Temporary Restraining Order Halting Implementation of HRSA's 340B Rebate Model Pilot Program
- Details
- Published: Monday, 29 December 2025 12:38
- Written by 340B Editor
Press Release: U.S. District Court in Maine Issues Temporary Restraining Order Halting Implementation of HRSA's 340B Rebate Model Pilot Program
FOR IMMEDIATE RELEASE
Portland, Maine — In a significant victory for safety-net hospitals and vulnerable patients nationwide, the U.S. District Court for the District of Maine has granted a Temporary Restraining Order (TRO) enjoining the U.S. Department of Health and Human Services (HHS) and its Health Resources and Services Administration (HRSA) from implementing the nine individual applications that comprise the 340B Model Rebate Pilot Program, pending further order of the court.
The ruling, stemming from a lawsuit filed by the American Hospital Association (AHA), the Maine Hospital Association (MHA), and four safety-net health systems, blocks the pilot program — set to begin on January 1, 2026 — which would have shifted the longstanding 340B Drug Pricing Program from upfront discounts to a retrospective rebate model for select high-volume drugs.
Under the proposed pilot, covered entities (including hospitals serving rural, low-income, and underserved communities) would have been required to pay full wholesale prices upfront and seek rebates later, imposing hundreds of millions in additional annual costs, cash-flow burdens, and administrative challenges. The court found that the plaintiffs demonstrated a strong likelihood of success on their claims that HRSA violated the Administrative Procedure Act through a rushed, opaque process that ignored substantial stakeholder concerns.
Key Impact of the Ruling
While the TRO is preliminary and applies directly to the defendants (HRSA/HHS), the broad enjoinment of implementing the nine applications effectively pauses the program nationwide. This relief protects all 340B covered entities — approximately 14,600 providers — from the immediate financial and operational disruptions that would have threatened patient care, including services for the uninsured, behavioral health, oncology, opioid treatment, and community benefits.
The 340B program, established in 1992, has enabled safety-net providers to stretch scarce resources to deliver essential care. In 2022 alone, 340B hospitals provided nearly $100 billion in community benefits. The TRO preserves this critical lifeline while the court reviews the merits of the case.
Quotes
Rick Pollack, President and CEO, American Hospital Association: "This decision recognizes the profound risks to patient care posed by an unlawful shift in the 340B program. We applaud the court's swift action to protect hospitals serving America's most vulnerable communities."
Andrew MacLean, CEO, Maine Hospital Association: "Rural and safety-net hospitals in Maine and across the country rely on 340B to maintain access to affordable drugs. This TRO ensures we can continue putting patients first without crippling new burdens."