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The hospital industry is suing the federal government for a second time to block HHS's 340B Rebate Model Pilot Program, set to launch January 1. The American Hospital Association argues the program would impose massive financial burdens on safety-net hospitals and that regulators ignored provider feedback. A prior version of the pilot was already blocked by the same court.
The American Hospital Association, the Maine Hospital Association, and three community providers have filed suit against HHS and HRSA in the U.S. District Court for the District of Maine, seeking to block the 340B Rebate Model Pilot Program before its January 1 launch. The lawsuit argues the administration unlawfully ignored provider feedback and failed to account for the enormous financial burden the program would place on safety-net hospitals.
This is round two of the same legal fight. A prior version of the pilot — slated to launch in early 2026 — was blocked by the same court and its appellate, which found the rollout was rushed and lacked adequate public input. HRSA scrapped that version and ran a more extensive comment process, but hospitals say the revised program still falls far short.
By the Numbers:
Why it matters: The 340B program is a cornerstone of how safety-net hospitals fund care for underserved patients. If the rebate model takes effect, hospitals warn it could divert critical resources away from patient care — making this legal battle one of the most consequential healthcare policy fights of the year.