Dr. Oz Device Scrutinized; $50B for Fake Diagnoses; Crisis Pregnancy Center Funds

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

Problems for Heart Device Co-Invented By Dr. Oz

A device co-invented by Mehmet Oz, MD, has been the subject of thousands of FDA adverse event reports and three recalls, KFF Health News reported.

In 2013, the FDA approved the implantable MitraClip device to treat leaky heart valves, with the former television personality and former U.S. Senate candidate Oz among its inventors. Manufacturer Abbott said the device provided new hope for severely ill individuals who have mitral regurgitation and are too frail to undergo surgery, and Oz said in a video that the device “changed the face of cardiac medicine.”

However, since FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries as well as more than 1,100 reports of patient deaths, KFF Health News reported. There have also been a trio of recalls, but the manufacturer has told doctors they can continue to use the recalled products.

Furthermore, a former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals, KFF Health News reported. Abbott has denied illegally marketing the device.

“The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices,” the article stated. “Manufacturer-sponsored research on the device has long been questioned.”

Both Abbott and the FDA described MitraClip as safe and effective in response to questions from KFF Health News.

A spokesperson for the FDA noted in part that reports to the agency about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results it reviewed for 2013 and 2019 approvals.

$50B for Medicare Advantage Fake Diagnoses

From 2018 to 2021, private insurers involved in Medicare Advantage made “hundreds of thousands of questionable diagnoses that triggered extra taxpayer-funded payments,” according to the Wall Street Journal.

In all, Medicare paid insurers about $50 billion from these diagnoses, WSJ reported in an analysis of billions of Medicare records.

Questionable diagnoses included “some for potentially deadly illnesses, such as AIDS, for which patients received no subsequent care, and for conditions people couldn’t possibly have,” WSJ reported. “Often, neither the patients nor their doctors had any idea.”

Medicare Advantage originated from the notion that the private sector could provide healthcare more economically, WSJ noted. It has expanded over the last 2 decades to cover more than half of the 67 million seniors and disabled people on Medicare.

However, instead of saving taxpayers money, Medicare Advantage has “added tens of billions of dollars in costs, researchers and some government officials have said,” WSJ reported. One reason for this is that insurers can add diagnoses to those that patients’ doctors submit. Insurers were given this option to catch conditions doctors neglected to record.

Insurers say they use home visits and chart reviews to help coordinate patients’ care and ensure accurate diagnoses, WSJ reported.

A spokesperson for CMS told WSJ that the agency was making changes that would continue to ensure “taxpayer dollars are appropriately spent,” adding that Medicare Advantage “offers robust and stable options” for beneficiaries.

Texas Spends Millions on Crisis Pregnancy Centers With Little Oversight

Though Texas spends millions of dollars on crisis pregnancy centers, it’s not known whether this funding is helping families in need, ProPublica and CBS News reported.

Budget infusions for the Alternatives to Abortion program grew from $5 million in 2005 to $140 million after the U.S. Supreme Court overturned Roe v. Wade, ProPublica and CBS News reported. Since abortion has become largely illegal in the state, lawmakers have said the purpose of the program has shifted to supporting affected families.

However, an investigation by ProPublica and CBS News found that the system that “funnels a growing pot of state money to anti-abortion nonprofits has few safeguards and is riddled with waste.” Officials with the state’s Health and Human Services Commission, which oversees the program, “don’t know the specifics of how tens of millions of taxpayer dollars are being spent or whether that money is addressing families’ needs.”

In some cases, crisis pregnancy centers may be billing $14 to hand out a few diapers or distribute a pamphlet, ProPublica and CBS News reported. And for years, state officials have “failed to ensure spending is proper or productive.”

Now, lawmakers in other states are considering their own programs modeled on the one in Texas, ProPublica and CBS News reported.

Last year, following a legislative mandate in Texas, lawmakers ordered the Health and Human Services Commission to set up a system to measure the program’s performance and impact, according to the article. The commission told the outlets that it’s “working to implement the provisions of the law.” A spokesperson added in part that their main contractor, Texas Pregnancy Care Network, was responsible for most program oversight.

The organization’s executive director Nicole Neeley told ProPublica and CBS News in part that subcontractors have broad freedom over how they spend revenue from the state, adding that subcontractors can save the money or use it for building renovations, for example.

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