2026-14327: Medicare and Medicaid Programs; CY 2027 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. Electronically. You may submit electronic comments on this

regulation to https://www.regulations.gov/docket/CMS-2026-2377. Follow the ``Submit a comment'' instructions.

2. By regular mail. You may mail written comments to the following

address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1848-P, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to

the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1848-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

A. Purpose

This major annual rule proposes to revise payment policies under the Medicare PFS and makes other policy changes, including proposals to implement certain provisions of the Full-Year Continuing Appropriations and Extensions Act, 2025 (Pub. L. 119-4, March 15, 2025), Further Continuing Appropriations and Other Extensions Act of 2024 (Pub. L. 118-22, November 17, 2023), Consolidated Appropriations Act, 2023 (Pub.

L. 117-328, December 29, 2022), Inflation Reduction Act of 2022 (IRA)

(Pub. L. 117-169, August 16, 2022), Consolidated Appropriations Act, 2022 (Pub. L. 117-103, March 15, 2022), Consolidated Appropriations Act, 2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018), the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L. 115- 271, October 24, 2018) and Consolidated Appropriations Act, 2026 (Pub.

L. 119-75, February 3, 2026), related to Medicare Part B payment. In

addition, this proposed rule includes provisions regarding other Medicare payment provisions described in sections III. and IV. of this proposed rule. This proposed rule updates policies for the Medicare Prescription Drug Inflation Rebate Program codified at 42 CFR parts 427 and 428 consistent with sections 1847A(i) and 1860D-14B of the Social Security Act (the Act). For the Medicare Part B Drug Inflation Rebate Program, this rule describes the identification of the Consumer Price Index for all Urban Consumers (CPI-U) for the payment amount benchmark quarter and the rebate period in certain instances when CPI-U survey data are unavailable and the calculation of the Part B rebate amount in such instances; proposes to clarify the definition of ``first marketed date''; and proposes to clarify that certain skin substitutes would not be excluded from the definition of a Part B rebatable drug. For the Medicare Part D Drug Inflation Rebate Program, this rule describes the identification of the CPI-U for the payment amount benchmark period and applicable period in certain instances when CPI-U survey data are unavailable and the calculation of the Part D rebate amount in such instances; proposes a modification to the methodology finalized in the CY 2026 PFS final rule to account for 340B-eligible units for AIDS Drug Assistance Program (ADAP) enrollees for the applicable period beginning October 1, 2025; and proposes to require Medicare providers and suppliers that are 340B covered entities to submit Part D 340B claims data to the Medicare Part D Claims Data 340B Repository beginning in 2027. This proposed rule proposes to modify policies for the Shared Savings Program, which is a voluntary program that started in 2012. The program allows groups of providers and suppliers to form or participate in Accountable Care Organizations (ACOs), and to be held accountable for the quality and total cost of care for an assigned population of Medicare fee-for-service (FFS) beneficiaries.

B. Summary of the Key Provisions

Section 1848 of the Act requires us to establish payments under the PFS, based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: work, practice expense (PE), and malpractice (MP) expense. In addition, the statute requires that each year we establish, by regulation, the payment amounts for physicians' services paid under the PFS, including geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major proposed rule, we are proposing RVUs for CY 2027 for the PFS to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes discussions and provisions regarding several other Medicare Part B payment policies, and other policies regarding programs administered by CMS. Specifically, this proposed rule addresses: Background (section II.A.) Determination of PE RVUs (section II.B.) Payment for Medicare Telehealth Services (section II.C.) Valuation of Specific Codes, Including Potentially Misvalued Codes (PMVC) (section II.D.) Redesigning Primary Care to Make America Healthy Again (section II.E.) Comprehensive Outpatient Rehabilitation Facility (CORF) Services and KX Modifier Thresholds (section II.F.) Supporting Beneficiaries Planning for Future Medical Decisions (section II.G.) [[Page 43844]] Current Procedural Terminology (CPT) Request for Information (RFI) (section II.H.) Drugs and Biological Products Paid Under Medicare Part B: Discarded Drugs (section III.A.) Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (section III.B.) Clinical Laboratory Fee Schedule (CLFS): CAA, 2026 (section III.C.) Proposed Changes to the Ambulatory Specialty Model (ASM) (section III.D.) Limiting Medicare Coverage of Certain Individuals (section III.E.) Medicare Prescription Drug Inflation Rebate Program (section III.F.) Medicare Shared Savings Program (section III.G.) Changes to the Regulations Associated with the Ambulance Fee Schedule (section III.H.) Request for Information (RFI) on Duplicate Laboratory Testing, Imaging, and Result Sharing and Interoperability (section III.I.) CY2027 Modifications to the Quality Payment Program Reporting and Data Submission (section IV.) Collection of Information Requirements (section V.) Response to Comments (section VI.) Regulatory Impact Analysis (section VII.)

C. Summary of Costs and Benefits

Based on our estimates, the Office of Information and Regulatory Affairs in the Office of Management and Budget has determined that this proposed rule is economically significant under section 3(f)(1) of Executive Order 12866. As required by section 1848(d)(1)(A) of the Act, beginning in 2026, there are two separate conversion factors (CFs): one for items and services furnished by a qualifying APM participant (QP) as defined in section 1833(z)(2) of the Act and 42 CFR 414.1305 (referred to as the qualifying APM conversion factor) and another for items and services furnished by clinicians who are not QPs (referred to as the nonqualifying APM conversion factor), equal to the respective conversion factor for the previous year multiplied by the update established under section 1848(d)(20) of the Act for such respective conversion factor for such year. Under these provisions, the 2027 qualifying APM conversion factor represents a projected decrease of $0.40 (-1.19 percent) from the current conversion factor of $33.4009. Similarly, the 2027 nonqualifying APM conversion factor represents a projected decrease of $0.56 (-1.68 percent) from the current conversion factor of $33.5875. For a detailed discussion of the economic impacts, see section VII., Regulatory Impact Analysis, of this proposed rule.

A. Background

In accordance with section 1848 of the Social Security Act (the Act), CMS has paid for physicians' services under the Medicare physician fee schedule (PFS) since January 1, 1992. The PFS relies on national relative values that are established for work, practice expense (PE), and malpractice (MP), which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the relative value units (RVUs) into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239, December 19, 1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990). The final rule published in the November 25, 1991 Federal Register (56 FR 59502) set forth the first fee schedule used for Medicare payment for physicians' services. We note that throughout this proposed rule, unless otherwise noted, the term ``practitioner'' is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for the services they furnish to Medicare beneficiaries.

1. Overview

Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding malpractice (MP) expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expenses, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service specific PE RVUs. We refer readers to the CY 2010 Physician Fee Schedule (PFS) final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.

2. Practice Expense Methodology

a. Direct Practice Expense We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the American Medical Association (AMA)/Specialty Society Relative Value Scale (RVS) Update Committee (referred to as the RUC) and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work RVUs under the PFS and proposed changes to the PE methodology in the CY 2007 PFS proposed rule (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629). b. Indirect Practice Expense per Hour Data We use survey data on indirect PEs incurred per hour (PE/HR) worked to develop the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty obtained from the AMA's Socioeconomic Monitoring System (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of physicians and NPPs paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We have stated that we believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey. When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology or how the PE/HR data are used. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for [[Page 43845]] some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section. Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data. Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data. Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data. We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare- recognized specialty data. Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and comment rulemaking and are available in the file titled ``CY 2027 PFS proposed rule PE/HR'' on the CMS website under downloads for the CY 2027 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. c. Allocation of PE to Services To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service. (1) Direct Costs The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service. (2) Indirect Costs Under current policy, we allocate the indirect costs at the code level based on the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows: For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00). Next, under current policy, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service. Then, we incorporate the specialty specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service. In the CY 2007 PFS final rule with comment period, we implemented the ``bottom up'' methodology for the development of PE RVUs (71 FR 69630-69643). We finalized the use of the work RVU or the clinical labor portion of the direct PE RVU, whichever is greater, to allocate indirect costs. We also finalized a modified formula for a global service (that is, a service with a professional component (PC) and a technical component (TC)) to utilize both the work RVU and the clinical labor PE RVU to allocate indirect costs. As noted in the CY 2007 PFS final rule with comment period, we do this to recognize that, for the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVU and the clinical labor PE RVU. This also allows the global component RVUs to equal the sum of the PC and TC RVUs. In recent years, as we have conducted analyses aimed at improving the accuracy of payment under the PFS, we have re-examined this longstanding policy that effectively allocates a larger share of indirect PE RVUs to services that can be reported using technical, professional, and global components than to those that cannot. We refer the reader to a report by RAND Corporation, under contract with CMS, which addresses several approaches to improving the accuracy of other PFS [[Page 43846]] services relative to services that have a professional and technical component. This report is available at https://www.rand.org/pubs/research_reports/RRA4720-2.html. This longstanding policy inadvertently advantages services that can be reported using technical, professional, and global components, referred to as ``triplet services'' in the report by RAND Corporation, because indirect PE RVUs are allocated on the sum, whereas services that can only be reported as a global service, referred to as ``non- triplet services'' in the report, depend on the maximum (rather than sum) of clinical labor PE RVUs and physician work RVUs. This is an unintended advantage of the arithmetic required for the global component RVUs to equal the sum of the PC and TC RVUs. We believe it would be more accurate than the current PE methodology to use the same allocation methodology for all PFS services. Therefore, we are proposing to allocate indirect PE using both the work RVU and the clinical labor RVU for all services, with the exception of codes with 010- and 090-day global periods, instead of just applying that methodology to those services that can be reported using technical, professional, and global components (typically diagnostic and imaging services). In the description of the calculation of the PE methodology below, we indicate the portion of the methodology that would be calculated differently under this proposal. (3) Facility and Non-Facility Costs For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: facility and non-facility. The methodology for calculating PE RVUs is generally the same for both the facility and non-facility RVUs but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the non-facility PE RVUs. In the CY 2026 PFS final rule (90 FR 49292-49296), we finalized a modification in the allocation of indirect PE to reduce the portion of the facility PE RVUs allocated based on work RVUs to half the amount allocated to non-facility PE RVUs beginning in CY 2026. (4) Services With Technical Components and Professional Components Diagnostic services are generally comprised of two components: a professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different healthcare providers, or they may be furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global direct PE RVUs.) (5) PE RVU Methodology For a more detailed description of the PE RVU methodology, we direct readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers to the file titled ``Calculation of PE RVUs under Methodology for Selected Codes'' which is available on our website under downloads for the CY 2027 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file contains a table that illustrates the calculation of PE RVUs as described in this proposed rule for individual codes. (a) Setup File First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/non-facility place of service level, and the specialty specific PE/HR data calculated from the surveys. (b) Calculate the Direct Cost PE RVUs Sum the costs of each direct input. Step 1: Sum the direct costs of the inputs for each service. Step 2: Calculate the aggregate pool of direct PE costs for the current year. We set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the projected aggregate work RVUs. Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregate direct costs for all services from Step 1 and the utilization data for that service. Step 4: Using the results of Step 2 and Step 3, use the CF to calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling adjustment to the direct costs for each service (as calculated in Step 1). Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs as long as the same CF is used in Step 4 and Step 5. Different CFs would result in different direct PE scaling adjustments, but this has no effect on the final direct cost PE RVUs since changes in the CFs and the associated direct scaling adjustments offset one another. (c) Create the Indirect Cost PE RVUs Create indirect allocators. Step 6: Based on the survey data, calculate direct and indirect PE percentages for each physician specialty. Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service. We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 52983) to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning a specialty mix based on the specialties of the practitioners reporting the services in the claims data, we use the expected specialty that we identify on a list developed based on medical review and input from expert interested parties. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and other interested parties on changes to this list annually. Services for which the [[Page 43847]] specialty is automatically assigned based on previously finalized policies under our established methodology (for example, ``always therapy'' services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule (82 FR 52982 through 52983) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category. In prior years, we reviewed information submitted during the proposed rule comment period regarding potential additions to the list of expected specialty assignments, to determine whether the specialty assignments commenters recommended were appropriate for the services in question. Our review process has been based on determining if the recommended specialty matched the dominant specialty in the claims data. However, we have long held reservations on whether this was the most accurate method for implementing updates to the expected specialty assignments list. Since these updates to the list were never formally proposed in the proposed rule of each calendar year, there was never an opportunity for interested parties to comment and provide feedback before the assignments were finalized in the final rule. We believe that it would provide greater transparency and more opportunities for public comment if additions to the expected specialty assignments list were instead proposed in each year's proposed rule. Therefore, we did not finalize any additions to the expected specialty assignments list in the CY 2026 PFS final rule (90 FR 49270). We stated that we would instead review the list of approximately 75 low volume HCPCS codes submitted by commenters and propose additions to the list in this year's CY 2027 PFS proposed rule. We will also review any submissions for inclusion to the expected specialty assignments list by the same February 10th deadline that we have finalized in the past for consideration of RUC recommendations and invoice-based updates to supply and equipment pricing. We believe that synchronizing submissions to the expected specialty assignments list for low volume services with the same annual date used for RUC recommendations and invoice submissions will help standardize the process, while also providing more opportunities for feedback from interested parties by going through the annual comment process. During the comment period for the CY 2026 PFS rule, several commenters stated that they had performed an analysis to identify all codes that meet the criteria to receive a specialty override under this CMS policy and drafted updated recommendations for codes that meet these criteria. Commenters stated that the purpose of assigning a specialty to these codes was to avoid the significant adverse impact on MP RVUs that results from errors in specialty utilization data magnified in representation (percentage) by small sample size. These commenters submitted a list of approximately 75 low volume HCPCS codes with recommended expected specialty assignments. After reviewing the information provided by the commenters to determine whether the specialty assignments they recommended were appropriate for the services in question, based on determining if the recommended specialty matches the dominant specialty in the claims data, we are proposing the additions to the list of expected specialty assignments for low volume services identified in Table A-B1. We agree with the commenters that, based on claims data, CPT codes 33277 through 33281 and 33287 through 33288 should be crosswalked to the Cardiac Electrophysiology specialty and that CPT codes 93584 through 93588 should be crosswalked to the Interventional Cardiology specialty. We also agree with commenters that CPT code 23077 should be crosswalked to the Surgical Oncology specialty. However, we do not have PE/HR data for these specialties as they were not part of the PPIS when it was conducted in 2007; therefore, we are crosswalking these CPT codes to the closest available specialties (Cardiology for the first two groups of codes and All Physicians for CPT code 23077), as listed on Table A- B1. We disagree with the commenters on a series of additional suggested assigned specialties. In each case, there was another specialty which was reported more than twice as often in the claims data as the specialty suggested by commenters and in some cases reported as much as five times as often. Therefore, we are crosswalking CPT codes 15135 and 41000 to the Otolaryngology specialty, CPT codes 26118 and 26650 to the Orthopedic Surgery specialty, CPT codes 93025 and 93150 to the Cardiology specialty, and CPT codes 93152 and 93153 to the Pulmonary Disease specialty as these were the dominant specialties in the claims data. These crosswalks are included in Table A-B1. BILLING CODE 4169-69-P [[Page 43848]] [GRAPHIC] [TIFF OMITTED] TP16JY26.010 [[Page 43849]] [GRAPHIC] [TIFF OMITTED] TP16JY26.011 BILLING CODE 4169-69-C The full list of expected specialty assignments is included in the CY 2027 public use files, which are available on the CMS website under downloads for the CY 2027 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVUs; the clinical labor PE RVUs; and the work RVUs. Under current policy, for most services the indirect allocator is: indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs. There are two situations where this formula is modified: If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs. If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs. (Note: Under current policy, for global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs would be allocated using the work RVUs, and for the TC service, indirect PEs would be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.) For presentation purposes, in the examples in the download file titled ``Calculation of PE RVUs under Methodology for Selected Codes'', the formulas were divided into two parts for each service. The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage). Under current policy, the second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step). We note that for CY 2026, we finalized a change to the methodology so that when work RVUs are used to allocate indirect PE to the facility RVUs, they are assigned at one-half the amount allocated to the non- facility PE RVUs for that same service. These PE methodology changes are discussed in greater detail in the CY 2026 PFS final rule (90 FR 49292 through 49296). Proposed Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVUs; the clinical labor PE RVUs; and the work RVUs. The proposed indirect allocator is: indirect PE percentage *(direct PE RVUs/direct percentage) + work RVUs + clinical labor RVUs. The proposed change is to include both the work RVUs and clinical labor RVUs in the indirect allocator for all services, except for codes with 010- and 090-day global periods, as opposed to including the [[Page 43850]] work RVUs and clinical labor RVUs only for global services as detailed above. If this proposed policy were to be finalized, this Proposed Step 8 would replace the Step 8 listed earlier. For presentation purposes, in the examples in the download file titled ``Calculation of PE RVUs under Methodology for Selected Codes,'' the formulas were divided into two parts for each service. The first part is the indirect percentage (direct PE RVUs/ direct percentage). The second part is the sum of the work RVU and the clinical labor PE RVU, including the methodology change finalized in CY 2026 for services performed in the facility setting (when work RVUs are used to allocate indirect PE to the facility RVUs, they are assigned at one-half the amount allocated to the non-facility PE RVUs for that same service). Apply a scaling adjustment to the indirect allocators. Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data. Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service. Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. Under current policy, calculate the indirect practice cost index (IPCI). We refer readers to the CY 2007 PFS final rule with comment period (71 FR 69633) for more information about the establishment of the IPCI. Step 12: Using the results of Step 11, calculate aggregate pools of specialty specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service. Step 13: Using the specialty specific indirect PE/HR data, calculate specialty specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty. Step 14: Using the results of Step 12 as the denominator and Step 13 as the numerator, calculate the specialty specific indirect PE scaling factors. Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty specific indirect scaling factor by the average indirect scaling factor for the entire PFS. Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.) Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs. Proposal regarding Steps 12 through 17: We develop the indirect practice expense (PE) RVUs under the PFS to reflect the relative resources involved in furnishing the services. Since the implementation of the resource-based PE RVUs, we have assumed that aggregate specialty level practice costs derived primarily from the 2007 PE/HR survey data are a reasonable way to help establish the resource-based indirect PE RVUs. We have historically used that data both to allocate indirect costs to each code and to re-scale the resulting PE RVUs for each code at the end of the established methodology to ensure that the overall allocation of PE RVUs for each specialty across the PFS approximates those expected based on the index derived from the PE/HR survey data. Over time, however, we have identified various limitations of the survey data, especially as the data we use has become increasingly dated and are intrinsically limited to small, selective samples based on pre-determined assumptions about where costs are likely to differ, and, as we addressed in CY 2026 PFS rulemaking, have not been adequately updated. (We refer readers to an extended discussion of our concerns with and decision not to update this data in the CY 2026 PFS final rule at 90 FR 49286 through 49292.) This has resulted in a PE methodology that privileges the historic survey data over incorporation of more recent data about specific services and produces unpredictable and counterintuitive results that are not transparent to the public. Because we have taken various steps to improve the data used in the pricing inputs and the indirect allocation methodologies, we are proposing to remove the steps of the current methodology that rely on the indirect practice cost index (IPCI) from the calculation of the PE RVUs. We propose this change, because the steps of the current methodology that rely on the IPCI calculation effectively favor the aggregate specialty-level survey data over the code level inputs and allocators and consequently limit the influence of improvements to inputs and allocation methodologies. We are proposing to implement this change over a 2-year transition period. Specifically, in the first year, only half of the measured variation in the IPCI will be applied to the indirect allocator. In the second year, the IPCI will no longer be applied. The steps of the current methodology that rely on the IPCI calculation are steps 12 through 17. Thus, under this proposal, steps 12 through 17 would no longer be a part of the calculation, and the total PE RVU, prior to the calculation of final PE RVUs described below at Step 18, would be the sum of step 5 (Direct Cost PE RVUs) and step 11 (Indirect Cost PE RVUs). (d) Calculate the Final PE RVUs Step 18: Under current policy, add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 to the aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS BN. (See ``Specialties excluded from ratesetting calculation'' later in this proposed rule). Under the proposed policy, add the direct cost PE RVUs from Step 5 to the indirect cost PE RVUs from Step 11 and apply the final PE BN adjustment. Proposed Step 19: Calculate and apply the PE stabilization factor for each PE RVU by comparing the result of step 18 with the results of the prior year's PE RVUs from step 18. As described previously in this section, we are proposing to remove the IPCI from the PE methodology, which we believe will improve the transparency and stability of PE RVUs over time. However, we recognize that the IPCI, because it is rooted in static PE/HR data, effectively resulted in stabilizing year-to-year changes in PE RVUs, especially due to changes in input valuations and changes to allocation methodologies. We have long noted that extreme volatility in PE RVUs can have [[Page 43851]] unintended consequences and distortions. To mitigate volatility that could otherwise occur, we are proposing a PE stabilization adjustment to further improve predictability and reduce volatility within the PE RVUs. Specifically, we are proposing that the PE RVU calculated after the application of the cognitive services floor and any adjustments that occur outside of the PE methodology will be subject to a cap and will not increase or decrease by more than 5 percent each year. In the proposed Step 19 we would compare the PE RVU after the application of the cognitive services floor and any code-level adjustments in the current ratesetting year to the allocation methodology from the prior year and then apply the 5 percent cap. We note that the proposed stabilization adjustment in Proposed Step 19 will be applied prior to the statutory phase-in of significant RVU reductions required by Section 1848(c)(7) of the Act, discussed in more detail later in this section, which limits all codes that are not new or revised to a 19 percent decrease in total RVU in an individual calendar year. Therefore, a code may be impacted by both the PE stabilization adjustment and the statutory phase-in, meaning a code's PE RVU may ultimately differ by greater than the PE stabilization adjustment detailed in proposed Step 19. This proposed adjustment would not apply to new and revised codes or codes formerly contractor priced that are newly nationally priced, because it is not clear what the comparison PE RVU would be for those codes. Because we believe the benefits of the PE stabilization adjustment would ideally apply to new and revised codes and newly nationally priced codes, we are seeking comment on an approach that would allow us to expand the PE stabilization adjustment to these categories of codes. Additionally, the proposed PE stabilization adjustment would not apply to revalued codes because we believe the statutory phase-in sufficiently limits large reductions to individual codes undergoing review and/or revaluation, and limits the amount of time a revalued code would remain overvalued by being significantly constrained from reductions found to be appropriate through revaluation. Step 19 (under our proposal, step 19 would be renumbered as step 20): Apply the phase-in of significant RVU reductions and its associated adjustment. Section 1848(c)(7) of the Act specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs must be phased in over a 2-year period. In implementing the phase-in, we consider a 19 percent reduction as the maximum 1-year reduction for any service not described by a new or revised code. This approach limits the year 1 reduction for the service to the maximum allowed amount (that is, 19 percent), and then phases in the remainder of the reduction. To comply with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the total RVUs for all services that are not new or revised codes decrease by no more than 19 percent, and then apply a relativity adjustment to ensure that the total pool of aggregate PE RVUs remains relative to the pool of work and MP RVUs. For a more detailed description of the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70931). In summary, for CY 2027, we are proposing to: Modify step 8 to calculate indirect PE based on both work RVUs and clinical labor RVUs for all services except 010- and 090-day global period codes; Remove steps 12 through 17 that rely on the IPCI from the calculation of the PE RVUs over a 2-year transition period, and; Add a new step to apply a stabilization adjustment to the PE RVUs (proposed step 19). (e) Setup File Information Specialties excluded from ratesetting calculation: To calculate the PE and MP RVUs, we exclude certain specialties, such as NPPs paid at a percentage of the PFS and low volume specialties, from the calculation. These specialties are included to calculate the BN adjustment. They are displayed in Table A-B2. [[Page 43852]] [GRAPHIC] [TIFF OMITTED] TP16JY26.012 Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties. Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy. Identify professional and technical services not identified under the usual technical component (TC) and professional component (PC or 26) modifiers: Flag the services that are PC and TC services but do not use TC and PC/26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report). Payment modifiers: In the CY 2013 PFS proposed rule (77 FR 68901), we introduced a more detailed methodology for adjusting volume and time to account for payment modifiers and other special payment rules, such as multiple procedure payment reductions, in the utilization data. We are proposing that, beginning in CY 2027, we would utilize a new approach to account for payment modifiers and other special payment rules. For each paid claim line, we would calculate the ratio of allowed charges to the national PFS payment amount. This would account for differences resulting from payment modifiers and other special payment rules, as well as differences in geography. We are proposing to use the same ratio to adjust time, rather than a separate calculation under our current methodology, with the exception of anesthesia, for which we calculate time using only procedures with modifiers indicating they are personally performed. These proposed changes will [[Page 43853]] allow us to more accurately capture any combination of modifiers and special payment rules and automatically account for updates in modifiers and/or special payment rules in future years. These proposed changes have a very minimal impact on the resulting PE RVUs but will produce a more accurate result. As under our current methodology, the adjusted volume will be displayed in the utilization file that is posted in conjunction with each PFS rule. Work RVUs: The setup file contains the work RVUs from this proposed rule. (6) Equipment Cost per Minute The equipment cost per minute is calculated as: (1/(minutes per year * usage)) * price * ((interest rate/( 1 (1/((1 + interest rate)- life of equipment)))) + maintenance) Where: minutes per year = maximum minutes per year if usage were continuous (that is, usage = 1); generally, 150,000 minutes. usage = variable, see discussion later in this proposed rule. price = price of the particular piece of equipment. life of equipment = useful life of the particular piece of equipment. maintenance = factor for maintenance; 0.05. interest rate = variable, see discussion later in this proposed rule. Usage: We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act. Useful Life: In the CY 2005 PFS final rule we stated that we updated the useful life for equipment items primarily based on the AHA's ``Estimated Useful Lives of Depreciable Hospital Assets'' guidelines (69 FR 66246). The most recent edition of these guidelines was published in 2018. This reference material provides an estimated useful life for hundreds of different types of equipment, the vast majority of which fall in the range of 5 to 10 years, and none of which are lower than 2 years in duration. We believe that the updated editions of this reference material remain the most accurate source for estimating the useful life of depreciable medical equipment. In the CY 2021 PFS final rule, (85 FR 84482 through 84483) we finalized a proposal to treat equipment life durations of less than 1 year as having a duration of 1 year for the purpose of our equipment price per minute formula. In the rare cases where items are replaced every few months, we noted that we believe it is more accurate to treat these items as disposable supplies with a fractional supply quantity as opposed to equipment items with very short equipment life durations. For a more detailed discussion of the methodology associated with very short equipment life durations, we refer readers to the CY 2021 PFS final rule (85 FR 84482 through 84483). Maintenance: We finalized the 5 percent factor for annual maintenance in the CY 1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY 2016 PFS final rule with comment period (80 FR 70897), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also noted that we believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding data sources containing equipment maintenance rates, commenters could not identify an auditable, robust data source that CMS could use on a wide scale. We noted that we did not believe voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, in the proposed rule, we did not propose a variable maintenance factor for equipment cost per minute pricing as we did not believe that we have sufficient information at present. We noted in the CY 2026 PFS proposed rule (90 FR 32593) that we would continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items. Interest Rate: In the CY 2013 PFS final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation (see 77 FR 68902 for a thorough discussion of this issue). The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). The interest rates are listed in Table A-B3. [GRAPHIC] [TIFF OMITTED] TP16JY26.013 We are not proposing any changes to the equipment interest rates for CY 2027.

3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index

(MEI) We have long stated that we believe that the MEI is the best measure available to determine the relative weights of the three components in payments under the PFS--work, practice expense (PE), and malpractice (MP). Accordingly, we believe that to ensure that the PFS payments reflect the relative resources in each of these PFS components as required by section 1848(c)(3) of the Act, the RVUs used in developing rates should reflect the same weights in each component as the cost share weights in the Medicare Economic Index (MEI). Accordingly, we have finalized to accomplish this (78 FR 74241 through 74242) by holding the work RVUs constant and adjusting the PE RVUs, MP RVUs, and conversion factor (CF) to produce the appropriate balance in RVUs among the three PFS [[Page 43854]] components and payment rates for individual services, that is, that the total RVUs on the PFS are proportioned to approximately 51 percent work RVUs, 45 percent PE RVUs, and 4 percent MP RVUs. Historically, as the MEI cost shares are updated, we have proposed to modify steps 3 and 10 to adjust the aggregate pools of PE costs (direct PE in step 3 and indirect PE in step 10) in proportion to the change in the PE share in the MEI cost share weights, and to recalibrate the relativity adjustment that we apply in step 18 as described in the CY 2023 PFS final rule (87 FR 69414 and 69415) and CY 2014 PFS final rule (78 FR 74236 and 74237). The most recent recalibration was done for the CY 2014 RVUs. However, due to overarching concerns with the data as described in the CY 2026 PFS final rule (90 FR 49287 through 49293) and our previously described policy goal to balance PFS payment stability and predictability with incorporating new data through routine updates to the MEI, we finalized our proposal to maintain the current PE/HR and 2006-based MEI cost shares (rather than transitioning to the 2017-based MEI cost shares), for CY 2026 PFS ratesetting due to the concerns about data quality and payment stability. Additionally, for CY 2027, we are proposing to continue to use the current PE/HR and 2006-based MEI cost shares for CY 2027 PFS ratesetting.

4. Changes to Direct PE Inputs for Specific Services

This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2027 direct PE input public use files, which are available on the CMS website under downloads for the CY 2027 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-fafor-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. a. Standardization of Clinical Labor Tasks As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640 through 67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and post service periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve the relativity of values among codes. For example, as medical practice and technologies change over time, standards could be updated simultaneously for all codes with the applicable clinical labor tasks instead of waiting for individual codes to be reviewed. In the CY 2016 PFS final rule with comment period (80 FR 70901), we solicited comments on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology. After consideration of comments received, we finalized standard times for clinical labor tasks associated with digital imaging at 2 minutes for ``Availability of prior images confirmed'', 2 minutes for ``Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist'', 2 minutes for ``Review examination with interpreting MD'', and 1 minute for ``Exam documents scanned into PACS'' and ``Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through 80186), we finalized a policy to establish a range of appropriate standard minutes for the clinical labor activity, ``Technologist QCs images in PACS, checking for all images, reformats, and dose page.'' These standard minutes will be applied to new and revised codes that make use of this clinical labor activity when they are reviewed by us for valuation. We finalized a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate case, 4 minutes as the standard for the complex case, and 5 minutes as the standard for the highly complex case. These values were based upon a review of the existing minutes assigned for this clinical labor activity; we determined that 2 minutes is the duration for most services and a small number of codes with more complex forms of digital imaging have higher values. We also finalized standard times for a series of clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902). We do not believe these activities would be dependent on the number of blocks or batch size, and we believe that the finalized standard values accurately reflect the typical time it takes to perform these clinical labor tasks. In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the ``Prepare room, equipment and supplies'' (CA013) clinical labor activity were split into 2 minutes for the ``Prepare room, equipment and supplies'' activity and 1 minute for the ``Confirm order, protocol exam'' (CA014) activity. We proposed to maintain the 3 minutes of clinical labor time for the ``Prepare room, equipment and supplies'' activity and remove the clinical labor time for the ``Confirm order, protocol exam'' activity wherever we observed this pattern in the RUC-recommended direct PE inputs. Commenters explained in response that when the new version of the PE worksheet introduced the activity codes for clinical labor, there was a need to translate old clinical labor tasks into the new activity codes, and that a prior clinical labor task was split into two of the new clinical labor activity codes: CA007 (Review patient clinical extant information and questionnaire) in the preservice period, and CA014 (Confirm order, protocol exam) in the service period. Commenters stated that the same clinical labor from the old PE worksheet was now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each activity. We agreed with commenters that we would finalize the RUC- recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code in situations where this was the case. However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include this old clinical labor task, and we also noted that several of the reviewed codes that contained the CA014 clinical labor activity code did not contain any clinical labor for the CA007 activity. In these situations, we believe that the three total minutes of [[Page 43855]] clinical staff time would be more accurately described by the CA013 ``Prepare room, equipment and supplies'' activity code, and we finalized these clinical labor refinements. We direct readers to the discussion in the CY 2019 PFS final rule (83 FR 59463 through 59464) for additional details. Following the publication of the CY 2020 PFS proposed rule, a commenter expressed concern with the published list of common refinements to equipment time. The commenter stated that these refinements were the formulaic result of applying refinements to the clinical labor time and did not constitute separate refinements; the commenter requested that CMS no longer include these refinements in the table published each year. In the CY 2020 PFS final rule, we agreed with the commenter that these equipment time refinements did not reflect errors in the equipment recommendations or policy discrepancies with the RUC's equipment time recommendations. However, we believed it was important to publish the specific equipment times that we were proposing (or finalizing in the case of the final rule) when they differed from the recommended values due to the effect these changes can have on the direct costs associated with equipment time. Therefore, we finalized the separation of the equipment time refinements associated with changes in clinical labor into a separate table of refinements. We direct readers to the discussion in the CY 2020 PFS final rule (84 FR 62584) for additional details. Historically, the RUC has submitted a ``PE worksheet'' that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time, and among the medical specialties developing the recommendations. These variations have made it difficult for the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC mandated the use of a new PE worksheet for its recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations helps us simplify and standardize the hundreds of clinical labor tasks currently listed in our direct PE database. To facilitate rulemaking for CY 2027, we are displaying the Labor Task Detail public use file that contains the current listing of clinical labor activity codes. This file is available on the CMS website under downloads for the CY 2027 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. b. Updates to Prices for Existing Direct PE Inputs In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. Beginning in CY 2019 and continuing through CY 2022, we conducted a market-based supply and equipment pricing update using information developed by our contractor which updated pricing recommendations for approximately 1300 supplies and 750 equipment items currently used as direct PE inputs. Given the potentially significant changes in payment that would occur, in the CY 2019 PFS final rule, we finalized a policy to phase in our use of the new direct PE input pricing over a 4-year period using a 25/ 75 percent (CY PFS 2019), 50/50 percent (CY PFS 2020), 75/25 percent (CY PFS 2021), and 100/0 percent (CY PFS 2022) split between new and old pricing. We believe that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy while maintaining stability and allowing interested parties to address potential concerns about changes in payment for particular items. This 4-year transition period to update supply and equipment pricing concluded in CY 2022; for a more detailed discussion, we refer readers to the CY 2019 PFS final rule with comment period (83 FR 59473 through 59480). For CY 2027, we are proposing to update the price of nine supplies and two equipment items in response to the public submission of invoices following the publication of the CY 2026 PFS final rule. These supply and equipment items with updated prices are listed in the valuation of specific codes section of the rule under Table A-D9, CY 2027 Invoices Received for Existing Direct PE Inputs. These proposed pricing updates include a request from the RUC to update the pricing of the moderate sedation pack (SA044) to more accurately reflect its components. The RUC determined that a sterile gown is not needed as part of the moderate sedation pack, however, a regular staff gown should be included to protect the sedation provider from all body fluids, substance, and excretions. The RUC also requested that a mask would be an appropriate addition in the sedation pack, resulting in a price change from the current $19.20, minus the $5.13 sterile gown, plus the $1.19 staff gown and $0.43 mask, for a new total price of $15.69. We are proposing this $15.69 price for the SA044 moderate sedation pack which is reflected in Table A-E, CY 2027 Invoices Received for Existing Direct PE Inputs. Additionally, we received a potentially misvalued code (PMVC) nomination for SA119 kit, low frequency ultrasound wound therapy (MIST) and are proposing an updated supply cost from $320.18 to $100 for SA119. We refer readers to section II.D. of this proposed rule for more information about this proposal. (1) Invoice Submission We remind readers that we routinely accept public submissions of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often, these invoices are submitted in conjunction with the RUC-recommended values for the codes. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations. However, we will consider invoices submitted as public comments during the comment period following the publication of the CY 2027 PFS proposed rule and will consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices. Interested parties are encouraged to submit invoices with their public comments or, if outside the notice and comment rulemaking process, via email at [email protected]. (2) Supply Pack Pricing Update Interested parties previously notified CMS that they identified numerous discrepancies between the aggregated cost of some supply packs and the individual item components contained within. The interested parties indicated that CMS should rectify these mathematical errors as soon as possible to ensure that the sum correctly matches the totals from the individual items, and they recommended that we resolve these pricing discrepancies in the supply packs during CY 2024 rule. The AMA RUC convened a workgroup on this subject and submitted recommendations to update pricing for a series of supply packs along with the [[Page 43856]] RUC's comment letter for the CY 2024 rule cycle. We appreciated the additional information and RUC workgroup recommendations regarding discrepancies in the aggregated cost of some supply packs. However, due to the projected significant cost revisions in the pricing of supply packs and because we did not propose to address supply pack pricing in the CY 2024 proposed rule, we stated in the CY 2024 final rule that this issue would be better addressed in future rulemaking. For example, the cleaning and disinfecting endoscope pack (SA042) is included as a supply input in more than 300 HCPCS codes, which could have a sizable impact on the overall valuation of these services, and which was not incorporated into the proposed RVUs published for the CY 2024 proposed rule. We stated that interested parties would be better served if we comprehensively addressed this topic during future rulemaking in which commenters could provide feedback in response to proposed pricing updates (88 FR 78833 through 78834). For CY 2025, we proposed implementing the supply pack pricing update and associated revisions as recommended by the RUC's workgroup (89 FR 97726 through 97727). We proposed to update the pricing of the ``pack, cleaning and disinfecting, endoscope'' (SA042) supply from $19.43 to $31.29, to update the pricing of the ``pack, drapes, cystoscopy'' (SA045) supply from $17.33 to $14.99, to update the pricing of the ``pack, ocular photodynamic therapy'' (SA049) supply from $16.35 to $26.35, to update the pricing of the ``pack, urology cystoscopy visit'' (SA058) supply from $113.70 to $37.63, and to update the pricing of the ``pack, ophthalmology visit (w-dilation)'' (SA082) supply from $3.91 to $2.33. As recommended by the RUC workgroup, we also proposed to delete the ``pack, drapes, laparotomy (chest- abdomen)'' (SA046) supply entirely. The updated prices for these supply packs were listed in the valuation of specific codes section of this rule under Table A-B5, CY 2025 Invoices Received for Existing Direct PE Inputs (89 FR 97852). In accordance with the RUC workgroup's recommendations, we also proposed to create eight new supply codes, including components contained within previously existing supply packs. Aside from the SB056 supply, which is a replacement in several HCPCS codes for the deleted SA046 supply pack, all of these new supplies are not included as standalone direct PE inputs in any current HCPCS codes, as they are, again, components contained within previously existing supply packs. We proposed to add: The kit, ocular photodynamic therapy (PDT) (SA137) supply at a price of $26.00 as a component of the SA049 supply pack; The Abdominal Drape Laparotomy Drape Sterile (100 in x 72 in x 124 in) (SB056) supply at a price of $8.049 as a replacement for the SA046 supply pack; The drape, surgical, legging (SB057) supply at a price of $3.284 as a component of the SA045 supply pack; The drape, surgical, split, impervious, absorbent (SB058) supply at a price of $8.424 as a component of the SA045 supply pack; The post-mydriatic spectacles (SB059) supply at a price of $0.328 as a component of the SA082 supply pack; The y-adapter cap (SD367) supply at a price of $0.352 as a component of the SA049 supply pack; The ortho-phthalaldehyde 0.55 percent (for example, Cidex OPA) (SM030) supply at a price of $0.554 as a component of the SA042 supply pack; and The ortho-phthalaldehyde test strips (SM031) supply at a price of $1.556 as a component of the SA042 supply pack. The new supply pack component items were listed in the valuation of specific codes section of the rule under Table A-B8, CY 2025 PFS (89 FR 97722) New Invoices (89 FR 97853). We also proposed the following additional supply substitutions based on the recommendations of the RUC workgroup. We proposed to remove the deleted SA046 supply pack and replace it with the drape, sterile, fenestrated 16in x 29in (SB011) supply for CPT codes 19020, 19101, 19110, 19112, 20101, and 20102. We proposed to remove the deleted SA046 supply pack and replace it with two supplies--the drape, sterile, three-quarter sheet (SB014) and the drape, towel, sterile 18in x 26in (SB019)--for CPT codes 19000 and 60300. We proposed to remove the deleted SA046 supply pack and replace it with 2 supplies--the drape, towel, sterile 18in x 26in (SB019) and the newly created Abdominal Drape Laparotomy Drape Sterile (100 in x 72 in x 124 in) (SB056) supply--for CPT codes 22510, 22511, 22513, and 22514. We proposed to remove the deleted SA046 supply pack without replacing it with anything for CPT code 22526; the RUC workgroup did not make a recommendation on what to do with CPT code 27278, which also previously contained the SA046 supply pack. Therefore, we also proposed not to replace the SA046 supply pack with any supplies for this code. The RUC workgroup also recommended removing the SA046 supply pack from CPT code 64595 with no replacement; however, this code was recently reviewed at the April 2022 RUC meeting and it no longer includes the SA046 supply. In the comments on the CY 2025 PFS proposed rule (89 FR 97727), several commenters supported the proposed supply pack pricing update as recommended by the RUC workgroup, however they indicated concern over the proposed decrease in the price of the urology cystoscopy visit pack (SA058) from $113.70 to $37.63. The commenters stated that the proposed pricing reduction in the SA058 supply could result in drastic payment rate cuts for physicians performing cystoscopy services in the office setting. The commenters requested that CMS either delay the pricing update or phase-in the supply pack changes over a 4-year period like it has done for other PE changes with significant redistributive effects, allowing independent urology practices to better prepare for the negative financial impact this change will have. After considering these comments, we agreed that the use of a phased-in transition period would be appropriate to allow practitioners to adjust to the updated pricing of these supplies. During our previous supply and equipment pricing update in the CY 2019 PFS final rule (83 FR 59475), we finalized a policy to phase in any updated pricing that we established during the 4-year transition period for very commonly used supplies and equipment, such as sterile gloves (SB024) or exam tables (EF023), even if invoices were provided as part of the formal review of a code family. Based on this previously established policy, we finalized the use of a pricing transition for three supply packs in Table A-B4. [[Page 43857]] [GRAPHIC] [TIFF OMITTED] TP16JY26.014 Following the same pattern as our previous supply/equipment and clinical labor pricing updates, we finalized the implementation of this pricing transition over 4 years such that one-quarter of the difference between the current price and the fully phased-in price is implemented for CY 2025 PFS (89 FR 97722), one-third of the difference between the CY 2025 PFS (89 FR 97722) price and the final price is implemented for CY 2026 PFS, and one-half of the difference between the CY 2026 price and the final price is implemented for CY 2027, with the new direct PE prices fully implemented for CY 2028. For the other proposed supply packs, the cystoscopy drapes pack (SA045) is only included in seven HCPCS codes and the ocular photodynamic therapy pack (SA049) is only included in a single HCPCS code which do not meet these criteria established in previous rulemaking and described previously in this section. Therefore, we finalized each of them at their updated pricing for CY 2025 PFS (89 FR 97722) as proposed in the proposed rule. We believe that the use of this pricing transition will minimize any potential disruptive effects during the 4-year transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply packs. Several commenters also stated that although five incomplete packs would have their pricing updated in the proposed rule, mathematical errors still remained for a number of additional supply packs. Commenters stated that only 3 of the 18 affirmed packs were priced correctly to match their components and provided tables showing the pricing of an additional 15 packs that needed mathematical correction by deconstructing the packs to determine the correct price through summing their individual components. Commenters requested that CMS initiate a correction of the packs pricing such that the sum of the individual components match the price of the corresponding pack as detailed in Table A-B5. [GRAPHIC] [TIFF OMITTED] TP16JY26.015 While we shared the concerns of the commenters regarding the need for accuracy in the pricing of these supply packs, we had reservations about their potential for pricing disruptions. Ten of these supply packs are included in the direct PE inputs for at least 100 HCPCS codes, and three of the packs are included in more than 1000 HCPCS codes. Many of these pricing updates would lead to drastic changes in pricing for these supply packs which are included in hundreds of HCPCS codes, such as the SA051 pelvic exam pack decreasing in price from $20.16 to $2.81 (-86 percent) and the SA048 minimum multi-specialty visit pack decreasing in price from $5.02 to $1.98 (-61 percent). We were particularly concerned that these changes in supply pack pricing could lead to significant shifts in the overall PE RVU for affected HCPCS codes, without these proposed rates appearing in the proposed rule or allowing any opportunity for public comment. Therefore, we did not finalize pricing updates for these additional 15 supply packs as requested by commenters. We anticipated returning to this subject in future rulemaking to allow any changes in associated pricing for HCPCS codes to appear in the proposed rule and provide an opportunity for the public to comment. Should these supply pack pricing updates be proposed in future [[Page 43858]] rulemaking, we anticipated that we might propose the same pricing transition described above due to the number of potentially affected HCPCS codes. We finalized all of the other supply pack pricing changes as proposed, with the exception of the 4-year pricing transition for three supply packs as described previously in this section. For CY 2026, we proposed to continue implementing the supply pack pricing update and associated revisions as previously recommended by the RUC's workgroup. We proposed to update the price of the 15 supply packs detailed in Table A-B5 which were received too late in CY 2025 PFS (89 FR 97722) to allow for proposed pricing or public comment. In the case of the surgical instruments cleaning pack (SA043), the moderate sedation pack (SA044) and the small ortho drapes pack (SA081), the proposed pricing update is modest enough that we proposed these supplies move immediately to their final prices for CY 2026. For the 12 other supply packs, we proposed that they be incorporated into the muti-year supply pack pricing transition finalized in CY 2025 rulemaking. Rather than having two separate 4-year pricing transitions associated with supply packs, we proposed that these 12 additional supply packs fold into the previous pricing transition using the same methodology, such that one-third of the difference between the CY 2025 PFS (89 FR 97722) price and the final price is implemented for CY 2026, and one-half of the difference between the CY 2026 price and the final price is implemented for CY 2027, with the new direct PE prices fully implemented for CY 2028 (89 FR 97728). With the inclusion of the SA042, SA058, and SA082 supply packs which began their pricing transition for CY 2025, we proposed the total supply pack pricing update detailed in Table A-B6. [GRAPHIC] [TIFF OMITTED] TP16JY26.016 Table A-B6 also includes the hydrophilic guidewire (SD089) supply which we proposed to transition in pricing over 3 years given its inclusion in approximately 100 HCPCS codes. We continue to believe that the use of this pricing transition will minimize any potential disruptive effects during the transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply items. After consideration of the public comments, we finalized our supply pack pricing policies as proposed in the CY 2026 PFS final rule (90 FR 49284). For CY 2027, these supply packs will continue with the third year of the previously finalized 4-year transition process as detailed in Table A-B6. As is the case with other supply and equipment pricing, we will consider invoices associated with these supply packs which are submitted as public comments during the comment period following the publication of the CY 2027 PFS proposed rule as part of our established annual process for requests to update supply and equipment prices. Interested parties are encouraged to submit invoices with their public comments or, if outside the notice and comment rulemaking process, via email at [email protected]. c. Technical Corrections to Direct PE Input Database and Supporting Files Following the publication of the CY 2026 PFS final rule, the RUC submitted a potential technical correction issue related to global period assignment for approximately three dozen codes. The RUC stated that these codes had long descriptors which indicated that they were add-on codes ``(List separately in addition to code for primary procedure)''; however, these codes were assigned the XXX global period instead of the ZZZ global period. The RUC requested that CMS consider assigning the ZZZ global period for these codes as a technical correction. We reviewed the list of codes submitted by the RUC and we agree that there appears to be a technical error in the global period assignment for these codes. Most of the affected codes have non-payable status codes and no RVUs, while the handful of affected HCPCS codes that do have RVUs specifically state in their descriptors that they were intended to be add-on codes, such as CPT code 88332 (Pathology consultation during surgery; each additional tissue block with frozen section(s)). We are therefore proposing to change the [[Page 43859]] following codes to the ZZZ global period: BILLING CODE 4169-69-P [GRAPHIC] [TIFF OMITTED] TP16JY26.017 BILLING CODE 4169-69-C The RUC also requested assigning the ZZZ global period to three anesthesia codes: CPT codes 01953, 01968, and 01969. However, currently all anesthesia codes use the XXX global period, and it is unclear whether the concept of an add-on global period would apply to anesthesia coding given that they are valued using base units and time units, unlike all other PFS services. For this reason, we are not proposing the ZZZ global period for these three codes at this time. We are soliciting comments from interested parties regarding the global period assignment for these three anesthesia codes, as well as the other codes listed in Table A-B7. d. Updates to Practice Expense (PE) Methodology--Site of Service Payment Differential We proposed a significant refinement to our PE methodology to better reflect trends in physician practice settings in the CY 2026 PFS final rule (90 FR 49292 through 49297). Under the finalized policy, we allocate half the amount of indirect PE RVUs per work RVU for services furnished in the facility setting compared to those allocated to services furnished in the non-facility setting. We noted in the CY 2026 PFS proposed rule (90 FR 32374) that this change to the indirect cost allocation methodology was intended to better recognize the relative resources involved in furnishing services paid under the PFS in facility and non-facility settings. We compared this change to our current methodology prior to CY 2026, which functionally presumed approximately equal indirect costs incurred by physicians across sites of service. This presumption was initially made in the context of most practitioners maintaining office practices independent of the facilities in which they provided care, and as we discussed in the CY 2026 PFS proposed and final rules, appears to be inconsistent with contemporary trends in physician practice where some significant portion of services furnished in facility settings are performed by medical practitioners who do not maintain fully independent practices [[Page 43860]] and are less likely to incur a comparable amount of indirect costs. Since finalizing the proposal in the CY 2026 PFS final rule, we have heard from interested parties that the implementation of this policy resulted in an unintended, but significant, site of service differential for physician visits in nursing facility settings based solely on whether the beneficiary's stay is covered under Part A. For purposes of PFS payment, a service furnished to a patient in a skilled nursing facility during a Part A hospital stay (place of service 31) is considered to be in the ``facility'' setting, while a service furnished to a patient in a Part B stay (place of service 32) is considered to be in the ``non-facility'' setting, per the Medicare Claims Processing Manual (MCPM), Chapter 12, Section 20.4.2 at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf. Prior to CY 2026, the payment rate for these E/M services furnished in a skilled nursing facility (``facility'') and a nursing facility (``non-facility'') were equal. As intended, the 50 percent reduction to the allocation of indirect PE based on work RVUs that we finalized for CY 2026 shifted PE RVUs from the facility setting to the non-facility setting. However, for nursing facility and skilled nursing facility visits, the current site of service differential is determined based on the status of the beneficiary (that is, a Part A versus Part B stay) in that setting, rather than in the setting of care itself. Given that the resource costs for the professional involved in furnishing an E/M service would not be expected to differ based on whether the patient is in a Part A stay or not, we believe it is more accurate for these E/M services to be paid the same amount without regard to the beneficiary's Part A status. Therefore, we are proposing to address this anomaly for CY 2027 by equalizing the rate for nursing facility visits without regard to the beneficiary's status by setting the facility PE RVU equal to the non-facility PE RVU for CPT codes 99304 (Initial nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and straightforward or low level of medical decision making. When using total time on the date of the encounter for code selection, 25 minutes must be met or exceeded.), 99305 (Initial nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. When using total time on the date of the encounter for code selection, 35 minutes must be met or exceeded.), 99306 (Initial nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. When using total time on the date of the encounter for code selection, 50 minutes must be met or exceeded.), 99307 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using total time on the date of the encounter for code selection, 10 minutes must be met or exceeded.), 99308 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using total time on the date of the encounter for code selection, 20 minutes must be met or exceeded.), 99309 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. When using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded.), 99310 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. When using total time on the date of the encounter for code selection, 45 minutes must be met or exceeded.), 99315 (Nursing facility discharge management; 30 minutes or less total time on the date of the encounter), and 99316 (Nursing facility discharge management; more than 30 minutes total time on the date of the encounter). This particular situation illuminates ongoing concerns regarding the current site of service differential. For example, interested parties have suggested that the current binary of facility and non- facility does not account for the range of employment models associated with physician services that drive significant differences in actual practice expenses. Interested parties have encouraged us to refine our previously finalized policy to ensure it is more empirically grounded and narrowly tailored to independent physicians, consistent with the policy's original intent. Interested parties have also stated that the facility PE reductions have had a disparate effect on hospital medicine groups and hospitalists, particularly those that operate independently from their hospital or health systems. Interested parties have stated that independent hospital medicine groups account for approximately one-third to one-half of the hospital medicine groups nationwide, and they are unable to cut administrative and overhead costs enough to absorb our CY 2026 facility PE reductions. As a result, some interested parties have stated that the reductions are accelerating the insolvency of independent physician practices and leading to an increase in hospital consolidation. We note that we have heard no general consensus among interested parties to this effect, and we have received feedback that this policy supports independent practices. In the CY 2026 PFS proposed rule, we sought comments on whether our proposal to reduce the portion of the facility PE RVUs allocated based on work RVUs to half the amount allocated to non-facility PE RVUs was an appropriate reduction or whether we should consider a different percentage reduction for CY 2026 or in future years. In finalizing the proposal, we noted that, while our change to the methodology for CY 2026 represented a starting point to correcting historic distortions in the allocation of indirect PE costs across settings of care, we intended to further examine our methodology and consider additional refinements based upon feedback received and any studies or data sources identified. For CY 2027, we remain open to more specific data that addresses the variability, as well as feedback on how to update the valuation and payment methodologies to better reflect the relative resources involved in furnishing the services, both across settings of care, and within the context of an evolving ecosystem of care models and business arrangements. Historically, we have relied extensively on specialty- specific PE/HR survey data and the binary site of service differential to best reflect variable PE costs. To better inform our consideration of how to account for practice expenses under the PFS methodologies, including the current differentials that are effectuated based on the binary facility/non- facility settings of care, we are seeking comment on how PE costs vary for physicians and other professionals, not only based on whether they practice in part or exclusively in a facility setting but also based on how their costs vary when they are employed by health systems, hospitals, or other entities. We noted in the CY 2026 PFS final rule that (90 FR 49292) that the AMA has stated [[Page 43861]] that physician practices maintain some indirect PE costs for physicians who are solely facility-based such as coding, billing, and scheduling. That being said, we generally agree with the concerns presented by MedPAC on the growth of exclusively facility-based physicians and agree that potential overpayments for indirect practice expense costs could be a driver of clinician movement to higher cost settings without creating commensurate clinical value. This is why we lowered indirect PE for facility-based physician to 50 percent in the CY 2026 PFS final rule. Moving forward, we remain interested in ensuring indirect PE RVUs are appropriately accounting for indirect PE costs. As such, we are seeking information that will help illuminate to what extent these costs are truly incurred when the professionals are employed by the hospital and/or practice primarily in the hospital and are not already accounted for in the existing OPPS payments. For example, when a physician is employed by and practicing in a hospital, what portion of the indirect PE is associated with the PFS service, versus costs that are associated with the payment to the hospital, such as those paid under the OPPS? We are seeking comment on the amount of indirect PE hospital- employed physicians incur when they furnish care within a facility. For these physicians, is the 50 percent indirect PE allocation accurate or could it possibly be less than 50 percent, such as 0 percent? In the case that there are little to no indirect costs incurred by the physician or other professionals, and these costs are borne by the hospital, we believe that these costs are not appropriately accounted for under the PFS and we may well be overestimating the relative resource costs compared to other PFS services. In consideration of the accuracy of the current 50 percent indirect PE allocation for services furnished in the facility setting, we are also seeking comment on whether and how we might, alternatively or additionally, define and identify physicians and professionals who are employed by hospitals, health systems, or other entities to ensure the services they furnish are not inappropriately consuming PE RVUs that would be more appropriately assigned to services furnished by professionals incurring comparatively greater practice expenses. Specifically, we are seeking comment on whether a new HCPCS modifier for employed physicians would be a reasonable way to identify and reduce facility PE from the services they perform in the facility setting, or whether there are other methods we could consider. We are seeking comment on what are the primary variables we should consider to continue to improve our data sources, allocation methodologies, and payment rates across settings of care, to best reflect the resources involved in furnishing PFS services by professionals and suppliers operating in a complex marketplace, across settings of care. We remain interested in objective data regarding payment arrangements between hospitals, health systems, other employers and physicians, including which costs are incurred and whether the full range of costs are truly incurred by physicians and other professionals in these kinds of employment relationships. This would help us understand and improve how PE is allocated across settings of care, both in general and for specific kinds of services. 6. Strategies To Improve Payment Transparency, Accuracy, and Congruency Across Payment Systems a. Professional and Technical Components Because PFS services are paid across settings of care, and are the primary way that Medicare pays medical professionals, understanding the structure of PFS payment is a critical part of price transparency for Medicare, other payers, and consumers. Likewise, misunderstanding or confusion about what relative resources are incorporated in specific PFS payment rates can be a significant obstacle for payers and consumers navigating the health care market. For example, approximately 4,100 services paid as ``global surgical packages,'' (herein `globals') are valued as bundled payments that aggregate multiple components of care into a single payment amount, including post-operative visits that are presumed to occur in particular settings (for example, inpatient hospital, outpatient hospital, office) regardless of where the services actually take place. Most PFS services are valued with a site of service binary, where the non-facility setting is the aggregation of all relative resources involved in furnishing the professional and technical aspects of the service, and the facility setting, where the rate generally excludes the facility costs involved in the service since those costs are addressed through separately reported facility fees. In contrast to these two constructs, there are other codes (mainly describing diagnostic and imaging services) that may be billed with professional component (PC, or modifier 26) and technical component (TC) modifiers, or without modifiers (global codes) that are paid for the complete global service. These differences in how payments are constructed and displayed can make it difficult for interested parties and CMS to evaluate relative payment rates, underlying resource costs, and value across settings of care. These challenges are further compounded by differences across Medicare payment systems in how similar services are defined, bundled, and paid. For example, some payment systems incorporate technical inputs and facility resources into a single payment. This variation can obscure meaningful comparisons across sites of care and may complicate efforts to advance site-neutral payment policies aimed at reducing incentives for hospitals to acquire physician practices and limit site- of-care decisions based on financial considerations. As CMS continues to consider approaches that remove obstacles from market competition across settings of care, especially by improving transparency, comparability of PFS payments is an important foundational step. To facilitate more consistent comparisons across services and settings, we have developed a public use file that displays, for services that are not currently billable with TC/26 modifiers, RVUs amounts that reflect the relative resources involved in furnishing professional and technical aspects of the services, which is available on the CMS website under downloads for the CY 2027 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file is intended to improve transparency regarding how PFS payments may be conceptually divided between physician professional and technical components of the services, especially to illuminate the differences in fees between technical aspects of PFS services compared to facility fees across settings of care. We believe that making these components more visible, where feasible, may help interested parties better understand the structure of PFS payments and support more informed comparisons across settings of care. We note that we have excluded 010- and 090-day global surgery services from display in this public use file since there are numerous ways to consider how the structure of payment for those codes may be best understood. The use of bundled payments for the 010- and 090-day global surgery services results in aggregated valuation for all pre-operative, intra-operative, and post- [[Page 43862]] operative services furnished over a defined period (0-, 10-, or 90-day global periods), including services by both physician and clinical staff and practice expense without clear visibility into how each component contributes to the total bundled valuation. While we note that the current structure of global surgery services has effectively obscured how the components of care are individually valued and limited our ability to disaggregate them for purposes of this public use file, we seek comment on how to address this problem, either in possible improvements to the global surgery packages or, at least, in the best way to make their component pieces transparent. Additionally, we note that there is a subset of additional exclusions from this public use file, such as codes subject to the cognitive services floor and the statutory phase-in of significant RVU reductions, due to technical challenges with how these policies are implemented that hinder the disaggregation of their component parts. We emphasize that we are not proposing any changes to existing payment or billing policies, including the use of the 010- and 090-day globals. Rather, this effort is intended to improve transparency and provide a foundation for future rulemaking. We believe that greater visibility into how the professional and technical aspects of PFS services are valued and paid, where feasible, may enhance the ability of consumers, and payers (including CMS) to assess relativity across services, may enhance CMS's efforts to improve valuation over time, and support broader efforts to align payments across settings of care. We are seeking comment on several aspects of this approach. First, we seek comment on the utility of displaying RVUs associated with professional and technical aspects of services that are not currently billable with TC/26 modifiers, including how we may use this information to assess payment differences across settings. Again, we also seek comment on potential approaches CMS could consider in future rulemaking to improve transparency for services currently paid as globals. Specifically, we are interested in feedback on how CMS could develop methodologies to more clearly identify and, where appropriate, disaggregate the underlying components of these services. We are also interested in comments on how CMS could ``right-size'' payments for the globals over time to ensure they remain aligned with current clinical practice and resource costs, are more readily updated based on empirical data, and do not obscure differences in cost and value across settings of care. b. Global Surgical Packages We finalized a policy in the CY 2015 PFS final rule (79 FR 67582 through 67591) to transition all 10-day and 90-day globals to 0-day globals, allowing any post-operative visits furnished after the day of the procedure to be billed as a standalone visit. CMS was prohibited from implementing this policy through section 523(a) of the Medicare Access and CHIP Reauthorization Act (MACRA) and was required to collect data on how to best value globals. CMS did so through a research contract with RAND and a data-collection process over several years to develop data to improve the payment rates for these services. Data collection has been based on reporting of CPT code 99024 (Postoperative follow-up visit, normally included in the surgical package, to indicate that an evaluation and management service was performed during a postoperative period for a reason(s) related to the original procedure), which is limited to practices with 10 practitioners or more, limited to nine States, and is used solely for data collection so it has no associated payment with reporting the code. In the CY 2019 PFS final rule (83 FR 59503), we released findings that only 4 percent of reviewed 10-day globals and 67 percent of reviewed 90-day globals had one or more post-operative visit which occurred during the global period and sought comment on potential approaches for revaluing the globals based on these findings (83 FR 59504). In the CY 2023 PFS proposed rule (87 FR 45877 through 45880), CMS reviewed the prior work and conversations around global valuations, solicited feedback from the public, and has continued to explore ways over the years to address valuation of the globals that would be minimally disruptive to the PFS. Over the past several years, CMS has taken several iterative steps to improve payment accuracy for the globals. In the CY 2025 PFS final rule (89 FR 97964 through 97968), CMS expanded the applicability of the transfer of care modifiers to address instances where separate practitioners are billing for standalone E/M visits during the global period more directly with mandatory reporting of payment modifiers in clinical cases when there is both a formal or informal transfer of care between practitioners furnishing distinct portions of a global service. CMS also created a post-operative care services add-on code to more appropriately reflect the time and resources involved for practitioners who were not involved in furnishing the surgical procedure. CMS is continuing to explore further steps to improve accountability and more accurate payment and what additional next steps CMS could take to improve the payment rates for global services. In keeping with the administration priorities and aligning spending and value, we are proposing to pause the data collection required by MACRA based on RAND's findings over the past several years. We remain interested in how best to use and collect this data going forward and ways we might consider improving this data collection. We currently have several years of data that have continued to illustrate what we believe is the issue with the post-operative visits during the global period and how these visits are not occurring, yet providers are still being paid for these visits under the current global payment policy. Additionally, we believe that the current data collection may be causing undo burden to providers and we believe that pausing the data collection will aid in burden reduction for practitioners. We do however question whether a more robust data collection would be appropriate and if we should have all providers report CPT code 99024. We are also seeking comment on the question we mentioned earlier in this section, as to whether CMS should have all providers report CPT code 99024, and also other data sources we might consider to more accurately value the globals. We are posting a public use file with this proposed rule to display the imputed RVUs associated with both the 10- and 90-day post-operative visits based on a purely arithmetic approach to understand the valuation of the services based on the data that was analyzed. This public use file shows the current work RVUs, the number of post- operative visits that are reported to CMS using no-pay HCPCS code 99024, and the work RVUs remaining if all post-operative visits are removed. This public use file is available on the CMS website under downloads for the CY 2027 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. We welcome comments on potential revaluation strategies that we may consider through future rulemaking.

C. Payment for Medicare Telehealth Services

As discussed in prior rulemaking, several conditions must be met for Medicare to make payment for [[Page 43863]] telehealth services under the PFS. See further details and full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006), the CY 2021 PFS final rule (85 FR 84502), the CY 2024 PFS final rule (88 FR 78861 through 78866), the CY 2026 PFS final rule (90 FR 49316 through 49320), and in 42 CFR 410.78 and 414.65. Our current 3-step review process reflects the stepwise method by which we consider requests to add services to or remove services from the Medicare Telehealth Services List, beginning with the CY 2026 Medicare Telehealth Services List: Step 1. Determine whether the service is separately payable under the PFS. Step 2. Determine whether the service is subject to the provisions of section 1834(m) of the Act. Step 3. Review the elements of the service as described by the HCPCS code and determine whether each of them is capable of being furnished using an interactive telecommunications system as defined in Sec. 410.78(a)(3).

1. Changes to the Medicare Telehealth Services List

a. Requests To Add Services to the Medicare Telehealth Services List for CY 2027 We did not receive any requests to add or remove services from the Medicare Telehealth Services List for CY 2027. Consistent with the deadline for our receipt of code valuation recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA RUC) and other interested parties established in the CY 2019 PFS final rule (83 FR 59491) and with the process set forth in prior calendar years, for CY 2027, requests to add services to the Medicare Telehealth Services List must have been submitted to and received by CMS by February 10, 2026. Consistent with the deadline for our receipt of code valuation recommendations from the AMA RUC and other interested parties established in the CY 2019 PFS final rule (83 FR 59491) and with the process set forth in prior calendar years, for CY 2028, requests to add services to the Medicare Telehealth Services List must be submitted to and received by CMS by February 10, 2027. Each request submitted by the deadline to add a service to the Medicare Telehealth Services List must include any supporting documentation the requester wishes CMS to consider. Because we use the annual PFS rulemaking process to make changes to the Medicare Telehealth Services List, requesters are advised that any information submitted as part of a request is subject to public disclosure for this purpose. For more information on submitting a request to add services to the Medicare Telehealth Services List, including where to send these requests, and to view the current Medicare Telehealth Service List, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html. b. CMS Proposal To Add New Codes to the List We are proposing to add HCPCS G-codes GACP1 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), first 20 minutes of clinical staff time with the patient, family member(s), directed by a treating physician or other treating qualified health care professional), GACP2 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), each additional 20 minutes with the patient, family member(s), directed by a treating physician or other treating qualified health care professional (List separately in addition to code for primary procedure)), GSMAS (Voluntary, group-based medical session involving multiple patients with common medical condition(s), receiving medical care in a group setting; billed and led by a physician or qualified nonphysician practitioner and may include services provided by other qualified healthcare professionals, clinical staff, or auxiliary personnel under the direction of the supervising physician or other practitioner. Session integrates group education, counseling, and peer support with individualized patient clinical assessment and care, 2-10 patients, billed once per patient, per session.), GSLPP (Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual; for the pediatric population up to age 18 or 21), and GADV1 (Office or other outpatient evaluation and management service(s) for the diagnosis and treatment of vaccine adverse effects, new or established patient; each 15 minutes personally performed by the physician or qualified healthcare professional (list separately in addition to CPT codes 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350)) to the Medicare Telehealth Services List. If finalized, these services will be separately payable under the PFS. These services will be subject to the provisions of section 1834(m) of the Act, as they are inherently face-to-face services and would serve as a substitute for an in-person encounter. We also believe that the elements of these services as described by the HCPCS codes are capable of being furnished using an interactive telecommunications system as defined in Sec. 410.78(a)(3). We refer readers to the relevant proposal in section II.D. of this proposed rule for further background on these proposed codes.

2. Telehealth Flexibilities and Modifiers

As discussed in the CY 2021 PFS final rule (85 FR 84506), legislation enacted to address the PHE for COVID-19 provided the Secretary with new authorities under section 1135(b)(8) of the Act, as added by section 102 of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020) and subsequently amended by section 6010 of the Families First Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section 3703 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020), to waive or modify Medicare telehealth payment requirements during the PHE for COVID-19. We used these authorities to establish several flexibilities to accommodate changes in the delivery of care during the PHE. Through waiver authority under section 1135(b)(8) of the Act, in response to the PHE for COVID-19, we removed the geographic and site of service originating site restrictions in section 1834(m)(4)(C) of the Act, as well as restrictions in section 1834(m)(4)(E) of the Act on the types of practitioners who may furnish telehealth services, for the duration of the PHE for COVID-19. We also used waiver authority to allow certain telehealth services to be furnished via audio-only communication technology. At the end of the PHE for COVID-19, these waivers and interim policies were set to expire, and payment for Medicare telehealth services would have once again been limited by the requirements of section 1834(m) of the Act. These flexibilities have been extended by Congress numerous times since, most recently in the Consolidated Appropriations Act, 2026 (CAA, 2026) (Pub. L. 119-75, February 3, 2026). Section 6209(a) and (b) of the CAA, 2026 extends the flexibilities for Medicare telehealth services to remove the geographic restrictions, expand the list of acceptable originating sites, and expand the array of practitioners eligible [[Page 43864]] to furnish telehealth services from January 30, 2026 to the extended date of December 31, 2027. Section 6209(d) of the CAA, 2026 delays the in-person visit requirements for mental health services furnished through telehealth from January 30, 2026 to the extended date of January 1, 2028. Section 6209(e) of the CAA, 2026 extends the flexibilities to allow audio-only Medicare telehealth services from January 30, 2026 to the extended date of January 1, 2028. To align with these extensions, Sec. 410.78 has been revised, detailed later in this proposed rule. Additionally, section 6209(g) of the CAA, 2026, requires CMS to establish modifiers for telehealth services in certain instances, effective January 1, 2027. These modifiers do not affect payment and are required for claims for telehealth services that are furnished through a virtual telehealth platform by a physician or practitioner that contracts with an entity that owns such virtual platform; or for which a physician or practitioner has a payment arrangement with an entity for use of such virtual platform; and for claims for telehealth services that are furnished incident to a physician's or practitioner's professional service. In accordance with section 6209(g) of CAA, 2026, we are creating modifiers BB and BC. Guidance on use of these modifiers will be available on the CMS website. Any updates to this policy will be issued via subregulatory guidance in accordance with section 6209(h) of the CAA, 2026, which authorizes the Secretary to implement section 6209 via program instruction or otherwise.

3. Telehealth Critical Care Consultations

In the CY 2017 PFS final rule (81 FR 80352 through 80353), we established HCPCS codes G0508 (Telehealth consultation, critical care, initial, physicians typically spend 60 minutes communicating with the patient and providers via telehealth) and G0509 (Telehealth consultation, critical care, subsequent, physicians typically spend 50 minutes communicating with the patient and providers via telehealth) to report telehealth consultations for a patient requiring critical care services. These services were modeled after CPT codes 99291 (Critical care, evaluation and management of the critically ill or critically injured patient; first 30 to 74 minutes) and 99292 (Critical care, evaluation and management of the critically ill or critically injured patient; each additional 30 minutes (list separately in addition to code for primary service)). When adding some services to the Medicare Telehealth Services List in the past, we have included certain frequency restrictions on how often physicians and other practitioners may furnish the service via telehealth. These include a limitation of one critical care consultation service furnished via telehealth per day, added in the CY 2017 final rule (81 FR 80198). In the CY 2026 PFS final rule, we finalized permanently removing frequency limitations on furnishing these services via telehealth (90 FR 49324 through 49325). We continue to believe that physicians and other practitioners, who have the greatest familiarity and insight into the needs of individual beneficiaries, can use their complex professional judgment to determine whether they can safely furnish a service via telehealth, given the entirety of the circumstances, including the clinical profile and needs of the beneficiary, to determine the appropriate service modality. We strive to balance the goals of increasing physician or practitioner and patient choice of service modality with consideration of patient safety for all Medicare beneficiaries. As technology advances and more services may be safely furnished via telehealth and paid under the PFS, it is increasingly important for physicians and other practitioners to exercise their professional judgment in determining the generally appropriate service modality for their patients to receive a service. Since the permanent removal of the frequency limitation of one critical care consultation service furnished via telehealth per day, we have received questions about language in the code descriptors for HCPCS codes G0508 (Telehealth consultation, critical care, initial, physicians typically spend 60 minutes communicating with the patient and providers via telehealth) and G0509 (Telehealth consultation, critical care, subsequent, physicians typically spend 50 minutes communicating with the patient and providers via telehealth) describing ``initial'' and ``subsequent'' consultations, as well as questions regarding the language about the typical time spent on the service. To clarify the requirements for billing these services, we are proposing the following revised code descriptors: G0508: Telehealth consultation, critical care; first 30 to 74 minutes. G0509: Telehealth consultation, critical care; each additional 30 minutes (List separately in addition to code for primary service). We welcome comments on this proposal.

4. Changes To Teaching Physicians' Billing for Services Involving

Residents or Teaching Physicians With Virtual Presence In the CY 2021 PFS final rule (85 FR 84577 through 84585), we finalized a temporary policy that allowed the teaching physician to have a virtual presence in all teaching settings, but only in clinical instances when the service was furnished virtually (for example, a three-way telehealth visit, with all parties in separate locations). This permitted teaching physicians to have a virtual presence during the key portion of the Medicare telehealth service for which payment was sought, through audio/video real-time communications technology, in all residency training locations through December 31, 2024. As summarized in the CY 2025 PFS final rule (89 FR 97764 through 97765), commenters encouraged CMS to establish this policy permanently and include in-person services to promote access to care, and stated that teaching physicians should be allowed to determine when their virtual presence would be clinically appropriate based on their assessment of the patient's needs and the competency level of the resident. In the CY 2026 PFS final rule, we finalized permanently allowing teaching physicians to have a virtual presence in all teaching settings, only in clinical instances when the service is a three-way telehealth visit, with the teaching physician, resident, and patient in different locations. We have received feedback from interested parties that indicates that our current policy for teaching physicians and residents can, in somewhat rare cases, cause logistical complexities in scenarios where either the teaching physician or resident is already in the same physical location as the beneficiary. For CY 2027, we are proposing a modification to our previously finalized policy. Rather than requiring the teaching physician, resident, and patient to each be in a different location, we are proposing to allow teaching physicians to bill for services involving residents when either the teaching physician or resident is in the same physical location as the beneficiary. We would generally interpret physical presence to be defined as either the teaching physician or resident in the same room as the beneficiary, but we are seeking comment on other scenarios in which this may be appropriate. This would only be applicable to services that are on the Medicare Telehealth Services List. As always, documentation in the [[Page 43865]] medical record must continue to demonstrate whether the teaching physician was physically present or present through audio/video real- time communications technology at the time of the Medicare telehealth service, which includes documenting the specific portion of the service for which the teaching physician was present through audio/video real- time communications technology. In accordance with section 1842(b)(7)(A)(i)(I) of the Act, the teaching physician must have personal oversight and involvement over the management of the portion of the case for which the payment is sought. We are seeking comments on this proposal.

5. Telehealth Originating Site Facility Fee Payment Amount Proposed

Update Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001 through December 31, 2002 at $20.00, and specifies that, for telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the Act. The proposed percentage increase in the MEI for CY 2027 is 2.5 percent and is based on the expected historical percentage increase of the 2017- based MEI. For the final rule, we propose to update the MEI increase for CY 2027 based on historical data through the second quarter of 2026. Therefore, for CY 2027, the proposed payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is $32.65. Table A-C1 shows the Medicare telehealth originating site facility fee and the corresponding MEI percentage increase for each applicable time period. BILLING CODE 4169-69-P [GRAPHIC] [TIFF OMITTED] TP16JY26.018 BILLING CODE 4169-69-C

1. Background: Process for Valuing New, Revised, and Potentially

Misvalued Codes Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review [[Page 43866]] process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the AMA's Relative Value Unit Update Committee (RUC) identified a number of potentially misvalued codes each year using various identification screens, as outlined in section II.C. of this proposed rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comments about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values and typically made any appropriate adjustments and finalized those values. In the CY 2015 PFS final rule with comment period (79 FR 67547), we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period (80 FR 70886), and re-proposed values for those codes in the CY 2017 PFS proposed rule. We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values. As part of our obligation to establish RVUs for the PFS, we thoroughly review and consider available information including recommendations and supporting information from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the Federal Government as part of our process for establishing valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we proposed those values as recommended. Additionally, we continually engage with interested parties, including the RUC, regarding our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process.

2. Methodology for Establishing Work RVUs

a. Background For each code identified in this section, we conduct a review that includes the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally include, but have not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the Federal Government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process. Components that we use in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We use the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilize an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. Section 1848(c)(1)(A) of the Act specifically defines the work component as the resources that reflect time and intensity in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refine the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time. Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages [[Page 43867]] reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the non-facility setting. We have developed several standard building block methodologies to value services appropriately when they have common billing patterns. For example, in cases where a service is typically furnished to a beneficiary on the same day as an E/M service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit. Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long- established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU. Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service. The following paragraphs discuss our approach to reviewing RUC recommendations and developing proposed values for specific codes. When they exist, we also include a summary of interested party reactions to our approach. We noted that many commenters and interested parties have expressed concern over the years with our ongoing adjustment of work RVUs based on changes in the best information we had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we use to make the adjustments is derived from their survey process. We note that we are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes. We observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we adjusted work RVUs to account for significant changes in time, we started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we employed different approaches (including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation) to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components. In so doing, rather than ignoring the RUC-recommended value, we used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC- recommended value. If we believe that such changes in time are already accounted for in the RUC's recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs and consider these work RVUs as potential options relative to the values developed through other options. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs, we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure (such as building blocks or crosswalks to key reference or similar codes). Several interested parties, including the RUC, have expressed general objections to our use of these methodologies and suggested that our actions in adjusting the recommended work RVUs are inappropriate; other interested parties have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we employed to identify potential values that reconcile the RUC-recommended work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time. We have historically relied on survey data provided by the American Medical Association (AMA)/Specialty Society Relative Value Scale (RVS) Update Committee (referred to as the RUC) to estimate practitioner time, work intensity, and practice expense for the purpose of establishing RVUs for the codes used for payment under the PFS. As described in section II.C. of this [[Page 43868]] proposed rule, CMS regularly revalues codes as part of its potentially misvalued codes initiative, as required by section 1848(c)(2)(K) of the Act, using RUC survey data that shows clinicians' estimates of how long a particular service takes to complete. In the CY 2025 PFS final rule, we summarized public comments that we had received expressing concerns with using RUC data as a source of valuation and identifying a need for empirical data in the context of valuing advanced primary care management services (89 FR 97898). In response to these comments, we indicated that we were open to alternative recommendations for how to price these and other services, and that we would consider all options presented to us with a preference for information with empirical evidence behind it. We also reminded commenters that we do not exclusively rely on RUC recommendations and can receive data and recommendations from other outside sources as well. In the CY 2019 PFS final rule (83 FR 59515), in response to comments, we clarified that terms ``reference services,'' ``key reference services,'' and ``crosswalks'' as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purpose of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate feedback from interested parties, we stated that we would seek to limit the use of the term, ``crosswalk,'' to those cases where we made a comparison to a CPT code with the identical work RVU (83 FR 59515). We noted that we also occasionally make use of a ``bracket'' for code valuation. A ``bracket'' refers to when a work RVU falls between the values of two CPT codes, one at a higher work RVU and one at a lower work RVU. We look forward to continuing to engage with interested parties and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and we will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the valuation considered for specific codes. Table A-DX contains a list of codes and descriptors for which we proposed work RVUs for CY 2027; this includes all codes for which we received RUC recommendations by February 10, 2026. The proposed work RVUs, work time and other payment information for all CY 2027 payable codes are available on the CMS website under downloads for the CY 2027 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Feefor-ServicePayment/PhysicianFeeSched/index.html). b. Efficiency Adjustment In the CY 2026 final rule, we finalized the establishment of an efficiency adjustment to the work RVUs, as well as corresponding updates to the intraservice portion of physician time inputs for non- time-based services, with refinements (90 FR 49334 through 49345). We finalized a policy to apply this efficiency adjustment to the intraservice portion of physician time and work RVUs every 3 years. To calculate the efficiency adjustment, we finalized the use of the MEI productivity adjustment over a 5-year look back period from CY 2022 to CY 2026. We noted that using more recent historical data from the BLS yielded an efficiency adjustment of 3.6 percent. As we discussed in the CY 2026 PFS proposed rule, our approach in applying an efficiency adjustment was to take into account changes in medical practice and to better reflect resources involved, and it was designed to be conservative in nature, as we were concerned about making too many changes at once to the current methodology. Therefore, we finalized the proposed efficiency adjustment of 2.5 percent. We also exempted additional codes, specifically time-based codes, services on the CMS telehealth list, and new codes for CY 2026, as reflected in the Codes Subject to Efficiency Adjustment file. This file with efficiency adjustment exemptions is issued annually and can be found in the public use files for CY 2027; the file is available on the CMS website under downloads for the CY 2027 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For a full discussion of the efficiency adjustment, we direct readers to the CY 2026 PFS final rule (90 FR 49334 through 49345). For CY 2027 rulemaking, the RUC made a number of work RVU recommendations prior to the finalization of the efficiency adjustment in the CY 2026 PFS final rule. In these cases, where the RUC's work RVU recommendation was based on a pre-adjusted work RVU, we have treated the recommendation as though the RUC had recommended the efficiency adjusted valuation. For example, the RUC initially recommended a work RVU of 0.35 for CPT code 95XX4 based on a crosswalk to the pre-adjusted work RVU of CPT code 95885. The work RVU of this crosswalk code became 0.34 after applying the efficiency adjustment, which we have used as the recommended valuation for CPT code 95XX4. This policy affected a relatively small number of the codes reviewed for CY 2027, and we have noted in the preamble where the efficiency adjustment affected a work valuation.

