Summary
Dompé U.S. Inc. has agreed to pay $32 million to resolve allegations that it used patient assistance foundations to cover Medicare beneficiary co-pays for Oxervate, potentially inducing purchases of the drug. The U.S. Department of Justice said the conduct occurred between 2018 and 2021 and violated the Anti-Kickback Statute and the False Claims Act (FCA).
The settlement announced on September 10, 2026, follows a voluntary self-disclosure by Dompé farmaceutici S.p.A., the Italian parent company of Dompé U.S. The company also cooperated with the government and received credit for its disclosure, cooperation and remediation.
Dompé Oxervate case at a glance
| Key detail | Information |
| Company | Dompé U.S. Inc. |
| Parent company | Dompé farmaceutici S.p.A., Italy |
| Company location | California, United States |
| Drug involved | Oxervate |
| Settlement amount | $32 million, plus applicable interest |
| Alleged conduct period | 2018–2021 |
| Programs involved | Medicare |
| Legal issues | Anti-Kickback Statute and False Claims Act |
| Patient assistance mechanism | Two patient assistance foundations |
| Disclosure | Voluntary self-disclosure by Dompé farmaceutici |
| Government agencies | DOJ and HHS-OIG, with the U.S. Attorney’s Office for Massachusetts |
The DOJ said the settlement resolves allegations only and that there has been no determination of liability.
Why Dompé agreed to the $32 million settlement
Alleged Medicare co-pay inducement
Medicare beneficiaries who receive covered prescription drugs may be required to pay part of the cost through a co-payment, co-insurance or deductible. The DOJ explained that these patient contributions are intended, among other purposes, to create a market-based check on healthcare costs.
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The Anti-Kickback Statute prohibits pharmaceutical companies from directly or indirectly providing remuneration to induce Medicare patients to purchase drugs reimbursed by Medicare. According to the DOJ, this prohibition can also apply when a manufacturer pays or facilitates the payment of a patient’s co-pay obligation.
The government alleged that Dompé used patient assistance foundations in a way that effectively helped cover Medicare beneficiaries’ Oxervate co-pays. The concern was that such assistance could remove a financial consideration that Congress intended to remain part of the Medicare drug purchasing system.
What happened around the Oxervate launch
Dompé U.S. launched Oxervate in the United States in December 2018. According to the settlement agreement, company employees had expressed reservations about launching the drug before the company made a payment to a patient assistance foundation that covered Oxervate co-pays.
Following discussions involving employees, two foundations opened funds that could cover these co-pays. The company subsequently contributed to those foundations.
The DOJ said the arrangement continued to involve foundation funding decisions in the following years. Between 2019 and 2021, the company sometimes approved mid-year increases in contributions or retained amounts in reserve before determining which foundation required additional funding.
How patient assistance foundations became part of the case
Patient assistance foundations can provide financial support to eligible patients who face prescription drug costs. The government alleged that Dompé’s interactions with the foundations went beyond simply making charitable contributions.
Foundation funding and patient data
The Department of Justice (DOJ) said Dompé solicited data from the patient assistance foundations and from the specialty pharmacy that provided hub services to Dompé U.S. patients.
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Some Dompé employees involved in the foundation budgeting process received this information directly or indirectly. The government identified this access to foundation data as part of the conduct resolved through the settlement.
The settlement agreement states that the United States contended Dompé U.S. improperly paid Medicare beneficiary co-pays through two foundations to induce purchases of Oxervate. The government further alleged that the conduct caused false claims to be submitted to Medicare.
DOJ and HHS-OIG respond to the Dompé case
The settlement brought together several federal enforcement authorities, including the Justice Department’s Civil Division, its Commercial Litigation Branch and Fraud Section, the U.S. Attorney’s Office for the District of Massachusetts, and the Department of Health and Human Services Office of Inspector General.
Assistant Attorney General Brett A. Shumate said the settlement demonstrates the government’s commitment to enforcing the Anti-Kickback Statute and preventing pharmaceutical manufacturers from using unlawful inducements. He also encouraged companies that discover improper kickbacks to voluntarily disclose them.
U.S. Attorney Leah B. Foley said kickbacks to Medicare beneficiaries undermine the purpose of the co-pay system and can increase drug costs. Her office said it has recovered more than $1.4 billion for taxpayers through settlements and enforcement actions involving drug company kickbacks to purported charities.
Acting HHS-OIG Deputy Inspector General for Investigations Miranda L. Bennett said pharmaceutical manufacturers that disguise kickbacks as charitable patient assistance can undermine medical decision-making and federal healthcare programs.
Dompé’s voluntary disclosure and cooperation
Dompé’s case also highlights the role of voluntary corporate disclosure in False Claims Act enforcement.
Dompé farmaceutici voluntarily disclosed the conduct to the U.S. Attorney’s Office for the District of Massachusetts after Dompé U.S. discovered the matter through an internal compliance review. The settlement documents state that the government was not already investigating the conduct when the company made its disclosure.
Following the disclosure, Dompé farmaceutici and Dompé U.S. cooperated with the government. According to the DOJ, the companies received credit under Justice Department guidelines for disclosure, cooperation and remediation in False Claims Act matters.
The settlement agreement says Dompé conducted an internal investigation, produced significant volumes of documents, made witnesses available, identified relevant individuals and third parties, implemented remedial measures, and admitted and acknowledged its conduct.
By 2022, Dompé had also implemented changes to its patient assistance foundation contribution practices, according to the U.S. Attorney’s Office for Massachusetts.
What the settlement means under the False Claims Act
The False Claims Act allows the U.S. government to pursue claims involving false or fraudulent requests for payment from federal programs.
In this case, the government alleged that improper co-pay payments violated the Anti-Kickback Statute and resulted in false claims being submitted to Medicare. The $32 million agreement resolves those civil claims without a judicial finding of liability.
The settlement agreement provides for a $32 million payment plus interest at 4.5% per year from June 29, 2026. The payment was required to be made within 30 days after the agreement’s effective date.
The DOJ emphasized that the claims resolved by the settlement are allegations and that there has been no determination of liability.
Who handled the Dompé investigation
The matter was handled by federal prosecutors and Justice Department attorneys from several offices.
The DOJ identified Senior Trial Counsel Sarah Arni of the Civil Division’s Commercial Litigation Branch, Fraud Section, along with Assistant U.S. Attorneys Lindsey Ross and Brian LaMacchia for the District of Massachusetts.
The case was coordinated among:
- U.S. Department of Justice (DOJ) Civil Division
- Commercial Litigation Branch, Fraud Section
- U.S. Attorney’s Office for the District of Massachusetts
- U.S. Department of Health and Human Services Office of Inspector General
The DOJ said the matter illustrates the government’s continued use of False Claims Act enforcement to combat fraud involving federal healthcare programs.
Why the Dompé case matters for pharmaceutical companies
The Dompé settlement highlights the compliance risks pharmaceutical companies can face when supporting patient assistance programs connected to federally reimbursed medicines.
The case shows why manufacturers need clear controls around foundation contributions, patient assistance funding, access to beneficiary information and communications with independent charitable organizations. Even when assistance is presented as charitable support, the government may examine whether the arrangement could influence Medicare patients’ decisions to use a particular drug.
To read the original order please visit Department of Justice (DOJ) website