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Prior authorization for colonoscopies, VCs' lessons for health tech on getting paid, & Eric Lander's new project

May 15, 2023
Reporter, Morning Rounds Writer
Good morning. Today we have an insurer's colonoscopy coverage decision causing consternation, an exclusive update on Eric Lander's latest venture, an advisory panel's vote on Sarepta's gene therapy for Duchenne muscular dystrophy.

cancer

United's plan to limit some colonoscopy coverage sparks outrage 

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Gastroenterologists are fuming over an insurance company's decision to start requiring prior authorization for colonoscopies performed to monitor or diagnose disease. The policy change by UnitedHealthcare won't affect the screening colonoscopies widely used to detect cancer in healthy people with no symptoms. Instead, patients and doctors will have to appeal to get procedures covered if they have symptoms of cancer or other conditions, a positive stool test, or a history of polyps. The same will be true for surveillance colonoscopies, which check people at high risk for cancer or polyps.

"That's crazy to me," Folasade May of UCLA told STAT's Angus Chen. "These are the highest-risk people in our community." UnitedHealthcare did not agree to an on-the-record interview with STAT, but an emailed statement said, "Multiple clinical studies have shown significant overutilization or unnecessary use of non-screening gastroenterology endoscopy procedures which may expose our members to unnecessary medical risks and additional out of pocket costs." Read more.


biotech

FDA panel narrowly favors accelerated approval for Sarepta's gene therapy

It was close, but a highly anticipated FDA advisory panel meeting ended with an 8-to-6 vote Friday in favor of accelerated approval for Sarepta's gene therapy for Duchenne muscular dystrophy, ruling that the potential benefit to patients outweighs concerns from the agency's reviewers. The FDA doesn't have to abide by the vote, but often does. Its decision is due by May 29.

Experts heard from the company, parents of children with the degenerative disease, and doctors who treat Duchenne who urged action to prevent muscle loss that young patients can't regain. But the FDA review team pointed to flaws in Sarepta's data, whose only randomized clinical trial failed to show that boys who received the drug had greater increases in muscle function over placebo. Another concern: Current gene therapies can be given only once, making patients ineligible to receive others in development. STAT's Jason Mast and Adam Feuerstein have more. 


science

Lander's new group is built to go after big problems

Eric Lander's latest venture isn't meant to be a standard think tank. Science for America, which he quietly launched last summer,  is "designed to be scientists and technologists coming together and asking 'where might there be game-changing solutions that aren't happening and how do we make them happen?'" he told STAT's Megan Molteni in an exclusive interview, one of his first since resigning from the White House in February 2022 following complaints of workplace bullying.

Funded by philanthropic foundations and individuals, the group will go after existential issues such as climate change, cancer, pandemic preparedness, and reimagining how research gets done in this country. First up: nuclear fusion, the process of merging lighter atoms with heavier ones to unleash massive amounts of carbon-emission-free energy. Also on the agenda: how drugs are developed for cancer patients. Read more.



Closer Look

Silicon Valley tech entrepreneurs hear how to get paid in health care

Bright ideas for transforming health care with artificial intelligence, sensors, or video calls can go only so far. Health tech entrepreneurs need to get paid for them. Articulating a viable business model is a particular challenge for many Bay Area health tech ventures, Greg Yap, a partner at the firm Menlo Ventures, told founders attending a business boot camp, if their founders aren't deeply enmeshed in the world of providers, payers, drug developers, and pharmacy benefit managers. 

"Companies are having a hard time getting paid for the value they're creating, proving they create the value and for actually getting stakeholders in the community to pay for it," he said. He thinks their products could actually help patients or meaningfully cut medical costs, but "the vast majority of them cannot adequately get paid by the health care system." STAT's Mohana Ravindranath has more.


neuroscience

Study says the placenta and the brain both play pivotal roles in genetic risk of schizophrenia

Schizophrenia may not be an illness just of the brain, but also of the placenta, a new genetic study suggests. Researchers link 139 genes expressed in the placenta to risk of schizophrenia, pinpointing their reduced ability to carry out normal functions such as providing nutrients and oxygen crucial to brain development. The researchers, who describe their discoveries in Nature Communications today, also identified genes in the placenta that are causative factors for diabetes, bipolar disorder, depression, autism, and ADHD, but they found far more genetic associations with genes for schizophrenia than for any of these other disorders.

Also, in a small sample of placentas from mothers who had Covid-19 during pregnancy, these schizophrenia genes were dramatically activated. Viral infections have been implicated in schizophrenia before, but the new finding indicates that Covid infection during pregnancy may be a risk factor for schizophrenia because of how infection affects the placenta. 


in the lab

To incubate, perchance to dream

"Targeted dream incubation" doesn't sound poetic, but its well-timed prompts as we drift off to sleep could transform our thoughts into creative flights of fancy, a new study in Scientific Reports suggests. Sleep onset is a rich phase for making unusual connections, so scientists experimented with suggesting a topic to dream about just at that point. 

With an app-connected glove that sensed when study subjects fell asleep and then quickly woke them up, researchers could see if they dreamed creatively about the topic suggested by the audio app just as they were nodding off. Among 49 participants divided into four  groups ("tree" prompt, "your own thoughts" prompt, no prompt, no nap), those instructed to think about trees were rated the most creative storytellers. Bonus: The paper cites Thomas Edison and Salvador Dali for habitually falling asleep holding a heavy object, which would wake them up after it fell, just when dreams are most vivid.


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What we're reading

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  • How a green card freeze will exacerbate the nursing crisis, Politico


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