CMS (the Centers for Medicare & Medicaid Services) has published draft guidance for the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act (IRA). The draft focuses on how drug manufacturers would “effectuate” (carry out) the maximum fair price that is set to begin in 2028.
This is part of CMS’s broader IRA implementation work for Medicare prescription drug affordability. CMS also says related IRA guidance is available on its website.
The notice invites public input on the draft guidance. Comments are a way for patients, drug companies, advocates, and other stakeholders to flag problems, suggest improvements, or ask for clarifications before CMS finalizes the guidance.
For the official draft and related IRA materials, see the CMS IRA Medicare prescription drug affordability page linked in the Federal Register notice.