Medical-device manufacturer Atricure, West Chester, Ohio, will pay nearly $3.8 million to settle civil charges that it engaged in off-label marketing of its surgical ablation devices, paid kickbacks to surgeons to promote use of the devices and advised hospitals to upcode surgical procedures using the ablation devices in order to get larger payments from Medicare.
Atricure has admitted no wrongdoing as a part of the settlement, according to a news release.
The agreement, reached with the U.S. Justice Department's civil division and HHS' inspector general's office, puts to rest a whistleblower lawsuit that charged Atricure with marketing its ablation devices to treat atrial fibrillation—a use that does not have Food and Drug Administration approval.
“The misuse of medical devices has the potential of exposing patients to dangerous procedures and taxpayers to payment of unwarranted claims against Medicare,” said Tim Johnson, U.S. attorney for the Southern District of Texas. “This settlement demonstrates that government's commitment to maintaining safe and affordable healthcare for its citizens.”