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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.”

Compliance and Oversight

As part of the settlement, Semler also agreed to adopt internal compliance measures under the oversight of the Department of Health and Human Services’ Office of Inspector General to prevent future misconduct.

The claims were first raised in a whistleblower lawsuit filed by two private parties, who will receive approximately $6.5 million from the recovery under the False Claims Act’s qui tam provisions.

No Immediate Comment

Representatives for Semler and Bard did not immediately respond to requests for comment Friday.

The settlement brings closure to a decade of alleged misrepresentations that prosecutors said improperly enriched the companies while depleting Medicare funds, reinforcing the DOJ’s aggressive stance on healthcare fraud and misuse of taxpayer dollars.