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 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 among older people: A systematic review and meta-analysis. Maturitas. 2024;188:108083–108083. doi:https://doi.org/ 10.1016/j.maturitas.2024.108083. 174 American Geriatrics Society. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society. 2023;71(7). doi:https://doi.org/10.1111/ jgs.18372. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00230 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 32581 because patients with chronic pain conditions, such as low back pain, are at an increased risk of developing depression.175 Comorbid depression can negatively impact quality of life, treatment adherence, and overall health outcomes.176 Screening for depression and providing appropriate follow-up care is an essential aspect of com d depression can negatively impact quality of life, treatment adherence, and overall health outcomes.176 Screening for depression and providing appropriate follow-up care is an essential aspect of comprehensive care for patients with low back pain, as depression may exacerbate pain and worsen functional status.177 Co-occurring depression has also been found to worsen low back pain outcomes and increase health care costs.178 Effective management of low back pain often requires a multidisciplinary approach to address the physical, psychological, and emotional aspects of the condition. Including this measure in the ASM low back pain measure set would encourage ASM participants treating low back pain to prioritize mental health screening and follow-up care. We believe this would lead to better management of physical and mental health, prevent worsening of a patient’s health status, and improve overall outcomes.179 180 We seek comment on the proposal to include the Preventive Care and Screening: Screening for Depression and Follow-Up Plan (MIPS Q134) measure in the ASM low back pain measure set. (iv) Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan (MIPS ning: Screening for Depression and Follow-Up Plan (MIPS Q134) measure in the ASM low back pain measure set. (iv) Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan (MIPS Q128) We propose to including the Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan (MIPS Q128) measure 175 Mullins PM, Yong RJ, Bhattacharyya N. Associations between chronic pain, anxiety, and depression among adults in the United States. Pain Practice. 2023;23(6). doi:https://doi.org/10.1111/ papr.13220. 176 Mullins PM, Yong RJ, Bhattacharyya N. Associations between chronic pain, anxiety, and depression among adults in the United States. Pain Practice. 2023;23(6). doi:https://doi.org/10.1111/ papr.13220. 177 North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. 178 Wong JJ, Tricco AC, Coˆ te´ P, et al. Association Between Depressive Symptoms or Depression and Health Outcomes for Low Back Pain: a Systematic Review and Meta-analysis. Journal of General Internal Medicine. 2021;37(5). doi:https://doi.org/ 10.1007/s11606-021-07079-8. 179 Pinheiro MB, ession and Health Outcomes for Low Back Pain: a Systematic Review and Meta-analysis. Journal of General Internal Medicine. 2021;37(5). doi:https://doi.org/ 10.1007/s11606-021-07079-8. 179 Pinheiro MB, Ferreira ML, Refshauge K, et al. Symptoms of Depression and Risk of New Episodes of Low Back Pain: A Systematic Review and Meta- Analysis. Arthritis Care & Research. 2015;67(11):1591–1603. doi:https://doi.org/10.1002/ acr.22619. 180 Tagliaferri SD, Miller CT, Owen PJ, et al. Domains of chronic low back pain and assessing treatment effectiveness: A clinical perspective. Pain Practice. 2019;20(2). doi:https://doi.org/10.1111/ papr.12846. in the low back pain measure set because obesity can predispose patients to and exacerbate chronic low back pain.181 182 Incorporating BMI screening and related follow-up into the care of patients with low back pain can improve outcomes by reducing the severity and recurrence of low back pain. The inclusion of this measure in the ASM low back pain measure set would incentivize a more holistic approach to low back pain management, addressing both the physical and lifestyle factors contributing to the condition. We believe ASM participants treating low ba et would incentivize a more holistic approach to low back pain management, addressing both the physical and lifestyle factors contributing to the condition. We believe ASM participants treating low back pain can play a crucial role in preventing and addressing modifiable risk factors like obesity and providing appropriate follow-up plans for weight management. In addition, this measure aligns with those used in other quality programs, such as the Rehabilitative Support for Musculoskeletal Care MVP in the Quality Payment Program. We seek comments on the proposal to include Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan (MIPS Q128) in the ASM low back pain measure set. (v) Functional Status Change for Patients With Low Back Impairments (MIPS Q220) We propose to include the Functional Status Change for Patients with Low Back Impairments (MIPS Q220) measure in the ASM low back pain measure set. This measure would encourage ASM participants to adopt a more patient- centered and holistic approach to improving functional status and quality of life in patients with low back pain. As a patient-reported outcome measure, the measure tracks changes in a patie patient- centered and holistic approach to improving functional status and quality of life in patients with low back pain. As a patient-reported outcome measure, the measure tracks changes in a patient’s functional status over time, assessing changes and rewarding meaningful improvement with a better measure score for the ASM participant. We believe measuring and improving functional status could increase self- efficacy, improve financial well-being, and lower future medical costs. Measuring a change in functional status can also be used to direct and assess the success of treatment. Furthermore, the adoption of validated objective measurements may enhance the reliability and sensitivity of detecting physical deficits or monitoring 181 Zhang TT, Liu Z, Liu YL, Zhao JJ, Liu DW, Tian QB. Obesity as a Risk Factor for Low Back Pain: A Meta-Analysis. Clinical Spine Surgery. 2018;31(1):22–27. doi:https://doi.org/10.1097/ BSD.0000000000000468. 182 North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. posttreatment improvements of low back pain in older adults.183 Notably, relevant lines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. posttreatment improvements of low back pain in older adults.183 Notably, relevant professional organizations and specialty societies recommend the use of functional status surveys to assess and monitor changes in low back pain over time. The American Academy of Orthopaedic Surgeons recommends the use of the Oswestry Disability Index, which can be used to fulfill this measure, as one of its preferred tools for spine care. While AAOS also recommends the Neck Disability Index, it is less relevant to ASM.184 185 These functional status surveys include questions related to modifiable lifestyle factors, such as physical activity and social isolation, prompting conversation with patients that can prevent the worsening of comorbid conditions and low back pain. In addition, this measure aligns with other quality programs, such as the Rehabilitative Support for Musculoskeletal Care MVP in the Quality Payment Program and the Core Quality Measures Collaborative Orthopedics set. By holding ASM participants who treat low back pain accountable for this measure, ASM promotes a comp re MVP in the Quality Payment Program and the Core Quality Measures Collaborative Orthopedics set. By holding ASM participants who treat low back pain accountable for this measure, ASM promotes a comprehensive approach to low back pain management, including appropriate assessment, treatment, and monitoring of changes. We seek comment on our proposal to include the Functional Status Change for Patients with Low Back Impairments (MIPS Q220) measure in the low back pain measure set. (d) Other Measures Under Consideration (i) Patient Activation Measure (PAM) (MIPS Q503) We seek comments on whether the Patient Activation Measure (PAM) (MIPS Q503) would be appropriate to include in both the heart failure and low back pain measure sets. Chronic conditions, in general, are influenced by external factors, such as lifestyle, education, nutrition, and activity. Patient activation, which refers to a patient’s knowledge, skills, and confidence in managing their health condition, is an important factor in achieving better health outcomes and 183 Wong AY, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis and Spinal Disorders tor in achieving better health outcomes and 183 Wong AY, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis and Spinal Disorders. 2017;12(1):1–23. doi:https://doi.org/ 10.1186/s13013-017-0121-3. 184 North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. 185 Performance Measures by Orthopaedic Subspecialty. Aaos.org. Published 2025. Accessed April 23, 2025. https://www.aaos.org/quality/ research-resources/patient-reported-outcome- measures/performance-measures-by-orthopaedic- subspecialty. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00231 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 32582 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules adherence to treatment plans. For chronic conditions , such as heart failure and low back pain, where self- management and active patient engagement are crucial, assessing and improving patient activation levels could help ASM participants tailor their , such as heart failure and low back pain, where self- management and active patient engagement are crucial, assessing and improving patient activation levels could help ASM participants tailor their ability to provide more patient-centered support and education. Including the PAM measure in ASM could incentivize clinicians to prioritize strategies that enhance patient activation, such as shared decision-making, goal setting, and self-management support.186 Furthermore, higher levels of patient activation have been associated with better health behaviors, such as physical activity, and improved mental health outcomes.187 We are concerned by the burden on participants and patients that may be introduced by: (1) adding an additional measure to the set, (2) using a patient survey measure, and (3) PAM being a proprietary measure. We seek comments on whether PAM could be applicable to the heart failure and low back pain measure sets. (ii) Advance Care Plan (MIPS Q047) We considered including the Advance Care Plan (MIPS Q047) measure in the heart failure measure set. Advance care planning is important for understanding and documenting a patient’s wishes regarding their medical treatment, g the Advance Care Plan (MIPS Q047) measure in the heart failure measure set. Advance care planning is important for understanding and documenting a patient’s wishes regarding their medical treatment, acknowledging that wishes may evolve as circumstances and health status change. Heart failure, depending on stage and other risk factors, can progress unpredictably and rapidly. According to one meta-analysis, survival rates for all patients with heart failure are 95.7 percent at one month, 86.5 percent at 1 year, and 56.7 percent at 5 years, with elderly patients having lower survival rates on average.188 Having a documented plan in place is necessary to ensure a patient’s wishes are followed should they become incapacitated and unable to make care decisions. One study of Medicare beneficiaries with severe illness found that timely advance 186 Newland P, Lorenz R, Oliver BJ. Patient activation in adults with chronic conditions: A systematic review. Journal of Health Psychology. Published online August 23, 2020:135910532094779. doi:https://doi.org/ 10.1177/1359105320947790. 187 Hosseinzadeh H, Downie S, Shnaigat M. Effectiveness of health literacy- and patient activation-targeted inte online August 23, 2020:135910532094779. doi:https://doi.org/ 10.1177/1359105320947790. 187 Hosseinzadeh H, Downie S, Shnaigat M. Effectiveness of health literacy- and patient activation-targeted interventions on chronic disease self-management outcomes in outpatient settings: a systematic review. Australian Journal of Primary Health. 2022;28(2). doi:https://doi.org/10.1071/ py21176. 188 Jones NR, Roalfe AK, Adoki I, Hobbs FDR, Taylor CJ. Survival of patients with chronic heart failure in the community: A systematic review and meta-analysis. European Journal of Heart Failure. 2019;21(11):1306–1325. doi:https://doi.org/10.1002/ ejhf.1594. care planning was associated with significantly less intensive end-of-life care utilization and fewer in-hospital deaths, hospital admissions, intensive care unit admissions, and emergency department visits.189 Another study on Medicare beneficiaries with heart failure found that beneficiaries who received advance care planning visits had 19 percent lower total end-of-life expenditure compared to those who did not.190 This measure could encourage ASM participants to have proactive discussions with their patients about end-of-life care, advance dire wer total end-of-life expenditure compared to those who did not.190 This measure could encourage ASM participants to have proactive discussions with their patients about end-of-life care, advance directives, and other important decisions related to their treatment plan. However, we decided not to include the measure, as we worry the measure would not result in sufficiently meaningful positive changes for patients to justify the increased burden. Also, we do not believe the cardiologist would be the most appropriate provider to oversee advance care planning in every case, and we want to avoid duplication of effort with PCPs. We seek comments on whether the Advance Care Plan measure could be meaningful if included in the heart failure measure set. (iii) Clinician and Clinician Group Risk- Standardized Hospital Admission Rates for Patients With Multiple Chronic Conditions (MIPS Q484) We considered including the Clinician and Clinician Group Risk- standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions (MIPS Q484) measure in the heart failure measure set. We believe evaluating potentially preventable hospital admissions could help assess the quality of ambul Patients with Multiple Chronic Conditions (MIPS Q484) measure in the heart failure measure set. We believe evaluating potentially preventable hospital admissions could help assess the quality of ambulatory care provided by cardiologists to patients with multiple chronic conditions, including heart failure. Nearly 90 percent of adults with heart failure have two or more additional chronic conditions, and almost 60 percent have five or more chronic conditions.191 For heart failure patients with multiple comorbidities, reducing potentially preventable hospitalizations is a key goal for improving outcomes and reducing 189 Weissman JS, Reich AJ, Prigerson HG, et al. Association of Advance Care Planning Visits With Intensity of Health Care for Medicare Beneficiaries With Serious Illness at the End of Life. JAMA Health Forum. 2021;2(7):e211829. doi:https:// doi.org/10.1001/jamahealthforum.2021.1829. 190 Brill SB, Riley SR, Prater L, et al. Advance Care Planning (ACP) in Medicare Beneficiaries with Heart Failure. Journal of General Internal Medicine. 2024;39(13):2487–2495. doi:https://doi.org/10.1007/ s11606-024-08604-1. 191 Dharmarajan K, Dunlay SM. Multimorbidity in Older Adults with Hea with Heart Failure. Journal of General Internal Medicine. 2024;39(13):2487–2495. doi:https://doi.org/10.1007/ s11606-024-08604-1. 191 Dharmarajan K, Dunlay SM. Multimorbidity in Older Adults with Heart Failure. Clinics in Geriatric Medicine. 2016;32(2):277–289. doi:https://doi.org/ 10.1016/j.cger.2016.01.002. health care costs. While incentivizing cardiologists to adopt best practices, such as improving care coordination with primary care and enhancing self- management support, is of interest to CMS, this measure is not adequately targeted to heart failure. We also do not consider this measure appropriate for the low back pain measure set, as the condition is less prone to hospital admissions and re-admissions. We seek comments on whether the Clinician and Clinician Group Risk-standardized Hospital Admission Rates for Patients with Multiple Chronic Conditions (MIPS Q484) measure should be considered for inclusion in the heart failure measure set. (iv) Cardiac Rehabilitation Patient Referral From an Outpatient Setting (MIPS Q243) We considered including the Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure in the heart failure measure set. This measure asse ferral From an Outpatient Setting (MIPS Q243) We considered including the Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure in the heart failure measure set. This measure assesses the percentage of patients evaluated in an outpatient setting who have qualified for cardiac rehabilitation and were referred to an outpatient cardiac rehabilitation program. As it relates to heart failure, Medicare patients only qualify for a cardiac rehabilitation program if they have stable chronic heart failure, defined as left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks.192 In these patients, cardiac rehabilitation is a comprehensive intervention that includes exercise training, education, and counseling to improve cardiovascular health and reduce the risk of future cardiac events. For patients with heart failure, meta- analyses on cardiac rehabilitation have shown that it improves functional capacity, exercise duration, and health- related quality of life.193 Also, cardiac rehabilitation programs have evolved to serve other purposes, such bilitation have shown that it improves functional capacity, exercise duration, and health- related quality of life.193 Also, cardiac rehabilitation programs have evolved to serve other purposes, such as disease management and prevention centers that assist with medication adherence, weight loss, smoking cessation, and other contributors to heart disease.194 192 Cardiac Rehabilitation Program Coverage. www.medicare.gov. https://www.medicare.gov/ coverage/cardiac-rehabilitation. 193 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. 194 Ades PA, Keteyian SJ, Wright JS, et al. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00232 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 Rule 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 32583 By including this measure in the heart failure measure set, CMS could incentivize cardiologists and other clinicians to refer eligible patients with heart failure to cardiac rehabilitation programs, which can potentially improve their long-term outcomes and reduce their risk of hospitalizations. We decided not to include the measure in the heart failure measure set because access to cardiac rehabilitation programs is significantly varied based on region due to factors like limited availability, density, eligibility, or distance, and these factors could negatively affect ASM participants due to no fault of their own.195 We seek comment on whether the Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure could be meaningful if included in the heart failure measure set. (v) Falls: Plan of Care We considered including the Falls: Plan of Care measure in the low back pain measure set. This measure assesses the percentage of patients aged 65 years and older with a e set. (v) Falls: Plan of Care We considered including the Falls: Plan of Care measure in the low back pain measure set. This measure assesses the percentage of patients aged 65 years and older with a history of falls that had a plan of care for falls documented within 12 months. The implementation of a falls plan of care for this population could address multiple aspects of patient safety and functional improvement. Such a plan may include assessment of environmental hazards, evaluation of medication side effects, and implementation of appropriate exercise interventions to improve strength, balance, and coordination.196 For low back pain patients specifically, the plan could incorporate targeted exercises that not only address fall prevention but also support their primary condition management, creating a comprehensive approach to their care. The Falls: Plan of Care quality measure is particularly relevant for the low back pain patient population as these patients may experience altered biomechanics, decreased mobility, and impaired balance, which may significantly increase their risk of falls. Patients with low back pain may also exhibit protective movement patterns and altered p ed biomechanics, decreased mobility, and impaired balance, which may significantly increase their risk of falls. Patients with low back pain may also exhibit protective movement patterns and altered postures that, while intended to minimize pain, may compromise their stability and balance. Hearts Cardiac Rehabilitation Collaborative. Mayo Clinic Proceedings. 2017;92(2):234–242. doi:https:// doi.org/10.1016/j.mayocp.2016.10.014. 195 Duncan MS, Robbins NN, Wernke SA, et al. Geographic Variation in Access to Cardiac Rehabilitation. Journal of the American College of Cardiology. 2023;81(11):1049–1060. doi:https:// doi.org/10.1016/j.jacc.2023.01.016. 196 CDC. Outpatient Care—STEADI in Primary Care. STEADI—Older Adult Fall Prevention. Published May 16, 2024. https://www.cdc.gov/ steadi/hcp/clinical-resources/outpatient-care.html. Studies have shown that some elderly patients with a recent history of back pain are at increased risk for falls, with that risk increasing as the number of locations they experience pain in their back increases.197 198 Another study found that community-dwelling older adults with chronic pain generally, such as low back pain, were more likely to have fallen in ns they experience pain in their back increases.197 198 Another study found that community-dwelling older adults with chronic pain generally, such as low back pain, were more likely to have fallen in the past 12 months and to fall again in the future.199 Additionally, low back pain patients may take medications such as muscle relaxants, anti-depressants, or other medications that can affect their balance and coordination, further elevating their fall risk.200 201 By including this measure in the low back pain measure set, we could promote ASM participants to assess the risk a patient is at for falls and implement any needed plan or corrective actions to mitigate the issues that may be present. We decided not to include the measure in the low back pain measure set as we are concerned that beneficiaries in ASM may have falls may for reasons, such as syncope, that are less relevant to the care of the ASM participant, and that the incidence of falls is not high enough in this patient population. We seek comments on whether the Falls: Plan of Care measure could be meaningful if included in the low back pain measure set. (e) Removal and Addition of Quality Measures While we do not plan t ation. We seek comments on whether the Falls: Plan of Care measure could be meaningful if included in the low back pain measure set. (e) Removal and Addition of Quality Measures While we do not plan to add or remove measures from either cohort’s 197 Marshall LM, Litwack-Harrison S, Makris UE, et al. A Prospective Study of Back Pain and Risk of Falls Among Older Community-dwelling Men. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. Published online November 16, 2016:glw227. doi:https://doi.org/ 10.1093/gerona/glw227. 198 Marshall LM, Litwack-Harrison S, Cawthon PM, et al. A Prospective Study of Back Pain and Risk of Falls Among Older Community-dwelling Women. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. 2016;71(9):1177–1183. doi:https://doi.org/10.1093/ gerona/glv225. 