3. Methodology for the Direct PE Inputs To Develop PE RVUs

a. Background On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code-by-code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the Federal Government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or non-facility direct PE inputs and refine the inputs accordingly. Our review and refinement of the RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table A-D11 details our refinements of the RUC's direct PE recommendations at the code-specific level. In section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), we address certain refinements that will be [[Page 43869]] common across codes. Refinements to particular codes are addressed in the portions of that section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. In this proposed rule, we also note that many of the refinements listed in Table A-D11 result in changes under the $0.35 threshold and would be unlikely to result in a change to the RVUs. We note that the proposed direct PE inputs for CY 2027 are displayed in the CY 2027 direct PE input files, available on the CMS website under the downloads for the CY 2027 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there have been used in developing the CY 2027 PE RVUs as displayed in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates). b. Common Refinements (1) Changes in Work Time Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies. (2) Equipment Time Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations. In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time will also reflect that use. We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also noted that we believe these same assumptions will apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question will be available if the room is not being occupied by a particular patient. For additional information, in that rule we referred readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639). (3) Standard Tasks and Minutes for Clinical Labor Tasks In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the ``PE worksheets.'' For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service. We refer readers to section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks. (4) Recommended Items That Are Not Direct PE Inputs In some cases, the PE worksheets included with the RUC's recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs. (5) New Supply and Equipment Items The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. However, some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2027 we received invoices for several new supply and equipment items. Tables A-D11 and A-D12 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units, we encourage interested parties to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encourage [[Page 43870]] interested parties to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations. We remind interested parties that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables A-D11 and A-D12 also include the number of invoices received and the number of non-facility allowed services for procedures that use these equipment items. We provide the non- facility allowed services so that interested parties will note the impact the particular price may have on PE relativity, as well as to identify items that are used frequently, since we believe that interested parties are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs, and we encourage interested parties to provide additional invoices so that we may identify and use accurate prices in the development of PE RVUs. In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we may use existing items as proxies for the newly recommended items. In other cases, we include the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the proposed PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so. (6) Service Period Clinical Labor Time in the Facility Setting Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address code-specific refinements to clinical labor in the individual code sections. (7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the Outpatient Prospective Payment System (OPPS) Cap We note that the list of services for the upcoming calendar year that are subject to the MPPR for diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services are displayed in the public use files for the PFS proposed and final rules for each year. In addition, the list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap, are also displayed in the public use files for the PFS proposed and final rules for each year. The public use files for CY 2027 are available on the CMS website under downloads for the CY 2027 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more information regarding the history of the MPPR policy, we referred readers to the CY 2014 PFS final rule with comment period (78 FR 74261 through 74263). Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171, enacted on February 8, 2006) amended section 1848(b)(4) of the Act to require that, for imaging services, if--(i) The technical component (TC) (including the TC portion of a global fee) of the service established for a year under the fee schedule without application of the geographic adjustment factor, exceeds (ii) The Medicare outpatient department (OPD) fee schedule amount established under the prospective payment system (PPS) for hospital OPD services under section 1833(t)(3)(D) of the Act for such service for such year, determined without regard to geographic adjustment under section 1833(t)(2)(D) of the Act, the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor under the PFS, for the fee schedule amount for such TC for such year. As required by section 1848(b)(4)(A) of the Act, for imaging services furnished on or after January 1, 2007, we cap the TC of the PFS payment amount for the year (prior to geographic adjustment) by the Outpatient Prospective Payment System (OPPS) payment amount for the service (prior to geographic adjustment). We then apply the PFS geographic adjustment to the capped payment amount. Section 1848(b)(4)(B) of the Act defines imaging services as ``imaging and computer-assisted imaging services, including X-ray, ultrasound (including echocardiography), nuclear medicine (including PET), magnetic resonance imaging (MRI), computed tomography (CT), and fluoroscopy, but excluding diagnostic and screening mammography.'' For more information regarding the history of the cap on the TC of the PFS payment amount under the DRA (the ``OPPS cap''), we referred readers to the CY 2007 PFS final rule with comment period (71 FR 69659 through 69662). For CY 2027, we identified new and revised codes to determine which services meet the definition of ``imaging services'' as defined at section 1848(b)(4)(B) of the Act for purposes of this cap. Beginning for CY 2027, we are proposing to include the following services in Table A-D1 on the list of codes to which the OPPS cap applies: [[Page 43871]] [GRAPHIC] [TIFF OMITTED] TP16JY26.019 We believe that these codes meet the definition of imaging services under section 1848(b)(4)(B) of the Act, and thus, should be subject to the OPPS cap. c. Valuation of Specific Codes for CY 2027 (1) Fine Needle Aspiration (CPT Codes 10005 and 10006) The RUC received notification of interest from a specialty society to re-review CPT codes 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and 10006 (Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion) at the January 2026 meeting. We are proposing the RUC-recommended work RVUs of 1.35 for CPT code 10005 and 1.00 for 10006. We are proposing the RUC recommended direct PE inputs for CPT codes 10005 and 10006 with one modification. The RUC submitted an invoice associated with this code family for an update in the price of the portable ultrasound (EQ250) equipment from its current price of $41,612.53 to $83,750.00. However, based on our review of current market pricing for portable ultrasounds, it appears that this type of equipment is becoming less expensive, not doubling in price over current . We also have reason to believe that the type of portable ultrasound listed on the submitted invoice represented the upper end of the market as opposed to the typical case. This invoice stated that the product in question constitutes ``a high-performance diagnostic ultrasound system'' including a 23-inch flat panel monitor. It is also not clear from the submitted invoice that the product in question is even a portable version of an ultrasound system. Given that the price on this invoice was significantly higher than other portable ultrasounds available for purchase, we are not proposing to update the price of the EQ250 portable ultrasound which is used in many other HCPCS codes. Instead, we are proposing to create a new equipment item that describes a ``Fine Needle Aspiration portable ultrasound'' (ER130) which we propose to price at the submitted $83,750.00 price. The ER130 equipment is proposed to replace the previous EQ250 portable ultrasound at the same 37 minutes for CPT code 10005 and 17 minutes for CPT code 10006 as recommended by the RUC. (2) Skin Cell Suspension Autograft (CPT Codes 15X19, 15X20, 15X21, and 15X22) In September 2025, the CPT Editorial Panel created four codes to report skin cell suspension autograft (SCSA): CPT code 15X19 (Skin cell suspension autograft (SCSA), trunk, arms, and/or legs; first 100 sq cm or less, or 1% of body area of infants and children), CPT code 15X20 (Skin cell suspension autograft (SCSA), trunk, arms, and/or legs; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)), CPT code 15X21 (Skin cell suspension autograft (SCSA), face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 100 sq cm or less, or 1% of body area of infants and children), and CPT code 15X22 (Skin cell suspension autograft (SCSA), face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)). The existing eight skin cell suspension autograft CPT codes (CPT codes 15011-15018) were deleted, and the ``Skin Cell Suspension Autograft'' guidelines were revised. The four new codes were surveyed for the January 2026 RUC meeting. For CY 2027, we are proposing the RUC-recommended work RVUs of 10.97 for CPT code 15X19, 0.59 for CPT code 15X20, 11.28 for CPT code 15X21, and 0.98 for CPT code 15X22. We are proposing the RUC- recommended direct PE inputs for CPT codes 15X19, 15X20, 15X21, and 15X22 without refinement. (3) Computer Assisted Surgical Navigation (CPT Code 20985) CPT code 20985 (Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less (List separately in addition to code for primary procedure)) was first identified via the high- volume growth screen in April 2024.\1\ The RUC's Relativity Assessment Workgroup (RAW) reviewed the action plan for 20985 and recommended that the RUC refer CPT code 20985 to the CPT Editorial Panel for revision, to modify the descriptor and address overlap with codes 0054T and 0055T. At the February 2025 CPT Editorial Panel meeting, CPT code 20985 was revised to remove ``image-less'' for reporting computer-assisted surgical navigational procedures for musculoskeletal procedures. --------------------------------------------------------------------------- \1\ https://www.ama-assn.org/system/files/raw-progress-report.pdf. --------------------------------------------------------------------------- We are proposing the RUC-recommended work RVU of 2.44, which is the current work RVU of CPT code 20985 after the efficiency adjustment was applied at the start of CY 2026. The RUC did not recommend and we are not proposing direct PE inputs for CPT code 20985. (4) Ablation Therapy--Bone Tumors (CPT Code 209XX) In February 2025, the CPT Editorial Panel approved new Category I add-on code 209XX (Ablation therapy for reduction or eradication of bone tumor, including adjacent soft tissue when involved by tumor extension, cryoablation, open) to describe and report cryoablation during an open [[Page 43872]] surgical procedure where the bone is frozen after a tumor resection. CPT code 209XX was surveyed for the April 2025 meeting where the specialty recommended an interim value; the code was resurveyed at the September 2025 RUC meeting and recommendations submitted to CMS. We are proposing the RUC-recommended work RVU of 2.70 for CPT code 209XX. The RUC did not recommend and we are not proposing any direct PE inputs for this code. (5) Intraosseous Fiducial Marker Placement (CPT Codes 209X1 and 209X2) At the May 2025 CPT Editorial Panel Meeting, CPT approved the addition of two codes and guidelines to report percutaneous intraosseous fiducial marker placement for the first target site and each additional target site, respectively: CPT codes 209X1 (Placement of localization marker(s) (e.g., fiducial marker[s]), intraosseous, percutaneous, including imaging guidance, when performed; first target site) and 209X2 (Placement of localization marker(s) (e.g., fiducial marker[s]), intraosseous, percutaneous, including imaging guidance, when performed; each additional target site) . The specialties clarified that these codes are not new technology but are new codes to more accurately describe existing technology. These codes were surveyed for the October 2025 RUC meeting. We are proposing the RUC-recommended work RVU of 3.00 for CPT code 209X1 and the RUC-recommended work RVU of 1.76 for CPT code 209X2. We are proposing the RUC-recommended direct PE inputs for both codes in the family without refinement. (6) Osteotomy--Spine (CPT Codes 22210, 22212, 22214, and 22216) In CY 2025 rulemaking, CPT codes 22210 (Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; cervical), 22212 (Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; thoracic), 22214 (Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; lumbar), and 22216 (Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; each additional vertebral segment (List separately in addition to primary procedure)) were nominated as potentially misvalued services. At the September 2025 CPT Editorial Panel Meeting, CPT revised the existing codes and guidelines to clarify that the codes include complete resection of the interspinous ligament and the entirety of the ligamentum flavum (i.e., laminar and subarticular) to allow deformity correction through spinal column realignment. The osteotomy includes resection of the inferior portion of the lamina, the inferior facet of the cranial vertebra, the superior portion of the lamina, and the superior facet of the caudal vertebra. Following the revisions to the CPT guidelines and parentheticals for the code family, CPT codes 22210, 22212, 22214, and 22216 were surveyed for the January 2026 RUC meeting. We disagree with the RUC's recommended work RVU for CPT codes 22210, 22212, and 22214 and we are proposing lower work RVUs in all three cases. We reviewed the RUC's recommended work valuations and found them to be high, relative to other codes with the same or similar times. We note that although the surveyed intraservice work time decreased substantially for all three of these codes, the RUC recommended either maintaining the current work RVU (for CPT code 22210) or increasing the work RVU (for CPT codes 22212 and 22214), stating that there was compelling evidence for increased work valuation based on a change in the patient population and a change in technology. However, these services maintained the same code descriptors, with only minor changes to their billing guidelines, indicating that despite the changes in technology and patient population the underlying procedure remains significantly similar. Therefore, we do not agree with the RUC that there has been an increase in intensity which would account for these recommended work RVUs. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to- one or linear decrease in newly valued work RVUs, we do believe that since the two components of work are time and intensity, absent an obvious or explicitly stated rationale why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. In the case of CPT codes 22210, 22212, and 22214, we believe that the work RVUs should be reduced to account for the significant decreases in surveyed intraservice work time. Additionally, the postoperative office visit levels in this code family are increasing from three level 2 evaluation and management visits to one level 4 and two level 3 office visits. The shifting of the post-operative visits in this code family to higher level office visit codes that require more time, maintains the total time and thus reflects a higher intensity and can contribute to a higher work RVU which highlights our overall concerns with visits during the global period and how we believe that all of these visits are not typically occurring. We refer readers to section II.B. of this proposed rule under ``b. Global Surgical Packages'' for that discussion. We disagree with the RUC recommended value of 24.75 for CPT code 22210 and we are instead proposing a work RVU of 23.12 based on a crosswalk to CPT code 34701 (Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the aortic bifurcation; for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, penetrating ulcer)). This code has a lower intraservice time and a similar total time. We noticed that the surveyed intraservice time for CPT code 22210 is decreasing by nearly an hour, from 170 minutes to 120 minutes, indicating that the procedure typically takes much less time to perform than it did at the time of last review. Although the RUC has recommended significantly more postoperative time in the inpatient and outpatient visits, which has caused the total time of the procedure to increase slightly, we note that this postoperative care should take place at a significantly lower intensity than the 50 minutes of intraservice time being removed from the code. We are concerned that, while the intraservice time for CPT code 22210 is decreasing from 170 to 120 minutes, this intraservice work time is being replaced with higher levels of post operative care to result in the total time being maintained similar to the current time. We believe that with the intraservice time going down, this reflects that the procedure has a lesser intensity than before and therefore it does not makes sense that the intensity of the post operative visit levels would increase. Separately, we continue to have concern with the post-operative visits in general and we do not believe the post-operative visits are happening and therefore would not justify the higher value. We believe that it better serves relativity to propose a work RVU of 23.12, which maintains the current intensity of CPT code 22210, as opposed to proposing the RUC's recommended [[Page 43873]] work RVU of 24.75 which results in an intensity increase for this code. We are supporting this proposed work RVU of 23.12 with a pair of other 90-day global codes with similar work time values: CPT code 34718 (Endovascular repair of iliac artery, not associated with placement of an aorto-iliac artery endograft at the same session, by deployment of an iliac branched endograft, including pre-procedure sizing and device selection, all ipsilateral selective iliac artery catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally in the internal iliac, external iliac, and common femoral artery(ies), and treatment zone angioplasty/stenting, when performed, for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, penetrating ulcer), unilateral), valued at a work RVU of 23.40 with an intraservice time of 120 minutes, and CPT code 34707 (Endovascular repair of iliac artery by deployment of an ilio-iliac tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally to the iliac bifurcation, and treatment zone angioplasty/stenting, when performed, unilateral; for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation)), valued at a work RVU of 21.72 with an intraservice time of 120 minutes. We disagree with the RUC recommended value of 23.20 for CPT code 22212 and we are instead proposing a work RVU of 21.72 based on a crosswalk to CPT code 34707. This code has a lower intraservice time and a slightly lower total time. We noticed that the surveyed intraservice time for CPT code 22212 is also decreasing significantly, from 147 minutes to 120 minutes, which is offset by the RUC's recommendation of significantly more time in the postoperative visits. We do not agree with the RUC that the work RVU should be increasing by nearly 3.00 RVUs for a procedure where the intraservice time, which is likely to be the most difficult and dangerous part of the procedure, is going down by approximately half an hour. We believe that the RUC's recommended work RVU of 23.20 results in an intensity increase for this code and therefore it better serves relativity to propose a work RVU of 21.72, which maintains the current intensity of CPT code 22212. This proposed work RVU of 21.72 accounts for the decrease in intraservice time and change in the level of the postoperative office visits and is well bracketed by CPT code 34701, valued at a work RVU of 23.12 work with an intraservice time of 120 minutes, and CPT code 38115 (Repair of ruptured spleen (splenorrhaphy) with or without partial splenectomy), valued at a work RVU of 21.33 with an intraservice time of 120 minutes. We disagree with the RUC recommended value of 21.72 for CPT code 22214 and we are instead proposing a work RVU of 19.53 based on a crosswalk to CPT code 44125 (Enterectomy, resection of small intestine; with enterostomy). This code has a lower intraservice time and a higher total time and its use as a crosswalk code maintains the current intensity of CPT code 22214. As was the case with the first two codes, we noticed that the surveyed intraservice time for CPT code 22214 is decreasing significantly, from 163 minutes to 120 minutes, which is offset by the RUC's recommendation of significantly more time in the postoperative visits. We do not agree with the RUC that the work RVU should be increasing for a procedure where the intraservice time, the most difficult and dangerous part of the procedure, is going down by more than half an hour. We believe that it better serves relativity to propose a work RVU of 19.53, which maintains the current intensity of CPT code 22214, as opposed to proposing the RUC's recommended work RVU of 21.72 which results in an intensity increase for this code. This proposed work RVU of 19.53 accounts for the decrease in intraservice time and change in the level of the postoperative office visits and is well bracketed by CPT code 38115, valued at a work RVU of 21.33 with an intraservice time of 120 minutes, and CPT code 42890 (Limited pharyngectomy), valued at a work RVU of 18.65 with an intraservice time of 120 minutes. We are proposing the RUC recommended work RVU of 3.00 for CPT code 22216, as this code maintains its current intensity at the RUC's recommended valuation and maintains relativity with other similar add- on codes. We are proposing the RUC recommended direct PE inputs for all the codes in this family without refinement. (7) Arthroplasty--Shoulder (CPT Codes 23470 and 23472) In April 2025, the RAW identified CPT code 23472 as having a site of service anomaly where Medicare data from 2021-2023 indicated it was performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital E/M services within the global period. The RAW concluded that CPT code 23472 represented a site of service anomaly and identified CPT code 23470 as part of this family of services. The RUC therefore surveyed CPT codes 23470 (Arthroplasty, glenohumeral joint; hemiarthroplasty) and 23742 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))) for the September 2025 meeting. We disagree with the RUC's recommended work RVU of 15.60 for CPT code 23470 and we are instead proposing a work RVU of 13.81 based on a crosswalk to CPT code 27416 (Osteochondral autograft(s), knee, open (e.g., mosaicplasty) (includes harvesting of autograft[s])). The RUC recommended a work RVU of 15.60, which is the current work RVU of the RUC's crosswalk code 67107 (Repair of retinal detachment; scleral buckling (such as lamellar scleral dissection, imbrication or encircling procedure), including, when performed, implant, cryotherapy, photocoagulation, and drainage of subretinal fluid) after the efficiency adjustment was applied at the start of CY 2026. In reviewing CPT code 23470, we note that the recommended intraservice time is decreasing from 113 minutes to 90 minutes (20 percent reduction), and the recommended total time is decreasing from 390 minutes to 330 minutes (22 percent reduction); however, the RUC-recommended work RVU is only decreasing from 17.44 to 15.60, which is a reduction of just over 10 percent. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. More specifically, CPT code 23470 was identified by the RAW as having a site of service anomaly in which the service was performed less than 50 percent of the time in the inpatient [[Page 43874]] setting yet included inpatient hospital Evaluation and Management services within the global period. The RUC has recommended the removal of five inpatient hospital visits along with recommending a decrease of 23 minutes to the intraservice work time based on the survey. We do not believe that the RUC's recommended work decrease of fewer than two RVUs appropriately captures this decrease in procedure time and physician work for CPT code 23470. We also noticed that the RUC's recommended work RVU of 15.60 results in an intensity increase for CPT code 23470. We disagree that an increase in intensity for this code is warranted, particularly given that the typical case for the procedure is moving from the inpatient to outpatient setting. The code descriptor for CPT code 23470 also remains unchanged which suggests that there has been no significant change in the procedure's performance or intensity. Furthermore, we also found that the recommended work RVU of 15.60 was higher than nearly all of the other 90 day global codes with similar time values, and we do not believe that this type of shoulder arthroplasty procedure, which is typically done on a routine and elective basis, would warrant an intensity and work valuation at the very top of the scale relative to other 90 day globals with similar time values. Because the PFS uses a relative value system, we believe it is important to highlight that these codes fail to maintain relativity with related surgical services. We are therefore proposing a work RVU of 13.81 based on a crosswalk to CPT code 27416 which preserves the current intensity of CPT code 23470 and better maintains relativity with the rest of the PFS. We disagree with the RUC's recommended work RVU of 19.35 for CPT code 23472 and we are instead proposing a work RVU of 17.49 based on a crosswalk to CPT code 67414 (Orbitotomy without bone flap (frontal or transconjunctival approach); with removal of bone for decompression). The RUC recommended a work RVU of 19.35, which is the current work RVU of the RUC's crosswalk code 61798 (Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 complex cranial lesion) after the efficiency adjustment was applied at the start of CY 2026. In reviewing CPT code 23472, we note that the recommended intraservice time is decreasing from 140 minutes to 120 minutes (15 percent reduction), and the recommended total time is decreasing from 448 minutes to 348 minutes (24 percent reduction); however, the RUC- recommended work RVU is only decreasing from 21.58 to 19.35, which is a reduction of just over 10 percent. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. More specifically, CPT code 23472 was identified by the RAW as having a site of service anomaly in which the service was performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital Evaluation and Management services within the global period. The RUC has recommended the removal of 3 inpatient hospital visits, one outpatient E/M visit, a decrease from a full to a half discharge visit, along with recommending a decrease of 20 minutes to the intraservice work time based on the survey. We do not believe that the RUC's recommended work decrease of just over two RVUs appropriately captures this decrease in procedure time and practitioner work for CPT code 23472. We also noticed that the RUC's recommended work RVU of 19.35 results in an intensity increase for CPT code 23472. We disagree that an increase in intensity for this code is warranted, particularly given that the typical case for the procedure is moving from the inpatient to outpatient setting. The code descriptor for CPT code 23472 also remains unchanged which suggests that there has been no significant change in the procedure's performance or intensity. Furthermore, we also found that the recommended work RVU of 19.35 was higher than nearly all of the other 90 day global codes with similar time values, and we do not believe that this type of total shoulder arthroplasty procedure, which is typically done on a routine and elective basis, would warrant an intensity and work valuation at the very top of the scale relative to other 90 day globals with similar time values. We are therefore proposing a work RVU of 17.49 based on a crosswalk to CPT code 67414 which preserves the current intensity of CPT code 23472 and better maintains relativity with the rest of the PFS. We are proposing the RUC-recommended direct PE inputs for CPT codes 23470 and 23472 without refinement. (8) Arthroplasty--Hip (CPT Code 27130) In April 2025, the RAW identified CPT code 27130 as having a site of service anomaly where Medicare data from 2021-2023 indicated it was performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital Evaluation and Management services within the global period. The RAW concluded that the code represented a site of service anomaly, and the RUC therefore surveyed CPT code 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft) for the September 2025 meeting. We disagree with the RUC's recommended work RVU of 16.70 for CPT code 27130 and we are instead proposing a work RVU of 15.37 based on a crosswalk to CPT code 43774 (Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components). The RUC recommended a work RVU of 16.70, which is the current work RVU of the RUC's crosswalk code 67108 (Repair of retinal detachment; with vitrectomy, any method, including, when performed, air or gas tamponade, focal endolaser photocoagulation, cryotherapy, drainage of subretinal fluid, scleral buckling, and/or removal of lens by same technique) after the efficiency adjustment was applied at the start of CY 2026. In reviewing CPT code 27130, we noted that the recommended total time is decreasing from 377 minutes to 305 minutes (19 percent reduction); however, the RUC-recommended work RVU is only decreasing from 19.11 to 16.70, which is a reduction of 13 percent. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. More specifically, CPT code 27130 was identified by the RAW as having a site of service anomaly in which the service was performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital Evaluation and Management services within the global period. The RUC has recommended the removal of 2 inpatient hospital visits, a decrease from [[Page 43875]] a full to a half discharge visit, along with recommending a decrease of 10 minutes to the intraservice work time based on the survey. We do not believe that the RUC's recommended work decrease of just over two RVUs appropriately captures this decrease in procedure time and practitioner work for CPT code 27130. We also noticed that the RUC's recommended work RVU of 16.70 results in an intensity increase for CPT code 27130. We disagree that an increase in intensity for this code is warranted, particularly given that the typical case for the procedure is moving from the inpatient to outpatient setting. The code descriptor for CPT code 27130 also remains unchanged which suggests that there has been no significant change in the procedure's performance or intensity. Furthermore, we also found that the recommended work RVU of 16.70 was higher than nearly all of the other 90 day global codes with similar time values, and we do not believe that this type of total hip arthroplasty procedure, which is typically done on a routine and elective basis, would warrant an intensity and work valuation at the very top of the scale relative to other 90 day globals with similar time values. We are therefore proposing a work RVU of 15.37 based on a crosswalk to CPT code 43774 which preserves the current intensity of CPT code 27130 and better maintains relativity with the rest of the PFS. We are proposing the RUC-recommended direct PE inputs for CPT code 27130 without refinement. (9) Sacroiliac Joint Arthrodesis (CPT Codes 27278 and 27279) At the May 2025 CPT Editorial Panel meeting. CPT code 27278 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive, including imaging guidance, unilateral; placement of intra-articular structural bone graft, metal and/or synthetic device(s) without cortical piercing, including use of osteopromotive material and/or obtaining bone graft, when performed) was revised to include imaging guidance, placement of intra-articular structural bone graft, metal, and/or synthetic device(s) without cortical piercing and CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive, including imaging guidance, unilateral; placement of transarticular and/or intra-articular device(s) that engage bone with intrinsic fixation (e.g., screw[s], flange[s], blade[s]) piercing the lateral cortex of the sacrum and the medial cortex of the ilium (with or without piercing the lateral cortex of the ilium), including use of osteopromotive material and/or obtaining bone graft, when performed) was revised to include placement of transarticular and/or intra- articular device(s) that engage bone with intrinsic fixation (e.g., screw(s), flange(s), blade(s)) piercing the lateral cortex of the sacrum and the medial cortex of the ilium. CPT codes 27278 and 27279 were surveyed for the September 2025 RUC meeting. We are proposing the RUC-recommended work RVUs of 7.66 for CPT code 27278 (which is the current work RVU of the code after the efficiency adjustment was applied at the start of CY 2026) and 11.00 for CPT code 27279. We are also proposing the RUC-recommended direct PE inputs for CPT codes 27278 and 27279 without refinement. (10) Arthroplasty--Knee (CPT Code 27447) In April 2025, the RAW identified CPT code 27447 as having a site of service anomaly where Medicare data from 2021-2023 indicated it was performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital Evaluation and Management services within the global period. The RAW concluded that the code represented a site of service anomaly, and the RUC therefore surveyed CPT code 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty)) for the September 2025 meeting. We disagree with the RUC's recommended work RVU of 16.70 for CPT code 27447 and we are instead proposing a work RVU of 15.94 based on a crosswalk to CPT code 65730 (Keratoplasty (corneal transplant); penetrating (except in aphakia or pseudophakia)). The RUC recommended a work RVU of 16.70, which is the current work RVU of the RUC's crosswalk code 67108 (Repair of retinal detachment; with vitrectomy, any method, including, when performed, air or gas tamponade, focal endolaser photocoagulation, cryotherapy, drainage of subretinal fluid, scleral buckling, and/or removal of lens by same technique) after the efficiency adjustment was applied at the start of CY 2026. In reviewing CPT code 27447, we noted that the recommended total time is decreasing from 374 minutes to 305 minutes (19 percent reduction); however, the RUC-recommended work RVU is only decreasing from 19.11 to 16.70, which is a reduction of 13 percent. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to- one or linear decrease in newly valued work RVUs we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. More specifically, CPT code 27447 was identified by the RAW as having a site of service anomaly in which the service was performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital Evaluation and Management services within the global period. The RUC has recommended the removal of two inpatient hospital visits, a decrease from a full to a half discharge visit, along with recommending a decrease of 7 minutes to the intraservice work time based on the survey. We do not believe that the RUC's recommended work decrease of just over two RVUs appropriately captures this decrease in procedure time and practitioner work for CPT code 27447. We also noticed that the RUC's recommended work RVU of 16.70 results in an intensity increase for CPT code 27447. We disagree that an increase in intensity for this code is warranted, particularly given that the typical case for the procedure is moving from the inpatient to outpatient setting. The code descriptor for CPT code 27447 also remains unchanged which suggests that there has been no significant change in the procedure's performance or intensity. Furthermore, we also found that the recommended work RVU of 16.70 was higher than nearly all of the other 90 day global codes with similar time values, and we do not believe that this type of total knee arthroplasty procedure, which is typically done on a routine and elective basis, would warrant an intensity and work valuation at the very top of the scale relative to other 90 day globals with similar time values. We are therefore proposing a work RVU of 15.94 based on a crosswalk to CPT code 65730 which preserves the current intensity of CPT code 27447 and better maintains relativity with the rest of the PFS. We are proposing the RUC-recommended direct PE inputs for CPT code 27447 without refinement. (11) Implantation of Extra-Articular Shock Absorber--Medial Knee (CPT Code 27X05) At the September 2025 CPT Editorial Panel Meeting, CPT created a new Category I code to describe the implantation of a medial knee extra-articular shock absorber. CPT code [[Page 43876]] 27X05 (Implantation of medial knee extra-articular shock absorber, including fluoroscopic guidance) was surveyed at the January 2026 RUC meeting. We are proposing the RUC-recommended work RVU of 13.16 for CPT code 27X05. We are proposing the RUC-recommended direct PE inputs for CPT code 27X05 without refinement. (12) Osteochondral Acellular Scaffold Implantation, Knee (CPT Code 27XX8) At the September 2025 CPT Editorial Panel Meeting, CPT created a new Category I CPT code 27XX8 (Acellular scaffold(s) (e.g., aragonite) implant(s), for osteochondral lesion(s), knee, open), which describes open cartilage knee repair procedures with an acellular scaffold implant. Based on the inorganic nature of these implants, the CPT Editorial Panel included the term ``acellular scaffold'' in the code descriptor for 27XX8, as it is a more comprehensive term and further defines the types of regenerative implants being used that are neither autologous nor allogenic. The CPT Editorial Panel did not request deletion for existing Category III code 0737T, which is currently being reported for this procedure, since it may appropriately describe procedures with this type of implant joints other than the knee. CPT code 27XX8 was surveyed for the January 2026 RUC meeting. We are proposing the RUC-recommended work RVU of 9.53 for CPT code 27XX8.We are proposing the RUC-recommended direct PE inputs for CPT code 27XX8 without refinement. (13) Cardiac Contractility Modulation (CPT Codes 33X01, 33X02, 33X03, 33X04, 33X05, 33X06, 33X07, 33X08, 33X09, 33X10, 33X11, 93X01, 93X02, 93X03, and 93X04) In May 2025, the CPT Editorial Panel approved a new family of 11 Category I CPT codes for insertion, removal, and replacement of cardiac contractility modulation (CCM) systems, generators, and leads in several combinations. A separate set of four codes was created to describe the corresponding CCM programming, interrogation, and remote interrogation services. All 11 of the insertion, removal, and replacement/repositioning/revision CCM codes, as well as three programming, interrogation, and remote interrogation CCM services that involve physician work, were surveyed for the September 2025 RUC meeting. The specialty societies detailed the four code subsets within the CCM code family. These include CCM insertion services: CPT codes 33X01 (Insertion of permanent cardiac contractility modulation system, including fluoroscopic guidance and programming of sensing and therapeutic parameters, with evaluation when performed; pulse generator and transvenous electrodes), 33X02 (Insertion of permanent cardiac contractility modulation system, including fluoroscopic guidance and programming of sensing and therapeutic parameters, with evaluation when performed; pulse generator only), 33X03 (Insertion of permanent cardiac contractility modulation system, including fluoroscopic guidance and programming of sensing and therapeutic parameters, with evaluation when performed; transvenous electrode, single), and 33X04 (Insertion of permanent cardiac contractility modulation system, including fluoroscopic guidance and programming of sensing and therapeutic parameters, with evaluation when performed; transvenous electrode, dual); CCM removal services: CPT code 33X05 (Removal of a permanent cardiac contractility modulation system; pulse generator and transvenous electrodes), 33X06 (Removal of a permanent cardiac contractility modulation system; pulse generator only), 33X07 (Removal of a permanent cardiac contractility modulation system; transvenous electrode, single), and 33X08 (Removal of a permanent cardiac contractility modulation system; transvenous electrode, dual); CCM replacement, repositioning, and revision services: CPT code 33X09 (Removal and replacement of permanent cardiac contractility modulation system, pulse generator only), 33X10 (Repositioning of previously implanted cardiac contractility modulation transvenous electrode(s), including fluoroscopic guidance and programming of sensing and therapeutic parameters), and 33X11 (Relocation or revision of skin pocket for implanted cardiac contractility modulation pulse generator); and CCM programming, interrogation, and remote interrogation services: CPT code 93X01 (Programming of the cardiac contractility modulation system (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, including review and report by a physician or other qualified health care professional), 93X02 (Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified healthcare professional, includes connection, recording and disconnection per patient encounter, implantable cardiac contractility modulation system), 93X03 (Interrogation device evaluation (remote), up to 90 days, cardiac contractility modulation system with interim analysis, review and report(s) by a physician or other qualified health care professional), and 93X04 (Interrogation device evaluation (remote), up to 90 days, cardiac contractility modulation system, remote data acquisition(s), receipt of transmissions, technician review, technical support, and distribution of results). We are proposing the RUC-recommended work RVU for all of the codes in this family. We are proposing a work RVU of 8.83 for CPT code 33X01, work RVU of 5.66 for CPT 33X02, work RVU of 6.00 for CPT 33X03, work RVU of 6.23 for CPT 33X04, work RVU of 9.90 for CPT 33X05, work RVU of 4.79 for CPT 33X06, work RVU of 7.30 for CPT 33X07, work RVU of 8.39 for CPT 33X08, work RVU of 6.00 for CPT 33X09, work RVU of 5.00 for CPT 33X10, work RVU of 5.12 for CPT 33X11, work RVU of 0.90 for CPT 93X01, work RVU of 0.80 for CPT 93X02, and work RVU of 0.59 for CPT 93X03. We note that several of these work RVUs were affected by the efficiency adjustment which was applied at the start of CY 2026, as the RUC recommendations were based on pre-adjustment work valuations. The RUC did not recommend, and we are not proposing, a work RVU for CPT code 93X04. We are proposing the RUC-recommended direct PE inputs for CPT codes 33X01-33X11 as well as for CPT codes 93X01-93X04 without refinement. (14) Insertion and Removal of Surgical Ventricular Assist Device (CPT Codes 33X12, 33X13, and 33X15) At the September 2025 CPT Editorial Panel meeting, the CPT Editorial Panel created three new category I CPT codes to describe the insertion and removal of a left heart ventricular assist device (VAD), specifically using an open arterial with conduit surgical approach. These new category I CPT codes include the insertion CPT codes 33X15 (Insertion of left heart ventricular assist device, including radiological supervision and interpretation, open; axillary, subclavian or innominate artery exposure with creation of conduit by infraclavicular or supraclavicular incision, unilateral) and 33X12 (Insertion of left heart ventricular assist device, including radiological supervision and interpretation, open; aorta exposure with creation of conduit [[Page 43877]] by transthoracic (e.g., median sternotomy, thoracotomy) incision) as well as the removal CPT code 33X13 (Removal of left heart ventricular assist device with resection and stapling of graft conduit and skin closure (e.g., infraclavicular, supraclavicular). We are proposing the RUC-recommended work RVU of 13.65 for CPT code 33X15, work RVU of 17.52 for CPT 33X12, and work RVU of 6.58 for CPT 33X13. We are proposing the RUC-recommended direct PE inputs for CPT codes 33X15, 33X12, and 33X13 without refinement. (15) Transcatheter Tricuspid Valve Implant, Edge-to-Edge Repair (CPT Codes 33X50, 33X51, and 33X52) In September 2025, the CPT Editorial Panel approved the addition of CPT codes 33X50 (Transcatheter tricuspid valve implantation (TTVI)/ replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed), CPT code 33X51 (Transcatheter tricuspid valve edge-to-edge repair (T-TEER), percutaneous approach; initial clip), and CPT code 33X52 (Transcatheter tricuspid valve edge-to-edge repair (T-TEER), percutaneous approach; each additional clip during same session). These codes were surveyed for the January 2026 RUC meeting. The RUC recommended the inclusion of an inpatient hospital visit (CPT code 99233) within the global period of CPT codes 33X50 and 33X51, despite the fact that both codes were recommended with 0 day global periods. We disagree that this inpatient hospital visit should be included within the valuation of these services, as 0 day global periods are specifically defined to include only postoperative care that takes place on the day of the procedure itself without incorporating any postoperative days. We are therefore proposing to remove the inpatient hospital visit (CPT code 99233) from both CPT codes 33X50 and 33X51, including the removal of 55 minutes of associated work time from each procedure. We disagree with the RUC-recommended work RVU of 24.38 for CPT code 33X50 and we are instead proposing a work RVU of 17.52 based on a crosswalk to CPT code 95391 (Percutaneous transcatheter closure of paravalvular leak; initial occlusion device, aortic valve). Our review of CPT code 33X50 found that the RUC's recommended work RVU of 24.38 placed it far higher than any other 0-day global code with similar time values on the PFS, especially after accounting for the removal of the work time associated with the inpatient hospital visit described earlier in this section. Most codes with 120 minutes of intraservice time and approximately 220 minutes of total time were valued around a work RVU of 13.00-15.00 and there were zero codes valued higher than a work RVU of 17.52. While we concur that CPT code 33X50 is a difficult and intensive procedure to perform, we do not believe it is accurately valued at 7 RVUs higher than any other code with comparable time values. We are instead proposing a work RVU of 17.52 based on a crosswalk to CPT code 95391, the highest 0-day global valuation with comparable work times, as this will avoid distorting relativity with other services on the PFS. We also note that CPT code 33X50 has comparable intensity at our proposed work RVU to the top reference code from the survey, CPT code 33477, which we believe better serves relativity than the RUC's recommended work RVU. The RUC's recommended work RVU of 24.38 would result in an intensity for CPT code 33X50 nearly 50 percent higher than the already complex and difficult transcatheter pulmonary valve implantation procedure described in the reference code, which we do not believe would be typical. For CPT code 33X51, we disagree with the RUC's recommended work RVU of 23.92 and we are instead proposing a work RVU of 17.06. Although we disagree with the RUC-recommended work RVU for CPT 33X51, we concurred that the relative difference in work between CPT codes 33X50 and 33X51 is equivalent to the recommended interval of 0.46 RVUs. Therefore, we are proposing a work RVU of 17.06 for CPT code 33X51, based on the recommended interval of 0.46 below our proposed work RVU of 17.52 for CPT code 33X50. For CPT code 33X52, we disagree with the RUC-recommended work RVU of 8.00 and we are instead proposing a work RVU of 6.34 based on a crosswalk to CPT 22552 (Arthrodesis, anterior interbody, including disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2, each additional interspace (List separately in addition to code for primary procedure). Our review of CPT code 33X52 found that the RUC's recommended work RVU of 8.00 placed it far higher than almost any other add-on code with similar time values on the PFS, with the sole exception of CPT code 61642 (Balloon dilatation of intracranial vasospasm, percutaneous; each additional vessel in different vascular territory which is an outlier valuation at a work RVU of 8.66. Most add-on codes with approximately 50 minutes of total time were valued around a work RVU of 3.00-5.00 and there was only a single code valued higher than a work RVU of 6.34. While we concur that CPT code 33X52 is a difficult and intensive procedure to perform, we do not believe it is accurately valued at nearly two RVUs higher than other codes with comparable time values. We are instead proposing a work RVU of 6.34 based on a crosswalk to CPT code 22522, the highest non-outlier add-on code valuation with comparable work times, as this will avoid distorting relativity with other services on the PFS. We note that this valuation will also maintain relative intensity between CPT code 33X52 and the first two codes in the family at our proposed work RVUs. The RUC did not recommend and we are not proposing any direct PE inputs for the three codes in this family. (16) Percutaneous Transcatheter Closure (CPT Code 33340) In April 2025, the RAW identified CPT code 33340 (Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation) as a code that has Medicare utilization of 10,000 or more that has increased by at least 100 percent from 2018 through 2023. The specialty societies indicated and the RUC agreed that CPT code 33340 be surveyed for the January 2026 RUC meeting. We disagree with the RUC's recommendation of the current work RVU of 9.99 for CPT code 33340 and we are instead proposing a work RVU of 9.00 based on crosswalk to CPT code 37271 (Revascularization, endovascular, open or percutaneous, femoral and popliteal vascular territory, with transluminal atherectomy, including transluminal angioplasty when performed, including all maneuvers necessary for accessing and selectively catheterizing the artery and crossing the lesion, including all imaging guidance and radiological supervision and interpretation necessary to perform the atherectomy and angioplasty when performed, within the same artery, unilateral; straightforward lesion, initial vessel). The RUC survey indicated that the typical time needed to perform CPT code 33340 has decreased, with the [[Page 43878]] intraservice time decreasing from 70 minutes to 62 minutes and the total time decreasing from 165 minutes to 154 minutes. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. The RUC's recommendation to maintain the current work RVU of 9.99 for CPT code 33340 can only be justified if the intensity to perform the service has increased over time. However, there has been no change to the code descriptor for CPT code 33340 and no apparent change in clinical practice which would warrant the roughly 15 percent increase in intensity as recommended by the RUC. Since we do not believe that there is evidence indicating that CPT code 33340 has typically become more intense to perform, we are therefore proposing a work RVU of 9.00 which maintains the current intensity of the service. This valuation is based on a crosswalk to CPT code 37271, a recently reviewed service from CY 2026 that has a higher intraservice time and nearly identical total time. We are proposing the direct PE inputs for CPT code 33340 as recommended by the RUC without refinement. (17) Treatment of Incompetent Veins (CPT Codes 36470, 36471, 36465, 36466, 36473, and 36474) In April 2025, the RAW identified CPT code 36465 (Injection of non- compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; single incompetent extremity truncal vein (e.g., great saphenous vein, accessory saphenous vein), as a code that has Medicare utilization of 10,000 or more that has increased by at least 100 percent from 2018 through 2023. The RAW reviewed the action plan and the RUC recommended CPT code 36465 along with the family of services be surveyed for the January 2026 RUC meeting. The RUC reviewed this family of services at the January 2026 meeting including all sclerosant treatment of incompetent veins. These services are: CPT code 36465; CPT code 36466 (Injection of non- compounded foam sclerosant with ultrasound compression maneuvers to guide dispersion of the injectate, inclusive of all imaging guidance and monitoring; multiple incompetent truncal veins (e.g., great saphenous vein, accessory saphenous vein), same leg); CPT code 36470 (Injection of sclerosant; single incompetent vein (other than telangiectasia)); CPT code 36471 (Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg); CPT code 36473 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated); and CPT code 36474 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure)). For CY 2027, we are proposing the RUC-recommended work RVUs for five of the six codes in this family. We are proposing the RUC- recommended work RVU of 2.29 for CPT code 36465, 0.73 for CPT code 36470, 1.18 for CPT code 36471, 3.41 for CPT code 36473, and 1.71 for CPT code 36474. We disagree with the RUC recommended work RVU of 2.93 for CPT code 36466. Instead, we are proposing a work RVU of 2.62 based on a crosswalk to CPT code 57156 (Insertion of a vaginal radiation afterloading apparatus for clinical brachytherapy). In reviewing CPT code 36466, we noted that the recommended intraservice time is decreasing from 35 minutes to 30 minutes (14 percent reduction), and the recommended total time is decreasing from 76 minutes to 68 minutes (11 percent reduction); however, the RUC recommended maintaining the current work RVU of 2.93. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner. The RUC's recommendation to maintain the current work RVU of 2.93 for CPT code 36466 can only be justified if the intensity to perform the service has increased over time. However, there has been no change to the code descriptor for CPT code 36466 and no apparent change in clinical practice which would warrant the roughly 17 percent increase in intensity as recommended by the RUC. Since we do not believe that there is evidence indicating that CPT code 36466 has typically become more intense to perform, we are therefore proposing a work RVU of 2.62 which maintains the current intensity of the service. This valuation is based on a crosswalk to CPT code 57156, which has the same intraservice work time of 30 minutes and higher total time. We are proposing the RUC-recommended direct PE inputs for all CPT codes in this family without refinement. (18) Microvascular Bypass, Lymphatic Vessels (CPT Codes 38X03 and 38X04) In September 2025, the CPT Editorial Panel approved two new Category I codes to describe microvascular bypass of lymphatic vessels, a microsurgical procedure. This newly created Category I CPT code family describes two services: a base code for the initial anastomosis, CPT code 38X03 (Microvascular anastomosis between a single vein opening and any number of lymphatic vessels, per limb; initial anastomosis), and the add-on code for each additional anastomosis, CPT code 38X04 (Microvascular anastomosis between a single vein opening and any number of lymphatic vessels, per limb; initial anastomosis; each additional anastomosis (List separately in addition to code for primary procedure)). CPT codes 38X03 and 38X04 were surveyed for the January 2026 RUC meeting. We reviewed the RUC's recommended work valuations and found the RUC's recommended work RVU of 16.00 for CPT code 38X03 to be high, based on a search of similarly timed codes in the RUC database. For CY 2027 we are proposing a work RVU of 14.00, based on the RUC survey 25th percentile, for CPT code 38X03. We are proposing the RUC recommended work RVU of 6.00 for CPT code 38X04. We are proposing the RUC- recommended direct PE inputs for both CPT codes without refinement. (19) Diaphragmatic Hernia Repair (CPT Codes 39540, 39541, 39XX3, 39XX4, 39XX5, 39XX7, 39XX8, 39XX9, 39X11, 39X12, and 39X13) At the September 2025 CPT Editorial Panel, the committee revised two existing CPT codes, CPT code 39540 (Repair, diaphragmatic hernia (other than neonatal), via laparotomy; traumatic, acute) and CPT code 39541 (Repair, diaphragmatic hernia (other than neonatal), via laparotomy; traumatic, chronic), describing diaphragmatic hernia repair. They also created nine new Category I codes, CPT [[Page 43879]] codes 39XX3 (Repair, diaphragmatic hernia (other than neonatal), via laparotomy; nontraumatic (ie, Bochdalek, Morgagni)), 39XX4 (Repair, diaphragmatic hernia (other than neonatal), via thoracotomy; traumatic, chronic), 39XX5 (Repair, diaphragmatic hernia (other than neonatal), via thoracotomy; nontraumatic (ie, Bochdalek, Morgagni)), 39XX7 (Laparoscopy, surgical, with repair of diaphragmatic hernia (other than neonatal); traumatic, acute), 39XX8 (Laparoscopy, surgical, with repair of diaphragmatic hernia (other than neonatal); traumatic, chronic), 39XX9 (Laparoscopy, surgical, with repair of diaphragmatic hernia (other than neonatal); nontraumatic (ie, Bochdalek, Morgagni)), 39X11(Thoracoscopy surgical, with repair of diaphragmatic hernia (other than neonatal); traumatic, chronic), 39X12 (Thoracoscopy surgical, with repair of diaphragmatic hernia (other than neonatal); nontraumatic (ie, Bochdalek, Morgagni)), and 39X13 (Implantation of mesh or other prosthesis with open, laparoscopic, or thoracoscopic diaphragmatic hernia repair (List separately in addition to code for primary procedure)) that expanded the range of surgical interventions included in this code family. The RUC reviewed these services at the January 2026 meeting. For CY 2027, we are proposing the RUC recommended work RVUs of 24.00 for CPT code 39540, 26.00 for CPT code 39541, 25.75 for CPT code 39XX3, 26.41 for CPT code 39XX4, 25.94 for CPT code 39XX5, 22.04 for CPT code 39XX7, 26.60 for CPT code 39XX8, 27.00 for CPT code 39XX9, 25.44 for CPT code 39X11, 25.94 for CPT code 39X12, and 3.00 for CPT code 39X13. We are proposing the RUC-recommended direct PE inputs for all CPT codes in this family without refinement. (20) Diaphragm Repair (CPT Codes 39545 and 395X2) In May 2025, the CPT Editorial Panel revised CPT code 39545 (Plication of diaphragm for eventration or paralysis, via thoracotomy) to specify plication of the diaphragm for eventration or paralysis, via thoracotomy, and created CPT code 395X2 (Thoracoscopy, surgical, with plication of diaphragm for eventration or paralysis) to report thoracoscopic plication of the diaphragm for eventration or paralysis. For CY 2027, we are proposing the RUC recommended work RVUs of 18.45 for CPT code 39545 and 20.00 for CPT code 395X2. We are proposing the RUC-recommended direct PE inputs for both CPT codes without refinement. (21) Division of Median Arcuate Ligament (CPT Codes 39XX1 and 39XX2) In February 2025, the CPT Editorial Panel created two new codes to report open and laparoscopic median arcuate ligament syndrome (MALS) treatment: CPT code 39XX1 (Division of median arcuate ligament and release of celiac trunk, with ganglionectomy, when performed) and CPT code 39XX2 (Laparoscopy, surgical, with division of median arcuate ligament and release of celiac trunk, with ganglionectomy, when performed). The two new codes were surveyed for the April 2025 RUC meeting. We are proposing the RUC-recommended efficiency adjusted work RVUs of 26.41 for CPT code 39XX1 and 25.94 for CPT code 39XX2. We are proposing the RUC-recommended direct PE inputs for CPT codes 39XX1 and 39XX2 without refinement. (22) Endoscopic Submucosal Dissection (CPT Codes 4XX01 and 4XX02) At the May 2025 CPT Editorial Panel Meeting, two new CPT codes were created for reporting endoscopic submucosal dissection (ESD) of both the upper and lower GI tract, including mucosal closure: CPT codes 4XX01 (Endoscopic submucosal dissection (ESD) of upper gastrointestinal tract, including mucosal closure, when performed) and 4XX02 (Endoscopic submucosal dissection (ESD) of lower gastrointestinal tract, including mucosal closure, when performed). These new CPT codes were surveyed at the September 2025 AMA RUC meeting. For CY 2027, we are proposing the RUC-recommended work RVUs of 15.00 for CPT code 4XX01 and 16.38 for CPT code 4XX02. We are proposing the RUC-recommended direct PE inputs for CPT codes 4XX01 and 4XX02 without refinement. (23) Transoral Oropharyngeal Procedures (CPT Codes 42808, 42XX1, and 42XX2) In February 2025, the CPT Editorial Panel approved two new Category I codes that describe transoral endoscopic surgery under magnification for the removal of tumors in the oropharynx, including robotic assistance when performed: CPT code 42XX1 (Transoral removal of oropharyngeal and/or pharyngeal neoplasm under magnification (e.g., microscope or telescope), includes robotic assistance, when performed, tongue base) and CPT code 42XX2 (Transoral removal of oropharyngeal and/or pharyngeal neoplasm under magnification (e.g., microscope or telescope), includes robotic assistance, when performed; tongue base; lateral pharyngeal wall, including tonsil). CPT code 42808 (Excision or destruction of lesion of pharynx, without magnification, any method) was revised to clarify that it is done without magnification, and it was surveyed along with the two new codes at the April 2025 RUC meeting. We are proposing the RUC-recommended work RVU for all three codes in this family. We are proposing a work RVU of 2.29 for CPT code 42808 (which is the current work RVU of the code after the efficiency adjustment was applied at the start of CY 2026), a work RVU of 20.00 for CPT code 42XX1, and a work RVU of 20.05 for CPT code 42XX2. We note that the RUC's recommended work RVU of 2.29 for CPT code 42808 assigns an intensity value of zero for this service; we are seeking comment from interested parties as to whether an alternate work valuation, such as the survey 25th percentile work RVU of 2.70, would be more appropriate. We are proposing the RUC-recommended direct PE inputs for all three codes without refinement. (24) Congenital Duodenal Obstruction Repair (CPT Codes 44XX1 and 44XX2) At the May 2025 CPT Editorial Panel Meeting, two new CPT codes were created for reporting surgical treatment for congenital duodenal obstruction via an open or laparoscopic approach, that were previously reported using unlisted codes: CPT codes 44XX1 (Duodenoduodenostomy or duodenojejunostomy for congenital duodenal obstruction) and 44XX2 (Laparoscopy, surgical; duodenoduodenostomy or duodenojejunostomy for congenital duodenal obstruction). These new CPT codes were surveyed at the September 2025 AMA RUC meeting. For CY 2027, we are proposing the RUC-recommended work RVUs of 50.00 for CPT code 44XX1 and 52.60 for CPT code 44XX2. We are proposing the RUC-recommended direct PE inputs for CPT codes 44XX1 and 44XX2 without refinement. (25) Irreversible Electroporation of Tumor, Pancreas (CPT Code 48XXX) In May 2025, the CPT Editorial Panel approved the addition of a new CPT code 48XXX (Ablation, irreversible electroporation of tumor(s) of the pancreas, open, including imaging guidance) to report open irreversible electroporation (IRE) ablation of tumors of the pancreas. [[Page 43880]] We are proposing the RUC-recommended work RVU of 25.19 for CPT code 48XXX, and the RUC-recommended direct PE inputs without refinement. (26) Prostate Biopsy Services (CPT Codes 55705, 55707, 55708, 55709, 55710, 55711, 55712, 55714, and 55715) This service was identified via the April 2022 RAW review of services performed by the same physician on the same date of service 75 percent of the time or more and was surveyed for the September 2024 RUC meeting. The data from the September 2024 survey indicated that the long descriptors did not adequately describe these services. While the codes were valued for the CPT 2026 cycle, the specialties and the RUC agreed that a new coding change application should be developed for the CPT Editorial Panel for restructuring in the CPT 2027 cycle. CPT revised the prostate biopsy code family in 2026 and it was surveyed for the January 2026 RUC meeting. The revisions to the family are as follows: CPT codes 55705 (Biopsy, prostate, any approach, non-imaging guided), 55707 (Biopsy, prostate, transrectal, including imaging guidance, regional), 55708 (Biopsy, prostate, transrectal, including imaging guidance, regional and fusion-targeted lesion(s)), 55709 (Biopsy, prostate, transperineal, including imaging guidance, regional), 55710 (Biopsy, prostate, transperineal, including imaging guidance, regional and of fusion-targeted lesion(s), 76872 (ultrasound, transrectal), and 55714 (Biopsy, prostate, including imaging guidance, in-bore-CT-or-MRI-guided; first targeted lesion) have work RVUs that were reaffirmed from CY 2026 by the RUC. CPT codes 55711 (Biopsy, prostate, transrectal or transperineal, including imaging guidance, fusion), 5XX14 (Biopsy, prostate, transrectal or transperineal, including imaging guidance, fusion-targeted lesion(s) without regional; each additional targeted lesion (List separately in addition to code for primary procedure) and 55715 (Biopsy, prostate, including imaging guidance, in-bore CT- or MRI-guided; each additional targeted lesion (List separately in addition to code for primary procedure)) are new and/or revised codes for CY2027. For CY 2027, we are proposing the RUC-recommended work RVU for eight of the nine codes in the family. We are proposing the RUC- recommended work RVUs of 1.88 for CPT code 55705, 2.63 for CPT code 55707, 3.39 for CPT code 55708, 3.23 for CPT code 55709, 3.81 for CPT code 55710, 2.37 for CPT code 55711, 3.62 for CPT code 55714, and 1.80 for CPT 55715. For CPT code 5XX14, we disagree with the RUC-recommended work RVU of 0.80. In the interest of maintaining relativity with similarly timed codes, we are instead proposing a work RVU of 0.68 based on a crosswalk to CPT code 93567 (Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report; for supravalvular aortography (List separately in addition to code for primary procedure)). CPT code 55X14 was surveyed with only 6 minutes of intraservice and total work time, yet the RUC recommended a work RVU of 0.80. We compared this recommended valuation against CPT code 55715, another add-on code within this same family, which was surveyed at 35 minutes of intraservice and total work time but with a recommended work RVU of 1.80. This results in CPT code 55X14 having an intensity nearly triple that of CPT code 55715 which we do not believe would be typical. We also found that there were no other add-on codes in the RUC database with comparable time values to CPT code 55X14 which had a work RVU approaching 0.80. The closest was CPT code 77063 (Screening digital breast tomosynthesis, bilateral) at a work RVU of 0.59, with that code having 8 minutes of work time instead of 6 minutes, and all other comparable add-on codes had a work RVU of 0.37 or lower. Although we agree that CPT code 55X14 is a difficult and intensive procedure, we believe that the RUC's recommended work RVU of 0.80 assigns too much work valuation and intensity to the service, and does not maintain relativity with other related codes on the PFS. We are instead proposing a work RVU of 0.68 for CPT code 5XX14 based on a crosswalk to CPT code 93567. Our proposed work RVU of 0.68 is also supported with add-on CPT codes with similar work time values. CPT code 93566 (Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report; for selective right ventricular or right atrial angiography (List separately in addition to code for primary procedure)) is valued at a work RVU of 0.49 with an intraservice time of 10 minutes and CPT code 64484 (Injection(s), anesthetic agent(s) and/or steroid; transforaminal epidural, with imaging guidance (fluoroscopy or CT), lumbar or sacral, each additional level (List separately in addition to code for primary procedure)) is valued at a work RVU of 0.98 with an intraservice time of 10 minutes. We are proposing the RUC-recommended direct PE inputs for all CPT codes in this family without refinement. (27) Maternity Care Services (CPT Codes 59320, 59325, 59412, 59871, 59XX1, 59XX2, 59XX3, 59XX4, 59030, 59051, 59XX5, 59XX6, 59414, 59300, 59XX7, 59XX8, 59XX9, 59X10, 59X11, 59X12, and 59160) a. Background and Proposal At the January 2026 AMA RUC meeting, the maternity global codes were revised to delete 17 legacy CPT codes, create 12 new CPT codes, and revise 9 CPT codes describing maternity care services. See Table A- D2 for a summary of the codes and their long descriptors. These codes were restructured from the MMM global period to individual codes to reflect changes in practice. The previous MMM global period included 12 prenatal E/M visits bundled into CPT codes 59400, 59510, 59610, and 59618. In May 2025, the American College of Obstetricians and Gynecologists (ACOG) published new clinical guidelines, recommending that obstetrician-gynecologists and other maternity care professionals tailor the visit frequency and monitoring schedule to the needs of the pregnant woman. These new clinical guidelines provide a sample schedule for prenatal care services and visit frequency, which describes 8 visits for average-risk pregnant women without medical or pregnancy complications, and 13 visits for pregnant women with greater-than- average risk. This sample schedule specifies that additional services may be offered as needed throughout the pregnancy. When the RUC reviewed these codes, they included 12 prenatal E/M visits (two level 2 established patient office visits, eight level 3 established patient office visits, and two level 4 established patient office visits) in the calculations to make these changes budget-neutral despite the revisions to the clinical guidelines suggesting that 12 visits would no longer be typical. As the clinical guidelines have changed to reflect a revised assumption about the typical number of visits, estimating work neutrality based on the assumption that all 12 prenatal E/M visits in the base year would be reported in the predictive year overestimates the total utilization and as a result, undervalues the work RVUs as recommended by the RUC. To improve payment accuracy of the new codes, we are proposing to refine the RUC's recommended utilization crosswalk to remove four E/M visits (two level 2 [[Page 43881]] established patient office visits and two level 4 established patient office visits) from the utilization estimate calculation and reallocate those RVUs within the code family to the new labor and delivery codes. This would mean reallocating 11,810 additional work RVUs to the new labor and delivery codes (CPT codes 59XX1-59XX8). Since the RUC provided a utilization estimate of 12,791 for CPT codes 59XX1-59XX8, this would result in a 15 percent increase in work RVUs for each labor and delivery code. We would like to emphasize that we are not endorsing a reduced number of prenatal visits for pregnant women. Our recalculation of the utilization estimates in the valuation of these services should not be used to determine the appropriate number of visits to provide reasonable and necessary care to beneficiaries. As with all PFS services, maternity services should be furnished when medically reasonable and necessary. There are no RUC-recommended direct PE inputs for these CPT codes. Table A-D2 also shows the RUC-recommended and CMS proposed work RVUs for the 21 CPT codes. [GRAPHIC] [TIFF OMITTED] TP16JY26.020 b. Comment Solicitation on Maintaining Current Coding Through Creation of HCPCS G-codes We are interested in thinking about different approaches to how maternity care codes are valued and paid under the PFS. Although the RUC asserts that these proposed coding changes discussed above reflect clinical consensus, we have concerns that our adoption of the new codes would be disruptive based on how the longstanding existing code structure is currently accounted for in clinical practice patterns. We are seeking comment on whether CMS should create HCPCS G-codes that would maintain the current coding and payment for maternity services to ameliorate this concern, while we continue to consider the potential impact that changes in the maternity care code family have on clinical outcomes for maternal care. These codes would be used in lieu of adoption of the new CPT codes for purposes of Medicare payment. We are specifically interested in additional information to support or oppose this concern, as well as additional information to support or oppose the use of the creation of HCPCS G-codes in lieu of adoption of the new CPT codes. Specifically, for payment for maternity care services under the PFS, we are considering, and are seeking comment on, the creation of 15 new HCPCS G-Codes for CY 2027 that reflect the previous MMM global code structure, with the code descriptors and work RVUs detailed in Table A- D3, as an alternative to the revaluation of the codes as discussed in Section (a), of this preamble. We are seeking public comment on these HCPCS G-codes and, after consideration of public comment, could finalize payment for these codes. We are seeking comment on these HCPCS G-codes and are also seeking comment on any other HCPCS G-codes that may be needed to reflect the necessary service elements for this code family. These HCPCS G-codes would adopt all current conditions of payment for the MMM global codes, as well as maintain the MMM global period, if finalized. [[Page 43882]] [GRAPHIC] [TIFF OMITTED] TP16JY26.021 (28) Stereotactic Computer-Assisted Volumetric Navigation (CPT Codes 61781, 61782, and 61783) In April 2024, CPT code 61783 (Stereotactic computer-assisted (navigational) procedure; spinal (List separately in addition to code for primary procedure)) was identified via the high-volume growth screen. In January 2025, the RAW reviewed the action plan for CPT code 61783 and determined that this service should be surveyed with the appropriate family of codes. The RUC recommended that CPT code 61781 be surveyed with CPT codes 61782 (Stereotactic computer-assisted (navigational) procedure; cranial, extradural (List separately in addition to code for primary procedure)) and 61783 (Stereotactic computer-assisted (navigational) procedure; spinal (List separately in addition to code for primary procedure)) for September 2025. We are proposing the RUC-recommended work RVU of 3.66 for CPT codes 61781 and 61783, and the RUC-recommended RVU of 2.06 for CPT code 61782. We note that all three of these RUC-recommended RVUs reflect the application of the CY 2026 efficiency adjustment described in the CY 2026 PFS final rule (90 FR 49334 through 49345). We are proposing the RUC's recommended direct PE inputs for CPT code 61782. Since CPT codes 61781 and 61783 are performed in the facility setting only, the RUC did not recommend, and we are not proposing, any direct PE inputs for these two codes. (29) Percutaneous Lumbar Decompression (CPT Code 62287) At the January 2025 RUC meeting, the surveying societies requested deletion of CPT code 62287 (Decompression, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle-based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar) due to declining Medicare utilization. At the May 2025 CPT Editorial Panel meeting, CPT reviewed additional utilization estimates, and requests from neurosurgery and radiology were received to resurvey and retain the code. CPT code 62287 was surveyed at the September 2025 AMA RUC meeting since it was not deleted in January 2025 with the other codes in the family. We disagree with the RUC's recommended work RVU of 7.06 for CPT code 62287 and we are instead proposing a work RVU of 6.23 based on a crosswalk to CPT code 46707 (Repair of anorectal fistula with plug (e.g., porcine small intestine submucosa [SIS])). We believe that the RUC's recommended work RVU of 7.06 is an overestimation based on a comparison to other codes with similar time values, particularly the key reference code CPT code 22869 (Insertion of interlaminar/ interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level). There was a decrease in the surveyed work times, such as the intraservice time decreasing from 60 minutes to 37 minutes, which was not fully accounted for in the RUC's recommended work RVU of 7.06. We also note that the procedure does not seem to have become more intense, as the code descriptor did not change. In the interest of maintaining relativity with similarly timed codes, we are instead proposing a work RVU of 6.23 based on a crosswalk to CPT code 46707. This code has an almost identical intraservice time and similar total time. The proposed work RVU accounts for the decrease in both intraservice time and total time and is well bracketed by CPT code 67912 (Correction of lagophthalmos, with implantation of upper eyelid lid load (e.g., gold weight)), valued at a work RVU of 6.20 with an intraservice time of 40 minutes, and CPT code 24358 (Tenotomy, elbow, lateral or medial (e.g., epicondylitis, tennis elbow, golfer's elbow); debridement, soft tissue and/or bone, open), valued at a work RVU of 6.49 with an intraservice time of 40 minutes. We are proposing the RUC-recommended direct PE inputs for all of the codes in this family. (30) Laminectomy (CPT Codes 63045, 63046, 63047, and 63048) In April 2025, the RAW identified CPT code 63047 (Laminectomy, facetectomy and foraminotomy [[Page 43883]] (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; lumbar) as a site of service anomaly where Medicare data from 2021 to 2023 indicated it was performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital Evaluation and Management services within the global period with 2023 Medicare utilization over 10,000. The RAW also worked with the specialty societies and identified other codes 63045 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; cervical), 63046 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; thoracic) and 63048 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; each additional vertebral segment, cervical, thoracic, or lumbar (List separately in addition to code for primary procedure)) as part of this family of services. These services were surveyed for September 2025. We are proposing the RUC-recommended work RVUs for all four CPT codes in this family. We are proposing a work RVU of 17.25 for CPT code 63045, a work RVU of 16.71 for CPT code 63046, a work RVU of 14.99 for CPT code 63047, and a work RVU of 3.38 for CPT code 63048. We note that several of these work RVUs were affected by the efficiency adjustment which was applied at the start of CY 2026, as the RUC recommendations were based on pre-adjustment work valuations. We are proposing the RUC recommended direct PE inputs for CPT codes 63045, 63046, 63047, and 63048 without refinement. (31) Injection Anesthetic Agent (CPT Codes 64400 and 64405) The RUC identified CPT code 64400 (Injection(s), anesthetic agent(s) and/or steroid; trigeminal nerve, each branch (i.e., ophthalmic, maxillary, mandibular)) via their database flag, ``Do not use to validate physician work'', and recommended to survey this CPT code and the related CPT code 64405 (Injection(s), anesthetic agent(s) and/or steroid; greater occipital nerve) for the September 2025 meeting. For CY 2027, we are proposing the RUC-recommended work RVUs of 0.73 for CPT code 64400 (which is the current work RVU of the code after the efficiency adjustment was applied at the start of CY 2026) and 0.84 for CPT code 64405. We are proposing the RUC-recommended direct PE inputs for both CPT codes without refinement. (32) MRA--Head, Neck (CPT Codes 70544, 70545, 70546, 70547, 70548, 70549, 70XX4, 70XX5, and 70XX6) In April 2024, the RAW noted that the rate at which CPT codes 70547 (currently described as Magnetic resonance angiography, neck; without contrast material(s)) and 70544 (currently described as Magnetic resonance angiography, head; without contrast material(s)) are reported together continued to increase after the initial identification of the trend in April 2022 and a 2-year delay in review to allow practice patterns in the inpatient and outpatient setting go back to how they were prior to the COVID-19 pandemic. At the September 2025 CPT Editorial Panel, six CPT codes were revised to include ``image postprocessing'': CPT codes 70544 (Magnetic resonance angiography, head, including image postprocessing; without contrast material(s)), 70545 (Magnetic resonance angiography, head, including image postprocessing; with contrast material(s)), 70546 (Magnetic resonance angiography, head, including image postprocessing; without contrast material(s), followed by contrast material(s) and further sequences), 70547 (Magnetic resonance angiography, neck, including image postprocessing; without contrast material(s)), 70548 (Magnetic resonance angiography, neck, including image postprocessing; with contrast material(s)), and 70549 (Magnetic resonance angiography, neck, including image postprocessing; without contrast material(s), followed by contrast material(s) and further sequences). Three additional codes were created to bundle magnetic resonance angiography (MRA) head and neck with/without contrast: CPT codes 70XX4 (Magnetic resonance angiography, head and neck, including image postprocessing; without contrast material(s)), 70XX5 (Magnetic resonance angiography, head and neck, including image postprocessing; with contrast material(s)), and 70XX6 (Magnetic resonance angiography, head and neck; without contrastmaterial(s) in one or both body regions, followed by contrast material(s) and further sequences in one or both body regions, including image postprocessing). The code family was surveyed for the January 2026 RUC meeting. We are proposing the RUC-recommended work RVU for all nine codes in the family. We are proposing the RUC-recommended work RVUs of 1.17, 1.17, 1.44, 1.17, 1.46, 1.76, 1.77, 2.10, and 2.23 for CPT codes 70544, 70545, 70546, 70547, 70548, 70549, 70XX4, 70XX5, and 70XX6, respectively. We are proposing the RUC recommended direct PE inputs for CPT codes 70544, 70545, 70546, 70547, 70548, 70549, 70XX4, 70XX5, and 70XX6 without refinement. (33) Computed Tomography-Upper Extremity With Contrast (CPT Codes 73200, 73201, and 73202) In April 2025, the RAW identified CPT code 73201 (Computed tomography, upper extremity; with contrast material(s)) via the CMS/ Other source and 2023 Medicare utilization over 20,000 screen. The family of services was surveyed for the January 2026 RUC meeting, including CPT codes 73200 (Computed tomography, upper extremity; without contrast material) and 73202 (Computed tomography, upper extremity; without contrast material, followed by contrast material(s) and further sections). We are proposing the RUC-recommended work RVUs of 1.00, 1.16, and 1.24 for CPT codes 73200, 73201, and 73202, respectively. We are proposing the RUC recommended direct PE inputs for CPT codes 73200, 73201, and 73202 without refinement. (34) Biofeedback Training (CPT Codes 90901, 90X03, 90912, and 90913) CPT codes 90901 (Biofeedback training by any modality (e.g., EMG, EEG, ECG); initial 15 minutes of direct patient contact by physician or other qualified health care professional), 90912 (Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; initial 15 minutes of one-on-one physician or other qualified health care professional contact with the patient) and 90913 (Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; each additional 15 minutes of one-on-one physician or other qualified health care professional contact with the patient (List separately in addition to code for primary procedure)) were surveyed at the January 2026 RUC meeting after having gone through revision at the September 2025 CPT Editorial Panel. CPT revised code 90901 to describe the [[Page 43884]] initial 15 minutes of biofeedback training by a physician or other qualified health care professional with direct patient contact and created one new code, CPT code 90X03 (Biofeedback training by any modality (e.g., EMG, EEG, ECG); each additional 15 minutes of direct patient contact by physician or other qualified health care professional (List separately in addition to code for primary procedure)), to describe each additional 15 minutes. CPT codes 90912 and 90913 were surveyed for the January 2026 RUC meeting since they are part of the same code family. CPT codes 90901 and new code 90X03 were surveyed for the January 2026 RUC HCPAC Review Board meeting. We are proposing the HCPAC-recommended work RVUs of 0.61 for CPT code 90901 and 0.48 for CPT code 90X03. We are proposing the RUC- recommended work RVUs of 0.90 for CPT code 90912 and 0.50 for CPT code 90913. We are proposing the direct PE inputs recommended by the HCPAC and the RUC for all four codes in the family without refinement. CPT codes 90901, 90912, and 90913 are all designated as sometimes therapy services, as such we are proposing to designate 90X03 as a sometimes therapy service. (35) Radiation Oncology Treatment Delivery (CPT Codes 77402, 77407, and 77412) In the CY 2026 PFS final rule (90 FR 49379 through 49383), we finalized our proposal to utilize the relationship between the Hospital Outpatient Prospective Payment System (OPPS) Ambulatory Payment Classifications (APC) relative weights for APCs 5621, 5622, and 5623 to inform the valuation of PE-only CPT codes 77402 (Radiation treatment delivery; Level 1 (e.g., single-electron field, multiple-electron fields, or 2D photons), including imaging guidance, when performed), 77407 (Radiation treatment delivery; Level 2, single-isocenter (e.g., 3D or IMRT), photons, including imaging guidance, when performed), and 77412 (Radiation treatment delivery; Level 3, multiple isocenters with photon therapy (e.g., 2D, 3D, or IMRT) or a single-isocenter photon therapy (e.g., 3D or IMRT) with active motion management, or total skin electrons, or mixed-electron/photon field(s), including imaging guidance, when performed) when paid under the PFS. We also stated that we calculated the RVUs for these codes so that the overall PE and MP RVUs for these services represent the same share of total PE and MP RVUs in CY 2025 and CY 2026. To accomplish this, we developed PE and MP RVUs using the assumed distribution of services indicated in the utilization crosswalk. We proposed to utilize the RUC-recommended crosswalk for these services, which assumed that 45 percent of the billed charges would be reported with CPT code 77412. Some commenters stated that CPT code 77412 would represent only 15 percent of the volume for these services. We stated in the CY 2026 PFS final rule that it is difficult to ascertain how services furnished in the past would be most accurately reported using a future code set (90 FR 49385). In response to comments and considering the disparate information we received, we finalized a modified crosswalk that adjusted downward the estimated portion that CPT code 77412 would be reported compared to CPT code 77407 based on commenters who represent those who provide care in the non-facility setting. Specifically, we modified the utilization crosswalk to crosswalk 35 percent of the utilization to CPT code 77412 and 55 percent of the utilization to CPT code 77407. Since the publication of the CY 2026 PFS final rule, interested parties have reported that the 35 percent utilization assumption for CPT code 77412 was still overstated despite our downward adjustment in the CY 2026 PFS final rule, and that the actual utilization for CPT code 77412 is approximately 18 percent. Given the importance of the assumed distribution of services in ensuring that we achieved our target of maintaining the same share of total PE and MP RVUs, we reviewed the claims data to evaluate the actual distribution of utilization among CPT codes 77402, 77407, and 77412. We noted that during the first 3 months of 2026, CPT code 77412 comprised approximately 18 of the total volume of these services. Given that we valued these services by utilizing the relative relationship between the OPPS APC relative weights rather than our standard PE methodology, shifts in utilization over time are not automatically incorporated into the annual development of PE RVUs for these services over time. Consequently, we are proposing to refine the relativity within this family of codes for CY 2027 based on available claim data that corroborates the information submitted to us by outside parties. We are not proposing to change the assumptions about the total number of services, but rather, to revalue the PE RVUs using the observed distribution of services, such that the PE and MP RVUs for these services represent the same share of total PE and MP RVUs as they did in CY 2025. (36) Proton Beam Treatment Delivery (CPT Codes 77520, 77522, 77523, and 77525) Payment amounts for proton beam treatment delivery services described by CPT codes 77520 (Proton treatment delivery; simple, without compensation), 77522 (Proton treatment delivery; simple, with compensation), 77523 (Proton treatment delivery; intermediate), and 77525 (Proton treatment delivery; complex) are currently determined by local Medicare Administrative Contractors (MACs). We have not previously established RVUs for these services due to the unique nature of the equipment costs associated with these services compared to other capital costs addressed by our usual PE methodology. In the CY 2026 PFS proposed rule, we sought comment on establishing national payment rates for proton beam treatment delivery services. In the CY 2026 final rule (90 FR 49390), we indicated our intent to establish national pricing for proton beam treatment delivery services in future rulemaking. Interested parties have raised concerns about wide geographic payment disparities with the current contractor pricing that are unrelated to the cost of providing care and have requested that CMS nationally price proton beam treatment delivery services. For example, 2024 claims data for CPT code 77525, which has the second highest utilization of the code family, reflects allowed charges that ranged from $122.15 to $1,374.26. Interested parties recommended that CMS establish identical payment rates for PFS and OPPS, calculating a weighted average of the payment rates to maintain budget neutrality across the PFS and OPPS. Other interested parties expressed concern about reliance on OPPS cost data to value proton beam treatment delivery services, as the substantial capital outlays required by freestanding centers could be greater than those faced by hospital systems and the freestanding centers lack the purchasing power or amortization flexibility that hospitals may have. After considering the comments we received in response to the CY 2026 PFS rule regarding establishing national payment rates for proton beam treatment, similar to the policy we finalized for CY 2026 for radiation treatment delivery services, we are proposing to calculate the PE RVUs for these services as follows: Use the total allowed charges paid by the MACs for CPT codes 77520, [[Page 43885]] 77522, 77523, and 77525 to establish the pool of PE RVUs to allocate to the services in this code family. Allocate PE RVUs to the individual services using the relationship between the APC relative weights for APCs 5625 (to which CPT codes 77522, 77523, and 77525 are assigned) and APC 5623 (to which CPT code 77520 is assigned) under the OPPS. We believe our proposal appropriately balances interested parties' requests to establish national payment rates with the difficulties we have faced when considering the capital-intensive and specialized resources for services like proton beam therapy services. (37) Intracoronary Drug Delivery Balloon Services (CPT Codes 9XX04 and 9XX07) In May 2025, the CPT Editorial Panel created two new codes, CPT code 9XX04 (Percutaneous transcatheter therapeutic drug delivery by intracoronary drug-delivery balloon (e.g., drug-coated, drug-eluting), including mechanical dilation by nondrug-delivery balloon angioplasty, single major coronary artery and/or its branch(es)) and CPT code 9XX07 (Percutaneous transcatheter therapeutic drug-delivery by intracoronary drug-delivery balloon (e.g., drug-coated, drug-eluting), single major artery and/or its branches (List separately in addition to code for primary procedure)) to describe percutaneous transcatheter therapeutic drug delivery by intracoronary drug-delivery balloons. The RUC reviewed these two new CPT codes at the September 2025 RUC meeting. We reviewed the RUC's recommended work valuations and found the RUC's recommended work RVU of 10.00 for CPT code 9XX04 to be high, based on a search of 000 global day codes with between 45 and 75 minutes of intraservice time and between 109 and 149 minutes of total time in the RUC database. For CY 2027 we are proposing a work RVU of 8.05, based on the RUC survey 25th percentile, for CPT code 9XX04. We are proposing the RUC-recommended work RVU of 4.38 for CPT code 9XX07. The RUC did not recommend, and we are not proposing any direct PE inputs for these codes. (38) Rotational Vestibular Assessment (CPT Codes 92XX5 and 92XX6) At the September 2025 CPT Editorial Panel Meeting, CPT code 92546 was deleted, and replaced with two new codes to report rotational vestibular assessment. The two new codes, CPT code 92XX5 (Rotational vestibular assessment by sinusoidal harmonic acceleration (SHA) testing with calibrated, computer-controlled chair, with interpretation and report (do not report 92XX5 in conjunction with 92270)) and 92XX6 (Rotational vestibular assessment by sinusoidal harmonic acceleration (SHA) testing with calibrated, computer-controlled chair, with interpretation and report; with velocity step testing (VST) (List separately in addition to code for primary procedure)) were surveyed for the September 2025 RUC meeting. We are proposing the RUC-recommended work RVU of 0.92 for CPT code 92XX5. We disagree with the RUC's recommended value of 0.48 for CPT code 92XX6 and we are instead proposing a work RVU of 0.35 which is the survey 25th percentile valuation. As valued by the RUC, the work RVU for add-on CPT code 92XX6 is half of the RUC's recommended work RVU of the base code (92XX5), despite the fact that CPT code 92XX6 has only 12 minutes of work time as compared with 45 minutes of work time for CPT code 92XX5. This leads to the intensity of CPT code 92XX6 being valued at double that of the base code, which we do not believe would be typical given that the same SHA testing is taking place in both services. We disagree with the RUC that valuing the work RVU of the add-on CPT code 92XX6 at half the work of the base CPT code 92XX5 would be appropriate, as this does not account for the substantial preservice and postservice work time contained in CPT code 92XX5, which together account for 20 of the 45 total minutes. We agree with the RUC that the intensity of this code is higher than the base code, and our proposed work RVU of 0.35 assigns a higher intensity to CPT code 92XX6 than CPT code 92XX5, but we disagree that the intensity of the add-on service would be double that of the base code. We are proposing the RUC recommended direct PE inputs for CPT codes 92XX5 and 92XX6 without refinement. Additionally, in the CY 2023 PFS final rule (87 FR 69656 through 69663) we created an exception to the physician order requirement at 42 CFR 410.32(a)(4) to allow patients to directly access audiologists. We also delineated the vestibular function tests as those not applicable for use with the AB modifier (for direct access)--see Audiology Services on the PFS website at https://www.cms.gov/medicare/payment/fee-schedules/physician/audiology-services. Based on the foregoing, for the new Rotational Vestibular Assessment Codes, CPT codes 92XX5 and 92XX6 will be added to the audiology services code list but they will not be eligible to be billed with the AB modifier. (39) Video Head Impulse--Vestibular Function (CPT Codes 92X10 and 92X11) At the September 2025 CPT Editorial Panel, the committee approved the addition of new CPT codes, 92X10 (Video head impulse testing (vhit) with recording, interpretation and report of lateral semicircular canal function) and 92X11 (Video head impulse testing (vhit) with recording, interpretation and report of lateral and vertical semicircular canal function) to report video head impulse testing (vHIT) and a corresponding parenthetical note. The RUC reviewed these services at the January 2026 meeting. For CY 2027, we are proposing the RUC-recommended work RVUs of 0.53 for CPT code 92X10 and 0.84 for CPT code 92X11. We are proposing the RUC-recommended direct PE inputs for both CPT codes without refinement. (40) Speech-Language Pathology Services (CPT Codes 92X0X, 92X1X, 92X2X, 92X3X, 92X4X, 92X5X, 92X6X, 92X7X, 92X8X, 92X9X, and 92508) At the September 2025 CPT Editorial Panel meeting, CPT code 92507 (Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual) was replaced with 10 new codes to report fluency disorder, speech sound production disorder, language comprehension and expression disorder, speech sound production disorder and language comprehension and expression disorder, and voice, upper airway dysfunction and/or resonance disorders. CPT codes 92X0X (Treatment of fluency disorder (e.g., stuttering and cluttering), direct (one-on-one) patient contact; initial 30 minutes), 92X1X (Treatment of fluency disorder (e.g., stuttering and cluttering), direct (one-on-one) patient contact; each additional 15 minutes (list separately in addition to code for primary service)), 92X2X (Treatment of speech sound production disorder (e.g., articulation, phonological process, apraxia, dysarthria), direct (one-on-one) patient contact; initial 30 minutes), 92X3X (Treatment of speech sound production disorder (e.g., articulation, phonological process, apraxia, dysarthria), direct (one-on-one) patient contact; each additional 15 minutes (list separately in addition to code for primary service)), 92X4X (Treatment of language comprehension and expression disorder (e.g., receptive and expressive language), direct (one-on-one) patient contact; initial 30 minutes), 92X5X (Treatment of language comprehension [[Page 43886]] and expression disorder (e.g., receptive and expressive language), direct (one-on-one) patient contact; each additional 15 minutes (list separately in addition to code for primary service)), 92X6X (Treatment of speech sound production disorder (e.g., articulation, phonological process, apraxia, dysarthria) and language comprehension and expression disorder (e.g., receptive and expressive language), direct (one-on-one) patient contact; initial 30 minutes), 92X7X (Treatment of speech sound production disorder (e.g., articulation, phonological process, apraxia, dysarthria) and language comprehension and expression disorder (e.g., receptive and expressive language), direct (one-on-one) patient contact; each additional 15 minutes (list separately in addition to code for primary service)), 92X8X (Treatment of voice, upper airway dysfunction, and/or resonance disorders, direct (one-on-one) patient contact; initial 30 minutes), 92X9X (Treatment of voice, upper airway dysfunction, and/or resonance disorders, direct (one-on-one) patient contact; each additional 15 minutes (list separately in addition to code for primary service)), and 92508 (Treatment of speech, language, voice, communication, and/or auditory processing disorder, group, 2 or more individuals) are new and/or revised codes for CY 2027. Additionally, the introductory guidelines were revised to clarify reporting of the services. The code family was surveyed for the January 2026 RUC HCPAC Review Board meeting. For CY 2027, we are proposing the RUC-recommended work RVU for all 11 codes in the family. We are proposing the RUC-recommended work RVUs of 0.92 for CPT code 92X0X, 0.44 for CPT code 92X1X, 0.90 for CPT code 92X2X, 0.44 for CPT code 92X3X, 1.00 for CPT code 92X4X, 0.48 for CPT code 92X5X, 1.00 for CPT code 92X6X, 0.50 for CPT code 92X7X, 0.98 for CPT code 92X8X, 0.48 for CPT code 92X9X, and 0.28 for CPT code 92508). We are proposing the RUC-recommended direct PE inputs for all the codes in the family without refinement. We are proposing to designate these codes as always therapy services which means they must be furnished under a therapy plan of care regardless of who provides them and billed with a therapy modifier (this includes physicians and NPPs when they furnish the service or therapists furnish the services incident to the physician/NPP). We are also proposing to designate the new CPT codes that each represent the initial 30 minutes--92X0X, 92X2X, 92X4X, 92X6X, and 92X8X--as subject to the multiple procedure payment reduction (MPPR) for therapy services. The new CPT codes that represent each additional 15 minutes-- 92X1X, 92X3X, 92X5X, 92X7X and 92X9X--are not subject to the MPPR as they are all add-on codes which we excluded in the CY 2011 PFS final rule along with contractor-priced and bundled codes (75 FR 73240) and noted in section 10.7 of chapter 5 of the Medicare Claims Processing Manual (MCPM). (a) Pediatric G-Code for Speech-Language Pathology Services We have heard from interested parties the need to preserve CPT code 92507 (Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual) specifically related to the pediatric population. Interested parties stated that the 10 new CPT codes do not accurately capture the time and intensity of work as it relates to pediatric patients. In an effort to be responsive to interested parties, we are proposing to create and pay separately for a new HCPCS code, HCPCS code GSLPP, to accurately reflect the time and resources spent in providing these services to pediatric patients. We propose the following code and descriptor for the proposed code: HCPCS code GSLPP (Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual; for the pediatric population up to age 21). We are proposing that HCPCS code GSLPP would be reported by a speech language pathologist performing these services specific to the pediatric population. We are proposing that this code could be billed only once per patient per day. We are proposing to assign a XXX global period payment indicator for HCPCS code GSLPP. The XXX global period payment indicator would indicate that the global period does not apply to this service. As previously discussed in this section, we are proposing to designate HCPCS code GSLPP as an always therapy service and add it to the list of codes that are subject to the MPPR for therapy services. (b) Proposed Valuation for HCPCS Code GSLPP We note that the proposed valuation of HCPCS code GSLPP is meant to reflect the time and resource costs, for speech-language pathology services inherent to the pediatric population. Therefore, we believe that CPT code 92507 serves as an appropriate reference for the purposes of valuing HCPCS code GSLPP. We believe there will be relatively the same work involved for HCPCS code GSLPP when compared to the work of CPT code 92507 as it relates to pediatric patients, considering the amount of time needed to furnish the elements discussed earlier in this section. Therefore, we are proposing a work RVU of 1.30, which represents the assigned work for 60 minutes of CPT code 92507. Additionally, we are proposing a work time of 60 minutes established for CPT code 92507, personally performed by the billing practitioner. We are proposing the same direct PE inputs for HCPCS code GSLPP as CPT code 92507, as we believe that the relative resource costs for this service will remain the same. To help inform whether our proposed valuation reflects the typical service for the pediatric population, we are seeking comment on the typical time and intensity practitioners spend furnishing these services. (41) Endoluminal Coronary Intravascular Ultrasound (IVUS) (CPT Codes 92978 and 92979) In April 2025, the RAW identified CPT code 92978 (Endoluminal imaging of coronary vessel or graft using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report; initial vessel (List separately in addition to code for primary procedure)) as a code that has Medicare utilization of 10,000 or more that has increased by at least 100 percent from 2018 through 2023. CPT codes 92978 and 92979 (Endoluminal imaging of coronary vessel or graft using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report; each additional vessel (List separately in addition to code for primary procedure)) were surveyed for the January 2026 RUC meeting. We disagree with the RUC-recommended work RVUs for these codes and instead we are proposing work RVUs of 1.40 for CPT code 92978 and 1.04 for CPT code 92979 to account for the significant decreases in physician intraservice time for both codes. The RUC's recommendation to maintain current work RVUs for these codes does not appear to fully account for these intraservice time decreases. While we do not believe that the decrease in time as reflected in survey values should always equate to a one-to- [[Page 43887]] one or linear decrease in newly valued work RVUs we do believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs although not necessarily in a linear manner, and we do not believe it is appropriate to decrease physician time while maintaining the current work RVUs. We reviewed the RUC recommendations and found them to be high, relative to other codes with the same or similar work times. Based on a search of similarly timed codes in the RUC database, the RUC- recommended work RVU of 1.76 for CPT code 92978 is higher than 44 of 47 add-on codes with 15 minutes of physician intraservice time. Similarly, the RUC-recommended work RVU of 1.40 for CPT code 92979 would be the second highest work RVU for add-on codes with 12 to 14 minutes of physician intraservice time. Therefore, we disagree with the RUC recommended work RVU of 1.76 for CPT code 92978 and we are instead proposing a work RVU of 1.40 based on a crosswalk to CPT code 93572 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress, when performed; each additional vessel (List separately in addition to code for primary procedure)). This proposed work RVU is higher than the reverse building block work RVU of 1.06 and results in a higher intensity for the code than its current work RVU and physician time. The resulting increase in intensity more accurately accounts for the RUC's assertion that the intensity and complexity has increased with the evolution of these services because a higher proportion of the skin-to-skin time is now dedicated to more intense activities and interventions. We also disagree with the RUC recommendation to maintain the current work RVU of 1.40 for CPT code 92979 and are proposing a work RVU of 1.04 based on the RUC-recommended increment of 0.36 work RVUs between CPT codes 96978 and 96979. Similarly, this represents an increase in intensity compared to the code's current work RVU and work time to account for the increased intensity that has occurred with the evolution of these services. The RUC did not recommend and we are not proposing any direct PE inputs for CPT codes 92978 and 92979. (42) Autonomic Function Testing (CPT Codes 95921, 95XX4, 95922, 95923, 95XX5, 95XX6, 95924, 95XX7, 95XX8, and 95XX9) In February 2025, the CPT Editorial Panel created six new codes to report autonomic function testing with the use of a tilt table, sudomotor tests, and combined procedures to address an earlier RUC referral: CPT code 95XX4 (Testing of autonomic nervous system function, with interpretation and report; use of tilt table), CPT code 95XX5 (Testing of autonomic nervous system function, with interpretation and report; sudomotor, thermoregulatory sweat test), CPT code 95XX6 (Testing of autonomic nervous system function, with interpretation and report; sudomotor, assessing the sympathetic skin response (SSR) potential), CPT code 95XX7 (Testing of autonomic nervous system function, with interpretation and report; combined parasympathetic and sudomotor testing, quantitative sudomotor axon reflex test (QSART) or silastic sweat imprint), CPT code 95XX8 (Testing of autonomic nervous system function, with interpretation and report; combined sympathetic adrenergic with at least 5 minutes of passive tilt (ie, tilt table) and sudomotor testing, quantitative sudomotor axon reflex test (QSART) or silastic sweat imprint), and CPT code 95XX9 (Testing of autonomic nervous system function, with interpretation and report; combined parasympathetic, sympathetic adrenergic function with at least 5 minutes of passive tilt (ie, tilt table), and sudomotor testing, quantitative sudomotor axon reflex test (QSART) or silastic sweat imprint). The CPT Editorial Panel also revised four existing codes to include interpretation and report and clarification on tilt table use: CPT code 95921 (Testing of autonomic nervous system function, with interpretation and report; cardiovagal innervation (parasympathetic function), including 2 or more of the following: heart rate response to deep breathing with recorded R-R interval, Valsalva ratio, and 30:15 ratio), CPT code 95922 (Testing of autonomic nervous system function, with interpretation and report; vasomotor adrenergic innervation (sympathetic adrenergic function), including beat-to-beat blood pressure and R-R interval changes during Valsalva maneuver and at least 5 minutes of passive tilt (ie, tilt table)), CPT code 95923 (Testing of autonomic nervous system function, with interpretation and report; sudomotor, quantitative sudomotor axon reflex test (QSART) or silastic sweat imprint), and CPT code 95924 (Testing of autonomic nervous system function, with interpretation and report; combined parasympathetic and sympathetic adrenergic function testing with at least 5 minutes of passive tilt (ie, tilt table)). This code family was surveyed for the April 2025 RUC meeting. We are proposing the RUC-recommended work RVU for seven of the ten codes in this family. We are proposing a work RVU of 0.34 for CPT code 95XX4, a work RVU of 0.96 for CPT code 95922, a work RVU of 0.88 for CPT code 95923, a work RVU of 1.00 for CPT code 95XX5, a work RVU of 0.50 for CPT code 95XX6, a work RVU of 1.50 for CPT code 95924, and a work RVU of 1.17 for CPT code 95XX7. We note that several of these work RVUs were affected by the efficiency adjustment which was applied at the start of CY 2026, as the RUC recommendations were based on pre- adjustment work valuations. We disagree with the RUC-recommended work RVU of 0.88 for CPT code 95921 and we are instead proposing a work RVU of 0.74 based on a crosswalk to CPT code 97813 (Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient). When reviewing this code family, we noticed that CPT code 95921 had one of the highest intensities in the family at the RUC-recommended work RVU of 0.88 despite having some of the shortest surveyed work times and describing one of the seemingly least intensive procedures. The revised code descriptor for CPT code 95921 describes a single test for cardiovagal innervation, and we do not agree that this service should be valued with a higher intensity than some of the other codes in this family that contain multiple kinds of autonomic function testing. The RUC's recommended work RVU would also value CPT code 95921 at the same 0.88 as CPT code 95923 despite the latter code having significantly more total work time (32 minutes as compared to 25 minutes). We are aware that these codes share the same current work RVU, however the new surveyed work times indicate that CPT code 95921 typically takes less time to perform than CPT code 95923, and, since the two components of work are time and intensity, we believe that CPT code 95921 should be valued at a lower rate. Therefore we are proposing a work RVU of 0.74 based on a crosswalk to CPT code 97813, an acupuncture procedure with the identical intraservice and total work time as CPT code 95921. We also note that this valuation of CPT code 95921 maintains the current intensity of [[Page 43888]] the procedure, as well as better maintaining relativity with the other codes in the family. We disagree with the RUC-recommended work RVU of 1.75 for CPT code 95XX8 and we are instead proposing a work RVU of 1.56 based on a crosswalk to CPT code 77047 (Magnetic resonance imaging, breast, without contrast material; bilateral). We disagree with the RUC's recommended work RVU of 1.75, based on the survey median result, as it represents a significant increase in work valuation and intensity over the other codes in this family. For example, the RUC recommended a work RVU of 1.50 for CPT code 95924 in comparison to 1.75 for this code, despite CPT code 95XX8 having only 5 minutes of additional intraservice time and 3 minutes of additional total time (50 minutes as compared with 47 minutes). CPT code 95XX8 would require an anomalously high intensity relative to the rest of the family to justify the recommended work valuation of 1.75, which we do not agree would be warranted here given that this code is performing the same autonomic function tests that take place in CPT code 95922 and 95923. Therefore we are proposing a work RVU of 1.56 based on a crosswalk to CPT code 77047, a breast MRI procedure with the identical intraservice time and similar total work time as CPT code 95XX8. We believe that this valuation of CPT code 95XX8 better maintains relativity with the other codes in the family instead of requiring an anomalously high intensity as was the case at the RUC's recommended work RVU. We disagree with the RUC-recommended work RVU of 1.91 for CPT code 95XX9 and we are instead proposing a work RVU of 1.77 based on a crosswalk to CPT code 78831 (Radiopharmaceutical localization of tumor, inflammatory process or distribution of radiopharmaceutical agent(s) (includes vascular flow and blood pool imaging, when performed); tomographic (SPECT), minimum 2 areas (e.g., pelvis and knees, chest and abdomen) or separate acquisitions (e.g., lung ventilation and perfusion), single day imaging, or single area or acquisition over 2 or more days). As was the case with CPT code 95XX8, we believe that the RUC's recommended work RVU of 1.91 for CPT code 95XX9, based on the survey 25th percentile result, represents a significant increase in work valuation and intensity over the other codes in this family. While we do agree with the RUC that CPT code 95XX9 includes the most autonomic function tests and should have the highest intensity within the code family, we disagree that CPT code 95XX9 should be valued at a work RVU that results in an intensity approximately 50 percent higher than the rest of this family. To use the same example again, the RUC recommended a work RVU of 1.50 for CPT code 95924 in comparison to 1.91 for this code, despite CPT code 95XX9 having only 5 minutes of additional intraservice time and 7 minutes of additional total time (52 minutes as compared with 47 minutes). We believe that the work valuation and intensity are simply too high at the RUC's recommended work RVU of 1.91 as this does not maintain relativity with the other codes in this family, given that the same tests are being performed. Therefore, we are proposing a work RVU of 1.77 based on a crosswalk to CPT code 78831, a radiopharmaceutical procedure with the identical intraservice time and similar total work time as CPT code 95XX9. We note that this work valuation still assigns the highest intensity in the family to CPT code 95XX9, while bringing it more in accordance with its peer codes. We believe that this valuation of CPT code 95XX9 better maintains relativity with the other codes in the family instead of requiring an anomalously high intensity as was the case at the RUC's recommended work RVU. We are proposing the RUC-recommended direct PE inputs for CPT codes 95921, 95XX4, 95922, 95923, 95XX5, 95XX6, 95924, 95XX7, 95XX8, and 95XX9 without refinement. (43) Unattended Sleep Testing (CPT Codes 95X18, 95X19, 95X20, 95X21, 95X22, and 95X23) At the February 2025 CPT Editorial Panel meeting, CPT codes 95800 (Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time), 95801 (Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (e.g., by airflow or peripheral arterial tone)) and 95806 (Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation, respiratory airflow, and respiratory effort (e.g., thoracoabdominal movement)) were deleted. They were replaced with six new CPT codes: 95X18 (Unattended sleep study, set-up, data acquisition and technical analysis; low complexity of 3-4 channels that generate at least 3-5 parameter categories), 95X19 (Unattended sleep study, set-up, data acquisition and technical analysis; moderate complexity of 5-10 channels that generate at least 6-8 parameter categories), 95X20 (Unattended sleep study, set-up, data acquisition and technical analysis; high complexity of 11 or more channels that generate at least 9 parameter categories), 95X21 (Unattended sleep study, interpretation and report by a physician or other qualified health care professional; low complexity of 3-4 channels that generate at least 3-5 parameter categories), 95X22 (Unattended sleep study, interpretation and report by a physician or other qualified health care professional; moderate complexity of 5-10 channels that generate at least 6-8 parameter categories), and 95X23 (Unattended sleep study, interpretation and report by a physician or other qualified health care professional; high complexity of 11 or more channels that generate at least 9 parameter categories). This code family describes the reporting of unattended sleep studies with set-up, data acquisition, and technical analysis, and with interpretation and report by a physician or other qualified health care professional. These new codes were surveyed for the April 2025 RUC meeting. For CY 2027, the RUC recommended a work RVU of 0.81 for CPT code 95X21, a work RVU of 1.05 for CPT code 95X22, and a work RVU of 1.60 for CPT code 95X23. These codes are professional component only services and have no direct PE inputs; we also note that the RUC recommendations for CPT codes 95X21 and 95X22 were affected by the efficiency adjustment which was applied at the start of CY 2026, as the RUC recommendations were based on pre-adjustment work valuations. For CPT code 95X21, we are proposing the RUC's recommended work RVU of 0.81 and for CPT code 95X22, we are proposing the RUC's recommended work RVU of 1.05. However, we disagree with the RUC's recommended work RVU of 1.60 for CPT code 95X23 and we are instead proposing a work RVU of 1.42 based on a crosswalk to CPT code 92014 (Ophthalmological services: medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; comprehensive, established patient, 1 or more visits), which has 24 minutes of intraservice time and 37 minutes of total time. CPT code 95X23 is a similarly timed code with 20 minutes of intraservice time and 39 minutes of total time. We are aware that the RUC's recommended work RVU is lower than the survey 25th percentile work RVU and further understand that the increase in intensity from moderate complexity of 5 to 10 channels that generate at least 6 to 8 parameter [[Page 43889]] categories to complexity of 11 or more channels that generate at least 9 parameter categories may not be linear. The additional parameters could be more complex, which could result in higher intensity and may not be fully captured in the previous two codes. We agree that the intensity for CPT code 95X23 should be higher; however, we do not believe that the intensity associated with the RUC recommended RVU of 1.60 is typical for this service since it would be nearly double the intensity of CPT codes 95X21 and 95X22. Therefore, we believe that CPT code 92014 is an appropriate crosswalk compared to the RUC's recommended crosswalk to CPT code 99203 (Office or other outpatient visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded.). We believe that our proposed valuation of 1.42, based on the crosswalk from 92014, more accurately values CPT code 95X23 since it does not result in the sizable increase in intensity as recommended by the RUC. In addition, we have maintained relativity between the codes in this family with similarly timed codes. For CPT codes 95X18, 95X19, and 95X20, which are Practice Expense (PE) only codes, we are proposing the RUC-recommended direct PE inputs. However, we note concerns regarding two direct PE inputs: CA021 (Perform procedure/service--NOT directly related to physician work time) and CA042 (Perform procedure/service in post-service period--NOT directly related to physician work time). For CPT codes 95X18 and 95X19, the RUC recommended 15 minutes for the CA021 activity, and 25 minutes for CPT code 95X20. The rationale for this increase from 15 minutes for CPT codes 95X18 and 95X19 to 25 minutes for CPT code 95X20 was not clearly stated in the PE Summary of Recommendations although this is an increase of 66.7 percent. Similarly, for the CA042 activity, the RUC recommended 40 minutes for CPT code 95X18, 50 minutes for CPT code 95X19, and 70 minutes for CPT code 95X20. We note that there is a 10-minute increase from CPT code 95X18 to CPT code 95X19, and a 20- minute increase from CPT code 95X19 to CPT code 95X20. The rationale for these 10-minute and 20-minute increases was also not clearly stated. We appreciate that explanations for the direct PE inputs were provided in the PE Summary of Recommendations, given that this is a non-standard clinical labor activity. However, as CPT code 95X18 describes a low-complexity study, CPT code 95X19 describes a moderate- complexity study, and CPT code 95X20 describes a high-complexity study, we welcome public comments providing additional information, particularly regarding the increases in time for these direct PE inputs across these three CPT codes. Also, for CPT codes 95X18, 95X19, and 95X20, the RUC recommended use of the ``other'' formula for three new equipment items and based the time assumption of 960 minutes (that is, 16 hours). We are soliciting comments on whether it would be typical for the equipment in question to be worn for the full 16 hours. According to the PE Summary of Recommendations, patients typically arrive later in the day (for example, around 4 p.m.) for an appointment to perform a test run with the equipment, then take the equipment home and return it the following morning (typically around 9 a.m.). Therefore, the RUC recommended a 16- hour period, representing two nights, as this duration currently exists in the RUC database and is generally consistent with clinical practice. However, we are seeking public comments on whether two nights of use are required and typical for home sleep testing, as the reported equipment time may represent the total period the patient has the device outside the office rather than the time it is actually in use. Lastly, we received invoices for a new supply item and three new equipment items for CPT codes 95X18, 95X19, and 95X20. The new supply item is SA143 (Nox A1 Sensor Kit adult), and the new equipment items are EQ417 (Nox A1s System with SpO2, US), EQ418 (Apnea Link Air), and EQ419 (Apnea Trak Legacy). However, a single invoice for each supply or piece of equipment may not be reflective of typical costs, we encourage interested parties to submit invoices to improve the accuracy of pricing for these items in the direct PE database. We are proposing the RUC-recommended direct PE inputs for CPT codes 95X18, 95X19, and 95X20 without refinement. (44) Laser Treatment for Inflammatory Skin Diseases (CPT Codes 96920, 96921, and 96922) In May 2025, the CPT Editorial Panel revised three codes to reflect the intended use for inflammatory or auto-immune skin diseases (e.g., psoriasis): CPT codes 96920 (Laser treatment, 308-312 nanometer wavelengths, for inflammatory or auto-immune skin diseases (e.g., psoriasis); total area less than 250 sq cm), 96921 (Laser treatment, 308-312 nanometer wavelengths, for inflammatory or auto-immune skin diseases (e.g., psoriasis); 250 sq cm to 500 sq cm), and 96922 (Laser treatment, 308-312 nanometer wavelengths, for inflammatory or auto- immune skin diseases (e.g., psoriasis); over 500 sq cm). These codes were last discussed in the CY 2025 PFS final rule (89 FR 97797 through 97801). These revisions were based on flaws in the prior valuation process and a change in the patient population. The specialty society surveyed the code family for the September 2025 RUC meeting. For CY 2027, we are proposing the RUC-recommended work RVUs of 1.00 for CPT code 96920, 1.24 for CPT code 96921, and 1.50 for CPT code 96922. We are proposing the RUC-recommended direct PE inputs for CPT codes 96920, 96921, and 96922 without refinement. (45) Real-Time Fluorescence Wound Imaging (CPT Code 976XX) In September 2025, the CPT Editorial Panel created a new code to report real-time florescence wound imaging, CPT code 976XX (Real-time fluorescence wound imaging with clinical darkness to identify presence, location, load of bacteria and measure wound size, per day). The specialty society did not conduct a survey for CPT code 976XX because they determined it would be unable to conduct a successful survey that met the RUC's minimum survey threshold, and therefore, the RUC recommended contractor pricing for CY 2027. Due to persistent payment variability for the predecessor CPT codes 0598T and 0599T, and limited geographical uptake of the technology, the device manufacturer requested that CMS actively price CPT code 976XX and provided work RVU and direct PE input recommendations. After consideration of the manufacturer's recommendations, we are proposing a work RVU of 0.80 and physician pre-evaluation time of 6 minutes, intraservice time of 15 minutes, and immediate post service time of 5 minutes, totaling 26 minutes of physician time. For direct PE in the non-facility, we are proposing a direct crosswalk of clinical labor activities and time from CPT code 97610 (Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day), with the addition of 10 minutes for CA026 Clean surgical instrument package for CPT code 976XX, for a total of 42 minutes of [[Page 43890]] clinical labor time. Additionally, we are proposing the following supply items and quantities in the non-facility for CPT code 976XX. [GRAPHIC] [TIFF OMITTED] TP16JY26.022 Additionally, we are proposing the following equipment items and equipment minutes in the non-facility to correspond with the 30 and 36 minutes of clinical labor time included in the default and instrument pack equipment formulas, respectively, for CPT code 976XX. The MolecuLight DX System (ER131) was added to the direct PE database for inclusion in CPT code 976XX assuming a 5-year useful life and purchase price of $21,500 based on the provided invoices. We are not proposing to include the MolecuLight carrying case in CPT code's 976XX's equipment costs as recommended by the device manufacturer. We have a longstanding policy that medical equipment must be at least $500 and all equipment inputs under $500 are considered indirect expense. We welcome public comment on the appropriateness of our proposed work RVU and the typicality of our proposed physician work times and direct PE inputs. [GRAPHIC] [TIFF OMITTED] TP16JY26.023 We are seeking comment on whether this service will typically be billed alongside wound debridement codes (that is, greater than 50 percent of the time), and if so, which of the proposed direct PE inputs may be duplicative of those already included in the wound debridement codes, such as CPT codes 11042 (Debridement, subcutaneous tissue (includes epidermis and dermis, if performed); first 20 sq cm or less) and 97597 (Debridement (e.g., high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel and forceps), open wound, (e.g., fibrin, devitalized epidermis and/or dermis, exudate, debris, biofilm), including topical application(s), wound assessment, use of a whirlpool, when performed and instruction(s) for ongoing care, per session, total wound(s) surface area; first 20 sq cm or less)). We note that CPT code 976XX's predecessor codes, CPT codes 0598T and 0599T, were billed with wound debridement codes 35.1 percent and 46.6 percent of the time, respectively. However, we understand that such concurrent billing with wound debridement may become more common as adoption of this technology increases. For example, we are seeking comment on whether the following proposed supply items are duplicative of debridement codes if it is anticipated that these codes will be typically billed together: SB007, SB019, SB044, SC056, SF007, SF018, SG035, SG051, SG052, SG079, SH069 and SJ046. We are also seeking comment on whether these wound care supply items are typical for CPT code 976XX, given that the code descriptor specifies wound imaging but does not include any wound care elements. Finally, we note that the direct PE crosswalk code, CPT code 97610, is billed alone 64.4 percent of the time and with debridement CPT code 11042 only 4.3 percent of the time. Therefore, we are seeking comment on the appropriateness of this code as a direct PE crosswalk considering the different billing patterns of CPT code 97610 and 976XX based on its predecessor codes. (46) Lactation Care Services (CPT Codes 978XX and 978X1) At the May 2025 CPT Editorial Panel meeting, two new CPT codes were created for reporting lactation care directed by a physician or qualified health care professional (QHP): CPT codes 978XX (Lactation care directed by a physician or other qualified health care professional, including history, assessment, training, and report; first 30 [[Page 43891]] minutes) and 978X1 (Lactation care directed by a physician or other qualified health care professional, including history, assessment, training, and report; each additional 15 minutes). These new CPT codes were surveyed at the September 2025 AMA RUC Meeting. For CY 2027, we are proposing the RUC-recommended work RVU of 0.18 for CPT code 978XX. The RUC did not recommend, and we are not proposing a work RVU for CPT code 978X1, which has been designed as a PE only service. We are proposing the RUC-recommended direct PE inputs for CPT codes 978XX and 978X1, including the creation of a new clinical staff type for Lactation Consultant (L076A) and a new EF052 equipment item (scale, infant, digital, fine gradation). We are adopting CPT language and requirements for the Lactation Consultant: ``The qualifications of the lactation consultant/counselor must be recognized by a physician society, nonphysician health care professional society/association, or other appropriate source.'' We are proposing to value this new clinical staff type at the same 0.76 rate per minute currently used by the RN (L051A) clinical staff type as recommended by the RUC; we are seeking comment regarding this new clinical staff type and whether there may be a more appropriate crosswalk than the RN clinical staff type. We are proposing the RUC-recommendation of the RN clinical staff type as a proxy for pricing purposes, but are seeking comment on whether Lactation Consultants are typically RNs with additional credentialing/ certification to be qualified to serve as a lactation consultant. (47) Adaptive Behavior Services (CPT Codes 97151, 97152, 97X1X, 97X2X, 97X3X, 97153, 97154, 97X4X, 97X5X, 97155, 97X6X, 97156, 97157, 97158) At the September 2025 CPT Editorial Panel meeting, the CPT Editorial Panel deleted CPT codes 0362T (Behavior identification supporting assessment, each 15 minutes of technicians' time face-to- face with a patient, requiring the following components: administration by the physician or other qualified health care professional who is on site; with the assistance of two or more technicians; for a patient who exhibits destructive behavior; completion in an environment that is customized to the patient's behavior.) and 0373T (Adaptive behavior treatment with protocol modification, each 15 minutes of technicians' time face-to-face with a patient, requiring the following components: administration by the physician or other qualified health care professional who is on site; with the assistance of two or more technicians; for a patient who exhibits destructive behavior; completion in an environment that is customized to the patient's behavior.), revised eight existing CPT codes: 97151 (Behavior identification assessment, administered by a physician or other QHP, each 15 minutes of the physician's or other QHP's time face-to-face with patient and/or caregiver(s) administering assessments and discussing findings and recommendations, and non- face-to-face analyzing past data, scoring and/or interpreting the assessment, and preparing the report and/or treatment plan), 97152 (Behavior identification-supporting assessment, administered by technician, face- to-face with the patient, each 15 minutes), 97153 (Adaptive behavior treatment by protocol, administered by technician, face-to-face with one patient, each 15 minutes), 97154 (Group adaptive behavior treatment by protocol, administered by technician, face-to-face with two or more patients, each 15 minutes), 97155 (Adaptive behavior direction of technician and analysis by physician or other QHP, face-to-face with a patient, each 15 minutes), 97156 (Family adaptive behavior treatment guidance with analysis, administered by physician or other QHP (with or without the patient present), including discussing protocols and treatment targets and/or training the caregiver(s) to implement assessment or treatment protocols with the patient, face-to-face with caregiver(s) for 1 patient, each 15 minutes), 97157 (Multiple-family group adaptive behavior treatment guidance with analysis, administered by physician or other QHP (without the patient present), face-to-face with multiple sets of caregivers for multiple patients, each 15 minutes) and 97158 (Group adaptive behavior treatment with analysis, administered by physician or other QHP, face-to-face with multiple patients, each 15 minutes), and created six new CPT codes: 97X1X (Behavior identification supporting assessment of harmful behavior, each 15 minutes of technician time face-to-face with a patient, requiring the following components: delivered by two technicians, for a patient who exhibits harmful behavior, conducted in an environment that is customized to the patient's behavior,), 97X2X (Behavior identification supporting assessment of harmful behavior, each 15 minutes of technician time face-to-face with a patient, requiring the following components: delivered by two technicians, for a patient who exhibits harmful behavior, conducted in an environment that is customized to the patient's behavior, additional technicians present, each 15 minutes (list separately in addition to code for primary procedure)), 97X3X (Adaptive behavior non-face-to-face services, personally performed by a physician or other QHP, each 15 minutes, with any of the following elements, when performed: review and analysis of data and session notes on patient treatment targets, clinical decision making regarding the need to modify treatment targets, goals, or protocols and/or making those modifications, clinical decision making regarding the need for additional assessment and developing or modifying assessment protocols, developing discharge or transition plan, reviewing treatment targets and/or revised assessment or treatment protocols with technician(s).), 97X4X (Adaptive behavior treatment of harmful behavior, each 15 minutes of technician time with a patient, requiring the following components: delivered by two technicians, for a patient who exhibits harmful behavior, conducted in an environment that is customized to the patient's behavior.), 97X5X (Adaptive behavior treatment of harmful behavior, each 15 minutes of technician time with a patient, requiring the following components: delivered by two technicians, for a patient who exhibits harmful behavior, conducted in an environment that is customized to the patient's behavior, each additional technician present, each 15 minutes (List separately in addition to code for primary procedure)), and 97X6X (Adaptive behavior treatment with analysis, administered by physician or other qualified health care professional, face-to-face with 1 patient, each 15 minutes), to better specify appropriate time, define terms, address reporting gaps, and clarify reporting for technician and physician/QHP face-to-face and non-face-to-face adaptive behavior services. The RUC HCPAC Review Board reviewed the 14 codes in the revised code family at the January 2026 RUC HCPAC. The RUC is recommending contractor pricing for all twelve codes in the family. The existing CPT codes 97151 through 97158 are currently contractor priced. We propose to contractor price the six new codes and make no change to the status indicator for the eight revised existing codes that are already contractor priced. [[Page 43892]] (48) Remote Monitoring (CPT Codes 98975, 98976, 98977, 98978, 98980, 98981, 98984, 98985, 98986, 98979, 99091, 99453, 99454, 99457, 99458, 99473, 99474, 99445, and 99470) (a) Background and Overview In recent years, we have established payment for two code families that describe certain remote monitoring services: remote physiologic monitoring (RPM) and remote therapy monitoring (RTM). In the CY 2018 PFS final rule, we summarized feedback from a comment solicitation aimed at informing new payment policies that would allow for separate payment for remote monitoring services (82 FR 53014). In the CY 2019 PFS final rule (83 FR 59574 through 59576), we established valuations and payment policy for the RPM code family. In the CY 2020 PFS final rule (84 FR 62697 through 62698), we explained that the RPM code family describes chronic care RPM services that involve the collection, analysis, and interpretation of digitally collected physiologic data, followed by the development of a treatment plan and the managing of a patient under the treatment plan (84 FR 62697). In the CY 2020 PFS final rule, we finalized that CPT codes 99457 and 99458 would be included as designated care management services, allowing RPM services to be furnished under the general supervision of the physician or other qualified health care professional (who is qualified by education, training, licensure/regulation and facility privileging) (84 FR 62698). In the CY 2023 PFS final rule, in response to comments, we clarified that RTM or RPM services could be billed concurrently with Chronic Care Management (CCM), Transitional Care Management (TCM), Principal Care Management (PCM), Chronic Pain Management (CPM), or Behavioral Health Integration (BHI) (86 FR 69528 through 69539). In September 2024, the Current Procedural Terminology (CPT) Editorial Panel added one code and made code revisions to report RPM device supply for 2 to 15 days and 16 to 30 days within a 30-day period; created one new code and code revisions to report RPM treatment management services for the first 10 minutes, first 20 minutes, and each additional 20 minutes thereafter; added three RTM device supply codes to report respiratory, musculoskeletal and cognitive behavioral therapy for 2 to 15 days and 16 to 30 days within a 30-day period; created one new code and made code revisions to report RTM treatment management services for the first 10 minutes, first 20 minutes, and each additional 20 minutes thereafter; and revised remote monitoring guidelines. We reviewed the RUC recommendations for these services in the CY 2026 PFS final rule (90 FR 49394 through 49404). In response to recent reports and recommendations from the Office of the Inspector General (Additional Oversight of Remote Patient Monitoring in Medicare Is Needed \2\ and Billing for Remote Patient Monitoring in Medicare \3\), for CY 2027, we are proposing refinements to the policies surrounding remote physiologic and remote therapeutic monitoring, as detailed later in this section. --------------------------------------------------------------------------- \2\ https://oig.hhs.gov/reports/all/2024/additional-oversight-of-remote-patient-monitoring-in-medicare-is-needed/. \3\ https://oig.hhs.gov/reports/all/2025/billing-for-remote-patient-monitoring/. --------------------------------------------------------------------------- (b) Established Patient Requirements In the CY 2021 PFS final rule (85 FR 84542 through 84546), we established that, when the PHE for COVID-19 ended, we again required that RPM services be furnished only to an established patient. Patients who received initial remote monitoring services during PHE were considered established patients for purposes of the new patient requirements that were effective after the last day of the PHE for COVID-19. For CY 2027, we are proposing to require that RTM services also be furnished only to established patients. We are proposing this condition of payment because we believe that a practitioner with an established relationship with a patient would likely have had the opportunity to collect relevant patient history and conduct a physical exam, as appropriate. As a result, the practitioner would possess information needed to understand the current medical status and needs of the patient prior to ordering RTM services to collect and analyze the patient's data and use the results of remote therapeutic monitoring to manage the patient under a specific treatment plan or therapy plan of care. This proposal would also assist in resolving OIG's findings that some practices did not have a prior relationship with patients for whom they billed remote monitoring services for (Billing for Remote Patient Monitoring in Medicare \4\). --------------------------------------------------------------------------- \4\ See the eCQI Resource Center description of the US Quality Core Implementation Guide (https://ecqi.healthit.gov/qi-core/about) and version 0.5.0 of the 2026 US Quality Core Implementation Guide (http://fhir.org/guides/onc/us-quality-core/ImplementationGuide/fhir.onc.us-quality-core). --------------------------------------------------------------------------- (c) Initiating Visit Requirements For CY 2027, we are proposing that practitioners reporting RPM or RTM services must furnish a separately reportable initiating visit in association with the onset of RPM or RTM services, since these services require a level of care coordination that cannot be effective without appropriate evaluation of the patient's needs. The initiating visit would also ensure the billing practitioner assesses the beneficiary to determine clinical appropriateness of RPM or RTM and provide an opportunity to obtain the required beneficiary consent to receive RPM or RTM services. We are proposing that RPM or RTM services must be initiated by the billing practitioner during a face-to-face (in-person or telehealth) visit. CPT codes that do not involve a face-to-face visit by the billing practitioner or are not separately payable under Medicare cannot be used as the visit for RPM or RTM initiation. If RPM or RTM is not discussed with the patient at that visit, that visit cannot count as the initiating visit for RPM or RTM. The RPM or RTM initiating visit can be separately billed. (d) Supervision Requirements Currently, RPM or RTM services may be outsourced to third-party companies that provide services via telephone and online contact only, using staff who have little to no established relationship with the beneficiary or other members of the care team and have little to no interaction with the office staff and billing practitioner. After reviewing the findings discussed in recent OIG reports, such as companies ``cold calling'' beneficiaries to solicit them for remote monitoring services they may not need (Additional Oversight of Remote Patient Monitoring in Medicare Is Needed \5\) and working to improve the transparency of ``incident to'' services, we believe outsourcing RPM/RTM services to a third party can fragment care, lead to insufficient involvement and oversight of the billing practitioner, or result in services that do not actually represent or facilitate all required aspects of RPM or RTM services. Provision of these services by entities having only a loose association with the treating practitioner can detract from longitudinal, patient-centered care. We do not believe that RPM or RTM services provided by clinical staff contracted by a third party can ensure the billing practitioner has adequate oversight, management, or collaboration [[Page 43893]] to bill RPM or RTM services. If there is little oversight by the billing practitioner or a lack of clinical integration between a third- party providing RPM/RTM and the billing practitioner, we do not believe that the full scope of service elements required to bill these codes are being met. --------------------------------------------------------------------------- \5\ https://oig.hhs.gov/reports/all/2024/additional-oversight-of-remote-patient-monitoring-in-medicare-is-needed/. --------------------------------------------------------------------------- We are proposing to only allow payment for RPM or RTM services when furnished by clinical staff employed by the practice. To count the time spent by clinical staff providing aspects of RPM or RTM services, the clinical staff must be a direct employee of the practitioner or the practitioner's practice. If finalized, this will mean that for the purposes of billing Medicare, beginning January 1, 2027, the RPM and RTM codes could not be billed in cases where the service is not performed by clinical staff of the billing practitioner and will not allow contracting out to third-party companies. This does not mean the clinical staff must necessarily always be physically located within the practice, nor does it require that the beneficiary be on-site for the provision of remote monitoring services. Under our proposed revised policy, the time spent by clinical staff providing RPM or RTM services can be counted, provided that the clinical staff are under the general supervision of the billing practitioner, all other requirements of the ``incident to'' regulations at Sec. 410.26 are met, and the clinical staff is a direct employee of the practitioner or the practitioner's practice. We are seeking comment on this proposal, specifically on how often third-party billing currently occurs and how this policy, if finalized, could impact access to remote monitoring services. (e) Valuation Remote physiologic monitoring (RPM) represents the remote monitoring of parameters such as weight, blood pressure, and pulse oximetry to monitor a patient's condition and inform their management. The remote physiologic monitoring code set currently includes CPT codes 99091, 99445, 99453, 99454, 99457, 99458, 99470, 99473, and 99474 (code descriptors in Table A-D6). Remote therapeutic monitoring (RTM) represents the monitoring of adherence to at-home therapeutic interventions. For RTM, there are distinct device supply codes for three types of therapeutic monitoring: respiratory system, cognitive behavioral therapy, and musculoskeletal system monitoring. The remote therapeutic monitoring code set currently includes CPT codes 98975, 98976, 98977, 98978, 98979, 98980, 98981, 98984, and 98985 (code descriptors in Table A-D6). There are three components of RPM and RTM services: education and setup, device supply, and treatment management. [GRAPHIC] [TIFF OMITTED] TP16JY26.024 For CPT codes 99453 and 98975, which are PE-only codes describing RPM and RTM initial set-up and patient education on use of equipment, respectively, we are proposing to crosswalk the direct PE inputs from CPT code 99473 (Self-measured blood pressure using a device validated for clinical accuracy; patient education/training and device calibration), as we believe the existing valuation of CPT codes 99453 and 98975 may not accurately reflect the resource costs involved in those services. Specifically, we are concerned that, due to lack of information regarding the typical device used to perform these procedures, these services are overvalued. We believe that [[Page 43894]] the typical device used for these procedures in the physician office setting may not be accurately captured in the data previously used for valuation, as we have received very little invoice or pricing information from interested parties for the specific devices used in RTM and RPM services. We believe that a crosswalk to the direct PE inputs associated with CPT code 99473 may more accurately capture the resource costs associated with a typical device set-up and patient education on use of equipment. We are seeking comment on this proposal, specifically information regarding the typical clinical workflow for the initial set-up and patient education on use of equipment services used in furnishing RPM or RTM and their associated costs. For CPT codes 99445 and 99454, which are PE-only codes describing RPM device(s) supply with daily recording(s) or programmed alert(s) transmission, we are proposing to crosswalk the direct PE inputs from CPT code 99474 (Self-measured blood pressure using a device validated for clinical accuracy; separate self-measurements of two readings one minute apart, twice daily over a 30-day period (minimum of 12 readings), collection of data reported by the patient and/or caregiver to the physician or other qualified health care professional, with report of average systolic and diastolic pressures and subsequent communication of a treatment plan to the patient). For CPT codes 98976, 98977, 98978, 98984, 98985, and 98986, which are PE-only codes describing RTM device(s) supply for data access or data transmissions, we are proposing to crosswalk the direct PE inputs from CPT code 93270 (External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom- related memory loop with remote download capability up to 30 days, 24- hour attended monitoring; recording (includes connection, recording, and disconnection)). We believe the existing valuation of CPT codes 99445, 99454, 98976, 98977, 98978, 98984, 98985, and 98986 may not accurately reflect the resource costs involved in these services, especially since we continue to lack data surrounding the typical RPM and RTM devices and the costs associated with them. Specifically, we are concerned that, due to lack of information regarding the typical device used to perform these procedures, these services are overvalued. We believe that the typical device used for these procedures in the physician office setting may not be accurately captured in the data previously used for valuation, as we have received very little invoice or pricing information from interested parties for the specific devices used in RTM and RPM services. We believe that the crosswalk to the direct PE inputs associated with the proposed codes discussed earlier may more accurately capture the resource costs associated with a typical device. We are soliciting comments on this proposal, specifically information regarding the typical devices used in furnishing RPM or RTM, not just their associated costs and invoices, but robust evidence detailing what providers are actually paying for these devices, including discounts or other typical pricing details. We are seeking other types of pricing data and information for RPM or RTM devices, including if the costs include software, hardware, or both, as well as more information about the typical devices. For CPT codes 99470, 99457, 99458, 98979, 98980, and 98981, which describe the physician/QHP work associated with treatment management, we are proposing to eliminate PE inputs for these codes, as we believe resource costs for these services are accurately captured in the work RVUs, and we do not believe the typical clinical workflow for these services would involve clinical staff time. We are proposing that the current work RVUs and current work times for these codes be maintained. We welcome information regarding the typical clinical workflow for these services. We are soliciting comments on these proposals, as well as requesting general feedback from the public that may be useful in further development of our payment policies for remote monitoring services that are currently separately payable under the PFS. (f) Comment Solicitation We have concerns about the administrative burden of the numerous remote monitoring codes and proliferation of this code family. We also continue to work to implement recommendations from the recent OIG reports that we are concerned cannot be fully resolved with the current coding structure of the remote monitoring code family, such as ensuring that beneficiaries receive all components of the remote monitoring service. For example, the OIG report found that, ``About 43 percent of enrollees who received remote patient monitoring did not receive all 3 components of it, raising questions about whether the monitoring is being used as intended.'' (Additional Oversight of Remote Patient Monitoring in Medicare Is Needed \6\). --------------------------------------------------------------------------- \6\ https://oig.hhs.gov/reports/all/2024/additional-oversight-of-remote-patient-monitoring-in-medicare-is-needed/. --------------------------------------------------------------------------- We are also considering, and are seeking comment on, bundling CPT codes 99453, 99445, 99454, 99091, 99470, 99457, 99458, 98975, 98984, 98976, 98985, 98977, 98986, 98978, 98979, 98980, and 98981 through the creation of new codes that describe initial set up and monthly monitoring/management for RPM and RTM, respectively. For payment for remote monitoring services under the PFS, we are also considering, and are seeking comment on, the creation of four new HCPCS G-Codes: GRPM1: RPM initial set-up and patient education. GRPM2: Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), per calendar month, including: ++ Device(s) supply with daily recording(s) or programmed alert(s) transmission. ++ 2 or more days of data transmission. ++ Treatment management services, requiring at least one real-time interactive communication with the patient/caregiver; time totaling at least 20 minutes. GRTM1: RTM initial set-up and patient education. GRTM2: Remote monitoring of therapeutic parameter(s) (e.g., therapy adherence, therapy response, digital therapeutic intervention), per calendar month, including: ++ Device(s) supply for data access or data transmissions. ++ 2 or more days of data transmission. ++ Treatment management services, requiring at least one real-time interactive communication with the patient or caregiver; time totaling at least 20 minutes. We are seeking comment on these HCPCS G-codes and are also seeking comment on any other revisions needed to the code descriptors to reflect the necessary service elements for this code family. These HCPCS G-codes would adopt all current conditions of payment for the remote therapeutic and remote physiologic codes finalized in prior rulemaking, as well as the proposed established patient, initiating visit, or supervision or both requirements outlined earlier in this section, if finalized. As drafted, all service elements outlined in the G-code descriptors would be required each [[Page 43895]] calendar month. We are seeking public comment on these HCPCS G-codes and, after consideration of public comment, could finalize payment for these codes. The creation of these G-codes could alleviate administrative burden, as this would reduce the number of remote monitoring codes from 17 to four. These HCPCS G-codes would also ensure that beneficiaries receive treatment management services when receiving remote monitoring services. According to the OIG Reports, billing for Remote Patient Monitoring in Medicare \7\ and Additional Oversight of Remote Patient Monitoring in Medicare Is Needed,\8\ some beneficiaries do not regularly receive treatment management services. The OIG Report, Additional Oversight of Remote Patient Monitoring in Medicare Is Needed,\9\ also stated that forty-three percent of enrollees who received remote patient monitoring did not receive at least one of the three components (patient education and set-up, device supply, and treatment management). Although we have not required that providers bill for all three components, this data from the OIG Report raises questions about how these services are being used. By incorporating device supply, data transmission, and treatment management into one code, we could ensure that those service elements are always provided. --------------------------------------------------------------------------- \7\ https://oig.hhs.gov/reports/all/2025/billing-for-remote-patient-monitoring/. \8\ https://oig.hhs.gov/reports/all/2024/additional-oversight-of-remote-patient-monitoring-in-medicare-is-needed/. \9\ https://oig.hhs.gov/reports/all/2024/additional-oversight-of-remote-patient-monitoring-in-medicare-is-needed/. --------------------------------------------------------------------------- In the CY 2024 PFS final rule (88 FR 79071 through 79073), we finalized the policy to add the suite of services that comprise RPM and RTM services to the general care management code, G0511 beginning January 1, 2024 as the requirements for RPM and RTM services are similar to the non-face-to-face requirements for the general care management services furnished in RHCs and FQHCs. Beginning January 1, 2025, RHCs and FQHCs are required to bill the individual codes that make up the general care management HCPCS code, G0511 (89 FR 97998 through 98010). Accordingly, we are seeking comment on implementing these HCPCS G-codes in RHCs and FQHCs. We are seeking comment on valuation for these HCPCS G-codes. For GRPM1 and GRTM1, which could be PE-only codes describing RPM and RTM initial set-up and patient education on use of equipment, respectively, we could crosswalk the direct PE inputs from CPT code 99473 (Self- measured blood pressure using a device validated for clinical accuracy; patient education/training and device calibration). We are seeking comment on this valuation, specifically information regarding the typical clinical workflow for the initial set-up and patient education on the use of equipment services used in furnishing RPM or RTM and their associated costs. For GRPM2, we could crosswalk the work RVU input of 0.61 RVUs from CPT code 99457 and the direct PE inputs from CPT code 99474 (Self- measured blood pressure using a device validated for clinical accuracy; separate self-measurements of two readings one minute apart, twice daily over a 30-day period (minimum of 12 readings), collection of data reported by the patient and/or caregiver to the physician or other qualified health care professional, with report of average systolic and diastolic pressures and subsequent communication of a treatment plan to the patient). For GRTM2, we could crosswalk the work RVU input of 0.62 RVUs from CPT code 98980 and the direct PE inputs from CPT code 93270 (External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; recording (includes connection, recording, and disconnection)). (49) National Payment for Non-Sheet Form Skin Substitutes In the CY 2026 PFS final rule (90 FR 49500), we finalized contractor pricing for non-sheet form skin substitutes. We stated that these products have the potential to be payable as skin substitutes; but that the units, as expressed in a product's coding, are difficult to standardize for payment purposes. Therefore, we finalized that we would maintain the current coding mechanism for these products and would direct the Medicare Administrative Contractors (MACs) to determine appropriate payment, which is generally consistent with how these products are currently paid. We stated that we would continue to evaluate payments for these products to determine if an alternative payment methodology may be better suited to non-sheet products. Based on ongoing analysis and feedback from internal and external interested parties, we have come to believe that, on the balance, the resource costs per cm\2\ for non-sheet form skin substitutes is consistent with the resource costs associated with those associated with sheet form skin substitutes. For non-sheet skin substitute products, cm\2\ reflects the wound surface area treated rather than the physical dimensions of the product. Therefore, for CY 2027, we are proposing to nationally price the non-sheet form skin substitutes consistent with the payment rates associated with the sheet form skin substitutes. For a list of the non-sheet form skin substitutes, please refer to the skin substitutes section located on the CMS website (https://www.cms.gov/medicare/payment/fee-schedules/physician-fee-schedule/skin-substitutes). (50) Smoking and Tobacco Use Cessation (CPT Codes 99406, 99407) and Screening, Brief Intervention, and Referral to Treatment (SBIRT) (HCPCS Codes G2011, G0396, G0397) The Trump Administration Executive Order, ``Establishing the President's Make America Health Again Commission'' \10\ is a top priority for CMS, as such we continue to focus on the prevention and management of chronic disease. Chronic disease remains a significant public health concern, with three in four American adults having at least one chronic condition, and more than half having two or more chronic conditions. Many preventable chronic diseases are caused by a short list of risk behaviors, including smoking, poor nutrition, physical inactivity, and excessive alcohol use.