The U.S. Department of Justice announced on September 10, 2026, that Dompe U.S. Inc. will pay $32 million to settle allegations that it violated the Anti-Kickback Statute and the False Claims Act by funneling money through two purportedly independent patient assistance foundations between 2018 and 2021. The foundations used those funds to cover Medicare co-payments owed by patients prescribed Oxervate, a costly eye drop approved to treat neurotrophic keratitis.

Federal law prohibits drug manufacturers from subsidizing Medicare beneficiaries’ cost-sharing obligations in this way because doing so removes a financial check that might otherwise lead patients and physicians to weigh a drug’s price against its value — effectively steering federally reimbursed purchases toward the manufacturer’s own product regardless of cost. The settlement resolves allegations against both Dompe U.S. and its Italian parent, Dompe farmaceutici S.p.A., and was handled by the DOJ Civil Division, the U.S. Attorney’s Office for the District of Massachusetts, and HHS-OIG.

Unlike most False Claims Act recoveries, this matter originated not from a whistleblower lawsuit but from a voluntary self-disclosure by Dompe farmaceutici. Because no relator filed a qui tam complaint here, there is no publicly reported whistleblower award associated with this settlement. Both Dompe entities received cooperation credit from the government in recognition of the self-disclosure and their assistance during the investigation.

The DOJ and HHS-OIG have pursued similar cases against numerous pharmaceutical manufacturers over the past decade, and the consistent theory of liability is that a manufacturer-funded subsidy of Medicare cost-sharing functions as an inducement that corrupts the integrity of the Medicare program and inflates costs for taxpayers.