DOJ probes device maker whose test resulted in lucrative diagnoses for UnitedHealth and other insurers

The Department of Justice is investigating Semler Scientific for possible violations of a federal anti-fraud law related to its marketing of a product known as QuantaFlo, a test used in the diagnosis of peripheral artery disease by UnitedHealth Group and other large insurers.

In a recent filing with the Securities and Exchange Commission, Semler disclosed that the government is investigating the use of QuantaFlo related to claims made for reimbursement from government health programs, which in some cases pay insurers more money to cover patients diagnosed with peripheral artery disease.

The SEC filing states that on Feb. 11, Semler began — but then cut off — settlement discussions with the Department of Justice related to possible violations of the False Claims Act, an anti-fraud law designed to prevent companies from collecting unwarranted payments from the federal government. The company indicated that the investigation began in 2017 and picked up in intensity in late 2024 and early 2025.

STAT+ Exclusive Story

This article is exclusive to STAT+ subscribers

Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

Already have an account? Log in

View All Plans

To read the rest of this story subscribe to STAT+.

After Pushback, J&J Allows Generics of Its TB Drug

Following a public pressure campaign, Johnson & Johnson (J&J) will allow a Swiss non-profit to provide generic bedaquiline (Sirturo) to low- and middle-income countries to

July 15, 2023

Shoreline cuts staff as its partnership with Gilead’s Kite is now in flux

Shoreline Biosciences, a gene editing and cell therapy biotech, has let go of staffers dedicated to a cell therapy project that’s working with Gilead’s Kite

January 10, 2025

Supercharge Your Portfolio with Future Health Stocks!

Join us for Profitable Insights & Expert Tips!

With expert analysis, comprehensive market coverage, and actionable insights, our newsletter equips you with the knowledge & tools necessary to make informed decisions & maximize your potential returns in the dynamic world of future health stocks.