Dompe to pay $32 million over Medicare co-pay scheme for eye drug

Dompé U.S. Inc., the American subsidiary of Italy-based 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 Justice Department announced.

The government alleged that the California-based company used two patient assistance foundations between 2018 and 2021 to pay Medicare beneficiaries’ co-pays for its eye drug Oxervate, inducing purchases of the medication.

According to the Justice Department, Medicare beneficiaries may be required to make partial payments — co-pays, co-insurance or deductibles — when obtaining covered prescription drugs. Congress included those requirements in the program in part to allow market forces to help restrain health care costs, including the prices drugmakers can charge. The Anti-Kickback Statute prohibits manufacturers from offering or paying, directly or indirectly, anything of value to induce Medicare patients to purchase their products, including by paying patients’ co-pay obligations.

As part of the settlement, Dompé admitted that around the time Oxervate launched in the United States in 2018, employees of its U.S. subsidiary expressed reservations about bringing the drug to market before making a payment to a patient assistance foundation that covered Oxervate co-pays. After conversations with Dompé employees, two foundations opened funds that, among other things, paid co-pays for the drug, and Dompé contributed to those foundations. The company also solicited patient assistance foundation data directly from the foundations and from a specialty pharmacy that provided hub services to Dompé U.S. patients. That data was provided, directly or indirectly, to certain individuals involved in the foundations’ budgeting process.

Dompé farmaceutici disclosed the conduct to the U.S. government, and both the Italian parent company and its U.S. subsidiary subsequently cooperated with the investigation. The Justice Department said the companies received credit under its False Claims Act guidelines for their self-disclosure, cooperation and remediation efforts.

Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division said the settlement reflects the government’s commitment to enforcing the Anti-Kickback Statute against unlawful inducements. U.S. Attorney Leah B. Foley for the District of Massachusetts said her office has recovered more than $1.4 billion for taxpayers through settlements and enforcement actions involving drug company kickbacks to purported charities. HHS-OIG Acting Deputy Inspector General for Investigations Miranda L. Bennett said Dompé’s conduct undermined Medicare safeguards, drove up costs for taxpayers and exploited patients.

The resolution resulted from a coordinated effort by the Civil Division’s Commercial Litigation Branch, Fraud Section; the U.S. Attorney’s Office for the District of Massachusetts; and the Department of Health and Human Services Office of Inspector General.

Although Dompé admitted the specified conduct as part of the settlement, the legal claims resolved by the agreement remain allegations, and there has been no determination of liability.