Regulatory NewsBREAK: CMS Issues Physician Fee Schedule Final Rule

On October 31, 2025, the Centers for Medicare and Medicaid Services (CMS) issued the Physician Fee Schedule final rule (Final Rule) to be published in the Federal Register on November 5, 2025. Among the provisions in the Final Rule:  

Medicare Prescription Drug Inflation Rebate Program:

• For the Part B Drug Inflation Rebate Program, the Final Rule describes the identification of benchmark quarters and the calculation of rebate amounts.
• For the Part D Drug Inflation Rebate Program, the Final Rule establishes a claims-based methodology to remove 340B units from rebate calculations and establishes a Part D Claims Data 340B Repository to begin usability testing with voluntary submissions by covered entities for Part D claims with dates of service on or after January 1, 2026. 

Calculating the manufacturer’s average sales price (ASP):

• CMS is defining the term bundled arrangement and providing guidance to manufacturers on how to account for bundled price concessions when calculating the manufacturer’s ASP. 
• CMS is clarifying that reasonable assumptions for the calculation of the manufacturer’s ASP are required as a part of the quarterly ASP data submissions, including documentation of the methodology used to determine fair market value (FMV) for current, new, and renewed bona fide service fees (BFSFs) contracts.  
• CMS is requiring verification from manufacturers that a BFSF is not passed on to a client, or customer of an entity for new and renewed BFSF contracts. 
• Units of selected drugs sold at the maximum fair price (MFP) are included in the calculation of the manufacturer’s ASP effective January 1, 2026.  

CMS will continue the existing bundled payment policy for CAR T-cell therapies:

• CMS is extending it to autologous cell-based immunotherapy and gene therapy. Preparatory procedures for patient-specific cell or tissue procurement required for manufacturing are included in the product payment.  

Medicare Shared Savings Program (MSSP): 

• CMS finalized changes projected to reduce Medicare spending by $20 million through 2035. 

More on This Topic:

• Final Rule
• Fact Sheet 

For questions, please reach out to Vicky Jucelin.