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

1. Overview of Ambulatory Specialty Model a. Introduction

Under the authority of the Center for Medicare and Medicaid Innovation (Innovation Center) in section 1115A(b) of the Act, we proposed the implementation and testing of the Ambulatory Specialty Model (ASM), a new mandatory alternative payment model with 5 performance years that would begin January 1, 2027, and end December 31, 2031. ASM will test whether adjusting payment for specialists based on their performance on targeted measures of quality, cost, care coordination, and meaningful use of certified electronic health record (EHR) technology (CEHRT) results in enhanced quality of care and reduced costs through more effective upstream chronic condition management.

To enhance quality of care and lower the costs of care, ASM will be established as a mandatory model focused on the care provided by select specialists to Medicare beneficiaries with the chronic conditions of heart

failure and low back pain. Under the model, clinicians will be required to report a select set of measures and activities clinically relevant to their specialty type and the chronic condition of interest. These measures and activities will assess quality, cost, interoperability, and care coordination practices, all of which are necessary for effective upstream chronic condition management. To incentivize improvements in quality and care coordination, CMS will assess the clinician's performance on those measures and activities relative to their peers, who are also participants of the model and of a similar specialty type treating the same chronic condition.

ASM falls within a larger framework of activities initiated by the Innovation Center to focus on high-volume, high-cost chronic conditions and direct engagement of specialists in value-based payment. The Innovation Center recently announced its new strategy based on three strategic pillars for improving the health of Americans and protecting taxpayers: preventing disease through evidence-based practices, empowering people with information to make better decisions, and driving choice and competition.\156\

\156\ CMS Innovation Center, CMS Innovation Center 2025 Strategy to Make America Healthy Again, May 2025. https://www.cms.gov/ priorities/innovation/about/strategic- direction#:~:text=Three%2DPronged%20Approach,served%20by%20the%20Inno vation%20Center.

In line with the updated Innovation Center principles, this final rule finalizes a new mandatory model that we believe will improve beneficiary and provider engagement, incentivize preventive care, and increase financial accountability for certain specialists. The model will build upon lessons learned from previous Innovation Center models and the Merit-based Incentive Payment System (MIPS) under the Quality Payment Program. We believe the model will answer the call to create a more cohesive and efficient health system that enhances the quality of care and reduces costs over time. To promote preventive care, the model will incentivize specialists who are ASM participants to ensure that their patients have a regular source of primary care and are screened to help identify risks and early signs of chronic conditions. This model will also seek to prevent deterioration and complications associated with established chronic conditions. To empower patients, the model will promote direct accountability for the quality of specialty care specific to heart failure and low back pain. By featuring patient-reported outcome measures in the finalized quality ASM performance category, this model encourages patients to report their improvement or decline in function, which directly impacts clinician payment and further incentivizes clinicians to incorporate patient voice and experience in clinical care decisions. We believe a focus on patient-reported measures elevates patient voice, leading clinicians to be more responsive to the patient's response to treatment, while also addressing the significant spending that results from functional impairment. These measures also provide a pathway for clinicians to have conversations about non-medical, lifestyle-based interventions with their patients. This finalized model is intent on removing the onus from patients with heart failure and low back pain to act as the go-between among clinicians they see for their care by incentivizing clinicians, specifically specialists, to coordinate care for their patients more seamlessly. For this reason, we believe that patients will be able to focus on solutions to their health, rather than resolving information and guidance they have received from multiple clinicians.

Finally, the model will require the participation of individual clinicians rather than organizations to encourage competition and create a level playing field for solo and small practices. By evaluating clinicians individually, ASM removes the unequal reporting and scoring benefits that have been previously afforded to consolidated health systems and group practices. This form of mandatory participation will bring transparency, accountability, and comparability at the clinician-level, helping to identify clinicians within large, consolidated health systems or provider networks providing low-value care.

Low-value care refers to services that: (1) may offer limited or no clinical benefit to a patient; or (2) may present risks of harm that outweigh the potential benefit. By requiring the participation of individual clinicians, we believe this model will reduce spending that represents low-value services and major cost-drivers for heart failure and low back pain (for example, unnecessary imaging, surgeries, hospital admissions). Ultimately, this model aims to drive competition among similar specialists with a targeted assessment of their performance relative to their peers in the treatment of a specific chronic condition and protect taxpayers by reducing low-value services by holding specialists accountable for the cost of services clinically related to their role in managing care.

We have designed ASM with a focus on clinicians who commonly treat patients in an ambulatory setting, develop longitudinal relationships with patients, and co-manage beneficiaries with primary care providers (PCP). In addition, we considered those who treat chronic conditions that are likely to benefit from improved integration between specialty and primary care to maximize opportunities for incentivizing high-value care and tertiary prevention. Specifically, we proposed to focus the model on the chronic conditions of heart failure and low back pain, as they have previously established episode-based cost measures (EBCMs) specified for the MIPS cost performance category.

The EBCMs were developed with specialists and interested parties through an extensive, collaborative process that, by design, focused on conditions with a large share of Medicare spending, a high number of responsible clinicians, and opportunities for care improvement. Based on recent estimates, heart failure and low back pain, in particular, account for 3.5 and 2.7 percent total Medicare Part A and B spending.\157\ These are significantly higher than other chronic conditions with EBCMs, which account for less than one percent of Medicare Part A and B spending, except for diabetes, which accounts for 4.2 percent of spending.\158\ In contrast, many Medicare beneficiaries with type 2 diabetes are capably managed by primary care physicians as the quarterback of their care with input from consulting specialists. Consequently, we do not believe it is an appropriate chronic condition for this specialty care model.

\157\ Quality Payment Program, 2025 Summary of Cost Measures, December 2024. https://qpp-cm-prod-content.s3.amazonaws.com/uploads/3129/2025-mips-summary-cost-measures.pdf.

\158\ Ibid.

ASM will be a mandatory model that begins on January 1, 2027 and ends December, 31, 2033. There will be 5 performance years, beginning January 1, 2027 and ending December 31, 2031. Final data submission of measures and activities will be in CY 2032, with final model payment adjustments in CY 2033.

To measure clinician performance in ASM, we will establish a mandatory set of measures and activities for physicians that meet the proposed ASM participant eligibility criteria described in section III.C.2.c.(3) of this final rule. ASM aims to assess the quality and cost performance of ASM participants providing care for Medicare beneficiaries with the targeted chronic

conditions at the individual clinician level (TIN/NPI) while measuring practice transformation and interoperability strengthening at the group level. Specifically, ASM will test whether adjusting Medicare Part B payments for covered professional services based on measures of quality, cost, care coordination, and CEHRT results in enhanced quality of care and reduced costs through more effective upstream chronic condition management.

ASM will leverage components of the existing MIPS Value Pathway (MVP) framework, as appropriate, to meaningfully engage specialists in improving the quality of care for high-volume, high-cost chronic conditions and better integrate specialists in primary care. MVPs are one MIPS reporting option that provides a smaller set of measures to choose from that are most relevant to a condition or specialty. Currently, for MIPS, CMS assesses the performance of each MIPS eligible clinician on measures and activities CMS has specified for a CY performance period/MIPS payment year for four performance categories: quality, cost, improvement activities, and Promoting Interoperability (which refers to the meaningful use of Certified Electronic Health Record Technology (CEHRT). In accordance with section 1848(q) of the Act, CMS calculates a composite performance score (a “final score” as defined at 42 CFR 414.1305) from 0 to 100 points for each MIPS eligible clinician. Then, CMS compares each MIPS eligible clinician's final score to the performance threshold established in prior rulemaking for that CY performance period/MIPS payment year to calculate the MIPS payment adjustment factor as specified in section 1848(q)(6) of the Act. For the applicable MIPS payment year, CMS calculates and applies to each MIPS eligible clinician: (1) a positive adjustment, if their final score exceeds the performance threshold; (2) a neutral adjustment, if their final score meets the performance threshold; or (3) a negative adjustment, if their final score is below the performance threshold. In calculating the MIPS payment adjustment factor for each MIPS eligible clinician, CMS accounts for scaling factor and budget neutrality requirements, as further specified in section 1848(q)(6) of the Act.

By applying these budget neutrality and scaling factor requirements, CMS' calculations of positive MIPS payment adjustment factors for each MIPS eligible clinician are limited by CMS' calculations of negative MIPS payment factors for each MIPS eligible clinician. In other words, CMS' estimated amounts of positive MIPS payment adjustment factors for MIPS eligible clinicians performing above the performance threshold must be offset by CMS' estimated amounts of negative MIPS payment adjustment factors for MIPS eligible clinicians performing below the performance threshold. In MVPs, however, clinicians still have flexibility to select which measures to report. Under MIPS, a clinician's performance is assessed against all MIPS clinicians, regardless of reporting option, specialty type, or the services they provide.

As CMS discussed in a 2024 Request for Information (RFI) (89 FR 61596),\159\ we expect that a more targeted approach where clinicians are evaluated: (1) on required reporting of a set of relevant performance measures; and (2) among clinicians furnishing similar sets of services, will produce scores and subsequent payment adjustments that are more reflective of clinician performance. We believe that a more targeted approach to measurement will also offer more insight into how clinical decisions and processes, such as care coordination, affect patient outcomes. This targeted approach will include reporting or required collection of patient-reported outcome measures that assess the change in a beneficiary's functional status over the course of the episode, ensuring clinicians prioritize the same goals as their patients. Furthermore, equipped with more specialty-relevant performance information, we expect clinicians will be more likely to invest resources in pursuit of better outcomes and improved care coordination, ultimately resulting in better care for patients. To test this more targeted approach, this finalized mandatory model leverages the existing MVP policies, deviating from MVP policies in specific ways, as applicable.

\159\ Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Medicare Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments.

First, unlike the voluntary measure and activity selection permitted under the MVP reporting option, ASM will require clinicians to report on a set of measures and activities clinically relevant to their specialty type and the chronic condition of interest. This will ensure a more analogous comparison between clinicians. Second, while clinicians reporting under MVPs are scored against the entire pool of MIPS clinicians, ASM will assess performance against only those clinicians treating the same chronic condition. Each clinician will receive a performance score based on the measures and activities included in the four ASM performance categories (which are based on the MIPS performance categories)--quality, cost, improvement activities, and Promoting Interoperability. In section III.C.2.d. of this final rule, we describe the finalized requirements in the quality, cost, improvement activities, and Promoting Interoperability ASM performance categories.

Third, we will use a different approach, compared to MVPs, for aggregating the ASM performance categories to calculate a final score and determine the ASM payment adjustment. This approach will broaden the distribution of final scores and increase the magnitude of payment adjustments, which we believe will incentivize performance improvements that will lead to more effective upstream chronic condition management. We refer readers to the CY 2022 PFS final rule for additional details on the MVP performance category weighting Sec. 414.1365(e). As described in section III.C.2.e. of this final rule, we will focus on value and variation in clinician performance by primarily measuring performance on quality and cost performance categories for calculating the ASM final score. We also understand the importance of the improvement activities and Promoting Interoperability performance categories and will apply potential negative scoring adjustments for non-reporting or poor performance. We are also finalizing positive scoring adjustments for clinicians in small practices participating in the model and for ASM participants treating a large proportion of medically complex patients. We refer readers to sections III.C.2.c., III.C.2.d., and III.C.2.e. of this final rule for additional details on the finalized policies related to ASM participant eligibility criteria, the quality, cost, improvement activities, and Promoting Interoperability ASM performance categories, and ASM final scoring calculations.

To ensure savings in the financial impacts for the model, ASM will also retain a percentage of the payments rather than distributing all funds as clinicians' payment adjustments. ASM participants will receive neutral, negative, or positive payment adjustments on future Medicare Part B payments for covered professional services based on their performance during an ASM performance year. As is done under MIPS, clinicians participating in ASM will continue to

bill Medicare under the traditional fee for service (FFS) system for services furnished to Medicare FFS beneficiaries. MIPS eligibility criteria described under 42 CFR 414.1305 are not factored into the ASM participant eligibility criteria described in section III.C.2.c.(3) of this final rule. However, MIPS eligible clinicians participating in this model will be exempt from MIPS reporting requirements for any ASM performance year that they are included in ASM. b. Background

Health care is becoming more fragmented as Medicare beneficiaries are increasingly seeing a greater number of specialists on a more regular basis. At the same time, the volume of primary care visits has remained relatively constant.160 161 Primary care teams must now coordinate with more specialists than ever before,\162\ despite persistent barriers to specialist access for certain patients.163 164 We believe there are opportunities to improve coordination between specialists and PCPs and increase beneficiary engagement in care decisions, particularly with respect to preventing the onset and progression of disease.

\160\ Barnett ML, Bitton A, Souza J, Landon BE. Trends in Outpatient Care for Medicare Beneficiaries and Implications for Primary Care, 2000 to 2019 [published correction appears in Ann Intern Med. 2022 Oct;175(10):1492]. Ann Intern Med. 2021;174(12):1658-1665. doi:10.7326/M21-1523.

\161\ Lori Timmins, Ph.D., Carol Urato, MA, Lisa M. Kern, MD, MPH, Arkadipta Ghosh, Ph.D., Eugene Rich, MD. Primary Care Redesign and Care Fragmentation Among Medicare Beneficiaries. The American Journal of Managed Care, March 2022, Volume 28, Issue 3.

\162\ The CMS Innovation Center's strategy to support person- centered, value-based specialty care. 2022. Retrieved from https://www.cms.gov/blog/cms-innovation-centers-strategy-support-person-centered-value-based-specialty-care.

\163\ McConnell KJ, Charlesworth CJ, Zhu JM, Meath THA, George RM, Davis MM, Saha S, Kim H. Access to Primary, Mental Health, and Specialty Care: A Comparison of Medicaid and Commercially Insured Populations in Oregon. J Gen Intern Med. 2020 Jan;35(1):247-254. doi: 10.1007/s11606-019-05439-z. Epub 2019 Oct 28. PMID: 31659659; PMCID: PMC6957609.

\164\ Romaire MA, Haber SG, Wensky SG, McCall N. Primary care and specialty providers: an assessment of continuity of care, utilization, and expenditures. Med Care. 2014;52(12):1042-1049. doi:10.1097/MLR.0000000000000246.

Although the Innovation Center has tested models that address the integration of primary and specialty care for chronic conditions that may benefit from greater collaboration and create opportunities for preventive care, these models have been largely focused on behaviors and practice patterns in primary care.\165\ This model test elects to focus on the behaviors and practice patterns in specialty care for those treating chronic conditions and would be the first Innovation Center model to use the MVP framework as the foundation for a model test.

\165\ See the evaluation reports of the Comprehensive Primary Care Plus (CPC+) model, which ran from 2017 to 2021, https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus. See also the evaluation reports of the Primary Care First (PCF) model, which began in 2021 and will end December 31, 2025, https://www.cms.gov/priorities/innovation/innovation-models/primary-care-first-model-options.

We believe the MVP framework has many benefits. First, the MVP framework advances value-based care by narrowing the available measure set based upon clinician specialty, medical condition, or patient population, which allows for meaningful comparisons to be made across providers and relevant feedback to be available to participants on their performance, strengthening the foundation for accountability in specialty care. The MVPs utilize a cohesive set of measures and activities focused on performance in rendering care for a particular specialty or clinical condition. Second, we believe that meaningful comparisons of performance combined with a payment methodology that includes more significant Medicare Part B payment adjustments, will encourage meaningful specialty care engagement with PCPs to both prevent and manage the onset of chronic conditions. Third, we intend to test ASM's more targeted approach to performance assessment, as described in the introduction section of this final rule, so it may provide a foundation to potentially expand this approach to other specialist cohorts treating other chronic conditions. While there are twenty-one MVPs for the CY 2025 performance period/2027 MIPS payment year spanning numerous specialties, CMS has a goal of creating additional MVPs relevant to the practices of 80 percent of MIPS eligible clinicians. The MVP reporting option, with its focused set of measures and activities aligned around specific specialties or conditions, provides a framework for applying ASM's targeted approach to other specialist cohorts treating other chronic conditions. Using an existing framework that is agnostic to specialty type, as opposed to creating multiple unique models that are each narrowly defined by a condition or specialty, will allow the Innovation Center to take a more inclusive and unified approach to increasing specialist engagement in value-based payment.

Using MVPs as a framework to test a chronic condition model, ASM will increase the number of specialists in value-based care arrangements and hold them accountable for ensuring beneficiaries have a regular source of primary care. Through required improvement activities and measures, the model will also encourage specialty care providers to actively engage with both beneficiaries and PCPs to improve care transitions and make certain their patients are receiving preventive care, such as screening for obesity and depression. When primary and specialty care providers collaborate across care settings, together they can deliver accountable care that best meets patients' needs and preferences.

We received several comments about ASM's clinical focus on heart failure and low back pain. The following is a summary of these comments and our responses.

Comment: A few commenters supported ASM because of the focus on value-based care for high-cost conditions like heart failure and low back pain, citing the importance of potential improvements in care quality, cost reduction, and specialist engagement. Several commenters supported the proposed chronic disease focus of ASM since heart disease and low back pain are leading causes of hospitalizations, readmissions, and high costs in the United States where care fragmentation can negatively impact patient outcomes; a commenter believes that ASM can be a critical step for addressing chronic illness burden. A few commenters commended the model's engagement of independent clinicians.

Response: We appreciate the commenters' support of ASM, including its focus on heart failure and low back pain. We agree that ASM creates opportunities for increasing specialist participation in value-based care to create improvements in care quality and reductions in cost. We also appreciate commenters' support for a model that engages independent clinicians.

Comment: A few commenters did not support the proposed focus on low back pain for ASM because of the broad and diverse range of specialties that care for low back pain at different stages of disease progression. Another commenter shared a concern with the focus on low back pain because it can often be a symptom of a variety of underlying clinical diagnoses and treating it as a single condition ignores physiological aspects of the disease, increases heterogeneity of patients, and underestimates the complexity of evaluating and treating the underlying diseases that cause low back pain.

Response: We appreciate commenters' feedback on including low back pain as a chronic condition of focus in ASM. As

we discuss in section III.C.2.c.(2).(b) of this final rule, we believe that several types of specialists can be held accountable for ongoing chronic condition management for low back pain. In the CY 2026 PFS proposed rule, we proposed to include these relevant specialty types in our ASM participant eligibility criteria to identify low back participants; we proposed to include anesthesiology, pain management, interventional pain management, neurosurgery, orthopedic surgery, or physical medicine and rehabilitation clinicians in the low back pain ASM cohort (90 FR 32564). We agree that low back pain can often be a symptom of other underlying clinical diagnoses; however, as many patients receive low back pain care from specialists, in addition to care for underlying and contributing diagnoses, we believe increasing accountability for low back pain care management presents opportunities for improving patient outcomes regardless of the heterogeneity of patients receiving care for low back pain. We believe that the collective measurement framework for low back pain will comprehensively evaluate the quality and cost of care related to low back pain regardless of the physiological aspects or complexity of the causes of low back pain, while creating incentives for practice improvements, such as stronger integration with PCPs and improving interoperability of EHRs.

Comment: A commenter acknowledged that heart failure and low back pain are significant chronic conditions, but requested more specific reasoning, information and justification for why heart failure and low back pain were selected as the focus of the model when other conditions may similarly satisfy the goals of the model.

Response: We appreciate this commenter's request for additional information and justification as to why heart failure and low back pain were selected for the model. We believe that low back pain and heart failure serve as ideal cohorts for ASM because these chronic conditions, in particular, present clinical complexity, financial impact, measurable outcomes, and improvement opportunities while maintaining sufficient volume and predictability for successful model implementation and evaluation. Heart failure affects millions of Americans and is one of the leading causes of Medicare hospitalizations. It accounts for significant Medicare spending due to frequent readmissions and complex care needs. Low back pain is one of the most common reasons for physician visits and disability claims. It, too, is the cause of substantial healthcare spending. Both conditions have well-defined roles for the specialists that treat them, clear quality measures and treatment pathways that can be measured and improved. Both conditions present opportunities for improvement with strong coordination between specialty and primary care. We believe both heart failure and low back pain will provide lessons learned for other chronic conditions. The model could expand to other chronic conditions if success in quality improvement and cost reduction is found with the treatment of heart failure and low back pain under the parameters of ASM.

Comment: Several commenters offered feedback on alternative chronic conditions, such as chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD) for inclusion in ASM.

Response: We appreciate commenters for their feedback on other chronic conditions that may be suitable for inclusion in ASM. We did not consider COPD or CKD, and their related specialties, for inclusion in ASM at this time. Should we consider expanding ASM to include additional chronic conditions, we would do so through notice-and- comment rulemaking.

Comment: A commenter recommended that CMS should provide additional details on how “low value” services within ASM are defined to ensure complex patients are not excluded from appropriate interventions.

Response: We appreciate the commenter for their input. For the purposes of ASM, low-value care refers to services that: (1) may offer limited or no clinical benefit to a patient; or (2) may present risks of harm that outweigh the potential benefit.

We also received several comments about making ASM a voluntary model instead of mandatory. The following is a summary of these comments and our responses.

Comment: Several commenters recommended that CMS ensure ASM is voluntary, patient-centered, and adequately resourced to avoid unintended negative impacts on clinicians and patient access to care. A few commenters recommended exploring voluntary, evidence-based alternatives, tied to stronger evidence of potential patient benefits.

Response: We appreciate commenters for their suggestion to make ASM voluntary. As we discuss in this section and in section III.C.2.c.(1) of this final rule, we believe mandatory participation is necessary to test ASM due to concerns that selection bias in a voluntary model would undermine ASM's incentives. Furthermore, we are finalizing several provisions that we believe will help avoid unintended negative impacts on clinicians and patient access to care. Such provisions include, but are not limited to, not subjecting ASM participants to payment adjustments if they cannot meet case minimums for required quality and cost measures, providing scoring adjustments to ASM participants that serve a high volume of medically or socially complex patients, and providing advance notification of mandatory participation to allow participants time to prepare. Several features of this model are patient-centered, including incorporating patient voice into quality measurement through patient-reported outcome measures and beneficiary incentives that can support upstream chronic condition management for heart failure and low back pain. As with all Innovation Center models, we will also monitor for potential unintended consequences and adjust model designs as necessary.

Comment: Many commenters advised CMS to pause implementation, collaborate with specialty societies, and redesign the model to better support specialists in voluntary and patient-centered models. A few commenters recommended pilot programs or iterative testing instead of mandatory participation.

Response: We appreciate the commenters for their feedback. As part of ASM's design, we received feedback from many interested parties. We received input from public comments to the 2024 Request for Information (RFI) (89 FR 61596), which included input from interested parties, provider groups, specialty societies, health systems, academics, and others. We believe that ASM's design incorporates feedback received by interested parties that allows for a reliable model test. We refer readers to section III.C.2.c.(1) of this final rule for more discussion on the rationale for ASM's mandatory nature.

We received several comments about ASM's alignment with the Quality Payment Program's MVP framework. The following is a summary of these comments and our responses.

Comment: Several commenters broadly support the goals of ASM but recommended CMS to closely monitor the Quality Payment Program MVP framework and other value-based care models to incorporate lessons- learned to mitigate potential unintended consequences of the model.

Response: We appreciate the commenters' support for ASM's goals.

We discuss throughout this section and in section III.C.2.d of this final rule, ASM's performance measurement approach and our rationale for aligning with the MVP framework. We believe that the MVP framework advances value-based care by narrowing the available measure set based upon clinician specialty, medical condition, or patient population, which allows for meaningful comparisons to be made across clinicians. We have collaborated with the Quality Payment Program in the development of ASM and will continue to do so throughout the implementation of ASM to ensure appropriate alignment. As part of the ecosystem of condition-specific value-based care models, we also intend to learn from other models' implementation experiences to adjust ASM requirements if the need arises. As part of our monitoring and evaluation efforts, we will also monitor unintended consequences and adjust ASM's design if necessary.

Comment: Many commenters shared concerns and made recommendations about ASM's design about the reliance on the MVP framework and that ASM would not provide an on-ramp into Advanced APMs. A few commenters supported building off the MVP framework, which may offer a scalable approach to specialty model designs.

Response: We appreciate the commenters who voiced support for ASM building off the MVP framework. We also appreciate the commenters for their recommendations and for detailing their concerns about relying on the MVP framework, especially when it would not provide an on-ramp into Advanced APMs. While the concern about ASM not providing a direct on- ramp to Advanced APMs for individual clinicians is valid, it should not overshadow the substantial value that ASM provides in building the foundational capabilities necessary for successful value-based care participation. ASM participation should be considered as one component of a comprehensive value-based care strategy. Organizations should leverage clinician participation in ASM to build internal capabilities while simultaneously pursuing other pathways to Advanced APM participation. This multi-pronged approach maximizes the benefits of current opportunities while positioning ASM participants for future Advanced APM success.

We received comments concerning participant burden that may be introduced by ASM. The following is a summary of these comments and our responses.

Comment: Many commenters emphasize the need for refinement to avoid unintended negative impacts on providers and patients. While ASM's goals are broadly supported, many commenters voiced concerns with administrative complexity and burden on clinicians at a time of workforce shortages, limited evidence of effectiveness of the model on improvement of health outcomes, and the mandatory nature of the model tied to a “tournament model” and potential financial penalties.

Response: We appreciate comments highlighting the concern of providers' burden with participating in ASM. We acknowledge that healthcare providers face many administrative burdens, and that workforce shortages can make additional requirements particularly challenging. The timing of new model implementation during staffing constraints is a legitimate operational concern. For this reason, ASM will not be implemented until January 1, 2027, and data submission for the model will not be required until the first quarter of 2028. Additionally, we will make every effort to alleviate provider burden with robust technical support and implementation guidance.

Comment: A commenter expressed concerns about ASM, noting that it could unintentionally encourage further consolidation in the health care market. The commenter also shared their belief that the financial and administrative burdens associated with ASM may push independent practices to join larger hospital systems or networks.

Response: We appreciate the commenter for stating their concern that ASMs may encourage independent practices to consolidate. However, we disagree because many of the clinicians that will be selected for participation in ASM, including those in independent practices, have experience with other value-based purchasing programs, such as MIPS, or alternative payment models, such as participating in an ACO, and likely have processes in place that can be used to meet ASM data submission requirements. Furthermore, as described in section III.C.2.e.(4) of this final rule, we provide a positive scoring adjustment to recognize the unique challenges faced by smaller and oftentimes independent providers to provide guardrails.

We received several comments about the effects of ASM on participants in small practices, rural areas, or that serve medically and socially complex patient populations. The following is a summary of those comments and our responses.

Comment: Several commenters raised concerns that participation in ASM could potentially negatively impact solo and small practices, safety net providers, and other vulnerable providers because of mandatory participation and the high financial risk associated with ASM. Many commenters emphasized that participation in ASM must be matched with adequate financial and technical support from CMS to avoid undermining its goals.

Response: We appreciate the commenters for raising their concerns related to participation of small practices and safety net providers in ASM. We recognize that these types of clinicians and practices have specific challenges that may make it more difficult for more of them to perform well in ASM without additional support. For these reasons, ASM will include specific positive scoring adjustments for ASM participants who we determine have a high degree of medically or socially complex patients, as well as scoring adjustments for participants in small practices or who are solo practitioners. We note that eligibility for these scoring adjustments would be evaluated separately, so ASM participants can qualify for both the complex patient scoring adjustment and small practice scoring adjustment. We refer readers to sections III.C.2.e.(3) and III.C.2.e.(4) of this final rule for further discussion on these provisions. While we did not consider specific financial support to any ASM participant (for example, an upfront infrastructure payment), we note that we will provide advanced notification of mandatory participation for the first ASM performance year beginning in CY 2027 and intend to provide educational resources in CY 2026 to help ASM participants prepare for ASM's requirements.

Comment: Several commenters recommended that CMS refine ASM to better reflect the realities of rural healthcare delivery and recommended that CMS provide targeted support to rural practices, help rural providers develop infrastructure and care partnerships for care coordination, and limit the administrative and financial burdens associated with participation in ASM. Another commenter advised CMS to provide adequate risk adjustment for rural populations. A commenter noted that often rural areas lack the broadband and high-speed internet infrastructure necessary to support telehealth and other technology- dependent components of ASM. A few commenters voiced concerns that mandating participation in ASM may force small,

rural practices to close or consolidate into hospital-affiliated systems, which may reduce patient access to specialists or reduce competition and increase costs for beneficiaries.

Response: We appreciate the commenters for raising feedback about participation of rural clinicians in ASM. We recognize that these types of clinicians and practices have specific challenges that may make it more difficult for more of them to perform well in ASM without additional support. For these reasons, ASM will include several scoring adjustments for which we believe rural ASM participants would likely be eligible. While we did not propose a rural-specific scoring adjustment, as we discussed in the CY 2026 PFS proposed rule (90 FR 32604), we observed that a high proportion of likely ASM participants in small practices were in rural areas, and that an additional rural adjustment on top of small practice scoring adjustments would potentially be duplicative and inappropriately skew the distribution of final scores. We also believe that some rural ASM participants will also qualify for the complex patient scoring adjustment. We refer readers to sections III.C.2.e.(3) and III.C.2.e.(4) of this final rule for further discussion on the small practice and complex patient scoring adjustments and how we expect some rural ASM participants to qualify for this adjustment. As part of ASM's monitoring efforts, we will monitor potential challenges for rural ASM participants and adjust ASM's provisions if necessary.

While we acknowledge the challenges that clinicians in rural areas may have in high-speed internet infrastructure and their ability to provide telehealth, we note that ASM does not require use of telehealth; ASM offers a telehealth waiver as described in section III.C.2.h.(3) of this final rule. ASM will require all participants to meet Promoting Interoperability requirements as described in section III.C.2.d.(5) of this final rule. We note that MIPS does not provide a specific Promoting Interoperability exception for eligible clinicians in rural practices; however, they may qualify for other Promoting Interoperability reweighting should they qualify as small practices as described at Sec. 414.1380(c)(2)(ii)(G). For these reasons and because we account for the Promoting Interoperability ASM performance category score through a possible negative scoring adjustment of up to 10 points to the final score, we believe that the small and solo positive scoring adjustment of 10 or 15 points, respectively, would likely offset any reductions in scores that a rural ASM participant may receive because of ASM's Promoting Interoperability requirements. As we discuss in section III.C.2.e.(4) of this final rule, we will monitor the sufficiency of these scoring adjustments throughout ASM's model test period.

We appreciate the commenters for sharing their concern that ASM may encourage independent rural practices to consolidate or lead to practice closures. However, we disagree because many of the clinicians that will be selected for participation in ASM, including those in independent practices, have experience with other value-based purchasing programs, such as MIPS, or alternative payment models, such as participating in an ACO, and likely have processes in place that can be used to meet ASM data submission requirements. While we acknowledge that ASM will introduce new requirements, we believe that clinician- level measurement and incentives are important for increasing accountability for chronic condition management for conditions like heart failure and low back pain. Further, we specifically designed ASM with several features to support diverse practice participation, including advanced notification of mandatory participation, scoring adjustment mechanisms, and planned technical resources. We believe these design elements help address the commenters' concerns while maintaining the model's core objective of improving care quality and reducing costs for Medicare beneficiaries.

Comment: Many commenters provided feedback on the technology and infrastructure implementation required to meet ASM requirements. A few commenters voiced concerns and challenges associated with meeting interoperability and other program requirements at an individual clinician or small group practice level. A few commenters noted their belief that meeting interoperability requirements can threaten the financial viability of some practices, especially small practices. A commenter noted that if patient-reported outcome measures (PROs) are central to the future of the model, some clinicians will need to build an infrastructure to support the collection and analysis of data.

Response: We appreciate commenters' feedback regarding the challenges associated with meeting interoperability requirements of the model. We believe investment in interoperability is a strategic imperative that enables healthcare organizations and their clinicians to deliver better patient care, operate more efficiently, and succeed in value-based care arrangements. We believe investing in interoperability could vastly improve outcomes and operational efficiency, laying the foundation for sustainable healthcare delivery. We acknowledge the upfront costs of interoperability can be significant, particularly for smaller practices, and so, we have designed the payment methodology to account for this potential challenge. The Promoting Interoperability performance category accounts for only a fraction of the final score from which the ASM payment adjustment is calculated. As described in section III.C.2.e of this final rule, final scores in ASM will be calculated based on equal weighting of quality (50 percent) and cost (50 percent) performance categories with potential for negative scoring adjustments based on improvement activities (up to negative 20 points) and Promoting Interoperability (up to only negative 10 points) performance category scores. Furthermore, ASM participants in practices between 2 to 15 total clinicians will also receive an automatic 10-point positive adjustment on their final score; solo practitioners receive an automatic 15-point positive adjustment on their final score. If an ASM participant is unable to meet ASM's interoperability requirements and is in a small practice, the small practice scoring adjustment negates the penalty of not meeting interoperability requirements in the model.

We received several comments and suggestions on providing guidance and support to ASM participants before and during ASM's implementation. The following is a summary of those comments and our responses.

Comment: Several commenters recommended that CMS provide more guidance to interested parties about the model structure and requirements for ASM participants. A few commenters recommended that CMS provide resources to ASM participants to increase their preparedness, specifically by offering technical assistance, including a preview of model results for claims-based measures and providing baseline performance reports for ASM EBCMs prior to the start of the first ASM performance year.

Response: We appreciate commenters for their suggestions for providing more guidance on ASM's requirements to interested parties and participants. We intend to provide publicly available educational resources for ASM participants in CY 2026 to help participants prepare for meeting model requirements beginning in CY 2027. We will also respond to email or phone inquiries related to ASM:

[email protected], or 1-844-711-2664 (Option 4). We also appreciate the suggestions related to baseline data and ongoing performance data that could be shared with ASM participants. We refer readers to section III.C.2.j. of this final rule for further discussion on the types of data sharing and data feedback that we intend to provide ASM participants once ASM begins.

Finally, we received comments providing suggestions on how we should engage interested parties in the implementation of ASM. The following is a summary of those comments and our responses.

Comment: A few commenters recommended collaborating with patients who live with the chronic condition relevant to ASM. A few commenters recommended ongoing interested parties engagement with specialty societies and practicing clinicians.

Response: We appreciate commenters for the suggestions on possible interested parties engagement approaches as we implement ASM. We intend to engage with specialty societies and groups that represent patients living with heart failure and low back pain as part of ASM's ongoing implementation.

We refer readers to the remainder of ASM's section of this final rule for detailed discussion on comments we received on specific proposals, our responses to those comments, and our finalized provisions and policies for ASM. 2. Provisions of the Ambulatory Specialty Model a. Definitions

In the CY 2026 PFS proposed rule (90 FR 32561), we proposed at 42 CFR 512.705 to define certain terms for ASM. We described the proposed definitions in context throughout section III.C.2 of the CY 2026 PFS proposed rule. We proposed to codify the definitions and policies of ASM at 42 CFR part 512 subpart G. In addition, we proposed that the definitions contained in the standard provisions for mandatory Innovation Center models at subpart A of part 512 would also apply to ASM, unless expressly stated otherwise in the policies set forth at Sec. 512.705 through Sec. 512.780. We sought comments on the proposed definitions for ASM and respond in context throughout section III.C.2 of this final rule. b. Length of Model Test

In the CY 2026 PFS proposed rule (90 FR 32561 through 32562), we proposed to define the “ASM test period” as the 7-year period from January 1, 2027 to December 31, 2033 that includes all ASM performance years and ASM payment years as described in Table B-D1. We proposed at Sec. 512.705 to define “ASM performance year” as a 12-month period beginning on January 1 and ending on December 31 for each year of the first 5 calendar years of the ASM test period. We proposed at Sec. 512.705 to define an “ASM payment year” as a calendar year in which CMS applies the ASM payment multiplier to Medicare Part B payments based on the final score achieved by that ASM participant for the ASM performance year 2 years prior.

In the 2026 PFS proposed rule (90 FR 32561), we proposed that, similar to MIPS, an ASM payment year would occur 2 calendar years following the ASM performance year. We explained that the ASM participant's final score and ASM payment adjustment factor would be determined for an ASM performance year and applied 2 years later in the corresponding ASM payment year. For instance, the CY 2027 ASM performance year would correspond to the CY 2029 ASM payment year. This will allow time for ASM participants to submit required data for each of the ASM performance categories as described in section III.C.2.d of the CY 2026 PFS proposed rule and for CMS to score submitted data for the ASM performance categories, calculate final scores, and determine payment adjustments as discussed in sections III.C.2.d., III.C.2.e, and III.C.2.f of the CY 2026 PFS proposed rule. We stated that the final data submission of measures and activities would occur in CY 2032, with final model payment adjustments in CY 2033. We explained that this timeline aligns with MIPS in that those who report traditional MIPS or MVPs receive an adjustment to their Medicare Part B fee-for-service payments 2 years after the corresponding MIPS performance period based on a total score calculated from reported measures and activities across the MIPS performance categories (see Sec. Sec. 414.1305, 414.1320, 414.1365, and 414.1405(e)). We stated our belief that 5 ASM performance years followed by 5 ASM payment years would allow sufficient time for ASM participants to invest in care delivery transformation and for CMS to evaluate the impact of the model's payment adjustments. [GRAPHIC] [TIFF OMITTED] TR05NO25.106

We believe that an ASM test period of 7 years, as opposed to a shorter duration, is necessary to obtain sufficient data to compute a reliable impact estimate and determine the next steps regarding potential expansion or

extension of the model. Further, we believe that a test period of 7 years is necessary to address and mitigate any potential implementation issues or unintended consequences. For a discussion of ASM's evaluation approach, please see section III.C.2.l of this final rule.

In the CY 2026 PFS proposed rule (90 FR 32562), we proposed an ASM start date of January 1, 2027. We also considered proposing an earlier January 1, 2026 ASM start date, but, given the rulemaking process, we believe an earlier start date would not give ASM participants enough time to prepare for participation.

We invited public comments on the proposal at Sec. 512.705 to define the “ASM test period” as the 7-year period from January 1, 2027 to December 31, 2033, “ASM performance year” as a 12-month period beginning on January 1 and ending on December 31 of each year during the first 5 calendar years of the ASM test period, and “ASM payment year” as a calendar year in which CMS applies the ASM payment multiplier to Medicare Part B payments based on the final score achieved by that ASM participant for the ASM performance year 2 years prior. The following is a summary of the comments we received and our responses.

Comment: A commenter supported the proposed test period of the model, noting that the length of time is an adequate period for participation and CMS data collection.

Response: We appreciate the commenter for their support.

Comment: A few commenters did not support the proposed 2-year gap between the ASM performance year and ASM payment year. The commenters recommended that the ASM payment be as close to real-time as possible, noting that reducing the gap would enhance the relevance of ASM to specialists, create a more effective incentive structure, and provide clinicians with the ability to reinvest in practice transformation, especially for small practices.

Response: While we understand the value in real-time data, ASM participants must be allowed ample time to submit the required data for each of the ASM performance categories. We are adopting a single data submission period to minimize burden for ASM participants and data submission will occur during the calendar year following the ASM performance year. Following data submission, we will need time to generate final scores and determine payment adjustments. Similar to MIPS, we believe EBCMs are the most appropriate and objective criteria by which to assess cost performance. Because EBCMs are constructed at the completion of each calendar year, the data will only become available in the year following the ASM performance year, at which time we will determine scores and payment adjustments. As the adjustments are applied on an annual basis, the soonest we could apply those ASM payment adjustments will be in the following calendar year. This policy is similar to MIPS in that Medicare Part B fee-for-service payment adjustments occur 2 years after the corresponding MIPS performance period. For these reasons, we are finalizing the “ASM performance year” and “ASM payment year” definitions as proposed. As we discuss in section III.C.2.j of this final rule, we intend to share data and provide data feedback with ASM participants during an ASM performance year to help participants better understand their potential performance.

Comment: A commenter supported the proposed start date of ASM on January 1, 2027, stating it allowed a satisfactory lead time for ASM participants. Another commenter supported January 1, 2027 as a reporting-only year with no incentives or penalties to allow clinicians time to build a baseline understanding of the model. Another commenter suggested CMS to release specific model requirements as soon as possible to help clinicians prepare for ASM implementation.

Several commenters indicated that additional time is needed for CMS to analyze MVP performance data to further inform model development, identify potential methodological flaws, and engage with interested parties. Many commenters recommended a delayed start date to ensure readiness and minimize technical and administrative disruptions to clinicians who will be required to build infrastructure to train staff, support clinical workflows, and submit data using eCQMs. Several commenters indicated that additional time is needed for third-party vendors to prepare for reporting requirements, such as developing and testing eCQM collection types for each required measure to allow full electronic submissions. A commenter called attention to the requirements for the improvement activities performance category and the care coordination that will be required. The commenter noted that if a final list of participants is not released until the middle of 2026, a start date of January 1, 2027 could create a burden for clinicians required to participate.

The commenters stated that the complexity of these tasks, especially for organizations with multiple reporting entities and systems, makes a 2027 deadline unrealistic for successful implementation. A few commenters stated that ASM should first be instituted as a pilot test. Another commenter stated implementation should be delayed allowing for comprehensive testing with appropriate safeguards and engagement with interested parties, particularly with rural providers and heart failure specialists. Another commenter stated that, because ASM directly targets clinicians who are deeply integrated into the established MIPS and MVP frameworks, ASM will be like a mandatory replacement for their current reporting structure, as such the more accelerated timelines adopted for other recent Innovation Center models, such as the Increasing Organ Transplant Access (IOTA) and Guiding an Improved Dementia Experience (GUIDE) models are less appropriate for ASM.

A commenter stated health IT vendors need adequate lead time to program, test, and deploy the necessary software solutions for data capture and submission. The commenter stated that because participant eligibility and lookup tools will require significant time to develop and stabilize, CMS should take additional time to conduct a robust, multi-year educational campaign to ensure clinicians and their support staff fully understand eligibility, data collection requirements, and the scoring methodology. The commenter suggested a 2028 or 2029 start date would allow time to finalize all rules and the technical infrastructure for data submission for ASM.

Response: We acknowledge the commenters' concerns regarding the time needed to prepare for ASM implementation. We introduced the model in the CY 2026 PFS rulemaking cycle, rather than the CY 2027 rulemaking cycle, to give clinicians an additional year to prepare for implementation. In addition, for the first year of the model, we will notify preliminarily eligible clinicians of their expected selection for the model to provide additional time to prepare and anticipate operational updates. We note that many of the clinicians that will be eligible for ASM are already familiar with MIPS reporting or have experience with other alternative payment models and have processes in place that can be used to meet ASM data submission requirements.

With respect to a pilot test of ASM, we note that ASM is itself a model test and disagree that it needs to be piloted

before implementation. We developed the model after learning from previous Innovation Center models and MIPS, public comments to the 2024 Request for Information (RFI) (89 FR 61596),\166\ and extensive input from provider groups, health systems, academics, and other interested parties. We agree with the commenter that ASM is purposely directed at clinicians who are already familiar with the MIPS framework. ASM is in part a direct response to input from interested parties regarding the need for more targeted cohorts and peer-to-peer comparisons. We believe ASM will provide valuable, pertinent, and actionable feedback to clinicians who have previously doubted the relevance of their performance scores.

\166\ Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Medicare Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments.

With respect to the time needed to update technical requirements to meet the reporting requirements of the model, we note that we plan to use the Quality Payment Program portal to reduce disruptions to current reporting processes.

Comment: A commenter stated that the proposed launch of ASM represents a departure from the established and historically successful precedent of a phased-in approach to transition clinicians to new models. A few commenters suggested a staged approach to ASM implementation would mitigate risk and ensure readiness. A commenter suggested allowing MVPs to become the primary quality reporting program for most specialists following the planned sunset of traditional MIPS. They suggested that launching ASM as a voluntary alternative to MVPs for eligible clinicians in its first 2 years to allow clinicians, vendors, and CMS to test the model in a real-world environment, gather crucial data, and resolve operational issues without penalizing unprepared participants.

Response: We acknowledge that we have previously staged implementation of model requirements when such an on-ramp was warranted. However, as value-based payment models have become more common, more providers have established processes in place that can be leveraged to meet ASM requirements. Therefore, ASM may not require entirely novel operational processes for all ASM participants, and we believe the advanced notice described in the CY 2026 PFS proposed rule is sufficient. We do not believe an alternative timeline for transitioning from MIPS to ASM is necessary as we did not propose a full-scale transition from MIPS or MVPs. As stated in the CY 2026 PFS proposed rule (90 FR 32593), we believe ASM can potentially inform updates to the Quality Payment Program and the MVP reporting option. While many participants who are assigned the specific specialty codes we have selected for ASM may shift between MIPS and ASM, depending on whether they meet the ASM eligibility criteria for a given year, ASM is only testing a small subset of provider types for the ASM heart failure and low back pain cohorts. That is, the majority of MIPS providers will not be eligible for ASM and will continue to report through MIPS throughout the ASM test period. As an Innovation Center model test, ASM will require evaluation and would need to meet the requirements for Innovation Center model certification to be expanded.

After consideration of public comments, we are finalizing our proposed definitions for “ASM test period” and “ASM payment year” as proposed at Sec. 512.705. We are also finalizing January 1, 2027 as the ASM start date as proposed. We did not receive any comments related to our proposed “ASM performance year” definition and are, therefore, finalizing as proposed at Sec. 512.705. c. ASM Participants (1) Mandatory Participation

In the CY 2026 PFS proposed rule (90 FR 32562 through 32563), we discussed our belief that requiring clinicians to participate in the model test is necessary to eliminate selection bias, yield generalizable results, and ensure an evaluable comparison group. Voluntary participation in Innovation Center models has demonstrated that those electing to voluntarily participate are more likely to have the infrastructure and experience to succeed under the model. Moreover, in a voluntary model, when the opportunity for financial gain is reduced or uncertain, participant attrition increases. We believe requiring participation in ASM would prevent this type of selection bias.

We stated that mandatory participation in ASM would also ensure a sufficient volume of participants to produce a diverse, representative evaluation of clinicians providing specialty care to Medicare beneficiaries with heart failure and low back pain. We believe ASM could highlight inefficient care utilization patterns and potentially inform quality improvement and care coordination incentives for application in the Quality Payment Program and future Innovation Center models. Finally, we stated mandatory participation is necessary to generate a statistically robust test of ASM with results that are reliable, generalizable, and able to support potential model expansion.

Therefore, we proposed at Sec. 512.710(a)(1) that participation in ASM would be mandatory for all clinicians who meet the ASM participant eligibility criteria at Sec. 512.710(b) and for any year that an ASM participant meets the ASM eligibility criteria, they would subject to the ASM requirements. Specifically, the ASM participant would be required to submit data in accordance with Sec. 512.720, would be assessed in accordance with Sec. 512.715, would be scored in accordance with Sec. 512.745, and would receive an ASM payment adjustment in accordance with Sec. 512.750. In addition, for any such year, the ASM participant would be eligible for any waivers described in section III.C.2.h. of this final rule. We also proposed that once a clinician meets the ASM participant eligibility criteria, they would be considered an ASM participant for the duration of the model. We also proposed that clinicians would be exempt from MIPS reporting for any ASM performance year that they meet ASM participant eligibility criteria.

We proposed at Sec. 512.710(a)(2) that for any subsequent ASM performance year that a previously selected ASM participant does not continue to meet the ASM participant eligibility criteria, the ASM participant would not be subject to the ASM requirements. Specifically, the ASM participant would not be required to submit data in accordance with Sec. 512.720, would not be assessed in accordance with Sec. 512.715, would not be scored in accordance with Sec. 512.745, and would not receive an ASM payment adjustment in accordance with Sec. 512.750. In addition, for any such year, the ASM participant would not be eligible for any waivers described in section III.C.2.h. of this final rule. Because the Medicare waiver at Sec. 512.775 only waives the requirements of section 1848(q) of the Act, and its implementing regulations for an ASM performance year that an ASM participant meets the ASM participant eligibility criteria, the ASM participant would be subject to any MIPS reporting obligations, if applicable, and would receive a MIPS payment adjustment 2 years later, in accordance with current regulations for any performance year

that they do not meet the ASM participant eligibility criteria. Because ASM participants may be subject to MIPS for any ASM performance year that they do not meet the ASM participant eligibility criteria, ASM payment adjustments may be applied during an ASM payment year during which an ASM participant is not actively participating in ASM and is instead participating in MIPS.

Specifically, we proposed for the--

2027 ASM performance year: ASM participants would be measured for performance and exempted from MIPS participation, if applicable, during CY 2027; report and be scored during CY 2028; and receive payment adjustments for CY 2027 performance in CY 2029;

2028 performance year: ASM participants meeting ASM participant eligibility criteria for the 2028 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2028; report and be scored during CY 2029; and receive payment adjustments for CY 2028 performance in CY 2030;

2029 ASM performance year: ASM participants meeting ASM participant eligibility criteria for the 2029 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2029; report and be scored during CY 2030; and receive payment adjustments for CY 2029 performance in CY 2031;

2030 ASM performance year: ASM participants meeting ASM participant eligibility criteria for the 2030 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2030; report and be scored during CY 2031; and receive payment adjustments for CY 2030 performance in CY 2032; and

2031 ASM performance year: ASM participants meeting ASM participant eligibility criteria for the 2031 performance year would be measured for performance and exempted from MIPS participation, if applicable, during CY 2031; report and be scored during CY 2032; and receive payment adjustments for CY 2031 performance in CY 2033.

We solicited public comments on our proposals at Sec. 512.710(a) to require mandatory participation in ASM, to consider ASM participants as ASM participants for the duration of the model, and to exempt ASM participants from reporting under MIPS for only those years that they meet ASM participant eligibility criteria. The following is a summary of the comments we received and our response.

Comment: Several commenters supported ASM as a mandatory model, noting that it would increase transparency, participation, and competition; minimize selection bias in terms of who participates and which measures are reported; and improve outcomes, reduce costs and low value care, and transform care delivery. A few commenters shared their belief that mandatory participation is necessary for ASM to gain the critical mass of participating clinicians required for robust data collection and improve the generalizability of model findings. A commenter noted that the low voluntary adoption rates of programs and reporting options, such as MVPs, suggest that mandatory participation is necessary for full adoption.

Response: We appreciate commenters for their support of ASM as a mandatory model.

Comment: Many commenters did not support mandatory participation for ASM, noting their belief that the model could impose significant financial risks and administrative burdens which are inappropriate since this is a new, untested performance framework that still has measures in development. A commenter recommended excluding clinicians who specialize in heart failure from mandatory ASM participation in the model. Another commenter recommended that CMS develop an optional track for physicians who treat potential conditions of focus. Many commenters shared concerns that mandatory ASM participation may destabilize practices, increase practice consolidation, and reduce patient access to community-based specialty care. They believe this is a particular risk for the rural, solo, and small practices, without the bandwidth for successful participation. They stated that vulnerable rural communities would not be able to overcome the administrative burden of ASM, potentially triggering hospital closures or result in physicians, such as cardiologists, dropping participation in Medicare altogether. Another commenter generally supported integrating rural clinicians into value-based care models but recommended that CMS allow an opt-out option for rural clinicians, if needed, because of additional burden related to a lack of bandwidth or readiness to participate. Another commenter shared a concern that mandatory participation may not uphold the statutory intent of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). A few commenters raised concerns about overlapping reporting and payment programs. Another commenter stated that a mandatory model with two-sided financial risk would require expensive technology investments. Many commenters recommended ASM participation incentives paired with voluntary participation to build trust between CMS and clinicians, ease administrative burdens, and allow time for adaptation. Another commenter recommended allowing ASM participants to opt-out of the model if their patient population within a cohort declined significantly since the attribution year.

Response: We acknowledge these comments but believe that the language in Section 1115A(d)(2) of the Act gives the Innovation Center the authority to implement and test ASM. Specifically, we believe that the preclusion of administrative or judicial review of the specific policies was intended to ensure our ability to implement mandatory models. We proposed ASM as a mandatory model because allowing voluntary participation would likely result in only high performers joining the model, rather than incentivizing all clinicians to improve care. As previously stated in this section of the final rule, we believe that requiring clinicians to participate in the model test is necessary to eliminate selection bias, yield generalizable results, and ensure an evaluable comparison group. Allowing clinicians to opt-out of ASM would undermine the model test given concerns about selection bias. We note that if an ASM participant has a significant decline in patient population and does not meet the required case minimums for quality or cost measures during ASM performance year, described in sections III.C.2.d.(2).(h) and III.C.2.d.(3).(f) of this final rule, they would not generate a performance score or receive a subsequent payment adjustment. We believe this is a fair approach to preventing undue penalties due to unexpectedly lower case volumes. We refer readers to further discussion on this provision in section III.C.2.e.(2).(b) of this final rule.

Including participants in rural areas is necessary to evaluate the impacts of the model were it to be expanded to rural areas. We note that CBSAs with a low volume of eligible episodes (that is, CBSAs with no eligible clinicians with at least 20 episodes in the reference year), which includes some rural areas, would be excluded from the model. Additionally, rural areas not assigned to a CBSA would be excluded. For a full discussion on the selection of mandatory geographic areas, please see section III.C.2.c.(4) of this final rule.

We previously noted that many of the clinicians that will be eligible for ASM, including those in rural areas, are experienced with other value-based payment models and have processes in place that can be used to meet ASM data submission requirements. In addition, ASM reporting can be done through the established MIPS portal to minimize disruptions to current reporting processes and reduce additional costs to providers. We do not anticipate that ASM participants will need to make significant technological investments to meet the reporting requirements of the model. We refer readers to sections III.C.2.d.(2)(b) and III.C.2.d.(2)(c) of this rule for a discussion of the finalized quality measure sets for the ASM heart failure and ASM low back pain cohorts. We also refer readers to section III.C.2.c.(4) of this rule where we discuss the model geography, including rural mandatory geographic areas.

Comment: A few commenters did not support the proposal requiring clinicians, once selected for ASM, to remain ASM participants for the entire duration of the model. A few commenters requested clarification on the proposed requirement that clinicians who meet ASM participant eligibility criteria for an ASM performance year would be considered an ASM participant for the remainder of the model. The commenters believed there was a discrepancy between the policy that clinicians who are ASM participants will remain participants for the duration of the model at Sec. 512.710(a)(1) and the proposed policy to reassess ASM participant eligibility each performance year and exclude clinicians who no longer meet the eligibility criteria for the upcoming ASM performance or payment year, making them eligible for MIPS. Another commenter requested clarity on MIPS exemptions if an ASM participant does not meet ASM eligibility criteria during a performance period.

Response: We are happy to provide further clarification regarding ASM participation. An ASM participant is any clinician who meets the ASM participant eligibility criteria for any ASM performance year. Once a clinician meets the ASM participant eligibility criteria for a given year, the clinician will remain an ASM participant for the remaining years of the model. We defined ASM participants this way because ASM participants will be considered ASM participants when submitting ASM data and receiving ASM payment adjustments during non-performance years.

The first ASM performance year that a clinician is selected as an ASM participant, the clinician would be required to meet ASM requirements and would be exempt from MIPS reporting requirements, if applicable. However, all ASM participants will be reassessed on an annual basis to determine whether they still meet the ASM participant eligibility criteria for each subsequent ASM performance year. Any subsequent year that an ASM participant meets the ASM participant eligibility criteria, the ASM participant must meet ASM model requirements, and is exempt from MIPS reporting requirements, if applicable. If an ASM participant does not meet the ASM participant eligibility criteria for a subsequent ASM performance year, they will remain an ASM participant but will not be required to meet ASM requirements for the applicable ASM performance year. For example, if a cardiologist meets the ASM participant eligibility criteria for the CY 2027 ASM performance year, that cardiologist is an ASM participant for the duration of the model. The cardiologist would be required to meet the ASM reporting requirements during CY 2027 and would be exempted from MIPS participation, if applicable, during CY 2027. However, when reassessed the following year, if the cardiologist does not meet the ASM participant eligibility criteria for the CY 2028 ASM performance year, while still considered an ASM participant, the cardiologist will not be required to meet ASM requirements in CY 2028 and will be required to report under MIPS in CY 2028, if applicable. The cardiologist would then be reassessed for the CY 2029 ASM performance year, and if they meet the ASM participant eligibility criteria for the CY 2029 ASM performance year, the cardiologist will be required to meet the ASM reporting requirements during CY 2029 and will be exempted from MIPS participation, if applicable, during CY 2029. (For information on the ASM participant notification process, please see section III.C.2.c.(5) of this final rule.)

Comment: A commenter suggested a defined process for clinicians to correct their ASM participation status. Another commenter noted that allowing a clinician to correct their participation status would help address potential discrepancies arising from administrative data or misalignment between PECOS specialty information and actual clinical practice.

Response: We appreciate the commenters' concerns. We note that ASM will not assign specialties to clinicians directly. Rather, we will rely on the specialty code assigned to a clinician's Medicare Part B claims, which is based on PECOS information provided by clinicians themselves, or, in the case that a clinician has listed more than one primary specialty in PECOS, the specialty assigned most frequently to their Part B claims. As we will be unable to correct ASM participation status, to avoid potential errors, clinicians should confirm and provide necessary updates to their PECOS information if they believe that their current specialty designation does not reflect their actual clinical practice.

Comment: A few commenters supported the proposed exemption of ASM participants from MIPS during the performance periods when they are eligible for ASM, thereby avoiding duplicative work and alleviating provider burden. Another commenter noted that although an ASM participant is exempt from MIPS requirements, ASM measures, scoring policies, and payment adjustments largely mirror those of MIPS.

Response: We appreciate the commenters who support our proposal to exempt ASM participants from MIPS reporting for years that they meet the ASM participant eligibility requirements. We agree with the commenter that ASM mirrors MIPS in many ways. However, ASM will employ a more targeted approach by using the same performance measures to evaluate clinicians furnishing the same services. ASM leverages the existing MVP policies, while deviating from MVP policies in specific ways. To ensure a more analogous comparison between specialists, unlike the voluntary measure and activity selection permitted under the MVP reporting option, ASM will require clinicians to report on a specific set of measures and activities clinically relevant to their specialty type and either heart failure or low back pain. Also, while clinicians reporting under MVPs are scored against the entire pool of MIPS clinicians, ASM will assess performance against only those clinicians treating the same chronic condition.

Comment: A commenter did not support the proposed exemption of ASM participants from participating in MIPS and recommended that CMS allow clinicians the option of reporting in MIPS rather than ASM if only a small portion of their patients are receiving chronic care for heart failure or low back pain. The commenter recommended that clinicians retain the ability to report on different quality measures within MIPS if the clinician believes those measures better reflect the types of services delivered for the majority of the patients they treat.

Response: We believe that the specialties selected for the ASM cohorts are targeted so that they would be unlikely to comprise providers caring for only a small portion of patients with low back pain or heart failure. The EBCM episode volume ASM participant eligibility criterion described in section III.C.2.c.(3)(b) must be met to ensure ASM participants provide a sufficient amount of care for heart failure or low back pain. Additionally, our intention in creating this model is to create like-to-like comparisons between similar providers and avoid the selection of disparate quality measures. This requires participants to report on the same measures related to the same condition. Continuing to allow providers to report on different quality measures would not be different than the current MIPS reporting option and obviates the goals of ASM.

Comment: A few commenters requested clarification on the interplay between MIPS and ASM. A commenter questioned whether group practices can still be submitted at the TIN level for MIPS if the group also has an identified ASM participant and supports ASM group submissions. Another commenter stated that exempting ASM participants from MIPS creates significant ambiguity regarding impacts for clinicians who are part of larger group reporting structures, such as those submitting under an MVP or as part of the Shared Savings Program reporting the APP measure set. The commenter stated that there are implications for group reporting requirements in other programs with respect to data completeness, and whether removing clinicians from the reporting pool would make it mathematically impossible for that group to meet its own program requirements. The commenter pointed to additional burden if an ASM-eligible clinician is expected to “dually report” for both ASM and an MVP/APP to satisfy Shared Savings Program ACO/APP data completeness obligations. Another commenter requested that CMS establish a clear program hierarchy for ASM participation and other reporting obligations. They also requested whether CMS would adjust the denominator for a group's data completeness calculation in its MVP or APP if ASM participation supersedes all other reporting obligations. Another commenter recommended that ASM participants not include clinicians who were part of a group practice for the QPP submission in CY 2024 or 2025.

Response: We appreciate the comments and will take them into consideration when determining how to address ASM participant overlap with subgroup-level or group-level reporting under MIPS. We will also ensure appropriate guidance is provided prior to model implementation.

After consideration of public comments, we are finalizing without modification our proposal at Sec. 512.710(a) that clinicians who meet the ASM participant eligibility criteria for any year of the model will remain ASM participants for the duration of the model. We are also finalizing our proposal to exempt ASM participants from reporting under MIPS for only those years that they meet ASM participant eligibility criteria as proposed. (2) ASM Participants

In the CY 2026 PFS proposed rule (90 FR 32563 through 32564), we proposed that only certain clinicians who treat heart failure and low back pain would be required to participate in ASM. We proposed at Sec. 512.705 to define the term “ASM participant” to mean an individual clinician who, for at least one ASM performance year, satisfies the ASM participant eligibility criteria described in section III.C.2.c.(3). of the CY 2026 PFS proposed rule and has been selected for participation in the model as described in section III.C.2.c.(5). of the CY 2026 PFS proposed rule. For ASM specifically, we proposed to define “clinician” as any “eligible professional” defined in section 1848(k)(3) of the Act, as identified by a unique TIN and NPI combination. We proposed to define “ASM heart failure participant” as an ASM participant who meets the ASM participant eligibility criteria related to heart failure and “ASM low back pain participant” as an ASM participant who meets the ASM participant eligibility criteria related to low back pain (discussed later in this section of this final rule). We note that the definition of “model participant” contained in Sec. 512.110 should be interpreted to include each ASM participant. We proposed to define an “ASM targeted chronic condition” as a medical condition that is a core focus of ASM; that is, heart failure or low back pain. We proposed to define an “ASM cohort” as a group of ASM participants who treat the same ASM targeted chronic condition; specifically, we proposed an ASM heart failure cohort and an ASM back pain cohort for this model. We proposed to define the “ASM heart failure cohort” to be composed of all ASM heart failure participants and the “ASM low back pain cohort” to be composed of all ASM low back pain participants. We noted that the proposed ASM cohorts would not include nonphysician practitioners (NPP) because Medicare does not currently assign specialty codes to NPPs. Therefore, NPPs would not meet the ASM participant eligibility criteria proposed at Sec. 512.710(b)(2), which states that only clinicians identified by one of the specialty types at Sec. 512.710(d) may be ASM participants.

We stated in the CY 2026 PFS proposed rule (90 FR 32563) that we also considered defining an ASM participant as a group of clinicians within a single practice, provided each clinician individually meets the ASM participant eligibility criteria. However, including groups of specialists would result in fewer ASM participants overall and add complexity to comparing performance across the ASM performance categories and determining final scores. We also believe a group-based approach to ASM participation may not reflect the variable arrangements of care teams, as clinicians may also work outside the group, across multiple service locations and teams. Under the alternative group-level scenario, we would need to provide the ASM participant with a list of clinicians who individually meet the ASM participant eligibility criteria for an applicable ASM performance year. In this case, each eligible clinician on an ASM participant's clinician list would be considered a downstream participant in ASM, and the ASM participant would be required to contractually bind all downstream participants to comply with all laws pertaining to any patient-identifiable data requested from CMS and the terms of any agreement with CMS, as a condition of receiving and maintaining data from the ASM participant.

We also considered whether the ASM participant under the alternative participant identification approach would be permitted to add or remove clinicians during an ASM performance year. We believe the addition of model policies and processes to account for individual clinician changes would increase operational complexity and the administrative burden of ASM participants if defined under this alternative group-based definition.

We solicited comments on our proposed definitions at Sec. 512.705. We also sought comments on adopting an alternative group participation policy and, if so, whether groups should be allowed to add or remove clinicians during a performance year.

The following is a summary of the comments we received on the proposed definitions for “clinician,” “ASM targeted chronic condition,” “ASM cohort,” and “ASM low back pain

participant” and our responses. We did not receive comments on the “ASM heart failure participant” definition. Because there was significant overlap between comments received regarding the “ASM heart failure cohort” definition and the proposals related to the ASM heart failure cohort, we have consolidated those comments and responses and included them in the ASM Heart Failure Cohort section at III.C.2.c.(2).(a) of this final rule. Similarly, because there was significant overlap between comments received regarding the “ASM low back pain cohort” definition and the proposals related to the ASM low back pain cohort, we have consolidated those comments and responses and included them in the ASM Low Back Pain Cohort section at III.C.2.c.(2).(b) of this final rule.

Comment: A few commenters supported the proposed definition of “ASM participant” to include only physicians in the model and exclude nonphysician practitioners from ASM. Another commenter supported excluding physical therapists and recommended that CMS explore future iterations of value-based models that allow direct participation by physical therapists in ways that are financially and structurally feasible.

Response: We appreciate the commenters for their support.

Comment: Many commenters did not support the proposed “ASM participant” definition to include only select specialty physicians. They shared their belief that non-physician practitioners and post- acute care providers should be included in the definition, as they have a role to potentially improve outcomes and reduce costs. Many commenters recommended the “ASM participant” definition be expanded to nurse practitioners, physician assistants, physical therapists, occupational therapists, psychologists, social workers, pharmacists and other health care professionals who should have the ability to participate and receive financial adjustments from inclusions in the program. Another commenter recommended including advanced practice registered nurses because they provide care in underserved rural areas. A few commenters recommended creating a voluntary pathway for participation for NPPs through the secondary or tertiary specialty designations in PECOS. Another commenter recommended including primary care and chiropractic physicians in the “ASM participant” definition. A few commenters also referenced Medicare's existing regulatory authority and specialty codes for advanced practice providers, stating that CMS has the capacity to include these professionals under the model. Another commenter recommended CMS recognize the important role that athletic trainers play in the delivery of specialty care, particularly in musculoskeletal and orthopedic care settings.

Response: We note that the proposed definition for “ASM participant” is an individual clinician who, for at least one ASM performance year, satisfies the ASM participant eligibility criteria and has been selected for participation in the model. We did not receive comments specific to the definition. Comments related to the selected specialties and other ASM participant eligibility criteria are discussed individually in section III.C.2.c.(3) of this final rule. We acknowledge the important role of NPPs, post-acute care providers, and other clinicians and agree that the subset of physicians selected for ASM are not the only provider types who deliver low back pain and heart failure care to Medicare beneficiaries. However, ASM aims to build cohorts of like providers who deliver similar services with a comparable ability to drive care improvements. To ensure appropriate comparison among peers, we are limiting ASM to specific physicians.

Providers who do not bill Medicare Part B claims or are not assigned a Medicare specialty code related to a particular chronic condition are not evaluable and are, therefore, not appropriate candidates for this particular model. Operationally, as described in section III.C.2.c.(3).(a).(iii) of this final rule, we have elected to identify ASM participants based on the medical specialty code assigned to Medicare Part B claims. While physicians may be assigned a specialty code specific to their medical specialty, NPPs (such as occupational therapists, physician assistants, nurse practitioners, and physical therapists) are assigned a Medicare Part B claim specialty code that denotes provider type. For instance, the Medicare Part B claim specialty code assigned to an occupational therapist is the same, regardless of whether they treat patients with low back pain or traumatic brain injury. In addition, we are not relying on PECOS directly for reasons described in section III.C.2.c.(3).(a).(iii) of this final rule, so would not be able to use secondary or tertiary PECOS specialty designations for NPPs. Therefore, we are only able to identify physicians for ASM.

We do not believe it is appropriate to include chiropractors in the model, as we would be unable to score chiropractors on all of the ASM performance metrics and chiropractic training and treatment modalities are not as comprehensive as for other physicians. For example, chiropractors cannot prescribe all medications or order additional testing, such as imaging. We are also unable to include providers, such as athletic trainers, who are not currently recognized as Medicare Part B providers and do not submit Medicare Part B claims. Through ASM, we aim to incentivize specialists directly to work with PCPs to improve outcomes; therefore, including PCPs as participants is outside the goal of the model.

Comment: A commenter recommended refining the “ASM low back pain participant” definition to a specific diagnosis such as stenosis or lumbar disc herniation and adding specialists to the participant definition based on the diagnosis. A few commenters did not support the proposed definition for “ASM low back pain participant” because attribution of a patient's care in a group practice can often start with non-physician practitioners, primary care physicians, or other specialty physicians not identified in the definition. A few commenters agreed with the specialists identified in the proposed “ASM low back pain participant” definition and recommend CMS consider adding additional specialists who oversee non-procedural interventions. Another commenter recommended adding primary care and post-acute care providers to the definition.

Response: We note that the proposed definition for “ASM low back pain participant” is an ASM participant who meets the ASM participant eligibility criteria related to low back pain. Comments related to the selected specialties and other ASM participant eligibility criteria are discussed individually in section III.C.2.c.(3) of this final rule.

Comment: A few commenters supported the proposed alternative to add a group participation option to ASM because of their belief that ASM participants work in multidisciplinary teams to deliver guideline- directed care and manage patients. They stated that allowing group participation would align incentives across the care team, reduce administrative complexity, broaden patient inclusion and increase data submissions. A commenter believed that team-based care is the only sustainable model for managing chronic conditions and that moving to individual-level assessment adds no value. Another commenter noted that

TIN level participation supports smaller practices, increasing the likelihood they can make investments in new staff or programs to drive improvements. Another commenter noted that specialty societies recommend multidisciplinary teams providing care for heart failure patients. A few commenters supported allowing groups the option to add or remove participants from ASM during a performance year because they believed it would ensure accurate reporting and fairness since clinicians often change practices. Another commenter believed not allowing for updates during the performance year would create inequities. Another commenter expressed a belief that clinicians practicing in groups should not be part of any ASM cohorts.

