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Atricure Inc., a medical device manufacturer based in West Chester, Ohio, has settled a False Claims Act suit with the United States government. The manufacturer has agreed to pay a handsome amount to resolve charges that it improperly marketed its surgical ablation devices to treat atrial fibrillation. Surgical ablation devices work by focusing energy on a patient’s organs to create planned scar tissue. But Atricure’s devices have not been cleared by the U.S. Food and Drug Administration for use with atrial fibrillation. It is a breach of the Food, Drug and Cosmetic Act to market medical devices for unapproved uses and a violation of the False Claims Act to seek reimbursement from government health programs in connection with such unapproved uses.
The government also alleged that Atricure engaged in an array of further violations, including: promoting the use of its devices in expensive heart surgery when less invasive alternatives were called for; encouraging hospitals to up-code surgeries using Atricure devices in order to inflate Medicare reimbursement; and paying illegal kickbacks to health care providers as an incentive for using Atricure devices.
The company’s misdeeds were first revealed in a whistleblower lawsuit brought under the Qui Tam provisions contained in the federal False Claims Act. The statute allows private citizens, known as “relators,” to file lawsuits on behalf of the government and to share in any recovery received. In enacting the Qui Tam portion of the statute, Congress sought to enlist the aid of concerned individuals interested in calling a halt to fraud against our government. In the field of health care alone, the Justice Department has relied on the False Claims Act to recover $2.2 billion since January 2009.
For more information, go to Department of Justice’s Press Release.