199 Stubbs B, Binnekade T, Eggermont L, Sepehry AA, Patchay S, Schofield P. Pain and the Risk for Falls in Community-Dwelling Older Adults: Systematic Review and Meta-Analysis. Archives of Physical Medicine and Rehabilitation. 2014;95(1):175–187.e9. doi:https://doi.org/10.1016/ j.apmr.2013.08.241. 200 Park H, Satoh H, Miki A, Urushihara H, Sawada Y. Me iew and Meta-Analysis. Archives of Physical Medicine and Rehabilitation. 2014;95(1):175–187.e9. doi:https://doi.org/10.1016/ j.apmr.2013.08.241. 200 Park H, Satoh H, Miki A, Urushihara H, Sawada Y. Medications associated with falls in older people: systematic review of publications from a recent 5-year period. European Journal of Clinical Pharmacology. 2015;71(12):1429–1440. doi:https://doi.org/10.1007/s00228-015-1955-3. 201 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?utm_source=TrendMD&utm_ medium=cpc&utm_campaign=US_Pharmacist_ TrendMD_0. measure set of the ASM test period, there may be circumstances in which it is necessary. We propose at § 512.725(d) that we would add or remove any quality measure for an ASM cohort through notice and comment rulemaking. 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 measur 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. Because the quality measures currently proposed are all part of MIPS, any updates CMS applies to the measures within MIPS would be incorporated into the quality measure sets accordingly. We seek comments on the proposed approach for removal or addition of quality measures. (f) Maintenance of Technical Specifications for Quality Measures We propose at § 512.725(d) to release technical specifications for the required quality measures in a form and manner determined by CMS for each ASM performance year via notice and comment rulemaking. We intend to use the most recent MIPS version of the technical specifications for all applicable measures. For non-MIPS measures, we would release the measure specifications in advance of the ASM performance year in which the specifications would be applicable via notice-and-comment rulemaking. If any changes are made to specifications for MIPS measures, and ASM chooses not to adopt these changes, we propose releasing the measure technical specificatio able via notice-and-comment rulemaking. If any changes are made to specifications for MIPS measures, and ASM chooses not to adopt these changes, we propose releasing the measure technical specifications applicable to ASM via notice and comment rulemaking before the start of each ASM performance year. We seek comments on our proposal to use the most recent MIPS version of technical specifications of quality measures for each ASM performance year. We also seek comment on our intent to release the technical specifications of non-MIPS measures via notice and comment rulemaking, and if it allows adequate time for ASM participants to make any needed adjustments to data collections systems or practice workflows. (g) Data Submission Criteria for the Quality ASM Performance Category We propose at § 512.725(e)(1) that ASM participants submitting data for measures with non-administrative claims-based measures would be required to submit data for each measure using one of the measure’s collection types identified for each required quality measure as detailed in Table 39. We propose at § 512.725(e)(2) VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00233 Fmt 4701 Sfmt 4702 E:\FR\FM\ types identified for each required quality measure as detailed in Table 39. We propose at § 512.725(e)(2) VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00233 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 32584 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules that for the applicable ASM performance year, each ASM heart failure participant would report all of the measures in the heart failure measure set as described in section III.C.2.d.(2).(b) of this proposed rule and each ASM low back pain participant would report all the measures in the low back pain measure set as described in section III.C.2.d.(2).(c) of this proposed rule. We seek comments on the proposed form, manner, and timing of quality measures reporting at § 512.725(e). (h) Data Completeness Requirement and Case Minimums for the Quality ASM Performance Category (i) Data Completeness Requirement We propose at § 512.725(f)(1) to set a data completeness requirement of at least 75 percent beginning in the 2027 ASM performance year. Data completeness is essential to ensure that data submitted on quality me at § 512.725(f)(1) to set a data completeness requirement of at least 75 percent beginning in the 2027 ASM performance year. Data completeness is essential to ensure that data submitted on quality measures are sufficiently complete to accurately assess each ASM participant’s quality performance. The data completeness requirement means that an ASM participant submitting measure data on MIPS clinical quality measures (MIPS CQMs) or eCQMs must submit data on at least a specific percent of their patients that meet the measure’s denominator criteria, regardless of payer. Also, the inclusion of eCQMs in ASM measure sets more easily enables submission of data on 100 percent of the patient records in a provider’s EHR, making data completeness more achievable. We believe it is important to maintain high data completeness to ensure the most accurate assessment of ASM participants. The CY 2025 PFS final rule set the CY 2025 MIPS performance period/2027 MIPS payment year MIPS data completeness requirement for the quality performance category at 75 percent (89 FR 98383 through 98387). Prior to this, the MIPS data completeness requirement had been periodically increasing from where it started, quirement for the quality performance category at 75 percent (89 FR 98383 through 98387). Prior to this, the MIPS data completeness requirement had been periodically increasing from where it started, which was at least 50 percent to where it currently is (89 FR 98383 through 98387). We do not intend to continue to align with MIPS data completeness requirements and instead propose to assess changes to the ASM quality measure data completeness as needed for model-specific purposes. Since some ASM participants would not have previously reported to MIPS and, therefore, may have limited experience and capabilities with quality reporting of this type, we considered data completeness requirement lower than 75 percent for 2027 ASM performance year and then increasing to 75 percent beginning in the 2028 ASM performance year 2028. We also propose at § 512.725(f)(2) that ASM participants would receive zero ‘‘measure achievement points,’’ which we propose at § 512.705 to mean numerical values assigned to an ASM participant’s reported performance data that we use to calculate an ASM performance category score, for any required measure that does not meet the proposed data completeness requiremen gned to an ASM participant’s reported performance data that we use to calculate an ASM performance category score, for any required measure that does not meet the proposed data completeness requirement. Meeting the data completeness requirement ensures that the measure represents an appropriate percentage of the clinical population applicable for a given quality measure. Therefore, we believe that not meeting the proposed data completeness requirement for a given required quality measure should result in the ASM participant receiving zero achievement points for that measure. Finally, we propose at § 512.725(f)(3) that we exclude from an ASM’s participant total measure achievement points and total available measure achievement points any required measures meet the respective measure’s data completeness requirement, but do not have a benchmark. As discussed later in this section of this proposed rule, we believe that it would not be appropriate to score quality measures for which we cannot determine a benchmark. We seek comments on the proposed data completeness requirement of 75 percent at § 512.725(f)(1) and whether a different data completeness percentage that we considered would ot determine a benchmark. We seek comments on the proposed data completeness requirement of 75 percent at § 512.725(f)(1) and whether a different data completeness percentage that we considered would be more appropriate. We also seek comment on our proposal at § 512.725(f)(2) that ASM participants would receive zero measure achievement points for any submitted quality measure that does not meet the data completeness requirement. Finally, we seek comment on our proposal at § 512.725(f)(3) for not scoring measures that meet data completeness requirements but for which we cannot determine a benchmark. (ii) Minimum Case Requirements We seek to ensure that ASM participants are measured reliably, therefore, we propose at § 512.725(g)(1) to use 20 cases as the minimum case requirement for each quality measure. We propose at § 512.725(g)(2) that ASM participants that report measures with fewer cases than the case minimum for the measure and meet the data completeness requirement proposed at § 512.725(f)(1) would receive recognition for submitting the measure, but we would not include the measure in the quality ASM performance category scoring as described later in this section of this prop 512.725(f)(1) would receive recognition for submitting the measure, but we would not include the measure in the quality ASM performance category scoring as described later in this section of this proposed rule. We believe this case minimum is appropriate as it aligns with the case minimum under MIPS as defined at § 414.1380(b)(1)(iii). We seek comments on our proposed case minimum for quality measures at § 512.725(g). (i) Quality Measure Achievement Points and Quality ASM Performance Category Scoring (i) Quality Measure Achievement Points We propose at 512.725(h)(1)(i) to assign 1 to 10 measure achievement points to each measure based on how an ASM participant performance compares to measure-specific benchmarks determined as described in section III.C.2.d.(2).(i) of this proposed rule. We propose at § 512.725(h)(1)(iii) that if an ASM participant fails to submit a measure required under the quality ASM performance category, then the ASM participant would receive zero measure achievement points for that measure. We propose at § 512.725(h)(1)(ii) and (iii) that measures reported by ASM participants must have the required case minimum as applicable for each measure, as proposed at § 5 t points for that measure. We propose at § 512.725(h)(1)(ii) and (iii) that measures reported by ASM participants must have the required case minimum as applicable for each measure, as proposed at § 512.725(g)(1), and meet the data completeness requirement, as proposed at § 512.725(f)(1), to receive a score. For example, if an ASM participant reports a measure that meets the data completeness requirement rule but does meet the required case minimum, then the ASM participant would not be scored on that measure, and that measure score would not be factored into the ASM participant’s quality ASM performance category score. An ASM participant who reports a measure that does not meet the data completeness requirement but meets the required case minimum of this proposed rule would receive a score of zero for the measure. An ASM participant who does not report the measure would receive a score of zero for the measure. We propose at § 512.725(h)(1)(iv) that an ASM participant that submits data for the same measure under two different collection types, if applicable, would be scored on the data submission that leads to the greatest number of achievement points for that required measure. The for the same measure under two different collection types, if applicable, would be scored on the data submission that leads to the greatest number of achievement points for that required measure. The quality ASM performance category score would be the sum of all the measure achievement points assigned for the scored measures required for the quality ASM performance category divided by the sum of total possible measure achievement points. We also propose not to score measures for which we could not VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00234 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 32585 determine a benchmark for a given ASM performance year as described in section.III.C.2.d.(2)(i)(ii) of this proposed rule. In this situation, the quality ASM performance category score would not include any measure or measures for which a benchmark could not be determined. We believe that it would be unfair to penalize ASM participants due to a lack of a benchmark. We seek comments on this proposed quality ASM performa ures for which a benchmark could not be determined. We believe that it would be unfair to penalize ASM participants due to a lack of a benchmark. We seek comments on this proposed quality ASM performance category scoring approach as described at § 512.725(h)(1). (ii) Benchmarking For the quality ASM performance category, we propose at § 512.725(h)(2) that the ASM performance standard is a measure-specific benchmark. We propose at §§ 512.725(h)(2)(i)(A) through (C) to determine benchmarks for each quality measure and for each of the measure’s collection types using data reported by ASM participants, to the extent feasible, during the ASM performance year, from a previous ASM performance year, or from another period determined by CMS. The benchmark determination is contingent on relevant available data for accurate calculation that is specific to ASM participants. For measures with an administrative claims-based collection type, we propose at § 512.725(h)(2)(iii) to calculate the benchmark using performance on the measure during the current ASM performance year. We believe it is important to determine separate benchmarks for each of a measure’s collection types since performance vari rk using performance on the measure during the current ASM performance year. We believe it is important to determine separate benchmarks for each of a measure’s collection types since performance varies by collection type in MIPS.202 We considered determining one benchmark per quality measure regardless of collection type since having a single benchmark may help ASM participants more readily calibrate their performance. Given the differences in MIPS performance by collection type for measures that we propose to require in ASM,203 we believe it would be more appropriate to calculate a benchmark for each collection type. We propose at § 512.725(h)(2)(iv) to determine benchmarks for each measure’s collection type using deciles based on the applicable period of data we use to determine the measure’s benchmark. Then, we would evaluate an ASM participant’s actual measure performance during the ASM performance year to determine the number of measure achievement points 202 https://qpp.cms.gov/resources/performance- data. 203 https://qpp.cms.gov/resources/performance- data. that should be assigned based on where the actual measure performance falls within the benchmark. We propose establish resources/performance- data. 203 https://qpp.cms.gov/resources/performance- data. that should be assigned based on where the actual measure performance falls within the benchmark. We propose establishing benchmarks using a percentile distribution, separated by decile categories, because it translates measure-specific score distributions into a uniform distribution of ASM participants based on actual performance values. For each set of benchmarks, we propose to calculate the decile breaks for measure performance and assign measure achievement points for a measure based on which benchmark decile range the ASM participant’s performance rate on the measure falls between. For example, an ASM participant in the top decile would receive 10 measure achievement points for the measure, and an ASM participant in the next lower decile would receive measure achievement points ranging from 9 to 9.9. We propose to assign partial measure achievement points to prevent performance cliffs for ASM participants near the decile breaks. The partial measure achievement points would be assigned based on the percentile distribution We propose at §§ 512.725(h)(2)(ii)(A) through (C) that we only calculate ben pants near the decile breaks. The partial measure achievement points would be assigned based on the percentile distribution We propose at §§ 512.725(h)(2)(ii)(A) through (C) that we only calculate benchmarks for measures that have a minimum of 20 ASM participants that report the measure: (1) meeting the data completeness requirement as proposed at §§ 512.725(f)(1) through (2) meeting the required case as proposed at §§ 512.725(g)(1) and (3) a performance rate greater than zero. We propose a minimum of 20 because our benchmarking methodology relies on assigning measure achievement points based on decile distributions with decimals. A decile distribution requires at least 10 observations. We would double the requirement to 20 so that we would be able to assign decimal measure achievement point values and minimize cliffs between deciles. Given the mandatory participation of ASM and the mandatory quality measure sets, we do not anticipate that we would encounter challenges with meeting this proposed minimum of 20 ASM participants reporting a measure to determine a benchmark. We seek comments on our proposed benchmark determination process as proposed at § 512.725(h)(2) and all alternat s proposed minimum of 20 ASM participants reporting a measure to determine a benchmark. We seek comments on our proposed benchmark determination process as proposed at § 512.725(h)(2) and all alternatives considered. (iii) Topped-Out Quality Measures We propose at § 512.725(h)(3) that we would identify topped out measures in the benchmarks for each ASM performance year, based on within- model performance on each measure. We considered but are not proposing an initial policy regarding topped out measures and differential benchmarking for measures with a topped-out status. MIPS defines at § 414.1305 a topped out non-process measure as a measure where the Truncated Coefficient of Variation is less than 0.10 and the 75th and 90th percentiles are within 2 standard errors; MIPS also defines at § 414.1305 a topped-out process measure as measure with a median performance rate of 95 percent or higher. We propose monitoring during initial ASM performance year(s) before designating an ASM measure with topped out status. We would propose using a definition like the definition used by MIPS and the Hospital Value- Based Purchasing (HVBP) Program: a Truncated Coefficient of Variation less than 0. with topped out status. We would propose using a definition like the definition used by MIPS and the Hospital Value- Based Purchasing (HVBP) Program: a Truncated Coefficient of Variation less than 0.10 and the 75th and 90th percentiles are within 2 standard errors as defined at § 412.164(c)(3) (88 FR 59333); or median value for a process measure that is 95 percent or greater (80 FR 49550). Topped out measures are of concern as it makes it difficult to assess relative performance to most accurately score the quality ASM performance category. However, since all ASM participants reporting one of the two measure sets would only be compared among others also reporting that measure set, and all the measures are mandatory to report, the benefit of selecting a topped-out measure is nullified. In this way, the reasoning for removing topped out measures is also nullified. Several of the measures included in our measure sets are topped out in other programs, such as MIPS, potentially because MIPS participants can select the measures on which they believe they would perform well. It is unclear whether requiring ASM participants to report a measure that is topped out in MIPS would present the S participants can select the measures on which they believe they would perform well. It is unclear whether requiring ASM participants to report a measure that is topped out in MIPS would present the same issues typically associated with topped-out measures or if the appearance of being topped out is simply due to voluntary reporting by only the highest performers in MIPS. We seek comment on our proposal at § 512.725(3) to identify topped out measures in the benchmarks for each ASM performance year, based on within-model performance on each measure, as well as all alternatives considered. (iv) Calculation of the Quality ASM Performance Score We propose at § 512.725(h)(4) to sum all quality measure achievement points determined for all measure reported by an ASM participant for an applicable ASM performance year. We would then divide that total achievement points by the total available measure achievement VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00235 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 32586 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules points f 02 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 32586 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules points for measures reported by the ASM participant that meets the case minimum requirements as defined at § 512.725(g) to determine an overall quality ASM performance category score, which could not exceed 100 percentage points. We propose at § 512.725(h)(4)(ii) that if data used to calculate a score for a quality measure are impacted by significant changes or errors affecting the ASM performance year, such that calculating the quality measure score would lead to misleading or inaccurate results, then the affected quality measure would be based on data for 9 consecutive months of the applicable ASM performance year. We propose at § 512.725(h)(4)(ii)(A) to consider ‘‘significant changes or errors’’ regarding instances in which a quality measure score could not be calculated as changes or errors external to the care provided, and that CMS determines may lead to misleading or inaccurate results that negatively impact the measure’s ability to reliably assess performance. We further propose at § 5 ternal to the care provided, and that CMS determines may lead to misleading or inaccurate results that negatively impact the measure’s ability to reliably assess performance. We further propose at § 512.735(h)(4)(ii)(A) that significant changes or errors include, but are not limited to, rapid or unprecedented changes to service utilization, the inadvertent omission of codes or inclusion of codes, or changes to clinical guidelines or measure specifications. We also propose at § 512.725(h)(4)(ii)(B) that we would publish a list of all measures scored in a form and manner specified by CMS. Finally, we propose at § 512.725(h)(4)(ii)(C) that if CMS determines sufficient measure data is not available, or that there is the possibility of patient harm or misleading results, a measure would be excluded from a participants score. We believe these proposed policies would appropriately adapt the proposed quality ASM performance category scoring policies so that ASM participants would not be penalized for changes or errors in the measure and associated submitted data that would be outside the control of the ASM participant. We propose at § 512.735(h)(4)(iii) that an ASM participant would not re zed for changes or errors in the measure and associated submitted data that would be outside the control of the ASM participant. We propose at § 512.735(h)(4)(iii) that an ASM participant would not receive a quality ASM performance category score if the ASM participant meets the quality ASM performance category data submission requirements proposed at § 512.720(a)(1)(i) but does not meet the case minimum requirements for any of the required quality measures in their applicable quality measure set. As discussed in sections III.C.2.e.(2)(b) and III.C.2.f.