Biotronik to Pay $13M to Settle Whistleblower Allegations

Biotronik has agreed to pay almost $13 million to settle allegations it violated the False Claims Act by causing false Medicare and Medicaid submissions via kickbacks to physicians to induce use of Biotronik’s pacemakers and defibrillators.
 
“Paying kickbacks to doctors to influence their selection of medical devices undermines the integrity of federal healthcare programs,” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division told the press. “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 on improper payments from manufacturers.”
 
“Kickbacks to doctors are illegal because they impose hidden costs on the health care system and they taint the doctor-patient relationship,” said Acting U.S. Attorney Stephanie S. Christensen for the Central District of California. “The resolution to this matter concludes a lengthy investigation that demonstrates our commitment to take strong action when patient care takes a backseat to generating profits.”
 
“Valuable taxpayer dollars that fund Medicare and Medicaid are meant to support the delivery of health care services most suitable for beneficiaries. The payment of kickbacks to medical providers to impel their use of certain devices can improperly divert those dollars and undermine the quality of care being provided to patients,” said Special Agent in Charge Timothy DeFrancesca of the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG). “HHS-OIG remains dedicated to working with fellow law enforcement agencies to safeguard the integrity of federal health care programs and the services they cover.”
 
Biotronik allegedly abused a new employee training program by paying physicians for excessive trainings and in some cases for training events that never occurred or were of little to no value. The payments were allegedly made despite concerns raised by its compliance department, which warned that salespeople had too much influence in choosing physicians to conduct new employee training and payments were being overused.
 
The settlement also resolves allegations that Biotronik violated the Anti-Kickback Statute when it paid for physicians’ holiday parties, winery tours, lavish meals with no legitimate business purpose, and international business class airfare and honoraria in exchange for making brief appearances at international conferences.
 
The civil settlement includes resolution of claims brought under whistleblower provision of the False Claims Act by former Biotronik independent sales reps Jeffrey Bell and Andrew Schmid.