Dompé U.S. Inc. (Dompé), based in California, has agreed to pay $32 million to resolve allegations that, between 2018 and 2021, it paid Medicare beneficiary co-pays through two patient assistance foundations to induce the purchase of its drug, Oxervate, in violation of the Anti-Kickback Statute and the False Claims Act.
“This settlement demonstrates the United States’ commitment to enforcing the Anti-Kickback Statute and ensuring that pharmaceutical manufacturers do not use unlawful inducements,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The Department encourages companies that uncover improper kickbacks to self-disclose such conduct.”
“Kickbacks to beneficiaries undermine the purpose of the Medicare co-pay system and drive up the cost of drugs,” said U.S. Attorney Leah B. Foley for the District of Massachusetts. “My Office has recovered over $1.4 billion for taxpayers through settlements and enforcement actions concerning drug company kickbacks to purported charities, and we will continue to pursue these matters to ensure that all drug companies play by the rules and to protect federal taxpayer funded healthcare programs.”
“Pharmaceutical manufacturers that attempt to disguise kickbacks as charitable patient assistance are engaging in blatant misconduct which corrupts medical decision‑making and drains federal health care programs,” said Acting Deputy Inspector General for Investigations Miranda L. Bennett of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “Dompé’s actions undermined critical safeguards Congress put in place to protect Medicare, driving up costs for taxpayers while exploiting patients. HHS-OIG does not tolerate such conduct and will continue to work tirelessly for justice and accountability.”
When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible (collectively “co-pays”). Congress included co-pay requirements in these programs, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs.
Under the Anti-Kickback Statute, a pharmaceutical manufacturer is prohibited from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the company’s drugs. This prohibition extends to the payment of patients’ co-pay obligations.
As part of the settlement, Dompé admitted that, around the time of Oxervate’s 2018 launch in the United States, Dompé U.S. employees expressed reservations about launching the drug before making a payment to a patient assistance foundation that paid the co-pays for Oxervate. After conversations with Dompé employees, two foundations opened funds that, among other things, paid co-pays for Oxervate, and Dompé made contributions to those foundations. Dompé also solicited patient assistance foundation data directly from the foundations, and from the specialty pharmacy that provided hub services to Dompé U.S. patients. This data was provided, directly or indirectly, to certain individuals involved in the patient assistance foundation budgeting process.
Dompé is the U.S. subsidiary of Dompé farmaceutici S.p.A., a pharmaceutical company incorporated in Italy. Dompé farmaceutici self-disclosed this conduct to the United States. Following the disclosure, both Dompé farmaceutici and Dompé U.S. cooperated with the government in this matter and received credit under the Department’s guidelines for taking self-disclosure, cooperation, and remediation into account in False Claims Act cases.
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, 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.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration’s war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division’s FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division’s FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.
The matter was handled by Senior Trial Counsel Sarah Arni of the Civil Division and Assistant U.S. Attorneys Lindsey Ross and Brian LaMacchia for the District of Massachusetts.
The claims resolved by the settlement are allegations only and there has been no determination of liability.