Dompé to Pay $32 Million Over Patient Assistance Foundation Kickback Allegations

Key Takeaways: 

• Dompé U.S. Inc. has agreed to pay $32 million to resolve allegations that it violated the Anti-Kickback Statute and False Claims Act by using patient assistance foundation contributions to subsidize Medicare beneficiaries’ copayments for Oxervate.^1,2
• The settlement highlights compliance risks associated with manufacturer access to foundation funding and patient assistance data, particularly when that information may influence contribution decisions.¹
• Dompé’s parent company voluntarily disclosed the conduct, and the Department of Justice credited the companies’ cooperation and remediation, underscoring the potential significance of internal compliance reviews and self-disclosure in False Claims Act matters.^1,2 

Dompé U.S. Inc. has agreed to pay $32 million to resolve allegations that it used contributions to independent patient assistance foundations to cover Medicare beneficiaries’ copayments for Oxervate (cenegermin-bkbj) in a manner that violated the Anti-Kickback Statute (AKS) and False Claims Act (FCA).^1,2

The September 10 settlement provides a detailed look at the compliance risks pharmaceutical manufacturers can face when contributing to patient assistance foundations, particularly when companies obtain information about foundation funding levels or patient activity that may influence contribution decisions.

The resolution is also notable because Dompé farmaceutici S.p.A., the Italian parent company of Dompé U.S., voluntarily disclosed the conduct to the government following an internal compliance review. The Department of Justice (DOJ) said Dompé received credit for its self-disclosure, cooperation, and remediation.^1,2

Settlement Centers on Oxervate Copay Assistance

Oxervate is a topical biologic approved by the U.S. Food and Drug Administration for neurotrophic keratitis, a rare degenerative eye disease that can lead to corneal damage and permanent vision loss.¹

According to the settlement agreement, Dompé U.S. employees expressed reservations around the time of the drug’s 2018 U.S. launch about launching Oxervate before the company had contributed to a patient assistance foundation that could help eligible patients with copayments.¹

Following discussions between Dompé personnel and the National Organization for Rare Disorders (NORD), NORD established a neurotrophic keratitis fund in December 2018. Dompé contributed to that fund. The PAN Foundation subsequently established a neurotrophic keratitis fund in 2019 with an initial contribution from Dompé.¹

The government alleged that between 2018 and 2021, Dompé’s contributions to these foundations were used to pay Medicare beneficiaries’ copayments for Oxervate and that the arrangement induced purchases of the company’s drug in violation of federal law.^1,2

The claims resolved by the settlement are allegations, and the agreement does not constitute a determination of liability.²

Foundation Data Raises Compliance Concerns

A particularly significant component of the settlement involves Dompé’s access to information concerning the patient assistance foundations.

According to the settlement agreement, Dompé had an annual budgeting process for determining foundation contributions but sometimes approved additional funding during the year. The company also maintained certain funds in reserve so it could determine which foundation was running low on funding and allocate additional contributions accordingly.¹

DOJ also said Dompé solicited patient assistance foundation data directly from the foundations and from the specialty pharmacy providing hub services to Oxervate patients. Certain employees involved in determining foundation budgets received this information directly or indirectly.^1,2

The settlement therefore highlights an important distinction for pharmaceutical compliance programs: manufacturer contributions to independent charitable foundations are not inherently prohibited, but the independence of those organizations and the information available to manufacturers when determining contributions can be critical.

An analysis of the settlement by FDA Law Blog noted that the government’s concern focused not simply on Dompé’s donations but on whether information about foundation funding and patient assistance activity allowed the manufacturer to make contribution decisions that benefited patients using its own product.³

Anti-Kickback Statute Creates Risks for Manufacturer Copay Assistance

The AKS prohibits pharmaceutical manufacturers from offering or paying remuneration, directly or indirectly, to induce Medicare beneficiaries to purchase their products.²

That prohibition can extend to manufacturers indirectly paying patients’ cost-sharing obligations through charitable organizations when the arrangements do not preserve sufficient independence between the manufacturer and foundation.

