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 the product. We solicit comment on this proposal. d. Summary In summary, 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 and that, beginning January 1, 2026, any preparatory procedures for tissue procurement required for manufacturing an autologous cell-based immunotherapy or gene therapy that were paid for by the manufacturer be included in the calculation of the manufacturer’s ASP. B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) 1. Background on RHC and FQHC Payment Methodologies As provided in 42 CFR part 405 subpart X of our regulations, RHC and FQHC visits generally are defined as face-to-face encounters between a patient and one or more RHC or FQHC practitioners during which one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, NPs, PAs, CNMs, clinical psychologists (CPs), licensed marriage and family therapists, mental health counselors, and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse that is furni ogists (CPs), licensed marriage and family therapists, mental health counselors, and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse that is furnishing care to a homebound RHC or FQHC patient in an area verified as having shortage of home health agencies. Transitional Care Management (TCM) services can also be paid by Medicare as an RHC or FQHC visit. In addition, Diabetes Self- Management Training (DSMT) or Medical Nutrition Therapy (MNT) sessions furnished by a certified DSMT or MNT program may also be considered FQHC visits for Medicare payment purposes. Only medically necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner are RHC or FQHC billable visits. Services furnished by auxiliary personnel (for example, nurses, medical assistants, or other clinical personnel acting under the supervision of the RHC or FQHC practitioner) are considered incident to the visit and are included in the per- visit payment. RHCs generally are paid an all- inclusive rate (AIR) for all medically VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00197 Fmt 4701 the visit and are included in the per- visit payment. RHCs generally are paid an all- inclusive rate (AIR) for all medically VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00197 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 32548 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules necessary medical and mental health services and qualified preventive health services furnished on the same day (with some exceptions). The AIR is subject to a payment limit, meaning that an RHC will not receive any payment beyond the specified limit amount per visit. As of April 1, 2021, all RHCs are subject to statutory upper payment limits determined in accordance with section 1833(f) of the Act, as amended by section 130 of the Consolidated Appropriations Act, 2021 (Pub. L. 116– 260). FQHCs were paid under the same AIR methodology until October 1, 2014. Beginning on that date, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the Patient Protection and Affordable Care Act (Pub. L. 111–148)), FQHCs began to transition to the FQHC PPS system, in which they e with section 1834(o) of the Act (as added by section 10501(i)(3) of the Patient Protection and Affordable Care Act (Pub. L. 111–148)), FQHCs began to transition to the FQHC PPS system, in which they are paid based on the lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services by the FQHC PPS geographic adjustment factor (GAF). The rate is increased by 34 percent when an FQHC furnishes care to a patient that is new to the FQHC, or to a beneficiary receiving an initial preventive physical examination (IPPE) or has an annual wellness visit (AWV). Both the RHC AIR and FQHC PPS payment rates were initially designed to reflect the cost of all services and supplies that an RHC or FQHC furnishes to a patient in a single day. These nearly all-inclusive rates are not adjusted at the individual level for the complexity of individual patient health care needs, the length of an individual visit, or the number or type of practitioners involved in the patient’s care. Instead for RHCs, all costs for the facility over the course of the year are aggregated and an AIR is derived from these aggregate expenditures. The FQHC practitioners involved in the patient’s care. Instead for RHCs, all costs for the facility over the course of the year are aggregated and an AIR is derived from these aggregate expenditures. The FQHC PPS base rate is updated annually by the percentage increase in the FQHC market basket reduced by a productivity adjustment. For CY 2025, we rebased and revised the 2017-based FQHC market basket to reflect a 2022 base year (89 FR 98023 through 98032). 2. Payment for Care Coordination Services a. Background In the last several years of rulemaking, we have expanded the scope of care coordination services (formerly referred to as care management services) that are billable using HCPCS code G0511. More recently, in the CY 2025 PFS final rule, we unbundled the individual HCPCS codes that make up G0511 (89 FR 97999 through 98000). We have also been engaged in a multi-year examination of coordinated and collaborative care services in professional settings, and as a result, established codes and separate payment to independently recognize and pay for these important services. As stated in the CY 2016 PFS Final Rule (80 FR 71080 through 71088), the care coordination included in services, such separate payment to independently recognize and pay for these important services. As stated in the CY 2016 PFS Final Rule (80 FR 71080 through 71088), the care coordination included in services, such as office visits, does not always adequately describe the non-face-to-face care management work involved in primary care and similar care relationships. We noted that payment for office visits may not reflect all the services and resources required to furnish comprehensive, coordinated care management for certain categories of beneficiaries, such as those who are returning to a community setting following discharge from a hospital or skilled nursing facility (SNF) stay. Over the last decade, we have updated RHC and FQHC payment policies as appropriate, and we remain committed to improving how Medicare payment recognizes the resources involved in furnishing covered services that encompass aspects of advanced primary care furnished by interprofessional care teams and typically concentrating on the delivery of appropriate preventive care to patients and the management of individuals’ chronic conditions as they progress over time. As a result, we reaffirmed our support of primary care and on the delivery of appropriate preventive care to patients and the management of individuals’ chronic conditions as they progress over time. As a result, we reaffirmed our support of primary care and recognized care management as one of the critical components of primary care by implementing significant changes aimed at better capturing the resources required for care management services, including chronic care management (CCM), principal care management (PCM), general behavior health integration (BHI), chronic pain management (CPM), transitional care management (TCM), remote physiologic monitoring (RPM), remote therapeutic monitoring (RTM), community health integration (CHI), principal illness navigation (PIN), PIN-peer support services and Advanced Primary Care Management (APCM). For RHCs and FQHCs, we established payment for these suites of care coordination services outside of the RHC AIR and FQHC PPS. That is, payment is made in addition to the otherwise billable visit. In the CY 2025 PFS final rule (89 FR 97870 through 97874), we discussed how we established coding and payment under the PFS for a newly defined set of APCM services described and defined by three new HCPCS G- c 2025 PFS final rule (89 FR 97870 through 97874), we discussed how we established coding and payment under the PFS for a newly defined set of APCM services described and defined by three new HCPCS G- codes. This new coding reflects the recognized effectiveness and growing adoption of the advanced primary care approach to care. It also encompasses a broader range of services and simplifies the billing and documentation requirements, as compared to existing care management codes. The finalized coding for APCM incorporated elements of several existing care management services into a bundle that we have already considered to be care coordination services paid separately to RHCs and FQHCs using HCPCS code G0511 (for example, CCM and PCM). In addition, the coding for APCM incorporated elements of communication technology-based services (CTBS) into a bundle that we have already considered to be virtual communications paid separately to RHCs and FQHCs using HCPCS code G0071. Therefore, to allow RHCs and FQHCs the ability to simplify the billing and documentation requirements associated with furnishing APCM services we finalized in the CY 2025 PFS final rule to allow RHCs and FQHCs to bill f RHCs and FQHCs the ability to simplify the billing and documentation requirements associated with furnishing APCM services we finalized in the CY 2025 PFS final rule to allow RHCs and FQHCs to bill for these services and receive separate payment. Further, the APCM code sets vary by the degree of complexity of patient conditions (that is, non-complex and complex CCM for multiple chronic conditions or PCM for a single high-risk condition), and whether the number of minutes spent by clinical staff or the physician or non-physician practitioner (NPP) is used to meet time thresholds for billing. In the CY 2025 final rule, we finalized and adopted the three new APCM codes G0556, G0557, and G0558. RHCs and FQHCs are required to use the more specific coding, that is, the three HCPCS G-codes listed above when furnishing APCM. These services are paid in addition to the otherwise billable visit under the RHC AIR methodology or FQHC PPS because we believe that they are similar to the other care coordination services, such as, CCM, PCM, and RPM. That is, APCM involves non-face to-face care coordination of which the costs associated with these services are not captured in the RHC AIR or FQHC PP oordination services, such as, CCM, PCM, and RPM. That is, APCM involves non-face to-face care coordination of which the costs associated with these services are not captured in the RHC AIR or FQHC PPS rate. Similarly to the care coordination services, payment for APCM is based on the PFS national non-facility rate. It is important to note that if RHCs and FQHCs furnish APCM services, the HCPCS codes for APCM are per calendar month bundles. Consequently, if the RHC/FQHC furnishes APCM then they would not bill for certain other individual care coordination services. For further discussion on duplicative services and concurrent billing restrictions regarding APCM policies, please refer to the CY 2025 PFS final rule (89 FR 97710). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00198 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 32549 b. Integrating Behavioral Health Into Advanced Primary Care Management (APCM) In the CY 2018 PFS final rule, we established requirements and separate payment for general Behavioral Health Rules 32549 b. Integrating Behavioral Health Into Advanced Primary Care Management (APCM) In the CY 2018 PFS final rule, we established requirements and separate payment for general Behavioral Health Integration (BHI) and Psychiatric Collaborative Care Model (CoCM) services furnished in RHCs and FQHCs (82 FR 53169 through 53180). General BHI and Psychiatric CoCM services are based on a model of behavioral health integration that enhances usual primary care by adding two key services to the primary care team: care management support for patients receiving behavioral health treatment and regular psychiatric inter-specialty consultation. In the CY 2018 PFS final rule, we also initiated the use of HCPCS codes G0511 and G0512 to pay for general care coordination services and CoCM services, respectively. As discussed in section II.G.1. of this proposed rule, we recognize that patients with chronic health conditions are ‘‘more likely to have related behavioral health concerns and find it easier to improve chronic conditions when these concerns are also addressed.’’ 113 Integrating behavioral health with primary care has been shown to improve outcomes like reduced depression severity, and er to improve chronic conditions when these concerns are also addressed.’’ 113 Integrating behavioral health with primary care has been shown to improve outcomes like reduced depression severity, and enhancing patient’s experience of care. 114 We explain that in response to comments received for CY 2025 rulemaking, for services paid under the 113 https://integrationacademy.ahrq.gov/about/ integrated-behavioral-health#:∼:text=Integrated% 20behavioral%20health%20offers%20many, these%20concerns%20are%20also%20addressed. 114 Balasubramanian, Bijal, Deborah Cohen, Katelyn Jetelina, Miriam Dickinson, Melinda Davis, Rose Gunn, Kris Gowen, Frank DeGruy 3rd, Benjamin Miller, Larry Green. ‘‘Outcomes of Integrated Behavioral Health with Primary Care.’’ J Am Board Fam Med. 2017 Mar–Apr;30(2):130– 139.doi: 10.3122/jabfm.2017.02.160234. PFS, we are proposing to create optional add-on codes for APCM services that would facilitate providing complementary BHI services. As discussed previously in this section, we adopted the coding for the defined set of APCM services described and defined by HCPCS codes G0556, G0557, and G0558 to allow RHCs and FQHCs the ability to simplify the billing and document ection, we adopted the coding for the defined set of APCM services described and defined by HCPCS codes G0556, G0557, and G0558 to allow RHCs and FQHCs the ability to simplify the billing and documentation requirements associated with furnishing APCM services (89 FR 98010 through 98012). In addition, and similarly to the discussion in section II.G of this proposed rule, since RHCs and FQHCs that fulfill the requirements to bill for APCM services must comply with requirements that ensure the integrity of the services provided, we believe that these settings should also be able to provide BHI and CoCM with simpler billing and documentation requirements. Therefore, for CY 2026, in alignment with the PFS and goals associated with APCM services, we are proposing 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 believe allowing for the use of these add-on codes would encourage RHCs and FQHCs to provide complementary BHI services, thereby improving access to BHI and CoCM for primary care patients in the RHC and FQHC settings. For further discussion regarding the optional add-on codes, ple to provide complementary BHI services, thereby improving access to BHI and CoCM for primary care patients in the RHC and FQHC settings. For further discussion regarding the optional add-on codes, please see section II.G.2 of this proposed rule. In the CY 2025 PFS final rule (89 FR 98010), commenters suggested that we consider unbundling HCPCS code G0512, similarly to what we did with HCPCS code G0511. That is, unbundle the services that comprise HCPCS code G0512 and permit billing of HCPCS codes 99492, 99493, and 99494. Commenters explained that allowing RHCs and FQHCs to report the dedicated CPT codes would support and encourage the adoption of CoCM in these settings. In addition, since we are proposing use of add-on codes for APCM services to facilitate payment of BHI and CoCM services when they are furnished by RHCs and FQHCs providing advanced primary care services, we believe that we would also need to unbundle HCPCS code G0512 to effectuate that policy. RHCs and FQHCs that are furnishing BHI and CoCM as advanced primary care services would not be able to bill for certain other individual CPT codes, such as, 99492, 99493, and 99484. Therefore, we are proposing to require RHCs urnishing BHI and CoCM as advanced primary care services would not be able to bill for certain other individual CPT codes, such as, 99492, 99493, and 99484. Therefore, we are proposing to require RHCs and FQHCs to report the individual codes that make up the CoCM HCPCS code, G0512 beginning January 1, 2026. Similar to what was finalized in the CY 2025 PFS final rule (89 FR 98000 through 98010) for the general care management HCPCS code G0511, HCPCS code G0512 would no longer be payable when billed by RHCs and FQHCs; instead, RHCs and FQHCs will be required to bill the individual CPT and HCPCS codes that make up HCPCS G0512. The current list of base codes and add-on codes that make up G0512 are listed in Table 34, titled ‘‘Psychiatric Collaborative Care Model HCPCS Codes and Descriptors.’’ Payment for these services will be based on the national non-facility PFS payment rate when the individual code is on an RHC or FQHC claim, either alone or with other payable services and the payment rates are updated annually based on the PFS amounts for these codes. We are proposing to revise § 405.2464(c) to reflect our proposal on payment of CoCM services for RHCs and FQHCs. BILLING CODE 4120– rates are updated annually based on the PFS amounts for these codes. We are proposing to revise § 405.2464(c) to reflect our proposal on payment of CoCM services for RHCs and FQHCs. BILLING CODE 4120–01–P 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00199 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32550 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 00200 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00201 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 00202 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32553 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 00203 Fmt 4701 Wednesday, July 16, 2025 / Proposed Rules 32553 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 00203 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00204 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 00205 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 32556 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules an RHC or FQHC practitioner, and we revised the regulations under § 405.2463 to state that an RHC or FQHC mental health visit can also include encounters furnished through interactive, real-time, audio/video telecommunications technology or audio-only interactions in cases where beneficiaries are not capable of, or do not consent to, the use of devices that permit a two-way, audio/ video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder. We also revised § able of, or do not consent to, the use of devices that permit a two-way, audio/ video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder. We also revised § 405.2469, to add a supplemental wraparound payment to be made to the FQHC when a covered face-to-face (that is, in-person) encounter or an encounter where services are furnished using interactive, real-time, telecommunications technology or audio-only interactions in cases where beneficiaries do not wish to use or do not have access to devices that permit a two-way, audio/video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder occurs between a MA enrollee and a practitioner as set forth in § 405.2463. We noted that these changes aligned with similar changes for Medicare telehealth services for behavioral health paid under the PFS. We also noted that this change would allow RHCs and FQHCs to report and be paid for mental health visits furnished via real-time, telecommunication technology in the same way they currently do when these services are furnished in-person. In addition, in the CY 2022 PFS final rule (86 FR 65210 and 65211), we revised ia real-time, telecommunication technology in the same way they currently do when these services are furnished in-person. In addition, in the CY 2022 PFS final rule (86 FR 65210 and 65211), we revised the regulations at §§ 405.2463 and 405.2469 to state that there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient’s medical record. In the CY 2025 PFS final rule, we announced that we would continue to delay the in-person visit requirement for mental health services furnished via communication technology by RHCs and FQHCs to beneficiaries in their homes rule, we announced that we would continue to delay the in-person visit requirement for mental health services furnished via communication technology by RHCs and FQHCs to beneficiaries in their homes until January 1, 2026. However, subsequent to the publication of the CY 2025 PFS final rule, section 2207(d) of the Full-Year Continuing Appropriations and Extensions Act, 2025 (Pub. L. 119–4, March 15, 2025) legislated the in-person visit requirement for mental health visits following September 30, 2025; we are implementing conforming regulatory changes as discussed in section III.B.3.d. of this proposed rule. As an additional regulatory flexibility, in the CY 2025 PFS final rule (89 FR 98013 through 98017), we extended our policy to deem the presence of the physician (or other practitioner) to include virtual presence for the purposes of direct supervision through audio/video real-time communications technology (excluding audio-only) through December 31, 2025. b. Direct Supervision via Use of Two- Way Audio/Video Communications Technology Under Medicare Part B, certain types of services are required to be furnished under specific minimum levels of supervision by a physician or practi se of Two- Way Audio/Video Communications Technology Under Medicare Part B, certain types of services are required to be furnished under specific minimum levels of supervision by a physician or practitioner. See section II.D.2 of this proposed rule for the discussion regarding direct supervision for services provided using telecommunications technologies under the PFS. In the CY 2024 PFS final rule (88 FR 79067), we explained that extending this definition of direct supervision for RHCs and FQHCs under our regulations at §§ 405.2413, 405.2415, 405.2448, and 405.2452 through December 31, 2024, would align the timeframe of this policy with many of the previously discussed PHE-related telehealth policies that were extended under provisions of the CAA, 2023. In addition, we were concerned about an abrupt transition to the pre-PHE policy of requiring the physical presence of the supervising practitioner beginning after December 31, 2024, given that RHCs and FQHCs have established new patterns of practice during the PHE for COVID–19. We also believed that RHCs and FQHCs would need time to reorganize their practices established during the PHE to reimplement the pre-PHE approach to direct ns of practice during the PHE for COVID–19. We also believed that RHCs and FQHCs would need time to reorganize their practices established during the PHE to reimplement the pre-PHE approach to direct supervision without the use of audio/video technology. Similar to services furnished in physician office setting, RHC and FQHC services and supplies furnished incident to physician’s services are limited to situations in which there is direct physician supervision of the person performing the service, except for certain care coordination services which may be furnished under general supervision. For CY 2024 we continued to define ‘‘immediate availability’’ as including real-time audio and visual interactive telecommunications through December 31, 2024, and solicited comment on whether we should consider extending the definition of ‘‘direct supervision’’ to permit virtual presence beyond December 31, 2024; specifically, we solicited comment on potential patient safety or quality concerns when direct supervision occurs virtually in RHCs and FQHCs; for instance, if certain types of services are more or less likely to present patient safety concerns, or if this flexibility would be more ap en direct supervision occurs virtually in RHCs and FQHCs; for instance, if certain types of services are more or less likely to present patient safety concerns, or if this flexibility would be more appropriate when certain types of auxiliary personnel are performing the supervised service. We were also interested in potential program integrity concerns such as overutilization or fraud and abuse that interested parties may have had in regard to this policy. In the CY 2025 final rule, (89 FR 98015) we finalized our policy to maintain the virtual presence flexibility on a temporary basis, that is, the presence of the physician (or other practitioner) would include virtual presence through audio/ video real-time communications technology (excluding audio-only) through December 31, 2025 as such a policy continues to support access and preserve workforce capacity. (1) Proposal for CY 2026 Regarding Direct Supervision in RHCs/FQHCs We have considered information from interested parties, particularly in response to the CY 2024 PFS proposed rule where we solicited comment on potential patient safety or quality concerns when direct supervision occurs virtually in RHCs and FQHCs; for instance cularly in response to the CY 2024 PFS proposed rule where we solicited comment on potential patient safety or quality concerns when direct supervision occurs virtually in RHCs and FQHCs; for instance, if certain types of services are more or less likely to present patient safety concerns, or if this flexibility would be more appropriate when certain types of auxiliary personnel are performing the supervised service. We were also interested in potential program integrity concerns such as overutilization or fraud and abuse that interested parties may have regarding this policy. As discussed in the CY 2025 final rule (89 FR 98014 through 98015), in response to our proposal to extend this definition through the end of 2025, commenters strongly supported the proposal to allow virtual direct supervision through real-time audio/ video communications technology in RHCs and FQHCs, citing benefits such as reduced inefficiencies, improved accessibility, better alignment with other outpatient providers, and enhanced healthcare delivery without compromising patient safety or program integrity. