Lexology November 3, 2025
On Friday, October 31, the U.S. Centers for Medicare & Medicaid Services (CMS) released a display copy of the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Final Rule (PFS Final Rule). CMS finalized several notable proposals from the CY 2026 PFS Proposed Rule that will have a substantial impact on pharmaceutical manufacturer government price reporting under Medicare Part B. These include new pass-through and fair market value (FMV) documentation requirements for pharmaceutical manufacturers in connection with bona fide service fees (BFSFs) under the Average Sales Price (ASP) calculation, the inclusion of units of selected drugs sold at the Maximum Fair Price (MFP) in the ASP calculation, and new provisions related to duplicate discounts under the 340B Drug Pricing...
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