PHILADELPHIA, Sept. 26, 2025 /PRNewswire/ -- Semler Scientific, Inc. will pay $29.75 million and Bard Peripheral Vascular, Inc. will pay $7.2 million to settle a whistleblower lawsuit under the False Claims Act nearly nine years after two whistleblowers came forward alleging widespread fraudulent Medicare billing relating to medical devices—known as "Flochec" and "QuantaFlo" (the "Devices")—manufactured by Semler and co-marketed by Semler and Bard. Other defendants in the case include UnitedHealth Group, Inc. and UnitedHealth Insurance Company (collectively "United"). The case against United has not settled and will proceed into litigation. At stake are hundreds of millions in taxpayer dollars and the health of thousands of Medicare patients.
The whistleblowers, Robert Kane and Frank West, allege that Semler and Bard violated the False Claims Act by marketing the Devices as being reimbursable for the diagnosis of peripheral artery disease ("PAD"), despite the existence of express Medicare requirements that prohibit such reimbursements.
The Devices use a single clip-on light sensor that is attached to the fingers and toes to generate a photoplethysmographic waveform ("photoplethysmography"). Since 1980, Medicare has refused to pay for certain diagnostic tests that use photoplethysmography because, among other things, Medicare considers those procedures "experimental." See Medicare National Coverage Determination 20.14 ("NCD"). Specifically, Medicare NCD 20.14 provides that...
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