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00206 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3. viders, and enhanced healthcare delivery without compromising patient safety or program integrity. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00206 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 32557 Given the information presented by interested parties on safety and effectiveness, we think direct supervision provided via two-way real time audio-video telecommunications technology meets the statutory requirements specific to RHCs and FQHCs at section 1861(aa)(2)(B) of the Act regarding necessary physician supervision and guidance. We note that in section II.D.2 of this proposed rule, we propose to permanently adopt a definition of direct supervision that allows ‘‘immediate availability’’ of the supervising practitioner using audio/ video real-time communications technology (excluding audio-only), for all services described under § 410.26, except for services that have global surgery indicators of, 010, or 090. These indicators are defined in IOM Pub. 100– 04, chapter 23, section 50.6 as 010 ‘‘Minor procedure wit scribed under § 410.26, except for services that have global surgery indicators of, 010, or 090. These indicators are defined in IOM Pub. 100– 04, chapter 23, section 50.6 as 010 ‘‘Minor procedure with preoperative relative values on the day of the procedure and postoperative relative values during a 10-day postoperative period included in the fee schedule amount; evaluation and management services on the day of the procedure and during this 10-day postoperative period generally not payable’’ and 090 ‘‘Major surgery with a 1-day preoperative period and 90-day postoperative period included in the fee schedule payment amount’’. These are services that describe a surgical service as well as its post-operative period of either 10 days, or 90 days, respectively. In the interests of aligning our approach toward direct supervision for RHCs and FQHCs with that discussed in section II.D.2. of this proposed rule, we believe that we should permanently adopt this flexibility in RHCs and FQHCs as it continues to support access and preserve workforce capacity. However, as we discuss in IOM Pub. 100–02, chapter 13, section 40.4, the Medicare global billing requirements do not apply to RHCs and FQ t continues to support access and preserve workforce capacity. However, as we discuss in IOM Pub. 100–02, chapter 13, section 40.4, the Medicare global billing requirements do not apply to RHCs and FQHCs, and global billing codes are not accepted for RHC or FQHC billing or payment. Since services that have global surgery indicators are not applicable in the RHC and FQHC settings, we are proposing revisions at § 405.2401(b) to define ‘‘Direct Supervision’’ to mean that the physician (or other supervising practitioner) must be present in the RHC or FQHC and immediately available to furnish assistance and direction throughout the performance of the service. It does not mean that the physician (or other supervising practitioner) must be present in the room when the service is performed. The presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology (excluding audio-only). c. Payment for Medical Visits Furnished via Telecommunications Technology Widespread use of telecommunications technology to furnish services during the PHE has illustrated interest within the medical community and among Medicare beneficiaries in lecommunications Technology Widespread use of telecommunications technology to furnish services during the PHE has illustrated interest within the medical community and among Medicare beneficiaries in furnishing and receiving care through the use of technology beyond the PHE. During the PHE, RHCs and FQHCs, much like other health care providers, had to change how they furnish care to meet the needs of their patients. RHCs and FQHCs heavily utilized the temporary authority to be paid for their services when provided as Medicare telehealth services during the PHE. Eliminating flexibilities under which RHC and FQHC services have been furnished to beneficiaries via telecommunications technology for over 5 years and resuming payment solely for in-person, face-to-face medical visits, would cause disruptions in access to services from RHC and FQHC practitioners. This would be particularly problematic for the underserved populations that these settings furnish services to since it could fragment care. We believe that we need to preserve the flexibilities under which RHC and FQHC services have been furnished to beneficiaries via telecommunications technology temporarily and to do so through nt care. We believe that we need to preserve the flexibilities under which RHC and FQHC services have been furnished to beneficiaries via telecommunications technology temporarily and to do so through an approach that these settings are familiar with to mitigate burden while we consider how to incorporate services furnished through telecommunications technology on a more permanent basis. For these reasons, in the event that Congress no longer authorizes payment to be made for telehealth services furnished via a telecommunications system by RHCs and FQHCs using a payment methodology based upon payment rates that are similar to the national average payment rates for comparable telehealth services under the PFS, we are proposing, on a temporary basis, to facilitate payment for non-behavioral health visits (hereafter referred to in this discussion as ‘‘medical visit services’’) furnished via telecommunications technology using an approach that closely aligns with this methodology. Like the methodology we used during and after the PHE, RHCs and FQHCs would continue to bill for RHC and FQHC medical visit services furnished using telecommunications technology, including services furnished methodology we used during and after the PHE, RHCs and FQHCs would continue to bill for RHC and FQHC medical visit services furnished using telecommunications technology, including services furnished using audio-only communications technology, by reporting HCPCS code G2025 on the claim. Since the costs associated with medical visit services furnished via telecommunications technology are not included in the calculations for the RHC AIR methodology and FQHC PPS, we believe, similar to the methodology described in section 1834(m)(8) of the Act, that we need to propose a proxy that would represent such resources used when furnishing these services. Therefore, we propose to continue to calculate the payment amount for these services billed using HCPCS code G2025 based on the average amount for all Medicare telehealth services paid under the PFS, weighted by volume for those services reported under the PFS. We believe that continuing to use this weighted average is appropriate during this interim period while we contemplate permanent policies for these services since there is a wide range of payment rates for the Medicare telehealth services paid under the PFS. As discussed in the CY 2 interim period while we contemplate permanent policies for these services since there is a wide range of payment rates for the Medicare telehealth services paid under the PFS. As discussed in the CY 2025 final rule (89 FR 98015 through 98016), we believe that RHCs and FQHCs generally furnish services that are similar to and at a frequency the same as physicians and other practitioners paid under the PFS. While we do not have actual cost information, we believe that this weighted average is an appropriate proxy since it addresses certain resource costs experienced by professionals and would mitigate any potential over or under payments. Costs associated with these services would continue to not be used in determining payments under the RHC AIR methodology or the FQHC PPS. We believe that the proposed approach would preserve the telecommunication technology flexibility under which RHC and FQHC services have been furnished for over 5 years and would not impact access to care for Medicare beneficiaries who currently benefit from these services while CMS contemplates next steps. We note that this is a stopgap approach to preserve access concerns temporarily. The same rationale that led beneficiaries who currently benefit from these services while CMS contemplates next steps. We note that this is a stopgap approach to preserve access concerns temporarily. The same rationale that led us to propose and finalize this policy last year applies again now given that congress has again extended this flexibility following publication of last year’s final rule; we beleive that our regulatory approach toward inclusion of these services furnished via telecommunications technology will continue to apply after the end of the statutory requirement that they be included. In addition, we believe that continuing this payment methodology on a temporary basis through December 31, 2026 would provide flexibility to respond to any future statutory changes. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00207 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 32558 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (1) Alternative Proposal Considered for Payment of Medical Visits Furnished via Telecommunication Technology We considered reevaluating the regulations regarding fa day, July 16, 2025 / Proposed Rules (1) Alternative Proposal Considered for Payment of Medical Visits Furnished via Telecommunication Technology We considered reevaluating the regulations regarding face-to-face visit requirements for encounters between a beneficiary and an RHC or FQHC practitioner in light of contemporary medical practices. That is, we considered proposing a revision to the regulatory requirement that an RHC or FQHC medical visit must be a face-to- face (that is, in-person) encounter between a beneficiary and an RHC or FQHC practitioner to also include encounters furnished through interactive, real-time, audio and video telecommunications technology. This would result in payment for services furnished via telecommunication technology to be made under the RHC AIR methodology and under the FQHC PPS, similar to how we revised the regulations for mental health visits. We believe interested parties may prefer the per visit payment that aligns with the RHC AIR or FQHC PPS. However, we did not propose this alternative because we determined that it would have unintended consequences, especially in cases where the RHC AIR or FQHC PPS per-visit rates would be significantly h owever, we did not propose this alternative because we determined that it would have unintended consequences, especially in cases where the RHC AIR or FQHC PPS per-visit rates would be significantly higher than the PFS rate that would apply if other entities furnished the same service to the same beneficiary in the same location. We believe that continuing to pay temporarily for RHC and FQHC services furnished via telecommunication technologies in the same manner as we have done over the past several years preserves the flexibility for RHCs and FQHCs to continue access to care, mitigates administrative burden, and mitigates potential program integrity concerns. However, we are soliciting comment on the alternative proposal we considered. That is, revising the definition of a visit to include interactive, real-time, audio/video telecommunication technology which would result in a capitated payment under the RHC AIR methodology or FQHC PPS. d. Proposal for Conforming Regulatory Text Changes Subsequent to the publication of the CY 2025 PFS final rule, section 2207(d) of the Full-Year Continuing Appropriations and Extensions Act, 2025 amended sections 1834(y)(2) and 1834(o)(4)(B) of th ges Subsequent to the publication of the CY 2025 PFS final rule, section 2207(d) of the Full-Year Continuing Appropriations and Extensions Act, 2025 amended sections 1834(y)(2) and 1834(o)(4)(B) of the Act by extending the delay of in-person requirements for mental health services furnished through telecommunication technology for RHCs and FQHCs, respectively, through September 30, 2025. We are therefore proposing to make conforming regulatory text changes based to the applicable RHC and FQHC regulations in 42 CFR part 405, subpart X, specifically, at § 405.2463, ‘‘What constitutes a visit,’’ we propose to amend paragraph (b)(3) and, at § 405.2469 ‘‘FQHC supplemental payments,’’ we propose to amend paragraph (d). Both of these provisions would require that, beginning October 1, 2025, there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of ment unications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient’s medical record. C. Ambulatory Specialty Model (ASM) 1. Overview of Proposed Ambulatory Specialty Model a. Introduction Under the authority of the Center for Medicare and Medicaid Innovation (Innovation Center) in section 1115A(b) of the Act, we are proposing the implementation and testing of the Ambulatory Specialty Model (ASM), a new mandatory alternative payment model with 5 performance years that would begin January 1, 2027 and end December 31, 2031. ASM would test whether adjusting payment for specialists based on their performance on targeted measures of quality, cost, care coordination, and meaningful use of certified electronic health record (EHR) technology (CEHRT) results in enhanced qu pecialists based on their performance on targeted measures of quality, cost, care coordination, and meaningful use of certified electronic health record (EHR) technology (CEHRT) results in enhanced quality of care and reduced costs through more effective upstream chronic condition management. To enhance quality of care and lower the costs of care, ASM would be established as a mandatory model focused on the care provided by select specialists to Medicare beneficiaries with the chronic conditions of heart failure and low back pain. Under the model, clinicians would be required to report a select set of measures and activities clinically relevant to their specialty type and the chronic condition of interest. These measures and activities would assess quality, cost, interoperability, and care coordination practices, all of which are necessary for effective upstream chronic condition management. To incentivize improvements in quality and care coordination, CMS would assess the clinician’s performance on those measures and activities relative to their peers, who are also participants of the model and of a similar specialty type treating the same chronic condition. ASM falls within a lar performance on those measures and activities relative to their peers, who are also participants of the model and of a similar specialty type treating the same chronic condition. ASM falls within a larger framework of activities initiated by the Innovation Center to focus on high-volume, high- cost chronic conditions and direct engagement of specialists in value-based payment. The Innovation Center recently announced its new strategy based on three strategic pillars for improving the health of Americans and protecting taxpayers: preventing disease through evidence-based practices, empowering people with information to make better decisions, and driving choice and competition.115 In line with the updated Innovation Center principles, this proposed rule proposes a new mandatory model that would improve beneficiary and provider engagement, incentivize preventive care, and increase financial accountability for certain specialists. The model would build upon lessons learned from previous Innovation Center models and the Merit-based Incentive Payment System (MIPS) under the Quality Payment Program. We believe the model would answer the call to create a more cohesive and efficient health s ovation Center models and the Merit-based Incentive Payment System (MIPS) under the Quality Payment Program. We believe the model would answer the call to create a more cohesive and efficient health system that enhances the quality of care and reduces costs over time. To promote preventive care, the model would incentivize specialists who are ASM participants to ensure that their patients have a regular source of primary care and are screened to help identify risks and early signs of chronic conditions. This model would also seek to prevent deterioration of and complications associated with established chronic conditions. To empower patients, the model would promote direct accountability for quality. By featuring patient-reported outcome measures in the proposed quality ASM performance category, this model encourages patients to report their improvement or decline in function, which directly impacts clinician payment and further incentivizes clinicians to incorporate patient voice and experience in clinical care decisions. We believe a focus on 115 CMS Innovation Center, CMS Innovation Center 2025 Strategy to Make America Healthy Again, May 2025. https://www.cms.gov/priorities/ inn experience in clinical care decisions. We believe a focus on 115 CMS Innovation Center, CMS Innovation Center 2025 Strategy to Make America Healthy Again, May 2025. https://www.cms.gov/priorities/ innovation/about/strategic-direction#: ∼:text=Three%2DPronged%20Approach,served% 20by%20the%20Innovation%20Center. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00208 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 32559 patient-reported measures elevates patient voice, leading clinicians to be more responsive to the patient’s response to treatment, while also addressing the significant spending that results from functional impairment. These measures also provide a pathway for clinicians to have conversations about non-medical, lifestyle-based interventions with their patients. This proposed model is intent on removing the onus from patients to act as the go- between among clinicians they see for their care by incentivizing clinicians to coordinate care for their patients more seamlessly. Patients would be able to focus on from patients to act as the go- between among clinicians they see for their care by incentivizing clinicians to coordinate care for their patients more seamlessly. Patients would be able to focus on solutions to their health, rather than resolving information and guidance they have received from multiple clinicians. Finally, the model would require the participation of individual clinicians rather than organizations to encourage competition and create a level playing field for solo and small practices. By evaluating clinicians individually, ASM removes the unequal reporting and scoring benefits that have been previously afforded to consolidated health systems and group practices. This form of mandatory participation would bring transparency, accountability, and comparability at the clinician-level, helping to identify clinicians within large, consolidated health systems or provider networks providing low-value care. Low-value care refers to services that: (1) may offer limited or no clinical benefit to a patient; or (2) may present risks of harm that outweigh the potential benefit. By requiring the participation of individual clinicians, we believe this model would reduce spending linical benefit to a patient; or (2) may present risks of harm that outweigh the potential benefit. By requiring the participation of individual clinicians, we believe this model would reduce spending that represents low-value services and major cost-drivers for heart failure and low back pain (for example, unnecessary imaging, surgeries, hospital admissions). Ultimately, this model aims to drive competition among similar specialists with a targeted assessment of their performance relative to their peers in the treatment of a specific chronic condition and protect taxpayers by reducing low-value services by holding specialists accountable for the cost of services clinically related to their role in managing care. We have designed ASM with a focus on clinicians who commonly treat patients in the ambulatory setting, develop longitudinal relationships with patients, and co-manage beneficiaries with primary care clinicians. In addition, we considered those who treat chronic conditions that are likely to benefit from improved integration between specialty and primary care to maximize opportunities for incentivizing high-value care and tertiary prevention. Specifically, we propose to foc are likely to benefit from improved integration between specialty and primary care to maximize opportunities for incentivizing high-value care and tertiary prevention. Specifically, we propose to focus the model on the chronic conditions of heart failure and low back pain, as they have previously established episode-based cost measures (EBCMs) specified for the MIPS cost performance category. The EBCMs were developed with specialists and stakeholders through an extensive, collaborative process that, by design, focused on conditions with a large share of Medicare spending, a high number of responsible clinicians, and opportunities for care improvement. Based on recent estimates, heart failure and low back pain, in particular, account for 3.5 and 2.7 percent total Medicare Part A and B spending.116 These are significantly higher than other chronic conditions with EBCMs, which account for less than one percent of Medicare Part A and B spending, except for diabetes, which accounts for 4.2 percent of spending.117 In contrast, many Medicare beneficiaries with type 2 diabetes are capably managed by primary care physicians as the quarterback of their care with input from consulting specia percent of spending.117 In contrast, many Medicare beneficiaries with type 2 diabetes are capably managed by primary care physicians as the quarterback of their care with input from consulting specialists. Consequently, we do not believe it would be an appropriate chronic condition for this specialty care model. ASM would be a mandatory model that begins on January 1, 2027 and ends December, 31, 2033. There would be 5 performance years, beginning January 1, 2027 and ending December 31, 2031. Final data submission of measures and activities would be in CY 2032, with final model payment adjustments in CY 2033. To measure clinician performance in ASM, we would establish a mandatory set of measures and activities for physicians that meet the proposed ASM participant eligibility criteria described in section III.C.2.c.