Dompe US Inc. to pay $32M over illegal co-pay subsidy scheme
Dompe US agrees to pay $32 million to settle False Claims Act claims over illegal co-pay subsidies.
Why it matters: This settlement highlights ongoing enforcement of the Anti-Kickback Statute and risks pharmaceutical companies face related to co-pay subsidy programs. Legal and compliance teams in healthcare must remain vigilant about the legality of patient assistance initiatives.
- Dompe US Inc. settled for $32 million over allegations of violating the Anti-Kickback Statute and False Claims Act from 2018-2021.
- The allegations involved Dompe paying Medicare beneficiary co-pays via two patient assistance foundations to induce purchases of Oxervate.
- Dompé's Italian parent company self-disclosed the conduct, cooperating fully with investigators and receiving credit under DOJ guidelines.
- DOJ officials emphasized that such kickbacks undermine Medicare’s co-pay system and inflate drug costs, stressing enforcement commitment.
Dompé U.S. Inc., a California-based pharmaceutical firm, has agreed to pay $32 million to resolve allegations that it violated the Anti-Kickback Statute and False Claims Act between 2018 and 2021. The Department of Justice stated that Dompé paid Medicare beneficiaries' co-pays through two patient assistance foundations as an unlawful inducement to purchase Oxervate, an FDA-approved eye drop used to treat neurotrophic keratitis.
The allegations centered on Dompé's use of patient assistance programs to subsidize co-pays, a practice that the DOJ warns can corrupt medical decision-making and increase federal healthcare costs. According to the DOJ press release, both Dompé U.S. and its Italian parent company, Dompé farmaceutici S.p.A., self-disclosed the conduct and cooperated fully with the government investigation. This cooperation earned them credit under the DOJ's self-disclosure and remediation policies.
Brett A. Shumate, Assistant Attorney General of the Civil Division, said the settlement "demonstrates the United States’ commitment to enforcing the Anti-Kickback Statute and ensuring that pharmaceutical manufacturers do not use unlawful inducements." Leah B. Foley, U.S. Attorney for the District of Massachusetts, added that "kickbacks to beneficiaries undermine the purpose of the Medicare co-pay system and drive up the cost of drugs." Miranda L. Bennett, Acting Deputy Inspector General at the HHS Office of Inspector General, noted pharmaceutical manufacturers disguising kickbacks as charitable patient assistance engage in "blatant misconduct which corrupts medical decision-making and drains federal health programs."
This case illustrates the continuing regulatory scrutiny on pharmaceutical co-pay subsidy arrangements and highlights the importance of legal compliance and ethical oversight of patient assistance programs in the healthcare industry.
By the numbers:
- $32 million — settlement amount to resolve False Claims Act allegations
- 2018-2021 — period during which the alleged unlawful co-pay subsidy scheme occurred