On March 15, 2023, the Centers for Medicare and Medicaid Services (CMS) issued initial program guidance related to implementation of the Medicare Drug Price Negotiation Program. CMS requested public comments on selected portions of the guidance by April 14, 2023. The criteria set forth in the guidance for selection of drugs subject to negotiation is final and not subject to comment, as the agency must select and publish the list of drugs subject to negotiation by September 1, 2023.
Authorized under Sections 11001 and 11002 of the Inflation Reduction Act (IRA), the Negotiation Program permits Medicare to negotiate the price of prescription drugs. In the March 15 guidance, CMS laid out the requirements and parameters of the Negotiation Program. It also announced the next steps for implementation of the Negotiation Program’s rates, which will take effect in 2026.
