(Semi) Sweet Charity: Dompé Pays $32 Million to Resolve Patient Assistance Foundation Kickback Allegations After Self-Disclosure

Earlier this month, the U.S. Department of Justice (DOJ) announced that Dompé U.S. Inc. (Dompé) agreed to pay $32 million to resolve False Claims Act (FCA) allegations stemming from its payment of Medicare beneficiaries’ Oxervate co-pays through two patient assistance foundations. According to the settlement agreement, Dompé admitted that, from 2018 through 2021, those payments were intended to induce purchases of Oxervate, in violation of the Anti-Kickback Statute (AKS). Below, we examine the alleged conduct, the credit DOJ extended for Dompé’s self-disclosure (including what appears to be a significantly reduced damages multiplier), and what the resolution signals for other manufacturers.

A Refresher on the AKS and Patient Assistance Foundations

Medicare beneficiaries who obtain prescription drugs covered by Medicare Part D may be responsible for co-pays, co-insurance, or deductibles. The AKS prohibits drug manufacturers from offering or paying remuneration, directly or indirectly, to induce Medicare beneficiaries to purchase their drugs, including by paying their co-pay obligations. As DOJ has long maintained, Congress included these cost-sharing requirements in part to ensure that market forces would help constrain healthcare costs, including pharmaceutical manufacturers’ pricing.

However, U.S. Department of Health and Human Services Office of Inspector General guidance recognizes a path for manufacturers to support this cost-sharing safety net without running afoul of the AKS: cash donations to independent, bona fide charitable foundations are permissible even when the foundation’s funds ultimately benefit the donor’s own patients. To stay within that guidance, the foundation generally must, among other conditions, operate free of donor control, define its disease funds broadly enough that they are not tied to a single manufacturer’s product, and withhold from donors any data that would let them track whether their contributions are subsidizing use of their own drugs.

Dompé’s Conduct

Dompé, a California-based subsidiary of Italian pharmaceutical company Dompé farmaceutici S.p.A., markets Oxervate, the only U.S. Food and Drug Administration-approved treatment for neurotrophic keratitis, a rare degenerative eye disease that can lead to permanent vision loss. Dompé launched Oxervate in the United States in December 2018.

According to the settlement agreement, Dompé employees expressed reservations about launching Oxervate before the company had contributed to a patient assistance foundation that would pay Oxervate co-pays. In late 2018, Dompé entered into an agreement to fund a neurotrophic keratitis fund at the National Organization for Rare Disorders. A second foundation, the PAN Foundation, opened a similar fund in 2019 after discussions with Dompé employees.

Dompé admitted that it obtained donor data directly from these foundations and from a specialty pharmacy that provided hub services to Dompé patients. That data was shared with Dompé employees involved in the foundation budgeting process. Dompé sometimes approved mid-year increases to foundation budgets after determining that a foundation was running low on funding.

Self-Disclosure, Cooperation, and Remediation

Dompé farmaceutici, Dompé’s parent company, voluntarily disclosed the conduct to the U.S. Attorney’s Office for the District of Massachusetts after an internal compliance review, and following this disclosure, both entities cooperated with the government. No DOJ component knew of the conduct at the time, and there was no qui tam suit, meaning this was a true voluntary self-disclosure within the meaning of DOJ’s guidance.

In addition to the self-disclosure, DOJ credited Dompé for, among other things: (1) conducting a thorough and proactive internal investigation, (2) producing documents and making witnesses available, including evidence and witnesses located outside the United States, (3) identifying individuals substantially involved in the conduct, (4) implementing remedial measures, and (5) admitting and accepting responsibility for the misconduct. Despite two senior employees failing to preserve data, Dompé’s broader cooperation, disclosure, and remediation efforts resulted in a civil FCA resolution that does not impose a Corporate Integrity Agreement, monitor, independent review organization, or reporting requirement.

Notably, the damages multiplier DOJ apparently applied stands out. Of the $32 million total, the settlement agreement explicitly states that $29 million is restitution, meaning the losses to federal health insurance programs. A multiplier of approximately 1.1 times that single damages figure yields a total of $32 million. DOJ’s Justice Manual § 4-4.112 provides that cooperation credit in False Claims Act cases “will most often take the form of a reduction in the damages multiplier and civil penalties.” Although not explicitly stated in the settlement agreement, if DOJ, in fact, used a multiplier that close to single damages, it would be a strong signal of its willingness to reward voluntary self-disclosure, cooperation, and remediation in FCA cases.

Compliance Policies Need Effective Controls

The settlement agreement also illustrates that an effective compliance program needs more than written guidance alone. In 2019, a Dompé compliance consultant cautioned employees against reverse-engineering patient assistance foundation data to inform contribution decisions. Yet the agreement describes continued efforts to obtain and use foundation and specialty-pharmacy data in connection with budget decisions and patient assistance communications, suggesting that Dompé employees did just that.

Dompé’s later remediation included modifying its procedures for interactions with, and contributions to, patient assistance foundations. Among other measures, the company prohibited its then-general manager from participating in foundation decision-making or accessing foundation data, required contribution budgets to be based on objective and documented criteria, and adopted enhanced procedures preventing key account managers and patient access managers from discussing foundations or foundation approval status.

Compliance Takeaways

The Dompé resolution offers several practical lessons for pharmaceutical manufacturers:

• Patient assistance remains a DOJ focus. The Dompé settlement extends a pattern the Boston U.S. Attorney’s Office has built over nearly a decade. Since 2017, that office has resolved foundation-related kickback allegations against many pharmaceutical manufacturers and four foundations. U.S. Attorney Leah Foley cited more than $1.4 billion recovered through this enforcement line in announcing the Dompé resolution, underscoring that patient assistance foundations remain a standing enforcement priority for that office rather than a one-off theory.
• The use of patient assistance foundation data creates meaningful AKS risk. Companies should carefully assess whether they receive, request, or use information that could allow them to connect funding decisions with their own patients, prescriptions, or anticipated sales.
• Self-disclosure credit depends on more than promptly alerting the government. DOJ highlighted the scope of Dompé’s internal investigation, its disclosure of investigative results, its production of foreign-located evidence and witnesses, its identification of involved individuals, and its remediation.
• A self-disclosure need not be flawless to be meaningful. The agreement notes that two senior employees failed to preserve device data after learning of the investigation, yet DOJ still credited the company’s overall self-disclosure, cooperation, and remediation.
• Compliance policies need effective detection and escalation mechanisms. Dompé’s compliance consultant warned against reverse-engineering foundation data to guide contribution decisions, but the practice continued. Companies should ensure that guidance is reinforced through controls, training, monitoring, clear escalation paths, and timely follow-up when potential departures are identified.

For questions about these developments, their implications, or related compliance considerations, please contact the authors or any member of Arnold & Porter’s White Collar Defense & Investigations or Life Sciences & Healthcare Regulatory practice groups.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.