Medical device manufacturer Atricure, Inc., has agreed to pay $3.76 million to resolve civil claims in a Medicare fraud case.
The Justice Department alleges that the West Chester, Ohio-based company marketed its medical devices to treat atrial fibrillation, a use that is not approved by the U.S. Food and Drug Administration.
Charges include the promotion of expensive heart surgery using the company’s devices when less invasive alternatives were appropriate, advising hospitals to up-code surgical procedures using the company’s devices to inflate Medicare reimbursement, and paying kickbacks to healthcare providers to use its devices.
Justice officials are charging that Atricure knowingly violated the Food, Drug and Cosmetic Act and caused the submission of false and fraudulent claims in violation of the False Claims Act.
"This settlement reflects our commitment to enforce the Food, Drug and Cosmetic Act and protect Medicare from the improper marketing practices of Atricure and other medical device manufacturers," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.
The allegations were made against Atricure in a lawsuit filed under the qui tam or whistleblower provisions of the False Claims Act.
"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, United States Attorney for the Southern District of Texas.