Fridley, Minn.-based Medtronic has agreed to pay $23.5 million to settle allegations that it paid kickbacks to physicians to induce their use of company pacemakers and defibrillators, according to a news release from the Department of Justice.
The United States claimed the company used physician payments related to post-market studies and device registries as vehicles for kickbacks. Post-market studies are meant to assess a device's clinical performance after it has been approved by the Food and Drug Administration, while registries are collections of data maintained by the manufacturer detailing the number of devices that have been sold and implanted.
The government contends that Medtronic solicited physicians for these studies and registries to persuade them to use Medtronic devices and stop using competitors' products. Each of the studies and registries allegedly required a new or previous implant of a Medtronic defibrillator or pacemaker in each patient.
For every patient implant, Medtronic allegedly paid participating physicians a fee ranging from approximately $1,000-$2,000. This allegedly resulted in false claims submitted to Medicare and Medicaid.
The settlement resolves allegations presented in two whistleblower suits. The relators who filed those suits will receive payments totaling more than $3.96 million out of the total settlement.
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The United States claimed the company used physician payments related to post-market studies and device registries as vehicles for kickbacks. Post-market studies are meant to assess a device's clinical performance after it has been approved by the Food and Drug Administration, while registries are collections of data maintained by the manufacturer detailing the number of devices that have been sold and implanted.
The government contends that Medtronic solicited physicians for these studies and registries to persuade them to use Medtronic devices and stop using competitors' products. Each of the studies and registries allegedly required a new or previous implant of a Medtronic defibrillator or pacemaker in each patient.
For every patient implant, Medtronic allegedly paid participating physicians a fee ranging from approximately $1,000-$2,000. This allegedly resulted in false claims submitted to Medicare and Medicaid.
The settlement resolves allegations presented in two whistleblower suits. The relators who filed those suits will receive payments totaling more than $3.96 million out of the total settlement.
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