Medtronic has agreed to pay a total of more than $9 million dollars to settle allegations that it paid kickbacks to a South Dakota neurosurgeon, federal prosecutors announced today.
The Minnesota-based medical device maker is accused of violating the False Claims Act and failing to accurately report to CMS payments it made to Dr. Wilson Asfora, allegedly to induce him to use one of its implantable devices. Medtronic also allegedly held more than 100 events over a nine-year period at a restaurant owned by Asfora.
“Allegations of kickbacks are taken very seriously. Such actions threaten the integrity of federal healthcare systems,” said Curt L. Muller, Special Agent in Charge for the Office of Inspector General of HHS. “We will continue working with our law enforcement partners to protect patients and taxpayers.”
“Outside of a small number of sales employees, DOJ’s investigation did not find that Medtronic was aware of this alleged misconduct at the time it occurred,” said a company spokesman in an emailed statement. “Upon investigation of this conduct, which violated the company’s policies, Medtronic took various remedial steps, including termination and other disciplinary action against employees directly or peripherally involved, and enhancing relevant training.”
Federal prosecutors allege that Medtronic made payments to Asfora’s restaurant at his request, knowing that Asfora owned the restaurant, but underreported those payments to CMS, a violation of CMS’ Open Payments Program.
Asfora and two of his other companies are defendants in a separate False Claims Act lawsuit that alleges Asfora received kickbacks to use certain implants in his spinal surgeries, according to a press release from the U.S. Department of Justice.
The claims resolved by the settlement are allegations only, and there has been no determination of liability. In the statement, Medtronic said it “remains committed to maintaining the highest standards of ethical conduct and compliance with all applicable regulatory guidelines.”