The Priority Review

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Negotiation Program

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  1. Regulation

    CMS codifies Medicare Drug Price Negotiation Program for 2029

    On Nov. 5 2026, the Centers for Medicare & Medicaid Services issued a final rule (CMS-4215-F) that codifies the Negotiation Program for the initial price applicability year 2029 and beyond, effective Dec. 5 2026. The rule also establishes new policies for selecting up to 20 drugs for negotiation each year and clarifies procedures for manufacturers and the publication of negotiated maximum fair prices.