A product photograph of the Quantaflow device plugged into a laptop computer on a plain white background
The QuantaFlo artery disease test used by UnitedHealth.

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.

A law firm representing health care fraud whistleblowers is suing UnitedHealth Group over its use of a peripheral artery disease test, called QuantaFlo, to increase payments it received from the government Medicare program, after the Department of Justice declined to pursue a case against the nation’s largest health care company. 

The DOJ’s decision was revealed in federal court documents unsealed on Friday as the government disclosed a $29.75 million settlement of fraud claims with Semler Scientific, the maker of the QuantaFlo test. The Justice Department also reached a $7.2 million agreement with CR Bard, the former distributor of the test now owned by BD, according to the documents unsealed in the Middle District Court of Florida.

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“Medical device companies that misrepresent the capabilities of their products and encourage providers to bill Medicare for services that do not meet coverage requirements drain critical taxpayer-funded resources,” said Isaac Bledsoe, acting special agent in charge of the Health and Human Services Department Office of Inspector General, in a statement

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