Dr. Oz’s Device Scrutinized; $50 Billion in False Diagnoses; Funding for Crisis Pregnancy Center

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

Problems with heart-testing device co-created by Dr. Oz

The device, co-invented by Dr. Mehmet Oz, 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, and its inventor included former TV host and former U.S. Senate candidate Oz. Manufacturer Abbott said the device offers new hope for seriously ill people with mitral valve regurgitation who are too weak to undergo surgery, and Oz said in the film that the device has “changed the face of heart medicine.”

However, since FDA approval, various versions of the device have been the subject of thousands of reports to the agency of patient failures or injuries, as well as more than 1,100 reports of patient deaths, KFF Health News reported. There were also three recalls, but the manufacturer told doctors they could continue to use the recalled products.

In addition, a former employee alleged in a federal lawsuit that Abbott promoted the device using illegal inducements to doctors and hospitals, KFF Health News reported. Abbott denied that it was illegally selling the device.

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

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

An FDA spokesperson noted that reports to the agency about failures, injuries and deaths the device may have caused or contributed to are “consistent” with the results of studies reviewed before approval in 2013 and 2019.

$50 Billion in Medicare Advantage Misdiagnosis

Private insurers involved in the Medicare Advantage program “issued hundreds of thousands of questionable diagnoses that resulted in additional taxpayer-funded payments,” according to data from 2018 and 2021. “Wall Street Journal”.

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

The questionable diagnoses included “some potentially fatal diseases, such as AIDS, for which patients received no further care, as well as conditions over which people had no control.” WSJ reported. “Often neither patients nor their doctors had any idea.”

The Medicare Advantage Program was founded on the belief that the private sector could provide health care more economically, WSJ noted. It has expanded over the past 2 decades to cover more than half of the 67 million seniors and disabled people who use Medicare.

But instead of saving taxpayers money, Medicare Advantage ‘has added tens of billions of dollars in costs, researchers and some government officials say’ WSJ reported. One reason is that insurers can add diagnoses to those that patients’ doctors submit. Insurers were given this option to catch conditions that doctors didn’t record.

Insurers say they use home visits and medical record reviews to coordinate patient care and ensure accurate diagnoses, WSJ reported.

A CMS spokesman said: WSJ that the agency is making changes that will continue to ensure “taxpayer dollars are spent appropriately,” adding that Medicare Advantage “offers strong and stable options” for beneficiaries.

Texas spends millions on crisis pregnancy centers with little oversight

While Texas spends millions of dollars on crisis pregnancy centers, it is unclear whether these funds are helping families in need, ProPublica AND CBS News reported.

Budget appropriations for the Abortion Alternatives program increased from $5 million in 2005 to $140 million after the U.S. Supreme Court overturned the ruling Roe v. Wade, ProPublica AND CBS News reported. Since abortion became largely illegal in the state, lawmakers said the program’s purpose has changed to supporting affected families.

However, an investigation conducted by ProPublica AND CBS News found that the system, which “channels a growing pool of state money into anti-abortion nonprofits, has few safeguards and is rife with waste.” Officials at the state Health and Human Services Commission, which oversees the program, “do not know the details about how tens of millions of taxpayer dollars are spent or whether the money is meeting families’ needs.”

In some cases, crisis pregnancy centers may charge $14 to provide a few diapers or a brochure, ProPublica AND CBS News reported. And for years, government officials “have been unable to ensure that spending is appropriate or productive.”

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

Last year, following a Texas legislative order, lawmakers ordered the Health and Human Services Commission to create a system to measure the program’s outcomes and impact, according to the article. The commission told media outlets it was “working to implement the provisions of the law.” The spokesperson added that its main contractor, the Texas Pregnancy Care Network, was responsible for most of the program’s oversight.

The organization’s executive director, Nicole Neeley, said: ProPublica AND CBS News partly because subcontractors have a lot of freedom in how they spend the state funds, and also because they can save money or spend it, for example, on renovating the building.

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    Jennifer Henderson joined MedPage Today in January 2021 as a business and investigative writer, where she has covered New York City healthcare, life sciences, and law.