Little Device That Made UnitedHealth Billions

 A STAT

opens in a new tab or window investigation revealed how, from 2018 to 2021, UnitedHealth ramped up screening for peripheral artery disease (PAD) with the widespread use of a device called QuantaFlo. The practice, according to STAT, allowed the company to earn billions in reimbursement from taxpayer-funded Medicare Advantage for both "valid and questionable PAD diagnoses."

Doctors and experts told STAT the device was not accurate enough, and that false positives had worried their patients and likely led to unnecessary treatment. QuantaFlo was approved through an accelerated FDA pathway and was quickly incorporated into UnitedHealth's primary care clinics and a UnitedHealth home visit program in nearly every state that screened for the disease, even without symptoms, according to the report.

Several doctors described either ignoring the mandate from their employer to use QuantaFlo, or using more accurate tests to verify the diagnoses.

UnitedHealth's guidance for its home visit program supported screening with no symptoms of PAD, but its own guidance for its insurance plan medical reviewers advised against this.

In an email between UnitedHealth leadership, one executive wrote to another, "You mentioned vasculatory disease opportunities, screening opportunities, etc with huge $ opportunities. ... Lets [sic] turn on the gas!"

This year, CMS eliminated the diagnostic code for peripheral artery disease without complications, and UnitedHealth's screenings for PAD plummeted. The company that makes QuantaFlo, however, is now seeking approval from the FDA to use its devices to diagnose "heart dysfunction."

https://www.medpagetoday.com/special-reports/features/111511