New Role for Anti-Abortion Obstetricians and Gynecologists; Challenging FDA ‘Withdrawals’; Boosting Profits with PADs

Welcome to the latest edition of Investigative Roundup, where we bring you the best investigative reporting in healthcare each week.

Anti-abortion obstetrician-gynecologist elected to Maternal Mortality Committee

The Texas Maternal Morbidity and Morbidity Review Commission, established by the Department of State Health Services in 2013 to track and investigate maternal deaths and “near misses,” has selected an anti-abortion activist physician for a position originally reserved for a rural community member, according to Texas Grandstand.

Ingrid Skop, M.D., who also ran for city council member and emergency physician on the commission, has been an obstetrician-gynecologist in San Antonio since 1998. She is one of the doctors who sued the Supreme Court to get mifepristone removed from sale, an effort that ultimately ended in defeat.

The 23 commission seats are filled mostly by doctors, but two were to be filled by community members who could represent the interests of patients with lived experience. Ultimately, state Health Department Deputy Commissioner Kirk Cole chose Skop over another candidate after commissioners were divided over the new nominees.

The state representative who wrote the 2023 bill to expand the number of community member positions from one to two said she never intended to fill those spots with more doctors or exclude people with lived experience. But the description was also changed in the bill from community advocate to “community members with experience in an appropriate field of health care, including a field involving the analysis of health care data,” according to Texas Grandstand.

Medical devices often remain in use after being “recall”

According to the report from CBS News AND KFF Health NewsWithdrawing a medical device from sale does not mean that the FDA is depriving doctors and patients of access to it.

Even in what the agency calls the most serious “Class I” recalls, in which a device has defects that could cause serious injury or death, the recall can involve “correcting” the problem by retraining doctors or repairing or relabeling the device, the article said. In some cases, companies advise doctors to discuss the risks of removing the device rather than leaving it in place with the patient.

“When deciding to remove a device from the market, the FDA considers the frequency and severity of adverse events, the effectiveness of the corrective action taken, and the benefits and risks of preserving patient access to the device,” an FDA spokesman said. CBS AND KFF.

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

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

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

Medtronic’s StealthStation S7 cranial software provided inaccurate views of the brain for surgery, and in one case, it “failed to detect a tumor,” the article said. But a 2021 recall left it in use, with a warning applied to the systems and promises of software updates. Devices from Abiomed and Getinge have been the subject of similar recalls, news agencies reported.

The Little Device That Made UnitedHealth Billions

AND STAT investigation revealed how UnitedHealth increased peripheral artery disease (PAD) screening from 2018 to 2021 through widespread use of a device called QuantaFlo. The practice, according to STATallowed the company to earn billions of dollars in reimbursement from the taxpayer-funded Medicare Advantage program for both “valid and questionable PAD diagnoses.”

Doctors and experts said STAT The device wasn’t accurate enough, and false positives worried patients and likely led to unnecessary treatment. QuantaFlo was approved under the FDA’s fast-track and quickly incorporated into UnitedHealth primary care clinics and the UnitedHealth home visit program in nearly every state that screened for the disease, even without symptoms, according to the report.

Several physicians described either ignoring their employer’s instructions to use QuantaFlo or using more accurate tests to confirm the diagnosis.

UnitedHealth’s guidelines for its home visit program recommended screening in the absence of PAD symptoms, but the company’s own guidelines for medical reviewers for its insurance plan advised against it.

In an email sent among UnitedHealth executives, one executive wrote to another: “You mentioned the opportunities for treating vascular disease, the opportunities for screening, etc., which have huge financial implications. … Let’s turn on the gas!”

This year, CMS eliminated the diagnostic code for uncomplicated peripheral artery disease, and UnitedHealth’s PAD screenings have plummeted. But the company that makes QuantaFlo is now seeking FDA approval to use its devices to diagnose “cardiac dysfunction.”