\11\ These patterns reinforce the need for accessible behavioral health services that can help individuals reduce these risk behaviors. --------------------------------------------------------------------------- \10\ https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/. \11\ https://www.cdc.gov/chronic-disease/about/index.html. --------------------------------------------------------------------------- In the CY 2024 PFS final rule (88 FR 79006 through 79010), we finalized an increase in the valuation for timed behavioral health services under the PFS by applying an upward adjustment of 19.1 percent to the work RVUs for time-based psychotherapy codes payable under the PFS. This increase is being implemented over a 4-year transition period. We believe similar adjustments are warranted for smoking and tobacco use cessation, CPT codes 99406 (Smoking and tobacco use cessation counseling visit; intermediate, greater than 3 minutes up to 10 minutes) and 99407 (Smoking and tobacco use cessation counseling visit; intensive, greater than 10 minutes) and screening, brief intervention, and referral to treatment (SBIRT) services, HCPCS codes G2011 [[Page 43896]] (Alcohol and/or substance (other than tobacco) misuse structured assessment (e.g., audit, dast), and brief intervention, 5-14 minutes), G0396 (Alcohol and/or substance (other than tobacco) misuse structured assessment (e.g., audit, dast), and brief intervention 15 to 30 minutes), and G0397(Alcohol and/or substance (other than tobacco) misuse structured assessment (e.g., audit, dast), and intervention, greater than 30 minutes). Smoking and tobacco cessation and SBIRT services are evidence supported behavioral health interventions. Quitting smoking provides immediate health improvements including lowering the likelihood of developing lung cancer and other smoking-related cancers, and reduces the risks of coronary heart disease, stroke, and chronic obstructive pulmonary disease. Evidence based smoking and tobacco cessation treatments are effective, including the combination of behavioral counseling and medication therapy.\12\ SBIRT effectively addresses substance use. In primary care and other clinical settings, SBIRT has been shown to help decrease unhealthy substance use and misuse.\13\ --------------------------------------------------------------------------- \12\ https://progressreport.cancer.gov/prevention/tobacco/cessation-aids#jump-links-field-background. \13\ https://pmc.ncbi.nlm.nih.gov/articles/PMC5551279/. --------------------------------------------------------------------------- The smoking and tobacco cessation services (CPT codes 99406 and 99407) and SBIRT services HCPCS codes G0396 and G0397 were last valued in 2008, and the SBIRT service HCPCS code G2011 was created and last valued in 2019. Given the evidence supported role these services play in preventing and managing chronic disease and behavioral health conditions including alcohol and/or substance misuse, we believe that valuation should more accurately reflect the clinical intensity and work associated with these time-based services. Therefore, we propose applying the same upward adjustment of 19.1 percent to the work RVUs for these time-based services aligning with the adjustments made to the time-based psychotherapy codes, in conjunction with the fourth and final year of the phase-in for time- based psychotherapy codes that we finalized in the CY 2024 PFS final rule (88 FR 79006 through 79010). Although the upward adjustment of 19.1 percent for the time-based psychotherapy codes has been implemented over a 4-year period, with CY 2027 being the fourth year, we are proposing to apply the full 19.1 percent to smoking and tobacco use cessation services and SBIRT services in this final year of the transition. This approach ensures that these services are brought into alignment with the psychotherapy codes at the completion of the 4-year phase-in timeline, rather than initiating a new multiyear phase-in period. We are proposing to refine the work RVU of smoking and tobacco use cessation services codes as follows: for CPT code 99406 by increasing the work RVU to 0.29 from the current 0.24, and CPT code 99407 by increasing the work RVU to 0.60 from the current 0.50; and for the SBIRT services codes, we are proposing to refine the work RVU as follows, for HCPCS code G2011 by increasing the work RVU to 0.39 from the current 0.33, for HCPCS code G0396 by increasing the work RVU to 0.77 from the current 0.65, and for HCPCS code G0397 by increasing the work RVU to 1.55 from the current 1.30. (51) Psychiatric Collaborative Care Model (CoCM) (CPT codes 99492, 99493, 99494, G2214) and APCM BHI Add-On Codes (HCPCS Codes G0568, G0569) Patients with chronic health conditions are ``more likely to have related behavioral health concerns and find it easier to improve chronic conditions when these concerns are also addressed.'' \14\ Integrating behavioral health with primary care has been shown to improve outcomes like reductions in depression severity and enhancing patient's experience of care.\15\ --------------------------------------------------------------------------- \14\ https://integrationacademy.ahrq.gov/about/integrated- behavioral- health#:~:text=Integrated%20behavioral%20health%20offers%20many,these %20concerns%20are%20also%20addressed. \15\ Balasubramanian, Bijal, Deborah Cohen, Katelyn Jetelina, Miriam Dickinson, Melinda Davis, Rose Gunn, Kris Gowen, Frank DeGruy 3rd, Benjamin Miller, Larry Green. ``Outcomes of Integrated Behavioral Health with Primary Care.'' J Am Board Fam Med. 2017 Mar- Apr;30(2):130-139.doi: 10.3122/jabfm.2017.02.160234 --------------------------------------------------------------------------- In the CY 2017 PFS final rule (81 FR 80230), we established separate payment for three services, HCPCS codes G0502 (Initial psychiatric collaborative care management, first 70 minutes in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional; initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan; review by the psychiatric consultant with modifications of the plan if recommended; entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant; and provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies), G0503 (Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: tracking patient follow-up and progress using the registry, with appropriate documentation; participation in weekly caseload consultation with the psychiatric consultant; ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers; additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant; provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies; monitoring of patient outcomes using validated rating scales; and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment), and G0504 (Initial or subsequent psychiatric collaborative care management, each additional 30 minutes in a calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional (list separately in addition to code for primary procedure); (use G0504 in conjunction with G0502, G0503), used to bill for monthly services furnished using the psychiatric collaborative care model (CoCM), an evidence-based approach to behavioral health integration that enhances ``usual'' primary care by adding care management support and regular psychiatric inter-specialty consultation. The G-codes were valued [[Page 43897]] to account for the work of the treating physician or other qualified health care professionals, based on a direct crosswalk to the work values for the complex Chronic Care Management (CCM) services, CPT codes 99487 (Complex chronic care management services with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored, moderate or high complexity medical decision making; first 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month.) and 99489 (Complex chronic care management services with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions that place the patient at significant risk of death, acute exacerbation/ decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored, moderate or high complexity medical decision making; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)). The valuation also accounted for the work of the psychiatric consultant, based on an estimated 10 minutes of psychiatric consultant time per patient per month, such that the work RVU was based on a crosswalk to the work per minute of a level 3 established patient office visit. These G-codes were replaced by CPT codes 99492, 99493, and 99494, which we established for payment under the PFS in the CY 2018 PFS final rule (82 FR 53077 and 53078). In the CY 2021 PFS final rule (85 FR 84548 through 84574), we increased the work RVUs for certain CPT codes that rely upon or are analogous to office/outpatient evaluation and management (O/O) (E/M) visits, consistent with the increases in values finalized for O/O E/M visits for CY 2021, such that the CoCM services valuation were updated as follows: 99492 (work RVU increased from 1.70 to 1.88), 99493 (work RVU increased from 1.53 to 2.05) and 99494 (work RVU remained 0.82). Interested parties have expressed concerns regarding the current valuation of CoCM and requested revaluation for these services. They stated that the current valuation undervalues the medical decision- making performed by the billing practitioner and psychiatric consultant and undervalues the labor rates assigned to the CoCM service. The interested parties recommend valuing the work RVUs for the two physicians or other qualified health care professional based on a blended rate based on level 4 and 5 O/O E/M visits based on medical decision-making, CPT codes 99204 and 99205 (for new patients), and 99214 and 99215 (for established patients), to account for the medical decision-making required for the CoCM service. CPT code 99492 would be adjusted from a work RVU of 1.88 to 3.67, 99493 from a work RVU of 2.05 to 2.99, and 99494 from a work RVU of 0.82 to 1.50. The interested parties noted that their recommendation would result in a higher work RVU for the initial psychiatric collaborative care management service, CPT code 99492, compared to the subsequent psychiatric collaborative care management service, CPT code 99493, since the initial month generally involves a new patient requiring more medical decision making. The interested parties recommend valuing CPT code 99494 at 50 percent of CPT code 99493. In addition, the interested parties requested refinements to the direct PE inputs, specifically for the Behavioral Health Care Manager clinical labor type (L057B). They recommend increasing the clinical labor value for Behavioral Health Care Manager (L057B) from a per minute rate of $0.57 to $0.70 per minute by crosswalking the valuation to CORF social worker/psychologist (L045C), rather than to the genetic counselors (L057A) which was used when the original CoCM G-codes were established. After reviewing the feedback from the interested parties, we reviewed the valuation of the CoCM codes and considered Medicare claims data for levels 3 through 5 O/O E/M services. The Medicare claims data shows that level 5 E/M visits (CPT codes 99205 and 99215), which represent the highest complexity of evaluation and management services, are billed substantially less frequently than level 3 E/M services (CPT codes 99203 and 99213) and level 4 E/M services (CPT codes 99204 and 99214). Based upon this billing pattern, we believe that a blended level 3 and 4 E/M rate would be more appropriate to value CoCM. Therefore, we propose to refine the work RVUs of CoCM as follows: CPT codes 99492 would be adjusted from a work RVU of 1.88 to 2.75, 99493 from a work RVU of 2.05 to 2.26, and 99494 from a work RVU of 0.82 to 1.13, which is 50 percent of 99493. We also propose conforming changes to the valuation of HCPCS codes G2214, G0568, and G0569, which also describe psychiatric collaborative care services. For HCPCS code G2214 (Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional), we propose to refine the work RVU from 0.77 to 1.13, representing one half of the time described by the existing code that describes subsequent months of CoCM services (CPT code 99493), consistent with how the code was valued in the CY 2021 PFS final rule (85 FR 84547 through 84548). For HCPCS code G0568 (Initial psychiatric collaborative care management, in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional, initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan, review by the psychiatric consultant with modifications of the plan if recommended, entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant, and provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies (list separately in addition to the advanced primary care management code)), we propose to refine the work RVU from 1.88 to 2.75, aligning with the direct crosswalk to the work RVU of CPT code 99492. For HCPCS code G0569 (Subsequent psychiatric collaborative care management, in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements: tracking patient follow-up and progress using the registry, with appropriate [[Page 43898]] documentation, participation in weekly caseload consultation with the psychiatric consultant, ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers, additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant, provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies, monitoring of patient outcomes using validated rating scales, and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment (list separately in addition to advanced primary care management code)), we propose to refine the work RVU from 2.05 to 2.26, as this code was valued based on a direct crosswalk to the work RVU of CPT code 99493. Additionally, consistent with the changes proposed for CPT codes 99492-99494, we propose refinements to the direct PE inputs for HCPCS codes G2214, G0568, and G0569 by revaluing the rate of Behavioral Health Care Manager (L057B) with a per minute rate of $0.57 to $0.70. This proposed change is based on a crosswalk of valuing Behavioral Health Care Manager (L057B) to the clinical labor CORF social worker/ psychologist (L045C), as opposed to basing the rates to genetic counselors as discussed in the CY 2017 final rule (81 FR 80350). We also note that HCPCS codes G2086 (Office-based treatment for opioid use disorder, including development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month), G2087 (Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month), and G2088 (Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (list separately in addition to code for primary procedure)) include clinical labor minutes for a Behavioral Health Care Manager (L057B), and therefore as part of this proposal, we are also proposing that that same increase in valuation for L057B from $0.57 to $0.70 would also apply to HCPCS codes G2086- G2088. We welcome comments on these proposals. (52) Tympanostomy (HCPCS Code G0561) In January 2026, the Practice Expense (PE) Subcommittee reviewed the following practice expense only add-on HCPCS code G0561 (Tympanostomy with local or topical anesthesia and insertion of a ventilating tube when performed with tympanostomy tube delivery device, unilateral) on the Medicare Physician Fee Schedule which is currently contractor priced. The RUC recommended one direct PE input for a new supply item, an Automated PE tube delivery device (SD395), and submitted invoices to price the supply at $497.50. We are proposing the RUC-recommended direct PE input for HCPCS code G0561 without refinement. The RUC did not recommend, and we are not proposing a work RVU for HCPCS code G0561, which has been designed as a PE only service. (53) Evaluation and Management (E/M) Visit Complexity Add-On (HCPCS Code G2211) (a) Background In the CY 2024 PFS final rule (88 FR 78970 through 78982), we finalized separate payment for the O/O E/M visit complexity add-on code, HCPCS code G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established)). This policy was originally proposed in CY 2019, as part of a proposed overhaul to the E/M code set (83 FR 59628) where we proposed two codes, one for primary care and one for non-procedure specialty care. We learned that the CPT Editorial Panel and AMA RUC were planning to review and refine the O/O E/M code set, so we did not finalize this proposal or the other proposed changes to the E/M code set. The CPT Editorial Panel and AMA RUC reviewed and refined the O/O E/M code set, which were finalized by CMS in the CY 2021 PFS final rule (84 FR 62844 through 62856). We combined the two proposed complexity add-on codes into one, and we finalized separate coding and payment for HCPCS code add-on code GPC1X in the CY 2020 PFS final rule (84 FR 62854 through 62856). This became HCPCS code G2211 in the CY 2021 final rule (85 FR 84569). However, implementation of G2211 was delayed by Congress (section 113 of Division CC of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260, December 27, 2020) (CAA, 2021)), and we began actively paying for HCPCS code G2211 in CY 2024. In the CY 2026 PFS final rule (90 FR 49462 through 49464), we finalized our proposal to allow HCPCS code G2211 to be billed as an add-on code with the home or residence E/M visits code family (CPT codes 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350). We finalized refinements to the code descriptor of HCPCS code G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (Add-on code, list separately in addition to home or residence or office/outpatient evaluation and management service, new or established) to reflect this change. This service is intended to recognize the longitudinal relationship between the patient and the practitioner, which differentiates the E/M visit from visits that are not longitudinal in nature. As discussed in section II.E. of this proposed rule, we are continuing to examine primary care in the PFS, and how we can appropriately recognize the resource costs of longitudinal and especially primary care, given the generality of E/M coding. (b) Proposed Changes to the Billing Mechanism for Inherent Complexity (i) Modifier MOD1 Since we began actively paying for HCPCS code G2211 in CY 2024, we have come to believe that the resource costs of furnishing longitudinal care for beneficiaries is not best characterized as a separate service requiring a separate code. Rather, we believe that since this work is an inherent part of the visit, it would be more accurately valued as a modifier to the base E/M code. We also believe that transitioning HCPCS code G2211 from an add-on code to a modifier will be more streamlined from an operational perspective. This should also reduce operational burden, as it will not require the submission of a separate claim line, because the modifier will be placed on the claim [[Page 43899]] line for the associated E/M code. We are therefore proposing to replace HCPCS code G2211 with a modifier, which we will refer to in this proposed rule as MOD1, which is a placeholder that would be replaced with a two-digit HCPCS modifier, if finalized. We are proposing that modifier MOD1 will be billed under the same circumstances that HCPCS code G2211 is billed now. We discussed in the CY 2024 final rule (88 FR 78973) that HCPCS code G2211 was intended to characterize the associated E/M code as a service with a practitioner who serves as the continuing focal point for all needed health care services, or with medical care that is part of ongoing care related to a patient's single, serious, or complex condition. HCPCS code G2211 was meant to describe the inherent complexity of these visits that would otherwise be unaccounted for. The application of the add-on code is not based on the characteristics of particular patients (even though the rationale for valuing the code is based on recognizing the typical complexity of patient needs), but rather the relationship between the patient and the practitioner. We are proposing to match the code descriptor for HCPCS code G2211 to MOD1, with some technical changes. The new proposed modifier descriptor is: Visit complexity inherent to new or established office/ outpatient or home or residence evaluation and management service, associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (ii) Modifier MOD1 Valuation When HCPCS code G2211 was finalized in the CY 2020 PFS final rule (84 FR 82854 through 82855), we crosswalked it to 100 percent of the valuation of CPT code 90785 (Interactive complexity (List separately in addition to the code for primary procedure)), which was created to capture additional work that occurs with certain psychiatric and psychotherapy codes. We believed that this service was analogous to the additional work involved in maintaining a longitudinal relationship with patients as described by CPT code 90785. CPT code 90785 has a work RVU of 0.33 and a physician time of 11 minutes. In reexamining this policy after a few years of utilization, we have come to believe that a flat rate as described by G2211 does not reflect the variation in work of the various E/M visit levels. [GRAPHIC] [TIFF OMITTED] TP16JY26.025 Table A-D7 illustrates that the addition of HCPCS code G2211 as an add-on to the associated E/M visit represents a higher increase in total value for base codes with lower total non-facility RVUs than it does for more intense services. For example, HCPCS code G2211 has a total RVU of 0.52 in the non-facility (NF) setting. CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using total time on the date of the encounter for code selection, 10 minutes must be met or exceeded.) has a total NF RVU of 1.78. So, when HCPCS code G2211 is appended to CPT code 99212, the overall value of the service is increased by 29 percent. However, when HCPCS code G2211 is appended to CPT code 99215 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and high level of medical decision making. When using total time on the date of the encounter for code selection, 40 minutes must be met or exceeded.) with a NF total RVU of 5.76, it only represents a 9 percent increase in the total value of the service. We believe that HCPCS code G2211 should reflect an increase to the base code that is proportional across all types of E/M visits. Therefore, we are proposing a modifier to replace HCPCS code G2211 with the valuation of 16 percent of the base E/M code. We established this percentage using a weighted average of the percentage increase that G2211 comprised relative to the O/O E/M code, weighted by HCPCS code G2211 utilization and adjusted to achieve budget neutrality. (c) G2211 in Medicare Accountable Care Organizations (ACOs) (i) Background The Medicare Shared Savings Program (Shared Savings Program) established under section 1899 of the Act, offers doctors, hospitals, and other health care providers an opportunity to create an Accountable Care Organization (ACO). Shared Savings Program ACOs are groups of doctors, hospitals, and other health care professionals that work together to give patients high-quality, coordinated service and health care, improve health outcomes, and manage costs.\16\ In Original Medicare, physicians are reimbursed for reasonable and necessary services necessary for diagnosis or treatment of illness or injury. In an ACO, the doctor-patient relationship in Original Medicare is expanded such that the doctors, hospitals and other health care professionals are not just providing services under the reasonable and necessary standard, but there is additional work conducted to manage the beneficiaries' overall health, considering their personal health goals and values. This is how CMS defines an ``accountable care relationship,'' and this relationship may lead patients to be less likely to get repeated medical tests or unnecessary services, since clinicians consider a patient's entire health history when developing a treatment plan, and the doctors and other health professionals communicate and collaborate to improve the patient's [[Page 43900]] long-term health.\17\ CMS believes accountable care supports the professional ethos of health professionals to take responsibility for their patients in a way that beneficiaries expect. When these accountable care relationships succeed and the ACO succeeds in delivering high-quality care and reducing expenditures, the ACO may be eligible to share in the savings. For more information on the Shared Savings Program and policies directly relating to Shared Savings Program, see section III.G. of this proposed rule. --------------------------------------------------------------------------- \16\ ``Accountable Care and Accountable Care Organizations.'' Centers for Medicare & Medicaid Services, CMS Innovation Center, https://www.cms.gov/priorities/innovation/key-concepts/accountable-care-accountable-care-organizations. Accessed 16 June 2026. \17\ ``Accountable Care and Accountable Care Organizations.'' Centers for Medicare & Medicaid Services, https://www.cms.gov/priorities/innovation/innovation-models/aco. Accessed 16 June 2026. --------------------------------------------------------------------------- The CMS Innovation Center recently announced the Long-term Enhanced ACO Design (LEAD) Model which will launch on January 1, 2027. LEAD builds upon previous accountable care work and was designed to attract health care providers that have previously had limited participation in ACOs. It also aims to encourage health care providers to deliver preventive care, empower beneficiaries to be more actively involved in their care, and support health care providers who serve high needs and dually eligible beneficiaries to improve care and reduce costs. (ii) Modifier MOD2 In the PFS, we have established a complexity add-code (HCPCS code G2211) that we are proposing to change to a modifier (MOD1) that supports care relationships which may approximate but are not accountable care. This modifier is meant to recognize the additional complexity of services associated with providing ongoing, longitudinal care to a beneficiary. We are proposing that the complexity of care established in that longitudinal relationship fundamentally differs in Original Medicare where physicians are providing all reasonable and necessary care for diagnosis and treatment of a clinical condition versus when they are in an accountable care relationship. As previously discussed, we are proposing applying the complexity add-on (we are proposing to change this to a modifier) to reflect the ongoing resource costs associated with being the focal point for all needed health care services performed under this reasonable and necessary standard. We believe this standard is distinct from care provided in an ACO, where in addition to being responsible for all needed health care services that are part of ongoing care, clinicians are also responsible for managing the accountable care relationship, which involves managing a beneficiary's overall health, personal goals, values, and coordinating care with responsibility for both quality and cost. We consider the complexity associated with serving as the focal point of care for all necessary services within an accountable care relationship, responsibility for the entire patient, and responsibility for quality and cost of care, to be inherently more complex than serving in this role outside of an accountable care relationship. We are therefore proposing two levels for this modifier to reflect the additional resource costs associated with accountable care. For example, the most common condition for which HCPCS code G2211 was billed in 2024 in Original Medicare was hypertension.\18\ Outside of an accountable care relationship, the complexity add-on (proposing in this rule to change to a modifier) would be billed by clinicians for E/M visits managing a beneficiary's hypertension over time. The additional time and resource costs for serving as this focal point in care may address a patient's reservations about initiating pharmacologic treatment for hypertension (for example, perhaps the beneficiary wishes to trial complementary or alternative medicine approaches, so the clinician and patient engage in shared decision- making to understand the risks and benefits of this approach preceding pharmacologic intervention).\19\ They may also discuss risk factor reduction (for example, smoking cessation) and lifestyle changes (for example, following the dietary approaches to stop hypertension or 'DASH` diet and meeting physical activity recommendations), or perhaps engage in motivational interviewing to facilitate behavior change. While the current HCPCS code G2211 is meant to take into account the additional time and resource intensity for these services, we expect even more from clinicians participating in an ACO. --------------------------------------------------------------------------- \18\ Ganguli I, Daley NE, Hicks AL, McWilliams JM, Rosenthal MB. Billing of Medicare's G2211 Longitudinal Care Code Among Traditional Medicare Beneficiaries. JAMA. 2026;335(11):1003-1006. doi:10.1001/ jama.2026.0424. \19\ ``Hypertension (High Blood Pressure).'' National Center for Complementary and Integrative Health, U.S. Department of Health and Human Services, July 2018, https://www.nccih.nih.gov/health/hypertension-high-blood-pressure. Accessed 16 June 2026. --------------------------------------------------------------------------- For example, a beneficiary has general anxiety disorder and hypertension and monitors their blood pressure at home. They have an instance in which their blood pressure exceeds 140/90mmHg, and they also feel panic or a sense of impending doom or chest pain. They decide to go to the emergency room, but the slightly elevated blood pressure may or may not be the physiologic trigger of their symptoms. This patient may continue to seek care at the emergency room for similar episodes indefinitely unless their practitioner identifies this trend on their own and provides education to the patient on distinguishing the symptoms of anxiety from hypertension, and when it may be appropriate to go to the emergency room. If this same patient was in an ACO, that ACO might have already established admission discharge transfer (ADT) notifications which would alert the team (near-real time) for the admission. This would allow for earlier intervention to ensure that both the patient's anxiety and blood pressure were being managed in the correct setting, and that the patient had the best information to understand their intersecting conditions. The additional time and resources associated with coordinating care for this complex patient considering both quality and cost are distinct. We are proposing differentiating the resource costs associated with HCPCS code G2211 outside of and within an accountable care environment to account for the additional resource costs associated with serving as the focal point of care for the entire beneficiary within an accountable care relationship. We are clarifying that we do not believe every encounter a patient has within an ACO qualifies as longitudinal. For example, if instead of presenting to the ED, the patient calls the clinic and is able to see another ACO participant, ACO professional, ACO provider/supplier (as each is defined at Sec. 425.20, for the Shared Savings Program), or LEAD Participant Provider who is available the same day, this encounter would not necessarily meet the criteria of inherent complexity, if that practitioner is not supporting the beneficiary's longitudinal care, and if this visit is not more inherently complex. Simply providing an E/M visit while being part of an ACO does not necessarily meet the threshold of inherent complexity. We believe that MOD2 aligns with the goals of the Shared Savings Program and LEAD, which involve groups of health care providers working together to enhance beneficiary health through high quality, longitudinal primary and preventative care. One of the features of Shared Savings Program and LEAD ACOs is that beneficiaries benefit from ACO participants balancing goals of having total cost of care accountability and improving quality of care, while avoiding unnecessary services and [[Page 43901]] medical errors. While the specifics vary between the Shared Savings Program and the LEAD model, in general, participating ACOs are required to report quality measures that align with these objectives, and they are measured against their past performance, and the performance of similar ACOs.\20\ --------------------------------------------------------------------------- \20\ https://www.cms.gov/medicare/payment/fee-for-service-providers/shared-savings-program-ssp-acos/guidance-regulations#quality. --------------------------------------------------------------------------- While these measures span a broad area of topics, many measures are focused on longitudinal care and care coordination, such as chronic disease management, preventive care and screenings and reducing avoidable hospitalizations.\21\ Current participation in the Shared Savings Program helps provide and future participation in LEAD will help provide a framework to allow health care providers to collaborate to give coordinated high-quality care, while also enabling investment to achieve those goals. For example, health care providers may join ACOs to help defray the costs of large capital investments such as electronic medical records.\22\ Health care providers also cite help with care coordination and quality reporting as a reason to join, increasing their access to resources and expertise to help with these areas in their practice.\23\ We also want to encourage health care providers to form and join ACOs to coordinate care for their beneficiaries. Similarly, ACO participants, ACO professionals, ACO providers/suppliers (as each is defined at Sec. 425.20, for the Shared Savings Program), and LEAD Participant Providers often provide advanced primary care to beneficiaries regardless of whether a particular beneficiary is assigned, aligned, or attributed to their ACO. Advanced primary care is a patient-focused approach to care wherein health care providers take extra steps to actively manage a beneficiary's health care needs.\24\ Further, additional beneficiaries to whom a health care provider provides care might be assigned to that ACO in the future, so encouraging similar care to be provided to all beneficiaries served by health care providers in ACOs would be in the interest of the ACO. This level of care coordination, which includes advanced primary care, is often inherent by virtue of participation in an ACO.\25\ --------------------------------------------------------------------------- \21\ https://www.cms.gov/priorities-innovation-key-concepts-accountable-care-accountable-care-organizations. \22\ https://www.cbo.gov/publication/60213. \23\ Berenson, R.A., Burton, R.A., & McGrath, M. (2016). Do accountable care organizations (ACOs) help or hinder primary care physicians' ability to deliver high-quality care? Healthcare, 4(3), 155-159. https://doi.org/10.1016/j.hjdsi.2016.02.011. \24\ https://www.cms.gov/medicare/payment/fee-schedules/physician-fee-schedule/advanced-primary-care-management-services and https://www.medicare.gov/coverage/advanced-primary-care-management-services. \25\ Centers for Medicare & Medicaid Services. Care Transformation Toolkit. CMS Innovation Center; 2021. Available at https://www.mathematica.org/publications/care-transformation-toolkit. --------------------------------------------------------------------------- We are proposing to match the descriptor of MOD2 to MOD1 and HCPCS G2211, with some small differences. The new proposed modifier descriptor is: Visit complexity inherent to new or established office/ outpatient or home or residence evaluation and management service, associated with medical care services furnished by a participant or practitioner participating in a Medicare accountable care organization. Services must serve as the continuing focal point for all needed health care services and/or be part of ongoing care related to a patient's single, serious condition or complex condition. (ii) Modifier Valuation for Medicare ACO Participants With these goals in mind, we are proposing that, in place of reporting G2211, ACOs would have the option to report a modifier on a claim (referred to in this proposed rule as placeholder MOD2, which if finalized would be replaced with a two-digit HCPCS modifier), which will be valued at 32 percent of the associated E/M visit when performed by Shared Savings Program ACO participants, ACO professionals, and ACO providers/suppliers (as each is defined at Sec. 425.20), as well as Participant Providers in the LEAD Model. We are proposing that MOD2 would pay twice the rate of MOD1 to better account for the inherent complexity of some visits in the ACO context, specifically applying to Shared Savings Program and LEAD ACOs in situations that require increased time and intensity. This increased valuation is meant to reflect the cognitive work of providing longitudinal care, follow-up discussions through an assigned care coordinator with the beneficiary or other providers, and expanded access to educational resources, care options, and provider communication methods. The value-based care provided through a Shared Savings Program or LEAD ACO puts greater emphasis on integrated care, meaning health care providers work together to address a person's physical, mental, behavioral and social needs. In this way, providers treat an individual as a whole person, rather than focusing on a specific health issue or disease.26 27 --------------------------------------------------------------------------- \26\ https://www.cms.gov/priorities/innovation/key-concepts/value-based-care. \27\ https://www.cms.gov/priorities/innovation/key-concepts/person-centered-care. --------------------------------------------------------------------------- The differential payment we propose to provide to Shared Savings Program ACO participants, ACO professionals, and ACO providers/ suppliers (as each is defined at Sec. 425.20) and to LEAD Participant Providers would further support the CMS Innovation Center 2025 Strategy to Make America Healthy Again which focuses on empowering Americans to achieve their health goals and live healthier lives.\28\ We recognize that not all E/M visits represent longitudinal care and so we would not expect MOD2 to be included on all claims for E/M visits, only visits that have an increased visit complexity that requires an increased valuation, as described in the examples provided earlier in this section. --------------------------------------------------------------------------- \28\ https://www.cms.gov/priorities/innovation/about/strategic-direction. --------------------------------------------------------------------------- (iii) Use of MOD2 Modifier by ACOs Modifier MOD2 would be exclusively available for ACO participants, ACO professionals, and ACO providers/suppliers (as each is defined at Sec. 425.20, for the Shared Savings Program), as well as LEAD Participant Providers, when the visit complexity is met, provided the individual is a medical professional who can bill office and outpatient E/M visits or home visit services, regardless of specialty. Utilization and claims of either modifier will be included in ACOs' expenditure calculations for benchmarking and performance year expenditures and used in the determination of total cost of care. As described earlier in this section, we are proposing a differential payment for MOD2 that is meant to provide a meaningful increase in the way we pay for primary care provided by ACO participants, ACO professionals, and ACO providers/suppliers (as each is defined at Sec. 425.20, for the Shared Savings Program), as well as LEAD Participant Providers who often provide additional care coordination to beneficiaries in their care as demonstrated by their participation in an ACO, as described in the examples provided earlier in this section. We are further proposing that the use of this modifier be voluntary; and ACO participants, ACO professionals, ACO providers/ suppliers (as each is defined at Sec. 425.20, for the Shared Savings Program), and LEAD Participant Providers would determine if this modifier is necessary based on visit complexity and would append MOD1, MOD2, or no modifier, as appropriate. Additionally, we are proposing that ACO participants, ACO professionals, [[Page 43902]] and ACO provider/suppliers (as each is defined at Sec. 425.20, for the Shared Savings Program), as well as LEAD Participant Providers may bill this modifier for all beneficiaries to whom they provide care, regardless of whether that beneficiary is assigned, aligned, or attributed to an ACO, to encourage similar care to be provided to all beneficiaries served by health care providers who participate in ACOs. Given that ACO Primary Care Flex (ACO PC Flex) Model participation is predicated on participation in the Shared Savings Program, we are proposing that ACO PC Flex Model ACOs may also utilize the MOD2 modifier. Finally, we are proposing that LEAD Participant Providers billing under a Participant TIN that is in a LEAD ACO may bill modifier MOD2. Refer to the discussion later in this section for additional information on the use of modifier MOD2 on alignment in the LEAD model. (A) Impacts on Assignment of Beneficiaries to Shared Savings Program ACOs HCPCS code G2211 is included in the definition of primary care services used for purposes of assignment under Sec. 425.400(c). Although we are proposing that HCPCS code G2211 be deleted, under this proposal, it would remain in the regulations at Sec. 425.400(c) to be included for purposes of determining the population of OM beneficiaries for whose care the ACO is accountable under 42 CFR subpart F, and for determining whether an ACO has achieved savings under 42 CFR subpart G, and will continue to be used for assigning beneficiaries to an ACO in benchmark years during which HCPCS code G2211 was still an allowable service. If the proposal is finalized, the code will no longer be payable, and there will be no impact on future calculations of allowed charges used for purposes of assignment. Modifier MOD2 can be appended to O/O or home or residence E/M services exclusively by ACO participants, ACO professionals, ACO providers/suppliers (as each is defined at Sec. 425.20, for the Shared Savings Program), and LEAD Participant Providers who can bill O/O or home or residence E/M service, regardless of specialty. In performing claims-based assignment under the Shared Savings Program, CMS determines whether allowed charges for a beneficiary's primary care services (as identified for ACO professionals, including at Electing Teaching Amendment hospitals and Method II Critical Access Hospitals, and services furnished at an FQHC or RHC) in an ACO are greater than allowed charges for the beneficiary's primary care services in any other ACO, or other individual health care providers, or groups of health care providers identified by Medicare-enrolled billing TINs or CMS Certification Numbers that are not participating in the Shared Savings Program. In making this determination, we determine where the beneficiary received the plurality of his or her primary care services. The allowed charges associated with O/O or home or residence E/M services billed with or without modifiers MOD1 or MOD2 will be used in determining beneficiary assignment. Since the CPT codes identified as O/O or home or residence E/M services are included in the definition of primary care services used for purposes of assignment as defined in 42 CFR 425.400(c), we do not believe that changes to the regulatory text are required. Certain operational changes will need to be implemented which will be communicated via Change Request,\29\ Medicare Learning Network (MLN) Matters[supreg] article,\30\ or other sub-regulatory guidance. --------------------------------------------------------------------------- \29\ Available at https://www.cms.gov/medicare/regulations-guidance/transmittals. \30\ Available at https://www.cms.gov/training-education/medicare-learning-networkr-mln/resources-training/mln-matters-articles. --------------------------------------------------------------------------- (B) Impacts on Assignment of Beneficiaries to LEAD ACOs In LEAD, if this proposal is finalized, we will handle the deletion of HCPCS code G2211 and the transition to the modifiers similarly to the Shared Savings Program. As indicated in Appendix C of the LEAD Request for Applications, the HCPCS code G2211 code is one of the Primary Care Qualified Evaluation and Management (PQEM) services that CMS uses to align beneficiaries to LEAD ACOs via claims-based alignment. We will continue to use HCPCS code G2211 allowable charges to conduct claims-based alignment in LEAD when HCPCS code G2211 was an allowable service in the requisite claims look back period. For example, when conducting initial claims-based alignment in Performance Year (PY) 2027, we will reference claims from October 1, 2025 to September 30, 2026. HCPCS code G2211 allowable charges will be included in the claims-based alignment run since it is an allowable service during this period. When aligning beneficiaries to LEAD ACOs, CMS looks first for an existing primary care relationship within the claims lookback period. If 10 percent or more of a beneficiary's PQEM allowable charges (measured by dollar amount) were billed by physicians or non-physician health care providers with a primary-care specialty (family medicine, internal medicine, geriatrics, general practice, nurse practitioner, physician assistant, and clinical nurse specialist), alignment is based solely on these primary care providers. If less than 10 percent of a beneficiary's PQEM allowable charges were billed by primary-care specialties, alignment considers certain non-primary care providers that manage chronic or complex conditions (for example, cardiology, nephrology, endocrinology, psychiatry, etc.). The beneficiary is aligned to a LEAD ACO if the Participant TIN that furnished the largest share of allowable charges incurred for PQEM services during the lookback period is participating in a LEAD ACO. Once the claims-based alignment look back period rolls forward to include 2027 (and future years) the LEAD alignment methodology will include the allowed charges associated with modifier MOD1 and MOD2 when conducting claims-based alignment (the underlying O/O or home or residence E/M service that will be modified by MOD1 and MOD2 are already LEAD PQEM services). LEAD ACOs will be accountable for expenditures incurred by using either modifier MOD1 or MOD2. Expenditures associated with modifier MOD1 and MOD2 will be included in total Medicare Parts A and B expenditures when CMS conducts financial settlement for LEAD ACOs. More information on the impact to claims processing, capitated payments, and LEAD benchmarks will be shared with ACOs that were selected for participation in LEAD in PY 2027. (iv) MOD1 and MOD2 Billed With Modifier -25 When we finalized the HCPCS code G2211 policy in the CY 2021 PFS final rule (85 FR 84572), we did not limit the use of HCPCS code G2211 with O/O E/M visits in which CPT Modifier -25 was appended. CPT Modifier -25 denotes a significant, separately identifiable O/O E/M visit by the same physician or other qualified health care professional on the same day as a procedure or other service. We finalized HCPCS code G2211 as payable in the CY 2024 PFS final rule (88 FR 78974), and in the CY 2025 PFS final rule (89 FR 97856 through 97858), we finalized that we would allow payment of HCPCS code G2211 with -Modifier 25 when the O/O E/M base code is reported by the same practitioner on the same day as an annual wellness visit (AWV), vaccine administration, or any Medicare Part B preventative service when furnished in [[Page 43903]] the office or outpatient setting. For CY 2027, we are proposing to maintain the same limitations we established for HCPCS code G2211 in the CY 2025 PFS final rule (89 FR 97856 through 97858) for MOD1 and MOD2 when billed with Modifier -25. Later in this section, we are making additional proposals related to changes for payment when modifier -25 is appended. Given these changes, we are seeking comment on whether we should consider changes to this policy, such as allowing MOD1 or MOD2 to be billed with modifier -25 when an O/O E/M is performed on the same day as a 0-, 10-, or 90- day global procedure? (54) Shared Medical Appointment (HCPCS Code GSMAS) In accordance with President Trump's Executive Order, ``Establishing the President's Make America Healthy Again Commission,'' \31\ the Administration is directing agency focus towards understanding and drastically lowering chronic disease rates. As part of this commitment, we remain focused on the prevention and management of chronic disease, including through approaches that address underlying behavioral and lifestyle drivers of health. --------------------------------------------------------------------------- \31\ https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/. --------------------------------------------------------------------------- In CY 2026, we solicited feedback on how CMS could further support the prevention and management of chronic diseases. In response to our request for information on chronic disease prevention and management, commenters indicated that many services that help prevent and manage chronic disease, such as lifestyle modification support, health education, and peer support, require time, coordination and multidisciplinary engagement that is not adequately supported under the current PFS. Additionally, many commenters indicated that social isolation and loneliness is a persistent barrier to effective care for Medicare beneficiaries. The commenters indicated that although health care providers are already implementing interventions to identify and address social isolation, these efforts are resource intensive and not adequately supported under the current PFS. Based on this feedback, we recognize the importance of health care delivery approaches that enable multidisciplinary support, foster beneficiary engagement, and encourage sustainable lifestyle and behavioral changes. Shared medical appointments (SMAs) are one such approach to offer a group-based environment in which beneficiaries can receive clinical guidance while also engaging with peers facing similar health challenges. SMAs may also help address social isolation and loneliness for some beneficiaries. SMAs, also known as shared medical visits or group visits, are voluntary group-based sessions where multiple patients with a common chronic condition, such as type 2 diabetes mellitus, receive medical care together. In general, SMAs involve more than one healthcare provider, such as a person trained or skilled in delivering patient education or facilitating patient interaction and a prescribing practitioner to make and initiate a comprehensive care plan. SMAs generally last from 60 to 120 minutes and incorporate time for social integration, interactive education, and adjustments to the patient's care plan.\32\ Compared with group education alone, SMAs allow patients to participate in clinical care activities that are tailored to the needs of both the group and the individual participants.\33\ During the SMA session, a practitioner may meet with a patient individually in a private or semi-private manner or conduct the visit in a group setting where other patients are able to listen and, in some cases, contribute to the discussion.\34\ --------------------------------------------------------------------------- \32\ https://www.ncbi.nlm.nih.gov/books/NBK99776/#. \33\ Kirsh, Susan R., Aron, David C., Johnson, Kimberly D., Santurri, Laura E., Stevenson, Lauren D., Jones, Katherine R., and Jagosh, Justin. ``A realist review of shared medical appointments: How, for whom, and under what circumstances do they work?'' Available from https://pmc.ncbi.nlm.nih.gov/articles/PMC5291948/pdf/12913_2017_Article_2064.pdf. \34\ Thompson-Lastad, Ariana. ``Group Medical Visits as Participatory Care in Community Health Centers.'' Available from https://pmc.ncbi.nlm.nih.gov/articles/PMC6500445/pdf/nihms-1015904.pdf. --------------------------------------------------------------------------- Reported advantages of shared medical appointments include providing patients more time with their health care provider, creating opportunities for patients to learn from and share self-management strategies with one another, improving access to care, incorporating nonpharmacologic treatment approaches, enhancing the overall quality of care, and helping reduce emergency department visits.\35\ --------------------------------------------------------------------------- \35\ Lacagnina, Salvatore, Tips, Jean, Pauly, Kaitlyn, Cara, Kelly, and Karlsen, Micaela. ``Lifestyle Medicine Shared Medical Appointments.'' Available from https://pmc.ncbi.nlm.nih.gov/articles/PMC7781059/. --------------------------------------------------------------------------- Currently there is no CPT or HCPCS code specifically designated for SMAs. However, practitioners typically bill SMAs using existing Evaluation and Management (E/M) codes, CPT codes 99212-99215, based on medical decision-making criteria; and if another billable clinician such as a registered dietician assists with the SMA, the registered dietician may also bill for their portion of the SMA separately (for example, CPT code 97804 (Medical nutrition therapy; group (2 or more individual(s)), each 30 minutes)). Therefore, we propose to create coding and valuation specifically for SMAs. We propose that SMAs be limited to beneficiaries who have received a professional service from the billing physician or other qualified health professional or another physician or other qualified health care professional of the exact same specialty and subspecialty who belongs to the same group practice within the previous 12 months. We believe this requirement is necessary to ensure beneficiaries have an existing clinical relationship with the practitioner before the beneficiary is integrated into a group-based medical care setting. We propose requiring beneficiaries to consent to SMA participation, since they may elect to receive individual medical appointments instead. Additionally, we propose that beneficiaries must consent to confidentiality terms because personal health information would be discussed in the group setting. SMA sessions generally last 60 to 120 minutes and may include up to 25 patients, however SMAs most commonly consist of 6 to 10 patients.\36\ We propose establishing SMAs as 60-minute sessions with a maximum of 10 beneficiaries per session. --------------------------------------------------------------------------- \36\ https://www.hsrd.research.va.gov/publications/esp/shared-med-appt.pdf. --------------------------------------------------------------------------- The expansion of telehealth services has increased opportunities for SMAs to improve access for individuals in geographically remote areas, and those with transportation challenges. We propose that SMA sessions can be held either in-person or via telehealth, and we are proposing to add the SMA service to the Medicare Telehealth list accordingly. We propose that each shared SMA session be documented in each participating beneficiary's medical record. Each beneficiary receives individualized clinical care, and the medical record must reflect the specific services that the individual beneficiary received during the SMA session. The need for individualized care may depend on the intervention and surrounding evidence. Therefore, if a beneficiary requires a level of individualized care that extends beyond what can appropriately be provided [[Page 43904]] within the group-based session of a SMA, that individualized care should be provided in a separate individual medical appointment. The services provided to the group as a whole at each session would also need to be captured in the medical record. We seek comments on additional guardrails to consider in preventing fraud, waste and abuse when billing SMAs, such as following an evidence-based protocol for delivery of the intervention, conducting fidelity checks to ensure it is being delivered as intended, identifying key outcomes and goals that are established in shared decision making, and ensuring that the interventionist is trained in the intervention as appropriate. SMAs are an approach in managing chronic conditions, especially among motivated patients.\37\ SMAs are an appropriate healthcare delivery approach for conditions that are modifiable with lifestyle change, including diabetes mellitus, obesity, hypertension, and hyperlipidemia, such that behavioral changes including diet, physical activity, and self-management- can influence health outcomes. Therefore, we propose to establish coding and payment for SMAs provided for medical conditions that are modifiable with lifestyle change. We seek comment on how to determine when SMAs would be appropriate, including identifying which medical conditions would be considered modifiable with lifestyle change, and suggest we would typically consider those conditions with medical guidelines that include lifestyle change as part of prevention and treatment of the condition in this category, such as evidence-based interventions that support lifestyle change.\38\ For example, the 2026 Standards of Care in Diabetes published by the American Diabetic Association (ADA) include lifestyle changes including improving nutrient composition and reducing caloric intake, establishing physical activity regimens to support weight loss, and highlighting the role of Medical Nutrition Therapy (MNT) as part of nutrition education.\39\ While the exact content the SMA and desired behavioral change would vary (for example, improving diet and exercise as part of both prevention and management of Type 2 Diabetes) we would not consider medication adherence or titrating medications for Type 2 Diabetes to be appropriate for an SMA, but we would consider SMAs focused on improving nutrient composition to be an appropriate SMA activity, for example. CMS acknowledges the substantial changes in patients' lives associated with coping with chronic illness, the behavioral modifications inherent in managing serious and unexpected illnesses, however we would reserve SMA provision for just those conditions which may be treated or prevented with lifestyle changes. --------------------------------------------------------------------------- \37\ https://pmc.ncbi.nlm.nih.gov/articles/PMC2464960/pdf/349.pdf. \38\ Centers for Disease Control and Prevention. ``Evidence- Based Intervention Planning Guides.'' CDC: Cancer, National Center for Chronic Disease Prevention and Health Promotion, 21 May 2024, https://www.cdc.gov/cancer/php/ebi-planning-guides/index.html. Accessed 7 July 2026 \39\ American Diabetes Association Professional Practice Committee for Diabetes. ``5. Facilitating Positive Health Behaviors and Well-Being to Improve Health Outcomes: Standards of Care in Diabetes--2026.'' Diabetes Care, vol. 49, suppl. 1, 2026, pp. S89- S131, https://doi.org/10.2337/dc26-S005. --------------------------------------------------------------------------- SMAs typically involve multiple healthcare providers, usually two to four. The sessions are generally led by a physician, physician assistant (PA), or an advanced practice registered nurse (APRN), and may have ancillary staff help when the provider is meeting with patients individually.\40\ We propose that a SMA session is billed and led by a physician or qualified nonphysician practitioner and may include other qualified healthcare professionals, clinical staff, or auxiliary personnel. We propose that HCPCS code GSMAS would be billed once per patient, per session and would accept any documentation to demonstrate the care was rendered so long as the physician or qualified nonphysician practitioner co-signature is included. In instances where another qualified healthcare professional, such as a registered dietitian, provides a service during the SMA session, such as CPT code 97804 (Medical nutrition therapy; group (2 or more individual(s)), each 30 minutes), that service is considered part of the SMA and should not be billed separately, in addition to the physician or qualified nonphysician practitioner billing for the SMA. --------------------------------------------------------------------------- \40\ https://pmc.ncbi.nlm.nih.gov/articles/PMC7781059/pdf/10.1177_1559827620943819.pdf. --------------------------------------------------------------------------- We propose requiring each SMA session to include the following components: Evaluation and Management (E/M) elements, consistent with the complexity of the beneficiary's condition. Individualized clinical care with medical documentation in the medical record that reflects the specific services that the individual beneficiary received during the SMA session. Education, based upon evidence-based content, and discussions related to self-care, wellness, and disease management. Discussion of positive lifestyle changes, focusing on behavior modification. Medication management, as clinically appropriate and applicable. In the event it is medically necessary for a beneficiary to receive an E/M visit on the same day as a SMA by the same physician or other qualified health professional or another physician or other qualified health care professional of the exact same specialty and subspecialty who belongs to the same group practice, we propose that any time and effort cannot be counted more than once. We propose not to consider and treat this as two E/M same-day visits and seek public comment on this proposal. Additionally, we seek comments on what components must be required for each SMA session. We propose the following descriptor for SMAs: HCPCS code GSMAS: Voluntary, group-based medical session involving multiple patients with common medical condition(s), receiving medical care in a group setting; billed and led by a physician or qualified nonphysician practitioner and may include services provided by other qualified healthcare professionals, clinical staff, or auxiliary personnel under the direction of the supervising physician or other practitioner. Session integrates group education, counseling, and peer support with individualized patient clinical assessment and care, 2-10 patients, billed once per patient, per session. Because SMA sessions would integrate group education, counseling, and peer support with individualized patient clinical assessment and care, in developing the valuation for the SMA HCPCS code, we propose to use a building block methodology that sums up the values associated with two reference codes. For the overall E/M elements of the SMA service, we are incorporating the work RVUs, work time and direct PE inputs associated with a level 3 O/O visit for an established patient, CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using total time on the date of the encounter for code selection, 20 minutes must be met or exceeded.), which has a work RVU of 1.30, and a total work time of 30 minutes, which is based on a pre-service evaluation time of 5 minutes, an intraservice time of 20 minutes, and a post service time of 5 minutes. E/M visit level selection does not need to be based on time; practitioners may select the [[Page 43905]] visit level based on the level of medical decision making (MDM). Additionally, as we discussed earlier in this section, we propose that SMAs be limited to beneficiaries who have received a professional service from the billing physician or other qualified health professional or another physician or other qualified health care professional of the exact same specialty and subspecialty who belongs to the same group practice within the previous 12 months. Given this pre-existing clinical relationship and the anticipated clinical profile of beneficiaries that would participate in an SMA, we believe that the level 3 O/O visit for an established patient represents the most typical level of service for the individualized patient clinical assessment component of the SMA. For the group education, counseling, and peer support elements of the SMA service, we are incorporating CPT code 96202 (Multiple-family group behavior management/modification training for parent(s)/ guardian(s)/caregiver(s) of patients with a mental or physical health diagnosis, administered by physician or other qualified health care professional (without the patient present), face-to-face with multiple sets of parent(s)/guardian(s)/caregiver(s); initial 60 minutes), which has a work RVU of 0.43 and a total work time of 15 minutes, which is based on a pre-service evaluation time of 2 minutes, an intraservice time of 10 minutes, and a post service time of 3 minutes. While a SMA may include up to 10 beneficiaries in a 60-minute session, the individualized care for a participating beneficiary may vary, such that some beneficiaries may receive more or less individualized care than others; nonetheless, documentation in the medical record must reflect the specific services that the individual beneficiary received during the SMA session. As we price services under the PFS based on a typical case, the proposed valuation for HCPCS code GSMAS reflects a typical SMA session and is not intended to represent the exact time distribution for every beneficiary in every SMA. We note that the total work time proposed is for the purposes of valuation and not meant as a requirement for billing. We believe this reflects a typical amount of time for both the individualized patient clinical assessment and the beneficiary's proportionate share of group education, counseling, and peer support that occurs concurrently across all participating beneficiaries during a SMA session. Considering the aforementioned building block methodology for SMA valuation, we are proposing a work RVU of 1.73 and a total work time of 45 minutes, which is based on a pre-service evaluation time of 7 minutes, an intraservice time of 30 minutes, and a post service time of 8 minutes. In addition to seeking comments on establishing the proposed HCPCS code GSMAS, we also seek comment on the proposed work RVUs, work times, and direct PE inputs. (55) Vaccine Adverse Effects Management (HCPCS Code GADV1) Vaccines prevent serious illnesses and even death in persons who receive them and serve a public health benefit. Vaccines are intended to produce active immunity to specific antigens. An adverse reaction is an undesirable side effect that occurs after a vaccination. Vaccine adverse reactions are classified as (1) local; (2) systemic; or (3) allergic. Local reactions (for example, redness) are usually the least severe and most frequent. Systemic reactions (for example, fever) occur less frequently than local reactions, and severe allergic reactions (for example, anaphylaxis) are the least frequent reactions.\41\ Modern vaccines are safe and effective; however, adverse events have been reported after administration of each type of available vaccine.\42\ Vaccine providers should be familiar with identifying immediate-type allergic reactions, including anaphylaxis, and be competent in treating these events at the time of vaccine administration. Providers, including practitioners, should also have a plan in place to contact emergency medical services immediately in the event of a severe acute vaccine reaction.\43\ --------------------------------------------------------------------------- \41\ https://www.cdc.gov/vaccines/hcp/imz-best-practices/preventing-managing-adverse-reactions.html#cdc_report_pub_study_section_3-preventing-adverse-reactions, accessed 5/1/2026. \42\ Ibid. \43\ Ibid. --------------------------------------------------------------------------- Before a vaccine is licensed, the Food and Drug Administration (FDA) takes steps to make sure the vaccine is safe. FDA requires that a vaccine goes through extensive safety testing. Even though careful studies are done before a vaccine is licensed, rare adverse effects may not be found until a vaccine is given to millions of people with different backgrounds and medical histories.\44\ According to clinical trial data, most vaccine[hyphen]associated adverse events are mild; however, severe adverse reactions such as anaphylaxis, myocarditis, thrombotic events, and pneumonitis have been reported.\45\ After a vaccine is licensed, the Vaccine Adverse Event Reporting System (VAERS) is one of the mechanisms used to monitor for any problems, or ``adverse events,'' that happen after vaccination.\46\ --------------------------------------------------------------------------- \44\ https://vaers.hhs.gov/docs/VAERS_Brochure_for_Parents_and_Caregivers_EN_508_2026.pdf. \45\ Suzuki T, Furuta H, Naganawa M, Hayashi K, Kiyotoshi H, Ohta C, Ninomiya S. COVID-19 Vaccine-Induced Severe Pneumonitis. Respirol Case Rep. 2025 Aug 21;13(8):e70274. doi: 10.1002/ rcr2.70274. PMID: 40860748; PMCID: PMC12371123. \46\ Ibid. --------------------------------------------------------------------------- We believe that the CPT evaluation and management code set may capture the work and clinical decision making involved in the evaluation and management of most vaccine adverse reactions. However, we believe that physician and nonphysician practitioners' work may not be accurately reflected under the CPT medical decision-making framework relating to the evaluation and management of rare and severe vaccine adverse reactions. E/M visits, like other services under the PFS, are valued based on an assumption of a typical case. We believe that these are additional resource costs that don't fit under a typical E/M. Therefore, we are proposing an add-on code and payment for diagnosis and management of a suspected vaccine adverse reaction for services going above and beyond those captured in an evaluation and management (E/M) visit. These services entail listening to patient concerns, answering questions, and building trust; selecting diagnosis strategies and conveying information in a manner specific to each patient's concerns, cultural and religious beliefs, and literacy level; providing patients with appropriate resources; and planning with patients the treatment of symptoms of vaccine adverse effects. We propose that this add-on code, HCPCS code GADV1 (Office or other outpatient evaluation and management service(s) for the diagnosis and treatment of vaccine adverse effects, new or established patient; each 15 minutes personally performed by the physician or qualified healthcare professional (list separately in addition to CPT codes 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350)), would be payable when a physician or nonphysician practitioner (NPP): (1) establishes and documents a temporal relationship to vaccination, and (2) performs a medically appropriate assessment to rule out alternative causes. For the purposes of valuation, we are proposing a direct crosswalk for HCPCS code GADV1 to HCPCS code G2212 (Prolonged office or other outpatient [[Page 43906]] evaluation and management service(s) beyond the maximum required time of the primary procedure which has been selected using total time on the date of the primary service; each additional 15 minutes by the physician or qualified healthcare professional, with or without direct patient contact (List separately in addition to CPT codes 99205, 99215, 99483 for office or other outpatient evaluation and management services) (do not report G2212 on the same date of service as 99358, 99359, 99415, 99416) (do not report G2212 for any time unit less than 15 minutes)) for 0.61 work RVUs and for direct PE inputs. We welcome comments on whether a second HCPCS code for 15 minutes of physician or NPP work time should be finalized and structured as a stand-alone code to more accurately capture the work entailed in cases where a patient is being evaluated for only a vaccine related complaint, outside the context of an E/M visit being furnished for a separate complaint. We also welcome comments on whether in finalizing such a stand-alone HCPCS code we should crosswalk its work RVU and PE inputs to HCPCS code G2212. Finally, we propose adding HCPCS code GADV1 to the Medicare Telehealth List. (56) Health Coaching (CPT Codes 0591T, 0592T, and 0593T) Per the Trump Administration's Executive Order, ``Establishing the President's Make America Healthy Again Commission,'' \47\ the Administration is directing agency focus towards understanding and drastically lowering chronic disease rates, through thinking on nutrition, physical activity, healthy lifestyles, over-reliance on medication and treatments, the effects of new technological habits, environmental impacts, and food and drug quality and safety. Furthermore, the Executive Order directs that agencies shall ensure the availability of expanded treatment options and the flexibility for health insurance coverage to provide benefits to support beneficial lifestyle changes and disease prevention. --------------------------------------------------------------------------- \47\ https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/. --------------------------------------------------------------------------- As such, in the CY 2026 PFS proposed rule, we sought comment on a wide range of possible rulemaking topics to promote prevention and management of chronic disease, and in particular, asked more detailed questions surrounding health coaching and motivational interviewing. More specifically, we asked whether we should consider coding and payment for health coaching and motivational interviewing beyond the current contractor-priced CPT codes describing health coaching, as an incident-to service performed under general supervision of a billing practitioner, what an appropriate description would be, what types of clinical staff perform motivational interviewing, how long a session lasts, the overlap between motivational interviewing and health coaching, training requirements for motivational interviewing and health coaches, the types of clinical circumstances where motivational interviewing and health coaching are performed, relevance for audiovisual or audio-only telecommunication, the experience of payers and providers using the CPT Category III CPT codes, and relevance for Evidence-Based Programs that effectively manage or prevent chronic disease. Commenters responded, stating that health coaching could support CMS' goal of preventing or managing chronic disease. Many health coaches wrote about their personal experience working with patients with chronic diseases, assisting them in making behavioral and lifestyle changes to self-manage their conditions, and noted that health coaching is a low-cost and highly effective strategy that empowers patients to manage their health. Many commenters requested paying separately for health coaching via the creation of HCPCS G-codes or another payment mechanism that would allow providers to reliably schedule and bill for health coaching services. Commenters also emphasized the importance of requiring that these services be provided by health coaches with appropriate training and certification. To ensure we adequately capture the time and resources for health coaching, we are proposing conditions of payment and valuation for 0591T (Health and well-being coaching face-to-face; individual, initial assessment, 60-90 minutes), 0592T (Individual, follow-up session, at least 30 minutes), and 0593T (Health and well-being coaching, group [2 or more individuals], at least 30 minutes). CPT code 0593T would be billed once per beneficiary in the group. We are also proposing to adopt the CPT prefatory language for 0591T, 0592T, and 0593T: ``Health and well-being coaching is a patient- centered approach wherein patients determine their goals, use self- discovery or active learning processes together with content education to work toward their goals, and self-monitor behaviors to increase accountability, all within the context of an interpersonal relationship with a coach. The health and well-being coach is qualified to perform health and well-being coaching by education, training, national examination and, when applicable, licensure/regulation, and has completed a training program in health and well-being coaching whose content meets standards established by an applicable national credentialing organization. The training includes behavioral change theory, motivational strategies, communication techniques, health education and promotion theories, which are used to assist patients to develop intrinsic motivation and obtain skills to create sustainable change for improved health and well-being.'' We are proposing that CPT codes 0591T, 0592T, and 0593T may be performed under direct supervision of the billing practitioner, as defined by Sec. 410.26(a)(3). We also propose that when the service is performed under direct supervision by auxiliary personnel, the auxiliary personnel must have received appropriate certification to perform the services, which includes, but is not limited to, fulfilling the National Board for Health and Wellness Coaching National Standards, the National Commission for Health Education Credentialing eligibility for Certified Health Education Specialists, or the American Holistic Nurses Credentialing national standards for Certified Nurse Coaches. In response to the Request for Information (RFI) in the CY 2026 PFS proposed rule (90 FR 49479 through 49480), we received comments from interested parties pointing us towards these standards. We also propose that appropriate certification for auxiliary personnel to perform the services can also be fulfilled by receiving training from the evidence- based health promotion and disease prevention programs funded under the Older Americans Act and overseen by the Administration for Community Living (ACL). These programs undergo review, meet significant evidence thresholds, and have training requirements built into the program requirements. We solicit comment on these certification standards for auxiliary personnel performing these services. Furthermore, we understand that occasionally, community-based organizations (CBOs) are the entities that employ health coaches. As noted in the CY 2023 PFS final rule (87 FR 69790) and explained in the CY 2023 PFS proposed rule (87 FR 46102), when we refer to CBOs, we mean public or private not-for-profit entities that provide specific services to the community or targeted populations in [[Page 43907]] the community to address the health needs of those populations. They may include community care hubs, community-action agencies, housing agencies, area agencies on aging, centers for independent living, aging and disability resource centers or other non-profits that apply for grants or contract with healthcare entities to perform social services. They may receive grants from other agencies in the U.S. Department of Health and Human Services, including Federal grants administered by the Administration for Children and Families (ACF), Administration for Community Living (ACL), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), or State-funded grants to provide social services. Generally, we believe such organizations know the populations and communities they serve and may have the infrastructure or systems in place to assist practitioners to provide these services. We note that individuals employed by CBOs may operate under general supervision of the billing practitioner, as long as the training and certification guidelines outlined earlier in this section are met. Finally, we are proposing national payment for CPT codes 0591T, 0592T, and 0593T. We are proposing to crosswalk work and direct PE inputs for 0591T and 0592T to CPT codes 99490 (Chronic care management) and 99439 (Chronic care management, each additional 20 minutes), respectively, since, like Chronic Care Management (CCM), these visit- based services are performed under general supervision. For 0593T, since it is a group visit billed in 30-minute increments, we are proposing to crosswalk the work and PE inputs to CPT code G0109 (Group diabetes self-management training). Therefore, we are proposing a work RVU of 1.00 for CPT code 0591T, 0.70 for CPT code 0592T, and 0.23 for CPT code 0593T. Since multiple sessions in the same calendar month may be needed, we are not proposing frequency limitations for these codes, as long as they are reasonable and necessary. We will monitor utilization and may re-evaluate these policies in future rulemaking. These services were added to the Medicare Telehealth Services List in the CY 2024 PFS Final Rule (88 FR 78859 through 78860). We solicit comments on the valuation of these services and the conditions of payment. We are also soliciting comment on whether should consider creating HCPCS G-codes to describe these services for CY 2027, rather than actively pricing these Category III CPT codes that describe health coaching services, including what the potential benefits of G- codes would be compared to using the existing codes. (57) Vascular Embolization or Occlusion Procedure With Use of a Pressure-Generating Catheter (HCPCS Code G0577) HCPCS code C9797 (Vascular embolization or occlusion procedure with use of a pressure-generating catheter (e.g., one-way valve, intermittently occluding), inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction) was created for the April, 2025 Quarterly Release for the OPPS and Ambulatory Surgical System (ASC) to describe use of a pressure-generating catheter inclusive of imaging guidance for vascular embolization. Subsequently, we also created HCPCS code C8004 (Simulation angiogram with use of a pressure-generating catheter (e.g., one-way valve, intermittently occluding), inclusive of all radiological supervision and interpretation, intraprocedural road mapping, and imaging guidance necessary to complete the angiogram, for subsequent therapeutic radioembolization of tumors) to describe the simulation angiogram associated with the use of the pressure-generating catheter described by HCPCS code C9797 for the April, 2025 OPPS Quarterly Release. For CY 2026, HCPCS code C9797 is assigned to APC 5194 with a payment rate of around $18,729 while HCPCS code C8004 is assigned to APC 5193 with a payment rate of around $11,874. Currently both HCPCS codes C9797 and C8004 are only payable in the OPPS and ASC settings, as there is currently no coding for the physician office setting describing use of this technology. Under the PFS, vascular embolization procedures are reported using CPT code 37243 (Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction) regardless of the technology used to perform the service. Interested parties have indicated that use of this technology has expanded beyond the OPPS and ASC settings and into the physician office setting; however, the resource costs associated with CPT code 37243 do not accurately account for the use of innovative catheter technology. While this technology may not yet be typical and as such is appropriately absent from the valuation of CPT code 37342, we are concerned that the lack of appropriate coding and payment for the use of innovative catheter technology may negatively impact access in the non-facility setting. Beginning July 1, 2026, we began making separate payment for vascular embolization or occlusion procedure with the use of a pressure-generating catheter through the contractor priced HCPCS code G0577 (Vascular embolization or occlusion procedure with use of a pressure-generating catheter (e.g., one-way valve, intermittently occluding), inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction performed in the non-facility setting) and are proposing to nationally price this service for CY 2027. We are seeking comment on whether there is a need for creation of a HCPCS G-code to mirror HCPCS code C8004 as currently there are no claims for this service in the HOPD setting. In the CY 2026 PFS final rule, we finalized use of the relationship between the OPPS APC relative weights for APCs describing radiation treatment delivery services to inform the PE RVUs for those services under the PFS. We believe a similar policy is necessary here to establish the initial valuation for vascular embolization using a pressure generating catheter given the lack of pricing information in the non-facility setting. Therefore we are proposing to use the relative relationship between the approximate APC payment amounts between CPT code 37243 and HCPCS code C9797 to value the PE portion of HCPCS code G0577 and a direct crosswalk to the work and MP RVUs associated with CPT code 37243 as well as the physician time. We are seeking comments on these values. We would also note that this valuation is preliminary and we will consider updates for future rulemaking if use of this technology becomes more widespread in the non-facility setting. (58) Accounting for E/M Resource Overlap Between Stand-Alone Visits and Global Periods (a) Background Surgical procedures with a global surgery period include all the necessary services normally provided by the practitioner before, during, and after a procedure. The global surgery payment includes things like pre-operative visits, [[Page 43908]] typical intra-operative services for that procedure, post-operative follow-up visits, supplies, and other services such as dressing changes, and removal of items used during or after surgery like sutures, staples, splints, or casts.\48\ The payment and coding structure of global surgery periods includes the same foundational pieces as other codes in the PFS: work RVUs, practice expense RVUs, and malpractice RVUs. The work RVUs include time crosswalked from E/M codes to reflect the valuation of things such as pre-operative and post- operative visits. Given that global surgical packages already account for the resource costs associated with visits, standalone E/M codes are not billable on the same day as a procedure code unless they are significant and separately identifiable from the procedure. These visits are identified through appending of modifier-25 to the claim. This proposal is meant to address the likely overlap and duplication of payment between the E/M services already paid for during the global surgical package, and any additional E/M services billed for through the use of modifier-25 as significant and separately identifiable. --------------------------------------------------------------------------- \48\ https://www.cms.gov/files/document/mln907166-global-surgery-booklet.pdf. --------------------------------------------------------------------------- The PFS has other existing policies where we reduce payments if multiple procedures are furnished on the same day for the same patient, the multiple procedure payment reduction (MPPR) policies. MPPR is a longstanding Medicare policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished on the same day to the same patient, largely based on the efficiencies in PE and pre- and post-surgical physician work. Since the implementation of the PFS, MPPR policies were also established on nuclear medicine diagnostic procedures, the professional and technical component of diagnostic imaging, the technical component of diagnostic cardiovascular and ophthalmology procedures, and always-therapy services. In the 2019 PFS proposed rule (83 FR 35840 through 35841), as part of a suite of proposals designed to modify the payment structure of E/M visits, we proposed to reduce payment by 50 percent for the least expensive 0-day global procedure or visit that the same physician (or a physician in the same group practice) furnishes on the same day as a separately identifiable E/M visit, currently identified on the claim by an appended modifier-25. In the 2019 PFS final rule (83 FR 59638 through 59640), many commenters opposed this proposal, stating that current billing rules allow these services to be billed only when modifier-25 is used, which makes it clear that the visits are significant and separately identifiable. Other commenters described that the RUC review process includes adjustments to account for any costs that the RUC considers duplicative, which means that CMS is making an unnecessary second adjustment. Commenters also stated that CMS provided insufficient rationale for a 50 percent payment reduction instead of other potential adjustments. Some physician organizations and patient advocacy groups also stated concerns that physicians might respond to financial incentives to bring patients back for necessary visits on a different day to avoid triggering the payment reduction. MedPAC, among others, were supportive of the proposal, stating that when a standalone E/M visit occurs on the same day as a procedure, there are efficiencies such as pre-service and post-service clinician work and practice expense, that are not currently accounted for in the system. Other commenters suggested alternative reductions, such as a 5 percent or 25 percent reduction. In our response to commenters in the CY 2019 final rule (83 FR 59638 through 59640), we stated that we continued to have concerns about 0- and 10-day global periods on the same day as E/M visits. We appreciated the efforts of the RUC to address overlaps when they recognize that a code is often reported with a same day E/M visit, but we also noted that the RUC tends to recommend only minor adjustments to physician time and direct PE inputs to account for overlap. We also discussed that there are several thousand codes with global periods, and while we routinely prioritize review of high-volume services, we believe code-level reviews are not a practical solution to ensuring the accuracy of accounting for these types of efficiencies. We also stated that if practitioners begin deliberately scheduling visits on separate days to avoid the payment adjustment, this could create undue burden and create potential medical risk for beneficiaries. We did not finalize this proposal in CY 2019 for a few reasons. First, we had concerns related to balancing the appropriate valuation of these codes with potential disruption to patient care. We reiterated that we find the possible practice of scheduling medical services to maximize payment highly problematic, and we invited interested party feedback regarding how to address these challenges. Second, we did not finalize any of the suite of proposals related to the valuation of the E/M code set in CY 2019, as the AMA and the CPT Editorial Panel stated plans to revisit coding for O/O E/M, and we delayed further action to allow that process to play out (83 FR 59638). (b) Proposed Changes to Payments Using Modifier-25 As we stated in the CY 2019 final rule (83 FR 59638 through 59640), we continue to believe that there are efficiencies when the same physician (or a physician in the same group practice) provides an E/M service for the same patient in conjunction with a procedure with a global period, and that we are likely duplicating payment under the current payment methodology. We are proposing to reduce payment, as described later in this section, when a separately identifiable O/O E/M visit is furnished by the same physician (or a physician in the same group practice) on the same day as a 0-, 10-, and 90-day global procedure. Under this proposal, the most expensive service (either surgical or E/M visit) would be paid at 100 percent, and all other surgical procedure(s) or E/M visit(s) would be paid at 50 percent. For example, a patient receives an O/O E/M visit using CPT code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using total time on the date of the encounter for code section, 10 minutes must be met or exceeded.) at a dermatologist's office, and then has two skin lesions removed, one using CPT code 11300 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms, or legs; lesion diameter 0.5cm or less) and one using CPT code 11301 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.6 to 1.0 cm). Using 2026 RVU values, the total non-facility (NF) RVU of CPT code 99212 is 1.78, the total NF RVU of CPT code 11300 is 2.89, and the total NF RVU of CPT code 11301 is 3.48. Since CPT code 11301 is the highest paid service, CPT code 11301 will be paid at 100 percent (total RVU of 3.48), and CPT code 11300 and the payment for CPT code 99212 will both be reduced by 50 percent, CPT code 11300 down to 1.445 RVUs and CPT code 99212 down to 0.89 RVUs. The 50 percent value aligns with our previous proposal from CY 2019 PFS proposed rule (83 FR 35840 through 35841) and matches the longstanding surgical MPPR discussed previously in this section. We welcome comments on [[Page 43909]] the value of this adjustment, including whether it would be more appropriate to match a different MPPR value, such as 25 percent. While we are proposing to apply this policy only to O/O E/M visits, we are seeking comments on whether it should also apply to other E/M visits, such as inpatient E/M visits. We reiterate that we do not find it appropriate to schedule medical services for patients to maximize payment, which would create undue burden and potential medical risk for beneficiaries. We have a number of data analysis tools to monitor for potentially problematic utilization patterns which may be useful in future, if necessary, for monitoring for this practice, including distinct claims editing to identify problematic utilization patterns, comparative billing reports to identify to providers their outlier status, and medical review capabilities to determine if the patterns are problematic and indicative of waste or abuse. We are also seeking comment on whether or not it is necessary to revise the conditions of payment to mitigate such payment abuses. (c) Intravitreal Eye Injections We are also seeking comment on how this policy might apply to an E/ M visit reported on the same day as intravitreal eye injection, such as CPT code 67028, a high volume 000-day global code. In recent years, since new injected medications were developed to treat retinal diseases, there has been new focus from auditors (such as the OIG), MACs, professional eye associations and the AMA, to better understand the standard of care for patients receiving these treatments, in terms of when same-day eye examinations are clinically indicated and separately identifiable from the injection procedure, for the injected eye or the fellow eye. We have heard that patients with retinal diseases require examination every one to three months based on their treatment response, and importantly, both eyes are examined at each visit because of the high incidence of bilateral (though often asynchronous) involvement. The associations have written to CMS outside of the rulemaking process, indicating that around 50 percent of the time, a separately reported E/M visit on the same day to examine the eye(s) may be prompted or required by the symptom or condition for which the injection is being provided. The fellow eye could require examination if the patient reports symptoms in that eye when they present for an injection, and same-day exams determine if the type of medication is appropriate and the length of time between injections can be extended. To help us ensure accurate payment, we are seeking to better understand the clinical circumstances involved, and any overlap with resources already accounted for in valuation of the global procedure, such as for (1) established patients without symptoms in the fellow eye; (2) established patients with symptoms in the fellow eye, whether prior or newly reported upon presenting for their injection; (3) new patients; (4) does it vary according to diagnosis and exam findings; (5) are injections in the fellow eye always deferred to another day; and (6) how CMS might be able to confirm or ensure that the visit being reported is significant and separately identifiable absent medical record review, for example, should we expect to see a new or different diagnosis code on the claim. We are also seeking to better understand whether the E/M work associated with new patients is typically included in valuation of the minor procedures, or whether there is extra work for new patients that is significant and separately identifiable enough to always warrant separate payment. (59) Revisions To Teaching Physician Policy Related to the Primary Care Exception (a) Background As a general matter, E/M visit codes under the PFS can only be reported when the care is personally provided by a qualified practitioner. Currently, under the primary care exception described at Sec. 415.174, in the case of certain visit codes of lower and mid- level complexity, Medicare contractors may be able to make PFS payment for a service provided by a resident without the presence of a teaching physician, but in specific outpatient primary care centers and when certain conditions must be met. For example, the teaching physician must direct the care from such proximity as to constitute immediate availability (that is, to effectively provide direct supervision). During the Public Health Emergency (PHE) for the 2019 Novel Coronavirus (COVID-19) pandemic, CMS allowed through an interim final rule (85 FR 19230 through 19292) that all levels of an O/O E/M service provided in specified primary care centers may be provided under supervision of the teaching physician by interactive telecommunications technology (85 FR 19259). At the conclusion of the PHE this flexibility expired, such that only lower and mid-level complexity visits (as specified by CMS in program instructions) could be provided without the presence of a teaching physician under the terms specified in Sec. 415.174. Additionally, in the CY 2020 PFS final rule (84 FR 62851 through 62854), E/M visits were revised to allow visits to be based on time and medical decision making. According to our claims data, we note that the most commonly billed O/O E/M visit level is now a moderate level visit (level 4), whereas in the past, a mid-level (level 3) visit was most common. (b) Revisions to Current Policy We have received multiple requests from interested parties requesting us to allow residents to perform moderate and high (level 4 and 5) E/M visits under the supervision of the teaching physician and to defer to the clinical judgment of that graduate medical education (GME) program as to whether or not these high level visits may be performed without the presence of the teaching physician. After consideration and evaluation of interested parties' requests, we are proposing that all levels of an O/O E/M service provided in primary care centers, and meeting the requirements in Sec. 415.174, may be provided under direct supervision of the teaching physician in such cases where the teaching physician believes such care is clinically appropriate and without the presence of a teaching physician. Specifically, we are proposing modifications to the requirements at Sec. 415.174 Exception: Evaluation and management services furnished in certain centers, to expand coverage of services for teaching physicians as part of a graduate medical education (GME) program. We are proposing to modify the requirements for certain E/M codes to allow physician fee schedule payment for a service furnished by a resident provided under direct supervision. We are proposing to modify paragraph (a) to state that certain evaluation and management codes (as specified by CMS in program instructions), may be paid by the physician fee schedule and are thus proposing to remove the language ``of lower and mid-level complexity'' to potentially allow for certain moderate and higher-level evaluation and management codes to be billed if the visit meets all the criteria in Sec. 415.174. We are proposing Sec. 415.174 (a) to read as follows: ``In the case of certain evaluation and management codes (as specified by CMS in program instructions), Medicare Administrative Contractors (MACs) may make physician fee schedule payment for a service furnished by a resident without the presence of a teaching physician. [[Page 43910]] For the exception to apply, all of the following conditions must be met.'' We believe this proposal would provide some autonomy to residents as well as the teaching physician if the specific GME program would support it. We considered that some visits may take more time in the beginning since residents are still learning and we will continue to monitor the visit levels over time. We welcome comments on this proposal. (60) Bundled Payments Under the PFS for Substance Use Disorders (HCPCS Codes G2086, G2087, and G2088) In the CY 2020 PFS final rule (84 FR 62673), we finalized the creation of new coding and payment describing a bundled episode of care for the treatment of Opioid Use Disorder (OUD). Then, in the CY 2021 PFS final rule, we finalized a revision to the code descriptors for HCPCS codes G2086, G2087, and G2088 by replacing ``opioid use disorder'' with ``a substance use disorder'' in response to requests to expand these bundled payments to be inclusive of other substance use disorders (SUDs), not just OUD, stating we agreed that doing so could expand access to needed care. The codes are: HCPCS code G2086: Office-based treatment for a substance use disorder, including development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month. HCPCS code G2087: Office-based treatment for a substance use disorder, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month. HCPCS code G2088: Office-based treatment for a substance use disorder, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (List separately in addition to code for primary procedure). Interested parties have pointed out disparities in payment for HCPCS codes G2086 through G2088 compared to payment for similar services under the Medicare Opioid Treatment Program (OTP) benefit. They state that both OTPs and non-OTP outpatient addiction treatment settings can provide American Society of Addiction Medicine ASAM Level 1.7's suite of services that include medically managed outpatient treatment services, including evaluation and management of intoxication, withdrawal, biomedical concerns, and common low complexity psychiatric concerns. They state that the only clinical difference between these places of service at ASAM Level 1.7 is that OTPs can provide methadone for the treatment of OUD, and the other cannot due to Federal regulations. OTPs are also governed by extensive Federal and State regulations, unlike office-based practices which are not federally regulated settings but may be subject to extensive State regulations. They note that since the time these codes were created, there is now a new Level 1.0 that describes remission monitoring services or services to patients in stable remission, similar to services described by outpatient E/M codes. The new Level 1.5 provides outpatient counseling and psychotherapeutic services, appropriate for patients with mild SUDs and those in early remission, and a new Level 1.7 that describes medically-managed outpatient treatment, including withdrawal management. They state that the services described by HCPCS codes G2086-G2088 align with Level 1.5, but that there is no existing coding under the PFS to describe level 1.7. We welcome additional information on this topic, including whether we should consider updates to the rates for HCPCS codes G2086 through G2088, and/or whether additional coding is needed to describe the ASAM 1.7 level of care. (61) Software as a Medical Service (SaMS) Laboratory Analyses In recent years, there have been rapid developments in the use of software-based technologies with novel functionalities, including artificial intelligence, to support clinical decision-making in the outpatient and physician office settings. New clinical software, which includes clinical decision support software, clinical risk modeling, and computer aided detection (CAD), is becoming increasingly available to practitioners. These technologies often perform data analysis of diagnostic images from patients, relying on complex algorithms or statistical predictive modeling to aid in the diagnosis or treatment planning of a patient's condition. In previous rulemaking, we have referred to these algorithm-driven services that assist practitioners in making clinical assessments or diagnoses as Software as a Service (SaaS). Some of the software functions that are used in these services are FDA-regulated medical devices. Unlike prescription digital therapeutics (PDTs), for example PDTs that provide cognitive behavioral therapy to treat substance disorders or chronic insomnia, SaaS technologies do not currently treat illnesses or patient injuries. SaaS is also separate from remote patient monitoring (RPM) and remote therapeutic monitoring (RTM), which are digital healthcare tools for tracking patient data outside traditional office settings (90 FR 49394). For CY 2027, we propose a change in terminology. We now understand that in other industries, the existing SaaS terminology is used for general cloud-based computing service models outside of a health care context, which may cause confusion as we are using it to describe specific services that provide a medical function for purposes of PFS Medicare payment policy. To dispel any ambiguity and clarify that distinction, we propose to change our terminology from SaaS to Software as a Medical Service (SaMS) to refer to software-based technologies that support clinical decision making through algorithmic analysis, including those that provide clinical or diagnostic functionality. We welcome public comments on the proposed change in terminology. For further discussion of this terminology and other OPPS SaMS proposals, please see the CY 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (91 FR 41918). In recent years, we have seen an increase in laboratory tests that combine laboratory analyses, such as genomic sequencing or immunoassays, with computer algorithms to produce a clinical test result. The AMA CPT Editorial Panel created a category called Multi- Analyte Assays with Algorithmic Analysis, to categorize test codes that combined laboratory analyses with computer algorithms to generate clinical information. More recently, however, we are seeing the development of distinct algorithmic analyses alone. For example, when the genomic sequencing of an individual is performed, this sequencing will likely only need to be performed once. However, once the genomic sequence has been generated, the subsequent algorithmic analyses of that sequence data can be performed an infinite number of times to produce a wide range of results and/or diagnostic or risk-related information. These secondary analyses of original genomic sequences can be proprietary and unique to a single laboratory but could also be conducted at a range of settings. For purposes of this proposal, we are referring to subsequent stand-alone algorithmic analyses that are separate from a CLIA certified laboratory's examination of human material, as defined by 42 CFR 493.2, as ``SaMS laboratory analyses performed on laboratory tests''. [[Page 43911]] Currently, certain SaMS analyses performed on laboratory tests are treated as clinical diagnostic laboratory tests (CDLTs) and paid under the Clinical Laboratory Fee Schedule (CLFS). Section 1861(s) of the Act specifies items and services included as ``medical and other health services'' under Part B, including diagnostic X-ray tests, diagnostic laboratory tests, and other diagnostic tests as described in section 1861(s)(3) of the Act. Section 1861(s)(17) of the Act states that no diagnostic tests performed in any laboratory shall be included within paragraph (3) unless such laboratory meets CLIA certification requirements under section 353 of the Public Health Service Act, among other requirements. Sections 1833(h) and 1834A of the Act and the implementing regulations at 42 CFR part 414, subpart G, set forth the CLFS ratesetting methodologies for CDLTs. We do not believe it is appropriate to consider these secondary algorithmic analyses to be CDLTs or establish CLFS payment rates for these analyses because these secondary algorithmic analyses do not require laboratory services or entities, regulated by CLIA, to perform them. Referring to the example above, while an individual's genomic sequence must be performed by a CLIA certified laboratory entity to allow for Medicare payment under the CLFS, the subsequent algorithmic analyses of the sequence data as part of the SaMS analyses performed on laboratory tests can be performed by any non-regulated entity with the computer software needed to perform the analyses. Our position is that the secondary analyses are ``other diagnostic tests'' under section 1861(s)(3) of the Act as opposed to ``diagnostic laboratory tests.'' As noted previously, Medicare will not pay for CDLTs on the CLFS unless they are furnished by laboratories that meet applicable CLIA certification requirements. Tests that examine materials derived from the human body are assigned to and paid under the CLFS only when furnished by such certified laboratories, in accordance with 42 CFR 410.32(d). Because SaMS analyses performed on laboratory tests are downstream evaluations of the data generated by a prior laboratory test, an entity that performs only algorithmic analyses of previously sequenced data may not qualify as a CLFS laboratory under 42 CFR 493.2 or require CLIA certification. We believe SaMS that evaluate data generated by a prior laboratory test should not be treated as CDLTs for Medicare payment purposes. We are also concerned that paying for these analyses based on existing CLFS payment methodologies may create significant vulnerabilities for the Medicare program, due to the lack of data transparency and CDLTs not being subject to beneficiary cost-sharing or budget neutrality. Section 414.508 outlines the ratesetting methodologies CMS uses to set payment rates for new tests on the CLFS. Under Sec. 414.508(b), CMS determines the payment amount based on either crosswalking or gapfilling methodologies until applicable information is available to establish a payment amount under the methodology described in Sec. 414.507(b). Crosswalking is used if it is determined that a new CDLT is comparable to an existing test, multiple existing test codes, or a portion of an existing test code. Gapfilling is used when no comparable existing CDLT is available. Public consultation for payment for new clinical diagnostic laboratory tests is required in determining payment amounts, receiving public comments and recommendations (and data on which the recommendations are based) as well as recommendations from the Advisory Panel on CDLTs per 42 CFR 414.506. A significant challenge to the ratesetting process for CMS is the lack of transparent data received from laboratories outlining resource costs of a test, particularly for the algorithmic portions of tests that are combined with other analytes. In the past, laboratories have explained to CMS that the algorithmic components of laboratory tests are highly proprietary and details cannot be shared. Thus, we have worked with the limited information available on the details of methods or resources for the algorithmic portions of tests or analyses and has thus far relied on the other laboratory methods provided in the CPT descriptor (i.e., NGS sequencing, RT-PCR, or DNA methylation analysis). As we have gathered more information on SaMS analyses performed on laboratory tests, we now believe that since these analyses are entirely computer-based, comparison based on laboratory methodologies is not appropriate. Additionally, in contrast to the PFS, the CLFS generally does not include beneficiary cost-sharing or budget neutrality adjustments, which limits transparency regarding pricing and creates challenges for ensuring appropriate valuation of these services. Finally, CMS has an interest in ensuring that services that are fundamentally similar are paid for and treated in the same way, regardless of the setting of care in which the service is furnished. Since SaMS analyses performed on laboratory tests do not require performance by a CLIA-certified laboratory and perform algorithmic analyses on previously generated data, we believe SaMS analyses performed on laboratory tests are substantively similar to other SaMS technologies that are currently paid under the PFS. Accordingly, we believe that whether the SaMS performs algorithmic analyses of an imaging test (e.g., CT scan) or whether it performs an algorithmic analysis on data generated from a laboratory test, all algorithmic analyses should be treated consistently with other comparable SaMS analyses and belong within the broader proposed framework for SaMS. We believe that this approach for SaMS technologies would promote stability and predictability in payment for similar services. Therefore, for CY 2027, we are proposing to contractor price ten HCPCS codes describing various SaMS analysis performed on laboratory tests under the PFS. Table A-D8 shows the list of currently payable SaMS analysis performed on laboratory tests under the CLFS that we are proposing to contractor price under the PFS. These ten HCPCS codes were identified by the CPT descriptor for the code. If there were no laboratory methods included in the code descriptor, and only a computer analysis was described, we identified the code as a SaMS analysis performed on laboratory tests. We refer to the 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (91 FR 41918) for discussion of payment for these services under the OPPS, where we are proposing to assign the same SaMS analysis performed on laboratory tests to new technology APCs. We would appreciate public comment on any other SaMS analysis performed on laboratory tests that should be removed from the CLFS and contractor priced under the PFS. We are seeking comment more broadly on other approaches to payment for these services, including, but not limited to, a direct crosswalk to the proposed OPPS new technology APC dollar amounts for all proposed analyses, a subset of these analyses, or specific analyses as opposed to contractor pricing. In addition, for CY 2027 and subsequent years, we propose to assign any new codes that describe SaMS analysis performed on laboratory testto contractor pricing for payment under the PFS. We request public comment on these proposals, including the list of ten HCPCS codes that we identified as [[Page 43912]] SaMS analysis performed on laboratory tests, as well as any additional HCPCS codes that we should designate as SaMS analysis performed on laboratory tests and pay under the PFS rather than as CDLTS paid on the CLFS. We may finalize a policy that includes such payment for additional HCPCS codes in the PFS final rule based on public comment. [GRAPHIC] [TIFF OMITTED] TP16JY26.026 (62) Caregiver Training Services (CTS) In the CY 2025 PFS final rule (89 FR 97817 through 97821), we finalized new G-codes and payment for direct care CTS: HCPCS codes G0541 (Caregiver training in direct care strategies and techniques to support care for patients with an ongoing condition or illness and to reduce complications (including, but not limited to, techniques to prevent decubitus ulcer formation, wound care, and infection control) (without the patient present), face-to-face; initial 30 minutes), G0542 (Caregiver training in direct care strategies and techniques to support care for patients with an ongoing condition or illness and to reduce complications (including, but not limited to, techniques to prevent decubitus ulcer formation, wound care, and infection control) (without the patient present), face-to-face; each additional 15 minutes (list separately in addition to code for primary service) (use g0542 in conjunction with g0541)), and G0543 (Group caregiver training in direct care strategies and techniques to support care for patients with an ongoing condition or illness and to reduce complications (including, but not limited to, techniques to prevent decubitus ulcer formation, wound care, and infection control) (without the patient present), face- to-face with multiple sets of caregivers). We are seeking comment on whether the resource costs associated with these services are best reflected through this existing coding or whether these resources costs are reflected in the valuation of other codes paid under the PFS, such as E/M visits. (63) Comment Solicitation on Payment for Physician-Patient Clinical Trial Discussions Despite the U.S. investing over $50 billion annually in biomedical research, fewer than 7 percent of adult cancer patients enroll in clinical trials.\49\ A central and modifiable reason is that physicians rarely initiate conversations about clinical trials with their patients. For example, national survey data show that 70 percent of oncologists discuss trials with less than a quarter of their patients,\50\ yet more than 50 percent of eligible patients enroll when actively offered a clinical trial.\51\ --------------------------------------------------------------------------- \49\ Unger JM, Shulman LN, Facktor MA, Helson H, Fleury ME. National estimates of the participation of patients with cancer in clinical research studies based on commission on cancer accreditation data. J Clin Oncol. 2024;42:2139-2148. \50\ Lee SJC, Murphy CC, Gerber DE, et al. Reimbursement matters: overcoming barriers to clinical trial accrual. Med Care. 2021;59(5):461-466. PMC8026490. \51\ Unger JM, Vaidya R, Hershman DL, Minasian LM, Fleury ME. Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst. 2019;111(3):245-255. --------------------------------------------------------------------------- Time and administrative burden are documented as the top barrier to conversations between physician and [[Page 43913]] patients about participation in clinical trials in virtually every survey.\52\ The current valuation of existing visit codes does not account for the additional time and resource costs associated with the structured physician counseling regarding clinical trial eligibility, options, risks and benefits associated with counseling a beneficiary on whether to enroll in a clinical trial. --------------------------------------------------------------------------- \52\ Kumar A, Bhatt DL, Fonarow GC, et al. Barriers for cancer clinical trial enrollment: a qualitative study of the perspectives of healthcare providers. Contemp Clin Trials Commun. 2022;28:100939. PMC9189774. --------------------------------------------------------------------------- We are therefore seeking comment on whether we should effectuate payment for these resource costs through the creation of a HCPCS G-code describing a minimum of 20 minutes of physician or other QHP time spent on clinical trial counseling. We are seeking comment on accurate valuation for this service, including inputs for work and practice expense, and whether the service should be available as a Medicare telehealth service. Interested parties suggested a work RVU value between 1.00 and 1.50 RVUs would accurately account for the physician work associated with this service. We are also seeking comment on what documentation requirements we might consider for such a service, such as the trial(s) discussed and the patient's decision. BILLING CODE 4169-69-P [GRAPHIC] [TIFF OMITTED] TP16JY26.027 [[Page 43914]] [GRAPHIC] [TIFF OMITTED] TP16JY26.028 [[Page 43915]] [GRAPHIC] [TIFF OMITTED] TP16JY26.029 [[Page 43916]] [GRAPHIC] [TIFF OMITTED] TP16JY26.030 [[Page 43917]] [GRAPHIC] [TIFF OMITTED] TP16JY26.031 [[Page 43918]] [GRAPHIC] [TIFF OMITTED] TP16JY26.032 [[Page 43919]] [GRAPHIC] [TIFF OMITTED] TP16JY26.033 [[Page 43920]] [GRAPHIC] [TIFF OMITTED] TP16JY26.034 [[Page 43921]] [GRAPHIC] [TIFF OMITTED] TP16JY26.035 [GRAPHIC] [TIFF OMITTED] TP16JY26.036 [[Page 43922]] [GRAPHIC] [TIFF OMITTED] TP16JY26.037 [[Page 43923]] [GRAPHIC] [TIFF OMITTED] TP16JY26.038 [[Page 43924]] [GRAPHIC] [TIFF OMITTED] TP16JY26.039 [GRAPHIC] [TIFF OMITTED] TP16JY26.040 [[Page 43925]] [GRAPHIC] [TIFF OMITTED] TP16JY26.041 [[Page 43926]] [GRAPHIC] [TIFF OMITTED] TP16JY26.042 [[Page 43927]] [GRAPHIC] [TIFF OMITTED] TP16JY26.043 [[Page 43928]] [GRAPHIC] [TIFF OMITTED] TP16JY26.044 [[Page 43929]] [GRAPHIC] [TIFF OMITTED] TP16JY26.045 BILLING CODE 4169-69-C

