Dompé agrees to pay $32 million over Medicare co-pay allegations
Dompé U.S. has agreed to pay $32 million, plus interest, to resolve federal civil allegations involving the company’s financing of Medicare co-pay assistance for Oxervate, a treatment for neurotrophic keratitis, a rare degenerative eye disease that can cause permanent vision loss.
The Justice Department announced the settlement on September 10, 2026. Under the executed agreement, Dompé must pay the $32 million settlement amount plus 4.5% annual interest calculated from June 29, 2026. Payment is due within 30 days after the agreement’s effective date. The agreement identifies $29,090,909 of the settlement as restitution to the United States.
What DOJ says happened
The covered period ran from October 1, 2018, through December 31, 2021. Dompé launched Oxervate in the United States in December 2018.
According to the settlement and DOJ announcements, Dompé employees discussed patient assistance with the National Organization for Rare Disorders, or NORD, before the drug’s launch. NORD opened a fund for neurotrophic keratitis patients in December 2018. The PAN Foundation opened another such fund in October 2019 after conversations with Dompé employees, with an initial contribution from the company.
Dompé U.S. admitted, acknowledged and accepted responsibility for specified facts in the settlement. The agreement says the company sometimes approved mid-year increases to the foundation budgets or held money in reserve so it could determine which foundation funds were running low and allocate contributions accordingly.
The agreement also says Dompé solicited patient-assistance data directly from the foundations and from a specialty pharmacy that provided hub services to Dompé patients. Some of that information reached members of the company’s Market Access team and employees involved in foundation budgeting. The agreement describes exchanges concerning the number of Oxervate patients waiting for assistance and requests by sales employees for information about individual patients’ foundation coverage.
Why the legal theories matter
The Anti-Kickback Statute generally prohibits a drug manufacturer from offering or paying money or another thing of value to induce Medicare beneficiaries to purchase a federally reimbursed drug. The prohibition can include paying a patient’s Medicare co-pay.
The settlement agreement’s explanation of the co-pay system specifically discusses Medicare Part D. The district attorney’s office announcement refers more generally to Medicare Part B or Part D, so the documents do not establish that every Oxervate prescription at issue was covered under Part B or that every prescription involved Medicare.
DOJ contended that Dompé’s conduct caused false claims to be submitted to Medicare. That allowed the government to pursue civil theories under the False Claims Act in addition to the Anti-Kickback Statute. The settlement resolves those civil claims, but DOJ states that the claims were allegations only and that there was no trial determination of liability.
The documents do not say that NORD or the PAN Foundation was found liable or acted unlawfully. The allegations and admissions concern Dompé’s interactions, contributions and use of patient-assistance information.
What the settlement requires
After receiving the settlement amount and interest, the United States will release specified civil and administrative monetary claims tied to the covered conduct. The agreement also says Dompé may not seek payment from beneficiaries or third-party payors for health-care billings covered by the agreement.
The release is limited. The agreement expressly reserves criminal liability, certain administrative liabilities and enforcement rights, claims involving individuals, tax liabilities and claims based on conduct outside the covered period or outside the covered conduct.
What Dompé changed
The settlement says Dompé voluntarily disclosed the conduct after an internal compliance review, conducted and shared an internal investigation, produced documents, cooperated with witness interviews and identified relevant people and records. DOJ credited those actions, along with the company’s admissions and remediation, under its guidelines for False Claims Act matters.
By 2022, Dompé had changed its foundation-contribution procedures. The agreement says the company barred its former general manager from foundation decision-making and access to foundation data, required foundation budgets to use objective and documented criteria, and restricted discussions between key account managers and patient-access managers about foundations or approval status.
What it means for patients
This is a financial-enforcement settlement, not a safety recall. The agreement does not find that Oxervate is ineffective, direct current patients to stop treatment or announce a change in Medicare coverage.
It also does not create a patient-refund program. The agreement identifies restitution to the United States rather than payments to individual patients.
For manufacturers, the case illustrates the legal risk of using charitable foundation funding or related patient data in ways that could steer Medicare beneficiaries toward a company’s drug. For patients, the immediate development concerns alleged reimbursement and co-pay practices—not a new treatment warning or coverage instruction.
The civil resolution is also not a complete release of every possible legal issue. Because criminal, administrative and individual liabilities remain reserved, the settlement resolves the specified civil claims without foreclosing all other potential claims.
Sources
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