(3). of this proposed rule. ASM aims to assess the performance of ASM participants providing care for Medicare beneficiaries with the targeted chronic conditions at the individual clinician level. Specifically, ASM would test whether adjusting Medicare Part B payments for covered professional services based on measures of quality, cost, care coordination, and CEHRT result idual clinician level. Specifically, ASM would test whether adjusting Medicare Part B payments for covered professional services based on measures of quality, cost, care coordination, and CEHRT results in enhanced quality of care and reduced costs through more effective upstream chronic condition management. ASM would leverage components of the existing MIPS Value Pathway (MVP) 116 Quality Payment Program, 2025 Summary of Cost Measures, December 2024. https://qpp-cm- prod-content.s3.amazonaws.com/uploads/3129/ 2025-mips-summary-cost-measures.pdf. 117 Ibid. framework, as appropriate, to meaningfully engage specialists in improving the quality of care for high- volume, high-cost chronic conditions and better integrate specialists in primary care. MVPs are one MIPS reporting option that provides a smaller set of measures to choose from that are most relevant to a condition or specialty. Currently, for MIPS, CMS assesses the performance of each MIPS eligible clinician on measures and activities CMS has specified for a CY performance period/MIPS payment year for four performance categories: quality, cost, clinical practice improvement activities, and meaningful use of CEHRT (referred to ities CMS has specified for a CY performance period/MIPS payment year for four performance categories: quality, cost, clinical practice improvement activities, and meaningful use of CEHRT (referred to as ‘‘Promoting Interoperability’’). In accordance with section 1848(q) of the Act, CMS calculates a composite performance score (a ‘‘final score’’ as defined at § 414.1305) from 0 to 100 points for each MIPS eligible clinician. Then, CMS compares each MIPS eligible clinician’s final score to the performance threshold established in prior rulemaking for that CY performance period/MIPS payment year to calculate the MIPS payment adjustment factor as specified in section 1848(q)(6) of the Act. For the applicable MIPS payment year, CMS would calculate and apply to each MIPS eligible clinician: (1) a positive adjustment, if their final score exceeds the performance threshold; (2) a neutral adjustment, if their final score meets the performance threshold; or (3) a negative adjustment, if their final score is below the performance threshold. In calculating the MIPS payment adjustment factor for each MIPS eligible clinician, CMS accounts for scaling factor and budget neutrality requirements, a inal score is below the performance threshold. In calculating the MIPS payment adjustment factor for each MIPS eligible clinician, CMS accounts for scaling factor and budget neutrality requirements, as further specified in section 1848(q)(6) of the Act. By applying these budget neutrality and scaling factor requirements, CMS’s calculations of positive MIPS payment adjustment factors for each MIPS eligible clinician are limited by CMS’s calculations of negative MIPS payment factors for each MIPS eligible clinician. In other words, CMS’s estimated amounts of positive MIPS payment adjustment factors for MIPS eligible clinicians performing above the performance threshold must be offset by CMS’s estimated amounts of negative MIPS payment adjustment factors for MIPS eligible clinicians performing below the performance threshold. In MVPs, however, clinicians still have flexibility to select which measures to report. Under MIPS, a clinician’s performance is assessed against all MIPS clinicians, regardless of reporting VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00209 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 , regardless of reporting VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00209 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 32560 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules option, specialty type, or the services they provide. As CMS discussed in a 2024 Request for Information (RFI) (89 FR 61596),118 we expect that a more targeted approach where clinicians are evaluated: (1) on required reporting of a set of relevant performance measures; and (2) among clinicians furnishing similar sets of services, 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. This targeted approach would include reporting or required collection of patient-reported outcome measures that assess the change in a beneficiary’s functional status over the course of the episode, ensuring clinicians prioritize the same goals as their patients. Furthermore, equipped with more e measures that assess the change in a beneficiary’s functional status over the course of the episode, ensuring clinicians prioritize the same goals as their patients. Furthermore, equipped with more specialty-relevant performance information, we expect clinicians would be more likely to invest resources in pursuit of better outcomes and improved care coordination, ultimately resulting in better care for patients. To test this more targeted approach, this proposed mandatory model leverages the existing MVP policies, deviating from MVP policies in specific ways, as applicable. First, unlike the voluntary measure and activity selection permitted under the MVP reporting option, ASM would require clinicians to report on a set of measures and activities clinically relevant to their specialty type and the chronic condition. of interest. This would ensure a more analogous comparison between clinicians. Second, while clinicians reporting under MVPs are scored against the entire pool of MIPS clinicians, ASM would assess performance against only those clinicians treating the same chronic condition. Each clinician would receive a performance score based on the measures and activities included inicians, ASM would assess performance against only those clinicians treating the same chronic condition. Each clinician would receive a performance score based on the measures and activities included in the four ASM performance categories (which are based on the MIPS performance categories)—quality, cost, improvement activities, and Promoting Interoperability. In section III.C.2.d. of this proposed rule, we describe the proposed requirements in the quality, cost, improvement activities, and Promoting Interoperability ASM performance categories. 118 Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Medicare Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments. Third, we would use a different approach, compared to MVPs, for aggregating the ASM performance categories to calculate a final score and determine the ASM payment adjustment. This approach would broaden the distribution of final scores and increase the magnitude of payment adjustments, which we believe would incentivize performance improvements that would l ent adjustment. This approach would broaden the distribution of final scores and increase the magnitude of payment adjustments, which we believe would incentivize performance improvements that would lead to more effective upstream chronic condition management. We refer readers to the CY 2022 PFS final rule for additional details on the MVP performance category weighting § 414.1365(e). As described in section III.C.2.e. of this proposed rule, we would focus on value and variation in clinician performance by primarily measuring performance on quality and cost performance categories for calculating the ASM final score. We also understand the importance of the improvement activities and Promoting Interoperability performance categories and would apply potential negative scoring adjustments for non-reporting or poor performance. We are also considering additional positive scoring adjustments for clinicians in small practices participating in the model and for ASM participants treating a large proportion of medically complex patients. We refer readers to sections III.C.2.c., III.C.2.d., and III.C.2.e. of this proposed rule for additional details on the proposed policies related to ASM pa ge proportion of medically complex patients. We refer readers to sections III.C.2.c., III.C.2.d., and III.C.2.e. of this proposed rule for additional details on the proposed policies related to ASM participant eligibility criteria, the quality, cost, improvement activities, and Promoting Interoperability ASM performance categories, and ASM final scoring calculations. To ensure savings in the financial impacts for the model, ASM would also retain a percentage of the payments rather than distributing all funds as clinicians’ payment adjustments. ASM participants would receive neutral, negative, or positive payment adjustments on future Medicare Part B payments for covered professional services based on their performance during an ASM performance year. As is done under MIPS, clinicians participating in ASM would continue to bill Medicare under the traditional FFS system for services furnished to Medicare FFS beneficiaries. MIPS eligibility criteria described under 42 CFR 414.1305 are not factored into the ASM participant eligibility criteria described in section III.C.2.c.(3). of this proposed rule. However, MIPS eligible clinicians participating in this model would be exempt from MIP factored into the ASM participant eligibility criteria described in section III.C.2.c.(3). of this proposed rule. However, MIPS eligible clinicians participating in this model would be exempt from MIPS reporting requirements for any ASM performance year that they are included in ASM. b. Background Health care is becoming more fragmented as Medicare beneficiaries are increasingly seeing a greater number of specialists on a more regular basis. At the same time, the volume of primary care visits has remained relatively constant.119 120 Primary care teams must now coordinate with more specialists than ever before,121 despite persistent barriers to specialist access for certain patients.122 123 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 disease. Although the Innovation Center has tested models that address the integration of primary and specialty care for chronic conditions that may benefit from greater collaboration and create opportunities for preventive care, these models have been largely foc ddress the integration of primary and specialty care for chronic conditions that may benefit from greater collaboration and create opportunities for preventive care, these models have been largely focused on behaviors and practice patterns in primary care.124 This proposed model test elects to focus on the behaviors and practice patterns in specialty care for those treating chronic conditions and would be the first Innovation Center 119 Barnett ML, Bitton A, Souza J, Landon BE. Trends in Outpatient Care for Medicare Beneficiaries and Implications for Primary Care, 2000 to 2019 [published correction appears in Ann Intern Med. 2022 Oct;175(10):1492]. Ann Intern Med. 2021;174(12):1658–1665. doi:10.7326/M21– 1523. 120 Lori Timmins, PhD, Carol Urato, MA, Lisa M. Kern, MD, MPH, Arkadipta Ghosh, PhD, Eugene Rich, MD. Primary Care Redesign and Care Fragmentation Among Medicare Beneficiaries. The American Journal of Managed Care, March 2022, Volume 28, Issue 3. 121 The CMS Innovation Center’s strategy to support person-centered, value-based specialty care. 2022. Retrieved from https://www.cms.gov/ blog/cms-innovation-centers-strategy-support- person-centered-value-based-specialty-care. 122 trategy to support person-centered, value-based specialty care. 2022. Retrieved from https://www.cms.gov/ blog/cms-innovation-centers-strategy-support- person-centered-value-based-specialty-care. 122 McConnell KJ, Charlesworth CJ, Zhu JM, Meath THA, George RM, Davis MM, Saha S, Kim H. Access to Primary, Mental Health, and Specialty Care: A Comparison of Medicaid and Commercially Insured Populations in Oregon. J Gen Intern Med. 2020 Jan;35(1):247–254. doi: 10.1007/s11606–019– 05439–z. Epub 2019 Oct 28. PMID: 31659659; PMCID: PMC6957609. 123 Romaire MA, Haber SG, Wensky SG, McCall N. Primary care and specialty providers: an assessment of continuity of care, utilization, and expenditures. Med Care. 2014;52(12):1042–1049. doi:10.1097/MLR.0000000000000246. 124 See the evaluation reports of the Comprehensive Primary Care Plus (CPC+) model, which ran from 2017 to 2021, https://www.cms.gov/ priorities/innovation/innovation-models/ comprehensive-primary-care-plus. See also the evaluation reports of the Primary Care First (PCF) model, which began in 2021 and will end December 31, 2025, https://www.cms.gov/priorities/ innovation/innovation-models/primary-care-first- model-options. VerDate Sep s of the Primary Care First (PCF) model, which began in 2021 and will end December 31, 2025, https://www.cms.gov/priorities/ innovation/innovation-models/primary-care-first- model-options. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00210 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 32561 model to use the MVP framework as the foundation for a model test. We believe the MVP framework has many benefits. First, the MVP framework advances value-based care by narrowing the available measure set based upon clinician specialty, medical condition, or patient population, which allows for meaningful comparisons to be made across providers and relevant feedback to be available to participants on their performance, strengthening the foundation for accountability in specialty care. The MVPs utilize a cohesive set of measures and activities focused on performance in rendering care for a particular specialty or clinical condition. Second, we believe that meaningful comparisons of performance combined with a payment methodology activities focused on performance in rendering care for a particular specialty or clinical condition. Second, we believe that meaningful comparisons of performance combined with a payment methodology that includes more significant Medicare Part B payment adjustments, would encourage meaningful specialty care engagement with primary care clinicians to both prevent and manage the onset of chronic conditions. Third, we intend to test ASM’s more targeted approach to performance assessment, as described in the introduction section of this proposed rule, so it may provide a foundation to potentially expand this approach to other specialist cohorts treating other chronic conditions. While there are 21 MVPs for the CY 2025 performance period/2027 MIPS payment year spanning numerous specialties, CMS has a goal of creating additional MVPs relevant to the practices of 80 percent of MIPS eligible clinicians. The MVP reporting option, with its focused set of measures and activities aligned around specific specialties or conditions, provides a framework for applying ASM’s targeted approach to other specialist cohorts treating other chronic conditions. Using an existing framework that is agnosti specific specialties or conditions, provides a framework for applying ASM’s targeted approach to other specialist cohorts treating other chronic conditions. Using an existing framework that is agnostic to specialty type, as opposed to creating multiple unique models that are each narrowly defined by a condition or specialty, would allow the Innovation Center to take a more inclusive and unified approach to increasing specialist engagement in value-based payment. Using MVPs as a framework to test a chronic condition model, ASM would increase the number of specialists in value-based care arrangements and hold them accountable for ensuring beneficiaries have a regular source of primary care. Through required improvement activities and measures, the model would also encourage specialty care providers to actively engage with both beneficiaries and PCPs to improve care transitions and make certain their patients are receiving preventive care, such as screening for obesity and depression. When primary and specialty care providers collaborate across care settings, together they can deliver accountable care that best meets patients’ needs and preferences. 2. Provisions of Proposed Ambulator n primary and specialty care providers collaborate across care settings, together they can deliver accountable care that best meets patients’ needs and preferences. 2. Provisions of Proposed Ambulatory Specialty Model a. Definitions We propose at 42 CFR 512.705 to define certain terms for ASM. We describe these proposed definitions in context throughout section III.C.2 of this proposed rule. We propose to codify the definitions and policies of ASM at 42 CFR part 512 subpart G (proposed § 512.705 through § 512.780). In addition, we propose that the definitions contained in the standard provisions for mandatory Innovation Center models at subpart A of part 512 would also apply to ASM, unless expressly stated otherwise in the proposed policies set forth at § 512.705 through § 512.780. We seek comments on these proposed definitions for ASM. b. Proposed Length of Model Test We propose at § 512.705 to define the ‘‘ASM test period’’ as the 7-year period from January 1, 2027, to December 31, 2033, that includes all ASM performance years and ASM payment years as described in Table 36. We propose at § 512.705 to define ‘‘ASM performance year’’ as a 12-month period beginning on January 1 and 033, that includes all ASM performance years and ASM payment years as described in Table 36. We propose at § 512.705 to define ‘‘ASM performance year’’ as a 12-month period beginning on January 1 and ending on December 31 of each year during the first 5 calendar years of ASM test period. We propose at § 512.705 to define an ‘‘ASM payment year’’ as a calendar year in which CMS applies the ASM payment multiplier to Medicare Part B payments based on the final score achieved by that ASM participant for the ASM performance year 2 years prior. Like MIPS, we propose that an ASM payment year occurs 2 calendar years following the ASM performance year that determines the ASM participant’s final score that then determines their payment adjustment factor applied in that ASM payment year. For instance, the CY 2027 ASM performance year would correspond to the CY 2029 ASM payment year to allow time for ASM participants to submit required data for each of the ASM performance categories as described in section III.C.2.d of this proposed rule and for CMS to score submitted data for the ASM performance categories, calculate final scores, and determine payment adjustments as discussed in sections III. section III.C.2.d of this proposed rule and for CMS to score submitted data for the ASM performance categories, calculate final scores, and determine payment adjustments as discussed in sections III.C.2.d., III.C.2.e, and III.C.2.f of proposed rule. Final data submission of measures and activities would be in CY 2032, with final model payment adjustments in CY 2033. This timeline aligns with MIPS in that those who report traditional MIPS or MVPs receive an adjustment to their Medicare Part B fee-for-service payments 2 years after the corresponding MIPS performance period based on a total score calculated from reported measures and activities across the MIPS performance categories (see §§ 414.1305, 414.1320, 414.1365, and 414.1405(e)). We believe 5 ASM performance years followed by 5 ASM payment years would allow sufficient time for ASM participants to invest in care delivery transformation and for CMS to evaluate the impact of the model’s payment adjustments. 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 00211 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32562 Federal Register / Vol. 90, No. 