4. Potentially Misvalued Services Under the PFS

a. Background Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the relative value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes (PMVC) under the PFS, using the same criteria used to identify PMVC, and to make appropriate adjustments. As outlined in section II.D. of the proposed rule, under Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association (AMA)/Specialty Society Relative Value Scale (RVS) Update Committee (referred to as the RUC), MedPAC, and other interested parties. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by- code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision- making process as authorized by statute. We may also consider analyses of work time, work RVUs, or direct practice expense (PE) inputs using other data sources, such as the Veterans Health Administration (VHA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recent available data, we assessed the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other interested parties such as from the general medical-related community and the public. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs. In its March 2006 Report to the Congress (https://www.medpac.gov/document/report-to-the-congress-2006-medicare-payment-policy/), MedPAC discussed the importance of appropriately valuing physicians' services, stating that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, ``When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.'' We believe services can also become overvalued when PE costs decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases, or PE costs rise. [[Page 43930]] As MedPAC noted in its March 2009 Report to Congress (https://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories: Codes that have experienced the fastest growth. Codes that have experienced substantial changes in PE. Codes that describe new technologies or services within an appropriate time-period (such as 3 years) after the relative values are initially established for such codes. Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service. Codes with low relative values, particularly those that are often billed multiple times for a single treatment. Codes that have not been subject to review since implementation of the fee schedule. Codes that account for the majority of spending under the PFS. Codes for services that have experienced a substantial change in the hospital length of stay or procedure time. Codes for which there may be a change in the typical site of service since the code was last valued. Codes for which there is a significant difference in payment for the same service between different sites of service. Codes for which there may be anomalies in relative values within a family of codes. Codes for services where there may be efficiencies when a service is furnished at the same time as other services. Codes with high intraservice work per unit of time. Codes with high PE RVUs. Codes with high-cost supplies. Codes as determined appropriate by the Secretary. Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using current processes for consideration of coding changes), which may involve consolidating individual services into bundled codes for payment under the PFS. b. CY 2027 Identification and Review of Potentially Misvalued Services In the CY 2012 PFS final rule with comment period (76 FR 73058 through 73059), we finalized a process for the public to nominate PMVC. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and interested parties may nominate PMVC for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of PMVC may include the following: Documentation in peer reviewed medical literature or other reliable data that demonstrate changes in physician work due to one or more of the following: technique, knowledge and technology, patient population, site-of-service, length of hospital stay and work time. An anomalous relationship between the code being proposed for review and other codes. Evidence that technology has changed physician work. Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases. Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation. Prices for certain high-cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information. Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data). National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations. We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be PMVC appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a PMVC. The public has the opportunity to comment on these and all other proposed PMVC. In each year's final rule, we finalize our list of PMVC. In each proposed rule, we seek nominations from the public and from interested parties of codes that they believe we should consider as potentially misvalued. We receive public nominations for PMVC by February 10th and we display these nominations on our public website (https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices), where we include the submitter's name, their associated organization and the submitted studies for full transparency. We sometimes receive submissions for specific PE-related inputs for codes, and discuss these PE-related submissions, as necessary under the Determination of PE RVUs section of the rule. We summarize later in this section this year's submissions under the PMVC initiative. For CY 2027, we received 15 requests concerning various codes as PMVC. The nominations are as follows: (1) Nasal Sinus Irrigation (CPT Codes 31000 and 31002) We received a request from one nominator to review nasal sinus irrigation codes, CPT 31000 (Lavage by cannulation; maxillary sinus (antrum puncture or natural ostium)), and CPT 31002 (Lavage by cannulation; sphenoid sinus), as potentially misvalued. We reviewed this code family for the CY 2026 PFS final rule and our extensive discussion and rationale for finalizing the current values can be found at 90 FR 49310 through 49311. We appreciate the information we received from the nominator. However, we note the information was the same as last year's submission. Additionally, the aforementioned CY 2026 PFS final rule specifically mentions for nasal sinus irrigation that interested parties were encouraged to submit relevant [[Page 43931]] documentation, such as invoices or other evidence that demonstrates the typical resource costs for providing these services (90 FR 49311). However, we did not receive any invoices from the nominator. In consideration of the information provided in this potentially misvalued nomination request as well as our previous valuation review and decision stated in the CY 2026 PFS final rule, we are seeking comments on the typicality and usage of the nasal sinus irrigation codes, CPT codes 31000 and 31002. (2) Urethral Bulking Material (CPT Code 51715) We received a request from a nominator to review CPT code 51715 (Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck) as potentially misvalued. The nominator stated that CPT code 51715 currently does not include a supply for the implant material necessary to properly perform CPT code 51715 in the office setting, which is a clinically desired place of service for this treatment. The nominator requested that CMS create a supply code for a urethral bulking agent sold in 2 mL vials, with a non-facility quantity of 1 priced at an average of $1,175 and incorporate this new supply into CPT code 51715 to appropriately value the service in the non-facility setting. We appreciate the nominator submitting invoices regarding the pricing of this urethral bulking agent. Given the information provided by the nominator as well as factoring in the amount of time that has passed since CPT code 51715 was last formally reviewed in the 1990s, we are proposing to create a new supply code (SD396) for this urethral bulking agent. The SD396 supply is based on a 2 mL vial which we are proposing to price at the requested $1,175 based on an average of the submitted invoices. We are proposing to add 1 quantity of this supply to CPT code 51715 in the non-facility setting to reflect current clinical practice. Given the cost of this supply and the length of time since last review, we are also seeking comment on whether CPT code 51715 should be referred to the RUC for review. (3) Complex Cystometrogram (CPT Codes 51728 and 51729) We received a request from a nominator to review CPT code 51728 (Complex cystometrogram (i.e., calibrated electronic equipment); with voiding pressure studies (ie, bladder voiding pressure), any technique) and CPT code 51729 (Complex cystometrogram (i.e., calibrated electronic equipment); with voiding pressure studies (ie, bladder voiding pressure) and urethral pressure profile studies (ie, urethral closure pressure profile), any technique). The nominator submitted invoices to request a pricing increase in the supply codes SD017 (catheter balloon), SD027 (catheter pressure), and SD131 (tubing pressure) for CPT codes 51728 and 51729. The invoices submitted from the requestor are dated from January 2025 to October 2025 and the nominator specifically is requesting an increase in the price of the SD017 supply from $35.89 to $74.00, an increase in the price of the SD027 supply from $19.35 to $86.80, and an increase in the price of the SD131 supply from $2.90 to $25.48. We appreciate the information submitted from the nominator and note we previously reviewed these supply codes in the CY 2026 PFS final rule and stated, ``Given the differences between the names of the items in question, and the significant increases in requested pricing, we proposed not to update the pricing of these three supplies as we cannot verify that the invoices refer to the same supply items.'' (90 FR 49279) Taking into consideration the invoice for the SD017 supply listed a ``Abdominal Sensor Catheter'', the invoice for the SD027 supply listed a ``Single Sensor Catheter'', and the invoice for the SD131 supply listed a ``Tubing, Pump, Infusion Line'' our rationale that we cannot verify the names of items in question remains the same. Therefore, based on a lack of additional information submitted to explain the differences in names of the supply codes in question, we are not proposing to update the pricing of these three supplies as we are still unable to verify that these invoices refer to the same supply items. (4) Carpal Tunnel Release Procedure (CPT Code 64728) We received a request from one nominator to review CPT code 64728 (Decompression; median nerve at the carpal tunnel, percutaneous, with intracarpal tunnel balloon dilation, including ultrasound guidance) as potentially misvalued. The nominator stated that this code is misvalued due to the following reasons: (1) the anomalous relationship between the valuation for CPT code 64728 and other CPT codes for carpal tunnel release procedures; (2) Incorrect assumptions were made based on the previous valuation of the service, including a misleading survey and flawed crosswalk assumptions; and (3) Analysis of work relative value units (RVUs) from reliable data sources support increased valuation. The nominator requested an increase in work RVUs to appropriately reflect the intensive work associated with this procedure. This code family was reviewed in the CY 2026 PFS final rule and our extensive discussion for finalizing a work RVU of 2.70 can be found in 90 FR 49374 through 49376. We previously addressed the concerns of the nominator in this preamble and we have received no new data for CY 2027 which would support a higher valuation for CPT code 64728. Based on the lack of new information submitted for CY 2027, we do not believe this code to be potentially misvalued. We are seeking comment on this issue, including the submission of new information to support the request. (5) Electronic Analysis of Implanted Neurostimulator Pulse Generator/ Transmitter (CPT Codes 95970, 95976, 95977) We received a request from one nominator to review CPT codes 95970 (Electronic analysis of implanted neurostimulator pulse generator/ transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming), 95976 (Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional), and 95977 (Electronic analysis of implanted neurostimulator pulse generator/ transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with [[Page 43932]] complex cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional). The nominator stated they believe this code family is potentially misvalued due to differing valuations relative to the recently reviewed CPT codes 93150 (Therapy activation of implanted phrenic nerve stimulator system, including all interrogation and programming), 93151 (Interrogation and programming (minimum one parameter) of implanted phrenic nerve stimulator system), and 93153 (Interrogation without programming of implanted phrenic nerve stimulator system), despite being clinical similar services. The nominator also believed there were discrepancies in equipment used to perform each procedure as opposed to what is included in the current valuation due to inaccurate assumptions about what clinical specialties most commonly furnish these procedures. To support their requests, the nominator shared 2024 utilization data showing an increase in certain clinical specialties furnishing these services. We appreciate the additional information and are seeking comment on the appropriate valuation of this code family as well as any additional information on the typical specialty and resource costs associated with furnishing these procedures. (6) Scalp Cooling (CPT Code 97007, 97008, 97009) We received a request from one nominator to review the mechanical scalp cooling family of services described by CPT codes 97007 (mechanical Scalp cooling, including individual cap supply with head measurement, fitting, and patient education), 97008 (mechanical scalp cooling; including hair preparation, individual cap placement, therapy initiation, and pre-cooling period), and 97009 (mechanical scalp cooling; each 30 minutes), as potentially misvalued. We reviewed this code family for the CY 2026 PFS final rule and our extensive discussion and rationale for finalizing the current values can be found at 90 FR 49405 through 49406. The nominator stated that they believe this code family may be potentially misvalued based on newly available empirical evidence (a Time and Motion Study) that demonstrates incorrect assumptions were made during our prior valuation decision for the CY 2026 PFS final rule. They reference in their nomination that the August 2024 Time and Motion Study demonstrated that the clinical staff and PE inputs required to furnish this service are materially greater than those reflected in the current valuation and were not made available to CMS prior to our valuation review and decision for CY 2026. Specifically, the nominator recommended an increase in PE clinical staff time to 103 minutes for CPT code 97007, 52 minutes for 97008, and 23 minutes for 97009. We appreciate the information we received from the nominator. However, we disagree with their assertion that CMS did not have the results of the August 2024 Time and Motion Study when making our valuation decision for CY 2026. The aforementioned CY 2026 PFS final rule discussion outlines the information considered for the valuation decision and specifically mentions the August 2024 Time and Motion Study results as well as the public comments received for the CY 2026 PFS proposed rule, which reflect the requested increase in PE clinical staff time. We assure the nominators and readers of this discussion that all the information provided in this potentially misvalued nomination request was considered when making our previous valuation review and decision for CY 2026. Accordingly, we disagree with the assertion that this family is misvalued. However, we are seeking comment, particularly updated information that could support a change in valuation for these services. (7) Hyperbaric Oxygen Under Pressure (HCPCS Code G0277) The RUC has requested the deletion of HCPCS code G0277 (Hyperbaric oxygen under pressure, full body chamber, per 30-minute interval), and recommended that CPT code 99183 be revised to be time-based as well to appropriately describe the treatment delivery, attendance and supervision. The RUC concluded that maintaining a separate G-code creates unnecessary coding complexity without adding clinical or administrative value and that one clear and consistent coding structure should exist for this service. In 2015, CMS created HCPCS code G0277 to describe direct practice expense inputs associated with CPT code 99183 (Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session). We noted that under the Outpatient Prospective Payment System (OPPS), the treatment used to be reported using separate treatment code C1300 (Hyperbaric oxygen under pressure, full body chamber, per 30-minute interval.) Therefore, we created HCPCS code G0277 to report the treatment delivery and to maintain consistency with the OPPS coding and PFS payment systems. HCPCS code G0277 was identified as a high-volume growth code that has Medicare utilization of 10,000 or more. High utilization of this magnitude reflects that the code has been broadly adopted across multiple care settings and underscores its operational importance within the Medicare program. Deleting or replacing a high-volume code without an equivalent can disrupt billing practices, create reporting gaps, and impose unnecessary administrative burden on providers who have integrated it into their standard practice. As such, we believe there is a reason to continue to maintain the use of the G-code for hyperbaric oxygen therapy since HCPCS code G0277 is utilized in multiple Medicare payment systems to report the time the patient uses the hyperbaric oxygen therapy. Accordingly, we are proposing to maintain HCPCS code G0277. (8) Image-Guided Robotic Linear Accelerator Stereotactic Radiosurgery (HCPCS Code G0339 and G0340) Image-guided robotic linear accelerator-based stereotactic radiosurgery services are currently reported by and paid for using HCPCS G-codes established the in CY 2007 PFS final rule HCPCS codes G0339 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment) and G0340 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment). In April 2025, the RAW identified HCPCS code G0340 with 2023 Medicare utilization over 10,000 and Medicare status of ``C'' contractor priced. The Workgroup requested an action plan for G0340 for September 2025. In September 2025, the Workgroup reviewed the action plan and recommended that the RUC request that CMS delete G0339 and G0340 having identified a CPT code 77373 (Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions) that is available to report in lieu of G0339 and G0340. A review of Medicare claims data shows that HCPCS codes G0339 and G0340 are billed frequently. HCPCS code G0339 was billed approximately 3,000 times and HCPCS code G0340 12,000 times in 2024 respectively. As [[Page 43933]] such, we believe there is a reason to maintain the G codes for image- guided robotic linear accelerator-based stereotactic radiosurgery services since both sets of codes are billed so frequently, and we do not want to cause disruption in billing practice. Since the RUC plans on reviewing these codes during its September 2026 meeting if the codes are not deleted for CY 2027, we welcome the RUC's additional information regarding appropriate coding and payment for these services. (9) Request for Revaluation of Physician Work Time Based on Empiric Data (CPT Codes 15734, 19318,19380, 23472, 27130, 27447, 37227, 37229, 43281, 43644, 47120, 88305, 88307) An interested party nominated 13 CPT codes as potentially misvalued. These codes are listed in Table A-D14. [GRAPHIC] [TIFF OMITTED] TP16JY26.046 The nominator provided evidence that current physician work time values in the PFS do not accurately reflect real-world clinical practice for 13 CPT codes across five code families. Their methodology focused on codes involving large discrepancies between empirically derived intraservice estimates and intraservice times assigned in the PFS. The nominator did not assert that their research provided confirmatory evidence for every intraservice time discrepancy, which is why their analysis focused on coding families related to the 13 CPT codes listed previously (Table A-D14). They provided additional details on their findings related to the 13 CPT codes and other codes included in their coding families in this section. Using the 2023 Maryland All-Payer Claims Database (MD-APCD), the nominator's analysis indicates that some of these codes are likely to be overvalued. In their nomination, their analysis reveals that the 88305 (Level IV Tissue Exam by Pathologist) code had the highest number of provider days with intraservice time exceeding an 8-hour workday, with more than 1,763 days, which was significantly higher than the other 12 CPT codes. There were 587 instances of physicians billing 88305 so many times in a single day that the total intraservice time exceeded 24 hours. For these 1,763 days, when they added up the total time spent on services (including other codes billed in a day, and pre- services times as well), the average time that services were billed for during these days was 2,217 minutes (approximately 37 hours). Additionally, despite the name of the code being ``Tissue Exam by Pathologist,'' they found that gastroenterologists and dermatologists frequently billed this code while exceeding eight hours of work in a single day. According to the nominator, data from a 2016 Urban study \53\ indicated that the median intraservice time for 88305 was only 2 minutes, compared to 25 minutes in the PFS, which is a 1,250 percent difference--larger than any of the empiric differences between NSQIP and the PFS intraservice times. --------------------------------------------------------------------------- \53\ https://www.urban.org/research/publication/collecting-empirical-physician-time-data-piloting-approach-validating-work-relative-value-units. Stephen Zuckerman, Ph.D., Katie Merrell, BA, Robert A. Berenson, MD, Susan Mitchell, RHIA, Divvy Upadhyay, MD, MPH, Rebecca Lewis, MPH, Collecting Empirical Physician Time Data: Piloting an Approach for Validating Work Relative Value Units. https://www.urban.org/sites/default/files/publication/87771/2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-rel.ative-value-units_0.pdf. --------------------------------------------------------------------------- They also reviewed additional codes outside of the Urban study that are in the Level IV tissue exam by pathologist coding family, specifically CPT codes 88302, 88304, 88307, and 88309, to conduct a thorough check. As a result, they found that CPT code 88307 had 40 provider days where the total intraservice time exceeded 8 hours. The nominator suggested that CMS should consider reviewing the physician time for all codes within this family to address the existing PFS intraservice times. In addition, they stated that several codes from the integumentary systems--CPT codes 15734 (Muscle, myocutaneous, or fasciocutaneous flap; trunk), 19318 (Breast reduction), and 19380 (Revision of reconstructed breast (e.g., significant removal of tissue, re- advancement and/or re-inset of flaps in autologous reconstruction or significant capsular revision combined with soft tissue excision in implant-based reconstruction))--are likely overvalued as clinicians spend 34, 90 and 14 days, respectively, performing these services, where the intraservice times of these codes themselves were more than 8 hours. Over these days, clinicians spent [[Page 43934]] an average of 32, 17, and 41 hours when the PFS times for all services they billed on these days were summed (including pre-service times). The RAND study \54\ identified that 21 codes in the integumentary system had PFS intraservice times that were likely too long, and 3 codes had PFS intraservice times that were likely too short. --------------------------------------------------------------------------- \54\ https://www.rand.org/pubs/research_reports/RRA3470-1.html. --------------------------------------------------------------------------- In the musculoskeletal system, they identified specific procedures with extended service times. For CPT codes 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder))), 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft), and 27447 (Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty)), there were 12, 10, and 26 Provider Days, respectively, that exceeded the 8-hour intraservice thresholds. These instances resulted in average total service times of 19, 19, and 21 hours, respectively. The NSQIP RAND study found that 97 musculoskeletal codes had intraservice times that were likely too long, while 14 had intraservice times that were likely too short. According to the nominator, CPT codes 43281 (Laparoscopy, surgical, repair of paraesophageal hernia, includes fundoplasty, when performed; without implantation of mesh), CPT 43644 (Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less)), and CPT 47120 (Hepatectomy, resection of liver; partial lobectomy) were found to have 15, 14, and 10 practitioner days, respectively, where the intraservice time exceeded 8 hours. On these days, the providers recorded average total service times of 25, 33, and 52 hours, respectively. Additionally, the nominator stated that the 2015 NSQIP RAND study identified 86 digestive system codes that were likely too long and 12 codes that were likely too short.\55\ --------------------------------------------------------------------------- \55\ https://www.rand.org/content/dam/rand/pubs/research_reports/RR600/RR662/RAND_RR662.pdf. --------------------------------------------------------------------------- We appreciate the detailed information provided to us by external interested parties and welcome comments from the public regarding any potential actions for CY 2027 or for future rulemaking. We acknowledge the limitations associated with NSQIP data in terms of its applicability to other settings, as it is representative of the hospital setting, however we believe this empirical data may be a better input than limited survey data. Therefore, we are seeking comment on whether we should make these changes for CY 2027, or for future rulemaking, and whether we should consider making corresponding changes to the work RVUs for these services or if changes to the physician time would be sufficient. (10) Request for Reassessment of Assigned RVUs for ``Harvard- Valued'' Codes (CPT Codes 24515, 22216, 22210, 64721, 29824, 20610, and 20680) We received notification from concerned interested parties about the ``Harvard-valued'' codes from 1992 that have not undergone a reassessment of assigned RVUs for over 20 years in some cases (see Table A-D15). We share their concerns about whether the current values for the CPT codes accurately reflect the resource inputs associated with furnishing the services. Because the CPT codes have not been recently reviewed and potentially significant technological changes have occurred during this time, we are proposing these CPT codes as potentially misvalued and requesting that the RUC and other interested parties review these services in terms of appropriate work RVUs, work time assumptions and direct PE inputs. [GRAPHIC] [TIFF OMITTED] TP16JY26.047 (11) Allergy Immunotherapy (CPT Code 95165) In the CY 2001 PFS final rule (65 FR 65393), we discussed the direct PE inputs for CPT code 95165 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses). As in the case of venoms, some non-venom antigens cannot be mixed together, that is, they must be prepared in separate vials. An example of this is mold and pollen. Therefore, some patients will be injected at one time from one vial--containing in one mixture all of the appropriate antigens--while other patients will be injected at one time from more than one vial. We extensively discussed how the practice expense component for mixing a multidose vial of antigens was computed, and how we observed that the most common practice at the time was to prepare a 10 cc vial; we also observed that the most common use was to remove aliquots with a volume of 1 cc. Therefore, a physician's removing 10 1cc aliquot doses captured the entire PE component for the service. Recently we have received interested parties' communication from relevant specialties on the definition of a dose as [[Page 43935]] it pertains to an allergy immunotherapy. They are concerned that clinical practice is not using this method of dosage to treat patients and the definition that Medicare is using is causing general confusion. They note that Medicare's 1cc aliquot dose is now creating reimbursement-driven changes to medical practice, rather than changes that align with clinical practice and is increasingly adopted by commercial payers and Medicaid plans, thereby negatively impacting the delivery of medically necessary and cost-effective patient care to Medicare beneficiaries. According to the specialty societies, when this Medicare policy was implemented, few Medicare beneficiaries received allergy immunotherapy--most practices report that less than 5 percent of patients receiving treatment at that time were Medicare beneficiaries. Today, specialty societies report, Medicare beneficiaries often comprise more than 20 percent of an individual practice's allergy immunotherapy patients. We invite comment from the wider medical community, including analyses or studies, regarding CPT code 95165 and the definition of an allergy immunotherapy dose. In particular, we are interested in how these concepts are interpreted and implemented within clinical practice. Additionally, Medicare utilizes a medically unlikely edit (MUE) of 30 doses per claim to flag potential overutilization. Specialty societies claim a more appropriate policy should use common clinical practice, by having an annual limit on doses of medically necessary treatment. For example, the annual limit of up to 160 doses per year during the first year of therapy would be higher to account for the build-up phase, then reduced to 130 or fewer doses per year thereafter when the beneficiary is receiving maintenance doses. We welcome comments, including research or opinions from the medical community, on appropriate annual dose limits billed for CPT code 95165 based on clinical practice. (12) Ultrasonic Wound Assessment (CPT Code 97610) An interested party nominated CPT code 97610 (Low frequency, non- contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day) as potentially misvalued due to an inflated supply costs direct PE input. The nominator stated that this inflation causes a site of service disparity where CMS pays significantly more for the non- facility practice expense compared to the hospital outpatient (OPPS) payment rate. The CY 2026 non-facility PE RVU of 11.51 for CPT code 97610 results in a payment of $384, compared to an OPPS payment rate of $205, representing a payment differential of $179. The nominator stated that this disparity is primarily driven by the $320 direct PE input, SA119 (kit, low frequency ultrasound wound therapy (MIST)). The nominator provided a hyperlink to the UltraMIST[supreg] system manufacturer's Investor Presentation \56\ from December 2025 which states that ``consumable costs = ~$100/procedure (list price).'' On slide 13 of the presentation, it states that the single use applicators are $100 and that the pricing reflects manufacturer's suggested retail price (MSRP). The nominator also estimated an implied sales price of $86 per disposable kit on average using publicly available manufacturer disclosures and Medicare claims data. The nominator stated that the manufacturer reported $21.0 million in U.S. consumable and parts net revenue for CY 2024. The nominator was able to estimate the total volume of kits sold by the manufacturer by assuming each of the 745 unique billing NPIs in Medicare claims have approximately one of the ~1,000 UltraMist[supreg] systems in the field, such that the 181,851 Medicare claim lines account for 74.5 percent of total volume ($21.0 million/[181,851/{745/1,000{time} ] = $86), noting that actual sales price would vary due to volume-based or other supplier discounts, commercial utilization, and other factors. --------------------------------------------------------------------------- \56\ https://sanuwave.com/investors/presentations. --------------------------------------------------------------------------- We agree with the nominator and are proposing CPT code 97610 as potentially misvalued. Additionally, we are proposing to change the cost of supply code SA119 to $100 in the direct PE database. We seek comment on this proposal and invite interested parties to submit paid invoices for supply code SA119 (kit, low frequency ultrasound wound therapy (MIST)). We also note that physician time may be currently overstated for CPT code 97610, as the December 2025 Investor Presentation asserts that the procedure takes about 3 to 20 minutes, with an average of 6 minutes. The current total physician time is nearly 26 minutes, with a work RVU of 0.39. Because the current intraservice time is over double the time asserted by the supply manufacturer in the Investor Presentation, we are seeking comment on whether the typical physician time to perform this service is closer to the manufacturer's assertion of 6 minutes or the current intraservice time of nearly 15 minutes. (13) Autologous Platelet Rich Plasma (HCPCS Code G0465) We received a request from a nominator to review HCPCS code G0465 (Autologous platelet rich plasma (PRP) or other blood-derived product for diabetic chronic wounds/ulcers, using an FDA-cleared device for this indication, (includes as applicable administration, dressings, phlebotomy, centrifugation or mixing, and all other preparatory procedures, per treatment) as potentially misvalued. The nominator requested that CMS update the work RVUs for HCPCS code G0465 from 1.78 to 5.50 based on the results of an independent survey of physicians and qualified health professionals who have training and experience treating chronic, non-healing diabetic wounds that was performed by a third party in the Fall of 2025. The nominator also requested that CMS update its policy to state that multiple procedure payment adjustments do not apply to HCPCS code G0465. Additionally, in the CY 2025 PFS Final rule, we finalized crosswalking G0465 to CPT code 15275 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area), however, the nominator believes this is not an appropriate crosswalk for G0465. We thank the nominator for submitting the information, including the survey conducted by the third party. However, we note the sample size of the survey shows only 34 respondents and so we have concerns as to whether this is a representative sample size of practitioners furnishing this service. Additionally, we continue to believe that the MPPR payment adjustment is applicable to multiple units of this service billed to the same beneficiary on the same day due to overlapping resource costs. Given that no additional information was submitted to support the increase in work RVU, we are not proposing this code as potentially misvalued.

1. Introduction

Primary care is an essential component of the HHS Secretarial priority to ``Make America Healthy Again'' commonly known as MAHA.\57\ [[Page 43936]] Relatively and accurately valuing primary care appropriately is essential. It is the cornerstone of a high-functioning health care system, helping enable the shift in U.S. health care toward a focus of preventive rather than reactive medicine--for health care rather than ``sick care.'' \58\ Critical to this transition is incentivizing investment in high-value care that reduces health care costs (especially from chronic disease) in the long term. Building off recent HHS rulemaking that established such incentives for commercial health plans,\59\ we are interested in how Original Medicare may similarly be able to incorporate more robust incentives to invest in high-value care, which will reduce costs of care in the long-term within the Physician Fee Schedule (PFS). More specifically, the agency is soliciting comment on how we might reconsider primary care service valuation to better support this objective amidst what may be a meaningful shift in how primary care is delivered given more recent technological innovation. --------------------------------------------------------------------------- \57\ U.S. Department of Health and Human Services. Make America Healthy Again (MAHA). HHS.gov, https://www.hhs.gov/maha/index.html. Accessed 29 Apr. 2026. \58\ Kennedy, R.F., Jr. (2025). Remarks on the U.S. ``sick-care system.'' Fox News interview. https://www.foxnews.com/health/rfk-jr-likely-confirmed-health-secretary-dr-siegel-saysAccessed5/31/26. \59\ ``Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program.'' Federal Register, vol. 91, 2026, p. 29683. U.S. Government, https://www.federalregister.gov/d/2026-10050/p-1540. --------------------------------------------------------------------------- Primary care services delivered in the physician office were the locus for continuous, coordinated, and comprehensive care when the PFS was established in 1992. This definition of primary care as a beneficiary's first point of contact with the health care system \60\ has been increasingly challenged by broader access to medical information through digital resources. This may accelerate as the increasing adoption of technology reshapes access to increasingly sophisticated sources of medical information before beneficiaries ever show up in the doctor's office.\61\ Advances in technology, including generative and agentic artificial intelligence (AI), are poised to transform both beneficiary experience \62\ and the role of the primary care clinicians.\63\ These were not anticipated when defining the relative value units and time and intensity of services delivered by physicians, which are essential inputs to the PFS.\64\ --------------------------------------------------------------------------- \60\ O'Connor, S.M. ``Citing Primary Care.'' British Journal of General Practice, vol. 61, no. 586, 2011, pp. 361-362. https://pmc.ncbi.nlm.nih.gov/articles/PMC3133574. \61\ Rastogi, Namrata. ``Healthcare's New Frontier: The Digital Front Door.'' BMJ Innovations, vol. 8, no. 2, 2022, https://doi.org/10.1136/bmjinnov-2021-000874. \62\ Yang, Betsy, et al. ``Transforming the Primary Care Journey with Generative AI: A Foundation Model to Boost Efficiency, Quality, and Engagement.'' Journal of General Internal Medicine, 2026, https://doi.org/10.1007/s11606-025-09716-y. \63\ Sarkar, Urmimala, and David W. Bates. ``Using Artificial Intelligence to Improve Primary Care for Patients and Clinicians.'' JAMA Internal Medicine, vol. 184, no. 4, 2024, pp. 343-344. https://doi.org/10.1001/jamainternmed.2023.7965. \64\ Berenson, Robert A., and Kevin J. Hayes. ``Could Artificial Intelligence Affect Physician Payment for Nonprocedural Services? Part 1.'' Health Affairs Forefront, Health Affairs, 2025, https://www.healthaffairs.org/content/forefront/could-artificial-intelligence-affect-physician-payment-nonprocedural-services-part-1. --------------------------------------------------------------------------- To both support broader MAHA priorities and to reconcile with how technology is reshaping primary care delivery for beneficiaries and clinicians, we are seeking comment on how to re-imagine and improve the relative valuation of primary care services. We are focused on understanding how that re-imagination might occur within the current construct of office/outpatient (O/O) evaluation and management (E/M) services as well as via alternatives to fee-for-service payment, including through outcomes-based payment and/or the expansion of prospective primary care payment (PPCP). The latter, in particular, has long been a goal of external policy experts, including as a recommendation from the 2021 National Academy of Science, Engineering, and Medicine report `Implementing High Quality Primary Care,' which recommends team-based delivery supported by `hybrid' payment models that combine prospective monthly and visit-based payments.\65\ Over the past decade, the CMS Innovation Center tested PPCP in Medicare using a series of increasingly sophisticated hybrid payment approaches from the Comprehensive Primary Care initiative (CPC) to Primary Care First (PCF). The lessons learned from these Innovation Center model tests led Medicare to establish advanced primary care management (APCM) codes in the CY 2025 PFS final rule as a first step towards PPCP.\66\ The potential changes to primary care practice with increasing adoption of technology also raises concerns for increasing opportunity for fraud, waste, and abuse from malicious actors.\67\ For these and other reasons, as the agency thinks about the re-imagination of primary care payment in the PFS, we are considering first establishing PPCP permanently in the Medicare Shared Savings Program. We would also like to better understand if there are suggestions on how to implement PPCP within the broader Original Medicare program with appropriate guardrails.\68\ --------------------------------------------------------------------------- \65\ National Academies of Sciences, Engineering, and Medicine. ``Designing Interprofessional Teams and Preparing the Future Primary Care Workforce.'' Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care, National Academies Press, 2021. \66\ Agarwal, Sumit D., et al. ``The Underuse of Medicare's Prevention and Coordination Codes in Primary Care: A Cross-Sectional and Modeling Study.'' Annals of Internal Medicine, vol. 175, no. 8, 2022, pp. 1100-1108. https://doi.org/10.7326/M21-4770. \67\ Gray, Jacob. ``Strengthening Healthcare Program Integrity with AI.'' ICF, 2026, https://www.icf.com/insights/health/healthcare-fraud-waste-abuse-ai. \68\ Centers for Medicare & Medicaid Services. Accountable Care Organization Operational System (ACO-OS). CMS, https://security.cms.gov/pia/accountable-care-organization-operational-system. --------------------------------------------------------------------------- We seek comment on three main topics: Reconsidering relative primary care payment in the Medicare PFS: We are increasingly concerned about the relative undervaluation of primary care services. We would like feedback on how to reconsider this relative undervaluation in the PFS under the current paradigm of O/O E/M visits, the Annual Wellness Visit (AWV), and care management codes. We seek comment on updating this code set, and how or if CMS should consider a `two-track' approach to care management services with one track focused on technology enabled care and the other track focused on `traditional' care management. The payment implications of technology-enablement of primary care: We are seeking comment on how technology and clinical AI are impacting primary care, both broadly and more narrowly within the care management codes and the AWV. We also would like to better understand how CMS might update its approach to paying for technology- enabled care given the potentially transformative effects on the beneficiary and clinician experience. If we were to approach paying for technology-enabled primary care differently, how should we consider the relative valuation, in terms of time and intensity of services? How else could these services be valued? How should we consider evidence of the impact or outcome of technology-enabled services in primary care? Establishing Prospective Primary Care Payment in the Medicare Shared Savings Program: Given the series of CMS Innovation Center PPCP model tests, how should CMS approach establishing PPCP in the Shared Savings Program, and more broadly across Original Medicare? In short, this RFI seeks comment on how we should evaluate which of the payment models discussed previously in this section (FFS payment models, outcomes-based payments, or prospective payment) makes the most [[Page 43937]] sense for primary care given the rapid changes that may arise for recent technological innovation.

2. Reconsidering Relative Primary Care Payment in the Medicare

Physician Fee Schedule a. O/O E/M Visits Under the PFS, in accordance with section 1848 of the Act, we establish payment amounts for covered physicians' services and update payment policies to address changes, including those in medical practice, coding, or new data on relative value components. Original Medicare's fee-for-service payments for primary care services are overwhelmingly made through traditional O/O E/M visit codes. E/M codes describe a broad range of physician services that occur in an office setting, and do not distinguish between a one-time consultative visit and care that is part of a longitudinal care relationship, which may require additional time, coordination, and resources. We have previously described our concern that the complexity of services required to provide longitudinal care is not fully incorporated as part of the valuation of the work RVUs when the E/M code itself is used as the primary way to report the work of the professional (88 FR 78972). The physician community had previously supported this view when they highlighted that the existing E/M services, such as office visits, do not adequately describe the typical non-face-to-face care management work required by certain categories of beneficiaries most often served by primary care practitioners (78 FR 43337). As a result, specialties that do not routinely furnish procedural interventions or diagnostic tests and for which E/M visits represent a greater share of total allowed services are paid differently and generally less than their counterparts who routinely furnish procedural interventions and diagnostic tests. Section 1848 of the Act prohibits specialty-specific payment under the PFS, so we cannot vary the conversion factor or the number of relative value units for a physician's service based on the specialty type of the physician. Instead, in CY 2021, we adopted the RUC's recommendations for increased E/M work RVUs, based on their review of physician time for the E/M visit code set (84 FR 62851 through 62854). Next, in the CY 2024 PFS final rule, we took steps to better recognize the inherent complexity of visits associated with primary and longitudinal care of patients by finalizing Healthcare Common Procedure Coding System (HCPCS) code G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care complex condition. (Add-on code, list separately in addition to office/outpatient evaluation and management service, new or established)). HCPCS code G2211 is used by practitioners furnishing services as the continuing focal point for all the patient's needed health care services, including but not limited to primary care practitioners (88 FR 78969). In the CY 2026 PFS final rule (90 FR 49462 through 49464), we finalized our proposal to allow HCPCS code G2211 to be billed as an add-on code with the home or residence E/M visits, in addition to office/outpatient E/M visits. We are proposing changes to HCPCS code G2211 for CY 2027; see section II.D of this proposed rule for further discussion. The current O/O E/M code set may still insufficiently reflect differences in the nature and intensity of care provided. As such, we are considering establishing distinct categories of O/O E/M visits in future rulemaking. Potential categories could be longitudinal care, acute care, or consultative visits, with distinctions based on the clinical purpose of the encounter and the associated resource costs of furnishing care. Longitudinal care visits involve care delivered both during and between encounters as part of an ongoing comprehensive care relationship. During these visits, a beneficiary establishes, maintains, or updates that relationship. For example, a beneficiary returns to the clinic 3 months after their AWV for ongoing management of their diabetes, which requires an oral medication titration, and elevated blood pressure and hyperlipidemia, which includes a discussion about lifestyle modification. The practitioner also notices that they are overdue for an immunization, schedules them for a necessary screening test, and updates their plan of care accordingly. We would distinguish this visit (including the valuation of the pre- and post- service time and proximity to prior visits) from the care delivered in an acute care visit. In the future, we may consider valuing these visits as a combination of the E/M service furnished during the encounter and certain between-visit care management activities. In contrast, acute care visits are focused on the evaluation and management of a discrete, episodic problem that is generally resolved after treatment. For example, a beneficiary may seek care for a sore throat and suspected streptococcal pharyngitis, with no expectation of an ongoing care relationship related to that condition once it is resolved. While consultative visits are distinct from longitudinal and acute care visits because they are furnished in response to a referral to address a specific clinical question, consultative services could be considered similar in complexity to acute care, distinguished largely by consultative services typically including an evaluation of the patient and communication of findings or recommendations back to the referring practitioner. We also note that CPT codes exist and are paid by private payers for consultative services (for example, CPT codes 99242 through 99245), although they are not paid by Medicare. We are seeking comment on whether to consider the complexity of these services to be closer to the acute care services versus the longitudinal care services. As a general matter, we would expect to consider consultative visits to be less complex than longitudinal care visits. We are seeking feedback on further actions we could take around appropriate valuation of primary care services: What updates to the HCPCS code G2211 policy (or the proposed modifiers, MOD1 and MOD2) should CMS consider to ensure the clinician billing HCPCS code G2211 (or proposed modifiers, MOD1 and MOD2) is serving as the focal point for beneficiaries, and that the practitioner is also considering preventive care, risk factor reduction, and other services necessary for coordinating the care of beneficiaries who have a complex condition? Given the broad range of changes CPT makes annually, we recognize updates to the CPT code set to reflect distinctions among O/O E/M visits by the function of the visit (longitudinal, acute, or consultative) may have significant advantages within the current billing and coding ecosystem. However, absent a change in CPT coding, should we consider the possibility of creating G codes to better recognize distinction between and among these kinds of visits? If so, what categories should we consider? How could we effectively differentiate longitudinal care visits from acute care visits? What number of levels would be needed and for which settings of care? Should we use existing CPT codes as templates? How should we consider valuing these potential G-codes under the PFS, including the basis for the standard inputs: work RVUs, time [[Page 43938]] values, specialty mix for utilization crosswalks, direct PE inputs, etc.? How would practitioners balance and manage the increasing number and complexity of these codes? If CMS were to propose longitudinal or primary care visit types, what should the service period be? Should subsequent care management services be bundled in? If so, for what period of time? Which care management services might be included? Are there specific data on the resources used in furnishing longitudinal care, acute care, or consultative services CMS should consider for potential categorization of O/O E/M services?

3. Care Management Code `Family'

We have for the last 14 years sought to unbundle services previously considered bundled into E/M services through separate coding and payment for care management services. In 2013, the agency implemented a transitional care management code for post-discharge care (77 FR 68978). This was then followed by the creation of a broader family of codes for care management, including for beneficiaries with multiple chronic conditions or chronic care management (CCM) (78 FR 74414), for those requiring complex medical decision-making (for example, complex CCM, 81 FR 80349), and for those with a single or principal condition (principal care management (PCM), 85 FR 84697). In total, the CCM and PCM code families now include five sets of codes which are reported monthly on a timed basis, each set with a base code of 20 to 60 minutes and an add-on code for each additional 30 minutes. In the CY 2025 PFS final rule (89 FR 97859), we finalized three APCM codes (HCPCS codes G0556, G0557, and G0558) to recognize the evolving way primary care practices manage prevention and chronic condition management through interprofessional care teams. See Table A-E1 for more specificity on the purpose of each of the codes. Despite these important steps to pay separately for care management services, uptake of the care management codes has been limited.\69\ Interested parties cite cost-sharing and non-trivial documentation requirements as the primary barriers to broader adoption.\70\ In response to these considerations, we removed the CCM requirement to count and document the minutes of care management services provided in the patients' medical record when billing APCM services. Interested parties had stated this was so burdensome it limited their use of the CCM Current Procedural Terminology (CPT) codes. At the same time, the agency was concerned about program integrity and therefore code auditability. In the absence of medical record documentation, we required that if a practitioner billed the APCM codes, they must report the Value in Primary Care MIPS Value Pathway (89 FR 97864). Despite these changes, uptake in the first year was less than anticipated. We seek feedback on whether a different payment structure might be more appropriate as well as what might be done to further simplify the code set and associated requirements. --------------------------------------------------------------------------- \69\ Agarwal SD, Basu S, Landon BE. The Underuse of Medicare's Prevention and Coordination Codes in Primary Care: A Cross-Sectional and Modeling Study. Ann Intern Med. 2022 Aug;175(8):1100-1108. doi: 10.7326/M21-4770. Epub 2022 Jun 28. PMID: 35759760; PMCID: PMC9933078. \70\ Agarwal SD, Barnett ML, Souza J, Landon BE. Adoption of Medicare's Transitional Care Management and Chronic Care Management Codes in Primary Care. JAMA. 2018;320(24):2596-2597. doi:10.1001/ jama.2018.16116. [GRAPHIC] [TIFF OMITTED] TP16JY26.048 We are also asking for comment on how to reconfigure the care management code `family' to better establish effective relative payment options for between visit care management services and how supervision requirements may need to change in technology-enabled care models where patients may initially engage with digital tools or receive care entirely in a digital environment. In addition, given our concerns about fraud, waste, and abuse in the care management code families, we would like to better understand how to ensure care management services are impacting care. To improve the utilization of care management services where it is clinically appropriate, we seek comment on the following questions: What additional requirements should CMS consider to reduce fraud, waste, and abuse in care management services? Specifically on the following: ++ What is the appropriate `trigger' or initiating visit for care management services? How would this change if it were an initiating visit vs. another event? ++ Should CMS consider changing supervision requirements in care management services to prevent fraudulent billing of care management services? What is the appropriate supervision requirement for care management services? ++ How should data submission to CMS change to verify services are received? ++ What guardrails should CMS consider to prevent inappropriate billing? ++ What proportion of care management services must be delivered [[Page 43939]] by the supervising provider, versus auxiliary personnel? Are there specific data on the resources used in furnishing advanced primary care, which incorporates population health management, enhanced communication technology, and longitudinal care management? We welcome submission of any such data. To what extent are the current care management codes duplicative? Are there efficiencies to be gained in simplifying the current care management code `family' into a more efficient code set? To what extent would this improve appropriate utilization of care management services? If reducing the number of care management codes would not increase efficiency or utilization of appropriate services, how else can CMS standardize the requirements across the care management codes? As care management becomes increasingly technology- enabled, how should CMS consider changing the code family and their relative valuations? How can CMS ensure that automated billing leveraging technology reflects actual care delivered to beneficiaries by care teams or practitioners? Should CMS create `technology-enabled care management' codes or a `two-track' approach to care management? How should we ensure these codes are appropriately differentiated?

4. Payment Implications of Technology Enablement of Primary Care

a. Changes to Primary Care and Care Management Due to Technology and Clinical AI Adoption of new technology and AI tools in primary care has the potential to transform clinical care to such a degree that it may challenge how we traditionally think about care delivery. However, as of this request for information, clinician-facing AI tools that are currently in widespread use are more focused on administrative burden reduction and clinical decision-support. For example, tools focused on reducing clinician documentation burden (e.g. AI scribes), have perhaps been the most widely taken up by clinicians,\71\ with an estimated 25% penetration among all US physicians.\72\ Early system-level evaluations demonstrate generally increased productivity among adopters along with decreases in perceived documentation burden.\73\ The most widely used AI tool in primary care is likely a clinical decision-support application, Open Evidence, which more than forty percent of US physicians have self-reported using.\74\ This software allows clinicians to ask an AI chat interface a wide variety of clinical questions and receive answers based on a large language model only drawing from well-known peer reviewed journals and guidelines (i.e. not the entire internet). AI-assisted care delivery agents have been deployed in a number of health systems but have not yet reached widespread use, to the best of CMS' knowledge.\75\ In general, we note greater technological adoption may support a shift in care management from reactive, manual processes to proactive, data-driven, and personalized care. --------------------------------------------------------------------------- \71\ Littrell, A. (2026, May 19). The AI tool physicians actually love: A conversation with Robert Wachter, M.D., chair of UCSF Medicine. Medical Economics. https://www.medicaleconomics.com/view/the-ai-tool-physicians-actually-love-a-conversation-with-robert-wachter-m-d-chair-of-ucsf-medicine. \72\ Doximity. (2026). State of AI in medicine report 2026. https://www.doximity.com/reports/state-of-ai-medicine-report/2026. \73\ Holmgren AJ, Fenton CL, Thombley R, et al. Ambient Artificial Intelligence Scribes and Physician Financial Productivity. JAMA Netw Open. 2026;9(1):e2553233. doi:10.1001/ jamanetworkopen.2025.53233. \74\ OpenEvidence. (2025, July 15). OpenEvidence, the fastest- growing application for physicians in history, announces $210 million round at $3.5 billion valuation. https://www.openevidence.com/announcements/openevidence-the-fastest-growing-application-for-physicians-in-history-announces-dollar210-million-round-at-dollar35-billion-valuation. \75\ Examples include ''Cedars-Sinai Connect'', from https://www.cedars-sinai.org/csconnect.html or 'Hartford Healthcare GPT' https://www.aha.org/aha-center-health-innovation-market-scan/2026-05-19-hartford-healthcare-embraces-ai-patientgpt. Retrieved May 31, 2026. --------------------------------------------------------------------------- In short, we believe technology is being used in increasingly innovative ways throughout primary care but would like to better understand that usage. Given this changing backdrop, we are seeking comment on how we develop a comprehensive and consistent approach to payment for technology-enabled care given likely lower cost-to-serve but potentially higher quality of care delivered. There are challenges in establishing appropriate valuation methodologies, due to the rapidly evolving nature, accuracy, impact, and scope of these technologies as well as the limited transparency into underlying costs and effect of these tools in primary care and other specialties. One potential approach may be to link payment more directly to demonstrated clinical outcomes. We are seeking additional information on how to best structure payment for these technologies in a way that aligns with our agency's mission to increase quality, improve health, reduce costs, and strengthen the healthcare system. Clinical technology tools of interest would include those that provide clinical decision- making support that deliver AI-assisted (or augmented, etc.) primary care, or that are otherwise of note. We seek input on the following: Our understanding is that clinical documentation and clinical decision-support tools are currently the most commonly used applications of AI in primary care. Does this reflect current practice? In particular, are there additional clinical AI tools and new technologies that are frequently being used in primary care settings with high accuracy, demonstrated safety, and clinical outcomes reported? If so, please describe how they impact the clinical workflow and the beneficiary experience. If you are a physician furnishing primary care services, how has your practice been impacted or how do you expect it will be impacted by clinical AI tools? How has incorporating technology and AI tools impacted the resource costs associated with primary care practice, in terms of the time and intensity of services delivered? How has the implementation of clinical AI tools led to improvements in the quality of care, or reduced downstream costs? In general, please cite any evidence available for your comments. If these tools are increasing productivity, what are clinicians and other health professionals doing with the additional time/bandwidth created? Are you seeing more patients in visits, engaging more with population-health management or care management, accomplishing administrative tasks, or something else? How do you ensure patient data and privacy is adequately protected during use of these tools? Please describe areas where clinical AI tools in primary care are not well captured in the current coding and payment system and suggest how these may be incorporated to facilitate high-value, technology-enabled primary care. What lessons can CMS learn and adopt from private payors with respect to clinical AI? More specifically, we ask the following: What can CMS learn from how private payors have approached payment and coverage of clinical AI in primary care? How are they monitoring for safety, privacy, fraud, waste, and abuse? How could private payor coverage of clinical AI in primary care streamline or otherwise facilitate CMS coverage or payment? [[Page 43940]] From an outcomes-based perspective, how should CMS evaluate and monitor the impact of technology-enabled care in primary care? What outcomes would accurately capture whether these technologies have improved or negatively affected primary care practice for both clinicians and beneficiaries? Are there different outcomes for short-term and long-term impacts? What type of outcomes data should be shared with CMS? For example, to what extent would submission via Fast Healthcare Interoperability Resources (FHIR)-based APIs of clinical outcomes or activity sets be an appropriate approach by which to tie payment? What submission frequency and formats would be most appropriate? How can we collect those outcomes in a way that minimizes administrative burden? Are there other payment structures, beyond outcomes-based and prospective (which will be discussed in the next section), that would be more suited to the unique nature and impact of these technologies? If so, please describe.