Response: We appreciate comments on the alternative approach of allowing group ASM participants and whether, under this alternative policy, groups should be allowed to add or remove ASM participants during an ASM performance year. We disagree that individual-level assessment adds no value and remind commenters that ASM is partly in response to interested parties requesting more targeted and individual performance feedback. We also believe that individual-level performance assessment can create a strong incentive for performance improvement. We will take these comments into consideration should we propose to include group participants in future years of the model. Any change would be undertaken under a notice and comment rulemaking.

After consideration of public comments, we are finalizing the definitions for “ASM participant” and “ASM low back pain participant” as proposed at Sec. 512.705. We did not receive public comments on the definitions for “clinician,” “ASM targeted chronic condition,” “ASM cohort,” or “ASM heart failure participant” and are, therefore, finalizing the definitions as proposed at Sec. 512.705. For comments and responses related to the “ASM heart failure cohort” and “ASM low back pain cohort” definitions, please see the ASM Heart Failure Cohort section III.C.2.c.(2).(a) and ASM Low Back Pain Cohort section III.C.2.c.(2).(b) of this final rule, respectively. (a) ASM Heart Failure Cohort

We proposed at Sec. 512.710(d)(1) to only select clinicians who have been assigned a specialty code of cardiology on the plurality of their Medicare Part B claims for the ASM heart failure cohort, provided they meet all applicable ASM participant eligibility criteria under Sec. 512.710(b) for an ASM performance year. We stated that, although other clinicians may treat heart failure, only cardiologists would be selected to participate in the model. Cardiologists commonly provide care to Medicare beneficiaries with heart failure and are well- positioned to improve outcomes by ensuring patients are optimized on guideline-directed medical therapy. We stated our belief that ASM would incentivize cardiologists to work with a primary care team to engage beneficiaries in addressing the root cause of their illness through lifestyle changes and preventing acute episodes.

In addition to the cardiology specialty code, we also considered including clinicians identified by additional cardiac specialty codes, as Medicare uses distinct specialty codes for subspecialists in cardiac electrophysiology, intensive cardiac rehabilitation, cardiac surgery, interventional cardiology, and advanced heart failure and transplant cardiology. Depending on the etiology of heart failure, a beneficiary could receive care from an interventional cardiologist or cardiac electrophysiologist. However, as proceduralists, these specialists do not commonly participate in the longitudinal management of beneficiaries with heart failure and have limited ongoing interactions with primary care.\167\ We also considered including cardiologists who specialize in adult congenital heart disease and advanced heart failure and transplant cardiology because these subspecialists often take over as primary managers of care. However, they do not generally co-manage patients or share responsibilities with primary care. Furthermore, they treat a particularly complex patient population, which makes comparing their performance to other cardiologists difficult. For these reasons, we did not propose to include clinicians with specialty codes other than cardiology as ASM participants.

\167\ Sokos G, Kido K, Panjrath G, et al. Multidisciplinary Care in Heart Failure Services. J Card Fail. 2023;29(6):943-958. doi:10.1016/j.cardfail.2023.02.011.

We solicited comments on our proposed definition of “ASM heart failure cohort” at Sec. 512.705 and our proposal at Sec. 512.710(d)(1) to only include in the ASM heart failure cohort clinicians with a cardiology specialty code on the plurality of their Medicare Part B claims. We also sought comments on including additional subspecialist cardiology codes in the ASM heart failure cohort.

The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed eligibility criteria to include only heart failure clinicians who have used a cardiology specialty code. One supported excluding heart failure subspecialists because they believed that cardiologists may provide the bulk of care for exceptionally complex patients.

Response: We appreciate the comments in support of the proposed eligibility criteria for the ASM heart failure cohort, particularly the use of the cardiology specialty code for those clinicians treating heart failure. We agree that cardiologists are in the best position to co-manage patients and share responsibilities with primary care and the exclusion of cardiology sub-specialists is appropriate given that they are more apt to treat complex patients.

Comment: A few commenters stated that the ASM heart failure cohort comprised only of cardiologists is overly narrow and excludes relevant cardiology subspecialists who provide essential components to heart failure care and clinicians who see sufficient volume of heart failure beneficiaries. They stated that excluding these clinicians from ASM would undermine the clinical validity of performance comparison fairness. Several commenters recommended that more cardiology subspecialties be included in the heart failure cohort. A commenter believed that treating heart failure takes multiple team-based approaches and should include specialties like cardiac surgery, interventional cardiology, allied health providers, post-acute care providers, primary care, and advanced primary care providers who manage heart failure patients longitudinally. Another commenter believed additional specialties should be included in the proposed eligibility criteria because they believed that the released EBCM heart failure data shows that half of patients with heart failure are attributed to other types of physicians and nonphysician providers, including cardiologists with subspecialty designations. Another commenter recommended CMS to reconsider the methodology to ensure that clinicians whose Part B payments are at risk can meaningfully participate in the model.

Response: We acknowledge that the subset of clinicians selected for ASM are not the only provider types who deliver care to Medicare beneficiaries and the important role of other clinicians in the treatment of heart failure. ASM is designed to test whether comparing to clinicians who are furnishing similar

services for a specific chronic condition improves our ability to assess performance and provides more pertinent and actionable information to specialists. ASM could broaden the pool of participants treating heart failure in future notice and comment rulemaking if it is determined that patterns of care exhibited by other subspecialty types make for fair comparison on the same set of measures.

Subspecialists such as cardiac surgeons and interventional cardiologists treat particularly complex patient populations that would create challenges for comparing performance, as they primarily function as proceduralists rather than comprehensive care managers. Their interactions with heart failure patients are often limited in scope and to a specific area of technical expertise. This contrasts sharply with general cardiologists who often provide ongoing, comprehensive management of heart failure patients. Allied health providers and post- acute providers represent a diverse group of providers who help patients manage their chronic condition(s). Yet, as they typically work under physician supervision, they may not have the clinical authority to make independent treatment decisions or the ability to assume financial risk for patient outcomes. Although some primary care and advanced primary care providers manage heart failure patients longitudinally, ASM focuses on the role of specialists in the treatment of chronic conditions and coordination with PCPs. It is true that EBCM heart failure data shows many patients with heart failure are attributed to subspecialty types and will, therefore, be excluded from the model. The goal of ASM is not to compare performance of all specialist types who have been attributed patients with heart failure. Rather, the goal is to measure the performance of a subset of those clinicians who are most alike in the pattern of care that they provide so that performance is aptly measured and scored.

Comment: A commenter requested that essential data be presented, analyzed, and supported for determining the composition of the ASM heart failure cohort, with discussion of the rationale for including and excluding clinicians who provide essential care for beneficiaries who require heart failure care.

Response: We appreciate the commenter for the response. We believe that we have provided sufficient rationale for determining the composition of the ASM heart failure cohort both in the CY 2026 PFS proposed rule and in this section in response to comments.

Comment: A commenter requested clarity on what “plurality” means within the context of the proposal at Sec. 512.710(d)(1) to only include in the ASM heart failure cohort clinicians with a cardiology specialty code on the plurality of their Medicare Part B claims.

Response: We appreciate the opportunity to clarify what is meant by plurality. Plurality captures the specialty code applied most frequently to a clinician's claims. Majority refers to the specialty code listed on more than 50 percent of claims. In the case that a clinician has more than one specialty code applied to their Medicare Part B claims, the specialty code applied most often would be the specialty code accepted for the purposes of the ASM participant eligibility criteria.

After consideration of public comments, we are finalizing without modification our proposal at Sec. 512.705 to define the “ASM heart failure cohort” as all ASM heart failure participants. We are also finalizing without modification our proposal at Sec. 512.710(d)(1) to include only clinicians with a cardiology specialty code on the plurality of their Medicare Part B claims in the ASM heart failure cohort. (b) ASM Low Back Pain Cohort

In the CY 2026 PFS proposed rule (90 FR 32564), we identified several nonsurgical and surgical specialties that commonly manage, treat, and maintain long-term relationships with patients with low back pain in the ambulatory setting. Both nonsurgical and surgical specialists offer meaningful, conservative (that is, less invasive) treatment options.\168\ However, some low back pain treatments, including spinal fusion for the treatment of non-complex low back pain, may be contributors to low-value care.\169\ For this reason, we believe that it would be prudent for ASM to include the specialists who most commonly perform these procedures.

\168\ Steinmetz A. Back pain treatment: a new perspective. Ther Adv Musculoskelet Dis. 2022 Jul 4;14:1759720X221100293. doi: 10.1177/1759720X221100293. PMID: 35814351; PMCID: PMC9260567.

\169\ Buchbinder R, Underwood M, Hartvigsen J, Maher CG. The Lancet Series call to action to reduce low value care for low back pain: an update. Pain. 2020 Sep;161 Suppl 1(1):S57-S64. doi: 10.1097/j.pain.0000000000001869. PMID: 33090740; PMCID: PMC7434211.

While surgical specialists are proceduralists, they are also commonly involved in the longitudinal management of Medicare beneficiaries with low back pain. We stated in the CY 2026 PFS proposed rule that we examined whether ASM would meet its goal of comparing like participants if we elected to include both nonsurgical and surgical specialists in the same ASM cohort.

As discussed in the CY 2026 PFS proposed rule (90 FR 32593 through 32597), we stratified 2023 EBCM data by beneficiaries who underwent surgery on their spine and who had complex low back pain and found that, across all specialty types, more than 80 percent of beneficiaries with episodes for low back pain did not undergo spine surgery (83.8 percent for neurosurgery; 90.8 percent for orthopedic surgery), as demonstrated in Table B-D2.

[GRAPHIC] [TIFF OMITTED] TR05NO25.107

Because orthopedic surgeons and neurosurgeons primarily treat low back pain non-surgically, we believe it is acceptable to include both surgical and nonsurgical specialists in the ASM low back pain cohort. Moreover, the EBCM episode volume eligibility criteria as described in section III.C.2.c.(3)(b) of this final rule would screen out specialists who are not treating low back pain longitudinally in the outpatient setting.

We proposed at Sec. 512.710(d)(2), for the ASM low back pain cohort, to select clinicians with a specialty type of anesthesiology, interventional pain management, neurosurgery, orthopedic surgery, pain management, and physical medicine and rehabilitation, provided they meet all applicable ASM participant eligibility criteria for an ASM performance year. We noted that there may be some overlap between pain management, interventional pain management, and anesthesiology. However, we proposed to include all three specialty designations to ensure we include anesthesiologists that have not yet updated their subspecialty with Medicare and those anesthesiologists treating low back pain without pursuing fellowship training.

Although other clinicians do treat low back pain, we proposed that only those specialists listed would be selected to participate in ASM. We also considered other specialists who could trigger higher volumes of low back pain episodes. For example, chiropractors and physical therapists work closely with both PCPs and specialists to treat low back pain, often providing first-line therapy. However, we believe the proposed specialties are better positioned to direct and be held accountable for the longitudinal management of low back pain that may employ a variety of modalities.

We solicited public comments on our proposal at Sec. 512.710(d)(2) to only include in the ASM low back pain cohort clinicians with a specialty code of anesthesiology, interventional pain management, neurosurgery, orthopedic surgery, pain management, or physical medicine and rehabilitation on the plurality of their Medicare Part B claims. We also sought comments on including alternative low back pain-related specialty types that were considered for the ASM low back pain cohort.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters agreed with the proposed ASM low back pain participant and ASM low back pain cohort definitions. A few commenters supported the specialties included in the ASM low back pain cohort with no need to expand to other specialties and believed that surgical care providers are better positioned to assume full accountability for low back pain episodes. A commenter believed that many orthopedic practices manage chronic musculoskeletal conditions, and it is realistic for specialty surgical practices to be included in the model.

Response: We appreciate the comments in support of the ASM low back pain participant definition and the specialties selected for the ASM low back pain cohort. We appreciate the commenters for agreeing that orthopedic surgeons are appropriate provider types for the ASM low back pain cohort.

Comment: A commenter requested clarification and reasoning for including the proposed identified clinicians within the ASM low back pain cohort while excluding other clinicians who provide essential care for beneficiaries. Another commenter said the collection of specialty types is too broad to be statistically useful because clinicians who are not focused on changing the course of lower back pain as a specialty focus area would not meaningfully contribute to the goal of improving lower back pain care. A couple of commenters recommended excluding surgeons from ASM. Another commenter stated that chronic low back pain is managed through long-term multidisciplinary approaches rather than surgical interventions. Another commenter recommended excluding neurosurgeons. A couple of commenters suggested CMS work with specialty societies for clinicians who treat spine patients to develop a more appropriate value-based opportunity that focuses on the aspects of care where spine surgeons have more direct control.

A commenter expressed a belief that the “ASM low back pain cohort” definition does not foster team-based management of a patient's care over the trajectory of a condition. A few commenters believed attribution of a patient's care in a group practice can often start with non-physician practitioners, primary care physicians, or other specialty physicians not identified in the definition.

Response: We selected the specialties that commonly manage, treat, and maintain long-term relationships with patients with low back pain in the ambulatory setting for the ASM low back pain cohort. We refer readers to section III.C.2.c.(2).(b) of this final rule for a more comprehensive discussion on the reasoning and justification for selecting the specialties for the ASM low back pain cohort. We disagree with the comment that ASM participants who are not clinically or academically focused on changing the course of lower back pain would not meaningfully contribute to improving lower back pain care. We believe this model would incentivize those providers to do so. We also understand that patient care may be transferred between providers in group practices, particularly when utilizing a team-based approach to care for low back pain patients. However, ASM will only focus on providers who meet the ASM participant eligibility criteria,

including those related to the volume of episodes for the low back pain EBCM described in section III.C.2.c.(3).(b) of this rule. Providers who see a patient once and refer them to another provider would be unlikely to meet the criteria for an EBCM episode for that patient, as an EBCM episode is only attributed to a clinician when they bill at least 30 percent of the Part B codes for the episode. We disagree that surgeons, including neurosurgeons, should be excluded from the model for the reasons stated in this section III.C.2.c.(2)(b) of the final rule. Specifically, we believe that it would be prudent for ASM to include the specialists who commonly perform spinal fusions.

Comment: A few commenters recommended CMS define ASM low back pain participant and the ASM low back pain cohort based on specific lumbar spine diseases and conditions rather than grouping all low back pain together. A commenter recommended refining the definition to a specific diagnosis such as stenosis or lumbar disc herniation and adding specialists to the participant definition based on the diagnosis. A commenter encouraged CMS to include a more common set of procedures and workflows that could be more applicable to specialties and groups.

Response: We acknowledge the recommendation to define ASM low back pain participant and ASM low back pain cohort at the diagnosis-level for a subset of low back pain patients. However, such episodes would not be appropriate for ASM because the conditions covered must have an associated MIPS EBCM. In addition, narrower definitions would reduce the volume of episodes and ASM participants in the model. We believe a broader low back pain category will encourage greater coordination among providers caring for patients with a chronic condition that is both complex and multi-factorial, often with overlapping diagnoses.

We also understand that several clinicians are involved when utilizing a team-based approach to care for low back pain patients. Although MIPS will continue to evaluate groups, where handoffs between providers in the same group are common, ASM will only focus on providers who meet the ASM participant eligibility criteria, including those related to the volume of episodes for the low back pain EBCM described in section III.C.2.c.(3).(b) of this final rule. We remind readers that an EBCM episode is only attributed to a clinician when they bill at least 30 percent of the Part B codes for the episode. Therefore, unless the clinician is sufficiently involved in the care for that episode, they would not be attributed to the episode, and the episode would not count toward the EBCM episode volume eligibility criteria.

Comment: A few commenters recommended CMS include additional specialties for the low back pain cohort. A few commenters did not support limiting the low back pain cohort to specialists, such as neurosurgeons and orthopedic surgeons, and recommended instead adding primary care physicians who manage patients with low back pain. A commenter recommended including primary care physicians because a substantial portion of patients are managed solely by PCPs. Another commenter recommended adding NPPs and believed that ASM should capture the chiropractors, behavioral health providers, physical therapists, occupational therapists, massage therapists, or acupuncturists employed in many physician practices. Another commenter believed that excluding physical therapists will limit ASM's ability to capture the true drivers of value in low back pain care. A few commenters believed the proposed methodology excludes clinicians who see sufficient volume of low back pain beneficiaries. They stated that, according to data released when the low back pain EBCM was being developed, most Medicare patients with low back pain are treated by chiropractors, physical therapists, and primary care physicians who are not included in the “ASM low back pain cohort” definition. Another commenter suggested CMS to ensure that clinicians whose Part B payments are at risk can meaningfully participate in the model. A commenter stated that additional specialists would increase opportunities to achieve Medicare cost savings while providing a more comprehensive, patient-centered, and longitudinal approach for beneficiaries experiencing low back pain. A commenter recommended that, if CMS were to add additional specialties, CMS should examine whether methodological adjustments are necessary to ensure appropriate comparison groups, especially since certain specialists inherently treat more complex, higher-cost conditions.

Response: We acknowledge the important role of other clinicians in the treatment of low back pain and that the subset of physicians selected for ASM are not the only provider types who deliver care to Medicare beneficiaries. While expanding the cohort to include additional provider types and specialties could increase greater cost savings, we remind commenters that ASM is a model test to determine whether comparing specific providers on similar services improves our ability to assess performance and provide more pertinent and actionable information to specialists. ASM also aims to include providers with a comparable ability to drive care improvements and the operational capacity to meet model requirements. Should ASM evaluations confirm its effectiveness in meeting its goals, broadening the pool of participants could certainly be considered in the future. We agree that if additional specialties were added to the model, we would need to consider whether other methodological adjustments were necessary to ensure appropriate comparison groups. At this time, we are not adding additional specialties or provider types.

Through ASM, we aim to incentivize specialists directly to work with PCPs to improve outcomes; therefore, including PCPs as participants is outside the goal of the model. To ensure appropriate comparison among peers, we are limiting ASM to specific specialists.

We do not believe it is appropriate to include chiropractors in the model, as we would be unable to score chiropractors on all of the ASM performance metrics and chiropractic training and treatment modalities are not as comprehensive. For example, chiropractors cannot prescribe all medications or order additional testing, such as imaging.

Operationally, as described in section III.C.2.c.(3).(a).(iii) of this final rule, we have elected to identify ASM participants based on the medical specialty code assigned to Medicare Part B claims. While physicians may be assigned a specialty code specific to their medical specialty, NPPs are assigned a Medicare Part B claim specialty code that denotes provider type. For instance, the Medicare Part B claim specialty code assigned to a physical therapist is the same, regardless of whether they treat patients with low back pain or traumatic brain injury. Therefore, we are only able to identify physicians for ASM.

Comment: A few commenters believed that anesthesiologists, pain management, and interventional pain management should be excluded because most of the clinicians would be at a significant disadvantage, have a low volume of low back pain patients, do not have control over the costs associated with caring for low back pain patients, and will receive negative payment adjustments. A commenter requested clarification in defining roles when the services fall outside a specialist's control, particularly in the case that an anesthesiologist is

providing anesthesia services, where the surgeon has primary control over the episode. They believed that pain management and integrated pain management are tertiary referrals, and these types of specialists do not have control of any of the expenses.

Response: We acknowledge comments regarding the perception that some care decisions may be outside of the control of an ASM participant. In fact, one of the aims of ASM is to increase engagement and communication between specialists and their referral sources, typically PCPs. By including specialists who have historically operated in silos, we hope to incentivize those specialists to work together with referring providers to improve care coordination and outcomes for Medicare beneficiaries with low back pain. We disagree that anesthesiologists, pain management, and interventional pain management should be excluded from the model, as these specialists commonly provide long-term care to beneficiaries and perform non-operative interventions to address low back pain. With respect to anesthesia, the EBCM methodology excludes the anesthesia billing codes commonly used when provided services in tandem with a surgical procedure, so those services would not trigger an episode. While some post-operative pain management codes are included in the EBCM methodology, we would not expect these services to trigger an episode as an EBCM episode is only attributed to a clinician when they bill at least 30 percent of the Part B codes for the episode. In this case, that episode would likely be attributed to the surgeon.

Comment: Several commenters did not support the proposed alternative to include additional specialists in the low back pain cohort because they believe the types of specialists currently selected align with the model's goals of managing patient's chronic disease. Another commenter did not support the proposed alternative to include a subset of orthopedic surgeons who treat low back pain.

Response: We appreciate the comments received on the alternative low back pain-related specialty types that were considered for the ASM low back pain cohort. Should we determine that additional provider types would be appropriate for inclusion in ASM, changes would be undertaken under a notice and comment rulemaking.

After consideration of public comments, we are finalizing the “ASM low back pain participant” and “ASM low back pain cohort” definitions as proposed at Sec. 512.705. We are also finalizing without modification our proposal at Sec. 512.710(d)(2) to include in the ASM low back pain cohort only clinicians with a specialty code of anesthesiology, interventional pain management, neurosurgery, orthopedic surgery, pain management, or physical medicine and rehabilitation on the plurality of their Medicare Part B claims. (3) ASM Participant Eligibility Criteria

As discussed in the CY 2026 PFS proposed rule (90 FR 32564 through 32568), when selecting participants for ASM, we sought to ensure (1) we include a sufficient volume of clinicians treating Medicare beneficiaries for the same clinical condition in the ambulatory setting; (2) there is a reasonable expectation that participants can be measured under the model and held accountable for the care provided to Medicare beneficiaries with heart failure and low back pain; (3) the selected clinicians have the operational capacity to meet the ASM performance requirements described in section III.C.2.d of this final rule; and (4) the model test results will be statistically valid, reliable, and generalizable to the specialty types included in ASM nationwide should the model test be successful and considered for expansion under section 1115A(c) of the Act.

Therefore, we proposed at Sec. 512.705 to define “ASM participant eligibility criteria” as the set of criteria defined at Sec. 512.710(b) that CMS uses to determine whether a clinician is selected to participate in ASM. We proposed at Sec. 512.710(b) that clinicians who meet all of the following ASM participant eligibility criteria would be required to participate in ASM:

Is a clinician who bills claims under the Medicare Physician Fee Schedule.

Is identified by TIN/NPI as a selected specialty type.

Meets the EBCM episode volume threshold applicable to an ASM targeted chronic condition.

Is located in one of the selected mandatory geographic areas.

At Sec. 512.705, we proposed to define “mandatory geographic area” to mean a core-based statistical area (CBSA) or metropolitan division as defined by the Office of Management and Budget (OMB) and selected by CMS under the terms of Sec. 512.710(f). We noted that the proposed mandatory geographic areas may include rural areas as defined by MIPS at Sec. 414.1305, which is a ZIP code designated as rural by the Health Resources and Services Administration's Federal Office of Rural Health Policy (FORHP), using the most recent FORHP Eligible ZIP Code file available.

We noted that, as is the case in MIPS, clinicians practicing in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) who provide services that are billed exclusively under the RHC or FQHC payment methodologies would not be selected to participate in ASM. This is because FQHCs and RHCs receive All-Inclusive Rate (AIR) or Prospective Payment System (PPS) payments and do not submit claims under the Medicare Physician Fee Schedule. However, if these clinicians, separately, provide and bill for services under the Physician Fee Schedule, they would be required to participate in ASM provided they meet the ASM participant eligibility criteria. We also stated that clinicians who provide services at Critical Access Hospitals (CAHs) that are paid under Method I would be required to participate, if they meet the ASM participant eligibility criteria, given that such services are paid under the Medicare PFS. Further, we stated that clinicians who provide services at CAHs that are paid under Method II, and meet all ASM participant eligibility criteria, would only be required to participate in ASM if they have not reassigned their billing rights to the Method II CAH; that is, if the clinician continues to submit professional claims through the PFS. This is because when a clinician reassigns their billing rights to a Method II CAH, the CAH bills those services through institutional claims. As stated in the CY 2026 PFS proposed rule, MIPS uses both professional and institutional claims to trigger EBCMs and include clinicians who have reassigned their billing rights to a Method II CAH. However, in contrast to MIPS, ASM would only use professional claims to trigger EBCMs, and, therefore, would not capture claims for clinicians who have reassigned their billing rights to a Method II CAH.

We sought comments on our proposed “ASM participant eligibility criteria” and “mandatory geographic area” definitions at Sec. 512.705. We also solicited comments on the proposed ASM participant eligibility criteria at Sec. 512.710(b). Specifically, we solicited comments on the proposals at Sec. 512.710(b)(1) that the clinician must bill claims under the Medicare Physician Fee Schedule; at Sec. 512.710(b)(2) that the clinician would be identified by TIN/NPI as a selected specialty type; at Sec. 512.710(b)(3) that the clinician must meet the EBCM episode volume threshold applicable to an ASM targeted chronic condition; and at Sec. 512.710(b)(4) the clinician must be

located in one of the selected mandatory geographic areas.

The following is the public comment we received on the “ASM participant eligibility criteria” definition and our response We did not receive comments on the “mandatory geographic area” definition or the criteria at 512.710(b)(1) that the clinician must bill claims under the Medicare Physician Fee Schedule. The remaining ASM participant eligibility criteria proposed at Sec. 512.710(b)(2), Sec. 512.710(b)(3), and Sec. 512.710(b)(4) are discussed in sections III.C.2.c.(3)(a), III.C.2.c.(3)(b), and III.C.2.c.(4) of this final rule, respectively.

Comment: A commenter supported the “ASM participant eligibility criteria” definition since they believed the criteria to be clear.

Response: We appreciate the commenter for their support of the “ASM participant eligibility criteria” definition.

We are finalizing the “ASM participant eligibility criteria” and “mandatory geographic area” definitions as proposed at Sec. 512.705. We are also finalizing the ASM participant eligibility criteria at Sec. 512.710(b)(1) that the clinician must bill claims under the Medicare Physician Fee Schedule as proposed. The remaining ASM participant eligibility criteria proposed at Sec. 512.710(b)(2), Sec. 512.710(b)(3), and Sec. 512.710(b)(4) are discussed in sections III.C.2.c.(3)(a), III.C.2.c.(3)(b), and III.C.2.c.(4) of this final rule, respectively. (a) ASM Participant and Specialty Type Identification

As discussed in section III.C.2.c.(2) of this final rule, we proposed at Sec. 512.710(d) that only a certain subset of clinicians who treat heart failure and low back pain would be required to participate in this model. To identify ASM participants, we proposed to align the Quality Payment Program policies for identifying clinicians and clinical specialty. Specifically, we proposed at Sec. 512.710(b)(2) that the clinician would be identified by TIN/NPI as a selected specialty type. (i) ASM Participant Identification

As discussed in the CY 2026 PFS proposed rule, Medicare claims are processed using TINs, which may represent an individual clinician or may represent a hospital or group practice. Because we proposed that ASM would evaluate performance at an individual clinician level (TIN/ NPI), TIN alone would not be useful for ASM. Individual providers are, however, identifiable by their unique NPI. We stated that when TIN and NPI are used together, CMS is able to identify and evaluate individual providers. NPI-level participation also aligns with the Innovation Center's goal of creating a level playing field for all clinicians and removing unequal benefits afforded to consolidated group practices and health systems.

We noted that the Quality Payment Program identifies MIPS eligible clinicians for the individual participation option, defined at Sec. 414.1305, by a combination of TIN and NPI, (hereafter TIN/NPI) and stated our belief this method is also the best method of identifying clinicians in ASM.

Using TIN/NPI for identifying ASM participants would offer several advantages. First, direct comparison of specialist performance between similar clinicians is a central feature of ASM. Participation at the TIN/NPI level puts the specialist as the unit of comparison, allowing for more meaningful assessment among peers. We stated that this level of participation would also produce more granular performance analysis and useful feedback for clinicians. Second, we also proposed to use TIN/NPI to determine whether clinicians meet the other ASM participant eligibility criteria. Specifically, we proposed to use TIN/NPI to ensure that each ASM participant has met the episode volume criteria for the EBCMs and for assigning clinicians to mandatory geographic areas described later in this section of this final rule. This approach would maintain consistency between participant identification and performance assessment within ASM and mirrors the methodology used in the Quality Payment Program. Finally, identifying ASM participants at the TIN/NPI level would enable us to identify claims for a single provider who works at more than one location or organization and, therefore, bills under multiple TINs.

We stated our belief that identifying ASM participants at the TIN/ NPI level drives direct accountability so that outcomes are clearly attributed to ASM participants. Identifying ASM participants at the TIN/NPI level will allow for like-to-like performance assessment of clinicians who meet ASM participant eligibility criteria. We believe this performance comparison approach will provide granular and actionable insights into best practices and specialty care delivery.

As discussed in the CY 2026 PFS proposed rule, we recognize that an individual clinician may assign their billing rights to multiple TINs (that is, practice across multiple TINs). Such an arrangement will have implications on how we identify ASM participants. For example, if a clinician's NPI is associated with two TINs and meets the ASM participant eligibility criteria for both TINs, then we would consider each TIN/NPI combination to be a separate ASM participant that must separately meet model requirements and report required data. Accordingly, we stated we would separately assess performance and determine payment adjustments for each unique TIN/NPI combination, as described in sections III.C.2.d.(1)(b) and III.C.2.f. of this final rule. We stated that if an NPI is associated with two TINs but only meets the ASM participant eligibility criteria for one TIN/NPI combination, the clinician would only be considered an ASM participant under that one TIN/NPI combination.

We also considered selecting a single TIN/NPI combination to be the ASM participant in the case that a clinician meets ASM eligibility requirements under more than one TIN/NPI combination. Under that scenario, we would have selected the TIN/NPI combination with the majority of EBCM-triggered episodes for a given ASM cohort (see section III.C.2.c.(3)(b) of this final rule for further discussion on EBCM as part of the ASM participant eligibility criteria). However, this alternative could adversely affect participant volume and exclude appropriate beneficiary episodes.

We solicited public comment on our proposal at Sec. 512.710(b)(2) to identify ASM participants at the TIN/NPI level. We also sought comments on the alternative method of using TIN-level specialty type for identifying ASM participants, as well as selecting a single TIN/NPI combination as an ASM participant in the case that a clinician meets ASM eligibility requirements under more than one TIN/NPI combination.

The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support requiring an individual clinician to participate in ASM separately under all applicable TIN/NPI combinations. They stated that clinicians who assign billing rights to multiple TINs should not be treated as separate participation entities who must meet reporting requirements for each applicable TIN/NPI combination.

Response: Identifying ASM participants at the TIN/NPI level will enable us to identify claims for a single provider who works at more than one location or organization and, therefore, bills under multiple TINs. We believe

identifying ASM participants at the TIN/NPI level will drive direct accountability for outcomes that are clearly attributed to each setting in which an ASM participant practices. We note that an ASM participant would only be held accountable for the care they provide under the TIN/ NPIs that meet the ASM participant eligibility criteria. Based on our internal analysis performed to inform this policy, we expect this to be a rare occurrence. Moreover, the proposed approach aligns with the ASM performance assessment policies and mirrors the methodology used in the Quality Payment Program. For comments and responses related to data submission for ASM participants who bill under multiple TINs, please see section III.C.2.d.(1) of this final rule.

Comment: A commenter supported the proposed policy to allow ASM participants affiliated with multiple TINs to determine which TIN/NPI combination would be reported to the model.

Response: We appreciate the comment on the alternative method considered for selecting a single TIN/NPI combination as an ASM participant in the case that a clinician meets ASM eligibility requirements under more than one TIN/NPI combination. To clarify, this alternative was not related to reporting but identifying clinicians for participation in ASM. We will take this comment into consideration if we propose changes to the policy in future years of the model.

After consideration of public comments, we are finalizing without modification our proposal at Sec. 512.710(b)(2) to identify ASM participants at the TIN/NPI level. (ii) Participant Exclusion Due to Change in TIN During an ASM Performance Year

In the CY 2026 PFS proposed rule (90 FR 32593 through 32597), we recognized that ASM participants may change practices (as reflected by a change in TIN) during an ASM performance year. In such circumstances, we stated that we would need to determine whether the ASM participant must continue to meet model requirements for the original TIN, for the new TIN, or would no longer be required to meet model requirements under either TIN for that ASM performance year. We proposed at Sec. 512.710(c)(1) that an ASM participant who, during an applicable ASM performance year, no longer assigns their billing rights to the TIN CMS used to identify them as an ASM participant must notify CMS of such change within 30 days of the change in a form and manner determined by CMS. We proposed at Sec. 512.710(c)(2) that an ASM participant who notifies CMS of a change in TIN during an ASM performance year would no longer be required to meet ASM requirements, including data submission requirements described at Sec. 512.720, for the applicable ASM performance year and would instead be subject to MIPS reporting obligations, if applicable. We also proposed that the waivers, including the MIPS waiver established at Sec. 512.775, would no longer apply beginning on the date we determine the clinician is no longer required to meet model requirements for the applicable ASM performance year. We stated that if the ASM participant fails to notify CMS within 30 days of no longer assigning billing rights to the original TIN in the form and manner determined by CMS, then the ASM participant would be required to meet the data submission requirements described at Sec. 512.720 for the applicable ASM performance year.

Given our proposal to determine annually whether clinicians meet ASM participant eligibility criteria for each applicable ASM performance year, we believe that we would naturally identify the movement of individual clinicians to a different TIN between ASM performance years. However, as discussed in the CY 2026 PFS proposed rule, if an ASM participant reassigns their billing rights to a new TIN during an ASM performance year, CMS would not have sufficient data for the new TIN/NPI combination to determine if the ASM participant continues to meet all ASM participant eligibility criteria. For example, we would not have timely EBCM data available for the new TIN/ NPI combination to determine if the ASM participant meets the 20 EBCM episode volume criterion (discussed in section III.C.2.c.(3)(b) of this final rule) under the new TIN. Without complete data to evaluate whether the ASM participant continues to meet the ASM participant eligibility criteria, we proposed, for that ASM performance year, we would not assess the ASM participant in accordance with Sec. 512.715, would not require the ASM participant to submit data in accordance with Sec. 512.720, would not score the ASM participant in accordance with Sec. 512.745, and the ASM participant would not receive an ASM payment adjustment in accordance with Sec. 512.750. Because the proposed Medicare waiver at Sec. 512.775 would only waive the requirements of section 1848(q) of the Act, and its implementing regulations, for an ASM performance year that an ASM participant meets the ASM participant eligibility criteria, we stated that the ASM participant would be required to satisfy any MIPS reporting obligations and would receive a MIPS payment adjustment 2 years later, in accordance with current regulations. In the CY 2026 PFS proposed rule, we stated we intend to monitor TIN changes in each ASM cohort within each ASM performance year and across the ASM model test period. If we determine that changes to this policy are warranted for future ASM performance years, we will propose those changes through notice and comment rulemaking.

We also considered requiring an ASM participant who reassigns their billing rights to a new TIN during an ASM performance year to continue to meet all model requirements for the applicable ASM performance year under the new TIN/NPI combination. As ASM focuses on specialty care related to specific chronic conditions, we considered that the ASM participant would likely continue to furnish services related to ASM targeted chronic conditions under the same specialty type and trigger applicable EBCM episodes during the remainder of the applicable ASM performance year. As discussed in sections III.C.2.d.(3) and III.C.2.e.(2)(b) of this final rule, in the case that an ASM participant under a new TIN/NPI combination does not trigger at least 20 episodes during the remainder of the applicable ASM performance year, the ASM participant would not receive a final score. Accordingly, as we stated in the CY 2026 PFS proposed rule, they would receive no payment adjustments in the corresponding ASM payment year as described at Sec. 512.750(d). However, if an ASM participant under a new TIN were to: (1) receive quality and cost ASM performance category scores discussed in sections III.C.2.d.(2)(i) and III.C.2.d.(3)(g) of this final rule, and (2) meet the requirements to receive a final score as discussed in section III.C.2.e.(2) of this final rule, then we believe it would be appropriate to determine an ASM payment adjustment factor and ASM payment multiplier for the ASM participant under the new TIN/ NPI combination. We ultimately decided to not propose this policy because we believe that conforming to the policy set forth in section III.C.2.c.(1) of this final rule, which requires an ASM participant to satisfy any MIPS reporting obligations when they no longer meet ASM participant eligibility criteria, would avoid adding unnecessary complexity to the model.

We also considered requiring the ASM participant to meet all model

requirements under the original TIN/NPI combination for the applicable ASM performance year and, therefore, not requiring the ASM participant to notify CMS of a change in TIN during an ASM performance year. However, we believe that it would be challenging for an ASM participant to access the necessary data to meet the data submission requirements if no longer affiliated with the original TIN. Therefore, we do not believe it would be appropriate to hold an ASM participant accountable for ASM requirements under the original TIN in this situation.

We solicited comments on our proposal at Sec. 512.710(c) to exclude ASM participants who change TIN during an applicable ASM performance year from ASM reporting requirements for that year of the model. We also sought comments on the alternatives of requiring the ASM participant to meet model requirements under their new TIN or under the original TIN/NPI combination that identified them as an ASM participant.

The following is a summary of the comments we received and our responses.

Comment: A commenter agreed with the policy to exclude participants who change TIN during the performance year from ASM requirements. The commenter advised CMS to require participation in the model for subsequent years with their new TIN/NPI combination.

Response: We appreciate the support of our policy to exclude ASM participants who change TIN during an ASM performance year. As discussed in section III.C.2.c.(1) of this rule, ASM participants will be reassessed annually using the ASM participant eligibility criteria to ensure all eligible clinicians are selected for participation in the model.

Comment: A commenter requested clarification on how CMS would handle a change in clinical practice during a measurement year if ASM participant eligibility is decided prior to the measurement year. For example, an anesthesiologist no longer manages low back pain and now only provides anesthesia services in an operating room based on practice decisions.

Response: We understand that, although infrequent, it would be possible for a clinician to change practice settings or service lines based on practice decisions, while remaining under the same TIN. If the ASM participant no longer provides the services that resulted in the provider meeting the ASM participant eligibility criteria, we do not expect they would trigger an adequate number of EBCMs to meet the episode volume criteria to receive a score during the ASM performance year. Therefore, although still an ASM participant, they would not receive a score for that ASM performance year or receive a payment adjustment in the applicable ASM payment year. For a more in-depth discussion on cost ASM performance category scoring, see section III.C.2.d.(3)(g). An ASM participant who changes clinical practice setting during an ASM performance year would be required to notify CMS within 30 days of a change in TIN in a form and manner determined by CMS.

After consideration of public comments, we are finalizing without modification our proposal at Sec. 512.710(c) to exclude ASM participants who change TIN during an applicable ASM performance year from ASM reporting requirements for that year of the model. (iii) ASM Specialty Identification

In the CY 2026 PFS proposed rule (90 FR 32593 through 32597), we proposed to define “specialty type” as the medical specialty determined by the specialty code indicated on the plurality of a clinician's Medicare Part B claims. We also proposed to identify specialty based on the specialty code indicated on the plurality of a clinician's Medicare Part B claims during the period described in section III.C.2.c.(5) of this final rule to ensure that all clinicians meeting the specialty requirements described at Sec. 512.710(d) are included in the model. Specifically, we proposed to use the same specialty codes used for the Quality Payment Program to identify the specialty of MIPS eligible clinicians as defined at Sec. 414.1305.\170\

\170\ https://www.federalregister.gov/d/2022-23873/page-70039.

As discussed in CY 2026 PFS proposed rule, the specialty codes used on Medicare Part B claims are not reported by clinicians but are assigned to claims by the Medicare Administrative Contractors (MACs) and derived from the clinician-reported specialty designations that are entered in the Provider Enrollment, Chain, and Ownership System (PECOS) as part of the Medicare provider enrollment application. Because a clinician's specialty code could change during an ASM performance year, we proposed to use the specialty code assigned most frequently to a clinician's Medicare Part B claims for determining specialty type for ASM.

We also considered using PECOS specialty designation alone for the purpose of determining specialty type for ASM. However, as discussed in the CY 2026 PFS proposed rule, the PECOS specialty codes are self- reported, and a single clinician may list more than one primary specialty, making it unreliable as a single source for identifying a clinician's primary specialty. We stated in the CY 2023 PFS final rule that given the strong alignment between PECOS data and claims data and our historical use of claims data to identify a clinician's specialty, we believe that Medicare Part B claims data would be the best data source to use to identify a clinician's specialty (87 FR 70039).\171\ Moreover, given that the Quality Payment Program uses Medicare claims data, we do not want to create inconsistencies between specialty types for ASM and MIPS. We also considered using the Health Care Provider Taxonomy Codes, which categorize the type, classification, and/or specialization of health care providers. These codes offer more specificity than PECOS (87 FR 70039) and are used when applying for an NPI from the National Plan and Provider Enumeration System (NPPES). However, they are not verified for accuracy.\172\ We previously elected not to use the Health Care Provider Taxonomy Codes for MIPS because of uncertainty regarding the reliability of NPPES as a data source for MIPS eligibility determinations (87 FR 70039). We analyzed the congruence between specialty designations made for the purposes of MIPS and those reported in NPPES for the proposed specialty types for both of the ASM targeted chronic conditions. Our analysis found a high degree of congruence between the two specialty type codes, likely because we provide a crosswalk of the Health Care Provider Taxonomy Codes and Medicare Specialty Codes that can be used by a clinician when they enroll in Medicare through PECOS.\173\ We stated that given the alignment between these coding systems, we believe that remaining consistent with the specialty type determination methodology used by the Quality Payment Program is important for potential scalability of ASM.

\171\ https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms855i.pdf.

\172\ https://data.cms.gov/resources/medicare-provider-and-supplier-taxonomy-crosswalk-methodology.

\173\ https://data.cms.gov/provider-characteristics/medicare-provider-supplier-enrollment/medicare-provider-and-supplier-taxonomy-crosswalk/data.

We solicited comments on our proposal at Sec. 512.710(d) to identify specialty type based on the specialty code indicated on the plurality of a clinician's Medicare Part B claims. We also sought comments on the alternative

approach of using PECOS specialty codes alone and Health Care Provider Taxonomy Codes for the purpose of determining specialty type for ASM. The following is a summary of the comments we received and our responses.

Comment: A commenter requested clarification on the use of the term “plurality” in determining specialty identification for mandatory ASM participation. They recommended that CMS provide a quantitative threshold or clear criteria for what constitutes plurality, such as a specific percentage of claims or patient volume because they believe this will ensure transparency and consistency in provider inclusion and reduce ambiguity in compliance. Another commenter recommended CMS identify clinicians who have a relevant specialty type on the majority of their claims instead of a simple plurality. They believe this approach could prevent some clinicians with relatively low procedure volume in the ASM specialties from being included in the model. Another commenter supported using specialty codes on the plurality of Medicare Part B claims to support the proposed specialty type definition. The commenter also recommended that CMS reevaluate this methodology after a period of time and provide detailed reports back to clinicians to help provide insights into why or how clinicians are being included in ASM.

Response: As previously discussed with respect to the ASM heart failure cohort in section III.C.2.c.(2)(a), we believe using plurality is a more appropriate criteria to use for the purpose of identifying ASM participants as it captures the specialty code applied most frequently to a clinician's claims. Using the majority, on the other hand, would imply that a particular specialty code is present on more than 50 percent of claims. In the case that a clinician has more than one specialty code applied to their Medicare Part B claims, the specialty code applied most often would be the specialty code accepted for the purposes of the ASM participant eligibility criteria. Because using the majority would require that a single specialty code be applied to more than half of all Medicare Part B claims, a clinician changing their specialty mid-year may not meet this threshold. Using plurality ensures all clinicians are assigned a specialty for the purposes of the ASM participant eligibility criteria. Using plurality is also aligned with how specialty is assigned for the purposes of the Quality Payment Program. As with all Innovation Center models, we will perform annual evaluations that will be made public on the ASM website.

Comment: A commenter recommended CMS clarify the source of the clinician's specialty designation assigned by the MACs. Another commenter requested clarification on how ASM will handle clinicians who have multiple specialty codes designated in PECOS. Specifically, they want to know if clinicians would be considered eligible if any of their specialty codes align, or if only their primary specialty code would be considered. Another commenter believed that physicians do not update their specialty designation when starting at new practices and thus the specialty codes can be misleading, especially for multispecialty providers or those working across multiple locations. Another commenter expressed concerns on how CMS would capture specialty designations, noting that many interventional cardiologists are enrolled in Medicare under the designation of cardiology, potentially resulting in inadvertent attribution of heart failure patients. The commenter recommended that CMS review the model to ensure transparency in physician selection and patient attribution. Another commenter recommended allowing specialists to attest to their subspecialty in determining eligibility because Medicare Part B claims do not always accurately reflect the type of care provided and do not reliably identify clinician specialty. Another commenter recommended CMS update PECOS to support the proposed specialty type definition to display specialty codes in addition to specialty description in order to increase transparency and provide guidance on how clinicians with multiple specialties will be handled under ASM eligibility criteria. Another commenter requested clarification on what “specialist” means within the context of low back pain care for ASM.

Response: Clinicians will be assessed for ASM eligibility based on the specialty code applied most frequently to their Medicare Part B claims. We agree with the commenter that clinicians should attest to and ensure that their specialty is correctly entered in PECOS. As discussed in the CY 2026 PFS proposed rule, the specialty codes used on Medicare Part B claims are derived from PECOS. However, we agree with commenters that the PECOS codes alone are unreliable for identifying a clinician's primary specialty. The PECOS specialty codes are self- reported, and a single clinician may list more than one primary specialty or may be delayed in updating their specialty code. In the case that PECOS has more than one primary specialty code listed, the MAC will assign a single specialty code to the claim. As explained in the Medicare Claims Processing Manual, the MAC assigns the code that corresponds to the greater amount of allowed charges for the previous year.\174\ For example, if the TIN/NPI is 50 percent cardiology and 50 percent interventional cardiology, the MAC compares the total allowed charges for cardiology and interventional cardiologist services and assigns the code with the greater amount of allowed charges. We recognize the recommendation that CMS update PECOS, but that is out of the scope of this model. We refer the commenter requesting clarification on what “specialist” means within the context of low back pain to the ASM low back pain cohort section III.C.2.c.(2)(b) of this final rule.

\174\ Medicare Claims Processing, Manual Chapter 26, 10.8.1 Assigning Specialty Codes by A/B MACs (B) and DME MACs. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c26pdf.pdf.

Comment: A few commenters did not support using specialty to include or exclude a physician from being an ASM participant.; the commenters believed that physicians who provide the same type of services to similar patients should not be subject to different payment rules simply because of the specialty code assigned to them. Another commenter believed that participation should be based on the types of patients treated rather than specialty code. Another commenter believed that ASM may inadvertently affect subspecialists who focus on treating other conditions in their practice and recommended adequate notification period for these subspecialities to object to classification and petition for removal.

Response: We disagree that specialty should not be used as one of the eligibility criteria. As explained elsewhere in this final rule, the policies proposed for ASM are, in part, a direct response to previous learnings from the Quality Payment Program and other Innovation Center models, as well as input from interested parties input regarding the need for more targeted cohorts and peer-to-peer comparisons. We have received feedback that in order for quality measurement and performance feedback to be accurate and actionable, clinician performance should be assessed among other clinicians of the same specialty treating similar conditions. We believe focusing on selected specialties will enable us to

compare like-to-like care delivery and provide clinicians with more salient data and performance feedback. We agree that ASM should focus on specific types of patients and have, therefore, focused ASM on patients with heart failure and low back pain. We do not expect ASM to affect subspecialists who treat other conditions, as the ASM cohorts only include specific Medicare Part B specialty codes. In addition, EBCMs will only attribute episodes to clinicians with more than 30 percent of episode spending. We encourage subspecialists to ensure their specialty code in PECOS is accurate and up to date to avoid the need to confirm or object to their specialty classification.

Comment: A commenter suggested CMS to consider supplementing the use of specialty codes in determining the specialty type definition and ASM participation with additional information, such as diagnosis, evaluation and management service mix, patient relationship codes, relevant board certification, etc.

Response: We appreciate the suggestion to supplement specialty codes with other sources of data. While clinicians will be assessed for ASM eligibility based on the specialty code applied most frequently to their Medicare Part B claims, we do rely on clinicians to ensure their specialty is accurate in PECOS. We also note that to account for service mix, MACs rely on the greater amount of allowed charges for the previous year to assign specialty codes to Medicare Part B claims. We stated in the CY 2023 PFS final rule that Medicare Part B claims data would be the best data source to use to identify clinical specialty (87 FR 70039). Moreover, given that the Quality Payment Program uses Medicare claims data, we do not want to create inconsistencies between specialty types for ASM and MIPS.

After consideration of public comments, we are finalizing without modification our proposal at Sec. 512.705 to define “specialty type” as the medical specialty determined by the specialty code indicated on the plurality of a clinician's Medicare Part B claims. We are also finalizing without modification our proposal at Sec. 512.710(d) to identify specialty type based on the specialty code indicated on the plurality of a clinician's Medicare Part B claims. (b) Episode-Based Cost Measure (EBCM) Episode Volume

In the CY 2026 PFS proposed rule, we discussed our belief that the ASM participant eligibility criteria must appropriately identify clinicians who furnish a sufficient volume of services related to ASM targeted chronic conditions and who can be appropriately evaluated on related costs for those conditions. We proposed to identify ASM participants using volume of services related to heart failure and low back pain furnished by clinicians who have a specialty designation that corresponds with the specialty types discussed in III.C.2.c.(2) of the CY 2026 PFS proposed rule (90 FR 32567). We stated that only clinicians with the proposed specialty types who furnish a volume of services above a specific threshold related to the applicable ASM targeted chronic condition would be identified as ASM participants. That is, not all clinicians who are assigned one of the proposed specialty types related to heart failure or low back pain would be required to participate in ASM.

We proposed to use MIPS EBCMs to determine service volume, rather than assess volume based on claims for individual services. Specifically, we stated that the volume of attributed episodes from EBCMs related to the ASM targeted chronic conditions would serve as the data source by which we evaluate the volume of furnished episodes for ASM. We proposed at Sec. 512.710(b)(3) to use an EBCM episode volume threshold applicable to an ASM targeted chronic condition as an ASM participant eligibility criterion. We proposed at Sec. 512.710(e)(1) to identify ASM heart failure participants using the volume of episodes attributed to a TIN/NPI in accordance with the heart failure EBCM as specified under MIPS. We proposed at Sec. 512.710(e)(2) to identify ASM low back pain participants using the volume of episodes attributed to a TIN/NPI in accordance with the low back pain EBCM as specified under MIPS. We refer readers to section III.C.2.c.(5) of this final rule for a discussion of the processes and specific years of data that we will use to assess EBCM volume to identify ASM participants.

As discussed in the CY 2026 PFS proposed rule, EBCMs assess Medicare resource use for a specific condition or procedure based on only those costs that occur as part of an attributed clinician's care management. CMS uses claims data from Medicare Parts A and B, and some Medicare Part D data, if applicable, to construct the EBCMs (90 FR 32567) . An episode is initiated when a clinician submits a professional claim for at least two separate services, provided to a single beneficiary, that are clinically related to the chronic condition being assessed. Although the episode is initiated and attributed to a particular clinician, the episode includes all Medicare Part A and B services for the length of the episode, as defined by the measure specifications (88 FR 79339 through79347). Therefore, regardless of who provides the care, an episode includes all services related to a beneficiary's condition, routine care services, and consequences of care, and excludes services that are clinically unrelated to the targeted condition of the measure.\175\

\175\ https://www.cms.gov/files/document/wave-4-measure-development-process-macra.pdf.

As further described in the CY 2026 PFS proposed rule, to attribute episodes to practices and clinicians, CMS first attributes episodes to a TIN when it performs two services indicating care for a particular condition for a single beneficiary within a certain number of days (for example, 180 days); both professional claims must have diagnosis codes for the relevant chronic condition. CMS then attributes episodes to each clinician (NPI) within the group (TIN) that rendered at least 30 percent of the total number of qualifying services during the episode (90 FR 32567). For the heart failure EBCM, CMS also checks that the clinician prescribed at least two condition-related prescriptions on different days to two different patients during the calendar year used to construct the episode plus a 1-year lookback period to ensure that attributed clinicians are actually involved in providing ongoing chronic care management.\176\ The low back pain EBCM does not use this additional check since the types of clinicians that manage low back pain may may not prescribe the relevant medication, which could prevent certain clinician types from being attributed episodes.\177\

\176\ https://www.cms.gov/files/zip/2024-cost-measure-information-forms-zip.zip-0.

\177\ https://www.cms.gov/files/zip/mips-chrcondition-episode-based-cost-measures-attribution-methodology-2023-zip.zip.

CMS began development and field testing of the heart failure and low back pain measures in 2022.\178\ We finalized the inclusion of the heart failure and low back pain measures to the MIPS cost performance category beginning in the 2024 MIPS performance period/2026 MIPS payment year (88 FR 79319). We also finalized the inclusion of the heart failure EBCM in the Advancing Care for Heart Disease MVP (88 FR 80022 through 80025; 89 FR 99015 through 99019) and the low back pain EBCM in the in the Rehabilitative Support for Musculoskeletal Care MVP (88 FR 80002 through 80007; 89 FR 99050 through 990054).

\178\ https://www.cms.gov/files/document/wave-4-measure-development-process-macra.pdf.

In the CY 2026 PFS proposed rule, we stated our belief that the construction of the EBCMs and the existing use of these measures within MIPS and MVPs relevant to ASM targeted chronic conditions make the measures an appropriate data source by which to identify ASM participants that furnish enough services and provide longitudinal care management for Medicare beneficiaries diagnosed with ASM targeted chronic conditions (90 FR 32568).

We believe that an annual threshold of 20 or more attributed episodes from an EBCM is appropriate for identifying ASM participants that can be held accountable for quality and cost related to ASM targeted chronic conditions. We have defined a case minimum of 20 episodes for the purposes of scoring chronic condition EBCMs in MIPS, including MVP reporting, as specified in Sec. 414.1350(c)(6) (88 FR 79346 through 79348). We believe using a similar 20-episode minimum from the calendar year used for determining ASM participant eligibility increases the likelihood that an ASM participant would trigger and be attributed at least 20 episodes within a given ASM performance year. Using a 20-episode threshold would also increase the likelihood that they could be scored on the applicable EBCM during the relevant ASM performance year, as described in section III.C.2.d.(3)(g) of this final rule.

We also considered using an EBCM episode threshold greater than 20 episodes. For example, we considered the effects of using a 30-episode or 50-episode threshold. In our analysis of calendar year 2023 data, we found that a 30-episode threshold would decrease the number of potentially eligible ASM participants by 43 percent for heart failure and 35 percent for low back pain relative to the 20-episode threshold. We found that a 50-episode threshold would decrease the number of potentially eligible ASM participants by 76 percent for heart failure and by 65 percent for low back pain relative to the 20-episode threshold. We believe that the smaller number of potentially eligible ASM participants under a higher EBCM episode threshold would make for a less reliable model test.

We considered but did not propose to add the MIPS low volume threshold of Medicare Part B allowed charges for covered professional services, Medicare patients that receive Medicare Part B covered professional services, and the number of Medicare Part B services provided for individual MIPS eligible clinicians as defined at Sec. 414.1305 as part of the ASM participant eligibility criteria. Adding the MIPS low volume threshold would mean that clinicians would have to meet the MIPS eligibility determinations as defined at Sec. 414.1305, as well as all other ASM participant eligibility criteria, to be identified as an ASM participant. We considered using the same low volume threshold for individual MIPS eligible clinicians given the use of the MVP framework for selecting measures for ASM and to identify ASM participants that furnish a sufficient volume of services related to ASM targeted chronic conditions. Given the importance of using EBCM episode volume to identify ASM participants, we found that inclusion of the MIPS low volume threshold in our ASM participant eligibility criteria would add a secondary service volume criterion. We estimate that the inclusion of the MIPS low volume threshold on top of the EBCM episode volume threshold could potentially decrease the number of ASM participants by more than 50 percent. We believe that the use of the EBCM 20-episode threshold would be a more appropriate criterion for identifying ASM.

We solicited public comments on our proposed ASM participant eligibility criteria at Sec. 512.710(b)(3) stating that the clinician must meet the EBCM episode volume threshold applicable to an ASM targeted chronic condition. We solicited public comments on our proposals at Sec. 512.710(e)(1) to use the heart failure EBCM as specified under MIPS to identify potential ASM heart failure participants and that clinicians who have 20 or more heart failure EBCM episodes attributed to them in accordance with the heart failure EBCM as specified under MIPS during the calendar year 2 years prior to the applicable ASM performance year would meet the ASM participant eligibility criterion at Sec. 512.710(b)(3). We solicited public comments on our proposal at Sec. 512.710(e)(2) to use the low back pain EBCM as specified under MIPS to identify potential ASM low back pain participants and clinicians who have 20 or more low back pain EBCM episodes attributed to them in accordance with the low back pain EBCM under MIPS during the calendar year 2 years prior to the applicable ASM performance year would meet the ASM participant eligibility criterion at Sec. 512.710(b)(3). We requested feedback on specifying a higher episode volume threshold and using the MIPS low-volume threshold of Medicare Part B allowed charges for covered professional services for identifying clinicians who provide a sufficient volume of services.

The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the use of the heart failure EBCM to determine ASM participant eligibility in order to promote consistency between MIPS, MVPs and ASM and align specialist incentives. Another commenter supported the proposal to use low back pain EBCM, noting alignment of specialty incentives with value-based care. A couple of commenters stated that the use of EBCMs has the potential to improve care coordination and reduce unnecessary spending.

Response: We appreciate the commenters for supporting use of EBCMs in the ASM participant eligibility criteria. We agree that it promotes consistency between MIPS and the alignment of specialist incentives. We also agree that the use of EBCMs could help reduce unnecessary spending, and we will include the measure as part of the cost ASM performance category.

Comment: A few commenters expressed concerns with the proposal to use the heart failure and low back pain EBCMs for determining ASM participation, particularly with attribution of the measure to clinicians. A few commenters stated that EBCMs may not attribute the right clinician or may capture short, high-complexity episodes and hold specialists accountable despite a lack of longitudinal control. Another commenter suggested that CMS add inclusion/exclusion criteria, such as geographic restriction, combination of care patterns or other options to remove episodes that are consultative or tertiary.

Response: We appreciate commenters sharing their concerns on the use of the EBCMs in determining ASM participation. We recognize that episodes based on visits may not pick up all beneficiaries with heart failure or low back pain, but do not agree that the included EBCMs would only capture short, high-complexity episodes. We also disagree that the EBCM episodes would purely be consultative in nature as they require an ongoing care relationship for attribution. We also do not agree that it would be necessary to add exclusion criteria for EBCMs, such as the ones suggested by the commenter. The triggering and confirming codes for the heart failure and low back pain EBCMs focus on care provided by clinicians practicing in non-inpatient hospital settings, so we would not expect to pick up episodes that are

primarily tertiary in nature.\179\ We remind commenters that the EBCM attribution methodology for the purposes of assessing performance is more complex in its use of triggering and confirming claims than for determining participation. We refer readers to our discussion of the EBCM attribution methodology in section III.C.2.d.(3) of this final rule.

\179\ https://qpp.cms.gov/docs/cost_specifications/2025-06-py2025-mif-ebcm-heart-fail.pdf.

Comment: A commenter expressed concern about using the low back pain EBCM for ASM eligibility, noting the measure is still new and scores have not been released to determine current performance.

Response: The Quality Payment Program began identifying clinicians that provide low back pain services using the low back pain EBCM in the CY 2024 performance period. We believe it is appropriate to similarly include it as an ASM participant eligibility criterion. We do not believe the newness of the measure reduces its effectiveness for ASM participant identification. EBCMs are developed through an extensive process in concert with a panel of clinicians with expertise related to the applicable condition or procedure, including those to whom the measure would be attributed once implemented. More information on the EBCM development process can be found in the annual MIPS Summary of Cost Measures.\180\

\180\ https://www.cms.gov/medicare/quality/value-based-programs/cost-measures/about.

Comment: A commenter expressed concern that the use of EBCMs introduces a complex and potentially burdensome attribution method for an ASM participant to determine which patients would be attributed to an EBCM. The commenter recommended that CMS study the applicability and utilization of patient relationship codes to indicate their level of involvement in the patient's care to factor into patient attribution.

Response: We acknowledge concerns around understanding which patients would be attributed to a particular clinician. We note that the use of EBCMs for determining ASM eligibility would be done retroactively and would simply determine whether a particular clinician saw a sufficient number patients with low back pain or heart failure to be appropriate for inclusion in ASM. The ASM participant eligibility criteria are not reflective of the patients treated by the clinician. We acknowledge the commenter's recommendation to consider patient relationship codes in the ECBM attribution methodology. However, multiple programs and initiatives use the EBCMs and adjustments to the EBCM attribution methodology are out of scope of the ASM provisions. Should we consider incorporating patient relationship codes in the ASM participant eligibility criteria in the future, we would do so through notice and comment rulemaking.

Comment: A couple of commenters supported the proposal for a minimum annual threshold of 20 episodes per EBCM. A commenter stated that EBCMs are specifically designed to assess the conditions of interest and using them to identify participants seems appropriate. The commenter recommended that a case minimum of 20 episodes over 2 years be used, at a minimum, but requested CMS to consider a threshold of 25 to ensure at least one applicable patient per month.

Response: We appreciate the commenters for their support of the proposed 20 EBCM episode threshold in the ASM participant eligibility criteria. We would like to clarify that the 20-episode threshold would be determined within the applicable calendar year used to evaluate clinicians for the ASM participant eligibility criteria. As we discuss in the participant selection and notification process in section III.C.2.c.(5) of this final rule, we will use 2 years of EBCM data to identify the first group of ASM participants for the 2027 ASM performance year. We will use data from CY 2024 to identify preliminarily eligible ASM participants for the 2027 ASM performance year and then confirm their continued eligibility using EBCM data from CY 2025 before the model start. Beginning with the 2028 ASM performance year, we will continue to evaluate eligibility and identify potentially new ASM participants, including NPIs that may change TINs between ASM performance years, using 1 year of EBCM data.

Comment: Several commenters did not support the proposed minimum annual threshold of 20 episodes for EBCM to identify ASM participants. They stated that the proposed minimum of 20 episodes does not ensure statistical adequacy, particularly with practices with a small caseload. A commenter recommended that CMS consult actuaries and program evaluation experts to determine the appropriate volume cut off. Many commenters expressed concern that the proposed volume of 20 episodes would represent a small subset of the ASM participant patient populations and would put ASM participants at a disproportionate amount of risk for an unrepresentative sample of patients.

Response: We acknowledge the commenters' concerns regarding the 20 EBCM episode volume threshold. However, we disagree that it is an inappropriate volume of cases for determining ASM participant eligibility. A 20 EBCM episode threshold is consistent with the established case volume finalized for scoring of EBCMs in MIPS as described at Sec. 414.1350(c)(6). As we discussed in the CY 2018 PFS proposed rule (82 FR 30050 through 30051), increasing the case minimum to improve measure reliability would reduce the number of clinicians assessed by the measure. This would, therefore, limit the applicability of the episode measures to larger group practices with sufficient case volume at the expense of individual providers who we wish to include in ASM. For measures to have the potential to improve performance, they should apply to as many clinicians as can be reliably measured. For a full discussion of the reliability of the 20-episode case minimum for the chronic condition EBCM measures, we refer readers to the CY 2022 PFS final rule (86 FR 65453 through 65455). We acknowledge that not all FFS beneficiaries with ASM targeted chronic conditions may be captured by the applicable EBCM given the EBCM attribution methodology. However, we believe that using an objective threshold based on these episode- based measures would appropriately identify clinicians who provide a higher volume of services related to heart failure or low back pain that would make it appropriate to hold them accountable for quality and spending. Therefore, we disagree with the comment that the 20-episode threshold would identify ASM participants who would have an underrepresented number of beneficiaries with ASM targeted chronic conditions. In the analysis we conducted to propose the 20-episode threshold, we found that the average historical EBCM episode volume for clinicians that would likely meet the ASM participant eligibility criteria was typically 2 to 6 times higher than the 20-episode threshold.

Comment: Several commenters recommended that CMS adopt higher minimum thresholds for EBCMs. A few commenters suggested increasing the threshold to 50 episodes at the individual or practice level. Another commenter suggested 30 episodes. A commenter referenced an Agency for Healthcare Research and Quality (AHRQ) recommendation of 30 to 50 patients per physician for calculating individual performance measure scores,

noting that larger samples are required for reliable comparisons; the commenter also stated that research in healthcare quality measurement confirms at least 35 to 45 observations are needed to make valid comparisons for physician quality assessment. Finally, another commenter shared their belief that given the complexities of heart failure management and the potential for multiple influencing factors, a more appropriate minimum sample size should be in the range of 100 to 200 encounters.

Response: We appreciate the commenters for their feedback on a potentially higher EBCM episode threshold in the ASM participant eligibility criteria. We acknowledge the commenter citing AHRQ's recommendation to use 30 to 50 patients per physician to calculate individual measure scores, as well as the suggestion that 35 to 45 observations would allow for valid physician-level measurement. While these recommendations are relevant to the measurement of ASM participants at the individual level, as we discussed earlier in this section of this final rule, we believe that the 20-episode threshold would be a reliable threshold to identify ASM participants who could be scored on ASM performance and, ultimately, held accountable for quality and spending. We based this threshold on the current minimum case volume for scoring the applicable EBCMs under the MIPS cost performance category described at Sec. 414.1350(c)(6). Therefore, the proposed 20- episode threshold under ASM aligns with the MIPS/MVP measurement framework that determines when a MIPS-eligible clinician should be held accountable on EBCMs. As we discussed in the CY 2026 PFS proposed rule, increasing the episode threshold in the ASM participant eligibility criteria to 30 or 50 episodes could significantly reduce the number of potential ASM participants and create a less reliable model test (90 FR 32568). Finally, given the average number of applicable EBCM episodes that were attributed to potential ASM participants, we believe that a 100 to 200-episode threshold would be limiting and exclude a high number of potential ASM participants that we believe should be held accountable for heart failure and low back pain outcomes and spending.

Comment: A few commenters acknowledged the CMS estimates of 43 percent of the cardiologists in the ASM heart failure cohort and 35 percent of specialists in the ASM low back pain cohort had only 20 to 29 heart failure and low back pain episodes, respectively.

Response: We appreciate the commenters for their input but would like to flag that their comments do not correctly reflect the data we provided in the CY 2026 PFS proposed rule. In the CY 2026 PFS proposed rule, we stated that increasing the EBCM episode from 20 episodes to 30 episodes would decrease the number of potentially eligible ASM participants by 43 percent for heart failure and 35 percent for low back pain relative to the 20-episode threshold (90 FR 32568). These figures represent percentage changes of eligible ASM participants between two different episode thresholds and not the percentage of likely ASM participants that had between 20 and 29 applicable EBCM episodes.

Comment: A commenter noted that the proposed 20-patient threshold for EBCMs systematically excludes rural clinicians from quality programs because rural cardiology practices maintain significantly smaller patient panels.

Response: We acknowledge the concern of potential exclusion of clinicians in small rural practices from ASM due to the size of their patient panels. We note that we have not proposed any specific exclusions for rural practices beyond that of rural areas that do not meet our definition of a mandatory geographic area; we refer readers to section III.C.2.c.(4) of this final rule for further discussion on the mandatory geographic area definition and potential exclusions. While we understand that some clinicians in small rural practices may not meet the 20 EBCM episode threshold, we believe that it would not be fair to include clinicians in ASM if we could not reliably score them on the applicable EBCM.

Comment: A commenter requested that CMS clarify eligibility related to the low back pain 20 EBCM episodes and requested CMS to publish draft ICD-10 and CPT inclusion lists at least 12 months prior to the first ASM performance year. The commenter shared their belief that early code transparency enables accurate EHR logic, clearer clinician communications, and seamless reporting for clinicians.

Response: We appreciate the commenter requesting additional clarity on the ICD-10 and CPT codes used in the EBCMs. We maintain a current Operational List of Care Episode & Patient Condition Codes with the ICD-10 and CPT/HCPCS codes used to construct EBCM episodes on the Quality Payment Program Cost Measures page of CMS website.\181\

\181\ 2026 Operational List of Care Episode & Patient Condition Codes (XLSX). https://www.cms.gov/medicare/quality/value-based-programs/cost-measures/about.

After consideration of public comments, we are finalizing without modification our proposal at Sec. 512.710(b)(3) to use the EBCM episode volume threshold applicable to an ASM targeted chronic conditions as an ASM participant eligibility criterion. We are also finalizing without modification our proposal at Sec. 512.710(e)(1) to use the heart failure EBCM as specified under MIPS to identify potential ASM heart failure participants and clinicians who have 20 or more heart failure EBCM episodes attributed to them during the calendar year 2 years prior to the applicable ASM performance year would meet the ASM participant eligibility criterion at Sec. 512.710(b)(3). We are similarly finalizing without modification our proposal at Sec. 512.710(e)(2) to use the low back pain EBCM as specified under MIPS to identify potential ASM low back pain participants and clinicians who have 20 or more low back pain EBCM episodes attributed to them during the calendar year 2 years prior to the applicable ASM performance year would meet the ASM participant eligibility criterion at Sec. 512.710(b)(3). (4) Mandatory Geographic Areas (a) Identification of Geographic Areas

We proposed at Sec. 512.710(f) that only clinicians in certain selected areas would be required to participate in the model. As proposed in Sec. 512.710(f), the proposed unit of selection is CBSAs except in cases where OMB has divided large metropolitan statistical areas (MSAs) into metropolitan divisions. For these MSAs, we proposed to use these metropolitan divisions in place of the CBSA. Using metropolitan divisions rather than large MSAs would enable more precise matching of intervention and control groups by using geographic units of more comparable size, which would improve the statistical validity of our evaluation approach.

