AHA, MHA and Four Safety-Net Hospitals File Suit to Stop Unlawful 340B Changes Threatening Patient Care

LEWISTON, Maine (December 1, 2025) — Today, the American Hospital Association (AHA), the Maine Hospital Association (MHA) and four safety-net health systems from across the country filed a lawsuit in the United States District Court for the District of Maine to stop unlawful changes to a critical program that provides lower-cost drugs to hospitals and clinics that serve rural, poor and vulnerable communities.

At a time when financially strapped hospitals are struggling to stretch their resources to care for the nation’s underserved populations, the U.S. Department of Health and Human Services (HHS) is abruptly forcing health care providers to adopt new, costly changes to the 340B Drug Pricing Program. For more than 30 years, the 340B program has helped safety-net hospitals provide care to millions of people and communities in need. In 2022 alone, thanks in part to these savings, 340B hospitals provided nearly $100 billion of benefits to their communities, including free or discounted drugs for patients, comprehensive care for the uninsured, behavioral health services, opioid treatment, oncology care, food pantries and more.

Under the HHS planned change to the 340B program, safety-net providers would have to pay drug manufacturers the full market price for drugs upfront and then seek reimbursement only after the drugs are administered to patients — a monumental shift that would impose hundreds of millions of dollars in additional annual costs and burdensome paperwork requirements on hospitals and other covered entities with no benefit to patients. 

“When the government announced its new rebate program just a few months ago, it recognized that it would fundamentally shift how the 340B program has operated for more than three decades. 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,” said Rick Pollack, president and CEO of the AHA. “And 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. We are asking the court to act quickly to protect access to vital care services.”

If implemented on Jan. 1, 2026, the 340B Rebate Model Pilot Program would impose overwhelming financial challenges on hospitals and providers participating in the 340B program, many of which already operate on razor thin margins while playing a vital role in their communities, often serving as the only source of care. The decision to move forward with the rebate program through a rushed, opaque process following its announcement on July 31, 2025, violates the most basic principles of administrative law and ignores the concerns of over a thousand 340B hospitals and other stakeholders, many of which highlighted the significant costs and community impact of administering the rebate model.

“Having upfront drug discounts has been a critical lifeline to our community and our ability to serve patients who otherwise wouldn’t be able to access care,” said Winfield S. Brown, president of St. Mary’s Regional Medical Center in Lewiston, Maine. “Allowing this program to go forward despite the objections that have been raised would do irreparable harm to the patients of Androscoggin County and other communities like ours across the country.”  

“Maine’s hospitals are already facing very difficult financial conditions as they strive to continue providing a full range of care to their communities,” said Steven Michaud, president of the Maine Hospital Association. “Maine hospitals simply cannot afford the immense costs of this hastily imposed rebate program.”

For more than 30 years, safety-net and rural hospitals that serve millions of Americans every year have relied on upfront drug discounts to expand access to care, make life-saving medications available, and provide critical care to vulnerable communities across America. The AHA and MHA are joined in this suit by St. Mary’s Regional Medical Center in Maine, the Unity Medical Center in North Dakota, the Dallas County Medical Center in Arkansas, and the Nathan Littauer Hospital and Nursing Home in New York — all community-based health care providers that participate in the 340B program. 

###

About the American Hospital Association (AHA)

The American Hospital Association (AHA) is a not-for-profit association of health care provider organizations and individuals that are committed to the health improvement of their communities. The AHA advocates on behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners – including more than 270,000 affiliated physicians, 2 million nurses and other caregivers – and the 43,000 health care leaders who belong to our professional membership groups. Founded in 1898, the AHA provides insight and education for health care leaders and is a source of information on health care issues and trends. For more information, visit the AHA website at www.aha.org.