Dompé U.S. Inc., the California-based arm of Italian drugmaker Dompé farmaceutici S.p.A., has agreed to pay $32 million to resolve civil allegations that it paid Medicare beneficiaries’ copays for the eye drug Oxervate through two patient assistance foundations between 2018 and 2021. The Justice Department and the U.S. Attorney’s Office for the District of Massachusetts announced the settlement on September 10, 2026, framing the alleged conduct as an unlawful inducement under the Anti-Kickback Statute rather than as charitable giving. Nearly $29.1 million of the payment is classified as restitution to the government, with the balance covering interest that began accruing at 4.5% a year in late June 2026. The government describes the resolved claims as allegations only, with no determination of liability against Dompé.
Why a Drugmaker Covering a Copay Counts as an Inducement, Not Charity
Under the Anti-Kickback Statute, a pharmaceutical company cannot pay, directly or indirectly, anything of value to induce a Medicare beneficiary to buy its drug, and prosecutors say that prohibition reaches a patient’s copay obligation just as much as a check written straight to a prescribing doctor. Congress built copay, co-insurance and deductible requirements into Medicare in part so patients and their physicians would feel some of a drug’s price, creating market pressure on what manufacturers can charge. When a manufacturer arranges for a foundation to quietly absorb that copay for its own product, prosecutors argue the price signal disappears for the patient while the company still collects full reimbursement from Medicare. That theory is why the government treated Dompé’s contributions to two patient assistance funds as remuneration to patients rather than as a donation: the funding was tied specifically to purchases of one drug, Oxervate, made by the same company that financed the foundations.
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Two Foundations, One Mid-Year ‘Reserve,’ and a Single Drug
According to the settlement agreement Dompé signed with the Justice Department and the Department of Health and Human Services’ Office of Inspector General, the company launched Oxervate — its treatment for the rare eye disease neurotrophic keratitis — in December 2018 after employees raised concerns about doing so before a foundation was in place to cover patients’ copays. Dompé reached an agreement with the National Organization for Rare Diseases that same month to fund a copay program for the drug, and in October 2019 a second foundation, the PAN Foundation, opened a similar fund with an initial Dompé contribution. Between 2019 and 2021, the agreement states, Dompé sometimes approved mid-year increases to the budgets it had set for both foundations, and it held part of its annual contribution in a “reserve” it could direct mid-year toward whichever foundation was running low on funding for Oxervate patients. Of the $32 million settlement, $29,090,909 is restitution, and Dompé must pay the full amount, plus 4.5% annual interest running from June 29, 2026, within 30 days of the agreement taking effect.
How Sales Staff and a Specialty Pharmacy Fed the Budgeting Process
Dompé also solicited data on foundation funding levels directly from the two foundations and from the specialty pharmacy that handled patient referrals for Oxervate, and that information reached employees on the company’s Market Access team who helped set the foundation budgets, according to the U.S. Attorney’s Office for the District of Massachusetts. On multiple occasions between 2019 and 2021, the office said, Dompé’s sales-facing account managers separately sought out information about individual patients’ foundation coverage status from the company’s own patient access managers, conduct the government said ran contrary to Dompé’s compliance guidance. A compliance consultant retained by Dompé warned employees, after Oxervate’s first year on the market, against using foundation funding data to steer future contribution decisions, according to the settlement. After learning of an internal investigation into its dealings with the foundations, two senior Dompé employees involved in the NORD and PAN Foundation contributions failed to preserve data on their devices, the agreement states. U.S. Attorney Leah B. Foley, whose office worked the case with the Justice Department’s Civil Division, said her district has now recovered more than $1.4 billion for taxpayers through settlements targeting drug company kickbacks routed through what she called “purported charities.”
Why Dompé’s Self-Disclosure Shaped the Size of the Penalty
Dompé farmaceutici, the Italian parent company, voluntarily disclosed the conduct to federal prosecutors after Dompé U.S. uncovered it during an internal compliance review, and both the parent and its U.S. subsidiary cooperated with investigators once the disclosure was made. Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division said in a Justice Department statement that the settlement “demonstrates the United States’ commitment to enforcing the Anti-Kickback Statute and ensuring that pharmaceutical manufacturers do not use unlawful inducements,” adding that the department “encourages companies that uncover improper kickbacks to self-disclose such conduct.” Dompé received credit under Justice Department guidelines for disclosure, cooperation and remediation in False Claims Act cases, credit the department factored into the $32 million figure rather than pursuing a larger recovery. The department was explicit that the claims resolved by the settlement “are allegations only and there has been no determination of liability.”
What Dompé Changed After the Investigation
By 2022, Dompé had overhauled how it handles patient assistance foundations, according to the settlement agreement. The company barred its U.S. general manager from involvement in foundation decisions or access to foundation data, moved to objective, documented criteria for setting foundation budgets, and separated its sales-facing account managers from any discussion of foundation coverage or approval status with patient access staff. The agreement Dompé’s chief operating officer signed with federal prosecutors this month closes out the civil claims tied to Oxervate’s copay funding between October 2018 and December 2021, while explicitly preserving the government’s ability to pursue criminal liability or claims against individuals involved in the conduct.
This article was produced with the assistance of AI and reviewed by The Financial Wire editorial team.
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Warren Cohen is a finance writer based in Phoenix, Arizona, covering personal finance topics including credit, banking, and beginner investing. He earned his degree in business administration from Arizona State University and began his career working in consumer finance, where he gained direct experience with lending and credit systems. He now writes for personal finance websites and fintech platforms, focusing on clear, practical content that helps readers make informed financial decisions.