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 00211 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32562 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules We propose an ASM start date of January 1, 2027. We alternatively considered proposing an ASM start date as January 1, 2026, but given the rulemaking process, an earlier start date would not have given ASM participants enough time to prepare for participation in ASM. We believe that the ASM test period of 7 years, as opposed to a shorter duration, is necessary to obtain sufficient data to compute a reliable impact estimate and to analyze the data from the Model to determine the next steps regarding potential expansion or extension of the Model. Further, we believe that a test period of 7 years is necessary to address and mitigate any potential implementation issues or unintended consequences. For a discussion of the proposed evaluation approach, please see section III.C.2.l of this proposed rule. We invite public comments on the proposed ASM test period of 7 years. We also seek comment on the proposed ASM start date of January 1, 2027. c ach, please see section III.C.2.l of this proposed rule. We invite public comments on the proposed ASM test period of 7 years. We also seek comment on the proposed ASM start date of January 1, 2027. c. Proposed ASM Participants (1) Proposed Mandatory Participation We believe that requiring clinicians to participate in the model test is necessary to eliminate selection bias, yield generalizable results, and ensure an evaluable comparison group. Voluntary participation in Innovation Center models has demonstrated that those electing to voluntarily participate are more likely to have the infrastructure and experience to succeed under the model. Moreover, in a voluntary model, when the opportunity for financial gain is reduced or uncertain, participant attrition increases. We believe requiring participation in ASM would prevent this type of selection bias. Mandatory participation in ASM would also ensure a sufficient volume of participants to produce a necessarily diverse, representative evaluation of clinicians providing specialty care to Medicare beneficiaries with heart failure or low back pain. We believe ASM could highlight inefficient care utilization patterns and potentially inf valuation of clinicians providing specialty care to Medicare beneficiaries with heart failure or low back pain. We believe ASM could highlight inefficient care utilization patterns and potentially inform quality improvement and care coordination incentives for application in the Quality Payment Program, the MVP reporting option, and future Innovation Center models. Finally, mandatory participation would generate a statistically robust test of ASM with results that are reliable, generalizable, and able to support potential model expansion. Therefore, we propose at § 512.710(a)(1) that participation in ASM would be mandatory for all clinicians who meet the ASM participant eligibility criteria at § 512.710(b). Specifically— • 2027 ASM performance year: ASM participants would be measured for performance and exempted from MIPS participation, if applicable, during CY 2027; report and be scored during CY 2028; and receive payment adjustments for CY 2027 performance in CY 2029; • 2028 performance year: ASM participants meeting ASM participant eligibility criteria for the 2028 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2 nce year: ASM participants meeting ASM participant eligibility criteria for the 2028 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2028; report and be scored during CY 2029; and receive payment adjustments for CY 2028 performance in CY 2030; • 2029 ASM performance year: ASM participants meeting ASM participant eligibility criteria for the 2029 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2029; report and be scored during CY 2030; and receive payment adjustments for CY 2029 performance in CY 2031; • 2030 ASM performance year: ASM participants meeting ASM participant eligibility criteria for the 2030 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2030; report and be scored during CY 2031; and receive payment adjustments for CY 2030 performance in CY 2032; and • 2031 ASM performance year: ASM participants meeting ASM participant eligibility criteria for the 2031 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2031; repo ASM participants meeting ASM participant eligibility criteria for the 2031 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2031; report and be scored during CY 2032; and receive payment adjustments for CY 2031 performance in CY 2033. We propose at § 512.710(a)(1) that once a clinician meets the ASM participant eligibility criteria, they would be considered an ASM participant for the duration of the model. We propose at § 512.710(a)(2) that clinicians would be exempt from MIPS reporting for any ASM performance year that they meet ASM participant eligibility criteria and, therefore, must meet ASM model requirements. However, for any model year that a previously selected ASM participant does not continue to meet the ASM participant eligibility criteria for the upcoming ASM performance year/ASM payment year, the ASM participant would not be required to submit data in accordance with § 512.720, as proposed, would not be scored in accordance with § 512.745, as proposed, and would not receive an ASM payment adjustment in accordance with § 512.750. In addition, because the proposed Medicare waiver at § 512.775 only waives t ed in accordance with § 512.745, as proposed, and would not receive an ASM payment adjustment in accordance with § 512.750. In addition, because the proposed Medicare waiver at § 512.775 only waives the requirements of section 1848(q) of the Act, and its implementing VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00212 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 00213 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 32564 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules a cardiology specialty code on the plurality of their Medicare Part B claims. We also seek comments on including subspecialist cardiology codes in the ASM heart failure cohort. (b) ASM Low Back Pain Cohort We identified several nonsurgical and surgical specialties that commonly manage, treat, and maintain long-term relationships with patients with low back pain in the ambulatory setting. Both nonsurgical and surgical specialists offer meaningful, conservative (that is mmonly manage, treat, and maintain long-term relationships with patients with low back pain in the ambulatory setting. Both nonsurgical and surgical specialists offer meaningful, conservative (that is, less invasive) treatment options.126 However, some low back pain treatments, including spinal fusion for the treatment of non- complex low back pain, contribute to low-value care.127 For this reason, we believe including the specialists who most commonly perform these procedures is prudent for this model. While surgical specialists are proceduralists, they are also commonly involved in the longitudinal management of Medicare beneficiaries with low back pain. Nevertheless, to ensure ASM would meet its goal of comparing like participants, we examined whether it would be appropriate to include nonsurgical and surgical specialists in the same ASM cohort. We stratified 2023 EBCM data by beneficiaries who underwent surgery on their spine and who had complex low back pain and found that, across all specialty types, more than 80 percent of beneficiaries with episodes for low back pain did not undergo spine surgery (83.8 percent for neurosurgery; 90.8 percent for orthopedic surgery), as demon all specialty types, more than 80 percent of beneficiaries with episodes for low back pain did not undergo spine surgery (83.8 percent for neurosurgery; 90.8 percent for orthopedic surgery), as demonstrated in Table 37. Because orthopedic surgeons and neurosurgeons primarily treat low back pain non-surgically, we believe it is acceptable to include both surgical and nonsurgical specialists in the ASM low back pain cohort. Moreover, the EBCM episode volume eligibility criteria as described in section III.C.2.c.(3)(b) of this proposed rule would screen out specialists who are not treating low back pain longitudinally in the outpatient setting. We propose at § 512.710(d)(2), for the ASM low back pain cohort, to select clinicians with a specialty type of anesthesiology, interventional pain management, neurosurgery, orthopedic surgery, pain management, and physical medicine and rehabilitation, provided they meet all applicable ASM participant eligibility criteria for an ASM performance year. We note that there may be some overlap between pain management, interventional pain management, and anesthesiology. However, we propose to include all three specialty designations to ensure we incl r. We note that there may be some overlap between pain management, interventional pain management, and anesthesiology. However, we propose to include all three specialty designations to ensure we include anesthesiologists that have not yet updated their subspecialty with Medicare and those anesthesiologists treating low back pain without pursuing fellowship training. Although other clinicians do treat low back pain, we propose that only those listed would be required to participate in ASM. We considered other specialties who could trigger higher volumes of low back pain episodes. For example, chiropractors and physical therapists work closely with both primary care and specialists to treat low back pain, often providing first-line therapy. However, we believe the selected specialties are better positioned to direct and be held accountable for the longitudinal management of low back pain that may employ a variety of modalities. We seek public comments on our proposal at § 512.710(d)(2) to only include in the ASM low back pain cohort clinicians with a specialty code of anesthesiology, interventional pain management, neurosurgery, orthopedic surgery, pain management, or physical medic to only include in the ASM low back pain cohort clinicians with a specialty code of anesthesiology, interventional pain management, neurosurgery, orthopedic surgery, pain management, or physical medicine and rehabilitation on the plurality of their Medicare Part B claims. We seek comments on alternative low back pain-related specialty types that we considered including the ASM low back pain cohort. (3) ASM Participant Eligibility Criteria In selecting participants for ASM, we seek to ensure (1) we include a sufficient volume of clinicians treating Medicare beneficiaries for the same clinical condition in the ambulatory setting; (2) there is a reasonable expectation that participants can be measured under the model and held accountable for the care provided to Medicare beneficiaries with heart failure and low back pain; (3) the selected clinicians have the operational capacity to meet the ASM performance requirements described in section III.C.2.d of this proposed rule; and (4) the model test results would be statistically valid, reliable, and generalizable to specialty types included in ASM nationwide should the model test be successful and considered for expansion under section 11 l test results would be statistically valid, reliable, and generalizable to specialty types included in ASM nationwide should the model test be successful and considered for expansion under section 1115A(c) of the Act. Therefore, we propose at § 512.705 to define ‘‘ASM participant eligibility criteria’’ as the set of criteria defined at § 512.710(b) that CMS uses to determine whether a clinician is selected to participate in ASM. We propose at § 512.710(b) that clinicians who meet all of the following ASM participant eligibility criteria would be required to participate in ASM: • Is a clinician who bills claims under the Medicare Physician Fee Schedule. • Is identified by TIN/NPI as a selected specialty type. • Meets the EBCM episode volume threshold applicable to an ASM targeted chronic condition. • Is located in one of the selected mandatory geographic areas. 126 Steinmetz A. Back pain treatment: a new perspective. Ther Adv Musculoskelet Dis. 2022 Jul 4;14:1759720X221100293. doi: 10.1177/ 1759720X221100293. PMID: 35814351; PMCID: PMC9260567. 127 Buchbinder R, Underwood M, Hartvigsen J, Maher CG. The Lancet Series call to action to reduce low value care for low back pain: an updat 1177/ 1759720X221100293. PMID: 35814351; PMCID: PMC9260567. 127 Buchbinder R, Underwood M, Hartvigsen J, Maher CG. The Lancet Series call to action to reduce low value care for low back pain: an update. Pain. 2020 Sep;161 Suppl 1(1):S57–S64. doi: 10.1097/j.pain.0000000000001869. PMID: 33090740; PMCID: PMC7434211. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00214 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00215 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 32566 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules on the alternative method of using TIN- level specialty type for identifying ASM participants, as well as selecting a single TIN/NPI combination as an ASM participant in the case that a clinician meets ASM eligibility requirements under more than one TIN/NPI combination. (ii) Participant Exclusion due to Change in TIN During an ASM Performance Year We recognize that ASM participants may change practices (as reflected by a change in TIN) during an ASM performance year. In such circumstances, we wo e to Change in TIN During an ASM Performance Year We recognize that ASM participants may change practices (as reflected by a change in TIN) during an ASM performance year. In such circumstances, we would need to determine whether the ASM participant must continue to meet model requirements for the original TIN, for the new TIN, or would no longer be required to meet model requirements under either TIN for that ASM performance year. We propose at § 512.710(c)(1) that an ASM participant who, during an applicable ASM performance year, no longer assigns their billing rights to the TIN CMS used to identify them as an ASM participant must notify CMS of such change within 30 days of the change in a form and manner determined by CMS. We propose at § 512.710(c)(2) that an ASM participant who notifies CMS of a change in TIN during an ASM performance year would no longer be required to meet ASM requirements, including data submission requirements described at § 512.720, for the applicable ASM performance year and would instead be subject to MIPS reporting obligations, if applicable. We also propose that the waivers, including the MIPS waiver, established at § 512.775 would no longer apply beg formance year and would instead be subject to MIPS reporting obligations, if applicable. We also propose that the waivers, including the MIPS waiver, established at § 512.775 would no longer apply beginning on the date we determine the clinician is no longer required to meet model requirements for the applicable ASM performance year. If the ASM participant fails to notify CMS within 30 days of no longer assigning billing rights to the original TIN in the form and manner determined by CMS, then the ASM participant would be required to meet the data submission requirements described at § 512.720 for the applicable ASM performance year. Given our proposal to determine whether clinicians meet ASM participant eligibility criteria for each ASM performance year, we believe that we would naturally identify the movement of individual clinicians to a different TIN between ASM performance years. However, if an ASM participant reassigns their billing rights to a new TIN during an ASM performance year, CMS would not have sufficient data for the new TIN/NPI combination to determine if the ASM participant continues to meet all ASM participant eligibility criteria. For example, we would not have t ear, CMS would not have sufficient data for the new TIN/NPI combination to determine if the ASM participant continues to meet all ASM participant eligibility criteria. For example, we would not have timely EBCM data available for the new TIN/ NPI combination to determine if the ASM participant meets the 20 EBCM episode volume criterion (discussed in section III.C.2.c.(3).(b) of this proposed rule) under the new TIN. Without complete data to evaluate whether the ASM participant continues to meet the ASM participant eligibility criteria, we propose, for that ASM performance year, the ASM participant would not be required to submit data in accordance with § 512.720, as proposed, would not be scored in accordance with § 512.745, as proposed, and would not receive an ASM payment adjustment in accordance with § 512.750. Because the proposed Medicare waiver at § 512.775 only waives the requirements of section 1848(q) of the Act, and its implementing regulations for an ASM performance year that ASM participants meets the ASM participant eligibility criteria, the ASM participant would be required to satisfy any MIPS reporting obligations and would receive a MIPS payment adjustment two years t ASM participants meets the ASM participant eligibility criteria, the ASM participant would be required to satisfy any MIPS reporting obligations and would receive a MIPS payment adjustment two years later, in accordance with current regulations. We intend to monitor TIN changes in each ASM cohort within each ASM performance year and across the ASM model test period. If CMS determines that changes to this policy are warranted for future ASM performance years, we would propose those changes through notice and comment rulemaking. We considered requiring an ASM participant who reassigns their billing rights to a new TIN during an ASM performance year to continue to meet all model requirements for the applicable ASM performance year under the new TIN/NPI combination. As ASM focuses on specialty care related to specific chronic conditions, we considered that the ASM participant would likely continue to furnish services related to ASM targeted chronic conditions under the same specialty type and trigger applicable EBCM episodes during the remainder of the applicable ASM performance year. As discussed in sections III.C.2.d.(3) and III.C.2.e.(2).(b) of this proposed rule, in the case that e and trigger applicable EBCM episodes during the remainder of the applicable ASM performance year. As discussed in sections III.C.2.d.(3) and III.C.2.e.(2).(b) of this proposed rule, in the case that an ASM participant under a new TIN/NPI combination does not trigger at least 20 episodes during the remainder of the applicable ASM performance year, the ASM participant would not receive a final score. Accordingly, they would receive no payment adjustments in the corresponding ASM payment year as described at § 512.750(d). However, if an ASM participant under a new TIN were to: (1) receive quality and cost ASM performance category scores discussed in sections III.C.2.d.(2).(i) and III.C.2.d.(3).(g) of this proposed rule, and (2) meet the requirements to receive a final score as discussed in section III.C.2.e.(2) of this proposed rule, then we believe it would be appropriate to determine an ASM payment adjustment factor and ASM payment multiplier for the ASM participant under the new TIN/NPI combination. We ultimately decided to not propose this policy because we believe that conforming to the policy set forth in section III.C.2.c.(1), which requires an ASM participant to satisfy any NPI combination. We ultimately decided to not propose this policy because we believe that conforming to the policy set forth in section III.C.2.c.(1), which requires an ASM participant to satisfy any MIPS reporting obligations when they no longer meet ASM participant eligibility criteria, would avoid adding unnecessary complexity to the model. We also considered not requiring an ASM participant to notify CMS if the change in TIN occurs during an ASM performance year and continuing to require the ASM participant to meet all model requirements under the original TIN/NPI combination for the applicable ASM performance year. However, we believe that it would be challenging for the ASM participant to access the necessary data to meet the data submission requirements if no longer affiliated with the original TIN. Therefore, we do not believe it would be appropriate to hold an ASM participant in this situation accountable for ASM requirements under the original TIN. We seek comments on our proposal at § 512.710(c) to exclude ASM participants who change TIN during an applicable ASM performance year from ASM reporting requirements for that year of the model. We also seek comments on the alte posal at § 512.710(c) to exclude ASM participants who change TIN during an applicable ASM performance year from ASM reporting requirements for that year of the model. We also seek comments on the alternatives of requiring the ASM participant to meet model requirements under their new TIN, as well as the alternative of requiring the ASM participant to meet model requirements and data submission requirements under the original TIN/NPI combination that identified them as an ASM participant. (iii) ASM Specialty Identification To ensure that all clinicians meeting the specialty requirements described at § 512.710(d) are included in the model, we propose to define ‘‘specialty type’’ based on the specialty code indicated on the plurality of a clinician’s Medicare Part B claims during the period described in section III.C.2.c.(5) of this proposed rule. Specifically, we plan to use the same specialty codes used for the Quality Payment Program to identify VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00216 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, Jul 265001 PO 00000 Frm 00216 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 32567 MIPS eligible clinicians as defined at § 414.1305.128 The specialty codes used on Medicare Part B claims are not reported by clinicians but are assigned to claims by the Medicare Administrative Contractors (MACs) and derived from the clinician-reported specialty designations that are entered in the Provider Enrollment, Chain, and Ownership System (PECOS) as part of the Medicare provider enrollment application. Because a clinician’s specialty code could change during an ASM performance year, we propose to use the specialty code assigned to the majority of a clinician’s Medicare Part B claims for determining specialty type for ASM. We also considered using PECOS specialty designation alone for the purpose of determining specialty type for ASM. However, the PECOS specialty codes are self-reported, and a single clinician may list more than one primary specialty, which may make it unreliable as a single source for identifying a clinician’s primary specialty ECOS specialty codes are self-reported, and a single clinician may list more than one primary specialty, which may make it unreliable as a single source for identifying a clinician’s primary specialty. We stated in the CY 2023 PFS final rule that given the strong alignment between PECOS data and claims data and our historical use of claims data to identify a clinician’s specialty, we believe that Medicare Part B claims data would be the best data source to use to identify a clinician’s specialty (87 FR 70039).129 Moreover, given that the Quality Payment Program uses Medicare claims data, we do not want to create inconsistencies between specialty types for ASM and MIPS. We also considered using the Health Care Provider Taxonomy Codes, which categorize the type, classification, and/ or specialization of health care providers. These codes offer more specificity than PECOS (87 FR 70039) and are used when applying for an NPI from the National Plan and Provider Enumeration System (NPPES). However, they are not verified for accuracy.130 We have previously elected not to use the Health Care Provider Taxonomy Codes for MIPS because of uncertainty regarding the reliability of NPPES as a data wever, they are not verified for accuracy.130 We have previously elected not to use the Health Care Provider Taxonomy Codes for MIPS because of uncertainty regarding the reliability of NPPES as a data source for MIPS eligibility determinations (87 FR 70039). We analyzed the congruence between specialty designations made for the purposes of MIPS and those reported in NPPES for the proposed specialty types for each of ASM’s targeted chronic 128 https://www.federalregister.gov/d/2022-23873/ page-70039. 129 https://www.cms.gov/Medicare/CMS-Forms/ CMS-Forms/downloads/cms855i.pdf. conditions. Our analysis found a high degree of congruence between the two specialty type codes, likely because we provide a crosswalk of the Health Care Provider Taxonomy Codes and Medicare Specialty Codes that can be used by a clinician when they enroll in Medicare through PECOS.131 Given the alignment between these coding systems, we believe that remaining consistent with the specialty type determination methodology used by the Quality Payment Program is important for potential scalability of ASM. We seek comments on our proposal at § 512.710(d) to identify specialty type based on the specialty code indicate logy used by the Quality Payment Program is important for potential scalability of ASM. We seek comments on our proposal at § 512.710(d) to identify specialty type based on the specialty code indicated on the plurality of a clinician’s Medicare Part B claims. We also seek comments on using PECOS specialty codes alone and Health Care Provider Taxonomy Codes for the purpose of determining specialty type for ASM. (b) Episode-Based Cost Measure (EBCM) Episode Volume We believe that ASM participant eligibility criteria must appropriately identify clinicians who furnish a sufficient volume of services related to ASM targeted chronic conditions and who can be appropriately evaluated on costs related to the ASM targeted chronic conditions. We propose to identify ASM participants using the volume of services related to heart failure and low back pain furnished by clinicians who have a specialty designation that corresponds with the proposed specialty types discussed in III.C.2.c.