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Special report: Fake implants to drive up payments; what the debt ceiling might mean for health care; & problems with a new polio vaccine

May 30, 2023
Reporter, Morning Rounds Writer
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special report

To make more money, a medical device maker implanted a fake plastic part in pain patients 

MedicalImplantFraud_Illustration_MollyFerguson_052223

Molly Ferguson for STAT

Imagine you are suffering from chronic pain, hoping a nerve-stimulating device can interrupt pain signals from your brain so you don't have to take opioids to dull them. For decades, these devices required clunky batteries to be implanted in patients' bodies. So when sleek wearables made by device company Stimwave became available, the allure was obvious. The product worked with a wearable battery attached to thin wires under the skin.

There was just one problem: Stimwave couldn't make as much money that way, compared to implanted batteries. Stimwave started selling dummy piece of plastic as part of its device that let it bill for more, but that did nothing at all. The company's CEO now faces 10 years in prison. STAT's Lizzy Lawrence spoke to former employees, physicians, and medical device experts to understand how the fraud unfolded, and what it tells us about the gaps in oversight of medical devices. Read more here. 


in the lab

Cells once dismissed as 'brain glue' may help explain hole in Alzheimer's amyloid hypothesis, study shows

STAT's Jonathan Wosen brings us this news: For decades, Alzheimer's researchers focused narrowly on the protein fragment beta-amyloid as the central driver of the deadly disease, often ignoring other potential contributors. But that view is changing. A team of scientists reports that astrocytes, cells once dismissed as "brain glue," may help explain why some people with clumps of beta-amyloid in their brain don't have Alzheimer's.

Researchers measured a protein known as GFAP, produced when astrocytes respond to injury and damage, in the blood of roughly 1,000 people without cognitive defects. Among those with elevated GFAP, high beta-amyloid levels meant higher levels of phosphorylated tau, a protein that accumulates within the neurons of Alzheimer's patients. Amyloid levels weren't linked with phosphorylated tau among those with low GFAP levels. The findings, published in Nature Medicine, could help scientists more precisely design clinical trials for Alzheimer's therapies that target earlier stages of disease.  


politics

How health care fares in the debt-ceiling bill

Called the "Fiscal Responsibility Act of 2023," the debt ceiling agreement reached over the weekend is all that stands between the nation and its first-ever default. The proposed two-year deal avoids Medicare and Medicaid cuts, dodging payment delays to thousands of health care providers. The bill claws back about $30 billion in Covid-19 relief funds, but keeps $5 billion for developing the next generation of vaccines. 

Also taking a hit: the Provider Relief Fund, the strategic national stockpile's testing and equipment needs, and programs targeting care in rural and Indian communities, according to a breakdown by House Appropriations ranking member Rep. Rosa DeLauro (D-Conn.) The deal would also limit access to food stamps for people under 54 with no children but expand it to others, including veterans and people who are homeless. Votes on the bill are scheduled for tomorrow.  



Closer Look

Not there yet: The finish line for polio eradication is still ahead

The dream of stamping out polio forever is still out of reach, despite hopes that a new oral vaccine would be a game-changer. Known as nOPV2 and in use for two years, it's much less likely than earlier oral vaccines to acquire the capacity to, on rare occasions, paralyze children. The new vaccine, much safer than the oral polio vaccine it replaced, faces a different challenge: Not enough children are being vaccinated.

"Eradication, it was never about the vaccines. It's all about coverage — getting the vaccine into the mouths of children," Roland Sutter, a consultant who has worked for decades on polio eradication, told STAT's Helen Branswell. Yet there are many more factors complicating eradication. Read more.


cost-effectiveness 

New analysis calls gene therapy for sickle cell disease an 'equitable therapeutic strategy'

How do you calculate the cost-effectiveness of a potentially curative gene therapy for a debilitating disease affecting people who likely live with systemic health inequities? Researchers writing in the Annals of Internal Medicine apply "distributional cost-effectiveness analysis" to sickle cell disease, an inherited blood disorder that strikes 1 of every 365 Black people in the U.S., many of whom experience bias and disbelief when they seek care. 

The nonprofit ICER previously determined that if priced at $1.9 million, the not-yet-approved treatments would be cost-effective compared with a lifetime of chronic and acute care, STAT's Ed Silverman has reported. The new study says by conventional metrics, gene therapy would not be cost-effective at $2.8 million vs. $1.2 million for standard care, but it could be a valuable approach — and reduce health disparities — when equity, cost, and value of treatment are weighed together.


health

Opinion: It's time to test and treat young people for 'bad' cholesterol

It's not every 27-year-old who asks his doctor for a cholesterol test as he's leaving a checkup. But First Opinion author Suhas Gondi did. He's also a physician and, as a South Asian man, at higher risk than white men of having a heart attack at an early age. But cholesterol screening guidelines don't recommend testing until age 35, and risk calculators to make sense of the results cover only ages 40 through 75.

That gap is troubling, Gondi says, because more than half of young adults in the U.S. have "bad" LDL levels high enough to increase lifetime cardiovascular risk, but only about 40% have had their cholesterol checked in the last five years. Few are prescribed statins to control it. "Under-checking is compounded by under-treating," he writes. "Our health care system is shortchanging young people like me and putting us at higher risk of preventable heart disease later in life." Read more.


More around STAT
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What we're reading

  • For Covid long-haulers, the pandemic is far from over, Washington Post
  • Maternity's most dangerous time: after mothers come home, New York Times
  • Neuralink can now study its brain implant in humans, but it's still catching up to its peers, STAT
  • Just how vulnerable is Medicare drug negotiation to legal challenges? STAT
  • Opinion: In defense of being 'Cali sober,' STAT

Thanks for reading! More tomorrow,


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