The Centers for Medicare & Medicaid Services finalized regulations codifying the Medicare Drug Price Negotiation Program and establishing new policies for the program and Medicare Part D. The final rule, issued on November 5, 2026, is published in the Federal Register. Primary source: cms.gov

The regulations are effective on December 5, 2026. They apply to the Negotiation Program beginning with initial price applicability year 2029 and to Part D Program coverage beginning January 1, 2029.

The Secretary will select up to 20 drugs for negotiation for initial price applicability year 2029 and subsequent years. The rule finalizes implementation of the Temporary Floor for Small Biotech Drugs for initial price applicability years 2029 and 2030.

CMS received approximately 11,330 timely comment letters on the proposed rule. The comment period for the Information Collection Requests for IPAY 2029 closed on August 17, 2026.

The final rule codifies policies established in final guidance for the Negotiation Program by adding new part 429 to title 42, Chapter IV of the Code of Federal Regulations. It also modifies policies for the Medicare Prescription Drug Benefit Program at part 423.

CMS establishes a policy for specific fixed combination drugs determined to be new formulations of existing drugs. Under the new policy, if CMS determines that products with the same New Drug Application or Biologics License Application holder differ in active moiety, active ingredient, or antigen component due to the inclusion of an active moiety, active ingredient, or antigen component that creates a new formulation and enables an alternative route of administration, CMS will identify the potential qualifying single source drug using all dosage forms and strengths of the shared active moiety, active ingredient, or antigen component offered by the same holder.

The rule clarifies how CMS will identify the day from which to measure the 7- and 11-year time since approval and licensure periods for drugs that formerly qualified for the Orphan Drug Exclusion. It codifies the process and schedule according to which CMS reviews information to determine if the manufacturer of a generic drug or biosimilar is engaged in Bona Fide Marketing.

The rule provides additional details related to the Primary Manufacturer transfer of responsibility for all requirements of the Negotiation Program Agreement to an acquiring entity. It explains how CMS will calculate the 30-day equivalent supply for a selected drug or therapeutic alternative payable under Part B that is typically administered one time.

The rule modifies the proposed stepwise approach for calculating a selected drug’s ceiling in the event that certain ceiling amounts are below the Temporary Floor for Small Biotech Drugs. It clarifies when off-label use would be considered for renegotiation eligibility and selection by aligning the renegotiation eligibility and selection policies for off-label use with the initial offer development process. The provisions apply with respect to all initial price applicability years beginning with initial price applicability year 2029.