Dompé U.S. Agrees to Pay $32 Million to Resolve False Claims Act Liability Over Patient Kickbacks

Dompé U.S. Inc., the California-based subsidiary of Italian pharmaceutical company Dompé farmaceutici S.p.A., has agreed to pay $32 million to resolve allegations that it violated the Anti-Kickback Statute and the False Claims Act. The settlement, announced by the Justice Department, resolves claims that between 2018 and 2021, Dompé paid Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug Oxervate, a treatment for neurotrophic keratitis.

When a Medicare beneficiary obtains a prescription drug, they may be required to make a partial payment, or co-pay. Congress included co-pay requirements to encourage market forces to serve as a check on healthcare costs. Under the Anti-Kickback Statute, pharmaceutical manufacturers are prohibited from offering or paying any remuneration, directly or indirectly, to induce Medicare patients to purchase their drugs. This prohibition extends to the payment of patients’ co-pay obligations.

As part of the settlement, Dompé admitted that around the time of Oxervate’s 2018 launch, its employees expressed reservations about launching the drug before making a payment to a patient assistance foundation that paid co-pays for Oxervate. After conversations with Dompé employees, two foundations opened funds that paid co-pays for Oxervate, and Dompé made contributions to those foundations. Dompé also solicited patient assistance foundation data directly from the foundations and from the specialty pharmacy that provided hub services to Dompé U.S. patients. This data was provided to individuals involved in the foundation budgeting process.

Dompé farmaceutici self-disclosed this conduct to the United States and received credit under the Department’s guidelines for taking self-disclosure, cooperation, and remediation into account in False Claims Act cases. The resolution resulted from a coordinated effort between the Justice Department’s Civil Division, the U.S. Attorney’s Office for the District of Massachusetts, and HHS-OIG. The government encourages companies that uncover improper kickbacks to self-disclose such conduct, emphasizing that whistleblowers and cooperative entities play a vital role in combating healthcare fraud.