Dompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-Disclosure🔒 SSL Verified

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"On September 10, 2026, the U.S. Attorney’s Office for the District of Massachusetts announced that Dompé U.S., Inc. agreed to pay $32 million to resolve allegations that it used patient assistance foundations to cover Medicare co-pays for patients receiving Oxervate, a biologic used to treat neurotrophic keratitis, a rare degenerative disease of the cornea. The settlement is the latest in a long line of government actions examining manufacturer support for patient assistance programs that subsidize Medicare beneficiaries’ out-of-pocket costs through independent charitable foundations. The publicly available settlement agreement contains a considerable amount of detail and provides useful insight into both the conduct at issue and the steps that earned the company cooperation credit."

"Companies that have followed enforcement in this area will recognize many of the themes in DOJ’s allegations. More noteworthy is DOJ’s decision to highlight the company’s disclosure, cooperation, and remediation efforts so prominently in announcing the settlement. Before turning to those aspects of the resolution, however, it is worth examining the conduct that prompted the investigation."

"According to the settlement agreement, prior to Oxervate’s U.S. launch, employees expressed reservations about bringing the product to market before patient-assistance funding was available. Following discussions with Dompé personnel, the National Organization for Rare Diseases (NORD) established a neurotrophic keratitis fund in late 2018, and the PAN Foundation later opened a similar fund in 2019, each receiving contributions from Dompé."

"The agreement also describes a compliance consultant cautioning company personnel against using information concerning foundation activity to inform contribution decisions and warning that Dompé should not “reverse engineer” patient-assistance foundation data when determining funding levels. DOJ similarly focused on the company’s collection of information from foundations and from a specialty pharmacy that provided patient-support and reimbursement services for Oxervate patients, including information reviewed by personnel involved in contribution decisions."

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