The Centers for Medicare & Medicaid Services June 30 released revised guidance detailing how it will implement an Inflation Reduction Act program to negotiate Medicare prices with makers of certain high-cost, single-source drug and biological products in 2023 and 2024 for prices effective in 2026. CMS said it revised the initial March guidance to clarify the drug selection process and how drug companies will participate in the program and expand opportunities for public engagement. 

“For initial price applicability year 2026, CMS does not expect manufacturers to provide access to the [Maximum Fair Price] of a selected drug to hospitals, physicians, and other providers of services and suppliers with respect to a drug furnished or administered to MFP eligible individuals enrolled under Part B, including an individual who is enrolled in an MA [Medicare Advantage] plan,” the guidance states.

The agency plans to publish by Sept. 1 a list of the first 10 Part D drugs selected for price negotiation; host a series of patient-focused listening sessions on the selected drugs this fall; and invite the public to submit data on the selected drugs and therapeutic alternatives by Oct. 2.

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