types who furnished at least 20 eligible episodes between January 1, 2024 and December 31, 2024 to be eligible for selection into ASM. We performed a simulation based on our proposed policies. We simulated the random selection of CBSAs and metropolitan divisions using CY 2023 data based on the methodology proposed at § 512.710(f), which would allow us to detect the minimum estimated savings impact of 3.5 percent described earlier in this section of this proposed rule. Based on this simulation, we expect to have approximately 3,400 ASM heart failure participants billing under 1,160 TINs and approximately 5,200 ASM low back pain participants billing under 2,400 TINs in the simulated mandated geography areas. Within the ASM heart failure cohort, we expect ASM to include der 1,160 TINs and approximately 5,200 ASM low back pain participants billing under 2,400 TINs in the simulated mandated geography areas. Within the ASM heart failure cohort, we expect ASM to include approximately 164,000 unique heart failure episodes, 162,600 unique beneficiaries triggering episodes, and $1.6 billion in total episode FFS spending (Medicare Part A and Part B only) of allowed charges for each ASM performance year. Within the ASM low back pain cohort, we expect ASM to include approximately 441,000 unique low back pain episodes, 398,500 unique beneficiaries triggering episodes, and $1.2 billion in total episode FFS spending of allowed charges for each ASM performance year. To determine the number of ASM participants in each ASM cohort, we counted the number of clinicians in mandatory geographic areas (as described at § 512.710(f)) with the proposed specialty types (as described at § 512.710(d)) that furnished at least 20 episodes related to the ASM’s cohort targeted chronic condition in CY 2023 (as described at § 512.710(e)). Similarly, to determine episode count, beneficiary count, and total spending estimates, we drew upon the historical data of ASM participants in ic condition in CY 2023 (as described at § 512.710(e)). Similarly, to determine episode count, beneficiary count, and total spending estimates, we drew upon the historical data of ASM participants in the simulated mandatory geographic areas selected for participation. We welcome public comments on the proposed scale of ASM. b. Effects on ASM Participants ASM would not alter the way ASM participants bill Medicare. Therefore, we believe that there will be no additional burden for ASM participants related to billing practices. We believe the audit and retention policies of ASM are generally consistent with existing policies under Medicare. Additionally, the monitoring requirements for ASM are consistent with the monitoring and evaluation requirements already in place under 42 CFR 405.1110(b) for participants in models tested under section 1115A of the Act. Therefore, we believe the audit and retention policies and the monitoring and evaluation requirements do not add additional regulatory burden on ASM participants. We do not believe that the model evaluation for ASM would include beneficiaries or clinicians completing surveys. We estimated the administrative costs of adjusting to and burden on ASM participants. We do not believe that the model evaluation for ASM would include beneficiaries or clinicians completing surveys. We estimated the administrative costs of adjusting to and complying with the measure reporting requirements for ASM to be approximately $3,077.36 per ASM participant per year. We believe the burden estimate for submitting data to meet the proposed quality, improvement activities, and Promoting Interoperability measure reporting requirements in sections III.D.2.d.(2), III.D.2.d.(4), and III.D.2.d.(5) of this proposed rule would apply to ASM participants that are and are not considered small entities (see section VI.E.7.b.(1). of this proposed rule for further discussion on the estimated effects of ASM on small businesses). To estimate the costs per ASM participant, we estimate the burden for submitting data in the quality, improvement activities, and Promoting Interoperability ASM performance categories generally using the same assumptions for time and labor categories for the staffing that the Quality Payment Program uses for MVP submissions in section V of this proposed rule. As discussed in section III.D.2.d.(1).(b) of this proposed rule, me and labor categories for the staffing that the Quality Payment Program uses for MVP submissions in section V of this proposed rule. As discussed in section III.D.2.d.(1).(b) of this proposed rule, ASM participants would not need to submit data for the cost ASM performance category and the administrative claims measures in the quality ASM performance category. Therefore, we did not estimate burden for the administrative claims measures in the cost and quality ASM performance categories. To estimate the burden for submitting quality measure data for an ASM cohort as described in section III.D.2.d.