(4) of this proposed rule, the ASM participant in this situation would not receive a payment adjustment for the applicable ASM payment year. We believe that we should hold all ASM participants accountable to performance on quality. Accordingly, it would be inappropriate to evaluate the performance of an ASM participant that reports complete quality measure data but cannot meet the case minimums for any required measure within the applicable quality measure set since they would not have sufficient case volume by which to evaluate clinical quality. We seek comments on our proposed approach to calculate measure achievement points for ea ble quality measure set since they would not have sufficient case volume by which to evaluate clinical quality. We seek comments on our proposed approach to calculate measure achievement points for each required quality measure and determine benchmarks for quality measures in the quality ASM performance category. We also seek comment on our proposed approach to monitor for topped out measure status and future considerations for how we should approach and manage identified topped out measures in ASM. Finally, we seek comment on our proposal to calculate the quality ASM performance category score, as well as the proposed exceptions that could prevent the calculation of an individual quality measure score. or an overall performance category score. (3) Proposed Cost ASM Performance Category The proposed cost ASM performance category supports the model goals to improve quality care as measured through a focused measure set relevant to ASM’s clinical specialties and targeted chronic conditions, while decreasing the cost of care for beneficiaries with ASM’s targeted chronic conditions. The cost ASM performance category ensures that Medicare beneficiaries are receiving clinically appropria ns, while decreasing the cost of care for beneficiaries with ASM’s targeted chronic conditions. The cost ASM performance category ensures that Medicare beneficiaries are receiving clinically appropriate, comprehensive, high-value care. The importance of the cost ASM performance category is reflected in the weight of the performance category contribution to the final score, discussed at section III.C.2.e.(1) of this proposed rule. (a) Background The cost ASM performance category is one of four ASM performance categories measuring an ASM participant’s performance on the care delivered related to ASM’s targeted chronic conditions. The cost ASM performance category incentivizes ASM participants to ensure Medicare beneficiaries are receiving clinically appropriate, comprehensive, high-value care. Like the cost performance category under the MVPs, ASM participants in each ASM cohort would be scored on a condition-relevant EBCM. We propose at § 512.730(b) to use two EBCMs specified for the MIPS cost performance category, the Heart Failure EBCM and the Low Back Pain EBCM. As discussed below, while we are proposing to evaluate ASM participants on their performance on these two MIPS cost mea PS cost performance category, the Heart Failure EBCM and the Low Back Pain EBCM. As discussed below, while we are proposing to evaluate ASM participants on their performance on these two MIPS cost measures, and are proposing to use the same MIPS cost benchmarking and scoring methodology finalized for the 2024 MIPS performance period defined at § 414.1380(b)(2)(i)(B), we are proposing to use different benchmark ranges. (b) Performance Year for Cost ASM Performance Category Beginning with ASM payment year 2029, we propose at § 512.730(a) that the ASM performance year for cost measures would be the full calendar year from January 1 to December 31 that occurred 2 years prior to an applicable ASM payment year. We believe that setting that setting the ASM performance year for cost measures in this way aligns with MIPS as defined at § 414.1320 and would be easily adoptable by ASM participants. We seek comments on our proposed approach at § 512.730(a) setting the ASM performance year for cost measures. (c) Cost Measure for the ASM Heart Failure Cohort For the ASM heart failure cohort, we propose at § 512.730(b)(1) to utilize the heart failure EBCM, a MIPS cost measure specified by CMS thro measures. (c) Cost Measure for the ASM Heart Failure Cohort For the ASM heart failure cohort, we propose at § 512.730(b)(1) to utilize the heart failure EBCM, a MIPS cost measure specified by CMS through rulemaking, to determine an ASM heart failure participant’s cost ASM performance category score.204 We are proposing the heart failure EBCM, in part, because the Advancing Care for Heart Disease MVP (88 FR 80022 through 80025; 89 FR 99015 through 99019) includes it as one of the mandatory cost measures. The heart failure EBCM evaluates a participant’s risk adjusted and specialty-adjusted cost to Medicare for beneficiaries receiving medical care to manage and treat heart failure.205 We are proposing the heart failure EBCM because the measure quantifies the costs of services that are clinically related to the participant’s role in managing care during a heart failure episode. We believe that the heart failure EBCM captures a targeted high-cost patient population, has robust clinician coverage, and can help lower Medicare spending. The heart failure EBCM is a complex, yet feasible, chronic condition measure that 204 https://www.cms.gov/medicare/quality/value- based-programs/cost-measu erage, and can help lower Medicare spending. The heart failure EBCM is a complex, yet feasible, chronic condition measure that 204 https://www.cms.gov/medicare/quality/value- based-programs/cost-measures/about. 205 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 00236 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 32587 addresses care delivered to manage heart failure. We believe holding ASM heart failure participants accountable on the heart failure EBCM represents an opportunity to measure reductions in the cost of care for beneficiaries with heart failure. Additionally, we are proposing this measure and the focus on heart failure, generally, due to the prevalence of heart failure in the Medicare FFS population, and the high costs associated with the management of the disease and its complications. The incidence of heart failure increases with age, rising from 20 per 1,000 individuals aged 65 to 69 to more than 80 per 1,000 individuals ove ith the management of the disease and its complications. The incidence of heart failure increases with age, rising from 20 per 1,000 individuals aged 65 to 69 to more than 80 per 1,000 individuals over 80 years of age.206 With an estimated 1 in 5 Americans 40 years and older expected to develop heart failure and 1 in 5 Americans expected to be 65 years or older by 2050, the number of Americans with heart failure is predicted to significantly increase in the future.207 Further, heart failure was listed as the cause of death on 13.4 percent of all death certificates in the United States in 2018.208 In addition to its prevalence, heart failure is also costly for the health care system. According to the Centers for Disease Control and Prevention (CDC), heart failure costs the United States $30.7 billion annually, including health care services, medications used to treat heart failure, and lost productivity.209 A large contributor to heart failure-related health care costs may be inpatient admissions, with one study estimating that roughly 1 in 6 beneficiaries returned to the hospital for admission for heart failure-related reasons within 90 days of their initial discharge.210 We seek c admissions, with one study estimating that roughly 1 in 6 beneficiaries returned to the hospital for admission for heart failure-related reasons within 90 days of their initial discharge.210 We seek comments on the proposed use of the heart failure EBCM at § 512.730(b)(1) to score the cost ASM performance category for the ASM heart failure cohort. (d) Cost Measure for ASM Low Back Pain Cohort For the ASM low back pain cohort, we propose at § 512.730(b)(2) to utilize the low back pain EBCM to determine 206 Yancy et al. ‘‘2013 ACCF/AHA Heart Failure Guidelines.’’ (2013). https://www.ahajournals.org/ doi/pdf/10.1161/CIR.0b013e31829e8776. 207 Yancy et al. ‘‘2013 ACCF/AHA Heart Failure Guidelines.’’ (2013). https://www.ahajournals.org/ doi/pdf/10.1161/CIR.0b013e31829e8776. 208 Centers for Disease Control and Prevention (CDC) ‘‘Heart Failure.’’ September 2020. https:// www.cdc.gov/heartdisease/heart_failure.htm. 209 Centers for Disease Control and Prevention (CDC) ‘‘Heart Failure.’’ September 2020. https:// www.cdc.gov/heartdisease/heart_failure.htm. 210 Kilgore et al., ‘‘Economic burden of hospitalizations of Medicare beneficiaries with heart failure,’’ Risk Management and Healthcare Po r 2020. https:// www.cdc.gov/heartdisease/heart_failure.htm. 210 Kilgore et al., ‘‘Economic burden of hospitalizations of Medicare beneficiaries with heart failure,’’ Risk Management and Healthcare Policy 10 (2017): 63–70, doi: 10.2147/ RMHP.S130341. an ASM low back pain participant’s cost ASM performance category score.211 The low back pain EBCM evaluates a participant’s risk adjusted and specialty- adjusted cost to Medicare for patients receiving medical care to manage and treat low back pain. We are proposing the low back pain EBCM, in part, to align with the Rehabilitative Support for Musculoskeletal Care MVP (88 FR 80002 through 80007; 89 FR 99050 through 990054). We also believe this chronic condition EBCM appropriately captures the costs of services that are clinically related to the participant’s role in managing the longitudinal care during a low back pain episode. We believe that use of the low back pain EBCM would help increase accountability on spending and limit low-value care related to low back pain. Low back pain is highly prevalent and a high driver of spending. For example, an estimated 20 percent of people living in the United States experience low back pain,212 care related to low back pain. Low back pain is highly prevalent and a high driver of spending. For example, an estimated 20 percent of people living in the United States experience low back pain,212 and a 2020 study found that low back and neck pain contributed the most to health care spending among 154 mutually exclusive diagnoses, at $134.5 billion in 2016.213 Other studies have also found large increases in resource use for low backpain despite only modest increase in its prevalence and little improvement in patient outcomes,214 215 216 which underscores the need for more precise measure of resource use and quality of care. Given these findings, we believe the low back pain EBCM would be an appropriate measure by which to accurately determine resource use related to low back pain and compare cost-related performance across ASM low back pain participants. We seek comments on the proposed use of the low back pain EBCM at § 512.730(b)(2) to determine the cost 211 https://www.cms.gov/medicare/quality/value- based-programs/cost-measures/about. 212 Will, Joshua Scott, David Bury, and John Miller, ‘‘Mechanical Low Back Pain.’’ American Academy of Family Physicians 98(7) (2018): 421– 4 edicare/quality/value- based-programs/cost-measures/about. 212 Will, Joshua Scott, David Bury, and John Miller, ‘‘Mechanical Low Back Pain.’’ American Academy of Family Physicians 98(7) (2018): 421– 428. 213 Dieleman, Joseph, Jackie Cao, and Abby Chapin, ‘‘US Health Care Spending by Payer and Health Condition, 1996–2016.’’ JAMA Network 323(9) (2020): 863–884. doi:10.1001/ jama.2020.0734. 214 Luo, Xuemei, Ricardo Pietrobon, Shawn Sun, Gordon Liu, and Lloyd Hey, ‘‘Estimates and Patterns of Direct Health Care Expenditures Among Individuals With Back Pain in the United States.’’ Spine 29(1) (2004): 79–86. doi:10.1097/ 01.BRS.0000105527.13866.0. 215 Deyo, Richard, Sohail Mirza, Judith Turner, and Brook Martin, ‘‘Overtreating Chronic Back Pain: Time to Back Off?’’ J Am Board Fam Med 22(1) (2009): 62–68. doi:10.3122/jabfm.2009.01.080102. 216 Norman Marcus Pain Institute, ‘‘Pain Facts.’’ Last updated 23 January 2012. https:// www.normanmarcuspaininstitute.com/tag/neck- and-shoulder-pain/. ASM performance category score for the ASM low back pain cohort. (e) Removal and Addition of Cost Measures We intend to avoid making significant changes to the cost measure over the ASM test period. Howev performance category score for the ASM low back pain cohort. (e) Removal and Addition of Cost Measures We intend to avoid making significant changes to the cost measure over the ASM test period. However, we propose at § 512.730(c) to add or remove measures through notice and comment rulemaking as discussed at § 512.730(c) 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. Because the cost measures currently proposed are all part of MIPS, any updates CMS applies to the measures within MIPS would be incorporated into the cost ASM measure sets accordingly. We seek comments on our proposed approach at § 512.730(c) for adding or removing cost measures if necessary. (f) Minimum Case Requirements Like under MIPS, as specified in § 414.1350(c)(6) (88 FR 79346 through 79348), we propose at § 512.730(d) that an ASM participant must have at least 20 attributed episodes (that is, cases) at the TIN/NPI level during an ASM performance year for the ASM participant to receiv 48), we propose at § 512.730(d) that an ASM participant must have at least 20 attributed episodes (that is, cases) at the TIN/NPI level during an ASM performance year for the ASM participant to receive a score on the applicable EBCM. A participant with an unscored EBCM would also remain unscored in their ASM cost performance category score, resulting in a neutral payment adjustment for the applicable ASM payment year because the participant is required to have an ASM cost performance category score to receive a final score as discussed in section III.C.2.e.(2)(b). As discussed in section III.C.2.c.(3)(b) of this proposed rule, we believe that setting a minimum volume threshold during the calendar year 2 years prior to the applicable ASM performance year for the heart failure EBCM and the low back pain EBCM as part of ASM participant eligibility criteria would mean that ASM heart failure participants and ASM low back pain participants would be likely to meet the same episode case minimum during each ASM performance year. We seek comment on the proposed case minimum of 20 attributed episodes for all cost measures at § 512.730(d) used to score the cost ASM performance category. VerDat m during each ASM performance year. We seek comment on the proposed case minimum of 20 attributed episodes for all cost measures at § 512.730(d) used to score the cost ASM performance category. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00237 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 32588 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules (g) Cost Measure Achievement Points and Cost ASM Performance Category Scoring (i) Cost Measure Achievement Points We propose to follow a similar methodology for establishing and assigning measure achievement points as is used by MIPS. We propose at §§ 512.730(e)(1)(i) and 512.730(e)(1)(ii) that for each cost measure attributed to an ASM participant, CMS assigns the ASM participant 1 to 10 achievement points (including partial points) based on the ASM participant’s performance on the cost measure during the ASM performance year compared to the cost measure’s benchmark. Achievement points are awarded based on which benchmark range the ASM participant’s performance on the measure is in. (ii) Benchmarking We propose at § 512.7 compared to the cost measure’s benchmark. Achievement points are awarded based on which benchmark range the ASM participant’s performance on the measure is in. (ii) Benchmarking We propose at § 512.730(e)(2)(i) that CMS bases cost measure benchmarks on cost measure performance of ASM participants during the ASM performance year. To develop reliable cost measure benchmarks, we propose at § 512.730(e)(2)(i)(A) that each benchmark must have a minimum of 20 ASM participants who meet the minimum case volume specified at § 512.730(d) for CMS to determine a benchmark for the cost measure. We propose at § 512.730(e)(2)(i)(B) if a benchmark is not determined for a cost measure, then the measure would not be scored. We propose at § 512.730(e)(2)(ii) to score each EBCM using 10 benchmark ranges based on the median (that is, 50th percentile) cost of all ASM participants attributed the relevant measure plus or minus standard deviations. We propose at § 512.730(e)(2)(ii) to center the 10 benchmarks ranges at half the measure achievement points achievable for each EBCM. Given that the measure achievement points range from 1 to 10, the ASM participant with the median cost would be assigned 6 EBCM ranges at half the measure achievement points achievable for each EBCM. Given that the measure achievement points range from 1 to 10, the ASM participant with the median cost would be assigned 6 EBCM measure achievement points. We would then determine the score ranges applicable to each of the 10 measure achievement points based on standard deviations above and below the median score. We propose to calculate these benchmark ranges separately for each EBCM. We believe the proposed benchmark ranges, calculated using the median and centered around half of the available points for each EBCM would be dynamic and responsive to changes in average spending per episode assessed by cost measures and performance thresholds for each ASM performance year. We would update the median and standard deviations used to determine cutoffs for benchmark ranges so that they are based on performance within the ASM performance year. To determine the benchmark ranges, we would adhere to the following principles: (1) determine benchmark ranges according to the distribution of the EBCM averages; and (2) ensure distribution of measure achievement points for cost measures is reflective of overall program perfo s: (1) determine benchmark ranges according to the distribution of the EBCM averages; and (2) ensure distribution of measure achievement points for cost measures is reflective of overall program performance. We refer readers to Table 40 for an example of how the proposed cost scoring methodology could be implemented for a specific cost measure. We propose at § 512.730(e)(2)(ii) to award up to 10 measure achievement points for each EBCM based on which benchmark range an ASM participant’s EBCM average corresponds using the following formula: EBCM Achievement Points = Benchmark Range # + [(measure score, expressed as a dollar amount¥bottom of benchmark range)/(top of benchmark range¥bottom of benchmark range)]. This scoring methodology for cost measures would align the assignment of measure achievement points for cost measures so that participants with costs near the measure’s median (that is, 50th percentile) would not receive a disproportionately low score. Rather participants with costs near the median would receive an individual EBCM score clustered closer to the median. We also considered using even decile benchmark ranges based on the distribution of each EBCM score. This altern s near the median would receive an individual EBCM score clustered closer to the median. We also considered using even decile benchmark ranges based on the distribution of each EBCM score. This alternative approach, however, would mean that ASM participants with EBCM averages near the 50th percentile would receive lower cost measure scores. Given the distribution of EBCM averages proposed for ASM, we believe even decile benchmark ranges would create narrow benchmark deciles that would result in a less accurate assessment of cost performance. For these reasons, we believe it would be more appropriate to use the proposed episode-based cost benchmarking and measure scoring methodologies. We seek comments on our proposed approach for assigning measure achievement points, calculating EBCM benchmarks and scoring each cost measure, as well as all alternatives considered. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00238 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 00239 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i 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 00239 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 32590 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Program and other Innovation Center models.219 (b) Performance Year for Improvement Activities Beginning with ASM payment year 2029, we propose at § 512.735(a) that the ASM performance year for improvement activities would be a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable ASM payment year, up to and including the full calendar year. We believe that setting the ASM performance year for improvement activities in this way aligns with MIPS as defined at § 414.1320 and would be easily adoptable by ASM participants. We seek comments on this proposal. (c) Improvement Activities We propose at § 512.735 the establishment of the improvement activities ASM performance category. We propose at § 512.735(c) to establish the following ASM improvement activities : (1) Improvement Activity 1 (IA–1): Connect the establishment of the improvement activities ASM performance category. We propose at § 512.735(c) to establish the following ASM improvement activities : (1) Improvement Activity 1 (IA–1): Connecting to Primary Care and Ensuring Completion of Health-Related Social Needs Screening and Improvement Activity 2 (IA–2): Establishing Communication and Collaboration Expectations with Primary Care using Collaborative Care Arrangements. (i) Improvement Activity 1 (IA–1): Connecting to Primary Care and Ensuring Completion of Health-Related Social Needs Screening In IA–1, we propose at § 512.735(c)(1) to require annual attestations by ASM participants on activities related to enhancing connections to and relationships with primary care. As the first part of IA–1, we propose at § 512.735(c)(1)(i) that ASM participants develop processes and workflows within their practices to identify patients without a PCP and assist them in finding one. Primary care is a vital resource for patients, providing an efficient and accessible level of care. We believe it is essential that the vast majority of patients have a PCP who can coordinate their overall health care needs, manage chronic conditions, and s an efficient and accessible level of care. We believe it is essential that the vast majority of patients have a PCP who can coordinate their overall health care needs, manage chronic conditions, and serve as the first point of contact for health concerns. However, some patients may not have a designated PCP, which can lead to fragmented care and suboptimal health outcomes. A 2022 219 Medicare and Medicaid Programs; CY 2025 Payment Policies Under the 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. study found that up to a third of Medicare beneficiaries don’t see a PCP yearly.220 Furthermore, we believe that connecting patients with a PCP could help reduce demand on specialists in situations where the patient could more appropriately be treated in the primary care setting. Continuity with a primary care practice or provider also has the potential to reduce costs.221 We believe specialists can play a crucial role in ensuring that their patients have access to these high-value primary care services. As part of IA–1, we also pro has the potential to reduce costs.221 We believe specialists can play a crucial role in ensuring that their patients have access to these high-value primary care services. As part of IA–1, we also propose at § 512.735(c)(1)(ii) to require that the ASM specialist always communicate relevant information back to the ASM beneficiary’s PCP following the ASM beneficiary’s visit with the ASM participant. This exchange of information is important to patient care planning and is an aspect of specialty care and primary care collaboration that has room for improvement.222 As the final element of IA–1, we propose at § 512.735(c)(1)(iii) that ASM participants collaborate with PCPs to ensure that their patients have received HRSN screenings. In addition to ensuring access to primary care, we also recognize the importance of addressing patients’ upstream drivers of health. These factors, such as housing, food insecurity, transportation, and financial constraints, are common in the Medicare population. One study found that of approximately 68,000 Medicare Advantage patients who responded to a HRSN screening, 33 percent experienced financial strain, 18.5 percent experienced food insecurity, and 17. . One study found that of approximately 68,000 Medicare Advantage patients who responded to a HRSN screening, 33 percent experienced financial strain, 18.5 percent experienced food insecurity, and 17.7 percent had poor housing quality.223 These unmet needs can significantly impact a patient’s well- being and contribute to the development or exacerbation of diseases, lead to unnecessary health care costs, and 220 Barnett ML, Bitton A, Souza J, Landon BE. Trends in Outpatient Care for Medicare Beneficiaries and Implications for Primary Care, 2000 to 2019. Annals of Internal Medicine. Published online November 2, 2021. doi:https:// doi.org/10.7326/m21-1523. 