(2). of this proposed rule. Only clinicians with the proposed specialty types that furnish a volume of services above a specific threshold related to the applicable ASM targeted chronic condition would be identified oposed rule. Only clinicians with the proposed specialty types that furnish a volume of services above a specific threshold related to the applicable ASM targeted chronic condition would be identified as ASM participants. That is, not all clinicians with the proposed specialty types related to heart failure and low back pain would be required to participate in ASM. We propose to use MIPS EBCMs to determine volume, rather than assessing volume based on claims for individual services. Specifically, the volume of attributed episodes from EBCMs related to the ASM targeted chronic conditions would serve as the data source by which we evaluate the volume of furnished episodes for ASM. We propose at § 512.710(e)(1) to identify ASM heart failure participants using the volume of episodes attributed to a TIN/NPI in accordance with the heart failure EBCM as specified under MIPS. We propose at 130 https://data.cms.gov/resources/medicare- 131 https://data.cms.gov/provider-characteristics/ § 512.710(e)(2) to identify ASM low back pain participants using the volume of episodes attributed to a TIN/NPI in accordance with the low back pain EBCM as specified under MIPS. We refer readers to section II (e)(2) to identify ASM low back pain participants using the volume of episodes attributed to a TIN/NPI in accordance with the low back pain EBCM as specified under MIPS. We refer readers to section III.C.2.c.(5). of this proposed rule on the proposed processes and specific years of data that we would use to assess EBCM volume to identify ASM participants. EBCMs assess Medicare resource use for a specific condition or procedure based on only those costs that occur as part of an attributed clinician’s care management. CMS uses claims data from Medicare Parts A and B, and some Medicare Part D data, if applicable, to construct the EBCMs. An episode is initiated when a clinician submits a professional claim for at least two separate services, provided to a single beneficiary, that are clinically related to the chronic condition being assessed. Although the episode is initiated and attributed to a particular clinician, the episode includes all Medicare Part A and B services for the length of the episode, as defined by the measure specifications (88 FR 79339 through79347). Therefore, regardless of who provides the care, an episode includes all services related to a beneficiary’s condition the episode, as defined by the measure specifications (88 FR 79339 through79347). Therefore, regardless of who provides the care, an episode includes all services related to a beneficiary’s condition, routine care services, and consequences of care, and excludes services that are clinically unrelated to the targeted condition of the measure.132 To attribute episodes to practices and clinicians, CMS first attributes episodes to a TIN when it performs two services indicating care for a particular condition for a single beneficiary within a certain number of days (for example, 180 days); both professional claims must have diagnosis codes for the relevant chronic condition. CMS then attributes episodes to each clinician (NPI) within the group (TIN) that rendered at least 30 percent of the total number of qualifying services during the episode. For the heart failure EBCM, CMS also checks that the clinician prescribed at least two condition-related prescriptions on different days to two different patients during the calendar year used to construct the episode plus a 1-year lookback period to ensure that attributed clinicians are actually involved in providing ongoing chronic care manage ferent patients during the calendar year used to construct the episode plus a 1-year lookback period to ensure that attributed clinicians are actually involved in providing ongoing chronic care management.133 The low back pain EBCM does not use this additional check since the types of clinicians that manage low back pain may may not prescribe the relevant medication, 132 https://www.cms.gov/files/document/wave-4- measure-development-process-macra.pdf. provider-and-supplier-taxonomy-crosswalk- methodology. medicare-provider-supplier-enrollment/medicare- provider-and-supplier-taxonomy-crosswalk/data. 133 https://www.cms.gov/files/zip/2024-cost- measure-information-forms-zip.zip-0. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00217 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 32568 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules which could prevent certain clinician types from being attributed episodes.134 CMS began development and field testing of the heart failure and low back pain measures in 2022.135 We finalized the inclusion of the heart failure and low bac types from being attributed episodes.134 CMS began development and field testing of the heart failure and low back pain measures in 2022.135 We finalized the inclusion of the heart failure and low back pain measures to the MIPS cost performance category beginning in the 2024 MIPS performance period/2026 MIPS payment year (88 FR 79319). We also finalized the inclusion of the heart failure EBCM in the Advancing Care for Heart Disease MVP (88 FR 80022 through 80025; 89 FR 99015 through 99019) and the low back pain EBCM in the in the Rehabilitative Support for Musculoskeletal Care MVP (88 FR 80002 through 80007; 89 FR 99050 through 990054). We believe that the construction of the EBCMs and the existing use of these measures within MIPS and MVPs relevant to ASM targeted chronic conditions make the measures an appropriate data source by which to identify ASM participants that furnish enough services and provide longitudinal care management for Medicare beneficiaries diagnosed with ASM targeted chronic conditions. We believe that an annual threshold of 20 or more attributed episodes from an EBCM is appropriate for identifying ASM participants that can be held accountable for quality and c ed chronic conditions. We believe that an annual threshold of 20 or more attributed episodes from an EBCM is appropriate for identifying ASM participants that can be held accountable for quality and cost related to ASM targeted chronic conditions. We have defined a case minimum of 20 episodes for the purposes of scoring chronic condition EBCMs in MIPS, including MVP reporting, as specified in § 414.1350(c)(6) (88 FR 79346 through 79348). We believe using a similar 20- episode minimum from the calendar year used for determining ASM participant eligibility increases the likelihood that an ASM participant would trigger and be attributed at least 20 episodes within a given ASM performance year. Using a 20-episode threshold would increase the likelihood that they could be scored on the applicable EBCM during the relevant ASM performance year, as described in section III.C.2.d.(3).(g) of this proposed rule. We also considered using an EBCM episode threshold greater than 20 episodes. For example, we considered the effects of using a 30-episode or 50- episode threshold. In our analysis of calendar year 2023 data, we found that a 30-episode threshold would decrease the number of potentially ple, we considered the effects of using a 30-episode or 50- episode threshold. In our analysis of calendar year 2023 data, we found that a 30-episode threshold would decrease the number of potentially eligible ASM 134 https://www.cms.gov/files/zip/mips- chrcondition-episode-based-cost-measures- attribution-methodology-2023-zip.zip. 135 https://www.cms.gov/files/document/wave-4- measure-development-process-macra.pdf. participants by 43 percent for heart failure and 35 percent for low back pain relative to the 20-episode threshold. We found that a 50-episode threshold would decrease the number of potentially eligible ASM participants by 76 percent for heart failure and by 65 percent for low back pain relative to the 20-episode threshold. We believe that the smaller number of potentially eligible ASM participants under a higher EBCM episode threshold would make for a less reliable model test. We considered but are not proposing to add the MIPS low volume threshold of Medicare Part B allowed charges for covered professional services, Medicare patients that receive Medicare Part B covered professional services, and the number of Medicare Part B services provided for individual MIPS elig ed charges for covered professional services, Medicare patients that receive Medicare Part B covered professional services, and the number of Medicare Part B services provided for individual MIPS eligible clinicians as defined at § 414.1305 as part of the ASM participant eligibility criteria. Adding the MIPS low volume threshold would mean that clinicians would have to meet the MIPS eligibility determinations as defined at § 414.1305, as well as all other ASM participant eligibility criteria, to be identified as an ASM participant. We considered using the same low volume threshold for individual MIPS eligible clinicians given the use of the MVP framework for selecting measures for ASM and to identify ASM participants that furnish a sufficient volume of services related to ASM targeted chronic conditions. Given the importance of using EBCM episode volume to identify ASM participants, we found that inclusion of the MIPS low volume threshold in our ASM participant eligibility criteria would add a secondary service volume criterion. We estimate that the inclusion of the MIPS low volume threshold on top of the EBCM episode volume threshold could potentially decrease the number of ASM pa ld add a secondary service volume criterion. We estimate that the inclusion of the MIPS low volume threshold on top of the EBCM episode volume threshold could potentially decrease the number of ASM participants by more than 50 percent. We believe that the use of the EBCM 20-episode threshold would be a more appropriate criterion for identifying ASM. We seek public comments on our proposals at § 512.710(e) to use the heart failure EBCM as specified under MIPS to identify potential ASM heart failure participants and the low back pain EBCM as specified under MIPS to identify potential ASM low back pain participants. We also seek comments on our proposal that clinicians who have 20 or more heart failure EBCM episodes attributed in accordance with the heart failure EBCM as specified under MIPS during the calendar year 2 years prior to the applicable ASM performance year would meet the ASM participation eligibility criterion at § 512.710(b)(3) and clinicians who have 20 or more low back pain EBCM episodes attributed in accordance with the low back pain EBCM under MIPS during the calendar year 2 years prior to the applicable ASM performance year would similarly meet the ASM participation EBCM episodes attributed in accordance with the low back pain EBCM under MIPS during the calendar year 2 years prior to the applicable ASM performance year would similarly meet the ASM participation eligibility criterion at § 512.710(b)(3). We also seek comment on specifying a higher episode volume threshold and using the MIPS low volume threshold of Medicare Part B allowed charges for covered professional services for identifying clinicians who provide a sufficient volume of services. (4) Mandatory Geographic Areas (a) Identification of Geographic Areas We propose at § 512.710(f) that only clinicians in certain selected areas would be required to participate in the model. As proposed in § 512.710(f), the proposed unit of selection is CBSAs except in cases where OMB has divided large metropolitan statistical areas (MSAs) into metropolitan divisions. For these MSAs, we propose to use these metropolitan divisions in place of the CBSA. Using metropolitan divisions rather than large MSAs would enable more precise matching of intervention and control groups by using geographic units of more comparable size, which would improve the statistical validity of our evaluation approach. OMB Bu would enable more precise matching of intervention and control groups by using geographic units of more comparable size, which would improve the statistical validity of our evaluation approach. OMB Bulletin 23–01, issued on July 21, 2023, states that there are 935 CBSAs in the United States and Puerto Rico. OMB delineates MSAs and micropolitan statistical areas, which are referred to collectively as CBSAs. The general concept of the MSA and micropolitan statistical area is that of a core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social integration with that core. MSAs contain at least one urban area of 50,000 or more population; micropolitan statistical areas contain at least one urban area of at least 10,000 and less than 50,000 population. If specified criteria are met, an MSA containing a single core with a population of 2.5 million or more may be subdivided into metropolitan divisions, which function as distinct areas within the larger metropolitan statistical area. CBSAs are composed of entire counties. There are 393 MSAs, of which 13 are subdivided into 37 metropolitan divisions, and 542 micropoli distinct areas within the larger metropolitan statistical area. CBSAs are composed of entire counties. There are 393 MSAs, of which 13 are subdivided into 37 metropolitan divisions, and 542 micropolitan statistical areas in the United States and Puerto Rico, as of July 2023. We also considered using the following geographic areas as the geographic unit from which ASM VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00218 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 32569 participants are identified: (1) certain ZIP Codes based on their Hospital Referral Regions (HRR); or (2) certain states. We considered selecting based on HRRs for ASM. HRRs represent regional health care markets for tertiary medical care and are defined by determining where most patients were referred for major cardiovascular surgical procedures and for neurosurgery. There are 306 HRRs with at least one city where both major cardiovascular surgical procedures and neurosurgery are performed. While HRRs may sufficiently reflect referral patterns for r neurosurgery. There are 306 HRRs with at least one city where both major cardiovascular surgical procedures and neurosurgery are performed. While HRRs may sufficiently reflect referral patterns for heart failure episodes of care, they are less appropriate for low back pain episodes. Therefore, we decided that using CBSAs and metropolitan divisions as a geographic unit is preferable over HRRs for this model. We also considered selecting states as the geographic unit of selection for ASM. However, we concluded that CBSAs and metropolitan divisions would provide a more granular unit of analysis, allowing for better matching of comparison areas. Additionally, selecting states would greatly reduce the number of independent geographic areas subject to selection under the model, and thus would decrease the statistical power of the model evaluation. Finally, CBSAs and metropolitan divisions straddle state lines where providers and Medicare beneficiaries can easily cross these boundaries for health care. We propose that we would select the CBSAs and metropolitan divisions through the stratified random sampling methodology described later in this section of this proposed rule to participat health care. We propose that we would select the CBSAs and metropolitan divisions through the stratified random sampling methodology described later in this section of this proposed rule to participate in ASM. Although CBSAs are revised periodically, we propose to use the CBSA and metropolitan division designations in OMB Bulletin 23–01 issued on July 21, 2023 as the CBSA designations for purposes of selecting participants for this model, regardless of whether such CBSA designations have changed since July 21, 2023, or would change at some point during the ASM test period. We believe that this approach would best maintain the consistency of the ASM participants in the model, which is crucial for our ability to evaluate the effects of the model test on quality of care and changes in Medicare spending. As discussed later in this in section III.C.2.c.(4).(e) of this proposed rule, we propose in § 512.710(f)(4) to use the ZIP Codes of the service locations of each clinician as discussed in section III.C.2.c.(4).(e) of this proposed rule to assign each clinician to a single CBSA or metropolitan division. Each clinician that CMS determines falls under the selected CBSA or metropolitan di section III.C.2.c.(4).(e) of this proposed rule to assign each clinician to a single CBSA or metropolitan division. Each clinician that CMS determines falls under the selected CBSA or metropolitan division, and that otherwise meets the other eligibility criteria set forth in § 512.710(b), would be required to participate in the model. Based on our proposal to randomly select CBSAs and metropolitan divisions as ASM’s mandatory geographic areas, III.CZIP Codes and other areas not located in a CBSA or metropolitan division would not be included in the ASM selection methodology as discussed in section III.C.2.c.(4).(b) of this proposed rule. We note that Transforming Episode Accountability Model (TEAM), a mandatory episode-based payment model, uses CBSAs as the geographic unit of selection (as defined in § 512.515). We note that the proposed mandatory geographic areas may include some areas considered as rural areas under MIPS, which defines rural areas at § 414.1305 as a ZIP Code designated as rural by the Health Resources and Services Administration’s Federal Office of Rural Health Policy (FORHP), using the most recent FORHP Eligible ZIP Code file available. We seek comments on our ted as rural by the Health Resources and Services Administration’s Federal Office of Rural Health Policy (FORHP), using the most recent FORHP Eligible ZIP Code file available. We seek comments on our proposal to use CBSAs and metropolitan divisions as the geographic unit from which ASM participants are identified. We seek comments on our proposal to use the ZIP Codes of the service locations of each clinician as discussed in section III.C.2.c.(4).(e) of this proposed rule to assign each clinician to a single CBSA or metropolitan division, including ZIP Codes designated as rural by HRSA’s FORHP using the most recent FORHP Eligible ZIP Code file available. We seek comment on our proposal to require all eligible clinicians within a CBSA or metropolitan division that the Innovation Center selects through the stratified random sampling methodology as part of the intervention group described in section III.C.2.c.(4).(d) in this proposed rule to participate in ASM. Finally, we seek comments on our proposal to use the CBSA and metropolitan division designations in OMB Bulletin 23–01 issued on July 21, 2023 as the CBSA designations for purposes of selecting participants for this model. (b) n our proposal to use the CBSA and metropolitan division designations in OMB Bulletin 23–01 issued on July 21, 2023 as the CBSA designations for purposes of selecting participants for this model. (b) Exclusion of Certain CBSAs and Metropolitan Divisions We propose at § 512.710(f)(1) that we would not consider certain CBSAs or metropolitan divisions for selection. Specifically, we propose at § 512.710(f)(1)(ii) that we would exclude any CBSA or metropolitan division located entirely in U.S. territories due to challenges we would have in finding suitable geographic areas for comparison. We also propose at § 512.710(f)(1)(i) to exclude any CBSAs or metropolitan divisions that do not have any clinicians of the mandated specialty types with at least 20 eligible episodes between January 1, 2024 and December 31, 2024 in accordance with the EBCM episode threshold described in section III.C.3.c.(3).(b). We believe it is unlikely for these CBSAs or metropolitan divisions to have data available for evaluation after the model starts. After applying these criteria, we expect to have approximately 600 CBSA and metropolitan divisions remain available for selection into ASM. We considered the alte or evaluation after the model starts. After applying these criteria, we expect to have approximately 600 CBSA and metropolitan divisions remain available for selection into ASM. We considered the alternative of excluding from ASM any CBSA or metropolitan divisions located within a state or portion of a state with a commitment to participate in the Advancing All-Payer Health Equity Approaches and Development (AHEAD) model. The AHEAD model is a state- wide CMS Innovation Center model implemented under section 1115A of the Act that aims to increase investment in primary care, provide financial stability for hospitals, and support beneficiary connections to community resources. We decided not to propose these exclusions because ASM would not interact with the payment methodology in AHEAD and may help align a broader set of clinicians towards the goals of AHEAD. We seek comments on our proposal to exclude from selection any CBSA or metropolitan division located entirely in a U.S. territory and any CBSAs or metropolitan divisions that do not have any clinicians of the mandated specialty types with at least 20 eligible episodes between January 1, 2024 and December 31, 2024. We seek commen and any CBSAs or metropolitan divisions that do not have any clinicians of the mandated specialty types with at least 20 eligible episodes between January 1, 2024 and December 31, 2024. We seek comments on the alternative to exclude AHEAD geographies from ASM’s mandatory CBSA or metropolitan divisions. (c) Geographic Selection Methodology To determine which CBSAs and metropolitan divisions would be included in the model, we propose to use a stratified random sampling method to select approximately 25 percent of CBSAs and metropolitan divisions into ASM following the process described in the following two sections of this proposed rule. We propose at § 512.710(f)(2) to stratify CBSAs and metropolitan divisions into mutually exclusive groups based on 3 CBSA/metropolitan division-level characteristics: average total Parts A and B episode spending, volume of eligible episodes, and metropolitan division status. We propose at § 512.710(f)(2)(i) VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00219 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 32570 Federal Register / Vol. 90, No. 134 / Wednesday, July PO 00000 Frm 00219 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 32570 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules through (vi) stratifying eligible CBSAs into six mutually exclusive groups: • Eligible CBSAs with ‘‘Low’’ average total episode spending (as defined below) and ‘‘Low’’ eligible episode volume (as defined below); • Eligible CBSAs with ‘‘Low’’ average total episode spending and ‘‘High’’ eligible episode volume (as defined below); • Eligible CBSAs with ‘‘High’’ average total episode spending (as defined below) and ‘‘Low’’ eligible episode volume; • Eligible CBSAs with ‘‘High’’ average total episode spending and ‘‘High’’ eligible episode volume; • Eligible CBSAs with ‘‘Very High’’ eligible episode volume (as defined below); • Eligible metropolitan divisions. (i) Average Total Parts A and B Episode Spending We propose at § 512.710(f)(2) to measure average total Medicare Parts A and B episode spending using claims data from January 1, 2024 to December 31, 2024. One of the main objectives of ASM is to reduce spending, and therefore, it would be important to account re Parts A and B episode spending using claims data from January 1, 2024 to December 31, 2024. One of the main objectives of ASM is to reduce spending, and therefore, it would be important to account for the significant variation in average episode spending across geographic areas. This stratification would help ensure that we can measure any variation in model effects between high and low spending areas. We propose to use a single, pooled measure including spending for both heart failure and low back pain episodes. This would help limit the number of overall strata and we believe would allow for adequate representation of both high spending low back pain areas and high spending heart failure areas, where the potential for savings may be greatest. We propose to categorize CBSAs into two categories based on average total parts A & B episode spending: below the median (‘‘Low’’) and at-or-above the median (‘‘High’’). (ii) Volume of Eligible Episodes We propose at § 512.710(f)(2) to measure eligible episode volume using claims data from January 1, 2024 to December 31, 2024. We expect significant variation in the volume of eligible episodes across areas. This variation may reflect diffe e eligible episode volume using claims data from January 1, 2024 to December 31, 2024. We expect significant variation in the volume of eligible episodes across areas. This variation may reflect differences in other characteristics that are related to ASM performance. For example, large, active markets with a larger number of specialists may have structural advantages in performing well in ASM compared to smaller, less active markets. The proposed stratification on volume of eligible episodes would help ensure we select an adequate sample of areas with varying levels of specialty activity so that we would be able to identify statistical differences in outcomes across levels of specialty activity. This stratification would also help ensure that selected CBSAs have sufficient episode volume to support a robust evaluation. We propose to use a single, pooled measure including both heart failure and low back pain episodes. This allows us to limit our number of stratification variables and analysis of 2023 episode-level data found that the episode volumes of the two conditions are highly correlated across CBSAs. We propose to categorize CBSAs into three categories based on total episode nalysis of 2023 episode-level data found that the episode volumes of the two conditions are highly correlated across CBSAs. We propose to categorize CBSAs into three categories based on total episode volume: below median (‘‘Low’’), at-or-above median up to the 95th percentile (‘‘High’’), and the 95th percentile and above (‘‘Very High’’). We propose to stratify out the top 5 percent of CBSAs by episode volume because of the right-skewed nature of the episode volume distribution. (iii) Metropolitan Divisions The largest 13 CBSAs are divided into 37 metropolitan divisions. Metropolitan divisions therefore represent a subdivision level compared to CBSAs. Additionally, these metropolitan divisions, all belonging to CBSAs with a core population of 2.5 million or more, may have important characteristics in common beyond episode volume and average total spending. To ensure adequate representation of metropolitan divisions in the sample, we propose to categorize metropolitan divisions into their own stratum. We considered stratifying by other characteristics, including ACO penetration, supply of PCPs, region, rurality, and participation in the AHEAD model. We seek comments on our proposed s r own stratum. We considered stratifying by other characteristics, including ACO penetration, supply of PCPs, region, rurality, and participation in the AHEAD model. We seek comments on our proposed selection strata as well as alternatives considered. 