Federal Register #CMS-4215-F

CMS finalizes Medicare drug negotiation and prescription benefit regulations

CMS finalized regulations governing Medicare drug price negotiation and prescription drug benefits. - Government buyer: Centers for Medicare & Medicaid Services (CMS), within the U.S. Department of Health and Human Services (HHS). - Opportunity type: Regulatory action, not a procurement; no products or services are being requested. - Key policy areas: Drug eligibility and selection, negotiated prices, biosimilar-related delays, manufacturer responsibilities, and certain fixed-combination drugs that qualify as new formulations. - OEMs and vendors: None identified.

Description

This final rule codifies the Medicare Drug Price Negotiation Program and establishes new policies for that program and the Medicare Prescription Drug Benefit Program, as required by the Inflation Reduction Act of 2022. It also finalizes a policy for specific fixed combination drugs that are new formulations. The rule adds part 429 to title 42 of the Code of Federal Regulations and modifies policies in part 423. It is effective December 5, 2026, and applies to the Negotiation Program beginning with initial price applicability year 2029 and to Part D coverage beginning January 1, 2029.

View original listing