221 Yang Z, Ganguli I, Davis C, et al. Physician- versus practice-level primary care continuity and association with outcomes in Medicare beneficiaries. Health Services Research. 2022;57(4):914–929. doi:https://doi.org/10.1111/ 1475-6773.13999. 222 Timmins, Lori, et al. ‘‘Communication Gaps Persist between Primary Care and Specialist Physicians.’’ The Annals of Family Medicine, vol. 20, no. 4, 1 July 2022, pp. 343–347, www.annfammed.org/content/20/4/343, https:// doi.org/10.1370/afm.2781. 223 Long CL, Franklin SM, Hagan AS, et al. hysicians.’’ The Annals of Family Medicine, vol. 20, no. 4, 1 July 2022, pp. 343–347, www.annfammed.org/content/20/4/343, https:// doi.org/10.1370/afm.2781. 223 Long CL, Franklin SM, Hagan AS, et al. Health-Related Social Needs Among Older Adults Enrolled In Medicare Advantage. Health Affairs. 2022;41(4):557–562. doi:https://doi.org/10.1377/ hlthaff.2021.01547. worsen overall outcomes.224 HRSN screening also has the opportunity to open a dialogue between the patient and provider about lifestyle factors, such as diet and physical activity. This discussion with the provider and associated education can promote the adoption of a healthier lifestyle, thereby mitigating the presence of new or worsening diseases. Feedback from interested parties has indicated that PCPs are best equipped to conduct HRSN screenings and may have established relationships with community resources to address identified needs. While specialists may not have the resources to conduct HRSN screenings or be the most appropriate provider to address these concerns, we believe they should have some responsibility in ensuring HRSN screenings have been completed, considering unmet social needs can have a direct impact ppropriate provider to address these concerns, we believe they should have some responsibility in ensuring HRSN screenings have been completed, considering unmet social needs can have a direct impact on the medical condition(s) they are managing. If a specialist identifies that a patient has not received an annual HRSN screening, they should communicate this information to the patient’s PCP and encourage them to conduct the screening and initiate any necessary follow-up action(s). The specialist may also choose to conduct the screening themselves, as long as they communicate the results and any follow-up actions to the patient’s PCP. (ii) Improvement Activity 1 (IA–1) Specifications IA–1 Name. Connecting to Primary Care and Ensuring Completion of Health-Related Social Needs Screening IA–1 Specifications ASM participants must have evidence of processes, workflows, and/or technology that require the ASM participant to: (1) confirm the ASM beneficiary has access to primary care services and, if not, assist the ASM beneficiary in finding a clinician who provides primary care services, (2) communicate relevant information back to the ASM beneficiary’s primary care provider following the nd, if not, assist the ASM beneficiary in finding a clinician who provides primary care services, (2) communicate relevant information back to the ASM beneficiary’s primary care provider following the ASM beneficiary’s visit with the ASM participant, and (3) determine whether the ASM beneficiary has received an annual HRSN screening in the primary care setting and, if not, encourage the primary care services provider to conduct the screening or allow the ASM participant to conduct the HRSN screening. 224 ROI Calculator for Partnerships to Address the Social Determinants of Health Review of Evidence for Health-Related Social Needs Interventions. (2019). https://www.commonwealthfund.org/sites/ default/files/2019-07/COMBINED-ROI-EVIDENCE- REVIEW-7-1-19.pdf. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00240 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 32591 Evidence can include items such as the following: • Documented workflows or protocols outlining the process for identifying patients without a designated PCP, as , July 16, 2025 / Proposed Rules 32591 Evidence can include items such as the following: • Documented workflows or protocols outlining the process for identifying patients without a designated PCP, assisting patients in finding and establishing care with a PCP (such as practice intake forms or integrated into normal practice in the patient’s visit), sharing relevant information (test results, treatment plans, follow-up recommendations) with the patient’s PCP after each visit, confirming if the patient has completed an annual HRSN screening, or conducting or communicating with the PCP to conduct an annual HRSN screening if it has not been done. • EHR system configurations or templates, or other health IT tools, that facilitate capturing and documenting the patient’s PCP information, generating and sending visit summaries or reports to the PCP, or recording HRSN screening status and prompting follow-up actions. • Staff training materials or competency assessments related to identifying patients without a PCP and assisting them in finding one, proper documentation and communication of information to the PCP, or inquiring about HRSN screening status and initiating appropriate follow-up atients without a PCP and assisting them in finding one, proper documentation and communication of information to the PCP, or inquiring about HRSN screening status and initiating appropriate follow-up. • Audit trails or reports from the EHR or practice management system demonstrating patients who were identified as not having a PCP and the actions taken, visit summaries or reports sent to the PCP after each patient encounter, or patients who were confirmed to have completed an annual HRSN screening or underwent one or were referred to the PCP for one. (iii) Improvement Activity 2 (IA–2): Establishing Communication and Collaboration Expectations With Primary Care Using Collaborative Care Arrangements In IA–2, we propose at § 512.735(c)(2) to require annual attestations by ASM participants on activities related to establishing collaboration expectations with primary care. We believe that formalizing the collaborative relationship between ASM participants and PCPs through a collaborative care arrangement (CCA) is an important step to reduce patient fragmentation of care and ensures vital coordination activities are occurring. As discussed further below, we propose defining ‘‘collabora care arrangement (CCA) is an important step to reduce patient fragmentation of care and ensures vital coordination activities are occurring. As discussed further below, we propose defining ‘‘collaborative care arrangement’’ to mean an arrangement that complies with all of the requirements set forth in § 512.771. We also propose to define ‘‘ASM beneficiary’’ at § 512.705 as a Medicare FFS beneficiary who is being treated by an ASM participant for a targeted chronic condition. There are several possible aspects to a CCA, but the goal of the CCA is to set forth expectations between the parties to facilitate primary care and specialty care integration for the benefit of the patient while ensuring both parties are held accountable for how they fulfill their duties. To receive achievement points for IA– 2, we propose at §§ 512.735(c)(2)(i) and (ii) that the ASM participant must enter into at least one CCA with a primary care practice that includes at least three of the following five following collaborative elements: data sharing, co- management, transitions in care planning, closed-loop connections, and care coordination integration as proposed at §§ 512.735(c)(2)(ii)(A) through (E). Al ng collaborative elements: data sharing, co- management, transitions in care planning, closed-loop connections, and care coordination integration as proposed at §§ 512.735(c)(2)(ii)(A) through (E). All of these CCA elements support an important prevention framework by promoting a seamless information ecosystem where providers collaborate to detect health risks before they occur and optimize care through communication. These elements also have properties that may overlap in their implementation with each other and IA–1, which together further the goals of the improvement activities ASM performance category. The sharing of data back to PCPs is crucial for ensuring continuity of care for shared patients. Specialists should have clear processes in place to provide timely updates, test results, treatment plans, and follow-up recommendations to the patient’s PCP, even outside the time of a referral between the parties. We also believe this exchange should be bi-directional, so that both entities have a comprehensive understanding of the patient’s condition and can provide appropriate follow-up care and management. Co-management is a collaborative approach where specialists and PCPs work ties have a comprehensive understanding of the patient’s condition and can provide appropriate follow-up care and management. Co-management is a collaborative approach where specialists and PCPs work together to provide coordinated care for patients with complex or chronic conditions. Generally, the different types of co-management include consultative co-management, where the specialist provides consultation and recommendations to the PCP who remains the primary manager of the patient’s care; shared co- management, where both the specialist and PCP actively participate in managing the patient’s care with clearly defined roles and responsibilities; and principal co-management, where the specialist takes the lead in managing the patient’s condition while the PCP provides overall coordination and management of other aspects of the patient’s care.225 The benefits of co- management include shared decision- making and treatment planning, consistent monitoring and follow-up of the patient’s condition, reduced duplication of tests and procedures, enhanced patient education and self- management support, and better management of comorbidities and potential drug interactions. Additionally, w condition, reduced duplication of tests and procedures, enhanced patient education and self- management support, and better management of comorbidities and potential drug interactions. Additionally, we believe co- management can lead to better health outcomes, improved patient satisfaction, and potentially lower health care costs by reducing fragmentation and unnecessary utilization of health care resources. Transition in care planning refers to the processes and protocols in place for seamlessly transitioning a patient’s care between specialists and PCPs, or between different care settings (for example, hospital to outpatient care).226 Care planning can include follow-up appointments, medication reconciliation, and clear communication of the treatment plan. We believe effective transitions in care planning can help prevent gaps in care, reduce hospital readmissions, and ensure continuity of care for the patient. It may also involve defining roles and responsibilities for coordinating care, conducting warm handoffs, and ensuring timely follow-up appointments. When meaningfully implemented, it promotes a seamless and coordinated approach to care, where all providers involved have a care, conducting warm handoffs, and ensuring timely follow-up appointments. When meaningfully implemented, it promotes a seamless and coordinated approach to care, where all providers involved have a shared understanding of the patient’s needs and can work together to provide high-quality, patient-centered care. Closed-loop communication and feedback between specialists and PCPs involve establishing a structured and coordinated process for when the patient is referred from primary care to specialty care and back. The model considers this to include elements such as structured referral templates, communication and information sharing, collaborative treatment planning, and shared monitoring of patient outcomes. By coordinating care effectively, providers can identify and address potential issues or gaps in care, reduce duplication of services or tests, and ensure that patients receive appropriate and timely care, ultimately improving quality and preventing 225 Kuo D, Gifford DR, Stein MD. A typology of specialists’ clinical roles. Arch Intern Med. 2009;169(11):1062–1068. doi:10.1001/ archinternmed.2009.114. 226 Smith, Lucia Rojas, et al. Care Transitions Framework. www.ncbi.nlm.nih.g . A typology of specialists’ clinical roles. Arch Intern Med. 2009;169(11):1062–1068. doi:10.1001/ archinternmed.2009.114. 226 Smith, Lucia Rojas, et al. Care Transitions Framework. www.ncbi.nlm.nih.gov, Agency for Healthcare Research and Quality (US), 1 Mar. 2014, www.ncbi.nlm.nih.gov/books/NBK196206/. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00241 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 32592 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules unnecessary utilization of health care resources.227 Care coordination activities generally refer to efforts by the ASM participant to identify areas of their practice that could be improved by codified workflows or initiatives, as well as establishment of these activities collaboratively with the partnered primary care practice. These innovations support an environment of continuous improvement for practices and positive outcomes for their shared patients. When selecting primary care practices for CCAs, ASM participants must ensure the CCA is with a primary care practice with whom they share at least one ASM bene tive outcomes for their shared patients. When selecting primary care practices for CCAs, ASM participants must ensure the CCA is with a primary care practice with whom they share at least one ASM beneficiary. We recommend that the ASM participant explore entering into a CCA with a primary care practice with whom the ASM participant shares a meaningful portion of their Medicare patients, to maximize the impact of the CCA activities. That is, ASM participants should seek to enter into an CCA with another primary care practice with which they share the largest number of ASM beneficiaries. If that is not feasible, then ASM participants should seek to enter into a CCA with a different primary care practice that they share a significant portion of ASM beneficiaries with. (iv) Improvement Activity 2 (IA–2) Specifications IA–2 Name. Establishing Communication and Collaboration Expectations with Primary Care Practices using Collaborative Care Arrangements IA–2 Specifications. Documentation of at least one executed CCA between a primary care practice with which the ASM participant shares ASM beneficiaries, and the CCA must include collaborative efforts related to at least three of the follow t least one executed CCA between a primary care practice with which the ASM participant shares ASM beneficiaries, and the CCA must include collaborative efforts related to at least three of the following five elements: • Data Sharing. Setting expectations for bi-directional sharing of patient information between the parties to the CCA, including but not limited to test results, treatment plans, and follow-up recommendations. This is aimed toward population health management of shared patients and is not necessarily coordinated around a specific referral episode. Elements may include: (1) evidence that the ASM participant always sends a report to the referring PCP; or (2) a process for capturing referral information that the ASM participant has a defined method for 227 Murray M. Reducing Waits and Delays in the Referral Process. Family Practice Management. 2002;9(3):39–42. https://www.aafp.org/pubs/fpm/ issues/2002/0300/p39.html. capturing reports from the primary care provider in the medical record, for example: reports transmitted between EHRs; documents that are electronically scanned and linked to the patient’s EHR; or chart documentation of the relevant details of the specialis edical record, for example: reports transmitted between EHRs; documents that are electronically scanned and linked to the patient’s EHR; or chart documentation of the relevant details of the specialist-patient interaction, such as notes written into a progress note. • Co-Management. Criteria that define co-management approaches, where the parties to the CCA work together to furnish complementary care for patients with complex or chronic conditions. The criteria should clearly set forth the available co-management approaches. Examples of such co- management relationships may include: (1) consultative co-management, (2) shared co-management, or (3) principal co-management. • Transitions in Care. Defined protocols for seamless transitions of care between ASM participants, the primary care practice, or different care settings. Elements may include: (1) patient- centered care transition action plans, such as documented plans from the ASM participant to the PCP, including outpatient follow-up recommendations, medication reconciliation, and any necessary post-transition support; (2) implementation of the transition plan, including documentation of staff involved in the care transition, re p recommendations, medication reconciliation, and any necessary post-transition support; (2) implementation of the transition plan, including documentation of staff involved in the care transition, records of real-time communication between the ASM participant and the primary care practice, and ensuring the primary care practice is included in any follow-up transition communication; or (3) care transition planning processes, which outline steps the ASM participant would take to prepare and implement the patient-centered care transition plan when transferring care to the PCP. • Closed-Loop Communication. Clearly articulated processes enforcing parameters on how ASM beneficiaries may be referred between the parties to an executed CCA. These structured and enhanced referral processes would add efficiency to communications between the parties to the CCA and ensure expectations around what is needed for effective specialty consultation and collaboration. Examples of provisions that should be included are as follows: (1) expectations for the structure, elements, and flow of information and responsibilities between practices during a referral; (2) monitoring of shared ASM beneficiaries th e included are as follows: (1) expectations for the structure, elements, and flow of information and responsibilities between practices during a referral; (2) monitoring of shared ASM beneficiaries through the entire process to ensure proper follow- up, integration of information, and maintenance of beneficiary choice; and (3) integration of information from the closed-loop connection into the ASM beneficiary’s plan of care. • Care Coordination Integration. Structured processes to embed care coordination processes into the ASM participant’s practice workflow. Such processes may include: (1) activity records documenting the implementation of care coordination activities with the primary care practice, such as meeting minutes on process improvements, workflow diagrams, training syllabi for training staff on new processes, copies of old and new processes on documenting care coordination activities; or (2) outcome measures demonstrating changes attributable to newly implemented care coordination processes. We seek comments on the goals and specifications of the required improvement activities proposed at § 512.735(b) and (c). (d) Improvement Activities Data Submission, Achievement Poin nation processes. We seek comments on the goals and specifications of the required improvement activities proposed at § 512.735(b) and (c). (d) Improvement Activities Data Submission, Achievement Points, ASM Performance Category Scoring We propose ASM participants must submit data on ASM improvement activities in the form of attestations meeting the submission requirements at § 512.720. We propose at § 512.735(d)(1) and (2) that ASM participants would receive 10 measure achievement points for reporting ‘‘yes’’ for each improvement activity specified at § 512.735(c) in accordance with the data submission requirements at § 512.720(a). We would sum the total achievement points for all submitted improvement activities and divide this sum by the total number of available achievement points for the required improvement activities as specified in paragraph § 512.735(c), not to exceed 100 percent. In our proposals, both improvement activities would be weighted the same, each accounting for half of the potential improvement activities ASM performance category scoring adjustments to the final score. We considered differential weighting, with IA–1 comprising a smaller number of points for the f of the potential improvement activities ASM performance category scoring adjustments to the final score. We considered differential weighting, with IA–1 comprising a smaller number of points for the scoring adjustment. The activities in IA–1, such as sharing patient information back to a PCP after a specialist visit, should already be occurring, whereas activities in IA–2, like the creation of a CCA, are less common and potentially more time consuming. We decided to propose to weight the improvement activities equally, each accounting for the same number of potential points in the improvement activities ASM performance category scoring adjustment, acknowledging the burden that these improvement activities may present to practices. For example, if an ASM participant is already conducting VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00242 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 32593 activities that satisfy IA–1 specifications but do not satisfy IA–2 specifications in the 2027 ASM performance year, they woul ster / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32593 activities that satisfy IA–1 specifications but do not satisfy IA–2 specifications in the 2027 ASM performance year, they would still be awarded 10 measure achievement points and an improvement activities ASM performance category score of 50 percent. We believe IA–1 would be achieved by the vast majority of ASM participants with limited effort, which may lessen the concern of initial improvement activity burden and impact to the ASM participant’s overall score. Simultaneously, we want to promote specialty collaboration with primary care, thus if ASM participants do not achieve the expectations in IA– 2, the ASM participant would only receive 10 measure achievement points. If ASM participants do not complete the requirements for IA–1 and do not complete the requirements for IA–2, they would receive zero measure achievement points and an improvement activities ASM performance category score of zero percent. We seek comments on our improvement activities ASM performance category scoring approach at § 