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Medtronic will pay the Government to Settle False Claims Allegations

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Medtronic will pay the Gov. to Settle False Claims

Medtronic will pay the Gov. to Settle False Claims

Medtronic will pay the United States government to settle a case involving allegations that the medical device maker caused some physicians from more than 20 states to submit false claims to Medicare, TRICARE and other federal health programs for the investigational and non-reimbursable “SubQ stimulation” procedures from 2007 through 2013.

SubQ stimulation devices are spinal cord stimulators that are inserted beneath the skin near an area where the patient is experiencing pain, typically the lower back. The SubQ devices are intended to release electrical impulses that cause a “tingling” meant to amend chronic pain. According to the U.S. Department of Justice (DOJ), Medtronic arranged company-sponsored “on-site training programs” for physicians and customers even though the procedure’s safety and efficacy had not yet been established under the U.S. Food and Drug Administration’s (FDA) mandates.

“Today’s settlement demonstrates our commitment to ensure that beneficiaries of federal health care plans, including Medicare recipients and military families, receive medical treatments that have been proven safe and effective,” said Acting Assistant Attorney General Joyce R. Branda of the DOJ’s Civil Division. “Targeting chronic pain patients with a medical procedure that lacks evidence of clinical efficacy wastes the country’s health care resources.”

The lawsuit was filed under the whistleblower provision of the False Claims Act, which enables private parties to bring litigation on behalf of the government for false claims, with the possibility of obtaining part of the government’s recovery. In this case, the former Medtronic sales represented who filed suit will collect $602,000, according to the DOJ.

Medtronic has settled cases with the DOJ in the past. The firm’s Sofamor Danek division (MSD) settled with the government over allegations that the company paid kickbacks to doctors to convince them to use MSD’s spinal products, thereby violating the Anti-Kickback Statute and the False Claims Act. The government also alleged that Medtronic engaged in other improper sales and marketing practices. Medtronic denied any wrongdoing, but agreed to place $40 million in escrow for the DOJ for distribution to the Department and the whistleblower. disclaimer: This article: Medtronic will pay the Government to Settle False Claims Allegations was posted on Tuesday, February 10th, 2015 at 4:04 pm at and is filed under Fraud Lawsuits.

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