The U.S. District Court for the District of Maine granted a preliminary injunction (PDF) on Dec. 29, 2025, prohibiting the Health Resources and Services Administration (HRSA) from implementing the 340B Rebate Program, which would require 340B covered entities to purchase ten 340B drugs at list price and receive 340B pricing through a retrospective rebate instead of an upfront discount [refer to Washington Highlights, Oct. 31, 2025]. The AAMC had joined an amicus brief in the case, supporting the American Hospital Association’s motion for injunctive relief [refer to Washington Highlights, Dec. 12, 2025]. Following the district court’s preliminary injunction, HRSA announced that it is pausing implementation of the 340B Rebate Program to comply with the district court’s decision.
After HRSA appealed the district court’s decision and requested a stay pending appeal, the AAMC joined 340B Health, America’s Essential Hospitals, the American Society of Health-System Pharmacists, and the Children’s Hospital Association in an amicus brief (PDF) opposing the government’s motion for a stay of the district court’s preliminary injunction preventing implementation of the 340B Rebate Program, which was scheduled to take effect Jan. 1.
The brief, filed on Jan. 5 in the U.S. Court of Appeals for the First Circuit in American Hospital Association et al. v. Kennedy et al., supports the plaintiffs’ opposition to the government’s motion for a stay pending appeal. The amicus brief argues that although HRSA announced the rebate model through an informal adjudication, it is still subject to the same arbitrary and capricious standard as formal adjudications or rulemaking.
The Court of Appeals subsequently denied the government’s request for a stay (PDF) on Jan. 7 and requested an expedited briefing schedule from the parties, noting it intends to resolve the appeal expeditiously.
- Washington Highlights