OMB Bulletin 23-01, issued on July 21, 2023, states that there are 935 CBSAs in the United States and Puerto Rico. OMB delineates MSAs and micropolitan statistical areas, which are referred to collectively as CBSAs. The general concept of the MSA and micropolitan statistical area is that of a core area containing a substantial population nucleus, together with adjacent communities having a high degree of economic and social

integration with that core. MSAs contain at least one urban area of 50,000 or more population; micropolitan statistical areas contain at least one urban area of at least 10,000 and less than 50,000 population.

If specified criteria are met, an MSA containing a single core with a population of 2.5 million or more may be subdivided into metropolitan divisions, which function as distinct areas within the larger metropolitan statistical area. CBSAs are composed of entire counties. There are 393 MSAs, of which 13 are subdivided into 37 metropolitan divisions, and 542 micropolitan statistical areas in the United States and Puerto Rico, as of July 2023.

We also considered using the following geographic areas as the geographic unit from which ASM participants are identified: (1) certain ZIP Codes based on their Hospital Referral Regions (HRR); or (2) certain states. We considered selecting based on HRRs for ASM. HRRs represent regional health care markets for tertiary medical care and are defined by determining where most patients were referred for major cardiovascular surgical procedures and for neurosurgery. There are 306 HRRs with at least one city where both major cardiovascular surgical procedures and neurosurgery are performed. While HRRs may sufficiently reflect referral patterns for heart failure episodes of care, they are less appropriate for low back pain episodes. Therefore, we decided that using CBSAs and metropolitan divisions as a geographic unit is preferable over HRRs for this model.

We also considered selecting states as the geographic unit of selection for ASM. However, we concluded that CBSAs and metropolitan divisions would provide a more granular unit of analysis, allowing for better matching of comparison areas. Additionally, selecting states would greatly reduce the number of independent geographic areas subject to selection under the model, and thus would decrease the statistical power of the model evaluation. Finally, CBSAs and metropolitan divisions straddle state lines where providers and Medicare beneficiaries can easily cross these boundaries for health care.

We proposed that we would select the CBSAs and metropolitan divisions through the stratified random sampling methodology described later in this section of this final rule to participate in ASM. Although CBSAs are revised periodically, we proposed to use the CBSA and metropolitan division designations in OMB Bulletin 23-01 issued on July 21, 2023 as the CBSA designations for purposes of selecting participants for this model, regardless of whether such CBSA designations have changed since July 21, 2023, or would change at some point during the ASM test period. We believe that this approach would best maintain the consistency of the ASM participants in the model, which is crucial for our ability to evaluate the effects of the model test on quality of care and changes in Medicare spending.

As discussed later in this in section III.C.2.c.(4).(e) of this final rule, we proposed in Sec. 512.710(f)(4) to use the ZIP Codes of the service locations of each clinician as discussed in section III.C.2.c.(4).(e) of this final rule to assign each clinician to a single CBSA or metropolitan division. Each clinician that CMS determines falls under the selected CBSA or metropolitan division, and that otherwise meets the other eligibility criteria set forth in Sec. 512.710(b), would be required to participate in the model.

Based on our proposal to randomly select CBSAs and metropolitan divisions as ASM's mandatory geographic areas, we proposed that IP Codes and other areas not located in a CBSA or metropolitan division would not be included in the ASM selection methodology as discussed in section III.C.2.c.(4).(b) of this final rule. We note that Transforming Episode Accountability Model (TEAM), a mandatory episode-based payment model, uses CBSAs as the geographic unit of selection (as defined in Sec. 512.515). We note that the proposed mandatory geographic areas may include some areas considered as rural areas under MIPS, which defines rural areas at Sec. 414.1305 as a ZIP Code designated as rural by the Health Resources and Services Administration's Federal Office of Rural Health Policy (FORHP), using the most recent FORHP Eligible ZIP Code file available.

We solicited comments on our proposal to use CBSAs and metropolitan divisions as the geographic unit from which ASM participants are identified. We sought comments on our proposal to use the ZIP Codes of the service locations of each clinician as discussed in section III.C.2.c.(4).(e) of this final rule to assign each clinician to a single CBSA or metropolitan division, including ZIP Codes designated as rural by HRSA's FORHP using the most recent FORHP Eligible ZIP Code file available. We sought comment on our proposal to require all eligible clinicians within a CBSA or metropolitan division that the Innovation Center selects through the stratified random sampling methodology as part of the intervention group described in section III.C.2.c.(4).(d) in this final rule to participate in ASM. Finally, we sought comments on our proposal to use the CBSA and metropolitan division designations in OMB Bulletin 23-01 issued on July 21, 2023 as the CBSA designations for purposes of selecting participants for this model.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters did not support the mandatory geographic area proposal citing concerns about the mandatory nature of the model, clinician inability to voluntarily opt-in, differential physician payment rates and access to quality patient care. A few commenters raised concerns about mandating rural clinicians to participate in the model. A commenter suggested that CMS finalize a voluntary participation option for clinicians within the FORHP- designated rural area. A commenter expressed concern that the model had not been piloted on a voluntary basis to assess operational feasibility, resource needs, and potential unintended consequences. Another commenter shared their belief that the proposed ASM geographic selection is too broad to test a mandatory model and encouraged CMS to limit its geographic scope initially and expand after conducting statutorily required evaluations. Another commenter voiced concern that mandatory ASM participation for specialists in selected geographic regions could stifle innovation. A few commenters recommended excluding specific states, Kentucky and Indiana, from mandatory geographic selection and cited rural health care challenges for clinicians.

Response: We appreciate commenters for their feedback on our proposed random selection of CBSAs and metropolitan divisions for mandatory participation in ASM. Mandatory participation in the model is important for ensuring a valid and robust model evaluation; allowing clinicians to opt in or opt out of the model would undermine the comparability between the intervention and comparison groups. The proposed geographic scope of ASM is important to ensure adequate statistical power to measure the effects of ASM on key outcomes. Including participants in rural areas is necessary to evaluate the impacts of the model if it were to be expanded to rural areas. We note that CBSAs with low volume of eligible episodes (that is, CBSAs with no eligible clinicians with at least 20

episodes in the reference year), which includes some rural areas, will be excluded from the model. Additionally, rural areas not assigned to a CBSA will be excluded.

Comment: A commenter recommended a voluntary approach to ASM to allow hospitals outside designated regions to participate. Another commenter recommended including the Los Angeles, Long Beach and Anaheim CBSA in Cohort 1, and shared their belief that diverse population, concentration of specialists, and healthcare environment would serve as an environment to test the model.

Response: We appreciate the commenters for their feedback on allowing hospitals outside designated regions to participate in ASM. Allowing participants to voluntarily opt into the model would allow participants to self-select into the model; hospitals, practices, or providers who voluntarily opt in would likely differ from those who do not opt in in important but unobservable ways and would therefore undermine the comparability between the intervention and comparison groups, which would weaken the model evaluation.

Comment: A commenter supported the proposal and shared their belief that it allows for real value comparisons.

Response: We appreciate the commenter for their feedback. Allowing for meaningful comparison between the model participants and a comparison group where the model is not being implemented is an important aspect of the model design and will help us to conduct a reliable evaluation of the model.

Comment: A commenter did not support the proposal and shared their belief that the heart failure EBCM attribution method assigns patients to cardiologists practicing at a distant location, even when the patients receive most of their care locally. The commenter recommended CMS to reconsider geographic attribution when patients live over 50 miles away and are primarily treated by clinicians locally.

Response: We appreciate the comment regarding patient attribution in the heart failure EBCM. This approach is used by MIPS to attribute episodes of care to a clinician or clinician group. This method is intended to reflect meaningful clinical involvement in an episode of care but does not directly account for the geographic location of the clinician and beneficiary; we acknowledge that in some cases, it may assign an episode to a clinician practicing at a distant location. Unfortunately, this is a limitation of the claims data available for episode attribution, and CMS does not have available any viable alternative data sources for attributing episodes.

Comment: Several commenters did not support the proposed mandatory geographic area sampling procedure for various reasons. A commenter expressed concern on whether CMS' proposed approach of mandating physician participation in randomly selected regions and prohibiting it in others would produce comparable groups for evaluation over time. Another commenter recommended allowing physicians in all CBSAs to participate, noting it would ensure fair evaluation and a more accurate quality performance assessment. A commenter suggested that CMS' proposal to randomly select a stratified sample of CBSAs for mandatory participation could raise fairness concerns, as practices in chosen regions could face unequal challenges or benefits. The commenter recommended that CMS implement risk adjustment approaches to address differences in patient populations and resources across regions. A separate? commenter shared their belief that the proposed geographic selection was too large for a mandatory model and encouraged CMS to narrow the geographic scope initially. Another commenter expressed concern that mandatory participation in ASM based on geographic location and specialty code could include physicians whose practices or patient populations are not relevant to the model's goals, such as proceduralists who lack longitudinal patient relationships necessary to impact patient outcomes. Another commenter expressed concerns about the potential impact of a mandatory design without adequate voluntary testing, particularly on smaller, independent, and rural specialists, who may often lack resources to manage two-sided risk and absorb financial losses.

Response: We appreciate the commenters for their feedback on our proposed geographic area sampling procedure. We acknowledge that participants may exit or enter the model from performance year to performance year based on changes in episode volume, but we do not anticipate that this will reduce the comparability of the comparison group over time because both intervention and comparison areas should be evenly affected.

Allowing participants to voluntarily opt into the model would undermine the comparability between the intervention and comparison groups, which would undermine the model evaluation. We acknowledge that clinicians and practices in selected regions could face challenges or benefits as part of the ASM test, but this is necessary to ensure a valid evaluation of the model test. The evaluation will use appropriate risk adjustment approaches to account for differences in patient populations and resources across regions.

We considered options for the geographic scope of the model and determined that the proposed model size is appropriate to maximize statistical power for evaluating the impacts of the model on spending and quality of care, and the proposed model size also aligns with CMS policy goals. The model limits participation to specific specialties identified as the most relevant and appropriate for inclusion for the model's goals. As ASM is a CMS model test and based on an existing MIPS and MVP framework, we do not agree that a voluntary model test of ASM is necessary before testing a mandatory design.

After consideration of public comments, we are finalizing our proposed policy to use CBSAs and metropolitan divisions as the geographic unit for selection and to use the ZIP Codes of the service locations of each clinician as discussed in section III.C.2.c.(4).(e) of this final rule to assign each clinician to a single CBSA or metropolitan division including ZIP Codes designated as rural by HRSA's FORHP using the most recent FORHP Eligible ZIP Code file available. We are finalizing our proposed policy to require all eligible clinicians within a CBSA or metropolitan division that the Innovation Center selects through the stratified random sampling methodology as part of the intervention group described in section III.C.2.c.(4).(d) in this final rule to participate in ASM. Finally, we are finalizing our proposed policy to use the CBSA and metropolitan division designations in OMB Bulletin 23-01 issued on July 21, 2023 as the CBSA designations for purposes of selecting participants for this model. We are finalizing these provisions at Sec. 512.710(f) and Sec. 512.710(f)(2). (b) Exclusion of Certain CBSAs and Metropolitan Divisions

We proposed at Sec. 512.710(f)(1) that we would not consider certain CBSAs or metropolitan divisions for selection. Specifically, we proposed at Sec. 512.710(f)(1)(ii) that we would exclude any CBSA or metropolitan division located entirely in U.S. territories due to challenges we would have in finding suitable geographic areas for comparison. We also proposed at Sec. 512.710(f)(1)(i) to exclude any CBSAs

or metropolitan divisions that do not have any clinicians of the mandated specialty types with at least 20 eligible episodes between January 1, 2024 and December 31, 2024 in accordance with the EBCM episode threshold described in section III.C.3.c.(3).(b) of this final rule. We believe it is unlikely for these CBSAs or metropolitan divisions to have data available for evaluation after the model starts. After applying these criteria, we expect to have approximately 600 CBSA and metropolitan divisions remain available for selection into ASM.

We considered the alternative of excluding from ASM any CBSA or metropolitan divisions located within a state or portion of a state with a commitment to participate in the Advancing All-Payer Health Equity Approaches and Development (AHEAD) model. The AHEAD model is a state-wide CMS Innovation Center model implemented under section 1115A of the Act that aims to increase investment in primary care, provide financial stability for hospitals, and support beneficiary connections to community resources. We decided not to propose these exclusions because ASM would not interact with the payment methodology in AHEAD and may help align a broader set of clinicians towards the goals of AHEAD.

We sought comments on our proposal to exclude from selection any CBSA or metropolitan division located entirely in a U.S. territory and any CBSAs or metropolitan divisions that do not have any clinicians of the mandated specialty types with at least 20 eligible episodes between January 1, 2024 and December 31, 2024. We sought comments on the alternative to exclude AHEAD geographies from ASM's mandatory CBSA or metropolitan divisions.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters wanted clarification on whether Maryland providers, historically excluded from other CMS models, would be included or excluded from ASM.

Response: We appreciate the commenters for seeking clarification on the reason for including Maryland providers in ASM. Maryland providers will not be excluded from ASM; CBSAs and metropolitan divisions that are in Maryland (either partially or completely) will be included for random selection. We acknowledge that other CMS models have excluded Maryland from participation because of concerns about model overlap (for example, with Maryland's all-payer model). We considered excluding CBSAs that overlap with Maryland from selection for ASM but determined that concerns about model overlap were not significant enough to justify exclusion from ASM.

Comment: A commenter recommended that CMS consider excluding CBSAs in states subject to CMS' new Wasteful and Inappropriate Service Reduction (WISeR) Model. The commenter expressed concern that this would create additional burden because the WISeR Model focuses on similar low back pain services.

Response: We appreciate the commenters for their feedback on our proposed geographic area exclusions. We considered exclusions on the basis of overlap with other Innovation Center models including WISeR. Like ASM, WISeR also seeks to reduce the use of low-value services. Participants in WISeR will be companies using technologies to try to improve the review process for select services. Clinicians, including ASM participants, will not directly participate in WISeR, but may be required to interact with the model when seeking prior authorization. However, we do not agree that overlap with WISeR will create significant burden on ASM participants to justify excluding these states from ASM.

After consideration of public comments, we are finalizing our proposed policy to exclude from selection any CBSA or metropolitan division located entirely in a U.S. territory and any CBSAs or metropolitan divisions that do not have any clinicians of the mandated specialty types with at least 20 eligible episodes between January 1, 2024 and December 31, 2024. We are finalizing these provisions at Sec. 512.710(f)(1). (c) Geographic Selection Methodology

To determine which CBSAs and metropolitan divisions would be included in the model, we proposed to use a stratified random sampling method to select approximately 25 percent of CBSAs and metropolitan divisions into ASM following the process described in the following two sections of this final rule. We proposed at Sec. 512.710(f)(2) to stratify CBSAs and metropolitan divisions into mutually exclusive groups based on three CBSA/metropolitan division-level characteristics: average total Parts A and B episode spending, volume of eligible episodes, and metropolitan division status. We proposed at Sec. 512.710(f)(2)(i) through (vi) stratifying eligible CBSAs into six mutually exclusive groups:

Eligible CBSAs with “Low” average total episode spending (as defined below) and “Low” eligible episode volume (as defined below);

Eligible CBSAs with “Low” average total episode spending and “High” eligible episode volume (as defined below);

Eligible CBSAs with “High” average total episode spending (as defined below) and “Low” eligible episode volume;

Eligible CBSAs with “High” average total episode spending and “High” eligible episode volume;

Eligible CBSAs with “Very High” eligible episode volume (as defined below);

Eligible metropolitan divisions. (i) Average Total Parts A and B Episode Spending

We proposed at Sec. 512.710(f)(2) to measure average total Medicare Parts A and B episode spending using claims data from January 1, 2024 to December 31, 2024. One of the main objectives of ASM is to reduce spending, and therefore, it would be important to account for the significant variation in average episode spending across geographic areas. This stratification would help ensure that we can measure any variation in model effects between high and low spending areas. We proposed to use a single, pooled measure including spending for both heart failure and low back pain episodes. This would help limit the number of overall strata and we believe would allow for adequate representation of both high spending low back pain areas and high spending heart failure areas, where the potential for savings may be greatest. We proposed to categorize CBSAs into two categories based on average total parts A & B episode spending: below the median (“Low”) and at-or-above the median (“High”). (ii) Volume of Eligible Episodes

We proposed at Sec. 512.710(f)(2) to measure eligible episode volume using claims data from January 1, 2024 to December 31, 2024. We expect significant variation in the volume of eligible episodes across areas. This variation may reflect differences in other characteristics that are related to ASM performance. For example, large, active markets with a larger number of specialists may have structural advantages in performing well in ASM compared to smaller, less active markets. The proposed stratification on volume of eligible episodes would help ensure we select an adequate sample of areas with varying levels of specialty

activity so that we would be able to identify statistical differences in outcomes across levels of specialty activity. This stratification would also help ensure that selected CBSAs have sufficient episode volume to support a robust evaluation. We proposed to use a single, pooled measure including both heart failure and low back pain episodes. This allows us to limit our number of stratification variables and analysis of 2023 episode-level data found that the episode volumes of the two conditions are highly correlated across CBSAs. We proposed to categorize CBSAs into three categories based on total episode volume: below median (“Low”), at-or-above median up to the 95th percentile (“High”), and the 95th percentile and above (“Very High”). We proposed to stratify out the top 5 percent of CBSAs by episode volume because of the right-skewed nature of the episode volume distribution. (iii) Metropolitan Divisions

The largest 13 CBSAs are divided into 37 metropolitan divisions. Metropolitan divisions therefore represent a subdivision level compared to CBSAs. Additionally, these metropolitan divisions, all belonging to CBSAs with a core population of 2.5 million or more, may have important characteristics in common beyond episode volume and average total spending. To ensure adequate representation of metropolitan divisions in the sample, we proposed to categorize metropolitan divisions into their own stratum.

We considered stratifying by other characteristics, including ACO penetration, supply of PCPs, region, rurality, and participation in the AHEAD model. We sought comments on our proposed selection strata as well as alternatives considered.

We did not receive public comments on this provision, and therefore, we are finalizing these provisions as proposed at Sec. 512.710(f)(2). [GRAPHIC] [TIFF OMITTED] TR05NO25.108

(d) Stratified Random Selection of Mandatory Geographic Areas

A representative sample of clinicians that meet eligibility requirements for the proposed ASM is necessary for a robust evaluation of the model. Testing the model in this manner would also allow us to learn more about utilization patterns of health care services and how to incentivize the improvement of quality and care coordination for chronic heart failure and low back pain. This learning could potentially inform the Quality Payment Program and the future of the MVP reporting option. Therefore, we proposed a broad, representative sample of clinicians in multiple geographic areas. We determined that the best method for obtaining the necessarily diverse, representative group of clinicians would be through stratified, random selection. A stratified, randomly selected sample would allow us to ensure statistical balance across characteristics of interest (for example, average spending and episode volume) and would provide results that applies generally to similar Medicare clinicians that submit FFS claims and treat heart failure or low back pain and would allow for a more robust evaluation of the model. We also believe that there could be broader learnings from ASM that could apply to other conditions and specialists.

At Sec. 512.710(f)(3), we proposed to randomly select CBSAs and metropolitan divisions for ASM from the six stratified groups described above at a 40 percent rate (that is, each CBSA and metropolitan division in each stratum has a 40 percent chance of being selected into the model). If 40 percent of a given stratum does not result in a whole number of CBSAs or metropolitan divisions, CMS would round up to the next whole number to ensure that at least 40 percent of areas from each stratum are selected. Table B-D3 provides an illustrative example of the six stratified groups based on CY 2023 data. We considered using other selection rates but based on preliminary analyses, we believe these selection rates would produce adequate sample size and participant mix for the model test. We refer readers to the regulatory impact analysis in section VII. of this final rule for further discussion on the scale of ASM and its estimated financial impact.

We conducted power analyses to identify detectable changes in total and episode spending between a potential group of CBSAs and metropolitan divisions selected for the model and a potential control group of CBSAs using a Type I error of 0.05 and Type 2 error of 0.2 (implying a power of 0.8). The analysis shows that, if 240 eligible CBSAs are selected for ASM, we would be able to detect about a 3.5 percent change in total episode spending if we look at heart failure and low back pain episodes separately. Allowing a higher Type I error of 0.25 and pooling heart failure and low back pain episodes would allow us to detect about a 1.7 percent change in total episode spending.

This model may be underpowered to detect statistically significant changes in total spending. However, the model may be more likely to generate statistically significant savings among certain low-value services or spending categories that are major cost drivers for heart

failure and low back pain (for example, imaging, surgeries, hospital admissions). In a case where the model's impact on total spending is ambiguous, significant savings among these categories of spending may provide strong supporting evidence that Medicare saved money overall.

We solicited public comments on our proposed approach to random selection of CBSAs and metropolitan divisions from our proposed selection strata as well as all alternatives considered.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter recommended that CMS should consider improving the ASM methodology to support the delivery of higher quality care for patients by eliminating the proposed limit of 240 for the number of randomly selected CBSAs and metropolitan divisions.

Response: We did not propose a limit of 240 CBSAs and metropolitan divisions but instead proposed to select about 40 percent of CBSAs and metropolitan divisions that meet the criteria for inclusion in the selection, which we estimate will result in approximately 240 CBSAs and metropolitan divisions being selected. This approach helps ensure as high a degree of statistical power as possible for the evaluation while also ensuring that we have an adequate number of CBSAs and metropolitan divisions not selected into the model to draw from for the comparison group.

Comment: A commenter recommended that CMS conduct certain statistical analyses (for example: power analysis) consistent with AHRQ guidelines and international standards to achieve at least 80 percent power to detect clinically meaningful differences.

Response: We appreciate the commenter for their feedback on our statistical approach. Our approach to conducting power analyses is consistent with AHRQ guidelines and we designed the model to maximize our ability to detect meaningful differences in total spending and relevant claims-based quality measures.

After consideration of public comments, we are finalizing our proposed policy for random selection of CBSAs and metropolitan divisions from our proposed selection strata as proposed at Sec. 512.710(f)(3). (e) Assignment of Geographic Areas to Clinicians

We proposed at Sec. 512.710(b)(4) that, to meet the ASM participant eligibility criteria, clinicians must be located in one of the selected mandatory geographic areas. We proposed at Sec. 512.710(f)(4) to assign a single CBSA or metropolitan division to each clinician based on the clinician's most common episode-level service location ZIP Code for each ASM performance year. We believe that it would be appropriate to use service location data from EBCM episodes to identify the CBSA or metropolitan division of clinicians' service locations given the use of the EBCMs as part of ASM participant eligibility criteria. As discussed in section III.C.2.c.(3).(b). of this final rule, EBCM episodes would help identify ASM participants who render a meaningful volume of services related to ASM's targeted chronic conditions. Using the service location from Medicare Part B claims of rendered services used to construct the episode as the basis for determining the service location of a clinician would keep a consistent and accurate source of data by which to make these geographic assignments. We also considered using the CBSA or metropolitan division related to the ZIP Code of the TIN to which a clinician has assigned billing rights for the purpose of determining whether a clinician furnishes ASM-related services in a mandatory geographic area. We believe that it would not be appropriate use a TIN's ZIP Code since a TIN's ZIP Code does not necessarily correlate to service location, particularly in the case of multi-site practices.

Using episode-level service location ZIP Code assignments, we proposed at Sec. 512.710(f)(4) the following process to identify clinician-level CBSA or metropolitan division assignments:

Identify all EBCM episodes relevant to ASM targeted chronic conditions attributed to a clinician during the calendar year 2 years before the applicable ASM performance year (or during January 1, 2024 through December 31, 2024 for initial CBSA or metropolitan division assignment).

For each episode, establish a service location ZIP Code. An episode may consist of several Medicare Part B Claims. Not all of the ZIP Codes set forth on the Medicare Part B claims form may be the same. To determine which ZIP Code the episode would be associated with, we proposed to review all applicable Medicare Part B claims associated with the episode and identify the Medicare Part B claim line ZIP Code appearing most often. An episode could have an equal number of ZIP Codes on claims associated with the episode. We would break any ties between ZIP Codes by determining the episode's ZIP Code based on the ZIP Code on the claim with the highest total cost indicated by the total standardized allowed amount, or in instances a second tie break is needed, by using the ZIP Code on the claim with the most recent date.

Match the ZIP Code assigned to each episode to a CBSA or metropolitan division. In other words, determine the CBSA or metropolitan division to which the episode is assigned. To do so, we proposed to use ZIP Code and CBSA/metropolitan division crosswalks published quarterly by the U.S. Department of Housing and Urban Development.\182\ Some CBSA and metropolitan division share ZIP Codes, meaning a ZIP Code could be assigned to multiple CBSAs and metropolitan divisions. In these instances, to ensure each ZIP Code is linked to a unique CBSA or metropolitan division, we would assign the ZIP Code to the CBSA or metropolitan division where the ZIP Code has the highest proportion of total addresses. For example, if ZIP-A spans CBSA-B and CBSA-C, and ZIP-A has more addresses in CBSA-B, then we would assign ZIP-A to CBSA-B. We would get the proportion of total addresses in each ZIP Code from the ZIP Code to CBSA/metropolitan division crosswalk published by the U.S. Department of Housing and Urban Development.\183\ The crosswalk also subdivides the proportion of total addresses into the number of business addresses, residence addresses, and other addresses. If the proportion of total addresses within the ZIP Code is equal across CBSAs or metropolitan divisions (meaning that we cannot use the proportion of total addresses to assign a single CBSA or metropolitan division to the ZIP Code), then we would assign the ZIP Code to the CBSA and metropolitan division (if applicable) with the highest proportion of business addresses (regardless of the number of residence addresses or other addresses). We use business addresses as the tiebreaker since business addresses would represent where clinicians would practice, which aligns with our overall approach for using service location for participant identification.

\182\ https://www.huduser.gov/portal/datasets/usps_crosswalk.html.

\183\ https://www.huduser.gov/portal/datasets/usps_crosswalk.html.

Determine the appropriate CBSA or metropolitan division for each clinician attributed applicable episodes. If the clinician is attributed multiple episodes in multiple CBSAs or metropolitan divisions, we would match the clinician with the CBSA or metropolitan division where the clinician has the most assigned episodes. If a clinician has an

equal number of episodes assigned to multiple CBSAs or metropolitan divisions, we will break such a tie by matching the clinician to the CBSA or metropolitan division that has the highest total risk-adjusted spending across all episodes assigned to each CBSA or metropolitan division. If a second tie break is needed, we would match the clinician to the CBSA or metropolitan division that has episodes with the more recent dates. For example, if a clinician has an equal number of episodes in CBSA-B and CBSA-C, but the episodes in CBSA-B collectively have a higher total risk-adjusted spending compared to all episodes in CBSA-C, then the clinician would be matched to CBSA-B.

We solicited comments on our proposed process at Sec. 512.710(f)(4) for determining the CBSA or metropolitan division of a clinician for each ASM performance year using EBCM data for the purposes of determining whether a clinician is located within a mandatory geographic area for each ASM performance year.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed use of episode- claims-based service ZIP Code to assign a CBSA or metropolitan division code to clinicians. A commenter recommended making the attribution method easier to track and identify ASM areas and patients. Another commenter acknowledged CMS for detailing the steps to assign providers performing services under multiple TINs within the same ZIP Code and participation requirements based on CBSA selections.

Response: We appreciate commenters for their support of our proposal to use the ZIP Code on claims used to construct EBCM episodes in assigning a CBSA or metropolitan division code to clinicians. Regarding the suggestion to make it easier to track and identify ASM areas and patients, the selected CBSAs and metropolitan divisions will not change during the model test period. Regarding the comment on how geographic area assignments would work for providers performing services under multiple TINs with the same ZIP Code, we would treat each TIN and NPI combination as separate entities to which we would assign a geographic area. We would assign each TIN and NPI combination a CBSA or metropolitan division based on the ZIP Code on the claims used to construct each EBCM episode that is attributed to each TIN and NPI combination. Under this approach, it is possible that an NPI could be assigned to the same or different geographic area for each TIN to which they have reassigned billing rights. We believe that this approach is preferable since our goal with using the ZIP Code from claims is to identify where clinicians are furnishing services the most.

Comment: A commenter supported the proposed approach to use a specialist's geographic location with a stratified sampling methodology to identify mandatory ASM participants

Response: We appreciate the commenters for their feedback on our proposed policy for assigning geographic areas to clinicians. We believe this is the most accurate and reliable approach given data and other constraints.

After consideration of public comments, we are finalizing the ASM participant eligibility criterion at Sec. 512.710(b)(4) as proposed. We are also finalizing our proposed policy to assign a single CBSA or metropolitan division to each clinician based on the clinician's most common episode-level service location ZIP Code for each ASM performance year as proposed at Sec. 512.710(f)(4). (5) Selection and Notification Process for ASM Participants

We proposed to identify ASM participants on an annual basis. At Sec. 512.710(g) we proposed to identify all clinicians furnishing covered services in accordance with the ASM participant eligibility criteria specified in section III.C.2.c.(3) of this final rule using applicable data from 2 calendar years prior to each ASM performance year. We also proposed that a clinician selected for participation for any ASM performance year would be considered an ASM participant for the remainder of the model.

We proposed at Sec. 512.710(g)(1)(i), for the 2027 ASM performance year/2029 ASM payment year only, to identify preliminarily eligible ASM participants using the ASM participant eligibility criteria and applicable data from calendar year 2024. If ASM is finalized as proposed, we proposed to make public preliminarily eligible ASM participants in a form and manner determined by CMS. We expected to release this information by the end of CY 2025. Then, to finalize the ASM participants for the 2027 ASM performance year/2029 ASM payment year, we proposed at Sec. 512.710(g)(1)(ii) to confirm that the preliminarily eligible ASM participants continue to meet the ASM participant eligibility criteria using more recent data from calendar year 2025. We proposed to make public the selected ASM participants for the 2027 ASM performance year/2029 ASM payment year in a form and manner determined by CMS. We expect to release this information by the end of July 2026, preceding the start of the 2027 ASM performance year/ 2029 ASM payment year. We believe that notifying preliminarily eligible ASM participants well before the start of the first ASM performance year in 2027 will provide ample time to become familiar with ASM requirements, make practice adjustments, and prepare for reporting of the required measures and data.

We also considered not releasing the preliminarily eligible ASM participants for the 2027 ASM performance year/2029 ASM payment year and, instead, only using applicable data from the 2025 calendar year to identify the final ASM participants for the 2027 ASM performance year/ 2029 ASM payment year. However, this alternative reduces the amount of time for ASM participants to prepare for the first ASM performance year and would potentially increase the operational burden for clinicians selected for the model.

We proposed at Sec. 512.710(g)(2)(i), for each ASM performance year beginning with the 2028 ASM performance year/2030 ASM payment year, to confirm that ASM participants continue to meet ASM participant eligibility criteria for the upcoming ASM performance year/ASM payment year using applicable data from the calendar year 2 years prior to the applicable ASM performance year. If an ASM participant does not meet the ASM participant eligibility criteria for the upcoming ASM performance year, then they would not be required to meet applicable ASM reporting requirements for the applicable ASM performance year. Further, waivers, including the MIPS waiver described at Sec. 512.775, would no longer apply to the ASM participant, and, if applicable, the ASM participant would be required to participate in MIPS.

Beginning with the 2028 ASM performance year/2030 ASM payment year, we proposed at Sec. 512.710(g)(2)(ii) to identify additional clinicians not previously identified as ASM participants who meet the ASM participant eligibility criteria at Sec. 512.710(b) for the upcoming ASM performance year/ASM payment year using data from the calendar year 2 years prior to the applicable ASM performance year.

We proposed that CMS would make public the final list of ASM participants for a given ASM performance year annually in a form and manner determined by CMS. We stated our

intention to release this information by the end of July in the year preceding the start of the applicable ASM performance year. We believe that annually identifying clinicians who meet the ASM participant eligibility criteria will ensure we are accurately selecting ASM participants. That is, ASM participants will continue to be of the required specialty type and meet the EBCM episode volume thresholds year-over-year. This approach to selecting ASM participants also allows us to account for movement of ASM participants to different practices within mandatory geographic areas and allows new ASM participants into the model over the ASM test period. We also believe that this approach will allow ASM to maintain an appropriate number of ASM participants over the ASM test period to produce a reliable model test.

We considered an alternative approach of establishing a fixed list of ASM participants for all ASM performance years. Under this alternative, we stated we would first identify ASM participants as clinicians that meet the ASM participant eligibility criteria using applicable data from the 2024 calendar year for the 2027 ASM performance year/2029 ASM payment year and release a list of preliminarily eligible ASM participants. We would then finalize the ASM participants for the 2027 ASM performance year/2029 ASM payment year using applicable data from the 2025 calendar year. Beginning in the 2028 ASM performance year/2030 ASM payment year, we would reconfirm that the final ASM participants identified for the 2027 ASM performance year/2029 ASM payment year continue to meet the ASM participant eligibility criteria for each ASM performance year thereafter using applicable data from 2 calendar years before the applicable ASM performance year. Under this alternative, we would not identify new ASM participants over the course of the ASM model test period. We stated that repeatedly reconfirming that the initial ASM participants continue to meet ASM participant eligibility criteria for each ASM performance year would result in attrition of any ASM participant who changes their association with a practice (that is, assigns billing rights to a different TIN) after the first ASM performance year based on our proposed identification of ASM participants at the TIN/NPI level. Accordingly, we believe that this alternative fixed-list approach would reduce the number of ASM participants over the ASM test period and the magnitude of this potential decrease could undermine the reliability of the model test.

We solicited comments on our proposed approach for selecting and notifying ASM participants at Sec. 512.710(g). We also sought comments on not producing a preliminary list of ASM participants using 2024 data for the 2027 ASM performance year/2029 ASM payment year and only identifying the final ASM participants using applicable data from the 2025 calendar year. We also sought comments on whether we should use a fixed list of ASM participants for all ASM performance years.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposal to evaluate the selection criteria for ASM participants on an annual basis.

Response: We appreciate the commenters for their support of evaluating ASM participant eligibility criteria annually.

Comment: A commenter recommended CMS to provide additional guidance on how clinicians would be selected for mandatory participation in ASM.

Response: We intend to release additional guidance about the ASM participant eligibility criteria following the publication of this final rule. We also intend to release the list of preliminarily eligible ASM participants for the CY 2027 ASM performance year in early 2026 through the CMS website. We refer the commenter to the ASM participant eligibility criteria review section III.C.2.c. of this final rule and the accompanying regulations at Sec. 512.710 for the final provisions related to mandatory participation.

Comment: A commenter supported the proposed release of a preliminary ASM participant list using data from CY 2024, noting that it would provide useful information for potential ASM participants. The commenter recommended that CMS provide multiple data snapshots throughout the year, similar to the Quality Payment Program Qualifying APM Participant status approach, to provide more accurate and timely participant data. Another commenter expressed concerns of a 2-year lag on episode attribution for the proposed preliminary ASM participant list using data from CY 2024. The commenter also noted that historical data may be insufficient to assess clinician practice patterns for a prospective model.

Response: We appreciate the support of our proposal to release the preliminary ASM participant list in advance. We recognize that releasing multiple data snapshots through the year, similar to the Quality Payment Program, would provide more timely data on potential eligibility to a clinician. We also recognize the challenges of lagged data. However, we believe that EBCM data is the most appropriate and objective criteria by which to identify clinicians for ASM participation. Because EBCMs are constructed at the completion of each calendar year, the data only becomes available on an annual basis. In order to provide as much advanced notice as possible to ASM participants, we must rely on EBCM data produced using data two years prior to the ASM performance year. Specifically, we will use the EBCM data from the year prior to notification, which takes place the year prior to the ASM performance year.

Comment: A few commenters expressed concern that ASM participants with only a few EBCM episodes may change ASM participation status year over year and not know if they were eligible until the end of the year. A commenter shared their belief that this could be confusing for ASM participants and possibly deter potential ASM participants from taking on more beneficiaries with heart failure or low back pain.

Response: We appreciate the commenters for their input. Use of an objective criteria, such as the 20 EBCM episode threshold, would mean that ASM participation status could change year-over-year depending on the volume of applicable EBCM episodes attributed to the clinician. We believe that this is inherent to a model that requires mandatory participation and reevaluates eligibility for each performance year. Beyond the first ASM performance year, for which we would give approximately 1 year notice of mandatory participation, we note that we intend to notify clinicians of their mandatory ASM participation status for all subsequent ASM performance years at least 6 months prior to the start of the ASM performance year, depending on data availability. This approach would prevent clinicians from being notified of mandatory participation at the end of a given ASM performance year. We do not agree that this threshold alone would create an incentive to drop or refuse to take on more FFS beneficiaries with heart failure or low back pain. As ASM is focused on specialists whose patient panels would include a high number of FFS beneficiaries with heart failure or low back pain, we believe decisions to avoid taking on additional beneficiaries with these conditions could lead to

downstream effects on the specialist's practice. Further, we believe that the potential for positive Part B payment adjustments through ASM would create an incentive for the clinician to continue to furnish services to FFS beneficiaries. We also note that we will monitor potential issues with patient access as part of ASM monitoring efforts.

Comment: A few commenters recommended CMS identify ASM participants with advance notice, establishing a clear and direct notification process for communicating to selected ASM participants. Another commenter requested CMS clarify how the Agency would communicate (for example, mail, email) with ASM participants about their inclusion in the model, considering ASM is a new model. Another commenter recommended CMS proactively reach out to solo and small practices with limited resources who may be disadvantaged by participating in a 5-year model. Another commenter recommended CMS clarify the types of data that would be included in the ASM preliminary eligibility notification.

Response: We appreciate commenters for their input. We are committed to ensuring potential ASM participants are appropriately notified through a variety of mechanisms. We expect to post the lists of ASM participants on the ASM website, contact selected ASM participants by email using the contact information on file with CMS, and work with the appropriate specialty societies to publicize the notification processes and communicate to their members the importance of ensuring their contact information is accurate and up to date. In addition, we intend to offer resources and webinars to preliminary ASM participants beginning in CY 2026. For the 2027 ASM performance year only, we will notify preliminarily eligible ASM participants using the ASM participant eligibility criteria and applicable data from CY 2024. Although we originally expected to release this information by the end of CY 2025, we now anticipate that the list will be made public in early 2026 in a form and manner determined by CMS. We anticipate subsequently notifying the final ASM participants for the 2027 ASM performance year around July 2026 using the ASM participant eligibility criteria and applicable data from calendar year 2025. We note that only clinicians on the preliminary eligible list will be considered for inclusion on the final participant list for the 2027 ASM performance year. For subsequent years, we expect to post the list of ASM participants on the ASM website and email ASM participants approximately 6 months before the start of the applicable ASM performance year using the ASM participant eligibility criteria and applicable data from the calendar year 2 years prior to the ASM performance year. Final lists will be maintained on the ASM website and selected ASM participants will be notified by email using the person of contact and contact information on file. We expect that the participant list will include at minimum, clinician NPI, state, and applicable ASM cohort. CMS will evaluate annually whether a clinician meets the ASM participant eligibility criteria using the information available in PECOS and specialties assigned to Medicare Part B claims. To avoid potential errors, clinicians can update their PECOS information if they believe that their specialty designation does not reflect their actual clinical practice.

Comment: A few commenters did not support the proposal to notify ASM participants only 6 months prior to the start of the first ASM performance year, noting an insufficient time for clinicians to prepare for model implementation. Another commenter requested CMS finalize the ASM participant list more than 6 months before the beginning of the first ASM performance year and notify both the individual clinicians and their TIN-level entity. Another commenter expressed concern that a 6-month advance notice would not be enough for ASM participants to prepare for new Electronic Clinical Quality Measure (eCQM) reporting.

Response: We appreciate the feedback on the timing of the release of the lists of ASM participants for each ASM performance year and the time that it would provide ASM participants to prepare for the model. As we discuss throughout this section of this final rule, we anticipate releasing the preliminary list of clinicians selected for participation for the 2027 ASM performance year based on CY 2024 data in early 2026; we would then reassess only clinicians on that list for the ASM participant eligibility criteria using CY 2025 data. We then plan to release that list 6 months before the start of the 2027 ASM performance year, providing nearly 12 months notice to potential ASM participants for the first ASM performance year. While we recognize that we intend to release the updated participant lists for subsequent ASM performance years, which could include new clinicians to the model, at least 6 months prior to the start of a given ASM performance year, we believe that clinicians who practice within a mandatory geographic area and would potentially be eligible for mandatory participation would likely be familiar with the model given our planned outreach and communication strategies. As we have discussed throughout this section of this final rule, we intend to provide educational resources throughout CY 2026 so that clinicians on the final 2027 ASM performance year participant list would be familiar with ASM's requirements and begin making the necessary adjustments, such as for eCQM reporting, to their workflows and systems.

After consideration of public comments, we are finalizing our proposed provisions related to identification and notification of ASM participants as proposed at Sec. 512.710(g). In particular, we are finalizing our proposal to produce a preliminary list of ASM participants using 2024 data for the 2027 ASM performance year/2029 ASM payment year as well as identifying the final ASM participants using applicable data from the 2025 calendar year as proposed. We are also finalizing as proposed to reassess clinicians for ASM participation annually, rather than use a fixed list of ASM participants for all ASM performance years. d. Performance Assessment Approach, Data Submission Requirements, and ASM Performance Category Requirements and Scoring

As discussed in the CY 2026 PFS proposed rule (90 FR 32560 through 90 FR 32561), we proposed to use the MVP framework, including its performance categories, to assess ASM participant performance related to improving quality of care and reducing low-value care related ASM targeted chronic conditions. We believe this framework offers a tested performance assessment framework to use in creating value-based incentives for ASM participants. In this section of this final rule, we discuss the performance measures and activities that will be used to assess the performance of ASM participants in four ASM performance categories of (1) quality, (2) cost, (3) improvement activities, and (4) Promoting Interoperability. We proposed to define at Sec. 512.705 in the CY 2026 proposed rule the “ASM performance category” as a group of applicable measures or activities used to assess an ASM participant's performance on quality, cost, improvement activities, or Promoting Interoperability. Tying a clinician's performance to certain measures and activities (as discussed below) in these performance categories would support ASM goals, as discussed

in section III.C.1 of this final rule, of decreasing the cost of care for beneficiaries with ASM's targeted chronic conditions as well as improving quality care as measured through a focused measure set relevant to ASM's clinical specialties and targeted chronic conditions.

The quality ASM performance category would assess the quality of care ASM participants delivered by measuring health care processes, outcomes, and patient experiences of care with the goal of improving the quality of care for beneficiaries with ASM's targeted chronic conditions.

The cost ASM performance category would assess the efficiency and cost-effectiveness of care provided to Medicare beneficiaries with ASM targeted chronic conditions with the goal of providing more cost-efficient care to generate cost savings.

The improvement activities ASM performance category would assess ASM participants in their efforts to make practice improvements that improve population health, enhance patient experiences and outcomes, reduce cost of care, and improve clinician experience. To meet ASM's practice improvement goals, ASM's improvement activities would incentivize practice improvements that would strengthen care management and processes related to ASM's targeted chronic conditions and would incentivize stronger integration between specialist and PCPs.

The Promoting Interoperability ASM performance category would assess ASM participants in their efforts to promote patient engagement and electronic exchange of information using CEHRT to enhance quality of care and reduce costs through more effective upstream chronic condition management and care integration related to ASM's targeted chronic conditions. Under ASM, CEHRT should meet the requirements set forth in Sec. 414.1305, except all instances of references to MIPS are to be replaced with references to ASM.

As further discussed in the CY 2026 proposed rule (90 FR 32576 through 32586), we proposed for the quality ASM performance category, cost ASM performance category, and promoting interoperability ASM performance category, to draw measures and activities from specific MVPs related to each of ASM's targeted chronic conditions to identify a cohesive set of vetted and clinically relevant measures and activities that would allow us to appropriately assess ASM participants on the care they deliver related to ASM's targeted chronic conditions. Using the same measures would mean the many ASM participants would already be familiar with the required measures and activities proposed in each of the ASM performance categories. However, as discussed in the CY 2026 PFS proposed rule (90 FR 32574 through 32576 and 90 FR 32604 through 32615), comparing performance on these measures and activities as measured by ASM performance category and final scores within each ASM cohort would result in payment adjustments based on direct peer-to-peer comparisons of similar specialists. For some ASM performance categories, we proposed to include measures from outside of the relevant MVP, such as from the broader inventory of MIPS measures, when we believe there is a clinically justifiable rationale for including such a measure. We proposed ASM-specific measures or activities in limited circumstances when we believe there is rationale for assessing performance or creating an incentive for practice improvement specific to ASM's targeted chronic conditions. For example, the improvement activities ASM performance category, as discussed in the CY 2026 PFS proposed rule (90 FR 32589 through 32594), includes ASM-specific improvement activities.

We also discussed how we proposed to score each ASM performance category within each of the ASM performance category sections within this section of this final rule. While many of the proposed scoring policies draw from MIPS, we proposed scoring policies that simplify some existing policies. As a mandatory model, simplification of scoring compared to some MIPS and MVP policies would make it easier for the ASM participant to understand how their performance in each of the ASM performance categories contributes to their final score and resulting payment adjustment. As part of this simplification, our proposed scoring policies ensure that each ASM participant would at minimum be measured on quality and cost, with further scoring adjustments based on performance in the improvement activities and Promoting Interoperability ASM performance categories, to determine payment adjustments.

As discussed in section III.C.2.e of this final rule, we plan to calculate a final score based on the quality, cost, improvement activities, and Promoting Interoperability performance categories scores for each ASM participant for each ASM performance year. The scores in the quality and cost ASM performance categories would positively impact the ASM final score while performance in the improvement activities and Promoting Interoperability ASM performance categories could result in negative scoring adjustments to the ASM final score.

In the following section III.C.2.d.(1).(a) of this final rule, we first discuss the ASM performance assessment approach. We then discuss data submission requirements applicable across the ASM performance categories in section III.C.2.d.(1).(b) of this final rule. Finally, we discuss specific requirements and scoring policies for each of the four ASM performance categories in sections III.C.2.d.(2) through III.C.2.d.(5) of this final rule. (1) Performance Assessment and Data Submission Requirements (a) ASM Performance Categories

We proposed in the CY 2026 proposed rule at Sec. 512.715(a)(1) through (3) that CMS uses the performance measures and activities described under Sec. Sec. 512.725(b) and (c), 512.730(b), 512.735(b), and 512.740(b) to assess ASM participants in the quality, cost, improvement activities, and Promoting Interoperability ASM performance categories. As discussed in section III.C.1 of this final rule, we believe that these ASM performance categories taken together would improve the quality of care and produce cost savings related to ASM's chronic conditions. Further, we believe that, taken together, the ASM performance categories provide a comprehensive understanding of an ASM participant's management of their beneficiaries' targeted chronic conditions.

We also believe that ASM participants, because of participation in other CMS programs including MIPS, would already be familiar with reporting (1) quality; (2) cost; (3) improvement activities; and (4) Promoting Interoperability performance categories to determine a final score. This proposed structure is similar to the performance assessment approach of other CMS programs like the MIPS reporting option of the Quality Payment Program. MIPS assesses the performance of MIPS eligible clinicians across four performance categories and then determines a MIPS payment adjustment factor that applies to the clinician's Medicare Part B payments for covered professional services finalized at Sec. Sec. 414.1380(a) and 414.1405(a) and as defined at Sec. 414.1305.

Under the proposed ASM performance categories, the value of care provided to chronic care patients would be assessed through performance

in the quality and cost performance categories, supported by performance in the improvement activities and Promoting Interoperability performance categories. Measures and activities CMS selects to assess an ASM's performance across the quality ASM performance category and cost ASM performance category would assess the value of care directly furnished to chronic care patients. Measuring ASM participants' cost and quality performance ensures that Medicare beneficiaries are receiving clinically appropriate, comprehensive, high-value care. Measuring cost and quality is essential to measuring the value of care provided to Medicare beneficiaries with chronic conditions. The improvement activities ASM performance category incentivizes care coordination and collaboration between specialty medicine and primary care, creating new opportunities for both groups playing vital roles in care management and coordination. And lastly, the Promoting Interoperability ASM performance category enables meaningful EHR use, the reporting of clinical quality measures, including electronic clinical quality measures (eCQMs) and continuous practice-based quality improvement and care transformation.

We believe that ASM's more targeted approach to performance assessment where we evaluate ASM participants within each ASM cohort across the ASM performance categories--(1) on a set of relevant performance measures that they are required to report; and (2) among clinicians furnishing similar sets of services, would produce final scores and subsequent payment adjustments, as described in section III.C.2.f of this final rule, that are more reflective of clinician performance. A more targeted approach to measurement would also offer more insight into how clinical decisions and processes, such as care coordination, affect patient outcomes. We believe this insight is necessary to support and incentivize accountable care, increasing beneficiary access to coordinated specialty care. Furthermore, equipped with more specialty-relevant performance information through participation in ASM, we expect clinicians would be more likely to invest resources in pursuit of better outcomes, reducing the incidence of poor outcomes arising from care fragmentation, ultimately resulting in better care for patients.

We proposed at Sec. 512.715(a), as further described in Sec. Sec. 512.725, 512.730, 512.735, and 512.740, that ASM participants would receive a specific number of points for their performance on each measure or activity within an ASM performance category. CMS assigns the total number of points that a measure or activity may receive. The total score across all four performance categories that an ASM participant may receive is capped at 100 points. The number of points awarded for an ASM's performance on a measure or activity corresponds to the level of performance, the higher the points, the better the performance. We proposed to define at Sec. 512.705 “ASM performance category score” as the assessment of each ASM participant's performance on the applicable measures and activities for a performance category during an ASM performance year based on the policies proposed at Sec. Sec. 512.715, 512.725, 512.730, 512.735, and 512.740. As further described later in this section of this final rule, CMS would, using an ASM participant's ASM performance category scores across all ASM performance categories, calculate an ASM participant's final score for an ASM performance year/ASM payment year in accordance with Sec. 512.745.

We proposed at Sec. 512.715(b)(1) to use Medicare claims data and administrative data to calculate some measures included in the quality and cost ASM performance categories under Sec. Sec. 512.725 and 512.730. We proposed at Sec. 512.715(b)(2) that we use other model- specific data reported by ASM participants to calculate measure or activity scores for the quality, improvement activities, and Promoting Interoperability ASM performance categories under Sec. Sec. 512.725, 512.735, and 512.740.

We solicited feedback from the public on our proposal to assess ASM participant performance across four ASM performance categories: (1) quality; (2) cost; (3) improvement activities; and (4) promoting interoperability. We sought comments on our proposal at Sec. 512.715(a) to set and assign specific points on measures or activities in each ASM performance category and to calculate a final score using points received across all four ASM performance categories as described at Sec. 512.745. Finally, we sought comments on our proposal at Sec. 512.715(b) to use Medicare claims, administrative data, and model- specific data reported by an ASM participant to calculate measure or activity scores used to calculate ASM performance category scores.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposal to use the four ASM performance categories for assessing the performance of ASM participants, noting that this approach would align the ASM performance framework with existing reporting programs and promote consistency in reporting. The commenters shared their belief that the proposed alignment would facilitate a smoother transition to ASM for clinicians and developers and increase participation in ASM.

Response: We appreciate the commenters for their support of the four ASM performance categories assessing performance. We, like the commenters, believe that aligning our performance framework with existing quality reporting programs will facilitate an easier transition into ASM.

Comment: A few commenters supported the proposed approach for ASM performance assessment and recommended that CMS should fully align ASM measure sets and scoring methodology with current MIPS reporting requirements, where feasible, to prevent duplicative reporting and ensure consistency across programs. A commenter recommended that CMS exclude from ASM any measure not included in MIPS or MIPS MVPs, to ensure alignment of measures for specialists across all reporting programs.

Response: We appreciate the commenters for their support of ASM's performance assessment framework. We note that all quality and cost measures being finalized for use in ASM in this final rule are already used in MIPS. However, we proposed different scoring policies for ASM performance categories compared to MIPS. Given ASM is a mandatory model that requires the reporting of a specific set of measures, compared to MIPS that allows for more flexibility in which measures a MIPS eligible clinician chooses to report, we believe that our scoring policies are fit-for-purpose so ASM participants will more easily understand how their performance will be determined under ASM. As a mandatory model, we also designed our scoring policies so that we ensure that quality and cost performance is factored into every participant's final score, which we believe aligns with holding all ASM participants accountable for quality and cost.

Comment: A few commenters did not support the proposed approach for ASM performance assessment using the four ASM performance categories. A commenter expressed concerns regarding ASM's approach to measuring specialist care, noting that a one-size-fits-all method is inadequate, and recommended CMS should assess performance at the episode level for more accuracy. Another commenter

noted specialists' concerns that the proposed ASM design based on the MVP framework relies on measures that are not relevant to low back pain and heart failure.

Response: We appreciate the commenters for sharing their concerns regarding ASM's four performance categories. We stress that though not all performance categories measure performance at the episode level, the cost performance category is evaluated at the episode level, which represents 50 percent of an ASM participant's final score. We believe a combination of episode-level cost scoring plus individual-level scoring of quality (or group-level in the case of small practices), in addition to improvement activities and Promoting Interoperability scores, is appropriate for determining overall participant performance. We also note that many of the selected measures, such as those finalized in the quality and cost measure sets, were chosen specifically for their relevance to ASM's targeted chronic conditions. The Promoting Interoperability and improvement activities ASM performance categories, though not condition-specific, are aimed at spurring transformational changes that support better quality care and lower costs.

Comment: A commenter expressed concern that ASM does not connect quality and cost measures in a meaningful way and recommended that CMS work with interested parties to identify better strategies for measuring quality and cost to ensure more accurate value-based evaluations of care.

Response: We appreciate the commenter for their comment but disagree because we believe that there is an alignment between the quality and cost measures applicable for each ASM cohort. Though not directly scored together, ASM's quality and cost performance categories are reflective of one another. For example, we believe that the Risk- Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with Heart Failure (MIPS Q492) quality measure will account for inappropriate withholding of care if a participant were to attempt to improve their cost performance through withholding of care. Additionally, the Low Back Pain Functional Status Change for Patients with Low Back Impairments (MIPS Q220) quality measure would result in a lower score for an ASM participant if they attempted to inappropriately limit necessary care to improve their cost performance score.

Comment: A commenter recommended either removing the improvement activities requirement or allowing flexibility in its selection, noting mandatory requirements for improvement activities would increase the burden on individual clinicians.

Response: We appreciate the commenter for sharing their concerns regarding the improvement activities ASM performance category measure. We believe that the improvement activities ASM performance category promotes collaboration between specialty and PCPs, opening new avenues for both to enhance their essential roles in patient care management and coordination. Ultimately, to lead to improved longitudinal care management, we believe it best to include the four ASM performance categories as proposed.

Comment: A commenter acknowledged CMS' approach to reduce the number of required reporting measures under ASM, noting that this change could decrease administrative burden and encourage greater clinician participation in ASM. Another commenter expressed concern that the manual clinical quality measure (CQM) reporting requirement could impose additional administrative burden as it would require working with a new external vendor.

Response: We appreciate the commenters for their support of our quality reporting measures. Though we acknowledge that reporting of manual clinical quality measures may create additional workstreams for ASM providers, we believe that those quality measures are important to evaluate the care provided by each ASM participant. Whenever possible, we attempted to lessen reporting burdens placed on ASM participants but in this instance the measures that require CQM reporting were selected because of their relevance to the participant's specialty and chronic condition that they manage. We note that several required quality measures have eCQMs collection types, which reduces burden, and that we are including an administrative claims-based measure for each cohort's quality measure set.

Comment: A few commenters expressed concern that ASM relies heavily on MIPS infrastructure and transfers several existing challenges including the lack of adequate outcome measures, lack of insight on performance that facilitates improvement, and a misalignment between cost and quality measures. The commenters suggested CMS to examine external benchmarks for what qualifies as a “good” quality measure score, for all measures including topped out measures, and reward high performers and improvement. The commenters suggested that CMS could exclude quality measures with consistently high performance.

Response: We appreciate the commenters for sharing their concerns that ASM, through its reliance on MIPS, has imported some of the same challenges facing MIPS. We believe that policies unique to ASM address some of the commenters' concerns. ASM's quality measure set includes at least one outcome measure in each cohort as described in sections III.C.2.d.(2).(b).(i) and III.C.2.d.(2).(c).(i) of this final rule. Additionally, ASM's quality and cost structure does in fact create alignment across performance categories. As it relates to topped-out measure status and measures with high performance, we will continue to monitor during initial ASM performance years before designating an ASM measure with topped out status. We are also engaging in multiple benchmark methodologies to facilitate that decision. We also note that topped-out status under MIPS may not equate to topped-out status under ASM because MIPS eligible clinicians can choose to report quality measures on which they perform well; in ASM, the mandatory nature of the quality measures may lead to a different distribution of quality measure scores.

After consideration of public comments on ASM's four performance categories, we are finalizing the definitions of “ASM performance category” and “ASM performance category score” as proposed at Sec. 512.705. We are also finalizing ASM's performance category approach as proposed at Sec. 512.715(a) and finalizing ASM's use of Medicare claims, administrative data, and model-specific data reported by an ASM participant to calculate measure or activity scores as proposed at Sec. 512.715(b). (b) Data Submission Requirements

We proposed at Sec. 512.720 that ASM participants would be required to submit data on the measures and activities for the quality, improvement activities, and Promoting Interoperability ASM performance categories in accordance with each ASM performance categories described in Sec. Sec. 512.725, 512.735, and 512.740. As further discussed in this section, we proposed to align some data submission requirements under this model with the data submission requirements under MIPS as defined at Sec. 414.1325. We believe that the use of similar processes and “submission types ”--which we proposed to define at Sec. 512.705 as the mechanism by which the ASM submitter submits data to us in the form and manner specified by us, including, but not limited to: (1) direct; (2) log in

and upload; and (3) log in and attest--would limit confusion and burden for those ASM participants that have previously participated in MIPS. We also intend to provide further resources on the exact data submission procedures prior to the first data submission deadline for the 2027 ASM performance year.

We proposed that ASM participants must submit data at the same level at which they are identified in the model. Since we proposed identifying ASM participants at the TIN/NPI level (as outlined in section III.C.2.c.(3).(a).(i). of this final rule), we likewise proposed that each ASM participant would be required to submit data for each ASM performance category at this same TIN/NPI level, unless specifically stated otherwise within the requirements for a particular performance category. Alignment between participant identification and data submission levels is necessary for a mandatory model and supports our goal of making accurate comparisons between similar participants. This approach differs from MIPS, which offers various reporting options (such as group, subgroup, or APM entity as defined in Sec. 414.1305). We have determined that allowing multiple reporting configurations would undermine ASM's design objective of creating clear peer-to-peer performance comparisons for determining payment adjustments.

We recognize that some of the required measures and attestations in each ASM performance category may reflect practice-level activities. We, therefore, considered whether to allow submission of required measures and attestations for the improvement activities and Promoting Interoperability ASM performance categories at the TIN level. We believe that it is more appropriate to align the data submission level across all the ASM performance categories instead of having some ASM performance categories with data submitted at the TIN/NPI level and others at the TIN level. Alignment of submission level across all ASM performance categories supports our goal of making like-to-like performance comparisons to determine payment adjustments.

We received public comments on our general data submission requirements and our proposal that ASM participants must submit data at the individual clinician level (TIN/NPI) for ASM performance categories. The following is a summary of the comments we received and our responses.

Comment: A commenter generally supported the proposed ASM data submission requirements.

Response: We appreciate the commenter for their support of the ASM data submission requirements.

Comment: Several commenters did not support the proposal requiring ASM participants to report on a fixed subset of measures and activities applicable to an ASM cohort for the entire duration of the model. The commenters recommended that similar to MVPs, ASM participants should be allowed to select the measures and activities that are most relevant to their practice and patient population. A few commenters recommended that CMS should offer flexibility for ASM participants to select between 3 and 5 quality measures relevant to their patients. Another commenter recommended allowing 3 out of 4 quality measures in an ASM cohort. Another commenter expressed concern that requiring clinicians to report measures outside their scope of practice undermines CMS' goal of aligning measurement with clinically meaningful outcomes. A commenter expressed concern that that not every measure applies to every patient, leading to missed data, exclusion bias, and increased reporting burden. Another commenter shared their belief that creating flexibility in measure selection would make reporting more meaningful and clinically relevant while reducing unnecessary reporting burden. Additionally, a commenter expressed concern that clinicians and practices have limited control over which data are collected regardless of the organization's size.

Response: We appreciate the commenters for their feedback on ASM's requirement to report on a fixed set of measures and activities applicable to each ASM cohort. We disagree that ASM participants should have flexibility to report measures, such as in MVPs, as we believe that more focused performance assessment on a clinically relevant measure set for heart failure or low back pain is important for creating accountability for outcomes and spending related to these conditions. Additionally, ASM will test whether more like-to-like comparisons of performance can lead to more meaningful incentives; allowing for flexibility in reporting of measures and activities would undermine this test. We do not believe that the required measures or activities would be out of scope for the types of specialists that we have identified. We carefully selected measures and activities to be clinically relevant and achievable by ASM participants, primarily drawing from existing programs like MIPS to maintain participant familiarity with ASM's requirements. In addition to familiarity with many of the ASM performance category requirements, we believe that the inclusion of eCQMs and administrative claims-based quality measures, as well as the EBCMs calculated by CMS for the cost ASM performance category, will reduce burden.

Comment: A few commenters supported setting ASM's unit of performance assessment at the TIN/NPI level to empower individual physicians to take the lead as it provides transparency about individual performance and accountability on quality and cost measures.

Response: We appreciate the commenters for their support of our unit of analysis and reporting level in ASM.

Comment: A few commenters expressed concern that quality measurement at the individual clinician level (TIN/NPI) is generally unreliable.

Response: We appreciate the commenters for their feedback but do not agree that quality measurement at the clinician level is unreliable as other quality reporting programs, such as MIPS, allow individual- level reporting of quality data.

Comment: Many commenters did not support the proposal requiring ASM data submission at the TIN/NPI level, noting significant administrative burden for ASM participants and their staff, particularly for those clinicians that are part of group practices and are already participating in traditional MIPS group reporting. A commenter expressed concerns about the administrative burden when a group is required to submit individual-level ASM data while the rest of the group reports measures to MIPS, potentially requiring clinicians and practices to collect ten or more measures for reporting. A few commenters recommended that CMS allow ASM participants to aggregate data at the registry-level or report as a group, virtual group, APM entity, or subgroup, particularly to maintain consistency across various reporting programs. Several commenters expressed concern that reporting at the TIN/NPI level conflicts with CMS' stated goal of promoting team-based care and care coordination which are essential for improving quality and efficiency. The commenters shared their belief that ASM group or aggregated data reporting would better represent team-based, multispecialty care; incentivize collaboration and accountability across the multidisciplinary clinician types essential for successful value-based care implementation; address low volume variations and eligibility thresholds; support health system improvements

and care coordination; reduce errors; uphold contractual obligations; ensure consistency with other programs; and reduce burden. Several commenters supported the alternative to assess ASM participants at the practice or TIN level because they believe this supports the current standard of practice, reporting would support team-based care, facility-based physicians, and clinicians participating in an ACO or AAPM. A few commenters specifically recommended that the improvement activities and Promoting Interoperability performance categories be attested to at the group level. A commenter also shared their belief that that there should be policy flexibilities for small practices due to limited capacity for data aggregation and reporting. Another commenter indicated that it is not more burdensome for small group practices to submit at the TIN/NPI measurement level.

Response: We appreciate commenters for sharing their concerns regarding the proposal to require data submission at the TIN/NPI level and the associated burden. We recognize that reporting quality measures at the TIN/NPI level may be particularly burdensome for small practices. We also refer readers to section III.C.2.d.(e).(4) of this final rule for ASM's definition of a “small practice” (that is, a single practice with 15 or fewer NPIs) and further discussion on comments we received related to ASM participants in small practices and the small practice scoring adjustment. We agree with the commenter's suggestion that we should adopt some data submission policy flexibilities for small practices given the challenges they may face in data reporting. Given that we considered TIN-level reporting for the improvement activities and Promoting Interoperability ASM performance categories, and that we received specific feedback from commenters to provide policy flexibilities for small practices because of the burden related to data aggregation and reporting, we are modifying our proposal to allow ASM participants in small practices to report the quality measures in the ASM performance category at the TIN-level. We believe this would reduce burden for small practices. We will monitor the performance of these small practices to determine whether there is a future state in which we could reconsider mandatory TIN-NPI-level reporting of quality measures for small practices. We believe that ASM participants in non-small practices would have the resources and infrastructure to report the quality measures in the quality ASM performance category at the TIN/NPI level.

Based on commenter's feedback, we also agree that our proposal to require submission of the improvement activities and Promoting Interoperability ASM performance categories data at the TIN/NPI level could increase administrative burden for ASM participants regardless of practice size. Reporting the improvement activities and Promoting Interoperability at the TIN level may better promote team-based care and coordination as the requirements of these ASM performance categories typically reflect work done at a practice level. Accordingly, ASM participants will report on the improvement activities and Promoting Interoperability ASM performance categories data at the TIN-level.

We acknowledge that different reporting level requirements between MIPS and ASM has the potential to increase burden for participants or practices that are reporting to both MIPS and ASM. However, we believe it necessary to appropriately measure performance and create payment adjustments that fairly represent the care provided across ASM's four performance categories.

We note that we did not consider subgroup reporting for ASM performance categories in this CY 2026 PFS proposed rule but may consider this in future notice-and-comment rulemaking.

Comment: A commenter recommended clarification on whether ASM participants would be required to submit separate individual submissions or could submit individual-level performance data within a single group submission file.

Response: We appreciate the commenters for their request for clarification. We note that each ASM participant would need to submit data for each ASM performance category at the level the performance category requires. Based on the data submission provisions we are finalizing in this final rule, we note that ASM participants will not have the flexibility to report both as an individual and as a group. While an ASM participant could submit the required data through multiple data submissions, each data submission much meet the reporting level requirements specified in Sec. 512.720.

Comment: A commenter recommended that CMS aggregate a clinician's performance across multiple years to overcome the statistical issues associated with reporting at the individual clinician level for ASM participants who treat a small number of patients that trigger an episode.

Response: We appreciate the commenter for their recommendation to aggregate a clinician's performance across multiple years. As described in section III.C.2.(c).(3) of this final rule, our ASM participant eligibility criteria require that a clinician be attributed at least 20 EBCMs applicable to their specialty using the applicable year of data used to evaluate the EBCM criterion. We believe that this criterion means that identified ASM participants would reliably meet the quality and cost case minimums for the required quality and cost measures during an ASM performance year. Further, our quality and cost ASM performance category scoring policies account for situations in which an ASM participant does not meet the case minimums for quality or cost measures, including accounting for situations in which the ASM participant cannot be scored on either the quality or cost measures. We refer readers to sections III.C.2.d.(2).(h)., III.C.2.d.(3).(f)., and III.C.2.e.(2). of this final rule for further discussion on the quality, cost, and final scoring policies related to case minimums.

Comment: A commenter recommended that both attribution and evaluation of beneficiaries should be conducted at the TIN/NPI level. The commenter shared their belief that clinicians and practices should be held accountable for care delivered within their TIN, noting that aligning ASM reporting and evaluation at the same level is essential for accurate and fair performance assessments.

Response: We appreciate the commenters for their recommendation regarding the attribution and evaluation of beneficiaries at the TIN/ NPI level. We note that we use EBCMs attributed at the TIN/NPI level for determining whether a clinician will meet the ASM participant eligibility criterion for minimum EBCM episode volume and for scoring the ASM participant's performance in the cost ASM performance category. Each TIN/NPI-attributed EBCM episode is attributed to a single beneficiary. As discussed earlier in this section of this final rule, with the exception of ASM participants in small practices due to the unique challenges they may face in data aggregation and reporting, aligning reporting and evaluation of quality and cost measures at the TIN/NPI level can make for fairer performance assessments. However, we believe allowing TIN-level reporting of improvement activities and Promoting Interoperability requirements for all ASM participants-- because they primarily reflect practice-level efforts and infrastructure--as well as TIN-level reporting of quality measures for ASM

participants in small practices will reduce the reporting burden on ASM participants without undermining ASM's performance assessment approach.

Comment: A commenter believed that required reporting for each of a clinician's TIN/NPI combinations would create redundant work and documentation, confusion, unneeded complexity, and increased costs. The commenter recommended adopting the MIPS structure of calculating a clinician's score for each TIN and then selecting the higher score and omitting the lower scores for assessment and comparison.

Response: We appreciate the commenter for their feedback. We believe that the commenter is referring to a situation where we identify a single clinician (that is, represented by one NPI) as multiple ASM participants under multiple TINs. As we discussed in section III.C.2.c.(3) of this final rule, we believe that this would be a rare but not impossible occurrence. Based on our participant identification approach, we believe that it is appropriate to hold that clinician accountable for the care they provide related to the applicable condition under each of the TINs for which we identify them as an ASM participant. While we did not consider a provision where we would use that NPI's highest scores from all their TIN/NPI submission, we do not believe this aligns with the performance assessment and incentive structure we are creating under ASM. Should we consider such an approach in the future, we would do in notice-and-comment rulemaking.

