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

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services </SUBAGY> <CFR>42 CFR Parts 405, 410, 414, 424, 425, 427, 428, 495, and 512</CFR> <DEPDOC>[CMS-1832-P]</DEPDOC> <RIN>RIN 0938-AV50 </RIN> <SUBJECT>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</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 12, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-1832-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">http://www.regulations.gov.</E> Follow the “Submit a comment” instructions. 2. <E T="03">By regular mail.</E> You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1832-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. <E T="03">By express or overnight mail.</E> You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1832-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for any issues not identified below. Please indicate the specific issue in the subject line of the email. For all questions related to reporting a service on a claim, please contact your Medicare Administrative Contractor. Michael Soracoe, Morgan Kitzmiller, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to practice expense, work RVUs, conversion factor, and PFS specialty-specific impacts. Hannah Ahn, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to potentially misvalued services under the PFS. Julie Rauch, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov, for issues related to Malpractice RVUs.</E> Morgan Kitzmiller, Terry Simananda, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> for issues related to Geographic Practice Cost Indices. Mikayla Murphy, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to direct supervision using two-way audio/video communication technology, telehealth, and other services involving communications technology. Erick Carrera, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to office/outpatient evaluation and management visit inherent complexity add-on and Digital Mental Health Treatment services. Maya Peterson, Terry Simananda, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to payment for advanced primary care management services. Sarah Leipnik, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to global surgery payment accuracy. Pamela West, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to outpatient therapy services and KX modifier thresholds. Michelle Cruse, Erick Carrera, Zehra Hussain, or Hannah Ahn <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to dental services inextricably linked to other covered medical services. Zehra Hussain, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to payment of skin substitutes. Laura Kennedy, (410) 786-3377, Rebecca Ray, (667) 414-0879, and Jae Ryu, (667) 414-0765 for issues related to Drugs and Biological Products Paid Under Medicare Part B. <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to complex drug administration. Allison Cipro, (667) 414-0758, for issues related to Medicare Diabetes Prevention Program. Sabrina Ahmed, (410) 786-7499, or <E T="03">SharedSavingsProgram@cms.hhs.gov</E> , for issues related to the Medicare Shared Savings Program (Shared Savings Program) quality performance standard and other quality reporting requirements. Janae James, (410) 786-0801, or <E T="03">SharedSavingsProgram@cms.hhs.gov</E> , for issues related to Shared Savings Program beneficiary assignment and benchmarking methodology and shared losses mitigation. Kari Vandegrift, (410) 786-4008, or <E T="03">SharedSavingsProgram@cms.hhs.gov</E> , for issues related to Shared Savings Program participation options, and ACO participant and SNF affiliate change of ownership requirements. Elisabeth Daniel, (667) 290-8793, for issues related to the Medicare Prescription Drug Inflation Rebate Program. Benjamin Picillo or Genevieve Kehoe, <E T="03">AmbulatorySpecialtyModel@cms.hhs.gov,</E> or 1-844-711-2664 (Option 4) for issues related to the Ambulatory Specialty Model. Amy Gruber, (410) 786-1542, for issues related to Ambulance Extender provisions. Kati Moore, (410) 786-5471, for inquiries related to the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program (QPP). Trevey Davis, (667) 290-8527, for inquiries related to the Advanced Alternative Payment Models (APMs) track of QPP. Jessica Warren, (410) 786-7519, and Lisa Marie Gomez, (410) 786-1175, for inquiries related to the Medicare Promoting Interoperability Program. Lisa Parker, (410) 786-4949, or <E T="03">FQHC-PPS@cms.hhs.gov</E> , for issues related to FQHC payments. Michele Franklin, (410) 786-9226, or <E T="03">RHC@cms.hhs.gov</E> , for issues related to RHC payments. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Addenda Available Only Through the Internet on the CMS Website:</E> The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available on the CMS website at <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.</E> Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS <E T="04">Federal Register</E> and other related documents. For the CY 2026 PFS proposed rule, refer to item CMS-1832-P. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this proposed rule and posted on the CMS website identified above should contact <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov.</E> <E T="03">Plain Language Summary:</E> In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this rule may be found at <E T="03">https://www.regulations.gov/.</E> <E T="03">CPT (Current Procedural Terminology) Copyright Notice:</E> Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2020 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. <E T="03">Deregulation Request for Information (RFI):</E> On January 31, 2025, President Trump issued Executive Order (EO) 14192 “Unleashing Prosperity Through Deregulation,” which states the Administration policy to significantly reduce the private expenditures required to comply with Federal regulations to secure America's economic prosperity and national security and the highest possible quality of life for each citizen. We would like public input on approaches and opportunities to streamline regulations and reduce administrative burdens on providers, suppliers, beneficiaries, and other stakeholders participating in the Medicare program. CMS has made available a Request for Information (RFI) at: <E T="03">https://www.federalregister.gov/documents/2025/04/11/2025-06316/request-for-information-deregulation.</E> Please submit all comments in response to this request for information through the provided weblink. <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose</HD> This major annual rule proposes to revise payment policies under the Medicare PFS and makes other ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 2879k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━