(2) of this proposed rule, we assume 50 percent of the ASM participants would submit data on quality measures using VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00459 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32810 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules the eCQM collection type, and the remining 50 percent of the ASM participants would submit data using the MIPS CQM collection type. For an ASM participant to submit a quality measure using the eCQM collect CQM collection type, and the remining 50 percent of the ASM participants would submit data using the MIPS CQM collection type. For an ASM participant to submit a quality measure using the eCQM collection type, we assume it would take a total of 5.3 hours [1.33 hours for a computer system analyst to submit data, 1.33 hours for a Medical and Health Services Manager to review the measure specifications, and 0.66 hours each for a computer system analyst, Licensed Practical Nurse (LPN), billing clerk, and physician to review the measure specifications]. For an ASM participant to submit a quality measure using the MIPS CQM collection type, we assume it would take a total of 5.97 hours [2 hours for a computer system analyst to submit data, 1.33 hours for a Medical and Health Services Manager to review the measure specifications, and 0.66 hours each for a computer system analyst, LPN, billing clerk, and physician to review the measure specifications]. To calculate the estimated cost, we used the May 2024 wage rate data from the U.S. Department of Labor (https://www.bls.gov/oes/ current/oes_nat.htm) and doubled the mean hourly wage to account for overhead and benefits. Accounting for overhe he May 2024 wage rate data from the U.S. Department of Labor (https://www.bls.gov/oes/ current/oes_nat.htm) and doubled the mean hourly wage to account for overhead and benefits. Accounting for overhead and benefits, we used salary estimates of $107.66/hr for a computer systems analyst, $132.44/hr for a Medical and Health Services Manager, $61.68/hr for a LPN, $47.60/hr for a billing clerk, and $296.74/hr for a physician. We estimate it would require ASM participants approximately 21.2 hours (4 eCQM measures x 5.3 hours) to submit data using the eCQM collection type or 23.88 hours (4 MIPS CQMs x 5.97 hours) to submit data using the MIPS CQM collection type for the required four quality data measures once annually. We estimate it would cost $658.37 (1.33 hours × $107.66/hr + 1.33 hours × $132.44/hr + 0.66 hours × $61.68/hr + 0.66 hours × $47.60/hr + 0.66 hours × $296.74/hr) per measure to submit quality data using the eCQM collection type and $730.50 (2 hours × $107.66/hr + 1.33 hours × $132.44/hr + 0.66 hours × $61.68/hr + 0.66 hours × $47.60/hr + 0.66 hours × $296.74/hr) per measure to submit quality data using the MIPS CQM collection type. Therefore, we estimate the total annual $132.44/hr + 0.66 hours × $61.68/hr + 0.66 hours × $47.60/hr + 0.66 hours × $296.74/hr) per measure to submit quality data using the MIPS CQM collection type. Therefore, we estimate the total annual cost for an ASM participant to submit the required measures in the quality ASM performance category using the eCQM collection type would be $2,633.48 (4 eCQM measures × $658.37) or $2,922 (4 MIPS CQM measures × $730.50) using the MIPS CQM collection type. We also estimate that data submission of the proposed improvement activities discussed in section III.D.2.d.(4). of this proposed rule would take 0.083 hours (or 5 minutes) and would be required once annually per ASM participant. Data submission for the Promoting Interoperability measures discussed in section III.D.2.d.(5). of this proposed rule would take 2.7 hours and would occur once annually per ASM participant. We used the salary estimate of $107.66/hr for a computer systems analyst to estimate burden for submitting data in the Promoting Interoperability and improvement activities ASM performance categories. For an ASM participant to submit data for the improvement activities ASM performance category, we estimate it would cost $8 ting Interoperability and improvement activities ASM performance categories. For an ASM participant to submit data for the improvement activities ASM performance category, we estimate it would cost $8.94 ($107.66/hr × 0.083 hours × 1 submission). For data submission for the Promoting Interoperability ASM performance category, we estimate it would cost $290.68 ($107.66/hr × 2.7 hours × 1 submission). We estimate that the burden for collecting and reporting quality, improvement activities, and Promoting Interoperability measures for an ASM participant submitting data using the eCQM collection type would be 23.983 hours (21.2 hours + 0.083 hours + 2.7 hours) at a cost of $2,933.10 ($2,633.48 + $8.94 + $290.68) and 26.663 hours (23.88 hours + 0.083 hours + 2.7 hours) at a cost of $3,221.62 ($2,922 + $8.94 + $290.68) for an ASM participate submitting data using the MIPS CQM collection type. We estimate approximately 7,622 ASM participants that would report data, therefore, the total burden estimate for all ASM participants collecting and reporting the measures in the quality, improvement activities, and Promoting Interoperability performance categories would be approximately 193,012 hou estimate for all ASM participants collecting and reporting the measures in the quality, improvement activities, and Promoting Interoperability performance categories would be approximately 193,012 hours (23.983 hours × 3,811 ASM participants + 26.663 hours × 3,811 ASM participants) at a cost of $23,455,621 ($2,933.10 × 3,811 ASM participants + $3,221.62 × 3,811 ASM participants). Additionally, we assume that approximately 50 percent of ASM participants that are currently not participating in MIPS would need to submit a one-time registration to access the CMS Enterprise Portal User Account (EUA). We estimate that it would take approximately 1 hour for an ASM participant or their representative to submit the registration for EUA. We used the salary estimate of $107.66/hr for a computer systems analyst to submit the registration for EUA access. Therefore, we estimate it would cost $107.66 ($107.66/hr × 1 hour) per registration. We estimate