We also proposed that data can be submitted on behalf of the ASM participant by an entity or individual designated to submit data to CMS, including a third-party intermediary as described in Sec. 512.720(a), on behalf of the ASM participant. We proposed at Sec. 512.705 to use with the definition of third-party intermediary set forth in MIPS at Sec. 414.1305 to align the data submission policies for third party intermediaries between MIPS and ASM.

We received comments on the proposal to allow third-party intermediaries to submit data on behalf of an ASM participants. The following is a summary of those comments and our responses.

Comment: A commenter generally supported the inclusion of third- party intermediaries in ASM and recommended CMS including Qualified Clinical Data Registries (QCDRs) and Qualified Registries (QRs) in the definition of the term “third-party intermediaries” as approved data submission mechanisms for ASM. The commenter shared their belief that QCDRs and QRs are foundational partners in QPP and that small or independent practices rely on registries for policy interpretation, education, data aggregation, and technical submission management and expressed concern that omitting QCDRs and QRs could create uncertainty and disrupt established clinical workflows for ASM participants.

Response: We appreciate the comment for their general support of the inclusion of third-party intermediaries in the ASM data submission mechanisms.

Comment: A commenter supported the proposal allowing ASM data to be submitted to CMS on behalf of ASM participants by a designated entity or individual, including third-party intermediaries as described in Sec. [thinsp]512.720(a).

Response: We appreciate the commenter for their support of the ASM policy allowing data to be submitted to CMS on behalf of ASM participants by third-party intermediaries.

Comment: A commenter supported the proposal to use the definition of third-party intermediary set forth in MIPS at Sec. [thinsp]414.1305 for ASM, aligning the data submission policies for third party intermediaries between MIPS and ASM.

Response: We appreciate the commenter for their support of the ASM third party intermediary definition and the alignment of third-party intermediaries between MIPS and ASM.

Comment: A commenter recommended that CMS include an option within the annual self-nomination and qualification process for QCDRs and QRs to be certified for the ASM. The commenter shared their belief that this would provide a clear and official pathway for registries to support their clinicians in new programs.

Response: We appreciate the commenter for their recommendation for QCDRs and QRs to be certified for ASM. We note third-party intermediaries permitted to report data under MIPS would be allowed to do the same for ASM. Although we did not consider a specific provision for a QCDR or QR to be certified specifically for ASM, should we, we would do so in future notice-and-comment rulemaking.

After reviewing public comments, we are finalizing our definition of “submission type” as proposed at Sec. 512.705.

We are also finalizing our proposal on the level at which ASM participants must submit the required data with some adjustments. ASM participants must:

Submit applicable quality ASM performance category data at the individual clinician level (that is, TIN/NPI level) unless the ASM participant is part of a small practice as described at Sec. 512.720(a)(1)(i),

Submit required improvement activities at the TIN level as described at Sec. 512.720(a)(1)(ii), and

Submit required Promoting Interoperability data at the TIN level as described at Sec. 512.720(a)(1)(iii).

After consideration of commenters' feedback, we are finalizing at Sec. 512.720(f) that ASM participants who are part of a small practice may submit quality ASM performance category data at the TIN level.

We are also finalizing our proposed definition of “third-party intermediary” as proposed at Sec. 512.705 and the proposed provision that allows third-party intermediaries to report data on behalf of an ASM participant as proposed at Sec. 512.720(a)(1). (i) Quality ASM Performance Category Data Submission Requirements

For the quality ASM performance category, we proposed at Sec. 512.720(a)(1)(i) that an ASM participant must report at least one required quality measure that is not an administrative claims-based collection type (discussed in sections III.C.2.d.(2).(b) and III.C.2.d.(2).(c) of this final rule) and meets the proposed data completeness requirement as discussed in section III.C.2.d.(2).(h).(i) of this final rule. The proposed requirements for the quality ASM performance category are similar to those required under MIPS as defined at Sec. 414.1325(1)(i) but with the addition of meeting the data completeness requirement. We believe that the addition of the data completeness requirement ensures that we would have complete data by which to score at least one required quality measure. We also considered that an ASM participant must report complete data for at least 2, at least 3, or all required quality measures that are not administrative claims-based collection types as the data submission requirement for the quality ASM performance category. However, not reporting all required measures would negatively affect an ASM's participant quality ASM performance category score as discussed in section III.C.2.(d).(i) of this final rule. Further, not meeting the data submission requirement for the quality ASM performance category would mean that an ASM participant would receive the maximum negative payment adjustment

for the applicable ASM payment year as discussed in section III.C.2.f.(4) of this final rule. Setting the minimum data submission requirement as reporting more than one complete quality measure could penalize ASM participants that are unable to report required measures. We believe that the proposed minimum data submission requirement combined with the proposed scoring policies would provide the appropriate incentive for reporting all required quality measures while ensuring that we can appropriately evaluate quality performance.

We received public comments on our proposed data submission requirements for the quality ASM performance category. The following is a summary of the comments we received and our responses.

Comment: A commenter did not support the proposed requirements for ASM low back pain participants to report on all the quality measures in the ASM low back pain cohort, noting that these requirements exceed those for MVP participants. The commenter also shared their belief that the measures have limited applicability to orthopedic surgeons.

Response: We appreciate the commenters for sharing their concern that ASM would require all low back pain participants to report on all low back pain quality measures. Although ASM's quality reporting requirements exceed those for MVPs, allowing participants to choose quality measures has historically led to overall high-quality scores within MIPS. Allowing ASM participants to select their quality measures would make it more difficult to meaningfully differentiate clinician performance. We disagree that the quality measures have limited applicability to orthopedic surgeons because we believe that orthopedic surgeons who are attributed 20 EBCMs provide longitudinal chronic condition care to beneficiaries with low back pain, which means it would be appropriate to hold them accountable for the low back pain quality measure set.

Comment: A commenter recommended that CMS should use eCQM quality measures in ASM whenever possible.

Response: We appreciate the commenters for stating their recommendation regarding interest in eCQM quality measures whenever possible. However, we disagree, because although we acknowledge the ease of reporting eCQMs, the CQMs selected for the quality measure sets better reflect ASM's goal to measure and incentivize improvement in the following three domains: (1) excess utilization, (2) evidence-based care and outcomes, and (3) patient-reported outcomes and experience.

Comment: A few commenters recommended that CMS provide additional clarification regarding the proposed requirements for the quality ASM performance category. A commenter expressed concern that the proposed rule does not clearly specify whether ASM participants must submit data for all ASM quality measures in their applicable cohort, or only for one quality measure (excluding administrative claims-based measures). Another commenter requested clarification on the exact number of quality measures clinicians are required to report on. Specifically, the commenter stated whether an ASM participant would need to contract with a third-party intermediary to report only the single MIPS CQM if their ASM cohort included three eCQMs and one MIPS CQM.

Response: We appreciate the commenters for their recommendation for further clarification regarding ASM quality measure reporting. As discussed in section III.C.2.e.(2).(b) of this final rule, for an ASM participant to receive a payment adjustment greater than the negative adjustment equal to the applicable ASM risk level (negative nine percent in the first two ASM payment years) they must meet the Quality ASM Performance Category Data Submission Requirement as discussed earlier in this section of this final rule. For an ASM participant to meet the quality ASM performance category data submission requirement, the ASM participant must report at least one required quality measure that is not an administrative claims-based collection type (discussed in sections III.C.2.d.(2).(b) and III.C.2.d.(2).(c) of this final rule) and meets the proposed data completeness requirement as discussed in section III.C.2.d.(2).(h).(i) of this final rule. Participants are still required to report all five measures in their quality set; however, if they do not meet the minimum case threshold as discussed in section III.C.2.d.(2).(h) they 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 as described in III.C.2.d.2.(i).(i) of this final rule. If a participant only reports three eCQMs and one MIPS CQM, they would be scored on those 4 measures but receive a zero for the measure for which they did not submit data, which means they would not meet the data completeness requirement for that measure.

After consideration of public comments, we are finalizing our provisions for data submission requirements for the quality ASM performance category as proposed at Sec. 512.720(a)(1)(i). (ii) Improvement Activities ASM Performance Category Data Submission Requirements

We proposed in Sec. 512.720(a)(1)(ii) that the data submission requirement for the improvement activities ASM performance category would require that an ASM participant attest to completing or not completing the required ASM improvement activities defined in Sec. 512.735. Unlike MIPS, we did not propose to include a “yes” attestation to the minimum data submission requirements to receive a final score under ASM as defined in Sec. 512.745(b) as it would conflict with how we proposed to factor in the ASM improvement activities performance category score into the final score as proposed at Sec. 512.745(a)(1)(iii).

We received public comments on our proposed data submission requirements for the improvement activities ASM performance category. The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support proposed data submission requirements for the improvement activities ASM performance category, noting the requirements as impractical and burdensome. Another commenter shared their concern that mandating two specific improvement activities for specialists could add significant burden for specialty practices already complying with other MIPS activities. The commenter recommended that CMS align the ASM improvement activities category with MIPS to allow greater flexibility and choice during the initial ASM performance years.

Response: We appreciate commenters for sharing their concerns regarding the data submission requirements for the improvement activities ASM performance category. We recognize that introducing two ASM-specific mandatory improvement activities may be burdensome for specialty practices that may participate as a group in MIPS. However, we believe that these ASM-specific improvement activities are important to incentivizing practice transformation and improved specialist-PCP integration to improve chronic condition management. We refer readers to section III.C.2.d.(4) of this final rule for additional discussion on the basis for our improvement activities

After consideration of public comments, we are finalizing our

provisions for data submission requirements for the improvement activities ASM performance category as proposed at Sec. 512.720(a)(1)(ii). (iii) Promoting Interoperability ASM Performance Category Data Submission Requirements

The proposed requirements for the Promoting Interoperability ASM performance category at Sec. 512.720(a)(1)(iii) align with the MIPS requirements as defined at Sec. 414.1325(1)(iii).

We did not receive any public comments on our proposed Promoting Interoperability data submission requirements and are, therefore, finalizing the provisions as proposed at Sec. 512.720(a)(1)(iii). (iv) ASM Performance Categories Without Data Submission Requirements

Like the cost performance category or administrative claims-based quality measures under MIPS, we proposed at Sec. 512.720(a)(2) that there would be no data submission requirements for the cost ASM performance category or for quality measures that have an administrative claims-based collection type. Like MIPS, performance in the ASM cost performance category and on some quality, measures would be calculated using administrative claims data, which includes claims submitted with dates of service during the applicable ASM performance year that are processed no later than 60 days following the close of the applicable ASM performance year.

We did not receive any public comments on our proposed provisions related to ASM performance categories without data submissions requirements and are, therefore, finalizing the provisions as proposed at Sec. 512.720(a)(2). (v) Data Submission Types

We proposed at Sec. Sec. 512.720(b)(1) and (2) that an ASM participant would, like an individual MIPS eligible clinician, be able to submit their ASM data using, for the quality ASM performance category, the direct, login and upload, submission types, and for improvement activities or Promoting Interoperability ASM performance categories, the direct, login and upload, or login and attest submission types as proposed at Sec. 512.720(b). These are the same submission types available under MIPS.

We received public comments on our proposed data submission types. The following is a summary of the comments received and our responses.

Comment: A commenter supported the proposal to align ASM data submission types-- including direct, log in and upload, and the use of third-party intermediaries, with the existing MIPS framework. The commenter shared their belief that alignment between ASM and MIPS data submission types would reduce confusion, limit the administrative burden on clinicians, and leverage a familiar infrastructure.

Response: We appreciate the commenters for their support of the ASM proposal to align ASM data submission types with the existing framework in MIPS leading to lower administrative burden on clinicians.

Like the policy established under MIPS, we proposed at Sec. 512.720(c) that ASM participants would be permitted to submit their ASM data using multiple submission types for any ASM performance category described at Sec. 512.720(b) as applicable; provided, however, that the ASM participant uses the same identifier for all ASM performance categories and all data submissions.

We did not receive any comments on our proposed provisions related permitting ASM participants to submit data using multiple submission types for any ASM performance category as applicable.

After consideration of public comments, we are finalizing our proposed provisions for data submission types as proposed at Sec. Sec. 512.720(b)(1) and (2). We are also finalizing our proposed provisions on multiple submission types as applicable for each ASM performance category as proposed at Sec. 512.720(c). (vi) Data Submission Deadline

We proposed at Sec. 512.720(d) that ASM participants would need to submit all required data and attestations as required for each ASM performance category by March 31 following the close of the applicable ASM performance year, or a later date as specified by CMS. This proposal aligns with the deadline policy established under MIPS at Sec. 414.325(e). We considered requiring a data submission deadline earlier than March 31 but believed that it would not provide ASM participants with sufficient time to prepare their data submission.

We received public comments on our proposed data submission deadline. The following is a summary of the comments we received and our responses.

Comment: A commenter did not support the proposed data submission deadline of March 31 following the close of the applicable ASM performance year, noting concerns with meeting the deadline due to the complex reporting requirements across multiple programs, and recommended extending the ASM data submission deadline to the end of April.

Response: We appreciate the commenters for sharing their concerns regarding our data submission deadline. However, ASM's data submission deadline aligns with the deadline in MIPS specified at Sec. 414.325(e).

Comment: A commenter supported the proposed data submission deadline of March 31 following the close of the applicable ASM performance year, noting its alignment with traditional MIPS and MVP deadlines could decrease burden on ASM participants.

Response: We appreciate the commenter for their support of our data submission deadlines and agree that alignment with MIPS and MVP deadlines decreases reporting burdens.

After consideration of public comments, we are finalizing our proposed data submission deadline as proposed at Sec. 512.720(d). (vii) Treatment of Multiple Data Submissions

Like the policy established under MIPS, for multiple data submissions received in the quality and improvement activities ASM performance categories, for an ASM participant submitters in multiple organizations (for example, qualified registry, practice administrator, or EHR vendor), we proposed at Sec. 512.720(e) to calculate and score each submission received and assign the highest of the scores. We proposed at Sec. 512.720(e)(1) that for multiple data submissions received for an individual ASM participant from one or multiple submitters in the same organization, we proposed to score the most recent submission. We proposed at Sec. 512.720(e)(2), that for multiple data submissions received for the Promoting Interoperability performance category, we would calculate a score for each data submission received and assign the highest of the scores.

We received public comments on our proposed provisions for the treatment of multiple data submissions. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed approach for multiple ASM data submissions. The commenters noted the proposed policy would allow an ASM participant to be scored on the data submission or measure with the greatest number of achievement points, aligned with MIPS and could help reduce confusion among clinicians and administrative staff during reporting.

Response: We appreciate the commenters for their support of our approach towards scoring multiple ASM data submissions and believe that our policy rewards participants for earned ASM performance achievement points.

After consideration of public comments, we are finalizing our proposed provisions related to multiple data submission types as proposed at Sec. 512.720(e). (2) Quality ASM Performance Category

The quality ASM performance category supports the model goals of improving quality of care with a focus on measures that are relevant to ASM clinical specialties and targeted chronic conditions. It also seeks to decrease the cost of care for beneficiaries with ASM-targeted chronic conditions. Measuring quality of care helps identify areas for improvement and ensures that clinical interventions are effective and lead to improved patient outcomes. The importance of the quality ASM performance category is reflected in the weight of the performance category on the final score, discussed in section III.C.2.e.(1) of this final rule. (a) Background

We proposed at Sec. 512.725(b) and (c) to use a quality measure set specific to each ASM cohort, one measure set for heart failure (HF) and one measure set for low back pain (LBP), which would contain condition-specific mandatory measures. Each ASM participant must report all finalized measures specified in Table B-D4 for their applicable chronic condition, except for the proposed administrative claims-based measures, which would be calculated by CMS based on their submitted claims. These measures would likely stay consistent throughout the duration of the model to support reporting continuity, minimize burden, and ensure a reliable and valid model evaluation. The quality measurement approach in ASM is similar to the MVP reporting option under MIPS in that it limits reporting to a subset of clinically relevant measures. However, while the MVP reporting option allows a clinician to select an MVP and choose which MVP measures to report, the ASM participant would be required to report all quality measures in their respective ASM measure set.

Medicare's payment landscape is continuing to transform, moving away from traditional FFS payments that are not tied to quality and towards value-based models with increased provider accountability. ASM is a continuation of these efforts, strengthening the connection between quality and payment. We aim, in payment models such as ASM, to utilize quality measures that incentivize evidence-based care and prevention, improve patient outcomes, and reduce low-value health care spending.

We proposed to avoid making significant changes to these measure sets over the period of model; however, we may propose to add or remove measures through notice-and-comment rulemaking if we believe refinements to the measure set are necessary. We may propose to add or remove measures in response to relevant public comments, recommendations from participants and their collaborators, new CMS program activities, or significant changes to the included measures. We would use notice-and-comment rulemaking to propose any modifications, such as adding or removing measures for monitoring quality or calculating scores for quality performance. We sought comment on this proposal.

ASM is designed to provide financial incentives for measurable improvements in clinical outcomes for beneficiaries. We expect our quality measurement strategy to increase adherence to clinical guidelines, focus attention on outcomes to reduce costs, and enhance the patient experience. Several of the finalized measures also promote prevention, as detailed in Table B-D4, by mitigating the progression of the chronic diseases that ASM targets and reducing the risk for other comorbid diseases that may exacerbate health issues. Each quality measure contains measures that aim to measure and incentivize improvement in the following three domains: (1) excess utilization, (2) evidence-based care and outcomes, and (3) patient-reported outcomes and experience. Each measure set would include a utilization-focused measure to assess appropriate use of select services in chronic disease management. This measurement area may also indicate where excess or inappropriate utilization is occurring, which aligns with CMS priorities to reduce spending related to unnecessary care, imaging, or procedures. Measures in the evidence-based care and outcomes domain are clinically relevant to the conditions of focus, can meaningfully discern differences in care furnished by ASM participants, and are associated with improved outcomes for patients. Finally, measures related to patient-reported outcomes capture what matters most to patients, and incentivizing ASM participants to be more attuned to the patient experience could drive improvements in functional status among beneficiaries receiving treatment for heart failure and low back pain. We believe that the measures in all three domains are clinically relevant to the conditions of focus and would align with other CMS programs and nationwide measurement efforts.

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(i) Performance Year for the Quality ASM Performance Category

We proposed at Sec. 512.725(a) that the ASM performance year for quality measures would be the full calendar year from January 1 to December 31, and the performance year would occur 2 years prior to an applicable ASM payment year. We believe that setting the ASM performance year for quality measures in this way aligns with MIPS as defined at Sec. 414.1320 and would be easily adoptable for ASM participants.

We solicited comments on our proposed approach setting the ASM performance year for quality measures.

We did not receive public comments on this provision, and therefore, we are finalizing the proposed ASM performance year for quality measures as proposed at Sec. 512.725(a). (b) Quality Measure Set for the ASM Heart Failure Cohort

We proposed at Sec. 512.725(b)(1) through (5) to include the following measures in the heart failure quality measure set. Each ASM heart failure participant must report each finalized measure using one of the collection types specified in Table B-D4. (i) Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients With Heart Failure (HF) (MIPS Q492)

We proposed to include Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with Heart Failure (HF) (MIPS Q492) in the ASM heart failure quality measure set. By assessing potentially preventable cardiovascular-

related hospital admissions, this measure incentivizes clinicians to adopt evidence-based practices in heart failure management, improve care coordination, and enhance the overall quality of care.

A hospital readmission, for any reason, is disruptive to patients and caregivers, costly to the health care system, and puts patients at additional risk of hospital-acquired infections and complications.\184\ Readmissions are also a major source of patient and family stress and may contribute substantially to a decline in functional ability, particularly in older patients.\185\ Some readmissions are unavoidable and result from inevitable progression of disease or worsening of chronic conditions. Patients with heart failure, particularly those at a more advanced stage, are vulnerable to a range of factors that may increase their risk for cardiovascular-related hospitalizations.\186\ risk of hospitalization may be related to an individual's clinical and social/community risk factors but may also be affected by the quality of care received. Activities that could improve quality of care include the adoption of guideline-directed medical therapy, early intervention for acute symptoms, optimal care coordination across providers, and support for self-management. Policy changes, such as the Medicare Hospital Readmissions Reduction Program, have led to a decrease in readmission rates for both principal and secondary heart failure hospitalizations; however, readmission rates in both groups remain high.\187\ We proposed to include this measure to continue the momentum on reducing avoidable hospital admissions and readmissions, as well as improve overall quality of care for Medicare patients with heart failure.

\184\ Dhaliwal JS, Dang AK. Reducing Hospital Readmissions. Nih.gov. Published June 7, 2024. https://www.ncbi.nlm.nih.gov/books/NBK606114/.

\185\ Dhaliwal JS, Dang AK. Reducing Hospital Readmissions. Nih.gov. Published June 7, 2024. https://www.ncbi.nlm.nih.gov/books/NBK606114/.

\186\ Malhotra C, Chaudhry I, Yeo Khung Keong, Sim D. Multifactorial risk factors for hospital readmissions among patients with symptoms of advanced heart failure. ESC heart failure. 2024;11(2):1144-1152. doi:https://doi.org/10.1002/ehf2.14670.

\187\ Blecker S, Herrin J, Li L, Yu H, Grady JN, Horwitz LI. Trends in Hospital Readmission of Medicare-Covered Patients With Heart Failure. Journal of the American College of Cardiology. 2019;73(9):1004-1012. doi:https://doi.org/10.1016/j.jacc.2018.12.040.

In addition, this measure aligns with other quality programs, such as the Quality Payment Program, which includes the measure in the Advancing Care for Heart Disease MVP. Another benefit of the measure is that it is calculated using administrative claims, which reduces reporting burden for the ASM participant.

Furthermore, ASM proposed to use this measure at the TIN/NPI level. We pursued additional testing and analyses to ensure measure validity at this level. To date, this measure has been validated at the TIN level in the MIPS program. Analyses have determined a certain threshold of attributed patients' needs to be met to ensure measure validity; this threshold can be challenging to achieve at the TIN/NPI level in MIPS given the wide range of specialty types that participate. Internal analyses indicate that, given the 20 EBCM episode threshold for participation of cardiologists described in section III.C.2.c.(3)(b) of this final rule, meeting this threshold of attributed patients in ASM would not be a significant issue or threat to measure validity. For that reason, we anticipate this measure would be valid and reliable at the TIN/NPI level for ASM participants treating heart failure.

We solicited comment on the proposal to include the Risk- Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with HF (MIPS Q492) measure in ASM and to assess performance at the TIN/NPI level.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed inclusion of MIPS Q492: Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients With Heart Failure measure in the ASM heart failure quality measure set. The commenters shared their belief that the inclusion of this measure would promote care coordination and enhance patient outcomes and quality of care. A commenter supported expanding the focus beyond a 30-day hospital readmission measure to emphasize the importance of long-term, chronic care needed for heart failure patients.

Response: We appreciate commenters' support of the proposed inclusion of MIPS Q492: Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients With Heart Failure measure in the ASM heart failure quality measure set. We agree that this is an important measure to promote accountability in care coordination and enhance patient outcomes. We also appreciate the feedback regarding the importance of expanding focus beyond 30-day readmission measures to emphasize long-term, chronic care management for heart failure patients.

Comment: A few commenters did not support the proposed inclusion of MIPS Q492: Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients With Heart Failure measure in the ASM heart failure quality measure set, noting that the majority of readmissions are not preventable through heart failure management. A commenter cited research indicating that only 17 to 35 percent of readmissions are attributed to heart failure re-exacerbation, and therefore, the commenter expressed concern that holding general cardiologists engaged in longitudinal care for heart failure patients accountable for total cardiovascular admission rates may unfairly penalize these clinicians for outcomes beyond their clinical control. A commenter requested clarification on how the measure would interact with the heart failure EBCM, to ensure clinicians are not subject to overlapping penalties for the same utilization events across quality and cost domains.

Response: We appreciate the feedback regarding concerns about the proposed inclusion of MIPS Q492: Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients With Heart Failure measure. The measure methodology has several mechanisms to account for situations when admissions are outside the control of providers, such as exclusion criteria for very ill or complicated patients, identification of planned admissions, a 10-day buffer period following discharge, and a risk adjustment model that includes demographic, clinical, and social risk factors. We believe these are appropriate safeguards that address the concerns raised about penalizing providers for outcomes beyond their clinical control. Additionally, the measure focuses specifically on admissions that are cardiovascular in nature, addressing the concern that providers may be penalized for admissions completely unrelated to heart failure care. A key goal of ASM is to promote enhanced accountability for longitudinal care by providers for their patients, and this measure complements the heart failure EBCM to ensure accountability as they measure different aspects of care. We do not perceive this as overlapping penalties, as they are different metrics and the cost of a heart failure episode is not encapsulated in unplanned admissions alone.

Comment: A few commenters did not support the proposal to apply the MIPS Q492: Risk-Standardized Acute Unplanned Cardiovascular-Related

Admission Rates for Patients With Heart Failure measure at the TIN/NPI level, noting that this measure was not designed to assess individual clinicians and has only been in used in MIPS for evaluating groups. A few commenters also noted that the measure's reliability has only been tested at the group level, not at the individual clinician or TIN/NPI level, and reliability scores decrease for groups with fewer heart failure patients. A commenter shared their concern that clinicians may have limited time to implement the measure, since CMS noted the measure's revised specifications would be released in the rule. Another commenter expressed concern that attributing this measure at the TIN/ NPI level, particularly for specialists working in team-based settings, could misrepresent individual accountability for admissions influenced by broader social risk factors or primary care coordination. The commenters recommended that CMS monitor for unintended disparities and ensure risk adjustment methodologies account for factors outside of cardiologists' direct control.

Response: We appreciate the feedback regarding the application of MIPS Q492: Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients With Heart Failure at the TIN/NPI level. Internal analyses identified that an overwhelming majority of likely heart failure ASM participants would individually meet or exceed the case minimum of 21 for this measure, which is the volume threshold used in other CMS programs. The analysis used the measure specification to simulate a performance year for providers that met the ASM participant inclusion criteria, demonstrating feasibility for implementation at the individual clinician (TIN/NPI) level.

To address concerns about attribution and accountability, ASM will slightly modify the measure specifications to attribute solely to ASM participants who have had 1 or more visits with the beneficiary. Focusing the measure in this way allows ASM participants to be accountable for the health of patients they have actively treated, while addressing concerns about misrepresenting individual accountability in team-based settings. We will release more technical details in the future in a form and manner determined by CMS.

We recognize the concerns about social risk factors and coordination issues beyond cardiologists' direct control, and we will continue to monitor unintended disparities while ensuring that risk adjustment methodologies appropriately account for factors outside of specialists' direct influence. The measure's established risk adjustment framework, combined with our attribution modifications, should help address these concerns while maintaining meaningful quality assessment.

After consideration of public comments, we are finalizing the inclusion of the MIPS Q492: Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with Heart Failure measure in the heart failure quality measure set as proposed as Sec. 512.725(b)(1). (ii) Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) (MIPS Q008)

We proposed to include Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) (MIPS Q008) in the ASM heart failure quality measure set. This measure aims to promote the appropriate use of beta-blocker therapy in select patients with heart failure with reduced ejection fraction (HFrEF). It assesses the percentage of patients aged 18 years and older with a diagnosis of heart failure with a current or prior left ventricular ejection fraction (LVEF) https://doi.org/10.1161/cir.0000000000001063.

\189\ 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.

Despite its survival benefits, use of beta blockers in eligible patients remains suboptimal.90 191 Nonadherence to medications prescribed for heart failure, including beta-blockers, can be associated with adverse outcomes such as hospital readmission and mortality.192 193 By including this measure, we aim to increase the appropriate use of beta-blocker therapy in eligible patients with heart failure. This aligns with the goals of ASM to drive improvements in the quality of care delivered to heart failure patients, particularly in evidence-based pharmacotherapy. In addition, inclusion of this measure aligns with other quality programs, such as the Quality Payment Program, which includes the measure in the Advancing Care for Heart Disease MVP, and the Cardiology Core Quality Measures Collaborative (CQMC) set. We sought comment on the proposal to include Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) (MIPS Q008) in the ASM heart failure quality measure set.

\190\ 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.

\191\ Kim SE, Byung Su Yoo. Treatment Strategies of Improving Quality of Care in Patients With Heart Failure. Korean circulation journal. 2023;53. doi:https://doi.org/10.4070/kcj.2023.0024.

\192\ Ruppar TM, Cooper PS, Mehr DR, Delgado JM, Dunbar-Jacob JM. Medication Adherence Interventions Improve Heart Failure Mortality and Readmission Rates: Systematic Review and Meta-Analysis of Controlled Trials. Journal of the American Heart Association. 2016;5(6). doi:https://doi.org/10.1161/jaha.115.002606.

\193\ Ho PM, Magid DJ, Shetterly SM, et al. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. American Heart Journal. 2008;155(4):772-779. doi:https://doi.org/10.1016/j.ahj.2007.12.011.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposal to include the MIPS Q008 Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) measure in the ASM heart failure measure set. A commenter noted that this measure would help address the under- prescription of evidence-based therapies and promote the appropriate use of combination or quadruple therapy, which includes beta-blocker therapy, in patients with HFrEF.

Response: We appreciate the commenters' supportive feedback regarding the inclusion of MIPS Q008: Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) in the ASM heart

failure measure set. We agree that this measure is essential for encouraging the adoption of comprehensive, evidence-based treatment approaches that have been shown to improve outcomes for heart failure patients. The measure aligns with current clinical guidelines that emphasize the importance of optimizing medical therapy, including the use of combination or quadruple therapy regimens that incorporate beta- blockers as a cornerstone of HFrEF management.

Comment: A few commenters expressed concern regarding the proposal to include the MIPS Q008 Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) measure in the ASM heart failure quality measure set, noting that the measure is topped out in MIPS. The commenters recommended that CMS consider alternative quality measures, that are not topped out, for inclusion in the ASM measure set. A few commenters specifically noted that the measure only applies to patients with reduced ejection fraction and excludes those with preserved ejection fraction. A commenter recommended that CMS consider respecifying this measure as an outcomes-based measure. Another commenter recommended that CMS ensure necessary exclusions for clinically justified cases, noting that some patients with left ventricular systolic dysfunction may have contraindications to beta- blocker therapy.

Response: We appreciate the comments regarding the proposed inclusion of MIPS Q008 Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) measure in the ASM heart failure quality measure set. While we are aware that the measure may be topped out in the MIPS program, we believe that the required reporting structure in ASM may yield different results than those seen in MIPS, where providers have flexibility in measure selection. We carefully considered several measures and selected those that are most clinically relevant and methodologically valid, though we acknowledge we are limited by existing measures and cannot develop outcome measures for every clinical scenario. We believe this measure set provides an adequate assessment of patient care quality related to heart failure. This measure is clinically valid and reliable, incorporating necessary exclusions for beta-blocker therapy when clinically documented reasons exist (for example, low blood pressure, fluid overload, asthma, recent intravenous positive inotropic agent treatment, allergies, intolerances, other medical reasons, patient refusal, or other patient- specific factors). While the measure may not apply to a cardiologist's entire patient panel, it remains a valid assessment tool for the significant portion of heart failure patients that cardiologists treat with reduced ejection fraction.

After consideration of public comments, we are finalizing the inclusion of the (MIPS Q008) HF: Beta-Blocker Therapy for LVSD in the heart failure quality measure set as proposed at Sec. 512.725(b)(2). (iii) Heart Failure (HF): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) or Angiotensin Receptor- Neprilysin Inhibitor (ARNI) Therapy for Left Ventricular Systolic Dysfunction (LVSD) (MIPS Q005)

We proposed to include Heart Failure (HF): Angiotensin-Converting Enzyme (ACEi) Inhibitor or Angiotensin Receptor Blocker (ARB) or Angiotensin Receptor-Neprilysin Inhibitor (ARNI) Therapy for Left Ventricular Systolic Dysfunction (LVSD) (MIPS Q005) in the heart failure quality measure set. This measure assesses the appropriate use of the specified medicines in patients with heart failure with reduced LVEF. Adherence to this class of medications, especially as part of guideline-directed medical therapy, offers cardioprotective benefits in patients with heart failure and reduces mortality and heart failure- related hospitalizations.194 195 Furthermore, McMurray et al. in PARADIGM-HF showed use of angiotensin receptor-neprilysin inhibitor compared to enalapril, an ACEi, not only reduced risk for cardiovascular death and hospitalization related to heart failure, but also decreased the symptoms and physical limitations of heart failure.\196\ Similar to beta blockers, optimal dosing and adherence to this group of medication in heart failure patients remains suboptimal.\197\ By including this measure, we can incentivize cardiologists participating in ASM to prescribe evidence-based pharmacotherapy for patients with HFrEF. In addition, inclusion of this measure aligns with other quality measurement efforts, such as the Advancing Care for Heart Disease MVP in the Quality Payment Program and the Cardiology Core Quality Measures Collaborative (CQMC) set. We sought comment on the appropriateness of including this measure in the heart failure quality measure set.

\194\ 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.

\195\ D[uuml]sing R. Mega clinical trials which have shaped the RAS intervention clinical practice. Therapeutic Advances in Cardiovascular Disease. 2016;10(3):133-150. doi:https://doi.org/10.1177/1753944716644131.

\196\ McMurray JJV, Packer M, Desai AS, et al. Angiotensin- Neprilysin Inhibition versus Enalapril in Heart Failure. New England Journal of Medicine. 2014;371(11):993-1004. doi:https://doi.org/10.1056/nejmoa1409077.

\197\ Kim SE, Byung Su Yoo. Treatment Strategies of Improving Quality of Care in Patients With Heart Failure. Korean circulation journal. 2023;53. doi:https://doi.org/10.4070/kcj.2023.0024.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters expressed concern about including the MIPS Q005: ACE Inhibitor or ARB or ARNI Therapy for LVSD in the ASM heart failure measure set, noting that the measure is topped out in MIPS. The commenters recommended that CMS consider alternative quality measures for inclusion in ASM that have not reached topped-out status. A commenter specifically noted that the measure steward would discontinue supporting the measure starting in CY 2027. Another commenter expressed concern that patients with left ventricular systolic dysfunction may have contraindications to ACEi/ARB/ARNI therapy and recommended that CMS include necessary exclusions for clinically justified cases.

Response: We appreciate the commenters' feedback regarding the inclusion of MIPS Q005: ACE Inhibitor or ARB or ARNI Therapy for LVSD in the ASM heart failure measure set. While we acknowledge that this measure may be topped out in the MIPS program, we believe that the required reporting structure in ASM may yield different results than those seen in MIPS, where providers have flexibility in measure selection.

We also believe this remains a valuable measure to include despite the measure steward's announcement that they will no longer maintain it in the future. The steward did not suggest measure alternatives, and there are no suitable substitutes that would be as impactful in our heart failure quality measure set. The steward's primary rationale for discontinuing maintenance was the topped-out status; however, as stated, we do not believe this will be the case given the mandatory nature of measures in our model.

Regarding concerns that patients with left ventricular systolic dysfunction may

have contraindications to ACEi/ARB/ARNI therapy, the measure addresses this through multiple built-in mechanisms. The measure includes denominator exclusions for clinically justified cases, such as patients with LVADs, documented medical reasons for not prescribing these medications, hypotensive patients at risk of cardiogenic shock, hospitalized patients with marked azotemia, and those with allergies, intolerances, or other medical contraindications. Additionally, patients who have declined therapy are excluded. These exclusions ensure that clinically justified cases are appropriately addressed, as the commenters recommended.

Comment: A commenter recommended that CMS consider a composite adherence measure or a PRO-PM linked measure to better capture the value of guideline-directed medical therapy in practice.

Response: We appreciate this comment regarding the use of composite adherence measures or patient-reported outcome process measures (PRO- PM) linked measures to better capture the value of guideline-directed medical therapy in practice. Our current ACE inhibitor/ARB/ARNI and beta-blocker measures are the best existing tools we have to promote guideline-directed medical therapy (GDMT) for heart failure patients. While we will continue to review whether other measures are developed in the future, we believe these measures are appropriate for assessing quality of care and incentivizing optimization of these therapies. We do include a patient-reported outcome process measure related to functional status, which serves as a complementary tool to determine quality of care and provides additional insight into patient outcomes.

Comment: A commenter supported the proposed inclusion of MIPS Q005: ACE Inhibitor or ARB or ARNI Therapy for LVSD in the ASM heart failure measure set, noting that the appropriate use of these therapies is associated with reductions in mortality and hospitalizations related to heart failure.

Response: We appreciate the commenter for their support of the proposed inclusion of MIPS Q005: ACE Inhibitor or ARB or ARNI Therapy for LVSD in the ASM heart failure measure set. We agree that the appropriate use of these evidence-based therapies is critical for improving patient outcomes in heart failure management. The clinical evidence demonstrates that ACE inhibitors, ARBs, and ARNIs are associated with significant reductions in mortality and hospitalizations for patients with left ventricular systolic dysfunction. Including this measure in the ASM heart failure measure set aligns with our commitment to promoting the use of guideline- directed medical therapy that has proven benefits for patients with heart failure.

Comment: A commenter supported the proposed inclusion of MIPS Q005: ACE Inhibitor or ARB or ARNI Therapy for LVSD in the ASM heart failure measure set and recommended that CMS consider broadening the measure to account for a wider range of future innovations or related therapies that may enter the market. The commenter further recommended that CMS establish higher standards for adherence to oral antihypertensive therapies within the model to address issues related to suboptimal dosing and medication adherence.

Response: We appreciate the support of the proposed inclusion of MIPS Q005: ACE Inhibitor or ARB or ARNI Therapy for LVSD in the ASM heart failure measure set. We appreciate the recommendation to consider broadening the measure to account for future innovations and related therapies that may enter the market. We will assess the measure set regularly to account for changes in clinical guidelines and medication therapies and innovations in care which could impact the model, and the measures included. Regarding the recommendation for higher standards for adherence to oral antihypertensive therapies, we believe this measure and the beta-blocker measure appropriately assess adherence to antihypertensive therapies and should promote improvements in medication management. We recognize that suboptimal dosing and medication adherence are important challenges in heart failure management, and these measures are designed to encourage providers to focus on evidence-based prescribing practices. The combination of these measures within the quality measure set will help drive quality improvements in heart failure care while maintaining flexibility to adapt to evolving clinical standards.

After consideration of public comments, we are finalizing the inclusion of the (MIPS Q005) HF: ACE Inhibitor or ARB or ARNI Therapy for LVSD measure in the heart failure quality measure set as proposed at Sec. 512.725(b)(3). (iv) Controlling High Blood Pressure (MIPS Q236)

We proposed including Controlling High Blood Pressure (MIPS Q236) in the heart failure quality measure set for ASM because optimal blood pressure management is a critical part of heart failure management and uncontrolled blood pressure can contribute to complications and progression.198 199 For example, severe hypertension can result in pulmonary edema (more common in patients with preserved LVEF), requiring urgent treatment to reduce blood pressure.\200\ Controlling blood pressure helps reduce the risk of adverse outcomes, such as hospitalizations and mortality related to heart failure.201 202 By including this measure, ASM incentivizes cardiologists to optimize blood pressure control, particularly given that patients with heart failure very commonly have a history of hypertension.\203\ In addition, this measure complements the two other quality measures for heart failure in ASM, as the use of beta blockers and ACEi/ARB/ARNIs also have favorable effects on heart failure outcomes and lower blood pressure.\204\ The complimentary emphasis on blood pressure control and medication management in this measure set may also slow disease progression and function as a form of tertiary prevention in heart failure patients. Furthermore, its inclusion in other quality measure sets, such as the CMS Universal Foundation Measure Set and the Cardiology Core Quality Measures Collaborative (CQMC) set has resulted in more widespread adoption, helping streamline reporting and reduce burden.\205\ We sought comment on our

inclusion of this measure in the heart failure quality measure set.

\198\ 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.

\199\ Oh GC, Cho HJ. Blood pressure and heart failure. Clinical Hypertension. 2020;26(1). doi:https://doi.org/10.1186/s40885-019-0132-x.

\200\ Ratko Lasica, Lazar Djukanovic, Jovanka Vukmirovic, et al. Clinical Review of Hypertensive Acute Heart Failure. Medicina (Kaunas Spausdinta). 2024;60(1):133-133. doi:https://doi.org/10.3390/medicina60010133.

\201\ The SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. New England Journal of Medicine. 2015;373(22):2103-2116. doi:https://doi.org/10.1056/nejmoa1511939.

\202\ 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.

\203\ Messerli FH, Rimoldi SF, Bangalore S. The Transition From Hypertension to Heart Failure. JACC: Heart Failure. 2017;5(8):543- 551. doi:https://doi.org/10.1016/j.jchf.2017.04.012.

\204\ Oh GC, Cho HJ. Blood pressure and heart failure. Clinical Hypertension. 2020;26(1). doi:https://doi.org/10.1186/s40885-019-0132-x.

\205\ Jacobs DB, Schreiber M, Seshamani M, Tsai D, Fowler E, Fleisher LA. Aligning Quality Measures across CMS -- The Universal Foundation. New England Journal of Medicine. 2023;388(9). doi:https://doi.org/10.1056/nejmp2215539.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support the proposed inclusion of MIPS Q236: Controlling High Blood Pressure in the ASM heart failure quality measure set. A commenter expressed concern that using a single, most recent blood pressure reading to determine a patient's blood pressure control does not align with clinical guidelines or best practices in hypertension management, which recommend longitudinal assessment of blood pressure to appropriately reflect a patient's status. A commenter noted that the measure should be revised to incorporate multiple blood pressure readings or longitudinal data before including in the ASM heart failure quality measure set.

Response: We appreciate the feedback regarding the inclusion of MIPS Q236: Controlling High Blood Pressure in the ASM heart failure quality measure set. The commenters' concerns about using a single, most recent blood pressure reading versus longitudinal assessment could be provided as feedback to the measure steward for future consideration. Currently, we believe that MIPS Q236 is the best measure available to ensure this vital activity occurs in heart failure care. Using this measure allows us to align with MIPS and other quality reporting programs, thereby reducing the administrative burden on ASM participants. While we acknowledge that clinical guidelines recommend longitudinal assessment of blood pressure, the current measure specification represents the most feasible approach for standardized quality measurement across CMS programs. We will continue to monitor developments in blood pressure quality measures and consider updates as improved measures become available through established measure development processes.

Comment: A commenter expressed concern that ASM participants may lack vendor support for reporting the measure, leading to increased costs and burden for clinicians. Another commenter recommended that CMS should provide credit to clinicians for evidence-based interventions, such as dietary advice or diuretics, even if blood pressure control is not achieved, since blood pressure control may not be fully within a clinician's influence.

Response: We acknowledge the potential burden that participants may face regarding vendor support for reporting measures, but we believe this is an important measure for our heart failure quality measure set. This measure has been part of the MIPS program since CY 2018, providing ample time for vendors and systems to adopt it. This measure's importance has also been signaled as important and relevant with its inclusion in the CMS Universal Foundation of Quality Measures. Participants have until 2027 to ensure that they can report this measure, which we believe provides enough advance notice to ensure those pursuing reporting can do so successfully. Also, we believe that the performance assessment structure of ASM will incentivize evidence- based interventions such as dietary advice and diuretic management. While there are no specific measures for these individual activities, our improvement activities complement whole person health activities such as diet counseling and screening for health-related social needs (HRSNs). We believe that participants who choose to provide these evidence-based interventions to their patients will see improved performance in ASM, thereby incentivizing these activities.

Comment: A few commenters supported the proposed measure, MIPS Q236: Controlling High Blood Pressure, because blood pressure management is a critical part of managing heart failure. A commenter stated that the measure is part of the Universal Foundation measure set, and thus including this measure in ASM will promote alignment across programs. A commenter supported the measure but suggested that CMS consider recommended pharmacological interventions to help control high blood pressure, such as loop diuretics. Another commenter recommended that CMS consider incorporating measures that assess sustained improvements in blood pressure. Finally, given the recent release of updated blood pressure guidelines, a commenter noted that CMS may have to modify this measure in the near future to reduce the current target blood pressure range which may result in limited comparability of results over the 5-year proposed timeframe.

Response: We appreciate the comments regarding the proposed inclusion of MIPS Q236: Controlling High Blood Pressure in the ASM heart failure quality measure set. We agree that blood pressure management is a critical component of heart failure care, and we believe that measuring this will promote clinical improvements by providers, such as implementing recommended pharmaceutical interventions like loop diuretics as suggested. We recognize the value of alignment across CMS programs, and including this Universal Foundation measure in ASM supports that goal. We are limited as there are not valid and reliable measures established for all clinical scenarios, and therefore, we must use the measures that are available to us. We believe this measure is an appropriate, clinically valid, and widely used measure for assessing blood pressure control. Regarding the recommendation for measures that assess sustained improvements in blood pressure, we will consider this feedback as we continue to evaluate the measure set. We will continue to review the latest guidelines in clinical care for heart failure, and the specifications of this measure could be adjusted in the future by the measure steward depending on research developments and updated clinical guidelines, including the recent blood pressure guideline updates mentioned. We acknowledge that modifications to align with updated guidelines may impact comparability over time, which is why we do not plan to make changes to the measure set over time, but ensuring clinical relevance and adherence to current evidence-based standards remains our priority.

Comment: A few commenters offered other recommendations to CMS on the proposed measure, MIPS Q236: Controlling High Blood Pressure. A commenter recommended updating the measure with risk stratification or digital quality components to address disparities, workflow issues, and patient non-compliance. The commenter also recommended that CMS consider accepting home or remote blood pressure readings. Finally, the commenter requested clarification regarding whether a missed reading due to a single skipped visit or lack of patient engagement would disproportionately impact performance scores under ASM. Additionally, a few commenters noted that pharmacists and registered dietitian nutritionists can play an important role in controlling blood pressure under the measure and therefore recommended that CMS include pharmacists and registered dietitian nutritionists in ASM.

Response: We appreciate the commenters' feedback regarding MIPS Q236: Controlling High Blood Pressure and the recommendations for measure enhancements. We aim to align with the specifications determined by the measure steward to ensure we do not create undue burden by changing

specifications across different programs. For recommendations regarding risk stratification, digital quality components, acceptance of home or remote blood pressure readings, and other measure specification changes, we recommend directly contacting the measure steward directly to suggest these modifications. We will not include pharmacists or registered dietitian nutritionists as eligible participants in ASM, but to perform well on this and other measures, ASM participants may partner with or leverage these valuable healthcare resources as part of their care delivery approach. This collaborative approach allows ASM participants to benefit from the expertise of pharmacists and dietitians in managing hypertension while maintaining the model's focus on specialty care providers as the primary participants accountable for quality and cost outcomes.

After consideration of public comments, we are finalizing the inclusion of MIPS Q236: Controlling High Blood Pressure in the heart failure quality measure set as proposed at Sec. 512.725(b)(4). (v) Functional Status Assessments for Heart Failure (MIPS Q377)

We proposed including Functional Status Assessments for Heart Failure (MIPS Q377) in the heart failure quality measure set in ASM because patients with heart failure often experience poor functional status and health-related quality of life, both of which tend to decline as the disease progresses. Assessing functional status is crucial for managing the complex health needs of patients who often have multiple comorbidities. Furthermore, standardized assessment of patient-reported health status using a validated questionnaire can be useful for providing incremental information related to patient functional status and prognosis. It is also an independent predictor of hospitalization and mortality.\206\ The measure emphasizes the importance of collecting relevant patient-reported health status from heart failure patients, such as functional limitations, symptom burden, and quality of life. It supports the creation of a dynamic conversation between patients and providers regarding care goals and priorities, which we believe can facilitate shared decision-making, empower patients, and incentivize clinicians to incorporate patient voice and lived experience in clinical care activities. This measure is appropriate for ASM as it encourages cardiologists to regularly assess, monitor, and help improve the functional status of their heart failure patients, which are crucial for providing patient-centered care and aligning treatment plans with individual goals and priorities. In addition, this measure aligns with other quality measurement efforts, such as the Advancing Care for Heart Disease MVP in the Quality Payment Program and the Cardiology Core Quality Measures Collaborative (CQMC) set. We sought comment on our inclusion of this measure in the heart failure quality measure set.

\206\ 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed inclusion of MIPS Q377: Functional Status Assessments for Heart Failure in the ASM heart failure measure set, noting that the measure should be included as a process measure for the CY 2027 ASM performance year, to ensure data collection is feasible and not overly burdensome to patients or clinicians prior to transitioning to a PRO-PM.

Response: We acknowledge the commenters' support of this measure. We agree that it is beneficial to the measure set in its current state and appreciate the commenters' recognition of its value for heart failure care. The measure balances the burden of reporting while incentivizing functional status assessments, which are critical components of comprehensive heart failure management.

Comment: A few commenters expressed concern about the proposed inclusion of MIPS Q377: Functional Status Assessments for Heart Failure measure in the ASM heart failure measure set. A commenter shared their concerns regarding the measure's feasibility and benchmarking, noting that limitations in data capture could unfairly penalize clinicians regardless of care quality. Another commenter expressed concern that some patients may require more than 180 days for meaningful improvement, depending on disease severity and comorbidities, noting that the measure timeframes must account for these actions.

Response: We appreciate the commenter's feedback. We understand the concerns about data capture feasibility and potential penalties for clinicians regardless of care quality. Success in ASM may mean ensuring that patient healthcare data is entered and captured in EHRs appropriately, and we are providing significant advance notice as the model does not start until 2027, thereby giving participants ample time to implement practices and systems to address concerns about data capture capabilities.

Regarding concerns about meaningful improvement within 180 days, we want to clarify that the measure in its current form only looks for documentation that a valid and standardized functional status assessment tool is being administered within 180 days before or after a qualifying heart failure encounter. This measure does not look for clinical improvement during that timeframe, rather, it focuses on whether appropriate assessment tools are being used to evaluate patient functional status as part of comprehensive heart failure care. The measure is designed to promote the systematic use of validated assessment instruments that can inform treatment decisions and care planning, rather than requiring specific improvement outcomes within the specified timeframe.

We note that the Functional Status Assessments for Heart Failure (MIPS Q377) measure is currently a process measure. We proposed that the process measure would be included for the 2027 ASM performance year, while we explore the benefit and applicability of developing a patient-reported outcome-based performance measure (PRO-PM). The current measure ensures a functional status assessment is completed. A PRO-PM would hold the ASM participant accountable for not only collecting patient-reported data but also improving or slowing progression of decline in functional status over time. We believe this would capture more meaningful changes in patient care. We sought comments on our proposal to include the Functional Status Assessments for Heart Failure (MIPS Q377) measure in ASM, the applicability of the measure as a PRO-PM, and whether the PRO-PM, if available, should be included in the heart failure quality measure set for future performance years of ASM.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter did not support development of the proposed MIPS Q377: Functional Status Assessments for Heart Failure measure into a PRO-PM and expressed concern that the measure incorporates factors that are beyond clinician control, such as patient-specific social risk factors and

patient literacy levels. Another commenter noted that the inclusion of PRO-PMs adds new burdens with limited demonstrated value. The commenter also stated that implementation requires new workflows, vendor contracts, and high costs. The commenter recommended that if PRO-PMs are to be included, CMS should allow clinicians flexibility in vendor selection, ensure that acceptable instruments are freely available, and provide technical assistance and phased adoption.

Response: We appreciate the feedback regarding the proposed MIPS Q377: Functional Status Assessments for Heart Failure measure and concerns about its potential development into a PRO-PM. We are finalizing the inclusion of the process version of this measure in this rule, not the PRO-PM version. We are continuing to explore whether a PRO-PM version is appropriate for future implementation and will take these concerns into account during this evaluation process.

We are committed to ensuring that measures included in the ASM measure set prioritize clinical acceptability while minimizing administrative burden on ASM participants. Under the potential development of a PRO-PM, we would seek to allow flexibility where possible in survey instruments used, recognizing the diverse needs and capabilities of different practice settings. We understand the concerns about factors beyond clinician control, such as patient-specific social risk factors and literacy levels and will carefully consider these limitations in any future PRO-PM development.

Any future implementation of this measure as a PRO-PM would be clearly indicated through future notice-and-comment rulemaking, which would provide ample time for adoption by ASM participants. We would also consider opportunities to support participants and phased implementation. We recognize the workflow changes, vendor considerations, and associated costs that PRO-PM implementation may require, and we are committed to working with interested parties to address these challenges should we move forward with PRO-PM development in the future.

Comment: A few commenters supported CMS' development of a validated PRO-PM for the proposed MIPS Q377: Functional Status Assessments for Heart Failure measure. A commenter noted that the PRO-PM would demonstrate a meaningful shift from documentation-based processes to measures of patient experience and lived health outcomes while another commenter stated that the PRO-PM would allow CMS to hold ASM participants accountable not only for completing assessments but also for improving or maintaining patients' functional status over time. However, a few commenters noted possible challenges around licensing, data sources, and inequitable scoring if a PRO-PM is implemented. A commenter recommended that the future PRO-PM for Functional Status Assessments for Heart Failure should not require licensing costly proprietary content. A commenter recommended that CMS phase in this measure as a reporting-only measure or include it as an ASM improvement activity.

Response: We appreciate the supportive feedback regarding the potential development of a PRO-PM for the proposed MIPS Q377: Functional Status Assessments for Heart Failure measure. We are finalizing the inclusion of the process version of this measure in this rule, not a PRO-PM version. We are continuing to explore if a PRO-PM would be appropriate and will take this support into account during this evaluation process. We agree that this tool would improve adherence to completing assessments and improving functional status over time, representing a meaningful shift from documentation-based processes to measures of patient experience and lived health outcomes. We understand the comments around licensing and data sources, and would consider these issues if the measure is developed into a PRO-PM. We recognize the importance of avoiding costly proprietary content requirements and ensuring equitable scoring across diverse patient populations. If a PRO-PM is developed and included in ASM, we would indicate it in advance via notice-and-comment rulemaking and would ensure there is adequate time for the survey(s) to be implemented.

We also received broad feedback on the heart failure quality measure set. The following is a summary of these comments and our responses.

Comment: Many commenters generally supported the proposed ASM heart failure quality measure set. A few commenters supported the use of PRO- PMs in the ASM heart failure quality measure set. A commenter shared their belief that the proposed PRO-PMs in ASM elevate patient voice and incentivize clinicians to be more responsive to the patient's treatment outcomes. Another commenter noted that the proposed quality measures in the ASM heart failure measure set would support early intervention of acute symptoms, self-management, and improve overall quality of care for patients with heart failure. A commenter recommended that CMS consider including outpatient management of worsening signs and symptoms in patients with heart failure and incorporating guidance from the 2022 AHA/ACC/HFSA Heart Failure Guideline. Another commenter appreciated CMS for the proposed measure set's conciseness and alignment with the Core Quality Measures Collaborative's work.

Response: We appreciate the supportive comments regarding the proposed ASM heart failure quality measure set and the recognition of its alignment with established quality frameworks. We will continue to explore opportunities for PRO-PM in the measure set. Our goal is to support early intervention and management of heart failure symptoms while ensuring that the measure set is appropriate for all levels of heart failure care. We appreciate the feedback regarding incorporating guidance from the 2022 AHA/ACC/HFSA Heart Failure Guideline and will consider how to better address outpatient management of worsening signs and symptoms in future iterations. The conciseness of the measure set and its alignment with the Core Quality Measures Collaborative's work reflects our commitment to reducing provider burden while maintaining meaningful quality assessment. We believe this balanced approach will support improved self-management capabilities and overall quality of care for patients with heart failure across the care continuum.

Comment: A commenter shared their concern that none of the proposed measures in the ASM heart failure measure set are PRO-PMs, noting that two of the heart failure quality measures, Beta Blocker Therapy for LVSD and ACE/ARB/ARNI for LVSD, only apply to patients with reduced ejection fraction while the cost measures include patients with preserved ejection fraction.

Response: We appreciate the commenter for the feedback regarding PRO-PMs and the scope of quality measures in the ASM heart failure measure set. We are limited by which measures are currently available and validated for heart failure care, and we believe the selected measures are appropriate for assessing quality care delivery in this population. We are continuing to explore opportunities for developing a heart failure-specific PRO-PM, but we believe the process-based quality measures in our current set appropriately assess evidence-based care delivery. Regarding the concern

about reduced ejection fraction measures, while the cost measures include patients with preserved ejection fraction, our goal is to improve care for all heart failure patients, not just certain subsets, though we recognize the clinical nuances and heterogeneity in their care needs. Certain quality measures are only applicable to specific patient subsets and should be applied as they were developed and specified, rather than being extended to other populations for which they were not designed or validated. We acknowledge that we currently do not have quality measures specifically for heart failure with preserved ejection fraction (HFpEF), partly because clinical guidelines for HFpEF continue to evolve and measure development has not kept pace with these advances. We will be assessing the quality measure set throughout the course of the model and could propose changes or additions in future years through notice-and-comment rulemaking as new evidence-based measures become available and validated for the heart failure population.

Comment: Several commenters offered recommendations on the proposed ASM heart failure quality measure set. A commenter recommended that CMS incorporate incentives for early screening and diagnosis of cardio- renal-metabolic (CRM) conditions to slow progression of CRM conditions and improve health outcomes. Another commenter recommended CMS adding palliative care as a treatment option for heart failure patients, noting alignment with the American Heart Association's recommendation to integrate palliative care for patients with advanced cardiovascular disease. Another commenter recommended incorporating patient experience measures, such as the CAHPS survey, to assess the domains of patient communication, care coordination, and shared decision-making. Another commenter recommended that CMS includes Preventive Care and Screening: Screening for Depression and Follow-up Plan measure in the heart failure quality measure set, because many heart failure patients suffer from depressive symptoms. A few commenters recommended that ASM recognize and accommodate novel therapeutic innovations and incorporate newer therapies, such as statins and SGLT2 inhibitors. A commenter recommended that CMS consider including future measures for novel therapies, cardiology visits, and medical nutrition therapy.

Response: We appreciate the feedback on additional measures and elements to improve the quality of care for heart failure patients, such as those focused on early screening and diagnosis of CRM conditions, palliative care, CAHPS patient experience measures, depression screening, novel medical therapies, and composite guideline- directed medical therapy (GDMT). With the heart failure quality measure set, we strive to balance clinical applicability and minimal burden on participants and patients. Due to this balance, the development of new measures is often unfeasible, considering the significant effort involved by CMS and participants in standing them up operationally.

We will take these suggestions into consideration. While we do not plan to adjust the quality measure sets during the model test period, we would consider modifications for significant changes in clinical guidelines, availability of new measures, or where the addition or removal of measures would incentivize quality care. Comment: A commenter shared their concern about using PRO-PMs as the foundation of ASM, noting the difficulty to collect data in vascular surgery populations.

Response: We appreciate the commenters for their feedback. We believe that PROMs are valuable tools in quality measurement as they capture the patient's perspective on their health status and treatment outcomes, which is essential for comprehensive quality assessment. However, we recognize that PRO-PMs do not exist in every clinical field yet, and their development and validation require significant time and resources.

We would like to clarify that ASM focuses specifically on heart failure and low back pain conditions, not vascular surgery. The measure sets are tailored to these specific clinical areas where an appropriate PROM has been identified and validated. We understand that different surgical specialties, including vascular surgery, may face unique challenges in implementing PROMs due to factors such as patient acuity, procedural complexity, and varying recovery timelines that can make standardized outcome measurement more difficult. However, because ASM does not focus on vascular surgery specialists, we believe that this comment is out of ASM's scope.

Comment: A few commenters recommended that CMS use existing MVPs that may be applicable to heart failure, such as the Advancing Care for Heart Disease MVP, since using existing MVPs would minimize reporting burden

Response: We appreciate the commenter's recommendation to use existing MVPs that may be applicable to heart failure, such as the Advancing Care for Heart Disease MVP. We agree that overlap in measures between programs can reduce administrative burden on providers and improve alignment across CMS quality initiatives. For this reason, during our measure selection process, we aligned as much as possible with the Advancing Care for Heart Disease MVP. Four of our five heart failure measures are the same as those included in the MVP, demonstrating our commitment to reducing duplicative reporting requirements while maintaining clinically meaningful quality assessment. This alignment supports provider efficiency by allowing participants to leverage existing workflows and data collection processes they may already have in place for MVP reporting. Also, acknowledging the burden this may present to small practices, we are finalizing allowing for flexibility for small practices to report quality measures in the quality ASM performance category at the TIN- level, as further described in section III.C.2.d.(1).(b) in this final.

Comment: A commenter recommended that CMS consider including arrhythmia detection in the ASM heart failure measure set, noting that the measure would help address a key, often undetected driver of heart failure morbidity and cost, and align with HHS's Make America Healthy Again initiative. The commenters recommended adding quality measures in the ASM heart failure measure set, such as documented rhythm monitoring, appropriate management initiation, and reduction in unplanned cardiovascular admissions attributable to atrial fibrillation.

Response: We appreciate the feedback regarding the recommendation to include arrhythmia detection measures in the ASM heart failure quality measure set. We recognize that arrhythmias, particularly atrial fibrillation, can be an important and often undetected driver of heart failure morbidity and healthcare costs. However, we do not currently have a validated MIPS measure that addresses this specific clinical nuance, particularly in regard to heart failure admissions and the comprehensive arrhythmia management components.

We considered existing measures such as those focused on atrial fibrillation and atrial flutter anticoagulation management, recognizing that some patients with heart failure also have atrial fibrillation. Ultimately, we did not choose to include these measures because they only apply to a subset of the heart

failure population, and we aimed to develop a measure set that would be broadly applicable to the diverse heart failure patient population served by ASM participants.

We appreciate the commenter noting the alignment with broader health initiatives and the clinical importance of rhythm monitoring and appropriate management. While we do not plan to adjust the quality measure sets during the model test period, we would consider modifications for significant changes in clinical guidelines, availability of new measures, or where the addition or removal of measures would incentivize quality care. We will consider incorporating arrhythmia-related measures in future iterations of the ASM heart failure quality measure set should validated measures become available. The feedback regarding documented rhythm monitoring, appropriate management initiation, and reduction in unplanned cardiovascular admissions attributable to atrial fibrillation will inform our ongoing evaluation of potential measure enhancements.

Comment: A few commenters expressed concerns about the proposed ASM heart failure quality measure set, noting that it may disadvantage 50 percent of heart failure patients with HFpEF as well as patients with advanced heart failure. The commenters shared their belief that the proposed quality measures are primarily aligned with evidence-based treatments for HFrEF and recommended that CMS develop dedicated quality measures for HFpEF populations that reflect the limited evidence base and different therapeutic approaches for these patients. The commenters encouraged CMS to adopt additional measures to incentivize quality of care for all heart failure patients.

Response: We appreciate the feedback regarding concerns about the proposed ASM heart failure quality measure set and its potential impact on patients with heart failure with preserved ejection fraction (HFpEF) and advanced heart failure. Our goal is to improve care for all heart failure patients, not just certain subsets, though we recognize the clinical nuances and heterogeneity in their care management approaches. We acknowledge the difference between patients with HFpEF and those with HFrEF, and that clinical guidelines for HFpEF are still evolving. We note that certain quality measures are only applicable to specific patient subsets based on the clinical evidence and populations for which they were developed and validated, and we would want to apply these measures as they were originally specified rather than extending them inappropriately to other populations. We also note that there are limited existing quality measures that apply to HFpEF. We will be assessing the quality measure set throughout the course of the model and could propose changes in future years as the clinical evidence base evolves and new validated measures become available. While we strive to incentivize quality care for all heart failure patients, we must balance this goal with the practical limitations of available, validated quality measures. We appreciate the clinical expertise reflected in these comments and will continue to engage with the heart failure clinical community to ensure our quality measurement approach supports optimal care for all patients across the heart failure spectrum.

Comment: A commenter shared their concern that patients with advanced heart failure may encounter treatment paradoxes, where standard care protocols may not be appropriate, potentially compromising the validity of quality measurement and unfairly penalizing clinicians caring for the most complex patients. The commenter, therefore, recommended that patients classified as New York Heart Association (NYHA) stage D be systematically excluded by CMS from all proposed quality measures.

Response: We appreciate the commenters for expressing their concerns about patients with advanced heart failure and the potential impact on quality measurement validity. We agree that there are scenarios in which advanced heart failure patients may present clinical complexities that could be less appropriate for assessing a participant's performance. For this reason, each quality measure includes elements such as denominator exclusions and risk adjustment methodologies specifically designed to address these challenging clinical situations. We also believe that our overall performance assessment approach, which includes multiple elements beyond quality measures and compares similar providers treating comparable patient populations, will help mitigate potential issues related to caring for complex patients. While we understand the clinical rationale for the recommendation, we believe that systematically excluding Stage D patients would be against ASM's overall goal of improving care for all heart failure patients and holding providers accountable for the full spectrum of patients they treat.

Comment: A commenter recommended that CMS clarify whether the proposed medication-based measures in the ASM heart failure measure set would apply to all heart failure patients under a clinician's care or only to those patients attributed to the clinician within ASM. The commenter expressed concerns that applying these measures to all heart failure patients could increase reporting burden, while limiting them to attributed patients may result in issues with sample size and representativeness.

Response: We appreciate the comment requesting clarification on the scope of the proposed measures in the ASM heart failure quality measure set. The medication measures (ACE Inhibitor or ARB or ARNI Therapy for LVSD and Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction) are all-payer measures, meaning they are reported regardless of insurance type for those patients that they apply to. We believe this approach is important because it allows full representation of an ASM participant's care across their entire patient panel, provides more stable denominators for meaningful measurement, enables streamlined workflows for reporting, and delivers improved quality insights. While we understand the concerns about potential reporting burden when applying measures to all heart failure patients under a clinician's care, we believe that the benefits of comprehensive measurement outweigh these concerns. The all-payer approach ensures that quality assessment reflects the totality of care provided by ASM participants rather than being limited to a subset that may not be representative of their overall practice patterns. Additionally, this approach addresses the sample size and representativeness issues that could arise from limiting measurements to only attributed patients, which could result in unreliable or skewed performance data.

Comment: A commenter recommended that CMS clarify whether heart failure patients without a confirming echocardiogram would be excluded from the proposed ASM heart failure quality measure set, noting that attributing such patients to specialists without definitive diagnostic confirmation would be inappropriate.

Response: To clarify for the commenter, each measure includes specific inclusion criteria that determine which portion of the participant's patient panel is included in the denominator or numerator for that particular measure. The measures do not universally require verification that the patient has heart failure with a confirming echocardiogram as part of

their standard specifications. We believe the all-payer and patient panel approach of the measures is appropriate as it allows the measures to comprehensively assess provider quality across their entire relevant patient population. Each measure has been rigorously tested for reliability and validity in the specific population it targets, and modifying these specifications to look exclusively for heart failure patients with a confirming echocardiogram would jeopardize the measures' established validity and reliability. The inclusion criteria for each measure are designed to identify the appropriate patient population based on the clinical evidence and methodology that supports that specific measure. This approach ensures that quality assessment reflects real-world clinical practice patterns while maintaining the scientific integrity of the measurement tools. After reviewing public comments, we are finalizing the inclusion of Functional Status Assessments for Heart Failure (MIPS Q377) as proposed at Sec. 512.725(b)(5). We intend to consider re-specification of this measure into a PRO-PM through future notice-and-comment rulemaking. (c) Quality Measure Set for the ASM Low Back Pain Cohort

We proposed at Sec. 512.725(c)(1) through (5) to include the following measures in the low back pain quality measure set. Each ASM low back pain participant must report each finalized measure using one of the collection types specified in Table B-D4. (i) Magnetic Resonance Imaging (MRI) Lumbar Spine for Low Back Pain, Respecified To Be Relevant to ASM Participants Treating Low Back Pain

We proposed to include a respecified MRI Lumbar Spine for Low Back Pain measure in the low back pain quality measure set. We believe this administrative claims-based measure can effectively assess overuse and incentivize reductions in inappropriate MRI imaging for low back pain. Routine imaging (such as MRI) is not recommended for patients with non- specific low back pain in the absence of certain clinical indicators with concerning features.\207\ However, studies have shown that a significant proportion of patients with low back pain undergo imaging, often within the first few weeks of symptom onset, despite the lack of clear indication.\208\ Overuse of imaging for low back pain can lead to unnecessary health care costs and potential patient harm from incidental findings that may prompt further unnecessary testing or procedures.209 210 By including this measure in the low back pain quality measure set, ASM aims to incentivize adherence to evidence-based guidelines and a reduction of unnecessary MRIs for patients with uncomplicated low back pain, particularly in the initial stages of evaluation and management. We believe this could also have a positive impact on patient experience as it reduces time spent at medical appointments and health care costs. Furthermore, as an administrative claims measure, ASM participants would not have to report data for this measure, reducing reporting burden.

\207\ North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/Guidelines/LowBackPain.pdf.

\208\ Medicare Payment Advisory Commission. Health Care Spending and the Medicare Program: A Data Book. Medicare Payment Advisory Commission; July 2021. Accessed [insert access date]. https://www.medpac.gov/wp-content/uploads/2021/10/July2021_MedPAC_DataBook_Sec7_SEC.pdf.

\209\ Litkowski PE, Smetana GW, Zeidel ML, Blanchard MS. Curbing the Urge to Image. The American Journal of Medicine. 2016;129(10):1131-1135. doi: https://doi.org/10.1016/j.amjmed.2016.06.020.

\210\ Chou R. Diagnostic Imaging for Low Back Pain: Advice for High-Value Health Care From the American College of Physicians. Annals of Internal Medicine. 2011;154(3):181. doi: https://doi.org/10.7326/0003-4819-154-3-201102010-00008.

