Dompé U.S. (Dompé), based in California, has agreed to pay $32 million to resolve allegations that, between 2018 and 2021, it paid Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug, Oxervate, in violation of the Anti-Kickback Statute and the False Claims Act.

When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible (collectively, “co-pays”).

Congress included co-pay requirements in these programs, in part, to encourage market forces to check health care costs, including the prices pharmaceutical manufacturers can demand for their drugs.

Under the Anti-Kickback Statute, a pharmaceutical manufacturer is prohibited from offering or paying, directly or indirectly, any remuneration—which includes money or any other thing of value—to induce Medicare patients to purchase the company’s drugs. This prohibition extends to paying patients’ co-pay obligations.

As part of the settlement, Dompé admitted that, around the time of Oxervate’s 2018 launch in the United States, Dompé U.S. employees expressed reservations about launching the drug before making a payment to a patient assistance foundation that paid the co-pays for Oxervate.

After conversations with Dompé employees, two foundations opened funds that, among other things, 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.

The data was provided, directly or indirectly, to certain individuals involved in the patient assistance foundation budgeting process.

Dompé is the U.S. subsidiary of Dompé farmaceutici S.p.A., a pharmaceutical company incorporated in Italy. Dompé farmaceutici self-disclosed this conduct to the United States.

After the disclosure, Dompé farmaceutici and Dompé U.S. cooperated with the government and received credit under the Department of Justice’s guidelines for self-disclosure, cooperation, and remediation in False Claims Act cases.