Dr. Oz Device Investigated; $50 Billion for Fake Diagnoses; Crisis Pregnancy Center Funds

Dr. Oz Device Investigated;  Billion for Fake Diagnoses; Crisis Pregnancy Center Funds

Welcome to the latest edition of Investigative Roundup, a weekly feature highlighting some of the best investigative reporting in healthcare..

Problems with Heart Device Co-Invented by Dr. Oz

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

In 2013, the FDA approved the implantable MitraClip device to treat leaky heart valves, including that of Oz, a former television personality and former U.S. Senate candidate. Manufacturer Abbott said the device provided new hope for severely ill patients with mitral regurgitation who were too weak to undergo surgery, and Oz said in a video that the device was “changing the face of cardiac medicine.”

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

Additionally, a former employee alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. KFF Health News Abbott has denied allegations that it marketed the device illegally.

“The MitraClip story is, in many ways, a cautionary tale about the science, commercialization and regulation of medical devices,” they said. “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. KFF Health News.

An FDA spokeswoman said reports the agency has received of malfunctions, injuries and deaths caused or contributed to by the device are “consistent” with the results of studies reviewed for the 2013 and 2019 approvals.

$50 Billion for Medicare Advantage Fraudulent Diagnoses

Private insurers included in Medicare Advantage filed “hundreds of thousands of suspected diagnoses that triggered taxpayer-funded copayments” from 2018 to 2021. , Wall Street Journal.

In total, Medicare has paid out approximately $50 billion to insurers due to these diagnoses. WSJ It was reported in an analysis of billions of Medicare records.

Questionable diagnoses included “potentially fatal diseases such as AIDS for which patients receive no subsequent care, and conditions that people absolutely cannot have.” WSJ “Most of the time, neither patients nor their doctors had any idea.”

Medicare Advantage arose from the idea that the private sector could provide health care more economically. WSJ It has expanded over the past 20 years to cover more than half of the 67 million elderly and disabled people on Medicare.

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

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

A spokesperson for CMS said: WSJ He noted that the agency has made changes to ensure “taxpayer dollars are spent appropriately” and that Medicare Advantage provides “robust and stable options” for beneficiaries.

Texas Spends Millions on Crisis Pregnancy Centers with Little Oversight

Although Texas spends millions of dollars on crisis pregnancy centers, it is unknown whether this funding is helping families in need. The public interest And CBS News It was reported.

The budget for the Abortion Alternatives program increased from $5 million to $140 million in 2005 after the U.S. Supreme Court overturned the decision. Roe v. Wade, The public interest And CBS News As abortion has become largely illegal in the state, lawmakers said the program’s purpose has shifted to supporting affected families.

However, an investigation The public interest And CBS News It found that “a system that funnels an increasing share of state money to anti-abortion nonprofits has few safeguards and is rife with waste.” Officials at the state Health and Human Services Commission, which oversees the program, “don’t know how tens of millions of taxpayer dollars are being spent or whether that money is meeting families’ needs.”

In some cases, crisis pregnancy centers may bill $14 to hand out a few diapers or a brochure. The public interest And CBS News And for years, state officials have “failed to ensure that spending is appropriate or productive.”

Now, lawmakers in other states are considering their own programs based on the Texas program. The public interest And CBS News reported.

According to the article, following a Texas legislative order last year, lawmakers ordered the Health and Human Services Commission to establish a system to measure the program’s performance and impact. The commission told outlets it was “working to implement the provisions of the law.” A spokesperson added that its primary contractor, the Texas Pregnancy Care Network, is responsible for overseeing the program.

The organization’s executive director, Nicole Neeley, said: The public interest And CBS News It is stated that subcontractors have wide freedom in how they spend the income they receive from the state, and that subcontractors can save this money or use it for building renovations, for example.

  • Jennifer Henderson joined MedPage Today in January 2021 as an entrepreneur and investigative writer, covering healthcare, life sciences, and the legal industry in New York.