approximately 530 ASM participants would submit the application for EUA access. Therefore, the total burden estimate for ASM participants submitting the registration for EUA access would be approximately 530 hours at a cost of $ 57,059.80 (530 hours he application for EUA access. Therefore, the total burden estimate for ASM participants submitting the registration for EUA access would be approximately 530 hours at a cost of $ 57,059.80 (530 hours × $107.66/hr). We note that we did not include the estimated burden for submitting the registration for EUA access in calculating the total estimated burden per ASM participant as this submission does not occur annually. We welcome public comments on our proposed estimated burden impacts on ASM participants. c. Effects on Small Entities As described in section VI.H of this proposed rule, the RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. HHS uses an RFA threshold of at least a 5 percent impact on the affected entities within an identified industry to determine whether a proposed rule is likely to have ‘‘significant’’ impacts on small entities.427 Approximately 95 percent of practitioners, other suppliers, and providers are considered small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Med ctitioners, other suppliers, and providers are considered 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 is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities. Although many ASM participants may be small entities as that term is used in the RFA, the proportion of revenue from Medicare Part B covered professional services to which ASM would adjust payments would represent a small fraction of revenue generated by the ASM participant. Our analysis assumed that ASM would include only Medicare FFS beneficiaries receiving services from ASM participants. During 2024, 53.3 percent of Medicare beneficiaries with both Medicare Part A and Part B coverage on average are estimated to be enrolled in Medicare Advantage plans.428 ASM participants may also 427 Office of Advocacy, Small Business Administration. (2012). A Guide for Government Agencies, How to Comply with the Regulatory Flexibility Act, Imp are Advantage plans.428 ASM participants may also 427 Office of Advocacy, Small Business Administration. (2012). A Guide for Government Agencies, How to Comply with the Regulatory Flexibility Act, Implementing the President’s Small Business Agenda and Executive Order 13272, Retrieved from www.sba.gov/sites/default/files/ rfaguide_0512_0.pdf (accessed March 18, 2019). 428 This figure comes from the 2024 Medicare Trustees Report, Table IV.C1, p157 from the footnote that has the A and B share. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00460 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32811 serve patients with other coverage, such as Medicaid or commercial insurance. Given that ASM would only adjust payments to Medicare Part B payments for covered professional services based on performance—not other revenue from other payers like Medicare Advantage and commercial insurance that we expect to be about 50 to 60 percent of total revenue combined—we expect that the anticipated average impact of revenue based solely on r payers like Medicare Advantage and commercial insurance that we expect to be about 50 to 60 percent of total revenue combined—we expect that the anticipated average impact of revenue based solely on Medicare Part B payments for covered professional services to be less than 1 percent. Therefore, we determine that the proposed provisions of ASM would not have a greater than 5 percent impact on total revenues on a substantial number of small entities. As discussed earlier in section VI.E.b.(1). of this proposed rule, we believe that burden estimate of reporting the required measures and activities for ASM would be the same for ASM participants regardless of their small business status. We welcome public comments on our analysis that estimates no differential impact of ASM on small entities. d. Effects on the Medicare Program (1) Overview Under the current Medicare FFS payment system, services are paid on a per service basis to clinicians through the PFS. As a proposed mandatory model, ASM would test whether rewarding clinicians based on measures of quality, cost, care coordination, and CEHRT interoperability results in enhanced quality of care and reduced costs through more effectiv SM would test whether rewarding clinicians based on measures of quality, cost, care coordination, and CEHRT interoperability results in enhanced quality of care and reduced costs through more effective upstream chronic condition management. As proposed, ASM would test adjusting Medicare Part B covered professional services claims of an ASM participant according to a payment adjustment that is determined by an ASM participant’s performance on a set of measures they must report (see sections III.D.2.d and III.D.2.f of this proposed rule). For each ASM participant, the payment adjustment amount would be determined as proposed at § 512.750. ASM is not a total cost of care model. ASM participants would still bill traditional FFS Medicare for services as usual. (2) Data and Methods A simulation based on the proposed policies was created to estimate the financial impacts of ASM. The simulation relied upon simulated final scores and ASM payment adjustments, as well as assumptions derived from EBCM episodes related to ASM’s targeted chronic conditions from CY 2023 and Medicare FFS claims data. We reviewed these assumptions and determined them to be reasonable for the estimates. We simulated