512.735(d)(1) and (2) and alternative improvement activity weighting and scoring options. (5) Proposed Promoting comments on our improvement activities ASM performance category scoring approach at § 512.735(d)(1) and (2) and alternative improvement activity weighting and scoring options. (5) Proposed Promoting Interoperability ASM Performance Category Our long-term goal for the Promoting Interoperability performance category is to ensure the meaningful use of CEHRT and information exchange throughout the year, for all data, all clinicians, and all patients. We believe it is important to leverage the Promoting Interoperability ASM performance category for scoring adjustments to the final score, as discussed in section III.C.2.e. of this proposed rule. (a) Background This section includes proposals for the performance year for Promoting Interoperability measures, the requirement for CEHRT use and related attestations, data submission criteria and scoring for the ASM Promoting Interoperability performance category. The Promoting Interoperability performance category score would be used to determine the Promoting Interoperability performance category scoring adjustment applied to the final score. (b) ASM Performance Year for the Promoting Interoperability ASM Performance Category At § 512.740(a) the Promoting Interoperability performance category scoring adjustment applied to the final score. (b) ASM Performance Year for the Promoting Interoperability ASM Performance Category At § 512.740(a), we propose the ASM performance year for Promoting Interoperability category. Beginning with ASM payment year 2029, the performance year for Promoting Interoperability measures is the minimum of a continuous 180-day period within the calendar year that occurs 2 years prior to the applicable ASM payment year, up to and including the full calendar year. Reporting for this period would provide ASM participants with the opportunity to continuously monitor their performance, identify gaps in reporting and identify areas that may require investigation and corrective action. Additionally, this performance period aligns with the MIPS performance period established for the MIPS Promoting Interoperability performance period established at § 414.1320(i)(1). We believe that alignment of the performance period between MIPS and the ASM model supports ASM participant’s transition from MIPS to ASM. We seek comments on our proposal at § 512.740(a) for the 180-day performance period for Promoting Inter ce period between MIPS and the ASM model supports ASM participant’s transition from MIPS to ASM. We seek comments on our proposal at § 512.740(a) for the 180-day performance period for Promoting Interoperability measures. (c) Reporting for the Promoting Interoperability Performance Category We propose at § 512.740(b) to earn a performance category score for the Promoting Interoperability Performance category for inclusion in the final score, an ASM participant must be a meaningful EHR user. A meaningful EHR user means an ASM participant who possesses CEHRT, uses the functionality of CEHRT, reports on applicable objectives and measures specified for the Promoting Interoperability performance category for a performance period in the form and manner specified by CMS, and engages in activities related to supporting providers with the performance of CEHRT. We are proposing to not include additional provisions related to information blocking as defined at 45 CFR 171.103 in the definition of a meaningful EHR user. The Promoting Interoperability ASM performance category would focus on the safe use and exchange of patient data. Our requirements to demonstrate meaningful CEHRT use through re a meaningful EHR user. The Promoting Interoperability ASM performance category would focus on the safe use and exchange of patient data. Our requirements to demonstrate meaningful CEHRT use through reporting Promoting Interoperability measures are discussed later in this section of this proposed rule. (i) Required CEHRT Use We propose our requirement for CEHRT use at § 512.740(b)(1) that ASM participants are required to provide evidence, in a form and manner specified by CMS, demonstrating use of CEHRT to fulfill the Promoting Interoperability measure requirements (as defined by a meaningful EHR user at § 414.1305) and receive a score greater than zero percentage points for the Promoting Interoperability ASM performance category. ASM participants must use certified health IT that meets the definition of CEHRT at § 414.1305 (which references health IT certification criteria finalized at 45 CFR 170.315) to receive a score greater than zero for the Promoting Interoperability ASM performance category. To demonstrate evidence of CEHRT use, ASM participants would be required to provide their EHR’s CMS identification ID from the Certified Health IT Product List, available on HealthIT.gov. ce category. To demonstrate evidence of CEHRT use, ASM participants would be required to provide their EHR’s CMS identification ID from the Certified Health IT Product List, available on HealthIT.gov. We believe requiring the use of CEHRT supports the goals of ASM by helping enable: (1) meaningful EHR use, further measured by ASM’s proposed Promoting Interoperability measures; (2) reporting of clinical quality measures, including eCQMs; (3) interoperability and data sharing between providers and with patients to drive better patient care, care coordination, and primary and specialty care integration; and (4) continuous practice-based quality improvement and care transformation. To promote standardization, we align with the definition of CEHRT at § 414.1305 used across CMS in other Promoting Interoperability and quality reporting programs. For example, CEHRT use is required for eligible clinicians participating in the MIPS program as stated at § 414.1375(b)(1). In addition to requiring use of CEHRT, we are also maintaining the requirement ASM participants submit confirmation of the following to earn a score for this category: • The Office of the National Coordinator for Health Infor use of CEHRT, we are also maintaining the requirement ASM participants submit confirmation of the following to earn a score for this category: • The Office of the National Coordinator for Health Information Technology (ONC) Direct Review attestation at 45 part 170, subpart E. • The Security Risk Assessment Measure. • The High Priority Practices Guide of the Safety Assurance Factors for EHR Resilience (SAFER) Guides 228 Measure. We are proposing to not include the Actions to Limit or Restrict Compatibility or Interoperability of CEHRT attestation in ASM at this time. We believe maintaining the ONC Direct Review process (45 CFR part 170, subpart E) in ASM increases accountability among certified health IT developers and vendors by ensuring ASM participants’ Health IT Module 229 conforms to ONC’s Health IT Certification Program requirements not 228 https://www.healthit.gov/topic/safety/safer- guides. 229 45 CFR 170.102. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00243 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 32594 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed R 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 32594 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules only during implementation of CEHRT, but also while CEHRT is being used during patient care and in care delivery. The Security Risk Analysis and SAFER measures are designed to optimize the safety of ASM participants’ EHR systems. We propose at § 512.740(b)(3)(ii) that an ASM participant must complete the activities included in the Security Risk Analysis measure within the calendar year of the ASM performance year. This aligns with a MIPS requirement for eligible clinicians in MIPS as stated at § 414.1375(b)(2)(ii)(A); ASM participants that previously participated in MIPS are likely familiar with these requirements. The security risk analysis is conducted to protect the security of individually identifiable health information and the systems that are used to create, receive, maintain, or transmit such information. An ASM participant would conduct a security risk analysi 230 in accordance with 45 CFR 164.308(a)(1)(A). As part of the security risk analysis, ASM participants would be or transmit such information. An ASM participant would conduct a security risk analysi 230 in accordance with 45 CFR 164.308(a)(1)(A). As part of the security risk analysis, ASM participants would be required to address the security of electronic protected health information (ePHI) created, received, maintained, or transmitted by CEHRT, including whether it would be reasonable and appropriate in the participants’ specific circumstances to encrypt ePHI in their CEHRT in accordance with requirements in 45 CFR 164.306(d)(3) and 45 CFR 164.312(a)(2)(iv), implement security updates as necessary, and correct identified security deficiencies as part of the ASM participant’s risk management process. We also propose at § 512.740(b)(3)(iii) that the ASM participant must confirm the ASM participant’s completion of the annual self-assessment under the SAFER Guides measure within the calendar year of the ASM performance year. The High Priority Practices SAFER Guide231 is used as an annual self- assessment to support consistent safety practices for all EHR users and further enable the electronic exchange of health information. This aligns with a requirement for eligible clinicians in MIPS as sta essment to support consistent safety practices for all EHR users and further enable the electronic exchange of health information. This aligns with a requirement for eligible clinicians in MIPS as stated at § 414.1375(b)(2)(ii)(D). Together, we believe these measures drive more secure, efficient, and meaningful use of CEHRT and health IT in ASM. Furthermore, given current and historical requirements in the Promoting 230 Security Risk Analysis: https://qpp.cms.gov/ docs/pi_specifications/Measure%20Specifications/ 2025-MIPS-Promoting%20Interoperability-Measure- Security-Risk-Analysis.pdf. 231 SAFER Guides. https://qpp.cms.gov/docs/pi_ specifications/Measure%20Specifications/2025- MIPS-Promoting-Interoperability-Measure-High- Priority-Practices-Guide-of-SAFER-Guides.pdf. Interoperability performance category in MIPS, these requirements are likely familiar and already implemented, or readily implementable, for many ASM participants. We considered the alternative of allowing identified ASM participants without CEHRT to opt-out of participating in ASM. However, we would be concerned an opt-out would: (1) disincentivize the adoption of CEHRT and participation of specialists in value-based participants without CEHRT to opt-out of participating in ASM. However, we would be concerned an opt-out would: (1) disincentivize the adoption of CEHRT and participation of specialists in value-based payment models, (2) be challenging for CMS to operationalize and audit, and (3) potentially result in a reduction in participant volume that would significantly affect ASM’s impact and evaluability. We recognize there are underlying reasons why certain practices have yet to adopt CEHRT and that these practices currently not on CEHRT may share certain characteristics, such as smaller practice sizes with 15 or fewer clinicians, as defined at § 414.1305. To support these practices, we propose additional policies and flexibilities in ASM, such as the complex patient scoring payment adjustment described in section III.C.2.e.(3) of this proposed rule and the small practice scoring adjustment described in section III.C.2.e.(4) of this proposed rule, with the goal of not inadvertently penalizing these practices, particularly those who disproportionally care for populations with higher medical complexity and social risk. We also considered the alternative of requiring CEHRT but not requiring C these practices, particularly those who disproportionally care for populations with higher medical complexity and social risk. We also considered the alternative of requiring CEHRT but not requiring CEHRT-related attestations and requirements mentioned earlier, such as the Security Risk Assessment and SAFER Guides measures. We decided to include them given they help ensure safer and more meaningful use of CEHRT amongst ASM participants. Because they have been a consistent part of MIPS reporting in the past, ASM participants are likely familiar with these attestations and measures, which could help reduce burden. We also considered the alternative of not requiring CEHRT to achieve a Promoting Interoperability ASM performance category score greater than zero. However, we were concerned this would deviate from existing MIPS policy and may disincentivize CEHRT adoption among ASM participants. Furthermore, requiring CEHRT to achieve a Promoting Interoperability category score underscores the role CEHRT plays in providing foundational IT capabilities to enable the reporting of quality data and inclusion of additional IT functionality, such as e-prescribing and health information exchange e role CEHRT plays in providing foundational IT capabilities to enable the reporting of quality data and inclusion of additional IT functionality, such as e-prescribing and health information exchange (HIE), which is captured in ASM’s Promoting Interoperability measures. CEHRT use plays an important role in helping ASM participants improve and transform care for Medicare beneficiaries with chronic conditions, whether through electronic clinical decision support, physician order entry or exchanging electronic health information with other clinicians or health care settings. Lastly, we considered inclusion of The Actions to Limit or Restrict Compatibility or Interoperability of CEHRT attestation in ASM as it would help ensure that ASM participants are acting in good faith when implementing and using CEHRT to exchange electronic health information, and not knowingly and willfully taking action to limit or restrict the compatibility or interoperability of CEHRT. We request comments on our proposals to require that ASM participants use CEHRT to receive a score for the ASM Promoting Interoperability performance category. We also seek comments on the definition of meaningful EHR user and proposals to require that ASM participants use CEHRT to receive a score for the ASM Promoting Interoperability performance category. We also seek comments on the definition of meaningful EHR user and other alternatives discussed in this section of this proposed rule that would be required for ASM participants to achieve a Promoting Interoperability ASM performance category score greater than zero; this includes allowing for a CEHRT-related opt-out, not requiring CEHRT, and requiring the Actions to Limit or Restrict Compatibility or Interoperability of CEHRT attestation. (ii) Promoting Interoperability Objectives and Measures To receive a score for the ASM Promoting Interoperability performance category, clinicians must complete the relevant attestations and measures related to CEHRT and report Promoting Interoperability objectives and measures. Our Promoting Interoperability objectives and measures align with model goals and objectives and measures used in other CMS programs, including MIPS. We propose at § 512.740(b)(2) that an ASM participant must report on objectives and associated MIPS measures specified by CMS to assess performance in the Promoting Interoperability ASM perform MIPS. We propose at § 512.740(b)(2) that an ASM participant must report on objectives and associated MIPS measures specified by CMS to assess performance in the Promoting Interoperability ASM performance category. We propose at § 512.740(b)(2) that an ASM participant must fulfill the following requirements to earn an ASM performance category score for the Promoting Interoperability performance category: For each measure, as applicable, ASM participants would report the numerator (of at least one) and denominator, or yes/no statement or an exclusion for each measure that includes an option for an exclusion. We would require ASM participants to report all Promoting Interoperability VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00244 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 32595 measures at the TIN/NPI level, which is consistent with the methodology used to identify eligible ASM participants, as described in section III.C.2.c.(3)(a)(i) of this proposed rule. We considered allowing for TIN-level reporting for Pr is consistent with the methodology used to identify eligible ASM participants, as described in section III.C.2.c.(3)(a)(i) of this proposed rule. We considered allowing for TIN-level reporting for Promoting Interoperability measures but decided to prioritize maintaining individual accountability and robust comparisons among ASM heart failure participants or ASM low back pain participants. We propose at §§ 512.740(b)(2)(i) through (iv) that ASM participants must attest to the objectives and associated measures for the ASM performance year. The Promoting Interoperability measures support the following objectives: Electronic Prescribing, HIE, Provider to Patient Exchange, and Public Health and Clinical Data Exchange, as shown in Table 41. The objectives encourage leveraging the electronic exchange of health information, with a focus on the safety of prescribing medications, communication between clinicians, patient access to their health information and reporting essential health data to public health agencies. 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 BILLING CODE 4120–01–C As discussed earlier in this section of this proposed public health agencies. 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 BILLING CODE 4120–01–C As discussed earlier in this section of this proposed rule, ASM participants would be required to submit collected data for the required measures in each objective (unless an applicable exclusion is claimed) for the same 180 continuous days (or more) during the calendar year. Given these measures have remained consistent, required measures in MIPS, as stated at § 414.1375(b)(2), they are likely familiar with the measure specifications and implemented by many MIPS clinicians, which represents a substantial portion of potential ASM participants. We believe these measures align with the goals of ASM and reflect meaningful use of CEHRT. Electronic prescribing and provider to patient exchange, for example, through a patient portal, support patient-centered care and VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00245 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00246 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 02 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00246 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 32597 A fourth alternative would be to develop new Promoting Interoperability measures specific to ASM. While new measures could potentially more meaningfully capture the use of health IT in patient care, we were concerned about the feasibility of new measure development and the operational challenges that would be imposed on ASM participants and their EHR vendors to implement these new measures. We seek comments on our proposals on Promoting Interoperability measures. We also seek comments on alternatives to reporting the full set of Promoting Interoperability performance category measures. We also seek comment on the alternative considered to adopt the PI category in MIPS in its entirety, in addition to the applicable scoring methods, for each applicable ASM performance year, including any ongoing updates to the MIPS PI category over the course of the model. (e) Promoting Interoperability ddition to the applicable scoring methods, for each applicable ASM performance year, including any ongoing updates to the MIPS PI category over the course of the model. (e) Promoting Interoperability ASM Performance Category Scoring We propose at § 512.740(c)(1) an ASM participant earns a score for each measure by fulfilling the reporting requirements specified at § 512.740(b) and if an exclusion, under the measure’s specifications as maintained and published by MIPS, is reported for a measure, the points available for that measure are redistributed to another measure. We propose at § 512.740(c)(1)(i) maintaining the score amounts and applicable redistribution scoring policies for each required measure as set forth in the MIPS measure specifications. We refer readers to Table 41 for the scores assigned to each measure as defined in the MIPS measure specifications. We considered the alternative of developing an ASM- specific scoring system that assigns different scores to each Promoting Interoperability measure. However, we were concerned this would deviate from MIPS, which is likely already familiar to ASM participants. Furthermore, the existing scoring in MIPS already reflects ASM Interoperability measure. However, we were concerned this would deviate from MIPS, which is likely already familiar to ASM participants. Furthermore, the existing scoring in MIPS already reflects ASM’s priorities, for example, with more measure achievement points assigned to the Health Information Exchange category compared to the others. As stated earlier and consistent with MIPS, the optional Public Health and Clinical Data Exchange measures (Public Health Registry Reporting, Clinical Data Registry Reporting, or Syndromic Surveillance Reporting) in ASM would remain optional in ASM. Furthermore, we are not adopting the MIPS scoring policy of assigning 5 bonus points for submitting a ‘‘yes’’ response for any of the optional Public Health and Clinical Data Exchange measures given they may be less relevant to the care provided to Medicare beneficiaries by ASM participant, for example, engaging with a public health agency to submit syndromic surveillance data from an urgent care setting. In addition, bonus points may signal greater importance of these measures over other Promoting Interoperability measures that more directly support ASM’s goals, such as interoperability to support pr In addition, bonus points may signal greater importance of these measures over other Promoting Interoperability measures that more directly support ASM’s goals, such as interoperability to support primary and specialty care integration. We continue to capture essential public health reporting activities on immunizations and reportable conditions in the two required Public Health and Clinical Data Exchange Promoting Interoperability measures. We propose at § 512.740(c)(2) that unless otherwise specified by CMS, provided an ASM participant meets the CEHRT requirements as described in section III.C.2.d.(5).(b), CMS sums the scores for each of the required Promoting Interoperability measures described at § 512.740(b) and divides this sum by the total number of available Promoting Interoperability points to determine the ASM Promoting Interoperability performance category score. The ASM Promoting Interoperability performance category score cannot exceed 100 percent. If an ASM participant does not demonstrate meaningful CEHRT use as described in section III.C.2.d.5.(b) they would receive a zero for their Promoting Interoperability ASM performance category score. The Promoting Interopera oes not demonstrate meaningful CEHRT use as described in section III.C.2.d.5.(b) they would receive a zero for their Promoting Interoperability ASM performance category score. The Promoting Interoperability ASM performance category score would be used as a Promoting Interoperability performance category scoring adjustment to the final score specified under § 512.745(a)(1)(iv). We considered automatically applying a score of zero for an ASM participant’s Promoting Interoperability performance score for any ASM participant who did not meet achieve full points on the Promoting Interoperability performance category, however, we recognize it is important to acknowledge and credit the achieved points on the individual measures. Therefore, we would leverage the Promoting Interoperability performance category score for the Promoting Interoperability performance category scoring adjustments to the ASM final score, as discussed in section III.C.2.e.