5. Technology and AI-Augmentation in Primary Care via the Medicare AWV

As we at CMS endeavor to shift US health care toward a focus on preventive rather than reactive medicine--for health care rather than `sick care'--there may be no more obvious starting place for Medicare than the Initial Preventive Physical Exam (IPPE) and Medicare AWVs. The IPPE is a one-time preventive check-up where practitioners review the beneficiary's medical history, make sure they are up to date on important screenings and vaccines, and talk with the beneficiary about their family history and how to stay healthy.\76\ Then every year following, beneficiaries have a conversation-focused visit to create a personalized prevention plan, called an Annual Wellness Visit (AWV).\77\ --------------------------------------------------------------------------- \76\ ``Welcome to Medicare Preventive Visit.'' Medicare.gov, Centers for Medicare & Medicaid Services, https://www.medicare.gov/coverage/welcome-to-medicare-preventive-visit. Accessed 16 June 2026. \77\ ``Yearly `Wellness' Visits.'' Medicare.gov, Centers for Medicare & Medicaid Services, https://www.medicare.gov/coverage/yearly-wellness-visits. Accessed 16 June 2026. --------------------------------------------------------------------------- The IPPE and AWV were established under section 4103 of the Affordable Care Act which requires Medicare to cover an AWV in which a personalized prevention plan is created (Pub. L. 111-148). The payment for AWVs has been updated to reflect the resource costs associated with advanced care planning (80 FR 70956), review of opioid use (85 FR 84713), and optionally physical activity and nutrition (90 FR 49483). The current requirements can be found on the CMS website.\78\ --------------------------------------------------------------------------- \78\ Centers for Medicare & Medicaid Services. ``Medicare Wellness Visits.'' Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services, https://www.cms.gov/medicare/coverage/preventive-services/medicare-wellness-visits. Accessed 7 July 2026. --------------------------------------------------------------------------- Section 1861(hhh)(4)(F) of the Act gives the Secretary the authority to experiment with the use of personalized technology focusing on health behavior change. We are interested in understanding whether advances in technology, including clinical AI, could improve the effectiveness, personalization, and both beneficiary and clinician experience for the AWV. Despite the importance of prevention and early identification of risk factors, evidence regarding the impact of the AWV on outcomes is mixed. Some studies have found that AWV receipt is associated with increased use of preventive services \79\ but may not sufficiently close gaps in preventive care.\80\ However, other studies have found no substantive association between AWV adoption and improvements in evidence-based screening, acute care utilization, or spending,\81\ or potentially increasing downstream low-value services.\82\ Given the heterogeneity of these findings, we are interested in whether technology-enabled AWVs can improve not only the proportion of Medicare beneficiaries completing an AWV but also meaningful outcomes. --------------------------------------------------------------------------- \79\ Beckman AL, et al. The effect of Medicare's Annual Wellness Visit on preventive care for the elderly. Prev Med. 2018;116:126- 133. \80\ Camacho F, Yao N, Anderson R. The Effectiveness of Medicare Wellness Visits in Accessing Preventive Screening. Am J Health Promot. 2017. \81\ Ganguli I, Souza J, McWilliams JM, Mehrotra A, et al. Association of Medicare's Annual Wellness Visit with Cancer Screening, Referrals, Utilization, and Spending. Health Affairs. 2019. \82\ Ganguli I, Lupo C, Mainor AJ, et al. Assessment of Prevalence and Cost of Care Cascades After Routine Testing During the Medicare Annual Wellness Visit. JAMA Netw Open. 2020;3(12):e2029891. doi:10.1001/jamanetworkopen.2020.29891. --------------------------------------------------------------------------- We are interested in whether clinical adoption of technology including clinical AI tools may facilitate transformation of the AWV from a point-in-time assessment to a more continuous, data-driven, and beneficiary-specific preventive care function. The function of these tools may support AWV completion from pre-visit activities as well as activities during and after the clinical encounter. As examples, clinical AI tools may support pre-visit collection of beneficiary reported information such as in the health risk assessment, adapting questions to a beneficiary's language or health literacy level.\83\ For reviewing the medical and family history, AI tools have demonstrated superiority to even human experts in summarizing health information from structured and unstructured fields.\84\ During the clinical encounter, AI tools may also support standardized clinical workflows embedded in the electronic health record environment,\85\ identify beneficiaries who may warrant additional assessment, and generate suggested follow up steps for clinicians to review.\86\ Following the encounter, AI tools may assist with developing post-encounter instructions in the language and health literacy level of the patient.\87\ --------------------------------------------------------------------------- \83\ Swisher AR, Wu AW, Liu GC, Lee MK, Carle TR, Tang DM. Enhancing Health Literacy: Evaluating the Readability of Patient Handouts Revised by ChatGPT's Large Language Model. Otolaryngol Head Neck Surg. 2024 Dec;171(6):1751-1757. doi: 10.1002/ohn.927. Epub 2024 Aug 6. PMID: 39105460. \84\ Van Veen D, Van Uden C, Blankemeier L, et al. Adapted large language models can outperform medical experts in clinical text summarization. Nature Medicine. 2024;30:1134-1142. \85\ Perkins SW, Muste JC, Alam T, Singh RP. Improving Clinical Documentation with Artificial Intelligence: A Systematic Review. Perspect Health Inf Manag. 2024 Jun 1;21(2):1d. PMID: 40134899; PMCID: PMC11605373. \86\ Yao, X., Rushlow, D.R., Inselman, J.W. et al. Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial. Nat Med 27, 815-819 (2021). https://doi.org/10.1038/s41591-021-01335-4. \87\ Young, Albert T., et al. ``Patients and Dermatologists Are Largely Satisfied with ChatGPT-Generated After-Visit Summaries: A Pilot Study.'' JAAD International, vol. 15, 2024, pp. 33-35. Elsevier, https://doi.org/10.1016/j.jdin.2023.12.004. --------------------------------------------------------------------------- We believe much of this can occur under current CMS billing guidance, and reiterate that under current policy, the AWV must be performed by a physician or other health professional, or team of medical professionals directly supervised by a physician currently enrolled as a Medicare provider. We are interested in what barriers--if any--these requirements create to innovative AWV delivery models in which an AI technology company develops or operates these clinical AI tools and affiliates with a Medicare enrolled provider or supplier. We seek comment on the following: How can CMS improve the effectiveness, efficiency, personalization, and beneficiary experience of the IPPE and Medicare AWV? Which, if any, AWV components are being delivered (or could be) more efficiently delivered through technology and clinical AI-enabled tools? Please comment on how technology is being used today within the AWV, how that [[Page 43941]] has changed over the last year, and how the community sees that changing over the next couple of years. Which activities require direct involvement by a physician, qualified non-physician practitioner, or medical professional under physician supervision? Could AI-enabled AWVs improve health outcomes that prior studies have found to be inconclusive? What evidence should CMS consider regarding whether technology or clinical AI-enabled AWVs improve clinical usefulness of visit and clinical outcomes, beneficiary reported outcomes, or utilization? In particular, research around changes in the use of preventive services, the application of preventive services to individual clinical risk factor assessment or in low-value downstream utilization are of specific interest. What existing statutory, regulatory, enrollment, billing, supervision, documentation, data-sharing or other requirements may create barriers to an AI technology company delivering AWV-related services while employing or contracting with appropriately licensed physicians or other medical professionals to perform AWVs? To what extent may program integrity concerns exist with these models? In what circumstances should CMS consider payment or policy changes that would allow technology-enabled organizations, including AI technology companies, to participate in AWV delivery models, either directly or through partnerships with Medicare-enrolled providers or suppliers? How should CMS evaluate whether AI-enabled AWVs are improving outcomes rather than merely increasing AWV volume, documentation completeness, coding intensity, or low-value care follow `cascades' of services? Specifically, for which outcomes should CMS hold technology companies accountable? How could CMS optimize information sharing from AWV throughout the duration of the primary care relationship? Where could AI-enabled tools facilitate this process?

6. Developing Prospective Payment in the Shared Savings Program

a. Background We stated at the beginning of this request for information that we are interested in further developing prospective primary care payment (PPCP) in Original Medicare, beginning with the Shared Savings Program. There is growing recognition that the fee-for-service (FFS) payment model has inherent limitations as a primary care payment mechanism, as it is not designed to support the comprehensive, coordinated care that primary care requires. In 2015, the Medicare Payment Advisory Commission (MedPAC) recommended a per beneficiary payment for primary care providers to support additional care coordination activities for Medicare beneficiaries.\88\ MedPAC explained that while a per beneficiary payment in itself will not guarantee an increase in care coordination activities or even an increase in compensation for eligible primary care practitioners, it would be a first step in transitioning from FFS to a beneficiary-centered payment approach that encourages care coordination, including the non-face-to-face activities that are a critical component of care coordination.\89\ --------------------------------------------------------------------------- \88\ Medicare Payment Advisory Commission. 2015. Report to the Congress: Medicare Payment Policy, page 106 Washington, DC: MedPAC. https://www.medpac.gov/document/http-www-medpac-gov-docs-default-source-reports-mar2015_entirereport_revised-pdf/. \89\ Medicare Payment Advisory Commission. 2015. Report to the Congress: Medicare Payment Policy, page 106 Washington, DC: MedPAC. https://www.medpac.gov/document/http-www-medpac-gov-docs-default-source-reports-mar2015_entirereport_revised-pdf/. --------------------------------------------------------------------------- In a 2021 report on implementing high-quality primary care, the National Academies of Sciences, Engineering, and Medicine (NASEM) recommended that health care payers ``pay for primary care teams to care for people, not doctors to deliver services'' and encouraged payers to adopt a hybrid reimbursement model that combines FFS and capitation over time with an overarching goal to eventually pay for the majority of primary care services through risk-adjusted prospective payment.\90\ NASEM recommended that a hybrid reimbursement model--with a mix of FFS and lump-sum or per-person payments--become the default method for paying for primary care teams.\91\ NASEM found that with time, hybrid reimbursement models show improvements in care and reductions in use, particularly for people with multiple complex chronic conditions.\92\ --------------------------------------------------------------------------- \90\ National Academies of Sciences, Engineering, and Medicine. ``Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care,'' pages 7-8. Washington, DC: The National Academies Press, 2021. https://doi.org/10.17226/3393 https://www.nationalacademies.org/read/25983/chapter/3#8. \91\ National Academies of Sciences, Engineering, and Medicine. ``Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care,'' page 8. Washington, DC: The National Academies Press, 2021. https://doi.org/10.17226/3393 https://www.nationalacademies.org/read/25983/chapter/3#8. \92\ National Academies of Sciences, Engineering, and Medicine. ``Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care,'' page 301. Washington, DC: The National Academies Press, 2021. https://doi.org/10.17226/3393 https://www.nationalacademies.org/read/25983/chapter/3#8. --------------------------------------------------------------------------- Over the past 13 years, the CMS Innovation Center has tested a number of models that have progressively moved away from FFS billing, including: CPC, Comprehensive Primary Care Plus (CPC+), PCF, Next Generation ACO (NGACO), Global and Professional Direct Contracting (GPDC) Model, ACO REACH, and ACO Primary Care (PC) Flex. These models have focused on testing whether Medicare payment for primary care services through hybrid payments (a mix of FFS and capitated payments), population-based payments (PBPs), or total care capitation (TCC) improves quality of care for beneficiaries and reduces Medicare spend. Evidence from these models suggests that primary care capitation (PCC) is most effective when it is embedded in an accountable care framework, such as the Shared Savings Program.\93\ Model design and evaluations are available on the model-specific websites that can be found on https://www.cms.gov/priorities/innovation/models#views=models. --------------------------------------------------------------------------- \93\ See, for example, O'Malley A, Singh P, Fu N, et al. Independent Evaluation of the Comprehensive Primary Care Plus (CPC+): Final Report. Mathematica, page xviii. December 2023. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report. --------------------------------------------------------------------------- Previous Innovation Center primary care model tests have yielded lessons that shape current and future work, including the development of codes and payment for APCM services. Participants, namely clinicians, in primary care models have indicated, however, difficulties with investing in and maintaining primary care redesign activities due to a range of challenges. First, additional non-visit- based primary care payments have been generally layered upon base payments that are still predominantly FFS in structure. While payment for APCM services represents a meaningful step toward non-visit-based payments in concept, we do not view APCM as the end goal of primary care payment reform. The payment amounts associated with APCM are predicated on furnishing and billing APCM services. As such, APCM retains the fundamental structure of FFS billing and may not provide sufficient incentives for practices to focus on proactive, population- based non-visit care management activities. Second, Innovation Center model funding that supports salaries for clinical and administrative staff, who are needed for advanced primary care coordination and population health [[Page 43942]] functions, is contingent on continued participation in these models. Unlike APCM codes,\94\ which are billing codes paid under the PFS and can be used to support ongoing primary care workforce investments, once the models end, practices are left without the funding that they received under the models for the clinical and administrative staff that had supported population health functions. Based on a review of internal CMS data related to billing for APCM services, billing for APCM services is higher for Shared Savings Program ACO-assigned beneficiaries compared to Medicare beneficiaries outside of an ACO. This finding suggests that the accountability and care management infrastructure associated with ACOs may support more robust adoption of non-visit based primary care payment mechanisms. --------------------------------------------------------------------------- \94\ Three APCM codes and payment amounts were established in the CY 2025 Physician Fee Schedule final rule (89 FR 97859 through 97902). In the CY 2026 PFS final rule, CMS established three new G- codes (HCPCS codes G0568, an add-on code based on CPT code 99492, G0569, an add-on code based on CPT code 99493 for CoCM services delivered to patients also receiving APCM services, and G0570, an add-on code for general behavioral health integration services based on CPT code 99484) to be billed as add-on services to APCM base codes: HCPCS codes G0556, G0557, and G0558 (90 FR 49464 through 49471). --------------------------------------------------------------------------- Table A-E3 identifies recent Innovation Center models that tested capitated payment arrangements. As outlined in the table, the payment arrangements tested across these models reflect a progression from hybrid (FFS + capitation) payment structures to PBPs and TCC, with each successive model designed to build upon the experience of previous models. CPC+ and PCF relied on care management fees, performance-based incentive payments, and PBPs that partially replaced traditional FFS billing. While neither model reduced total Medicare expenditures or achieved net savings, the CPC+ evaluation found that independent practices who spent a longer time in the model, and those participating in the Shared Savings Program tended to have more favorable results.\95\ This finding underscores the importance of embedding primary care payment reform within an accountable care framework. --------------------------------------------------------------------------- \95\ O'Malley A, Singh P, Fu N, et al. ``Independent Evaluation of the Comprehensive Primary Care Plus (CPC+): Final Report,'' page 209. Mathematica. December 2023. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report. --------------------------------------------------------------------------- Other Innovation Center models that have tested different kinds of cash flow and primary care capitated payments have focused on ACOs in models that build on the foundation of the Shared Savings Program. For example, ACOs in the NGACO model could select from four payment mechanisms: (1) traditional FFS; (2) FFS with a fixed per beneficiary per month (PBPM) infrastructure payment; (3) PBPs that gave ACOs a fixed percentage of expected FFS claims reductions in prospective monthly payments; or (4) all-inclusive PBPs, in which the ACO received expected FFS claim reductions in prospective monthly payments. Three quarters of NGACOs primarily chose FFS-based payment mechanisms such as the FFS or FFS with infrastructure payment (FFS+ISP). NGACOs electing PBP mechanisms had larger spending reductions of 3 percent ($409.1 per beneficiary per year (PBPY), p<0.01), compared with 1.3 percent ($172.9 PBPY, p<0.01) for NGACOs electing FFS-based payment mechanisms. Additionally, NGACOs, particularly the 35 that remained through PY 6, showed improvements in model reported quality measures over time for prevention and screening and for chronic disease management. Further, 25 of 35 NGACOs had reduced cumulative Medicare spending while maintaining or reducing rates of ambulatory care-sensitive conditions- related hospitalizations or 30-day unplanned readmissions, tended to reduce outpatient spending and Emergency Department visits, and tended to reduce skilled nursing facility spending and utilization. Over the course of the model, NGACOs invested in initiatives to better manage their patient populations, toward the goals of reduced spending and improved quality.\96\ --------------------------------------------------------------------------- \96\ Lowell, K.H., and contributing authors. ``Evaluation of the Next Generation Accountable Care Organization (NGACO) Model, Final Report,'' page 10. Bethesda, MD: NORC at the University of Chicago, 2024. https://www.cms.gov/priorities/innovation/data-and-reports/2024/nextgenaco-sixthevalrpt. --------------------------------------------------------------------------- Under the GPDC Model \97\ (the successor to the NGACO model) and the ACO REACH model,\98\ we offered two capitation options: (1) TCC (a PBPM capitated payment for all Medicare Part A and Part B services) and (2) PCC for primary care services equal to seven percent of the estimated total cost of care and composed of both a base amount and an enhanced amount designed to provide upfront revenue. Direct contracting entities and ACOs that selected PCC could also select an advanced payment option (APO), which provided upfront payments for services beyond primary care. --------------------------------------------------------------------------- \97\ Lowell, K.H., and contributing authors. ``Evaluation of the Global and Professional Direct Contracting Model, Annual Report 2.'' Bethesda, MD: NORC at the University of Chicago, 2024. https://www.cms.gov/priorities/innovation/data-and-reports/2024/gpdc-2nd-ann-report. \98\ ``ACO REACH Model, PY 2026 Financial Operating Policies: Capitation and Advanced Payment Mechanisms.'' Baltimore, MD: RTI International, 2025. https://www.cms.gov/priorities/innovation/files/aco-reach-py26-financial-ops-capitation-payment-mechanisms.pdf. --------------------------------------------------------------------------- The ACO PC Flex model extends capitated payment arrangements to ACOs participating in the Shared Savings Program. The model is designed to test how prospective payments and increased funding for primary care in ACOs affects health outcomes, quality, and costs of care within the Shared Savings Program.\99\ Model participants are limited to ACOs that participate in the Shared Savings Program and qualify as a ``low revenue ACO'' as defined by Sec. 425.20.\100\ ACOs participating in the ACO PC Flex Model receive two payments: a monthly PPCP and a one- time advanced shared savings payment. The PPCP is a PBPM payment for primary care services that replaces FFS payments for eligible primary care services with a monthly prospective payment composed of a county base rate (based on a county's average primary care spending), an ACO enhanced amount, and a population adjustment.\101\ ACOs are required to spend at least 90 to 95 percent (depending on the performance year) of the total PPCP payment on the provision of care.\102\ The ACO enhanced amount includes three types of payment enhancements: (1) the county enhancement, which is applied at the county level in counties designated as low spending counties relative to standardized spending nationally; (2) the flex enhancement, which is applied at the ACO level to all PC Flex ACOs, regardless of location or utilization, and (3) the enhancement add-on, which is a fixed amount PBPM for a performance year that may be used to increase the [[Page 43943]] ACO enhanced amount for underlying changes in the Medicare PFS that are not reflected in the rate book. The enhanced amount will not be subject to recoupment in full by CMS based on the PC Flex ACO's performance in achieving shared savings.\103\ Although interest in the ACO PC Flex model was robust, many eligible ACOs that expressed initial interest in the model ultimately did not submit applications, citing challenges associated with the application timeline. Additionally, several interested parties shared that concurrent interest in the Making Care Primary model was a factor in their decision not to participate in ACO PC Flex. --------------------------------------------------------------------------- \99\ ACO PC Flex (ACO Primary Care Flex) Model website: https://www.cms.gov/priorities/innovation/innovation-models/aco-primary- care-flex-model. \100\ Under Sec. 425.20, a ``low revenue ACO'' is an ACO whose total Medicare Parts A and B fee-for-service revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available, is less than 35 percent of the total Medicare Parts A and B fee-for-service expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available. \101\ ACO Primary Care Flex Model Financial Methodology: Rate Book Development, Calculation of Monthly Prospective Primary Care Payment, and Financial Settlement, June 2025, version 2, pages 1-2. https://www.cms.gov/files/document/aco-pc-flex-fin-meth-ratebook-dev.pdf. \102\ ACO Primary Care Flex Model Financial Methodology: Rate Book Development, Calculation of Monthly Prospective Primary Care Payment, and Financial Settlement, June 2025, version 2, page 56. https://www.cms.gov/files/document/aco-pc-flex-fin-meth-ratebook-dev.pdf. \103\ ACO Primary Care Flex Model Financial Methodology: Rate Book Development, Calculation of Monthly Prospective Primary Care Payment, and Financial Settlement, June 2025, version 2, page 33. https://www.cms.gov/files/document/aco-pc-flex-fin-meth-ratebook-dev.pdf. --------------------------------------------------------------------------- The Innovation Center recently announced the Long-term Enhanced ACO Design (LEAD) model,\104\ which is scheduled to begin on January 1, 2027. As currently designed, LEAD's capitated payment architecture builds directly on the framework used in ACO REACH and ACO PC Flex. Similar to ACO REACH and the ACO PC Flex model, participating ACOs will be required to select from either: (1) TCC payment or (2) PCC payment. The LEAD model plans to offer ACOs that elect PCC the option to receive additional payments to extend value-based arrangements beyond primary care. Specifically, ACOs may elect the non-primary care capitation (NPCC) or the APO to support alternative payment arrangements for non- primary care providers. It is anticipated that these options would allow ACOs to incrementally expand capitation beyond primary care without adopting full TCC. --------------------------------------------------------------------------- \104\ https://www.cms.gov/priorities/innovation/innovation-models/lead. [GRAPHIC] [TIFF OMITTED] TP16JY26.049 b. Primary Care Capitated Payment Arrangements Considerations for the Shared Savings Program The goal of capitated payments is to give health care providers additional flexibility in how they deliver care and to reduce the volume-based incentives of Original Medicare (OM) payment. With capitated payments, health care providers receive steady, predictable cash flow that is not tied to the number of services they provide. This flexibility frees health care providers to deliver care in innovative and flexible ways, such as non-face-to-face care management, telehealth, and electronic messaging, without worrying about foregone OM revenue, tying these services to overall outcomes. We are interested in building on the experience of previous Innovation Center models that tested capitated payment arrangements. Section 1899(i)(2) of the Act authorizes the Secretary to use partial capitation in which an ACO is at financial risk for some, but not all, of the items and services covered under parts A and B, such as at risk for some or all physicians' services or all items and services under part B, provided that the partial capitation payments for a year made under the partial capitation model do not result in additional program expenditures than would otherwise be expended for such ACO for such beneficiaries for such year if the model were not implemented. The Secretary may limit a partial capitation model to ACOs that are highly integrated systems of care and to ACOs capable of bearing risk, as determined to be appropriate by the Secretary. Additionally, section 1899(i)(3) of the Act authorizes the Secretary to use other payment models instead of the one-sided model described in section 1899(d) of the Act as long as the Secretary determines that the other payment model will improve the quality and efficiency of items and services furnished to Medicare beneficiaries without additional program expenditures. We have previously described how primary care teams are central to the relative success of Shared Savings Program ACOs.105 106 In 2024, as in [[Page 43944]] previous years, ACOs comprised of larger proportions of primary care clinicians had significantly higher net per capita savings than ACOs comprised of smaller proportions of primary care clinicians (with $403 vs $224 in net per capita savings).\107\ In recent years, we have received significant input from interested parties regarding opportunities to increase participation in ACO initiatives. One such option to increase participation would be to identify ways that the Shared Savings Program can support ACOs' efforts to strengthen primary care, such as by providing prospective monthly primary care capitated payments to primary care practices, to reduce reliance on OM payments and support innovations in care delivery that better meet beneficiary needs. --------------------------------------------------------------------------- \105\ ``Medicare Shared Savings Program Continues to Deliver Meaningful Savings and High-Quality Health Care'', October 29, 2024, Press Release. https://www.cms.gov/newsroom/press-releases/medicare-shared-savings-program-continues-deliver-meaningful-savings-high-quality-health-care. \106\ ``Medicare Shared Savings Program Saves Medicare More Than $1.8 Billion in 2022 and Continues to Deliver High-quality Care'', August 24, 2023, Press Release. https://www.cms.gov/newsroom/press-releases/medicare-shared-savings-program-saves-medicare-more-1-8-billion-2022-continues-deliver-high-quality. \107\ Medicare Shared Savings Program Accountable Care Organizations Updated Performance Year 2024 Financial and Quality Results Fact Sheet, September 29, 2025. https://www.cms.gov/files/document/fact-sheet-ssp-py24-financial-quality-results.pdf. --------------------------------------------------------------------------- In the CY 2026 PFS proposed rule (90 FR 32502), we solicited comments on whether CMS should consider new payments to Shared Savings Program ACOs for prospective monthly APCM payments to be delivered to primary care practices that satisfy the APCM billing requirements, with the payments reconciled under the ACO benchmark. Nearly all commenters supported giving ACOs the option to receive prospective APCM payments. Only one commenter opposed prospective APCM payments, arguing that APCM delivery solely through ACOs risks undermining the core principles of CCM. We are seeking feedback regarding potential primary care capitated payment arrangements in the Shared Savings Program. Specifically, we are requesting input on the following questions: ACO and ACO Participant Readiness To what extent are Shared Savings Program ACOs and ACO participants, and their associated health care providers (referred to herein as ``ACO providers/suppliers''), ready to take on capitated payment arrangements? Please describe ACO and ACO participant level of readiness for each of the following: ++ Hybrid capitation (a combination of capitated and OM payments). ++ Full capitation for primary care services (that could enable ACOs to provide downstream payments to ACO participants). ++ PBPs as a fixed percentage of expected OM claims. We are interested in understanding what operational changes ACOs would need to undertake to effectively receive, manage, and distribute capitated payments. Please describe any barriers or conditions--legal, financial, or operational--that could affect an organization's readiness to participate in each type of arrangement. If an ACO received capitated payments for primary care services furnished by ACO providers/suppliers billing through the TIN of an ACO participant (as defined in Sec. 425.20), what organizational and programmatic goals would the ACO seek to advance with those payments? For example, we are interested in understanding whether ACOs would use capitated payments to expand the scope or capacity of existing care coordination and population health programs, or whether capitated payments would instead enable ACOs to operationalize new care delivery initiatives. Please describe the specific types of initiatives that ACOs would seek to implement, and how ACOs would ensure that these payments went to support primary care practices directly. Eligibility for Participation Should CMS limit access to capitated payment arrangements exclusively to ACOs participating in two-sided risk tracks (BASIC tracks C, D, E or the ENHANCED track), or should all ACOs be eligible to receive some form of capitated payments, regardless of the ACO's participation track? ACOs participating in two-sided risk tracks must establish a repayment mechanism prior to the start of an agreement period, and we are interested in whether similar proof that an ACO could repay losses should be required as a condition for receiving capitated payments, even for ACOs in one-sided risk tracks. Should CMS limit capitated payment arrangements to ACOs with prior risk-bearing experience--either through participation in a previous Shared Savings Program agreement period in a two-sided risk track (BASIC tracks C, D, E or the ENHANCED track) or through prior participation in a risk-bearing track in an Innovation Center model, such as ACO REACH--or should risk-bearing ACOs in their first Shared Savings Program agreement period also be eligible to participate in capitated payment arrangements? Why would commenters support one approach over the other? We are interested in whether prior experience with risk-bearing should be an explicit prerequisite for capitated payment eligibility or whether risk-bearing ACOs in their first agreement period should also be eligible to participate in capitated payment arrangements. Should CMS permit some, but not all, ACO participants within an ACO to participate in capitated payment arrangements, or should CMS require all ACO participants within an ACO to participate in capitated payment arrangements? Should CMS establish a minimum percentage of attributed beneficiaries \108\ for whom eligible primary care practices must be furnishing care management services to receive capitated payments, either at the ACO level or at the individual ACO participant level? --------------------------------------------------------------------------- \108\ Specific Medicare beneficiaries for whom an ACO is responsible for the care and total cost of care. Generally determined based on care furnished during a specific calendar window and the clinicians that provided the care. --------------------------------------------------------------------------- To what extent should the payment design and structure differ based on the level of risk or participation track of an ACO? Payment Design and Structure What percentage of base year OM payments should be replaced by PCC, and what factors should guide this determination? For example, under the ACO REACH model, the PCC payment--including both the base PCC and the enhanced PCC--is set at 7 percent of the REACH ACO's prospective monthly performance year benchmark, a level designed to provide ACOs with a predictable, non-visit-based revenue stream for primary care services. What services should be included in primary care capitation (and reciprocally, in a fee reduction) to accurately capture an appropriate scope of primary care services furnished to beneficiaries, balancing the importance of providing up-front flexible payments, with the potential for risk to practices if service utilization grows? For example, under both the ACO REACH and ACO PC Flex models, the set of services eligible for primary care capitated payments is based on a specific list of CPT and HCPCS codes billed by primary care specialists (health care providers with specific specialty codes). In both models, the PCC bundle includes certain E/M office visits along with CCM, behavioral health integration, transitional care management, AWVs, advance care planning, and virtual communication services. We are interested in feedback about whether and in what form we should establish an enhanced primary care payment amount--in addition to the base primary care capitated payment amount--as a feature of primary care capitated payment arrangements in the Shared Savings Program. Specifically, we are interested in: [[Page 43945]] ++ Calculation: For example, in ACO REACH, the enhanced primary care payment is calculated as a fixed percentage of the ACO's performance year benchmark, while in ACO PC Flex, the Flex Enhancement component of the primary care payment is calculated as a fixed dollar amount ($125) per eligible beneficiary per year, with additional enhancements (i.e. the County Enhancement) derived from county-level or regional spending benchmarks. ++ Reconciliation: In ACO REACH, enhanced primary care capitation (EPCC) is subject to recoupment at the end of the performance year. In ACO PC Flex the enhanced amount is included in total cost of care, subject to offsets from the prior savings adjustment and/or the regional adjustment. We are interested in whether CMS should consider offering an advanced payment option (APO) within the Shared Savings Program, similar to the APO offered by the ACO REACH model, to ACOs that have elected PCC. Specifically, we are interested in: ++ Does the availability of an APO enhance an ACO's ability to align specialist financial incentives with the ACO's total cost of care goals, or do the structural and administrative requirements of implementing an APO within the Shared Savings Program present barriers that outweigh the potential benefits? ++ Do Shared Savings Program ACOs have access to sufficient data-- shadow bundles, claims data, public use files, and data from arrangements with other payers--to support the development and ongoing administration of an APO? If not, what data would be necessary? The ACO REACH model has offered TCC as a payment option for ACOs assuming the highest level of financial risk. The LEAD model also plans to offer TCC as a payment option for ACOs assuming the highest level of financial risk. We are interested in whether CMS should provide a full capitation option to Shared Savings Programs ACOs. Specifically, we seek feedback on: ++ Should CMS consider offering a full capitation option to Shared Savings Program ACOs that have demonstrated readiness to administer prospective payments, under which all Medicare Part A and Part B services furnished to assigned beneficiaries by ACO providers/suppliers billing through the TIN of ACO participants--but not services furnished to assigned beneficiaries by providers that are not on the ACO's participant list--would be paid through a TCC payment? ++ Should CMS limit full capitation to ACOs in tracks with the highest level of risk--ENHANCED track or BASIC track Level E--on the basis that full capitation should be reserved for ACOs that have already assumed downside financial risk and the organizational readiness to manage prospective payment for Medicare Part A and Part B services? ++ Are there other flexibilities that CMS should give ACOs to make TCC effective? ++ How should CMS calculate the per-beneficiary, per-month payment amount under a full capitation arrangement in the Shared Savings Program? Under ACO REACH, the monthly TCC payment amount paid to the ACO equals 1/12 of the performance year benchmark, adjusted by the TCC withhold.\109\ --------------------------------------------------------------------------- \109\ Because it is expected that a portion of the total cost of care for aligned beneficiaries will be for services provided by providers and suppliers not participating in the TCC arrangement, CMS will withhold a portion of the monthly TCC amount to avoid the need for significant year-end recoupments from the REACH ACOs. https://www.cms.gov/priorities/innovation/files/aco-reach-py26-financial-ops-capitation-payment-mechanisms.pdf. --------------------------------------------------------------------------- Should CMS issue prospective capitated payments on a monthly or quarterly basis? Please describe the potential advantages, disadvantages, and operational implications of each approach. Should capitated payments be paid to ACOs and distributed downstream to ACO participants, or should CMS make payments directly to ACO participants that provide primary care services, similar to how CMS makes payments for APCM services, and what are the implications of each approach? Should CMS consider alternative mechanisms for delivering capitated payments directly to ACO Participants that are also primary care practices participating in Shared Savings Program ACOs? If so, what payment design, infrastructure, and policy considerations should guide the development of such alternative payment mechanisms? If capitated payments are issued directly to ACOs, should CMS require ACOs to provide a specific percentage of those payments to ACO participants that provide primary care services? How might this be audited? Additionally, should CMS require ACOs to have written capitated payment agreements with ACO participants to specify that a minimum percentage of the capitated payment will flow to ACO participants? Care Delivery Requirements Should CMS require ACOs seeking to participate in capitated payment arrangements to make commitments to specific care delivery goals as a condition for participation? If so, what goals should be required and how should compliance be assessed and enforced? For example, we are interested in whether we should require ACOs to submit a primary care transformation plan--similar to the care delivery requirements under the CPC+ model, which required participating practices to demonstrate progress across five comprehensive primary care functions, including access and continuity, care management, comprehensiveness and coordination, patient and caregiver engagement, and planned care and population health--that specifies measurable targets for care delivery improvements, such as expanding after-hours access, increasing care management for high-risk beneficiaries, or reducing avoidable emergency department utilization. How should CMS balance meaningful capitated payment levels with reduced administrative and reporting burdens for participating ACOs, and what primary care delivery requirements should CMS establish as conditions of eligibility for capitated payment arrangements in the Shared Savings Program? Should compliance with any care delivery requirements be monitored on a quarterly or annual basis, with the potential for payment recoupment in cases of noncompliance? Should CMS require that ACOs and ACO participants receiving capitated payments demonstrate the use of data-driven risk stratification methods to identify high-risk beneficiaries and target enhanced care management resources toward those beneficiaries? CMS provides Shared Savings Program ACOs with data that could be used for risk stratification, such as claims-based beneficiary data, risk scores, and quality performance reports. We are interested in whether CMS should require ACOs and ACO participants to use these data as a baseline input for their risk stratification methodologies or whether ACOs and ACO participants should be given the flexibility to design their own risk stratification approaches. Should care delivery requirements for capitated payment eligibility increase depending on the level/type of capitated payment selected by the ACO or ACO participants? For example, should ACOs that are receiving a higher percentage of capitated payments be subject to more comprehensive care delivery requirements or should a uniform set of care delivery requirements apply to all ACOs, regardless of the percentage of capitated payments they receive? [[Page 43946]] c. Primary Care Capitated Payment Arrangements Considerations Outside of the Shared Savings Program Though CMS is first exploring the development of PPCP within the guardrails of accountable care discussed in the third section of this RFI, we are also considering extending these efforts in future years to develop a bundled or capitated approach, called a `global period' in the broader Original Medicare program (OM). In OM, many services, including surgical and maternity care services, are managed as `global' periods by OM, where reasonable and necessary medical services are delivered throughout an episode. Primary care, once an initiating visit has occurred, could also be reimbursed over an interval of care consistent with the development of a trusting, longitudinal relationship between clinician and patient. We have not previously proposed a primary care `global' period, in part because of the difficulty to ascertain where a primary care relationship starts, and where it stops, through claims data or other information readily obtained by CMS. We do attribute beneficiaries to organizations participating in alternative payment models, such as ACOs in the Medicare Shared Savings Program, based on a plurality of primary care services delivered and also maintain the possibility for beneficiaries to voluntarily align to a Shared Savings Program ACO through Medicare.gov where beneficiaries select a primary care provider. To establish a primary care global period would require a number of services to be `bundled' within the primary care global code family, including the IPPE or AWV, O/O E/M services, and care management services such as advanced primary care management services. Central to the challenge inherent in bundling together previously disparate services is ensuring beneficiaries would maintain access to care. CMS could monitor for any potential denials or limitations in care associated with the transition to a global period. We also would like to seek public input on which and how many of the services should be bundled, if they should be bundled entirely or through a `hybrid' capitation with reduced FFS model, and how best to establish the payment levels for this global period. We seek input on the following: What would be the appropriate services to bundle in such a primary care global period (e.g. E/M, care management codes, AWV, etc.)? How should the agency consider the benefits and drawbacks regarding quality of care, patient safety, and evidence regarding care delivery changes in a fully or globally capitated approach with no per- visit payment vs. a hybrid payment approach with reduced per-visit payment and per-member per-month payment? For both a fully capitated and hybrid payment approach, CMS has in past considered patient complexity (e.g. number of chronic conditions or HCC level) in our alternative payment models for primary care. How should CMS approach defining these levels or stratum for payments in a fully capitated or hybrid payment model for primary care? How many levels should be considered? In the absence of an encounter, is there another appropriate `trigger' or initiation for a primary care global period? How long should it last? Is beneficiary receipt of an AWV in the previous 12 months sufficient? What necessary reporting requirements and accountability should CMS require for clinicians receiving primary care capitated payments? For example, should there be explicit minimum visit requirements for a clinician to be eligible to receive primary care capitated payments for their Original Medicare patients? Should we require specific clinical outcomes-based reporting? If so, what clinical outcomes should we measure? Broadly, to what extent should the approach Original Medicare takes to primary care payment differ between the Shared Savings Program and the broader program? If yes, how? In so much as the agency considers a prospective primary care payment (PPCP) for primary care, to what extent should the IPPE/ AWV be the initiating visit for that global period?

F. Comprehensive Outpatient Rehabilitation Facility (CORF) Services and

KX Modifier Threshold, and Medical Review Threshold

1. Technical Corrections of CORF Regulations

During rulemaking for CY 2008 (72 FR 66399), we made several regulation text revisions and redesignations at Sec. 410.100 without changing a related regulatory provision of Sec. 410.105 for the requirements for coverage of CORF services. We also created a new subpart M at 42 CFR 414.1105 for payment of CORF items and services that includes references to Sec. 410.100 without making the corresponding revisions to the sections that were amended during CY 2008 PFS rulemaking. We are proposing to revise Sec. 410.105(b)(3)(ii) for the home environment evaluation to indicate that the home environment evaluation is specified at Sec. 410.100(l) and not Sec. 410.100(m) as it currently reads. We are proposing to amend the regulation at Sec. 414.1105(c) for CORF supplies and durable medical equipment to indicate that the supplies and durable medical equipment that are CORF services is specified at Sec. 410.100(k) instead of Sec. 410.100(l), as it currently reads. At the same time, we are also proposing to remove from Sec. 414.1105(c) language that relates to CORF drugs and biologicals because the provisions relating to payment for drugs and biologicals that are CORF services are at Sec. 414.1105(d), which was added in the CY 2008 PFS final rule. We are requesting comments on these proposals.

2. KX Modifier Thresholds

The KX modifier thresholds were established through section 50202 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 9, 2018) (BBA) and were formerly referred to as the therapy cap amounts. These per-beneficiary amounts under section 1833(g) of the Act (as amended by section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33, August 5, 1997) are updated each year based on the percentage increase in the Medicare Economic Index (MEI). Specifically, these amounts are calculated by updating the previous year's amount by the percentage increase in the MEI for the upcoming calendar year and rounding to the nearest $10.00. Thus, for CY 2027, we propose to increase the CY 2026 KX modifier threshold amount by the most recent forecast of the 2017-based MEI. For CY 2027, the proposed MEI increase is estimated to be 2.5 percent and is based on the expected historical percentage increase of the 2017-based MEI. Multiplying the CY 2026 KX modifier threshold amount of $2,480 by the proposed CY 2027 percentage increase in the MEI of 2.5 percent ($2,480 x 1.025) and rounding to the nearest $10.00 results in a proposed CY 2027 KX modifier threshold amount of $2,540 for physical therapy and speech-language pathology services combined and $2,540 for occupational therapy services. We also propose to update the MEI increase for CY 2027 based on historical data through the second quarter of 2026, and we propose to use such data, if appropriate, to determine the final MEI percentage increase and the CY 2027 KX modifier threshold amounts in the CY 2027 PFS final rule. [[Page 43947]] Section 1833(g)(7)(B) of the Act describes the targeted medical review (MR) process for services of physical therapy, speech-language pathology, and occupational therapy services. The threshold for targeted MR is $3,000 through CY 2027. Effective beginning with CY 2028, the MR threshold levels will be annually updated by the percentage increase in the MEI, per section 1833(g)(7)(B) of the Act. Consequently, for CY 2027, the MR threshold is $3,000 for physical therapy and speech-language pathology services combined and $3,000 for occupational therapy services. Section 1833(g)(5)(E) of the Act states that CMS shall identify and conduct targeted medical review using factors that may include the following: The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this title. The therapy provider has a billing pattern for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day. The therapy provider is newly enrolled under this title or has not previously furnished therapy services under this part. The services are furnished to treat a type of medical condition. The therapy provider is part of a group that includes another therapy provider identified using the factors described previously in this section. We track each beneficiary's incurred expenses for therapy services annually and count them towards the KX modifier and MR thresholds by applying the PFS rate for each service less any applicable multiple procedure payment reduction (MPPR) amount for services of CMS- designated ``always therapy'' services (see the CY 2011 PFS final rule at 75 FR 73236). We also track therapy services furnished by critical access hospitals (CAHs), applying the same PFS-rate accrual process, even though they are not paid for their therapy services under the PFS and may be paid on a cost basis (effective January 1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through 74410). When the beneficiary's incurred expenses for the year for outpatient therapy services exceed one or both of the KX modifier thresholds, therapy suppliers and providers use the KX modifier on claims for subsequent medically necessary services. Using the KX modifier, the therapist and therapy provider attest that the services above the KX modifier thresholds are reasonable and necessary and that documentation of the medical necessity for the services is in the beneficiary's medical record. Claims for outpatient therapy services exceeding the KX modifier thresholds without the KX modifier included are denied.

1. Advance Care Planning (ACP) Services (HCPCS Codes GACP1 and GACP2)

a. Background Medicare currently pays for ACP services as an optional element of the annual wellness visit (AWV) or a Part B medically necessary service (see 80 FR 70955 and https://www.cms.gov/files/document/mln-advanced-care-planning.pdf). While the Social Security Act covered a similar service as a voluntary part of the initial preventive physical exam under section 1861(ww)(3) of the Act since CY 2012, in CY 2016 we adopted new coding developed by the American Medical Association for payment of ACP services as a separate Part B medically necessary service or an optional element of the annual wellness visit (AWV). In this section of our proposed rule, we propose to create additional codes in this family that more explicitly describe and value the contributions of clinical staff in the provision of ACP services. We emphasize that clinicians must not, under any circumstances, attempt to influence their patients' decisions for ACP. For CY 2015, the CPT Editorial Panel created two new codes describing ACP services by physicians and other qualified healthcare professionals (QHPs): CPT code 99497 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to- face with the patient, family member(s), and/or surrogate) and an add- on code, CPT code 99498 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), by the physician or other qualified health care professional; each additional 30 minutes (List separately in addition to code for primary procedure)) (80 FR 70955). In the CY 2015 PFS final rule with comment period (79 FR 67670), we assigned a PFS interim final status indicator of ``I'' (Not valid for Medicare purposes. Medicare uses another code for the reporting and payment of these services. This code is not subject to a 90-day grace period.) to CPT codes 99497 and 99498. We had received many public comments in response to the CY 2015 proposed rule recommending that we recognize and make separate payment for both CPT codes, in view of the time required to furnish the services and their importance for the quality of care and treatment of the patient. In the CY 2015 PFS final rule with comment period we responded that we would consider paying for CPT codes 99497 and 99498 after we had the opportunity to go through notice and comment rulemaking (80 FR 70955). The following year, in the CY 2016 PFS final rule, we finalized our proposal to assign CPT codes 99497 and 99498 a PFS status indicator of ``A'' (Active) with RVUs based on the RUC recommended values. We adopted the RUC-recommended work RVU, physician time and direct PE inputs: 1.5 work RVUs and 1.4 work RVUs for CPT codes 99497 and 99498, respectively. We also added ACP as an optional element, at the beneficiary's discretion, of the AWV and made conforming changes to our regulations at Sec. 410.15 that describe the conditions for and limitations on coverage for the AWV (80 FR 70959). In addition to adopting both CPT codes, we adopted CPT provisions regarding the reporting of timed services (80 FR 70956). We have also instructed practitioners that when reporting ACP as part of managing a beneficiary's illness, the condition discussed with the beneficiary is reported on the claim, whether or not an E/M visit is billed the same day (https://www.cms.gov/files/document/mln-advanced-care-planning.pdf). When ACP services are part of an AWV and furnished on the same day by the same practitioner as the AWV, an administrative exam or exam diagnosis is reported along with modifier 33 indicating the ACP services are preventive and not subject to cost sharing (https://www.cms.gov/files/document/mln-advanced-care-planning.pdf). In the CY 2016 PFS final rule, we also adopted CPT's coding guidance for ACP performed in conjunction with an E/M visit. CPT prefatory language indicates that when using CPT codes 99497 and 99498, no active management of the problem(s) is undertaken during the time period reported, and these codes may be reported separately if performed on the [[Page 43948]] same day as most E/M visits.\110\ We cited a clinical vignette from the RUC recommendations, illustrating when the services described by CPT codes 99497 and 99498 could be reasonable and necessary for the diagnosis or treatment of illness or injury, stating that this could occur in conjunction with the management or treatment of a patient's current condition, such as a 68 year old male with heart failure and diabetes on multiple medications seen by his physician for the E/M of these two diseases, including adjusting medications as appropriate (80 FR 70955). In addition to discussing the patient's short-term treatment options, the patient might express interest in discussing long-term treatment options and planning, such as the possibility of a heart transplant if his congestive heart failure worsens, and advance care planning including the patient's desire for care and treatment if the patient suffers a health event that adversely affects the patient's decision-making capacity (80 FR 70956). In this case the physician would report a standard E/M CPT code for the E/M service and one or both of the CPT codes describing ACP, depending upon the duration of the ACP service (80 FR 70956). Moreover, the ACP service would not necessarily have to occur on the same day as the E/M service (80 FR 70956). --------------------------------------------------------------------------- \110\ Current Procedural Terminology, (CPT[supreg]) 2026 (CPT Codebook), Professional Edition, American Medical Association, page 61. --------------------------------------------------------------------------- The CPT Codebook published by the American Medical Association contains prefatory language that describes CPT codes 99497 and 99498 as a ``face-to-face service between a physician or other qualified health care professional and a patient, family member, or surrogate in counseling and discussing advance directives, with or without completing relevant legal forms.'' \111\ While this code descriptor language indicates that the time being billed is personally spent by the physician/QHP and the codes are valued accordingly, we finalized a provision in the CY 2016 PFS final rule that allowed the time of clinical staff to be counted if the billing physician or other billing practitioner managed, participated and meaningfully contributed to the provision of the services, because public commenters persuaded us that ACP was performed at times by a team of a treating physician or other treating practitioner and their staff. Therefore, in the CY 2016 PFS final rule (80 FR 70957), we stated that we believed the services described by CPT codes 99497 and 99498 could be appropriately provided by physicians or using a team-based approach where ACP would be provided by physicians, non-physician practitioners (NPPs), and other staff under the order and medical management of the beneficiary's treating physician or treating practitioner. To provide clarity on who could report the new codes, we noted that the CPT code descriptors described the services as furnished by physicians or other qualified health professionals, which for Medicare purposes, has been consistent with allowing these codes to be billed by the physicians and NPPs whose scope of practice and Medicare benefit category include the services described by the CPT codes and who are authorized to independently bill Medicare for those services. Therefore, we finalized that only these practitioners may report CPT codes 99497 and 99498, and ``incident to'' rules in Sec. 410.26 would apply when these services would be provided incident to the services of the billing practitioner under a minimum of direct supervision. We stated that we expected the billing physician or NPP, in addition to providing a minimum of direct supervision, to manage, participate and meaningfully contribute to the provision of the services. Also, we noted that PFS payment rules would apply when ACP is furnished incident to other physicians' services, including where applicable, that State law and scope of practice must be met (80 FR 70959). Accordingly, even though CPT codes 99497 and 99498 describe (and are valued as) services performed only by the billing practitioner, we finalized a policy allowing the time of clinical staff to be included since we did not have G codes at that time that would have provided coding specific to that situation. --------------------------------------------------------------------------- \111\ CPT Codebook 2026, AMA, page 61. --------------------------------------------------------------------------- b. Proposals for CY 2027 Since 2016, we have heard from interested parties that ACP services may be under-utilized because some practitioners believe that only time they personally spend can count. While growth in ACP services utilization has been increasing, interested parties have communicated to CMS that the increase in utilization is not commensurate with the need for ACP services. Utilization of ACP services has increased since 2016 from about 650,000 services to about 2.5 million per year in 2025. We note that for patients in critical care, advance care planning is bundled into payment for the critical care service codes (CPT codes 99291-2) and is therefore not separately billed, so these patients may receive ACP services that is not identifiable in the claims data. We believe that new coding could more accurately distinguish and value the work of the billing practitioners from time that is spent by their clinical staff in the provision of ACP services. Therefore, we are proposing to create two new HCPCS codes to describe ACP services furnished by clinical staff under the direct supervision of the billing physician or other practitioner (and incidental to their professional services), and proposing that the existing CPT codes 99497 and 99498 would only be used to report time personally spent by the billing practitioner. The proposed new codes would be: HCPCS G-code GACP1 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), first 20 minutes of clinical staff time with the patient, family member(s), surrogate directed by a treating physician or other treating qualified health care professional) and GACP2 (Advance care planning including the explanation and discussion of advance directives such as standard forms (with completion of such forms, when performed), each additional 20 minutes with the patient, family member(s), surrogate directed by a treating physician or other treating qualified health care professional (List separately in addition to code for primary procedure)). We are proposing a work RVU of 1.00 for HCPCS code GACP1, based on a crosswalk to the work time of CPT code 99490 (Chronic care management services with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored; first 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month). For direct PE, we are proposing 20 minutes of clinical labor (L037D) in the service period. We are proposing a work RVU of 0.7 for HCPCS code GACP2, based on a crosswalk to the work time of CPT code 99439 (Chronic care management services with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or [[Page 43949]] functional decline, comprehensive care plan established, implemented, revised, or monitored; each additional 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure)). For direct PE, we are proposing 20 minutes of clinical labor (L037D) in the service period. Under this proposal, the new G codes and CPT codes 99497 and 99498 could be reported together, if time thresholds by the billing practitioner and clinical staff were each met with these respective code sets. We are seeking public comment on whether it would be better for the new G codes to represent, and be valued for, the combined time of a billing practitioner and their clinical staff within a single code, in case, for example, the billing practitioner and staff did not meet time thresholds for separate reporting of their respective times, but might meet the threshold for a code combining their time. For both the existing codes (describing physician time but allowing use for clinical staff time, as discussed previously) and newly proposed ACP codes (describing clinical staff time) to be paid ``incident to,'' the reporting practitioner must furnish a prior professional service to which the services of the clinical staff are incidental, such as a prior E/M visit or ACP services personally performed by the billing practitioner the same day. Our manual provides that ``[s]uch a service or supply could be considered to be incident to when furnished during a course of treatment where the physician performs an initial service and subsequent services of a frequency which reflect his/her active participation in and management of the course of treatment'' (Medicare Benefit Policy Manual, Chapter 15, Section. 60.1.B, available at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf). We are seeking clarity from interested parties about whether these ``incident to'' criteria (the requirement for the billing practitioner to perform initial and subsequent services reflecting their participation in and management of the course of treatment) are typically met for beneficiaries needing ACP services, by a separately billed E/M visit (whether the same day as the ACP services or prior), or might best be included in a new code inclusive of combined time spent by both a reporting practitioner and their clinical staff. If the billing practitioner is by definition participating and managing by performing part of the ACP code itself, there would not be a need to require a prior initiating visit as we do for care management services provided ``incident to.'' To help us craft new coding in a manner that reflects typical clinical practice as well as ``incident to'' rules governing payment for services by clinical staff, we are seeking public comments that specify or clarify for the alternative new coding, the typical care team structure; how much time is typically spent by the billing practitioner and spent by their staff, and when; and the clinical circumstances of patients, for example, the care settings and whether the patient is typically a well patient or is doing advance care planning in conjunction with a particular illness. This would inform how the coding structure reflects work that is personally performed by the billing practitioner in conjunction with ACP. Medicare has not made a national coverage determination regarding ACP services; however, we note that in 2021 a Medicare Administrative Contractor made a Local Coverage Determination, revised in 2023. Contractors remain responsible for local coverage decisions in the absence of a national Medicare policy. We also note that direct supervision may be satisfied by audio visual technology. Furthermore, for CY 2027 we are proposing to add both HCPCS codes GACP1 and GACP2 to the Medicare Telehealth list. Finally, we note that we are aware of additional factors beyond the scope of this rule that could be influencing uptake of the existing codes. Among these are: practitioner training for bringing ACP up for voluntary discussion, how to ensure that care planning that includes delineation of patient goals, preferences and advance directives are available and actionable at the point of care (especially emergency care), enabling interoperable access to ACP information, lowering out- of-pocket costs for ACP services, and new quality measure that best capture meaningful ACP conversations and documented preferences.

2. Request for Information (RFI) on Community-Based Palliative Care

a. Background In the FY 2027 Hospice proposed rule, CMS solicited comment on the development of community-based palliative services outside of the hospice benefit (90 FR 17360). By community-based palliative care, we are broadly considering where palliative services can be delivered outside of the hospital, in outpatient clinics, in patients' homes, and other non-hospital settings. In this request for information we sought feedback on whether current evaluation and management (E/M) services, care management services, and ACP services reflected current billing and payment practices for physicians and other health professionals delivering palliative services, as well as on whether challenges in meeting documentation requirements, issues with compliance, or enhancements to current services could be considered to better enhance palliative care service delivery. In addition, in the 2027 ESRD proposed rule, concurrently, we are requesting information to advance payment policy and better understand the differences between maintenance dialysis and dialysis delivered in a comfort-focused context. Comments regarding either of these subjects are best delivered to their respective rules. In coordination with these requests for information, we are additionally seeking comment on the specific requirements we should consider given the prior CMS Innovation Center model tests focused on complex and serious illness care. The evaluation findings from these prior tests are best summarized in the CMS Innovation Center white paper on `Palliative care projects: Synthesis of Evaluation Results 2012-2021'.\112\ These results indicate that a comprehensive approach to palliative care services, including access to interdisciplinary teams, home visits, and shared-decision-making may improve care for Medicare beneficiaries. --------------------------------------------------------------------------- \112\ https://www.cms.gov/priorities/innovation/data-and-reports/2022/palliative-care-synthesis-2012-2021. --------------------------------------------------------------------------- We continue to prioritize reducing fraud, waste, and abuse throughout CMS programs, and have prioritized reducing fraud, waste, and abuse in hospice programs. While hospice care is not palliative care, in related disciplines and sites of care we are very interested in how to better address fraud, waste, and abuse. Where should CMS focus on potential fraud, waste, and abuse in community-based palliative care? Please support your statements with peer-reviewed evidence or evidence from your institution with sufficient detail for review. b. Eligibility for Serious Illness Care Defining which beneficiaries are eligible for serious illness care is a principal challenge in palliative and supportive care. While many Medicare beneficiaries may benefit from additional supportive care to manage pain and symptom burden, understanding which beneficiaries [[Page 43950]] should be eligible for this service is of central importance to Medicare. For example, complex chronic care management services require two or more chronic conditions placing the beneficiary at high risk for hospitalization, decline, or death, and requires moderate to high complexity medical decision-making. To elect the Medicare Hospice Benefit, two or more physicians must certify a beneficiary is within 6 months to the end of their life (or, if a beneficiary does not have an attending physician, then the hospice physician alone is permitted to provide the certification). We are requesting feedback on eligibility and care management services, and for all comments please support your statements with peer-reviewed evidence or evidence from your institution (in sufficient detail for review): For any future supportive or palliative care service for Medicare beneficiaries, should eligibility be restricted to certification of a likely life expectancy duration? If eligibility is restricted to those beneficiaries with a terminal prognosis, is there evidence to suggest a reasonable interval (that is, less than 1 year of life expectancy as in some States' Medicaid programs)? c. Eligibility for Palliative Services Defining eligibility for palliative services beyond the potential criterion of a terminal prognosis is likely necessary to better understand who is eligible for serious illness care.\113\ While for complex care management services we restrict eligibility to beneficiaries requiring moderate to complex medical decision making as well as a count of chronic conditions, common definitions of serious illness include not just chronic condition counts but also indicators of the impact on a person's daily function or excessive caregiver strain.\114\ --------------------------------------------------------------------------- \113\ Kelley AS, Covinsky KE, Gorges RJ, McKendrick K, Bollens- Lund E, Morrison RS, Ritchie CS. Identifying Older Adults with Serious Illness: A Critical Step toward Improving the Value of Health Care. Health Serv Res. 2017 Feb;52(1):113-131. doi: 10.1111/ 1475-6773.12479. Epub 2016 Mar 18. PMID: 26990009; PMCID: PMC5264106. \114\ https://pmc.ncbi.nlm.nih.gov/articles/PMC5756466/pdf/jpm.2017.0548.pdf. --------------------------------------------------------------------------- We are requesting feedback on the following: For any future supportive or palliative care service for Medicare beneficiaries, how could we consider impact on the daily functions of life or activities of daily living as part of who is eligible for the service? Would eligibility best be based on impact on daily function, on caregiver strain, or both? How can we avoid overly burdensome requirements for defining eligibility for services? d. The Future of the Care Management Services In section II.E. of this proposed rule, we are explicitly reconsidering the future of the care management services that form the basis for payment adequacy for important between visit care (in addition to E/M services for outpatient or home visits). Care for the seriously ill involves interdisciplinary care teams and involves even greater coordination and between visit care than primary care services.\115\ --------------------------------------------------------------------------- \115\ https://www.capc.org/toolkits/building-and-supporting-effective-palliative-care-teams/. --------------------------------------------------------------------------- We are requesting feedback on the following: How should we differentiate the care management requirements for seriously ill beneficiaries from other Medicare beneficiaries? What are the essential service elements that must be included? For example(s), continuity with a designated team member, access to timely clinical support, comprehensive symptom and caregiver assessment, electronic care plans, coordination with treating physicians, patient/caregiver education, timely follow up after ED/ discharge. What other service elements should be included? Should any not be included? e. Advanced Primary Care Management Currently, for Advanced Primary Care Management (APCM) services (HCPCS codes G0556 through G0558), we require physicians to report to the MIPS Value Pathway for primary care as part of our safeguards for high quality primary care. If we elect to develop additional care management services for seriously ill beneficiaries, however we may define serious illness in the future, determining how best to report quality of care safeguards will be essential to ensure high quality care delivery. We are requesting feedback on the following: Should care management services for seriously ill beneficiaries also require reporting to a MIPS Value Pathway? Which quality measures should be reasonably included? If no viable MIPS Value Pathway reporting mechanism is found, what are the essential quality elements required for palliative care management? Is sole reporting of ambulatory palliative care patients feeling heard and understood (CBE 3665) sufficient? Should other measures be considered?

3. Request for Information on Intensive Lifestyle Interventions To Slow

Progression of Alzheimer's Disease a. Background In the CY 2026 Physician Fee Schedule proposed rule, CMS sought comment in a `Prevention and Management of Chronic Disease' Request for Information (90 FR 32507), addressing management and self-management of chronic disease, services that address root causes of disease, social isolation and loneliness, improving physical activity, intensive lifestyle interventions, enhancing uptake of the annual wellness visit (AWV), supporting partnerships with AAAs and community care hubs, and addressing motivational interviewing and health coaching. For some topics, responses were of adequate depth for CMS to consider further action, addressed elsewhere in this rule, but as is not uncommon when CMS requests information across a broad range of topics, in other areas responses were limited in the depth and granularity necessary for CMS to address the resource costs to establish coding and payment options. Because of the overwhelming priority for CMS to support the aging processes, given that American older adults commonly cite their fear of Alzheimer's as an even greater health related fear than the development of cancer,\116\ and the growing evidence base for using lifestyle changes to slow the progression of cognitive decline and the development of Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD), CMS is requesting additional information to better understand the resource costs and requirements for developing intensive lifestyle interventions to reduce the risk of AD/ADRD for Medicare beneficiaries. Intensive lifestyle interventions would be in concert with but would not specifically include risk factor reduction in modifiable behaviors such as controlling contributing conditions (for example, hypertension, diabetes), eliminating tobacco use (in any form), and addressing hearing loss.\117\ In other [[Page 43951]] countries, there is randomized controlled trial evidence that multi- domain approaches can slow cognitive decline amongst at-risk older adults,\118\ which appear to be superior to individual domain interventions such as physical activity programming or diet changes.\119\ In the U.S. there have also been a number of studies demonstrating the potential impact of diet changes on cognition (for example, the MIND trial demonstrated improved cognition for both groups undergoing diet changes, however one diet was not shown to be superior).12 13 14 120 To support high-value care, the payer assuming financial risk for an individual's health would do so over a long-term to give that payer an incentive to invest in high-value care that reduces health care costs over that long-term. As discussed in the recent HHS Notice of Benefit and Payment Parameters for 2027,\121\ creating these incentives for payers throughout the healthcare system is an HHS priority. Outside of these needed incentives exists Medicare fee-for-service, which has historically employed price-setting regimes that are not market-based and are slow to change with improvements and health innovations. As HHS continues to improve incentives for private payers to invest in preventive health care, we are interested in how to ensure fee-for-service Medicare is similarly able to benefit from better incentives to invest in high-value care. --------------------------------------------------------------------------- \116\ Ornish, Dean, et al. ``Effects of Intensive Lifestyle Changes on the Progression of Mild Cognitive Impairment or Early Dementia Due to Alzheimer's Disease: A Randomized, Controlled Clinical Trial.'' Alzheimer's Research & Therapy, vol. 16, 2024, p. 122. https://link.springer.com/article/10.1186/s13195-024-01482-z. \117\ National Institute on Aging. ``Cognitive Health and Older Adults.'' National Institutes of Health, https://www.nia.nih.gov/health/brain-health/cognitive-health-and-older-adults. Accessed 30 Apr. 2026. \118\ Ngandu, Tiia, et al. ``A 2 Year Multidomain Intervention of Diet, Exercise, Cognitive Training, and Vascular Risk Monitoring versus Control to Prevent Cognitive Decline in At-Risk Elderly People (FINGER): A Randomised Controlled Trial.'' The Lancet, vol. 385, no. 9984, 2015, pp. 2255-2263. https://doi.org/10.1016/S0140-6736(15)60461-5. \119\ ``2024 Lancet Commission Underscores the Potential for Dementia Risk Reduction, Identifying 14 Modifiable Risk Factors across the Life Course.'' Alzheimer Europe, 31 July 2024, https://www.alzheimer-europe.org/news/2024-lancet-commission-underscores-potential-dementia-risk-reduction-identifying-14-modifiable. \120\ Barnes, Lisa L., et al. ``Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons.'' The New England Journal of Medicine, vol. 389, no. 7, 2023, pp. 602-611. https://www.nejm.org/doi/10.1056/NEJMoa2302368. \121\ https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10050.pdf --------------------------------------------------------------------------- To better understand resource costs associated with intensive, multi-domain interventions: Given the discussion of the evidence to date on the effectiveness of intensive lifestyle interventions for CMS to pursue, we are particularly interested in demonstrations of cost-savings associated with these and other interventions. Please cite any evidence available in your discussion. Given CMS' concern for addressing fraud, waste, and abuse throughout the Medicare program, please comment on any potential or observed FWA in diagnosis, treatment, or management of AD/ADRD. Given the emerging role of biomarker diagnostic testing (for example, p-tau217, et. al) for AD/ADRD leading to early diagnosis, please provide any evidence supporting earlier detection and its role in supporting improving AD/ADRD care and any potential role in identifying eligibility for an intensive lifestyle intervention focused on AD/ADRD. What are the essential domains to address in a multi- domain intensive lifestyle intervention to reduce the risk of cognitive decline for older adults at risk for developing AD/ADRD that would be appropriate to include under Medicare? Should these interventions be made available as a one-time service (that is, to teach older adults how to make changes in their lifestyle to help reduce AD/ADRD risk) or on a recurring (for example, annual) basis? Should the eligibility for these services be restricted to beneficiaries with a diagnosis of mild cognitive impairment (MCI), or early-stage dementia? If so, how should this diagnosis be made or confirmed? Respondents to the general intensive lifestyle intervention question in the prior RFI focused on the differentiation between intensive lifestyle interventions (ILIs) and intensive behavioral therapy (IBT) where ILIs are more multi-domain, longitudinal, and comprehensive and typically incorporate a multi-disciplinary team and are delivered in a community setting, and noting these are needed flexibilities that current IBT coding does not currently accommodate. To better understand the resource costs and requirements for future AD/ ADRD ILI services: Given ILI's are multi-domain, and likely include physical activity, nutrition, potentially additional domains such as sleep and stress management, who are the essential interdisciplinary team members that CMS should account for in developing appropriate resource costs for future services? How should supervision be determined for AD/ADRD ILI's? Is general supervision sufficient for ensuring clinical safety and oversight? Is direct supervision required? While there are many variations of ILI's focusing on AD/ADRD that are delivered, the essential `dose' of intervention or minimum frequency and duration of a future service, as well as the modality (that is, must this intervention be delivered purely in person, can it be delivered virtually) are all important to consider: What is the minimum frequency of sessions for an AD/ADRD ILI per week? What is the minimum number of weeks that will be necessary? Should CMS require a future AD/ADRD ILI to be delivered in person? Can it be delivered virtually? Finally, while we are currently accepting applications for a CMS Innovation Center payment model to generate evidence associated with lifestyle interventions (MAHA ELEVATE),\122\ including potentially intensive lifestyle interventions focused on reducing risk and/or slowing progression of AD/ADRD, currently CMS has no endorsement process for specific interventions. In development of the CMS Health Technology Ecosystem \123\ and the library of applications: --------------------------------------------------------------------------- \122\ Centers for Medicare & Medicaid Services. ``MAHA ELEVATE (Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-Based Approaches Through Evidence) Model.'' CMS.gov, 2026, https://www.cms.gov/priorities/innovation/innovation-models/maha-elevate. \123\ Centers for Medicare & Medicaid Services. ``Health Technology Ecosystem.'' CMS.gov, https://www.cms.gov/priorities/health-technology-ecosystem/overview. Accessed 30 Apr. 2026. --------------------------------------------------------------------------- How should CMS support the development of our Health Technology Ecosystem to support older adults reducing their risk for developing AD/ADRD using intensive lifestyle changes? Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency's full consideration, are not generally considered information collections and therefore not subject to the PRA.

H. Current Procedural Terminology (CPT) Request for Information (RFI)

The Current Procedural Terminology (CPT[supreg]) coding system is owned and copyrighted by the American Medical Association (AMA) and CMS uses CPT[supreg] under a royalty-free licensing agreement with the AMA.\124\ The CPT[supreg] coding [[Page 43952]] system was introduced by the AMA in 1966,\125\ in part to ``encourage the use of standard terms and descriptors to document procedures in the medical record'' and ``help communicate accurate information on procedures and services to agencies concerned with insurance claims,'' and it ``provided the basis for a computer oriented system to evaluate operative procedures and contributed basic information for actuarial and statistical purposes.'' \126\ The CPT[supreg] coding system went through a series of early version changes and in 1977 the AMA established the CPT-4 or 4th edition which established the current five-digit numeric structure of the CPT[supreg] coding system still used today.\127\ The Health Care Financing Administration or HCFA, later renamed CMS,\128\ in 1983 required the use of the Healthcare Common Procedure Coding System (HCPCS) for physician services and expanded to non-physician services in 1991.\129\ and since this time HCPCS Level I services have been considerd synonymous with CPT, where Level II HCPCS refers to additional products, supplies, and services not included in the CPT[supreg] codes.\130\ --------------------------------------------------------------------------- \124\ Centers for Medicare & Medicaid Services. AMA Terms and Conditions. Centers for Medicare & Medicaid Services, n.d., https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/AMA-Terms-Conditions.pdf. \125\ American Medical Association. History of CPT[supreg] Content. American Medical Association, 5 Dec. 2025, https://www.ama-assn.org/practice-management/cpt/history-cpt-content. \126\ American Medical Association. The Purpose of the CPT[supreg] Coding System & the CPT[supreg] Editorial Panel. American Medical Association, 10 Sept. 2025, https://www.ama-assn.org/about/cpt-editorial-panel/purpose-cpt-coding-system-cpt-editorial-panel. \127\ American Medical Association. The Purpose of the CPT[supreg] Coding System & the CPT[supreg] Editorial Panel. American Medical Association, 10 Sept. 2025, https://www.ama-assn.org/about/cpt-editorial-panel/purpose-cpt-coding-system-cpt-editorial-panel. \128\ Centers for Medicare & Medicaid Services, Department of Health and Human Services. Statement of Organization, Functions, and Delegations of Authority. Federal Register, 5 July 2001, https://www.federalregister.gov/documents/2001/07/05/01-16800/centers-for-medicare-and-medicaid-services-statement-of-organization-functions-and-delegations-of. \129\ Medicare Program; Fee Schedule for Physicians' Services; Proposed Rule. Federal Register, vol. 56, no. 108, 5 June 1991, pp. 25792-25978. U.S. Government Publishing Office, https://www.govinfo.gov/content/pkg/FR-1991-06-05/pdf/FR-1991-06-05.pdf \130\ Centers for Medicare & Medicaid Services. ``Healthcare Common Procedure Coding System (HCPCS).'' Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services, https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system. Accessed 7 July 2026. --------------------------------------------------------------------------- Following the passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) the Department of Health and Human Services (HHS) in subsequent regulation defined the combination of HCPCS, as maintained and distributed by HHS, and CPT-4, as maintained and distributed by the AMA, as the nationally required medical data code sets for physician services, physical and occupational therapy services, radiologic procedures, clinical laboratory tests, other medical diagnostic procedures, hearing and vision services, and transportation services including ambulance services (45 CFR 162.1002(a)(5)). This is commonly understood as a regulatory requirement for CPT-4 codes to be used to define physician services. While this is HHS' current regulatory interpretation of the HIPAA (Pub.

L. 104-191), it is important to note that HHS has only specified in

regulation that HCPCS and CPT-4 to be used in combination. There is no specification in the HIPAA statute regarding the manner in which these national coding sets may be used or how they may be combined, and only HHS interpretation, not the Act itself, mentions CPT[supreg]. New CPT[supreg] codes are introduced by the CPT[supreg] Advisory Committee. This committee was established following the initial publication of the CPT[supreg] coding system in 1966, which provides advice on procedure coding and appropriate nomenclature as relevant to the committee member's specialty and consists of ``members of national medical specialty societies seated in the AMA House of Delegates.'' \131\ When a new CPT[supreg] code is defined by the CPT[supreg] Advisory Committee, it is then assigned a payment value by the AMA Relative Value Scale Update Committee or RUC.\132\ --------------------------------------------------------------------------- \131\ American Medical Association. CPT[supreg] Nominations & Opportunities. American Medical Association, 11 Feb. 2025, https://www.ama-assn.org/about/cpt-editorial-panel/cpt-nominations-opportunities. \132\ American Medical Association. RVS Update Committee (RUC). American Medical Association, 4 Mar. 2026, https://www.ama-assn.org/about/rvs-update-committee-ruc/rvs-update-committee-ruc. --------------------------------------------------------------------------- The AMA RUC was established in 1992, after CMS transitioned to the resource-based relative value scale (RBRVS) to provide recommendations on the valuation of physician services. As established in section 1848 of the Act, CMS began paying for physician services in 1998 on the basis of a product of the relative value of the physician service, incorporating the physician work, the practice expense, and the malpractice component. These elements form the basis for the RBRVS. The components of physician services were originally established by a team of Harvard researchers (William Hsiao, et al.) and CMS has occasionally referenced the `Harvard' valuations making reference to these original contributions.\133\ According to the AMA, the AMA RUC ``provides medicine a voice in shaping Medicare relative values,'' and by all published estimates this has been an effective mechanism.\134\ --------------------------------------------------------------------------- \133\ Hsiao WC, Braun P, Kelly NL, Becker ER. Results, Potential Effects, and Implementation Issues of the Resource-Based Relative Value Scale. JAMA. 1988;260(16):2429-2438. doi:10.1001/ jama.1988.03410160105013. \134\ American Medical Association. RVS Update Committee (RUC). American Medical Association, 4 Mar. 2026, https://www.ama-assn.org/about/rvs-update-committee-ruc/rvs-update-committee-ruc. --------------------------------------------------------------------------- There has also been longstanding concern expressed over the Federal reliance on a private organization with such an obvious conflict of interest as providing information on the time and resource requirements to conduct physician services when this information may influence their own payment. For nearly 20 years, MedPAC has expressed concern over the influence of the AMA RUC to value services, specifically noting that CMS has ``over-relied on specialty societies with a financial stake in the process'' and has recommended that CMS establish a separate group of experts to make payment recommendations.\135\ Further, we note the historic reliance on the CPT and RUC process as a potential contributor to the development of US health care as a `sick care` system with limited emphasis on prevention and lifestyle modifications and which may inhibit progress on the Secretarial priority to Make America Healthy Again. Additionally, we note a recent National Academies of Sciences, Engineering, and Medicine (NASEM) report recommending RUC alternatives for establishing primary care payment valuation and recommendations for alternative sources for data collection.\136\ --------------------------------------------------------------------------- \135\ Medicare Payment Advisory Commission. Testimony: Options to Improve Medicare's Payments to Physicians. 8 May 2007, https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/congressional-testimony/051007_Testimony_MedPAC_physician_payment.pdf. \136\ National Academies of Sciences, Engineering, and Medicine. Improving Primary Care Valuation Processes to Inform the Physician Fee Schedule. National Academies Press, 2025, https://doi.org/10.17226/29069. --------------------------------------------------------------------------- Given these longstanding concerns, we are seeking comment on a number of areas regarding the influence of the CPT[supreg] coding system and AMA process on physician payment policy as part of the Secretarial priority to Make America Healthy Again. (1) What, if any, evidence is there for CMS to consider regarding the harms or [[Page 43953]] challenges associated with AMA's monopoly over CPT-4 licenses for health care entities? Please cite potential improvements to patient care diverted or delayed due to AMA'S monopoly over CPT codes, including inhibited innovations and acquisition or maintenance costs of CPT[supreg] licensure. (2) What, if any, evidence is there that the generation of CPT-4 codes follows a process of identification of medical necessity? What opportunities or examples from other populations, sites of care, or international health systems could instruct a process of identification of medical necessity in the CPT-4 code development process? (3) A combination of CPT-4 and HCPCS codes were formally adopted by HHS as the legal standard for national coding for physician and other services as part of implementing HIPAA (45 CFR 162.1002(a)(5)). If CMS were to revisit this standard in future rulemaking, which if any alternatives exist to CPT-4 for CMS to consider as part of the national coding standard for physician services? Would CMS need to specify a separate legal standard, or could CMS allow for private competition to supplement the existing CPT-4 coding standard? (4) What objective alternatives exist, or could be developed, to maintain a more objective process to the current AMA CPT and RUC committee processes? How would these alternatives support or inhibit innovation? (5) What are the benefits and drawbacks of paying for physician procedural services on the basis of the underlying International Classification of Diseases, 10th Revision (ICD-10) procedure code, as an alternative to CPT-4 code? How could the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) services be grouped or bundled into payment categories, similar to Medicare Severity Diagnosis Related Groups (MS-DRGs), or Outpatient Prospective Payment System (OPPS) Ambulatory Payment Classifications (APCs)? What other alternatives exist for bundling or grouping procedural services?

1. Requiring Manufacturers of Certain Single-Dose Container or Single-

Use Package Drugs To Provide Refunds With Respect to Discarded Amounts (Sec. Sec. 414.902 and 414.940) a. Background Section 1847A(h) of the Act requires manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single- dose container or single-use package drug (hereinafter referred to as ``refundable drug'') for calendar quarters beginning January 1, 2023. The calculation of the refund is codified at Sec. 414.940(c). For a new refund quarter (as defined at Sec. 414.902) beginning on or after January 1, 2023, an amount equal to the estimated amount (if any) by which: The product of the total number of units of the billing and payment code for such drug that were discarded during such new refund quarter; and the amount of payment determined for such drug or biological under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such new refund quarter. Exceeds an amount equal to the applicable percentage of the estimated total allowed charges for such drug for the new refund quarter. Section 1847A(h)(3)(B)(i) of the Act establishes an applicable percentage of 10 percent, but provides that, in the case of a refundable drug that has unique circumstances involving similar loss of product as that described in section 1847A(h)(8)(B)(ii) of the Act, the Secretary, through notice and comment rulemaking, may increase such applicable percentage as determined appropriate by the Secretary. Section 1847A(h)(8)(B)(ii) of the Act describes a drug or biological approved by the Food and Drug Administration (FDA) for which dosage and administration instructions included in the labeling require filtration during the drug preparation process, prior to dilution and administration, and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process. Drugs with an increased applicable percentage are listed on the CMS website.\137\ --------------------------------------------------------------------------- \137\ https://www.cms.gov/medicare/payment/part-b-drugs/discarded-drugs. --------------------------------------------------------------------------- For previous rulemaking in which we finalized to increase the applicable percentage of a drug with unique circumstances involving similar loss of product as that described in section 1847A(h)(8)(B)(ii) of the Act, we explained specifically why the loss of product met the statutory requirements. In the CY 2023 Physician Fee Schedule (PFS) final rule (87 FR 69729), we finalized an increase in the applicable percentage for a drug reconstituted with a hydrogel and administered via ureteral catheter or nephrostomy tube into the kidneys, where a substantial amount of reconstituted hydrogel adheres to the vial wall during preparation and cannot be withdrawn for administration. Because this unavoidable preparation-related loss is similar to the loss described in section 1847A(h)(8)(B)(ii) of the Act, we stated that such a drug that is reconstituted with a hydrogel and has variable dosing based on patient-specific characteristics (for example, Jelmyto[supreg] (mitomycin for pyelocalyceal solution)) should be considered to have unique circumstances as described in section 1847A(h)(3)(B)(ii) of the Act that would warrant an increased applicable percentage. In the CY 2024 PFS final rule (88 FR 79052), we increased the applicable percentage for certain drugs with low volume doses and stated that such drugs have unique circumstances because certain FDA- labeled amounts on the vial or package are unused and discarded after administration of the labeled dose and these amounts are not available to be administered. The unique circumstances described for such drugs are similar to loss of product from filtration described in section 1847A(h)(8)(B)(ii) of the Act because in both circumstances, such amounts lost are amounts that are not part of the recommended dose and are not available to be administered to the patient (one being loss due to labeled amounts remaining in the filter and the other due to labeled amounts remaining in other areas such as the vial or syringe). In the CY 2024 PFS final rule, we also finalized an increased applicable percentage for certain orphan drugs furnished to fewer than 100 unique beneficiaries per calendar year. We explained (88 FR 79053 through 79057) that because of the substantial statistical variation (based on demonstrated JW modifier claims data from 2021 and 2022) from quarter to quarter for such drugs, we believe it would be difficult to optimize the presentation of the drug to consistently minimize the discarded amounts to less than 10 percent given the small number of patients receiving the drug. We considered the higher percentage of unused and discarded amounts from such drugs as [[Page 43954]] unavoidable loss due to both the low number of unique beneficiaries receiving the drug contributing statistically higher variability in discarded amounts. Also, due to the low numbers of patients available to study for rare disease, it may be more difficult to determine the most efficient vial size for the patient population who receive the drug post-marketing. We stated this is similar to the loss of product due to filtration described in section 1847A(h)(8)(B)(ii) of the Act because the loss is unavoidable in both circumstances. In the case of filtration described in statute, the loss is unavoidable because certain amounts of product will be left within the filter and unavailable for administration; in the case of rarely utilized orphan drugs, the loss is unavoidable because of the variability of potential doses (and low number of patients receiving the drug) leading to an inability to develop a package size that will result in a consistent average percentage of discarded units. We stated in the CY 2024 PFS final rule (88 FR 79057) that we do not consider the following to be unique circumstances warranting an increased applicable percentage at this time: weight-based doses, body surface area (BSA)-based doses, varying surface area of a wound, loading doses, escalation or titration doses, tapering doses, and dose adjustments for toxicity because we believe manufacturers can optimize the availability of products for these circumstances to limit the percentage of discarded units for a drug, unlike the circumstances of manufacturers of drugs that require filtration during the preparation process, as described in section 1847A(h)(8)(B)(ii) of the Act. We also explained in the CY 2024 PFS final rule (88 FR 79060) that, while we cannot anticipate future drug development or what unique circumstances might arise, we can offer our analysis of the unique circumstances we consider involving similar loss of product as that described in section 1847A(h)(8)(B)(ii) of the Act for drugs that are reconstituted in hydrogel and with variable dosing based on patient- specific characteristics (87 FR 69727 through 69731), drugs with low volume doses, and rarely utilized orphan drugs (88 FR 79052 through 79057). Regarding examples of evidence, we noted minimum vial fill studies and dose preparation studies in the CY 2024 PFS proposed rule, both of which are suitable for justifying increased applicable percentages because they can establish that certain unusable amounts of a product are necessarily included in a container to safely and consistently administer the labeled therapeutic dose to a patient. b. Application for Increased Applicable Percentage Section 1847A(h)(3)(B)(ii) of the Act permits the Secretary to increase the applicable percentage for a refundable drug that has unique circumstances through notice-and-comment rulemaking. In the CY 2024 PFS final rule (88 FR 79057 through 79060), we finalized an application process (CMS-10835, OMB 0938-1435) by which manufacturers can apply for an increased applicable percentage for a drug and may request that we consider an individual drug to have unique circumstances for which an increased applicable percentage is appropriate. Under Sec. 414.940(e)(2), an application must be submitted by February 1 of the CY prior to the year the increased applicable percentage would apply; for a drug that is not FDA-approved by February 1, the application must have FDA approval by August 1, and the manufacturer must notify CMS and submit the FDA-approved label by September 1 of that year. The application must include a written request that the drug be considered for an increased applicable percentage based on its unique circumstances; FDA-approved labeling for the drug (or, if the drug is not approved by the February 1 application deadline described in paragraph (e)(2) of this section, documentation of FDA acceptance of the application for review); justification for the consideration of an increased applicable percentage based on such unique circumstances; and justification for the requested increase in the applicable percentage. Following review of timely applications, CMS will summarize its analyses of applications and propose appropriate increases in rulemaking. If adopted, the increased applicable percentage will be the applicable percentage beginning January 1 of the following calendar year. We received one application requesting an increased applicable percentage for consideration for CY 2027 from the manufacturer of Leukine[supreg] (sargramostim),\138\ who resubmitted a request for a 72 percent applicable percentage after applying the previous 2 years. The applicant submitted the information required at Sec. 414.940(e)(1), including, as applicable, FDA-approved labeling for the drug, justification for consideration of an increased applicable percentage, and justification for the requested applicable percentage. --------------------------------------------------------------------------- \138\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103362s5249lbl.pdf. --------------------------------------------------------------------------- Leukine[supreg] is a leukocyte growth factor with five FDA-approved indications related to hematological conditions and hematopoietic recovery, as well as one indication to increase survival following acute exposure to myelosuppressive doses of radiation. The applicant's submitted FDA-approved labeling for the drug does not include the adjuvant uses described in the application (further described later in this paragraph) due to ongoing cancer vaccine adjuvant trials. The applicant reemphasized that multiple sponsors are in late-stage development, with a total of 27 Phase II and Phase III clinical trials, an increase from 22 reported in the previous year, investigating Leukine[supreg] as a vaccine adjuvant for oncology indications, specifically to stimulate the immune response of dendritic cells when used alongside these vaccines. We note that cancer treatment vaccines differ from the vaccines that protect against viruses, such as the influenza virus. Instead of preventing disease, cancer treatment vaccines aim to stimulate the immune system to attack existing cancer cells in the body.\139\ The applicant stated that it has no ownership stake in the development of these cancer treatment vaccines and does not possess control or influence over the design and execution of the clinical trials. The applicant further explained that the estimated completion dates for Phase III clinical trials vary, with the earliest expected in late 2026 140 141 and the latest in March 2029.\142\ --------------------------------------------------------------------------- \139\ https://www.cancer.org/cancer/managing-cancer/treatment-types/immunotherapy/cancer-vaccines.html. \140\ https://clinicaltrials.gov/study/NCT04229979. \141\ https://clinicaltrials.gov/study/NCT05232916. \142\ https://clinicaltrials.gov/study/NCT05100641. --------------------------------------------------------------------------- The adjuvant use of Leukine[supreg] in predetermined dosage is distinct from its six FDA-approved indications, all of which have dosages that are based on body weight or body surface area (BSA). The adjuvant use dosages of Leukine[supreg] in clinical trials are generally much smaller than dosages for indications in the FDA-approved labeling. The smallest dose of Leukine[supreg] used for vaccine adjuvant purposes of which the applicant is aware (that is, 70 mcg) would lead to as much as 72 percent of the drug being discarded from a single-dose 250 mcg lyophilized vial, which is the only size available commercially. The applicant suggests that if use of these small doses were to become more common for an approved indication, the percentage of discarded units could [[Page 43955]] increase the discarded drug refund amount that could be owed by the applicant, even though the applicant lacks control or knowledge of the potential variability of the discarded amounts that may occur if Leukine[supreg] were used for such purposes. The applicant notes that if another manufacturer were to seek FDA approval for adjuvant use of sargramostim but was not involved in its production, the available single-dose 250-mcg vial presentation of Leukine[supreg] would likely not be optimized for the small doses being studied in these trials. The applicant also expresses concern about potential refund liability if small-dose adjuvant use becomes more common. The application builds on prior submissions by reiterating that Leukine[supreg] appears on FDA's list of essential medicines,\143\ that the Administration for Strategic Preparedness and Response (ASPR) has documented a requirement to procure and stockpile Leukine[supreg] as a medical countermeasure for neutropenia resulting from acute radiation syndrome,\144\ and that the applicant continues to collaborate with the Biomedical Advanced Research and Development Authority (BARDA). In this application, the applicant also newly states that Leukine[supreg] has been designated a ``Medical Product Priority'' by the Department of Defense (DoD) under Public Law 115-92 (enacted December 12, 2017).\145\ DoD maintains a Medical Product Priority list as part of the DoD-FDA coordination framework established following Public Law 115-92 and formalized in the FDA-DoD Memorandum of Understanding.\146\ Under this framework, DoD identifies and maintains a list of its highest-priority medical products to support focused, recurring engagement with FDA; however, we could not corroborate a Leukine[supreg] designation using resources available for public review. The applicant's 2022 public announcement of an Other Transaction Agreement with the DoD references Leukine[supreg] as a potential medical countermeasure for sulfur mustard gas exposure,\147\ but it does not reference a ``Medical Product Priority'' designation. Additionally, a study published in 2025 comparing essential medicines across U.S. Federal agencies and the World Health Organization did not identify Leukine[supreg] on DoD's operational medicines list. The study noted that the DoD operational medicines list is a subset of FDA's essential medicines list--meaning medicines on the DoD list also appear on FDA's list, but not all medicines on FDA's list appear on the DoD list.\148\ Nevertheless, these emergency-response and preparedness-related listings or designations do not, by themselves, demonstrate unique circumstances related to discarded amounts for purposes of an increased applicable percentage because they are designed to support Federal planning, procurement, and interagency coordination to ensure adequate supply of essential products, rather than to provide evidence of drug-specific, unavoidable product loss similar to loss of product as described in section 1847A(h)(8)(B)(ii) of the Act. --------------------------------------------------------------------------- \143\ https://www.fda.gov/media/143406/download?attachment. \144\ https://sam.gov/opp/f4735f1f235847a0bb138c13333097de/view. \145\ To amend the Federal Food, Drug, and Cosmetic Act to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war, Public Law 115-92, 131 Stat. 2023 (2017). \146\ https://www.fda.gov/about-fda/domestic-mous/mou-225-19-001. \147\ https://www.partnertx.com/partner-therapeutics-announces-contract-with-u-s-department-of-defense-for-advanced-development-of-leukine-to-treat-sulfur-mustard-gas-hd-exposure/. \148\ ML Janvrin, A Kanagaratnam, VA Suarez et al. A comparison of the essential medicines lists of the U.S. Department of Health and Human Services, the U.S. Department of Defense, the U.S. Food and Drug Administration, and the World Health Organization, Journal of the American Pharmacists Association, 65(5),2025. --------------------------------------------------------------------------- As part of CMS' review of the application, we analyzed existing claims data from the first quarter of 2018 through the last quarter of 2025 and found the percentage of units discarded for Leukine[supreg] (HCPCS code J2820) ranged from 1.1 percent to 4.9 percent, which is below the applicable percentage of 10 percent. The quarterly discarded percentages during this time frame were stable, with a standard deviation of less than 1 percentage point and values tightly clustered around a mean of approximately 2.4 percent. This is notably lower than the 6.21 percent average standard deviation observed for rarely utilized orphan drugs, as reported in the CY 2024 PFS final rule (88 FR 79053). Accordingly, the applicant's requested applicable percentage relies on assumptions about hypothetical future dosing and utilization that are not evident in Part B claims data available to date. At the time of the CY 2026 PFS proposed rule, the impact of a potential adjuvant indication with a type of immunotherapy commonly referred to as cancer vaccines \149\ on the current percentage of units discarded was uncertain. Additionally, it was not yet known whether sargramostim would be approved for additional indications and dosages described by the applicant, and the available data was insufficient for CMS to determine whether Leukine[supreg] had unique circumstances prompting an increase in the applicable percentage. Therefore, we did not propose to increase the applicable percentage in the CY 2026 PFS proposed rule. The applicant agreed with CMS' rationale for this decision. --------------------------------------------------------------------------- \149\ https://www.cancerresearch.org/treatment-types/cancer-vaccines. --------------------------------------------------------------------------- Although the applicant agreed with CMS's rationale in the CY 2026 PFS proposed rule, they submitted a new application for CY 2027 with updated information on oncology vaccine-adjuvant clinical trials and projected timing for potential FDA approvals, as well as an asserted DoD ``Medical Product Priority'' designation. However, the core uncertainties identified in the CY 2026 PFS proposed rule persist: the absence of FDA-approved labeling for the asserted adjuvant indication(s) or dosage(s) and uncertainty regarding whether such uses would be utilized to an extent that discarded amounts would exceed the applicable percentage in a calendar quarter. The existing claims data and trends for discarded amounts of sargramostim discussed earlier do not support a determination that Leukine[supreg] has qualifying unique circumstances that would support an increased applicable percentage under section 1847A(h)(3)(B)(ii) of the Act. Unlike the analysis leading to an increased applicable percentage for certain orphan drugs as described earlier in the Background section III.A.1.a. of this proposed rule, which relied on evidence indicating that certain orphan drugs have unavoidable loss of drug similar to the loss of product described in section 1847A(h)(8)(B)(ii) of the Act, the justification presented by the applicant for an increased applicable percentage for their product is based largely on projections regarding potential future oncology vaccine-adjuvant use at smaller doses. These projections assume a utilization scenario in which sargramostim use would shift predominantly to the studied indications at the lowest study dose discussed earlier in this section, rather than remaining primarily under the FDA-approved indications, for which claims data currently demonstrate very low discarded amount percentages with no trending increase. In the absence of qualifying unique circumstances, we do not reach the question of whether the requested applicable percentage would be appropriate. Accordingly, we are not proposing an increase in the applicable percentage for [[Page 43956]] Leukine[supreg] for CY 2027. The applicant may reapply in a future application cycle when more information, such as FDA-approved labeling reflecting new indications or dosages, becomes available. We welcome comments on the application for increased applicable percentage.

