CMS opens comments on how drug makers must deliver negotiated prices in 2028

September 18 is the date to note. The Centers for Medicare and Medicaid Services has published draft guidance specifying the requirements for manufacturer effectuation of maximum fair prices in 2028 under the Medicare Drug Price Negotiation Program, and opened a public comment period that closes on that day. The program was created by sections 11001 and 11002 of the Inflation Reduction Act of 2022 and sits in sections 1191 through 1198 of the Social Security Act. It negotiates maximum fair prices for certain high expenditure, single source drugs and biological products. The notice carries the number CMS-4219-N and was filed on July 16 for publication on July 20.

Effectuation is the mechanical half. A negotiated price is a number on a page until there is a specified method for making it reach the pharmacy counter, and this draft is where that method for 2028 is set out. CMS said the draft and its other guidance related to the Inflation Reduction Act are posted on its website. Written comments go to a departmental mailbox named in the notice, under the subject line the notice specifies.