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

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.

The Conduct at Issue

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.

The government’s concern was not simply that Dompé contributed to charitable foundations. Rather, the allegations focused on whether the company’s visibility into foundation funding needs and patient-assistance activity allowed it to make contribution decisions that benefited users of its own product. In DOJ’s view, those types of insights may call into question whether a foundation is operating independently from a manufacturer or instead functioning, at least in part, as a mechanism for subsidizing demand for a particular drug.

The Legal Backdrop

Medicare beneficiaries generally are required to bear a portion of the cost of covered drugs through co-payments, coinsurance, or deductibles. The government’s position has long been that manufacturers may not eliminate those costs for their own products, directly or indirectly, because doing so can influence purchasing decisions and increase utilization. In the government’s view, routing financial assistance through a nominally independent charitable foundation does not resolve that concern if the manufacturer effectively steers or influences the assistance being provided.

At its core, the case centers on a recurring DOJ concern: whether a manufacturer’s interactions with a charitable foundation effectively allow it to influence the availability of financial assistance for its own products. The government alleged that Dompé’s funding practices and access to foundation-related information crossed that line.

Those concerns have animated DOJ’s co-pay foundation enforcement efforts for years. In 2019, the Chronic Disease Fund, the Patient Access Network Foundation, and the Patient Advocate Foundation each resolved allegations that they functioned as conduits for pharmaceutical manufacturers to subsidize Medicare beneficiaries’ use of the manufacturers’ own products. Those settlements helped establish the enforcement framework that continues to shape DOJ’s analysis of manufacturer interactions with patient assistance foundations today.

Self-Disclosure, Cooperation, and Remediation

The settlement agreement sheds additional light on why DOJ emphasized the company’s disclosure, cooperation, and remediation efforts in announcing the resolution.

According to the settlement agreement, Dompé farmaceutici S.p.A., the company’s Italian parent, voluntarily disclosed the conduct after issues were identified through an internal compliance review. The agreement notes that the company’s then-Chief Executive Officer personally contacted the U.S. Attorney’s Office for the District of Massachusetts to initiate the disclosure and that neither the U.S. Attorney’s Office nor other DOJ components were investigating the conduct at the time. The agreement further describes the matter as among the first disclosures made by a pharmaceutical company under DOJ’s False Claims Act self-disclosure guidelines that took effect in 2019.

By 2022, Dompé had revised its foundation-contribution practices, including removing its general manager from foundation decision-making, restricting access to foundation data, requiring objective and documented budgeting criteria, and limiting communications regarding foundation approval status between commercial and patient-access personnel. The settlement agreement also states that Dompé received cooperation credit under DOJ’s False Claims Act guidelines for its disclosure, internal investigation, production of overseas evidence, witness cooperation, remediation efforts, and acceptance of responsibility.

In announcing the settlement, the Department stated that it “encourages companies that uncover improper kickbacks to self-disclose such conduct,” using the resolution to reinforce its broader message regarding disclosure and cooperation.

Self-disclosure plainly did not insulate the company from a substantial resolution. Nevertheless, DOJ’s discussion of the company’s disclosure, cooperation, and remediation efforts suggests that the Department continues to view these cases as opportunities to reinforce broader compliance incentives. Notably, the announcement devoted substantial attention to how the issue was discovered and addressed, rather than focusing exclusively on the underlying allegations. And the “value” of the disclosure is notable in the multiplier applied to the restitution amount ($29 million), which was just a touch above singles and divergent from the typical doubles required for settled matters.

Takeaways

Foundation independence remains the core issue. The allegations centered on whether Dompé’s visibility into foundation funding levels and patient-assistance activity influenced its contribution decisions in a manner inconsistent with foundation independence. The settlement serves as a reminder that seemingly routine decisions regarding contribution levels, reserve funding, and information sharing may later be cited as evidence that a foundation was not operating as independently as its structure might suggest.

DOJ continues to emphasize cooperation and remediation. The settlement agreement describes a proactive disclosure made before DOJ initiated an investigation, a substantial internal review, cooperation that included overseas evidence and witnesses, and significant remedial measures. While self-disclosure does not eliminate liability, the resolution provides another example of how DOJ evaluates disclosure, cooperation, and remediation under its False Claims Act enforcement policies.

Expect continued scrutiny of manufacturer-supported patient assistance programs. The U.S. Attorney’s Office emphasized that it has recovered more than $1.4 billion through settlements and enforcement actions involving drug-company contributions to purported charities. That figure suggests that DOJ continues to view patient assistance programs involving co-pay foundations as an enforcement priority and that manufacturers should expect ongoing scrutiny of both the structure and operation of those arrangements.