Anti-Abortion Ob/Gyn’s New Role; Questioning FDA ‘Recalls’; Padding Profits With PAD

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Anti-Abortion Ob/Gyn Chosen for Maternal Mortality Committee

The Texas maternal mortality and morbidity review committee, formed by the Department of State Health Services in 2013 to track and study maternal deaths and “near-misses,” chose an anti-abortion activist physician for a position originally reserved for a rural community member, according to the Texas Tribune.

Ingrid Skop, MD, who also applied for the urban community member and emergency medicine positions on the committee, has worked as an ob/gyn in San Antonio since 1998. She is among the doctors who sued to get mifepristone pulled off the market in the Supreme Court case that ultimately failed.

The 23 committee slots are filled mostly with doctors, but two were meant to be taken by community members who might advocate on behalf of patients with lived experience. Ultimately, the state health department’s deputy commissioner Kirk Cole chose Skop over another applicant after committee members were divided on new applicants.

A state representative who wrote 2023 legislation to increase the community member positions from one to two said it was never her intention to have those slots filled by more doctors, or to exclude people with lived experience. But the description was also changed in the legislation from a community advocate to “community members with experience in a relevant health care field, including a field involving the analysis of health care data,” according to the Texas Tribune.

Medical Devices Often Stay in Use After a “Recall”

According to a report from CBS News and KFF Health News, a recall of a medical device doesn’t mean the FDA takes it away from doctors and patients.

Even in what the agency calls its most serious “Class I recalls,” where a device has flaws that can cause serious injury or death, a recall can consist of “correcting” the problem by retraining doctors or repairing or re-labeling the device, the article stated. In some cases, companies tell doctors to discuss risks of removing the device versus leaving it in place with the patient.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” an FDA spokesperson told CBS and KFF.

Another FDA spokesperson said that of 338 Class I medical device recalls from 2019 to 2023, 164 were corrections and 174 were removals.

For example, Abbott’s MitraClip line, which uses equipment to implant tiny clips into the heart’s mitral valve to treat mitral regurgitation, has had three rounds of recalls, but none were removed from use.

Doctors in some cases were unable to separate the clip from the delivery system, or faced “clip locking malfunctions,” according to the report. Patients underwent surgeries where they experienced serious complications, and at least two patients died, though the manufacturer said the deaths were related to the procedure itself or “case-specific circumstances.”

Medtronic’s StealthStation S7 cranial software was providing inaccurate views of the brain for surgery and even “missed the tumor” in one case, the article stated. Yet a 2021 recall left it in use, with a warning applied to the systems and promises of a software update. Devices from Abiomed and Getinge have been subject to similar recalls, the news outlets reported.

The Little Device That Made UnitedHealth Billions

A STAT 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.”

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