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) Stratified Random Selection of Mandatory Geographic Areas A representative sample of clinicians that meet eligibility requirements for the proposed ASM is necessary for a robust evaluation of the model. Testing the model in this manner would also allow us to learn more about utilization patterns of health care services and how to incentivize the improvement of quality and care coordination for chronic heart failure and low back pain. This learning could potentially inform the Quality Payment Program and the future of the MVP reporting option. Therefore, we are proposing a broad, representative sample of clinicians in multiple geographic areas. We determined that the best method for obtaining the necessarily diverse, representative group of clinicians would be through stratified, random selection. A stratified, randomly selected sample would allow us to ens at the best method for obtaining the necessarily diverse, representative group of clinicians would be through stratified, random selection. A stratified, randomly selected sample would allow us to ensure statistical VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00220 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00221 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 32572 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules • Determine the appropriate CBSA or metropolitan division for each clinician attributed applicable episodes. If the clinician is attributed multiple episodes in multiple CBSAs or metropolitan divisions, we would match the clinician with the CBSA or metropolitan division where the clinician has the most assigned episodes. If a clinician has an equal number of episodes assigned to multiple CBSAs or metropolitan divisions, we would break such a tie by matching the clinician to the CBSA or metropolitan division that has the highest total risk-adjusted spending across all episodes assigned to each metropolitan divisions, we would break such a tie by matching the clinician to the CBSA or metropolitan division that has the highest total risk-adjusted spending across all episodes assigned to each CBSA or metropolitan division. If a second tie break is needed, we would match the clinician to the CBSA or metropolitan division that has episodes with the more recent dates. For example, if a clinician has an equal number of episodes in CBSA–B and CBSA–C, but the episodes in CBSA–B collectively have a higher total risk- adjusted spending compared to all episodes in CBSA–C, then the clinician would be matched to CBSA–B. We seek comments on our proposed process at § 512.710(f)(4) for determining the CBSA or metropolitan division of a clinician for each ASM performance year using EBCM data for the purposes of determining whether a clinician is located within a mandatory geographic area for each ASM performance year. (5) Proposed Selection and Notification Process for ASM Participants We propose to identify ASM participants on an annual basis. At § 512.710(g) we propose to identify all clinicians furnishing covered services in accordance with the ASM participant eligibility criteria spec pose to identify ASM participants on an annual basis. At § 512.710(g) we propose to identify all clinicians furnishing covered services in accordance with the ASM participant eligibility criteria specified in section III.C.2.c.(3) of this proposed rule using applicable data from 2 calendar years prior to each ASM performance year. We also propose that a clinician selected for participation for any ASM performance year would be considered an ASM participant for the remainder of the model. We propose at § 512.710(g)(1)(i), for the 2027 ASM performance year/2029 ASM payment year only, to identify preliminarily eligible ASM participants using the ASM participant eligibility criteria and applicable data from calendar year 2024. If ASM is finalized as proposed, we propose to make public the preliminarily eligible ASM participants in a form and manner determined by CMS. We expect to release this information by the end of CY 2025. Then, to finalize the ASM participants for the 2027 ASM performance year/2029 ASM payment year, we propose § 512.710(g)(1)(ii) to confirm that the preliminarily eligible ASM participants continue to meet the ASM participant eligibility criteria using more recent ance year/2029 ASM payment year, we propose § 512.710(g)(1)(ii) to confirm that the preliminarily eligible ASM participants continue to meet the ASM participant eligibility criteria using more recent data from calendar year 2025. We propose to make public the selected ASM participants for the 2027 ASM performance year/2029 ASM payment year in a form and manner determined by CMS. We expect to release this information by the end of July 2026, preceding the start of the 2027 ASM performance year/2029 ASM payment year. We believe that notifying preliminarily eligible ASM participants well before the start of the first ASM performance year in 2027 would provide ample time to become familiar with ASM requirements, make practice adjustments, and prepare for reporting of the required measures and data. We considered not releasing the preliminarily eligible ASM participants for the 2027 ASM performance year/ 2029 ASM payment year and, instead, only using applicable data from the 2025 calendar year to identify the final ASM participants for the 2027 ASM performance year/2029 ASM payment year. However, this alternative would provide less time for ASM participants to prepare for the first ASM ear to identify the final ASM participants for the 2027 ASM performance year/2029 ASM payment year. However, this alternative would provide less time for ASM participants to prepare for the first ASM performance year and potentially increase the operational burden for clinicians selected for the model. If ASM is finalized, as proposed, for each ASM performance year, beginning with the 2028 ASM performance year/ 2030 ASM payment year, we propose at § 512.710(g)(2)(i) to confirm that ASM participants continue to meet ASM participant eligibility criteria for the upcoming ASM performance year/ASM payment year using applicable data from the calendar year 2 years prior to the applicable ASM performance year. If an ASM participant does not meet the ASM participant eligibility criteria for the upcoming ASM performance year, then they would not be required to participate in ASM for the applicable ASM performance year and would not need to meet applicable reporting requirements of ASM. Further, waivers, including the MIPS waiver, described at § 512.775 would no longer apply to the ASM participant, and the ASM participant must participate in MIPS if applicable. Beginning with the 2028 ASM per waivers, including the MIPS waiver, described at § 512.775 would no longer apply to the ASM participant, and the ASM participant must participate in MIPS if applicable. Beginning with the 2028 ASM performance year/2030 ASM payment year, we propose at § 512.710(g)(2)(ii) to identify additional clinicians not previously identified as ASM participants but who meet the ASM participant eligibility criteria at § 512.710(b) for the upcoming ASM performance year/ASM payment year using data from the calendar year 2 years prior to the applicable ASM performance year. We propose that CMS would make public the ASM participants for a given ASM performance year annually in a form and manner determined by CMS. We intend to release this information by the end of July in the year preceding the start of the applicable ASM performance year. We believe that the proposed approach of annually identifying clinicians who meet the ASM participant eligibility criteria would ensure we are accurately selecting ASM participants. That is, we would ensure that ASM participants continue to be of the required specialty type and meet the EBCM episode volume thresholds year- over-year. This proposed approach to sele M participants. That is, we would ensure that ASM participants continue to be of the required specialty type and meet the EBCM episode volume thresholds year- over-year. This proposed approach to selecting ASM participants also allows us to account for movement of ASM participants to different practices within mandatory geographic areas and allows new ASM participants into the model over the ASM test period. We also believe that this approach would allow ASM to maintain an appropriate number of ASM participants over the ASM test period to produce a reliable model test. We considered an alternative approach of establishing a fixed list of ASM participants for all ASM performance years. Under this alternative, we would first identify ASM participants as clinicians that meet the ASM participant eligibility criteria using applicable data from the 2024 calendar year for the 2027 ASM performance year/2029 ASM payment year and release a list of preliminarily eligible ASM participants. We would then finalize the ASM participants for the 2027 ASM performance year/2029 ASM payment year using applicable data from the 2025 calendar year. Beginning in the 2028 ASM performance year/2030 ASM paym d then finalize the ASM participants for the 2027 ASM performance year/2029 ASM payment year using applicable data from the 2025 calendar year. Beginning in the 2028 ASM performance year/2030 ASM payment year, we would reconfirm that the final ASM participants identified for the 2027 ASM performance year/2029 ASM payment year continue to meet the ASM participant eligibility criteria for each ASM performance year thereafter using applicable data from 2 calendar years before the applicable ASM performance year. Under this alternative, we would not identify new ASM participants over the course of the ASM model test period. Repeatedly reconfirming that the initial ASM participants continue to meet ASM participant eligibility criteria for each ASM performance year would result in attrition of any ASM participant who changes their association with a practice (that is, assigns billing rights to a different TIN) after the first ASM performance year based on our proposed identification of VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00222 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 te Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00222 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 32573 ASM participants at the TIN/NPI level. Accordingly, we believe that this alternative fixed-list approach would reduce the number of ASM participants over the ASM test period and the magnitude of this potential decrease could undermine the reliability of the model test. We seek comments on our proposed approach for selecting and notifying ASM participants at § 512.710(g). We also seek comment on only identifying the final ASM participants for the 2027 ASM performance year/2029 ASM payment year using applicable data from the 2025 calendar year and the use of a fixed list of ASM participants for all ASM performance years. d. Proposed ASM Performance Assessment Approach, Data Submission Requirements, and ASM Performance Category Requirements and Scoring As discussed earlier in section III.C.1.b. of this proposed rule, we propose to use the MVP framework, including its performance categories, to assess ASM participant perf ory Requirements and Scoring As discussed earlier in section III.C.1.b. of this proposed rule, we propose to use the MVP framework, including its performance categories, to assess ASM participant performance related to improving quality of care and reducing low-value care related ASM targeted chronic conditions. We believe this framework offers a tested performance assessment framework to use in creating value-based incentives for ASM participants. In this section of this proposed rule, we discuss the performance measures and activities that would be used to assess the performance of ASM participants in four ASM performance categories of (1) quality, (2) cost, (3) improvement activities, and (4) Promoting Interoperability. We propose to define at § 512.705 ‘‘ASM performance category’’ as a group of applicable measures or activities used to assess an ASM participant’s performance on quality, cost, improvement activities, or Promoting Interoperability. Tying a clinician’s performance to certain measures and activities (as discussed below) in these performance categories would support ASM goals, as discussed in section III.C.1 of this proposed rule, of decreasing the cost of care for certain measures and activities (as discussed below) in these performance categories would support ASM goals, as discussed in section III.C.1 of this proposed rule, of decreasing the cost of care for beneficiaries with ASM’s targeted chronic conditions as well as improving quality care as measured through a focused measure set relevant to ASM’s clinical specialties and targeted chronic conditions. • The quality ASM performance category would assess the quality of care ASM participants delivered by measuring health care processes, outcomes, and patient experiences of care with the goal of improving the quality of care for beneficiaries with ASM’s targeted chronic conditions. • The cost ASM performance category would assess the efficiency and cost- effectiveness of care provided to Medicare beneficiaries with ASM targeted chronic conditions with the goal of providing more cost-efficient care to generate cost savings. • The improvement activities ASM performance category would assess ASM participants in their efforts to make practice improvements that improve population health, enhance patient experiences and outcomes, reduce cost of care, and improve clinician experience. To meet ASM participants in their efforts to make practice improvements that improve population health, enhance patient experiences and outcomes, reduce cost of care, and improve clinician experience. To meet ASM’s practice improvement goals, ASM’s improvement activities would incentivize practice improvements that would strengthen care management and processes related to ASM’s targeted chronic conditions, and incentivize stronger integration between specialist and primary care providers. • The Promoting Interoperability ASM performance category would assess ASM participants in their efforts to promote patient engagement and electronic exchange of information using CEHRT to enhance quality of care and reduce costs through more effective upstream chronic condition management and care integration related to ASM’s targeted chronic conditions. Under ASM, CEHRT should meet the requirements set forth in § 414.1305, except all instances of references to MIPS are to be replaced with references to ASM. As further discussed below in section III.C.2.d.(2) of this proposed rule, we propose for the quality ASM performance category, cost ASM performance category, and promoting interoperability ASM performan further discussed below in section III.C.2.d.(2) of this proposed rule, we propose for the quality ASM performance category, cost ASM performance category, and promoting interoperability ASM performance category, to draw measures and activities from specific MVPs related to each of ASM’s targeted chronic conditions to identify a cohesive set of vetted and clinically relevant measures and activities that would allow us to appropriately assess ASM participants on the care they deliver related to ASM’s targeted chronic conditions. Using the same measures would mean the many ASM participants would already be familiar with required measures and activities proposed in each of the ASM performance categories. proposed in these ASM performance categories. However, as we discuss in sections III.C.2.d.(1) and III.C.2.f of this proposed rule, comparing performance on these measures and activities as measured by ASM performance category and final scores within each ASM cohort would result in payment adjustments based on direct peer-to-peer comparisons of similar specialists. For some ASM performance categories, we propose to include measures from outside of the relevant MVP, such as from the br t adjustments based on direct peer-to-peer comparisons of similar specialists. For some ASM performance categories, we propose to include measures from outside of the relevant MVP, such as from the broader inventory of MIPS measures, when we believe there is a clinically justifiable rationale for including such a measure. We propose ASM-specific measures or activities in limited circumstances when we believe there is rationale for assessing performance or creating an incentive for practice improvement specific to ASM’s targeted chronic conditions. For example, the improvement activities ASM performance category, as discussed in section III.C.2.d.(4). of this proposed rule, includes ASM-specific improvement activities. We also discuss how we propose to score each ASM performance category within each of the ASM performance category sections within this section of this proposed rule. While many of the proposed scoring policies draw from MIPS, we are proposing scoring policies that simplify some existing policies. As a mandatory model, simplification of scoring compared to some MIPS and MVP policies would make it easier for the ASM participant to understand how their performance in eac y some existing policies. As a mandatory model, simplification of scoring compared to some MIPS and MVP policies would make it easier for the ASM participant to understand how their performance in each of the ASM performance categories contributes to their final score and resulting payment adjustment. As part of this simplification, our proposed scoring policies ensure that each ASM participant would at minimum be measured on quality and cost, with further scoring adjustments based on performance in the improvement activities and Promoting Interoperability ASM performance categories, to determine payment adjustments. As discussed in section III.C.2.e of this proposed rule, we plan to calculate a final score based on the quality, cost, improvement activities, and Promoting Interoperability performance categories scores for each ASM participant for each ASM performance year. The scores in the quality and cost ASM performance categories would positively impact the ASM final score while performance in the improvement activities and Promoting Interoperability ASM performance categories could result in negative scoring adjustments to the ASM final score. In the following section III.C.2. rformance in the improvement activities and Promoting Interoperability ASM performance categories could result in negative scoring adjustments to the ASM final score. In the following section III.C.2.d.(1).(a) of this proposed rule, we first discuss the ASM performance assessment approach. We then propose data submission requirements applicable across the ASM performance categories in section III.C.2.d.(1).(b) of this proposed rule. Finally, we propose specific requirements and scoring policies for each of the four ASM performance categories in sections VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00223 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 32574 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules III.C.2.d.(2) through III.C.2.d.