MRI Lumbar Spine for Low Back Pain measure was specified for use in Hospital Outpatient Departments at the facility level and was previously included in the Hospital Outpatient Quality Reporting Program (HOQRP) as OP-8 (73 FR 68766).\211\ Part of our re- specification efforts would involve ensuring validity and reliability at the TIN/NPI level. We are also exploring the denominator criteria of the measure and potentially redefining the denominator. This potential change is pending further internal analyses to determine whether participants would be able to meet denominator minimum and specification changes and ensure the measure accurately identifies unwarranted MRI usage. We would propose the measure's specifications through notice-and-comment rulemaking when available and in advance of using the measure in the low back pain cohort.

\211\ Hospital Outpatient Quality Reporting [verbar] Partnership for Quality Measurement. P4qm.org. Published 2025. Accessed April 23, 2025. https://p4qm.org/taxonomy/term/216.

We solicited comments on the re-specification and inclusion of MRI Lumbar Spine for Low Back Pain measure in the low back pain quality measure set.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters expressed concerns about the proposed MRI Lumbar Spine for Low Back Pain measure in the ASM low back pain measure set. A few commenters did not support the inclusion of the measure, noting the measure is still in development resulting in limited insight into the measure specifications. A few commenters recommended that CMS defer the inclusion until the measure is fully developed, clinically vetted, and made available for public review. A few commenters noted that the measure was previously removed from the Hospital Outpatient Quality Reporting program due to stable performance and low average volumes, as well lack of alignment with current clinical guidelines. A commenter recommended CMS to clarify the timeline for measure development and validation. Another commenter expressed concern that the measure could inappropriately drive clinicians to focus narrowly on reducing utilization, rather than ensuring appropriate and timely imaging when clinically indicated. The commenter recommended that CMS replace the proposed MRI Lumbar Spine for Low Back Pain measure with the Falls: Plan of Care measure. A few commenters recommended CMS to clarify attribution and reporting requirements for the measure. A commenter recommended that CMS provide specifications for MRI utilization and identify high-risk medications. Another commenter expressed concern that the measure would not accurately reflect the quality of care or be applicable to all ASM low back pain cohort participants.

Response: We appreciate the commenters for their feedback regarding the proposed MRI Lumbar Spine for Low Back Pain measure in the ASM low back pain quality measure set. Based on this feedback, we are not finalizing the MRI Lumbar Spine for Low Back Pain measure in the ASM low back pain quality measure set at this time. We are continuing to explore this measure and/or other measures focused on low back pain low-value care that are claims-based for inclusion by the January 1, 2027 ASM start date. We will propose the measure we would like to move forward with through future notice-and-comment rulemaking. We believe that, given our intention to use an administrative claims-based measure, which limits participant burden, indicating the measure and specifications during the CY 2027 PFS notice of public rulemaking would

provide ample time for participants to prepare for implementation. We acknowledge the concerns raised about measure development status, clinical validation, and the need for public review, as well as the feedback regarding the measure's previous removal from other quality reporting programs. Our commitment is to ensure that any low-value care measure we ultimately include will be fully developed, clinically appropriate, and aligned with current evidence-based guidelines. We will continue to work with clinical experts and interested parties to identify the most appropriate and effective measure while ensuring that clinically indicated care is not compromised.

Comment: A commenter recommended that CMS re-specify the proposed MRI Lumbar Spine for Low Back Pain measure in the ASM low back pain quality measure set, noting that the measure should evaluate care based on specific lumbar spine diseases or conditions, including lumbosacral and sacroiliac conditions, rather than grouping all chronic low back pain patients together. The commenter also recommended that CMS provide a list of ICD-10 codes that would trigger a “non-specific low back pain” classification, as well as the CPT codes included within the non-specific low back pain group.

Response: We appreciate the commenter's feedback on the proposed MRI Lumbar Spine for Low Back Pain measure in the ASM low back pain quality measure set. We are not finalizing the inclusion of the MRI Lumbar Spine for Low Back Pain measure in the ASM measure set at this time. We intend to revisit this measure or possible alternatives in the CY 2027 PFS notice of public rulemaking. At that time, we may consider the recommendation to re-specify the measure to evaluate care based on specific lumbar spine diseases or conditions, including specific diagnostic categorizations and appropriate code specifications that better reflect the clinical nuances of different lumbar spine conditions.

After consideration of public comments, we are not finalizing inclusion of Magnetic Resonance Imaging (MRI) Lumbar Spine for Low Back Pain, Respecified to Be Relevant to ASM Participants Treating Low Back Pain in the low back pain quality measure set at this time. We intend to revisit this measure or alternatives in future notice-and-comment rulemaking. (ii) Use of High-Risk Medications in Older Adults (MIPS Q238)

We proposed to include the Use of High-Risk Medications in Older Adults (MIPS Q238) measure in the low back pain quality measure set. Older adults with low back pain who receive a prescription for a high- risk medication as part of their treatment plan, may have a range of adverse events, including medication side effects, drug interactions, a prescribing cascade, or hospitalization. Individuals ages 65 and older are more likely to have multiple chronic conditions, increasing their risk for adverse drug effects associated with polypharmacy.\212\ Forty percent of individuals 65 and older filled at least one prescription for a potentially inappropriate medication and 13 percent filled two or more, leading to as much as $7.2 billion spent per year on inappropriate medications in older adults.213 214 Several of the medications included in the measure are prescribed for treatment of musculoskeletal conditions and pain, such as skeletal muscle relaxants and tricyclic antidepressants.215 216 217 Skeletal muscle relaxants may be prescribed as an alternative to conventional pain medication; however, they carry considerable risk of falls and associated morbidity due to common side effects of dizziness, drowsiness, and hypotension. One study found that elderly patients who were using skeletal muscle relaxants were 2.25 times more likely to visit the emergency room for a fall or fracture than elderly patients who were not prescribed these medications.\218\ Similarly, a meta- analysis exploring the risks associated with use of tricyclic antidepressants in elderly patients found a significant increased risk of falls and fracture.\219\ In addition to the morbidity and substantial costs associated with falls in the older adult population, falls in a patient with low back pain could significantly worsen their condition and functional status. We believe including this measure in the low back pain quality measure set could encourage ASM participants to be more cautious in their prescribing of high-risk medications to patients with low back pain and potentially prevent falls and other adverse events that may negatively impact patient outcomes. It also could align clinical practice with efforts to avoid inappropriate describing in older adults, such as the Beers criteria, and deprescribe where appropriate.\220\ We believe the measure may promote positive changes in care delivery, such as incorporating regular medication review and reconciliation. This measure could be particularly impactful in ASM given the promotion of specialty and primary care integration as a goal of the model. We solicited comments on our inclusion of the Use of High-Risk Medications in Older Adults (MIPS Q238) measure in the ASM low back pain quality measure set.

\212\ Medicare Payment Advisory Commission. Polypharmacy and opioid use among Medicare Part D enrollees. In: Report to the Congress: Medicare and the Health Care Delivery System. June 2015. Chapter 5. Accessed [insert access date]. https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/chapter-5-polypharmacy-and-opioid-use-among-medicare-part-d-enrollees-june-2015-report-.pdf.

\213\ Fick DM, Mion LC, Beers MH, L. Waller J. Health outcomes associated with potentially inappropriate medication use in older adults. Research in Nursing & Health. 2008;31(1):42-51. doi:https://doi.org/10.1002/nur.20232.

\214\ Fu AZ, Jiang JZ, Reeves JH, Fincham JE, Liu GG, Perri M. Potentially Inappropriate Medication Use and Healthcare Expenditures in the US Community-Dwelling Elderly. Medical Care. 2007;45(5):472- 476. doi:https://doi.org/10.1097/01.mlr.0000254571.05722.34.

\215\ North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCar.

\216\ Santandreu J, Francisco F[eacute]lix Caballero, M Pilar G[oacute]mez-Serranillos, Gonz[aacute]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

\217\ Castillo S. Inappropriate Use of Skeletal Muscle Relaxants in Geriatric Patients. Uspharmacist.com. Published January 21, 2020. Accessed April 17, 2025. https://www.uspharmacist.com/article/ inappropriate-use-of-skeletal-muscle-relaxants-in-geriatric- patients#:~:text=Skeletal%20muscle%20relaxants%20are%20on,opioids%20i n%20the%20geriatric%20population.

\218\ Castillo S. Inappropriate Use of Skeletal Muscle Relaxants in Geriatric Patients. Uspharmacist.com. Published January 21, 2020. Accessed April 23, 2025. https://www.uspharmacist.com/article/inappropriate-use-of-skeletal-muscle-relaxants-in-geriatric-patients?utm_source=TrendMD&utm_medium=cpc&utm_campaign=US_Pharmacist_TrendMD_0.

\219\ Santandreu J, Francisco F[eacute]lix Caballero, M Pilar G[oacute]mez-Serranillos, Gonz[aacute]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.

\220\ 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters did not support the proposed inclusion of MIPS Q238: Use of High-Risk

Medications in Older Adults in the ASM low back pain quality measure set. A few commenters expressed concern that the measure may unfairly penalize clinicians for appropriate prescribing of medications and recommended that CMS monitor the impact of this measure. The commenters shared their belief that clinicians should be encouraged to individualize medication regimens relevant to the patient's unique needs, rather than being penalized for prescribing a “high risk” medication. A commenter recommended that CMS should not hold ASM participants accountable for use of high-risk medications to manage care for low back pain, noting that these medications are indicative of patients with a wide range of diagnoses beyond low back pain, are often prescribed or initiated by a primary care physician rather than specialists, limiting the specialist's authority to discontinue or alter those prescriptions. Another commenter recommended that CMS should test the reliability and validity of the measure at the individual level prior to its inclusion in ASM, noting that the measure was developed at the health-plan level and not the individual clinician level. Another commenter expressed concern that the measure is topped out.

Response: We appreciate the feedback regarding the proposed inclusion of MIPS Q238: Use of High-Risk Medications in Older Adults in the ASM low back pain quality measure set. We want to note that the use of two or more high-risk medications is a concern for overall health, and there are not common circumstances in which patients would have this medication mix and it would be appropriate. This measure has been extensively reviewed and approved for use because of its ability to discern inappropriate prescribing patterns. Furthermore, if there were a rare instance of a medication combination that would be captured in the numerator of this measure being relevant to a patient, the rest of the ASM participant's patient panel would balance out this outlier, as the measure focuses on the total percentage of patients 65 years of age and older. The measure largely looks for trends in inappropriate medication use, and providers that would perform the worst are those who have a significant number of patients on these high-risk medications.

Regarding concerns that these medications are applicable to several conditions beyond low back pain, ASM is focused on promoting accountability of our participants for their patients' whole-person health. When seeing a patient, the participant should examine the patient's suite of medications they are on and scrutinize if any are high-risk, especially given the connection between some of these high- risk medications, low back pain, and adverse events like falls. Additionally, if a medication is ordered by a provider who is not the ASM participant, they would not be penalized based on the measure methodology.

Regarding reliability at the TIN/NPI level, we note this measure is currently used in MIPS at the individual clinician level and our model aims to align with MIPS measures and measurement approaches whenever possible. While it can also be used to assess health plan performance, we note that the health plan level is not the only level of reporting or analysis for the measure. We also believe ASM's minimum case count criteria for quality measures as described in section III.C.2.d.(2).(h).(ii) of this final rule will ensure that only participants that meet the case minimum will be scored on the measure. Finally, concerning the topped-out status, we believe the mandatory set of measures in ASM reduces choice compared to MIPS, where providers could typically report measures on which they perform best. We believe mandatory reporting could significantly change the distribution of measure scores and whether the measure would be considered topped-out in ASM. We refer readers to section III.C.2.d.(2).(i).(iii) of this final rule for further discussion on topped-out measure status in ASM.

Comment: A commenter shared their belief that pharmacists are essential in ensuring patients receive medications that best align with their treatment plan under the proposed MIPS Q238: Use of High-Risk Medications in Older Adults measure in the ASM low back pain quality measure set and recommended that CMS include pharmacists in the ASM, as many of the proposed measures are applicable to them.

Response: We appreciate this comment regarding the important role of pharmacists in medication management and patient care. While ASM does not include pharmacists as ASM participants, we recognize that to succeed, participants would ideally connect with pharmacists and collaborate on optimizing patient care. We believe the overall incentive approach of the model ensures discussion and coordination with the overall care team, which may include a pharmacist. The quality measures, including MIPS Q238: Use of High-Risk Medications in Older Adults, are designed to encourage ASM participants to take a comprehensive approach to patient care that naturally involves collaboration with other healthcare professionals who can contribute to better outcomes. This collaborative approach aligns with our broader goals of promoting coordinated, patient-centered care that leverages the expertise of all relevant healthcare professionals.

After consideration of public comments, we are finalizing the inclusion of the (MIPS Q238) Use of High-Risk Medications in Older Adults in the low back pain quality measure set as proposed at Sec. 512.725(c)(1). (iii) Preventive Care and Screening: Screening for Depression and Follow-Up Plan (MIPS Q134)

We proposed to including Preventive Care and Screening: Screening for Depression and Follow-Up Plan (Q134) in the low back pain quality measure set because patients with chronic pain conditions, such as low back pain, are at an increased risk of developing depression.\221\ Comorbid depression can negatively impact quality of life, treatment adherence, and overall health outcomes.\222\ 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.\223\ Co-occurring depression has also been found to worsen low back pain outcomes and increase health care costs.\224\ 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 quality 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.225 226 We sought 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 quality measure set.

\221\ 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.

\222\ 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.

\223\ North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020.

\224\ Wong JJ, Tricco AC, C[ocirc]t[eacute] 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.

\225\ 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.

\226\ 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed inclusion of MIPS Q134: Preventive Care and Screening: Screening for Depression and Follow-Up Plan measure in the ASM low back pain quality measure set, noting that depression can exacerbate pain and negatively affect function, treatment adherence, and overall health outcomes. A commenter shared their belief that this measure would encourage providers to prioritize mental health screening and follow-up care. Another commenter recommended CMS to clarify whether the proposed measure aligns with the Universal Foundation.

Response: We appreciate the support for the proposed inclusion of MIPS Q134: Preventive Care and Screening: Screening for Depression and Follow-Up Plan measure in the ASM low back pain quality measure set. We believe it is vital to whole-person low back pain care, as depression can exacerbate pain and negatively affect function, treatment adherence, and overall health outcomes. This measure encourages providers to prioritize mental health screening and follow-up care, which is essential for comprehensive pain management. This measure does align with the CMS Universal Foundation's and our model aligns with the Center's focus on prevention, wellness, and chronic disease management across CMS programs.

Comment: A few commenters did not support the proposed inclusion of MIPS Q134: Preventive Care and Screening: Screening for Depression and Follow-Up Plan measure in the ASM low back pain quality measure set, noting that screening for depression is not specific to patients with low back pain and could also be applied to more diverse patient populations and expressed concern that some clinicians, specifically anesthesiologists and orthopedic surgeons, do not routinely screen for depression. Another commenter shared their belief that using broadly applicable measures for the ASM low back pain cohort illustrates CMS' challenges to create a one-size-fits-all measure set, noting that these measures generally would not lead to meaningful comparisons of clinicians across different specialties and subspecialties.

Response: We acknowledge the comments regarding the proposed inclusion of MIPS Q134: Preventive Care and Screening: Screening for Depression and Follow-Up Plan measure in the ASM low back pain quality measure set. While the measure is not exclusive to low back pain, we described in the CY 2026 PFS proposed rule (90 FR 32589 through 32594) how a significant portion of patients who have low back pain also experience depression and that there is an established connection between depression and low back pain. While some specialties may not routinely conduct these screening, we are purposefully incentivizing this activity to occur in ASM to improve whole-person care for low back pain patients. We believe that participants meeting our criteria for inclusion treat enough patients with low back pain that they should be routinely exploring this comorbid condition as part of comprehensive care. The model is limited by the measures available in existence, and we also took several steps to ensure alignment across CMS programs (like MIPS) to reduce administrative burden on providers. However, we believe that each measure is clinically important to the conditions we are focusing on and, therefore, believe they create a cohesive set that can appropriately identify differences in physician performance and promote quality improvement. We believe that encouraging this practice across different specialties will ultimately lead to improved patient outcomes for those suffering from low back pain.

After consideration of public comments, we are finalizing the inclusion of the (MIPS Q134) Preventive Care and Screening: Screening for Depression and Follow-Up Plan in the low back pain quality measure set as proposed at Sec. 512.725(c)(2). (iv) Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan (MIPS Q128)

We proposed to including the Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan (MIPS Q128) measure in the low back pain quality measure set because obesity can predispose patients to and exacerbate chronic low back pain.227 228 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 quality 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 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 sought 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 quality measure set.

\227\ 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.

\228\ North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter supported the proposed inclusion of MIPS Q128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan in the ASM low back pain quality measure set, noting that including the measure with weight management strategies could help reduce low back pain as obesity is a modifiable risk factor which may exacerbate chronic low back pain.

Response: We appreciate and agree that this measure can be beneficial for patients with low back pain. The inclusion of MIPS Q128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan in the ASM low back pain quality measure set recognizes the important connection between obesity and chronic low back pain. We agree that obesity is a modifiable risk factor that may exacerbate chronic low back pain, and incorporating weight management strategies through BMI screening and

follow-up planning can help reduce pain and improve patient outcomes.

Comment: A few commenters did not support the proposed inclusion of MIPS Q128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan in the ASM low back pain quality measure set. A commenter shared their concerns that using BMI as the sole indicator for screening and follow-up is not aligned with current clinical understanding. Another commenter recommended that the measure be revised to incorporate more meaningful and individualized indicators of health risk, noting concerns that BMI is an outdated and overly simplistic tool. Another commenter expressed concern that BMI screening is not routinely reported by some specialists, specifically anesthesiologists. A commenter expressed concern that the current measure specifications apply for larger patient populations, rather than just patients with low back pain. Another commenter expressed concern that the measure does not appropriately address the desired outcome of holding patients accountable for meeting their weight loss goals and recommended CMS to incentivize weight-loss programs and reimbursement for counseling or nutrition services for motivating patients to lose weight.

Response: We appreciate the comments regarding the proposed inclusion of MIPS Q128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan in the ASM low back pain quality measure set. As we described in the CY 2026 PFS proposed rule (90 FR 32589 through 32594), while the measure is not specific to low back pain patients, a significant portion of patients have low back pain and there is a well-documented connection between elevated BMI and low back pain, including increased pain severity, functional disability, and treatment complexity. Clinical evidence demonstrates that excess weight places additional mechanical stress on the spine and can contribute to inflammatory processes that exacerbate pain conditions. While some specialties do not routinely conduct these screenings, we are purposefully incentivizing this activity in ASM to improve whole-person care for low back pain patients. We believe participants meeting our criteria for inclusion treat enough patients with low back pain that they should be routinely exploring this comorbid condition as part of comprehensive care management. This approach recognizes that effective low back pain treatment often requires addressing underlying contributing factors rather than focusing solely on symptom management. We also do not see harm in this measure reaching beyond the low back pain population as BMI screening activity is widely applicable and may positively impact other conditions commonly managed by these providers, including cardiovascular disease, diabetes, and other musculoskeletal conditions. The model is limited by the measures available in existence, and we also took several steps to ensure alignment across CMS programs, like MIPS, to reduce administrative burden on providers while maintaining clinical relevance.

Regarding concerns about BMI as a screening tool, we acknowledge the ongoing clinical discussions about BMI limitations and the evolution toward more individualized health risk indicators. However, BMI remains a widely accepted, standardized, and practical measure across healthcare settings that provides valuable population-level health information. The measure focuses on screening and follow-up planning rather than BMI as the sole determinant of health risk, allowing providers flexibility in developing individualized treatment approaches based on comprehensive patient assessment. The model does allow participants to provide beneficiary incentives that could be used to improve care outcomes, including those related to BMI management, weight loss programs, and comprehensive lifestyle interventions. We refer readers to section III.C.2.k.(1) of this final rule for further information on beneficiary incentives. These incentives can support patient accountability and engagement in weight management goals while providing resources for counseling and nutrition services as recommended by commenters. Additionally, other CMS programs and Innovation Center models, aligning with the prevention focus of CMS, encourage these screening activities and offer possibilities for improvement in patient outcomes through early identification and coordinated intervention strategies.

Comment: A commenter requested clarification on how ASM participants that are part of a group would “count” a patient when reporting this measure. For example, they noted that if each clinician must report their own measures, the EHR may require each clinician to document a BMI screening for the same patient, even if it was already done by another clinician the day before. This could lead to the patient having to undergo the same screening and counseling twice, which is redundant. Alternatively, if a practice reports quality measures as a group, once a BMI screening is documented for a patient, regardless of which clinician did it, the EHR will recognize the measure has been met and other clinicians in the group will not be prompted to repeat the BMI screening for the same patient within the same reporting period.

Response: We appreciate the commenter's request for clarification on how ASM participants within group practices would report the MIPS Q128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan measure. This is an important operational question that affects both provider workflow and patient experience. The BMI may be documented in the medical record of the provider or in outside medical records obtained by the provider. Per the measure specifications, the measure only requires a BMI documented during the current encounter or during the measurement period AND who had a follow-up plan documented if BMI was outside of normal parameters.\229\ Therefore, the screening should not need to be repeated. If the BMI is documented in the patient's chart, the BMI screening will not need to be repeated for the provider to get credit for this measure, addressing concerns of duplication of efforts.

\229\ 2025 MIPS Q128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan Measure Specifications. https://qpp.cms.gov/docs/QPP_quality_measure_specifications/CQM-Measures/2025_Measure_128_MIPSCQM.pdf.

After consideration of public comments, we are finalizing the inclusion of the (MIPS Q128) Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan in the low back pain quality measure set as proposed at Sec. 512.725(c)(3). (v) Functional Status Change for Patients With Low Back Impairments (MIPS Q220)

We proposed to include the Functional Status Change for Patients with Low Back Impairments (MIPS Q220) measure in the ASM low back pain quality 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 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 posttreatment improvements of low back pain in older adults.\230\ 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.231 232 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 comprehensive approach to low back pain management, including appropriate assessment, treatment, and monitoring of changes. We sought comment on our proposal to include the Functional Status Change for Patients with Low Back Impairments (MIPS Q220) measure in the low back pain quality measure set.

\230\ 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.

\231\ North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020.

\232\ 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters did not support the proposed inclusion of MIPS Q220: Functional Status Change for Patients with Low Back Impairments in the ASM low back pain quality measure set, noting concerns that while Focus on Therapeutic Outcomes, Inc (FOTO) permits free access to components of the measure, the website's functionality is not interoperable with clinicians' chosen health IT systems and leading to a disjointed and labor intensive manual process, requiring the licensed FOTO's tools to report measure data and increasing reporting burden and costs for both clinicians and vendors. The commenters expressed concern that it could disadvantage small or rural practices due to limited or no access to FOTO's systems. The commenters noted that CMS should consider only including eCQMs in ASM and recommended that CMS should wait until an eCQM has been developed for the measure. A few commenters did not support the measure, noting its reliance on the FOTO Low Back Functional Status PRO-PM. A commenter expressed concerns with the risk-adjustment algorithm, noting it is proprietary and undisclosed, restricting clinicians to replicate or validate results. Another commenter noted that the FOTO Low Back Status PRO-PM tool is not used by neurosurgeons, who instead commonly use tools such as the Oswestry Disability Index. A few commenters expressed concern regarding the measure's reliability and validity as it was last reviewed for endorsement maintenance in 2019. The commenters also shared their concern that the measure was originally developed to evaluate quality of care for physical therapists, chiropractors, and other nonphysician practitioners, who are excluded from ASM. The commenters also expressed concern that the measure focuses primarily on rehabilitation services rather than care provided by other specialties, such as neurosurgery. They also noted that these specialties may need to interface with a new system outside of their usual workflows and EHRs to report data for this measure. A few commenters also noted that the measure is defined using a different set of diagnosis codes than those used for the Low Back Pain EBCM. A few commenters noted that the measure relies on the FOTO Low Back Patient-Reported Outcome tool, and it is not clear whether this survey aligns with the Oswestry Disability Index, which is referenced in the measure's justification. A commenter noted that it requires both the initiation and completion of a functional status episode within a single calendar year, while care episodes for low back pain often span multiple calendar years. Another commenter noted that the measure is not reported in significant numbers by certain specialists, specifically anesthesiologists. Another commenter recommended that CMS should not include any patient reported outcome measure that is beyond a clinician's control. A commenter shared their belief that low back pain patients may require more than 180 days for meaningful improvement, based on disease severity and comorbidities, and recommended that the measure timeframes appropriately account for these factors.

Response: We appreciate the comments regarding burden and concerns related to the survey tools for functional status assessment in low back pain patients under MIPS Q220: Functional Status Change for Patients with Low Back Impairments. We understand the operational challenges raised by commenters regarding system interoperability and the potential impact on smaller practices and believe our flexibility for small practices to report quality measures in the quality ASM performance category at the TIN-level, as further described in section III.C.2.d.(1).(b)., help address this concern. We chose not to restrict the measure to eCQMs specifically to allow greater flexibility to participants in selecting appropriate assessment tools that best fit their practice workflows and patient populations. While we acknowledge the concerns about FOTO's system integration challenges, the measure allows multiple validated survey instruments to satisfy reporting requirements, so it is not limited solely to FOTO tools. The Oswestry Disability Index, which several commenters noted as commonly used by neurosurgeons, is an appropriate and accepted tool under this measure's specifications. This flexibility in tool selection addresses many of the commenters' concerns about being restricted to a single proprietary system.

We believe this measure and the tools included are clinically appropriate and methodologically sound, given their established use in MIPS and their demonstrated validity in assessing patient functional status and promoting clinical improvement. The measure has undergone rigorous evaluation processes, and while the last formal endorsement review was in 2019, we believe the underlying clinical principles and measurement approaches remain current with accepted standards of care for functional assessment in low back pain management. Regarding concerns that the measure was

originally developed for rehabilitation services, we believe the measure's focus on functional improvement is relevant across specialties, as neurosurgeons, anesthesiologists, and other specialists all contribute to patients' functional recovery, even if through different intervention modalities.

By requiring this measure in ASM, we ensure that functional status outcomes are reported adequately and allow for like-to-like comparisons across ASM participants and specialties. This standardized approach is essential for meaningful quality assessment and improvement initiatives. The model's five-year test period provides sufficient time for patient improvement to be reflected year-to-year or over the model's five-year duration, which would accommodate the longer recovery timelines that some commenters noted may be necessary for complex low back pain cases. Regarding concerns about episodes spanning multiple calendar years, the measure methodology accounts for these clinical realities while maintaining the integrity of annual reporting cycles. For specialists who may not currently report this measure in significant numbers, ASM provides an opportunity to establish baseline performance and drive improvement in functional outcome assessment across all participating specialties. The inclusion of patient-reported outcome measures reflects our commitment to patient-centered care and recognizes that functional improvement is a critical indicator of treatment success that should be within the influence of all ASM participants, regardless of their specific intervention approach.

Comment: A few commenters offered recommendations on the proposed inclusion of MIPS Q220: Functional Status Change for Patients with Low Back Impairments in the ASM low back pain quality measure set. A commenter recommended that CMS work with the measure steward to improve ease of access and interoperability for clinicians and HIT vendors to program the necessary measure components into their systems. The commenter also recommended re-specifying the measure to remove the FOTO Lumbar PRO-PM and instead use an alternative modern measurement science-based PRO-PM that has fewer proprietary restrictions on interoperability and use within HIT systems, such as the PROMIS Physical Function or the PROMIS Pain Interference. A commenter recommended CMS to clarify the measure specifications as the proposed rule language references the use of Oswestry Disability Index instead of the Modified Oswestry Disability Index for the MIPS Q220 measure, noting concerns that these versions are not interchangeable. Another commenter shared their belief that clinicians not currently using FOTO- supported platforms may face technical and operational challenges in adopting the measure which may introduce complexity in terms of governance, licensing, and implementation and recommended that CMS clarify whether it intends to reconfigure the measure into a PRO-PM; how it plans to engage with non-CMS measure stewards ; and the timeline and process for testing and validation.

Response: We appreciate the recommendations regarding the inclusion of MIPS Q220: Functional Status Change for Patients with Low Back Impairments in the ASM low back pain quality measure set. We believe the January 1st, 2027 start date should provide adequate lead time for participants to update their systems, enhance their measure reporting capabilities, and work with their vendors as needed.

While we appreciate the recommendations for changing measures or re-specifying to use alternative PRO-PMs such as PROMIS Physical Function or PROMIS Pain Interference, we will adhere to the existing MIPS specifications to ensure alignment with MIPS, thereby reducing burden caused by model-specific measures and specifications. The latest specifications for the MIPS Q220 measure should be referenced as the source of truth for which survey instruments are appropriate. Importantly, the MIPS Q220 measure includes the FOTO Low Back Functional Status PROM/FOTO Public Access Survey, which is available free of charge for use in individual clinical practice. Additionally, there is a validated crosswalk available from the Modified Oswestry Disability Index for participants who prefer to use this alternative tool, which has been tested for reliability and validity.

We recognize the potential effort that further implementing this measure may introduce, but it is vital to the integrity of the model as it represents our best outcome measure available for low back pain.

These measurement activities should be occurring to ensure improvement in patient outcomes, and therefore we will include the measure in our set. We believe that the January 1st, 2027 start date and any support we may provide to enhance adoption during this period before model start will address the primary concerns raised by commenters, particularly given the availability of free tools and validated crosswalks that reduce barriers to implementation.

Comment: A few commenters supported the proposal to include the measure MIPS Q220: Functional Status Change for Patients with Low Back Impairments in the ASM measure set, noting that tracking and assessing a patient's functional status over time is a patient-centered way to reward meaningful improvement for ASM participants. A commenter specifically noted several advantages of the measure, including its non-condition-specific design, allowing clinicians to select validated measures appropriate to their clinical workflows; established implementation in EHRs and registries, reducing technical and operational burden; and alignment with existing quality initiatives, making it easier for providers to integrate into current reporting structures.

Response: We appreciate the support and feedback regarding the inclusion of MIPS Q220: Functional Status Change for Patients with Low Back Impairments in the ASM measure set. We are pleased that commenters recognize the patient-centered value of tracking functional status over time as a meaningful way to reward improvement for ASM participants.

The advantages highlighted by commenters reinforce our belief that this measure will enhance care delivery within ASM and beyond, focusing on prevention and functional status improvement that directly benefits patients with low back pain.

After consideration of public comments, we are finalizing the inclusion of the MIPS Q220: Functional Status Change for Patients with Low Back Impairments in the low back pain quality measure set as proposed at Sec. 512.725(c)(4).

We also received broad feedback regarding the low back pain quality measure set. The following is a summary of the comments we received and our responses

Comment: Several commenters expressed concerns about the proposed inclusion of proprietary measures in ASM that are controlled by private vendors, rely on non-transparent instruments or risk adjustment methods. A commenter expressed concern that requiring measures with proprietary dependencies undermines transparency, equity, and scalability and conflicts with CMS' own standards to avoid measures with misleading or inaccurate results. Another commenter recommended that the proposed ASM measures must be transparent, reproducible, and broadly accessible

and that CMS should not use measures that are dependent on closed tools or private algorithms. The commenters specifically highlighted the proposed measures MIPS Q220: Functional Status Change for Patients With Low Back Impairments and MIPS Q503: Patient Activation Measure (PAM) as proprietary measures and recommended that CMS remove these measures from the ASM low back pain quality measure set unless all PRO-PM items, scoring rules, and risk-adjustment models are fully disclosed and publicly available. A commenter also recommended that if these measures are finalized, CMS should permit alternatives or substitutions with open measures of functional status and patient engagement supported in certified health IT. Another commenter recommended that CMS prioritize validated, accessible tools that do not require licensing fees, such as the Modified Oswestry Disability Index or the PROMIS Global10.

Response: We appreciate the feedback on the proprietary nature of some measures. We would like to note that MIPS Q220: Functional Status Change for Patients With Low Back Impairments, while it uses a proprietary tool, has a version of the tool available free of charge for individual clinical practices. The survey tool used by the measure also includes a free crosswalk from the Modified Oswestry Disability Index, addressing concerns related to the ability to use multiple validated instruments.

Additionally, we are not including PAM measures in the final ASM measure set, so the proprietary nature of this measure is not an issue for the model. We believe we have included only measures that make the most clinical sense and create a holistic view of a participant's care furnished to patients. We also believe these measures will help promote improvement in certain areas, such as comorbid conditions related to low back pain.

Regarding alternatives, we purposefully created a mandatory set of measures in ASM that all participants will report. This will enable like-to-like comparison and accountability for the same activities. This standardized approach ensures consistent quality measurement across all ASM participants while maintaining the clinical integrity of the model.

Comment: Several commenters generally expressed their support for the proposed ASM low back pain quality measure set. The commenters shared their belief that the proposed measure set aligns with modern, evidence-based guidelines, focuses on promoting high-value care by discouraging the use of low-value imaging, fostering patient- centeredness by incorporating the patient's voice through patient- reported outcome performance measures (PRO-PMs), promoting functional status and patient self-efficacy, and drawing attention to impactful co-factors, such as depression, that should be clinically managed to help achieve optimal chronic low back pain outcomes. A commenter specifically supported the proposed PRO-PMs, noting that they elevate patient voice and incentivize clinicians to be more responsive to the treatment outcomes.

Response: We appreciate the strong support for the proposed ASM low back pain quality measure set. We are encouraged that interested parties recognize the alignment with evidence-based guidelines and the focus on high-value care delivery.

Comment: Several commenters recommended that CMS include other quality measures in the ASM low back pain quality measure set. A few commenters recommended that CMS adopt functional-status PRO-PMs for low back pain with remote capture, such as the PROMIS Physical Function or Oswestry Disability Index for low back pain functional outcomes. A commenter specifically stated that remote PRO-PMs reduce documentation burden, improve completion rates, and are more equitable for beneficiaries with mobility or transportation barriers. The commenter also recommended that CMS recognize FHIR-enabled, application-based PROMIS capture and acceptance of patient-entered data into certified EHRs which aligns with ASM's interoperability aims. A commenter recommended that CMS adopt and re-specify the MSK-3 measure for this measure set, noting that the MSK-3 measure utilizes PROMIS Pain Interference, which would offer significant benefits, such as enabling cross-cutting comparability of results across diverse patient populations and care settings that are not limited solely to low back pain. The commenter shared their belief that this measure is an outcome measure, may result in better performance than a process measure, would reduce patient response burden while maintaining optimal reliability and validity through use of existing “short-form” versions. Another commenter recommended that CMS include a measure on physical therapy referrals to incentivize access to high value services for patients with low back pain. The commenter noted that the measure would decrease the use of more costly, low-value, testing and interventions such as imaging, injections surgery, and opioids, reduce the overall cost of managing low back pain, and improve patient outcomes. A few commenters recommended that CMS include measures to assess lifestyle interventions. A commenter recommended measures on pain management effectiveness and care coordination. Another commenter recommended that CMS use the CAHPS for MIPS survey to better measure patient experience and capture domains, such as patient communication, care coordination, and shared decision-making.

Response: We appreciate these recommendations for additional quality measures in the ASM low back pain quality measure set. We have carefully considered these measures during model development and decided that the current proposed set represents the best approach to target the condition specifically, minimize burden on providers, support alignment with other CMS programs, and achieve our broader model objectives.

Several of the general domains recommended by commenters are already covered by our measures in different but effective ways. For example, our inclusion of MIPS Q220: Functional Status Change for Patients with Low Back Impairments addresses the functional status outcomes that commenters sought through PROMIS Physical Function or Oswestry Disability Index measures, while maintaining alignment with existing MIPS specifications. This measure captures patient-reported functional improvements over time, which is fundamental to assessing the effectiveness of low back pain treatment.

The patient experience domains highlighted by commenters, including patient communication, care coordination, and shared decision-making are integral to the patient-reported outcome measures we have included and will be further supported through the model's emphasis on care coordination and patient engagement activities. We believe our overall ASM measurement approach, which combines targeted quality measures with improvement activities and cost accountability, will effectively meet the goals of promoting high-value, patient-centered care while reducing the administrative burden on ASM participants.

While we recognize the potential benefits of remote PRO-PM capture and FHIR-enabled applications, our current approach balances innovation with implementation feasibility during the model's initial years. We will continue

to evaluate opportunities to enhance our measurement approach as health IT capabilities evolve and as we gain experience with the model's implementation.

Comment: Many comments generally expressed concern about the proposed ASM low back pain quality measure set. A few commenters shared their concern that many of the proposed measures were designed for therapists, chiropractors, and other non-physician practitioners and are not reflective of the specialties included in the ASM low back pain cohort, such as physiatry, surgery or anesthesiology. A commenter expressed concern that anesthesiologists have a limited set of relevant quality measures in MIPS and further noted that the proposed measures in the ASM low back pain cohort are either not top-performing or not commonly used by anesthesiologists. A few commenters also shared their belief that the proposed measures would not appropriately assess whether Medicare beneficiaries with low back pain achieve better outcomes, reflect quality of care provided to patients, or protect patients from underuse caused by efforts to reduce spending. A few commenters shared their concern that none of the proposed quality measures are included in the MIPS Neurosurgery Specialty Set or the MIPS Orthopedic Specialty Set. A few commenters also expressed concern that the ASM low back pain quality measure set is skewed to focus more heavily on a reduction of services and does not include enough patient- reported outcome measures to assess quality of life, functional status, and patient-clinician relationships. A few commenters shared their concern that the proposed measures would focus on younger patients and all-payer patients rather than being limited to Medicare patients. A commenter noted that the measures would not be relevant to ASM participants' practices or the care they provide. Another commenter noted that the proposed measure set relies heavily on process-based measures and quality measures that would not foster holistic, patient- centered improvements in care. A commenter also expressed concern that ASM quality measures may discourage clinicians from treating high need individuals with complex or severe low back pain and may add complexity to determine ASM financial incentives relevant to outcomes.

Response: We appreciate the feedback regarding the proposed ASM low back pain quality measure set. We are limited by which measures are available and validated for the specialists included in the model, and we believe the selected measures are appropriate for assessing quality care delivery for patients with low back pain, for multiple specialties. All-payer measures provide valuable insights into care quality across diverse patient populations and payer types, which enhances the robustness and generalizability of our quality assessment approach. We aimed for alignment with MIPS and MVPs in many areas to reduce administrative burden and maintain consistency across CMS quality programs, while also focusing on the measures most pertinent to low back pain management and outcomes.

We include a low back pain patient-reported outcome measure (PRO- PM) which is a strong tool for understanding functional outcomes and patient-centered results that matter most to beneficiaries. This measure directly addresses concerns about assessing quality of life, functional status, and patient experience with their care. The measures include established risk adjustment practices that should ensure scoring is equitable across different patient populations and practice settings, and these adjustments are designed to prevent practices from turning away patients with complex conditions or higher severity. Our measure set balances process and outcome measures to provide a comprehensive assessment of care quality while maintaining feasibility for specialty providers participating in ASM. We believe this targeted approach will effectively assess whether Medicare beneficiaries with low back pain achieve better outcomes while supporting the delivery of high-value, patient-centered care.

Comment: A commenter recommended that CMS limit the proposed measures to patients who have been in established care for 90-plus days and exclude patients who are seeking procedural care only. A commenter recommended that CMS provide a clear set of specific diagnosis codes and definitions that will be used to determine the denominators for low back pain measures, which should include a look back period of no more than 2 years. A commenter expressed concern that applying the proposed efficiency adjustment to rehabilitative therapy codes may impact patients with low pain. A commenter recommended that CMS ensure CPT codes and coverage for therapies, such as aquatic therapy, massage therapy, and other non-medication, non-procedural treatments, which are vital for patients with low back pain.

Response: We appreciate the commenters for the feedback regarding the ASM low back pain quality measures and related concerns. We are aligning quality measures with the existing inclusion criteria for each measure that has been thoroughly reviewed for validity. Furthermore, adjusting the measure specifications would present a significant burden to practices that already report some of the same quality measures in MIPS. We refer readers to the publicly available measure specifications to determine details on diagnosis codes for denominators, as these specifications provide comprehensive information about the specific codes and definitions used for each measure. ASM does not have a proposed adjustment to rehabilitative therapy codes, as the model focuses on quality measurement and cost accountability rather than modifying existing payment structures for specific service categories. ASM does not change which services are covered under Medicare, so all therapies typically covered for patients continue to be available to beneficiaries. The model's focus is on improving the quality and efficiency of care delivery while maintaining access to the full range of appropriate treatment options for patients with low back pain.

Comment: A few commenters recommended the use of objective pain data and databases for measurement in the ASM low back pain cohort. The commenters shared their belief that CMS would need access to existing objective pain databases in order to measure an individual's pain objectively and ensure cost-effective care. A commenter shared their belief that pain data would provide specialists with proper metrics to help guide the patients' care journey, reduce avoidable hospitalizations, and provide the right level of care to a patient. The commenters further shared their belief that pain data can allow patients to be screened more effectively for coordinated care and be used as an outcome measure to assess improvement after a procedure or surgery, noting that incorporating pain data into healthcare practice would align with ASM goals and contribute to improved outcomes for Medicare beneficiaries with low back pain.

Response: We appreciate commenters' feedback regarding the use of objective pain data and databases for measurement in the ASM low back pain cohort. We believe that our patient-reported outcome measure (PRO- PM) focused on functional status will help meet these goals of providing meaningful metrics to guide patient care and assess treatment effectiveness. We currently do not have an appropriate way to incorporate pain databases into

the model without creating undue burden and operational complications for participants. However, ASM participants can engage in these activities if they find them clinically meaningful and beneficial for their patient care, as part of their broader quality improvement efforts. We appreciate the recognition that pain measurement aligns with ASM goals, and we believe our functional status PRO-PM will capture important patient-centered outcomes that reflect the effectiveness of low back pain treatment while maintaining feasibility for widespread implementation.

Comment: A commenter recommended that CMS prioritize interested parties' feedback in measure selection for ASM measure sets. The commenter suggested that CMS collect patient feedback prior to finalizing measure sets as it is essential to creating meaningful measure sets. A commenter also recommended that CMS explore mechanisms to account for primary care influence in quality metrics.

Response: We appreciate the commenter for the feedback regarding interested party input and patient feedback in measure selection for ASM measure sets. We ensure that patient voice and whole person's health is accounted for in our measure set design and development process. We believe that including a PROM in each measure set helps to ensure the patient's perspective is heard and valued in quality assessment. We also received input from several entities during the measure development process, including those that represent beneficiary feedback and patient advocacy perspectives. This interested parties' engagement was essential to creating meaningful measure sets that reflect both clinical excellence and patient-centered care priorities. Our improvement activities strategy is focused on primary care engagement and collaboration, and that should be reflected in the model through this mechanism. These activities are designed to promote coordination between specialty care providers and primary care teams, ensuring that patients receive comprehensive, well-coordinated care that addresses their full range of health needs rather than focusing solely on the specialty condition being managed under ASM.

After consideration of public comments, we are finalizing the inclusion of the (MIPS Q220) Functional Status Change for Patients with Low Back Impairments in the low back pain quality measure set as proposed at Sec. 512.725(c)(4). (d) Other Measures Under Consideration (i) Patient Activation Measure (PAM) (MIPS Q503)

We sought comments on whether the Patient Activation Measure (PAM) (MIPS Q503) would be appropriate to include in both the heart failure and low back pain quality 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 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 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.\233\ Furthermore, higher levels of patient activation have been associated with better health behaviors, such as physical activity, and improved mental health outcomes.\234\ 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 quality measure sets.

\233\ 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.

\234\ 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters supported the proposed inclusion of MIPS Q503: Patient Activation Measure (PAM) in the ASM quality measure set. These commenters noted that this measure is a valuable outcome measure that can help predict and assess health, utilization, and cost. They believed that this measure would help patients become more empowered and engaged in their care, improve self-management skills, and promote shared decision-making between patients and clinicians. A few commenters stated their belief that the measure has been used in various and diverse settings, including the Kidney Care Choices Model, to understand risk, support disease management and care, allocate resources, and improve equity. A few commenters stated that PAM is the only validated tool that comprehensively assesses patients' knowledge, skills, and confidence in managing their health that has been endorsed by the Consensus-Based Entity. A few commenters also noted that the PAM imposes minimal operational burden relative to its value in clinical care and that it would provide CMS with a parsimonious and consistent measurement approach across model cohorts and other quality programs. Specifically, a commenter noted that the measure addition would be offset by the expected relatively low volume of qualifying episodes, which will result in a smaller eligible survey population and therefore reduce reporting burden. A few commenters addressed CMS' concerns about the PAM being a proprietary measure and stated that CMS uses other proprietary measures in various other reporting programs. A few commenters also noted that inclusion of the measure would provide CMS with a more complete view of patient capacity, complementing rather than duplicating functional status measures. They also stated that the measure enables clinicians to tailor education and support individual patient needs. A commenter recommended that CMS should not focus so heavily on reporting burden and that CMS could reduce the burden of the PAM by removing other proposed quality measures while another commenter noted that the PAM is aligned with the CMS Innovation Center 2025 Strategy to Make America Healthy Again.

Response: We appreciate the thoughtful comments that supported the inclusion of MIPS Q503: Patient Activation Measure (PAM) in the ASM quality measure set. We recognize the value that commenters see in PAM as a tool for assessing patient engagement, self-management skills, and shared decision-making capabilities.

While we acknowledge the benefits highlighted by commenters, we believe that adding an additional survey instrument that is not directly tied to low back pain would weaken our focused measure set and introduce unnecessary reporting burden. Our goal is to maintain a streamlined, clinically

relevant measure set that directly addresses the specific conditions and outcomes most important to the ASM cohorts.

We want to emphasize that many of the patient engagement and empowerment benefits noted by commenters regarding PAM will be addressed in part by ASM's improvement activities and care coordination requirements. These activities focus on reducing care fragmentation for patients, improving collaboration between providers, and enhancing communication with patients. Additionally, ASM's improvement activities performance category includes health-related social needs screening requirements, which can promote valuable conversations between providers and patients and address some of the same patient engagement aspects as PAM while being relevant and actionable for the clinical conditions being managed.

Comment: Several commenters did not support the proposed inclusion of the MIPS Q503: Patient Activation Measure (PAM) because they believed it would increase burden since patients would have to respond to ten or more questions and be difficult to implement. A commenter noted that CMS should wait until data collection is more feasible and more resources are available to practices to implement the measure. Another commenter believed that smaller practices may lack the survey administration, longitudinal tracking, and analytic infrastructure needed to implement the measure. They also noted that scoring and submission complexities of the measure may further disadvantage resource-limited providers. Another commenter did not support the measure, because they believed it was not tested at the individual clinician level (TIN/NPI) and that the measure requires too many patients to meet the minimum reliability level. Additionally, a commenter recommended utilizing the four-question version of the PROMIS Self-Efficacy measure, which they believe is more accessible and interoperable than the PAM. A commenter did not support the measure, because it has not been validated in spine care or for chronic pain populations and recommended CMS conduct a pilot of PAM in ASM to assess feasibility and clinical utility before requiring widespread adoption.

Response: We appreciate commenters for their thoughtful feedback regarding the proposed inclusion of MIPS Q503: Patient Activation Measure (PAM) in the ASM quality measure set. We agree with the concerns raised by commenters about implementation burden and added survey administration challenges for smaller practices, and are finalizing the exclusion of the PAM measure from ASM. Our decision aligns with our goal of implementing a focused, clinically relevant measure set that minimizes administrative burden while maintaining meaningful quality measurement.

Based on the feedback, we are not including MIPS Q503: Patient Activation Measure (PAM) in the heart failure or low back pain quality measure sets. (ii) Advance Care Plan (MIPS Q047)

We considered including the Advance Care Plan (MIPS Q047) measure in the heart failure quality 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 1 month, 86.5 percent at 1 year, and 56.7 percent at 5 years, with elderly patients having lower survival rates on average.\235\ 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 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.\236\ 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.\237\ 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 quality measure set.

\235\ 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[hyphen]analysis. European Journal of Heart Failure. 2019;21(11):1306-1325. doi:https://doi.org/10.1002/ejhf.1594.

\236\ 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.

\237\ 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support the proposed inclusion of the MIPS Q047: Advance Care Plan measure, because they believed the measure is burdensome to implement and is better suited for primary care settings.

Response: We appreciate the feedback regarding the proposed inclusion of MIPS Q047: Advance Care Plan measure in the ASM quality measure set. We agree with the concerns raised by commenters about the implementation burden and the measure's suitability for specialty care settings.

Comment: A commenter supported the proposed inclusion of the MIPS Q047: Advance Care Plan measure because they believed that the measure would result in meaningful positive changes for patients which would justify any increased burden. The commenter also noted that the cardiologist is often the most appropriate provider to oversee advance care planning, since they can become the practical primary provider for patients with heart failure.

Response: We appreciate the support for including MIPS Q047: Advance Care Plan measure and the recognition of its potential value for heart failure patients. However, we are not including this measure in the ASM quality measure set. At this time, we are concerned about the implementation burden and want to keep the measure set clinically focused on the specific conditions being managed under ASM.

We believe that the activities included in the improvement activities and other elements of ASM designed to improve care coordination and patient engagement will promote important conversations like advance care planning between providers and patients. These elements can facilitate meaningful patient-provider discussions while maintaining our focus on

condition-specific quality measures that directly relate to the clinical care being provided under the model.

After consideration of public comments, we are not including the MIPS Q047: Advance Care Plan measure in the heart failure quality 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 quality 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.\238\ For heart failure patients with multiple comorbidities, reducing potentially preventable hospitalizations is a key goal for improving outcomes and reducing 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 quality 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 quality measure set.

\238\ 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support the proposed inclusion of the MIPS Q484: Admission rates for Multiple Chronic Conditions (MCC) measure and noted that while this may be a meaningful measure it does not target patients with heart failure. A commenter noted that the measure is only endorsed at the group level, and reliability testing showed results of only 0.413 for practices with at least 15 clinicians and 18 patients with multiple chronic conditions.

Response: We appreciate commenters' feedback regarding the proposed inclusion of MIPS Q484: Admission rates for Multiple Chronic Conditions (MCC) measure in the ASM quality measure set. We agree with the concerns raised by commenters and are not including this measure in the heart failure quality measure set. Our goal is to maintain a streamlined, condition-specific measure set that directly relates to the care and outcomes most relevant to heart failure management under the ASM.

After consideration of public comments, we are not including the MIPS Q484: Admission rates for Multiple Chronic Conditions (MCC) measure in the heart failure quality 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 quality 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.\239\ 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.\240\ 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.\241\ By including this measure in the heart failure quality 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 quality 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.\242\ We seek comment on whether the Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure could be meaningful if included in the heart failure quality measure set.

\239\ Cardiac Rehabilitation Program Coverage. www.medicare.gov. https://www.medicare.gov/coverage/cardiac-rehabilitation.

\240\ 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.

\241\ Ades PA, Keteyian SJ, Wright JS, et al. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clinic Proceedings. 2017;92(2):234-242. doi:https://doi.org/10.1016/j.mayocp.2016.10.014.

\242\ 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.

We received public comments on this proposal. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed inclusion of the MIPS Q243: Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure, because they believed it would incentivize cardiologists and other clinicians to refer eligible patients to cardiac rehabilitation programs that improve long-term health outcomes, thereby reducing risk of hospitalizations. A commenter recognized the challenges in access to cardiac rehabilitation programs but noted that including the measure would help close gaps in access by ensuring eligible patients are referred promptly wherever programs exist. They also recommended that CMS could exempt ASM participants from reporting the measure if they attest that cardiac rehabilitation programs are unavailable in their referral region. Another commenter supported the inclusion of the measure and also recommended that CMS consider the MIPS Q374: Closing the Referral Loop: Receipt of Specialist Report measure. The commenters also requested that an eCQM equivalent be made available. Another commenter recommended that CMS include this

measure as an optional measure or improvement activity given its strong clinical value and evidence base.

Response: We appreciate the support expressed by commenters for including MIPS Q243: Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure and understand the clinical value they see in promoting cardiac rehabilitation referrals. We recognize that cardiac rehabilitation can provide significant benefits for eligible heart failure patients by improving long-term health outcomes and potentially reducing hospitalizations. However, after careful consideration of the feedback and operational realities, we have decided not to include this measure in the ASM heart failure quality measure set at this time. While cardiac rehabilitation is clinically appropriate in some cases of heart failure, it is not indicated for all heart failure patients, and persistent barriers to access across different geographic regions would disadvantage providers where these programs are not readily available. This creates challenges in establishing a universally applicable measure for ASM participants. The proposed attestation mechanism would introduce significant operational burden and administrative complexity that conflicts with our goal of streamlining quality measurement under ASM. We are committed to establishing a cohesive set of measures that nearly all ASM participants can meaningfully report on, ensuring fair and consistent evaluation across the model. While we cannot include this measure as a formal quality measure or improvement activity within the ASM framework, the overall value-based structure of ASM will naturally incentivize the use of cardiac rehabilitation where it is clinically reasonable and appropriate for patient care.

Comment: A few commenters did not support the proposed inclusion of the MIPS Q243: Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure. Commenters agreed with CMS' concerns pertaining to access challenges and regional variation in the availability of cardiac rehabilitation services. They highlighted the importance of increasing access to cardiac rehabilitation for Medicare patients before including this measure. A few commenters noted that some payers do not cover cardiac rehabilitation services. A commenter believed that access to cardiac rehabilitation is limited, because nurse practitioners are not authorized to refer patients to these services.

Response: We acknowledge commenters' feedback regarding the proposed inclusion of MIPS Q243: Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure. We agree with the concerns about access challenges and regional variation in the availability of cardiac rehabilitation services, and we are finalizing the exclusion of this measure from the measure set.

We recognize the importance of addressing barriers to cardiac rehabilitation access, including coverage limitations by some payers and authorization restrictions for nurse practitioners, before implementing quality measures that depend on these services. The regional disparities in program availability would create inequitable reporting conditions for ASM participants, which conflicts with our goal of establishing fair and consistent quality measurement across the model.

After consideration of public comments, we will not include the MIPS Q243: Cardiac Rehabilitation Patient Referral from an Outpatient Setting measure in the heart failure quality measure set. (v) Falls: Plan of Care

We considered including the Falls: Plan of Care measure in the low back pain quality 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.\243\ 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 postures that, while intended to minimize pain, may compromise their stability and balance. 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.244 245 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.\246\ 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.247 248 By including this measure in the low back pain quality 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 propose to include the measure in the low back pain quality 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 sought comments on whether the Falls: Plan of Care measure could be meaningful if included in the low back pain quality measure set.

\243\ 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.

\244\ 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.

\245\ 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.

\246\ 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.

\247\ 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.

\248\ 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.

We received public comments on this proposal. The following is a summary of

the comments we received and our responses.

Comment: A few commenters did not support the proposed inclusion of the Falls: Plan of Care measure. These commenters believed that patients may be at risk of falls for reasons unassociated with the care provided by ASM participants and that the measure appears to be topped out according to 2022 Quality Payment Program data.

Response: We appreciate the comment regarding the proposed inclusion of the Falls: Plan of Care measure. We agree that it is not the most applicable or appropriate measure for the low back pain quality measure set, particularly given the concerns raised about patients being at risk of falls for reasons unassociated with the care provided by ASM participants. We believe that other activities promoted in the improvement activities performance category would address concerns in this area and help reduce falls and other adverse events through comprehensive care coordination and addressing adjacent social needs.

Comment: A few commenters supported the proposed inclusion of the Falls: Plan of Care measure. These commenters noted that this measure would encourage clinicians to systematically assess patient fall risk and implement corrective actions to mitigate those risks. Regarding CMS' concerns that falls in the ASM population may occur for reasons less directly related to their musculoskeletal condition, the commenters noted that older adults with a history of back pain are at significantly higher risk of falls. A commenter specifically recommended replacing the proposed respecified MRI Lumbar Spine for Low Back Pain measure with the Falls: Plan of Care measure.

Response: We appreciate the support expressed by commenters for the Falls: Plan of Care measure and recognize the clinical rationale regarding fall risk assessment for older adults with back pain. However, we are not including this measure in the ASM measure set to maintain a targeted and focused measure set specifically designed for low back pain management. We will not be replacing the proposed MRI Lumbar Spine for Low Back Pain measure with the Falls measure, as we are focused on including a utilization-based measure to identify and discourage low-value care. We believe that the improvement of activities and care coordination requirements within ASM will provide opportunities for participants to address broader patient safety concerns, including fall risk, through their overall patient management approach.

After consideration of public comments, we will not include the Falls: Plan of Care measure in the low back pain quality measure set. (e) Removal and Addition of Quality Measures

While we do not plan to add or remove measures from either cohort's measure set during the ASM test period, there may be circumstances in which it is necessary. We proposed at Sec. 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 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 solicited comments on the proposed approach for removal or addition of quality measures.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters supported removing quality measures from the ASM quality measure set through notice-and-comment rulemaking and agreed with the overall desire to keep a consistent and stable set of measures. A few commenters believed it is important to have mechanisms in place to add or remove measures to adjust for advances in evidence and changes in practices that may make measures no longer meaningful and believed rulemaking was the appropriate mechanism. A commenter recommended that CMS avoid removing quality measures without a clear rationale and to maintain metrics that reflect long-term function, quality of life, and patient experience.

Response: We appreciate the supportive feedback regarding our proposed approach to quality measure maintenance in the ASM quality measure set through notice-and-comment rulemaking. We agree that rulemaking provides the appropriate level of transparency, interested parties engagement, and deliberative process for making changes to quality measures that affect ASM participants. We take seriously the recommendation to avoid removing quality measures without clear rationale and are committed to maintaining metrics that meaningfully reflect long-term function, quality of life, and patient experience. Any future proposals to modify the ASM quality measure sets will include comprehensive justification based on clinical evidence, measure performance data, interested parties feedback, and alignment with the model's objectives. We believe the notice-and-comment rulemaking process provides the appropriate framework to achieve the right balance between measure stability and the flexibility needed to ensure our measures remain clinically relevant.

Comment: A commenter did not support removing quality measures from the ASM quality measure set through notice-and-comment rulemaking and believed that maintaining a stable set of measures for 5 years and limiting submission options would restrict the ability of participants to adapt to evolving clinical standards and provide comprehensive, evidence-based care.

Response: We appreciate the feedback regarding our proposed approach to quality measure maintenance through notice-and-comment rulemaking. However, we believe that maintaining a stable set of measures for all ASM performance years within the ASM model test period is essential to provide participants with predictability and allow them to make meaningful investments in quality improvement initiatives. The notice-and-comment rulemaking process ensures appropriate transparency and interested parties' engagement when changes to the measure set are warranted based on significant advances in clinical evidence or practice standards. We do not agree that this approach would restrict participants' ability to provide comprehensive, evidence-based care, as the measures are designed to promote high-quality, evidence-based practices within the specialty care settings. The stability of the measure set will allow participants to focus their efforts on improving performance rather than continuously adapting to changing measurement requirements.

Comment: A commenter supported removing measures from scoring if the data are compromised by external errors (for example, code omissions, EHR glitches, guideline changes), because they believed it would help maintain the accuracy and credibility of final performance scores.

Response: We appreciate the commenter's support for our policy regarding the removal of measures from scoring when data are compromised by external errors, as this approach helps maintain the accuracy and credibility of final performance scores. The policy outlined at Sec. 512.725(h)(4)(ii)(A)

provides that for each measure impacted by significant changes or errors prior to the data submission deadline, performance is based on data for 9 consecutive months of the applicable ASM performance year. Significant changes or errors are defined as changes to or errors in a measure that are outside the control of the clinician and its agents and that CMS determines may result in patient harm or misleading results, including but not limited to changes to codes, inadvertent omission of codes, or changes to clinical guidelines or measure specifications. This policy ensures that ASM participants are not unfairly penalized for circumstances beyond their control while maintaining robust quality measurement standards.

After consideration of public comments, we are finalizing our proposed provisions related to the removal, addition, and maintenance of technical specifications of quality measures as proposed at Sec. 512.725(d). (f) Maintenance of Technical Specifications for Quality Measures

We proposed at Sec. 512.725(d) to communicate any updates or changes to the quality measure sets via notice and comment rulemaking. This would include releasing technical specifications for the required quality measures in a form and manner determined by CMS for each ASM performance year. 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 proposed releasing the measure technical specifications applicable to ASM via notice-and-comment rulemaking before the start of each ASM performance year.

We solicited comments on our proposal to use the most recent MIPS version of technical specifications of quality measures for each ASM performance year. We also sought 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposal to maintain technical specifications for MIPS measures in ASM, because this is more cost-effective and efficient than developing and maintaining separate measures for ASM and MIPS. Commenters believed that any re- specification of existing MIPS measures would be appropriate for both MIPS and ASM. Additionally, a commenter recommended that CMS finalize and release all MIPS and non-MIPS measure specifications no later than 1 year prior to the start of the applicable ASM performance year.

Response: We appreciate the supportive feedback regarding our proposal to maintain technical specifications for MIPS measures in ASM, and we agree that this approach is more cost-effective and efficient than developing and maintaining separate measures for ASM and MIPS. We concur with commenters that maintaining consistent specifications reduces administrative burden for participants who may be reporting under multiple CMS quality programs and ensures alignment across our quality measurement initiatives. We also agree that any re- specification of existing MIPS measures would be appropriate for both programs, promoting consistency and reducing confusion for participating clinicians. We will rely on the MIPS program to release technical specifications in accordance with their typical timeframes.

After consideration of public comments, we are finalizing our proposal to communicate any updates or changes to the quality measure sets, including the releasing of technical specifications for the required quality measures in a form and manner determined by CMS for each ASM performance year as proposed at Sec. 512.725(d). (g) Data Submission Criteria for the Quality ASM Performance Category

We proposed at Sec. 512.725(e)(1) that ASM participants submitting data that are not 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 in the finalized measures in Table B-D4. We proposed at Sec. 512.725(e)(2) that for the applicable ASM performance year, each ASM heart failure participant would report all of the measures in the heart failure quality measure set as described in section III.C.2.d.(2).(b) of this final rule and each ASM low back pain participant would report all the measures in the low back pain quality measure set as described in section III.C.2.d.(2).(c) of this final rule.

We solicited comments on the proposed form, manner, and timing of quality measures reporting at Sec. 512.725(e).

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters supported making quality measures available via the eCQMs for ASM quality measure set. A commenter believed that eCQMs help maximize the efficiency of electronic health systems while providing more accurate and comprehensive data. Another commenter supported the inclusion of eCQMs because they believed it aligns with other CMS programs, reduces reporting burden, and is a reliable and efficient method for data reporting. A few commenters recommended that all ASM measures have eCQM versions to make reporting more consistent and to support the transition towards digital quality measurement. A commenter recommended that CMS eliminate all measures that are not eCQMs in the ASM while another recommended that all measures be eCQMs or claims-based measures.

Response: We appreciate the support expressed by commenters for making quality measures available via eCQMs for the ASM quality measure set. We agree with commenters that eCQMs support the efficiency of electronic health systems while providing accurate and comprehensive data, and we recognize their value in aligning with other CMS programs to reduce reporting burden. We support the transition towards digital quality measurement and support making eCQM versions available for ASM measures where technically feasible and clinically appropriate. While we understand the recommendation to remove non-eCQM measures, we must balance this goal with the need to maintain clinically meaningful measures that may not yet have fully developed eCQM specifications. We will consider eCQM availability for ASM measures over time, supporting participants' preference for reliable and efficient electronic reporting methods.

Comment: A commenter requested clarification on what “using one” collection type means. Specifically, they sought clarity on whether an ASM participant who chooses to report using the eCQM collection type would still be required to report on the MIPS CQM, as that would constitute a different collection type.

Response: We appreciate the commenter's question seeking clarification on what “using one” collection type means for ASM quality measure reporting. Each measure must be reported using one collection type per performance period. If a measure has both CQM and eCQM collection types available, the ASM participant can choose which collection type they prefer to use for that specific measure.

Participants do not need to report both collection types for the same measure; they should select the single collection type that works best for their practice's technical capabilities and reporting infrastructure. This approach provides flexibility while maintaining consistency in how each individual measure is reported within ASM.

Comment: Several commenters did not support limiting the collection type of measures in ASM and recommended that CMS maintain flexibility for ASM participants in collecting, validating, and reporting their quality measurement data. They believed that reporting flexibility ensures that clinicians can select the most practical submission pathway based on the capabilities available in their EHR environment while also minimizing administrative burden. Additionally, they believed that ASM participants will have to use multiple reporting methodologies to meet measure reporting requirements, since some of the proposed measures can be reported either through MIPS CQMs or eCQMs. The commenters believed that some providers have limited technical infrastructure to successfully report eCQM and recommended that CMS allow ASM participants to select the collection type that is most appropriate with their existing reporting platforms when reporting measures.

Response: We appreciate commenters for their feedback. To clarify, ASM allows participants to choose a measure's collection type if more than one collection type is available. For example, if a measure is a CQM or an eCQM, the participant may choose to report the CQM or the eCQM, but not both. We promote the adoption and reporting of eCQMs; however, if a measure specification allows reporting via CQM, we will allow participants to report using that collection type.

After consideration of public comments, we are finalizing our proposed data submission requirements for the quality ASM performance category as proposed at Sec. 512.725(e). (h) Data Completeness Requirement and Case Minimums for the Quality ASM Performance Category (i) Data Completeness Requirement

We proposed at Sec. 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, 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 proposed at Sec. 512.725(f)(2) that ASM participants would receive zero “measure achievement points,” which we propose at Sec. 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 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 proposed at Sec. 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 final rule, we believe that it would not be appropriate to score quality measures for which we cannot determine a benchmark.

We sought comments on our proposed definition of “measure achievement points” proposed at Sec. 512.705. We sought comments on the proposed data completeness requirement of 75 percent at Sec. 512.725(f)(1) and whether a different data completeness percentage that we considered would be more appropriate. We also sought comment on our proposal at Sec. 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 sought comment on our proposal at Sec. 512.725(f)(3) for not scoring measures that meet data completeness requirements but for which we cannot determine a benchmark.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter supported the proposed data completeness requirement of 75 percent.

Response: We appreciate the commenter for supporting this requirement. We believe it is vital to the integrity of our quality measures that we set an adequate data completeness threshold.

Comment: A commenter expressed concern about enforcing a strict 75 percent data completeness threshold and believed that specialists who provide episodic care may be unable to fully document all required fields when reporting measures.

Response: We appreciate the concern regarding the 75 percent data completeness threshold and understand the documentation challenges specialists providing episodic care may face. However, we believe maintaining this threshold is essential to ensure the integrity and reliability of quality measurement under ASM. The 75

percent standard aligns with other CMS quality programs and represents the minimum level needed for statistically reliable and clinically meaningful quality scores. We encourage participants to work with their health IT vendors in advance of model start to optimize their documentation workflows. This period should provide adequate time to meet this important standard.

Comment: A few commenters did not support assigning zero measure achievement points for any submitted quality measure that does not meet the data completeness requirement. A commenter believed that because of the limited number of measures in the ASM, this may increase the number of lower scores. Another commenter recommended that CMS avoid point- based penalties for partial or incomplete reporting during the early implementation phases of the ASM. A commenter recommended that CMS create denominator exceptions when information is not accessible to an ASM participant so that incomplete records are not considered failures. Another commenter recommended that when certain measures are removed or suppressed due to data completeness requirements, such as the lack of a benchmark, CMS should automatically assign full points for the affected measure to prevent an unfair distribution of scores and mitigate the impact of smaller measure sets.

Response: We appreciate the feedback regarding our proposal to assign zero achievement points for quality measures that do not meet the data completeness requirement.

However, we will maintain the zero achievement points policy for quality measures that fail to meet data completeness requirement. We must be able to appropriately compare providers, and therefore, we believe there should be an incentive to report complete data. A single quality measure represents only a portion of the overall performance assessment approach in ASM, so if data completeness is not met for one measure, there are several other compensating areas including the other quality measures, as well as the cost, improvement activities, and Promoting Interoperability performance categories. Quality measures have built-in denominator exclusions that ASM will adhere to for reliability purposes, and we will not impose additional exclusions beyond these established parameters. If we score measures that do not meet data completeness due to inadequate data capture by the participant, then participants may choose which portion of data to report and could be at an advantage in performance comparisons. Relaxing the data completeness requirement would undermine the integrity of the performance comparison approach. We believe promoting data completeness is essential to accurate assessment and the integrity of the model's goals and payment adjustment methodology. The limited number of measures in ASM makes each measure's data quality even more critical for meaningful performance evaluation, and maintaining this standard ensures that all participants are held to the same rigorous reporting requirements that support fair and accurate comparisons across the model.

Comment: A few commenters supported the alternative proposal to set the data completeness requirement to lower than 75 percent beginning in the 2027 ASM performance year and then implementing a phase-in approach over the first few years of the model performance period to gradually increase the data completeness requirement. They believed it would provide ASM participants with time to adjust to the new model, minimize burden, and reduce inequity. A commenter recommended that CMS provide a clear guide and consider hardship exemptions when setting the data completeness threshold.

Response: We appreciate the feedback from commenters supporting a phased-in approach to the data completeness requirement, and we understand the concerns about providing ASM participants with adequate time to adjust to the new model while minimizing burden and reducing potential inequities. However, after careful consideration of all comments received, we have decided to maintain the 75 percent data completeness requirement beginning with the 2027 ASM performance year. We believe this threshold is essential to ensure the integrity and reliability of quality measurement in ASM and represents the minimum level of data completeness necessary to generate statistically reliable quality scores. The 75 percent standard aligns with established requirements in other CMS quality programs and reflects our commitment to maintaining robust quality measurement that can accurately assess performance and support valid comparisons across ASM participants. We believe that the notice provided by this rule and our planned release of a preliminary eligibility list in early CY 2026 will provide adequate time for participants to work with their health IT vendors and optimize their documentation workflows to meet this standard.

