May 18, 2023

Senators probe Medicare Advantage plans over algorithms

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Sen. Richard Blumenthal (D-Conn.) PATRICK SEMANSKY/AP

During a hearing on Wednesday, Senators reminded Medicare Advantage plans that they cannot use algorithms to deny care to people who need it. The hearing comes on the heels of a STAT investigation that found some of the insurers are doing just that.

Sen. Richard Blumenthal said that lawmakers in both parties have asked UnitedHealth Group, Humana, and CVS Health's Aetna for internal documents that "will show how decisions are made to grant or deny access to care, including how they are using [artificial intelligence]," STAT's Bob Herman and Casey Ross report.

"I want to put these companies on notice," said Blumenthal. "If you deny life-saving coverage to seniors, we are watching. We will expose you. We will demand better. We will pass legislation if necessary. But action will be forthcoming."

Clinical trials

Advancing digital biomarkers in clinical trials

Earlier this month, I went to the Digital Biomarkers Summit USA at Regeneron's headquarters, where hundreds of leaders from the drug development industry met to discuss the emerging science of using data measured by devices like wearables as endpoints in clinical trials.

One of the event's highlights was a presentation from Bellerophon Therapeutics CEO Peter Fernandes who described how his company worked with device company ActiGraph to propose the first FDA-endorsed primary endpoint in a pivotal trial using wearable data. The company used wearable measured physical activity as an endpoint in its recently concluded Phase 3 trial of its INOpulse treatment for patients with pulmonary fibrosis.

Ultimately, the goal of the conference was to promote collaboration among companies to advance the science of digital biomarkers such that one day they might be used broadly in trials.

"If you have a better way to measure something, by default, we should utilize it," Regeneron's Rinol Alaj told me. "It's just a matter of creating awareness, showing case studies, and sharing with the industry."

Digital therapeutics

Pear Therapeutics goes on the block today

In about an hour, the remains of Pear Therapeutics will be auctioned off. The pioneering digital therapeutics company filed for bankruptcy last month after failing to build a sustainable business for its prescription apps that treat opioid use disorder, substance use disorder, and insomnia. I've heard murmurs that several different types of companies have been poking around at the assets, and it will be very interesting to see who bites. Stay tuned for my coverage when the news breaks.

regulation

FDA leaders dish on AI rules

AI in medicine — its dangers, its potential, and how to regulate it — was top of mind at the Food and Drug Law Institute's conference on Tuesday, STAT's Lizzy Lawrence reports from the event. FDA CDRH chief Jeff Shuren neatly summed up Washington's feelings towards the tech as, "Be afraid. Be very, very afraid."

Shuren said the cautious impulse is mostly right, despite tech's potential to more efficiently and effectively prevent, diagnose, or monitor conditions.

"I think folks struggle with having the right data, to have AI that's fit for purpose," Shuren said. "That's why we see a lot of bad results and biased results at the end of the day."

Shuren and others referenced this week's Senate hearing, where AI developers and senators alike called for aggressive oversight. Sonja Fulmer, acting deputy director of the Digital Health Center of Excellence, touched on the FDA's own preliminary efforts to regulate AI. She plugged the agency's draft guidance that allows device makers to more easily update software. It's early days, so not many device makers have taken advantage of the framework so far — just one person in the room raised their hand when a panelist asked who was looking to submit a plan.

On the FDA's recent guidance for AI-enabled clinical decision support tools, which promises to regulate more of the industry in a move that blindsided developers, Shuren said implementation is lax at the moment: "At this point, we appreciate it's new. We're not coming out of the gate, guns blazing and taking folks down."

Medical records

Speaking directly to the EHR

AI voice assistant company Suki this week announced an integration with Epic's electronic health records, making it easier for providers to use its ambient note-generating capabilities. The software can blend notes typed into Epic and dictated into Suki. For notes generated by Suki from a patient-provider conversations, it can also fill out all the sections, codes, and comments in Epic's EHR. The company claims over 100 customers.

Looking ahead, CEO Punit Soni told STAT's Brittany Trang that Suki plans to publish studies on the accuracy of its technology in the next quarter or so. As Brittany has reported, none of the major players in the AI medical note generation space have published such work before.

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What we're reading

Fake rehab clinics reportedly fleeced state of 'hundreds of millions,' victimized tribal members, azcentral
Feds turn antitrust focus to digital pharma ads, Politico
Pregnancy app Premom shared users' sensitive information, Federal Trade Commission
Global mental health services and the impact of artificial intelligence–powered large language models, JAMA Psychiatry