Comment Letter on CMS IPAY 2029 Proposed Rule

The Duke-Margolis Institute for Health Policy appreciates the opportunity to comment on the proposed rule on the Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program (Proposed Rule), published on June 16, 2026, by the Centers for Medicare and Medicaid Services (CMS). The Proposed Rule would codify policies governing the Medicare Drug Price Negotiation Program (Negotiation Program) beginning with initial price applicability year (IPAY) 2029 and establish several new or modified policies for the selection, negotiation, and renegotiation of maximum fair prices (MFPs) for certain high-expenditure, single-source drugs and biologics.
The Inflation Reduction Act (IRA) directed CMS to implement the Negotiation Program through program instruction or other forms of guidance for IPAYs 2026 through 2028. Beginning with IPAY 2029, CMS is transitioning the program to formal notice-and-comment rulemaking. We appreciate CMS’ efforts to solicit public input through the earlier guidance processes and this transition to a permanent regulatory framework that provides stakeholders with a formal opportunity to comment on the policies governing the Negotiation Program. We also recognize the substantial work CMS has undertaken to codify the Negotiation Program’s existing policies while identifying areas in which additional clarification or refinement is needed.

Read the full comment letter here.