Comment: A commenter recommended that CMS waive or lower the 75 percent data completeness threshold for PRO-PMs for at least the first performance year. They also suggested that CMS consider omitting or reducing the weight of PRO-PMs in determining payment adjustments. The commenter further recommended that CMS incorporate a voluntary “rapid learning collaborative program” in which participants agree to use a learning platform for collection and analysis of patient-reported data.

Response: We appreciate the commenter's feedback regarding PRO-PM data completeness requirements and payment adjustment considerations. However, we will not be changing the 75 percent data completeness threshold for PRO-PMs, as this standard is essential to ensure the integrity and reliability of patient-reported outcome measurement under ASM. We will not be removing or reducing the weight of PRO-PMs in determining payment adjustments, as these measures are a vital aspect of our quality measurement strategy and represent critical patient- centered outcomes fundamental to assessing care quality and effectiveness. We appreciate the recommendation for a voluntary “rapid learning collaborative program” and intend to pursue efforts to promote learning and diffusion among ASM participants regarding best practices for quality measurement and beyond.

We did not receive specific comments on our proposed definition of “measure achievement points,” so we are finalizing it as proposed at Sec. 512.705.

After consideration of public comments, we are finalizing the proposal to set the data completeness threshold at least 75 percent as proposed at Sec. 512.725(f)(1). We are finalizing the proposal that participants receive zero measure achievement points for any submitted quality measure that does not meet the data completeness requirement as proposed at Sec. 512.725(f)(2).

Finally, as we did not receive any comments on the proposal, we are finalizing the proposal that we would exclude quality measures that do not have a benchmark in the calculation of the quality ASM performance category score as proposed at Sec. 512.725(f)(3). (ii) Minimum Case Requirements

We seek to ensure that ASM participants are measured reliably, therefore, we proposed at Sec. 512.725(g)(1) to use 20 cases as the minimum case requirement for each quality measure.

We proposed at Sec. 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 Sec. 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 final rule. We believe this case minimum is appropriate as it aligns with the case minimum under MIPS as defined at Sec. 414.1380(b)(1)(iii).

We solicited comments on our proposed case minimum for quality measures at Sec. 512.725(g). We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support setting the case minimum requirement to 20 cases for each quality measure because they believed it is statistically insufficient. A commenter believed that this case minimum systematically excludes rural providers. Another commenter believed that the 20-case minimum may be insufficient to generate stable benchmarks for certain measures and recommended CMS to evaluate safeguards or confidence intervals for measures that may demonstrate year-to-year variation. A commenter recommended that CMS adopt a higher minimum because it would also reduce the risk of punishing providers who treat more vulnerable patients.

Response: We acknowledge the concerns raised about statistical sufficiency, rural provider inclusion, and benchmark stability. For each measure, the case minimum was established during the measure development process and determined to be reliable and valid at this case minimum threshold, based on established standards and statistical analysis conducted during measure testing and validation. We believe most ASM participants should meet this minimum considering that the threshold for inclusion in the model requires meeting the 20 EBCM cost measure minimum, meaning they see at least 20 patients with the relevant condition, and likely many more given the nature of specialty practice patterns. Therefore, these clinically specific quality measures should be applicable to ASM participants, and the case minimum should be achievable for most participants who treat sufficient volumes of patients with these conditions. Also, we are finalizing allowing for flexibility for small practices to report quality measures in the quality ASM performance category at the TIN-level, as further described in section III.C.2.d.(1).(b) in this final rule. However, we do not plan to increase the minimum case requirement, as the current threshold aligns with other thresholds established throughout the model, is consistent with existing measurement specifications and criteria used in other CMS quality programs and avoids excluding providers who should appropriately be assessed under the model. Regarding concerns about year-to-year variation and benchmark stability, we will monitor measure performance data and evaluate the need for additional safeguards or statistical adjustments as we gain experience with the model. Our goal is to balance statistical reliability with inclusive participation that captures the spectrum of providers delivering care to Medicare beneficiaries with these conditions, while ensuring that quality measurement remains meaningful and actionable for driving improvements in patient outcomes.

Comment: A commenter supported the proposal to exclude measures from the quality ASM performance category score if the case minimum is not met. The commenter also recommended that clinicians should not be required to participate in the ASM for a reporting year in which they do not meet the case minimums.

Response: We appreciate the commenter's support on case minimums and the proposal to exclude measures from the quality ASM performance category score when the case minimum is not met. We agree that this approach ensures statistical reliability and meaningful quality measurement for ASM participants. However, we will not exclude providers from participating in ASM for a reporting year in which they do not meet the case minimums for specific quality measures. Instead, those measures where providers do not meet the minimum case requirements will not be counted against them in their overall performance assessment, allowing them to continue participating in the model while ensuring fair and statistically valid quality measurement.

After consideration of public comments, we are finalizing our proposed provision for minimum case requirements for quality measures as proposed at Sec. 512.725(g). (i) Quality Measure Achievement Points and Quality ASM Performance Category Scoring (i) Quality Measure Achievement Points

We proposed 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 final rule. We proposed at Sec. 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 proposed at Sec. 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 Sec. 512.725(g)(1), and meet the data completeness requirement, as proposed at Sec. 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 not 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 proposed at Sec. 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 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 proposed not to score measures for which we could not determine a benchmark for a given ASM performance year as described in section.III.C.2.d.(2)(i)(ii) of this final 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 sought comments on this proposed quality ASM performance category scoring approach to assigning measure achievement points as described at Sec. 512.725(h)(1).

We did not receive specific comments on this provision, and therefore, we are finalizing our proposed provisions for quality ASM performance category scoring as proposed at Sec. 512.725(h)(1). (ii) Benchmarking

For the quality ASM performance category, we proposed at Sec. 512.725(h)(2) that the ASM performance standard is a measure-specific benchmark. We proposed at Sec. Sec. 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 proposed at Sec. 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 varies by collection type in MIPS.\249\ 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 proposed to require in ASM,\250\ we believe it would be more appropriate to calculate a benchmark for each collection type.

\249\ https://qpp.cms.gov/resources/performance-data.

\250\ https://qpp.cms.gov/resources/performance-data.

We proposed at Sec. 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 that should be assigned based on where the actual measure performance falls within the benchmark. We proposed 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 proposed 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 proposed 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 proposed at Sec. Sec. 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 Sec. Sec. 512.725(f)(1) through (2) meeting the required case as proposed at Sec. Sec. 512.725(g)(1) and (3) a performance rate greater than zero. We proposed 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 solicited comments on our proposed benchmark determination process as proposed at Sec. 512.725(h)(2) and all alternatives considered.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter did not support calculating benchmarks for each quality measure and collection type because they believed it may unintentionally penalize clinicians who adopt certain reporting pathways that perform differently due to measure specifications or data completeness.

Response: We appreciate the feedback regarding our proposal to calculate benchmarks for each quality measure and collection type. However, we are not concerned about the potential for unintentionally penalizing clinicians who adopt certain reporting pathways, as we believe our benchmarking methodology appropriately accounts for differences in measure specifications and data completeness across collection types.

Our approach to calculating separate benchmarks by collection type is designed to ensure fair and accurate comparisons among participants using the same reporting method, thereby maintaining the integrity of performance assessment while providing flexibility in reporting options. This methodology aligns with established practices in other CMS quality programs and supports equitable evaluation of clinical performance regardless of the chosen collection pathway.

Comment: A commenter recommended that CMS compare the calculated ASM benchmarks to the corresponding MIPS benchmarks by collection type and select the benchmark that is most favorable to the ASM participant because they believed it would ensure fair and equitable scoring.

Response: We appreciate the commenter's recommendation regarding benchmark comparison between ASM and MIPS programs. However, we will not be comparing the calculated ASM benchmarks to the corresponding MIPS benchmarks by collection type and selecting the benchmark that is most favorable to the ASM participant. ASM has different goals than MIPS and adopting this approach could undermine how ASM will make more like-to-like performance comparisons to achieve in improved care delivery. ASM is specifically designed to test innovative payment and care delivery approaches for specialty care, with benchmarks that reflect the unique patient populations, care patterns, and quality improvement objectives of the participating specialties. The ASM benchmarks will reflect performance from clinicians in each ASM cohort, whereas MIPS benchmarks would not reflect the performance of our participants and would introduce heterogeneity in the form of different provider types. Using MIPS benchmarks could undermine the model's ability to drive meaningful change and improvement in specialty care settings, as it would dilute the incentives for participants to achieve the higher

performance standards that ASM is designed to promote. Our ASM-specific benchmarks are calibrated to support the model's goals of improving patient outcomes and reducing costs within the specialty care context.

Comment: A commenter recommended that CMS be transparent about the benchmarks it uses.

Response: We appreciate the commenter's recommendation for transparency regarding the benchmarks we use in ASM. We believe our proposed approach provides substantial transparency through the detailed methodology outlined in our regulations.

Our benchmarking process will determine measure-specific benchmarks for each quality measure and collection type using data from ASM participants during the performance year or previous periods, with separate benchmarks calculated for each collection type due to performance variations observed in MIPS. The benchmark methodology uses decile distributions based on actual ASM participant performance, with measure achievement points assigned based on where a participant's performance falls within these deciles. We will only calculate benchmarks for measures that have a minimum of twenty ASM participants reporting the measure while meeting data completeness and case minimum requirements. This approach ensures statistical reliability while providing clear, performance-based standards that all ASM participants can understand and work toward achieving. We plan to release the benchmarks in a form and manner determined by CMS for each performance year.

Comment: A few commenters did not support the proposed quality benchmarks requirements and believed that if developed without specialty input, it would risk misaligning incentives by undervaluing the clinical complexity and safety requirements of image-guided spinal interventions performed in the office setting. A commenter believed that benchmarks should account for the precision, specialized equipment, and significant physician expertise that interventional pain procedures require. They were concerned that if benchmarks do not account for these factors, then the benchmarks could distort clinical decision-making and diminish access to these appropriate services.

Response: We appreciate the feedback regarding quality benchmark requirements and understand the concerns about specialty input and the unique aspects of interventional pain procedures. However, we believe our proposed benchmarking methodology appropriately addresses these concerns by using data reported specifically by ASM participants rather than external standards that may not reflect specialty practice patterns. Our approach to determining benchmarks for each quality measure using data from ASM participants during the performance year or previous ASM performance years ensures that benchmarks are based on actual performance within the specialty care context. The methodology accounts for the clinical complexity and specialized nature of interventional procedures by establishing benchmarks using decile distributions based on actual ASM participant performance. The participants included in each cohort supports more like-to-like comparisons, addressing concerns of broad differences in care patterns between providers treating different conditions.

By calculating benchmarks for each measure's collection types using ASM participant data, we ensure that the unique characteristics of specialty care, including the precision, specialized equipment, and physician expertise required for interventional pain procedures, are inherently reflected in the performance standards. This participant- specific benchmarking approach prevents the misalignment of incentives that commenters were concerned about, as the benchmarks will be calibrated to the actual performance patterns of ASM participants in a specialty care setting.

Comment: A few commenters did not support using deciles for benchmarks because they believed that scoring clinicians according to a distribution and subjecting those in the bottom deciles to the maximum risk could harm high-performing providers and those who are improving year-over-year but in the lower decile. They believed that not recognizing both attainment and improvement creates a negative behavioral economic incentive, where clinicians who are improving but still ranked low may feel discouraged to improve further. A few commenters requested clarity on the standard for what constitutes a “good” quality measure score. These commenters recommended that CMS establish external benchmarks that define acceptable performance for quality measures and believed this approach would reduce reliance on relative scoring and avoid unfair penalties.

Response: We appreciate the feedback regarding our use of deciles for benchmarking in ASM and understand the concerns about potential negative impacts on high-performing providers and those showing improvement. However, we believe that creating a benchmark based on data reported by a group of similar providers provides meaningful quality assessment and accountability within the specialty care context. Our decile-based approach is designed to incentivize value and reward clinicians who are delivering high-quality care while encouraging those who are performing below their peers to improve their practices. This relative scoring methodology ensures that we maintain appropriate performance standards that evolve with the overall performance of the ASM participant pool, rather than static benchmarks that may become outdated or inappropriate over time. Regarding the request for external benchmarks that define “acceptable” performance, we believe that specialty care quality is best evaluated in the context of peer performance rather than external standards that may not reflect the realities of specialty practice patterns or patient populations. The decile approach ensures that quality expectations remain appropriately challenging and relevant to the specific clinical contexts within ASM. We will continue to review our benchmarking approach as the model evolves to ensure it effectively rewards high- quality care delivery and promotes continuous improvement while maintaining fair and meaningful performance standards. Our goal is to create a system that recognizes excellence, supports improvement, and ultimately benefits Medicare beneficiaries through enhanced quality of specialty care.

After consideration of public comments, we are finalizing our proposed provisions for quality measure benchmarking as proposed at Sec. 512.725(h)(2). (iii) Topped-Out Quality Measures

We proposed at Sec. 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 Sec. 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 Sec. 414.1305 a topped -out process measure as measure with a median performance rate of 95 percent or higher. We proposed monitoring during the initial ASM performance year(s)

before designating an ASM measure with topped out status. We proposed 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 Sec. 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 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 solicited comment on our proposal at Sec. 512.725(h)(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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters generally supported not removing topped out measures in ASM. A commenter encouraged CMS to include topped out measures, because they represent established standards of high-quality care and that maintaining these measures helps ensure ongoing focus on critical aspects of care and consistency across the model. Another commenter recommended that CMS consider mitigation strategies for topped out measures, such as narrowing measure definitions, transitioning to outcome-focused specifications, or suppressing topped out measures from final scoring to avoid clustering.

Response: We appreciate the supportive feedback from commenters regarding our approach to topped out measures in ASM.

We will continue to identify topped out measures within ASM but plan to not immediately remove them from the measure set. Instead, we will carefully evaluate each topped out measure's continued relevance and consider the mitigation strategies suggested by commenters to address performance clustering while maintaining the clinical integrity these measures provide. Any changes to our approach for handling topped out measures will be addressed through notice-and-comment rulemaking, ensuring appropriate interested parties' engagement and transparency in our decision-making.

Comment: A few commenters generally did not support keeping topped out measures in ASM and recommended CMS replace topped out measures with metrics that meaningfully differentiate performance and reward improvement. These commenters also recommended that CMS incorporate external benchmarks and set a “floor” for negative adjustments once providers achieve collective improvement on a topped out measure.

Response: We appreciate the feedback regarding topped out measures in ASM and understand the desire for metrics that better differentiate performance. However, we believe fewer measures would be considered topped-out in ASM given the mandatory reporting of all quality measures applicable for each ASM cohort. Maintaining consistency during the model performance period allows participants to focus their quality improvement efforts effectively. We also do not intend to review external benchmarks or set a floor for negative adjustments as it would not align with ASM's performance assessment approach and goals. We will continue reviewing topped-out measures as the model progresses and assess their ability to meaningfully differentiate performance among ASM participants. While changes are unlikely, any modifications would be proposed through future notice-and-comment rulemaking to ensure appropriate interested parties engagement and transparency.

After consideration of public comments, we are finalizing the proposed topped-out measure policy as proposed atSec. 512.725(h)(3). (iv) Calculation of the Quality ASM Performance Score

We proposed at Sec. 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 the total achievement points by the total available measure achievement points for measures reported by the ASM participant that meets the case minimum requirements as defined at Sec. 512.725(g) to determine an overall quality ASM performance category score, which could not exceed 100 percentage points.

We proposed at Sec. 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 proposed at Sec. 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 proposed at Sec. 512.725(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 proposed at Sec. 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 proposed at Sec. 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 proposed at Sec. 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 Sec. 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 final 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 solicited 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 solicited comments 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 sought 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter did not support the proposed quality performance category scoring methodology because they believed the proposed scoring methodology is different than MIPS and that ASM effectively creates two separate sets of scores for one specialty group. The commenter believed that since ASM does not provide specific benchmarks for when a positive or negative payment adjustment may be applied, clinicians and their group would have no actionable information or incentive to improve their performance. The commenter expressed concern that the specialty group would also have to identify where to place its limited resources to improve performance, deciding whether to focus on the 6 measures required to report for MIPS or the measures that are required to report for the individuals required to participate in the ASM.

Response: We appreciate the feedback regarding our proposed quality performance category scoring methodology for ASM. ASM is intentionally designed as a distinct alternative payment model with its own performance standards and benchmarks, separate from MIPS, to test innovative approaches to specialty care delivery and payment focused on high cost, highly prevalent chronic conditions. While we understand the concern about managing multiple reporting requirements, ASM's focused measure set is specifically tailored to the clinical conditions and care patterns relevant to the participating specialties and targeted chronic conditions, which differs from the broader scope of MIPS measures. We also have used MIPS measures in our measure set to reduce burden and align with other CMS programs. Regarding benchmarks and payment adjustments, our methodology provides clear performance standards through decile-based scoring that allows participants to understand their relative performance and identify areas for improvement. The model's design ensures that participants have actionable information through transparent scoring methodologies and performance feedback, even though the payment adjustment methodology may differ from other CMS programs.

Comment: A commenter wanted clarification on how quality measures are counted and scored for clinicians. They requested whether clinical action, such as a screening performed by one provider within a TIN (regardless of ASM eligibility), could be “counted” by an ASM participant to meet their own quality measure requirements. The commenter recommended that clinical actions by any provider within the same TIN should count toward meeting quality measures, as the patient's care is managed within the same TIN.

Response: We appreciate the commenter's question seeking clarification on how quality measures are counted and scored for clinicians in ASM. To understand each individual measure's specific requirements, we refer readers to the measure specifications which are publicly available and provide detailed guidance on measure calculation and attribution. In instances like the BMI screening and follow-up measure, the measure looks to see if a BMI screening has occurred during the performance year and is documented in the patient's chart. In this instance, it can be conducted by someone else in the practice and the ASM participant can receive credit, assuming other measure criteria are met, and the screening is properly documented and attributed. ASM promotes individual accountability as quality and cost elements are scored at the TIN/NPI level. We recognize the collaborative nature of practice-level efforts, and practice-level efforts may be reflected in quality measure reporting as described by each measure's specifications. However, acknowledging the burden this may present to small practices, we are finalizing allowing for flexibility for small practices to report quality measures in the quality ASM performance category at the TIN-level, as further described in section III.C.2.d.(1).(b) in this final rule.

Comment: A few commenters did not support calculating a quality measure score based on nine consecutive months of data from the performance year in the event of significant changes or errors. A commenter shared their belief that shortening reporting periods is not feasible for eCQMs. Another commenter believed that partial-year scoring introduces inconsistency and distorts results. The commenters recommended that CMS suppress or remove the measure from scoring, which they believe is consistent with MIPS, rather than truncating the reporting period.

Response: We appreciate the feedback regarding our proposed approach to calculating quality measure scores when significant changes or errors occur during the performance year. We align with MIPS on the principle of protecting participants from circumstances beyond their control that could unfairly impact their quality scores. We did not propose a provision that would allow us to remove a measure from scoring when appropriate circumstances warrant such action. We understand the concerns raised about the feasibility of shortened reporting periods for eCQMs and the potential for partial-year scoring to introduce inconsistency in results. We will consider which of these two approaches, using 9 consecutive months of data or removing the measure from scoring entirely, would be most beneficial to participants in each specific situation and execute the approach that best serves the integrity of the measurement system and fairness to ASM participants. We will also review the MIPS approach to not truncate qualifying eCQMs as discussed in the CY 2024 PFS final rule (88 FR 79369) to determine if such an approach would be appropriate for ASM. Our decision-making process will consider the nature of the significant change or error, the impact on data quality and reliability, and the operational feasibility for participants.

Comment: A commenter did not support suppressing measures when certified health IT is unavailable or when scoring could be misleading, because they believed this conflicts with CMS principles and ASM's regulatory structure. The commenter believed that proprietary PRO-PMs and undisclosed

risk adjustment can create risks when health IT is unavailable.

Response: We appreciate the commenters feedback regarding our proposal. However, we believe this approach is fundamental to fair and accurate performance assessment. We have clarified that there are resources available to help participants understand PRO-PMs, including publicly available measure specifications and we believe these patient- reported outcome measures are vital tools for our assessment of care quality and patient-centered outcomes. We are aligning our approach with MIPS standards and methodology, which provides consistency across CMS quality programs and reduces administrative burden for participants who may be reporting under multiple programs. We believe that the measures in our proposed set represent the best available tools for assessing quality in our specialty care settings of focus, and therefore we will maintain the measure set as proposed.

After consideration of public comments, we are finalizing the proposed calculation of the quality ASM performance score as proposed at Sec. 512.725(h)(4). (3) Cost ASM Performance Category

The 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 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 final 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 proposed at Sec. 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 in this section, while we proposed to evaluate ASM participants on their performance on these 2 MIPS cost measures, and proposed to use the same MIPS cost benchmarking and scoring methodology finalized for the 2024 MIPS performance period defined at Sec. 414.1380(b)(2)(i)(B), we proposed to use different benchmark ranges. (b) Performance Year for Cost ASM Performance Category

Beginning with ASM payment year 2029, we proposed at Sec. 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 the ASM performance year for cost measures in this way aligns with MIPS as defined at Sec. 414.1320 and would be easily adoptable by ASM participants.

We solicited comments on our proposed approach at Sec. 512.730(a) for setting the ASM performance year for cost measures.

We did not receive public comments on the proposed performance year for cost measures, and therefore, we are finalizing this proposal as proposed at Sec. 512.730(a). (c) Cost Measure for the ASM Heart Failure Cohort

For the ASM heart failure cohort, we proposed at Sec. 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.\251\ We proposed 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.\252\ We proposed 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 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.

\251\ https://www.cms.gov/medicare/quality/value-based-programs/cost-measures/about.

\252\ https://www.cms.gov/files/zip/2024-cost-measure-information-forms-zip.zip-0.

Additionally, we proposed 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 over 80 years of age.\253\ 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.\254\ Further, heart failure was listed as the cause of death on 13.4 percent of all death certificates in the United States in 2018.\255\ 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.\256\ 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.\257\

\253\ Yancy et al. “2013 ACCF/AHA Heart Failure Guidelines.” (2013). https://www.ahajournals.org/doi/pdf/10.1161/CIR.0b013e31829e8776.

\254\ Yancy et al. “2013 ACCF/AHA Heart Failure Guidelines.” (2013). https://www.ahajournals.org/doi/pdf/10.1161/CIR.0b013e31829e8776.

\255\ Centers for Disease Control and Prevention (CDC) “Heart Failure.” September 2020. https://www.cdc.gov/heartdisease/heart_failure.htm.

\256\ Centers for Disease Control and Prevention (CDC) “Heart Failure.” September 2020. https://www.cdc.gov/heartdisease/heart_failure.htm.

\257\ 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.

We solicited comments on the proposed use of the heart failure EBCM at Sec. 512.730(b)(1) to score the cost ASM performance category for the ASM heart failure cohort.

We received public comments on these proposals. The following is a

summary of the comments we received and our responses.

Comment: A commenter expressed concern with the proposal to use only administrative claims measures for the cost ASM performance category. The commenter recommended that CMS collaborate with patient groups and specialty societies to explore the use of alternative data sources, such as clinical registries. The commenter shared their belief that incorporating additional data sources could help ensure that ASM cost measures provide a more comprehensive and accurate assessment of patient care, including outcomes and preferences.

Response: We appreciate the commenter for sharing their concern regarding the cost ASM performance categories use of only administrative claims-based EBCMs. While clinical registries and patient-reported outcomes can be valuable for research and targeted quality improvement, we do not believe that they are appropriate for use in ASM because not all specialists have robust and mature registries whereas all ASM participants would generate claims used in EBCMs. Accordingly, we believe it crucial for all ASM participants within an ASM cohort to be scored on the same EBCM.

Comment: A few commenters offered general feedback related to EBCM measurement. A commenter suggested limiting eligibility to potential ASM participants that have a comparatively higher cost point until quality is measured so that there can be a low-cost, high-quality standard. Another commenter recommended that EBCM measurement volume should be robust to consider both major and minor complications and systematically prevent patient harm and unnecessary costs.

Response: We appreciate the commenters for their feedback related to EBCM measurement. We believe that ASM's approach to quality and cost measurement provides a more comprehensive approach to incentivizing quality improvements and reductions in unnecessary or low-value care spending related to ASM's targeted chronic conditions. We believe that a more complex participant identification logic comparing historical cost relative to some quality threshold would limit the potential impact of ASM by focusing on a narrow subset of specialists. By way of their construction, EBCM episodes account for attributable cost related to major or minor complications, which creates an incentive for the attributed clinician to improve upstream chronic condition management since they will perform better on the measure if they reduce unnecessary costs. For reasons discussed throughout this section of this final rule, we believe that the 20-episode threshold as part of the ASM participant eligibility criteria and as part of the cost ASM performance category measurement approach would be robust to evaluate clinicians on their efforts to reduce unnecessary costs while improving the quality of care.

Comment: A few commenters stated that retrospective EBCM attribution methodology prevents ASM participants from knowing their at-risk population prospectively. A commenter also shared their belief that episodes based on visits do not attribute all beneficiaries and leaves a measurement gap.

Response: We note that we only plan to use historical EBCM data to evaluate clinicians in mandatory geographic areas for the ASM participant eligibility criteria. ASM participants will be scored on the applicable EBCM as part of the cost ASM performance category that aligns with a given ASM performance year (that is, ASM participants for the 2027 ASM performance year will be scored using 2027 EBCM scores). While we expect that ASM participants would continue to reach the EBCM episode minimum of 20 to be scored, ASM participants that cannot be scored would not receive a final score or payment adjustment as described in sections III.C.2.e.(2).(b) and III.C.2.f.(4) of this final rule. We refer readers to our discussion of the EBCM attribution methodology earlier in this section of this final rule. However, prospective attribution of beneficiaries is not required for ASM's performance measurement framework. Should a participant want to identify beneficiaries that would likely trigger an episode, we believe they could do so by using the triggering and confirming codes provided in each EBCM's specifications. Further, we do not agree that use of EBCMs leaves a measurement gap. The goal of the heart failure and low back pain EBCMs is to evaluate a clinician's performance by assessing the cost of services related to a defined episode of care for a beneficiary with whom the clinician has a longitudinal relationship as determined by the triggering and confirming claims.

Comment: A few commenters expressed concern about the reliability of the proposed Heart Failure EBCM, noting that the measure did not meet the “high” reliability threshold at the TIN or TIN-NPI level. The commenters shared their belief that the EBCM reliability levels at 20 attributed patients are too low for measures used to adjust payments for clinicians. A commenter expressed concern that relying on a measure with only moderate reliability could lead to misleading conclusions about actual differences in performance.

Response: We recognize the commenters' concerns regarding the heart failure EBCM 20-episode volume threshold. However, we disagree that the 20-episode minimum is an inappropriate volume of cases for determining ASM cost performance category scores. An EBCM 20-episode threshold is consistent with the established episode threshold finalized for MIPS at Sec. [thinsp]414.1350(c)(6) for the EBCM. As we discussed in the CY 2018 PFS final rule (82 FR 53697 through 53699), increasing the case minimum to improve measure reliability would reduce the number of clinicians assessed by the measure. A higher case minimum would, therefore, limit the scoring of EBCMs to larger group practices with sufficient case volume at the expense of individual providers who are the focus of ASM. We believe that an EBCM 20-episode threshold remains aligned with other CMS programs and will reliably, just like in the QPP program, measure ASM participants on cost performance.

Comment: A commenter did not support the proposed heart failure EBCM, noting concerns that the measure is narrowly defined and may not capture potential savings from efficient team-based care. The commenter also expressed concern that the proposed attribution to individual ASM participants is not patient-centered and may not recognize the efficiencies of team-based care.

Response: We appreciate the commenters' feedback but disagree that the heart failure EBCM is narrowly defined. The heart failure EBCM is designed to capture a wide spectrum of care events that occur once an episode is triggered and that are appropriately attributable to a TIN or TIN/NPI. It includes but is not limited to inpatient admissions, outpatient follow-up, medication management, diagnostic testing, and post-acute care. We also disagree that the cost EBCM, though measured at the individual level, would not recognize the efficiencies of team- based care. The EBCM reflects costs from any provider rendering an included service for an attributed beneficiary--centering the beneficiary at the heart of the measure. Therefore, efficiencies in team-based practices such as reducing duplicative services could potentially improve the ASM participant's EBCM score.

Comment: A few commenters expressed concern that the proposed heart failure EBCM does not reflect the

quality of care provided by ASM participants. A commenter recommended CMS to align quality and cost scoring to prevent duplicative accountability under the heart failure EBCM, noting that the proposed quality measures include patients younger than 65, while the cost measure applies only to those older than 65. A commenter expressed concern that CMS does not account for how changes in spending and utilization may impact quality. Another commenter recommended that CMS collaborate closely with prospective ASM participants to identify measures that accurately reflect savings.

Response: We appreciate the commenters for their feedback. However, we disagree that the proposed heart failure EBCM is not aligned with the quality of care provided to participants. We believe that the Risk- Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with heart Failure (MIPS Q492) quality measure as discussed in section III.C.d.2.(b).(i) of this final rule would account for the inappropriate withholding of care in an effort for a participant to improve their cost ASM performance category score. Though we understand that the inclusion and exclusion criteria for the quality and cost measures may differ, taken individually both collective measure sets are appropriate for assessing heart failure quality of care and its associated costs. We are aligning the approach used in MIPS to reduce burden and ensure alignment across CMS programs. We disagree that the EBCMs would not reflect opportunities for findings savings and we note that the EBCMs have already undergone extensive with interested parties input, including specialty societies and technical expert panels.

Comment: A few commenters expressed concern that ASM participants may not be able to control all costs included in the proposed heart failure EBCM such as emergency department visits or post-acute care decisions made by other clinicians. Another commenter shared their belief that the heart failure EBCM could potentially penalize clinicians for poor performance even when they provide care that adheres to evidence-based clinical guidelines and is in the best interest of the patient. A commenter shared their concern that the proposed EBCM has limited the ability to distinguish between spending within, and outside of the clinician's control. Another commenter expressed concerns about the inclusion of Part D medications within the heart failure EBCM, noting that varied access to prescription medications can cause fluctuations in the cost of care.

Response: We appreciate the commenters' feedback, but we disagree that the heart failure EBCM penalizes clinicians for high costs beyond their control, or for providing care adhering to evidence-based guidelines in the best interest of the patient. The heart failure EBCM is designed to reflect the clinical appropriateness of care. The EBCM also accounts for a variety of clinically appropriate care variations, and necessary treatments. Though we acknowledge that not every care decision is controlled by the attributed participant by including services initiated by other clinicians, the measure appropriately incentivizes specialists to coordinate care and manage transitions to reduce avoidable, duplicative, fragmented and costly services. The EBCM measure specifications include all services that are included in the measure. Those services were selected as part of the scope of longitudinal heart failure chronic condition management in consultation with specialty societies and practices. While Part D costs are included within the episode, we note that Part D costs are winsorized such that extreme observations at and above the 98th percentile are excluded from the EBCM's calculations. We believe it is important to include Part D spending because Part D spend oftentimes represents a significant portion of episode's total cost. The inclusion of Part D spending creates participant accountability for that portion of spend. Furthermore, including Part D spend prevents any inappropriate cost shifting that may occur if Part D spend is excluded such that participants were incentivized to move Part B spend to Part D spend to artificially deflate Part B measured spending.

Comment: A few commenters expressed concerns about the proposed attribution methodology for the heart failure EBCM. A commenter recommended that CMS continue to refine the heart failure EBCM attribution methodology to better account for the nuances between cost and clinical appropriateness.

Response: We appreciate the commenters' feedback, but we disagree that the heart failure EBCM relies on a flawed attribution methodology. The heart failure EBCM is built upon a two-stage process to identify clinically appropriate patients receiving longitudinal heart failure care. A heart failure episode is only attributed to an ASM participant if two Part B Physician/Supplier (Carrier) claims are billed by the same ASM participant within 180 days of one another. The pair of services must include a trigger claim and confirming claim from any of the set of clinically relevant outpatient CPT/HCPCS codes and services when accompanied by an ICD-10 diagnosis code indicating heart failure. This sophisticated methodology ensures that only beneficiaries receiving longitudinal heart failure management from the same ASM participant will trigger an episode. We did not consider refinements to the attribution methodology to remain aligned with the existing measure specifications under MIPS and to ease participant burden.

Comment: Several commenters expressed concern that the heart failure EBCM does not capture the clinical complexity of the patients with heart failure, which can impact episode costs. A few commenters shared their belief that the proposed EBCM does not adjust for many social and economic factors that affect the number and types of services patients receive or improvements in care access that could increase costs but also improve outcomes, which could significantly disadvantage clinicians serving more complex patients. A few commenters recommended that CMS continue to refine risk adjustment to better reflect the nuances between cost and clinical appropriateness, particularly for high-risk populations such as older adults with multiple comorbidities. A few commenters requested that CMS publish more details on how patient complexity and comorbidities will be incorporated into risk adjustment and clarify how risk adjustment differs between the MIPS/MVPs EBCM and the ASM version of the EBCM. A commenter recommended that certain cases be excluded or separately benchmarked, including advanced therapies, cardiogenic shock/ECMO, multi-organ failure, high-risk electrophysiology/device dependence, active transplant evaluation (where diagnostic intensity and consultative services dominate spending), and end-of-life care with hospice election during the episode window.

Response: We appreciate the commenters for their concerns that the low heart failure EBCMs do not reflect patient complexity, however, we disagree. The heart failure EBCM's sophisticated risk adjustment methodology accounts for patient complexity, and comorbidities outside of the participant's control. The EBCM risk adjustment methodology uses clinical factors such as age, comorbidities, recent hospitalizations and other relevant conditions to

standardize costs. The heart failure risk adjustment methodology employed in ASM is the same methodology used in MIPS/MVPs EBCM. Additionally, the exclusion criteria are designed to remove unique groups of patients or episodes from the measure calculation in cases where it may be impractical or unfair to compare the costs of caring for these patients to the costs of caring for the cohort at large. Heart failure EBCM exclusions include amyloidosis, congenital heart disease, high-output heart failure, hypertrophic cardiomyopathy, prior and/or recent left ventricular assist device (LVAD), prior and/or recent heart transplant, peripartum cardiomyopathy, and other infiltrative disease. While the EBCM does not account for all social risk factors in its risk adjustment methodology, we stress that beneficiary social and economic characteristic and challenges faced by small or solo practices are addressed in the complex patient scoring adjustment section III.C.d.4.(3) of this final rule and small practice scoring adjustment in section III.C.d.4.(4) of this final rule. We believe that both the complex patient scoring adjustment and the small practice scoring adjustment properly addresses the realities those ASM participants face because those adjustments are simpler and do not require any additional participant reporting.

Comment: A commenter recommended that CMS provide actionable data and definitions and identify ways to improve cost performance on the heart failure EBCM.

Response: We appreciate the commenters for their recommendation to provide actionable data and methods to improve performance. We are exploring ways to provide participants with the right data at the right intervals to assist their performance in ASM.

After consideration of public comments, we are finalizing as proposed at Sec. 512.730(b)(1) the use of the heart failure EBCM 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 proposed at Sec. 512.730(b)(2) to utilize the low back pain EBCM to determine an ASM low back pain participant's cost ASM performance category score.\258\ 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 proposed 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.

\258\ https://www.cms.gov/medicare/quality/value-based-programs/cost-measures/about.

We believe that the 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,\259\ 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.\260\ Other studies have also found large increases in resource use for low back pain despite only modest increase in its prevalence and little improvement in patient outcomes,261 262 263 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.

\259\ Will, Joshua Scott, David Bury, and John Miller, “Mechanical Low Back Pain.” American Academy of Family Physicians 98(7) (2018): 421-428.

\260\ 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.

\261\ 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.

\262\ 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.

\263\ Norman Marcus Pain Institute, “Pain Facts.” Last updated 23 January 2012. https://www.normanmarcuspaininstitute.com/tag/neck-and-shoulder-pain/.

We sought comments on the proposed use of the low back pain EBCM at Sec. 512.730(b)(2) to determine the cost ASM performance category score for the ASM low back pain cohort.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters expressed concerns about the proposed low back pain EBCM for ASM participants, noting low reliability thresholds at the individual clinician level. The commenters noted that the reliability levels for TIN/NPIs with 20 or more attributed patients are too low for measures used to adjust payments for clinicians.

Response: We recognize commenters' concerns regarding the low back pain EBCM 20-episode threshold. However, we disagree that the 20- episode minimum is an inappropriate volume of cases for determining ASM cost performance category scores. An EBCM 20-episode threshold is consistent with the established case volume finalized for MIPS at Sec. [thinsp]414.1350(c)(6) for EBCMs. As we discussed in the CY 2018 PFS final rule (82 FR 53697 through 53699), increasing the case minimum to improve measure reliability would reduce the number of clinicians assessed by the measure. A higher case minimum would, therefore, limit the scoring of EBCMs to larger group practices with sufficient case volume at the expense of individual providers who are the focus of ASM. We believe that a minimum EBCM 20-episode threshold remains aligned with other CMS programs and will reliably, just like in the QPP program, measure ASM participants on cost performance.

Comment: A few commenters expressed concern that the proposed low back pain EBCM may not align with the quality measures for the ASM low back pain cohort or that the low back pain EBCM may not accurately reflect the quality of care provided by ASM participants. A few commenters shared their concern that assessing cost without considering outcomes could create unintended incentives, such as encouraging clinicians to avoid complex patients, limiting necessary care, or promoting pharmacologic or surgical interventions that may not be appropriate. A commenter recommended that CMS develop quality and cost measures in tandem to create a single value measure that integrates both dimensions. Another commenter suggested CMS to collaborate closely with prospective ASM participants to identify measures that meaningfully reflect savings.

Response: We appreciate the commenters for their feedback. However, we disagree that the proposed low back pain EBCM is not aligned with the quality of care provided to participants. For example, the low back pain Functional Status Change for Patients with Low Back Impairments (MIPS Q220) score would lower if an ASM participant attempted to inappropriately limit necessary care to

improve their cost performance score. We further stress that the EBCM's risk adjustment methodology accounts for patient acuity and complexity. The EBCM risk adjustment methodology uses clinical factors such as age, comorbidities, recent hospitalizations and other relevant conditions to standardize costs. We did not consider merging quality and cost measurement into a single value because we believe that measuring them separately ensures direct accountability for performance on quality and cost. We note that the low back pain EBCM has already undergone extensive interested parties input, including with specialty societies and technical expert panels. Further, we believe that the EBCM performance can help ASM participants identify areas for potential savings.

Comment: Several commenters expressed concern that ASM participants may not control all costs included in the proposed low back pain EBCM, such as patient emergency department visits or post-acute care decisions made by other clinicians. A commenter recommended that CMS consider separating spending into categories, distinguishing between expenditure on avoidable services controlled by ASM participants and all other costs. A commenter also expressed concern that holding ASM participants, particularly proceduralists, accountable for care beyond their control is not clinically appropriate and may result in unjust penalties. Another commenter recommended CMS clarify which services are included in the low back pain EBCM.

Response: We appreciate the commenters for expressing their concern. However, we disagree and believe that including services performed in the emergency room or post-acute care decisions made by other clinicians is vital to incentivizing ASM participants to provide upstream care management to reduce unnecessary services. Though we acknowledge that not every care decision is controlled by the ASM participant, including services initiated by other clinicians appropriately incentivizes specialists to coordinate care and manage transitions to reduce avoidable, duplicative, fragmented and costly services. This is especially the case for proceduralists for whom we would like to extend accountability for their management of beneficiaries with chronic conditions beyond the procedure they initiate. We also note that for a beneficiary to be attributable to a proceduralist the triggering event must include an ICD-10 diagnosis code indicating low back pain as well as a confirming code within 60 days. Meeting the requirements set forth through this attribution process suggests that a longitudinal care relationship that between the proceduralist and beneficiary. We refer commenters to the cost measure codes lists available on the 2024 MIPS cost performance category resources for a comprehensive EBCM services list.\264\

\264\ https://www.cms.gov/medicare/quality/value-based-programs/cost-measures/about.

Comment: A commenter did not support the proposed low back pain EBCM, noting concerns that the measure is narrowly defined and may not capture potential savings from efficient team-based care. The commenter also expressed concern that the proposed attribution to individual ASM participants is not patient-centered and may not recognize the efficiencies of team-based care.

Response: We appreciate the commenters' feedback but disagree that the low back pain EBCM is narrowly defined. The low back pain EBCM is designed to capture a wide spectrum of care events that occur once an episode is triggered. And that are appropriately attributable to a TIN or TIN/NPI The EBCM includes inpatient admissions, outpatient follow- up, medication management, diagnostic testing, and post-acute care services. We also disagree that the cost EBCM, though measured at the individual would not recognize the efficiencies of team-based care. The EBCM reflects costs from any provider rendering an included service. Therefore, efficiencies in team-based care such as the reduction of duplicative services will improve the ASM participant's EBCM score.

Comment: A commenter expressed concern that services provided by anesthesiologists, including pain medicine physicians who treat patients with lower back pain, may not be captured by the existing cost measure methodology for the low back pain EBCM. The commenter expressed concern that CMS' reliance on the remaining single ASM performance category for anesthesiologists, quality, could undermine a comprehensive assessment of how clinicians or their groups deliver care to Medicare patients.

Response: We appreciate the commenters for sharing their concerns. However, we disagree with their assessment that an anesthesiologist is not likely to meet the cost performance category minimum requirements to receive a cost performance category score. Selection into ASM requires that a participant must have already met the 20- episodethreshold from the calendar year determining performance year eligibility. The likelihood that the participant would also meet the case 20-episode threshold during the given ASM performance year, would be high. Therefore, the participant would receive a cost score on any of the quality measures for which they meet those minimum data and submission requirements as described in sections III.C.d.(2).(g) and III.C.2.d.(2).(h) of this final rule.

Comment: A few commenters expressed concerns about the proposed attribution methodology for low back pain EBCM, noting concerns that the attribution methodology would identify the correct clinician, particularly for low back pain, where care is often fragmented and patients may see multiple clinicians. A commenter expressed concern that most potential ASM participants would have a low volume of EBCM cases, which may not accurately represent their overall practice.

Response: We appreciate the commenters for expressing their concerns regarding the low back pain EBCM attribution methodology. However, we disagree with the commenters' concerns. The low back pain EBCM requires that a triggering event must include an ICD-10 diagnosis code indicating low back pain as well as a confirming code within 60 days from the same Tin/NPI--or in ASM's case the ASM participant. This ensures that only beneficiaries with a diagnosis of low back pain are included in the measure. By assigning accountability for costs to a provider that initiated a low back pain episode, we have created the incentive structure to reduce fragmented care. Additionally, to receive a cost score an ASM participant must meet the 20 episode threshold. As discussed earlier in this section of this final rule, a 20-episode threshold is consistent with the established case volume to score MIPS participants at Sec. 414.1350(c)(6) and with ASM's participant eligibility criteria.

Comment: A few commenters expressed concern that the proposed low back pain EBCM may not capture the clinical complexity of the patients with low back pain, which could impact episode costs. A few commenters noted the difference between general low back pain and more complex cases, noting that comorbidities can affect treatment choices. A commenter requested that several cases be excluded or stratified, such as those involving malignancy, infection, fracture, major structural abnormalities, urgent neurologic compromise, prior spine surgery, implanted hardware (including spinal cord stimulators or fusion constructs),

failed comprehensive conservative care with documented non-response to multimodal therapy, and non-spinal mimics. Another commenter noted that the model does not adjust for many social and economic factors that affect the types and number of services patients receive, which could disadvantage ASM participants serving patients from lower income communities. Another commenter recommended that attribution and benchmarks account for issues specific to smaller practices.

Response: We appreciate the commenters for their concerns that the low back pain EBCMs does not reflect patient complexity, however, we disagree. The low back pain EBCM's sophisticated risk adjustment methodology accounts for patient complexity, and comorbidities outside of the participant's control. The EBCM risk adjustment methodology uses clinical factors such as age, comorbidities, recent hospitalizations and other relevant conditions to standardize costs. Additionally, the exclusion criteria are designed to remove unique groups of patients or episodes from the measure calculation in cases where it may be impractical or unfair to compare the costs of caring for these patients to the costs of caring for the cohort at large. Low back pain exclusions include cauda equina syndrome, spinal infection, osteoporotic compression fracture, myelopathy, trauma, and spinal neoplasms. Any additional exclusions would diverge from the EBCMs structure as used by MIPS, potentially increasing administrative burden to have model-specific modifications to the measure's specifications. While the EBCM does not account for all social risk factors in its risk adjustment methodology, we stress that beneficiary social and economic characteristic and challenges faced by small or solo practices are addressed in the complex patient scoring adjustment section III.C.2.e.e(3) of this final rule and small practice scoring adjustment in section III.C.2.e.2d.e(4) of this final rule. We believe that both the complex patient scoring adjustment and the small practice scoring adjustment better address the realities those participants face because those policies are simpler and do not require any additional participant reporting.

Comment: A commenter recommended that CMS provide actionable data and definitions and identify ways to improve performance on the low back pain EBCM.

Response: We appreciate the commenters for their recommendation to provide actionable data and methods to improve performance. We are exploring ways to provide participants with the right data at the right intervals to assist their performance.

After consideration of public comments, we are finalizing as proposed at Sec. 512.730(b)(2) the use of the low back pain EBCM to score the cost ASM performance category 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 proposed at Sec. 512.730(c) to add or remove measures through notice and comment rulemaking as discussed at Sec. 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 solicited comments on our proposed approach at Sec. 512.730(c) for adding or removing cost measures if necessary.

We did not receive public comments on this provision, and therefore, we are finalizing as proposed at Sec. 512.730(c). (f) Minimum Case Requirements

Like under MIPS, as specified in Sec. 414.1350(c)(6) (88 FR 79346 through 79348), we proposed at Sec. 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) of this final rule. As discussed in section III.C.2.c.(3)(b) of this final 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 sought comment on the proposed case minimum of 20 attributed episodes for all cost measures at Sec. 512.730(d) used to score the cost ASM performance category.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters expressed concern with the proposed 20- episode threshold for the ASM EBCMs, noting that a small denominator for patient attribution may not produce a reliable performance score. A few commenters recommended increasing volume thresholds to better account for statistical variation. Specifically, a commenter suggested that clinicians should not be scored on the heart failure EBCM unless they have at least 50 attributed episodes, or if the number of episodes meets the reliability threshold of at least 0.8, whichever is greater. A few commenters shared their concern that even a single outlier case or event could disproportionately impact performance results and unfairly penalize clinicians who treat patients that are frail or vulnerable with complex medical conditions.

Response: We recognize the commenters' concerns regarding the heart failure and low back pain EBCM 20-episode threshold. However, we disagree that it is an inappropriate volume of cases for determining cost ASM performance category scores. An EBCM 20-episode threshold is consistent with the established minimum case volume finalized for MIPS at Sec. [thinsp]414.1350(c)(6) for both the heart failure and low back pain EBCMs. As we discussed in the CY 2018 PFS final rule (82 FR 53697 through 53699), increasing the case minimum upwards of a figure like 50 episodes would reduce the number of clinicians assessed by the measure. This would, therefore, limit the scoring of EBCMs to larger group practices with sufficient case volume at the expense of individual providers who are the focus of ASM. We believe that a minimum EBCM 20- episode threshold remains aligned with other CMS programs and will reliably, just like in the QPP program, measure ASM participants on cost performance. We also note that Part D costs are winsorized such that extreme observations at and above the 98th percentile are excluded from the EBCM's calculations.

After consideration of public comments, we are finalizing at Sec. 512.730(d) the proposed case

minimum of 20 attributed episodes for all cost measures used to score the cost ASM performance category as proposed. (g) Cost Measure Achievement Points and Cost ASM Performance Category Scoring (i) Cost Measure Achievement Points

We proposed to follow a similar methodology for establishing and assigning measure achievement points as is used by MIPS. We proposed at Sec. Sec. 512.730(e)(1)(i) 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.

We sought comment on the proposed methodology for establishing and assigning measure achievement points for the cost ASM performance category as proposed at Sec. Sec. 512.730(e)(1)(i).

We did not receive specific comments on the proposed provisions at Sec. Sec. 512.730(e)(1)(i) and are, therefore, finalizing as proposed. (ii) Benchmarking

We proposed at Sec. 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 proposed at Sec. 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 Sec. 512.730(d) for CMS to determine a benchmark for the cost measure. We proposed at Sec. 512.730(e)(2)(i)(B) if a benchmark is not determined for a cost measure, then the measure would not be scored.

We proposed at Sec. 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 proposed at Sec. 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 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 proposed 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 performance. We refer readers to Table B-D5 for an example of how the proposed cost scoring methodology could be implemented for a specific cost measure. [GRAPHIC] [TIFF OMITTED] TR05NO25.110

We proposed at Sec. 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 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 solicited comments on our proposed approach for calculating EBCM benchmarks and scoring each cost measure, as well as all alternatives considered.

The following is a summary of the comments we received and our responses.

Comment: A commenter recommended the use of prospective peer- grouped benchmarks with case-mix stratification and regional price standardization and stated their belief that such benchmarks could potentially limit cost differences in high-acuity versus community practices.

Response: We appreciate the commenter for sharing their recommendation that we use prospective peer-grouped benchmarks with case-mix stratification and regional price standardization to limit cost differences in high-acuity versus community practices. We note that EBCMs do use standard, Medicare allowed amounts, in their calculations. However, we disagree with the recommendation to use prospective peer-grouped benchmarks because of our overarching goal when calculating benchmarks to follow a similar methodology as is used by MIPS so that most ASM participants would be familiar with the benchmarking approach. Though we did not consider this approach to benchmarking, if we did, we would do so in future notice-and-comment rulemaking.

Comment: A few commenters recommended that CMS clarify how benchmarking will be applied when the same measure is used in MIPS and in ASM, given the distinct clinician populations. The commenters suggested that CMS compare the benchmarks between MIPS and ASM to illustrate any differences. A commenter expressed concern that the heart failure EBCM was originally developed across multiple specialties and recommended selecting the benchmark that is most favorable to ASM participants to ensure fair and equitable scoring.

Response: We appreciate the commenters for sharing their recommendation to clarify our benchmarking approach when it differs from other CMS cost benchmarking methodologies like in MIPS. We stress that the ASM benchmark ranges will only be calculated using ASM participant EBCM data, which would allow for fair comparisons of performance of ASM participant performance. Any modifications at the end of the performance year to the methodology to benefit some participants would hurt other participants. We further clarify that ASM benchmarks are calculated separately for each cohort.

Comment: A commenter did not support the proposed methodology to calculate benchmarks for ASM EBCMs. For the heart failure EBCM a commenter expressed concern that benchmarking based solely on cardiologists, particularly at the individual clinician level, could bias rankings and result in inconsistent or misleading scores. A commenter recommended that CMS stratify the heart failure EBCM results by ejection fraction phenotype. The commenter also recommended CMS develop a more granular, specialty-specific benchmarking approach that reflects clinical realities and avoids applying measures validated in one population to another with different practice patterns and patient profiles.

Response: We appreciate the commenter for their concern, however, we disagree that the benchmarking approach as proposed would result in inconsistent scores because by determining benchmarks based off cardiologists' performance, we are creating benchmark sets calculated from ASM participants' peers. Further, we did not consider stratifying the cost cohort by heart failure type because EBCM scores and data are not stratified by condition so we would be unable to calculate benchmarks segmented by condition. Additionally, we disagree that the EBCMs apply measures validated in one population onto another. The EBCMs were developed for specific specialty types and to adjust for fairer comparison based on patient profiles include a sophisticated risk adjustment methodology as discussed earlier in this section.

After consideration of public comments, we are finalizing at Sec. 512.730(e)(2) our benchmarking policies that base cost measure benchmarks on cost performance during the ASM performance year, and the formation of 10 benchmark ranges based on median cost and standard deviations as proposed. (iii) Calculation of the Cost ASM Performance Category Score

We proposed at Sec. 512.730(e)(3) that the cost ASM performance category score would be calculated as the sum of the total number of measure achievement points earned by the ASM participant from each required measure divided by the total number of available measure achievement points for each required cost measure, not to exceed 100 percent, for ASM heart failure participants or ASM low back pain participants. As discussed in section III.C.2.d.(3)(g) of this final rule, we proposed at Sec. 512.730(e)(3)(i) that an ASM participant who does not have 20 attributed episodes during an ASM performance year would not receive a cost ASM performance category score and would not receive a final score as discussed in section III.C.2.e.(b) of this final rule.

We believe that this proposed cost ASM performance category score ensures that ASM participants can be appropriately held accountable on spending related to ASM's targeted chronic conditions. This proposed cost ASM performance category scoring methodology means that the cost ASM performance category would be equivalent to the score for the heart failure EBCM for ASM heart failure participants and the low back pain EBCM for ASM low back pain participants since each participant group is only scored on 1 cost measure.

We proposed at Sec. 512.730(e)(3)(ii) that if data used to calculate a score for a cost measure are impacted by significant changes or errors affecting the ASM performance year, such that calculating the cost measure score would lead to misleading or inaccurate results, then the affected cost measure is excluded from the ASM participant's cost performance category score and a cost performance category score is not calculated.

We proposed at Sec. 512.730(e)(3)(ii)(A) to define “significant changes or errors” regarding instances in which the cost 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 proposed at Sec. 512.730(e)(3)(ii)(B) that significant changes or errors include, but are not limited to, rapid or unprecedented changes to service utilization, changes to codes (such as ICD-10, CPT or HCPCS codes), the inadvertent omission of codes or inclusion of codes, or changes to clinical guidelines or measure specifications.

We also proposed at Sec. 512.730(e)(3)(ii)(C) that we would empirically assess the affected cost measure to determine the extent to which the changes or errors impact the calculation of a cost measure score such that calculating the cost measure score would lead to misleading or inaccurate results that negatively impact the measure's ability to reliably assess

performance. We believe these proposed policies would appropriately adapt the proposed cost 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 solicited comments on our proposed methodology for calculating the cost ASM performance category score.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters expressed concerns on the proposed cost scoring for the ASM EBCMs, noting misaligned incentives may discourage specialist participation. The commenters shared their belief that inherently higher costs of complex cases driven by patient severity, rather than inefficiencies or poor quality, combined with the emphasis on cost without appropriate risk adjustments, and severe financial consequences could discourage skilled specialists from participating in ASM and from providing care in resource-intensive but clinically appropriate settings like hospitals and rural facilities, ultimately limiting patient access to necessary care. A commenter suggested CMS to gradually phase in cost accountability, with safeguards to avoid unintended penalties and support the goal of increasing specialist participation in value-based care. Another commenter expressed concern that cost benchmarks for ASM, if set without specialty input, may undervalue the complexity and safety needs of image-guided spinal interventions, could impact clinical decisions and reduce access to essential, minimally invasive treatments, potentially leading to increased opioid use or unnecessary surgery, contradicting CMS' goals of improving quality and reducing costs

Response: We appreciate the commenters for expressing their concerns on ASM scoring of EBCMs, however, we disagree that the cost category creates improper incentives. We stress that the EBCMs use an advanced risk adjustment methodology so that cost comparisons are not raw cost versus cost. But rather, risk standardized cost versus their peers' costs treating similar patients. We did not consider phasing in cost accountability because our ASM cost performance category closely mirrors the cost performance category as defined in MIPS, so specialists should be familiar with this measure. Additionally, our benchmarking methodology uses risk adjusted costs so as not to penalize or reward participants on patient complexity or lack thereof.

Comment: A few commenters generally expressed concerns on the Cost ASM scoring policies. A commenter expressed concern that including spending on necessary services in EBCMs could inadvertently reward clinicians for reducing spending on essential care, potentially leading to worse patient outcomes that may not be reflected in quality measures, noting that average spending on patients could increase due to factors outside a clinician's control, such as rising drug prices or services ordered by other physicians, which could unfairly penalize clinicians. Another commenter recommended that cost metrics account for the influence of primary care or consider exclusion criteria for patients not primarily managed by specialists, to ensure fair attribution and avoid penalizing specialists for outcomes beyond their control.

Response: We appreciate the commenter for their concerns on Cost ASM scoring policies, however, we disagree that the cost ASM scoring policies reward clinicians for reducing spend on essential care. Both the heart failure and low back pain quality measure sets, as discussed earlier in this section, contain measures whose performance may lower if participants choose to inappropriately withhold care. We note that the EBCMs do not compare participants to prior year spending, rather they are scored based off of performance relative to their cohort. We did not consider adjusting the EBCM for the influence of primary care because the EBCM has already undergone extensive review by multiple specialty societies and clinicians. Lastly, EBCMs are only attributed to specialists if they render a triggering and confirming service with a corresponding ICD-10 code. We believe that that threshold is high enough to assume that ASM participants with EBCMs assigned to them are active in managing the care of their patients.

Comment: A commenter suggested establishing clear performance benchmarks for EBCMs to guide positive and negative adjustments, allowing clinicians to make informed practice and investment decisions with assurance that their performance will be evaluated fairly. A commenter further recommended that CMS publish the cost measure specifications used in the model along with the claims used for calculating the measures to support transparency and effective performance monitoring.

Response: We appreciate the commenter for their recommendation. However, we disagree with their recommendation because positive and negative payment adjustments are based off of numerous factors beyond the cost performance category. Therefore, it would be improper to set a performance threshold in the cost benchmarking category. We also note that all EBCM measure specifications are publicly available on the CMS website.

After consideration of public comments, we are finalizing as proposed at Sec. 512.730(e)(3) that the cost ASM performance category score would be calculated as the sum of the total number of measure achievement points earned by the ASM participant from each required measure divided by the total number of available measure achievement points for each required cost measure, not to exceed 100 percent, for ASM heart failure participants or ASM low back pain participants. We did not receive public comments on the provisions at Sec. 512.730(e)(3)(ii), Sec. 512.730(e)(3)(ii)(A), Sec. 512.730(e)(3)(ii)(B), and Sec. 512.730(e)(3)(ii)(C) and therefore, we are finalizing as proposed. (4) Improvement Activities ASM Performance Category

The requirements in the improvement activities ASM performance category aim to improve care coordination, increase collaboration between specialty and primary care, and better address upstream drivers of health for patients. These activities support the model goals to improve quality care as measured through a focused measure set relevant to ASM participants. They also support prevention efforts that incentivize ASM participants to ensure that their patients have a regular source of primary care and are screened to help identify early signs of chronic conditions. The improvement activities ASM performance category would be used to determine a potential scoring adjustment to the final score. We refer readers to sections III.C.2.e.(1) and III.C.2.e.(5) of this final rule for details on how the scores in the improvement activities scoring adjustment would be applied to the ASM final score. (a) Background

The improvement activities ASM performance category provides ASM participants with an opportunity to support broader improvements in health care delivery. Improvement activities originated in MIPS to improve care coordination, foster beneficiary engagement, and advance population health management as described at

Sec. 414.1355. ASM leverages this structure and proposes at Sec. 512.705 to define “improvement activities” as activities relating to care coordination, integration of specialty and primary care, and addressing health-related social needs (HRSN) of patients.

Care coordination helps to ensure that all healthcare providers involved in a patient's care have appropriate access to relevant patient information and are working towards the same care goals. The exchange of up-to-date and detailed patient information among healthcare providers can improve patient outcomes, safety, and support clinical decision making.\265\ Integration of specialty and primary care would also positively impact the patient experience. A 2022 study examining fragmentation in ambulatory care for Medicare FFS beneficiaries found that 4 in 10 beneficiaries experience highly fragmented care, with a mean of 13 ambulatory visits across seven practitioners in 1 year.\266\ By providing a more seamless and coordinated approach to beneficiary care, providers reduce the need for patients to spend as much time navigating the health care system and lower any undue costs for patients that may be associated with an increased number of clinical visits and services. This approach also can prevent the worsening of disease by ensuring all parties are aware of a patient's needs, aligned with a care plan, and receiving appropriate prevention and screening services. We borrow elements from the care coordination improvement activities subcategory of MIPS to align with activities in which organizations may already be engaged.

\265\ Foy R. Meta-analysis: Effect of Interactive Communication Between Collaborating Primary Care Physicians and Specialists. Annals of Internal Medicine. 2010;152(4):247. doi:https://doi.org/10.7326/0003-4819-152-4-201002160-00010.

\266\ Centers for Medicare & Medicaid Services. CMS Innovation Center's Strategy to Support Person-Centered, Value-Based Specialty Care. CMS.gov Blog. Published October 19, 2023. https://www.cms.gov/blog/cms-innovation-centers-strategy-support-person-centered-value-based-specialty-care (accessed 2/24/25).

Consistent with our model goals, we believe it is important to create a single set of achievable improvement activities that are applicable to all ASM participants. We took several steps to ensure these improvement activities are consistent with our intent to improve meaningful coordination and collaboration. We developed the measures for this ASM performance category based on our review of feedback provided in response to our RFI (89 FR 61596), interviews with interested parties, and an environmental scan of existing practice coordination activities from the Quality Payment Program and other Innovation Center models.\267\

\267\ 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.

We solicited comments on our proposed definition for “improvement activities.” We did not receive specific comments on our proposed definition of “improvement activities,” so we are finalizing it as proposed at Sec. 512.705. (b) Performance Year for Improvement Activities

Beginning with ASM payment year 2029, we proposed at Sec. 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 Sec. 414.1320 and would be easily adoptable by ASM participants. We sought comments on this proposal.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter supported the proposal to align the ASM performance year for improvement activities with MIPS, noting continuity in reporting, leveraging existing infrastructure and reducing burden.

Response: We appreciate this supportive feedback regarding the performance year alignment. We are finalizing the policy to establish the ASM performance year for improvement activities as 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. This approach maintains consistency with existing MIPS reporting frameworks and supports operational efficiency for ASM participants and their technology vendors.

Comment: A commenter recommended CMS publish ASM improvement activities requirements with the CY 2026 final rule and include them in the existing MIPS inventory and data validation and audit spreadsheet, so clinicians can prepare and adjust workflows ahead of ASM participation in CY 2027.

Response: We appreciate the commenter's interest in the Improvement Activities (IA) requirements and specifications for ASM and their thoughtful suggestions regarding publication timing. The details provided in the final rule constitute the specifications for the IAs, and the program is designed with built-in flexibility to support practices in approaching these activities as they determine most appropriate for their clinical workflows and patient populations. We understand the interest in comprehensive guidance on improvement activity implementation and recognize the importance of supporting ASM participants in their preparation efforts. ASM will continue to evolve as we gather experience from current ASM participants. Our approach allows clinicians the autonomy to tailor an IA to their specific practice environments while meeting the model's quality improvement objectives. We intend to provide participants with additional resources on model requirements and performance category requirements in the year leading up the model start. We intend to make these resources available on the ASM website.

Comment: A commenter expressed concern that the proposed IA requirements could force small practices to close, increase consolidation within the health care industry, and discourage specialists from treating Medicare patients.

Response: We appreciate the commenters for their concern about the improvement activities requirements. While we acknowledge that these ASM-specific requirements may be new activities that may require additional effort, we do not believe these IA requirements would force small practices to close. To support the small practices, we proposed additional policies and flexibilities in ASM, such as the small practice scoring adjustment described in section III.C.2.e.(4) of this final rule and adjusted data submission requirements at Sec. 512.720(a)(1)(ii) to allow for the Improvement Activities to be reported at the TIN level. Also, we do not believe small practices will need to consolidate in order to meet the improvement activity requirements as we allow ample flexibility in the specifications and provide significant time for implementation as the model does not start until January 1, 2027. For these same reasons, we do not believe that the model will discourage providers from treating Medicare patients and believe that the opportunity for positive payment adjustments from the model will motivate participants.

After consideration of public comments, we are finalizing the proposed performance year for

improvement activities as proposed at Sec. 512.735(a). (c) Improvement Activities

We proposed at Sec. 512.735 the establishment of the improvement activities ASM performance category. We proposed at Sec. 512.735(b) that we would evaluate ASM participants on the proposed improvement activities at Sec. 512.735(c): (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 (CCAs).

We did not receive any comments on our proposed general approach to evaluating ASM participants on the required improvement activities. Comments specific to the proposed improvement activities are summarized and discussed below. Therefore, we are finalizing the provision related to evaluating ASM participants on the finalized improvement activities as proposed at Sec. 512.735(b). (i) Improvement Activity 1 (IA-1): Connecting to Primary Care and Ensuring Completion of Health-Related Social Needs Screening

In IA-1, we proposed at Sec. 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 proposed at Sec. 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 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 study found that up to a third of Medicare beneficiaries do not see a PCP yearly.\268\ 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.\269\ 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 proposed at Sec. 512.735(c)(1)(ii) to require that the ASM participant 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.\270\

\268\ 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.

\269\ Yang Z, Ganguli I, Davis C, et al. Physician[hyphen] versus practice[hyphen]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.

\270\ 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.

As the final element of IA-1, we proposed at Sec. 512.735(c)(1)(iii) that ASM participants collaborate with PCPs to ensure that their patients have received health-related social needs (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 17.7 percent had poor housing quality.\271\ 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 worsen overall outcomes.\272\ 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 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.

\271\ 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.

\272\ 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.

(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 PCP 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.

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.

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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed IA-1, noting that enhanced coordination between specialists and PCPs is critical for effective cardiovascular care and improving care coordination.

Response: We appreciate the support for IA-1 and believe the implementation of this improvement activity will bring valuable insights and impact of HRSN screening in specialty care settings. We agree that coordination between primary and specialty care is essential for achieving comprehensive patient care and addressing upstream drivers of health that significantly influence chronic disease management and outcomes.

Comment: A few commenters supported the proposed IA-1: Connecting to Primary Care and offered additional recommendations. A commenter suggested CMS consider a multidisciplinary, system-level approach rather than holding the ASM participant responsible for the activity at the individual level. Another commenter shared their belief that some practices may not have the data infrastructure to handle IA-1, which would unfairly penalize clinicians. Another commenter shared their belief that the proposed IA-1 focuses more on the process rather than the outcomes, which could add administrative burden leading to clinician burnout. A commenter suggested CMS to simplify the IA-1 by: developing additional quality measures for specialists to demonstrate collaboration with primary care, requiring specialists to meet a threshold percentage for having a PCP listed, confirming whether the HRSN screening or an annual wellness visit was completed, or assisting patients in finding a PCP that can perform the screening.

Response: We appreciate commenters for their support and recommendations regarding the proposed IA-1: Connecting to Primary Care. We have adjusted the data submission requirements of ASM at Sec. 512.720(a)(1)(ii) to allow for the Improvement Activities to be reported at the TIN level, in order to promote team-based care and coordination as the requirements of this ASM performance category typically reflect work done at the practice level. We believe that changing this reporting level from the individual clinician to the TIN level decreases administrative burden while still maintaining accountability for these important care coordination activities. We intend to provide participants with additional resources on model requirements and performance category requirements in the year leading up the model start. We intend to make these resources available on the ASM website. While we appreciate the comment to create a quality measure for this activity to assess coordination and collaboration, that is not feasible at this time and would present an additional burden to ASM participants. We also believe that the annual attestation of this activity is low burden as it does not require ongoing submission of detailed data.

Comment: A few commenters did not support the IA-1: Connecting to Primary Care, noting concerns around the need for manual data when electronic health records (EHR) or Health Information Exchange (HIE) are not shared between practices, lack of interoperability for social determinants of health (SDOH) data, absence of closed-loop referral tracking and misalignment of financing. A commenter specifically called out anesthesiologists as being the inappropriate care team member to identify a PCP due to their limited interactions with patients during episodic care. The commenter recommended that CMS propose an improvement activity that better reflects the expected roles and workflows of anesthesiologists.

Response: We appreciate the feedback about IA-1. While there may be effort associated with implementing IA-1: Connecting to Primary Care, we believe the activities proposed in IA-1 are vital to patient care and reducing care fragmentation, and many of these coordination activities should already be occurring as part of comprehensive patient management. The preliminary participant list for CY2027 will be posted in early 2026, nearly a year in advance of the model start. This will provide ASM participants with nearly a year in advance to prepare their HIE systems and adjust to some of these activities, such as HRSN screening checks.

The ASM participant themself does not need to directly connect the patient to a PCP. It can be a separate activity not tied to the HIE system and/or an initiative/process within their practice or health system to ensure this coordination is happening effectively. Also, even though anesthesiologists may have limited interactions with patients during episodic care, we believe anesthesiologists should still be ensuring their patients are receiving longitudinal care coordination and help connect them to a PCP when needed. Furthermore, we believe our methodology for participant inclusion in ASM is focused on providers that have been attributed at least 20 patients with the condition of interest, which will identify clinicians that are more likely to have ongoing relationships with patients. This makes it more reasonable to expect these care coordination activities from these anesthesiologists who are ASM participants.

Comment: A few commenters expressed general concerns regarding the proposed IA-1: Connecting to Primary Care. A commenter expressed concern that the model may be less effective for primary care practices due to the lack of direct funding for PCPs, who are already overburdened. A commenter recommended that CMS offer technical assistance and upfront funding to PCPs. Another commenter suggested that CMS should provide additional resources for investments to support coordination.

