AHA challenges 340B Rebate Pilot

On Oct. 9, the American Hospital Association, Maine Hospital Association, and four safety-net hospitals filed a lawsuit seeking to block the Department of Health and Human Services’ (HHS) revised 340B Rebate Model Pilot Program. Under the pilot, participating manufacturers would provide 340B pricing for certain drugs through post-purchase rebates rather than upfront discounts.

The plaintiffs argue that HHS and the Health Resources and Services Administration (HRSA) failed to adequately account for the financial and administrative burdens the model would impose on covered entities, including the costs associated with purchasing drugs upfront and seeking rebates afterward. An earlier version of the pilot from 2025 was blocked by federal courts.

The revised pilot is scheduled to begin Jan. 1, 2027, unless the legal challenge delays or blocks implementation.