AtriCure, based in West Chester, Ohio, manufactures surgical ablation devices, which use focused energy to create controlled lesions or scar tissue on the heart or other organs.
“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 Justice Department, in a written statement.
According to the Justice Department, AtriCure also allegedly promoted expensive heart surgery that used the company’s devices when less invasive alternatives were appropriate, advised hospitals to up-code surgical procedures involving the company’s products to inflate Medicare reimbursement and paid kickbacks to providers to use its devices, all in violation of the federal False Claims Act.
“Moving forward, the men and women of AtriCure have never been more passionate and committed to our mission of improving and preserving human life or more confident in the power of our strategic plan,” said David Drachman, president and CEO of AtriCure, in a written statement.
The allegations against AtriCure were made in a lawsuit filed under the whistleblower provisions of the False Claims Act. The settlement was coordinated by the Justice Department’s Civil Division, the U.S. Attorney’s Office for the Southern District of Texas, HHS’ Office of the Inspector General and the FDA Office of Chief Counsel.
Read the U.S. Justice Department’s release about AtriCure.
Read AtriCure’s press release about the settlement.