Response: We appreciate the feedback regarding concerns about the effectiveness of IA-1: Connecting to Primary Care for primary care practices and the need for additional support resources. We understand the challenges facing PCPs and recognize the importance of supporting their participation in care coordination activities. Codes for e- consults and interprofessional communication already exist for ASM participants and PCPs to receive reimbursement for their collaborative efforts. Furthermore, we

believe these coordination efforts will reduce care fragmentation and improve efficiency, which may provide financial benefits to ASM participants and the primary care practices with whom they partner through reduced duplicative services, improved patient outcomes, and more streamlined care delivery. The improved coordination should also lead to better patient satisfaction and potentially reduced administrative burden over time as communication pathways become more established. We recognize that successful implementation of this improvement activity requires adequate support for both specialists and PCPs. We intend to provide participants with additional resources and support on model requirements and performance category requirements in the year leading up the model start. We intend to make these resources available on the ASM website.

Comment: Several commenters provided recommendations for IA-1. One commenter recommended a more holistic approach to screening that included connecting patients to resources and offering community solutions.

Response: The primary goal of IA-1 is to ensure comprehensive care coordination and HRSNs that significantly impact outcomes for beneficiaries with these chronic conditions. We appreciate the commenter's support for our HRSN screening efforts and the observation that screening alone does not connect patients to resources. We believe that incentivizing screening is the essential first step to connecting patients to these resources. As ASM operates at the specialist level, there are minimal direct levers for the model to connect patients to community resources, but the screening and coordination requirements create pathways for PCPs and care teams to facilitate these connections.

Comment: Several comments provided recommendations about IA-1. One commenter suggested that longitudinal models that engage specialists over the course of chronic care conditions such as through condition- based or per-person payments would allow for team based care, collaborations, and interventions. Another commenter stated their belief that FFS payment models do not account for the time and effort needed to implement screening and refer patients.

Response: We appreciate the supportive feedback and thoughtful recommendations regarding IA-1. Our model is for low back pain and heart failure, two chronic diseases in which HRSN screening and collaboration can greatly improve care and reduce fragmentation for the patient. We agree that longitudinal care models are important, but this is not the sole goal of ASM. We are targeting specific conditions for improvement and believe that within the larger context of the healthcare ecosystem, ACOs and other value-based care systems will be supported. By promoting this connection between providers, we are enforcing longitudinal relationships and care continuity for patients with heart failure and low back pain. Furthermore, we believe that the payment structure of the model incentivizes these efforts and rewards them more than the traditional FFS system. ASM promotes coordination, HRSN screening, and quality improvement efforts by measuring them and providing potential positive payment adjustments for those participants achieving these desired goals.

Comment: Several commenters provided feedback on IA-1 related to interoperability. A commenter also recommended that CMS define the expectations now and measure them later and align the model to the HL7 Gravity FHIR Implementation Guide for data transfer and timeline should be coordinated with Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health IT (ASTP/ONC) certification and vendor upgrades. Another commenter noted that CMS should phase in expectations aligned with national standards such as Gravity, CCA templates, and finance operations.

Response: We appreciate the comments. We recognize the importance of aligning with national standards such as the Gravity Project to promote interoperability and reduce implementation burden. We will also explore opportunities in the future to align with these efforts and others that will support effective implementation. Also, we are interested in providing resources and materials to support the improvement activities performance category and other model requirements. We intend to make these resources available on the model website.

Comment: A few commenters stated this proposal will add burden to specialists. One commenter noted the time this will take during already packed office visits, workflow changes, interoperability concerns, and buy-in from clinicians with other employers who are not ASM participants. The commenter recommended that CMS codify “screen once, share widely” to prevent duplication and that compliance be achievable through EHR rather than separate portals or manual lookups. Another commenter suggested simplifying the HRSN policy, because it could lead to finger pointing between specialists and PCPs. A commenter stated their belief that infrastructure, workflow standards, and financing will drive duplicative screening and increased the administrative burden.

Response: We appreciate the commenters' feedback. We understand the concerns about infrastructure, workflow standards, and buy-in. We believe that the advanced notification of mandatory participation as described in section III.C.2.c.(5) of this final rule would provide ASM participants with time to prepare for the model requirements, such as developing workflows and partnerships that support effective HRSN screening and care coordination. We also intend to release additional guidance and resources before the model launches in CY 2027. The model's emphasis on communication and care coordination should ultimately reduce fragmentation and improve efficiency for both specialists and PCPs while ensuring that patients receive comprehensive care that addresses both their clinical conditions and HRSNs. Regarding concerns about duplication and the need to codify “screen once, share widely,” we believe the current IA-1 policy is effective because it promotes coordination between specialists and PCPs while addressing HRSN screening for beneficiaries with heart failure and low back pain. The existing policy already encourages the “screen once, share widely” principle by allowing specialists to satisfy requirements when they can access valid existing screening results through established communication channels and HIEs. Also, while there is a chance that minor duplication of HRSN screening may occur between specialists and PCP, we believe this can be mitigated by proper communication process and that it is a reasonable trade-off to ensure that patients are receiving appropriate screening and being connected to the resources they need to maintain their health. The primary goal of IA-1 is to ensure comprehensive care coordination and address social determinants of health that significantly impact outcomes for beneficiaries with these chronic conditions.

Comment: A commenter expressed their belief that misalignment between programs increases administrative complexity, including workflow changes and data infrastructure investments, as seen in the proposed removal of HRSN from the MIPS Quality and Improvement Activities categories

and the inclusion of IA-1 in ASM. A commenter stated it was contradictory to include HRSN screening in ASM but remove SDOH screenings. A commenter recommended CMS review proposed SDOH changes across programs for consistency.

Response: We appreciate the commenter's feedback. ASM is a distinct model separate from other payment programs. While we strive to align where possible, differing approaches may persist. HRSN screening is especially important in patients who have heart failure and low back pain and may be at greater risk, and therefore greater benefit, from screening and intervention. For this reason, we will include HRSN screening in ASM and continue aligning with other payment programs where possible.

Comment: A commenter recommended CMS collect and disseminate HRSN information since they are better positioned and the HRSN screening falls outside of heart failure and low back pain specialists' clinical scope.

Response: We appreciate the feedback regarding the dissemination of HRSN information. We believe that ensuring HRSN screening has occurred is important when dealing with patients with the ASM chronic conditions of focus, and therefore, it is within scope. We plan to provide as much relevant information and data to participants in advance of and during the model. This may not explicitly include HRSN screening data, but other information that we believe will be beneficial to ASM participants.

Comment: A commenter expressed their belief that some patients may not have a PCP and that physicians may not share their HRSN information. A commenter expressed their concern about the role of the specialist ensuring the PCP completes the screen and the potential of the patient being unwilling to see a PCP. A commenter expressed their belief that there should be clear exceptions for specialists if a patient declines a PCP, lives in a primary care shortage area, or the primary care physician declines the screening.

Response: We appreciate the comments around the roles of the specialist and PCP in HRSN screening. We support the connection of patients to care but recognize that this is not always the primary role of the specialist, so we have specified that the specialist should ensure the HRSN screening is completed by the PCP, or by them if needed, and believe that the proper next steps will occur through this coordination. We appreciate the comment around clear exceptions in cases where patients decline PCP connections, live in primary care shortage areas, or when primary care physicians decline to participate in screening activities. The improvement activity requires that there are processes, workflows, or technology in place to connect all patients to a PCP and HRSN screening. We want to incentivize as much action toward achieving these ASM goals as possible, acknowledging that there may be specialists who are well positioned to help identify a PCP for the patient when a PCP is difficult for the patient to find themself.

Comment: A few commenters recommended that CMS should advise which HRSN screening tools are acceptable so vendors can integrate these tools into clinical workflows.

Response: We appreciate the request to advise on screening tools. We do not specify a particular HRSN screening tool to allow flexibility for participants to choose tools that work best with their existing workflows and EHR systems. We may provide additional guidance in the future to support decision-making. Also, we note that the IA-1 does not require that the HRSN screening be conducted by the specialist, unless it is unable to be completed by the PCP, acknowledging that PCPs may have more experience with HRSN screenings and connecting patients to resources, if needed.

Comment: A commenter recommended that specialists receive full credit for sending EHR documentation and visit summary to a primary care physician within a defined timeframe.

Response: Participants have flexibility to integrate the IA-1 requirements however they choose whether through manual processes or automated systems as part of their EHR or other health information technology platforms. The situation described by the commenter would meet the expectations for communicating relevant information back to the ASM beneficiary's PCP, which is one part of IA-1. This communication between specialists and PCPs should help minimize duplication of HRSN screening when existing results can be accessed and shared effectively through established workflows and HIE.

After consideration of public comments, we are finalizing IA-1 and its specifications as proposed at Sec. 512.735(c)(1). (iii) Improvement Activity 2 (IA-2): Establishing Communication and Collaboration Expectations With Primary Care Using Collaborative Care Arrangements (CCAs)

In IA-2, we proposed at Sec. 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 proposed defining “collaborative care arrangement” to mean an arrangement that complies with all of the requirements set forth in Sec. 512.771. We also proposed to define “ASM beneficiary” at Sec. 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.

We sought comments on our proposed definition for “ASM beneficiary”. We did not receive specific comments on our proposed definition of “improvement activities,” so we are finalizing it as proposed at Sec. 512.705.

To receive achievement points for IA-2, we proposed at Sec. Sec. 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 Sec. Sec. 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 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.\273\ 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, 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.

\273\ 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.

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).\274\ 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 shared understanding of the patient's needs and can work together to provide high-quality, patient- centered care.

\274\ 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/.

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 unnecessary utilization of health care resources.\275\

\275\ 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.

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 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 a 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 (CCAs).

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 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 capturing reports from the PCP 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 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, 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 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 solicited comments on the goals and specifications of the required improvement activities proposed at Sec. 512.735(c)(2).

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed Improvement Activity 2 (IA-2) requiring ASM participants to enter a CCA with PCPs with three of the five following areas including data sharing, co- management, transitions in care planning, closed loop connections and care coordination integration and offered further recommendations. A commenter recommended that CMS take a similar approach to the Making Care Primary (MCP) program by implementing specific coding and payment for consultations, noting that incentivizing collaboration is more likely to have a meaningful impact. Another commenter recommended that CMS align ASM care coordination requirements with existing Chronic Care Management (CCM)/Advanced Primary Care Management (APCM) frameworks to reduce reporting burden.

Response: We appreciate the support of IA-2. We do not believe model specific payment codes would add value or align with the goals of ASM. We believe the improvement activities framework adequately supports the goals that these codes would accomplish. ASM participants and their partnered PCPs will more often be collaborating and coordinating care, providing more opportunities for them to appropriately bill the existing CCM, APCM, IPC, and e-consult codes. We will continue to think about how we can communicate the use of these existing codes and their alignment with our improvement activities goals in future guidance. Finally, we believe these coordination efforts required by ASM will reduce fragmentation and improve efficiency, which may provide financial benefits to participants and partnered primary care practices alike.

Comment: A commenter recommended CMS permit specialists to partner with third-party care management companies to meet coordination requirements and ensure access to infrastructure. Another commenter recommended that CMS publish clear requirements for CCAs, including requiring specialists and PCPs to have detailed operational plans and coordination activities. Another commenter recommended requiring specialists to share a copy of the CCA to provide insights into how market participants operationalize collaborative elements.

Response: We appreciate the feedback regarding partnerships with third-party care management companies and the development of CCAs for ASM. If a high-value third party can support coordination efforts, an ASM participant may work with them to achieve the improvement activity requirements.

We would be interested in participant feedback as they implement these coordination activities. However, we are not requiring the submission of CCAs as we are concerned with creating an excess administrative burden for ASM participants. We believe that the annual attestation approach strikes the appropriate balance between ensuring accountability for coordination activities and minimizing reporting burden. This approach allows participants the flexibility to develop coordination strategies that work best for their specific practice environments while still maintaining oversight of these important activities.

Comment: A few commenters supported the proposed IA-2. The commenters acknowledged the importance of incentives for promoting coordination between primary care physicians and specialists.

Response: We appreciate commenters' supportive feedback regarding the proposed IA-2. We agree with commenters about the importance of incentives for promoting coordination between primary care physicians and specialists. We believe that establishing clear collaboration expectations through annual attestations will help strengthen the care coordination framework that is essential to the success of ASM. We believe success in ASM and potential positive payment adjustments is the incentive.

Comment: Several commenters did not support IA-2. A commenter shared their belief that specialists should not be required to have any type of coordination arrangements with primary care physicians. Another commenter expressed concern that the CCAs were overly burdensome, particularly for clinicians outside of a larger system who lack the staff to manage such arrangements. Another commenter shared their concerns that 6 months is insufficient for providers to establish care coordination processes, and that the policy imposes significant workflow adjustments and administrative burdens within a short timeframe. A commenter expressed concern that ASM participants are at a disadvantage in negotiating CCAs, as PCPs are not required to participate. A few commenters expressed concern that it would be burdensome for ASM participants to enter into multiple CCAs given the range of patient primary care services. Another commenter noted that, despite having EHRs, reliance on fax persists due to external clinician systems, and the proposed improvement activity depends on cooperation from unaffiliated clinicians. Another commenter recommended granting credit for the improvement activity if clinicians share a common EHR or HIE.

Response: We appreciate the feedback regarding Improvement Activity (IA) 2. We are purposefully requiring specialists to engage with PCPs as a core goal of the model is to reduce fragmentation for patients and improve care collaboration. We believe an appropriate mechanism to achieve this is through CCAs.

We recognize the effort this requirement may take but intend to provide additional resources to support practices and believe that in the long

term, the coordination that IA-2 promotes may create efficiency through streamlined interactions with PCPs in situations of co-management or referral optimization. Also, for the CY 2027 performance year, we intend to release the preliminarily eligible list of participants in early CY 2026. This provides nearly a year of advance for ASM participants to prepare for IA-2. Further, IA-s only need to be implemented for a portion of the performance year in order to attest to the activity, providing additional time for the participant to meet the requirements.

We believe that primary care practices will be interested in engaging in CCAs as they also benefit them by building and strengthening relationships that can improve care coordination. We do not require the participant to enter into multiple CCAs, only one. Identifying a PCP with whom the ASM participants has the most shared patients could maximize the impact of the CCA.

We believe this coordination requirement is necessary to promote the collaboration we aim to achieve in ASM. Additionally, IA-2 does not specify that the primary care partner must be external. If an ASM participant is in a multi-specialty system, the participant may develop a CCA with a primary care group within that system. In this way, there is the opportunity to minimize additional complications related to external CCAs, if the other expectations of the CCA are met.

Regarding concerns about EHR interoperability and reliance on external systems, we acknowledge these challenges but believe we allow enough flexibility in IA-2 for ASM participants to explore multiple avenues to address them. If participants share an EHR, the benefit would be the minimal effort involved in achieving improvement activity requirements.

Comment: A few commenters supported the proposed IA-2 but shared additional recommendations. A commenter shared their belief that specialists should not be penalized for primary care actions and credit should only be applied to the actions within the specialist's control. Another commenter recommended that CMS further clarify the operational details of the five proposed collaborative elements to avoid a check- the-box approach.

Response: We appreciate the commenters for the supportive feedback regarding the proposed IA-2. The improvement activity focuses on the specialist's role in establishing and maintaining collaborative relationships and communication pathways with PCPs, rather than holding them accountable for PCP actions or decisions. Regarding the recommendation to clarify operational details of the five proposed collaborative elements, we appreciate this feedback and intend to provide additional resources to clarify details of CCAs in advance of the model start. Our goal is to ensure that these improvement activities promote meaningful collaboration rather than a check-the-box approach, and we will work to provide guidance that helps participants understand how to operationalize these coordination requirements in ways that genuinely improve patient care and reduce fragmentation.

Comment: A commenter recommended that ASM improvement activities be approved as improvement activities in traditional MIPS for the CY 2026 performance period to allow time for likely ASM participants to prepare.

Response We appreciate the feedback regarding the alignment of ASM improvement activities with MIPS. We will take the comment into consideration for future coordination with MIPS. We note that there is overlap between the requirements of the MIPS IAs in the Care Coordination section and the ASM IAs.

After consideration of public comments, we are finalizing our definition of “collaborative care arrangement” without modification at Sec. 512.705. We are also finalizing IA-2 and its specifications as proposed at Sec. 512.735(c)(2). (d) Improvement Activities Data Submission, Achievement Points, ASM Performance Category Scoring

We proposed that ASM participants must submit data on ASM improvement activities in the form of attestations meeting the submission requirements at Sec. 512.720. We proposed at Sec. 512.735(d)(1) and (2) that ASM participants would receive 10 measure achievement points for reporting “yes” for each improvement activity specified at Sec. 512.735(c) in accordance with the data submission requirements at Sec. 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 Sec. 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 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 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 will receive zero measure achievement points and an improvement activities ASM performance category score of zero percent.

We solicited comments on our improvement activities ASM performance category scoring approach at Sec. 512.735(d)(1) and (2) and alternative improvement activities weighting and scoring options. We did not receive public comments on this provision, and therefore, we are finalizing as proposed at Sec. 512.735(d). (5) 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, clinicians, and 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 final rule.

(a) Background

In the CY 2026 PFS proposed rule (90 FR 32593 through 32597), we included proposals for defining the performance year for Promoting Interoperability measures, the requirement for CEHRT use and related attestations, and data submission criteria and scoring for the ASM Promoting Interoperability performance category. As discussed in section III.C.2.e. of this final rule, the Promoting Interoperability ASM performance category score will be used to determine the Promoting Interoperability ASM performance category scoring adjustment applied to the final score. (b) ASM Performance Year for the Promoting Interoperability ASM Performance Category

At Sec. 512.740(a), we proposed the ASM performance year for Promoting Interoperability ASM performance category. Beginning with ASM payment year 2029, the performance year for Promoting Interoperability measures will be a 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.

As discussed in the CY 2026 PFS proposed rule (90 FR 32593), this reporting period aligns with the MIPS performance period established at Sec. 414.1320(i)(1) and provides ASM participants adequate opportunity to monitor and submit performance data. We believe that alignment of the performance period between MIPS and ASM helps support the transition of ASM participants from MIPS to ASM and reduce administrative burden for clinicians who are familiar with reporting in the existing MIPS performance period.

We solicited comments on our proposal at Sec. 512.740(a) for the 180-day performance period for Promoting Interoperability measures. The following is a summary of the comments we received on defining the Promoting Interoperability ASM performance year and our responses.

Comment: A few commenters supported the proposal to use a continuous 180-day period within the calendar year as the performance year for the Promoting Interoperability ASM performance category, noting alignment with MIPS and the Medicare Promoting Interoperability programs. The commenters shared this approach would reduce administrative burden for clinicians who are already familiar with these reporting timelines and processes and would allow leveraging existing infrastructure.

Response: We appreciate the commenters for their support of using a continuous 180-day period during the calendar year as the performance year for the Promoting Interoperability ASM performance category.

Comment: A commenter recommended CMS not to extend the ASM Promoting Interoperability performance year beyond 180-days in a future rule, expressing concern that a longer reporting period could create challenges to electronic health records (EHR) vendors who require adequate time for software updates, user training, and testing while supporting multiple facilities.

Response: We want to clarify that we did not propose to extend the ASM Promoting Interoperability performance period beyond 180-days. We appreciate the commenter for the suggestion and will consider it in the future should we decide to make changes to the proposed definition being finalized at Sec. 512.740(a).

After consideration of public comments, we are finalizing this proposed definition of the ASM Promoting Interoperability performance year at Sec. 512.740(a). (c) Reporting for the Promoting Interoperability Performance Category

We proposed at Sec. 512.740(b) to earn a performance category score for the Promoting Interoperability ASM performance category for inclusion in the final score, an ASM participant must be a meaningful EHR user meeting certain criteria. In the CY 2026 PFS proposed rule (90 FR 32593), we proposed to define “meaningful EHR user” at Sec. 512.705 to mean an ASM participant who possesses CEHRT, uses the functionality of CEHRT, reports on applicable objectives and measures specified for the Promoting Interoperability ASM performance category for a performance period in the form and manner specified by CMS, and engages in activities related to supporting clinicians with the performance of CEHRT. We proposed to not include additional provisions related to information blocking as defined at 45 CFR 171.103 in the definition of a meaningful EHR user. In addition, the Promoting Interoperability ASM performance category will focus on the safe use and exchange of patient data. Our requirements to demonstrate meaningful CEHRT use through reporting Promoting Interoperability objectives and measures are discussed later in this section of this final rule at III.C.2.d.(5)(c)(ii). (i) Required CEHRT Use

We proposed our requirement for CEHRT use at Sec. 512.740(b)(1) that ASM participants are required to provide evidence, in a form and manner specified by CMS, demonstrating their use of CEHRT to fulfill the Promoting Interoperability measure requirements (as defined at Sec. 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 Sec. 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.

As discussed in the CY 2026 PFS proposed rule (90 FR 32593 through 32594), 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 objectives and measures; (2) reporting of clinical quality measures, including eCQMs; (3) interoperability and data sharing between clinicians 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 proposed to align with the definition of CEHRT at Sec. 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 Sec. 414.1375(b)(1).

In addition to requiring use of CEHRT, we also proposed (90 FR 32593 through 32594) 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 \276\ Measure.

\276\ https://www.healthit.gov/topic/safety/safer-guides.

We proposed (90 FR 32593 through 32594) to not include the Actions to Limit or Restrict Compatibility or

Interoperability of CEHRT attestation in ASM currently required under MIPS at 42 CFR 414.1375(b)(3)(iii).

As discussed in the CY 2026 PFS proposed rule (90 FR 32593 through 32594), 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 \277\ conforms to ONC Health IT Certification Program's requirements not only during implementation of CEHRT, but also while CEHRT is being used during patient care and in care delivery. In addition, we proposed at Sec. 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. As discussed in the CY 2026 PFS proposed rule (90 FR 32594), this aligns with a MIPS requirement for eligible clinicians in MIPS as stated at Sec. 414.1375(b)(2)(ii)(A); we anticipated ASM participants that previously participated in MIPS would likely be 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 analysis \278\ in accordance with 45 CFR 164.308(a)(1)(A). As part of the security risk analysis, ASM participants will be required to address the security of electronic protected health information (ePHI) created, received, maintained, or transmitted by CEHRT, including whether it will 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.

\277\ 45 CFR 170.102.

\278\ Security Risk Analysis: https://qpp.cms.gov/docs/pi_specifications/Measure%20Specifications/2025-MIPS-Promoting%20Interoperability-Measure-Security-Risk-Analysis.pdf.

We also proposed at Sec. 512.740(b)(3)(iii) that the ASM participant must confirm the ASM participant's completion of the annual self-assessment under the High Priority Practices Guide of the SAFER Guides measure within the calendar year of the ASM performance year. As discussed in the CY 2026 PFS proposed rule (90 FR 32594), the High Priority Practices Guide of the SAFER Guides measure \279\ is an annual self-assessment to support consistent safety practices for all EHR users, which helps enable the electronic exchange of health information and aligns with a requirement for eligible clinicians in MIPS as stated at Sec. 414.1375(b)(2)(ii)(D).

\279\ SAFER Guides. https://qpp.cms.gov/docs/pi_specifications/Measure%20Specifications/2025-MIPS-Promoting-Interoperability-Measure-High-Priority-Practices-Guide-of-SAFER-Guides.pdf.

As discussed in the CY 2026 PFS proposed rule (90 FR 32594), 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 Interoperability performance category in MIPS, these requirements are likely familiar and already implemented, or readily implementable, for many ASM participants.

In the CY 2026 PFS proposed rule (90 FR 32594), we considered the alternative of allowing identified ASM participants without CEHRT to opt-out of participating in ASM. However, we were 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 recognized 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 Sec. 414.1305. To support these practices, we proposed additional policies and flexibilities in ASM, such as the complex patient scoring payment adjustment described in section III.C.2.e.(3) of this final rule and the small practice scoring adjustment described in section III.C.2.e.(4) of this final rule, with the goal of not inadvertently penalizing these practices, particularly those who disproportionally care for populations with higher medical complexity and greater social needs. 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 High Priority Practices Guide of 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, we anticipated that ASM participants are likely familiar with these attestations and measures, which could help reduce burden.

In the CY 2026 PFS proposed rule (90 FR 32594), 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, we believe that requiring CEHRT to achieve a Promoting Interoperability ASM performance 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 (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, in the CY 2026 PFS proposed rule (90 FR 32594), we considered inclusion of an affirmative attestation to The Actions to Limit or Restrict Compatibility or Interoperability of CEHRT measure in ASM to receive a score greater zero in the Promoting Interoperability ASM performance category 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 requested comments on our proposals to require that ASM participants use CEHRT to receive a score for the ASM Promoting Interoperability performance category. We also sought comments on the definition of meaningful EHR user and other alternatives discussed in this section of this final 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.

We received public comments on these proposals. The following is a

summary of the comments we received and our responses.

Comment: A few commenters supported the proposal to require the use of CEHRT for the Promoting Interoperability ASM performance category. A commenter shared their belief that CEHRT requirement would ensure standardized data exchange across clinicians.

Response: We appreciate the commenters for their support for the use of CEHRT in ASM.

Comment: A commenter recommended that CMS take full advantage of the flexibility to demonstrate use of CEHRT (for example, a straightforward attestation) found in The Health Information Technology for Economic and Clinical Health (HITECH) Act.

Response: We appreciate the commenters for their recommendation. We believe that attestation to demonstrate use of CEHRT in ASM is straightforward and not burdensome; participants would be required to provide their EHR's CMS identification ID from the Certified Health IT Product List, available on HealthIT.gov. This is the same process currently in place for MIPS and should be familiar to ASM participants. In addition, we want to emphasize that ASM builds on the work done as a result of the HITECH Act. Notably, ASM aligns with the definition of CEHRT at Sec. 414.1305, which was created in collaboration with the Office of the National Coordinator for Health Information Technology (ONC), now the Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health IT (ASTP/ONC). The HITECH Act required ONC to establish the Health IT Certification Program, which CMS' definition for CEHRT at Sec. 414.1305 cross-references.

Comment: A few commenters did not support the use of CEHRT in ASM. A commenter expressed concern that CEHRT may contain errors in medication prescribing, diagnoses, and treatments, resulting in physicians being unfairly penalized for errors beyond their control. Another commenter did not support CMS' concerns that providing flexibility in CEHRT reporting for ASM participants may disincentivize CEHRT adoption, noting that it does not consider the reality that the clinician relationship to CEHRT contains a multitude of factors above Medicare value-based payment reporting. The commenter recommended additional time and investment before CMS can rely on CEHRT to provide an accurate depiction of clinical decision making and patient care in surgery centers. Another commenter expressed concern that Ambulatory Surgery Centers (ASCs) may not have the necessary EHR or operational capabilities to successfully participate in a model that relies on CEHRT. A commenter recommended that CMS provide additional information on the impact of low utilization of EHR and CEHRT in the Ambulatory Surgery Center setting on ASM overall.

Response: We appreciate the commenters for sharing their concerns and recommendations regarding the use of CEHRT, including in ASCs. While we recognize that EHRs may contain documentation errors or may not have all functionality to comprehensively support clinical decision making and patient care in surgery centers, we disagree that this should preclude incentivizing adoption of CEHRT in ASM and that CEHRT cannot currently be relied on without additional time or investment. CEHRT, as a baseline, promotes more standardized ways of storing, capturing, and sharing data in a structured format to aid patient care. We believe it is important to align with our Promoting Interoperability programs that require and incentivize CEHRT adoption to help improve interoperability, especially as the exchange of data captured through CEHRT can be critical to enabling seamless, high-quality patient care across different settings of care, including in and out of ASCs. We recognize that clinicians may want or need additional functionality beyond the defined standards and certification criteria associated with CEHRT to support more nuanced clinical decision-making or to improve documentation integrity; if desired, clinicians, health care organizations, and EHR vendors can further collaborate to develop and implement these additional solutions on-the-ground. We otherwise may consider inclusion of additional functionality beyond CEHRT in ASM in future rulemaking.

We also recognize the decision to adopt CEHRT can be multifactorial and can extend beyond participation in Medicare value-based payment programs. We disagree that clinicians and practices, including ASCs as a whole lack the capacity to adopt CEHRT, but we acknowledge that certain practices, such as smaller practices or practices with fewer resources that may be caring for more complex patient populations, could face greater challenges when it comes to CEHRT adoption. For those reasons, additional policies are outlined in sections III.C.2.e.(3) and III.C.2.e.(4) of this final rule that discuss the complex patient scoring adjustment and small practice scoring adjustment as well as in section III.C.2.d.(1)(b) of this final rule that discusses allowing flexibility for small practices to report quality measures in the quality ASM performance category at the TIN- level to help these clinicians and practices sustain investments in CEHRT and other infrastructure; in particular, clinicians practicing in ASCs who meet these criteria would be eligible. Regarding ASCs in particular, we disagree that ASCs as a whole have low EHR utilization. While recent data related to the use of EHRs and CEHRT in different settings are limited, a survey by the Ambulatory Surgery Center Association in July 2025 found that 76 percent of ASCs use EHRs, an increase from 64 percent in 2023 and 55 percent in 2021.\280\ This is complemented by 96 percent of hospitals and 78 percent of office-based physicians using CEHRT as of 2021.\281\ Furthermore, we note that given ASM is focused on the longitudinal management of targeted chronic conditions, including the surgical and non-surgical treatment of low back pain, we anticipate the majority of ASM participants meeting ASM's eligibility and attribution criteria as defined in section III.C.2.s will not be practicing solely in ASCs.

\280\ Taira A. ASCA Survey Shows Continued Growth of EHR Usage by ASCs. ASC Focus: The ASCA Journal. Published August 21, 2025. https://www.ascfocus.org/ascfocus/content/articles-content/articles/2025/digital-debut/asca-survey-shows-continued-growth-of-ehr-usage-by-ascs. Accessed October 02, 2025.

\281\ Office of the National Coordinator for Health Information Technology. “National Trends in Hospital and Physician Adoption of Electronic Health Records,” Health IT Quick-Stat #61. https://www.healthit.gov/data/quickstats/national-trends-hospital-and-physician-adoption-electronic-health-records. Accessed October 02, 2025.

As a result, we are not finalizing any alternative policies for not requiring CEHRT to achieve a Promoting Interoperability score greater than zero or to allow for a CEHRT-related opt-out from ASM.

Comment: A commenter recommended CMS should require other clinicians and developers of CEHRT be prohibited from information blocking electronic health information to pharmacists and penalize developers for doing so. The commenter noted information blocking causes delays in patient care and prevents clinicians from having a complete picture of the patient's health, which can lead to inefficient and ineffective care.

Response: We appreciate the commenters for their recommendation and agree that information blocking can lead to ineffective exchange of information that can result in adverse

effects on patient care. This applies not only to data exchange with pharmacists but also with other clinicians, including with ASM participants. Accurate and timely data exchange is not only critical to patient care delivered by various interdisciplinary team members, but also when patients traverse multiple settings of care, from physician offices to hospitals to post-acute care facilities to patients' homes and communities. Information blocking by an EHR vendor or by any clinician or care team member working in any setting may result in delayed, inefficient, lower quality care and increased health care costs, which are counter to the goals of ASM. As a result, we believe in holding ASM participants accountable to not knowingly or willingly have taken action to limit or restrict the compatibility or interoperability of their CEHRT. We are finalizing our alternative to include the Actions to Limit or Restrict Compatibility or Interoperability of CEHRT attestation in ASM at Sec. 512.740(b)(4)(ii), which creates alignment between ASM and MIPS and promotes consistency across our Promoting Interoperability programs. Of note, inclusion of this attestation does not imply inclusion of the broader information blocking requirements created by the 21st Century Cures Act in ASM.

After consideration of public comments, we are finalizing our proposal to require use of CEHRT at Sec. 512.740(b)(1) as well as our alternative for which we sought comments that the ASM participant must attest to the “Actions to Limit or Restrict Compatibility or Interoperability of CEHRT” at Sec. 512.740(b)(4)(ii). to receive a score greater than zero in the Promoting Interoperability ASM performance category.

We received no comments on our definition of “meaningful EHR user” and are therefore finalizing this provision without modification at Sec. 512.705.

We also received no comments on our proposal that an ASM participant must complete the ONC direct review attestation to receive a score greater zero in the Promoting Interoperability ASM performance category and are therefore finalizing this provision without modification at Sec. 512.740(b)(4)(i).

In addition, we received no comments on our proposal that an ASM participant must complete the activities included in the Security Risk Analysis measure within the calendar year of the ASM performance year to receive a score greater zero in the Promoting Interoperability ASM performance category and are therefore finalizing this provision without modification at Sec. 512.740(b)(3)(ii).

Lastly, we received no comments on our proposal the ASM participant must attest to completion of the annual self-assessment under the High Priority Practices Guides of SAFER Guides measure within the calendar year of the ASM performance year to receive a score greater zero in the Promoting Interoperability ASM performance category and are finalizing this provision without modification at Sec. 512.740(b)(3)(iii). (ii) Promoting Interoperability Objectives and Measures

As discussed in the CY 2026 PFS proposed rule (90 FR 32594 through 32597), to receive a score for the Promoting Interoperability ASM performance category, an ASM participant 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 the goals, objectives, and measures used in other programs, including in MIPS. We proposed at Sec. 512.740(b)(2) that an ASM participant must report on MIPS Promoting Interoperability objectives and measures specified by CMS to assess performance in the Promoting Interoperability ASM performance category.

We proposed at Sec. 512.740(b)(3)(i) that an ASM participant must fulfill the following requirements to earn an ASM performance category score for the Promoting Interoperability ASM 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. As described in the CY 2026 PFS proposed rule (90 FR 32595), we proposed for ASM participants to report all Promoting Interoperability 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 final rule. In the CY 2026 PFS proposed rule (90 FR 32595), we also considered allowing for TIN-level reporting for Promoting Interoperability measures but decided then to prioritize maintaining individual accountability and robust comparisons among ASM heart failure participants or ASM low back pain participants. We proposed at Sec. Sec. 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 would support the following objectives: Electronic Prescribing, HIE, Provider to Patient Exchange, and Public Health and Clinical Data Exchange, as shown in Table B-D6. The objectives would encourage leveraging the electronic exchange of health information, with a focus on the safety associated with prescribing medications, communication between clinicians, patient access to their health information, and reporting essential health data to public health agencies.

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As discussed, in section III.C.2.d.(5).(b) of this final 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. As discussed in the CY 2026 PFS proposed rule (90 FR 32595), given these measures have remained consistent in MIPS, as stated at Sec. 414.1375(b)(2), ASM participants who participated in MIPS would likely be familiar with and implemented these measure specifications. As noted in the CY 2026 PFS proposed rule (90 FR 32595), 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 improve communication between patients and clinicians. Interoperability is needed for effective collaboration between specialists and PCPs (aligning with the goals and activities of ASM's Improvement Activities), comprehensive care coordination, and seamless transitions of care.

Of the measures in the Public Health and Clinical Data Exchange category in MIPS, we proposed at Sec. 512.740(b)(2)(iv) including the required MIPS measures only (Immunization Registry Reporting and Electronic Case Reporting) in ASM as they provide critical information to the mission and operations of our public health agencies. As described in the CY 2026 PFS proposed rule (90 FR 32596), the other measures in this category (Public Health Registry Reporting, Clinical Data Registry Reporting, and Syndromic Surveillance Reporting) would remain optional in ASM. Given these measures have been a stable part of the MIPS Promoting Interoperability measure set, keeping them optional allows for ease of reporting for ASM participants who may already have developed workflows and infrastructure to capture this data.

(iii) Adding, Removing, and Modifying Measures

In the CY 2026 PFS proposed rule (90 FR 32596), we proposed to avoid making significant changes to these measure sets over the period of model; however, we may propose to add or remove measures in response to relevant public comments, recommendations from ASM participants and interested parties, new CMS program activities, or significant changes made to the MIPS Promoting Interoperability measures set through rulemaking. Of note, because the measures currently proposed are all part of MIPS, any technical updates CMS applies to the measure specifications within MIPS would be incorporated into the Promoting Interoperability ASM measure sets accordingly (without rulemaking). Alternatively, we considered requiring notice and comment rulemaking before adopting any modifications made to the measures' specifications during rulemaking for MIPS.

We solicited public comments on these proposals on the Promoting Interoperability ASM performance category measures and objectives, including our proposal to add, remove, or modify measures in the Promoting Interoperability ASM performance category through rulemaking but to align with the MIPS technical specifications without rulemaking.

We received public comments on these proposals. The following is a summary of the comments we received related to the Promoting Interoperability ASM performance category measures and objectives and our responses.

Comment: A commenter recommended suppressing the Electronic Case Reporting measure in ASM to avoid confusion, as it was also proposed for suppression in the QPP program.

Response: We appreciate the commenter for their recommendation. The CY 2026 PFS proposed rule (90 FR 32734 through 32736) included a proposal to suppress the Electronic Case Reporting measure for the CY 2025 performance year and the EHR reporting period in CY 2025 in MIPS due to the Centers for Disease Control and Prevention temporarily pausing electronic case reporting registration and onboarding of new health care organizations to establish a more efficient and automated process. This is not currently applicable to ASM given ASM's first performance year is not until 2027. That being said, we will continue to monitor updates to this measure as ASM's first performance year approaches with the goal of continuing to maintain alignment with the MIPS Promoting Interoperability performance category where possible and we may propose changes to this measure in ASM in the future.

Comment: A commenter supported the proposed approach to align the requirements for the Promoting Interoperability ASM performance category with MIPS requirements. The commenter expressed concerns with the requirement to report all Promoting Interoperability measures at the TIN/NPI level, noting that measures and objectives are coordinated at a facility level and reporting at the individual level does not provide useful information. Another commenter supported a group reporting approach so that an ASM participant can “count” a clinical action taken by another clinician in their group towards a PI measure. The commenter acknowledged that this is appropriate since the patient's care is managed within the same TIN, and requiring clinicians to repeat clinical actions at the individual level would be duplicative, increase burden, and potentially cause confusion for patients.

Response: We appreciate the commenters for their support and appreciate the commenters' suggestions on TIN-level reporting for Promoting Interoperability measures in ASM. We agree that TIN-level reporting may be less burdensome to clinicians and could better capture team-based activities and investments in infrastructure; this could result in more streamlined workflows and potentially less confusion for clinicians and patients. As discussed in section III.C.2.d.(1).(b) of this final rule, we are finalizing Promoting Interoperability ASM performance category requirements to be fulfilled by ASM participants via TIN-level reporting.

Comment: A commenter supports the policy where any future changes to the Promoting Interoperability ASM performance category should be made through a notice and comment rulemaking process. The commenter supports consistency in methodology across programs but notes there may be certain circumstances that would warrant differences in policy across programs and at a minimum, notice and rulemaking would provide the appropriate awareness for model participants to know in advance which changes may be made year to year in methodology.

Response: We appreciate the commenters for their support for adopting changes to the Promoting Interoperability ASM performance category objectives and measures through notice and comment rulemaking. We agree this would give advanced notice to ASM participants and would allow ASM to add, remove, or modify any objectives or measures that may be less aligned with ASM's goals, due to operational considerations, or for other reasons. We want to clarify, as discussed in section III.C.2 d.(5)(c)(iii) of this final rule, that updates to the technical specifications made in MIPS for these objectives and measures would be adopted without notice and comment rulemaking in ASM. This allows ASM to align in a real-time manner with the most up-to-date technical versions of these measures and promote standardization across Promoting Interoperability programs. ASM would rely on the technical expertise across other programs involved in maintaining these measures and avoid duplicating those efforts. Therefore, we are not finalizing our alternative proposal to adopt changes to the technical specifications of ASM's Promoting Interoperability measures through rulemaking.

Comment: A commenter recommended maintaining the same measure set for the entire duration of the model for the Promoting Interoperability ASM performance category. The commenter noted that this could reduce the administrative burden for ASM participants and strengthen the reliability of longitudinal assessments of measures by ensuring consistent methodology over time.

Response: We appreciate the commenter for the suggestion. While we also support burden reduction and robust longitudinal assessments where possible, we disagree that we must maintain the same measure set for the Promoting Interoperability ASM performance category for the entire duration of ASM. We recognize the importance of alignment and consistency, particularly when it comes to operationalizing measure reporting, and thus, we decided to adopt existing MIPS Promoting Interoperability objectives and measures in ASM as opposed to requiring ASM participants to implement new measures. That being said, as discussed in section III.C.2.d.(5)(c)(iii), we believe we need a process to add, remove, or modify the objectives and measures to ensure the performance category requirements continue to align with ASM's goals and give us flexibility to be able to respond to feedback and concerns from internal and external interested parties as well as account for any evolving circumstances.

After consideration of public comments, we are finalizing our proposal without modification that an

ASM participant must comply with reporting requirements for each measure at Sec. 512.740(b)(3)(i) and report on the Promoting Interoperability objective and measures specified by CMS to assess performance in the Promoting Interoperability ASM performance category at Sec. 512.740(b)(2), including the objectives and measures at Sec. Sec. 512.740(b)(2)(i) through (iv): Electronic Prescribing, HIE, Provider to Patient Exchange, and Public Health and Clinical Data Exchange. (iv) Supporting Use of CEHRT

ASM aims to support the electronic exchange of health information using CEHRT to improve patient care and coordination of care.

We proposed at Sec. 512.740(b)(4)(i)(A)(1) and (2) that the ASM participant support use of CEHRT by providing acknowledgement of the requirement to cooperate in good faith with ONC direct review of the ASM participant's health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC direct review is received; and if requested, cooperate in good faith with ONC direct review of the ASM participant's health information technology certified under the ONC Health IT Certification Program as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by the ASM participant in the field. Furthermore, we proposed at Sec. 512.740(b)(4)(i)(B) that an ASM participant has the option to attest to the following objectives and measures: at Sec. 512.740(b)(4)(i)(B)(1) that the ASM participant acknowledges the option to cooperate in good faith with ONC-ACB surveillance of his or her health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC-ACB surveillance is received; and at Sec. 512.740(b)(4)(i)(B)(2) if requested, that the ASM participant cooperate in good faith with ONC-ACB surveillance of the ASM participant's health information technology certified under the ONC Health IT Certification Program as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by the ASM participant in the field. These proposals (90 FR 32596) to support physicians with the performance of CEHRT aligns with requirements of the MIPS program as finalized at Sec. 414.1375(b)(3)(i) through 414.1375(b)(3)(i)(B)(2).

We solicited comments on our policies supporting the use and performance of CEHRT via affirmative attestation to cooperating with the ONC direct review process. We did not receive public comments on this provision, and therefore, we are finalizing as proposed at Sec. 512.740(b)(4)(i). (d) Alternatives Considered for the Promoting Interoperability Reporting Requirements

CY 2026 PFS proposed rule (90 FR 32593 through 32597), we considered alternatives for the Promoting Interoperability reporting requirements. Our proposals mostly aligned with reporting requirements for the Promoting Interoperability performance category with the MIPS program for multiple reasons. Aligning with MIPS Promoting Interoperability objectives and measures where appropriate promotes standardization across CMS and its programs. Measure alignment can also reduce confusion, burden, and operational complexity for ASM participants by limiting the need for ASM participants to implement different specifications for potentially similar or related measures. Furthermore, the MIPS Promoting Interoperability measure set has been stable for several years and has been successfully reported in MIPS by most of its participants. Therefore, we do not believe it would be an undue burden for ASM participants to continue reporting these measures, particularly given they support the goals of ASM.

As discussed in the CY 2026 PFS proposed rule (90 FR 32596), in our first alternative, we considered requiring reporting for CEHRT attestation, the ONC direct review Attestation, the Security Risk Assessment Measure, and the High Priority Practices Guide of the SAFER Guides Measure; each of these items is required in MIPS to get a Promoting Interoperability performance category score greater than zero. This option would not require specific reporting of other Promoting Interoperability measures.

We also considered a second alternative that would require the attestations in the first alternative as well as reporting one of the Health Information Exchange options. We believe this option would emphasize the importance of exchanging health information seamlessly to the ASM.

A third alternative we considered was to adopt, by reference, the provisions of MIPS for the PI category, including both the measures and scoring policies. We also considered deferring the PI category measures within ASM to the PI category within MIPS such that the ASM would automatically update to align with MIPS for each future ASM performance year. Aligning with the PI category within MIPS would reduce complexity for ASM participants, especially those who have been participating in MIPS. While we believe this would limit confusion and align objectives across CMS, we decided that this could introduce risk to ASM insofar changes to the PI category could be introduced in MIPS that may not align with ASM's goals and priorities; in these cases, ASM could consider not adopting or delaying adoption of these changes. We believe that maintaining the PI category in ASM through rulemaking would be the better approach; however, we invite comment on the merits of ASM deferring measure selection and scoring to the MIPS PI category.

A fourth alternative we considered was 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 solicited comments on our alternatives, including only requiring attestations related to CEHRT use (without or without the Health Information Exchange objective), adopting the PI category in MIPS in its entirety, and developing new Promoting Interoperability measures specific to ASM

We received public comments on these proposals. The following is a summary of the comments we received on alternative requirements for the Promoting Interoperability ASM performance category and our responses.

Comment: A few commenters supported the alternative to only require attestations related to CEHRT. A commenter recommended that ASM should be focused on improving quality of care and outcomes for heart failure and lower back pain patients, noting concern that requiring the full MIPS Promoting Interoperability performance category scoring and measure policies would detract from ASM's primary goals.

Response: We appreciate the commenters for their support of this alternative proposal. While we recognize that only requiring the CEHRT- related attestations helps alleviate reporting burden, not requiring reporting of the Promoting Interoperability objectives and measures results in this performance category becoming less meaningful. We disagree that these measures detract from ASM's goals, one of ASM's primary goals is to improve primary and specialty care integration which requires advancing interoperability, whether it be through use of a Health Information Exchange or e-prescribing or sharing electronic data securely with patients or public health agencies. We believe it is also important to capture performance related to health IT beyond CEHRT use only. Given that we are aligning with existing MIPS measures that have been stable and successfully reported in the past by the majority of their participants, many of whom will be ASM participants, we believe this will limit the burden associated with implementing new or different Promoting Interoperability measures. Therefore, we are not finalizing the alternative proposals to only require reporting of CEHRT and CEHRT-related attestations, including with and without the Health Information Exchange objective.

Comment: A few commenters shared recommendations on this proposal to develop new measures specific to ASM in the Promoting Interoperability performance category. A commenter suggested CMS include metrics in ASM that support sharing information with pharmacists and ensure all clinicians have access to CEHRT for seamless data exchange. Another commenter recommended developing specific Promoting Interoperability measures related to heart failure and low back pain, and measures that enhance interoperability. A commenter expressed concern that the MIPS measures are too limiting, especially given CEHRT is already widely in use, and that it could unintentionally discourage adoption of remote patient monitoring or telemedicine tools, noting that patient engagement and interoperability are vital for value-based care and suggested that information blocking and HIPAA regulations offer more meaningful incentives.

Response: We appreciate the commenters for their support of the proposal to develop new Promoting Interoperability measures. We believe the e-prescribing and Health Information Exchange objectives described in section III.C.2.d.(5).(c).(ii) of this final rule help support and capture information sharing with pharmacists. ASM also incentivizes the adoption of CEHRT by ASM participants by requiring it to achieve a score greater than zero in the Promoting Interoperability ASM performance category, as discussed in section III.C.2.d.(5).(c).(i) of this final rule; this aligns with other CMS programs and can help increase systemic adoption of CEHRT. ASM seeks to complement other regulatory requirements, such as HIPAA, including any of its incentives. While we recognize there may be opportunities to develop and implement more condition-specific Promoting Interoperability measures, we believe the finalized measure set at Sec. 512.740(b)(2) captures performance for a set of baseline interoperability functions that are applicable to all ASM participants caring for beneficiaries with heart failure and low back pain without imposing undue burden on them. New measure implementation is resource intensive, and we are concerned that some ASM participants may face operational challenges and that those with fewer resources may be at a disadvantage. That being said, ASM participants can consider adoption of additional technologies, such as remote monitoring or telemedicine tools, beyond these measures, and we may consider additional incentives or measures related to this in the future. However, due to concerns related to operationalizing new measure development and increased ASM participant burden, we are not finalizing this alternative proposal to require reporting of new Promoting Interoperability measures in ASM.

Comment: A few commenters supported adopting the full MIPS Promoting Interoperability category and its scoring policies for ASM, including applying any future updates to the category throughout the model's performance years.

Response: We appreciate the commenters for their support of this alternative proposal. While we recognize that adopting the full MIPS Promoting Interoperability category in ASM can streamline reporting and promote standardization, it does not provide any flexibility for the model to tailor requirements to ensure they align with ASM's goals and priorities, including the deviations introduced in section III.C.2.d.(5) of this final rule. This includes situations where there are changes in the future to the MIPS category that are less applicable to ASM participants or other features specific to ASM participants (and less relevant to MIPS) that ASM may want to introduce. As a result, we are not finalizing this alternative proposal to adopt the full MIPS Promoting Interoperability category, by reference, into ASM.

After consideration of public comments, we are not finalizing any of these alternative proposals related to Promoting Interoperability ASM performance category requirements (e) Promoting Interoperability ASM Performance Category Scoring

We proposed at Sec. 512.740(c)(1) an ASM participant earns a score for each measure by fulfilling the reporting requirements specified at Sec. 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, as specified in Table B-D6. We proposed at Sec. 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 B-D6 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's priorities, for example, with more measure achievement points assigned to the Health Information Exchange category compared to the others.

As stated earlier in section III.C.2.d.(5).(ii) 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. In the CY 2026 PFS proposed rule (90 FR 32597), we discussed 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 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 proposed at Sec. 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 Sec. 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).(c)of this final rule, 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 Sec. 512.745(a)(1)(iv).

In the CY 2026 PFS proposed rule (90 FR 32597), we considered automatically applying a score of zero for an ASM participant's Promoting Interoperability performance score for any ASM participant who did not achieve full points on the Promoting Interoperability performance category. However, we recognized 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 final rule. The concepts represented in these Promoting Interoperability requirements support ASM participants in improving patient care while maintaining or lowering cost of care.

In the CY 2026 PFS proposed rule (90 FR 32597), we did not propose any exceptions for the Promoting Interoperability ASM performance category requirements. CMS has established automatic reweighting criteria of the Promoting Interoperability category in MIPS at Sec. 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 Sec. 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 who meets automatic reweighting criteria does not submit Promoting Interoperability data. Due to ASM's participant selection criteria (see section III.C.2.c.(3). of this final rule), many ASM participants, except for those in small practices with 15 or fewer clinicians, will 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 adjusting their final scores as described in section III.C.2.e.(4) of this final rule and allowing for flexibility for reporting quality measures at the TIN-level as detailed in section III.C.2.d.(1).(b) of this final 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 ASM participants.

Lastly, we proposed an Extreme and Uncontrollable Circumstances policy at Sec. 512.780 and discussed in section III.C.2.i. of this final rule, but we did not propose to include a Promoting Interoperability-specific hardship application in ASM in the CY 2026 PFS proposed rule (90 FR 32597) 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 only a few practices may receive.

We sought comments on these proposals to score the Promoting Interoperability ASM performance category.

We received public comments on these proposals. The following is a summary of the comments we received related to scoring the Promoting Interoperability ASM performance category and our responses.

Comment: A few commenters did not support the proposal to exclude bonus points for optional measures. A commenter recommended that CMS should allow ASM participants to be eligible for the same bonuses awarded for these measures in the MIPS program, noting their relevance for patients with chronic diseases such as HF. Another commenter shared their belief that awarding bonus points to facilities submitting data to Public Health Registries is essential for closing data gaps in rural communities and may encourage more EHR vendors to certify modules for these measures.

Response: We appreciate the commenters for their suggestions. While we recognize the role of the Public Health and Clinical Data Exchange measures in public health reporting and are thus, requiring two measures and allowing for reporting of the optional measures, we disagree that these optional measures should be incentivized in ASM by rewarding ASM participants bonus points for reporting. As discussed in section III.C.2.d.(5).(e) of this final rule, these measures are less relevant to the direct care being delivered by the ASM participant to beneficiaries with heart failure and low back pain. For example, the Public Health Registry Reporting optional measure includes reporting data on cancer and antimicrobial use and resistance,\282\ which are clinical areas in which the majority of ASM cardiologists and ASM low back pain specialists are unlikely to spend large portions of their time working in; this would not be the case if ASM participants included oncologists and infectious disease specialists. Furthermore, we want to emphasize that the focus of ASM is on the outpatient setting and would encourage facilities and hospitals to continue to submit this data and receive bonus points as part of their participation in our other Promoting Interoperability programs, including for eligible hospitals and critical access hospitals (CAHs) located in rural areas. In addition, we are concerned that awarding bonus points for this category deprioritizes other goals in ASM that we are trying to actively incentivize, such as improved collaboration with primary care through interoperability and advancing patient outcomes through communicating via a patient portal or e-prescribing medications. As a result, we are not finalizing the inclusion of bonus points for reporting optional public health measures in ASM.

\282\ Centers for Disease Control. “Public Health Registries Reporting.” Published December 17, 2024. https://www.cdc.gov/data-interoperability/php/about/public-health-registries-reporting.html. Accessed October 02, 2025.

Comment: A few commenters recommended that CMS include MIPS special status designations and exceptions in the Promoting Interoperability ASM policies. Several commenters did not support the proposal to not apply a Promoting

Interoperability hardship exception in ASM. A few commenters expressed concern that a lack of an exception could lead to inappropriate penalization of certain clinicians, such as anesthesiologists; may prevent clinicians from meeting Promoting Interoperability ASM requirements; may undermine the objectives of the model; would create misalignment between ASM and MIPS; and could result in clinicians not accepting Medicare patients.

Response: We appreciate the commenters for their feedback. While not implementing the automatic weighting criteria and hardship application in ASM is a deviation from MIPS, we disagree they are needed in ASM. We believe that many of the MIPS criteria related to automatic reweighting and hardship exceptions would not be applicable to ASM participants as defined by our participant criteria discussed in sections III.C.2.c.(2) and III.C.2.c.(3) in this final rule. For example, as part of the EBCM methodology, a specialist with a relevant specialty type would have needed to have billed 30 percent of triggering or confirming codes on Part B Physician/Supplier claim lines related to the ASM condition for the beneficiary in addition to having at least 20 EBCM episodes attributed to them to participate in ASM. Therefore, the majority of physicians who are non-patient-facing or facility-based or ASC-based, such as anesthesiologists only working in the Operating Room, and who would have been considered for automatic reweighting in MIPS will likely not meet participation criteria for ASM as outlined in sections III.C.2.c.(2) and III.C.2.c.(3) in this final rule. Meanwhile, ASM participants working in small practices with 15 or fewer clinicians, who would receive automatic reweighting in MIPS, will receive a small practice scoring adjustment in ASM to try to prevent inappropriate penalization, as described in section III.C.2.e.(4) of this final rule; ASM participants in small practices will also receive flexibility to report quality measures in the quality ASM performance category at the TIN-level as discussed in section III.C.2.d.(1).(b) of this final rule, which can help reduce burden.

We disagree that lacking a hardship exception (as operationalized in MIPS) would undermine ASM's goals. ASM will enforce an Extreme and Uncontrollable Circumstances policy at Sec. 512.780 (and discussed in section III.C.2.i. of this final rule), which will account for weather disasters and other circumstances that would be covered under a MIPS Promoting Interoperability hardship exception. ASM otherwise aims to incentivize adoption of CEHRT and promote interoperability and we believe that offering a hardship exception--which had very low uptake historically amongst MIPS clinicians that would have met ASM participation criteria (as discussed in section III.C.2.d.(5).(e) of this final rule)--undermines that goal. Given CEHRT helps enable success in other ASM performance categories, such as reporting quality data or performing care coordination with primary care, we believe it is important that ASM participants meet, rather than be exempted from, the Promoting Interoperability ASM performance category requirements.

After consideration of public comments, we are finalizing our proposal without modification for scoring the Promoting Interoperability ASM performance category at Sec. 512.740(c). e. Final Score Methodology

In this section, we proposed 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 proposed to define at Sec. 512.705 “final score” to 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 performance standards for applicable measures and activities for each ASM performance category as described in Sec. 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 final rule, we proposed 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 proposed 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 proposed at Sec. 512.745(a) to calculate a final score of zero to 100 points using the formula we proposed in section III.C.2.e.(5) of this final rule and specified at Sec. 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 final rule and specified at Sec. 512.745(a)(2). We proposed policies to determine scores for the ASM performance categories in sections III.C.2.d.(2) through III.C.2.d.(5) of this final 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 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 final 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 proposed at Sec. 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 proposed 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 improvement activities and Promoting Interoperability ASM performance category scoring adjustments are described in Table B- D7.

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We proposed 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.

We also proposed 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 final 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 final 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 proposed at Sec. Sec. 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 activities and Promoting Interoperability ASM performance categories. We proposed at Sec. 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 proposed at Sec. 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 activities) would receive an improvement activities ASM performance category scoring adjustment of negative 10 points to the final score specified at Sec. 512.745(a). We proposed at Sec. 512.745(a)(1)(iii)(C) that ASM participants that receive a zero percent improvement activities ASM performance category score would receive an improvement activities ASM performance category scoring adjustment of negative 20 points to the final score specified at Sec. 512.745(a). The maximum improvement activities ASM performance category scoring adjustment would be negative 20 points.

To determine the Promoting Interoperability performance category scoring adjustment, we proposed at Sec. 512.745(a)(1)(iv)(A) and (B) that we would multiply the Promoting Interoperability ASM performance category score by 100 then subtract that product from 100 and divide by the maximum negative Promoting Interoperability ASM performance category scoring adjustment of 10 points. The maximum Promoting Interoperability ASM performance category scoring adjustment would be negative 10 points. For example, if an ASM participant's Promoting Interoperability ASM performance category score was 73 percent, we would multiply 73 percent by 100, subtract 73 from 100 and divide the score by the maximum negative Promoting Interoperability ASM performance category scoring adjustment of 10, resulting in a negative Promoting Interoperability ASM performance category scoring adjustment of 2.7 points.

We considered weighting all the ASM performance category scores to determine a final score instead of proposing the scoring adjustments for the improvement activities and Promoting Interoperability ASM performance category scores. Under this alternative, we considered the following ASM performance category weights to calculate the final score when there is no reweighting: (1) quality 30 percent; (2) cost 30 percent; (3) improvement activities 25 percent, and (4) Promoting Interoperability 15 percent. For similar reasons discussed earlier in this section of this final rule, we believe that increasing the weight on the improvement activities and decreasing the Promoting Interoperability ASM performance category weights relative to performance category weights in MVPs as defined at Sec. 414.1365(e)(1) would increase the incentive to achieve the desired aims of improved primary care and specialty care integration under ASM. We believe that the improvement activities would be important to meet ASM's goal of better integrating specialty and PCPs as described in section III.C.2.d.(4) of this final rule. Ultimately, we believe that the proposed ASM performance category weights and scoring adjustments, as discussed earlier in this section of this proposed rule, would overcome the potential challenges in determining meaningful payment adjustments if final scores were clustered around a small range of performance scores.

We also considered using the same ASM performance category weights used by the Quality Payment Program to score performance categories in MVPs as defined at Sec. 414.1365(e)(1) but without the potential for reweighting as defined at Sec. 414.1365(e)(2) (89 FR 98345). As defined at Sec. 414.1365(e)(1), MVPs use the following performance category weights to calculate the final score when there is no reweighting: (1) quality 30 percent; (2) cost 30 percent; (3) improvement activities 15 percent; and (4) Promoting Interoperability 25 percent. We believe that the improvement activities ASM performance category's goal of integrating specialty managed care with primary care specialists is central to ASM's larger goal. Therefore, a higher weight should be given to the

improvement activities ASM performance category over the Promoting Interoperability ASM performance category.

We believe weighting the quality and cost performance categories at 50 percent more accurately assigns points in support of ASM's goals. With regards to the negative scoring adjustments, the improvement activities ASM performance category's goal of integrating specialty managed care with primary care specialists is central to ASM's larger goal. Therefore, a higher number of potential negative scoring adjustment points should be given to ASM participants that do not meet requirements of the improvement activities ASM performance category over the Promoting Interoperability ASM performance category.

We solicited comments on our proposed ASM performance category weights and scoring adjustments as proposed at Sec. 512.745(a)(1) and the alternative ASM performance category weights we considered in this final rule.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters did not support CMS' proposal to score ASM participants exclusively on the quality and cost performance with equal weighting of 50 percent for each. A few commenters noted that CMS proposed to score specialists on quality and cost measures that only a few report, some of which their registries do not report. A few commenters noted that shifting individual clinicians into a model where 100 percent of scoring rests on quality and cost for a small ASM heart- failure cohort is a sharp departure from prior MIPS and MVP scoring, while also noting the low adoption rate of MVPs and need to better support clinicians transition to value-based care.

Response: We appreciate the commenters for their feedback on our scoring proposals. However, we disagree and believe that weighting the quality and cost ASM performance categories at 50 percent, respectively, properly distributes ASM participants' final scores to create meaningful ASM payment adjustments. We note that all cost and quality measures being finalized for use in ASM at this time are already reportable under MIPS. Creating like-to-like comparisons between similar providers requires participants to report on the same measures related to the same condition. We also acknowledge the commenters' desire for the ASM performance category weights and reweighting policy to match MIPS policies. Although we recognize that including the improvement activities and Promoting Interoperability ASM performance categories as scoring adjustments is different from MIPS, it is important to note that our scoring policy is not solely based on performance on the cost and quality categories. Cost and quality weights supplemented by zero or negative scoring adjustments from performance on the improvement activities and Promoting Interoperability performance categories are still used to determine an ASM participant's final score. We also believe that starting the model in CY 2027 gives appropriate time for ASM participants to begin adopting the right reporting mechanisms and registries to properly participate in ASM and overcome the low adoption rate of MVPs amongst certain specialties, which we note is a voluntary reporting option under the Quality Payment Program.

Comment: A few commenters offered recommendations regarding the proposed weighting of the ASM performance categories. The commenters recommended that CMS lower the ASM cost category weight to 30 percent initially and phase in increases gradually over time, using a reasonable year-over-year glidepath to limit large swings. Another commenter recommended that all ASM performance categories should be linked to quality improvement, not solely cost. Additionally, a commenter recommended that CMS ensure alignment between cost and quality scoring to ensure that they accurately reflect outcomes and improvement.

Response: We appreciate the commenters' suggestions on the weighting of the cost ASM performance category and improvement scoring. However, we disagree that weighting the ASM cost performance category at 30 percent and incrementally raising it over time would reward the right behaviors. We want to reward participants for performance on lowering spending related to unnecessary or low-value services, and we believe a 30 percent weight creates an inadequate incentive to improve cost performance; therefore, we believe that a glidepath to a larger cost ASM performance category weight is unnecessary. All ASM performance categories directly contribute to an ASM participant's final score. We did not consider directly aligning cost and quality scoring because our cost and quality measures are aligned and accurately reflect outcomes and improvements in quality and spending.

Comment: Several commenters expressed concern that the proposed cost category weighting of 50 percent would inappropriately overemphasize the cost category. A few commenters noted that as proposed, a single EBCM would constitute 50 percent of the ASM participant's final score. A few commenters expressed concern that the proposed cost category weight, coupled with potential negative adjustments for the improvement activities and Promoting Interoperability ASM performance categories, would undermine quality improvement and run the risk of incentivizing cost-cutting over clinical quality. A few commenters expressed concern that the proposal would also inadvertently penalize providers delivering necessary, appropriately higher cost care. The commenters also shared their belief that the proposed cost category weighting could lead clinicians to avoid managing complex, high-acuity patients, and avoid resource- intensive but clinically appropriate settings like hospitals (including rural and critical access facilities); such shifts in care could disadvantage clinicians serving patients from communities with lower incomes or have negative upstream influences on beneficiaries' health.

Response: We appreciate the commenters for their feedback on the weighting of the cost ASM performance category. However, we disagree and believe that weighting the cost category at 50 percent appropriately emphasizes participant's incentives to work to lower costs by identifying ways to reduce the provision of unnecessary or low-value services. As noted earlier in this section of this final rule, though the cost category and the applicable EBCM score compose 50 percent of an ASM participant's final score, their score receives potential neutral or downward adjustments depending on a participant's performance in the improvement activities and Promoting Interoperability performance categories. Those potential downward adjustments amount to 30 negative downward adjustment points, further stressing to participants that activities beyond reducing spend in the ASM cost performance category affect scoring. We stress that the EBCM's risk adjustment methodology accounts for patient acuity and complexity. The cost category weight would not penalize providers delivering necessary, higher cost care because the EBCM's risk adjustment methodology ensures that cost comparisons are not raw cost versus other physicians' costs. Rather, ASM participants risk standardized costs versus their peers' costs treating similar patients. The EBCM risk adjustment methodology uses clinical factors such

as age, comorbidities, recent hospitalizations and other relevant conditions to standardize costs. Additionally, the EBCMs are structured so that if a provider inappropriately avoids admitting a patient to a clinically appropriate setting, such as a hospital, the patient is likely to eventually require an even costlier admission, ultimately driving up total episode costs. For these reasons, we believe that the use of a clinically relevant EBCM and the weighting of the cost ASM performance category would create an appropriate incentive to improve upstream chronic condition management to avoid costlier downstream services that would be attributed to an ASM participant through the EBCM attribution methodology.

Comment: A few commenters did not support the proposed ASM performance category scoring adjustments for Promoting Interoperability and improvement activities. The commenters recommended that clinicians have the opportunity to earn points towards their ASM final score based on their performance across all four performance categories, similar to their scoring under MIPS. A few commenters recommended that CMS allow for only positive scoring or credit in the improvement activities and Promoting Interoperability ASM performance categories, rather than a neutral or reduced score. The commenters expressed concerns that the proposed scoring structure would create a structure that is punitive rather than supportive and could discourage participation in improvement activities and Promoting Interoperability, thus undermining the value of these activities while failing to promote comprehensive performance improvement. Additionally, commenters believe clinicians who exceed expectations in the improvement activities and Promoting Interoperability ASM performance categories should be rewarded, not penalized, especially since performance improvement takes time.

Response: We recognize the commenters' concerns regarding improvement activities and Promoting Interoperability ASM performance categories functioning solely as neutral or negative scoring adjustments as opposed to MIPS and MVPs where all performance categories contribute positively towards a participant's score. However, we disagree with the comment that this weighting approach is inappropriate for calculating ASM participants' final scores. We proposed applying weights only to the quality and cost categories, while leaving the improvement activities and Promoting Interoperability ASM performance categories unweighted to broaden the distribution of final scores. Historically, high improvement activities and Promoting Interoperability performance would make it difficult to distinguish scores because many participant's scores would be grouped in the upper quarter or even decile of the scoring range. We believe the proposed policy provides sufficient recognition for high-performing providers, especially since participants are evaluated relative to peers rather than against a predetermined performance threshold while also establishing a fairer basis for payment adjustments.

Comment: A few commenters supported the alternative using MIPS performance category weights in ASM, weighting all the four ASM performance categories. Additionally, a commenter suggested that both improvement activities and Promoting Interoperability performance categories should be weighted in alignment with MIPS policies to contribute positively to the overall score and offer opportunities for bonus points. A commenter also suggested CMS to more closely align the proposed ASM reweighting of the performance categories with MIPS policy. Another commenter encouraged CMS to align its scoring policies with traditional MIPS, APM Performance Pathway or MVP scoring policies.

Response: We recognize the commenters' desire for the ASM performance category weights and reweighting policy to match those used in MIPS. However, we believe the weights and corresponding adjustments for the improvement activities ASM performance category better suit ASM's stated goal of integrating specialty managed care with primary care specialists. To incentive that integration, weighting the improvement activities ASM performance category higher than the Quality Payment Program's 15 percent weight as defined at Sec. 414.1365(e)(1) is necessary. We also believe that our reweighting policy, though different from MIPS, meaningfully promotes the goals of the Promoting Interoperability category and aligns with CMS' broader efforts to move towards CEHRT adoption.\283\ Though we appreciate the commenters' feedback that different reporting requirements for MIPS, APM Performance Pathway, MVP scoring policies and ASM may add additional reporting burdens, we believe it necessary to weight and measure as proposed to create sufficient performance and payment incentives to achieve ASM's objectives.

\283\ https://www.cms.gov/medicare/regulations-guidance/promoting-interoperability-programs.

Comment: A few commenters did not support the proposed 20-point maximum negative adjustment for the improvement activities ASM performance category. The commenters expressed concerns that as proposed, the ASM scoring policies for the improvement activities performance category would be burdensome for specialists who would be required to enter into formal CCAs with a primary care physician and would act as a disproportionately punitive policy rather than one that encourages quality or performance improvement. A commenter expressed concern that the proposed scoring adjustment policy may indicate to clinicians that the improvement of activities performance category is not meaningful.

Response: We appreciate the comments regarding the proposed 20- point maximum negative adjustment for the improvement activities performance category under the ASM final scoring methodology. However, because participants are evaluated relative to their peers rather than against an arbitrary threshold, we disagree that this policy is punitive and believe that it encourages the increased engagement between PCPs and specialists that we seek to achieve through ASM. We refer readers to section III.C.2.d.(4) of this final rule for further discussion on the CCA requirements related to the improvement activities ASM performance category. We also note that the improvement activities maximum negative scoring adjustment of 20 points is larger in relative magnitude than in MIPS, in which the improvement activities score contributes 15 percent to the participant's final score as defined at Sec. 414.1365(e)(1). The larger magnitude of adjustment under ASM emphasizes the importance of improvement activities ASM performance category is to an ASM participant's successful performance.

Comment: A few commenters recommended that CMS adopt a policy allowing performance on improvement activities to contribute positively to the ASM final score.

