Medicare Drug Price Negotiation Program Guidance

On March 15, 2023, CMS published a memorandum of proposed initial guidance pertaining to the Medicare Drug Price Negotiation Program as enacted in the Inflation Reduction Act (IRA, P.L. 117-169). The IRA required the HHS Secretary to implement the Negotiation Program for 2026-2028 through program instruction or other forms of program guidance, rather than notice-and-comment rulemaking. This memorandum is the most comprehensive program guidance to date on the Negotiation Program. Although CMS is not required to obtain comment from stakeholders in this program guidance, it is voluntarily soliciting comment on certain topics, as noted throughout this summary. Comments are due by April 14, 2023. After considering the public comments, CMS will issue revised guidance for initial applicability year 2026.