(Oct. 13, 2026) - The American Hospital Association, Maine Hospital Association and four safety-net hospitals filed a lawsuit on Oct. 9, 2026, in the United States District Court for the District of Maine challenging changes by the U.S. Department of Health and Human Services to the 340B Drug Pricing Program that would expand the use of a proposed rebate model previously halted by the courts. The lawsuit seeks to prevent the implementation of the new rebate pilot program, scheduled to take effect on Jan. 1, 2027.
As you may be aware, the rebate program would impose significant new financial and administrative burdens on covered entities. Estimates show the proposed rebate program could impose more than $1 billion in annual administrative costs on hospitals. The lawsuit is summarized in AHA’s press release.
We thank Congressman Tracey Mann (KS-01) and several bipartisan colleagues for introducing the 340B Rebate Model Delay Act, which would require drugmakers to provide 340B discounts upfront at the time of purchase from Jan. 1, 2027, through Dec. 31, 2028. It would also prohibit the use of federal funds to implement the rebate pilot or a substantially similar program during that period.
Additionally, the National Rural Health Association recently shared its letter to the Health Resources and Services Administration reiterating NRHA’s concerns about the 340B Rebate Pilot. In the letter, NRHA asks HRSA to exempt small rural hospitals and clinics from rebate requirements or, at a minimum, offer a delayed effective date or a simplified claims pathway. If a rebate model proceeds, NRHA asked HRSA to make changes to the program to reduce administrative burden and protect rural hospitals and clinics from continued overreach by pharmaceutical manufacturers.