Response: We recognize the commenters' concerns that the improvement activities ASM performance category does not yield a positive effect to the participant's final score. However, we disagree with the commenters that the negative scoring adjustment for the improvement activities category is appropriate for the model. We proposed applying weights

only to the quality and cost categories, while scoring the improvement activities and Promoting Interoperability categories as negative scoring adjustments to broaden the distribution of final scores so that we could make more meaningful performance comparisons of ASM participants. If the improvement activities and Promoting Interoperability ASM performance categories were weighted similarly to MIPS, contributing only positively to the ASM final score, historically high performance in these categories would lead to clustering of final scores within a small range. By giving greater weight to the cost and quality ASM performance categories we can better differentiate performance and operationalize a wider range of payment adjustments.

Comment: A few commenters did not support the ASM final score proposal for calculating the ASM Promoting Interoperability negative adjustment and provided recommendations about scoring the Promoting Interoperability ASM performance category. A few commenters noted the ability to only earn points for cost and quality categories, interoperability measures at best maintain a neutral score and at worst a 20 percent reduction, indicating these measures are not valued. A commenter recommended that Promoting Interoperability ASM performance category should contribute positively to the final score. A commenter recommended adopting the threshold to 80 points to avoid a reduction and align with the 2026 IPPS Medicare Interoperability Program.

Response: We appreciate the commenters for their feedback. However, we disagree and believe that applying weights only to the quality and cost categories, while scoring the improvement activities and Promoting Interoperability categories as potential negative scoring adjustments creates the right incentives for ASM participants to meet these categories' requirements while allowing for meaningful comparisons of performance. If the improvement activities and Promoting Interoperability categories were weighted similarly to MIPS, contributing only positively to the ASM final score, historically high performance in these categories would lead to clustering of final scores around a small range of final scores. By giving greater weight to the cost and quality performance categories we can better differentiate performance and operationalize a wider range of payment adjustments. We disagree that our scoring policy indicates that Promoting Interoperability is not valued. ASM participants would need to perform well on all ASM performance categories to receive high final scores. We appreciate the commenters for their proposed approach to scoring the Promoting Interoperability category with a threshold at 80 points. However, we disagree with the commenters because the Promoting Interoperability performance threshold of 80 points in the FY 2026 IPPS Medicare Interoperability Program (90 FR 37056) is designed with hospitals as the participants, not individual clinicians. Because a differentiation in participant performance is key to the successful implementation of ASM, a predetermined cutoff could potentially restrict the range of participant scores negating the intended effects of the negative scoring adjustments for the Promoting Interoperability ASM performance category.

After consideration of public comments, we are finalizing our proposed provisions on ASM performance category weights and scoring adjustments as proposed at Sec. 512.745(a)(1). We did not receive specific comments on our proposed definition of “final score,” so we are finalizing it as proposed at Sec. 512.705. (2) Requirements To Receive a Final Score (a) Determining a Final Score When an ASM Participant Meets or Does Not Meet Minimum Data Submission Requirements

We proposed at Sec. 512.745(a)(2) that we would determine whether an ASM participant is eligible to receive a final score for the applicable ASM performance year depending on the data submitted by the ASM participant. We proposed at Sec. 512.745(a)(2)(i) that ASM participants who meet the data submission requirement for the quality ASM performance category as proposed at Sec. 512.725(a)(1)(i) and receive quality and cost ASM performance category scores would receive a final score greater than zero but not exceeding 100 for the applicable ASM performance year. These ASM participants would receive a payment adjustment based on the methodology in section III.C.2.f of this final rule. We proposed at Sec. 512.745(a)(2)(ii) that ASM participants who do not meet the data submission requirement for the quality ASM performance category as proposed at Sec. 512.725(a)(1)(i) would receive a final score of zero for the applicable ASM performance year. As discussed in section III.C.2.f of this final rule, these ASM participants would be subject to the maximum negative payment adjustment for the applicable ASM payment year. We also note that an ASM participant's final score may also be affected if the ASM participant is affected by an eligible extreme and uncontrollable circumstance during an ASM performance year as discussed in section III.C.2.i of this final rule. We refer readers to section III.C.2.e.(2).(b) later in this section of this final rule for proposals related to final scores when ASM participants meet the quality ASM performance category data submission requirements but do not receive a quality or cost ASM performance category score. We also refer readers to Table B-D8 later in this section of this final rule for a summary of the proposed final score policies and their impact on payment adjustments.

As we proposed ASM to be a mandatory model, we believe that we must set a minimum data submission requirement for an ASM participant to meet or otherwise be subject to the maximum negative payment adjustment as discussed in section III.C.2.f of this final rule. We believe that our proposed minimum data submission requirement is reasonable because it requires that an ASM participant reports at least one non- administrative claims-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 final rule.

We solicited comments on our proposed requirements at Sec. 512.745(a)(2)(i) to calculate a final score for ASM participants and our proposal at Sec. 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.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter supported the proposal that ASM quality data is required for at least one quality measure for an ASM participant to receive a final score.

Response: We appreciate the commenter for their support of the proposal.

After consideration of public comments, we are finalizing at Sec. 512.745(a)(2)(i) the requirements to receive a final score for ASM participants as proposed and we are finalizing at Sec. 512.745(a)(2)(ii) our proposal that an ASM participant who does not meet these requirements would receive a final score of zero for the applicable ASM performance year as proposed. (b) Not Determining a Final Score When an ASM Participant Cannot Be Scored on the Quality or Cost ASM Performance Category

At Sec. 512.745(a)(2)(iii), we proposed that ASM participants who meet the data submission requirement for the quality ASM performance category as proposed at Sec. 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 final 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 final 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 final 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 final rule, based on that final score for the applicable ASM payment year; otherwise, we proposed 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 final 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 final 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 final rule or does not meet the case minimum for the required EBCM as discussed in section III.C.2.d.(3).(g) of this final 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 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 final 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 minimum.

Table B-D8 summarizes the 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 final rule.

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We sought comments on our proposal at Sec. 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 sought comments on the alternative of requiring data submission for all four ASM performance categories that we considered.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter did not support CMS' proposal to avoid reweighting and instead issue neutral payment adjustments in ASM when scores cannot be generated due to case minimums or data availability. The commenter expressed concern that while this approach may reduce administrative complexity, it would limit flexibility for ASM participants. The commenter recommended that CMS allow ASM participants the opportunity to supplement with available improvement activities or Promoting Interoperability ASM scores instead.

Response: We recognize the commenters' desire to promote flexibility by allowing improvement activities and Promoting Interoperability scores to supplement for when cost and quality ASM performance category scores are unavailable. However, 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 ASM performance categories. Therefore, scoring ASM participants only on improvement activities and Promoting Interoperability performance categories would lead to extremely high scores and not accurately reflect the complex and nuanced care delivered to ASM beneficiaries. We further stress that it is essential to score a participant on both cost and quality to adequately measure participant performance. Without those two ASM performance categories as discussed earlier in this section participants would not receive an ASM payment adjustment.

After consideration of public comments, we are finalizing at Sec. 512.745(a)(2)(iii) our proposal 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 as proposed. (3) Complex Patient Scoring Adjustment

We proposed at Sec. 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 final rule. We proposed 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 proposed at Sec. 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 Sec. 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 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 Sec. 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 interested parties 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 did not propose, 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 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.\284\ 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 patients is more appropriate as it recognizes that providing excellent care for complex beneficiaries may require more physician services, resources, and capacity.\285\

\284\ https://aspe.hhs.gov/sites/default/files/private/pdf/263676/Social-Risk-in-Medicare%25E2%2580%2599s-VBP-2nd-Report-Executive-Summary.pdf.

\285\ https://aspe.hhs.gov/sites/default/files/private/pdf/263676/Social-Risk-in-Medicare%25E2%2580%2599s-VBP-2nd-Report-Executive-Summary.pdf.

Since the goal of the complex patient scoring adjustment policy in ASM is: (1) to protect access to care for complex patients and provide them with excellent whole-person care; and (2) to avoid placing ASM participants who care for complex patients at a potential disadvantage, we believe applying this complex patient scoring adjustment to the final score to determine payment adjustments is appropriate because caring for complex patients can affect all aspects of a practice, not just success in specific ASM performance categories. However, we recognize the importance of holding providers accountable for overall results, regardless of social and medical risk, and would want ASM participants to know the contribution of the complex patient scoring adjustment, if applicable, to their final score. Therefore, an ASM performance report, as discussed later in this section of this final rule, would include an ASM participant's complex patient scoring adjustment, if applicable, in addition to their final scores to ensure transparency in final score calculations.

We proposed at Sec. 512.745(a)(3)(i) that ASM participants who have at least one risk indicator (HCC risk scores and dual proportion) that is equal to or greater than the reference median for the risk indicator, described later in this section, for an applicable ASM performance year would have the complex patient scoring adjustment added to their final score for a given ASM performance year. The complex patient scoring adjustment would only be provided if the ASM participant meets the requirements to receive a final score greater than zero proposed at Sec. 512.745(a)(2)(i) and discussed in section III.C.2.e.(2). of this final rule. We note that the proposed complex patient scoring adjustment calculation methodology is similar to MIPS' complex patient bonus. However, we proposed limited methodological adjustments to better align the scoring adjustment with ASM's scoring approach.

To determine whether an ASM participant would qualify for the complex patient scoring adjustment, we proposed to calculate a reference median for each risk indicator (HCC risk score and dual proportion) for each ASM cohort and for each ASM performance year. We proposed to calculate the reference median of the ASM cohort's HCC risk scores and dual proportions using applicable data from 1 calendar year prior to the start of the applicable ASM performance year. We would only use applicable data from ASM participants that meet the data submission requirements for the quality ASM performance category for the applicable ASM performance year as described at Sec. 512.725(a)(1)(i). For example, we would calculate the reference medians for the 2027 ASM performance year using data from the 2026 calendar year. We would then calculate each risk indicator (HCC risk score and dual proportion) for each ASM participant using data from the current ASM performance year (in this example, the 2027 ASM performance year). ASM participants who have at least one calculated risk indicator for the ASM performance year that is equal to or greater than the reference median risk indicator calculated for their applicable ASM cohort would be eligible to receive the complex patient scoring adjustment. ASM participants that do not have data available to calculate either risk indicator score for an applicable ASM performance year would not be eligible to have the complex patient scoring adjustment added to their final score.

We also proposed to determine the reference median of each risk indicator separately for each ASM cohort to align

with our proposed approach to make separate performance comparisons within each of these participant cohorts. We considered determining the reference median for each risk indicator using data from data from the concurrent ASM performance year but were concerned that Medicare claims runout periods would not provide complete data to calculate these medians within an ASM performance year. This approach would mirror the method that MIPS uses in calculating the complex patient bonus under Sec. 414.1380(c)(3) with adaptations to align with the overall performance comparison approach of ASM. We also considered not requiring that an ASM participant have a median or higher value for at least one of the two risk indicators to qualify for the complex patient scoring adjustment. While this alternative would expand the number of ASM participants that would qualify for the complex patient scoring adjustment for an ASM performance, we believe targeting the complex patient scoring adjustments to ASM participants treating a higher caseload of highly complex patients would be more appropriate. We also considered using the mean, instead of the proposed median of the risk indicator as the cutoff point but believe it could decrease the percentage of ASM participants that would receive the complex patient scoring adjustment like what was observed by the Quality Payment Program in exploratory analyses for the MIPS complex patient bonus methodology (86 FR 65110).

We proposed at Sec. 512.745(a)(3)(ii)(C), like in MIPS, to determine a standardized score for each risk indicator based on the mean and standard deviation of the raw risk indicator score to provide a standardized measurement of the distance between each risk score and the mean: (raw risk indicator score-risk indicator mean)/risk indicator standard deviation. We proposed to use the mean and standard deviation from 1 calendar year prior to the ASM performance year using applicable data from ASM participants identified for that ASM performance year. Standardization allows us to determine how far each risk indicator score is from the mean. For example, the mean and standard deviations for the 2027 ASM performance year would be determined based on data from CY 2026 for ASM participants identified for the 2027 ASM performance year, which is a similar methodology to our proposed methodology to calculate the risk indicator reference medians described earlier in this section of this final rule.

We proposed at Sec. 512.745(a)(3)(ii)(A) to calculate the social complex patient scoring adjustment component as follows:

Medically complex patient scoring adjustment component = 1.5 + 4 * associated HCC standardized score calculated with the average HCC risk score assigned to beneficiaries (under the HCC risk adjustment model established by CMS under section 1853(a)(1) of the Act) seen by an ASM participant.

We proposed at Sec. 512.745(a)(3)(ii)(B) to calculate the medical complex patient scoring adjustment component as follows:

Social complex patient scoring adjustment component = 1.5 + 4 * associated with dual proportion standardized score.

We proposed Sec. 512.745(a)(3)(ii)(C) to add the components together to calculate one overall complex patient scoring adjustment.

We proposed at Sec. 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 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 Sec. 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.\286\ 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 populations but would also reduce inappropriate payments for ASM participants that care for less complex populations.

\286\ 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.

We solicited 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 sought 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 sought 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 to receive the complex patient scoring adjustment.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters supported the proposed use of a complex patient scoring adjustment as it helps ensure that clinicians are not inadvertently penalized for treating medically or socially complex populations. Additionally, a commenter noted that Medicare Advantage also uses HCC coding and risk adjustment to account for the higher costs associated with complex patients. A commenter explicitly supported the use of a cohort median as the basis for the complex patient scoring adjustment but also recommended that CMS monitor the results of each ASM cohort to ensure that the complex patient scoring adjustment is properly sized. Similarly, another commenter also noted that CMS must maintain the correct balance between supporting ASM participants and ensuring all participants have a fair chance to achieve a positive ASM payment adjustment.

Response: We appreciate the commenters for their support of the proposal. We agree that complex patient adjustment helps ensure that ASM participants are not penalized for providing care for medically or socially complex beneficiaries. We appreciate the commenters for their support of the median as the basis for determining a

complex patient scoring adjustment. We will monitor participant results to ensure the adjustment is appropriately sized and changes are needed, will address those changes in future notice-and-comment rulemaking. Lastly, we believe that as currently proposed the complex patient scoring adjustment strikes the right balance of supporting participants facing unique challenges while also maintaining a scoring system that recognizes high performance.

Comment: Several commenters noted limitations with the proposed complex patient scoring adjustment. A few commenters noted that HCC codes do not appropriately capture the severity of illness, particularly for pain, and that HCC risk scores are designed for predicting cost and utilization across broad medical conditions not the conditions in the ASM cohort. A few commenters noted that dual-eligible proportion is a useful proxy for socioeconomic risk but does not differentiate between patients with complex pain syndromes and those with other chronic conditions. A commenter expressed concern that calculating a standardized score based on mean and standard deviation may dilute the impact of truly complex pain patients, especially in specialty practices where pain-related complexity is common but not well-coded. Another commenter expressed concern that applying the complex patient scoring adjustment to those above the median for the risk indicator may exclude those serving moderately complex populations who also experience care management burden. Another commenter shared their belief that because the complex patient scoring adjustment is applied to the ASM final score, and not to each performance category, clinicians whose quality or cost performance is negatively impacted by patient complexity may still be at risk. A commenter expressed concern on whether a 10-point cap is a sufficient adjustment if the cost performance category has a weight of 50 percent. Additionally, a few commenters recommended that the risk adjustment should account for patient complexity and co-morbidities.

Response: We appreciate the commenters' feedback, but we disagree with their perspective that the complex patient scoring adjustment is limited in its measurement of medically or socially complex beneficiaries. Even though HCC codes do not directly capture beneficiary pain, they do capture relative severity and comorbidities including many conditions relevant to pain. We believe in using HCCs because it is consistent, auditable and resistant to subjective interpretation as compared to ad-hoc clinical judgments on pain levels. We agree with the commenters that the rate of dual-eligible proportion is a useful proxy for socioeconomic risk, yet we note that the rate of dual-eligible proportion is not meant to capture the nuances between patients with complex pain syndromes and those with chronic conditions. The HCC score best addresses those factors as well as patient complexity and co-morbidities. Standardizing scores for each risk indicator based on the mean and standard deviation of the raw risk indicator scores is a standard statistical method to ensure comparability across participants and specialties. We do not believe standardizing scores dilutes complex patients, rather it normalizes variation so that providers are not unfairly advantaged or disadvantaged by the differences in coding practices like, for example, in specialty practices where pain related complexity is common. Awarding the complex patient scoring adjustment to participants whose risk indicator is equal or greater than the reference median ensures the bonus awards clinicians facing significant care management burden. If we were to award the complex patient scoring adjustment to everyone, or expand the cap beyond 10 points, we could potentially weaken the ASM incentive structure and begin to blur meaningful differences in performance. We also believe that aligning the proposed complex patient scoring adjustment maximum point value with the MIPS complex patient scoring adjustment maximum point value would reduce confusion for ASM participants who may previously have participated in MIPS. It is also important to note that the ASM cost performance category includes a sophisticated risk adjustment methodology meant to address the commenters exact concerns as described in III.C.2.d.(3) of the final rule. The Risk Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with Heart Failure (MIPS Q492) also includes a risk-adjustment process to account for clinical variables and social risk factors.

Comment: Several commenters offered recommendations to address the limitations in the proposed complex patient scoring adjustment. Recommendations include: expanding the methodology to include additional risk factors, adding a variety of clinical modifiers/markers and functional status to the risk adjustments, excluding New York Heart Association (NYHA) stage D patients from the analysis, adding a mechanism to identify when ASM participants treat chronic medical conditions, such as recognizing an add-on complexity code like G2211 or a quantity or variety of CPT codes, and incentivizing pain ASM participants who drive the Improvement Activities. A few commenters suggested adding 10 or 15 performance add-on points for clinicians practicing in challenged economic areas, such as those with a high score in the area deprivation index while another commenter suggested providing bonus points or favorable benchmarks for ASM participants serving high-risk populations. A commenter recommended specialty- specific risk adjustment, noting that interventional pain care involves unique clinical burdens that are not often captured by general medical risk models. Additionally, the commenter recommended that CMS engage with specialists to ensure scoring adjustment aligns with the realities of clinician practices and does not inadvertently penalize high-quality care.

Response: We appreciate the commenters' recommendations on possible adjustments to the complex patient scoring adjustment. However, we disagree because at a high level, we wanted to align the complex patient scoring adjustment in ASM with the complex patient bonus policy in MIPS to reduce confusion for participants who have previously participated in MIPS. Though we did not consider the recommendations referenced within these comments, if we did, we would do so in future notice-and-comment rulemaking. We also appreciate the commenters for expressing their concerns that the complex patient scoring adjustment may inadvertently penalize participants providing high-quality care. However, the magnitude of the complex patient scoring adjustment was set to reward beneficiaries facing unique challenges, but it is capped to maintain appropriate scoring rewards for ASM participants providing high-value care. We will monitor ASM participants' final scores, the adequacy of the complex patient scoring adjustment, and will address any possible refinements to the adjustment in future notice-and-comment rulemaking.

Comment: Several commenters recommended the need for a robust risk adjustment without discussing the complex patient score adjustment specifically. The commenters expressed concern that safety net providers and other ASM participants who treat complex and underserved populations may be disadvantaged. A few commenters also expressed concern that the lack of a robust adjustment could

lead to unintended consequences, such as under-reimbursement for high- value services, disincentives to serve complex Medicare patients, or reduced access to care for vulnerable patients. A commenter expressed concern that the one-size-fits all design of ASM does not reflect material differences between community practices and tertiary referral centers and that the current methodology offers limited protection for rare, appropriate, high-cost care. Another commenter noted that ASM participants in low-income communities have compounded costs and pressures to meet more than just primary care needs. Another commenter suggested using patient-centered outcomes that reflect patient goals and value, not just cost metrics.

Response: We appreciate the recommendations to further enhance risk adjustment and strengthen support for safety net providers. It is important to note that the EBCM methodology used to determine the cost ASM performance category score utilizes a sophisticated risk adjustment methodology that benefits safety net providers and other ASM participants treating complex and underserved populations. Coupled with the complex patient scoring adjustment, we believe our policies as proposed sufficiently recognize the challenges facing safety-net providers and would not inherently lead to reduced access to care for vulnerable patients. We would not expect to identify ASM participants that furnish most of their services in tertiary referral centers because of our ASM participant eligibility criteria; we refer readers to section III.C.2.c.(3) of this final rule for further discussion. Although we did not consider scoring community practices differently, if we did, we would do so in future notice-and-comment rulemaking. Separately, we would also like to note two points. First, we, like the commenters, understand that ASM participants in low-income communities face different pressures than those in higher-income communities. For these reasons, we proposed that the complex patient scoring adjustment utilizes the proportion of patients with dual eligible status in the adjustment's calculation. The link between dual eligible status and income level is well documented and researched.\287\ Second, we refer commenters to the quality ASM performance category discussion in section III.C.2.d.(2) of this final rule which includes measures like the Functional Status Change for Patients with Low Back Impairments (MIPS Q220) which, as a patient-reported outcome measure, tracks changes in a patient's reported functional status over time.

\287\ https://www.kff.org/medicare/a-profile-of-medicare-medicaid-enrollees-dual-eligibles.

Comment: A commenter expressed concern that ASM may encourage specialists to seek care for low acuity patients who can be managed by a primary care practice, noting those beneficiaries are likely to score well on most of the model's quality and episode cost measures. The commenter also noted that earlier stage low back pain and congestive heart failure are not currently included in Medicare Advantage risk adjustment models.

Response: We appreciate the commenter for their feedback. We disagree that ASM may encourage specialists to seek out care for low acuity patients because the EBCM's risk adjustment process and will not sufficiently reward participants for seeking out low acuity patients. We also see value in ASMs longitudinal care approach to patients with chronic conditions. Providing early, preventive care to low acuity patients should result in better health outcomes and reduce beneficiary expenditures to prevent those patients falling into a higher acuity status.

Comment: A few commenters expressed concerns about fairly measuring performance of ASM participants when providing care to high-need patients. A commenter expressed concern with how specialists will be attributed in complex cases when multiple clinicians are involved. A commenter recommended comprehensive risk adjustment to mitigate potential risks associated with treating high-need patients.

Response: We appreciate commenters for raising these concerns. We note that the complex patient scoring adjustments would help increase the final scores of qualifying ASM participants as it acknowledges the challenges in providing care to high-needs patients, which may result in lower performance in some ASM performance categories. We refer commenters to the EBCM methodology in sections III.C.2.d.(3)(b) and III.C.2.d.(3)(c) of this final rule which detail how episodes are attributed, even in complex cases. As we have stated throughout this section of this final rule, we believe that measure-specific risk adjustment coupled with the complex patient scoring adjustment provides a simple but comprehensive risk adjustment approach to increase final scores and the likelihood for a more favorable payment adjustment for qualifying ASM participants.

After consideration of public comments, we are finalizing the proposed complex patient scoring adjustment provisions at Sec. 512.745(a)(3).

We did not receive public comments on the proposed definitions of “dual eligible proportion,” and “risk indicator” at Sec. 512.705 and therefore, we are finalizing as proposed (4) Small Practice Scoring Adjustment

We proposed at Sec. 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 proposed at Sec. 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 Sec. 512.710(g). We proposed at Sec. 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 Sec. 512.710(g). Our proposed definitions for small practice and solo practitioner align with MIPS' small practice definition at Sec. 414.1305.

We proposed at Sec. 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 Sec. 512.705; (2) is not a solo practitioner as defined at Sec. 512.705; and (3) and meets the requirement to receive a final score greater than zero as described at Sec. 512.745(a)(2)(i) for an applicable ASM performance year. We proposed at Sec. 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 Sec. 512.705 and meets the requirement to receive a final score greater than zero as described at Sec. 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, including scoring and reweighting policies as defined at Sec. 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 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 refer readers to section III.C.2.f.(4).(b) of this final 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 final rule for further discussion on our proposed payment methodology). Since we did not propose 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 did not propose a similar flat-point adjustment for ASM participants in rural areas as defined at Sec. 512.705 (which aligns with the MIPS rural area definition at Sec. 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 Sec. 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 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 solicited comments on our proposal at Sec. 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 sought comment on our proposal at Sec. 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 sought comments on the alternative we considered of applying a similar flat-point adjustment for ASM participants in rural areas.

We received public comments on these proposals. The following is a summary of the comments we received related to the small practice scoring adjustment and solo practice scoring adjustment.

Comment: Several commenters supported the proposed small practice scoring adjustment of 10 points for small practices that are not solo practitioners and meets the requirement to receive a final score greater than zero and a 15-point scoring adjustment for solo practitioners that meets the requirement to receive a final score greater than zero. Commenters noted this is a simple, transparent approach and an appropriate, fair compromise for known disparities in reporting infrastructure, staffing, and capacity. A commenter supported the proposal but requested CMS to closely monitor the results of each cohort in the ASM to ensure that the small practice scoring adjustment is properly sized so that ASM participants from small practices are not unfairly punished or rewarded.

Response: We appreciate commenters for their support of this proposal. We agree that the small practice scoring adjustment is a simple approach to support practices that face additional burdens in Innovation Center models. We will monitor the results of these cohorts to identify if any refinements to the small practice scoring adjustments would be justified.

Comment: A few commenters supported the proposed small practice scoring adjustment contingent on CMS adoption a group practice participation option. Some of the commenters noted that because ASM is proposed as an individual clinician model, every ASM participant is performing as a solo practitioner relative to reporting burden, performance management, and financial impact.

Response: We appreciate the commenters' feedback, but we disagree that the small practice scoring adjustment should be contingent on CMS adopting a group practice participation option. The ASM small practice scoring adjustment reflects the reality that small and solo practitioners face challenges in their ability to participate in historical programs like MIPS which include costs to implement and maintain CEHRT, staff and training costs and a more limited staff capacity (89 FR 98452). These challenges and burdens persist regardless of the ASM participation level set by CMS. Even though the ASM participants are individual providers, providers practicing in a larger group still have access to reporting structures and support unavailable to providers in smaller groups.

Comment: Several commenters expressed concern that small practices would still be disproportionately harmed by ASM. The commenters expressed concern that solo practices may be less likely to engage or may have lower scores due to limited resources and the requirements of the model and that the proposed small practice scoring adjustment is not sufficient to offset the burden and cost associated with the model. A few commenters stated their belief that small practices typically do not have the staff and resources to compete with larger practices and may divert resources away from small and rural practices. A few commenters

requested CMS provide resources and technical assistance to enable small practices to transition to value-based care. Another commenter requested that CMS ensure that ASM participants are not penalized for a lack of infrastructure prior to the model.

Response: We appreciate the commenters' feedback but believe that our small practice scoring adjustment, our finalized provision in section III.C.2.d.(1).(b) of this final rule to allow for small practice TIN level quality ASM performance category reporting, and the length of time participants have to prepare for ASM appropriately accounts for the burdens small practices face. The 10/15 point small/ solo provider scoring adjustments provides ASM participants with the recognition of their hardships without undermining their incentives to pursue meaningful performance improvement. Our finalized provision in section III.C.2.d.(1).(b) of this final rule to allow for group reporting of the quality ASM performance category for small practices and group reporting for the improvement activities and Promoting Interoperability ASM performance categories for all participants should ease smaller practice burden in meeting the requirements of these performance categories. To assist providers to be ready for ASM's requirements by the model start, we plan to share educational resources with eligible ASM participants beginning in 2026. Additionally, launching the model in 2027, though announced in 2025, gives appropriate time for ASM participants, from both large but especially smaller practices, to begin adopting the right infrastructure to participate in the model. For the reasons provided we do not believe it necessary to exempt providers in small practices from ASM.

Comment: A commenter suggested that policy flexibilities or exemptions from mandatory reporting should be extended to small practices. Additionally, a commenter suggested that benchmarks should be adjusted for smaller practices in an effort to reduce financial risk.

Response: We appreciate these commenters for their suggestions to address the challenges faced by small practices. Our finalized provision in section III.C.d.(1).)(b) of this final rule allows for small practice to report quality measures in the quality ASM performance category at the TIN level. However, we did not consider exemptions from mandatory reporting for small practices because ASM is designed to ensure that all participants are evaluated. Exemptions would create gaps in measurement that could reduce the integrity of the model. We also did not consider adjusting benchmarks for the realities faced by smaller practices because as discussed earlier in this section, we believe that the small practice scoring adjustment, and our finalized provision to ease quality reporting burden for ASM participants in small practices would account for those challenges in a simpler and more transparent way. Lastly, the small practice scoring adjustment automatically raises the participant's final score, helping them achieve a higher score and therefore lowering small practices' financial risk.

Comment: A commenter agreed with the proposed approach CMS is taking in applying a scoring adjustment for those who are participating in small practices but expressed concern that the continued relaxation of CEHRT use requirements will only isolate smaller practices from benefiting from interoperability. The commenter recommended providing more incentive-based approaches for those who are solo practitioners or small practices and perhaps promoting the adoption of certified technology, while not requiring full Base CEHRT, may be a way to bring these practices into the current environment of an interoperable network.

Response: We appreciate the commenter for their recommendation. However, we disagree and note that small practices are not exempt from the CEHRT requirement within the Promoting Interoperability performance category. The small practice scoring adjustment is awarded regardless of a small practice's performance on the Promoting Interoperability performance category and may help provide additional support for infrastructure investments such as CEHRT. We may consider the exploration of additional incentives or support for small practices in the future.

We also solicited comments on an alternative where a similar flat- point adjustment would be applied for ASM participants in rural areas.

Comment: A few commenters supported the alternative considered to use ASM rural scoring adjustment, a scoring adjustment for ASM participants in rural areas, similar to the small practice scoring adjustment. A commenter expressed support for ASM rural adjustment, noting unique challenges, such as limited funding for technology upgrades, insufficient staff for reporting requirements, barriers to interoperable systems and the ASM requirement for individual rather than group reporting. Another commenter expressed support for ASM rural scoring adjustment, noting that rural physicians treating patients with low back pain often encounter individuals with limited access to care management and first-line treatments, as well as complex needs that require more time to address.

Response: We appreciate commenters for their feedback. Although we considered implementing a rural scoring adjustment we found in our analysis of historical MIPS performance data among likely ASM participants that there were no systematic differences in the performance data between likely ASM participants in rural and non-rural areas. We believe that the small and solo practice scoring adjustments support ASM participants in smaller practices directly by addressing participation barriers without undermining incentives for ASM participants in large rural systems to improve.

Comment: A few commenters supported and provided recommendations on the alternative approach to have a rural scoring adjustment, a scoring adjustment for ASM participants in rural areas, similar to the small practice scoring adjustment. A commenter acknowledged CMS rationale for not including a rural adjustment but recommended that CMS monitor performance by geographic location and implement significant geographic adjustments to ensure rural practices are not disproportionately harmed and to account for rural healthcare challenges. Another commenter recommended that CMS provide technical assistance for ASM participants in rural areas and implement protection for clinicians in rural areas, including a differential penalty structure, considering specific quality measures to reflect unique care delivery patterns, such as stabilization and transfer protocols.

Response: We appreciate commenters for their feedback. As previously discussed in this section of this final rule, we considered implementing a rural scoring adjustment but did not find evidence of differences in historical performance between likely ASM participants in rural versus non-rural areas. We will continue to monitor performance and final scores by geographic location. If systematic differences in final scores were to arise, we could consider additional provisions to address these differences in future notice-and-comment rulemaking. To help providers in rural areas with technical assistance, we plan to provide educational materials to eligible ASM participants beginning in CY 2026. We did not consider protections for clinicians in rural areas because ASM is designed to ensure that all participants

are evaluated under a consistent framework. Exemptions would create gaps in measurement that could reduce the integrity of the model. As noted earlier in this section of this final rule, we also expect a high degree of overlap between ASM participants in rural areas in small practices based on historical MIPS performance data we analyzed, meaning that we believe that many rural practices would be eligible for the small practice scoring adjustment.

After consideration of public comments, we are finalizing our proposed definition of “small practice” and “solo practitioner” as proposed at Sec. 512.705. We are also finalizing at Sec. 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 as proposed. We are also finalizing at Sec. 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 as proposed. (5) Final Score Calculation

We proposed at Sec. 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 final rule:

Final score = [(quality ASM performance category score x quality ASM performance category weight) + (cost ASM performance category score x cost ASM performance category weight)] x 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 final 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 activities 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 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 x 50 percent) + (0.75 x 50 percent)] x 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 x 50 percent) + (0.75 x 50 percent)] x 100), before the scoring adjustments are applied, and a final ASM score of 80.3 points

We solicited comments on the proposed final score calculation formula.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed ASM final score formula. A commenter agreed with CMS that the final score could provide a broader range of scores and outcome distributions. A commenter acknowledged the changes in ASM from MIPS scoring and recommended that CMS closely monitor these changes to ensure there is not a recurring issue with edge cases in the ASM cohort.

Response: We appreciate the commenters for their support of the proposal. We agree that the ASM final score formula will provide a broad range of scores and outcome distributions. We will monitor scoring results and address any needs for refinements in future notice- and-comment rulemaking.

Comment: A few commenters recommended that CMS provide additional clarity, safeguards, and simplification of the proposed ASM final score formula. A commenter suggested adding reliability and volume safeguards, such as reweighting when measure reliability or case counts are low, and recommended more details on the proposed formulas, benchmarks, and reference populations. Another commenter suggested that CMS to significantly simplify the proposed final score formula before ASM is finalized, noting that many healthcare organizations already struggle to follow requirements for existing programs.

Response: We appreciate commenters for feedback on the final score calculation formula. However, we believe that as proposed in section III.C.2.e.(5) of the final rule, the final score formula is as simple as possible while appropriately utilizing the quality and cost ASM performance category scores as outlined in sections III.C.2.e of this final 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. To help healthcare organizations who may struggle to follow ASM requirements and scoring policies, we plan to release educational materials beginning in CY 2026. We note that many of ASM's scoring requirements, including both the cost and quality performance categories as discussed in sections III.C.2.d.(3).(f) and III.C.2.d.(2).(h).(ii) of the final rule respectively, require minimum volumes to be scored. We will also release benchmark ranges, reference populations, and formulas as they become finalized in each ASM performance year in a form and manner determined by CMS.

Comment: A commenter expressed concern that the proposed ASM scoring methodology does not adequately adjust for ASM participants treating patients with high clinical severity, such as frailty, device dependence, transplant candidacy, and multi-organ comorbidity. The commenter shared their belief that the proposed scoring methodology puts too much emphasis on cost without appropriately balancing the value of advanced therapies.

Response: We appreciate the commenters' feedback, but we believe the ASM scoring methodology as proposed in section III.C.2.e.(5) of the final rule is inclusive of the factors mentioned in the comment. The complex patient scoring adjustments

includes a positive adjustment for ASM participants with higher than median HCC scores and the cost EBCMs scored in the cost ASM performance category utilizes an advanced risk adjustment formula as discussed in section III.C.2.d.(3)(c) and III.C.2.d.(3)(d) of the final rule. Additionally, the EBCMs include comprehensive exclusion criteria for both the heart failure and low back pain episodes. We expect that the advanced therapies the commenter is referring to would most likely meet those EBCM exclusion criteria.

After consideration of public comments, we are finalizing our final score calculation proposal at Sec. 512.745(a)(5) as proposed. (6) ASM Performance Report

We proposed at Sec. 512.745(b) to release an ASM participant's final score for each ASM performance year through an “ASM performance report,” which we proposed to define at Sec. 512.705 as the notification that CMS provides to the ASM participant for each ASM performance year, which contains the information specified at Sec. 512.745(b). We proposed at Sec. 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 final 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 final 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 final rule.

We solicited comments on our proposal at Sec. 512.745(b) to provide ASM participants with an ASM performance report for each ASM performance year. We also solicited comments on the proposed components of the ASM performance report.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters offered recommendations on the proposed approach to provide ASM participants with an ASM performance report for each ASM performance year. The commenters suggested CMS to provide clinicians with more timely, interim performance feedback on patient quality, cost, and service utilization, noting that faster feedback would help clinicians monitor progress, adjust interventions, reduce care variation, and eliminate avoidable services, supporting continuous improvement. The commenters specifically recommended that CMS deliver timely and actionable feedback, including Medicare claims data, in real time or at regular monthly or quarterly intervals. A commenter recommended CMS to develop improvement activities that utilize real- time, actionable data, enabling physicians and care teams to promptly review and enhance patient care and office protocols. A few commenters recommended that CMS implement safeguards to account for data fluctuations and provide more frequent, real-time data sharing and reporting, noting that clinician and patient attribution data from ASM is currently unavailable until 2 years after the performance year. A commenter suggested CMS to develop and provide a standardized scoring calculator or dashboard tool to assist clinicians in real-time performance tracking and planning to promote transparency, reduce administrative burden, and support compliance. A commenter expressed concerns with retroactive data, emphasizing that timely information is essential for clinical practice transformation. Another commenter also recommended that CMS provide retrospective cost data from up to 2 years prior to the measurement year, along with intermittent reporting during the ASM performance year, to improve visibility into cost trends.

Response: We appreciate the commenters for providing feedback on our proposal to provide ASM participants with an ASM performance report for each ASM performance year. We understand the commenters' desires for timelier, and interim performance feedback reports as well as calculators and dashboard tools to understand their performance. We are exploring ways to provide participants with the right data at the right intervals to assist them throughout the performance year. Though we did not consider the recommendations to provide retrospective cost, and real time improvement activity data to participants, if we did, we would do so in future notice-and-comment rulemaking.

Comment: A few commenters offered additional recommendations to CMS regarding the proposed ASM performance report. The commenters recommended that CMS provide performance data in a clear, publicly accessible format. Another commenter suggested CMS to offer training to assist smaller practices to interpret and act on information in the ASM performance report.

Response: We appreciate the commenters' suggestions on the ASM performance report. The proposed ASM performance report, as proposed, would help ASM participants understand their performance on each of the required measures, activities and attestations, as well as their resulting payment adjustment information. To assist providers, both large and small, who may struggle to follow the ASM performance report, we plan to offer educational resources and ad hoc support (for example, help desk support) on the data contained in the ASM performance report as those reports become available. We also acknowledge the commenters' suggestions on making performance data available in a clear and publicly accessible format. We will consider this suggestion and determine whether it would be appropriate and feasible to share this performance data in a public manner.

Comment: A commenter did not support the proposed approach to provide ASM participants with an ASM performance report for each ASM performance year, noting that delayed feedback mechanisms hinder meaningful improvement, while disproportionately burdening providers who care for high-risk populations with complex needs.

Response: We appreciate the commenters for providing feedback on our proposal to provide ASM participants with an ASM performance report for each ASM performance year. We understand the commenters' concerns and are exploring ways to provide participants with the right data

at the right intervals to assist them throughout the performance year. We also intend to make efforts to provide performance data to ASM participants in a more timely manner following the data submission deadline.

After consideration of public comments, we are finalizing our definition of “ASM performance report” as proposed at Sec. 512.705. We are also finalizing our proposal to provide ASM participants with an ASM performance report for each ASM performance year, including the proposed components of the ASM performance report, as proposed at Sec. 512.745(b). f. Payment Approach (1) Payment Approach

In this section, we discuss our 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 will 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 related to each of ASM's targeted chronic conditions directly incentivizes performance improvement through financial incentives. We believe the 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 final 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 payment methodology for an ASM participant to receive a positive, neutral, or negative payment adjustment based on their performance creates a strong incentive to promote performance improvement and achieve ASM's objectives. (2) Payment Methodology Overview

In the CY 2026 PFS proposed rule, we proposed at Sec. 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 proposed to define at Sec. 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 incentive pool for each ASM cohort for each ASM payment year as described at Sec. 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 proposed 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 final 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.

In the CY 2026 PFS proposed rule, we also proposed to define at Sec. 512.705 an “ASM payment adjustment factor” as a percent value based on an ASM's participant's final score as described at Sec. 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 proposed to define at Sec. 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 Sec. 512.750(c).

As proposed at Sec. 512.750(a) in the CY 2026 PFS proposed rule, 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 Sec. 512.750(d) because they do not receive a final score for the corresponding ASM performance year. We refer readers to Sec. 512.745(a)(2) and section III.C.2.e.(2) of this final rule for policies related to final scores. We also refer readers to section III.C.2.f. of this final rule and Sec. 512.750(f) for further policies on how payment adjustments will be 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) \288\ and the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP Program).\289\

\288\ https://www.cms.gov/medicare/quality/initiatives/hospital-quality-initiative/hospital-value-based-purchasing.

\289\ https://www.cms.gov/medicare/quality/nursing-home-improvement/value-based-purchasing.

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 Sec. 412.164(a).\290\ 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 to, or more than the applicable reduction for that program year (88 FR 59063 through 59108).

\290\ https://www.cms.gov/medicare/quality/initiatives/hospital-quality-initiative/hospital-value-based-purchasing.

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.\291\ 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.\292\ 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 53276 through 53304).\293\ 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).

\291\ 42 U.S.C. 1395yy(h).

\292\ 42 U.S.C. 1395yy(h).

\293\ https://www.cms.gov/medicare/quality/nursing-home-improvement/value-based-purchasing.

Our proposed payment methodology differs from the Hospital VBP Program and the SNF VBP Program in that we did not propose a prospective withhold of ASM participants' Medicare Part B payments during an ASM performance year. Instead, we proposed 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 proposed that 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 the CY 2026 PFS proposed rule (90 FR 32605), we proposed 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 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 stated that we believed 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 performance threshold. In accordance with section 1848(q)(6) of the Act and Sec. 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 Sec. 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 of 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 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, we have 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 Sec. 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 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 solicited 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 sought comments on the alternative approach we considered that would use a performance threshold similar to MIPS in our payment methodology. We also sought comments on our proposed definitions of “ASM incentive pool,” “ASM payment adjustment factor,” and “ASM payment multiplier.”

We received public comments on our overall proposed payment approach. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed two-sided financial risk in ASM, giving specialists more opportunities to move into accountable care arrangements. However, the commenters recommended a change in the payment incentives to move away from traditional FFS Medicare towards population-based payment and alignment. A commenter supported the proposed two-sided risk and suggested that assumption of risk is critical to minimize selection bias and development of generalizable results.

Response: We appreciate commenters for the support of the two-sided financial risk in ASM's payment approach. We also appreciate the commenter's support of two-sided risk under a mandatory model as it would provide more generalizable evaluation results. We agree that ASM would provide opportunities for select specialists to move into accountable care arrangements. ASM's payment approach allows for ASM participants to achieve payment adjustments on traditional FFS Part B payments while participating in other population-based payment models, such as shared savings initiatives. We believe that the flexible model overlap creates complementary incentives to improve quality and reduce unnecessary spending for beneficiaries with ASM's targeted chronic conditions.

Comment: A commenter supported calculating the proposed ASM payment adjustment by withholding Part B payments and suggested implementing a retrospective withhold of hospital-based Part A payments for distribution, to leverage savings from avoiding unnecessary procedures, which are a primary source of potential savings that are challenging to capture.

Response: We appreciate the commenter for their support of the overall ASM payment methodology. We note that the proposed payment methodology did not include a prospective withhold. Instead, we proposed that we would scale ASM payment adjustments factors so that the expected value of the negative adjustments would be larger than the expected value from the positive adjustments, resulting in a net savings to Medicare (90 FR 32606). While we expect that ASM would create downstream incentives to reduce hospital-based Part A payments for services related to ASM's targeted chronic conditions, this type of adjustment would be outside of the scope of ASM given its focus on FFS spending by specialists in the ambulatory spending.

Comment: A few commenters did not support the proposed ASM financial structure, which could lead to blanket reductions in payment to all ASM participants and relies on median scores, quality performance, and cost measure data that are typically not available to ASM participants until well beyond the ASM performance year. A commenter shared their belief that savings to the Medicare program should not be generated by reduced payments to physicians.

Response: We appreciate commenters raising their concerns about the proposed ASM financial structure. However, we note that ASM's payment approach would not lead to blanket payment reductions to all ASM participants. As we stated in the CY 2026 PFS proposed rule, there would not be a prospective withhold on ASM participants' Part B payments (90 FR 32606). While ASM payment adjustments factors would be calculated so that the expected value of the negative adjustments would be larger than the expected value of the positive adjustments, some ASM participants would still earn net positive payment adjustments. Regarding the availability of quality measure performance data, most quality measures are not based on administrative claims (see section III.C.2.d.(2) of this final rule), meaning that ASM participants would be able to track their own performance on the required measures throughout an ASM performance year. As we discussed in section III.C.2.j. of this final rule, we are considering ways by which to provide ASM participants with more updated information on claims-based quality measures and cost measures during an ASM performance year to aid performance monitoring in advance of data submission.

Comment: A few commenters suggested delaying the model and proposed ASM payment adjustments allowing CMS time to create a model that would not result in negative payment adjustments for ASM participants below the median final score, regardless of their improvements in care quality or cost efficiency. Further, the commenters shared their belief that delaying the model by a year or more would allow clinicians to gain experience with ASM measures, feedback information that can be used to improve patient care, and time to develop new staff resources and update workflows. A few commenters noted that ASM performance should be based on achievement and improvement.

Response: We appreciate commenters expressing their concerns on the planned start of ASM on January 1, 2027 and the possibility of negative payment adjustments in the first ASM payment year in CY 2029. We believe that our participant notification policies discussed in section III.C.2.c.(5) of this final rule would provide adequate time for a selected ASM participant to become familiar with the required measures and make the necessary workflow adjustments to meet the model's requirements. As we discuss in our response to comments on the proposed exchange function in section III.C.2.f.(4).(c) of this final rule, use of an ASM cohort's median final score in the exchange function does not inherently mean that ASM participants scoring below that median would automatically receive a negative ASM payment adjustment factor. As discussed in the CY 2026 PFS proposed rule, use of the median final score within the proposed logistic exchange function would mean that more ASM participants would be likely to receive positive ASM payment adjustment factors compared to centering the function at 50 points, which represents the midpoint of the possible range of final scores (90 FR 32613). We appreciate the commenters' recommendations to incorporate improvement scoring into our scoring approaches. While we did not consider this into our scoring approaches in the CY 2026 PFS proposed rule, should we

do so, we would do so in future notice-and-comment rulemaking.

Comment: A commenter recommended additional weighting of planned Shared Savings Program metrics of index patient admission and readmission rates rather than the weighting of the risk payments if the specialists are not ready for the downside risk in ASM.

Response: We appreciate the commenter for their recommendation. While some ASM participants may be associated with a Shared Savings Program ACO, we do not believe that it would be appropriate at this time to include Shared Savings Program metrics as part of the performance assessment for determining payment adjustments under ASM. As we discussed in section III.C.2.m. of this final rule, we designed ASM so that ASM's incentives could be layered with incentives introduced by other models or shared savings initiatives, such as the Shared Savings Program. As we are not differentiating between ASM participants that are and are not ready for downside risk under ASM, we do not believe that using planned Shared Savings Program metrics for a subset of ASM participants would be an appropriate performance measurement approach by which to determine payment adjustments.

Comment: Several commenters supported the alternative approach of establishing a performance threshold prior to the start of each ASM performance year that would clearly define the level of achievement needed to avoid negative payment adjustments and provide a benchmark and to minimize uncertainty for ASM participants. A few commenters recommended eliminating a tournament scoring model in which the ASM participant's payment adjustment is dependent on whether their performance exceeds the majority of other ASM participants each year. A commenter recommended an implementation strategy that encourages gradual participation and performance improvement while ensuring fairness.

Response: We appreciate commenters for the feedback on an alternative approach to using a performance threshold, similar to what is used in MIPS, in ASM's payment methodology. While we acknowledge that the use of a prospectively determined final score performance threshold that determines whether an ASM participant would receive a positive or negative payment adjustment would provide ASM participants with a target for their final scores, we do not believe that it would be appropriate for ASM. As we discussed in the CY 2026 PFS proposed rule, we believe that our payment approach 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 (90 FR 32607). The use of a performance threshold could lead to smaller net positive payment adjustments if an overly high proportion of ASM participants were to have final scores exceeding the performance threshold. As we received feedback during the development of the model that the magnitude of upside adjustments would need to be meaningful to engender the practice transformations that ASM aims to achieve, we believe that using an approach that creates a consistent incentive for all ASM participants to continually improve performance on the required measures and attestations is preferable. As discussed in section III.C.2.d. of this final rule, we intend to keep the requirements of each ASM performance category consistent across ASM's model test period. Following the first ASM performance year, ASM participants would have more detailed feedback on their performance relative to other ASM participants in their applicable ASM cohort, which would allow them to calibrate their performance improvement goals for future ASM performance years. As discussed in section III.C.2.j. of this final rule, we are considering ways to provide ASM participants with data on performance during an ASM performance year to allow ASM participants to calibrate their performance improvement goals.

Comment: A few commenters expressed concerns about the model's ability to accurately reflect clinician performance, measure improvement from previous performance periods and assess payment impacts. Specifically, a few commenters expressed concerns about recognizing high performance in ASM and the fairness of assessing performance in the first ASM performance year, without a baseline for comparison.

Response: We appreciate the commenters but disagree with their concerns that ASM would not be able to measure clinician performance or assess payment impacts as a result of participation in ASM. As discussed in the CY 2026 PFS proposed rule, ASM's performance measurement framework leverages the tested MVP framework used in creating value-based incentives for eligible clinicians receiving Medicare FFS payments (90 FR 32573). While ASM will include substantive enhancements to this performance measurement framework to make more like-to-like comparison of clinicians who treat similar conditions, we believe that using quality, cost, and Promoting Interoperability measures that would be familiar to most ASM participants would allow us to appropriately evaluate clinician performance over time and to evaluate whether ASM achieves its overall objectives. We also appreciate the commenters' feedback on performance assessment within the first ASM performance year. The use of measures and attestations that would be familiar to many ASM participants, as well as our advanced notification of mandatory participation, leads us to believe that it would be fair to compare ASM participant performance for the first ASM performance year. As discussed in section III.C.2.j. of this final rule, we are considering ways to provide ASM participants with data that would potentially help them understand some aspects of their quality and cost performance during the first ASM performance year.

Comment: A few commenters recommended that payment could be provided upfront for ASM participants to assist practices in investing in updated processes, infrastructure and other practice improvements, noting concerns that the lag in reimbursement and mandated participation create financial strain and force clinicians into value- based models before they are truly ready or have the necessary capabilities. A few commenters suggested that this upfront financing or a monthly billing procedure to support enhanced preventive care, coordination with primary care physicians, care management, and other services that could improve outcomes for patients. These commenters suggested the ability to bill transitional care management (TCM), principal care management (PCM), and chronic care management (CCM) codes.

Response: We appreciate the commenters for their recommendations to have upfront infrastructure payments to support ASM participants' readiness. We did not propose these types of payments in the CY 2026 PFS proposed rule nor did we solicit comment on them, and therefore, these comments are out of scope. As discussed in section III.C.2.d. of this final rule, we believe that the majority of ASM participants would be familiar with many of the ASM performance category requirements by virtue of previous participation in the Quality Payment Program and because the quality measures are directly related to the care provided by the included specialties. We also believe that the advanced

notification of mandatory participation as described in section III.C.2.c.(5) of this final rule would provide ASM participants with time to prepare for the model requirements, such as adjusting workflows. We also would like to clarify that we are not excluding any specific PFS codes under ASM. As long as ASM participants meet the criteria and follow the rules for the TCM, PCM, or CCM codes, they can bill them.

Comment: Several commenters suggested that CMS consider alternative incentives for ASM participants to prevent reduction of payments for ASM participants regardless of their performance. A commenter recommended further efforts to move beyond FFS payments, and test payments such as a shared savings approach, bundled payments, lump sum rewards not tied to Part B payments or capitated payments. Another commenter suggested including approaches to assist clinicians in reducing avoidable Medicare spending on hospitalization and other services in lieu of payment reductions. A commenter recommended that CMS offer payment incentives to reward cost avoidance, such as reduction of emergency room visits, imaging and elective surgeries. Another commenter recommended that CMS explore alternative ASM incentives beyond FFS, such as lump sum rewards or capitated payments, to better reward providers for maintaining the health of their patients.

Response: We appreciate commenters for their suggestions on different alternative incentives that ASM could consider as part of its payment methodology. We did not propose or consider these incentives in the CY 2026 PFS proposed rule, so these comments are out of scope to the proposed provisions. Should we choose to consider them in ASM's payment methodology, we would do so through future notice-and-comment rulemaking.

Comment: A few commenters shared their concerns that carveouts are needed for fundamentally different and complex indications, noting that specialists' performance may be misrepresented due to statistical variability rather than actual care of quality or improvement. The commenters recommended that CMS create safe harbors to prevent payment penalties when proprietary tools are unavailable on fair, non- discriminatory terms.

Response: We appreciate commenters for their suggestion related to the potential for unfair payment adjustments should performance be assessed on measures requiring proprietary tools. We refer readers to section III.C.2.d.(2) of this final rule for discussion related to the use of proprietary tools in required quality measures. We do not agree that payment carveouts or adjustments are needed by virtue of statistical variability in the required measures and attestations across the four ASM performance categories. We designed our performance assessment framework so that we would evaluate ASM participants on a focused set of utilization measures, evidence-based prevention and outcome measures, patient-reported outcome measures, and cost measures as applicable for each ASM targeted chronic condition. We believe that our scoring policies discussed throughout sections III.C.2.(d) and III.C.2.(e) of this final rule will appropriately evaluate ASM participant clinical performance so that we can make appropriate payment adjustments. We also note that we have broadly accounted for the medical and social complexity of beneficiaries to whom ASM participants furnish services by inclusion of the complex patient scoring adjustment in our final scoring methodology as discussed in section III.C.2.(e).(4) of this final rule. Should we consider a safe harbor to prevent payment penalties when proprietary tools are unavailable, we would do so through future notice-and-comment rulemaking.

Comment: A few commenters recommended that CMS tailor incentive payments for ASM participants to the unique needs of specialty surgery practices to account for their episodic, procedural, and resource- intensive nature.

Response: We appreciate the commenters' feedback that we should consider specific incentive payments for ASM participants in specialty surgical practices. As discussed earlier in this section of this proposed rule, we did not consider incentive payments as part of ASM's payment methodology and disagree that there are specific needs of specialty surgical practices that would require ASM-specific incentive payments. We believe that our participant eligibility criteria would identify appropriate surgical specialists who provide longitudinal care management for beneficiaries with low back pain by way of the EBCM attribution methodology. As ASM is not focused on surgical practices alone, we do not believe specific incentive payments for ASM participants in these practices are justified at this time.

Comment: A commenter expressed concern that the proposed ASM incentives may not sufficiently encourage meaningful collaboration of specialists with PCPs.

Response: We appreciate the commenters for their feedback related to how the incentives introduced through ASM's payment methodology may not encourage primary care collaboration. We note that the scoring of the improvement activities ASM performance category creates an incentive for ASM participants to collaborate with PCPs and that failure to meet this requirement could reduce an ASM participant's final score and increase the likelihood of a negative payment adjustment. We refer readers to section III.C.2.d.(4) of this final rule for further discussion on the required improvement activities. Should we consider additional financial incentives for primary care collaboration in the future, we would do so through notice-and-comment rulemaking.

Comment: A few commenters expressed concern that ASM relies heavily on MIPS infrastructure and transfers several existing challenges, including the MIPS scoring methodology that forces distribution of ASM performance scores and uses the maximum negative payment for the lower deciles. The commenters suggested CMS to create a floor for negative payment adjustments once ASM participants collectively improve outcomes.

Response: We appreciate the commenters for the feedback. While our ASM performance measurement framework leverages the MVP framework, ASM's scoring methodology discussed in section III.C.2.e. of this final rule makes several changes from that of MIPS, including different scoring policies within each ASM performance category, different adjustments to the final score, and a different weighting scheme for ASM performance categories in calculating the final score. We designed ASM's scoring methodology to more appropriately evaluate the performance of ASM participants and to determine payment adjustments. We note that our proposed payment methodology does not use the same determination of maximum negative payment adjustments for MIPS eligible clinicians that receive a score at or below one-fourth of the applicable performance threshold that is required under MIPS as described at Sec. 414.1405(b)(2). As discussed later in this section of this final rule, ASM participants that receive a final score of zero would receive the maximum negative ASM payment adjustment factor for the applicable ASM payment year. We appreciate the recommendation on creating a floor of

negative payment adjustments once ASM participants collectively improve outcomes but do not believe that this would be appropriate for ASM as it could lead to a reduction in the magnitude of upside payment adjustments, which could lead to less meaningful incentives to improve quality and reduce unnecessary spending.

After consideration of public comments on ASM's payment approach, we are finalizing ASM's general payment methodology at Sec. 512.750(a) as proposed. We did not receive any specific comments on our proposed definitions of ASM incentive pool, ASM payment adjustment factor, and ASM payment multiplier; therefore, we are finalizing their definitions as proposed at Sec. 512.705. (3) Comparison of ASM Participant Performance

We proposed at Sec. 512.750(b) to separately compare the final scores of ASM participants in each ASM cohort to determine the payment adjustments 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 stated in the CY 2026 PFS proposed rule that we believed separately comparing ASM participants' final scores for each of the ASM targeted chronic conditions would provide more meaningful performance comparisons (90 FR 32607). 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 with section 1848(q)(6) of the Act and Sec. 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 Sec. 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 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 as defined at Sec. 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 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 that competitive markets reward top performers with profits.

We solicited comments on our proposal at Sec. 512.750(b) to determine ASM payment adjustment factors and ASM payment multipliers by comparing final scores separately among each ASM cohort. We also sought comment on the alternative we considered comparing final scores of all ASM participants together, like the MIPS approach for comparing performance scores.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters supported the proposed incentive pools that are distinct and separate for each ASM cohort, allowing comparisons between peers, which is a significant step toward more meaningful measurement.

Response: We appreciate the commenters for their support of the proposal. We agree that comparisons within ASM cohorts would provide more meaningful performance assessment.

Comment: Several commenters supported the proposed comparison of clinicians within each ASM cohort but also expressed concerns regarding the fairness and appropriateness of comparisons. The commenters specifically noted factors such as variation in patient demographics, resource access and care infrastructure, which may require geographic or other adjustments in the ASM cohort methodology. The commenters suggested CMS to monitor the results of each ASM cohort in the model to ensure the complex patient adjustment and small practice scoring adjustments are properly sized. A commenter recommended that CMS examine approaches to ensure that ASM participants primarily supporting high-risk patients are not unfairly penalized.

Response: We appreciate commenters' support for comparing clinicians within each ASM cohort and agree that this is the preferred way to compare performance in ASM. We understand that the context in which ASM participants furnish services may differ based on geographic or practice-level factors. As we discuss in section III.C.2.e. of this final rule, we believe that the complex patient and small practice scoring adjustments provide adequate and straightforward adjustments to support ASM

participants that serve more medically or socially complex beneficiaries, or practice within a smaller setting to achieve a higher final score. As part of ASM's implementation, we would continue to monitor the complex patient and small practice scoring adjustments to determine if adjustments would be required to ensure those adjustments achieve their intended purpose and not unfairly penalize certain ASM participants. Any adjustments to those scoring adjustments would be done through future notice-and-comment rulemaking. We also refer readers to section III.C.2.d.(1).(b) of this final rule for further discussion on our provision to allow ASM participants in small practices to report quality measures in the ASM quality performance category at the TIN level. We do not believe that allow this subset of ASM participants to report data at the TIN level would not undermine our performance comparison approach.

Comment: A commenter expressed a belief that the current ASM cohort definition may undermine the fairness of performance comparison fairness under ASM and presents a challenge in accurately attributing relevant measures and performance to any one clinician in the cohort.

Response: We appreciate the commenter for their feedback. We clarify that an ASM cohort includes individual ASM participants identified for a specific chronic condition. That is, the heart failure ASM cohort includes only ASM heart failure participants and the low back pain ASM cohort includes only ASM low back pain participants. Based on ASM's data submission requirements discussed in section III.C.2.d.(1) of this final rule, we believe that this data reporting and scoring structure does not create an issue with attributing relevant measures and performance to ASM participants in the cohort. Accordingly, we do not believe that this structure of the ASM cohort would lead to unfair performance comparisons.

Comment: Several commenters did not support the proposed comparison within an ASM cohort using a tournament style payment structure that potentially penalizes clinicians even if they significantly improve quality and reduce spending, discourage collaboration and the care of patients in the ASM cohort, and primarily focuses on cutting costs. The commenters recommended CMS to modify the methodology to reward any ASM participant that exceeds a predetermined performance threshold to incentivize care improvement.

Response: We appreciate the commenters for feedback on the proposed comparison approach and our proposal to not use a predetermined performance threshold of final scores within our payment methodology. As we discuss in our response to comments earlier in this section of this final rule, we believe that not using a performance threshold 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. The use of a performance threshold could also lead to smaller net positive payment adjustments if an overly high proportion of ASM participants were to have final scores exceeding the performance threshold. As we received feedback during the development of the model that the magnitude of upside adjustments would need to be meaningful to engender the practice transformations that ASM aims to achieve, we believe that using an approach that creates a consistent incentive for all ASM participants to continually improve performance on the required measures and attestations is appropriate.

After consideration of public comments, we are finalizing our proposed approach to compare the final scores of ASM participants within each ASM cohort to determine ASM payment adjustment factors and ASM payment multipliers as proposed at Sec. 512.750(b). (4) Calculation of ASM Payment Adjustment Factors and ASM Payment Multipliers

In the CY 2026 PFS proposed rule, we provided an overview of the proposed process to calculate ASM payment adjustment factors and ASM payment multipliers (90 FR 32607). We also discussed the calculation of the ASM incentive pool using the “ASM risk level,” which we proposed to define at Sec. 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 Sec. 512.750(c)(1)(i), and the “ASM redistribution percentage,” which we proposed to define at Sec. 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 Sec. 512.750(c)(1)(iii).

We also discussed 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 proposed to define at Sec. 512.705 as the function used to translate an ASM participant's final score into an ASM payment adjustment factor as described at proposed Sec. 512.750(c)(1)(ii). We also proposed to define at Sec. 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 Sec. 512.750(c)(1)(iv).

Finally, we discussed 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 Factors and Payment Multiplier Calculation Process

We proposed at Sec. 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 B-D8 in section III.C.2.e.(2) of this final 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. Multiply the total calculated in Step 1 by the ASM risk level for each ASM payment year proposed at Sec. 512.750(c)(1)(i) and discussed in section III.C.2.f.(4).(b).(i) of this final rule.

Step 3. Multiply the amount calculated in Step 2 by the ASM redistribution percentage proposed at Sec. 512.750(c)(1)(iii) and discussed in section III.C.2.f.(4).(b).(ii) of this final 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 Sec. 512.750(c)(1)(ii) and described in section III.C.2.f.(4).(c) of this final rule.

Step 5. Calculate a scaling factor as proposed at Sec. 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 Sec. 512.745(a)(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 Sec. 512.750(c)(1)(i):

ASM payment adjustment factor

= (ASM risk level x transformed final score x scaling factor)-ASM risk level

Step 6B. For ASM participants that receive a final score of zero as described at Sec. 512.745(a)(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 Sec. 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 Sec. 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, and an ASM payment multiplier less than 1 would result in a net negative payment adjustment.

We proposed at Sec. 512.750(d) that ASM participants who do not receive a final score as discussed in section III.C.2.e.(2).(b) of this final 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 provided 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 assumed 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 the $1 billion calculated in Step 1 by the 9 percent ASM risk level and the 85 percent ASM redistribution percentage to determine an ASM incentive pool of $76.5 million for this example.

Step 4. An ASM participant, in this example, received a final score of 80 points and the median score for the example ASM cohort was 50 points. When transformed under the exchange function, this final score would result in a transformed final score of 0.95.

Step 5. We calculate a scaling factor of 1.5 applicable for all ASM participants in this example ASM cohort to ensure that the amount in the ASM incentive pool would be distributed in the form of scaled payment adjustments. The numerator of the scaling factor would be the $76.5 million in the ASM incentive pool (calculated in Steps 2 and 3) and the denominator would be calculated as $51 million based on the sum of all ASM participant's transformed final scores multiplied by their respective total Medicare Part B covered professional services payments and the 9 percent ASM risk level: ($76.5 million/$51 million = 1.5).

Step 6A. The ASM payment adjustment factor, in this example, would be calculated as: [ASM risk level (9 percent) x transformed final score (0.95) x scaling factor (1.5)]-ASM risk level (9 percent) = 0.0385.

Step 7. The resulting ASM payment multiplier, in this example, would be calculated as: 1 + ASM payment adjustment factor (0.0385) = 1.0385. The value of this ASM payment multiplier would mean that the example ASM participant would receive a positive adjustment of 3.85 percent on all Medicare Part B covered professional service payments during the corresponding ASM payment year. We note that the parameters of the previous calculation are fictitious and may look entirely different when calculating the ASM payment adjustment factors and ASM payment multipliers for the model, depending on the distribution of final scores, the magnitude of Medicare Part B covered professional service payments associated with ASM participants, the size of ASM incentive pool, among other factors.

As discussed earlier in this section of this final rule, we did not propose to use a performance threshold to determine a cutoff between positive and negative ASM payment adjustment factors and resulting ASM payment multipliers. We would, therefore, calculate ASM payment adjustment factors and resulting ASM payment multipliers based on the size of the ASM incentive pool and the distribution of final scores for a given ASM performance year using the proposed payment methodology described throughout this section of this final rule.

The process to calculate ASM payment adjustment factors and adjust an ASM participant's Medicare Part B payments using an ASM payment multiplier during an applicable ASM payment year as proposed at Sec. 512.750 aligned with the processes and timelines by which the Quality Payment Program applies MIPS payment adjustments for each Medicare Part B claim made for covered professional services furnished by a MIPS eligible clinician as defined at Sec. 414.1405(e). We believed that aligning the timeline and processes with the Quality Payment Program's application of MIPS payment adjustments would ensure operational consistency and minimize confusion. As discussed in section III.C.2.e.(6) of the CY 2026 PFS proposed rule (90 FR 32605), we proposed to provide an ASM participant with their ASM payment adjustment factor and ASM payment multiplier in the ASM performance report provided to each ASM participant for the applicable ASM performance year.

We solicited comments on our proposed process as described at Sec. 512.750(c) to calculate the ASM payment adjustment factors and ASM payment multipliers, and how we would apply ASM payment multipliers to an ASM participant's Medicare Part B payment during an ASM payment year.

We received public comments about our general proposal to calculate and apply ASM payment adjustment factors and multipliers. The following is a summary of the comments we received and our responses.

Comment: A few commenters did not support the proposed calculation of the ASM payment adjustment, noting a high risk of negative financial impacts to ASM participants, uncertainty, lack of predictability, and payment delays. The

commenters suggested CMS to reconsider the methodology by establishing clear performance standards and revising the financial structure to eliminate payment reductions. The commenters believed that these changes would potentially avoid unintended consequences, such as clinician burnout, shifts of employment type, adverse patient selection, reduced specialist collaboration, disproportionate burden on providers who care for high-risk populations, and limited incentives to improve care delivery.

Response: We appreciate the commenters for their suggestion on the proposed calculation of payment adjustments under ASM. We disagree with their suggestion to eliminate payment reductions as we believe that two-sided risk is most appropriate for creating the right financial incentives to achieve ASM's objectives. While we recognize the challenges some clinicians face, as cited by the commenters, we believe that introducing a model that would incentivize improved upstream chronic condition management through two-sided risk is appropriate given the high prevalence and high spending related to ASM's targeted chronic conditions. We also note that we designed our final scoring policies, discussed in section III.C.2.e. of this final rule, so that ASM we would reward participants that provide care to higher-risk beneficiaries to avoid adverse beneficiary selection. With the complex patient scoring adjustment, ASM participants that care for a higher proportion of higher-risk beneficiaries would be more likely to receive a higher final score. We also disagree that ASM would create limited incentives to improve care delivery as we believe that the collective performance measurement approach and the payment methodology would hold specialists accountable for improving quality over time while finding ways to reduce the use of some unnecessary or low-value services.

After consideration of public comments, we are finalizing the proposed approach to calculate ASM payment multipliers, and ASM payment adjustment factors as proposed at Sec. 512.750(c). We did not receive specific comments on our proposed calculation of the scaling factor, so we are finalizing that calculation as proposed at Sec. 512.750(c)(1)(iv). Finally, we did not receive specific comments on our proposed definitions for ASM risk level, ASM redistribution percentage, exchange function or scaling factor. Therefore, we are finalizing their definitions as proposed at Sec. 512.705.

We refer readers to the remainder of this section of this final rule for comments and responses related to additional components of ASM's payment methodology. (b) ASM Incentive Pool

As discussed in the CY 2026 PFS proposed rule (90 FR 32608), we proposed to calculate the ASM incentive pool for each ASM cohort based on two factors: (1) the ASM risk level as described at Sec. 512.705(c)(1) (that is, 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) and (2) the ASM redistribution percentage as described at Sec. 512.750(c)(1)(iii) (that is, the percentage of Medicare Part B covered professional services payments to ASM participants during an ASM performance year that would be distributed in the form of payment adjustments to ASM participants during an ASM payment year). The total amount in an ASM incentive pool would directly determine the magnitude of ASM payment adjustment factors and resulting ASM payment multipliers that each ASM participant would receive during an ASM payment year. We discuss our proposals and public comments received on for the magnitude of ASM risk level and ASM redistribution percentage later in this section of this final rule.

We describe the step-by-step process of calculating the ASM incentive pool earlier in this section of this final rule. In summary, we proposed at Sec. 512.750(c)(1)(iii) to calculate an ASM incentive pool for each ASM cohort for applicable for each ASM payment year using the following formula: