Semler Scientific and Bard: A Medicare Billing Pitch That Would Not Go in Writing

In the Semler Scientific QuantaFlo settlement, Semler agreed to pay $29.75 million and Bard Peripheral Vascular agreed to pay $7.2 million over allegations that they caused false Medicare claims for FloChec and QuantaFlo tests. The government alleged that the devices did not perform the test required by the billing codes the companies promoted. The whistleblowers’ complaint describes the sales pitch down to a clinic that received reimbursement advice the manufacturer allegedly refused to put in writing.

The Department of Justice announced the settlement on September 26, 2025. From approximately 2010 through 2024, Semler manufactured, marketed and distributed the devices for use in diagnosing peripheral arterial disease. Bard served as its distributor from 2012 through 2022. The health care fraud case traced what the companies told healthcare providers into the claims those providers sent Medicare.

What FloChec and QuantaFlo Measured

FloChec and QuantaFlo used a light sensor to detect changes in blood volume, a technique called photoplethysmography. The government’s allegation turned on the difference between that measurement and the ankle brachial index, commonly called an ABI.

Peripheral arterial disease in the legs involves narrowing or blockage of the vessels carrying blood between the heart and legs. An ABI compares blood pressure in the ankle with blood pressure in the arm. The government alleged that Semler promoted CPT billing codes 93922, 93923 and 93924, which required an ABI plus additional testing. According to the Justice Department, Medicare also excluded the noninvasive vascular tests using photoplethysmography at issue here.

The Food and Drug Administration had cleared both devices. But, as the government described it, the agency had also told Semler that they did not perform an ABI and could not be called a digital ABI. The alleged billing pitch depended on a capability the agency had specifically told the manufacturer its devices did not have.

How Does Reimbursement Work for Medical Devices?

The government alleged that FloChec and QuantaFlo tests did not qualify for Medicare reimbursement: the devices did not perform the ABI required by the promoted codes, and their light-sensor technology fell within the coverage exclusion. Semler allegedly told providers that tests using FloChec and QuantaFlo could be reimbursed under those codes anyway.

The Reimbursement Pitch in Semler’s Own Materials

The whistleblowers’ complaint alleged that reimbursement was part of the product’s appeal. It quoted Semler marketing FloChec as a quick office test requiring no capital equipment purchase or specialized personnel. The company’s coverage FAQ addressed the absence of a code specific to FloChec by pointing customers toward existing codes.

The complaint quoted the FAQ’s explanation:

According to the complaint, Semler placed an existing code’s definition beside its description of FloChec, told customers that other customers were getting paid, and advertised that approximately three procedures per month could cover the rental fee. The sales proposition joined a small operating burden to an expected Medicare payment.

QuantaFlo’s promotional materials made a similar appeal to the work involved. The complaint quoted a Semler presentation saying that a medical aide could perform the test in less than five minutes and that a vascular specialist was no longer needed. Speed, staffing and reimbursement were all part of what the company was selling.

For a physician practice, a manufacturer’s answer to a coding question can influence both the purchase and the bill that follows. Here, the government alleged that Semler continued promoting reimbursement even after third parties raised concerns about it.

Bard’s Referral and the Advice Kept Off Paper

Bard’s alleged role included answering the same reimbursement question. The complaint quoted a letter from a Bard executive describing FloChec as a digital ABI and asserting that it met the definition of a vascular-testing code. It also alleged that Bard’s sales representatives and other employees told providers the devices qualified for Medicare reimbursement.

According to the complaint, Bard encouraged Vascular and Leg Center, a Bakersfield provider specializing in peripheral arterial disease, to buy QuantaFlo units. When the clinic asked whether the test was reimbursable, Bard referred it to Semler. Semler allegedly supplied billing codes, followed by this qualification:

The alleged answer supplied billing instructions that the manufacturer would not document. A customer on the receiving end of that conversation can explain a part of the sales pitch that never reaches the written materials.

The Complaint Also Challenged QuantaFlo’s Accuracy

The whistleblowers alleged that follow-up testing found false-positive QuantaFlo results in 16 of 24 patients referred with abnormal findings suggesting peripheral arterial disease. That evaluation gave the complaint a second way to challenge the product’s promotion: what the device suggested about the patient, alongside what the manufacturer said a provider could bill.

The Complaint’s Medicare Advantage Allegations

The complaint separately alleged Medicare Advantage risk-adjustment fraud: false peripheral arterial disease diagnoses increased the government’s payments to health plans. It described Medicare Advantage, or Part C, as a system in which private plans receive government payments that reflect patients’ recorded health conditions.

The whistleblowers alleged that Semler pitched its devices to those plans as a way to identify more patients with peripheral arterial disease and increase payments. In that account, the sales pitch reached beyond reimbursement for performing a test to the money a diagnosis could bring a health plan.

What Kind of Proof Is Needed to Be a Whistleblower?

For a device coding case, useful evidence connects what the product did, what customers were told and what providers billed. The Semler complaint makes those connections tangible through product descriptions, a coverage FAQ, promotional presentations, a distributor’s letter and a clinic’s reimbursement inquiry.

If you worked in regulatory affairs, you may know what the Food and Drug Administration told the manufacturer. If you handled sales or reimbursement, you may know how the company answered customers after coverage concerns arrived. As a provider, you may know which device was used and which service appeared on the claim. We work with you to connect that knowledge to the company’s decisions and the Medicare billing they influenced.

The same manufacturer-to-provider connection appeared in THD America’s settlement. The government alleged that the device company encouraged additional or substitute procedure codes to get around denials associated with a temporary procedure code. In each case, the manufacturer’s advice allegedly shaped a claim submitted by its customer.

What Semler and Bard Agreed to Do

The Justice Department reported that Bard, the smaller payer, admitted certain allegations and received cooperation credit.

Semler also entered a five-year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General, requiring substantial internal compliance reforms.

How Much Does a Medicare Fraud Whistleblower Get Paid?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. In this case, the Justice Department announced that the two whistleblowers would receive approximately $6.5 million as their collective share of the companies’ settlement recovery.

The whistleblowers brought the allegations in a qui tam case. Their complaint drew on experience in noninvasive vascular diagnostics and cardiovascular health. That experience helped them question both the tests and the reimbursement representations used to sell them.

You Know What Customers Were Told

If you handled the device, the reimbursement questions or the resulting bills, speak with our whistleblower experts about the pitch you saw. We build your strongest Medicare device whistleblower case with you, connecting what the device could do, what the company told customers and what Medicare paid. We bring in medical device whistleblower lawyers who understand coding and coverage, and work with you throughout the case.