1. Background on RHC and FQHC Payment Methodologies

As provided in 42 CFR part 405, subpart X of our regulations, RHC and FQHC visits generally are defined as face-to-face encounters between a patient and one or more RHC or FQHC practitioners during which one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, nurse practitioners (NPs), physician assistants (PAs), Certified Nurse Midwives (CNMs), clinical psychologists (CPs), licensed marriage and family therapists, mental health counselors, and clinical social workers, and, subject to certain conditions, a registered nurse or licensed practical nurse that is furnishing care to a homebound RHC or FQHC patient in an area verified as having shortage of home health agencies. Transitional Care Management (TCM) services can also be paid by Medicare as an RHC or FQHC visit. In addition, Diabetes Self-Management Training (DSMT) or Medical Nutrition Therapy (MNT) services furnished by a certified DSMT or MNT program may also be considered FQHC visits for Medicare payment purposes. Only medically necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner are RHC or FQHC billable visits. Services furnished by auxiliary personnel acting under the supervision of the RHC or FQHC practitioner, are considered incident to the visit and are included in the per-visit payment. RHCs generally are paid an all-inclusive rate (AIR) for all medically necessary medical and mental health services and qualified preventive health services furnished on the same day (with some exceptions). The AIR is subject to a payment limit, meaning that an RHC will not receive any payment beyond the specified limit amount per visit. As of April 1, 2021, all RHCs are subject to statutory upper payment limits determined in accordance with section 1833(f) of the Act, as amended by section 130 of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260). FQHCs were paid under the same AIR methodology until October 1, 2014. Beginning on that date, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the Patient Protection and Affordable Care Act (Pub. L. 111-148, March 23, 2010)), FQHCs began to transition to the FQHC PPS system, in which they are paid based on the lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services by the FQHC PPS geographic adjustment factor (GAF). The rate is increased by 34 percent when an FQHC furnishes care to a patient that is new to the FQHC, or to a beneficiary receiving an initial preventive physical examination (IPPE) or has an annual wellness visit (AWV). Section 1834(o)(2)(B)(ii) requires the FQHC PPS base rate be updated annually by the percentage increase in a market basket of Federally qualified health center goods and services as promulgated through regulations, or if such an index is not available, by the percentage increase in the Medicare Economic Index (MEI) (as defined in section 1842(i)(3)) for the year involved. See section III.B.4 of this proposed rule, for the proposed CY 2027 updates. Under the general authority of section 1834(o) of the Act, CMS codified at Sec. Sec. 405.2462 and 405.2464 to pay historically excepted tribal FQHCs using the Medicare outpatient per visit rate established annually by IHS, rather than the FQHC PPS rate (80 FR 71089). These rates are set by IHS under sections 321(a) and 322(b) of the Public Health Service (PHS) Act based on prior-year cost reports. The outpatient per visit rate applies only to provider-based IHS or tribal facilities (Sec. 413.65(m)) and historically excepted tribal FQHCs. For CY 2026, the rate is $733 per visit in the lower 48 States. Both the RHC AIR and FQHC PPS payment rates were initially designed to reflect the cost of all services and supplies that an RHC or FQHC furnished to a patient in a single day. These nearly all-inclusive rates are not adjusted at the individual level for the complexity of individual patient health care needs, the length of an individual visit, or the number or type of practitioners involved in the patient's care. Instead for RHCs, all costs for the facility over the course of the year are aggregated, and an AIR is derived from these aggregate expenditures. Section 1834(o)(2)((B)(ii) of the Act requires the FQHC PPS base rate be updated annually by the percentage increase in a market basket of Federally qualified health center goods and services as promulgated through regulations, or if such an index is not available, by the percentage increase in the MEI (as defined in section 1842(i)(3)) of the Act for the year involved. RHCs and FQHCs are also paid for non-face-to-face care management work involved in coordinating care outside of the RHC AIR and FQHC PPS (Sec. 405.2464(c)). That is, payment is based on the PFS national non- facility payment rate and is made in addition to the otherwise billable visit for patients utilizing chronic care management (CCM), principal care management (PCM), general behavior health integration (BHI), chronic pain management (CPM), remote physiologic monitoring (RPM), remote therapeutic monitoring (RTM), community health integration (CHI), principal illness navigation (PIN), PIN-peer support services, advanced primary care management (APCM), and psychiatric collaborative care model (CoCM). In addition, payment is based on the PFS national non-facility payment rate and is made in addition to the otherwise billable visit for communication technology-based services (CTBS) and remote evaluation services (Sec. 405.2464(e)). In the CY 2026 PFS final rule (90 FR 49556 through 49558), we finalized a policy that effective January 1, 2026, services that are established and paid under the PFS and designated as care management services would be considered ``care coordination services'' for purposes of separate payment for RHCs and FQHCs. The care coordination codes can be found in the PFS table entitled ``Designated Care Management Services'', which is published annually with the PFS Final Rule Addenda on the CMS website.

2. Payment for Certain Preventive Services

a. Background Medicare Part B covers a comprehensive set of preventive services aimed at promoting early detection and reducing the risk of chronic disease.\150\ These services include wellness visits (such as the IPPE and AWV), evidence-based screenings for cancer and chronic conditions, behavioral health and risk factor screenings, certain vaccinations, and preventive counseling interventions. Coverage for many of these services was expanded under sections 4103 and 4104 of the Affordable Care Act; the services [[Page 43957]] are covered without beneficiary cost-sharing when furnished according to Medicare requirements. Collectively, they are designed to support proactive, patient-centered care and improve long-term health outcomes, particularly when delivered in primary care settings. CMS has implemented these statutory provisions through regulations at 42 CFR part 410, which define, among other things, the coverage, eligibility, and frequency requirements for preventive services. --------------------------------------------------------------------------- \150\ https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-quickreferencechart-1.html. --------------------------------------------------------------------------- CMS also establishes and updates coverage of preventive services through the National Coverage Determination (NCD) process, if such services are recommended with a grade of A or B by the U.S. Preventive Services Task Force (USPSTF). These processes specify the conditions under which preventive services are considered reasonable and necessary for Medicare beneficiaries. Payment for preventive services is made in accordance with applicable Medicare payment systems, for example, the PFS under 42 CFR part 414. CMS provides additional operational guidance through subregulatory instructions, including manuals and program transmittals, to ensure consistent implementation of coverage and payment policies. Beneficiary copayment and deductible (where applicable) is waived by the Affordable Care Act for the IPPE and AWV, and for Medicare-covered preventive services recommended by the USPSTF with a grade of A or B. When statutorily permissible, we pay for covered preventive services under Medicare Part B to RHCs and FQHCs pursuant to such facilities' encounter-based payment methodologies, rather than as PFS separately billable services, except where otherwise specified. RHCs are paid under the AIR methodology for a limited number of qualified preventive health services furnished by an RHC practitioner. FQHCs are paid under the FQHC PPS for qualified preventive health services and preventive primary health services required under section 330 of the PHS Act.\151\ A qualified preventive health service refers to a Medicare-covered preventive service that also meets the requirements for a billable RHC or FQHC visit, including a face-to-face encounter with a RHC or FQHC practitioner (that is, the service is at a level that requires the expertise of a RHC or FQHC practitioner). Specifically, RHCs and FQHCs are paid for the professional component of allowable preventive services when the program requirements are met and frequency limits (where applicable) have not been exceeded.\152\ In this context, professional component refers to the practitioner's clinical service associated with a preventive service, as opposed to the technical or ancillary elements of the service. Preventive services furnished in other settings, for example, physician offices, are generally paid on a service-by-service basis. However, preventive services that do not constitute a separate billable RHC or FQHC visit must be furnished as part of a qualified RHC or FQHC visit (for example, an evaluation and management (E/M) visit) to be billable to Medicare. If a preventive service, that does not constitute a billable RHC or FQHC visit, is furnished and is not part of a qualified RHC or FQHC visit, it may not be payable under Medicare. --------------------------------------------------------------------------- \151\ Section 1861(aa)(3) of the Act (42 U.S.C. 1395x(aa)(3)) defines Federally Qualified Health Center (FQHC) services to include services and supplies furnished by an FQHC, including preventive primary health services required under section 330 of the Public Health Service Act (42 U.S.C. 254b). \152\ Pub. 100-02, Chapter 13, Section 220--Preventive Health Services. --------------------------------------------------------------------------- b. Federal Initiatives To Improve Health Outcomes and Access to Care (1) The Make America Healthy Again (MAHA) Commission On February 13, 2025, the President signed an Executive Order establishing the MAHA Commission within the Department of Health and Human Services (HHS).\153\ The Commission is chaired by the Secretary of HHS and includes representatives from multiple Federal agencies. The Commission was directed to assess contributing factors to chronic disease and to develop a coordinated Federal strategy to improve population health outcomes, with an initial focus on pediatric populations. --------------------------------------------------------------------------- \153\ Exec. Order No. 14212, Establishing the Make America Healthy Again Commission, 90 FR 9833 (Signed, February 13, 2025). --------------------------------------------------------------------------- In 2025, the Commission released an assessment identifying a range of factors associated with chronic disease, including dietary patterns, environmental exposures, physical inactivity, and other behavioral and upstream drivers of health. The Commission subsequently issued a strategy outlining potential Federal actions to address these factors through cross-agency coordination, research, and programmatic initiatives.\154\ --------------------------------------------------------------------------- \154\ https://www.usda.gov/about-usda/news/press-releases/2025/09/09/maha-commission-unveils-sweeping-strategy-make-our-children-healthy-again. --------------------------------------------------------------------------- Although the Commission's initial focus is on childhood health, its findings are relevant to Federal health programs serving other populations, including Medicare beneficiaries. Chronic conditions associated with the factors identified by the Commission are prevalent among Medicare beneficiaries and are significant drivers of program expenditures. (2) The Rural Health Transformation (RHT) Program The RHT Program was authorized by section 71401 of the Working Families Tax Cut (WFTC) (Pub. L. 119-21, July 4, 2025) legislation and empowers States to strengthen rural communities across America by improving healthcare access, quality, and outcomes by transforming the healthcare delivery ecosystem. On September 15, 2025, we announced the availability of funding under the RHT Program and program objectives for States seeking to participate in this initiative, among other information. The RHT Program represents a $50 billion Federal investment over 5 Federal fiscal years (FY 2026 to FY 2030), with $10 billion available annually, intended to strengthen health care infrastructure, expand access to care, and improve health outcomes in rural communities across the United States. The program has five strategic goals, grounded in the permissible uses of funds under the statute: Make Rural America Healthy Again-- Support rural health innovations and new access points to promote preventive health and address the root causes of disease; Sustainable Access--Improve the efficiency and long-term sustainability of rural health care providers as enduring access points for care; Workforce Development--Strengthen recruitment and retention of qualified health care professionals in rural communities; Innovative Care--Advance innovative care models that improve health outcomes, coordinate care, and promote flexible care arrangements; and Technology Innovation-- Foster the adoption of innovative technologies that promote efficient care delivery, data security, and access to digital health tools for rural facilities, providers, and patients.\155\ --------------------------------------------------------------------------- \155\ https://www.cms.gov/priorities/rural-health-transformation-rht-program/overview. --------------------------------------------------------------------------- c. Increasing Access to Diabetes Self-Management Training (DSMT) and Medical Nutrition Therapy (MNT) Services in RHCs Section 4105 of the Balanced Budget Act of 1997 added section 1861(qq) of the Act to permit Medicare coverage of outpatient DSMT services when these services are furnished by a certified provider who meets certain quality [[Page 43958]] standards. This program is intended to educate beneficiaries in the successful self-management of diabetes. The program includes instructions in self-monitoring of blood glucose; education about diet and exercise; an insulin treatment plan developed specifically for the patient who is insulin dependent; and motivation for patients to use the skills for self-management. DSMT services may be covered by Medicare only if the treating physician or treating qualified non- physician practitioner who is managing the beneficiary's diabetic condition certifies that such services are needed. The referring physician or qualified non-physician practitioner must maintain the plan of care in the beneficiary's medical record and documentation substantiating the need for training on an individual basis when group training is typically covered, if so ordered. A designated certified provider bills for DSMT provided by an accredited DSMT program. Certified providers must submit a copy of their accreditation certificate to the contractor. The statute states that a ``certified provider'' is a physician or other individual or entity designated by the Secretary that, in addition to providing outpatient self-- management training services, provides other items and services for which payment may be made under title XVIII of the Act, and meets certain quality standards. We designated all providers and suppliers that bill Medicare for other individual services such as hospital outpatient departments, renal dialysis facilities, physicians and durable medical equipment suppliers, as eligible to be certified providers. All suppliers/ providers who may bill for other Medicare services or items and who represent a DSMT program that is accredited as meeting quality standards can bill and receive payment for the entire DSMT program. Registered dietitians are eligible to bill on behalf of an entire DSMT program on or after January 1, 2002, if the provider employing or contracting with the dietitian has obtained a Medicare provider number. A dietitian may not be the sole practitioner of the DSMT service.\156\ Under our regulations at Sec. 410.144(a)(4)(ii), there is an exception for dietitians working in rural areas. In a rural area, an individual who is qualified as a registered dietitian and as a certified diabetic educator who is currently certified by an organization approved by us may furnish training and is deemed to meet the multidisciplinary team requirement. DSMT requirements for coverage, beneficiary eligibility, services and frequency of services and provider certification and accreditation are codified in 42 CFR 410 subpart H and the National Coverage Determination (NCD) 40.1.\157\ --------------------------------------------------------------------------- \156\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/b02062.pdf. \157\ https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=251&ncdver=1&keyword=DSMT&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. --------------------------------------------------------------------------- Section 1861(s)(2)(V) of the Act authorizes Medicare Part B coverage of MNT for certain beneficiaries who have diabetes or a renal disease. Regulations for MNT were established effective January 1, 2002, at 42 CFR 410 subpart G (66 FR 55246 and 55331). An NCD establishes the duration and frequency limits for the MNT benefit and coordinates MNT and DSMT.\158\ MNT services are defined in section 1861(vv) of the Act as nutritional diagnostic, therapeutic, and counseling services provided by a registered dietitian or nutrition professional for the purpose of managing diabetes or a renal disease under a referral by a physician. The provider qualifications for registered dieticians and nutrition professionals are defined in Sec. 410.134. --------------------------------------------------------------------------- \158\ https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=252. --------------------------------------------------------------------------- Effective January 1, 2022, coverage of MNT, for the first year a beneficiary receives MNT, with either a diagnosis of renal disease or diabetes as defined at 42 CFR 410.130 is 3 hours of administration. Coverage in subsequent years for renal disease or diabetes is 2 hours. The dietitian/nutritionist may choose how many units are administered per day as long as all of the other requirements of the NCD and Sec. Sec. 410.130 through 410.134 are met. Under the exception at Sec. 410.132(b)(5), additional hours are considered to be medically necessary and covered if the physician determines that there is a change in medical condition, diagnosis, or treatment regimen that requires a change in MNT and orders additional hours during that episode of care. If the physician determines that receipt of both MNT and DSMT is medically necessary in the same episode of care, Medicare will cover both DSMT and MNT initial and subsequent years without decreasing either benefit as long as DSMT and MNT are not provided on the same date of service. Section 5114 of the Deficit Reduction Act of 2005 amended section 1861(aa)(3) of the Act to add DSMT and MNT services as covered and paid under the FQHC benefit, effective January 1, 2006. Then the Affordable Care Act further expanded the scope of FQHC services to include preventive services defined under section 1861(ddd)(3) of the Act, however, RHCs were not similarly addressed. Under this statutory authority, DSMT and MNT services furnished by certified providers are stand-alone billable visits in FQHCs when all of the requirements are met. If DSMT or MNT services are provided on the same day as another qualified visit, the FQHC is paid for one visit, and the charges associated with DSMT or MNT are waived from coinsurance obligations (79 FR 25447). We note, group DSMT is not payable in FQHCs because Medicare payment is limited to individual, face-to-face encounters under the FQHC PPS, and group training does not meet the definition of a billable visit. For RHCs, DSMT services and MNT services rendered by registered dietitians or nutrition professionals are included under the RHC benefit, if all relevant program requirements are met. Separate payment under Part B to RHCs for these services provided by these practitioners is precluded as set forth in regulations at Sec. Sec. 414.63 and 414.64. However, RHCs are permitted to become certified providers of DSMT and MNT services and bundle the cost of such services into their clinic payment rates. The provision of these services would not generate an RHC visit, though their costs may be included in the cost report and used for determining the AIR.\159\ Consequently, RHCs are not paid for encounters where only DSMT or MNT services are provided. --------------------------------------------------------------------------- \159\ https://www.cms.gov/regulations-and-guidance/guidance/transmittals/downloads/a03021.pdf. --------------------------------------------------------------------------- For several years, interested parties have expressed concern about access to DSMT and MNT services in RHCs. Commenters stated that because these are preventive services, not treating these services as a separate encounter is impacting access to care for rural beneficiaries. They state that there are additional concerns regarding the payment for DSMT and MNT services between RHCs and FQHCs and rural interested parties have requested aligning payment for these services. They believe that we should recognize DSMT and MNT services as a qualified visit for RHCs when these services are provided by a certified provider and all the requirements are met. They believe that the utilization rate is low for beneficiaries receiving care in RHCs and explained that if we allow RHCs to receive payment for furnishing DSMT [[Page 43959]] and MNT services, then this rate may increase. Recent studies highlight a continued need for DSMT and MNT services in rural areas, driven by rising diabetes prevalence and significant access disparities. Some of the barriers identified for people living in rural communities, especially for getting access to diabetes education and prevention programs, include limited number of providers, longer distance to medical facilities, higher costs, outdated cultural beliefs, lack of transportation, and limited community resources. More efforts to reduce these barriers may help reduce the overall high burden of diabetes in the rural US.\160\ The necessity of DSMT and MNT in rural areas is supported by findings such that, they are clinically essential, diabetes control is improved, complications are reduced, lower costs, rural populations have equal or greater need, there are higher diabetes burden (widely established in rural health literature), access is systematically worse in rural areas, there are fewer providers, geographic maldistribution, and lower utilization despite need. Therefore, expanding DSMT and MNT in rural areas is not just beneficial, it is necessary to address documented health differences in access and outcomes.\161\ In addition, we have observed that utilization for these services is low in rural settings. That is, an analysis of Medicare claims data from 2024 indicate that utilization of DSMT and MNT in RHC settings is substantially lower than in comparable care settings. In CY 2024, DSMT services were furnished to approximately 125 RHC beneficiaries, representing 0.005 percent of the total RHC beneficiary population of approximately 2.3 million. MNT services were furnished to approximately 439 RHC beneficiaries, representing 0.019 percent of the total RHC beneficiary population. On a claims basis, DSMT accounted for 0.002 percent and MNT for 0.007 percent of total RHC claims in CY 2024. By comparison, FQHCs, showed DSMT utilization rates approximately 22 times higher and MNT utilization rates approximately 28 times higher than RHCs on a per- beneficiary basis. On a claim basis, FQHC utilization of DSMT and MNT exceeded RHC utilization by approximately 31 times and 32 times, respectively. Rural physician offices, which share the geographic and demographic characteristics of RHC patient populations, showed DSMT and MNT utilization rates approximately 17 times and 7 times higher than RHCs, respectively, on a per-beneficiary basis. The analysis further demonstrated that within the PFS setting where DSMT and MNT are most readily identifiable in claims data, these services represent a very small share of total Medicare spending--less than 0.01 percent and 0.02 percent of total PFS line payments, respectively, in CY 2024. This could suggest that beneficiaries receiving care in RHCs may have disproportionately lower participation due to potential provider shortages and structural payment barriers when compared to other settings of care. participation due to potential provider shortages and structural payment barriers when compared to other settings of care. --------------------------------------------------------------------------- \160\ Khavjou O, Tayebali Z, Cho P, Myers K, Zhang P. Rural- Urban Disparities in State-Level Diabetes Prevalence Among US Adults, 2021. Prev Chronic Dis. 2025 Jan 16;22:E05. doi: 10.5888/ pcd22.240199. PMID: 39819894; PMCID: PMC11870018. \161\ Rhudy, C., Schadler, A., & Talbert, J.C. (2020). Rural/ urban disparities in utilization of diabetes self-management training to the fee-for-service Medicare population. Rural and Underserved Health Research Center, University of Kentucky. --------------------------------------------------------------------------- As such, we believe that we should attempt to align access and payment for RHCs and FQHCs to the extent possible, given the statutory differences in benefit design between the two settings of care. Because DSMT and MNT are affirmatively covered Medicare Part B benefits under sections 1861(s)(2)(S) and 1861(s)(2)(V) of the Act, respectively, and are defined under sections 1861(qq) and 1861(vv) of the Act, there is a compelling basis for ensuring these clinically essential services are payable under the RHC benefit. Continuing to exclude these services from RHC payment limits access for rural Medicare beneficiaries and would be inconsistent with both the statutory coverage framework and the foundational purpose of the RHC program. Reducing differences between RHCs and other settings in which DSMT and MNT are furnished and paid, such as in FQHCs and physician office, may help expand access to care for Medicare beneficiaries in rural areas. This policy would strengthen access to services that address chronic conditions prevalent among Medicare beneficiaries which are significant drivers of program expenditures. Since DSMT and MNT services may be furnished by certified providers other than RHC practitioners as defined in Sec. Sec. 410.141 and 410.134, respectively, these services could be furnished by certified providers under the direct supervision of an RHC practitioner. Direct supervision does not require the physician (or other supervising practitioner) to be present in the same room. However, the physician (or other supervising practitioner) must be in the RHC or FQHC and immediately available to provide assistance and direction throughout the time the incident to service or supply is being furnished. See definitions at Sec. 405.2401(b) ``Direct Supervision.'' We propose to recognize DSMT and MNT services as qualified preventive services that are covered and paid the AIR as stand-alone billable visits under the RHC benefit. To constitute as a billable RHC visit, these services would need to be furnished by a certified provider under the direct supervision of RHC professional staff. We believe aligning payment policies in RHCs with other settings, for example FQHCs and physician offices, would help expand access to care for Medicare beneficiaries in rural areas while supporting Federal initiatives to strengthen rural healthcare. As such, we are proposing to revise Sec. 405.2463(a) and (b)(2) to allow DSMT and MNT services to be stand-alone billable visits in RHCs. Similar to FQHCs, when DSMT or MNT is furnished on the same day as another qualified visit, the RHC would be paid one AIR for that encounter. We consider these policies to align an incongruency between FQHC and RHC access to preventive services and do not expect in future rulemaking to propose additional preventive services beyond which are currently paid for in FQHCs and physician offices. We invite public comments on these proposals.

3. Services Furnished Using Telecommunication Technology

a. Background Section 3704 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020) directed the Secretary to establish payment for RHC and FQHC services that are provided as Medicare telehealth services by RHCs and FQHCs serving as a distant site (that is, where the practitioner is located) during the PHE for COVID-19. Specifically, section 1834(m)(8)(B) of the Act, as added by section 3704 of the CARES Act, required that, for the duration of the PHE for COVID-19, the Secretary develop and implement payment methods for FQHCs and RHCs that serve as a distant site. The payment methodology outlined in the CARES Act requires that rates be based on rates that are similar to the national average payment rates for comparable telehealth services under the Medicare PFS. Accordingly, we established payment rates for these services furnished by RHCs and FQHCs based on the average PFS payment amount for all Medicare telehealth services, weighted by volume in a [[Page 43960]] Special Edition Medicare Learning Network Article (SE20016). Congress has extended this payment flexibility beyond the PHE for COVID-19 through a series of statutory amendments, most recently under section 6209(c) of the CAA, 2026, which extended this payment flexibility through December 31, 2027. We codified this payment policy at 42 CFR 405.2464(g). As amended in the CY 2025 PFS final rule (89 FR 98554), Sec. 405.2464(g) states that for an encounter furnished using interactive, real-time, audio/ visual telecommunications technology or for certain audio-only interactions in cases where the patient is not capable of, or does not consent to, the use of video technology services that are not described in Sec. 405.2463(b)(3), payment to RHCs and FQHCs are subject to the national average payment rates for comparable services under the PFS and costs associated with these services shall not be used in determining payments under the RHC all-inclusive rate or the FQHC prospective payment system. In the CY 2022 PFS final rule (86 FR 65210 and 65211), we revised payment for mental health visits in RHCs and FQHCs furnished via interactive, real-time, audio/visual or audio-only telecommunications technology. Instead of paying for these services under the national average payment rates for comparable services under the PFS, as is done for non-behavioral health services, we amended the regulation at Sec. 405.2463 to permit mental health visits in RHCs and FQHCs furnished via audio/visual or audio-only telecommunication to be paid under the RHC AIR and FQHC PPS rates. In addition, to align with the Medicare telehealth statutory requirements for mental health services, we finalized at Sec. Sec. 405.2463(b)(3) and 405.2469(d) that there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in- person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record. However, beginning with section 304 of the Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103, March 15, 2022), the in-person visit requirements for mental health visits were delayed. These requirements were further delayed through various laws that included extension of the telehealth flexibilities. Following the publication of the CY 2026 PFS final rule, section 6208 of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Pub. L. 119-37, November 12, 2025) extended the delay until January 30, 2026. Most recently, section 6209(d) of the CAA, 2026 extended the abeyance of the RHC/FQHC mental health in-person requirements through December 31, 2027. b. Proposal for Conforming Regulatory Text Changes Because section 6209(c) of the CAA, 2026 extended authority for CMS to pay for FQHC and RHC non-behavioral health telecommunication technology services as Medicare telehealth services, we are not proposing any modifications for this provision to Sec. 405.2464(g). Because section 6209(d) of the CAA, 2026 extended the abeyance of the RHC and FQHC mental health in-person requirements through December 31, 2027, we are proposing to make conforming regulatory text changes at Sec. Sec. 405.2463(b)(3) and 405.2469(d). This provision, as proposed, would require that the in-person visit requirements not apply to any services furnished through December 31, 2027.

4. Proposed CY 2027 FQHC PPS Market Basket Update

Section 1834(o)(2)(B)(ii) of the Act requires the FQHC PPS base rate be updated annually by the percentage increase in a market basket of Federally qualified health center goods and services as issued through regulations, or if such an index is not available, by the percentage increase in the MEI (as defined in section 1842(i)(3) of the Act) for the year involved. For CY 2027 (that is, January 1, 2027, through December 31, 2027), we propose to use an estimate of the percentage increase in the 2022-based FQHC market basket to update payments to FQHCs based on the best available data. Consistent with CMS practice, we propose to use the update based on the most recent historical data available at the time of publication of the final rule. For example, the final CY 2027 FQHC update would be based on the four- quarter moving-average percent change of the 2022-based FQHC market basket through the second quarter of 2026 (based on the final rule's statutory publication schedule). At the time of this proposed rule, we do not have the second quarter of 2026 historical data, and therefore, the proposed CY 2027 FQHC update is based on the most recent projection available at this time. As finalized in the CY 2025 final rule (89 FR 98032), a productivity adjustment is included in the 2022-based FQHC market basket. For CY 2027, we propose to update the CY 2026 FQHC PPS base rate by the historical percentage increase through the second quarter of 2026 of the productivity-adjusted FQHC market basket (which we refer to as the FQHC market basket update). For CY 2027, the proposed FQHC market basket update is estimated to be 2.5 percent and is based on the expected historical percentage increase of the productivity-adjusted 2022-based FQHC market basket (referred to as the FQHC market basket update). Multiplying the CY 2026 FQHC PPS base rate amount of $207.72 by the proposed CY 2027 FQHC market basket update of 2.5 percent ($207.72 x 1.025) results in a proposed CY 2027 FQHC PPS base rate amount of $212.91. For the final rule, we propose that the CY 2027 market basket update and the productivity adjustment will be updated to reflect historical data through the 2nd quarter of 2026.

5. Proposed Technical Changes

a. Section 405.2464(b)(1) and (2) We propose revisions at Sec. 405.2464(b)(1) and (2) to correct the references within these paragraphs so that they reference the appropriate paragraph or sections under subpart X of part 405. We propose to revise Sec. 405.2464(b)(1) by replacing ``paragraphs (d) and (e)'' with ``paragraphs (c) and (h)'' since the payment discussed under these paragraphs are not based on the FQHC PPS per diem rate. We propose to revise Sec. 405.2464(b)(2)(i) and (ii) to reference Sec. 405.2462(e). This reference should have been revised when we redesignated this section in the CY 2022 PFS final rule (86 FR 65660). b. Sec. 405.2464(g) In the CY 2025 PFS final rule (89 FR 98015 through 98017) we discussed medical visit services furnished via telecommunications technology. We revised Sec. 405.2464 by adding new paragraph (g) to reflect our payment policy for these services. That is, for non- behavioral health services, an encounter furnished using telecommunications technology, payment to RHCs and FQHCs are [[Page 43961]] subject to the national average payment rates for comparable services under the PFS and costs associated with these services shall not be used in determining payments under the RHC AIR or the FQHC PPS. During a recent review of our regulation, we noticed that we inadvertently used the term ``an encounter'' instead of ``services.'' We are proposing to revise Sec. 405.2464(g) to be consistent with the authority under section 1834(m)(8) of the Act. c. Section 405.2469(d) In the CY 2022 PFS final rule (86 FR 65210 and 65211), we explained that Sec. 405.2469(d) was revised to describe the same in-person mental health visit requirement applicable under Sec. 405.2463. In subsequent PFS rulemaking, as discussed previously in this section, we described revisions to both provisions as technical changes intended solely to conform the regulations to the applicable statutory delay of the in-person requirement. Because the current text of Sec. 405.2469(d) separately restates the technology modalities and in-person requirement language, it creates an unnecessary risk of divergence from Sec. 405.2463(b)(3). Accordingly, we propose to revise the regulatory text at Sec. 405.2469(d) to align the description of permissible telecommunications modalities with the language used in Sec. 405.2463. Specifically, Sec. 405.2469(d) currently refers to audio-only interactions in cases where beneficiaries do not wish to use, or do not have access to, devices that permit two-way, audio/video communication. In contrast, Sec. 405.2463 permits the use of audio-only interactions in cases where the patient is not capable of, or does not consent to, the use of video technology. To ensure consistency across these provisions we are proposing to revise the descriptions to match what is described at Sec. 405.2463, namely that the use of audio-only interactions is permissible in cases where the patient is not capable of, or does not consent to, the use of video technology. We are also proposing to revise Sec. 405.2469(d) to align the description of the in-person visit requirement for mental health services with the requirements set forth in Sec. 405.2463(b)(3). We believe that these amendment are non-substantive and clarifying because they do not alter payment policy; they merely align duplicative regulatory text and eliminate any potential internal inconsistency.

1. Background on the Clinical Laboratory Fee Schedule

Prior to January 1, 2018, Medicare paid for clinical diagnostic laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) under section 1833(a), (b), and (h) of the Act. Under the previous payment system, CDLTs were paid based on the lesser of: (1) the amount billed; (2) the local fee schedule amount established by the Medicare Administrative Contractor (MAC); or (3) a national limitation amount (NLA), which is a percentage of the median of all the local fee schedule amounts (or 100 percent of the median for new tests furnished on or after January 1, 2001). In practice, most tests were paid at the NLA. Under the previous payment system, the CLFS amounts were updated for inflation based on the percentage change in the Consumer Price Index for All Urban Consumers (CPI-U), and reduced by a productivity adjustment and other statutory adjustments, but were not otherwise updated or changed. Coinsurance and deductibles generally do not apply to CDLTs paid under the CLFS. Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for CDLTs under the CLFS. In a final rule that appeared in the June 23, 2016 Federal Register (81 FR 41036), entitled Medicare Clinical Diagnostic Laboratory Tests Payment System (hereinafter referred to as the CLFS final rule), we established requirements to implement section 1834A of the Act at 42 CFR part 414, subpart G. Under the CLFS final rule, ``reporting entities'' must report to CMS during a ``data reporting period'' ``applicable information'' collected during a ``data collection period'' for their component ``applicable laboratories.'' The first data collection period occurred from January 1, 2016, through June 30, 2016. The first data reporting period occurred from January 1, 2017, through March 31, 2017. On March 30, 2017, we announced a 60-day period of enforcement discretion for the application of the Secretary's potential assessment of civil monetary penalties for failure to report applicable information with respect to the initial data reporting period.\162\ --------------------------------------------------------------------------- \162\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf. --------------------------------------------------------------------------- In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we solicited public comments from applicable laboratories and reporting entities to better understand the applicable laboratories' experiences with data reporting, data collection, and other compliance requirements for the first data collection and reporting periods. We discussed these comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and stated that we would consider the comments for potential future rulemaking or guidance. As part of the CY 2019 Medicare PFS rulemaking, we finalized two changes to the definition of ``applicable laboratory'' at Sec. 414.502 (see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850, 35855 through 35862). First, we excluded Medicare Advantage plan payments under Part C from the denominator of the Medicare revenues threshold calculation to broaden the types of laboratories qualifying as an applicable laboratory. Second, consistent with our goal of obtaining a broader representation of laboratories that could potentially qualify as an applicable laboratory and report data, we also amended the definition of applicable laboratory to include hospital outreach laboratories that bill Medicare Part B using the CMS-1450 14x Type of Bill.

2. Payment Requirements for Clinical Diagnostic Laboratory Tests

In general, under section 1834A of the Act, the payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected during the data collection period and reported to CMS during the data reporting period and is equal to the weighted median of the private payor rates for the test. The weighted median is calculated by arraying the distribution of all private payor rates, weighted by the volume for each payor and each laboratory. The payment amounts established under the CLFS are not subject to any other adjustment, such as geographic, budget neutrality, or annual update, as required by section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of the Act, implemented at Sec. 414.507(d), provides for a phase-in of payment reductions, limiting the amounts the CLFS rates for each CDLT (that is not a new advanced diagnostic laboratory test (ADLT) or new CDLT) can be reduced as compared to the payment rates for the preceding year. Under the original provisions enacted by section 216(a) of PAMA, for the first 3 years after implementation (CY 2018 through CY 2020), the reduction could not be more [[Page 43962]] than 10 percent per year. For the next 3 years after implementation (CY 2021 through CY 2023), section 216(a) of PAMA stated that the reduction could not be more than 15 percent per year. Under sections 1834A(a)(1) and (b) of the Act, as enacted by PAMA, for CDLTs that are not ADLTs, the data collection period, data reporting period, and payment rate update were to occur every 3 years. As such, the second data collection period for CDLTs that are not ADLTs was originally scheduled to take place from January 1, 2019, through June 30, 2019, and the next data reporting period was originally scheduled to take place from January 1, 2020, through March 31, 2020, with the next update to the Medicare payment rates for those tests based on that reported applicable information scheduled to take effect on January 1, 2021. Section 216(a) of PAMA established a new subcategory of CDLTs known as ADLTs, with separate reporting and payment requirements under section 1834A of the Act. The definition of an ADLT is set forth in section 1834A(d)(5) of the Act and implemented at Sec. 414.502. Generally, under section 1834A(d) of the Act, the Medicare payment rate for a new ADLT is equal to its actual list charge during an initial period of 3 calendar quarters. After the new ADLT initial period, ADLTs are paid using the same methodology based on the weighted median of private payor rates as other CDLTs. However, under section 1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs occur annually instead of every 3 years. Additional information on the private payor rate-based CLFS is detailed in the CLFS final rule (81 FR 41036 through 41101) and is available on the CMS website.\163\ --------------------------------------------------------------------------- \163\ https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule/clfs-history. ---------------------------------------------------------------------------

3. Previous Statutory Revisions to the Data Reporting Period and Phase-

In of Payment Reductions Beginning in 2019, Congress repeatedly extended the data reporting periods for CDLTs that are not ADLTs and revised the phase-in of CLFS payment reductions through multiple laws, including: section 105 of the Further Consolidated Appropriations Act, 2020 (FCAA) (Pub. L. 116-94, December 20, 2019); section 3718 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020); section 4 of the Protecting Medicare and American Farmers from Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71, December 10, 2021); section 4114 of the Consolidated Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-328, December 29, 2022); section 502 of the Further Continuing Appropriations and Other Extensions Act, 2024 (FCAOEA, 2024) (Pub. L. 118-22, November 17, 2023); and section 221 of the Continuing Appropriations and Extensions Act, 2025 (CAEA, 2025) (Pub. L. 118-83, September 26, 2024). For a detailed discussion of these statutory revisions, please see the CY 2025 PFS final rule (89 FR 98038 through 98043) and the prior PFS rules referenced in the CY 2025 discussion.

4. Additional Statutory Revisions to the Data Reporting Period, Phase-

In of Payment Reductions and Data Collection Period Section 6209 of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Pub. L. 119-37, enacted November 12, 2025) made further revisions to the CLFS requirements for the next data reporting period for CDLTs that are not ADLTs and to the phase-in of payment reductions under section 1834A of the Act. Specifically, section 6209(b) of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 delayed the next data reporting period for CDLTs that are not ADLTs so that reporting would be required during the period of February 1, 2026 through April 30, 2026, instead of the data reporting period of January 1, 2025, through March 31, 2025 established under the FCAOEA, 2024. Section 6209 of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 did not modify the data collection period that applies to the next data reporting period for these tests. Thus, under section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of the FCAA, the next data reporting period for CDLTs that are not ADLTs (February 1, 2026, through April 30, 2026) continued to be based on the data collection period of January 1, 2019, through June 30, 2019, as defined in Sec. 414.502. Section 6209(a) of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 amended the provisions in section 1834A(b)(3) of the Act regarding the phase-in of payment reductions under the CLFS. First, it extended the statutory phase-in of payment reductions resulting from private payor rate implementation by an additional year, that is, through CY 2029. It further amended section 1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent for CY 2026 was 0 percent, meaning that the payment amount determined for a CDLT for CY 2026 shall not result in any reduction in payment as compared to the payment amount for that test for CY 2025. Section 6209(b) of this law further amended section 1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of 15 percent would apply for CYs 2026 (January 31, 2026 through December 31, 2026), 2027, and 2028. Most recently, section 6226 of the Consolidated Appropriations Act, 2026 (CAA, 2026) (Pub. L. 119-75, February 3, 2026) amended section 1834A of the Act to revise the data reporting period, data collection period, and requirements for the phase-in of payment reductions. Specifically, section 6226 of the CAA, 2026 revised the next required data reporting period for CDLTs that are not ADLTs to be May 1, 2026, through July 31, 2026, and specified that the applicable data collection period is January 1, 2025, through June 30, 2025. Section 6226 of the CAA, 2026 also amended section 1834A(b)(3) of the Act to specify that the applicable percent was 0 percent for all of CY 2026, meaning that the payment amount determined for a CDLT for CY 2026 shall not result in any reduction in payment as compared to the payment amount for that test for CY 2025, and to extend the statutory phase-in of payment reductions resulting from private payor rate implementation by an additional year, that is, through CY 2029. Therefore, the applicable percent of up to 15 percent would apply for CYs 2027 through 2029. Section 6226 of the CAA, 2026 further provided that, notwithstanding any other provision of law, the Secretary may implement the amendments made by this section by program instruction or otherwise.

5. Proposed Conforming Regulatory Changes

In accordance with section 6226 of the CAA, 2026, we are proposing to make certain conforming changes to the data reporting and payment requirements at 42 CFR part 414, subpart G. Specifically, we are proposing to revise Sec. 414.502 to update the definitions of both the ``data collection period'' and ``data reporting period,'' specifying that the data collection period is the 6-month period from January 1 through June 30, during which applicable information is [[Page 43963]] collected and that precedes the data reporting period, and that the data reporting period for CDLTs that are not ADLTs is the 3-month period, May 1 through July 31, and for ADLTs is the 3-month period, January 1 through March 31, during which a reporting entity reports applicable information to CMS and that follows the preceding data collection period. We are also proposing to revise Sec. 414.504(a)(1) to indicate that initially, data reporting begins January 1, 2017, and is required every 3 years beginning May 1, 2026. In addition, we are proposing to make conforming changes to our requirements for the phase- in of payment reductions to reflect the amendments in section 6226 of the CAA, 2026. Specifically, we are proposing to revise Sec. 414.507(d) to indicate that for CY 2026, payment may not be reduced by more than 0.0 percent as compared to the amount established for CY 2025, and for CYs 2027 through 2029, payment may not be reduced by more than 15 percent as compared to the amount established for the preceding year. We note that the CYs 2018 through 2026 CLFS payment rates for CDLTs that are not ADLTs are based on applicable information collected in the data collection period of January 1, 2016 through June 30, 2016. Under current law, the CLFS payment rates for those tests for CY 2027 through CY 2029 will be based on applicable information collected during the data collection period of January 1, 2025 through June 30, 2025, and reported to CMS during the data reporting period of May 1, 2026 through July 31, 2026.

6. Technical Correction (Sec. 414.523(a)(1))

a. Background Section 1833(h)(3)(A) of the Act generally requires the Secretary to provide for and establish a nominal fee to cover the appropriate costs in collecting the sample on which a CDLT was performed and for which Medicare payment is made, in addition to the amounts provided under the Medicare CLFS. In addition, section 1834A(b)(5) of the Act requires that, when the sample is collected from an individual in a skilled nursing facility (SNF) or by a laboratory on behalf of a home health agency (HHA), the otherwise applicable nominal specimen collection fee be increased by $2.00. In the CY 2023 PFS final rule (87 FR 69744 through 69760), we finalized a policy to codify specimen collection fee provisions at Sec. 414.523(a)(1), including updating the base specimen collection fee amount and establishing an annual CPI-U update. In that rulemaking, we also stated that the statutory $2.00 increase for specimens collected from a Medicare beneficiary in a SNF or by a laboratory on behalf of an HHA would continue to apply, consistent with section 1834A(b)(5) of the Act. However, due to a drafting or codification error, the operative regulatory text implementing this increase in the CY 2023 PFS final rule (87 FR 70225 through 70226) was not fully included in Sec. 414.523(a)(1), and only a partial introductory clause remains in paragraph (a)(1)(v). Specifically, the introductory text to Sec. 414.523(a)(1) states that payment is made ``[e]xcept as provided in paragraph (a)(1)(v),'' but Sec. 414.523(a)(1)(v), as codified, consists only of the fragment: ``For a specimen collected from a Medicare beneficiary.'' This text is incomplete and does not contain operative language establishing an exception or alternative payment methodology. In addition, other provisions within Sec. 414.523(a)(1), including paragraph (a)(1)(ii), already specify that the specimen must be collected from a Medicare beneficiary, creating an apparent internal inconsistency when read together with the introductory exception clause. b. Proposed Technical Correction To resolve this internal inconsistency and accurately reflect the statutory provisions and longstanding policy, we are proposing to revise Sec. 414.523(a)(1) to restore the complete and operative language implementing the statutory $2.00 increase. That is, we propose revising Sec. 414.523(a)(1)(v) to state that for a specimen collected from a Medicare beneficiary in a skilled nursing facility or on behalf of a home health agency, the specimen collection fee otherwise paid under paragraph (a)(1) of this section is increased by $2.00. We do not believe that this proposal reflects a substantive policy change. In the CY 2023 PFS proposed rule (87 FR 46043), we proposed to codify existing specimen collection fee policies and to incorporate the statutory $2.00 increase for SNF and HHA collections into Sec. 414.523(a)(1) as a discrete paragraph. Specifically, we proposed that, beginning April 1, 2014, for a specimen collected from a Medicare beneficiary in a SNF or on behalf of an HHA, the specimen collection fee otherwise paid under Sec. 414.523(a)(1) would be increased by $2.00, consistent with section 1834A(b)(5) of the Act. In the CY 2023 PFS final rule (87 FR 69744 through 69760), we finalized policies consistent with this framework, including the continued application of the statutory $2.00 increase. We note that it has been, and continues to be, CMS' policy to pay the specimen collection fee only for qualifying specimens collected from Medicare beneficiaries, and to apply the additional $2.00 increase for specimens collected from a Medicare beneficiary in a SNF or by a laboratory on behalf of an HHA, as required by statute. We have consistently implemented this policy operationally through claims processing systems, subregulatory guidance, and annual payment updates.

1. Executive Summary and Background

a. Executive Summary (1) Purpose We are proposing to make changes to the Ambulatory Specialty Model (ASM or model) effective on the model start date of January 1, 2027. (2) Summary of Major Provisions ASM is a mandatory alternative payment model tested by the CMS Center for Medicare and Medicaid Innovation (Innovation Center) under section 1115A of the Act. ASM will have 5 performance years that begin January 1, 2027 and end December 31, 2031 with performance-based payment adjustments occurring 2 calendar years (CYs) following the end of each ASM performance year. We finalized ASM through notice-and-comment rulemaking in the 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 final rule (hereinafter ``CY 2026 PFS final rule'') (90 FR 49562 through 49720). However, based on the feedback we received after the publication of the CY 2026 PFS final rule and our own internal review, we are proposing several technical refinements and adjustments to the model. As described in detail in section III.D.2 of this proposed rule, we propose the following modifications: Revising select ASM definitions and adding new ASM definitions. Clarifying ASM participant exceptions from specified model requirements due to taxpayer identification number (TIN) changes before or during an ASM performance year. Excepting certain ASM heart failure participants from specified model [[Page 43964]] requirements due to a redesignated specialty type. Incorporating an option to terminate ASM participants under certain circumstances. Incorporating an option for data submission for the improvement activities ASM performance category at either the individual or group level. Clarifying the scoring of multiple quality measure data submissions from ASM participants in small practices. Adding an administrative claims-based low back pain imaging quality measure and replacing the patient-reported outcome measure for low back pain with a functional status outcome process measure. Adjusting benchmarking and scoring policies for quality measures. Adding a quality ASM performance category scoring incentive for the voluntary submission of patient-reported outcome (PRO) data to support the development of patient-reported outcome performance-based measures (PRO-PM) under ASM. Revising requirements of the Promoting Interoperability ASM performance category to align with proposed changes to the Merit- based Incentive Payment System (MIPS) Promoting Interoperability performance category and adding a Promoting Interoperability measure suppression policy. Incorporating a rural scoring adjustment for ASM participants in rural areas. Revising the contents of the ASM performance report to include additional information related to scoring-related proposals in this proposed rule. Clarifying language on the application of ASM payment adjustments when an ASM participant reassigns billing rights to a new TIN during an ASM payment year. Clarifying the availability of the CMS-sponsored model arrangements and patient incentives safe harbor and applicability of programmatic waivers for ASM to reflect that such flexibilities are associated with active performance under ASM and would not be available or applicable during an ASM performance year in which an ASM participant is either ineligible for, or excepted from, specified model requirements. Revising provisions establishing collaborative care arrangement (CCA) requirements to improve clarity and update the permissible parties, remuneration conditions, documentation requirements, and compliance terms. Clarifying and reorganizing select regulatory text to improve readability and flow. The proposals in this proposed rule reflect our commitment to ensuring ASM's incentives help drive quality of care improvements for beneficiaries and reductions in Medicare spending. b. Background (1) Statutory Authority Section 1115A of the Act authorizes the Secretary to test innovative payment and service delivery models to reduce program expenditures under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) while preserving or enhancing the quality of care furnished to beneficiaries. Under this authority, we may test models that modify payment methodologies, establish accountability for quality and cost outcomes, and incorporate financial risk arrangements. Under the authority of sections 1115A and 1871(a)(2) of the Act, through notice-and-comment rulemaking, we finalized ASM in the CY 2026 PFS final rule that appeared in the November 5, 2025, Federal Register (90 FR 49562 through 49720). (2) Background ASM will test whether holding physician specialists accountable for the quality and cost of care associated with the longitudinal management of specific chronic conditions, heart failure and low back pain, can reduce Medicare expenditures while preserving or enhancing quality of care for Original Medicare beneficiaries. Clinical decisions made by specialists in ambulatory settings can meaningfully influence disease progression as well as downstream utilization and spending. ASM's design, in its goal to reduce Medicare expenditures while preserving or enhancing the quality of care, aims to: (1) improve the management of chronic disease and slow disease progression through more effective risk assessment; (2) increase active collaboration between specialists and primary care providers, and (3) reduce avoidable hospitalizations and low-value procedures (that is, procedures that provide little clinical benefit or the risk of harm outweighs its potential benefit). In developing ASM, we considered specialist-managed conditions that often require ongoing outpatient management, diagnostic evaluation, medication management, coordination by specialists with other clinicians across different care settings, and, in some cases, procedural or surgical intervention (90 FR 49562 through 49564). Based on these factors, ASM selects individual specialists who manage one of two ASM targeted chronic conditions, heart failure or low back pain. As we designed ASM's participation criteria and performance evaluation framework to cover multiple conditions and associated specialists, we continue to explore whether including additional conditions and specialists would be appropriate. Our goal with the model test is to select specialists who have a meaningful level of engagement in the care of Original Medicare beneficiaries with ASM targeted chronic conditions as ASM participants. Under the provisions finalized in the CY 2026 PFS final rule (90 FR 49571 through 49596), we select ASM participants by a combination of a TIN and a National Provider Identifier (NPI). ASM participants are clinicians who meet four ASM participant eligibility criteria: (1) bill claims under the Medicare Physician Fee Schedule, (2) have a selected physician specialty type relevant to an ASM targeted chronic condition, (3) meet a historical volume threshold of condition-specific episode- based cost measure (EBCM) episodes, and (4) have a service location in a selected mandatory geographic area (that is, selected Core-Based Statistical Areas (CBSAs) and metropolitan divisions). ASM heart failure participants include cardiologists, and ASM low back pain participants include physicians with specialty types of anesthesiology, interventional pain management, neurosurgery, orthopedic surgery, pain management, and physical medicine and rehabilitation. ASM evaluates ASM participants across four ASM performance categories: quality, cost, improvement activities, and Promoting Interoperability. The evaluation of ASM participant performance leverages the MIPS Value Pathways (MVP) framework, which utilizes a cohesive set of measures and activities focused on performance in furnishing care for a particular specialty or clinical condition. ASM participants must meet each ASM performance category's requirements and report required data. We use data reported by ASM participants and other administrative data, such as inputs gathered from claims, to evaluate each ASM participant's performance on an annual basis. We determine a composite final score for each ASM participant based on performance across the four ASM performance categories and adjust final scores to account for beneficiary medical and social complexity as well as practice size. [[Page 43965]] Based on performance relative to other specialists treating the same ASM targeted chronic condition in an ASM cohort, ASM participants will receive a positive, neutral, or negative payment adjustment on all Medicare Part B claims for covered professional services during the CY 2 years following the applicable ASM performance year (for example, performance during the 2027 ASM performance year results in the application of ASM payment adjustments during the 2029 ASM payment year). Payment adjustments will range from negative 9 percent to positive 9 percent in the first 2 ASM payment years, gradually increasing to 12 percent in the final ASM payment year. We refer readers to the CY 2026 PFS final rule (90 FR 49562 through 49720) and ASM's provisions at 42 CFR part 512, subpart G, for additional information on all finalized provisions.