(5). of this proposed rule. (1) Proposed Performance Assessment and Data Submission Requirements (a) ASM Performance Categories We propose at § 512.715(a)(1) through (3) that CMS uses the performance measures and activities described under §§ 512.725(b) and (c), 512.730(b), 512.735(b), and 512.740(b) to assess ASM participants in th pose at § 512.715(a)(1) through (3) that CMS uses the performance measures and activities described under §§ 512.725(b) and (c), 512.730(b), 512.735(b), and 512.740(b) to assess ASM participants in the quality, cost, improvement activities, and Promoting Interoperability ASM performance categories. As discussed in section III.C.1 of this proposed rule, we believe that these ASM performance categories taken together would improve the quality of care and produce cost savings related to ASM’s chronic conditions. Further, we believe that, taken together, the ASM performance categories provide a comprehensive understanding of an ASM participant’s management of their beneficiaries’ targeted chronic conditions. We also believe that ASM participants, because of participation in other CMS programs including MIPS, would already be familiar with reporting (1) quality; (2) cost; (3) improvement activities; and (4) Promoting Interoperability performance categories to determine a final score. This proposed structure is similar to the performance assessment approach of other CMS programs like the MIPS reporting option of the Quality Payment Program. MIPS assesses the performance of MIPS eligible roposed structure is similar to the performance assessment approach of other CMS programs like the MIPS reporting option of the Quality Payment Program. MIPS assesses the performance of MIPS eligible clinicians across four performance categories and then determines a MIPS payment adjustment factor that applies to the clinician’s Medicare Part B payments for covered professional services finalized at §§ 414.1380(a) and 414.1405(a) and as defined at § 414.1305. Under the proposed ASM performance categories, the value of care provided to chronic care patients would be assessed through performance in the quality and cost performance categories, supported by performance in the improvement activities and Promoting Interoperability performance categories. Measures and activities CMS selects to assess an ASM’s performance across the quality ASM performance category and cost ASM performance category would assess the value of care directly furnished to chronic care patients. Measuring ASM participants’ cost and quality performance ensures that Medicare beneficiaries are receiving clinically appropriate, comprehensive, high-value care. The measurement of cost and quality is essential to measu ipants’ cost and quality performance ensures that Medicare beneficiaries are receiving clinically appropriate, comprehensive, high-value care. The measurement of cost and quality is essential to measuring the value of care provided to Medicare beneficiaries with chronic conditions. The improvement activities ASM performance category incentivizes care coordination and collaboration between specialty medicine and primary care, creating new opportunities for both groups playing vital roles in care management and coordination. And lastly, the Promoting Interoperability ASM performance category enables meaningful EHR use, the reporting of clinical quality measures, including electronic clinical quality measures (eCQMs) and continuous practice-based quality improvement and care transformation. We believe that ASM’s more targeted approach to performance assessment where we would evaluate ASM participants within each ASM cohort across the ASM performance categories—(1) on a set of relevant performance measures that they are required to report; and (2) among clinicians furnishing similar sets of services, would produce final scores and subsequent payment adjustments, as described in section formance measures that they are required to report; and (2) among clinicians furnishing similar sets of services, would produce final scores and subsequent payment adjustments, as described in section III.C.2.f of this proposed rule, 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. Furthermore, equipped with more specialty-relevant performance information through participation in ASM, we expect clinicians would be more likely to invest resources in pursuit of better outcomes, reducing the incidence of poor outcomes arising from care fragmentation, ultimately resulting in better care for patients. We propose at § 512.715(a) that, as further described in §§ 512.725, 512.730, 512.735, and 512.740, ASM participants would receive a specific number of points for their performance on each measure or activity within an ASM performance category. CMS assigns the total number of points th and 512.740, ASM participants would receive a specific number of points for their performance on each measure or activity within an ASM performance category. CMS assigns the total number of points that a measure or activity may receive. The total score across all four performance categories that an ASM participant may receive is capped at 100 points. The number of points awarded for an ASM’s performance on a measure or activity corresponds to the level of performance, the higher the points, the better the performance. We propose to define at § 512.705 ‘‘ASM performance category score’’ as the assessment of each ASM participant’s performance on the applicable measures and activities for a performance category during an ASM performance year based on the policies proposed at §§ 512.715, 512.725, 512.730, 512.735, and 512.740. As further described below in this section of this proposed rule, CMS would, using an ASM participant’s ASM performance category scores across all ASM performance categories, calculate an ASM participant’s final score for an ASM performance year/ASM payment year in accordance with § 512.745. We propose at § 512.715(b)(1) to use Medicare claims data and administr ategories, calculate an ASM participant’s final score for an ASM performance year/ASM payment year in accordance with § 512.745. We propose at § 512.715(b)(1) to use Medicare claims data and administrative data to calculate some measures included in the quality and cost ASM performance categories under §§ 512.725 and 512.730. We propose at § 512.715(b)(2) that we use other model- specific data reported by ASM participants to calculate measure or activity scores for the quality, improvement activities, and Promoting Interoperability ASM performance categories under §§ 512.725, 512.735, and 512.740. We are soliciting feedback from the public on our proposal to assess ASM participant performance across four ASM performance categories: (1) quality; (2) cost; (3) improvement activities; and (4) promoting interoperability. We seek comments on our proposal at § 512.715(a) to set and assign specific points on measures or activities in each ASM performance category and to calculate a final score using point received across all four ASM performance categories as described at § 512.745. Finally, we seek comments on our proposal at § 512.715(b) to use Medicare claims, administrative data, and e using point received across all four ASM performance categories as described at § 512.745. Finally, we seek comments on our proposal at § 512.715(b) to use Medicare claims, administrative data, and model-specific data reported by an ASM participant to calculate measure or activity scores used to calculate ASM performance category scores. (b) Data Submission Requirements We propose at § 512.720 that ASM participants would be required to submit data on the measures and activities for the quality, improvement activities, and Promoting Interoperability ASM performance categories in accordance with each ASM performance categories described in §§ 512.725, 512.735, and 512.740. As further discussed below, we are proposing to align some data submission requirements under this model with the data submission requirements under MIPS as defined at § 414.1325. We believe that the use of similar processes and ‘‘submission types’’—which we propose to define at § 512.705 as the mechanism by which the ASM submitter submits data to us in the form and manner specified by us, including, but not limited to: (1) direct; VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00224 Fmt 4701 Sfmt 47 e ASM submitter submits data to us in the form and manner specified by us, including, but not limited to: (1) direct; VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00224 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 32575 (2) log in and upload; and (3) log in and attest—would limit confusion and burden for those ASM participants that have previously participated in MIPS. We also intend to provide further resources on the exact data submission procedures prior to the first data submission deadline for the 2027 ASM performance year. We propose that ASM participants must submit data at the same level at which they are identified in the model. Since we propose identifying ASM participants at the TIN/NPI level (as outlined in section III.C.2.c.(3).(a).(i). of this proposed rule), we are likewise proposing that each ASM participant would be required to submit data for each ASM performance category at this same TIN/NPI level, unless specifically stated otherwise within the requirements for a particular performance categor icipant would be required to submit data for each ASM performance category at this same TIN/NPI level, unless specifically stated otherwise within the requirements for a particular performance category. Alignment between participant identification and data submission levels is necessary for a mandatory model and supports our goal of making accurate comparisons between similar participants. This approach differs from MIPS, which offers various reporting options (such as group, subgroup, or APM entity as defined in § 414.1305). We have determined that allowing multiple reporting configurations would undermine ASM’s design objective of creating clear peer-to-peer performance comparisons for determining payment adjustments. We recognize that some of the required measures and attestations in each ASM performance category may reflect practice-level activities. We, therefore, considered whether to allow submission of required measures and attestations for the improvement activities and Promoting Interoperability ASM performance categories at the TIN level. We believe that it is more appropriate to align the data submission level across all the ASM performance categories instead of having ing Interoperability ASM performance categories at the TIN level. We believe that it is more appropriate to align the data submission level across all the ASM performance categories instead of having some ASM performance categories with data submitted at the TIN/NPI level and others at the TIN level. Alignment of submission level across all ASM performance categories supports our goal of making like-to-like performance comparisons to determine payment adjustments. We are proposing the following data submission requirements at § 512.720(a)(1)(i) through (iii) (the order of the requirements aligns with the order in which similar data submission requirements for MIPS appear in § 414.1325): • Quality ASM performance category data submission requirements. For the quality ASM performance category, we propose at § 512.720(a)(1)(i) that an ASM participant must report at least one required quality measure that is not an administrative claims-based collection type (discussed in sections III.C.2.d.(2).(b) and III.C.2.d.(2).(c) of this proposed rule) and meets the proposed data completeness requirement as discussed in section III.C.2.d.(2).(h).(i) of this proposed rule. The proposed requiremen d.(2).(b) and III.C.2.d.(2).(c) of this proposed rule) and meets the proposed data completeness requirement as discussed in section III.C.2.d.(2).(h).(i) of this proposed rule. The proposed requirements for the quality ASM performance category are similar to those required under MIPS as defined at § 414.1325(1)(i) but with the addition of meeting the data completeness requirement. We believe that the addition of the data completeness requirement ensures that we would have complete data by which to score at least one required quality measure. We also considered that an ASM participant must report complete data for at least two, at least three, or all required quality measures that are not administrative claims-based collection types as the data submission requirement for the quality ASM performance category. However, not reporting all required measures would negatively affect an ASM’s participant quality ASM performance category score as discussed in section III.C.2.(d).(i) of this proposed rule. Further, not meeting the data submission requirement for the quality ASM performance category would mean that an ASM participant would receive the maximum negative payment adjustment for th osed rule. Further, not meeting the data submission requirement for the quality ASM performance category would mean that an ASM participant would receive the maximum negative payment adjustment for the applicable ASM payment year as discussed in section III.C.2.f.(4) of this proposed rule. Setting the minimum data submission requirement as reporting more than one complete quality measure could penalize ASM participants that are unable to report required measures because of extenuating circumstances. We believe that the proposed minimum data submission requirement combined with the proposed scoring policies would provide the appropriate incentive for reporting all required quality measures while ensuring that we can appropriately evaluate quality performance. • Improvement activities ASM performance category data submission requirements. We propose § 512.720(a)(1)(ii) that the data submission requirement for the improvement activities ASM performance category would require that an ASM participant attest to completing or not completing the required ASM improvement activities defined in § 512.735. Unlike MIPS, we are not proposing to include a ‘‘yes’’ attestation to the minimum data s articipant attest to completing or not completing the required ASM improvement activities defined in § 512.735. Unlike MIPS, we are not proposing to include a ‘‘yes’’ attestation to the minimum data submission requirements to receive a final score under ASM as defined in § 512.745(b) as it would conflict with how we propose to factor in the ASM improvement activities performance category score into the final score as proposed at § 512.745(a)(1)(iii). • Promoting Interoperability ASM performance category data submission requirements. The proposed requirements for the Promoting Interoperability ASM performance category at § 512.720(a)(1)(iii) align with the MIPS requirements as defined at § 414.1325(1)(iii). • ASM performance categories without data submission requirements. Like the cost performance category or administrative claims-based quality measures under MIPS, we propose at § 512.720(a)(2) that there would be no data submission requirements for the cost ASM performance category or for quality measures that have an administrative claims-based collection type. Like MIPS, performance in the ASM cost performance category and on some quality, measures would be calculated using admi for quality measures that have an administrative claims-based collection type. Like MIPS, performance in the ASM cost performance category and on some quality, measures would be calculated using administrative claims data, which includes claims submitted with dates of service during the applicable ASM performance year that are processed no later than 60 days following the close of the applicable ASM performance year. • Data submission types for ASM participants. We propose at §§ 512.720(b)(1) and (2) that an ASM participant would, like an individual MIPS eligible clinician, be able to submit their ASM data using, for the quality ASM performance category, the direct, login and upload, submission types, and for improvement activities or Promoting Interoperability ASM performance categories, the direct, login and upload, or login and attest submission types as proposed at § 512.720(b). These are the same submission types available under MIPS. • Use of multiple data submission types. Like the policy established under MIPS, we propose at § 512.720(c) that ASM participants would be permitted to submit their ASM data using multiple submission types for any performance category described the policy established under MIPS, we propose at § 512.720(c) that ASM participants would be permitted to submit their ASM data using multiple submission types for any performance category described at § 512.720(b) as applicable; provided, however, that the ASM participant uses the same identifier for all ASM performance categories and all data submissions. • Data submission deadlines. We propose at § 512.720(d) that ASM participants would need to submit all required data and attestations as required for each ASM performance category by March 31 following the close of the applicable ASM performance year, or a later date as specified by CMS. This proposal aligns VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00225 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 32576 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules with the deadline policy established under MIPS at § 414.325(e). We considered requiring a data submission deadline earlier than March 31 but believed that it would not provide ASM participants with sufficient time to prepare their data submission. • Trea 4.325(e). We considered requiring a data submission deadline earlier than March 31 but believed that it would not provide ASM participants with sufficient time to prepare their data submission. • Treatment of multiple data submissions. Like the policy established under MIPS, for multiple data submissions received in the quality and improvement activities ASM performance categories, for an ASM participant submitters in multiple organizations (for example, qualified registry, practice administrator, or EHR vendor), we propose at § 512.720(e) to calculate and score each submission received and assign the highest of the scores. We propose at § 512.720(e)(1) that for multiple data submissions received for an individual ASM participant from one or multiple submitters in the same organization, we propose to score the most recent submission. We propose at § 512.720(e)(2) that for multiple data submissions received for the Promoting Interoperability performance category, we propose to calculate a score for each data submission received and assign the highest of the scores. We also propose that data can be submitted on behalf of the ASM participant by an entity or individual designated to su a score for each data submission received and assign the highest of the scores. We also propose that data can be submitted on behalf of the ASM participant by an entity or individual designated to submit data to CMS, including a third-party intermediary as described in § 512.720(a), on behalf of the ASM participant. We propose at § 512.705 to use with the definition of third-party intermediary set forth in MIPS at § 414.1305 to align the data submission policies for third party intermediaries between MIPS and ASM. We seek comments on the proposed data submission requirements and submission types for each ASM performance category, the data submission deadline, and the proposed treatment of multiple data submissions and scoring at § 512.720. We also seek comments on our proposal to require data submission at the level by which we determine ASM participation. We also seek comments on the alternative data submission requirements for the quality ASM performance category that we considered. (2) Proposed Quality ASM Performance Category The proposed quality ASM performance category supports the model goals of improving quality of care with a focus on measures that are relevant to ASM cli (2) Proposed Quality ASM Performance Category The proposed quality ASM performance category supports the model goals of improving quality of care with a focus on measures that are relevant to ASM clinical specialties and targeted chronic conditions. It also seeks to decrease the cost of care for beneficiaries with ASM-targeted chronic conditions. Measuring quality of care helps identify areas for improvement and ensures that clinical interventions are effective and lead to improved patient outcomes. The importance of the quality ASM performance category is reflected in the weight of the performance category on the final score, discussed in section III.C.2.e.(1) of this proposed rule. (a) Background We propose at § 512.725(b) and (c) to use a quality measure set specific to each ASM cohort, one measure set for heart failure and one measure set for low back pain, which would contain condition-specific mandatory measures. Each ASM participant must report all measures specified in Table 39 for their applicable chronic condition, except for the proposed administrative claims- based measures, which would be calculated by CMS based on their submitted claims. These measures would likely s 9 for their applicable chronic condition, except for the proposed administrative claims- based measures, which would be calculated by CMS based on their submitted claims. These measures would likely stay consistent throughout the duration of the model to support reporting continuity, minimize burden, and ensure a reliable and valid model evaluation. The quality measurement approach in ASM is similar to the MVP reporting option under MIPS in that it limits reporting to a subset of clinically relevant measures. However, while the MVP reporting option allows a clinician to select an MVP and choose which MVP measures to report, the ASM participant would be required to report all quality measures in their respective ASM measure set. Medicare’s payment landscape is continuing to transform, moving away from traditional FFS payments that are not tied to quality and towards value- based models with increased provider accountability. ASM is a continuation of these efforts, strengthening the connection between quality and payment. We aim, in payment models such as ASM, to utilize quality measures that incentivize evidence- based care and prevention, improve patient outcomes, and reduce low-va ection between quality and payment. We aim, in payment models such as ASM, to utilize quality measures that incentivize evidence- based care and prevention, improve patient outcomes, and reduce low-value health care spending. We propose to avoid making significant changes to these measure sets over the period of model; however, we may propose to add or remove measures through rulemaking if we believe refinements to the measure set are necessary. We may propose to add or remove measures in response to relevant public comments, recommendations from participants and their collaborators, new CMS program activities, or significant changes to the included measures. We would use notice and comment rulemaking to propose any modifications, such as adding or removing measures for monitoring quality or calculating scores for quality performance. We seek comment on this proposal. As proposed, ASM is designed to provide financial incentives for measurable improvements in clinical outcomes for beneficiaries. We expect our quality measurement strategy to increase adherence to clinical guidelines, focus attention on outcomes to reduce costs, and enhance the patient experience. Several of the measu iciaries. We expect our quality measurement strategy to increase adherence to clinical guidelines, focus attention on outcomes to reduce costs, and enhance the patient experience. Several of the measures also promote prevention, as detailed in Table 39, by mitigating the progression of the chronic diseases that ASM targets and reducing the risk for other comorbid diseases that may exacerbate health issues. Each quality measure proposed contains measures that aim to measure and incentivize improvement in the following three domains: (1) excess utilization, (2) evidence-based care and outcomes, and (3) patient-reported outcomes and experience. Each measure set would include a utilization-focused measure to assess appropriate use of select services in chronic disease management. This measurement area may also indicate where excess or inappropriate utilization is occurring, which aligns with CMS priorities to reduce spending related to unnecessary care, imaging, or procedures. Measures in the evidence-based care and outcomes domain are clinically relevant to the conditions of focus, can meaningfully discern differences in care furnished by ASM participants, and are associated with impr the evidence-based care and outcomes domain are clinically relevant to the conditions of focus, can meaningfully discern differences in care furnished by ASM participants, and are associated with improved outcomes for patients. Finally, measures related to patient-reported outcomes capture what matters most to patients, and incentivizing ASM participants to be more attuned to the patient experience could drive improvements in functional status among beneficiaries receiving treatment for heart failure and low back pain. We believe that the measures in all three domains are clinically relevant to the conditions of focus and would align with other CMS programs and nationwide measurement efforts. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00226 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 32577 (i) Performance Year for the Quality ASM Performance Category We propose at § 512.725(a) that the ASM performance year for quality measures would be the full calendar year from January 1 to December 31, and the performance y the Quality ASM Performance Category We propose at § 512.725(a) that the ASM performance year for quality measures would be the full calendar year from January 1 to December 31, and the performance year would occur 2 years prior to an applicable ASM payment year. We believe that setting the ASM performance year for quality measures in this way aligns with MIPS as defined at § 414.1320 and would be easily adoptable for ASM participants. We seek comments on our proposed approach setting the ASM performance year for quality measures. (b) Quality Measure Set for the ASM Heart Failure Cohort We propose at § 512.725(b)(1) through (5) to include the following measures in the heart failure measure set. Each ASM heart failure participant must report each measure using one of the collection types specified in Table 39. (i) Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients With Heart Failure (HF) (MIPS Q492) We propose to include Risk- Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with Heart Failure (HF) (MIPS Q492) in the ASM heart failure measure set. By assessing potentially preventable cardiovascular-related hospital nned Cardiovascular-Related Admission Rates for Patients with Heart Failure (HF) (MIPS Q492) in the ASM heart failure measure set. By assessing potentially preventable cardiovascular-related hospital admissions, this measure incentivizes clinicians to adopt evidence-based practices in heart failure management, improve care coordination, and enhance the overall quality of care. A hospital readmission, for any reason, is disruptive to patients and caregivers, costly to the health care system, and puts patients at additional risk of hospital-acquired infections and complications.138 Readmissions are also a major source of patient and family stress and may contribute substantially to a decline in functional ability, particularly in older patients.139 Some readmissions are unavoidable and result from inevitable progression of disease or worsening of chronic conditions. Patients with heart failure, particularly those at a more advanced stage, are vulnerable to a range of factors that may increase their risk for cardiovascular- 138 Dhaliwal JS, Dang AK. Reducing Hospital Readmissions. Nih.gov. Published June 7, 2024. https://www.ncbi.nlm.nih.gov/books/NBK606114/. 139 Dhaliwal JS, Dang AK. rease their risk for cardiovascular- 138 Dhaliwal JS, Dang AK. Reducing Hospital Readmissions. Nih.gov. Published June 7, 2024. https://www.ncbi.nlm.nih.gov/books/NBK606114/. 139 Dhaliwal JS, Dang AK. Reducing Hospital Readmissions. Nih.gov. Published June 7, 2024. https://www.ncbi.nlm.nih.gov/books/NBK606114/. related hospitalizations.140 Risk of hospitalization may be related to an individual’s clinical and social/ community risk factors but may also be affected by the quality of care received. Activities that could improve quality of care include the adoption of guideline- directed medical therapy, early intervention for acute symptoms, optimal care coordination across providers, and support for self- management. Policy changes, such as the Medicare Hospital Readmissions Reduction Program, have led to a decrease in readmission rates for both principal and secondary heart failure hospitalizations; however, readmission rates in both groups remain high.141 We propose to include this measure to continue the momentum on reducing avoidable hospital admissions and readmissions, as well as improve overall 140 Malhotra C, Chaudhry I, Yeo Khung Keong, Sim D. Multifactorial risk factors fo asure to continue the momentum on reducing avoidable hospital admissions and readmissions, as well as improve overall 140 Malhotra C, Chaudhry I, Yeo Khung Keong, Sim D. Multifactorial risk factors for hospital readmissions among patients with symptoms of advanced heart failure. ESC heart failure. 2024;11(2):1144–1152. doi:https://doi.org/10.1002/ ehf2.14670. 141 Blecker S, Herrin J, Li L, Yu H, Grady JN, Horwitz LI. Trends in Hospital Readmission of Medicare-Covered Patients With Heart Failure. Journal of the American College of Cardiology. 2019;73(9):1004–1012. doi:https://doi.org/10.1016/ j.jacc.2018.12.040. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00227 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 00228 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 32579 comment on the appropriateness of including this measure in the heart failure measure set. (iv) Controlling High Blood Pr Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32579 comment on the appropriateness of including this measure in the heart failure measure set. (iv) Controlling High Blood Pressure (MIPS Q236) We propose including Controlling High Blood Pressure (MIPS Q236) in the heart failure measure set for ASM because optimal blood pressure management is a critical part of heart failure management and uncontrolled blood pressure can contribute to complications and progression.152 153 For example, severe hypertension can result in pulmonary edema (more common in patients with preserved LVEF), requiring urgent treatment to reduce blood pressure.154 Controlling blood pressure helps reduce the risk of adverse outcomes, such as hospitalizations and mortality related to heart failure.155 156 By including this measure, ASM incentivizes cardiologists to optimize blood pressure control, particularly given that patients with heart failure very commonly have a history of hypertension.157 In addition, this measure complements the two other quality measures for heart failure in ASM, as the use of beta blockers and ACEi/ARB/ARNIs also have favorable effects on heart failure outcomes .157 In addition, this measure complements the two other quality measures for heart failure in ASM, as the use of beta blockers and ACEi/ARB/ARNIs also have favorable effects on heart failure outcomes and lower blood pressure.158 The complimentary emphasis on blood pressure control and medication management in this measure set may also slow disease progression and function as a form of tertiary prevention in heart failure patients. Furthermore, 152 Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart failure: a Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18). doi:https:// doi.org/10.1161/cir.0000000000001063. 153 Oh GC, Cho HJ. Blood pressure and heart failure. Clinical Hypertension. 2020;26(1). doi:https://doi.org/10.1186/s40885-019-0132-x. 154 Ratko Lasica, Lazar Djukanovic, Jovanka Vukmirovic, et al. Clinical Review of Hypertensive Acute Heart Failure. Medicina (Kaunas Spausdinta). 2024;60(1):133–133. doi:https:// doi.org/10.3390/medicina60010133. 155 The SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-Pre Heart Failure. Medicina (Kaunas Spausdinta). 2024;60(1):133–133. doi:https:// doi.org/10.3390/medicina60010133. 155 The SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. New England Journal of Medicine. 2015;373(22):2103–2116. doi:https://doi.org/ 10.1056/nejmoa1511939. 156 Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart failure: a Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18). doi:https:// doi.org/10.1161/cir.0000000000001063. its inclusion in other quality measure sets, such as the CMS Universal Foundation Measure Set and the Cardiology Core Quality Measures Collaborative (CQMC) set has resulted in more widespread adoption, helping streamline reporting and reduce burden.159 We seek comment on our inclusion of this measure in the heart failure quality measure set. (v) Functional Status Assessments for Heart Failure (MIPS Q377) We propose including Functional Status Assessments for Heart Failure (MIPS Q377) in the heart failure measure set in ASM because patients with heart failure ofte essments for Heart Failure (MIPS Q377) We propose including Functional Status Assessments for Heart Failure (MIPS Q377) in the heart failure measure set in ASM because patients with heart failure often experience poor functional status and health-related quality of life, both of which tend to decline as the disease progresses. Assessing functional status is crucial for managing the complex health needs of patients who often have multiple comorbidities. Furthermore, standardized assessment of patient- reported health status using a validated questionnaire can be useful for providing incremental information related to patient functional status and prognosis. It is also an independent predictor of hospitalization and mortality.160 The measure emphasizes the importance of collecting relevant patient-reported health status from heart failure patients, such as functional limitations, symptom burden, and quality of life. It supports the creation of a dynamic conversation between patients and providers regarding care goals and priorities, which we believe can facilitate shared decision-making, empower patients, and incentivize clinicians to incorporate patient voice and lived experience in providers regarding care goals and priorities, which we believe can facilitate shared decision-making, empower patients, and incentivize clinicians to incorporate patient voice and lived experience in clinical care activities. This measure is appropriate for ASM as it encourages cardiologists to regularly assess, monitor, and help improve the functional status of their heart failure patients, which are crucial for providing patient-centered care and aligning treatment plans with individual goals and priorities. In addition, this measure aligns with other quality measurement efforts, such as the Advancing Care for Heart Disease MVP in the Quality Payment Program and the Cardiology Core Quality Measures 159 Jacobs DB, Schreiber M, Seshamani M, Tsai D, Fowler E, Fleisher LA. Aligning Quality Measures across CMS—The Universal Foundation. New England Journal of Medicine. 2023;388(9). doi:https://doi.org/10.1056/nejmp2215539. 157 Messerli FH, Rimoldi SF, Bangalore S. The Transition From Hypertension to Heart Failure. JACC: Heart Failure. 2017;5(8):543–551. doi:https:// doi.org/10.1016/j.jchf.2017.04.012. 158 Oh GC, Cho HJ. Blood pressure and heart failure. Clinical Hypertension. 2020;26( rtension to Heart Failure. JACC: Heart Failure. 2017;5(8):543–551. doi:https:// doi.org/10.1016/j.jchf.2017.04.012. 158 Oh GC, Cho HJ. Blood pressure and heart failure. Clinical Hypertension. 2020;26(1). doi:https://doi.org/10.1186/s40885–019–0132-x. 160 Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart failure: a Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18). doi:https:// doi.org/10.1161/cir.0000000000001063. Collaborative (CQMC) set. We seek comment on our inclusion of this measure in the heart failure quality measure set. We note that the Functional Status Assessments for Heart Failure (MIPS Q377) measure is currently a process measure. We propose that the process measure would be included for the 2027 ASM performance year, while we explore the benefit and applicability of developing a Patient—patient-reported outcome-based performance measure (PRO–PM). The current measure ensures a functional status assessment is completed. A PRO–PM would hold the ASM participant accountable for not only collecting patient-reported data but also ce measure (PRO–PM). The current measure ensures a functional status assessment is completed. A PRO–PM would hold the ASM participant accountable for not only collecting patient-reported data but also improving or slowing progression of decline in functional status over time. We believe this would capture more meaningful changes in patient care. We seek comments on our proposal to include the Functional Status Assessments for Heart Failure (MIPS Q377) measure in ASM, the applicability of the measure as a PRO– PM, and whether the PRO–PM, if available, should be included in the heart failure measure set for future performance years of ASM. (c) Quality Measure Set for the ASM Low Back Pain Cohort We propose at § 512.725(c)(1) through (5) to include the following measures in the low back pain measure set. Each ASM low back pain participant must report each measure using one of the collection types specified in Table 39. (i) Magnetic Resonance Imaging (MRI) Lumbar Spine for Low Back Pain, Respecified To Be Relevant to ASM Participants Treating Low Back Pain We propose to include a respecified MRI Lumbar Spine for Low Back Pain measure in the low back pain measure set. We believe this ad especified To Be Relevant to ASM Participants Treating Low Back Pain We propose to include a respecified MRI Lumbar Spine for Low Back Pain measure in the low back pain measure set. We believe this administrative claims-based measure can effectively assess overuse and hopefully incentivize reductions in inappropriate MRI imaging for low back pain. Routine imaging (such as MRI) is not recommended for patients with non- specific low back pain in the absence of certain clinical indicators with concerning features.161 However, studies have shown that a significant proportion of patients with low back pain undergo imaging, often within the first few weeks of symptom onset, 161 North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. https:// www.spine.org/Portals/0/assets/downloads/ ResearchClinicalCare/Guidelines/LowBackPain.pdf VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00229 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 32580 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / m 00229 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 32580 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules despite the lack of clear indication.162 Overuse of imaging for low back pain can lead to unnecessary health care costs and potential patient harm from incidental findings that may prompt further unnecessary testing or procedures.163 164 By including this measure in the low back pain measure set, ASM aims to incentivize adherence to evidence-based guidelines and a reduction of unnecessary MRIs for patients with uncomplicated low back pain, particularly in the initial stages of evaluation and management. We believe this could also have a positive impact on patient experience as it reduces time spent at medical appointments and health care costs. Furthermore, as an administrative claims measure, ASM participants would not have to report data for this measure, reducing reporting burden. MRI Lumbar Spine for Low Back Pain measure was specified for use in Hospital Outpatient Departments at the facility level and was previously included in the Hospital Outpatient Quality Repo ng burden. MRI Lumbar Spine for Low Back Pain measure was specified for use in Hospital Outpatient Departments at the facility level and was previously included in the Hospital Outpatient Quality Reporting Program (HOQRP) as OP–8 (73 FR 68766).165 Part of our re- specification efforts would involve ensuring validity and reliability at the TIN/NPI level. We are also exploring the denominator criteria of the measure and potentially redefining the denominator. This potential change is pending further internal analyses to determine whether participants would be able to meet denominator minimum and specification changes and ensure the measure accurately identifies unwarranted MRI usage. We would propose the measure’s specifications through notice and comment rulemaking when available and in advance of using the measure in the low back pain cohort. We seek comment on the re- specification and inclusion of MRI Lumbar Spine for Low Back Pain measure in the low back pain measure set. 162 Medicare Payment Advisory Commission. Health Care Spending and the Medicare Program: A Data Book. Medicare Payment Advisory Commission; July 2021. Accessed [insert access date]. https://www.medpac.gov/wp-co re Payment Advisory Commission. Health Care Spending and the Medicare Program: A Data Book. Medicare Payment Advisory Commission; July 2021. Accessed [insert access date]. https://www.medpac.gov/wp-content/ uploads/2021/10/July2021_MedPAC_DataBook_ Sec7_SEC.pdf. 163 Litkowski PE, Smetana GW, Zeidel ML, Blanchard MS. Curbing the Urge to Image. The American Journal of Medicine. 2016;129(10):1131– 1135. doi:https://doi.org/10.1016/ j.amjmed.2016.06.020. 164 Chou R. Diagnostic Imaging for Low Back Pain: Advice for High-Value Health Care From the American College of Physicians. Annals of Internal Medicine. 2011;154(3):181. doi:https://doi.org/ 10.7326/0003-4819-154-3-201102010-00008. 165 Hospital Outpatient Quality Reporting √ Partnership for Quality Measurement. P4qm.org. Published 2025. Accessed April 23, 2025. https:// p4qm.org/taxonomy/term/216. (ii) Use of High-Risk Medications in Older Adults (MIPS Q238) We propose to include the Use of High-Risk Medications in Older Adults (MIPS Q238) measure in the low back pain quality measure set. Older adults with low back pain who receive a prescription for a high-risk medication as part of their treatment plan, may have a range of adverse e ) measure in the low back pain quality measure set. Older adults with low back pain who receive a prescription for a high-risk medication as part of their treatment plan, may have a range of adverse events, including medication side effects, drug interactions, a prescribing cascade, or hospitalization. Individuals ages 65 and older are more likely to have multiple chronic conditions, increasing their risk for adverse drug effects associated with polypharmacy.166 Forty percent of individuals 65 and older filled at least one prescription for a potentially inappropriate medication and 13 percent filled two or more, leading to as much as $7.2 billion spent per year on inappropriate medications in older adults167 168 Several of the medications included in the measure are prescribed for treatment of musculoskeletal conditions and pain, such as skeletal muscle relaxants and tricyclic antidepressants.169 170 171 Skeletal muscle relaxants may be prescribed as an alternative to conventional pain medication; however, they carry considerable risk of falls and associated 166 Medicare Payment Advisory Commission. Polypharmacy and opioid use among Medicare Part D enrollees. In: Report to the Cong medication; however, they carry considerable risk of falls and associated 166 Medicare Payment Advisory Commission. Polypharmacy and opioid use among Medicare Part D enrollees. In: Report to the Congress: Medicare and the Health Care Delivery System. June 2015. Chapter 5. Accessed [insert access date]. https:// www.medpac.gov/wp-content/uploads/import_ data/scrape_files/docs/default-source/reports/ chapter-5-polypharmacy-and-opioid-use-among- medicare-part-d-enrollees-june-2015-report-.pdf. 167 Fick DM, Mion LC, Beers MH, L. Waller J. Health outcomes associated with potentially inappropriate medication use in older adults. Research in Nursing & Health. 2008;31(1):42–51. doi:https://doi.org/10.1002/nur.20232. 168 Fu AZ, Jiang JZ, Reeves JH, Fincham JE, Liu GG, Perri M. Potentially Inappropriate Medication Use and Healthcare Expenditures in the US Community-Dwelling Elderly. Medical Care. 2007;45(5):472–476. doi:https://doi.org/10.1097/ 01.mlr.0000254571.05722.34. 169 North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. https:// www.spine.org/Portals/0/assets/downloads/ Resea ne Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. https:// www.spine.org/Portals/0/assets/downloads/ ResearchClinicalCar. 170 Santandreu J, Francisco Fe´lix Caballero, M Pilar Go´ mez-Serranillos, Gonza´lez-Burgos E. Association between tricyclic antidepressants and health outcomes among older people: A systematic review and meta-analysis. Maturitas. 2024;188:108083–108083. doi:https://doi.org/ 10.1016/j.maturitas.2024.108083. 171 Castillo S. Inappropriate Use of Skeletal Muscle Relaxants in Geriatric Patients. Uspharmacist.com. Published January 21, 2020. Accessed April 17, 2025. https:// www.uspharmacist.com/article/inappropriate-use- of-skeletal-muscle-relaxants-in-geriatric-patients# :∼:text=Skeletal%20muscle%20relaxants%20are %20on,opioids%20in%20the%20geriatric% 20population. morbidity due to common side effects of dizziness, drowsiness, and hypotension. One study found that elderly patients who were using skeletal muscle relaxants were 2.25 times more likely to visit the emergency room for a fall or fracture than elderly patients who weren’t prescribed these medications.172 Similarl ents who were using skeletal muscle relaxants were 2.25 times more likely to visit the emergency room for a fall or fracture than elderly patients who weren’t prescribed these medications.172 Similarly, a meta-analysis exploring the risks associated with use of tricyclic antidepressants in elderly patients found a significant increased risk of falls and fracture.173 In addition to the morbidity and substantial costs associated with falls in the older adult population, falls in a patient with low back pain could significantly worsen their condition and functional status. We believe including this measure in the low back pain measure set could encourage ASM participants to be more cautious in their prescribing of high-risk medications to patients with low back pain and potentially prevent falls and other adverse events that may negatively impact patient outcomes. It also could align clinical practice with efforts to avoid inappropriate describing in older adults, such as the Beers criteria, and deprescribe where appropriate.174 We believe the measure may promote positive changes in care delivery, such as incorporating regular medication review and reconciliation. This measure could b ia, and deprescribe where appropriate.174 We believe the measure may promote positive changes in care delivery, such as incorporating regular medication review and reconciliation. This measure could be particularly impactful in ASM given the promotion of specialty and primary care integration as a goal of the model. We seek comments on our inclusion of the Use of High-Risk Medications in Older Adults (MIPS Q238) measure in the ASM low back pain measure set. (iii) Preventive Care and Screening: Screening for Depression and Follow- Up Plan (MIPS Q134) We propose to including Preventive Care and Screening: Screening for Depression and Follow-Up Plan (Q134) in the low back pain measure set 172 Castillo S. Inappropriate Use of Skeletal Muscle Relaxants in Geriatric Patients. Uspharmacist.com. Published January 21, 2020. Accessed April 23, 2025. https:// www.uspharmacist.com/article/inappropriate-use- of-skeletal-muscle-relaxants-in-geriatric- patients?utm_source=TrendMD&utm_ medium=cpc&utm_campaign=US_Pharmacist_ TrendMD_0. 173 Santandreu J, Francisco Fe´lix Caballero, M Pilar Go´ mez-Serranillos, Gonza´lez-Burgos E. Association between tricyclic antidepressants and health outcomes amon