(1). of this proposed rule. The concepts represented in the Promoting Interoperability requirements support ASM participants in improving value, by improving patient care while maintaining or lowering the cost of care. We are not proposing any exc ented in the Promoting Interoperability requirements support ASM participants in improving value, by improving patient care while maintaining or lowering the cost of care. We are not proposing any exceptions for the Promoting Interoperability ASM performance category requirements. CMS has established automatic reweighting criteria of the Promoting Interoperability category in MIPS at § 414.1380(c)(2)(i)(C)(9) for certain MIPS eligible clinicians, such as hospital- based clinicians and Ambulatory Surgical Center-based clinicians, and for clinicians in small practices as defined in § 414.1305. The MIPS reweighting policy generally excludes the Promoting Interoperability performance category from the MIPS final score if the applicable clinician or group practice does not submit Promoting Interoperability data. Due to ASM’s participant selection criteria (see section III.C.2.c.(3). of this proposed rule) many ASM participants, except for those in small practices with 15 or fewer clinicians, would not qualify for this automatic reweighting criterion if they were to be considered eligible clinicians under MIPS. For ASM participants in small practices or solo practitioner ASM participants , would not qualify for this automatic reweighting criterion if they were to be considered eligible clinicians under MIPS. For ASM participants in small practices or solo practitioner ASM participants, we are proposing to adjust final scores as described in section III.C.2.e.(4). of this proposed rule. We believe the potential confusion and complexity to develop and implement an exclusion policy for the Promoting Interoperability ASM performance category would outweigh any potential benefits it would have for a likely small number of participants. Lastly, we are proposing an Extreme and Uncontrollable Circumstances policy at § 512.780 and discussed in section III.C.2.i. of this proposed rule, but we are not proposing to include a Promoting Interoperability-specific hardship application in ASM. Data analysis of 2023 data submitted by clinicians who participated in MIPS that would have met the ASM participant selection criteria showed that less than 1 percent of those clinicians submitted a Promoting Interoperability -specific hardship application. The operational lift and resources needed to develop and maintain a hardship application for ASM likely outweigh the potential benefit on d a Promoting Interoperability -specific hardship application. The operational lift and resources needed to develop and maintain a hardship application for ASM likely outweigh the potential benefit only a few practices may receive. We seek comments on these proposals and discussed alternatives to score the ASM Promoting Interoperability performance category. e. Proposed Final Score Methodology In this section, we propose a scoring methodology for assessing the total performance of each ASM participant (referred to as a ‘‘final score’’) that allows for accountability and alignment for performance within each ASM cohort. Specifically, we propose to define at § 512.705 ‘‘final score’’ to VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00247 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 32598 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules mean a composite assessment (using a scoring scale of zero to 100 points) for each ASM participant for an ASM performance year determined using the methodology for assessing the total performance of an ASM participant according to p ng a scoring scale of zero to 100 points) for each ASM participant for an ASM performance year determined using the methodology for assessing the total performance of an ASM participant according to performance standards for applicable measures and activities for each ASM performance category as described in § 512.745. The methodology discussed in this section would calculate a final score based on the quality and cost ASM performance categories scores for each ASM participant while considering negative scoring adjustments for the improvement activities and Promoting Interoperability ASM performance categories. Additional points would be added to the final score for ASM participants that address complex care and ASM participants that are part of small practices. Later in this section of the proposed rule, we propose specific data submission requirements for ASM participants to receive a final score. ASM participants that do not meet these minimum data submission requirements would receive a final score of zero, which would lead to the maximum negative payment adjustment applicable for the corresponding ASM payment year. We also propose that ASM participants who meet the data submis ive a final score of zero, which would lead to the maximum negative payment adjustment applicable for the corresponding ASM payment year. We also propose that ASM participants who meet the data submission requirements to receive a final score but cannot be measured on quality or cost performance would not receive a final score and would therefore receive a neutral payment adjustment. Specifically, we propose at § 512.745(a) to calculate a final score of zero to 100 points using the formula we propose in section III.C.2.e.(5). of this proposed rule and specified at § 512.745(a)(5) for each ASM participant that meets the requirements to receive a final score as proposed in section III.C.2.e.(2) of this proposed rule and specified at § 512.745(a)(2). We propose policies to determine scores for the ASM performance categories in sections III.C.2.d.(2). through III.C.2.d.(5). of this proposed rule. ASM performance category scores reflect the assessment of each ASM participant’s performance on the applicable measures and activities for an ASM performance category for its applicable performance period based on the performance standards for those measures and activities. We would use the fi n the applicable measures and activities for an ASM performance category for its applicable performance period based on the performance standards for those measures and activities. We would use the final score to determine an ASM payment adjustment factor for the ASM participant for the applicable ASM payment year as discussed in section III.C.2.f. of this proposed rule. (1) ASM Performance Category Weights and Scoring Adjustments To create a final score from zero to 100 based on the individual ASM performance category scores, we propose at § 512.745(a)(1)(i) through (iv) to assign an ASM performance category weight of 50 percent to each of the quality and cost ASM performance categories and to apply adjustments to the final score based on scores in the improvement activities and Promoting Interoperability ASM performance categories. Accordingly, we propose that the improvement activities and Promoting Interoperability ASM performance categories would not have a performance category weight but would have separately applied scoring adjustments that are potentially applied to the final score. The proposed weights for the quality and cost ASM performance categories, as well as the imp ight but would have separately applied scoring adjustments that are potentially applied to the final score. The proposed weights for the quality and cost ASM performance categories, as well as the improvement activities and Promoting Interoperability ASM performance category scoring adjustments are described in Table 42. We are proposing to only add weights to the quality and cost ASM performance categories for the final score and to not add weights to the improvement activities and Promoting Interoperability ASM performance categories to broaden the distribution of final scores. Based on historical MIPS performance in the improvement activities and Promoting Interoperability performance categories, we believe ASM participants would be likely to achieve higher ASM performance category scores in these two performance categories. One of the stated goals of ASM is to increase two-sided risk and create payment adjustments of a higher magnitude for ASM participants to incentivize performance improvements. If final scores were clustered around a small range of performance scores, differentiating performance and operationalizing a wider range of payment adjustments could prove difficult. e improvements. If final scores were clustered around a small range of performance scores, differentiating performance and operationalizing a wider range of payment adjustments could prove difficult. We are also proposing to weight the cost and quality ASM performance category scores at 50 percent each because those weights align with ASM’s goal, as described in sections III.C.2.d.(2). and III.C.2.d.(3). of this proposed rule, of decreasing the cost of care for beneficiaries with ASM’s targeted chronic conditions and improving quality care through a focused measure set relevant to ASM’s clinical specialties and targeted chronic conditions. To drive cost and quality improvement as described in sections III.C.2.d.(2). and III.C.2.d.(3). of this proposed rule, we believe that weighting cost and quality ASM performance category scores at 50 percent creates the necessary incentives to lower chronic condition cost of care while improving quality metrics. We propose at §§ 512.745(a)(1)(iii) and 512.745(a)(1)(iv) to introduce improvement activities and Promoting Interoperability scoring adjustments to the ASM participant’s final score dependent on the performance in the improvement activit nd 512.745(a)(1)(iv) to introduce improvement activities and Promoting Interoperability scoring adjustments to the ASM participant’s final score dependent on the performance in the improvement activities and Promoting Interoperability ASM performance categories. We propose at § 512.745(a)(1)(iii)(A) that ASM participants that achieve a 100 percent score for the improvement activities ASM performance category would not receive an improvement activities ASM performance category scoring adjustment to their final scores. We propose at § 512.745(a)(1)(iii)(B) that ASM participants that receive a 50 percent improvement activities ASM performance category score (that is, an ASM participant that attested to meeting the requirements of one of the two proposed required improvement VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00248 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 00249 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 32600 Federal Register / Vol. 90, No. 134 / 025 Jkt 265001 PO 00000 Frm 00249 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 32600 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules based quality measure that also meets the data completeness requirement. Ultimately, this requirement would mean that the ASM participant is held accountable on the quality ASM performance category. Since we do not require ASM participants to submit data for the cost ASM performance category because we directly calculate the EBCMs, this proposed minimum data submission requirement would allow us to hold ASM participants accountable for quality and cost performance except in the case the ASM participant does not meet the case minimums for the quality and cost ASM performance category measures as discussed later in section III.C.2.e.(2).(b) of this proposed rule. We seek comments on our proposed requirements at § 512.745(a)(2)(i) to calculate a final score for ASM participants and our proposal at § 512.745(a)(2)(ii) that an ASM participant who does not meet these requirements would receive a final score of zero for the applicable ASM performance score for ASM participants and our proposal at § 512.745(a)(2)(ii) that an ASM participant who does not meet these requirements would receive a final score of zero for the applicable ASM performance year. (b) Not Determining a Final Score When an ASM Participant Cannot Be Scored on the Quality or Cost ASM Performance Category At § 512.745(a)(2)(iii), we propose that ASM participants who meet the data submission requirement for the quality ASM performance category as proposed at § 512.725(a)(1)(i) but do not receive a quality ASM performance category or a cost ASM performance category score would not receive a final score for the applicable ASM performance year. As discussed in section III.C.2.f.(4) of this proposed rule, these ASM participants would not receive payment adjustments in the corresponding ASM payment year. That is, only ASM participants who meet the requirements to receive a final score proposed earlier in this section of this proposed rule and receive a quality or cost ASM performance category score would receive a final score for the applicable ASM performance year. As proposed in section III.C.2.f.(4) of this proposed rule, ASM participants that receive a final sco SM performance category score would receive a final score for the applicable ASM performance year. As proposed in section III.C.2.f.(4) of this proposed rule, ASM participants that receive a final score greater or equal to zero and not exceeding 100 would receive an ASM payment adjustment factor, defined in section III.C.2.f of this proposed rule, based on that final score for the applicable ASM payment year; otherwise, we propose that the ASM participant would not receive a final score and would receive no payment adjustments for the applicable ASM payment year. We also refer readers to section III.C.2.i of this proposed rule for how the proposed extreme and uncontrollable circumstance policy influences an ASM participant’s final score if an ASM participant has been deemed to be affected by an eligible circumstance. We believe that it is appropriate to hold ASM participants accountable for quality and cost for the purpose of determining payment adjustments. We recognize that there may be instances where an ASM participant meets the minimum data submission requirements for the ASM performance category to receive a final score described earlier in this section of this proposed rule be instances where an ASM participant meets the minimum data submission requirements for the ASM performance category to receive a final score described earlier in this section of this proposed rule but does not meet the case minimums for any required quality measure as discussed in section III.C.2.d.(2).(h) of this proposed rule or does not meet the case minimum for the required EBCM as discussed in section III.C.2.d.(3).(g) of this proposed rule. An ASM participant who does not receive a final score would receive a no payment adjustment (that is, neutral payment adjustment), meaning that they would not receive an upward or downward payment adjustment to their Medicare Part B payments for covered professional services for the applicable payment year because of participation in ASM. We believe that not determining a final score for the ASM participant and not adjusting payments during the applicable ASM payment year ensures that the ASM participant would not be unfairly penalized. We also believe that this proposal avoids complex reweighing policies. Reweighting policies would potentially mean that each final score represents a different mix of measures from different ASM performa also believe that this proposal avoids complex reweighing policies. Reweighting policies would potentially mean that each final score represents a different mix of measures from different ASM performance categories. For example, one ASM participant could have a final score comprised of a cost ASM performance category score with improvement activities and Promoting Interoperability ASM performance category scoring adjustments whereas another could have a final score comprised of quality and cost ASM performance category scores. We believe that ensuring that all ASM participants’ final scores reflect quality and cost performance is the most appropriate for determining payment adjustments that incentivize the care improvement and transformation that we seek to achieve through ASM. We considered requiring that an ASM participant would only receive a final score if we could score them on all four proposed ASM performance categories as discussed in section III.C.2.d. of this proposed rule. We believed, however, that such a requirement would potentially be burdensome and not as well aligned with our intention to hold all ASM participants accountable for quality and cost performance at a m e believed, however, that such a requirement would potentially be burdensome and not as well aligned with our intention to hold all ASM participants accountable for quality and cost performance at a minimum. Table 43 summarizes the proposed requirements to receive a final score and the resulting impact on payment adjustments discussed in this section and in section III.C.2.f of this proposed rule. 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 00250 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32601 We seek comments on our proposal at § 512.745(a)(2)(iii) that ASM participants that we cannot score on the quality or cost ASM performance category would not receive a final score for an ASM performance year. We also seek comments on the alternative of requiring data submission for all four ASM performance categories that we considered. (3) Complex Patient Scoring Adjustment We propose at § 512.745(a)(3) to apply a complex patient scoring adjustment to ASM participants’ final scores for eligible ASM participants as desc e considered. (3) Complex Patient Scoring Adjustment We propose at § 512.745(a)(3) to apply a complex patient scoring adjustment to ASM participants’ final scores for eligible ASM participants as described later in this section of this proposed rule. We propose to use two risk indicators, Hierarchical Condition Category (HCC) risk scores and the proportion of patients with dual eligible status, ‘‘dual eligible proportion,’’ to calculate the complex patient scoring adjustment to ASM participants’ final scores. For the purposes of ASM, we propose at § 512.705 that ‘‘risk indicator’’ refers to Hierarchical Condition Category (HCC) risk scores under the HCC risk adjustment model established by CMS under section 1853(a)(1) of the Act or the proportion of beneficiaries with dual eligible status used in calculating the complex patient scoring adjustment as defined at § 512.745(a)(3). Social and medical risk factors, such as income and co-occurring chronic conditions, play a major role in health status and, accordingly, the types of services and procedures furnished to a beneficiary. Physicians may face unique challenges delivering care to those with more ‘‘patient complexity,’’ a term use th status and, accordingly, the types of services and procedures furnished to a beneficiary. Physicians may face unique challenges delivering care to those with more ‘‘patient complexity,’’ a term used to describe and account for a combination of factors that impact beneficiaries’ health outcomes. In ASM, our aim is to shift the focus away from volume and towards direct accountability for the cost and quality of health care services delivered. At the same time, by introducing an assessment of performance among physicians with similar clinical profiles but who may have different caseloads of complex patients, we seek to ensure that the care furnished by ASM participants is assessed fairly to espouse predictability and sustainability. We believe that inclusion of a complex patient scoring adjustment in the determination of final scores would help to achieve these objectives. The Quality Payment Program calculates a complex patient bonus and adds it to the MIPS final score for qualifying MIPS eligible clinicians based on their caseload of complex patients using two well-established risk indicators within the Medicare program: HCC risk scores and dual-eligible proportion under § 414.13 MIPS eligible clinicians based on their caseload of complex patients using two well-established risk indicators within the Medicare program: HCC risk scores and dual-eligible proportion under § 414.1380(c)(3). The CY 2018 Quality Payment Program final rule established a complex patient bonus to be added to the final score for the CY 2020 MIPS payment year (82 FR 53771 through 537756) as required by MACRA. The purpose of the policy was to address the impact patient complexity may have on MIPS scoring and mitigate discrepancies without masking performance. Subsequent rulemaking continued using the complex patient bonus and modified the formula based on several factors including stakeholder feedback, updated analysis, and implications from the HHS Assistant Secretary for Planning and Evaluation (ASPE) reports to Congress (86 FR 65510 through 65519). We considered, but are not proposing, adopting an approach in which quality performance is risk adjusted for complex patients. We believe that providers have substantial control over the health care encounter and the outcomes assessed after the encounter. Thus, we decided that adjustments made at the quality measure or quality ASM performa t providers have substantial control over the health care encounter and the outcomes assessed after the encounter. Thus, we decided that adjustments made at the quality measure or quality ASM performance category level would undermine our core aim to promote direct accountability and high-quality outcomes for all beneficiaries. Further, ASPE’s second report released in June 2020, Social Risk and Performance in Medicare’s Value-Based Purchasing Programs, provides recommendations for addressing risk factors in Medicare’s value-based payment programs, including discouraging risk adjustments on measures that assess the process and outcome of care given in the care setting.232 The report reasoned that adjusting quality measures may have a negative impact on transparency for consumers and may inadvertently lower the standard of care. Instead, the report suggests including additional payments or bonuses for practices with a greater share of dual eligible and high-risk 232 https://aspe.hhs.gov/sites/default/files/ private/pdf/263676/Social-Risk-in- Medicare%25E2%2580%2599s-VBP-2nd-Report- Executive-Summary.pdf. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00251 Fmt 4701 Sfmt /sites/default/files/ private/pdf/263676/Social-Risk-in- Medicare%25E2%2580%2599s-VBP-2nd-Report- Executive-Summary.pdf. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00251 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 00252 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 32603 We propose at § 512.745(a)(3)(iii) that ASM participants with an HCC risk score or dual-eligible proportion above their respective medians, as calculated earlier in this section, would receive a complex patient scoring adjustment that cannot exceed 10 points and cannot be below zero points. We considered a complex scoring patient adjustment that could exceed 10 points and a complex scoring adjustment with a maximum point value less than 10 points but not below zero points. However, we believe that aligning the proposed complex patient scoring adjustment maximum point value with the MIPS complex patient bonus max point value less than 10 points but not below zero points. However, we believe that aligning the proposed complex patient scoring adjustment maximum point value with the MIPS complex patient bonus maximum point value would reduce confusion across ASM participant who would have previously participated in MIPS. We believe the proposed formula compensates for a potential difference in payment related to HCC risk scores and dual proportion since MIPS uses the same approach in calculating the MIPS complex patient bonus defined at § 414.1380(c)(3) (86 FR 65510 through 65519). We believe this methodology and formula are strongly supported by data and analyses explained in the CY 2022 PFS proposed rule (86 FR 65510 through 65519). Furthermore, dual enrollees tend to have lower income, a greater prevalence of mental health conditions, somatic chronic conditions, and significantly higher annual costs of care than their nondual counterparts.234 Thus, we believe that a complex patient scoring adjustment based on HCC risk scores and dual proportions, as is done in MIPS, would not only reduce inappropriate penalties among ASM participants that disproportionately care for dual eligible, high-risk stment based on HCC risk scores and dual proportions, as is done in MIPS, would not only reduce inappropriate penalties among ASM participants that disproportionately care for dual eligible, high-risk populations but would also reduce inappropriate payments for ASM participants that care for less complex populations. We seek comments on the proposed inclusion of the complex patient scoring adjustment in final scores and the proposed methodology for calculating the complex patient scoring adjustment. We also seek comments on our alternatives considered related to calculating the reference median based on data from the concurrent ASM performance year and using a reference mean instead of a reference median. We also seek comment on the alternative of not requiring ASM participants to have at least one risk indicator that is equal to or greater than the reference median 234 Johnston KJ, Joynt Maddox KE. The Role Of Social, Cognitive, and Functional Risk Factors In Medicare Spending For Dual And Nondual Enrollees. Health Aff (Millwood). 2019;38(4):569– 576. doi:10.1377/hlthaff.2018.05032. https:// www.healthaffairs.org/doi/10.1377/ hlthaff.2018.05032. to receive the complex patient scor l And Nondual Enrollees. Health Aff (Millwood). 2019;38(4):569– 576. doi:10.1377/hlthaff.2018.05032. https:// www.healthaffairs.org/doi/10.1377/ hlthaff.2018.05032. to receive the complex patient scoring adjustment. (4) Small Practice Scoring Adjustment We propose at § 512.745(a)(4) that an ASM participant would be eligible to receive a small practice scoring adjustment in the calculation of their final score. We propose at § 512.705 to define a ‘‘small practice’’ as a practice consisting of 15 or fewer clinicians at the time we identify ASM participants for an ASM performance year as described at § 512.710(g). We propose at § 512.705 to define a ‘‘solo practitioner’’ as a practice consisting of 1 clinician at the time we identify ASM participants for an ASM performance year as described at § 512.710(g). Our proposed definitions for small practice and solo practitioner align with MIPS’ small practice definition at § 414.1305. We propose at § 512.745(a)(4)(i) to add 10 points to the final score of an ASM participant who: (1) is in a small practice as defined at § 512.705; (2) is not a solo practitioner as defined at § 512.705; and (3) and meets the requirement to receive a final sco al score of an ASM participant who: (1) is in a small practice as defined at § 512.705; (2) is not a solo practitioner as defined at § 512.705; and (3) and meets the requirement to receive a final score greater than zero as described at § 512.745(a)(2)(i) for an applicable ASM performance year. We propose at § 512.745(a)(4)(ii) to add 15 points to the final score of an ASM participant who is a solo practitioner as defined at § 512.705 and meets the requirement to receive a final score greater than zero as described at § 512.745(a)(2)(i) for an applicable ASM performance year. We believe that it is necessary to support ASM participants against the potential challenges that they face in participation in Innovation Center models and other CMS value-based payment programs, like the Quality Payment Program. Participants in MIPS have provided feedback that many small practices and solo practitioners face challenges in their ability to participate in MIPS, including the costs to implement and maintain CEHRT, staff and training costs, and limited staff capacity to manage the complexity of the program (89 FR 98452). MIPS has several policies that aim to support small and solo practices, inc maintain CEHRT, staff and training costs, and limited staff capacity to manage the complexity of the program (89 FR 98452). MIPS has several policies that aim to support small and solo practices, including scoring and reweighting policies as defined at § 414.1380. We considered adopting some of these policies for the purposes of ASM given our use of the MVPs as a framework for this model. However, our goal in designing a scoring policy for ASM was to increase incentives for participation and to reduce the complexity of reweighting policies based on the characteristics of an ASM participant or the context in which they practice. We analyzed historical MIPS final score performance among a pool of likely ASM participants for both heart failure and low back pain. We found that small practices, including solo practitioners, were more likely to receive lower final MIPS scores compared to MIPS eligible clinicians in larger practices (that is, TINs with more than 15 clinicians). We also found that solo practitioners were more likely to receive lower scores than MIPS eligible clinicians in small practices (that is, practices with 2 to 15 clinicians in this situation). For these reasons, we that solo practitioners were more likely to receive lower scores than MIPS eligible clinicians in small practices (that is, practices with 2 to 15 clinicians in this situation). For these reasons, we believe that ASM participants in small practices would likely score lower than their counterparts in larger practices under ASM, with solo practitioners potentially scoring lower than other small practices. While we would not want to inadvertently skew the distribution of ASM participant final scores, we believe that it would be appropriate to support ASM participants in small practices to receive a final score adjustment. We based the proposed magnitudes of the final scoring adjustments based on the distribution of MIPS final scores among likely ASM participants. We also considered small practice scoring adjustments that were lower and higher than the proposed 10 points for non- solo practitioner ASM participants in small practices and 15 points for solo practitioner ASM participants. However, we believe that the proposed magnitudes of the scoring adjustments would appropriately increase the applicable ASM participants’ score and would be easily understood by ASM participants. We ref wever, we believe that the proposed magnitudes of the scoring adjustments would appropriately increase the applicable ASM participants’ score and would be easily understood by ASM participants. We refer readers to section III.C.2.f.(4).(b). of this proposed rule for an alternative level of risk that we considered for ASM participants in small practices. We believe that using a flat adjustment on the final score would be a clear and transparent method to support ASM participants to increase their score relative to other ASM participants so as to avoid potentially creating a barrier for them to achieve a net positive payment adjustment (see section III.C.2.f in this proposed rule for further discussion on our proposed payment methodology). Since we are not proposing to reweight ASM performance categories in the calculation of final scores as discussed earlier in this section of this proposed rule to simplify the data submission requirements and scoring policies, we believe that a flat adjustment would be a simple but effective mechanism to support ASM participants in small practices. We considered but are not proposing a similar flat-point adjustment for ASM VerDate Sep 2014 23:26 Ju justment would be a simple but effective mechanism to support ASM participants in small practices. We considered but are not proposing a similar flat-point adjustment for ASM VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00253 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 32604 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules participants in rural areas as defined at § 512.705 (which aligns with the MIPS rural area definition at § 414.1305). We, however, found in our analysis of historical MIPS performance data among likely ASM participants that there was not a systematic difference in the performance data between likely ASM participants in rural and non-rural areas. While MIPS reduces the reporting requirements for the improvement activities performance category for MIPS eligible clinicians in rural areas as defined at § 414.1380(b)(3), the lack of a systematic difference in historical MIPS performance between likely ASM participants of rural and non-rural status led us to not propose a scoring adjustment for ASM participants in rural areas. Furthermore, we obse erence in historical MIPS performance between likely ASM participants of rural and non-rural status led us to not propose a scoring adjustment for ASM participants in rural areas. Furthermore, we observed that a high proportion of likely ASM participants in small practices were in rural areas. Adding a rural scoring adjustment on top of the small practice scoring adjustments would potentially be duplicative and inappropriately skew the distribution of final scores. We seek comments on our proposal at § 512.745 (a)(4)(i) to add 10 points to the final score of an ASM participant who is in a small practice, is not a solo practitioner, and meets the requirements to receive a final score greater than zero and not exceeding 100. We also seek comment on our proposal at § 512.745 (a)(4)(ii) to add 15 points to the final score of an ASM participant who is a solo practitioner and meets the requirements to receive a final score greater than zero and not exceeding 100. Finally, we seek comments on the alternative we considered of applying a similar flat-point adjustment for ASM participants in rural areas. (5) Final Score Calculation We propose at § 512.745(a)(5) the following formula to calcu the alternative we considered of applying a similar flat-point adjustment for ASM participants in rural areas. (5) Final Score Calculation We propose at § 512.745(a)(5) the following formula to calculate the final score for each ASM participant that meets the minimum data submission requirements discussed in section III.C.2.e.(2).(a) of this proposed rule: Final score = [(quality ASM performance category score × quality ASM performance category weight) + (cost ASM performance category score × cost ASM performance category weight)] × 100 + improvement activities ASM performance category scoring adjustment + Promoting Interoperability ASM performance category scoring adjustment + Complex Patient scoring adjustment + Small Practice scoring adjustment. NOTE: The final score cannot be below zero points or exceed 100 points We believe that this proposed final score calculation appropriately utilizes the quality and cost ASM performance category scores as outlined in sections III.C.2.e of this proposed rule, weights the quality and cost ASM performance categories, and considers the inclusion of the negative improvement activities ASM performance category scoring adjustment, the negative is proposed rule, weights the quality and cost ASM performance categories, and considers the inclusion of the negative improvement activities ASM performance category scoring adjustment, the negative Promoting Interoperability ASM performance category scoring adjustment, the positive complex patient payment adjustment, and positive small practice scoring adjustment. For example, under the proposed final score calculation and the proposed weights for the quality and cost performance category, if an ASM participant has a quality performance category score of 80 percentage points [(40 measure achievement points out of 50 available measure achievement points)], a cost performance category score of 75 percentage points [(7.5 achievement points out of 10 available achievement points)], a negative improvement activity performance category scoring adjustment of ¥10 from successfully attesting to one improvement activity, a negative Promoting Interoperability ASM performance category scoring adjustment of ¥2.7 ((100 potential maximum Promoting Interoperability ASM performance category points¥73 Promoting Interoperability ASM performance category score)/¥10), a complex patient scoring adjust justment of ¥2.7 ((100 potential maximum Promoting Interoperability ASM performance category points¥73 Promoting Interoperability ASM performance category score)/¥10), a complex patient scoring adjustment of 5.5, and a small practice scoring adjustment of 10 from being in a small practice, the final score would be as follows: Final Score = [0.80 × 50 percent) + (0.75 × 50 percent)] × 100 + (¥10) + (¥2.7) + 5.5 + 10 = 80.3. The ASM participant under the example conditions described above would have 77.5 points from the quality and cost ASM performance categories ([(0.80 × 50 percent) + (0.75 × 50 percent)] × 100), before the scoring adjustments are applied, and a final ASM score of 80.3 points We seek comments on the proposed final score calculation formula. (6) ASM Performance Report We propose at § 512.745(b) to release an ASM participant’s final score for each ASM performance year through an ‘‘ASM performance report,’’ which we propose to define at § 512.705 as the notification that CMS provides to the ASM participant for each ASM performance year, which contains the information specified at § 512.745(b). We propose at § 512.745(b)(1) through (7) that the ASM performance report w CMS provides to the ASM participant for each ASM performance year, which contains the information specified at § 512.745(b). We propose at § 512.745(b)(1) through (7) that the ASM performance report would, at minimum, provide each ASM participant: (1) individual measure-level scores for each of the measures required under each ASM performance category; (2) ASM performance category-level scores; (3) complex patient scoring adjustment, as applicable; (4) small practice or solo practitioner scoring adjustment, as applicable; (5) final score, and (6) the applicable ASM payment adjustment factor and (7) ASM payment multiplier for the applicable ASM payment year as discussed in section III.C.2.f of this proposed rule. As proposed, the ASM performance reports would not contain any protected health information or personally identifiable information of beneficiaries. Accordingly, we would share the ASM performance reports with ASM participants as a matter of course without following the attestation and data sharing agreement process for CMS sharing of beneficiary-identifiable information proposed in section III.C.2.j. of this proposed rule. We believe that the proposed approach to releasing tion and data sharing agreement process for CMS sharing of beneficiary-identifiable information proposed in section III.C.2.j. of this proposed rule. We believe that the proposed approach to releasing ASM participant data would be a transparent way to help the ASM participant understand their performance on each of the required measures, activities, attestations, how those individual scores roll up to an overall ASM performance category score, and then how each ASM performance category score rolls up into the final score. We believe that this ASM performance report would be complementary to the other proposed data sharing approaches discussed in section III.C.2.j. of this proposed rule. We seek comments on our proposal at § 512.745(b) to provide ASM participants with an ASM performance report for each ASM performance year. We also seek comments on the proposed components of the ASM performance report. f. Proposed ASM Payment Approach (1) Payment Approach In this section, we discuss our proposed payment methodology to use an ASM participant’s final score to determine net positive, neutral, or negative payment adjustments to an ASM participant’s future Medicare Part B payments for an proposed payment methodology to use an ASM participant’s final score to determine net positive, neutral, or negative payment adjustments to an ASM participant’s future Medicare Part B payments for an applicable ASM payment year. ASM would test whether payment adjustments to ASM participants’ future Part B FFS payments would preserve or improve the quality of care for beneficiaries with ASM’s targeted chronic conditions receiving service from ASM participants while reducing program expenditures. Determining payment adjustments based on an ASM participant’s performance across the ASM performance categories relative to other specialists furnishing services VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00254 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 32605 related to each of ASM’s targeted chronic conditions would directly incentivize performance improvement through financial incentives. We believe the proposed individualized payment adjustments under ASM would be reflective of the range of performance of specialis ctly incentivize performance improvement through financial incentives. We believe the proposed individualized payment adjustments under ASM would be reflective of the range of performance of specialists caring for beneficiaries with ASM targeted chronic conditions. As discussed in section III.C.1. of this proposed rule, we believe that the risk of a potential negative payment adjustment coupled with the incentive of a potential positive payment adjustment would incentivize the quality improvement and reduced low- value care spending that we aim to achieve through ASM. This type of risk arrangement would reward high performance and encourage ASM participants to improve the quality of care that they furnish to Medicare beneficiaries with ASM’s targeted chronic conditions. Further, we believe that this type of incentive payment approach aligns with existing value- based purchasing programs, such as the Quality Payment Program, in which ASM participants may have previously participated, and through which they may have received payment adjustment on future Medicare Part B payments based on their performance in MIPS. We believe our proposed payment methodology for an ASM participant to r d through which they may have received payment adjustment on future Medicare Part B payments based on their performance in MIPS. We believe our proposed payment methodology for an ASM participant to receive a positive, neutral, or negative payment adjustment based on their performance would be a strong incentive to promote performance improvement and achieve ASM’s objectives. (2) Payment Methodology Overview We propose at § 512.750 a payment methodology for ASM where we would distribute, based on performance and in the form of scaled payment adjustments, a portion of the Medicare Part B payments paid to ASM participants for covered professional services during an ASM performance year, which would result in net positive, neutral, or negative payment adjustments during an ASM payment year. Accordingly, we propose to define at § 512.705 an ‘‘ASM incentive pool’’ that would be a fixed percentage of the total amount of Medicare Part B covered professional service claims paid to ASM participants with final scores within an ASM cohort during an ASM performance year that would be distributed in in the form of scaled payment adjustments during an ASM payment year. We would calculate an ASM ants with final scores within an ASM cohort during an ASM performance year that would be distributed in in the form of scaled payment adjustments during an ASM payment year. We would calculate an ASM incentive pool for each ASM cohort for each ASM payment year as described at § 512.750(c)(1)(iii). The ASM incentive pool would be the total amount of funds that we would use to calculate scaled payment adjustments for an ASM payment year. We propose to separately calculate an ASM incentive pool for each ASM cohort. For example, we would calculate a separate ASM incentive pool for the ASM heart failure cohort and ASM low back pain cohort. As discussed later in this section of this proposed rule, we would not prospectively withhold a portion of Part B payments for covered professional services during an ASM performance year to create the ASM incentive pools but would instead create virtual incentive pools based on actual spending during the ASM performance year. We also propose to define at § 512.705 an ‘‘ASM payment adjustment factor’’ as a percent value based on an ASM’s participant’s final score as described at § 512.750(c)(1) that we use in calculating adjustments to the ASM partici § 512.705 an ‘‘ASM payment adjustment factor’’ as a percent value based on an ASM’s participant’s final score as described at § 512.750(c)(1) that we use in calculating adjustments to the ASM participant’s Medicare Part B payments for covered professional services during an ASM payment year. Based on their performance, an ASM participant could earn an ASM payment adjustment factor percentage that is less than, equal to, or more than the percentage of their Medicare Part B payments used to calculate the ASM incentive pool, leading to a net negative, neutral, or positive net payment adjustment. Similar to our proposal to calculate separate ASM incentive pools for each ASM cohort, we would determine ASM payment adjustment factors separately for each ASM cohort as described later in this section of this proposed rule. We also propose to define at § 512.705 an ‘‘ASM payment multiplier’’ as the numerical value equal to 1 plus the ASM payment adjustment factor determined for the ASM participant for an applicable ASM payment year as described at § 512.750(c). As proposed at § 512.750(a), to adjust payments, the amount otherwise paid under Medicare Part B for covered professional services ant for an applicable ASM payment year as described at § 512.750(c). As proposed at § 512.750(a), to adjust payments, the amount otherwise paid under Medicare Part B for covered professional services furnished by an ASM participant during an ASM payment year would be multiplied by the ASM participant’s ASM payment multiplier unless that ASM participant receives no payment adjustment (that is, a neutral payment adjustment) as described at § 512.750(d) because they do not receive a final score for the corresponding ASM performance year. We refer readers to § 512.745(a)(2) and section III.C.2.e.