CMS issues draft guidance on Medicare Drug Price Negotiation Program
CMS recently published draft guidance on policies for the third cycle of negotiations and first cycle of renegotiations for the Medicare Drug Price Negotiation Program, which will occur during 2026 and may result in negotiated maximum fair prices (MFP) that would become effective in 2028.
Established through the 2022 Inflation Reduction Act, the program allows CMS to negotiate the prices of eligible drugs with pharmaceutical manufacturers. Eligible drugs are those that account for the most Medicare spending and have no generic/biosimilar competition.
Previous program guidance has outlined what information should be used in negotiations, relevant timelines, and the number of drugs selected per cycle. The negotiated prices for the 10 Part D drugs selected in the first cycle are scheduled to take effect in 2026, and the prices for the 15 Part D drugs from the second cycle will take effect in 2027.
Building on policies established during the first two cycles of negotiations, the draft guidance includes new policies to incorporate Part B drugs into the program for the first time. CMS is soliciting comments on how to facilitate access to any negotiated MFPs for Part B drugs. The draft guidance also includes new policies to renegotiate prices for certain drugs from the first two rounds.
CMS has until February 1, 2026, to publish the list of 15 drugs selected for negotiation for initial price applicability year 2028, as well as any drugs selected for renegotiation, if applicable.
CMS also provided refinements and clarifications to MFP effectuation policies for 2026 and 2027, including adjustments to Medicare Transaction Facilitator operations, and the extension of such policies to 2028.
After publishing the draft guidance, CMS initiated a 45-day public comment period that will close on June 26. CMS is seeking comments on increasing transparency in the negotiation process, asking for feedback on data sources, calculation methods, clinical evidentiary factors, and more. The agency is also soliciting feedback on reducing burden, future modifications to MFP effectuation, and manufacturer oversight and compliance. Comments received by June 26 will be considered for final guidance on these policies, which CMS plans to publish later this year.
Revenue cycle professionals can read CMS’ press release and fact sheet on the draft guidance for more information.