The Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would codify policies for the Medicare Drug Price Negotiation Program beginning in 2029.
Established by the Inflation Reduction Act, the Drug Price Negotiation Program allows CMS to negotiate maximum fair prices for certain high-cost, single-source prescription drugs and biological products covered by Medicare. This proposed rule would formalize policies previously implemented through guidance, increase transparency in the negotiation process, establish requirements for manufacturers, and address potential loopholes related to certain drug formulations. CMS also proposes revisions and clarifications based on lessons learned from the program’s first years of implementation.
Comment by August 17, 2026.