(2). of this proposed rule for proposals related to final scores. We also refer readers to section III.C.2.f. of this proposed rule and § 512.750(f) for further proposals on how payment adjustments are applied in the case the ASM participant bills during an ASM payment year under a different TIN than the TIN we used to identify them as an ASM participant for the corresponding ASM performance year. The proposed payment methodology is similar in design to existing incentive payment structures in CMS value-based programs, such as the Hospital Valued- Based Purchasing Program (Hospital VBP Program) The proposed payment methodology is similar in design to existing incentive payment structures in CMS value-based programs, such as the Hospital Valued- Based Purchasing Program (Hospital VBP Program) 235 and the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP Program).236 • The Hospital VBP Program rewards acute care hospitals with incentive payments based on the quality of care they provide, rather than just the quantity of services they provide. The statutory requirements of the Hospital VBP Program are set forth in Section 1886(o) of the Social Security Act. The program uses selected measures that were first specified under the Hospital Inpatient Quality Reporting Program as established by section 1886(o)(2)(A) of the Act and defined at § 412.164(a).237 A fixed percentage withhold of base operating Diagnosis-Related Group (DRG) payments for each discharge during an applicable fiscal year determines the amount of money that can be redistributed to participating hospitals through value-based incentive payments based on a participating hospital’s total performance score. A hospital may earn back a value-based incentive payment percentage that is less than, equal t itals through value-based incentive payments based on a participating hospital’s total performance score. A hospital may earn back a value-based incentive payment percentage that is less than, equal to, or more than the applicable reduction for that program year (88 FR 59063 through 59108). • Section 215 of the Protecting Access to Medicare Act of 2014 and subsequent additions of sections 1888(g) and (h) of the Act established the SNF VBP Program.238 Then, section 111 of the Consolidated Appropriations Act, 2021 amended section 1888(h) of the Act to allow the Secretary to apply up to 9 additional measures to the SNF VBP Program.239 The SNF VBP Program requires CMS to evaluate SNFs based on their performance on multiple measures, including improvement and achievement, provide quarterly performance reports to SNFs, and calculate incentive payments for SNFs based on their performance (88 FR 235 https://www.cms.gov/medicare/quality/ initiativeshospital-quality-initiative/hospital-value- based-purchasing. 236 https://www.cms.gov/medicare/quality/ nursing-home-improvement/value-based- purchasing. 237 https://www.cms.gov/medicare/quality/ initiatives/hospital-quality-initiative/hospital-v sed-purchasing. 236 https://www.cms.gov/medicare/quality/ nursing-home-improvement/value-based- purchasing. 237 https://www.cms.gov/medicare/quality/ initiatives/hospital-quality-initiative/hospital-value- based-purchasing. 238 42 U.S.C. 1395yy(h). 239 42 U.S.C. 1395yy(h). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00255 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 32606 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 53276 through 53304).240 To determine and fund the statutorily required incentive payments, CMS withholds 2 percent of SNFs’ Medicare FFS Part A payments to fund the SNF VBP Program. CMS then redistributes 60 percent of this total withhold to SNFs as incentive payments, which CMS applies prospectively to all Medicare FFS Part A claims paid under the SNF Prospective Payment System (PPS) for the applicable program year (82 FR 36619 through 36621). Our proposed payment methodology differs from the Hospital VBP Program and the SNF VBP Program in that we are not proposing a prospective withhold of ASM participants’ Medicare Part B payments during an r proposed payment methodology differs from the Hospital VBP Program and the SNF VBP Program in that we are not proposing a prospective withhold of ASM participants’ Medicare Part B payments during an ASM performance year. Instead, we are proposing to determine a virtual ASM incentive pool as a fixed percentage of ASM participants’ Medicare Part B covered professional service payments during the ASM performance year. We would then distribute this virtual incentive pool through scaled payment adjustments on ASM participants’ future Medicare Part B payments during an ASM payment year. The size of each ASM incentive pool and the distribution of final scores within each ASM cohort would together influence the possible magnitude of the scaled payment adjustments and the distribution of net negative, neutral, and positive payment adjustments. As discussed earlier and later in this section of this proposed rule, we propose to calculate ASM incentive pools, ASM payment adjustment factors, and ASM payment multipliers separately for each ASM cohort. The higher an ASM participant’s final score, the greater the likelihood that they would receive a positive payment adjustment. Under this propos ASM payment multipliers separately for each ASM cohort. The higher an ASM participant’s final score, the greater the likelihood that they would receive a positive payment adjustment. Under this proposed methodology, the ASM participant’s performance during an ASM performance year would not have an immediate financial impact but would result in a future net payment adjustment determined by the ASM participant’s performance relative to other ASM participants. We believe that this proposed payment methodology would allow ASM to create net positive, neutral, and negative payment adjustments based on the annual distribution of final scores in each ASM cohort. We also recognize that MIPS, under the Quality Payment Program, uses a value-based purchasing approach but determines payment adjustments based on performance relative to a 240 https://www.cms.gov/medicare/quality/ nursing-home-improvement/value-based- purchasing. performance threshold. In accordance with section 1848(q)(6) of the Act and § 414.1405(b), MIPS compares each MIPS eligible clinician’s final score against the performance threshold established for that MIPS payment year and against the other MIPS eligible clinicians in a and § 414.1405(b), MIPS compares each MIPS eligible clinician’s final score against the performance threshold established for that MIPS payment year and against the other MIPS eligible clinicians in a single comparison pool to determine whether each MIPS eligible clinician will receive a positive, negative, or neutral payment adjustment. As defined at § 414.1405, scores equal to the defined performance threshold receive a neutral (zero percent) payment adjustment. Scores falling below one-quarter of the performance threshold receive a negative adjustment of minus 9 percent, while scores between one-quarter of the performance threshold and the performance threshold receive a negative payment adjustment less than zero percent and up to minus 9 percent based on a linear sliding scale. Scores above the performance threshold can receive positive payment adjustments greater than zero percent and up to positive 9 percent based on a linear sliding scale. Depending on the range of scores within a given MIPS performance period, a scaling factor (ranging from zero to 3 is applied to the positive adjustments to retain budget neutrality. We considered, but decided not to propose, a payment meth a given MIPS performance period, a scaling factor (ranging from zero to 3 is applied to the positive adjustments to retain budget neutrality. We considered, but decided not to propose, a payment methodology that includes a performance threshold like MIPS uses to determine ASM payment adjustment factors. To determine a MIPS payment adjustment factor for each MIPS eligible clinician for a MIPS performance period, CMS compares the MIPS eligible clinician’s final score for the given year to the performance threshold CMS established for that same year in accordance with Section 1848(q)(6)(D) of the Act. Section 1848(q)(6)(D)(i) of the Act requires that CMS compute the performance threshold such that it is the mean or median (as selected by the Secretary) of the final scores for all MIPS eligible clinicians with respect to a ‘‘prior period’’ specified by the Secretary. Section 1848(q)(6)(D)(i) of the Act also provides that the Secretary may reassess the selection of the mean or median every 3 years. For each CY performance period/MIPS payment year, CMS has finalized a performance threshold based on the mean final score of all MIPS eligible clinicians from a previous MIPS performance per 3 years. For each CY performance period/MIPS payment year, CMS has finalized a performance threshold based on the mean final score of all MIPS eligible clinicians from a previous MIPS performance period, as set forth in § 414.1405(b)(4) through (10). CMS establishes the performance threshold via rulemaking prior to the beginning of each MIPS performance period. Adopting a similar performance threshold and payment adjustment approach for ASM would introduce several operational complexities. First, given the proposed separate comparison of final scores and separate calculation of ASM payment adjustment factors and ASM payment multipliers for each ASM cohort, we would need to determine a performance threshold for each ASM cohort for each ASM performance year. Because ASM is a new Innovation Center model, we would need to set a prospective performance threshold for the first ASM performance year without historical data on final scores. This lack of historical data could present challenges in calibrating the performance threshold to actual performance within the first ASM performance year. Second, we believe that a payment methodology that leverages a prospective performance threshold in calibrating the performance threshold to actual performance within the first ASM performance year. Second, we believe that a payment methodology that leverages a prospective performance threshold would limit the magnitude of ASM’s negative and positive payment adjustments and, ultimately, the model’s incentives to improve performance compared to our proposal to scale the payment adjustments distributed to ASM participants to equal the amount of an ASM incentive pool. For example, if a larger proportion of participants score above the performance threshold relative to the proportion of participants who score below the performance threshold, then the positive payment adjustments for those participants scoring above the performance threshold may be smaller in magnitude due to there being fewer negative adjustments from participants scoring below the performance threshold that can be distributed in positive payment adjustments. We seek comment on our overall payment approach for ASM, which would include an ASM incentive pool that is distributed in the form of scaled payment adjustments to ASM participants’ future Medicare Part B payments based on their performance. We also seek com hich would include an ASM incentive pool that is distributed in the form of scaled payment adjustments to ASM participants’ future Medicare Part B payments based on their performance. We also seek comments on the alternative approach we considered that would use a performance threshold similar to MIPS in our payment methodology. In the following sections, we propose and seek comments on our proposed policies to (1) compare performance across ASM participants within each ASM cohort and (2) calculate ASM payment adjustment factors and ASM payment multipliers, including how we propose to calculate the ASM incentive pools. (3) Comparison of ASM Participant Performance We propose at § 512.750(b) to separately compare the final scores of ASM participants in each ASM cohort to determine the payment adjustments VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00256 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 32607 for each ASM participant. We believe that the ASM participant eligibility criteria appropriately identify speci k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32607 for each ASM participant. We believe that the ASM participant eligibility criteria appropriately identify specialists that can be held accountable for cost, quality, and practice improvement for specific chronic conditions. Accordingly, we believe that separately comparing ASM participants’ final scores for each of the ASM targeted chronic conditions would provide more meaningful performance comparisons. Since each ASM cohort would be compared on the same set of requirements reported at the same TIN/ NPI level (that is, the level at which an ASM participant is identified), the proposed performance comparison approach would allow for better differentiation in performance upon which to determine the payment adjustments. Currently, under MIPS, performance measurement and the subsequent payment adjustment are based on a range of measures voluntarily reported by clinicians, each of whom receives a final score based on the submitted measures. A MIPS eligible clinician’s performance is assessed against a pool of all clinicians, regardless of specialty type or the services they provide. In accordance w score based on the submitted measures. A MIPS eligible clinician’s performance is assessed against a pool of all clinicians, regardless of specialty type or the services they provide. In accordance with section 1848(q)(6) of the Act and § 414.1405(b), CMS compares each MIPS eligible clinician’s final score against the performance threshold established for that MIPS payment year and against one another in a single comparison pool to determine whether each MIPS eligible clinician will receive a positive, negative, or neutral payment adjustment. CMS calculates MIPS payment adjustment factors in accordance with regulations at § 414.1405 (89 FR 61985). In ASM, we wish to test whether a more targeted approach where clinicians are evaluated: (1) on a set of relevant performance measures they are required to report; and (2) among clinicians furnishing similar sets of services, would produce final scores and subsequent payment adjustments that are more reflective of clinician performance. We believe our proposed approach to separately compare ASM heart failure participants against other ASM heart failure participants and ASM low back pain participants against other ASM low back pain partic elieve our proposed approach to separately compare ASM heart failure participants against other ASM heart failure participants and ASM low back pain participants against other ASM low back pain participants supports and incentivizes accountable care by creating more meaningful payment adjustments that differentiate and reflect ASM participant performance related to the chronic condition for which we believe the ASM participant should be accountable. We considered not separating ASM participants in each ASM cohort when comparing final scores to determine ASM payment adjustment factors and ASM payment multipliers, and instead, comparing the final scores of all ASM participants together. This approach would potentially be administratively easier to operationalize and would align with the current practice of comparison under MIPS, including MVPs, as defined at § 414.1405. It would also potentially lead to a more varied distribution of final scores that would translate into a more varied distribution of payment adjustment, which could be helpful in creating the desired payment incentives. However, we believe that comparing performance within each ASM cohort is more appropriate in meetin stribution of payment adjustment, which could be helpful in creating the desired payment incentives. However, we believe that comparing performance within each ASM cohort is more appropriate in meeting our aim to test whether like-to- like performance comparisons based on a clinically relevant measure set and the resulting payment incentives achieve ASM’s objectives of increasing accountability for specialty care related to ASM targeted chronic conditions. We also believe that comparing performance using a continuous distribution of final scores would result in more meaningful incentives for ASM participants because payment adjustments would be determined on relative performance across ASM participants instead of relative to a prospectively determined performance threshold. This approach also more closely mirrors the general market for goods and services, which does not provide an upfront guarantee of a certain market share or profit margin based on a predetermined threshold of performance. Rather, ASM participants would compete to provide the highest quality, most efficient care to ASM beneficiaries, and the top performers would receive positive payment adjustments—in the same way ance. Rather, ASM participants would compete to provide the highest quality, most efficient care to ASM beneficiaries, and the top performers would receive positive payment adjustments—in the same way that competitive markets reward top performers with profits. We seek comments on our proposal at § 512.750(b) to determine ASM payment adjustment factors and ASM payment multipliers by comparing final scores separately among each ASM cohort. We also seek comment on the alternative we considered of comparing final scores of all ASM participants together, like the MIPS approach for comparing performance scores. (4) Calculation of ASM Payment Adjustment Factors and ASM Payment Multipliers In this section, we first provide an overview of the proposed process to calculate ASM payment adjustment factors and ASM payment multipliers. We then break down each part of the calculation process and discuss our proposals and alternatives considered. As part of this process, we discuss the calculation of the ASM incentive pool using the ‘‘ASM risk level,’’ which we propose to define at § 512.705 as the magnitude of the maximum positive or negative net payment adjustment percentage to which an ASM par the ASM incentive pool using the ‘‘ASM risk level,’’ which we propose to define at § 512.705 as the magnitude of the maximum positive or negative net payment adjustment percentage to which an ASM participant would be subject during an ASM payment year as described at § 512.750(c)(1)(i), and the ‘‘ASM redistribution percentage,’’ which we propose to define at § 512.705 as a percentage of Medicare Part B covered professional services payments to ASM participants during an ASM performance year that CMS distributes in the form of payment adjustments to ASM participants during an ASM payment year as described at § 512.750(c)(1)(iii). We then discuss our proposals on how we would convert final scores into ASM payment adjustment factors and ASM payment multipliers based on the ASM incentive pool and our proposed ‘‘exchange function,’’ which we propose to define at § 512.705 as the function used to translate an ASM participant’s final score into an ASM payment adjustment factor as described at proposed § 512.750(c)(1)(ii). We also propose to define at § 512.705 a ‘‘scaling factor’’ as a numerical value calculated by CMS to ensure that the total estimated payment adjustments in an ASM paym t proposed § 512.750(c)(1)(ii). We also propose to define at § 512.705 a ‘‘scaling factor’’ as a numerical value calculated by CMS to ensure that the total estimated payment adjustments in an ASM payment year are equal to an ASM incentive pool for an applicable ASM payment year as described at § 512.750(c)(1)(iv). Finally, we discuss how these ASM payment multipliers would be applied to future Medicare Part B claims for covered professional services during an ASM payment year. (a) Overview of ASM Payment Adjustment Factor and Payment Multiplier Calculation Process We propose at § 512.750(c) to use the following process to calculate ASM payment adjustment factors and ASM payment multipliers for each ASM payment year for ASM participants with final scores for the corresponding ASM performance year. We refer readers to Table 43 in section III.C.2.e.(2). of this proposed rule for a summary of how an ASM participant’s final score influences their payment adjustment. Calculation of ASM Incentive Pool • Step 1. Calculate total Medicare Part B payments for covered professional services made to ASM participants with final scores in each ASM cohort during an ASM performance year. • Step 2. M tive Pool • Step 1. Calculate total Medicare Part B payments for covered professional services made to ASM participants with final scores in each ASM cohort during an ASM performance year. • Step 2. Multiply the total calculated in Step 1 by the ASM risk level for each ASM payment year proposed at VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00257 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 32608 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules § 512.750(c)(1)(i) and discussed in section III.C.2.f.(4).(b).(i). of this proposed rule. • Step 3. Multiply the amount calculated in Step 2 by the ASM redistribution percentage proposed at § 512.750(c)(1)(iii) and discussed in section III.C.2.f.(4).(b).(ii) of this proposed rule to determine the total ASM incentive pool amount available for payment adjustment for each ASM cohort. Calculation of ASM Payment Adjustment Factor • Step 4. Convert each ASM participant’s final score into a transformed numerical final score by using the exchange function proposed at § 512.750(c)(1)(ii) and described in section III.C.2.f.(4).(c r • Step 4. Convert each ASM participant’s final score into a transformed numerical final score by using the exchange function proposed at § 512.750(c)(1)(ii) and described in section III.C.2.f.(4).(c). of this proposed rule. • Step 5. Calculate a scaling factor as proposed at § 512.750(c)(1)(iv) to ensure that the sum of applied ASM payment adjustment factors would equal the ASM incentive pool for each ASM cohort. The scaling factor is calculated by dividing the total amount in the ASM incentive pool (calculated in Step 3) by the sum of all ASM participant’s transformed final scores (calculated in Step 4) multiplied by their respective total Medicare Part B covered professional services payments and the ASM risk level. • Step 6A. For ASM participants that receive a final score greater than zero as described at § 512.745(2)(i), calculate an ASM payment adjustment factor for each ASM participant within each ASM cohort by multiplying the ASM risk level, the ASM participant’s transformed final score (calculated in Step 4), and the scaling factor (calculated in Step 5), and then subtracting the ASM risk level from this product as described at § 512.750(c)(1)(i): ASM payment adjustment final score (calculated in Step 4), and the scaling factor (calculated in Step 5), and then subtracting the ASM risk level from this product as described at § 512.750(c)(1)(i): ASM payment adjustment factor = (ASM risk level × transformed final score × scaling factor)¥ASM risk level • Step 6B. For ASM participants that receive a final score of zero as described at § 512.745(2)(ii), calculate the ASM payment adjustment factor for each ASM participant equal to the negative of the applicable ASM risk level as described at § 512.750(c)(1)(i). Calculation of ASM Payment Multiplier • Step 7. Calculate the ASM payment multiplier for each ASM participant by using the following formula as described § 512.750(c): ASM payment multiplier = 1 + ASM payment adjustment factor Under this proposed calculation process, an ASM payment adjustment factor could be negative (meaning net negative payment adjustments), zero (meaning neutral or no payment adjustments), or positive (meaning net positive payment adjustments). Accordingly, an ASM payment multiplier above 1 would result in net positive payment adjustments; an ASM payment multiplier of 1 would result in no (that is, neutral) payment adjustments, adjustments). Accordingly, an ASM payment multiplier above 1 would result in net positive payment adjustments; an ASM payment multiplier of 1 would result in no (that is, neutral) payment adjustments, and an ASM payment multiplier less than 1 would result in a net negative payment adjustment. We propose at § 512.750(d) that ASM participants that do not receive a final score as discussed in section III.C.2.e.(2).(b). of this proposed rule would receive an ASM payment adjustment factor of zero and an ASM payment multiplier of 1 (that is, a neutral payment adjustment) for the applicable ASM payment year. To illustrate how this process would work, we provide the following example of how we would calculate the ASM payment adjustment factor and ASM payment multiplier for individual ASM participants who received a final score greater than zero. In this example, we assume an ASM risk level of 9 percent and an ASM redistribution percentage of 85 percent. • Step 1. We determine that all ASM participants with final scores in the example ASM cohort had a total of $1 billion in Medicare Part B covered professional service payments during the ASM performance year. • Steps 2 and 3. We multiply th