Biotronik Reaches $12.95 Million Settlement With DOJ Over Improper Payment Allegations

Biotronik today agreed to pay a $12.95 million settlement with the United States Department of Justice (DOJ) to resolve allegations that it violated the False Claims Act.

The DOJ alleged that the heart device maker violated the False Claims Act by causing false claims to be submitted to Medicare and Medicaid by paying bribes to doctors to induce them to use Biotronik’s implantable heart devices, such as as pacemakers and defibrillators.

According to a Biotroink press release, the allegations included excessive use of paid consultants on its behalf and that of highly valued medical partners. The company said the parties – the company, the DOJ, the U.S. Attorney’s Office for the Central District of Californiaand the US Department of Health and Human Services (HHS) – agreed that the settlement is not an admission of liability.

“The company is pleased to put this investigation behind us so that we can continue our mission to provide innovative solutions that save and improve the lives of patients every day,” said Biotronik’s president. Ryan Walters said. “Our guiding principle, ‘Excellence for Life’, is reflected in everything we do, including continuous improvements to our compliance culture. Acting responsibly with our customers and partner doctors is essential.

A separate DOJ press release said Biotronik allegedly abused a new employee training program by paying doctors for excessive training and – in some cases – for training events that never took place. or had little or no value to trainees.

Biotronik is said to have made the payments despite concerns raised by its own compliance department, which warned that vendors had “too much influence” in selecting doctors to provide training for new employees and that training payments were being overused.

The settlement also resolves allegations that Biotronik paid for doctors’ holiday parties, wine tours and lavish meals without a legitimate business purpose, as well as international business class airfare and honorarium in exchange for cameo appearances. at international conferences. These allegations would mean that Biotronik violated anti-bribery law.

As a result of the settlement, Arizona, California, Illinois, Missouri and Nevada paid a portion of the Medicaid claims at issue and will receive a total of approximately $933,400.

The civil settlement includes the resolution of claims filed under the qui tam (whistleblower) provisions of the False Claims Act by Jeffrey Bell and Andrew Schmid, both of whom were previously employed as independent sales representatives for Biotronik. Bell and Schmid will receive approximately $2.1 million as their share of the recovery in this case.

“Paying bribes to doctors to influence their selection of medical devices undermines the integrity of federal health care programs, said Senior Assistant Deputy Attorney General Brian M. Boynton, Division Chief Civil Service from the Department of Justice. “When medical devices are used in surgical procedures, patients deserve to know that their device was selected based on quality of care considerations and not improper payments from manufacturers.”

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