The Centers for Medicare & Medicaid Services proposed a number of changes to its Medicare negotiation guidance on Friday, some of which would affect how the next round of drug prices is negotiated under the Inflation Reduction Act. On Monday, industry groups PhRMA and BIO raised new concerns about the guidance.
For prices taking effect in 2027, CMS will select up to 15 therapies for Medicare negotiations next year. The agency is still in the middle of negotiations for the first round of 10 drugs set for 2026, but said it’s looking for ways to make the next round more “efficient and effective.”
That may include fewer industry-CMS meetings during the negotiation process, the centers said in the new draft guidance.
Currently, CMS invites drug manufacturers to meet at least once to discuss the initial offer and counteroffer, with the opportunity for up to two additional meetings. However, CMS noted that holding three meetings may become “increasingly challenging” with more drugs up for negotiation.
“CMS is considering changes to the number and format of these negotiation meetings and is soliciting comments from interested parties on the most efficient and effective approach to facilitating negotiation within the statutory deadlines, including whether three meetings are necessary and whether it would be preferable to contemplate an additional written offer to be made in lieu of one or more meetings,” the agency wrote.
The pharma industry condemned the new guidance on Monday, citing a lack of transparency in the negotiation process.
Alex Schriver“CMS’ draft guidance fails to meaningfully improve transparency in the process, ignores patient and provider concerns around how prices are set and turns a blind eye to insurers who are choosing to limit coverage options for seniors,” PhRMA’s senior VP of public affairs Alex Schriver said in a statement to Endpoints News.
A BIO spokesperson told Endpoints on Monday that the organization is “concerned about proposed attempts to limit opportunities for manufacturer engagement, as well as a lack of transparency within CMS about how information from those discussions will be used.”
CMS is also seeking public comment on other aspects of the process, including how it collects input from patients. PhRMA has accused CMS of discounting patient perspectives in the past, noting in June that “it’s not clear how much patients and providers will truly be able to affect the process of price setting.”
The latest draft guidance notes that CMS wants to improve the design of patient-focused listening sessions, with a particular interest in “events that promote discussion versus listen-only events,” such as round tables or focus groups.
The agency added Friday that it intends to use a Medicare Transaction Facilitator, or MTF, to help verify patients’ eligibility for the new prices. The second round of drugs up for negotiation will be announced by Feb. 1, 2025, according to the draft guidance.
“Given the timing overlap between the development of this draft guidance and the negotiation period for initial price applicability year 2026, CMS may make additional adjustments in the final guidance based on the agency’s experience, including experience from the first cycle of negotiations,” CMS added.