DOJ: Dompe US Agrees to Pay $32 Million to Resolve Anti-Kickback Allegations Involving Patient-Assistance Foundations
Last updated 2026-09-16 · Source: justice.gov
Primary source: justice.gov: DOJ: Dompe US Agrees to Pay $32 Million to Resolve Anti-Kickback Allegations Involving Patient-Assistance Foundations
The Department of Justice announced a $32 million settlement with Dompe US to resolve False Claims Act allegations. The drug manufacturer was accused of violating the Anti-Kickback Statute by using patient-assistance foundations to pay Medicare beneficiary co-pays for its drug, Oxervate, thereby inducing purchases.
What this means for your practice
This enforcement action underscores the federal government's unwavering commitment to prosecuting violations of the Anti-Kickback Statute and the False Claims Act. For telehealth companies, medspas, dental practices, chiropractic offices, and other healthcare businesses, this case serves as a critical reminder that any financial arrangement or patient assistance program that could be perceived as an inducement for referrals or the use of specific products or services can trigger severe scrutiny. Providers and entities must ensure their patient financial assistance programs, or any interactions with such programs, are structured to prevent even the appearance of impropriety. The government explicitly states that kickbacks to beneficiaries undermine the purpose of Medicare co-pays and drive up healthcare costs. While this case focuses on a pharmaceutical manufacturer, the underlying principles apply broadly to all participants in federal healthcare programs, including how patient co-pays, deductibles, or other out-of-pocket expenses are handled or influenced.
Washington, D.C. – The Department of Justice (DOJ) recently announced a $32 million settlement with Dompé U.S. Inc. (Dompé), a pharmaceutical manufacturer, to resolve allegations under the False Claims Act. These allegations stemmed from the company's alleged violation of the Anti-Kickback Statute, specifically concerning its use of patient-assistance foundations to cover Medicare beneficiaries' co-pays.
The Core Allegations
Between 2018 and 2021, Dompé U.S. was accused of paying Medicare beneficiary co-pays through two patient assistance foundations. The intent of these payments, according to the DOJ, was to induce the purchase of its drug, Oxervate. Such actions are considered a violation of the Anti-Kickback Statute and subsequently, the False Claims Act.
Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division emphasized, “This settlement demonstrates the United States’ commitment to enforcing the Anti-Kickback Statute and ensuring that pharmaceutical manufacturers do not use unlawful inducements.”
Understanding the Anti-Kickback Statute (AKS) and False Claims Act (FCA)
Congress established co-pay requirements in federal healthcare programs, such as Medicare, to encourage market forces to help control healthcare costs, including drug prices. The Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) broadly prohibits individuals or entities from knowingly and willfully offering, paying, soliciting, or receiving any remuneration—which includes anything of value—to induce or reward referrals for items or services reimbursable by a federal healthcare program. This prohibition extends to pharmaceutical manufacturers paying patients’ co-pay obligations, as such payments can serve as inducements.
When such inducements result in claims submitted to federal healthcare programs, those claims become
Key Facts
| Detail | Value | |---|---| | Settlement Amount | $32 million | | Accused Party | Dompé U.S. Inc. | | Alleged Conduct Period | 2018 and 2021 | | Allegations | Paying Medicare beneficiary co-pays through patient assistance foundations to induce Oxervate purchases | | Violated Statutes | Anti-Kickback Statute and False Claims Act | | Resolution | Settlement of False Claims Act liability; credit for self-disclosure, cooperation, and remediation |
Frequently Asked Questions
What was Dompe US accused of in this settlement?
Dompe US was accused of paying Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug, Oxervate, between 2018 and 2021.
Which federal laws were allegedly violated?
The company allegedly violated the Anti-Kickback Statute and the False Claims Act.
What is the government's concern regarding paying patient co-pays?
The government views such payments as kickbacks that undermine the purpose of the Medicare co-pay system, which is designed to encourage market forces to serve as a check on healthcare costs, and can drive up drug prices.
Can pharmaceutical manufacturers directly or indirectly pay a patient's co-pay obligation?
No, under the Anti-Kickback Statute, a pharmaceutical manufacturer is prohibited from offering or paying, directly or indirectly, any remuneration, including money or other things of value, to induce Medicare patients to purchase the company’s drugs. This prohibition extends to the payment of patients’ co-pay obligations.
Did Dompe US receive any credit for its actions?
Yes, Dompé farmaceutici self-disclosed the conduct to the United States, and both Dompé farmaceutici and Dompé U.S. cooperated with the government, receiving credit under the Department’s guidelines for self-disclosure, cooperation, and remediation in False Claims Act cases.