The Priority Review

Regulation Brief

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.

Primary source

CMS fact sheet, November 5, 2026

Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Final Rule (CMS-4215-F)

Read the source: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Final Rule (CMS-4215-F) cms.gov

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