Drug manufacturers subject to government price negotiations starting in 2026 must submit to Medicare by Oct. 2 specific data on their product’s research and development costs, among other information, according to guidance issued Wednesday.
The drug industry and other stakeholders have 30 days to submit comments on the draft recommendations from the Centers for Medicare & Medicaid Services. The 91-page document includes some of the most comprehensive details to date on how the CMS will approach its new authority under the Inflation Reduction Act (Public Law 117-169) to negotiate the prices for some of Medicare’s highest-spending drugs.
“Through the Medicare ...