The U.S. Department of Justice announced Friday that two medical device companies will pay nearly $37 million to settle allegations they pushed healthcare providers to submit improper Medicare claims for artery disease tests.
DOJ Targets False Claims
According to the DOJ, Semler Scientific Inc. and Bard Peripheral Vascular Inc. misled providers by promoting that tests using Semler’s FloChec and QuantaFlo devices were reimbursable under Medicare, even though the U.S. Food and Drug Administration had not cleared the devices for the reimbursable diagnostic use.
The deal requires Semler to pay $29.8 million, while Bard — which distributed the devices between 2012 and 2022 — will contribute $7.2 million.
Marketing Despite Warnings
The DOJ said both companies continued marketing the devices as reimbursable even after concerns were raised by third parties about Medicare coverage. Officials alleged this conduct led healthcare providers to file thousands of false claims.
“Government programs expect an honest exchange between suppliers and programs funded by taxpayer dollars,” said U.S. Attorney Gregory W. Kehoe for the Middle District of Florida. “When facts are misrepresented for profit, the resources meant for patients are drained.”