The AAMC joined 340B Health, America’s Essential Hospitals, and the Children’s Hospital Association in an amicus brief (PDF) supporting a challenge to the Health Resources and Services Administration (HRSA) 340B Rebate Model Program, which is scheduled to take effect Jan. 1, 2027. The brief, filed on Oct. 19 in the U.S. District Court for the District of Maine in American Hospital Association et al. v. Kennedy et al., supports plaintiffs’ motion for a temporary restraining order, citing the rebate model’s immediate and irreparable harm to safety-net hospitals and their patients.
Since 1992, the 340B Drug Pricing Program has provided upfront discounts on covered drugs to safety-net hospitals, community clinics, and other health providers. In 2025, HRSA approved a rebate program to require providers to purchase 10 drugs at higher list price and then submit a claim for a retrospective rebate from drug manufacturers. After a successful legal challenge by the American Hospital Association, in which the AAMC joined an amicus brief, the court prevented the implementation of that rebate program, originally set to take effect on Jan. 1, 2026 [refer to Washington Highlights, Jan. 9].
HRSA subsequently issued a request for information, soliciting additional comments, and then published a notice announcing that a new and expanded 340B Rebate Program will take effect on Jan. 1, 2027, requiring 340B providers to purchase 18 drugs at significantly higher list prices and then pursue rebates from drug manufacturers [refer to Washington Highlights, July 31].The amicus brief illustrates how the rebate program will threaten patient access to the essential health care services provided by 340B hospitals and how HRSA failed to assess the significant costs and burdens that the rebate model will impose on 340B hospitals.
- Washington Highlights