It has emerged that several medical device makers are being investigated by the U.S. Justice Department over the marketing of surgical-ablation devices.
Surgical ablation devices use focused energy to create controlled lesions or scar tissue on a patient’s heart or other organs.
According to a report filed by The Wall Street Journal, the Justice Department is investigating whether companies that make these surgical-ablation devices have been violating the law by actively marketing them for non-FDA-approved uses, such as treating atrial fibrillation. The report also mentioned that in the case of surgical ablation, an examination of some documents from leading device makers suggests that the industry has been treading a fine line. Although the documents aren’t always explicit, some companies seem to have encouraged hospitals and doctors to consider the possibility of using their devices specifically for A-fib.
In February this year, Atricure Inc., a medical device manufacturer, agreed to pay $3.76 million to resolve civil claims in connection with the alleged promotion of its surgical ablation devices, according to the Justice Department.
The settlement resolved allegations that the West Chester, Ohio-based company marketed its medical devices to treat atrial fibrillation (the most common cardiac arrhythmia or abnormal heart rhythm), a use that is not approved by the FDA.
Atricure also allegedly promoted expensive heart surgery using the company’s devices when less invasive alternatives were appropriate, advised hospitals to up-code surgical procedures using the company’s devices to inflate Medicare reimbursement, and paid kickbacks to health care providers to use its devices.
It was asserted that by engaging in this conduct, 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 was part of the government’s emphasis on combating health care fraud. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover approximately $2.2 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 have topped $3 billion.