2. Proposed Changes to Provisions of the Ambulatory Specialty Model

(ASM) a. Definitions In the CY 2026 PFS final rule, we finalized certain terms for ASM. We described these finalized definitions in context throughout section III.C.2 of the CY 2026 PFS final rule and codified them at Sec. 512.705 (90 FR 49569). After internal review of ASM's provisions, we believe minor modifications to select definitions would improve the readability and overall clarity of ASM's provisions. Accordingly, we propose at Sec. 512.705 to modify the definition of ``ASM beneficiary'' to clarify this term means a Medicare FFS beneficiary who is being treated by an ASM participant for an ASM targeted chronic condition. We believe this edit would improve the precision of the definition by using the finalized definition of ``ASM targeted chronic condition'' that is used throughout ASM's provisions, rather than just ``targeted chronic condition'' as the definition currently reads. We also propose to revise the definition of ``Dual eligible proportion'' at Sec. 512.705 for clarity. Specifically, we propose to clarify that the definition of ``Dual eligible proportion'' means ``the share of an ASM participant's beneficiaries who are dually eligible Medicare beneficiaries''. This revision would more clearly refer to an ASM participant. We refer readers to section III.D.2.f.(3) of this proposed rule for the proposed definition of ``Rural area'' as it is described in context of the proposed rural scoring adjustment. We seek comment on the proposed revisions to the ``ASM beneficiary'' and ``Dual eligible proportion'' definitions at Sec. 512.705. b. Participation (1) Background As discussed in the CY 2026 PFS final rule (90 FR 49571 through 49596), we designed ASM with a focus on clinicians who commonly treat Original Medicare beneficiaries in an ambulatory setting, develop longitudinal relationships with patients, and co-manage beneficiaries with primary care providers (PCP). In addition, we believe clinicians who treat ASM targeted chronic conditions are well-positioned to benefit from improved integration between specialty and primary care, creating greater opportunities to incentivize high-value care and tertiary prevention. We determined the model would assess quality of care provided at the individual clinician level, as identified by a combination of TIN and NPI, rather than at the level of a group practice or facility, with limited exceptions, to align accountability with individual clinical decision-making and to better capture variation in individual clinical practice patterns among clinicians within the same organization (90 FR 49574). As a result, each ASM participant is individually responsible for meeting model requirements and is evaluated independently for the purposes of ASM performance category scoring, final scoring, and determining an ASM payment adjustment factor and corresponding ASM payment multiplier. (2) Mandatory Participation In the CY 2026 PFS final rule (90 FR 49571 through 49574), we finalized that once a clinician meets the ASM participant eligibility criteria and is selected as an ASM participant, they remain an ASM participant for the duration of the ASM test period. Once selected as an ASM participant, there may be circumstances where the ASM participant does not meet the ASM participant eligibility criteria for a specific ASM performance year. Accordingly, we developed a policy whereby an ASM participant is only subject to certain ASM requirements for the ASM performance year(s) in which they meet ASM participant eligibility criteria. We also finalized provisions that describe the effect of not meeting ASM participant eligibility criteria for an ASM performance year (90 FR 49571 through 49574). Specifically, under existing provisions, an ASM participant who does not meet ASM participant eligibility criteria for an ASM performance year is: (1) not subject to the requirements for performance assessment described at Sec. 512.715, data submission described at Sec. 512.720, and final scoring described at Sec. 512.745; (2) not subject to payment adjustment described at Sec. 512.750 for the corresponding ASM payment year; and (3) not eligible for Medicare program waivers described at Sec. 512.775 provided under the model for the applicable ASM performance year. To clarify and better incorporate policies related to exceptions of specific ASM performance requirements and ASM participant terminations discussed later in this section of this proposed rule, we are proposing to revise our regulatory text describing mandatory ASM participation and the effects of not meeting ASM participant eligibility criteria for an ASM performance year. Specifically, we propose at Sec. 512.710(a)(1) that a clinician who we select as an ASM participant for at least one ASM performance year is considered an ASM participant for the duration of the ASM test period unless we (1) terminate ASM in accordance with Standard Provisions for Mandatory Innovation Center Models described at Sec. 512.165, or (2) terminate the ASM participant as described under proposed Sec. 512.710(h). We believe this proposed revision is consistent with our original policy finalized in the CY 2026 PFS final rule describing that an ASM participant, once selected, remains an ASM participant for the ASM test period. Our proposal also incorporates the effect of a possible ASM participant termination, which we propose later in this section of this proposed rule. We also propose to add a paragraph heading and revise Sec. 512.710(a)(2) to clarify that this paragraph describes the effects of not meeting ASM participant eligibility criteria for an ASM performance year. We propose to move select regulatory text at current Sec. 512.710(a)(2)(i) to Sec. 512.710(a)(2) to improve readability and to incorporate new proposals on the effects of not meeting ASM participant eligibility criteria for an ASM performance year. First, we propose to separate select regulatory text included in current Sec. 512.710(a)(2)(i) into separate paragraphs by revising paragraph Sec. 512.710(a)(2)(ii) and adding new paragraph Sec. 512.710(a)(2)(iii). Under this proposal, Sec. 512.710(a)(2)(i) would describe the specified model requirements that an ASM participant would not be required to meet for the applicable ASM performance year, Sec. 512.710(a)(2)(ii) would describe the specific model requirements not applicable for the corresponding ASM [[Page 43966]] payment year, and Sec. 512.710(a)(2)(iii) would describe an ASM participant's ineligibility for waivers provided under the model for the applicable ASM performance year. These revisions do not introduce substantive changes to finalized provisions describing the effects of an ASM participant not meeting ASM participant eligibility criteria for an ASM performance year; rather, we believe such revisions help clarify that not meeting ASM participant eligibility criteria would not nullify the application of ASM payment adjustments on Medicare Part B claims for covered professional services during the corresponding ASM payment year based on performance in a prior ASM performance year. For example, a clinician may be selected for mandatory participation for the 2027 ASM performance year. If that ASM participant does not meet the ASM participant eligibility criteria for the 2029 ASM performance year, the revisions here help clarify that while the ASM participant would not be subject to the applicable performance assessment, data reporting, and scoring requirements during the 2029 ASM performance year (that is, CY 2029), but that ASM payment adjustments based on the ASM participant's performance from the 2027 ASM performance year would still be applied in CY 2029. Second, we propose at Sec. 512.710(a)(2)(iv) that an ASM participant who does not meet ASM participant eligibility criteria for an ASM performance year would not be eligible for the CMS-sponsored model arrangements and patient incentives safe harbor described at Sec. 512.765 for the applicable ASM performance year. We believe this proposal is consistent with our intent to make this safe harbor available for ASM performance years where the ASM participant is actively performing in the model (90 FR 49709). We refer readers to section III.D.2.h. of this proposed rule for further explanation of this proposal. We seek comment on our proposed revisions to Sec. Sec. 512.710(a)(1) and 512.710(a)(2). (3) Specialty Type Participation is limited to clinicians who are within specialties and furnish covered professional services related to ASM targeted chronic conditions--heart failure or low back pain. As finalized in the CY 2026 PFS final rule, we determine specialty type based on the specialty code most frequently reported on a clinician's Medicare Part B claims (90 FR 49583 through 49585). Medicare Administrative Contractors (MACs) derive specialty codes on claims from clinician- reported specialty types provided during Medicare enrollment. Physicians report their specialty type as part of their Medicare enrollment application through the Provider Enrollment, Chain, and Ownership System (PECOS) or through submission of the CMS 855I paper application.\164\ The Medicare enrollment form is also used for revalidations and ad hoc changes to certain information. We use data from the CY 2 years prior to each ASM performance year to determine whether a clinician meets the model's specialty type criteria. For example, we use CY 2025 data, including specialty type data, to select final ASM participants for the 2027 ASM performance year. --------------------------------------------------------------------------- \164\ https://www.cms.gov/medicare/cms-forms/cms-forms/cms-forms-items/cms019477. --------------------------------------------------------------------------- For the ASM heart failure cohort, we finalized inclusion of physicians with a specialty type of cardiology. Our rationale for including cardiologists as ASM heart failure participants, as explained in the CY 2026 PFS final rule, is that they commonly provide care to Original Medicare beneficiaries with heart failure and are well- positioned to manage outcomes by ensuring patients are optimized on guideline-directed medical therapy to prevent exacerbation of their condition (90 FR 49576). We did not finalize the inclusion of other cardiac-related specialties (for example, cardiac electrophysiology, intensive cardiac rehabilitation, cardiac surgery, interventional cardiology, and advanced heart failure and transplant) as these clinicians are often proceduralists and not commonly involved in the longitudinal management of patients with heart failure (90 FR 49576). Because one of ASM's goals is to measure the performance of clinicians with similar patterns of heart failure care, we include cardiologists, but not other cardiac-related specialties, even though those cardiac- related specialists may be attributed patients with heart failure as measured through the heart failure EBCM (90 FR 49577). For the ASM low back pain cohort, we finalized inclusion of physicians who have a specialty of anesthesiology, pain management, interventional pain management, neurosurgery, orthopedic surgery, or physical medicine and rehabilitation. In the CY 2026 PFS final rule (90 FR 49577 through 49580), we emphasized that specialty types for the ASM low back pain cohort include physicians who are most directly involved in the evaluation and management of low back pain and whose clinical decision-making is expected to meaningfully influence downstream utilization and spending. We explained that the included specialists commonly furnish services to Original Medicare beneficiaries with low back pain and play a central role in determining the use of imaging, injections, procedures, and surgical interventions. We also noted that we did not include certain other specialties that may occasionally treat low back pain but are not typically responsible for its longitudinal management. By focusing on a defined set of specialties with similar roles in managing low back pain, we aim to support more meaningful comparisons of performance and to align model incentives with opportunities to improve care coordination, reduce unnecessary procedures, and promote evidence-based treatment. We are not proposing any adjustments to the specialty types included in each ASM cohort as finalized at Sec. 512.710(d) in the CY 2026 PFS final rule (90 FR 49576 through 49580). As part of this proposed rule, we are proposing to correct small typographical errors in the regulatory text at Sec. Sec. 512.710(d)(1) and 512.710(d)(2). These revisions do not introduce substantive changes to existing provisions. We seek comment on the proposed correction of the typographical errors at Sec. Sec. 512.710(d)(1) and 512.710(d)(2). (4) ASM Participant Exceptions We recognize that there may be limited circumstances in which an ASM participant selected for participation for an ASM performance year should be excepted from certain ASM requirements for that ASM performance year and should consequently be excepted from the application of an ASM payment multiplier to the ASM participant's Medicare Part B payments for covered professional services during the corresponding ASM payment year. Accordingly, we finalized a narrow set of ASM participant ``exclusions,'' or situations in which an ASM participant is excepted from specified ASM requirements in the CY 2026 PFS final rule to balance operational feasibility with the need for robust evaluation and generalizable findings (90 FR 49582 through 49583). As finalized at Sec. 512.710(c), an ASM participant who stops reassigning billing rights to the TIN we used to select the ASM participant and begins reassigning billing rights to a new TIN during an ASM performance year is not subject to certain ASM requirements-- specifically the requirements for performance assessment described at Sec. 512.715, data submission described at Sec. 512.720, final scoring described at Sec. 512.745, and [[Page 43967]] payment adjustment described at Sec. 512.750--and is no longer eligible for Medicare program waivers provided under the model described at Sec. 512.775 for the applicable ASM performance year. An exception from specified ASM requirements for one ASM performance year does not apply for the entire ASM test period because we consider clinicians who meet ASM participant eligibility criteria for at least one ASM performance year to be an ASM participant for the remainder of the ASM test period. This means that an ASM participant will receive payment adjustments during a corresponding ASM payment year based on performance from an ASM performance year for which they were required to meet these specified ASM requirements (90 FR 49571 through 49574). In other words, if an ASM participant meets the ASM participant eligibility criteria for the 2027 and 2028 ASM performance years, but not the 2029 and 2030 ASM performance years, by continuing to remain an ASM participant, the ASM payment multipliers calculated based on the ASM participant's performance during the 2027 and 2028 ASM performance years would continue to be applied to the ASM participant's Medicare Part B payments for covered professional services during the corresponding ASM payment years (that is, CY 2029 and CY 2030). After internal review, we believe it would be more precise to refer to the situations in which an ASM participant is not required to meet specified ASM requirements for applicable ASM performance year(s) as ``exceptions'' to ASM requirements rather than ASM participant ``exclusions.'' We believe this revision to the terminology will better capture the intended policy to not require an ASM participant to meet certain ASM requirements for an ASM performance year under certain circumstances. Accordingly, throughout this section of this proposed rule, we are proposing revisions to existing regulatory text to clarify the current circumstances under which an ASM participant may be excepted from certain ASM requirements and are proposing new provisions to include additional circumstances under which an exception would apply. In the remainder of this section of this proposed rule, we propose, in addition to the current exception due to a change in the reassignment of billing rights (that is, change in TIN), to recognize a new exception. Specifically, we propose that ASM heart failure participants who meet certain specialty type redesignation requirements may be excepted from specified model requirements. For each exception, we discuss proposals around the requirements and process for notifying us of a change that may warrant an exception. Finally, in accordance with the proposed revisions to Sec. 512.710(a)(2) discussed earlier in this section of this proposed rule, we make proposals at Sec. 512.710(c) to describe the effect and duration of an exception due to a change in TIN or redesignation of primary specialty type. (a) Exceptions Due to TIN Changes In the CY 2026 PFS final rule (90 FR 49582 through 49583), we finalized that an ASM participant who stops reassigning billing rights to the TIN used to select the ASM participant and begins reassignment to a new TIN during the same ASM performance year would no longer be subject to specified ASM requirements for that ASM performance year under either TIN if the ASM participant notifies us of the reassignment change within 30 days. We explained that a TIN change during an ASM performance year may limit our ability to determine continued ASM participant eligibility and assess performance under the model using consistent claims history and EBCM data. Since the finalization of the CY 2026 PFS final rule, interested parties have shared examples with us of additional circumstances, beyond changes in reassignment, that impact a clinician's affiliation with a particular TIN (for example, retirement from practice) and inquired whether those circumstances would qualify an ASM participant for exception from specific ASM requirements. Our finalized provisions also do not account for situations when an ASM participant reassigned their billing rights to a new TIN before the start of an ASM performance year. After internal review, we believe that it would be appropriate to address such circumstances in ASM's provisions. Accordingly, we are making multiple proposals to simplify the exception from specified model requirements based on TIN changes including to recognize additional TIN change scenarios for possible exception from specified ASM requirements. First, we are proposing to redesignate the provisions at current Sec. 512.710(c)(1), which describes the notification process for TIN changes that occur during an ASM performance year, as new Sec. 512.710(c)(1)(i)(B). We propose to revise Sec. 512.710(c)(1) to describe how we may determine an exception applies. Specifically, we propose that an ASM participant who demonstrates the circumstances described by an exception apply (that is, change in TIN or approved primary specialty type redesignation) would be excepted from specified ASM requirements, subject to CMS determination for the duration specified for each exception. For each of these exception situations, we discuss the proposed requirements that an ASM participant would be required to meet and, later in this section of this proposed rule, the duration of the exception. Second, we propose at new Sec. 512.710(c)(1)(i) that an ASM participant who (1) stops reassigning billing rights to the TIN we used to select them as ASM participant for an applicable ASM performance year and (2) satisfies the TIN change notification requirements at proposed Sec. 512.710(c)(1)(i)(A) or Sec. 512.710(c)(1)(i)(B), as applicable, may be excepted from specified ASM requirements. We believe the addition of this provision provides additional clarity on how the notification processes proposed at Sec. Sec. 512.710(c)(1)(i)(A) and 512.710(c)(1)(i)(B) could lead to an exception. Third, we propose new provisions related to ASM participant TIN changes that occur before the start of an ASM performance year. At Sec. 512.710(c)(1)(i)(A), we propose that an ASM participant who stops reassigning billing rights to the TIN we used to select them as an ASM participant before the applicable ASM performance year must notify us in writing no later than 60 days after the start of the applicable ASM performance year; after receiving such notice, we may determine an exception to specified ASM requirements applies for the ASM performance year. We recognize that ASM participants may change organizational affiliations between the time we select ASM participants and the start of an ASM performance year. Based on our previously finalized provisions related to the TIN change exception in the CY 2026 PFS final rule, we believe that the same challenge of having consistent claims history and EBCM data to evaluate ASM participant eligibility criteria under the new TIN would apply in this circumstance and thus an exception would be appropriate. We believe that requiring the ASM participant to notify us in writing no later than 60 days after the start of the ASM performance year would provide an adequate window to provide us with notice of such change after we release the list of ASM participants for a given ASM performance year. Finally, we propose at Sec. 512.710(c)(1)(i)(B) that an ASM participant who stops reassigning their [[Page 43968]] billing rights to the TIN we used to select them for participation in ASM during an ASM performance year is not required to reassign billing rights to a new TIN during the same ASM performance year to be potentially eligible for an exception from specified ASM requirements. We believe the proposed modification would capture additional organizational affiliation changes, such as retirements, that merit an exception from specified ASM requirements. We further believe this proposal is consistent with the original intent of the TIN change exception policy we finalized in the CY 2026 PFS final rule. We are also proposing that an ASM participant who changes their TIN during an ASM performance year must provide written notice of the change in a form and manner determined by us within 30 days of stopping reassignment to that TIN. We believe that adding this additional detail on the form of the notification and required timing clarifies the notification process for ASM participants. We seek comment on our proposal at Sec. 512.710(c)(1) describing the notice and determination process for an exception from specified model requirements. We also seek comment on our proposal at Sec. 512.710(c)(1)(i) to describe the requirements for an exception from specified model requirements for an ASM participant who stops reassigning billing rights to the TIN we used to select them as an ASM participant. We also seek comment on: (1) our proposed notification process for TIN changes that occur before the start of an ASM performance year described at Sec. 512.710(c)(1)(i)(A); (2) our proposal to remove the requirement that an ASM participant who no longer reassigns their billing rights to the TIN we used to select them as an ASM participant during an ASM performance year must begin reassigning billing rights to a new TIN to be eligible for exception as described at Sec. 512.710(c)(1)(i)(B); and (3) our proposal that an ASM participant must provide written notice of the change in TIN within 30 days of stopping reassignment of billing rights to the ASM participant's TIN as described at Sec. 512.710(c)(1)(i)(B). (b) Exceptions Due to Heart Failure-Related Specialty Type Redesignations In the CY 2026 PFS final rule, we did not propose or consider an exception based on redesignations of specialty type made through Medicare enrollment before or during an ASM performance year. Since publication of the CY 2026 PFS final rule, we have received interested parties' feedback that we should consider adjustments to ASM participant eligibility determinations based on more recent Medicare enrollment information related to specialty type, which is used to derive the Medicare Part B claims-based specialty type that we use to evaluate ASM participant eligibility criteria. We believe that using historical data to evaluate ASM participant eligibility criteria for each ASM performance year is still appropriate. In the CY 2026 PFS final rule (90 FR 49583 through 49585), we explained that determining a clinician's specialty type based on historical data from 2 CYs before an ASM performance year provides an objective and consistent approach because it allows us to use historical claims data to evaluate clinician specialty type, as well as the EBCM episode threshold, as part of the ASM participant eligibility criteria. This approach also supports operational feasibility because it enables us to provide advance notification for ASM participants to prepare for the start of an ASM performance year. However, we recognize that clinicians may not have had sufficient time to formally update an out-of-date specialty type before the end of CY 2025 because ASM was not finalized until November 2025. For example, specialty type redesignations made in CY 2026 would not be reflected in the CY 2025 data used to select final ASM participants for the 2027 ASM performance year. Setting an appropriate scope of ASM participant exceptions is important in a mandatory model such as ASM to preserve the integrity of the model design and evaluation, and to ensure a representative ASM participant population. While allowing unrestricted ASM participant exceptions due to specialty type redesignations could introduce selection bias and undermine the model test, we believe that certain limited and clinically appropriate redesignations may warrant consideration based on the timing of ASM's announcement and selection of ASM participants. Accordingly, we are proposing that ASM heart failure participants who officially redesignate their primary specialty type through an approved Medicare enrollment application (either PECOS or CMS-855 form paper application) to a limited set of specialty types and demonstrate proof of board certification would be excepted from specified ASM requirements and ineligible for Medicare program waivers and the safe harbor provisions available in the model for the applicable ASM performance year and for all remaining ASM performance years in the ASM test period. We further discuss the proposed duration of this specific exception later in this section of this proposed rule. Specifically, we propose at Sec. 512.710(c)(1)(ii) that we may approve an exception from specified model requirements for an ASM heart failure participant upon receipt of written notification of updated Medicare enrollment to the following redesignated primary specialty types described at Sec. 512.710(c)(1)(ii)(A): cardiac electrophysiology, cardiac surgery, interventional cardiology, advanced heart failure and transplant cardiology, and adult congenital heart disease. We propose at Sec. 512.710(c)(1)(ii)(B) that an ASM heart failure participant who redesignated their primary specialty type through an approved Medicare enrollment application (either PECOS or CMS-855 form paper application) would need to provide us written notification of the approved redesignation, along with verification of board certification in the newly designated primary specialty type described under Sec. 512.710(c)(1)(ii)(A) within 30 days of the effective date of the approved redesignation. Recognizing an exception for ASM heart failure participants that redesignate their specialty type to one of the proposed specialty types would be appropriate because these specialty types reflect highly specialized or procedure-focused practice areas that are distinct from the broader management of cardiovascular disease and heart failure captured under the cardiology specialty. Excepting cardiac electrophysiology, cardiac surgery, and interventional cardiology would be appropriate because these specialties are predominantly procedure- focused and are generally organized around the performance of invasive or technical interventions rather than the longitudinal medical management of cardiovascular disease. Cardiac electrophysiology primarily involves the diagnosis and treatment of cardiac arrhythmias through procedures such as ablation and device implantation; interventional cardiology centers on catheter-based interventions (for example, percutaneous coronary intervention). Cardiac surgery involves operative treatment for cardiac conditions. Advanced heart failure and transplant cardiology specialists primarily manage patients with end- stage heart failure, mechanical circulatory support, or transplant- related care, while adult congenital heart disease specialists treat individuals with complex congenital conditions that persist into adulthood. Because the specialty types proposed for [[Page 43969]] exception represent narrower scopes of practice than general heart failure management, their exception from specified requirements helps ensure that ASM remains focused on specialists who manage heart failure in a comprehensive and ongoing manner, thereby improving the specificity and consistency of the ASM heart failure cohort. To be excepted from the specified ASM requirements under this proposal, we believe that the ASM participant must (1) officially redesignate their primary specialty type to one of the specialty types described earlier through an approved Medicare enrollment application and (2) provide evidence of board certification in the redesignated specialty to ensure that an exception to specified ASM requirements is valid and appropriate. While Medicare enrollment requirements stipulate a clinician must supply documentation supporting eligibility for Medicare enrollment under Sec. 424.510(d), these enrollment regulations do not specify a mechanism for substantiating specialty type. Initial enrollment, revalidation, and any interim changes to an existing enrollment require a physician to select a primary specialty and attest that they meet all state or Federal requirements for their selected primary specialty. Physicians must meet the same requirements for any secondary specialty selected. They must also provide information on the active certification relating to their selected primary specialty type, specifically certification number, effective data, certifying entity, and state where issued. If no certification is associated with the selected primary specialty, then the physician must report the certification relevant to the secondary specialty.\165\ MACs have operational authority to validate reported information, including requesting supporting documentation, if needed. In addition to requiring the redesignation through a Medicare enrollment application, we believe that requiring an ASM participant to report additional proof of board certification in one of the proposed specialty types eligible for exception would promote a more accurate approach to the exception process while avoiding unrestricted or unverified exceptions that could introduce selection bias into the model test. Further, all of the proposed specialty types for exception have a certifying entity that provides evidence of board certification. The American Board of Internal Medicine provides board certification for cardiac electrophysiology, interventional cardiology, advanced heart failure and transplant cardiology, and adult congenital heart disease specialty types. The American Board of Thoracic Surgery provides board certification for the cardiac surgery specialty type. Therefore, we believe that an ASM heart failure participant seeking an exception would be able to produce evidence of board certification for all specialty types proposed for exception. --------------------------------------------------------------------------- \165\ https://www.cms.gov/medicare/cms-forms/cms-forms/cms-forms-items/cms019477. --------------------------------------------------------------------------- We considered an alternative proposal whereby we would only recognize specific specialty type redesignation-based exceptions that occur during 2027 and 2028 ASM performance years to limit the number of ASM participants potentially excepted. Based on the announcement of ASM in the CY 2026 PFS final rule in November 2025, we believe that potential ASM participants may not have had adequate time to officially redesignate their primary specialty type such that it is reflected in the Medicare Part B claims used to select ASM participants for these ASM performance years. For example, a 2027 ASM participant who redesignated their primary specialty type in CY 2026 would not have that change reflected in the CY 2025 claims data used to evaluate their eligibility. A similar timing challenge could occur for the 2028 ASM performance year because we will use CY 2026 data to select ASM participants for the 2028 ASM performance year. We believe that finalization of ASM in the CY 2026 PFS final rule provided potential ASM participants advanced notice to redesignate their specialty type, if appropriate, for CY 2027, which is the year of data that we will use to select ASM participants for the 2029 ASM performance year. However, we recognize that appropriate specialty type redesignations could occur after the 2028 ASM performance year and that allowing the potential for an exception based on specific specialty type redesignations for a longer period would retain consistency in the application of the proposed exception for specified ASM requirements. We considered but are not proposing exceptions based on specialty type redesignations for ASM low back pain participants. Unlike cardiac specialties, the specialty types included in the ASM low back pain cohort typically do not have Medicare specialty types that reflect further specialization that would be appropriate for excepting ASM low back pain participants. We also believe that the larger number of specialty types in the ASM low back pain cohort would naturally capture common changes in specialty type by ASM low back pain participants over time. For example, we would capture an anesthesiologist ASM low back pain participant who redesignates their primary specialty type to pain management or interventional pain management over the course of the ASM test period through our existing use of historical Mediare Part B claims to identify specialty type. Our rationale for recognizing exceptions based on specialty type redesignation is to ensure each ASM cohort represents specialists who can be appropriately held accountable for longitudinal management of heart failure or low back pain. Accordingly, we believe that the existing ASM low back pain participant specialty type criteria, together with the minimum episode attribution volume for the low back pain EBCM, accomplishes this objective and allowing unrestricted exceptions based on specialty type redesignations in the ASM low back pain cohort could introduce selection bias into the model test. We seek comment on the proposed timeline and documentation requirements for notifying us of an ASM heart failure participant specialty type redesignation for the purpose of determining an exception proposed under Sec. 512.710(c)(1)(ii). We also seek comment on the proposed specialty types--cardiac electrophysiology, cardiac surgery, interventional cardiology, advanced heart failure and transplant cardiology, and adult congenital heart disease--to which an ASM heart failure participant may redesignate their primary specialty type through an approved Medicare enrollment application to be considered for an exception from specified ASM requirements. We further seek comment on the proposed requirement to provide us with direct evidence of board certification in one of the proposed specialty types eligible for exception. We also seek comment on our alternative to only consider exceptions for specific specialty type redesignations based on notifications that occur during the 2027 and 2028 ASM performance years. Finally, we seek comment on whether we should consider ASM low back pain participant exceptions based on primary specialty type redesignations, including rationale on specific specialty type redesignations that we could consider for ASM low back pain participants. (c) Effect and Duration of Exceptions to Specific ASM Performance Requirements We propose at Sec. 512.710(c)(2) to define the effect of an approved [[Page 43970]] exception on an ASM participant. Specifically, we propose that the ASM participant with an approved exception would: (1) not be subject to performance assessment described at Sec. 512.715, data submission described at Sec. 512.720, and final scoring described at Sec. 512.745 for the applicable ASM performance year; (2) not be subject to payment adjustments described at Sec. 512.750 for the corresponding ASM payment year; (3) not be eligible for Medicare program waivers available under the model described at Sec. 512.775 for the applicable ASM performance year, and (4) not be eligible for the CMS-sponsored model arrangements and patient incentives safe harbor described at Sec. 512.765 for the period for which we determine an exception applies. We believe that the proposed effect of an exception retains the intent of the finalized provisions related to ASM participant exclusions due to TIN changes in the CY 2026 PFS final rule while adding new elements that strengthen program integrity. This proposal is also similar to the effect of an ASM participant not meeting the ASM participant eligibility criteria for an ASM performance year discussed earlier in this section of this proposed rule. We propose at Sec. 512.710(c)(3)(i) that an exception related to a TIN change would be effective on the CMS-determined date and would only apply for the applicable ASM performance year. We believe that limiting an exception to a single ASM performance year would allow us to select the ASM participant with the exception (that is, the same TIN/NPI combination) for a future ASM performance year should the NPI again reassign billing rights to that same TIN and meet ASM participant eligibility criteria under that TIN. We considered whether to extend an exception related to a TIN change for the remainder of the ASM test period. However, we believe that this approach could lead to unnecessary exceptions for later ASM performance years, particularly in the case that an excepted ASM participant begins reassigning billing rights to the same TIN under which we previously selected them as an ASM participant, and excepted them, for a previous ASM performance year. We provide several illustrative examples of how the proposed exception related to TIN changes would work in practice, including the effect of such exceptions on the application of payment adjustments under ASM. In our first example, ASM participant Dr. A (TIN A/NPI A) receives a final score and an ASM payment multiplier for their performance at TIN A in the 2027 ASM performance year. Dr. A receives an exception for the 2028 ASM performance year based on termination of billing rights to TIN A and reassignment of billing rights to TIN B. Under TIN B, Dr. A remains located in the same mandatory geographic area as they were located under TIN A. Dr. A is not required to meet the specified ASM requirements under TIN A or TIN B for the 2028 ASM performance year. However, because Dr. A began reassigning billing rights to TIN B after the end of the 2027 ASM performance year but before the end of the 2029 ASM payment year, we would apply the ASM payment multiplier determined for the 2027 ASM performance year to payments for Medicare Part B covered professional service claims submitted by Dr. A under TIN B during the 2029 ASM payment year. We refer readers to section III.D.2.g. of this proposed rule and Sec. 512.750(f) for additional information on payment adjustment provisions related to TIN changes that occur after an ASM performance year but before the end of the corresponding ASM payment year. We also note that Dr. A in this example could be selected as an ASM participant under TIN B for the 2030 ASM performance year if they meet ASM participant eligibility criteria under TIN B based on CY 2028 data. In this situation, Dr. A would be included in the list of ASM participants for the 2030 ASM performance year. We also provide an example of how the proposed exception due to TIN changes would work for an NPI who is selected as an ASM participant under multiple TIN/NPI combinations. As discussed in the CY 2026 PFS final rule, we believe that it would be rare, but possible, for the same NPI to be selected as an ASM participant under multiple TINs for the same ASM performance year (90 FR 49602). An exception based on a TIN change for one TIN/NPI combination does not affect the ASM participant's obligation to meet specified ASM requirements under any other TIN/NPI combination for which we selected the NPI as an ASM participant. For example, Dr. B (NPI B) is selected as an ASM participant under TIN C and TIN D for the 2028 ASM performance year. If Dr. B stops reassigning billing rights to TIN C during the 2028 ASM performance year and receives an exception for the 2028 ASM performance year, then Dr. B is excepted from the specified ASM requirements under TIN C but must continue to meet ASM's requirements under TIN D for the 2028 ASM performance year. We propose at Sec. 512.710(c)(3)(ii) that an exception related to specialty type redesignation would be effective on the CMS-determined date and would apply for the applicable ASM performance year and remain effective for all ASM performance years in the remainder of the ASM test period. We believe that excepting ASM participants for specified specialty type redesignations for the remainder of the ASM test period would be appropriate since these ASM participants do not represent the target specialty type of an ASM cohort, and would, therefore, improve the specificity and consistency of the ASM cohort for the purposes of performance comparison. We considered effectuating the exception related to specialty type redesignation type on the CMS-determined date and only having it apply for the applicable ASM performance year. However, we believe that effectuating the exception for the remainder of the ASM test period would be preferrable since we believe an ASM participant would be unlikely to revert to their previous primary specialty type redesignation during the remainder of the ASM test period. We provide several illustrative examples of how the proposed exception related to specialty type redesignations would work in practice, including the effect of such exception on the application of payment adjustments under ASM. For example, consider ASM heart failure participant Dr. C (TIN E/NPI C) who receives a final score and an ASM payment multiplier for their performance under TIN E for the 2027 ASM performance year. Dr. C receives an exception during the 2028 ASM performance year because they redesignated their primary specialty type to cardiac electrophysiology as part of their Medicare enrollment and met the notification requirements. Dr. C would be excepted from the specified ASM requirements for the 2028 ASM performance year and the remainder of the ASM test period under TIN E. However, they would continue to receive payment adjustments on their Medicare Part B covered professional service claims submitted under TIN E during the 2029 ASM payment year based on the ASM payment multiplier determined for their performance during the 2027 ASM performance year. As we emphasized in the CY 2026 PFS final rule (90 FR 49696 through 49699), our goal is to maintain accountability for an ASM participant's performance for a given ASM performance year through performance-based payment adjustments during the corresponding ASM payment year. We also note that a specialty type redesignation exception would apply to [[Page 43971]] all TIN/NPI combinations for which we selected the NPI as an ASM participant, provided the notification requirements are met and we approve an exception for each TIN/NPI combination. For example, Dr. D (NPI D) is considered an ASM heart failure participant under TIN F and TIN G for the 2028 ASM performance year. Dr. D redesignates their primary specialty type to interventional cardiology as part of their Medicare enrollment during the 2028 ASM performance year and meets the notification requirements for both TIN F and TIN G. If we approve the exception, Dr. D would be excepted from specified ASM requirements for the 2028 ASM performance year and the remainder of the ASM test period under both TIN F and TIN G. We seek comment on the proposed effect of an exception from specified ASM requirements at Sec. 512.710(c)(2). We also seek comment on the proposed duration of an exception related to TIN changes as proposed at Sec. 512.710(c)(3)(i), as well as the alternative we considered of setting the duration of a TIN change-related exception as the remainder of the ASM test period. We seek comment on the proposal at Sec. 512.710(c)(3)(ii) that an exception related to specialty type redesignation would apply for the ASM performance year for which we approve the exception and for the remainder of the ASM test period. Finally, we seek comment on the alternative we considered to effectuate an exception related to specialty type redesignation for the applicable ASM performance year only. (5) ASM Participant Terminations In the 2026 PFS final rule, we finalized application of the Standard Provisions for Mandatory Innovation Center Models (42 CFR part 512, subpart A) to ASM (90 FR 49720). These provisions describe actions that we may take to remediate actions associated with risks to program integrity. We discussed how the standard provisions are not intended to encompass all the terms and conditions that would apply to each Innovation Center model, because each model has unique design features and implementation plans that may require additional, more tailored provisions. In addition to the remedial actions enumerated in the standard provisions at Sec. 512.160(b), we now propose to include an additional remedial action for purposes of ASM whereby we could terminate an ASM participant from participation in the model upon determining that one or more grounds for remedial action described in Sec. 512.160(a) has taken place. Grounds for remedial action include, for example, when a model participant has: failed to comply with terms of the Innovation Center Model or applicable Medicare program requirements; taken action to threaten the health or safety of a patient; submitted false data or made false representations in connection with the Innovation Center model; or undergone a change in control that presents a program integrity risk. We also propose that we could terminate an ASM participant if we determine that their continued participation would be inconsistent with the purposes of ASM or applicable law. Under this proposal, any termination of an ASM participant's participation would occur only upon a determination by CMS. For the avoidance of doubt, our proposal would not establish a right for an ASM participant to terminate their participation. We believe that reserving authority to terminate an ASM participant's participation, where appropriate, such as in circumstances involving egregious conduct, would provide additional protections for the program and for beneficiaries. We propose to codify this provision at Sec. 512.710(h) and to include a corresponding reference to termination in proposed revised Sec. 512.710(a)(1), which addresses the duration of participation under ASM. We seek comment on this proposal at Sec. 512.710(h). c. Data Submission (1) Background We finalized in the CY 2026 PFS final rule that an ASM participant must meet established data submission requirements across the quality, improvement activities, and Promoting Interoperability ASM performance categories, consistent with Sec. Sec. 512.725, 512.735, and 512.740, respectively (90 FR 49596 through 49605). We did not establish data submission requirements for the cost ASM performance category or for administrative claims-based quality measures as we will calculate performance on these measures using administrative claims data. For the quality ASM performance category, we require the submission of numerator and denominator data for at least one required quality measure that satisfies the data completeness criteria (that is, data is submitted on at least 75 percent of the ASM participant's patients that meet a quality measure's denominator criteria). ASM participants in small practices (that is, a TIN with 15 or fewer clinicians) may submit quality data at the group level (that is, TIN level) while ASM participants in non-small practices must submit quality measure data at the individual clinician level (that is, TIN/NPI level). Data submission for the improvement activities ASM performance category requires an ASM participant to attest at the group level (that is, TIN level) that the required activities are completed by all ASM participants within the TIN. Finally, for the Promoting Interoperability ASM performance category, ASM participants must submit all required measure data (or claim any applicable exclusions), attestations, CMS Electronic Health Record (EHR) Certification ID, and performance period dates at the group level (that is, TIN level). Data submission for the Promoting Interoperability ASM performance category may reflect data from clinicians who are not ASM participants. Regardless of the data submission level for each ASM performance category, each ASM participant receives an individual-level final score and corresponding ASM payment adjustment factor and ASM payment multiplier, which is used to adjust payments for each ASM participant's Medicare Part B covered professional service claims. (2) Quality ASM Performance Category Data Submission for ASM Participants in Small Practices We finalized policies at Sec. 512.720(a) addressing data submission for the quality ASM performance category, including the requirement that quality measure data be submitted at the individual level (that is, TIN/NPI level). However, as finalized at Sec. 512.720(f), an ASM participant that is in a small practice may report quality ASM performance category data at the group level (that is, TIN level). After reviewing our provisions finalized in the CY 2026 PFS final rule, we believe it would improve readability and overall clarity of the regulatory text if we addressed the quality data submission policy for ASM participants in small practices together with the generally applicable policies for each ASM performance category, which appear at Sec. 512.720(a). Accordingly, we propose to remove existing Sec. 512.720(f) and instead address our quality ASM performance category data submission policy for ASM participants in small practices at Sec. 512.720(a)(1)(i)(C). In relocating this regulatory text, we also propose to make technical clarifying edits to better reflect our policy intent that an ASM participant in a small practice has the option to submit ASM quality measure [[Page 43972]] data at either the group level (that is, TIN level) or the individual level (that is, TIN/NPI level). Our intent is to provide ASM participants in small practices an additional flexibility in reporting ASM quality measure data. We propose conforming adjustments at Sec. 512.720(a)(1)(i)(A) to correct a minor typographical error and at Sec. 512.720(a)(1)(i)(B) to cross-reference to proposed new Sec. 512.720(a)(1)(i)(C). Our proposed reorganization of these provisions would not substantively change the policy under existing provisions, but we believe the proposed changes would bring greater clarity to the structure of the regulation and regulatory text. We invite public comment on these proposed adjustments to Sec. 512.720(a)(1)(i). (3) Improvement Activities ASM Performance Category Data Submission In the CY 2026 PFS final rule, we finalized that ASM participants submit improvement activity ASM performance category data by attesting to the completion of required improvement activities at the group level (that is, TIN level) (90 FR 49599 through 49602). We believed that group-level data submission would be appropriately reflective of the team-based care and coordination envisioned by the improvement activities (90 FR 49601). We also believed that group-level data submission for the improvement activities ASM performance category would reduce administrative burden (90 FR 49601). In subsequent sub- regulatory guidance, we clarified that a group-level attestation for completing a required improvement activity means that all ASM participants within a TIN successfully completed the requirements of that improvement activity for the applicable ASM performance year. We also clarified that a clinician who is not an ASM participant, but who has reassigned billing rights to a TIN that includes one or more ASM participants, would not be subject to any ASM participation obligations solely on that basis, including the requirements of the improvement activities ASM performance category. Since the publication of the CY 2026 PFS final rule, we have received feedback from interested parties that group-level data submission for the improvement activities ASM performance category may have unintentional consequences on scoring for ASM participants in certain circumstances. For example, if only 8 ASM participants in a TIN with 10 ASM participants complete a required improvement activity, then the group could not submit an attestation that all ASM participants within the group completed the improvement activity. In this example, each of the 8 ASM participants who completed the improvement activity would receive a 10-point deduction on their final score. While the group-level data submission for the improvement activities ASM performance category may reduce administrative burden related to data reporting, we believe it would be appropriate to adjust these data submission provisions to reduce the likelihood of final score penalties on an ASM participant who fully or partially completes the requirements of the improvement activities ASM performance category and associated data submission requirements. Accordingly, we propose at Sec. 512.720(a)(1)(ii)(B) to allow an ASM participant to submit data for the improvement activities ASM performance category at either the group level (that is, TIN level) or the individual level (that is, TIN/NPI level). We believe this proposal would offer greater flexibility in how an ASM participant or their affiliated group submits data for the improvement activities ASM performance category depending on their specific circumstances and data submission preferences. While we believe that many of ASM's improvement activities would be jointly implemented by ASM participants within a group to improve team-based care and coordination, we believe that this added data submission flexibility would mitigate the chance of an unintended negative adjustment to the final score of an ASM participant who fully or partially meets the improvement activities ASM performance category requirements. We note that this proposal would not affect how an ASM participant or its affiliated TIN may choose to structure a CCA required under IA-2. We seek comment on our proposal at Sec. 512.720(a)(1)(ii)(B) to allow ASM participants to attest to completing ASM's improvement activities at either the group level (that is, TIN level) or the individual level (that is, TIN/NPI level). (4) Treatment of Multiple Data Submissions for the Quality, Improvement Activities, and Promoting Interoperability ASM Performance Categories In the CY 2026 PFS final rule, we finalized policies addressing the treatment of multiple data submissions for the quality, improvement activities, and Promoting Interoperability ASM performance categories at Sec. 512.720(e) (90 FR 49604 through 49606). For the quality and improvement activities ASM performance categories, when we receive multiple data submissions for an individual ASM participant from multiple organizations (for example, a qualified registry, practice administrator, or an electronic health record (EHR) vendor), we calculate and score each submission and assign the highest score to the ASM participant. When we receive multiple data submissions for an individual ASM participant from the same organization, we score the most recent submission. For the Promoting Interoperability ASM performance category, we calculate each submission and assign the highest score. We believe our policies for multiple data submissions would be clearer if we addressed each ASM performance category separately, rather than discussing the quality ASM performance category and the improvement activities ASM performance category together. Accordingly, we propose to make technical modifications to regulatory text describing multiple data submissions, such that Sec. 512.720(e)(1) would address the quality ASM performance category, Sec. 512.720(e)(2) would address the improvement activities ASM performance category, and Sec. 512.720(e)(3) would address the Promoting Interoperability ASM performance category. Except for the proposed new policy for small practices at proposed Sec. 512.720(e)(1)(iii), discussed later in this section of this proposed rule, the remaining proposed revisions to Sec. 512.720(e)(1) would not constitute substantive changes from the policies finalized in the CY 2026 PFS final rule. Rather, those proposed revisions would reorganize the existing provisions and make clarifying modifications to the regulatory text. Specifically, we propose to: Address the multiple data submissions policy for the ASM quality performance category at Sec. 512.720(e)(1), the improvement activities ASM performance category at Sec. 512.720(e)(2), and the Promoting Interoperability ASM performance category at Sec. 512.720(e)(3). To accomplish this, we would: ++ Add the informative heading ``Quality ASM performance category'' to Sec. 512.720(e)(1). ++ Revise Sec. Sec. 512.720(e)(1)(i) and 512.720(e)(1)(ii) to reflect our policy for scoring multiple data submissions for the quality ASM performance category and make technical revisions to the text. ++ Redesignate existing Sec. 512.720(e)(2) describing our multiple data submission policy for the Promoting Interoperability ASM [[Page 43973]] performance category as new paragraph Sec. 512.720(e)(3)(i). ++ Redesignate the portions of Sec. Sec. 512.720(e)(1)(i) and 512.720(e)(1)(ii) that address our multiple data submission policy for the improvement activities ASM performance category to Sec. Sec. 512.720(e)(2)(i) and 512.720(e)(2)(ii). ++ Add the informative heading ``Improvement activities ASM performance category'' at Sec. 512.720(e)(2). ++ Revise newly redesignated Sec. Sec. 512.720(e)(2)(i) and 512.720(e)(2)(ii) to make technical clarifications for the treatment of multiple data submissions for the improvement activities ASM performance category. ++ Add the informative heading ``Promoting Interoperability ASM performance category'' to new paragraph Sec. 512.720(e)(3). We invite public comment on this proposed reorganization of Sec. 512.720(e). (a) Multiple Data Submissions for the Quality ASM Performance Category for ASM Participants in Small Practices In the CY 2026 PFS final rule, we finalized that ASM participants in small practices may report quality measures in the quality ASM performance category at the group level (that is, TIN level) (90 FR 49602). We finalized this policy because we recognize that reporting quality measures at the individual clinician level (that is, TIN/NPI level) may be particularly burdensome for ASM participants in small practices who may have limited capacity for data aggregation and reporting. We believe that EHR customization for individual-level reporting, and the costs associated with updating reporting mechanisms, may pose a larger burden on ASM participants in small practices compared to ASM participants in larger practices because small practices may not have the requisite support, such as infrastructure or staffing, to facilitate individual-level reporting. Importantly, this reporting flexibility does not change ASM's intention to measure individual ASM participant performance; rather, this flexibility is limited to the reporting and scoring of ASM non-administrative claims- based quality measures. All other reporting and scoring requirements for the cost and quality ASM performance categories remain at the individual ASM participant level regardless of practice size. ASM participants in small practices would retain the option to report quality measure data at the individual level if they choose. After internal review of the provisions finalized in the CY 2026 PFS final rule, we believe that permitting multiple submissions at different reporting levels within a small practice could create unintended incentives and scoring effects. If multiple reporting levels are permitted within the same small practice, an ASM participant's quality ASM performance category score could depend in part on the reporting level used, rather than on a consistent approach to reporting and evaluating quality performance. For example, a small practice could submit individual-level data for higher-performing ASM participants and group-level data for lower performing ASM participants. This variability could reduce comparability across ASM participants and create inconsistent scoring outcomes among ASM participants in similar practice arrangements. We believe ASM participants in small practice should report quality data at the reporting level that best meets their needs and capabilities. To ensure fair and consistent scoring of the quality ASM performance category, we are proposing at Sec. 512.720(e)(1)(iii) that if we receive any quality ASM performance category data at the group level (that is, TIN level) from an ASM participant in a small practice, we would score the group-level submission and assign that score to all individual ASM participants in the small practice. This proposal would mean that any individual-level (that is, TIN/NPI-level) submission received for any ASM participants in that small practice would not be scored if any group-level quality data submission is received. We believe this proposal would maintain the desired reporting flexibility to lower the administrative burden for ASM participants in small practices while preserving the integrity of the ASM scoring framework. Specifically, ASM participants in small practices would continue to have the option to report non-administrative claims-based ASM quality measures at either the group or individual level. Our proposed policy would mitigate the opportunity for ASM participants in small practices to submit data at multiples levels most opportune to achieve a higher score and establish a consistent scoring framework so that ASM participants in small practices are encouraged to submit required data based on needs and capabilities, rather than strategic performance considerations. Table B-D1 in this section of this proposed rule summarizes existing finalized policies and new proposals relating to our treatment of multiple data submissions for the quality ASM performance category. [[Page 43974]] [GRAPHIC] [TIFF OMITTED] TP16JY26.050 We seek comment on our proposal at Sec. 512.720(e)(1)(iii) to score any group-level quality data submission received from small practices and assign that score to all ASM participants in the small practice regardless of any individual-level quality data submission received for individual ASM participants in that same small practice. d. Quality ASM Performance Category (1) Background As discussed in the CY 2026 PFS final rule, the quality ASM performance category supports the broader goals of the model by incentivizing improvements in the quality of care and reductions in unnecessary or low-value services for patients with heart failure and low back pain. To accomplish these objectives, we finalized in the CY 2026 PFS final rule the use of ASM cohort-specific quality measure sets at Sec. 512.725(b) (heart failure) and Sec. 512.725(c) (low back pain) (90 FR 49606). ASM participants must report all measures applicable to their ASM cohort, with administrative claims-based measures calculated by us. This structure is similar to other CMS programs, such as MIPS Value Pathways (MVPs), that entail reporting on a clinically relevant subset of measures tailored to an eligible clinician's specialty and patient population. It also minimizes reporting burden, promotes consistency in measurement over the duration of the ASM test period, and supports rigorous evaluation by maintaining a stable set of quality indicators. In finalizing these policies, we sought to ensure that each ASM cohort-specific quality measure set reflects agency goals to advance value-based care by linking payment to meaningful improvements in clinical outcomes and beneficiary experience. The measures selected for ASM represent a mix of utilization-focused measures, evidence-based care measures, and patient-reported outcome or experience measures. This structure supports nationwide measurement efforts focused on outcomes, safety, and patient experience. We intend for the quality measure sets applicable to each ASM cohort to remain stable throughout the ASM test period; however, we may propose additions or removals through notice-and-comment rulemaking if refinements to the measure sets are warranted. Such updates may be considered in response to interested parties' feedback, changes in clinical guidelines, updates to measures used in ASM or other CMS programs, or the development of new quality measures. This framework keeps the quality ASM performance category aligned with current clinical practice while providing predictability that may reduce administrative burden over time. (2) Low Back Pain Quality Measure Set (a) Low Back Pain Imaging Measure for the ASM Low Back Pain Cohort In the CY 2026 PFS proposed rule, we proposed inclusion of the ``Magnetic Resonance Imaging (MRI) Lumbar Spine for Low Back Pain, Respecified to Be Relevant to ASM Participants Treating Low Back Pain'' measure in the ASM low back pain quality measure set (90 FR 32593 through 32597), but did not finalize its inclusion based on interested parties' feedback (90 FR 49616 through 49618). We indicated in the CY 2026 PFS final rule that we intended to revisit the inclusion of this measure in future notice-and-comment rulemaking (90 FR 49617). We indicated revisiting because the ASM low back pain cohort had only four quality measures, and none were focused on excess utilization or efficiency. As our goal is to have a well-rounded measure set for each ASM cohort that includes this focus area, we sought to include a measure that would complete the ASM low back pain quality measure set. We are proposing at Sec. 512.725(c)(5) to include the ``Magnetic Resonance Imaging (MRI) Lumbar Spine for Low Back Pain (modified for ASM)'' measure in the ASM low back pain quality measure set. This proposal would meet the goals of the ASM low back pain cohort's quality measure set of having an excess utilization focused measure. This measure is modified from the [[Page 43975]] ``Magnetic Resonance Imaging (MRI) Lumbar Spine for Low Back Pain'' measure that was specified for use in hospital outpatient departments at the facility level and previously included in the Hospital Outpatient Quality Reporting Program (HOQRP) as OP-8 (73 FR 68766).\166\ While we removed the measure from the HOQRP in 2017 due to limited reliability from low average facility-level volumes, we have since re-evaluated the measure for use in ASM. In reassessing this measure, we considered interested parties' feedback, technical expert input, and measure reevaluation activities. Commenters and experts indicated that, while the clinical concept remains important for assessing low-value imaging, the prior specification presented challenges related to attribution at the facility level, small sample sizes, and limited applicability to certain care delivery contexts. Interested parties also recommended exploring refinements to improve measure reliability and alignment with clinician decision-making in ambulatory specialty settings. --------------------------------------------------------------------------- \166\ Hospital Outpatient Quality Reporting [verbar] Partnership for Quality Measurement. P4qm.org. Published 2025. Accessed April 23, 2025. https://p4qm.org/taxonomy/term/216. --------------------------------------------------------------------------- In response, we have made targeted specification modifications to improve the measure's applicability and statistical reliability in the ASM context. We believe these modifications address the previously identified limitations while preserving the measure's clinical intent of reducing unnecessary imaging for low back pain. We believe the proposed administrative claims-based quality measure would effectively evaluate 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 and concerning features.\167\ However, analyses 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.\168\ Overuse of imaging for low back pain can lead to unnecessary health care costs and potential patient harm from the cascade effect, where MRI findings, many incidental, may prompt further unnecessary testing or procedures.169 170 By including this measure in the ASM low back pain quality measure set, ASM would aim to incentivize adherence to evidence-based guidelines and a reduction of unnecessary MRIs for patients with uncomplicated low back pain, where an MRI is not clinically indicated, particularly in the initial stages of evaluation and management. We believe this could also improve patient experience to the extent it reduces time spent at medical appointments and out-of-pocket health care costs. Furthermore, as an administrative claims-based quality measure, ASM low back pain participants would not assume new reporting requirements for this measure. We would provide detailed measure information for the MRI Lumbar Spine for Low Back Pain (modified for ASM) on the ASM website before the start of the 2027 ASM performance year, if finalized, to educate ASM participants on how they would be measured. --------------------------------------------------------------------------- \167\ 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. \168\ Medicare Payment Advisory Commission. Health Care Spending and the Medicare Program: A Data Book. Medicare Payment Advisory Commission; July 2021. Accessed July 7, 2026. https://www.medpac.gov/wp-content/uploads/2021/10/July2021_MedPAC_DataBook_Sec7_SEC.pdf. \169\ 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. \170\ 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. --------------------------------------------------------------------------- Our modifications seek to improve clinical validity and reliability for the purposes of ASM. Two of our modifications were related to denominator exclusions and the measure's performance period. We also made modifications to provider attribution, minimum case count, and the lookback period for antecedent care, for which we offer alternative options that seek comment on. We believe the modifications we propose in this proposed rule as part of the ``Magnetic Resonance Imaging (MRI) Lumbar Spine for Low Back Pain (modified for ASM)'' measure to be appropriately tailored to measure performance of ASM participants ordering inappropriate MRIs for patients with low back pain. We seek comment on the inclusion of MRI Lumbar Spine for Low Back Pain (modified for ASM) measure in the ASM low back pain quality measure set at Sec. 512.725(c)(5). We discuss modifications to the measure's specifications in the remainder of this section of this proposed rule, including seeking comment on potential alternatives to the proposed modifications related to provider attribution, minimum case count, and the lookback period for antecedent care. (i) Denominator Exclusions We conducted an evaluation of the measure's denominator exclusions to ensure that they reflect current clinical guidelines and appropriately identify cases where early lumbar spine imaging is clinically justified. This evaluation focused on exclusions that previously removed a large number of cases under the OP-8 specifications and involved reviewing each diagnosis code individually. Removing a large number of cases in OP-8 presented risks to the applicability and reliability of the measure. We identified three clinical areas that had a large number of exclusions: cancer diagnoses, neurological impairment, and autoimmune or inflammatory conditions. Physicians assessed each code under these categories for appropriateness to include in the measure denominator. Most conditions, such as ``red flag'' signs and symptoms and for malignant neoplasms and autoimmune disorders where imaging would be warranted (regardless of completion of conservative therapy), were maintained as denominator exclusions. Conditions, such as benign neoplasm of the colon and hemangioma of skin and subcutaneous tissue, were removed as denominator exclusions since their presence would not warrant an immediate MRI for a patient with low back pain; the condition alone would not preclude a patient with low back pain from attempting conservative therapy prior to receiving a lumbar MRI. To improve clinical validity and acceptability, conditions and diagnoses were not removed as denominator exclusions if they were present in the list of denominator exclusions in the Healthcare Effectiveness Data and Information Set (HEDIS) Use of Imaging Studies for Low Back Pain measure.\171\ Under this approach, we ultimately aligned with the same exclusion logic used in the HEDIS Use of Imaging Studies for Low Back Pain measure and only diagnosis codes present in that measure and supported by clinical review remained as denominator exclusions in our ASM measure. As a result of these refinements, the ASM measure's exclusion criteria differ from the prior OP8 specification in these three clinical areas with the goal of [[Page 43976]] more closely aligning to evidence-based practice guidelines. --------------------------------------------------------------------------- \171\ National Committee for Quality Assurance. Use of Imaging Studies for Low Back Pain (LBP). NCQA, https://www.ncqa.org/report-cards/health-plans/state-of-health-care-quality-report/use-of-imaging-studies-for-low-back-pain-lbp/. Accessed 6 Apr. 2026. --------------------------------------------------------------------------- In our analysis, these changes result in the inclusion of a significant number of imaging studies that would previously have been excluded, representing 52 percent of the cases that would have been removed under the earlier specification. Retaining these cases strengthens this measure by increasing denominator volume and improving our ability to identify potentially unnecessary imaging. We believe these refinements enhance the measure's clinical validity by ensuring that exclusions are limited to diagnoses that represent appropriate indications for more immediate imaging that do not warrant a prior trial of conservative therapy. (ii) Performance Period We evaluated the performance period for the measure to ensure that ASM participant-level scores are reliable and suitable for use in the model's quality assessment framework. The original HOQRP version of the measure used a single-year performance period, which limited the number of eligible MRI studies available for scoring and contributed to concerns about measure reliability.\172\ To address these issues, we tested an expanded performance period that included all eligible lumbar spine MRI studies occurring within a rolling 24-month window. Under this approach, each MRI meeting denominator criteria during the 2-year period was included in measure calculation, thereby significantly increasing the number of cases available for analysis. Testing showed that the expanded 2-year performance period resulted in approximately a 100 percent increase in denominator volume relative to a 1-year period. This increase in case volume improved the precision of ASM participant- level estimates and reduced small-sample volatility, particularly for clinicians with lower annual MRI volumes. We believe that a 2-year performance period enhances measure stability and supports more dependable performance assessment across all ASM low back pain participants and overcomes limitations and concerns that existed when the measure existed in the HOQRP. This is especially important for utilization measures, where annual case counts can vary substantially among specialties and practice types. Based on these findings, we believe that a rolling 24-month period provides the most robust and actionable representation of clinician imaging practices. --------------------------------------------------------------------------- \172\ Hospital Outpatient Specifications Manuals, Hospital Outpatient Quality Reporting. CMS.gov. Accessed March 27, 2026. https://qualitynet.cms.gov/outpatient/specifications-manuals. --------------------------------------------------------------------------- (iii) Provider Attribution The management of low back pain often involves several specialists over an extended period, and diagnostic and treatment decisions typically develop through multiple clinical encounters rather than a single visit. In modifying the original HOQRP measure for use in ASM, we had to address how to transition the measure from its original hospital outpatient department attribution method, which assigned imaging only to the facility that billed the MRI claim, to an approach that reflects physician-level accountability. This work included evaluating a single-participant attribution method that assigns each MRI to the physician with the highest number of qualifying encounters during the lookback period and a multiple-participant attribution method that assigns the MRI to all physicians who provided qualifying services to the patient. Testing showed that the multiple-participant method increased the number of attributed MRI studies by roughly 26 percent after exclusions, which strengthened measure stability and improved representation of the various physicians involved in that beneficiary's care. Multiple attribution better reflects real-world care patterns, particularly in increasingly common cases where beneficiaries receive longitudinal care by different team members over time. This approach also supports ASM's goals by recognizing the shared nature of clinical responsibility for decisions that influence downstream utilization and patient outcomes. Also, including all clinicians who contributed meaningfully to the beneficiary's care ensures that performance assessment captures the full set of ASM low back pain participants who may influence imaging decisions. We believe this attribution method provides a more complete and accurate understanding of imaging practices within the ASM low back pain cohort. For these reasons, we are proposing multiple-participant attribution. We also considered an alternative approach that would attribute each MRI to a single physician. Under this option, an MRI would be assigned to the ASM participant who furnished the highest number of qualifying encounters during the attribution window, which reflects a single point of clinical responsibility for many beneficiaries. This approach would provide a more streamlined assignment method and could reduce attribution complexity for the measure, but may not be reflective of real-world practice patterns and results in fewer attributed beneficiaries per ASM participant and thus slightly lower measure reliability. We seek comment on the proposed use of a multiple-participant attribution method for this quality measure. We also seek comment on the alternate proposal of an attribution method involving a single ASM participant. (iv) Minimum Case Count We evaluated the appropriate minimum case count threshold for the MRI Lumbar Spine for Low Back Pain (modified for ASM) measure to ensure that clinician-level performance scores are reliable for use in the model's quality assessment framework. Low case volumes may produce substantial variation in provider scores and a wider distribution of results, which could reduce the measure's ability to distinguish true performance differences. At lower thresholds, such as one or 10 cases, our analysis found that many ASM low back pain participants would have insufficient volume to support stable estimates, and reliability decreased accordingly. At a threshold of 20 cases, the measure showed stronger reliability and a narrower distribution of scores across ASM participants, indicating that estimates were more consistent and reflective of meaningful patterns of imaging use. The threshold of 20 cases aligns with the ASM participant eligibility criteria that, in part, requires an ASM low back pain participant to have historically been attributed at least 20 low back pain EBCM episodes. The threshold of 20 cases also aligns with the case minimums for the other quality measures in the ASM low back pain quality measure set. This alignment ensures that the case count threshold is both operationally feasible and representative of the expected care volume for ASM participants. In addition, maintaining a minimum of 20 cases reduces the influence of isolated or atypical events that may disproportionately affect results when volumes are low. The analysis further showed that a substantial proportion of ASM low back pain participants would continue to meet eligibility for scoring at this case threshold, preserving the ability to assess quality performance across a broad ASM participant population. We believe that maintaining a minimum of 20 cases appropriately balances inclusiveness and methodological rigor. For these reasons, we propose a threshold of 20 cases for the MRI Lumbar Spine for Low Back Pain (modified for ASM) measure. We also considered an alternative minimum case count of 10 for the MRI [[Page 43977]] Lumbar Spine for Low Back Pain (modified for ASM) measure. A threshold of 10 would allow a greater number of ASM low back pain participants to be scored on the measure, particularly those with smaller patient panels or lower annual imaging volume. Although reliability is lower at this threshold relative to a minimum of 20 cases, a 10-case minimum would offer meaningful insight into specialist practice patterns while expanding the proportion of ASM low back pain participants scored on the measure. We seek comment on the proposed minimum case count of 20. We also seek comment on the alternate proposal of a minimum case count of 10. (v) Lookback Period We evaluated the attribution lookback period to determine the timeframe during which clinician services should be considered for assigning each lumbar spine MRI to ASM low back pain participants. The measure needs a lookback period long enough to capture clinical encounters that inform decisions about imaging, while still maintaining a clear and comprehensive lookback approach. Chronic low back pain is managed over extended periods, and patients frequently receive evaluation and treatment, and require care coordination from multiple clinicians during this time. Based on these care patterns, we examined whether a longer window would more accurately identify the set of clinicians who meaningfully influence imaging decisions. Testing demonstrated that a 365-day lookback period compared to a shorter window like 90-days substantially increased the number of attributed MRI studies by approximately 27 percent. We believe a 365-day period better reflects the longitudinal nature of chronic low back pain management and ensures that attribution captures the full course of care that precedes a patient's imaging event. A full-year window also aligns with the model's annual performance period and improves consistency across the various quality measures included in the model. We believe that adopting a 365-day lookback window strengthens the completeness of performance assessment by ensuring that clinicians who contribute meaningfully to care are appropriately included. For these reasons, we are proposing to use a 365-day lookback period for attribution of MRI studies within the measure. We also considered an alternative 120-day lookback period. This approach would limit attribution to ASM low back pain participants who furnished lower back pain-related services in closer proximity to the imaging event and, therefore, would provide a more focused reflection of recent clinical decision-making. However, it would also result in fewer cases per ASM participant, which could create a narrower view of the ASM participant's trends related to MRI referral and low back pain. We seek comment on the proposed 365-day lookback period and the alternative of a 120-day lookback period. (b) Removing Functional Status Change for Patients With Low Back Impairments (MIPS Q220) and Adding Functional Outcome Assessment (MIPS Q182) In the CY 2026 PFS final rule (90 FR 49620 through 49622), we finalized inclusion of Functional Status Change for Patients with Low Back Impairments (MIPS Q220) in the ASM low back pain quality measure set because it captures functional outcomes that are directly relevant to patients' experience of low back pain and their ability to perform daily activities. We noted that the measure aligns with the model's emphasis on patient-centered outcomes and longitudinal management and complements the broader set of prevention and utilization-focused measures included in the ASM low back pain quality measure set. Since publication of the CY 2026 PFS final rule, the measure steward has indicated that they no longer intend to maintain Functional Status Change for Patients with Low Back Impairments (MIPS Q220), including key operational components such as the survey's online portal. Consistent with this change, we are removing this measure from the MIPS measure inventory. Accordingly, we are proposing at Sec. 512.725(c)(4) to remove the Functional Status Change for Patients with Low Back Impairments (MIPS Q220) from the ASM low back pain quality measure set and replace it with Functional Outcome Assessment (MIPS Q182). This proposal would address the absence of the MIPS 220 measure by replacing one measure of functional status with another. We believe that Functional Outcome Assessment (MIPS Q182) represents an appropriate replacement as it meets similar goals as the inclusion of MIPS Q220 and may be familiar to many ASM low back pain participants. However, we note that we intend to pursue the future adoption of a more robust patient-reported outcome performance measure (PRO-PM) to further emphasize the importance of functional status improvement within ASM. Such a change to the ASM low back pain quality measure set would be proposed via future notice-and-comment rulemaking. Functional Outcome Assessment (MIPS Q182) promotes the routine assessment of functional status and requires clinicians to document a care plan when functional outcome deficiencies are identified. As such, the measure supports a more patient-centered approach to care by encouraging ASM participants to incorporate patients' reported experiences and functional status assessments and limitations into clinical decision-making. The measure leverages patient-reported outcome tools and surveys to facilitate meaningful communication between clinicians and their patients regarding symptoms, daily functioning, and treatment goals; as a result, identified concerns can be addressed as part of the evaluation and management of the patient. We believe that systematic measurement and improvement of functional status can increase patient self-efficacy, improve overall well-being, and potentially reduce downstream healthcare utilization and costs. Additionally, the use of validated and standardized assessment tools may enhance the reliability and sensitivity of detecting functional impairments and monitoring changes over time, particularly among older adults with low back pain.\173\ --------------------------------------------------------------------------- \173\ 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. --------------------------------------------------------------------------- Although Functional Outcome Assessment (MIPS Q182) does not require the use of a specific instrument, examples of appropriate, validated tools relevant to the ASM low back pain cohort include the Modified Oswestry Disability Index and the Patient-Reported Outcomes Measurement Information System (PROMIS). The use of such tools is supported by clinical guidelines and professional organizations. For example, the American Academy of Orthopaedic Surgeons recommends the Modified Oswestry Disability Index as a preferred instrument for assessing functional outcomes in spine care.174 175 These functional status instruments may also capture information related to [[Page 43978]] modifiable risk factors, such as physical activity levels and social isolation, which can inform clinical discussions and interventions aimed at preventing the progression of low back pain and associated comorbid conditions. --------------------------------------------------------------------------- \174\ North American Spine Society. Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain. North American Spine Society; 2020. \175\ 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. --------------------------------------------------------------------------- This proposal also responds to interested parties' feedback regarding operational concerns with Functional Status Change for Patients with Low Back Impairments (MIPS Q220). In addition, Functional Outcome Assessment (MIPS Q182) aligns with the Quality Payment Program's Rehabilitative Support for Musculoskeletal Care MIPS Value Pathway (MVP), further supporting its inclusion in the ASM. We also note that Functional Outcome Assessment (MIPS Q182) has a MIPS CQM collection type, the same collection type as the Functional Status Change for Patients with Low Back Impairments (MIPS Q220). By embedding accountability for assessing and addressing functional status into the ASM quality measure set for ASM participants who treat low back pain, this measure supports a comprehensive, longitudinal approach to low back pain management, including appropriate evaluation, treatment planning, and ongoing monitoring of patient outcomes. We seek comment on our proposal at Sec. 512.725(c)(4) to remove the Functional Status Change for Patients with Low Back Impairments (MIPS Q220) from the ASM low back pain quality measure set and replace it with Functional Outcome Assessment (MIPS Q182). (3) Data Completeness Requirement for the Quality ASM Performance Category As discussed in the CY 2026 PFS final rule (90 FR 49631), we finalized policies to establish a data completeness requirement for applicable quality measures in the quality ASM performance category. Under this requirement, ASM participants reporting MIPS clinical quality measures (MIPS CQMs) or eCQMs would be required to submit data for at least 75 percent of patients who meet the denominator criteria for each measure, regardless of payer. The regulatory text at Sec. 512.725(f)(3) describing the data completeness requirement includes a non-substantive typographical error of a misplaced possessive ``s'' on ``ASM''. We propose at Sec. 512.725(f)(3) correct this typographical error so that it would read: ``CMS excludes from an ASM participant's total measure achievement points and total available measure achievement points any measure required under paragraph (b) or (c) of this section that meets the respective measure's data completeness requirement but does not have a benchmark.'' We believe this correction clarifies the regulatory text without substantively changing the policy under existing provisions. We seek comment on our proposal to modify Sec. 512.725(f)(3) to correct this typographical error. (4) Scoring and Benchmarks for Quality Measures As discussed in the CY 2026 PFS final rule (90 FR 49634 through 49635), we finalized policies to benchmark and score ASM quality measures. We will use measure-specific benchmarks where separate benchmarks are calculated for each measure and collection type to reflect meaningful performance differences among ASM participants. Quality measure benchmarks will be derived from ASM participant data from the current or prior ASM performance years, or another CMS- determined period. We determined that separate benchmarks by collection type (for example, MIPS CQM and eCQM) are more appropriate than a single benchmark for each measure aggregated across collection types due to established scoring variation across collection types. Benchmarks will be decile-based percentile distributions, which enable consistent scoring and translate measure performance values uniformly. To score reported data against the benchmarks, ASM participants' performance on each measure will be mapped to decile ranges, with one to 10 achievement points assigned according to the decile in which the measure's reported rate falls. In the CY 2026 PFS final rule, we explained that administrative claims-based quality measures do not require data submission (90 FR 49616) and finalized corresponding administrative claims-based quality measure scoring policies (90 FR 49630). However, we did not specify whether we would score such measures at the group (that is, TIN) or individual (that is, TIN/NPI) level. We are now proposing to specify the level at which we would calculate administrative claims-based quality measures. Specifically, we propose at Sec. 512.725(e)(3)(i) to score all administrative claims-based quality measures at the individual (that is, TIN/NPI) level to ensure that performance assessment reflects the individual ASM participant performance regardless of eligibility to report quality measures at the group (that is, TIN) level. Administrative claims-based quality measures do not require ASM participants to submit data, thereby reducing reporting burden for all ASM participants, including those that may be from a small group practice or face resource constraints. Scoring these measures at the individual (that is, TIN/ NPI) level preserves the model's intended focus on individual specialist accountability. We also propose modifications to Sec. Sec. 512.725(h)(1) and 512.725(h)(2) to clarify quality ASM performance category scoring policies applicable to quality measures reported by an ASM participant, compared to administrative claims-based quality measures calculated by us. These proposals aim to align regulatory text with the nature of quality measure collection types, distinguishing quality measures for which ASM participants actively submit data from administrative claims- based quality measures that we calculate and therefore do not require data submission. Accordingly, we propose to reorganize and revise regulatory text at Sec. 512.725(h)(1)(i) to clarify the different requirements that administrative claims-based quality measures and non-administrative claims-based quality measures must meet to be scored. Specifically, we propose to remove the phrase ``on which data is submitted'' from Sec. 512.7250(h)(1)(i), which describes how ASM participants are awarded achievement points for quality measures that meet the specified criteria, to conform with the proposed reorganization of this section of regulatory text. We also propose to describe all scoring requirements for non- administrative claims-based quality measures at Sec. 512.725(h)(1)(i)(A). Specifically, we propose to redesignate former regulatory text Sec. 512.725(h)(1)(i)(A) through (h)(1)(i)(C) as Sec. 512.725(h)(1)(i)(A)(1) through (h)(1)(i)(A)(3), respectively. We then propose to revise Sec. 512.725(h)(1)(i)(A) to describe that quality measures other than administrative claims-based quality measures must meet the requirements described at Sec. 512.725(h)(1)(i)(A)(1) through (h)(1)(i)(A)(3) to be scored. We also propose to redesignate regulatory text formerly at Sec. 512.725(h)(1)(i)(D) to Sec. 512.725(h)(1)(i)(B) and to revise text to clarify the scoring requirements for administrative claims-based quality measures. We note that these proposed revisions do not make substantive changes to existing scoring requirements but would provide greater clarity to ASM participants on the specific requirements for quality measures to be scored. [[Page 43979]] We also propose to clarify our provisions related to the determination of quality measure benchmarks. Specifically, we propose to remove Sec. 512.725(h)(2)(iii), which describes the periods we may use to calculate administrative claims-based quality measure benchmarks. We believe this paragraph is unnecessary in light of Sec. 512.725(h)(2)(i), which sufficiently describes the periods we may use to calculate any quality benchmark, whether administrative claims-based or otherwise. To conform with this proposal, we also propose to remove cross-references to Sec. 512.725(h)(2)(iii) from Sec. Sec. 512.725(h)(1)(i)(D) and 512.725(h)(2)(i), as well as redesignate former Sec. 512.725(h)(2)(iv) as new Sec. 512.725(h)(2)(iii). These proposals would allow more flexibility in determining appropriate and fair benchmarks and ensure that benchmark time periods align with the performance periods of the administrative claims-based quality measures. We also propose to clarify quality measure scoring when we are unable to determine a benchmark. Specifically, we propose at Sec. 512.725(h)(2)(iv) that we would exclude any required quality measure for which we cannot calculate a benchmark in the determination of an ASM participant's quality ASM performance category score. We would do so by removing the total measure achievement points (that is, the points calculated for the numerator of the quality ASM performance category score) and the total available measure achievement points (that is, the points calculated for the denominator of the quality ASM performance category score) from the quality ASM performance category score calculation for any quality measure that lacks a benchmark. While we state that a quality measure must have a benchmark to be scored under proposed Sec. 512.725(h)(1)(i), we believe that this proposal clarifies the effect of a quality measure lacking a benchmark on the overall quality ASM performance category score. We seek comment on our proposal at Sec. 512.725(e)(3)(i) to score all administrative claims-based quality measures at the TIN/NPI level. We also seek comment on our proposed reorganization of regulatory text at Sec. 512.725(h)(1)(i) to separately describe the scoring requirements for non-administrative claims-based quality measures and administrative claims-based quality measures. We seek comment on our proposals at Sec. 512.725(h)(2) to clarify provisions related to the determination of quality measure benchmarks. Finally, we seek comment on our proposal at Sec. 512.725(h)(2)(iv) describing how we would account for quality measures without benchmarks in the quality ASM performance category score calculation. (5) Voluntary Data Submission for the Development of Patient-Reported Outcome-Based Performance Measures (PRO-PMs) As discussed in the CY 2026 PFS final rule (90 FR 9612), we are considering future adoption of one or more patient-reported outcome- based performance measures (PRO-PMs) in ASM that would evaluate changes in patient-reported health status, physical function, symptoms, aggregate patient-reported health status, or other related outcomes over time. Unlike a functional status process measure that assesses whether a functional status assessment or other patient-reported assessment was completed, a PRO-PM would collect information directly from patients to assess whether the care furnished by an ASM participant is associated with improvement in, or slowing of decline in, ASM beneficiary-reported outcomes. We believe such measures could better capture outcomes that matter to ASM beneficiaries and support more patient-centered specialty care. 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.\176\ PRO-PMs may also encourage ASM participants to incorporate the patient voice and lived experience into clinical decision-making, treatment planning, longitudinal monitoring, and shared decision-making. At this time, we are considering the development of PRO-PMs specific to each ASM targeted chronic condition. --------------------------------------------------------------------------- \176\ 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 are interested in using the Patient-Reported Outcomes Measurement Information System (PROMIS) as the basis for a PRO-PM as it is a set of standardized, validated patient-reported outcome instruments that can be used to assess domains such as physical function, symptoms, pain interference, mental health, social health, and quality of life.\177\ We believe PROMIS would allow for a standardized measurement framework across ASM participants, ASM targeted chronic conditions, and care settings. Unlike other patient- reported outcome (PRO) instruments that exclusively focus on a particular clinical population, PROMIS includes domains relevant across chronic conditions and can be administered through flexible formats, including short forms and computer adaptive tests. It also has condition-specific profiles, like PROMIS+HF, that is relevant to ASM.\178\ Finally, other Innovation Center models either use or plan to use PROMIS, such as the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model.\179\ We also note that PROMIS is already a permitted standardized tool to satisfy the Functional Status Assessments for Heart Failure measure (MIPS Q377) in the ASM heart failure cohort quality measure set and the proposed Functional Outcome Assessment measure (MIPS Q182) in the ASM low back pain cohort quality measure set. --------------------------------------------------------------------------- \177\ ``Patient-Reported Outcomes Measurement Information System (PROMIS).'' NIH Common Fund, National Institutes of Health, https://commonfund.nih.gov/promis. \178\ Ahmad, Fatima S., et al. ``Validation of PROMIS+HF Profile Instruments in Heart Failure Patients.'' ESC Heart Failure, vol. 9, no. 5, 2022, pp. 3380-3392. PubMed Central, https://pmc.ncbi.nlm.nih.gov/articles/PMC9715763/. \179\ ``ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model.'' Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services, https://www.cms.gov/priorities/innovation/innovation-models/access. --------------------------------------------------------------------------- We recognize that some ASM participants may currently use different patient-reported assessment instruments. To the extent scientifically appropriate, existing crosswalks or linking methods may help inform transitions from other instruments to PROMIS. For example, PROsetta Stone provides methods for linking PROMIS scores with other patient- reported outcome measures (PROMs) that assess similar concepts, which may support comparability across instruments.\180\ This could provide flexibility for ASM participants using other instruments while preserving the standardized measurement framework that would be important for PRO-PM development. --------------------------------------------------------------------------- \180\ ``PROsetta Stone.'' PROsetta Stone, https://www.prosettastone.org. --------------------------------------------------------------------------- While we are prioritizing PROMIS data collection, we are also interested in collecting data from other PRO instruments where appropriate to support evaluation and validation of PROM-to-PROM crosswalks that may facilitate future PRO-PM implementation. We believe providing an opportunity for voluntary data submission would be an important step toward developing [[Page 43980]] meaningful, patient-centered outcome measures for ASM. Incentivizing early submission of PROMIS and, potentially, other PRO data would help us determine whether future PRO-PMs are feasible and appropriate to be proposed for inclusion in the model through notice-and-comment rulemaking. This voluntary data submission approach would also provide ASM participants an opportunity to build PRO data collection infrastructure before any future PRO-PM would be proposed as a quality measure used in evaluating performance under ASM. (a) Quality ASM Performance Category Scoring Incentive for Voluntary Patient-Reported Outcome (PRO) Data To support the development of PRO-PMs under ASM, we propose to establish a voluntary data submission opportunity and scoring incentive for ASM participants to report PRO data, including data collected using PROMIS instruments and, as applicable, other CMS-specified PRO instruments. The goal of this data submission would be to support the development, testing, and potential future inclusion of PRO-PMs in ASM's quality measure sets. Since ASM currently does not require ASM participants to submit PROMIS or other PRO data for measure development purposes, we recognize that there may be insufficient incentives for ASM participants to voluntarily collect and submit such data. We believe establishing an appropriate incentive for voluntary data submission by ASM participants would support efforts to collect the data needed to inform PRO-PM development and whether any developed PRO- PM would be feasible for inclusion in an ASM cohort's quality measure set during the ASM test period. We believe this proposal is consistent with the Innovation Center's authority under section 1115A of the Act to test innovative payment and service delivery models that improve the quality and coordination of care, including approaches that support development and assessment of patient-centered quality measurement and beneficiary-reported outcomes. Specifically, we propose at Sec. 512.725(i) to create a quality ASM performance category scoring incentive by adding 5 points to an ASM participant's quality ASM performance category score for an applicable ASM performance year if the ASM participant submits beneficiary-level PRO data that meets criteria established by CMS, provided such additional points would not cause the ASM participant's score to exceed the maximum quality ASM performance category score otherwise available under the model. We refer readers to the proposed PRO data submission criteria discussed later in this section of this proposed rule. We also refer readers to section III.D.2.f.(4) of this proposed rule where we propose to notify an ASM participant if they meet the data submission requirements to receive the quality ASM performance category scoring incentive through their annual ASM performance report. We believe that this scoring incentive approach would recognize the additional effort required to collect and submit PRO data and would avoid disadvantaging ASM participants not yet prepared to voluntarily collect and submit PRO data. The proposed 5-point scoring incentive added to the quality ASM performance category score represents half of the maximum quality measure achievement points for a single quality measure. We believe this amount appropriately incentivizes voluntary data submission by offering an increase to the quality ASM performance category score without equaling the maximum achievement points that can be earned through performance on quality measures. We believe such an approach would preserve the integrity and importance of the existing quality measure set required of each ASM participant. We further believe that structuring the scoring incentive so that an ASM participant's total quality ASM performance category score cannot exceed the category's maximum score would preserve the integrity and fairness of performance comparisons while encouraging voluntary data submission. Eligibility for the scoring incentive for voluntary data submission would be limited to the ASM cohorts for the ASM performance years in which we are actively developing a PRO-PM. For example, if we establish a voluntary heart failure PRO data submission opportunity in the 2027 ASM performance year, only ASM heart failure participants would be eligible to receive the 5-point scoring incentive for the 2027 ASM performance year and ASM low back pain participants would not be eligible for the scoring incentive for that year. We clarify that we are not proposing at this time to (1) adopt a new PRO-PM in the quality measure for either ASM cohort, (2) evaluate ASM participants on PROMIS performance, or (3) require ASM participants to collect or submit PROMIS or other PRO data. Rather, this proposal is intended to support voluntary data collection to support our evaluation of the feasibility, reliability, validity, and appropriateness of one or more future PROMIS-based or other PRO-based PRO-PMs before any such measure would be proposed for inclusion in an ASM cohort's quality measure set, which we would propose through future notice-and-comment rulemaking. We considered an alternative approach under which ASM participants could receive a higher number of additional points as this could provide greater incentive to voluntarily submit sufficient data for measure development purposes. We are not proposing a higher number of additional points because it could reduce the distinction between the measure achievement points available for existing performance-based quality measures and the voluntary submission of PRO data for measure development purposes. Conversely, we are not proposing a lower number of additional points to the quality ASM performance category score because we believe this may not provide a sufficient incentive to encourage meaningful participation in voluntary data submission. We also considered an alternative approach to award 10 points, the maximum quality measure achievement score, for the existing PROM- related process measure for ASM participants who successfully: (1) submit a required PROM-related process measure included in the quality ASM performance category measure set and (2) voluntarily submit the CMS-specified PRO data for an applicable ASM performance year. For example, under this alternative, an ASM heart failure participant who successfully reports the Functional Status Assessments for Heart Failure measure (MIPS Q377) and voluntarily submits the CMS-specified PRO data would automatically receive 10 measure achievement points for the Functional Status Assessments for Heart Failure measure regardless of actual performance as assessed against the applicable benchmark. For the same reasons noted above regarding our intent to draw distinction between performance-based quality measurement and data submission, we are not proposing this alternative. Additionally, we believe this approach would not provide meaningful incremental incentives for some ASM participants because those ASM participants who successfully collect and voluntarily submit the required PRO data may already be likely to perform well on the associated PROM-related process measure. We also considered establishing a tiered incentive structure under which the number of additional points awarded to the quality ASM [[Page 43981]] performance category score would be scaled based on the quantity, completeness, representativeness, or other related characteristics of the voluntarily submitted PRO data. For example, ASM participants that submit data for a larger number of ASM beneficiaries, achieve higher response or follow-up completion rates, or submit additional data elements that could support measure development and testing would receive a larger scoring incentive than ASM participants that meet the minimum data submission requirements. We are not proposing this alternative because our goal is that all voluntarily submitted data intended for measure development should meet the minimum requirements necessary to support reliable and scientifically sound measure development and testing. We are concerned that a tiered approach could create an incentive that prioritizes submission volume over data quality or could imply that data meeting the minimum submission requirements is less valuable for measure development purposes. Therefore, we believe a single incentive tied to successful completion of all required data submission requirements is a more appropriate approach. We also considered whether to encourage voluntary PRO data submission through non-scoring mechanisms, such as providing ASM participants with enhanced feedback reports, analytic tools, educational resources, or other related support. We recognize that such resources could be of operational value to ASM participants while supporting our development of PRO-based quality measures. However, we are not proposing a non-scoring-based incentive as we do not believe this would, by itself, provide sufficient incentive to encourage broad voluntary participation in PRO data collection and submission activities. While we may consider providing operational support or resources in the future, we believe a direct scoring incentive is more likely to generate the quantity and quality of data necessary to support timely PRO-PM development and testing. We further considered another alternative whereby the maximum quality ASM performance category score would not be capped, allowing an ASM participant's quality ASM performance category score to exceed the maximum points otherwise available for the quality ASM performance category for the limited purpose of encouraging voluntary PRO data submission. For example, under this alternative, an ASM participant who earns a quality ASM performance category score of 46 points and voluntarily submits PRO data for the applicable performance year would receive 51 points out of 50 points available for the final quality ASM performance category. We are not proposing this alternative because it would be inconsistent with the existing quality ASM performance category scoring methodology. The quality and cost ASM performance categories were intentionally designed to have equal weight in the calculation of a final score. Allowing the quality ASM performance category score to exceed its current maximum could disrupt that balance and place disproportionate emphasis on quality scoring relative to cost performance. We believe maintaining the current maximum quality ASM performance category score preserves comparability across ASM participants and the integrity of the quality scoring framework. Finally, we considered another alternative incentive whereby we would add additional points to the final score of an ASM participant who successfully reports the CMS-specified PRO data for the applicable ASM performance year. Under this approach, the additional points would be added to the final score after calculation of any applicable ASM performance category scores to directly increase the ASM participant's final score. We are not proposing this alternative because it would disconnect the incentive from the quality ASM performance category, where the benefits of collecting and reporting PRO data are most appropriately reflected. In addition, applying additional points directly to an ASM participant's final score could have broader effects on overall model performance and payment adjustment outcomes than intended and would be less consistent with the targeted objective of encouraging voluntary data submission to support future PRO-PM development. We seek comment on our proposal at Sec. 512.725(i) to provide 5 additional points to the quality ASM performance category score of an ASM participant who voluntarily submits CMS-specified PRO data and meets all data submission requirements for an applicable ASM performance year. We seek comment on all alternatives that we considered. We also invite comment on whether the proposal and alternatives would support voluntary data submission to achieve the goal of developing PRO-PMs applicable to ASM. (b) Requirements for Successful Voluntary PRO Data Submission Development of a valid, reliable, and feasible PRO-PM requires sufficient beneficiary-level PRO data prior to implementation and scoring of the measure. In particular, data is needed to: (1) analyze measure reliability and validity, (2) evaluate feasibility of data collection and submission, (3) measure response rates and missingness, (4) examine potential nonresponse bias, (5) identify appropriate risk adjustment variables, and (6) determine whether a measure can meaningfully and fairly distinguish performance across ASM participants within a given ASM cohort. For potential PRO-PMs, development may require that data be collected over an extended episode or longitudinal assessment period, including baseline and follow-up PRO assessments. Accordingly, early collection and submission of PRO data by ASM participants is important to support timely development and testing of PRO-PMs such that we could propose measures for future inclusion in ASM's respective quality measure sets through future notice-and-comment rulemaking. To support PRO-PM development, we would specify the applicable PRO instrument(s), the required data that an ASM participant would need to voluntarily submit, and applicable data collection periods. Accordingly, we propose to define the data submission requirements that an ASM participant would need to meet to ensure we receive sufficient and reliable data to develop and test PRO-PMs applicable to ASM. Specifically, at Sec. 512.725(i)(1), we propose to define all data submission requirements an ASM participant would need to meet to receive the proposed scoring incentive in the quality ASM performance category for an applicable ASM performance year. First, at Sec. 512.725(i)(1)(i), we propose that an ASM participant would need to submit CMS-specified baseline assessment data for at least 20 ASM beneficiaries during the first data collection period specified by us. By baseline data, we mean the initial CMS- specified PRO assessment data collected for an ASM beneficiary during the applicable data collection period that occurs before the collection of any corresponding follow-up assessment data for the beneficiary. After baseline data is collected, an ASM participant would submit CMS- specified follow-up assessment data for at least 20 ASM beneficiaries for whom they previously submitted a baseline assessment during the preceding data collection period specified by us. Our goal in establishing minimum baseline and follow-up assessment requirements is to ensure we receive sufficient longitudinal PRO data to support development and testing of [[Page 43982]] future PRO-PMs. We believe that collecting baseline assessment data initially then collecting corresponding follow-up assessment data during a subsequent data collection period would allow us to evaluate changes in beneficiary-reported outcomes over time while reducing operational burden during the initial year of data collection. The specific amount of time between a baseline and follow-up assessment would depend on the selected PRO instrument(s) and ASM targeted chronic condition, however, we anticipate that a collection period of at least 6 months between a beneficiary's baseline and follow-up assessments may be necessary to allow sufficient time to observe meaningful changes in patient-reported outcomes. We would provide specifications regarding the timing of baseline and follow-up assessments and specific data collection periods through sub-regulatory technical guidance. Second, at Sec. 512.725(i)(1)(ii), we propose that an ASM participant would need to report all required data elements for the applicable PRO instrument as specified by us for the applicable data collection period. We anticipate that required data elements would include at least: (i) the PRO instrument name and version, (ii) ASM participant identification information, (iii) ASM beneficiary identification information and linkage information, (iv) assessment date, (v) baseline or follow-up assessment indicator, (vi) mode of administration, (vii) item-level responses, (viii) nonresponse and missingness indicators, (ix) raw and standardized scores, (x) score calculation method, and (xi) other data elements needed to support measure testing and risk adjustment model testing. If testing would require use of a crosswalk, such as PROsetta, we anticipate that we would also require reporting of data elements specific to the crosswalk. The required data elements and format in which an ASM participant would need to submit the data would be specific to the selected PRO instrument(s) and would be specified by us in sub- regulatory technical guidance. Third, at Sec. 512.725(i)(1)(iii), we propose that an ASM participant would need to submit data on a minimum set of risk variables for each ASM beneficiary from whom they collect PRO data. Risk adjustment is necessary to ensure that performance results under a PRO-PM reflect quality of care rather than patient complexity to avoid penalizing clinicians who may serve higher-risk beneficiary populations. Reporting a minimum set of risk variables for each ASM beneficiary receiving a PRO assessment would allow us to develop a scientifically acceptable, robust, and reliable risk model for any developed PRO-PM. The reported risk variable data would be used to conduct assessments of association between risk variables and the measured PRO to inform risk variable selection and ensure the risk model captures the most clinically and statistically relevant risk variables. Example risk variables could include but are not limited to age, race, ethnicity, socioeconomic status, clinical comorbidities, baseline clinical severity, physiological measures (for example, body mass index or blood pressure), pain history, surgical history, disease classification, medication usage, behavioral factors, functional and disability status, and other condition-specific characteristics. We believe that the risk variables would be different for each ASM targeted chronic condition for which we would develop a PRO-PM. We intend to provide the minimum risk variables applicable for the selected PRO instrument(s), including each risk variable's technical specifications, through sub-regulatory technical guidance. Fourth, at Sec. 512.725(i)(1)(iv), we propose that an ASM participant must submit the PRO data for any applicable data collection period by the generally applicable data submission deadline for the applicable ASM performance year, which is March 31st, or later in the calendar year, as specified by as, following the close of the applicable ASM performance year. We recognize that--depending on the applicable PRO instrument, measure concept, and assessment interval-- baseline and follow-up assessments for an ASM beneficiary may need to occur across ASM performance years to allow a sufficient interval between the initial and follow-up PRO assessments. In such cases, we would specify through technical guidance how ASM participants would submit baseline and follow-up data for data collection periods that span ASM performance years and how this would impact the availability of the scoring incentive for a given ASM performance year. We believe that aligning the voluntary PRO data submission deadline with the generally applicable data submission deadline for ASM performance category data would streamline and simplify the data submission and would provide us adequate time to confirm if the submitted PRO data meets the requirements to receive the proposed scoring incentive for the quality ASM performance category. We anticipate that the PRO data submission would occur through one or more mechanisms, such as a CMS- specified file format, registry submission, qualified clinical data registry or other intermediary, Health Level Seven Fast Healthcare Interoperability Resources (HL7 FHIR)-based submission, or another electronic submission mechanism specified by CMS. We would provide additional operational details through technical guidance, including applicable submission deadlines, data formats, validation processes, and any minimum data completeness or case minimum requirements. We also seek to preserve flexibility to align submission requirements with existing ASM participant workflows and health information technology capabilities to the extent feasible. We recognize that in some instances ASM participants may need to correct their voluntary data submission. Accordingly, we propose at Sec. 512.725(i)(2) that ASM participants could correct and resubmit any PRO data corresponding with voluntary data submission by the proposed data submission deadline of March 31st in accordance with the generally applicable data submission deadline for the applicable performance year, or a later date specified by CMS. Because the proposed scoring incentive would affect the quality ASM performance category score, we propose to only accept timely submissions, corrections, or resubmissions and reject those received after the data submission deadline. We believe this approach is necessary to preserve the integrity and finality of the scoring process and payment adjustment methodology and to align voluntary PRO data submission with other ASM performance category data submission requirements. We would consider providing submission error reports or other technical feedback identifying errors, missing data elements, beneficiary linkage issues, data completeness concerns, or other issues before the applicable data submission deadline to support ASM participants. Relatedly, we propose at Sec. 512.725(i)(3) that an ASM participant may seek review under ASM's timely error notice process for technical errors related to CMS' determination of whether the ASM participant met the voluntary PRO data submission requirements or correctly received the quality ASM performance category scoring incentive for the applicable ASM performance year as provided in the ASM participant's annual ASM performance report. To align with ASM's timely error notice requirements [[Page 43983]] and process described at Sec. 512.755, the ASM participant may submit a written timely error notice if they believe an error occurred in calculations due to data quality, misapplication of methodology, or other related issues that would relate to whether the ASM participant qualified for the proposed quality ASM performance category scoring incentive for the applicable ASM performance year. Examples of such errors include beneficiary linkage errors, failure to account for data timely submitted by the ASM participant, or other technical errors in our evaluation of the voluntary PRO data submission against data requirements. We considered requiring that an ASM participant submit PRO data on more than 20 ASM beneficiaries or fewer than 20 ASM beneficiaries during each CMS-specified data collection period specified. We also considered requiring that an ASM participant submit PRO data on a minimum percentage of their ASM beneficiaries (for example, 25 to 100 percent) during the applicable data collection period. However, we believe an adequate number of ASM participants collecting and reporting PRO data on a minimum of 20 ASM beneficiaries each would provide an adequate sample size for PRO-PM development and align with the 20-case minimum for quality measures under ASM. We also considered requiring an ASM participant to submit PRO data more frequently during an ASM performance year (for example, quarterly or biannually). Multiple data submission time points, such as quarterly or on a rolling basis rather than a single annual submission, may offer several advantages. It would enable the selected submission mechanism (for example, data submission portal) to provide ASM participants who voluntarily submit data with timely, actionable feedback on the quality of the data submitted, flagging inaccuracies and offering opportunities for correction and resubmission before the applicable data collection period and ASM performance year ends. Iterative data collection and feedback could support a continuous improvement process, helping ASM participants identify and resolve data quality issues early. This would be particularly helpful for avoiding the scenario where a provider submits data once annually, only for that data to be found unusable at the point of determining eligibility for the quality ASM performance category scoring incentive. More frequent data submissions would likely improve the quality of data for measure development and testing. While more frequent data submission would offer several advantages, we believe that aligning the voluntary data submission deadline with the overall data submission deadline for ASM performance category data would be administratively simpler for ASM participants. We also considered requiring ASM participants to submit both baseline and follow-up assessment data for the same ASM beneficiaries during a single ASM performance year. Under this alternative, an ASM participant would be required to collect and submit both the initial and follow-up PRO assessments within the same ASM performance year to receive the voluntary PRO data submission scoring incentive. We recognize that this approach could accelerate collection of matched assessment data and potentially expedite certain measure development and testing activities. However, we are not proposing this alternative because the appropriate interval between baseline and follow-up assessments may vary depending on the selected PRO instrument, the targeted chronic condition, and the future PRO-PM concept under development. We are also concerned that requiring both assessments within a single ASM performance year could limit flexibility, increase operational burden on ASM participants, and reduce the amount of time available to observe meaningful changes in ASM beneficiary-reported outcomes. For any data collection period following a baseline data collection period, we considered that an ASM participant would need to submit baseline assessment data for additional ASM beneficiaries that were either newly eligible for a selected instrument or had not previously been assessed using a selected instrument. This new baseline data would be in addition to the follow-up assessment data that we propose to require. We believe that this structure could increase the amount of data available to develop a PRO-PM over time. However, we would require additional information to determine the minimum number of new baseline assessments that would be appropriate to require the ASM participant to collect during a subsequent data collection period. We also considered whether to require additional criteria for successful voluntary PRO data submission, including submission of a denominator file of eligible ASM beneficiaries; use of a CMS-specified sampling methodology, such as consecutive, all-eligible, all-payer, or random sampling; minimum response or completion rates; minimum baseline and follow-up completion thresholds; and documentation of exclusions, where applicable, for identified ASM beneficiaries. We are not proposing these additional requirements at this time because the appropriate denominator, sampling approach, response-rate threshold, completion threshold, and exclusion documentation requirements may vary based on the selected PRO instrument, ASM targeted chronic condition, data submission mechanism, and measure concept under consideration for development. We seek comment on the proposed requirements for voluntary PRO data submission at Sec. 512.725(i)(1) that an ASM participant would need to meet to receive the proposed quality ASM performance category scoring incentive. We also seek comment on all alternatives considered and other data submission requirements we should consider to support PRO-PM development under ASM. Additionally, we seek comment on the appropriate timing of data submission and the scope of data elements that should be required for successful voluntary data submission, particularly data elements necessary to evaluate a PRO-PM's feasibility, reliability, and validity. We also invite comment on the specific risk variables applicable for each ASM targeted chronic condition that we should require ASM participants to report. We are particularly interested in comments on the earliest feasible timeframe for ASM participants to begin collecting and submitting PROMIS or other CMS-specified PRO data, the operational challenges ASM participants may face, and the types of technical assistance or guidance that would facilitate voluntary data submission. Finally, we seek comment on data submission mechanisms that would simplify the voluntary reporting of PRO data to support PRO-PM development under ASM. e. Promoting Interoperability ASM Performance Category (1) Background As discussed in the CY 2026 PFS final rule (90 FR 49658 through 49661), we believe the Promoting Interoperability ASM performance category measures finalized under Sec. 512.740 support the overall goals of ASM to enhance the quality of care, reduce costs by encouraging upstream chronic condition management, empower patients to engage in their care, and promote collaboration between specialists and primary care. ASM's Promoting Interoperability objectives and measures align with the Promoting [[Page 43984]] Interoperability goals, objectives, and measures used in other programs, including MIPS. We finalized at Sec. 512.740(b)(2) that an ASM participant must report on MIPS Promoting Interoperability objectives and measures, as specified in technical documents. Specifically, under Sec. Sec. 512.740(b)(2)(i) through (iv), we finalized inclusion of the following objectives under the Promoting Interoperability ASM performance category: Electronic Prescribing; Health Information Exchange (HIE); Provider to Patient Exchange; and Public Health and Clinical Data Exchange (90 FR 49658). We aim to align ASM and MIPS Promoting Interoperability requirements where possible to promote consistency across programs and reduce burden and operational complexity for ASM participants who may already be familiar with MIPS Promoting Interoperability measures and attestations. In support of alignment with MIPS, we propose certain updates in ASM, to include proposals that align with those being issued through this proposed rule for the MIPS Promoting Interoperability performance category, as well as proposals that align with policies previously finalized for inclusion in MIPS that we did not yet adopt for ASM. We refer readers to section IV.A.4.f.(4) of this proposed rule for further discussion on MIPS Promoting Interoperability proposals. Specifically, we propose to: Revise the HIE objective at Sec. 512.740(b)(2)(ii) to reorganize its structure and add an optional measure, Electronic Prior Authorization (Measure ID # PI_HIE_7), for the 2027 ASM performance year at proposed new Sec. 512.740(b)(2)(ii)(B); Starting in the 2028 ASM performance year, require the Electronic Prior Authorization measure and require the new Electronic Prior Authorization for Prescription Drugs measure (Measure ID # PI_HIE_8) at proposed new Sec. 512.740(b)(2)(ii)(C); Adopt a measure exclusion policy for ASM for measures within the Public Health and Clinical Data Exchange objective at proposed Sec. 512.740(b)(2)(iv), consistent with a longstanding MIPS policy; Make technical modifications to the language describing measure-level exclusions for measures that include an option to claim an exclusion at Sec. 512.740(b)(3)(i)(C); Remove the requirement to report through attestation the security risk analysis measure by striking Sec. 512.740(b)(3)(ii); Remove Office of the National Coordinator for Health Information Technology (ONC) direct review required attestations by striking Sec. 512.740(b)(4)(i); Retain the requirement to avoid knowingly and willfully taking actions to limit or restrict interoperability of CEHRT but redesignate it from current Sec. 512.740(b)(4)(ii) to Sec. 512.740(b)(4)(i); Redesignate current Sec. 512.740(c)(2) describing the Promoting Interoperability ASM performance category scoring policy as Sec. 512.740(c)(3) without changing the regulatory text; and Adopt a measure suppression policy at new Sec. 512.740(c)(2) that aligns with the policy we adopted in the CY 2026 PFS final rule for MIPS. Table B-D2 summarizes existing finalized requirements and new proposals in this proposed rule for the objectives and measures in the Promoting Interoperability ASM performance category for the 2027 ASM performance year. We discuss new proposals in the remainder of this section of this proposed rule. [GRAPHIC] [TIFF OMITTED] TP16JY26.051 [[Page 43985]] (2) Proposed Update to CEHRT Definition We refer readers to section IV.A.4.f.(4) of this proposed rule for a discussion of proposed updates to the definition of CEHRT under MIPS. Under Sec. 512.705, we define CEHRT for the purposes of ASM as technology that meets the requirements set forth in MIPS regulations at Sec. 414.1305. We are not proposing to depart from this approach. Therefore, any updates finalized to the definition of CEHRT under MIPS would be incorporated for purposes of ASM under the existing definition at Sec. 512.705. We refer readers to Table C-G1 of this proposed rule for a summary of changes. (3) Electronic Prior Authorization Measures in the Health Information Exchange Objective (a) Overview In the ``Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program'' final rule (89 FR 8758) (hereinafter referred to as the ``2024 CMS Interoperability and Prior Authorization final rule''), we finalized requirements for Medicare Advantage organizations, Medicaid managed care plans, State Medicaid agencies, CHIP agencies, CHIP managed care entities, and issuers of qualified health plans on the Federally-facilitated Exchanges (collectively, ``impacted payers'') to improve the electronic exchange of health care information and streamline prior authorization for medical items and services. Impacted payers must implement and maintain prior authorization application programming interface (API) technology to communicate information related to prior authorization requests (89 FR 8763). As we explained in the 2024 CMS Interoperability and Prior Authorization final rule, the efficiencies associated with payer implementation of these APIs will be more fully realized when requesting providers also use API-enabled processes to submit prior authorization requests. Accordingly, we finalized the addition of an Electronic Prior Authorization measure as a required measure for MIPS eligible clinicians under the MIPS Promoting Interoperability performance category HIE objective (89 FR 8910 through 8927). (b) 2027 ASM Performance Year: Electronic Prior Authorization Measure We believe adopting the Electronic Prior Authorization measure within ASM would support broader Departmental efforts to advance interoperability, modernize prior authorization processes by encouraging ASM participants to develop capabilities that advance the interoperable exchange of data related to prior authorization requests, and support alignment with MIPS. This measure describes requesting a prior authorization electronically using CEHRT to send a request through a payer's Prior Authorization API for at least one medical item or service (excluding prescription drugs) ordered within the applicable performance year. We now propose to include the Electronic Prior Authorization measure (Measure ID # PI_HIE_7) in the Promoting Interoperability ASM performance category under the HIE objective, consistent with MIPS, starting in the 2027 ASM performance year. For the 2027 ASM performance year, we propose that the Electronic Prior Authorization measure would be available as an optional, unscored ASM Promoting Interoperability measure, without any scoring penalty for non-reporting. We propose to codify this measure for ASM at Sec. 512.740(b)(2)(ii)(B). We propose to rely on the measure specifications used in MIPS for the Electronic Prior Authorization measure and refer readers to section IV.A.4.f.(4) of this proposed rule for a discussion of the technical specifications for the Electronic Prior Authorization measure under MIPS, including proposed modifications to the measure specifications, which we propose to adopt in ASM. To report the Electronic Prior Authorization measure, an ASM participant would submit a ``yes'' response attesting they satisfactorily met the requirements of the measure. We do not propose to adopt any exclusions for this measure for the 2027 ASM performance year, since the measure would be optional and attesting ``no'' or not attesting at all would not result in a scoring penalty. Under our proposal for ASM, the Electronic Prior Authorization measure would be included under the HIE objective, consistent with MIPS. Under the current ASM HIE objective, an ASM participant satisfies the objective by reporting one of three available reporting options: Support Electronic Referral Loops by Sending Health Information (Measure ID # PI_HIE_1) and Support Electronic Referral Loops by Receiving and Reconciling Health Information (Measure ID # PI_HIE_4). Health Information Exchange (HIE) Bi-Directional Exchange (Measure ID # PI_HIE_5). Enabling Exchange Under the Trusted Exchange Framework and Common Agreement (TEFCA) (Measure ID # PI_HIE_6). We are not proposing to change that an ASM participant must satisfy one of these three reporting options to fulfill the requirements for the HIE objective. Rather, our proposal makes the Electronic Prior Authorization measure available as an optional, voluntary measure that could be reported in addition to one of the required HIE reporting options for the 2027 ASM performance year. While no points would be awarded to ASM participants that report this measure through submission of a ``yes'' attestation, we believe including the Electronic Prior Authorization as an optional measure could encourage ASM participants to develop workflows and infrastructure to support reporting the measure once it is required beginning with the 2028 ASM performance year. We emphasize that, under our proposal, ASM participants who elect not to report for the Electronic Prior Authorization measure in the 2027 ASM performance year would not be penalized. We considered, but do not propose, offering 5 bonus points to an ASM participant's Promoting Interoperability ASM performance category score for the 2027 ASM performance year if an ASM participant voluntarily attests ``yes'' to the Electronic Prior Authorization measure as an alternative policy to our proposal to treat this optional measure as unscored for the 2027 ASM performance year. We considered this approach because temporary bonus points during an optional performance year could encourage ASM participants to begin establishing and operationalizing the capabilities needed to use a Prior Authorization API with CEHRT before the measure would be required beginning with the 2028 ASM performance year. We further recognize that MIPS proposes to offer bonus points for this measure. However, we do not propose to offer bonus points for the [[Page 43986]] Electronic Prior Authorization measure within the Promoting Interoperability ASM performance category because we intend to maintain a more simplified and streamlined scoring framework that does not incorporate the full complexity of MIPS bonus point structures. MIPS offers bonus points for certain optional measures under the Public Health and Clinical Data Exchange objective, however ASM does not offer bonus points for these measures. Our proposal to not offer bonus points for the Electronic Prior Authorization measure is consistent with our approach for optional measures within the Public Health and Clinical Data Exchange objective. We believe that including bonus points in the Promoting Interoperability ASM performance category would add administrative and scoring complexities we do not intend to introduce. We seek comment on the proposal at Sec. 512.740(b)(2)(ii)(B) to include the Electronic Prior Authorization measure as an optional, unscored measure in the Promoting Interoperability ASM performance category for the 2027 ASM performance year. We also seek comment on the alternative we considered where we would offer bonus points to ASM participants who attest ``yes'' to the Electronic Prior Authorization measure for the 2027 ASM performance year. Specifically, we seek comment on whether offering bonus points would encourage early adoption among ASM participants. (c) 2028 ASM Performance Year: Electronic Prior Authorization Measure Beginning with the 2028 ASM performance year, we propose that an ASM participant would be required to report the Electronic Prior Authorization measure through submission of a ``yes'' attestation or, alternatively, claim an applicable exclusion, to satisfy the measure requirements. In such cases, the Electronic Prior Authorization measure would not affect the total score for the Promoting Interoperability ASM performance category. However, if an ASM participant submits a ``no'' response, fails to submit any attestation, or does not claim an applicable exclusion for the Electronic Prior Authorization measure, the ASM participant would receive a score of zero for the Promoting Interoperability ASM performance category. This scoring approach is consistent with the approach taken for MIPS eligible clinicians under proposed and existing policies. Also starting in the 2028 ASM performance year, we propose to recognize exclusions to this measure and would adopt the same exclusion criteria as MIPS adopted in 2024 CMS Interoperability and Prior Authorization final rule (89 FR 8909 through 8927), which are discussed in this proposed rule without proposed modifications. We believe requiring this measure beginning with the 2028 ASM performance year rather than in the 2027 ASM performance year would provide ASM participants time and flexibility to prepare to successfully report the measure. We propose to include this requirement at Sec. 512.740(b)(2)(ii)(C)(1). We seek public comment on our proposal to require the Electronic Prior Authorization measure beginning with the 2028 ASM performance year. (d) 2028 ASM Performance Year: Electronic Prior Authorization for Prescription Drugs Measure The proposed rule ``Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges'' (hereinafter referred to as the ``2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule'') introduced proposals that would require impacted payers to support various exchange standards in support of prior authorization for prescription drugs (91 FR 19890). Specifically, beginning on October 1, 2027, impacted payers would be required to support electronic prior authorization for all prescription drugs that require prior authorization. As more payers support standardized electronic prior authorization capabilities, we believe measuring the use of prior authorization for prescription medications would be a valuable addition to our assessment of meaningful use of CEHRT under the Promoting Interoperability ASM performance category. Standards-based electronic prior authorization may improve timeliness and transparency of medication access by facilitating documents-gathering and tracking of prior authorization status within clinician EHR workflows to support care coordination and close the prescriber-to-dispenser loop. Accordingly, beginning with the 2028 ASM performance year, we propose at Sec. 512.740(b)(2)(ii)(C)(2) to adopt the Electronic Prior Authorization for Prescription Drugs measure (Measure ID # PI_HIE_8) as a required measure under the Promoting Interoperability ASM performance category. This measure would focus on prescription drugs covered under a pharmacy benefit and dispensed at pharmacies. We propose to include this measure under the HIE objective, consistent with our proposal to include the Electronic Prior Authorization measure under this objective. We propose to include the availability of exclusions for the Electronic Prior Authorization for Prescription Drugs measure, consistent with those recognized under MIPS, starting in the 2028 ASM performance period. We propose to adopt the same measure specification and exclusion criteria for the Electronic Prior Authorization for Prescription Drugs measure that are being proposed under MIPS for the MIPS Promoting Interoperability performance category. We refer readers to section IV.A.4.f.(4) of this proposed rule for discussion on measure specifications and exclusions. To successfully report this measure, an ASM participant would be required to submit a ``yes'' response attesting that they have requested electronic prior authorization using CEHRT for at least one prescription drug during the performance period, or alternatively, claim an applicable exclusion. Under our proposal, this measure would not contribute to an ASM participant's Promoting Interoperability ASM performance category score; however, if an ASM participant submits a ``no'' response, fails to submit any attestation, or does not claim an applicable exclusion for the Electronic Prior Authorization for Prescription Drugs measure, the ASM participant would receive a score of zero for the Promoting Interoperability ASM performance category starting in the 2028 ASM performance year. We emphasize that, under our proposal to include the prior authorization measures under the HIE objective for ASM, an ASM participant would continue to be required to report one of the three existing HIE reporting options at current Sec. 512.740(b)(2)(ii). We also underscore that we are not proposing to require the Prior Authorization measure or the Prior Authorization for Prescription Drugs measure until the 2028 ASM performance year. As stated, we aim to align proposals for ASM, as appropriate, with the direction of MIPS policy for the Promoting Interoperability performance category. This includes alignment for the Electronic Prior Authorization measures with MIPS and with broader [[Page 43987]] Departmental goals of improving interoperability and modernizing prior authorization processes. In the 2024 CMS Interoperability and Prior Authorization final rule, we explained that electronic prior authorization policies are intended to encourage provider adoption of electronic prior authorization processes and improve the exchange of information needed to support more efficient prior authorization workflows (89 FR 8910 through 8927). Although that final rule finalized the Electronic Prior Authorization measure only for medical items and services, excluding drugs, we believe those same policy goals support adoption of an Electronic Prior Authorization for Prescription Drugs measure under ASM beginning with the 2028 ASM performance year. We believe requiring both electronic prior authorization measures beginning in the 2028 ASM performance year would promote more consistent electronic prior authorization capabilities and workflows across ASM participants' operations and would support broader movement toward more efficient exchange of prior authorization information. We seek comment on all aspects of these proposals. (4) Exclusions to the Public Health and Clinical Data Exchange Objective in the Promoting Interoperability ASM Performance Category In the CY 2026 PFS final rule, we finalized that an ASM participant must submit a ``yes'' attestation for the two required measures in the Public Health and Clinical Data Exchange objective (the Immunization Registry Reporting and Electronic Case Reporting measures) to earn 25 points for the objective (90 FR 49658 through 49662). We noted the potential availability of exclusions for the Immunization Registry Reporting and Electronic Case Reporting measures in tables published in the preamble to the proposed rule (Table 61; 90 FR 32745) and in the preamble to the final rule (Table B-D6; 90 FR 49659). However, we did not explicitly propose an exclusion policy in the narrative preamble text or memorialize that policy in the regulatory text itself. As a result, the current regulation at Sec. 512.740(b)(2)(iv) reads as though an ASM participant must report both measures to satisfy the objective, without the availability of exclusions for either measure. We propose to clarify that exclusions are available to ASM participants for the Immunization Reporting Registry and Electronic Case Reporting measures by amending our regulation at Sec. 512.740(b)(2)(iv). Under our proposal, an ASM participant would receive full credit for the Public Health and Clinical Data Exchange objective by reporting both Public Health and Clinical Data Exchange measures (Immunization Registry Reporting and Electronic Case Reporting), reporting one measure and claiming one exclusion, or claiming two exclusions. We believe this proposal would simplify ASM participant reporting requirements by aligning exclusions available in MIPS and redistributing points for excluded measures in accordance with MIPS redistribution policies. MIPS specifies certain exclusion criteria that apply to each of the Immunization Registry Reporting and Electronic Case Reporting measures. We propose to adopt the same exclusion criteria as specified in MIPS sub-regulatory guidance for ASM, consistent with our aim to drive alignment where possible. We seek comment on this proposal at Sec. 512.740(b)(2)(iv), including the proposal to use the same exclusion criteria that MIPS uses for the Immunization Registry Reporting and Electronic Case Reporting measures. (5) Security Risk Analysis Measure The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as implemented through the HIPAA Security Rule (45 CFR part 160 and subparts A and C of part 164), includes administrative safeguards required of covered entities and business associates, including a risk analysis component and a risk management component. The Security Risk Analysis measure was adopted to require that MIPS eligible clinicians attest to having conducted a security risk analysis and security risk management activities as required by the HIPAA Security Rule. In the CY 2026 PFS final rule (90 FR 49656 through 49568), we incorporated this measure into the Promoting Interoperability ASM performance category by requiring that ASM participants complete the actions included in the MIPS Promoting Interoperability Security Risk Analysis measure. At the time, we believed it would help drive more secure, efficient, and meaningful use of CEHRT under ASM. To reduce reporting burden, beginning with the 2027 ASM performance year, we now propose to remove the requirement at Sec. 512.740(b)(3)(ii) that an ASM participant submit an affirmative attestation as to completing a security risk analysis within the calendar year . We consider the use of CEHRT to demonstrate security risk analysis and security risk management activities sufficient as it complies with requirements pertaining to the security of data created and maintained by CEHRT in accordance with the HIPAA Security Rule. Given that ASM participants are covered entities under the HIPAA Security Rule and the requirements of the Security Risk Analysis measure are derived from the HIPAA Security Rule requirements, we do not believe that removing the Security Risk Analysis measure from the Promoting Interoperability ASM performance category will weaken any cybersecurity requirements for ASM participants. Furthermore, our proposal aligns with the proposal in MIPS to remove the Security Risk Analysis from MIPS Promoting Interoperability; we refer readers to section IV.A.4.f.(4) of this proposed rule for further discussion. To conform with removal of the Security Risk Analysis measure, we propose to redesignate current Sec. 512.740(b)(3)(iii) as Sec. 512.740(b)(3)(ii). We seek comment on the proposal to remove the Security Risk Analysis measure and attestation requirement from the Promoting Interoperability ASM performance category. (6) Supporting Providers With the Performance of CEHRT In the CY 2026 PFS final rule (90 FR 49661), we finalized that an ASM participant must support the performance of CEHRT by submitting certain affirmative attestations to receive a Promoting Interoperability ASM performance category score greater than zero. Specifically, as finalized at Sec. Sec. 512.740(b)(4)(i)(A)(1) and (2), an ASM participant must support the performance of CEHRT by: Providing acknowledgement of the requirement to cooperate in good faith with the Office of the National Coordinator for Health Information Technology (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 [[Page 43988]] capabilities as implemented and used by the ASM participant in the field. An ASM participant may optionally attest to the following: 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. If requested, that the ASM participant cooperates 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. Consistent with the proposal to remove these attestations from the MIPS Promoting Interoperability performance category, we propose to remove the ONC Direct Review attestation and ONC-ACB Surveillance attestation from the Promoting Interoperability ASM performance category starting in the 2027 ASM performance year. This proposal aligns with our goals of reducing administrative burden while focusing on high-value, outcome-oriented measures. Removing attestations from the Promoting Interoperability ASM performance category reduces the number of discrete manual steps and reporting fields required for successful adherence to reporting requirements without diminishing central goals of the Promoting Interoperability ASM performance category. We refer readers to section IV.A.4.f.(4) of this proposed rule for further discussion on the proposal to remove these attestations in MIPS. We seek comment on the proposal to remove the ONC Direct Review attestation and ONC-ACB Surveillance attestation. (7) Adopting a Measure Suppression Policy for the Promoting Interoperability ASM Performance Category We finalized a measure suppression policy under the MIPS Promoting Interoperability performance category beginning with the CY 2026 MIPS performance year (90 FR 49881 through 49887). Under this policy, when circumstances arise that impede effective measurement of a MIPS Promoting Interoperability measure, we may suppress the measure by excluding it from MIPS Promoting Interoperability performance category scoring or from the determination of whether a MIPS clinician is a meaningful EHR user for the applicable MIPS performance year (Sec. 414.1380(b)(4)(iii)). A decision to suppress a measure does not eliminate the requirement that MIPS eligible clinicians report the measure. However, regardless of the data, attestation, or other information related to the suppressed measure that is submitted by the MIPS eligible clinician, the suppressed measure would not affect the objective's score or the determination of meaningful EHR user status (90 FR 49883). We also finalized suppression of the Electronic Case Reporting measure for the CY 2025 MIPS performance year because the Centers for Disease Control and Prevention (CDC) temporarily paused onboarding new health care organizations for production of electronic case reporting data and new local public health agencies for receipt of electronic case reporting data (90 FR 49886 through 49893). We did not adopt a measure suppression policy for the Promoting Interoperability ASM performance category because ASM performance had not yet begun. We stated we would monitor developments as the first ASM performance year approaches, with the goal of maintaining alignment with the MIPS Promoting Interoperability performance category where possible and indicated we may propose changes in future rulemaking. After further consideration, we propose at Sec. 512.740(c)(2) to adopt a Promoting Interoperability measure suppression policy within ASM starting in the 2027 ASM performance year. Specifically, we are proposing that if certain circumstances occur that impact our assessment of ASM participant performance on a measure specified for the Promoting Interoperability ASM performance category under Sec. 512.740(b), we may suppress the affected measure by: (1) excluding it from our calculation of the Promoting Interoperability ASM performance category objective score under Sec. 512.740(c); or (2) excluding it from the determination of meaningful EHR user status, if the affected measure is not scored. We propose to redesignate current Sec. 512.740(c)(2) describing the Promoting Interoperability ASM performance category scoring policy as Sec. 512.740(c)(3), without making changes to that existing regulatory text, to describe the measure suppression policy at Sec. 512.740(c)(2). For an applicable ASM performance year, we propose to determine whether circumstances warrant suppression of an ASM Promoting Interoperability measure based on consideration of the same factors we identified for MIPS (90 FR 49883): The nature, breadth, and duration of the circumstance's effect on ASM participants' ability to fulfill the measure requirement; The availability of certified health IT modules to fulfill the measure; Whether the circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, including with respect to performance or compliance; Out-of-date or conflicting technical standards; Technical or operational capacity of required partners; or Other factors as determined by CMS. We are further proposing that, if we determine that a measure must be suppressed, we would notify ASM participants through existing communication channels. To the extent technically feasible, we intend to notify ASM participants prior to the beginning of the applicable data submission period. We note that, like in MIPS, the duration of suppression for a measure in ASM would be for an entire ASM performance year. If prolonged issues persist regarding a given circumstance, we would assess the circumstance to determine if a measure would warrant suppression for a subsequent ASM performance year. We believe this policy would ensure the integrity of the ASM scoring methodology while protecting ASM participants from being penalized for circumstances beyond their control. We invite public comment on our proposal at Sec. 512.740(c)(2) to adopt the proposed measure suppression policy. f. Final Score (1) Background In the CY 2026 PFS final rule (90 FR 49664 through 49679), we adopted a scoring methodology to evaluate the annual performance of each ASM participant through a final score. The final score represents an ASM participant's aggregate performance on a scale of zero to 100 points based on applicable performance standards for measures and activities in each ASM performance category. This scoring framework promotes accountability for performance across ASM participants within each ASM cohort. We use the final score to determine the ASM payment adjustment factor applied to an [[Page 43989]] ASM participant's Medicare Part B claims for covered professional services during the corresponding ASM payment year. We calculate the final score based on performance in the quality, cost, improvement activities, and Promoting Interoperability ASM performance categories (90 FR 49677). We also established policies to award additional points to ASM participants who furnish care to complex patient populations and to ASM participants who are part of small practices or who are solo practitioners (90 FR 49670 through 49676). (2) Requirements To Receive a Final Score In the CY 2026 PFS final rule (90 FR 49668 through 49669), we finalized that an ASM participant must meet minimum data submission requirement to receive a final score for an ASM performance year. An ASM participant who does not meet these data submission requirements receives a final score of zero points for the applicable ASM performance year, which results in the maximum negative payment adjustment applicable for the corresponding ASM payment year. Conversely, an ASM participant who meets the minimum data submission requirements but cannot be evaluated on quality and cost performance does not receive a final score and instead receives a neutral payment adjustment for the applicable ASM payment year. We refer readers to Table B-D8 in the CY 2026 PFS final rule for a summary of ASM's final score policies and their impact on payment adjustments (90 FR 49670). After internal review of ASM's final scoring provisions, we believe we could clarify regulatory text describing when we will not assign an ASM participant a final score. Specifically, we propose to revise Sec. 512.745(a)(2)(iii)(B) by striking the ``Do not receive'' language that starts Sec. Sec. 512.745(a)(2)(iii)(B)(1) and 512.745(a)(2)(iii)(B)(2). We then propose to revise Sec. 512.745(a)(2)(iii)(B) to read ``Do not receive either:'', referring to the conditions described at Sec. Sec. 512.745(a)(2)(iii)(B)(1) and 512.745(a)(2)(iii)(B)(2). These specific changes do not introduce substantive changes to current requirements. We seek comment on the proposed changes to clarify the regulatory text at Sec. 512.745(a)(2)(iii)(B). (3) Rural Scoring Adjustment In the CY 2026 PFS proposed rule, we considered, but did not propose, including a rural scoring adjustment in the calculation of an ASM participant's final score (90 FR 32604), as our analysis of historic data did not reveal a systematic difference in expected performance between likely ASM participants in rural and non-rural areas. In response to our discussion considering the rural scoring adjustment in the CY 2026 PFS proposed rule, we received interested parties' feedback recommending that we award a rural scoring adjustment to ASM participants in rural areas because ASM participants in rural areas face unique demands (90 FR 49676). However, we finalized ASM's final score policy without including a rural scoring adjustment. The CY 2026 PFS final rule did establish policies to award additional points on the final score to ASM participants who furnish care to complex patient populations (up to 10 points) and to ASM participants who are part of small practices (10 points for ASM participants in small practices, 15 points for solo practitioner ASM participants) (90 FR 49670 through 49676). In the CY 2026 PFS final rule, we noted that small practice and solo practitioner scoring adjustments better support ASM participants in small practices by compensating for increased administrative burden and additional reporting requirements (90 FR 49676). We noted in the CY 2026 PFS final rule that we expected a high degree of overlap between ASM participants in rural areas and those in small practices based on historical MIPS performance data that we analyzed (90 FR 49677), indicating that ASM participants in rural areas would be eligible for the small practice scoring adjustment and be supported accordingly. We also noted that a rural scoring adjustment could weaken incentives for ASM participants in large rural systems to improve (90 FR 49676). However, as supported by interested parties' comments on the CY 2026 PFS proposed rule, together with additional research and analysis, the unique circumstances facing ASM participants in rural areas may warrant adjustments to their final scores. We recognize that ASM participants in rural areas may face structural challenges that affect their ability to perform under ASM, including limited resources for technology modernization, workforce shortages that constrain reporting capacity, and barriers to system interoperability. A 2025 analysis of physician participants in the Quality Payment Program found significantly higher physician adoption of EHRs in urban areas (74 percent) compared to rural areas (64 percent).\181\ Another recent study suggests that physicians in rural areas were less likely to report ideal interoperability experiences for medication notes.\182\ A report from the HHS Assistant Secretary for Technology Policy (ASTP) notes that urban hospitals were more likely to engage in routine interoperable exchange (47 percent were routinely interoperable) than their rural counterparts (36 percent were routinely interoperable).\183\ These findings align with interested parties' feedback highlighting additional interoperability barriers faced by rural clinicians. Accordingly, we believe ASM's existing scoring methodology may not adequately address the complex factors that may affect rural ASM participant's performance particularly because ASM has a unique focus on incentivizing interoperability improvements to strengthen care coordination. --------------------------------------------------------------------------- \181\ Anzalone AJ, Geary CR, Dai R, Watanabe-Galloway S, McClay JC, Campbell JR. Lower electronic health record adoption and interoperability in rural versus urban physician participants: a cross-sectional analysis from the CMS quality payment program. BMC Health Serv Res. 2025 Jan 23;25(1):128. doi: 10.1186/s12913-024- 12168-5. PMID: 39849475; PMCID: PMC11755824. \182\ Everson J, Adler-Milstein J, Phillips RL, Bazemore AW, Patel V. EHR Interoperability Experiences Reported by Family Physicians. JAMA Netw Open. 2025;8(11):e2542460. doi:10.1001/ jamanetworkopen.2025.42460. \183\ https://healthit.gov/data/data-briefs/interoperable-exchange-patient-health-information-among-us-hospitals-2023/. --------------------------------------------------------------------------- Additionally, our analysis of preliminary ASM participants for the 2027 ASM performance year provides an updated understanding of the practice size of ASM participants in rural areas. In previous notice- and-comment rulemaking, we noted that we expected ASM participants in rural areas were primarily practicing in small practices and, therefore, would qualify for ASM's small practice or solo practitioner scoring adjustments (90 FR 49677). An additional rural scoring adjustment, on top of small practice or solo practitioner adjustments, for these ASM participants could have been duplicative and result in a disproportionate scoring benefit. However, upon review of updated data on preliminary ASM participants for the 2027 ASM performance year, we found that ASM participants in rural areas are typically part of larger practices and would be less likely to receive the small practice scoring adjustment. To address continued interested parties' feedback about ASM participants in rural areas and additional analysis of preliminary ASM participants for the 2027 ASM performance year, we are proposing the [[Page 43990]] inclusion of a rural scoring adjustment in the calculation of an ASM participant's final score. We believe adding a rural scoring adjustment would adequately increase final scores to account for the unique challenges faced by this group of ASM participants. To determine if an ASM participant is in a rural area, we propose at Sec. 512.705 to adopt the same definition and determinations of a ``rural area'' as defined, interpreted, and updated at Sec. 414.1305 under MIPS. We believe that aligning our rural area definition with MIPS will reduce confusion for ASM participants in rural areas who have previously participated in MIPS and received associated flexibilities with rural special status under MIPS. To incorporate the rural scoring adjustment proposal into ASM's regulatory text, we first propose to redesignate current Sec. 512.745(a)(5) as new Sec. 512.745(a)(6). We then propose at new Sec. 512.745(a)(5) to add 5 points to the final score of an ASM participant who (1) is in a rural area as proposed to be defined at Sec. 512.705, and (2) meets the requirements to receive a final score greater than zero as described at Sec. 512.745(a)(2)(i) for an applicable ASM performance year. We emphasize that ASM participants in rural areas remain eligible to receive ASM's small practice or solo practitioner scoring adjustment and the complex patient scoring adjustment if they meet such scoring adjustment's eligibility criteria described at Sec. 512.745(a)(4) and Sec. 512.745(a)(3), respectively. We considered but are not proposing an alternative rural scoring adjustment policy to add 5 points to the final score of each ASM participant who (1) is in a rural area as proposed to be defined at Sec. 512.705, (2) meets the requirements to receive a final score greater than zero as described at Sec. 512.745(a)(2)(i) for an applicable ASM performance year, and (3) does not receive a small practice scoring adjustment as described in Sec. 512.705(a)(4). However, rural practices regardless of size often face thinner operating margins that limit their potential investment in the quality and technology infrastructure necessary to succeed in ASM.\184\ Uneven access to affordable broadband may further burden ASM participants in rural areas by financially challenging their ability to leverage health information exchanges and data sharing.\185\ We believe that a rural scoring adjustment for ASM participants in small and non-small rural practices alike most accurately accounts for the potential burdens faced by ASM participants in rural areas. --------------------------------------------------------------------------- \184\ HRSA National Advisory Committee on Rural Health and Human Services. Interoperability and Broadband: Challenges to Rural Information Exchange (January 2016). https://www.hrsa.gov/advisory-committees/rural-health/correspondence/20160101. \185\ Pritzker, Penny, and Tom Vilsack. ``Broadband Opportunity Council Report and Recommendations.'' USDA, US Department of Commerce, 20 Aug. 2015, obamawhitehouse.archives.gov/sites/default/files/broadband_opportunity_council_report_final.pdf. --------------------------------------------------------------------------- We also considered but are not proposing an alternative policy waiving Improvement Activity 2 (IA-2), Establishing Communication and Collaboration Expectations with Primary Care using CCAs, for ASM participants in rural areas. Although ASM participants in rural areas may face challenges forming partnerships with primary care practices due to limited primary care availability,\186\ we believe that a rural scoring adjustment more broadly accounts for challenges that could affect ASM participant performance across the four ASM performance categories compared to only waiving IA-2. --------------------------------------------------------------------------- \186\ https://www.ers.usda.gov/data-products/charts-of-note/chart-detail?chartId=106208. --------------------------------------------------------------------------- To account for the proposed addition of the rural scoring adjustment, we propose corresponding adjustments to the final score formula at Sec. 512.745(a)(6) We also propose to revise Sec. 512.745(a) to cross-reference the final score formula now described at Sec. 512.745(a)(6). We seek public comment on our proposed definition of rural area at Sec. 512.705 and our proposal at Sec. 512.745(a)(5) to add 5 points to the final score of an ASM participant who is in a rural area and meets the requirements to receive a final score greater than zero. We also seek comment on the alternative we considered to only add the rural scoring adjustment to the final scores of ASM participants in rural areas who are not eligible to receive a small practice scoring adjustment, as well as the alternative to waive IA-2 for ASM participants in rural areas. We seek comment on our corresponding proposal at Sec. 512.745(a)(6) to incorporate the rural scoring adjustment into the final score formula. (4) ASM Performance Report In the CY 2026 PFS final rule (90 FR 49678), we finalized that we will provide performance information to each ASM participant for each ASM performance year through an annual ASM performance report. The ASM performance report will include information on each ASM performance category score, scoring adjustments as applicable, the final score, the ASM payment adjustment factor, and the ASM payment multiplier. To incorporate additional information on scoring incentives and scoring adjustments proposed in this proposed rule, we propose to revise the structure of the regulatory text on the ASM performance report in Sec. 512.745(b). These proposed structural revisions to the regulatory text's structure are intended to improve readability on the logical flow of components of the annual ASM performance report, starting with each ASM performance category score, scoring incentives, scoring adjustments, final score, and ending with the resulting payment adjustment information. These specific changes do not introduce substantive changes to current requirements. We also propose at revised Sec. 512.745(b)(2) to provide ASM participants with information on whether they receive the quality ASM performance category scoring incentive for successful voluntary reporting of PRO data through the annual ASM performance report, as applicable. We refer readers to section III.D.2.d.(5) of this proposed rule for additional information on the proposed voluntary PRO data submission and associated quality ASM performance category scoring incentive. We also propose at revised Sec. 512.745(b)(5) to provide ASM participants with information on their rural scoring adjustment, if applicable, in the annual ASM performance report. We believe these proposals would help an ASM participant understand their performance and whether they qualified for new scoring incentives and scoring adjustments proposed in this proposed rule. We seek comment on our proposed clarifying revisions to Sec. 512.745(b). We also seek comment on our proposal at Sec. 512.745(b)(2) to provide information on the quality ASM performance category incentive for voluntary reporting of patient-reported outcome data, as applicable, and our proposal at Sec. 512.745(b)(5) to provide information on the rural scoring adjustment, as applicable, in the annual ASM performance report. g. Payment Approach (1) Background In the CY 2026 PFS final rule, we finalized the overall payment approach for ASM (90 FR 49679 through 49699). We will apply performance-based payment adjustments to all payments for Medicare Part B covered professional service claims from ASM participants [[Page 43991]] during an ASM payment year based on their performance during the corresponding prior ASM performance year. We explained that this approach will create meaningful financial incentives tied to performance in the model, while maintaining administrative feasibility and transparency (90 FR 49679 through 49680). To determine these payment adjustments, we finalized a methodology to compare ASM participant performance within each ASM cohort using final scores, which reflect ASM participants' performance across the four ASM performance categories (90 FR 49681 through 49683). We also finalized a methodology to calculate ASM payment adjustment factors and ASM payment multipliers used to apply the payment adjustments from the distribution of final scores (90 FR 49685 through 49696). We also finalized the level of two-sided risk (that is, the maximum and minimum payment adjustment), including the gradual increase in the two-sided ASM risk level from 9 percent in the 2027 and 2028 ASM performance years to 12 percent in the 2031 ASM performance year. We explained that this methodology supports strong incentives for performance improvement while maintaining ASM risk levels similar to MIPS during early model years. We will apply the ASM payment multiplier to all payments for Medicare Part B for covered professional services, not only those services related to each ASM cohort's ASM targeted chronic condition, during an ASM payment year (90 FR 49696 through 49699). (2) Application of ASM Payment Adjustments With Changes in TIN Affiliations In the CY 2026 PFS final rule, we finalized that Medicare Part B professional service claims submitted by an NPI who is an ASM participant for an ASM performance year but under a TIN (1) that we did not select the NPI as an ASM participant for the applicable ASM performance year and (2) to which the NPI began assigning billing rights after the ASM performance year but before the end of the corresponding ASM payment year would be adjusted using the ASM payment multiplier calculated for the ASM participant. In the limited instances where a single NPI is selected as an ASM participant under multiple TINs for an ASM performance year, we finalized that we would apply the highest of any ASM payment multipliers to all Medicare Part B covered professional service claims submitted under a new TIN during the applicable ASM payment year (90 FR 49696). We refer readers to Table B- D10 in the CY 2026 PFS final rule for additional information on how ASM payment adjustments will be applied under multiple scenarios (90 FR 49697). The goal of these policies is to maintain accountability for the ASM participant's performance through the application of their performance-based payment adjustments. By doing so, we track accountability to the ASM participant regardless of their specific TIN affiliation at the time we make payment adjustments. While we are not proposing substantive changes to these policies in this proposed rule, we note that there are inconsistencies in the regulatory text describing how we will adjust payment in situations where the ASM participant begins reassigning billing rights to a new TIN during an ASM payment year. Accordingly, to maintain consistency with the regulatory text governing the application of ASM's payment adjustments as described at Sec. 512.750(a), at Sec. Sec. 512.750(f)(1) and (f)(2), we propose to revise the regulatory text at Sec. 512.750(f) to replace the phrases ``adjusts payments'' and ``adjust claims'' with ``multiplies the amount otherwise paid under Medicare Part B for covered professional services''. We are also proposing clarifying revisions to Sec. 512.750(f)(1). We propose to remove unnecessary text at Sec. 512.750(f)(1)(i) because we only calculate ASM payment multipliers for ASM participants with final scores as described at Sec. 512.750(c)(1). To improve readability of the provision with the proposed removal of Sec. 512.750(f)(1)(i), we propose to revise Sec. 512.750(f)(1) to incorporate the text previously described at Sec. 512.750(f)(ii). We are also proposing revisions to clarify how we would adjust payments for NPIs selected as ASM participants under multiple TINs and who reassign billing rights to a new TIN after an ASM performance year. Accordingly, we propose to remove unnecessary language in Sec. 512.750(f)(2) and Sec. 512.750(f)(2)(i) to more clearly describe how we would adjust payments using the highest ASM payment multiplier calculated for an NPI who we select as an ASM participant under multiple TINs. We also propose at Sec. 512.750(f)(2)(ii) to replace the phrase ``assigning billing rights'' with ``reassigning billing rights'' to improve the accuracy of the regulatory text. These proposals do not create substantive changes to the proposed policies but would ensure clarity and consistency in language used to describe the application of payment adjustments under ASM under Sec. 512.750. We seek comment on our proposals to revise the regulatory text at Sec. 512.750(f)(1) and Sec. 512.750(f)(2). h. Applicability of CMS-Sponsored Model Safe Harbor at 42 CFR[thinsp]1001.952(ii) In the CY 2026 PFS final rule, we determined that the CMS- model arrangements and patient incentives safe harbor at Sec. 1001.952(ii) would be available to ASM participants that comply with applicable requirements (90 FR 49709) and codified the availability of the safe harbor for ASM at Sec. 512.765 in regard to remuneration associated with beneficiary incentives and remuneration exchanged under CCAs. Once a clinician is selected as an ASM participant for any ASM performance year during the ASM test period, that clinician remains an ASM participant for the duration of the ASM test period. However, in limited circumstances, an ASM participant may not be required to meet specified model requirements for a given ASM performance year. Specifically, if we determine that an ASM participant does not satisfy the ASM participant eligibility criteria as specified under Sec. 512.710(a)(2) or is determined to meet an exception under Sec. 512.710(c) for a given ASM performance year, the ASM participant is not: (1) subject to ASM performance assessment under Sec. 512.715, (2) required to submit data under Sec. 512.720, (3) subject to final scoring under Sec. 512.745, and (4) eligible for the waivers available under the model described at Sec. 512.775 (90 FR 49572, 90 FR 49583). We finalized the application of these policies in the CY 2026 PFS final rule, however, we did not address the availability of the CMS- sponsored model arrangements and patient incentives safe harbor under Sec. 1001.952(ii), as made available for ASM at Sec. 512.765, in instances where an ASM participant is not subject to specified ASM requirements due to not meeting ASM participant eligibility criteria as described in Sec. 512.710(a)(2) or a determination that an exception applies under Sec. 512.710(c). We now propose that the CMS-sponsored model arrangements and patient incentives safe harbor would be available only for remuneration attributable to periods during which an ASM participant is performing under the model. Conversely, the CMS-sponsored model arrangements and patient incentives safe harbor would not be available for remuneration [[Page 43992]] attributable to a period during which an ASM participant is not performing under the model due to not meeting ASM participant eligibility criteria as described at Sec. 512.710(a)(2) or a determination that an exception applies under Sec. 512.710(c). We believe this proposal appropriately ties the availability of the model-specific safe harbor to underlying model activities performed during a period of model performance. For example, we recognize that remuneration associated with a CCA may not be exchanged contemporaneously with the ASM performance year to which it relates. In such instance, remuneration exchanged pursuant to a CCA may be calculated based on an ASM participant's performance during an ASM performance year in which the ASM participant was eligible for and not excepted from ASM performance but may not be exchanged until a subsequent year because the applicable ASM payment adjustment factor, and net payment adjustment, would not calculated until after the close of the ASM performance year. An ASM participant who reassigns billing rights to a new TIN or redesignates their primary specialty type mid- ASM performance year may be excepted from ASM participation for that performance year under Sec. 512.710(c). In such instance, the ASM participant may rely on the availability of the safe harbor during the portion of the year in which they were performing under the model. Our proposal is not intended to retrospectively render the safe harbor unavailable with respect to remuneration attributable to the period in which the ASM participant was actively performing under the model and all applicable safe harbor requirements were satisfied. The limitation on safe harbor availability described at proposed Sec. 512.765(c) would apply prospectively from the date we determine the exception applies under Sec. 512.710(c). Accordingly, we propose that the availability of the CMS-sponsored model safe harbor would depend on the period of ASM performance to which the remuneration is attributable. Specifically, we propose to add Sec. 512.765(c) to state that the CMS-sponsored model arrangements and patient incentives safe harbor is available only with respect to remuneration attributable to a period in which the ASM participant was performing under the model, and is not available with respect to remuneration attributable to any period of the ASM test period for which the ASM participant does not meet ASM participant eligibility criteria under Sec. 512.710(a)(2) or is excepted from specified ASM requirements under Sec. 512.710(c). Limiting the availability of the safe harbor to remuneration attributable to model performance helps support program integrity and beneficiary protections while preserving flexibility for ASM participants to use incentives that support patient and primary care engagement in performance activities aligned with the model's purpose. We seek comment on this proposal. i. Collaborative Care Arrangements (CCAs) (1) Background The improvement activities ASM performance category is intended to advance core goals of ASM to drive better outcomes through improved care coordination, increased collaboration between specialists and primary care practices, and interventions that address upstream drivers of health. We finalized two improvement activities for ASM in the CY 2026 PFS final rule at Sec. 512.735 that we believe best support these aims: 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 CCAs (90 FR 49648 through 49655). To receive the maximum score available for the improvement activities ASM performance category, an ASM participant must attest ``yes'' to both improvement activities. IA-2 specifications require an ASM participant to enter into at least one collaborative care arrangement (CCA) with a primary care practice with which the ASM participant shares a patient who is an ASM beneficiary. IA-2 also requires that a CCA address at least three of the five elements specified at Sec. 512.735(c)(2)(ii): data sharing, co-management, transitions in care planning, closed-loop connection, and care coordination integration. In addition to IA-2 specifications at Sec. 512.735(c)(2)(ii), we outline requirements for CCAs at Sec. 512.771. The function of the CCA is to memorialize the coordination activities central to ASM and described in IA-2. We now propose certain updates to the CCA provisions at Sec. 512.771 to improve implementation by ASM participants and primary care practices and to more closely align CCA conditions with IA-2 by revising Sec. 512.771(a) and adding new paragraph Sec. 512.771(d). In summary, and as discussed in detail in respective sections of this proposed rule, our proposed changes to Sec. 512.771 include: Permitting one or more ASM participant to enter into a CCA with the same primary care practice, provided each ASM participant reassigns billing rights through the same entity's TIN and are named as parties to the CCA; Clarifying the requirement that an ASM participant and a primary care practice share a patient who is an ASM beneficiary and how this requirement applies in the context of the limitation on considering the volume or value of referrals; Streamlining the provision containing an illustrative list of authorities with which parties to a CCA must comply to simplify it, improve clarity, and reduce ambiguity; Updating the provisions that currently reference any elective exchange of payments between CCA parties to instead refer to the elective exchange of remuneration, to reflect a broader scope of value that may be exchanged under a CCA; Reorganizing regulatory requirements under Sec. 512.771(a) that are associated only with the exchange of any elective remuneration under a CCA such that they appear together under a new paragraph at Sec. 512.771(d) to bring greater clarity and to distinguish between those requirements that apply to all CCAs and those that apply only to CCAs that electively include the exchange remuneration; Revising the payment limitation that caps the exchange of remuneration based on an ASM participant's performance adjustment such that it can be more readily calculated in a timely manner and requiring that parties that elect to exchange remuneration before the limitation can be calculated reconcile any amounts that exceed the limitation following reconciliation; Clarifying that current requirements relating to traceability will continue to apply to monetary remuneration; Updating the contemporaneous documentation requirements to reflect any remuneration exchanged and add requirements to bring transparency into the methodologies used to determine the value of such remuneration; and Relocating the conditions associated with remuneration at current Sec. Sec. 512.771(a)(7) and 512.771(a)(8) to new paragraphs Sec. Sec. 512.771(d)(2) and 512.771(d)(3), respectively, in accordance with our proposal to address requirements associated with CCAs that include an exchange of remuneration [[Page 43993]] together under one paragraph. To conform with this relocation, we would redesignate existing sections Sec. Sec. 512.771(a)(9) through 512.771(a)(13) to Sec. Sec. 512.771(a)(7) through 512.771(a)(11). We would revise newly redesignated Sec. 512.771(a)(7) (former Sec. 512.771(a)(9)) to reference ``[a]ll parties'' rather than ``[b]oth parties'' and revise newly redesignated Sec. 512.771(a)(9) (former Sec. 512.771(a)(11)) to update documentation requirements as described, but otherwise would not revise text at newly redesignated Sec. 512.771(a)(8) (former Sec. 512.771(a)(10)), Sec. 512.771(a)(10) (former Sec. 512.771(a)(12)), or Sec. 512.771(a)(11) (former Sec. 512.771(a)(13)). (2) Parties to a CCA In the CY 2026 PFS final rule, we finalized at Sec. 512.771(a)(1) a requirement that a CCA be in writing, signed by both parties, and contain the effective date of the arrangement. We also finalized at Sec. 512.771(a)(2) a requirement that a CCA be exclusively between an ASM participant and a primary care practice with which the ASM participant shares at least one established patient who is an ASM beneficiary. At that time, we considered, but declined to permit, multiple ASM participants reassigning billing rights through the same TIN to be parties to a single CCA with a primary care practice party, citing concerns around the ability of ASM participants to accurately track any remuneration exchanged under a multi-ASM participant arrangement (90 FR 49712). Following publication of the CY 2026 PFS final rule, we received interested party feedback anticipating significant burden associated with establishing separate CCAs for each individual ASM participant when more than one ASM participant is in the same group practice and such ASM participants wish to collaborate with the same primary care practice. As an example, 20 ASM participants operate within a single health system and reassign their billing rights to that system's TIN. Even if such ASM participants coordinate care regularly with the same primary care practice and wish to establish a CCA with the same primary care practice, the current regulation would require negotiation, execution, documentation, and tracking of 20 separate CCAs. We believe that requiring a separate CCA for each ASM participant could impose administrative burden without a corresponding programmatic benefit. We now believe that concerns related to tracking remuneration under CCAs involving multiple ASM participants could be addressed through more targeted safeguards that apply to CCAs that elect to include remuneration, rather than a broader restriction applicable to all CCAs, including those that do not involve any exchange of remuneration. Accordingly, we propose to amend Sec. Sec. 512.771(a)(1) and 512.771(a)(2) to permit one or more ASM participants to be parties to the same CCA, subject to defined conditions. First, each ASM participant would be required to be explicitly named as a party to the CCA. Second, we propose that for multiple ASM participants to participate in the same CCA, all such ASM participants would be required to reassign billing rights to the same TIN. We would maintain the existing requirements at Sec. 512.771(a)(1) that the CCA be in writing and specify an effective date; we would also maintain the requirement that a CCA be signed by the parties but propose to amend regulatory text to stipulate CCA execution would be required for ``all'' parties rather than ``both'' parties. We believe restricting a multi-ASM participant CCA to ASM participants within the same TIN is appropriate as clinicians who practice under the same group practice are more likely to be supported by shared operations, such as shared EHR systems, clinical support staff, and standardized administrative workflows. Accordingly, we believe terms of a CCA could be standardized across ASM participants within the same organization (that is, TIN) without compromising the level of detail needed to support meaningful care coordination. In contrast, ASM participants from separate, unaffiliated TINs may have distinct infrastructure, care coordination needs, support structures, and operational workflows. It is therefore unclear how a single arrangement could establish cohesive terms regarding shared responsibilities with a primary care partner in a manner consistent with the intent of CCAs. We are concerned that attempting to encompass these different capabilities and variable workflows within a single agreement could result in vague, overly broad, or highly fragmented contractual terms, which could undermine the intent of the CCA. Our proposal to permit one or more ASM participants billing under the same TIN to join the same CCA with a primary care partner does not alter ASM's fundamental accountability framework. As noted, we propose to clarify that any ASM participant seeking to join and rely on one CCA be expressly named as a party to the arrangement. We believe such requirement maintains individual ASM participant accountability, while reducing administrative burden. We are not proposing to permit a group practice or TIN to serve as a sole contracting party on behalf of unnamed ASM participants, as this could obfuscate individual ASM participant accountability and introduce operational complexity, particularly when an ASM participant departs a group practice during an ASM performance year. Requiring each ASM participant to be named as a party would mitigate such concerns while still reducing contracting burden. We wish to emphasize that our proposals do not preclude an ASM participant's group practice from supporting the ASM participant or ASM participants with administrative functions associated with a CCA, such as recordkeeping or maintaining documentation on ASM participants' behalf, provided such support is consistent with other applicable authorities. Such administrative support does not substitute for the requirement that each ASM participant be named as a party and remain accountable for the core responsibilities described by the model and CCAs. Rather, we intend for our proposals to better account for the operational realities of group practices and the nature of the activities envisioned by a CCA, which inherently entails practice-level support. We do not intend for our proposals to disrupt such support arrangements. We also note that we do not intend, and do not propose, to impose prescriptive requirements around the meaning of a ``primary care practice'' that must be a party to a CCA. Our intent is that a CCA reflects coordination between the ASM participant and their ASM beneficiary's source of primary care services. We refer readers to discussion in response to interested party questions in the CY 2026 PFS final rule for further information (90 FR 49653). Our proposal is also intended to reduce burden for ASM participants who practice within the same group and coordinate care with the same primary care practice. It is not intended to discourage individual CCAs. ASM participants who belong to the same group may continue to enter into separate CCAs and should consider a separate arrangement when doing so better reflects individual clinical relationships, sources of primary care for their individual ASM beneficiary panel, and care coordination needs. We also continue to encourage ASM participants to consider entering into multiple CCAs to the extent it would support meaningful coordination for a [[Page 43994]] broader population of ASM beneficiaries but note that only one CCA is required to meet IA-2 specifications. We seek comment on these proposals, including whether it would reduce administrative burden to permit more than one ASM participant to enter the same CCA while preserving individual accountability, program integrity, and appropriate oversight. We also seek feedback on whether this proposal could be read as disadvantaging ASM participants who are solo practitioners or part of a group practice where they are the only selected ASM participant. We do not believe this proposal would have any negative effect on these ASM participants, but we invite interested party perspectives on this. (3) Requirement That CCA Parties Share a Patient Who Is an ASM Beneficiary Sections 512.735(c)(2)(i) and 512.771(a)(2) both require that parties to a CCA share a patient who is an ASM beneficiary. Under our proposal to permit more than one ASM participant to join the same CCA, we would maintain the requirement at proposed revised Sec. 512.771(a)(2) that an ASM participant party or ASM participant parties and the primary care practice party share at least one patient who is an ASM beneficiary. That is, the requirement that an ASM participant party or ASM participant parties and the primary care practice share a patient who is an ASM beneficiary would be satisfied so long as at least one shared patient who is ASM beneficiary exists between any one ASM participant party to the CCA and the primary care practice party, regardless of the total number of ASM participants who are parties to that CCA. We emphasize that the purpose of the requirement to share ``one or more'' patients who are ASM beneficiaries is to ensure a clear nexus exists between the CCA and coordination activities on behalf of ASM beneficiaries for whom both the primary care practice party and ASM participants have a care relationship. In the absence of shared ASM beneficiaries, there would be no care relationship to coordinate and, therefore, no basis for a CCA. We require only one shared ASM beneficiary as a minimum threshold condition because we believe that parties who commit to meaningfully coordinate care in a manner consistent with the purpose of a CCA will, organically, identify and collaborate on behalf of a much broader shared patient population as the arrangement is implemented. Thus, we continue to underscore, as we did in the CY 2026 PFS final rule (90 FR 49712 through 49713), that we encourage ASM participants to select primary care partners with whom they share multiple ASM beneficiaries as this would more meaningfully fulfill the goals of the CCA. Lastly, current Sec. 512.771(a)(2) requires that, for the purposes of the shared ASM beneficiary requirement, the ASM beneficiary must be an ``established'' patient. IA-2 specifications at Sec. 512.735(c)(2)(i) does not include the ``established'' qualifier. Upon further review, we do not believe it is necessary to include the term ``established'' in CCA regulations and therefore propose to strike the term ``established'' at Sec. 512.771(a)(2) to conform with IA-2 specifications. We seek comment on our proposal to require at least one shared patient who is an ASM beneficiary under a CCA regardless of how many ASM participants are parties to such CCA. We invite feedback on whether requiring one shared patient who is an ASM beneficiary is sufficient to encourage the coordination goals envisioned by CCAs. We also seek comment on our proposal to remove the term ``established'' from CCA regulations at Sec. 512.771(a)(2). (4) Requirement To Comply With Applicable Laws We finalized in the CY 2026 PFS final rule at Sec. 512.771(a)(5) that both parties to a CCA must comply with all applicable statutes, regulations, and guidance, including without limitation: Federal criminal laws; the False Claims Act (31 U.S.C. 3729 et seq.); the anti- kickback statute (42 U.S.C 1320a-7b(b)); the civil monetary penalties law (42 U.S.C. 1320a-7a); and the physician self-referral law (42 U.S.C. 1395nn). We now believe the illustrative list at Sec. 512.771(a)(5) is unnecessary and that a simplified version of regulatory text may reduce potential confusion. Accordingly, we are proposing to remove the illustrative list of legal authorities and instead retain only the requirement that both parties to a CCA comply with all applicable statutes, regulations, and guidance. To conform with other proposals to Sec. 512.771, we also propose to amend regulatory text to strike reference to ``[b]oth'' parties and instead require that ``[a]ll'' parties comply with this provision. We invite comment on the proposed changes. (5) Restriction on Conditioning Remuneration on Referrals In the CY 2026 PFS final rule, we established that neither the opportunity to enter a CCA nor the amount of any payment under a CCA may be conditioned, directly or indirectly, on the volume or value of past or anticipated referrals or business generated by, between, or among the parties to the arrangement or any other person (90 FR 49711). Separately, Sec. 512.771(a)(2) requires that an ASM participant and a primary care practice party to a CCA share at least one patient who is an ASM beneficiary. Upon further consideration, we are concerned that the current language at Sec. 512.771(a)(6) on conditioning entry into a CCA, in the context of the requirement for shared ASM beneficiaries at Sec. 512.771(a)(2), may be read to unnecessarily constrain the formation of the type of arrangements the model is designed to promote. Because shared ASM beneficiaries among parties to a CCA may result from existing care relationships between ASM participants and primary care practices, the current language of Sec. 512.771(a)(6) could be read to prohibit potential collaborators from considering the beneficiary- sharing relationship required by Sec. 512.771(a)(2). We did not intend the prohibition on conditioning entry into a CCA on referrals or business generated to prevent parties from considering whether they satisfy the shared-beneficiary requirement that is itself a requirement to CCAs. Accordingly, we propose to revise Sec. 512.771(a)(6) that an ASM participant may consider, as one criterion for entering into a CCA, whether they share at least one ASM beneficiary with a primary care practice. We propose that this would not violate the volume or value standard in Sec. 512.771(a)(6) if the purpose of such criteria is to further the purpose of the CCA. This clarification is intended to remove an unintended barrier to CCA formation while preserving the prohibition on entering into arrangements based on referral patterns or that reward or induce referrals or other business generated. This targeted revision would permit parties to consider whether they share one or more ASM beneficiaries only for purposes of satisfying the shared-beneficiary requirement at Sec. 512.771(a)(2) and furthering the purpose of the CCA. We seek comment on this proposal. We also invite comment on whether the proposed approach is sufficiently clear and appropriately accommodates the operational realities of how practices contemplate establishing CCAs. (6) CCAs That Include the Exchange of Remuneration In the CY 2026 PFS final rule, we stated our intent to allow ASM participants and their primary care [[Page 43995]] partners to negotiate arrangements that are best suited to their practices (90 FR 49712). We also recognized that parties to a CCA may wish to include model-related incentives under a CCA to support shared accountability for the outcomes of ASM beneficiaries and to support coordination activities that benefit shared patients (90 FR 49713). Accordingly, we made the CMS-sponsored model arrangements safe harbor at Sec. 1001.952(ii)(1) available under ASM at Sec. 512.765 to protect remuneration exchanged under a CCA, provided that all requirements of the safe harbor at Sec. 1001.952(ii)(1) and CCA regulations at Sec. 512.771 are met (90 FR 49713). Upon further review, we believe that provisions of Sec. 512.771 that refer to payments exchanged under a CCA should be revised to apply more broadly to remuneration exchanged under a CCA to the extent applicable. Applying these provisions to remuneration would better align Sec. 512.771 with Sec. 512.765 and the CMS-sponsored model arrangements safe harbor at Sec. 1001.952(ii)(1), both of which address remuneration. It would also more accurately reflect the full range of value that parties may exchange under a CCA, including monetary payments and in-kind items or services that support care coordination and other model-related activities. Accordingly, we propose to revise Sec. 512.771 such that applicable provisions referencing payment instead reflect and apply more broadly to remuneration exchanged under a CCA. We believe this proposed modification would clarify that safe harbor protections and requirements in Sec. 512.771 apply to both monetary and in-kind remuneration exchanged under a CCA. We emphasize that remuneration is not a required element of a CCA. Rather, parties to a CCAs may elect to include monetary or in-kind incentives that promote improvement activities or the goals of the model, provided that all applicable requirements are met (90 FR 49654). In-kind remuneration, such as shared data analytics platforms, care managers, or technology infrastructure could support the type of care coordination envisioned by ASM. We also propose to add new paragraph Sec. 512.771(d) to introduce the requirements that apply when parties to a CCA elect to exchange remuneration and to relocate the proposed, revised conditions applicable to remuneration under a CCA such that they appear together under new paragraph Sec. 512.771(d). We believe this construction would more clearly distinguish the regulatory requirements that apply to all CCAs from the additional conditions that apply when remuneration is exchanged under a CCA. We seek comment on our proposals to address remuneration, as applicable, throughout Sec. 512.771 rather than just payment, and to reorganize Sec. 512.771 such that conditions associated with remuneration at current Sec. Sec. 512.771(a)(7) and (a)(8) are located under new paragraph Sec. 512.771(d) at Sec. Sec. 512.771(d)(2) and (d)(3), respectively. We are interested in whether the proposed reorganization would bring greater clarity to our regulations. We also welcome comment on the types of services and remuneration that specialists and primary care partners exchange or contemplate exchanging to support and encourage coordination and collaboration goals, as we described in the CY 2026 PFS final rule (90 FR 49712). We remain interested in learning about the types of remuneration used to support collaborative care, such as shared personnel, infrastructure, data analytics, care management resources, technology, or other in-kind items or services, so that we may more clearly understand how such incentives are used to promote activities designed to aid coordination and can consider such feedback in future rulemaking. (a) Requirement for Remuneration to Reasonably Relate to CCA Purpose In the CY 2026 PFS final rule, we finalized at Sec. 512.771(a)(3) that a CCA must be entered into for the purpose of either furthering the ASM participant's performance in the improvement activities ASM performance category or furthering the clinical goals of the model as described by Sec. 512.771(b) (90 FR 49712 through 49714). We did not include a corresponding requirement that any remuneration exchanged under a CCA connect to those purposes. Upon further review, we are concerned that, absent such a requirement, remuneration could be structured in a manner that is not sufficiently connected to the objectives the CCA intends to support. We propose that any remuneration exchanged by the ASM participant party or parties and the primary care practice party to a CCA would be required to have a reasonable relationship to activities undertaken to further the ASM participant's performance in the improvement activities ASM performance category or to advance the model's clinical goals, which are: (1) promoting preventive care through improved management of ASM targeted chronic conditions; (2) empowering patients to actively participate and be accountable for quality and whole health outcomes; and (3) facilitating meaningful and efficient coordination between specialists and primary care providers to increase independent physician participation in value-based payment programs. Specifically, we propose to require at new Sec. 512.771(d)(1) that any remuneration exchanged by the parties to a CCA be reasonably related to the purpose of the CCA, as defined in Sec. 512.771(a)(3). We believe that aligning the purpose of any exchange of remuneration with the purpose of the CCA would support bona fide care coordination incentives while protecting program integrity. We do not anticipate that this requirement will result in any meaningful increase in compliance burden, particularly since including remuneration under a CCA is voluntary and because we already require that a CCA be entered into for the purposes specified at Sec. 512.771(a)(3). We seek comment on our proposal at Sec. 512.771(d)(1) to require that any remuneration exchanged under a CCA be reasonably related to the purpose of the arrangement, consistent with Sec. 512.771(a)(3). (b) Limitation on Remuneration In the CY 2026 PFS final rule (90 FR 49712 through 49714), we finalized a limitation to the amount of any payments exchanged under a CCA at Sec. 512.771(a)(7). Specifically, we finalized a requirement that any payment exchanged under a CCA must not exceed the sum total of the payment adjustments made to an ASM participant's claims for a given ASM payment year, which would be calculated based on the of application of the ASM payment adjustment factor to the ASM participant's payments for Medicare Part B covered professional services during the corresponding ASM payment year. Our intent was to ensure that any financial or in-kind exchanges between CCA parties remain appropriately tied to patient outcomes and ASM's clinical goals (90 FR 49712). Upon further consideration, we believe the current methodology may be difficult for parties to operationalize and warrants revision. ASM payment adjustments are applied 2 CYs after the applicable ASM performance year. As a result, the information needed to determine the maximum amount permitted to be exchanged may not be available until well after the close of the applicable ASM performance year. This could create operational difficulty for [[Page 43996]] parties that wish to exchange remuneration during or near the ASM performance year when care coordination activities are occurring. Accordingly, we propose updates to modify the temporal period used to calculate this limitation and provide for a reconciliation and repayment process to support compliance with the limitation. Consistent with our organizational update to Sec. 512.771, we propose to include the revised limitation on remuneration in new Sec. 512.771(d)(2). We propose to maintain a limitation on the amount of remuneration exchanged under a CCA and to tie that limitation to performance-based payment adjustments made to an ASM participant's payments for Medicare Part B covered professional services. However, we propose that this limitation would be calculated using the ASM participant's ASM payment adjustment factor for the applicable ASM performance year, multiplied by the amount otherwise paid to the ASM participant by CMS under Medicare Part B for covered professional services during that ASM performance year. Stated another way, the proposed revision would change the temporal period used to calculate the limitation amount from the ASM payment year to the ASM performance year. Under both the current and proposed methodologies, the operative component is the ASM payment adjustment factor based on performance for the ASM performance year; the proposed revision changes only the temporal period used to calculate the limitation amount. In accordance with our proposal permitting more than one ASM participant to join the same CCA, we propose to clarify that the remuneration limitation under proposed Sec. 512.771(d)(2) would be calculated separately for each ASM participant that is a party to a CCA. This means that, where more than one ASM participant is included in the same CCA, the limitation on the amount of remuneration that may be exchanged under the arrangement would be calculated per each ASM participant. Accordingly, the remuneration limitation would be calculated separately for each ASM participant based on that ASM participant's ASM payment adjustment factor and the amount otherwise paid to that ASM participant by CMS under Medicare Part B for covered professional services during the applicable ASM performance year. We believe this clarification is necessary to preserve individual ASM participant accountability while allowing multiple ASM participants to participate in a single CCA where appropriate. We are also proposing additional safeguards to support consistent implementation of this limitation. Specifically, under proposed Sec. 512.771(d)(2)(i), the CCA would be required to specify a methodology for identifying and calculating the total value of remuneration exchanged under the arrangement for the ASM performance year and determine whether the total value exceeds the applicable limitation. To the extent that remuneration is in-kind, we propose at Sec. 512.771(d)(2)(ii) that the valuation of such remuneration would be based on the offeror's costs using any reasonable accounting methodology, or the fair market value of the in-kind item or service. We believe this would support ASM participants that elect to exchange in-kind remuneration in ensuring such exchange complies with our regulations. Under proposed Sec. 512.771(d)(2)(iii), the arrangement would be required to provide for reconciliation, if applicable, after the limitation is determined. Under proposed Sec. 512.771(d)(2)(iv), if the total value of remuneration exchanged under the arrangement for the ASM performance year exceeds the limitation, the party that received the excess amount would be required to repay that excess amount to the other party within a reasonable time. We believe these provisions would promote consistent administration, clarify compliance requirements, and facilitate CMS oversight. We anticipate that these revisions to the remuneration limitation would establish a more viable pathway for parties to exchange remuneration during or close to the applicable ASM performance year by offering greater regulatory certainty that, should those exchanges exceed the final limitation, there would be a defined mechanism to reconcile the difference later. We recognize the inherent complexity with a limitation based on a mathematical formula as described in proposed Sec. 512.771(d)(2) in the context of in-kind remuneration. Valuing in-kind remuneration to ensure it does not exceed the calculated threshold, and 'repaying' excess in-kind value during the reconciliation process, may present operational difficulties that could impede good faith exchanges of in- kind items or services intended to support the purpose of the CCA. We considered but are not proposing an alternative where the limitation in proposed Sec. 512.771(d)(2) would apply only to monetary payments (or cash equivalents) exchanged under a CCA. Under such alternative, we would establish a separate limitation for in-kind remuneration, such as requiring that any in-kind items or services exchanged meet a fair market value and commercial reasonableness standard rather than a limitation based on a dollar amount. While a separate safeguard tailored to in-kind remuneration could ease operational burden for ASM participants and their primary care partners, we believe that having one mathematical formula for valuing any remuneration exchanged under a CCA would be simpler for parties to CCAs to implement and therefore did not propose this approach. We seek comment on these proposals, including the proposed update for calculating the limitation using the ASM performance year rather than the corresponding ASM payment year, the methodology and reconciliation requirements at proposed Sec. 512.771(d)(2) and whether the proposed updates bring greater clarity to requirements that apply to CCAs that elect to include remuneration. We also seek comment on the alternative considered for in-kind remuneration limitations. (c) Other Requirements for Remuneration Exchanged Under a CCA We finalized in the CY 2026 PFS final rule that any payment exchanged under a CCA must be solely between the parties and be made by check, electronic funds transfer, or another traceable cash transaction (Sec. 512.771(a)(8)) (90 FR 49712 through 49714). Consistent with our organizational update to Sec. 512.771, we propose to include this requirement, with revisions to address remuneration more broadly, in new Sec. 512.771(d)(3). Specifically, we would require that any remuneration exchanged under a CCA be solely between the parties and that, to the extent the exchange is a monetary payment, payment must be made by check, electronic funds transfer, or other traceable transaction at Sec. 512.771(d)(3). We seek comment on these proposals. (d) Documentation Requirements We finalized a requirement that ASM participants maintain contemporaneous documentation regarding all CCAs, including the relevant agreement and date and amount of payment at Sec. 512.771(a)(11). We propose to update documentation requirements to better support ASM participants and their primary care partners in their compliance with applicable regulations and to update references to conform with other changes proposed under Sec. 512.771, including that we propose to [[Page 43997]] redesignate existing Sec. 512.711(a)(11) to Sec. 512.711(a)(9). Specifically, we propose to revise the documentation requirement at proposed revised Sec. 512.771(a)(9) such that an ASM participant would be required to maintain contemporaneous documentation, in accordance with Sec. 512.135, regarding all CCAs entered into, records of all remuneration exchanged for each ASM participant under a CCA, a description of the remuneration, the value of the remuneration, the methodology for determining the value of any in-kind remuneration, and the date on which the remuneration was exchanged. We also propose to require documentation of the identity of each ASM participant that would be a party to the CCA. We propose this change to conform with our proposal that a CCA may include more than one ASM participant to promote appropriate recordkeeping regarding the identity of each ASM participant covered by a CCA. Together, we believe these proposed changes would clarify the minimum documentation that must be maintained by an ASM participant, better support compliance, and reduce ambiguity regarding documentation when a CCA includes multiple ASM participants as parties. These proposed changes would be reflected in proposed revised Sec. 512.771(a)(9), if finalized. We considered requiring that ASM participants maintain documentation supporting that all ASM participants who join the same CCA reassign their billing rights through the same TIN as a safeguard supporting compliance with our proposal that, if more than one ASM participant joins as a party to a CCA, such ASM participants must all reassign billing rights to the same TIN. We did not propose this approach as we believe we would be able to verify this information based on data already available to us. We seek comment on these proposed changes. We also seek comment on the alternative documentation approach we considered and whether this approach would better support compliance and monitoring. j. Medicare Program Waivers In the CY 2026 PFS final rule, we adopted a policy at Sec. 512.775 whereby we waive MIPS reporting obligations for an ASM participant in each ASM performance year in which the ASM participant meets ASM eligibility criteria at Sec. 512.710(b), except as specified in Sec. 512.710(a)(2). Section 512.710(a)(2) describes an ASM participant who does not meet eligibility requirements for mandatory participation in ASM for a given ASM performance year. We also discussed in the CY 2026 PFS final rule how the waiver pertaining to MIPS reporting obligations would not apply in instances where an ASM participant is not subject to specified ASM performance requirements due to a change in TIN (90 FR 49582). However, the regulatory text at Sec. 512.771(a) does explicitly reflect this policy. Accordingly, we propose to update Sec. 512.775(a) to replace the reference to ``Sec. 512.710(a)(2)'' with ``Sec. 512.710(a)(2) or Sec. 512.710(c)'' such that the regulatory text accurately reflects our policy. We seek comment on this proposal.

