The hospital industry has launched a legal rematch with the federal government over the second iteration of its pilot program swapping out safety-net hospitals’ upfront drug discounts for after-the-fact rebates.

The American Hospital Association, the Maine Hospital Association and three community-based providers filed litigation against the Department of Health and Human Services and the Health Resources and Services Administration on Friday in the U.S. District Court for the District of Maine.

They seek a temporary and permanent block on the 340B Rebate Model Pilot Program ahead of its Jan. 1 launch, arguing that HHS and HRSA illegally ignored their feedback on the substantial expenses that would be borne by providers and suggestions for alternative approaches.

“For covered entities to continue providing their current levels of care to their patients, this Court must quickly enjoin this unlawful, unnecessary, and unexplained program that jeopardizes one of the key pillars of U.S. healthcare,” hospitals’ complaint reads. “The Rebate Program is arbitrary and capricious and must be set aside.”

The hospital industry is returning to a successful legal playbook. A prior iteration of the program. slated to launch at the start of 2026. was blocked by the same court and its corresponding appellate, with judges telling the administration the rollout was hasty and did not properly solicit or integrate public feedback on the planned program.

HRSA voluntarily withdrew the first attempt after those temporary blocks and returned to the drawing board with a more drawn-out public comment process. 2 million per year among all covered entities—while noting that the pilot’s second iteration had increased the number of eligible products and participants (21 drugs and 10 manufacturers, HRSA announced last week ).

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