Press Releases May 12, 2025
The Centers for Medicare & Medicaid Services (CMS) is issuing draft guidance for public comment on the third cycle of negotiations under the Medicare Drug Price Negotiation Program (Negotiation Program). The draft guidance includes policies that will improve the transparency of the Negotiation Program, prioritize the selection of prescription drugs with high costs to the Medicare program, and minimize any negative impacts of the negotiated maximum fair price (MFP) on pharmaceutical innovation within the United States. This announcement builds off the historic efforts of President Trump’s first term to lower prescription drug prices and continues to deliver on his promise to put American patients first as outlined in his Executive Order “Lowering Drug Prices by Once Again Putting Americans First.”
“CMS is committed to ensuring that Americans with Medicare have access to affordable, lifesaving medications,” said Chris Klomp, Director of the Center for Medicare. “This draft guidance is critical to creating a transparent, competitive, and fair prescription drug market that puts American patients first. These efforts will ensure CMS negotiates the lowest maximum fair price for each selected drug for Medicare beneficiaries, strengthens Medicare for future generations, saves billions for American taxpayers, and preserves incentives for genuine innovation.”
The draft guidance includes new policies to incorporate drugs payable under Part B into the Negotiation Program for the first time and solicits comments on how to facilitate access to any negotiated MFPs for drugs payable under Part B. Additionally, the draft guidance outlines how CMS would choose for renegotiation certain drugs that were negotiated for initial price applicability years 2026 or 2027. The draft guidance also includes clarifications regarding how participating manufacturers would make any negotiated MFPs available in 2026 and 2027 and extends such policies for drugs covered under Part D to 2028.
Negotiations on the first set of 10 prescription drugs covered under Part D concluded in August 2024, and the second cycle of negotiations for 15 additional drugs covered under Part D are underway. CMS will announce up to 15 additional drugs covered under Part D or payable under Part B for potential negotiation in the third cycle of negotiations by February 1, 2026. This third cycle of negotiations will occur during 2026 and negotiated MFPs will be effective for this third set of drugs starting January 1, 2028. Additionally, CMS will publish the selected drug list for negotiation for initial price applicability year 2028 by February 1, 2026. At the same time CMS will announce any drugs selected for the first cycle of renegotiation, with renegotiated prices also taking effect on January 1, 2028.
To allow for public input, CMS is seeking comments on this draft guidance for drug selection and negotiation for initial price applicability year 2028 and manufacturer effectuation of negotiated MFPs in 2026, 2027, and 2028. Across the draft guidance, CMS seeks input on a range of topics to promote greater transparency in processes, reduce administrative burden for participating manufacturers, and evolve the Negotiation Program to achieve greater value for beneficiaries and taxpayers. The comment period is open for 45 days. Comments received by 11:59 p.m. PT, June 26, 2025 will be considered during the development of final guidance.
To review the fact sheet on the Medicare Drug Price Negotiation Program Draft Guidance for Initial Price Applicability Year 2028, visit: https://www.cms.gov/files/document/ipay-2028-draft-guidance-fact-sheet.pdf and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028 visit: https://www.cms.gov/files/document/ipay-2028-draft-guidance.pdf
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