Medtronic, a medical device manufacturer based in Minneapolis, has paid the federal government $2.8 million to resolve allegations it caused certain physicians to submit false claims to federal healthcare programs, according to the Department of Justice.
In its lawsuit, the government alleged Medtronic "knowingly caused dozens of physicians located throughout more than 20 states to submit claims to Medicare and TRICARE for investigational medical procedures known as SubQ stimulation that were not reimbursable," according to the DOJ.
The government further alleged Medtronic promoted SubQ stimulation — a method used to alleviate chronic back pain that the Food and Drug Administration had not established the safety and efficacy of — by having physician-customers attend "on-site training programs" that were sponsored by Medtronic. The alleged violations of the False Claims Act occurred from 2007 through 2011.
The lawsuit was originally filed under the qui tam, or whistle-blower, provisions of the False Claims Act by Jason Nickell, a former Medtronic sales representative.
"Today's settlement demonstrates our commitment to ensure that beneficiaries of federal healthcare plans, including Medicare recipients and military families, receive medical treatments that have been proven safe and effective," said Joyce R. Branda, acting assistant attorney general for the Justice Department's Civil Division.
Regarding the settlement, Medtronic released a statement saying it "denies any wrongdoing, and makes no admission that any of its activities were improper or unlawful." Medtronic said it is "committed to following appropriate marketing and reimbursement practices at all times, and for many years has had in place a comprehensive and robust employee compliance program."
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