The American Hospital Association, Maine Hospital Association and four safety-net hospitals have filed a federal lawsuit to halt “unlawful” changes to the 340B drug pricing program, warning the shift could impose major financial harm on rural and underserved communities.
Four things to know
1. The lawsuit was filed Dec. 1 in the U.S. District Court for the District of Maine and challenges the HHS’ plan to implement a new rebate-based model for 340B starting Jan. 1, 2026. Under the planned change, safety-net hospitals and clinics would be required to pay full market price for drugs up front and seek reimbursement after administration, replacing the longstanding upfront discount model that has supported 340B providers for more than 30 years, according to the AHA.
“When making such a major change, with such far-reaching consequences for patients and hospitals, it is important that the government follow the basic administrative rules of the road. Unfortunately, it did not do so here,” AHA President and CEO Rick Pollack said in a Dec. 1 news release.
2. The AHA argues the new structure would saddle hospitals with “hundreds of millions” in added annual costs, extensive administrative burdens and no benefit to patients. The final rebate model was announced July 31 and, according to the lawsuit, was pushed forward through a “rushed, opaque process” that ignored concerns from hundreds of 340B hospitals and violated administrative law, according to the lawsuit.
“Giving hospitals only a few months to comply with these burdensome new requirements or risk losing millions of dollars in discounts they are entitled to under the law will harm patients and communities across the country,” Mr. Pollack said. “We are asking the court to act quickly to protect access to vital care services.”
3. In 2022 alone, 340B hospitals provided nearly $100 billion in community benefits, according to the AHA — including free or discounted medications, behavioral health services, opioid treatment and food pantry support.
4. Plaintiffs in this case include St. Mary’s Regional Medical Center in Lewiston, Maine; Unity Medical Center in North Dakota; Dallas County Medical Center in Arkansas; and Nathan Littauer Hospital and Nursing Home in Gloversville, N.Y.
Becker’s has reached out to HHS for comment and will update this story as more information becomes available.
