On July 22, 2022, the United States Department of Justice (DOJ) announced a $12.95 million settlement with Biotronik Inc., a medical device manufacturer, to resolve allegations that the company violated the False Claims Act.

The civil suit, originally brought under the qui tam provisions of the False Claims Act by former independent sales representatives for Biotronik alleged that Biotronik caused the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce their use of Biotronik’s cardiac devices (i.e., pacemakers and defibrillators). The United States intervened in the qui tam case in June 2021.

More specifically, the DOJ alleges that Biotronik abused a new employee training program by paying physicians for an excessive number of trainings, and in some cases, paying the physicians for training events that either did not actually take place or did take place but offered little to no value to new employees. Under written agreements between Biotronik and the training physicians, physicians paid a fixed fee of roughly $400 each time a Biotronik employee received training during one of the physician’s CRM implant procedures. During the training program implant procedure, the training physician was supposed to educate the Biotronik employee on Biotronik’s devices and how to assist a physician during an implant procedure.

The settlement also covers allegations that Biotronik paid for physician holiday parties, winery tours, and lavish...

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