Medicare Drug Price Negotiation Program Proposed Rule

CMS recently issued a proposed rule that would codify policies established in guidance documents for the Medicare Drug Price Negotiation Program with the initial price applicability year of 2029 and beyond (“Negotiation Program”) (CMS-4215-P). Sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. L. 117-169) establish the Negotiation Program to negotiate maximum fair prices (MFPs) for certain high-expenditure, single-source drugs and biological products. For the initial price-applicability years 2026 through 2028 of the Negotiation Program, the law directed CMS to implement the Program through instructions and other guidance.

With this program instruction authority expiring, CMS is now proposing to codify the Negotiation Program for 2029 and beyond. Additionally, CMS is proposing new policies to continue implementing statutory provisions under the Negotiation Program, as well as revisions or clarifications to certain previously established policies to incorporate lessons learned from ongoing experience. For the initial price applicability year 2029, CMS will select up to 20 drugs covered under Part D and/or payable under Part B. In addition to the drugs selected for negotiation, CMS can also select drugs for renegotiation if selected drugs with an agreed-upon maximum fair price meet certain eligibility and selection criteria

Comments are due on Monday, August 17, at 5:00 p.m.