Medicare Drug Price Negotiation: Proposed Rules and Industry Implications
On June 12, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule concerning the Medicare drug price negotiation program, initially outlined by the Inflation Reduction Act. This initiative empowers CMS to conduct the program through guidance over the first three years, covering 2026, 2027, and 2028. The agency plans to finalize this rule by Fall 2026, aiming for implementation in 2029. Public comments are invited by August 17, 2026, following its publication in the Federal Register on June 16, 2026.
The period for manufacturers to apply for the voluntary Generous (GENErating cost Reductions fOr U.S. Medicaid) payment model concluded on June 11, 2026. CMS reported a high volume of applications for this initiative, reflecting significant industry interest.
President Trump announced on June 5, 2026, the expansion of the TrumpRx portal with 160 additional drugs. This update broadens the resources available on the platform, enhancing support for users.
Ongoing discussions focus on the implications of the Most Favored Nation (MFN) drug pricing policy. Dr. Mehmet Oz, CMS Administrator, noted the expiration of 17 MFN agreements by major manufacturers coincides with the current administration's term. He urged Congress to legislate these agreements to ensure their permanence.
Federal Register Notice and Data Submission Requirements
On June 12, 2026, the Health Resources & Services Administration issued a Federal Register notice detailing stakeholders' data submission responsibilities for the 340B rebate pilot program. This initiative will involve manufacturers with Medicare Drug Price Negotiation Program Agreements for 2026 and 2027. Eleven manufacturers are required to provide monthly data submissions to the 340B Prime Vendor.
There is a growing trend of manufacturers requiring claims-level data from covered entities, involving all 340B dispenses. Stakeholder discussions around these policies are ongoing, reflecting the evolving landscape of information sharing and compliance.
In April 2026, the US District Court for the District of Columbia overturned the Health Resources & Services Administration's guidance on group purchasing organization prohibitions. The decision passed without further appeals as the deadline had expired. Meanwhile, litigation against state-enacted 340B laws by drug manufacturers continues. States are introducing legislation to prevent manufacturers from limiting contract pharmacy access, with some proposals mandating the disclosure of 340B discounts by covered entities.
In legislative developments, Minnesota and Illinois are exploring the creation of Prescription Drug Affordability Boards aimed at regulating drug pricing within these states. These efforts underline a focused approach to addressing drug pricing pressures at the state level.