Medicare beneficiaries may be responsible for copayments, coinsurance, or deductibles when receiving covered prescription drugs. Federal enforcement authorities have long viewed those cost-sharing requirements as part of the program’s mechanism for influencing utilization and health care spending.²

For manufacturers, the Dompé settlement reinforces the importance of maintaining appropriate separation between charitable contributions and commercial objectives.

Self-Disclosure and Remediation Play Prominent Role

Unlike many pharmaceutical kickback settlements, Dompé’s voluntary disclosure is a central element of the resolution.

Dompé farmaceutici voluntarily disclosed the conduct after Dompé U.S. identified it through an internal compliance review. Following the disclosure, both companies cooperated with the government’s investigation.²

According to the U.S. Attorney’s Office for the District of Massachusetts, Dompé had also implemented changes to its patient assistance foundation contribution practices by 2022.²

The government explicitly credited Dompé under DOJ guidelines for voluntary self-disclosure, cooperation, and remediation in FCA matters.^1,2

The resolution therefore provides a practical example of how an effective compliance program can affect enforcement outcomes even after potentially problematic conduct has occurred. Internal monitoring that identifies potential violations, followed by disclosure and remediation, may be considered by DOJ when resolving FCA investigations.

Compliance Implications for Pharmaceutical Manufacturers

The settlement reinforces several considerations for manufacturers that contribute to independent patient assistance foundations.

Compliance programs should evaluate controls governing:

• the information employees may receive from patient assistance foundations;
• how contribution amounts and timing are determined;
• whether commercial personnel participate in funding decisions;
• communications with foundations regarding disease-specific funds;
• information obtained from specialty pharmacies and patient hub providers;
• mid-year or supplemental foundation contributions; and
• documentation demonstrating the independence of charitable giving decisions.

Manufacturers may also benefit from reviewing whether aggregate data could effectively reveal information about patients receiving their products, particularly in disease states with small patient populations or few available therapies.

The Dompé matter illustrates that compliance risk may arise not merely from making a charitable contribution but from the relationship between the manufacturer’s funding decisions, the information available to company personnel, and the use of those contributions to subsidize federal health care program beneficiaries.

Looking Ahead

The $32 million resolution adds to a substantial history of federal enforcement involving pharmaceutical manufacturer donations to patient assistance foundations.

At the same time, the prominent treatment of Dompé’s voluntary disclosure distinguishes the settlement as an important compliance case study. The government’s acknowledgment of the company’s internal review, self-disclosure, cooperation, and remediation provides pharmaceutical manufacturers with additional insight into how DOJ evaluates corporate conduct after potential violations are identified.

For manufacturers operating patient support and charitable giving programs, the settlement reinforces two complementary compliance priorities: maintaining sufficient independence between commercial interests and patient assistance foundation contributions, and establishing internal systems capable of detecting, escalating, and addressing potential violations when they occur.

References

1. U.S. Department of Justice. Settlement Agreement: United States of America and Dompé U.S. Inc. Published September 2026. Accessed September 16, 2026. https://www.justice.gov/opa/media/1460856/dl
2. Dompé U.S. Agrees to Pay $32 Million to Resolve Kickback Allegations Involving Patient Assistance Foundations. U.S. Attorney’s Office for the District of Massachusetts. Press release. Published September 10, 2026. Accessed September 16, 2026. https://www.justice.gov/usao-ma/pr/dompe-us-agrees-pay-32-million-resolve-kickback-allegations-involving-patient-assistance 
3. Santiago A, Wasserstein JN, Walsh AK. Dompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-Disclosure. FDA Law Blog. Published September 15, 2026. Accessed September 16, 2026.  https://www.thefdalawblog.com/2026/09/dompe-u-s-pays-32-million-to-resolve-co-pay-foundation-kickback-allegations-following-voluntary-self-disclosure/