Walden Macht Haran & Williams LLP: Semler Scientific, Inc. & Bard Peripheral Vascular, Inc. Agree to Pay a Combined $36.95 Million to Resolve Whistleblower Claims Alleging Fraudulent Medicare Billing; Related Case Against UnitedHealth Group, Inc. and United Health Insurance Company to Proceed

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 photoplethysmography "is considered useful only in determining whether or not a pulse is present, and does not provide reproducible measurements of blood flow."

As alleged in the whistleblower qui tam lawsuit, in direct contravention of this written Medicare payment rule, Semler and Bard marketed the Devices as being reimbursable to diagnose PAD by (allegedly) measuring blood flow. 

As also alleged in the lawsuit, a clinical evaluation of QuantaFlo's accuracy in diagnosing PAD revealed that QuantaFlo falsely diagnosed over 66% of the patients in the study—that is, as alleged, although two thirds of the patients in the study did not have PAD, the results of the QuantaFlo test falsely stated that the patients had the condition. 

PAD is a serious ailment that increases an individual's risk of life-threatening health issues (including coronary heart disease, heart attack, and stroke), and which can result in amputation of affected limbs.  Due to the severity of the condition, PAD is often treated with significant pharmacological and/or medical interventions, so a false positive PAD diagnosis can result in medically unnecessary and potentially harmful treatments.

Today's settlements resolve the submission of alleged false claims to Medicare Part B (a/ka/ "Traditional Medicare") for tests performed using the Devices.  The settlements do not address the qui tam whistleblowers' allegations regarding the conduct of defendant United—involving hundreds of millions of taxpayer dollars and the health of thousands of Medicare beneficiaries—with respect to Medicare Part C.

Unlike Traditional Medicare, Medicare Part C—also known as Medicare Advantage—is administered by private insurance companies, including United.  Under Medicare Advantage, users of the Devices (often vascular physicians and other providers treating conditions related to blood flow) do not submit claims involving the Devices to CMS.  Instead, providers submit claims to Medicare Advantage insurers.

Under Medicare Advantage, once a patient is diagnosed with a condition such as PAD, insurers can "add" that diagnosis to the patient's medical history, and can increase that patient's "risk adjustment factor" a/k/a "risk score."  The higher a patient's risk score, the more money the Medicare Advantage insurer receives from CMS each month for that patient.  As outlined in the qui tam whistleblower lawsuit, United allegedly added false positive PAD diagnoses to many patients' risk scores and thereafter collected inflated monthly payments from CMS.  These financial incentives, and their alleged massive impact on the costs to CMS for patient care, have been the subject of various news articles involving the use of the Devices to diagnose PAD within the Medicare Advantage program. For example, see https://www.wsj.com/business/unitedhealth-doj-medicare-billing-investigation-8d56800d?gaa_at=eafs&gaa_n=ASWzDAjVXFThgfJ7-hEc5cLdSSR87dcmgB58wi9PyiRtM-FkUtw3H4ZbE3CI8pM2OVU%3D&gaa_ts=68c1d654&gaa_sig=S5h5mVNflIrh65CSHp5b8ghAxAeExKZNdrFNcjxTYXqpMxRQKNozepQ6b6epjY2CqZLRCq1C6ctKDCrPF2-3yw%3D%3D; https://www.statnews.com/2024/08/07/unitedhealth-peripheral-artery-disease-screening-program-medicare-advantage-gold-mine/.

Under the False Claims Act, the Department of Justice ("DOJ") had the option of intervening in the whistleblowers' qui tam lawsuit against United.  DOJ declined to intervene in the case, leaving the whistleblowers and their lawyers to take the lead in pursuing the claims against United in court.

"A single mid-sized law firm litigating potential billion-dollar fraud allegations against a behemoth like United is really a David vs. Goliath situation.  So we welcome anyone with information regarding the allegations against United to contact us," said lead counsel for the whistleblowers Dan Miller of Walden Macht Haran & Williams LLP ("Walden Macht").

The case is captioned United States ex rel. Robert Kane and Franklin W. West v. Semler Scientific Inc., C.R. Bard, Inc., Bard Peripheral Vascular, Inc. Collaborative Care Diagnostics, LLC, d/b/a Biomedix, United Health Group, Inc., and United Healthcare Insurance Company, C.A. No. 3:16-cv-1516J-20MCR (M.D. Fla.).  The claims are allegations only, and there has been no determination of liability.

The Walden Macht whistleblower practice group is led by former prosecutor Dan Miller and Jon DeSantis.  Attorneys in the group have worked on cases throughout their careers, both before and while at Walden Macht, that have collectively returned more than $3 billion to state and federal treasuries across the country, including more than a dozen cases that were initially declined by the government.

SOURCE Walden Macht Haran & Williams LLP