1. Background

On July 4, 2025, Public Law 119-21, which we refer to as the ``Working Families Tax Cut'' (WFTC) legislation, was enacted. Section 71201 of the WFTC legislation amended title XVIII of the Social Security Act (the Act) to add a new section 1899C, which provides that, subject to section 1899C(b) of the Act, an individual may be entitled to, or enrolled for, Medicare benefits only if the individual is in one of the following four groups: (1) a citizen or national of the United States; (2) an alien who is lawfully admitted for permanent residence under the Immigration and Nationality Act (INA) (lawful permanent resident or LPR); \187\ (3) an alien who has been granted the status of Cuban and Haitian entrant (CHE); or (4) an individual who lawfully resides in the United States \188\ in accordance with a Compact of Free Association (COFA migrant). --------------------------------------------------------------------------- \187\ As defined in section 501(e) of the Refugee Education Assistance Act of 1980 (Pub. L. 96-422). \188\ See section 402(b)(2)(G) of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA). --------------------------------------------------------------------------- Prior to enactment of the WFTC legislation, benefits payable under the Medicare program for noncitizens generally depended on whether the individual was ``lawfully present.'' Section 401 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) (Pub. L. 104-193, August 22, 1996), codified at 8 U.S.C. 1611, generally provides that, subject to certain exceptions, only ``qualified aliens'' are eligible for Federal public benefits. However, section 401(b)(3) of PRWORA provides that Medicare benefits under title XVIII of the Act are not limited solely to ``qualified aliens,'' but instead may be available to individuals who are lawfully present in the United States. Section 401(b)(2) of PRWORA similarly provides that noncitizens who are lawfully present in the United States may be eligible for benefits payable under title II, such as Social Security retirement or disability insurance benefits. Historically, before paying Medicare or title II benefits, the Social Security Administration (SSA) used a common process to verify an individual's lawful presence status by determining whether the applicant was a U.S. citizen or was otherwise lawfully present in the United States and whether the individual resided in the United States. SSA maintains a large set of policy and operational guidance, called Program Operations Manual System (POMS), that CMS and SSA update as needed. The SSA's procedures for verifying lawful presence before payment of title II and Medicare benefits are delineated in POMS. Prior to the statutory changes to Medicare eligibility made by the WFTC legislation, a noncitizen could qualify for payment of Medicare benefits if they met all other eligibility criteria and the individual was in an immigration status or category considered lawfully present under 8 CFR 1.3(a), which encompasses a broad range of immigration classifications. These ``lawfully present'' categories included: An alien who is an LPR.\189\ --------------------------------------------------------------------------- \189\ Under the Immigration and Nationality Act (INA) [8 U.S.C. 1101 et seq.]. --------------------------------------------------------------------------- An alien who is granted asylum.\190\ --------------------------------------------------------------------------- \190\ Under section 208 of INA [8 U.S.C. 1158]. --------------------------------------------------------------------------- A refugee who is admitted to the United States.\191\ --------------------------------------------------------------------------- \191\ Under section 207 of INA [8 U.S.C. 1157]. --------------------------------------------------------------------------- An alien who is paroled into the United States for a period of at least 1 year.\192\ --------------------------------------------------------------------------- \192\ Under section 212(d)(5) of INA [8 U.S.C. 1182(d)(5)]. --------------------------------------------------------------------------- An alien who is a Cuban and Haitian entrant.\193\ --------------------------------------------------------------------------- \193\ As defined in section 501(e) of the Refugee Education Assistance Act of 1980 (Pub. L. 96-422). --------------------------------------------------------------------------- An individual who lawfully resides in the United States under a Compact of Free Association (COFA).\194\ --------------------------------------------------------------------------- \194\ Public Law 99-239; Public Law 99-658; see also 8 U.S.C. 1612(b)(2)(G). --------------------------------------------------------------------------- The WFTC legislation did not modify the requirements for payment of title II benefits under sections 202(y) and 223 of the Act. As such, noncitizens who are lawfully present in the United States, as defined by 8 CFR 1.3(a), may remain eligible for payment of title II benefits. As a result, eligibility for payment of title II benefits is no longer coextensive with eligibility for payment of Medicare benefits under title XVIII of the Act for [[Page 43998]] certain noncitizens. Because continued reliance on the lawful presence verification framework used to determine noncitizen eligibility for payment of title II benefits would conflict with section 1899C of the Act when applied to Medicare, we propose to establish Medicare-specific definitions and related enrollment and termination criteria concerning citizenship, nationality, and immigration status.

2. Limiting Coverage Under Medicare Part A and Part B to Certain

Individuals a. Amending the Eligibility Criteria for Part A and Part B Sections 226 and 226A of the Act establish the conditions under which individuals are entitled to Medicare Part A benefits based on attainment of age 65, disability, or end-stage renal disease (ESRD). Individuals entitled to Medicare Part A under these provisions are not required to pay premiums for such coverage (known herein as premium- free Medicare Part A) and may elect to enroll in Medicare Part B. In general, individuals entitled to title II retirement benefits prior to attaining age 65 or entitled to title II disability benefits, upon attainment of age 65 or after satisfying any applicable waiting period, respectively, are automatically enrolled in premium-free Medicare Part A and will be enrolled automatically in Medicare Part B unless they decline Medicare Part B enrollment.\195\ There are no statutory requirements for citizenship, nationality, immigration status, or residency in sections 226 and 226A of the Act. Eligibility determinations, including citizenship and lawful presence verification, for premium-free Medicare Part A have historically been made through the title II lawful presence verification framework administered by the SSA. --------------------------------------------------------------------------- \195\ Section 1837 of the Act and the enrollment process outlined in 42 CFR 407.17. --------------------------------------------------------------------------- Section 1818 of the Act establishes the conditions under which certain individuals who are not entitled to premium-free Medicare Part A may enroll in the hospital insurance program by paying a monthly premium (herein referred to as premium Medicare Part A). Under section 1818 of the Act, an individual who has attained age 65, enrolled in Medicare Part B, and is not otherwise entitled to premium-free Medicare Part A may enroll if the individual is a resident of the United States and is either a citizen of the United States or an alien lawfully admitted for permanent residence who has resided continuously in the United States for the 5 years immediately preceding the month in which the individual applies for enrollment. Section 1836 of the Act establishes eligibility requirements for Medicare Part B (also known as supplementary medical insurance). Under section 1836 of the Act, an individual may enroll in Medicare Part B if the individual is entitled to Medicare Part A or, alternatively, has attained age 65, is a resident of the United States and is either a citizen of the United States or an alien lawfully admitted for permanent residence who has resided continuously in the United States for the 5 years immediately preceding the month in which the individual applies for enrollment. The WFTC legislation did not eliminate the 5- year continuous residency requirement for LPRs in sections 1818(a)(3) and 1836(a)(2) of the Act and, as a result, we are not proposing to alter this requirement. In other words, LPRs who meet the 5-year continuous residency requirement and other applicable Medicare requirements would maintain their Medicare benefit. Similar to premium-free Medicare Part A, enrollment in Medicare Part B under section 1836(a)(1) of the Act has historically been administered in coordination with the SSA's lawful presence verification framework for confirming citizenship, nationality, lawful presence, and residency status for payment of title II benefits. However, section 1899C of the Act establishes specific statutory categories of individuals who may be entitled to, or enrolled in, Medicare under title XVIII of the Act. As a result, title II's lawful presence requirements no longer fully align with the Medicare Part B eligibility framework established by section 1899C of the Act. To align Medicare eligibility regulations with section 1899C of the Act, we are proposing to add a new definition of ``eligible noncitizen'' at 42 CFR 400.200 that includes the categories of noncitizens eligible for Medicare under sections 1899C(a)(2) through (4) of the Act. Specifically, the proposed definition would state that an ``eligible noncitizen'' is an individual who is (1) an alien lawfully admitted for permanent residence under the INA; (2) an alien who has been granted the status of CHE, as defined in section 501(e) of the Refugee Education Assistance Act of 1980 (Pub. L. 96-422); or (3) an individual who lawfully resides in the United States in accordance with a COFA referred to in 8 U.S.C. 1612(b)(2)(G). The proposed definition of ``eligible noncitizen'' is not intended to apply to noncitizen U.S. nationals who are expressly eligible for Medicare under section 1899C(a)(1) of the Act. The proposed definition of ``eligible noncitizen'' applicable to Medicare eligibility would be distinguishable from the immigration status or category criteria in 8 CFR 1.3 applicable to noncitizen eligibility for title II benefits, which continues to be based on the ``lawfully present'' framework in section 401(b)(2) of PRWORA. We further propose to amend regulations at 42 CFR part 406 (Medicare Part A) and 42 CFR part 407 (Medicare Part B) to incorporate the proposed definition of ``eligible noncitizen.'' We propose to add that, effective July 4, 2025, an individual must be a citizen or national of the United States or an eligible noncitizen as a basis for entitlement. These proposed changes would be added or included into the following sections: Premium-Free Medicare Part A: ++ New paragraph (a)(2) would be added to Sec. 406.5 (Basis of eligibility and entitlement). This proposed new paragraph would add the requirement that, in addition to satisfying the applicable age, disability, or ESRD-based entitlement criteria, an individual must also be a citizen or national of the United States or an eligible noncitizen. This revision would align the eligibility and entitlement criteria for premium-free Medicare Part A with section 1899C(a) of the Act. ++ New paragraph (a)(2) would be added to Sec. 406.10 (Individual age 65 or over who is entitled to Social Security or Railroad Retirement benefits, or who is eligible for Social Security benefits). This proposed new paragraph would clarify that individuals age 65 or over who otherwise qualify for premium-free Part A through Social Security or Railroad Retirement pathways must also satisfy the citizenship, nationality, or immigration status or category requirements established by section 1899C(a) of the Act. This would ensure that automatic or application-based entitlement under this section is limited to U.S. citizens, U.S. nationals, and eligible noncitizens. ++ Paragraph (b)(2) would be revised in Sec. 406.11 (Individual age 65 or over who is not eligible as a Social Security or Railroad Retirement benefits beneficiary, or on the basis of government employment). This proposed revision would align the eligibility language in Sec. 406.11 with section 1899C(a) of the Act and clarify that individuals qualifying under this pathway must also satisfy the citizenship, nationality, or immigration status or category standards in section 1899C(a) of the Act. This change would ensure that entitlement is not available [[Page 43999]] under this section unless the individual is a U.S citizen, U.S. national, or eligible noncitizen. ++ New paragraph (a)(2) would be added to Sec. 406.12 (Individual under age 65 who is entitled to Social Security or Railroad Retirement disability benefits). This proposed new paragraph would provide that individuals under age 65 who otherwise qualify for premium-free Part A on the basis of disability must also meet the citizenship, nationality, or immigration status or category requirements of section 1899C(a) of the Act. This would align the regulation implementing premium-free Part A entitlement based on disability with the requirements in section 1899C(a) of the Act. ++ New paragraph (c)(4) would be added to Sec. 406.13 (Individual who has ESRD). This proposed new paragraph would clarify that individuals who otherwise qualify for premium-free Part A on the basis of ESRD must also be a citizen or national of the United States or an eligible noncitizen. This revision would align the regulation implementing premium-free Part A entitlement based on ESRD with the eligibility limitations in section 1899C(a) of the Act. Premium Medicare Part A: ++ In Sec. 406.20 (Basic Requirements), paragraphs (b)(2)(i) and (b)(2)(ii) would be revised and new paragraphs (b)(2)(iii), (b)(2)(iv), and (c)(5) would be added. These proposed revisions would update the eligibility requirements for enrollment in premium Part A to incorporate the proposed definition of eligible noncitizen. These changes would align premium Part A eligibility with section 1899C(a) of the Act by clarifying that only U.S. citizens, U.S. nationals, and eligible noncitizens may enroll under this pathway. Medicare Part B: ++ New paragraphs (a)(2)(ii)(A) through (D) would be added in Sec. 407.10 (Eligibility to Enroll). These proposed revisions would update the Part B enrollment regulation to incorporate the proposed definition of eligible noncitizen. These proposed changes would align the Part B eligibility regulation with section 1899C(a) of the Act and clarify that only U.S. citizens, U.S. nationals, and eligible noncitizens may enroll under this pathway. We note that the WFTC legislation also has implications for the Medicare Part B Immunosuppressive Drug benefit (Part B-ID) under section 1836(b) of the Act. Part B-ID is a limited Part B benefit that provides coverage only for immunosuppressive drugs for certain individuals whose entitlement to Medicare based solely on end-stage renal disease (ESRD) ended 36 months after a successful kidney transplant and who do not have other disqualifying health coverage. Although eligibility for Part B-ID is governed by the specific criteria set forth in Sec. 407.55, individuals seeking to enroll in, or remain enrolled in, Part B-ID must also satisfy the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act. Accordingly, we propose to revise Sec. 407.55 (Eligibility to Enroll) to add new paragraphs (a)(1) and (2) to clarify that eligibility for Part B-ID is also subject to the limitations established by section 1899C(a) of the Act. b. Termination of Entitlement for Individuals Who Were Entitled to, or Enrolled for, Medicare as of July 4, 2025, in Accordance With Section 71201 of the WFTC Legislation (``Grace Period'' Population) Due to the statutory changes to Medicare eligibility made by section 71201 of the WFTC legislation, individuals who are not U.S. citizens or U.S. nationals and who have an immigration status or category other than LPR, CHE, or COFA migrant, and who were entitled to, or enrolled for, Medicare as of July 4, 2025, will no longer be eligible for Medicare on the date that is 18 months after July 4, 2025. As shorthand, we are referring to this 18-month time period as the ``grace period'' and the applicable individuals identified and notified during the grace period as the ``grace period population.'' Section 1899C(b)(2)(A) of the Act directs the SSA to complete a review of all individuals entitled to, or enrolled for, Medicare as of July 4, 2025, and identify those beneficiaries entitled to, or enrolled for, Medicare as of July 4, 2025, who do not meet the requirements of section 1899C(a) of the Act. Section 1899C(b)(2)(A) provides 1 year for SSA to complete this task for the grace period population. Section 1899C(b)(2)(B) of the Act directs the SSA to provide notice to such beneficiaries as soon as practicable after identifying such beneficiaries that their entitlement to, or enrollment in, Medicare will be terminated as of the date that is 18 months after July 4, 2025. The SSA shall identify all individuals who do not or potentially do not meet one of the eligibility criteria in section 1899C(a) per section 1899C(b)(2) of the Act. In accordance with section 1899C(b)(2)(B) of the Act, upon identifying individuals who do not or potentially do not meet one of the eligibility criteria in section 1899C(a), the SSA will then send, as soon as practicable, a notice to these identified individuals. The notice will inform them that SSA records indicate that they do not meet one of the eligibility criteria in section 1899C(a) of the Act, and their Medicare entitlement and enrollment will be terminated if they cannot provide evidence proving eligibility. Individuals would be instructed to contact the SSA if they believe the information is incorrect and to provide updated evidence of eligibility before their entitlement and enrollment is terminated. If applicable, the notice would state that a formal initial determination of ineligibility will be sent prior to their termination date if the individual takes no action to update their records or if the individual confirms that they do not meet the eligibility criteria in section 1899C(a) of the Act. As proposed, the SSA would provide a termination notice towards the end of December 2026 to all identified individuals determined to be ineligible based on data available to the SSA.. The termination notice would explain that the identified individuals do not satisfy the requirements in section 1899C(a) of the Act and therefore are not entitled to, and may not be enrolled for, Medicare. The notice would state that termination of enrollment will be effective February 1, 2027. The notice would inform individuals of their appeal rights under existing appeals regulations for initial determinations delineated in 42 CFR, part 405, subpart I. Specifically, 42 CFR 405.900(b)(1) establishes that appeals of initial determinations for entitlement to benefits under Part A or Part B of Medicare are administered in accordance with the SSA's regulations governing reconsiderations of these initial determinations at 20 CFR, part 404, subpart J. We note that entitlement to premium-free Part A and enrollment in premium Part A and Part B are referenced in the Act as ``monthly insurance benefits'' or ``benefits for a month'' (see section 226(c)(1) and (2) of the Act) and entitlement to or enrollment in Medicare always begins on the first day of the month and always ends on the last day of the month (see section 1838(a) and (b) of the Act). Consequently, the termination in proposed Sec. Sec. 406.14(d)(2), 406.28(g)(3)(ii), and 407.27(e)(3)(ii) would be at the end of the calendar month. Accordingly, we propose to amend the following regulations to implement termination procedures for individuals who were entitled to, or enrolled for, Medicare as of July 4, 2025, but do not meet or potentially do not meet the [[Page 44000]] eligibility requirements of section 1899C(a) of the Act: Premium-Free Medicare Part A: ++ New Sec. 406.14 (End of Entitlement Due to Change in Citizenship, Nationality, or Immigration Status or Category) would be added, in accordance with section 1899C(b)(1) of the Act, to establish the termination framework for individuals who were entitled to, premium-free Part A as of July 4, 2025, but who either do not meet or potentially do not meet the eligibility requirements of section 1899C(a) of the Act. Specifically, new paragraph (b) would provide that individuals entitled or enrolled as of July 4, 2025, who either do not meet or potentially do not meet the requirements of Sec. 406.5(a)(2) will be identified and notified by the SSA per section 1899C(b)(2) of the Act. Individuals not meeting Sec. 406.5(a)(2) requirements will have their entitlement or enrollment terminated in accordance with paragraph (d). ++ New paragraph (b)(3) would be added to Sec. 406.10 (Individual age 65 or over who is entitled to Social Security or Railroad Retirement benefits, or who is eligible for Social Security benefits) to add a cross reference to the termination provision in the new Sec. 406.14. ++ New paragraph (d)(2)(v) would be added to Sec. 406.12 (Individual under age 65 who is entitled to Social Security or Railroad Retirement disability benefits) to add a cross reference to the termination provision in the new Sec. 406.14. ++ New paragraph (f)(3) would be added to Sec. 406.13 (Individual who has end-stage renal disease) to add cross reference to the termination provision in the new Sec. 406.14(b). Premium Medicare Part A: ++ New paragraph (g)(1) would be added to Sec. 406.28 (End of Entitlement Due to Change in Citizenship, Nationality, or Immigration Status or Category) in accordance with section 1899C(b)(1) of the Act, to establish the termination framework for individuals who were entitled to, or enrolled for, premium Part A as of July 4, 2025, but who either do not meet or potentially do not meet the eligibility requirements of section 1899C(a) of the Act. Specifically, the new paragraph (g)(1) would provide that individuals entitled to or enrolled as of July 4, 2025, who either do not meet or potentially do not meet the requirements of Sec. 406.20(b)(2) will be identified and notified by the SSA per section 1899C(b)(2) of the Act. Individuals not meeting Sec. 406.20(b)(2) requirements will have their entitlement or enrollment terminated in accordance with subparagraph (3). Medicare Part B: ++ New paragraph (e)(1) would be added to Sec. 407.27 (Termination of entitlement: Individual), in accordance with section 1899C(b)(1) of the Act, to establish the termination framework for individuals who were enrolled in Part B as of July 4, 2025, but who either do not meet or potentially do not meet the eligibility requirements of section 1899C(a) of the Act. Specifically, the new paragraph (e)(1) would provide that individuals enrolled as of July 4, 2025, who either do not meet or potentially do not meet the requirements of Sec. 407.10(a)(2) will be identified and notified by the SSA per section 1899C(b)(2) of the Act. Individuals not meeting Sec. 407.10(a)(2) requirements will have their enrollment terminated in accordance with paragraph (3). c. Proposed Termination Process for Certain Noncitizens Entitled to, or Enrolled for, Medicare Who Were Not Identified and Notified by the SSA per Section 1899C(b)(2) of the Act (Outside of the ``Grace Period'' Population) We turn now to the proposed termination processes that would be used for all other individuals whose eligibility for Medicare, including both initial eligibility and continued eligibility, is impacted by the statutory changes to Medicare eligibility made by section 71201 of the WFTC legislation and whose entitlement and enrollment was not terminated by the SSA under the processes implementing section 1899C(b) of the Act. The proposed termination processes for this population provides the framework to terminate enrollment in Medicare if they are not eligible to be entitled or enrolled per section 1899C of the Act while ensuring all impacted individuals are notified of termination and retain their appeal rights. Under this proposal, all terminations made under section 1899C of the Act would be prospective. We propose that entitlement and enrollment for those not identified during the grace period and found not to meet the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act would end according to the termination processes in the following proposals: Sec. 406.14(c) and (d) for those with premium-free Part A, Sec. 406.28(g)(2) and (3) for those with premium Part A, and Sec. 407.27(e)(2) and (3) for those with Part B benefits. The proposed termination processes in Sec. Sec. 406.14(d), 406.28(g)(3) and 407.27(e)(3) include providing notice to such individuals that their entitlement and enrollment for Medicare will be terminated if they do not meet section 1899C(a) of the Act, and for terminating entitlement or enrollment where the SSA determines that the individual either does not or no longer meets the requirements of section 1899C(a) of the Act. As stated, this proposed termination process would apply to anyone enrolled in Medicare whom the SSA determines does not meet eligibility requirements under section 1899C(a) of the Act and was not part of the grace period population per section 1899C(b)(2)(B) of the Act. There is a period of time between enactment of the WFTC legislation on July 4, 2025, and the SSA starting to screen individuals for new Medicare enrollment under the criteria in section 1899C(a) of the Act, which is expected in 2026. Individuals enrolled after enactment of the WFTC legislation but before screening procedures are implemented do not fall into the grace period population because they were not enrolled as of the date of enactment. Thus, individuals enrolled during the previously discussed time period who do not meet the eligibility requirements in section 1899C(a) of the Act would be terminated according to proposed Sec. Sec. 406.14(d), 406.28(g)(3) or 407.27(e)(3), as appropriate. Additionally, the proposed termination process would apply to anyone enrolled in Medicare whom the SSA determines does not meet the eligibility requirements in section 1899C(a) of the Act and was not notified as part of the grace period population per section 1899C(b)(2)(B) of the Act. This would include individuals whose status changed prior to the implementation of this proposed rule, if finalized as proposed, such as an individual who was enrolled in Medicare in October 2024 and met the eligibility requirements under section 1899C(a) of the Act based on their conditional LPR status when SSA identified and notified the grace period population. Therefore, they were not included in the grace period population per section 1899C(b)(2)(B) of the Act. However, if SSA's records indicate that their conditional LPR status expires December 2026, this proposed termination process would apply upon expiration of their conditional LPR status and would provide the framework for this individual's Medicare enrollment to be terminated as they would no longer satisfy the requirements of section 1899C(a) of the Act. We emphasize that the same process would also apply to individuals enrolled after this proposed rule is implemented, if finalized as proposed. As an example, consider the case of an individual enrolled in Medicare with conditional LPR status whose enrollment began in April 2028. In [[Page 44001]] February 2030, SSA records indicate that the individual's conditional LPR status expires in April 2030. Upon expiration of the individual's conditional LPR status in April 2030, the individual would no longer satisfy the requirements of section 1899C(a) of the Act, and the SSA would send notice to the individual that they no longer meet the requirements of section 1899C(a) of the Act. As a result, under the proposed process for termination of enrollment, the individual's Medicare enrollment would be terminated at the end of the month following the month in which the notice is dated. There are several circumstances in which individuals are identified as no longer meeting the requirements of section 1899C(a) of the Act outside the grace period. We propose the same termination process for individuals in these circumstances in proposed Sec. Sec. 406.14(d), 406.28(g)(3) or 407.27(e)(3), as appropriate. For these individuals outside the grace period, we propose that a termination notice from the SSA would be sent to each individual identified as ineligible. We propose the notice would explain that, per data available to the SSA, the individual does not satisfy the requirements of section 1899C(a) of the Act. Under the proposed termination process, an individual would not lose Medicare entitlement or enrollment during the month in which the SSA determines that the individual does not or no longer meets the requirements of section 1899C(a) of the Act. Rather, Medicare entitlement or enrollment would terminate at the end of the month following the month in which the notice is dated. For example, if the date of the termination notice is in March 2027, termination would be effective at the end of April 2027. This proposed termination timeline would be explained in the notice. The SSA will not terminate anyone's entitlement or enrollment prior to notification. Further, no termination of Medicare would occur for any individual entitled to, or enrolled for, Medicare for failure to meet the requirements of section 1899C(a) of the Act prior to the effective date of this rule, if finalized as proposed. We propose an effective date of January 1, 2027. We propose that individuals whose Medicare entitlement and enrollment are terminated because they do not meet the requirements of section 1899C(a) of the Act would be provided appeal rights under the CMS' existing appeals regulations for initial determinations. Appeals of initial determinations for entitlement to benefits under Medicare Part A or Part B are administered in accordance with 20 CFR, part 404, subpart J. See 42 CFR 405.900(b)(1). We propose to include the information about appeal rights in the proposed termination notices. Under this proposal, termination notices would be sent to affected individuals on an ongoing basis, as applicable, when the SSA receives information that an individual enrolled in Medicare does not meet the requirements of section 1899C(a) of the Act. These proposals are necessary to ensure implementation of section 1899C of the Act is consistent with the efficient administration of the Medicare program under section 1102(a) of the Act. Therefore, to implement the proposed termination framework, we propose adding and revising the following sections: Premium-Free Medicare Part A: ++ New Sec. 406.14 (End of entitlement due to change in citizenship, nationality, or immigration status or category) would be added. The proposed new Sec. 406.14(c) would provide the termination framework for individuals entitled to premium-free Part A who were not identified and notified by the SSA per section 1899C(b)(2) of the Act and were subsequently determined by the SSA as not meeting the requirements of Sec. 406.5(a)(2). Proposed Sec. 406.14(d) describes the proposed termination notice and appeal rights in accordance with existing regulations governing Medicare entitlement determinations, states the effective date of premium-free Part A entitlement termination, and states that the individual should contact the SSA if their citizenship, nationality, or immigration status or category changes such that they may be entitled to, or enrolled for, premium- free Part A benefits. ++ New paragraph (b)(3) would be added to Sec. 406.10 (Individual age 65 or over who is entitled to Social Security or Railroad Retirement benefits, or who is eligible for Social Security benefits). This proposed new paragraph would add a cross-reference to Sec. 406.14 so that individuals entitled to, or enrolled for, premium-free Part A through the age-65 pathway would be subject to the termination procedures in that section if they do not or no longer meet the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act. ++ New proposed paragraph (d)(2)(v) would be added to Sec. 406.12 (Individual under age 65 who is entitled to Social Security or Railroad Retirement disability benefits). This proposed new paragraph would add cross-references to Sec. 406.14(b) and (c) so that disability-based premium-free Part A entitlement would be subject to the proposed termination procedures for an individual who does not or no longer meets the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act. ++ New proposed paragraph (f)(3) would be added to Sec. 406.13 (Individual who has ESRD). This proposed new paragraph would add a cross-reference to Sec. 406.14 to specify that individuals entitled to, or enrolled for, premium-free Part A on the basis of ESRD would be subject to the proposed procedures for termination when an individual does not or no longer meets the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act. Premium Medicare Part A: ++ New proposed paragraph (g)(2) would be added to Sec. 406.28 (End of entitlement) for individuals who were entitled to, or enrolled for, premium Part A, who were not identified and notified by the SSA per section 1899C(b)(2) of the Act and were subsequently determined by the SSA as not meeting the requirements of Sec. 406.20(b)(2). Under proposed paragraph (g)(2), entitlement would end as provided under paragraph (g)(3) of this section. ++ New proposed paragraph (g)(3) would be added to Sec. 406.28 (End of entitlement). It describes the proposed termination notice, which would specify the individual's appeal rights in accordance with existing regulations governing Medicare entitlement determinations, state the effective date of premium Part A enrollment termination, and state that the individual should contact the SSA if their citizenship, nationality, or immigration status or category changes such that they may be entitled to, or enrolled for, premium Part A benefits. ++ Paragraphs (a) and (b) of Sec. 406.50 would be revised to change the word ``alien'' to ``eligible noncitizen.'' Medicare Part B: ++ New proposed paragraph (e)(2) would be added to Sec. 407.27 (Termination of entitlement: Individual enrollment). This new paragraph would specify that individuals who are enrolled in Part B, who were not identified and notified by the SSA per section 1899C(b)(2) of the Act and were subsequently determined by the SSA as not meeting the requirements of Sec. 407.10(a)(2), would have their enrollment terminated under the new proposed paragraph (e)(3) of the section. [[Page 44002]] ++ New proposed paragraph (e)(3) would be added to Sec. 407.27 (Termination of entitlement: Individual enrollment). This new paragraph would describe the termination notice, which would specify the individual's appeal rights in accordance with existing regulations governing Medicare entitlement determinations, state the effective date of Part B enrollment termination, and state that the individual should contact the SSA if their citizenship, nationality, immigration status or category changes such that they may be enrolled for, Part B benefits.

3. Enrollment Pathway for Individuals Who Gain or Regain Eligibility

Section 1899C of the Act limits eligibility for Medicare to specified categories of individuals based on citizenship, nationality, or immigration status or category. As a result, except as provided in section 1899C(b) of the Act, no individual may be entitled to, or enrolled for, Medicare if the individual does not meet the requirements of section 1899C(a) of the Act. Conversely, individuals may later become eligible if their citizenship, nationality, or immigration status or category changes, such that they satisfy section 1899C(a) of the Act, as well as applicable Medicare eligibility requirements. To address circumstances in which individuals who initially did not meet the eligibility requirements of section 1899C(a) of the Act at the time they met all other Medicare eligibility requirements but, subsequently, do meet the section 1899C(a) of the Act requirements, we propose to establish a special enrollment period (SEP) under Sec. Sec. 406.27(f) and 407.23(f). The SEP would also apply to those individuals whose Medicare entitlement or enrollment is terminated because they do not or no longer meet the requirements in section 1899C(a) of the Act, but who subsequently experience a change such that they meet the requirements of section 1899C(a) of the Act. Establishing an SEP for these scenarios is within the Secretary's authority under sections 1837(m) and 1838(g) of the Act, which provide for the establishment of SEPs for exceptional conditions. We consider the enactment of the WFTC legislation and addition of section 1899C of the Act to constitute an exceptional condition because it created a new and narrower class of noncitizens who may be eligible for Medicare than are eligible for title II benefits, despite the close associations between title II entitlement and Medicare entitlement, as discussed in section F.1. of this preamble, and despite the fact that lawful presence has been the standard for noncitizen eligibility for both title II and Medicare benefits for decades. In addition, the statutory changes made by the WFTC legislation fundamentally altered the consequences of changes in immigration status. Prior to enactment of the WFTC legislation, noncitizens enrolled in Medicare who had a loss of lawful presence status would have remained enrolled in Medicare, but payment for benefits would have been suspended. Now, in accordance with section 1899C of the Act, an individual who no longer meets the requirements of section 1899C(a) of the Act must have their entitlement and enrollment terminated. If such an individual later meets the requirements of section 1899C(a) of the Act, it may be at a time that does not clearly fall within an established enrollment period. In addition, individuals who otherwise meet the eligibility requirements for Medicare but for the eligibility requirements of section 1899C(a) of the Act may gain eligibility at a time that does not clearly fall within an established enrollment period. For this proposed SEP, we also propose that the general rule in Sec. Sec. 406.27(a) and 407.23(a) that an individual must have missed an enrollment period due to the exceptional condition would not apply. We believe this is necessary because, for example, as explained below, the 7-month initial enrollment period under sections 1818(c)(1) and 1837(d) of the Act does not align well with the unpredictable nature as to when an individual may experience a change in citizenship, nationality, or immigration status or category, such that they would meet the requirements of section 1899C(a) of the Act. As another example, an individual may lose and subsequently regain eligibility under section 1899C(a) of the Act during a period that does not overlap with an otherwise available enrollment period, such that no enrollment period is actually missed. Accordingly, this SEP would be available to individuals who later meet, or again meet, the requirements of section 1899C(a) of the Act, regardless of whether an enrollment period was missed. We propose that the special enrollment period would begin in the month in which the individual, upon contacting the SSA, provides sufficient documentation to establish eligibility, and the proposed special enrollment period would end 6 months later. The duration of this proposed special enrollment period would be the same time frame afforded to individuals granted a special enrollment period for exceptional conditions under Sec. Sec. 406.27 and 407.23. We propose that entitlement and enrollment would be prospective for premium Part A and Part B, beginning with the first day of the month following the month of enrollment. We believe a prospective effective date is appropriate and consistent with the Secretary's authority under section 1818(c)(8) of the Act for premium Part A and section 1838(g) of the Act for Part B to establish the date on which coverage begins for individuals enrolling during an SEP, in a manner consistent, to the extent practicable, with protecting continuity of health benefit coverage. Although an individual may in some cases be able to demonstrate an earlier date on which the requirements of section 1899C(a) of the Act were met, we are proposing a uniform prospective effective date for premium Part A and Part B because citizenship data in SSA records is gathered and verified at a point in time. o and does not provide a reliable or administrable basis for consistently establishing earlier eligibility dates for enrollment purposes. In addition, a retroactive effective date for premium Part A and Part B could require the assessment of back-due premiums for months of coverage that the individual had not yet affirmatively elected, which would add operational complexity and could create unexpected financial obligations for beneficiaries. We believe a prospective-only approach is therefore the most practicable and administrable method for implementing this SEP for premium Part A and Part B. We considered an alternative pathway which consisted of establishing an initial enrollment period for premium Part A and Part B for eligible noncitizens who would have been eligible for Medicare based on entitlement to benefits under title II of the Act and attainment of age 65 or completion of the 24-month waiting period for disability benefits, as applicable, but whose entitlement was never effectuated because they did not meet the citizenship, nationality, or immigration status or category requirements specified in section 1899C(a) of the Act. However, we note that the 7-month initial enrollment period articulated in sections 1818(c)(1) and 1837(d) of the Act is largely tied to the attainment of age 65 or completion of the 24-month waiting period for disability benefits and begins on the first day of the third month before the month in which an individual meets the eligibility requirements for premium Part A and Part B. Traditionally, this 3- [[Page 44003]] month pre-eligibility period provides an opportunity for individuals to explore coverage options (for example, original Medicare or Medicare Advantage) and enroll in Part A and Part B. This 3-month period helps individuals avoid delays and gaps in coverage. As a practical matter, such an initial enrollment period could not be applied in an analogous manner to changes that would make an individual eligible for Medicare by virtue of meeting the requirements of section 1899C(a) of the Act because an individual may not be enrolled for Medicare benefits unless and until they meet the requirements of section 1899C(a) of the Act. As a result, establishing an initial enrollment period under sections 1818(c)(2) and 1837(d) of the Act or these individuals would effectively shorten the enrollment period by 3 months because such individuals could not be enrolled in Medicare until the section 1899C(a) of the Act requirements are met, which would conflict with the requirements of the Act. Instead, we opted for a proposed approach of establishing a SEP for individuals enrolling in Medicare for the first time, as well as individuals who lost and regained Medicare, due to changes in citizenship, nationality, or immigration status or category because it comports with the requirements of the Act. For premium-free Medicare Part A, we propose that entitlement may be retroactive for up to 6 months, but not earlier than the first month in which the individual met all the eligibility requirements in proposed Sec. 406.5(a). Under this proposal, if acceptable evidence establishes the month in which the individual first satisfied the citizenship, nationality, or immigration status or category requirements in Sec. 406.5(a)(2), the SSA would use that month, subject to the applicable retroactivity limit. If the earliest month of eligibility cannot be established based on acceptable documentary evidence, entitlement would instead begin on the first day of the month in which the SSA verifies that the individual satisfies Sec. 406.5(a)(2). Accordingly, to implement the enrollment processes described earlier for individuals who establish or reestablish eligibility under section 1899C(a) of the Act, we propose to amend the regulations at 42 CFR part 406 (Medicare Part A) and 42 CFR part 407 (Medicare Part B) to specify the availability, duration, and effective date rules for enrollment under these circumstances. We propose to add and revise the following sections: Premium-Free Medicare Part A: ++ Paragraph (b) would be revised in Sec. 406.6 (Application or enrollment for hospital insurance) to include the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act for individuals who need not file an application for hospital insurance. ++ New paragraph (f) would be added to Sec. 406.6 (Application or enrollment for hospital insurance) to establish rules for individuals who would otherwise qualify for premium-free Part A based on entitlement to title II benefits, but who were not entitled because they did not meet the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act at the time they otherwise would have become eligible. It would also specify how such individuals may initiate entitlement upon later meeting those requirements and clarify the applicable entitlement effective date, including the circumstances under which premium-free Part A entitlement would begin consistent with current law. Subparagraph (1) applies to those who meet the conditions of paragraph (b) of this section and, as such, need not file an application for hospital insurance. These individuals must contact the SSA to initiate entitlement to hospital insurance. Subparagraph (2) applies to those who meet the conditions of paragraph (c) of this section and, as such, must file an application for hospital insurance. These individuals must contact the SSA to file such application. Premium Medicare Part A: ++ Paragraph (f) would be redesignated as paragraph (g) and new paragraph (f) would be added to Sec. 406.27 (Special enrollment periods for exceptional conditions). This new paragraph would establish an SEP for individuals whose premium Part A enrollment was previously terminated because they lost the citizenship, nationality, or immigration status or category required under section 1899C(a) of the Act, but who later regain a qualifying status and again become eligible. The SEP would also apply to individuals who would otherwise meet the eligibility requirements for Medicare, except for those in section 1899C(a) of the Act, and later meet the eligibility requirements of section 1899C(a) of the Act. The new provision would specify the availability and duration of this SEP and clarify that enrollment under this pathway would be prospective, consistent with the Secretary's authority to establish SEPs for exceptional conditions. An individual does not need to miss an applicable enrollment period to be eligible for this SEP. Medicare Part B: ++ Paragraph (f) would be redesignated as paragraph (g) and new paragraph (f) would be added to Sec. 407.23 (Special enrollment periods for exceptional conditions). This new paragraph would establish a SEP for individuals whose Part B enrollment was terminated because they no longer met the citizenship, nationality, or immigration status or category requirements in section 1899C(a) of the Act, but who subsequently regain a qualifying status and again become eligible to enroll. The SEP would also apply to individuals who otherwise met the eligibility requirements for Medicare, except for those in section 1899C(a) of the Act, and later meet the eligibility requirements of section 1899C(a) of the Act. It would specify the duration of the SEP and the prospective effective date of Part B coverage for individuals enrolling under this pathway. An individual does not need to miss an applicable enrollment period to be eligible for this SEP.

4. Limiting Coverage Under Medicare Part C, Medicare Part D, and Cost

Plans to Certain Individuals Under section 1851(a)(3) of the Act, Medicare Part C (Medicare Advantage (MA)) is available only to individuals who are entitled to Medicare Part A and are enrolled in Medicare Part B. Medicare Part D (the Medicare prescription drug benefit) is available to individuals who are entitled to Medicare Part A or are enrolled in Medicare Part B, as specified in section 1860D-1(a)(3) of the Act. Section 1876(a)(1)(A) of the Act outlines eligibility requirements to enroll in Medicare cost plans and provides that individuals may enroll in cost plans if they are entitled to Medicare Part A and are enrolled in Part B or are enrolled in Part B only. Eligibility for enrollment in an MA plan, Part D plan, or cost plan is therefore dependent on an individual's underlying entitlement to and/or enrollment in Medicare Part A and/or Part B, as applicable. Prior to the enactment of section 1899C of the Act, individuals who satisfied the statutory conditions for Medicare Part A entitlement and/or Medicare Part B enrollment, as applicable, were likewise eligible to enroll in MA plans, Part D plans, or cost plans, provided they met applicable enrollment requirements. The eligibility requirements in section 1899C of the Act apply to all parts of Medicare. Individuals who do not meet the eligibility requirements of section 1899C of the Act are not eligible for [[Page 44004]] Medicare Part A or Part B and may not enroll or remain enrolled in MA plans, Part D plans, or cost plans. Individuals enrolled in MA plans, Part D plans, or cost plans who do not meet the eligibility requirements of section 1899C of the Act must be disenrolled from those plans. Under 42 CFR 417.460(b)(2)(iii), 422.74(b)(2)(ii), and 423.44(b)(2)(ii), individuals who lose eligibility for enrollment are involuntarily disenrolled from the plan. Such disenrollments will be prospective and effective the first day of the calendar month following the last month of entitlement to Part A or Part B as specified under 42 CFR 417.460(h), 422.74(d)(5), and 423.44(d)(3). Plans do not process these disenrollments. CMS processes these automatically through the MARx system when the SSA provides updated eligibility and entitlement records and CMS will notify the plan of the disenrollment due to loss of entitlement, through MARx transaction reply codes. Plans have the option, but are not required, to provide a notice of disenrollment due to loss of entitlement. Since the SSA provides a loss of entitlement notice for Part A and Part B, there is no need to require plans to provide additional notification. Accordingly, we propose to amend the regulations at 42 CFR part 417, part 422, and part 423 to incorporate the new eligibility limitations established by section 1899C of the Act. We propose to revise the following sections to reflect the applicability of section 1899C of the Act: Paragraph (b) of Sec. 417.2 (Basis and scope): We propose to amend paragraph (b) of Sec. 417.2 to add a reference to section 1899C of the Act, which establishes eligibility limitations applicable to cost plan enrollment. Paragraphs (a)(1)(xii) and (a)(2) of Sec. 422.1 (Basis and scope): We propose to amend Sec. 422.1 to add paragraph (a)(1)(xii) to reference section 1899C of the Act, which establishes eligibility limitations applicable to MA enrollment. We further propose to remove and reserve paragraph (a)(2) that references 8 U.S.C. 1611. Paragraphs (a)(1) and (3) of Sec. 423.1 (Basis and scope): We propose to amend paragraph (a)(1) of Sec. 423.1 to add a reference to section 1899C of the Act, which establishes eligibility limitations applicable to Part D enrollment. We further propose to remove and reserve paragraph (a)(3) of Sec. 423.1 that references 8 U.S.C. 1611. We are also proposing to add that effective July 4, 2025, an individual must be a citizen or national of the United States or an eligible noncitizen as a basis for entitlement. We propose to revise the following sections to add this language: Paragraph (h) of Sec. 417.422 (Eligibility to enroll in an HMO or CMP). Paragraph (a)(7) of Sec. 422.50 (Eligibility to elect an MA plan). Paragraph (a)(1)(iii) of Sec. 423.30 (Eligibility and enrollment). Additionally, we propose to update the regulations at 42 CFR part 417, part 422 and part 423 to clarify the circumstances under which individuals must be disenrolled from MA plans, Part D plans, or cost plans due to failure to meet the eligibility requirements of section 1899C of the Act. Though failure to meet the eligibility requirements of section 1899C of the Act results in a loss of Part A and Part B eligibility, we propose to create an involuntary disenrollment process for MA plans, Part D plans, and cost plans that is separate from the existing loss of entitlement to Part A or Part B disenrollment process. Administratively, separating failure to meet section 1899C of the Act eligibility requirements from all other reasons for loss of Part A or Part B entitlement allows CMS to better track the impact of this provision and create new technical processes with the SSA and internally. Specifically, we propose to revise the following sections to add this language: Paragraphs (b)(2)(iv) and (j) of Sec. 417.460 (Disenrollment of beneficiaries by an HMO or CMP): We propose to amend paragraph (b)(2)(iv) of Sec. 417.460 to state that a cost plan must disenroll an enrollee if they no longer meet the requirements of Sec. 417.422(h). We propose to amend paragraph (j) of Sec. 417.460 related to the disenrollment effective date to apply to an enrollee who is not a U.S. citizen, U.S. national, or eligible noncitizen. Paragraphs (b)(2)(v) and (d)(9) of Sec. 422.74 (Disenrollment by the MA organization): We propose to amend paragraph (b)(2)(v) of Sec. 422.74 to state that an MA plan must disenroll an enrollee if they no longer meet the requirements of Sec. 422.50(a)(7). We propose to amend paragraph (d)(9) of Sec. 422.74 related to the disenrollment effective date to apply to an enrollee who loses U.S. citizenship or nationality, or eligible noncitizen status.