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Texas AG reaches settlement in health AI probe
In other legal news, the Texas Attorney General has reached a settlement with a Dallas health AI company that the government charged with making false claims about its products’ accuracy and safety before deploying them at Texas hospitals. The company, called Pieces, sells generative AI technology it says provides summaries of patients’ condition and treatment to clinicians. The AG concluded that Pieces’ metrics for accuracy, and its claims about a relatively low hallucination rate, were themselves inaccurate. Read more.
Can AI reduce fraud, waste and abuse?
A study in NEJM Catalyst suggests that using AI to screen medical claims for fraud, waste and abuse could reduce erroneous charges. In the analysis led by several employees of health analytics company Health at Scale and personalized health tech platform Personify Health and the Massachusetts Institute of Technology and the University of Michigan, authors report that the AI screening flagged almost $12 million in inappropriate claims before they were paid, about 1.2% of total spending across almost 300,000 claims. The technology, sold by Health at Scale, requested medical records for patients whose claims were flagged to ensure the “alignment of medical services and interventions with established guidelines and standards of medical care.” Read more.
Novartis strikes AI drug development deal with Generate:Biomedicines
Flagship Pioneering‘s Generate:Biomedicines, which uses AI to make new medicines, has unveiled a deal with Novartis to come up with targets for various disease areas, Brittany Trang reports. The deal comes with milestone payments, netting the company a potential $1 billion in addition to royalties. Generate gets $65 million up front from Novartis, including $15 million for some equity — an undisclosed amount — in the company. Read more on the deal here.
HHS watchdog probes remote patient monitoring
Virtual care advocates and skeptics have long argued about the extent to which telehealth and remote monitoring introduce new risks for fraud and abuse. Now, a new Health and Human Services Department watchdog report suggests remote patient monitoring and billing for those services — think devices like digital blood pressure cuffs that clinicians can use to monitor patients from afar — are ripe for abuse, my colleague Katie Palmer reports.
HHS’ Office of the Inspector General‘s report calls for more oversight of remote patient monitoring and devices like connected scales and continuous glucose monitors, at least within Medicare. The report’s also chock-full of data on RPM use: The number of Medicare patients receiving remote patient monitoring services jumped from 55,000 to 570,000 between 2019 and 2022; Medicare Advantage patients increased 14 times in that time period. Total Medicare spending on RPM services topped $311 million in 2022.
Where’s the potential misuse? Providers could be overusing these tools and services and driving up costs, the analysis suggests.
“The incentives of the provisioners are very misaligned at times with the actual value to patients and society as a whole,” Harvard Business School doctoral student Mitchell Tang, who’s studied RPM in Medicare, told Katie. Read more about the OIG findings.
New bill on telehealth prescription of stimulants
Also on virtual care, some members of Congress are racing to ensure clinicians’ ability to prescribe controlled substances via telehealth doesn’t expire: My colleagues Lev Facher and Mario Aguilar report exclusively on a new bill drafted by longtime advocates Sen. Mark Warner (D-Va.) and Rep. Doris Matsui, (D-Calif.) to extend pandemic-era prescribing flexibilities through 2026. That bill is being drafted as the Drug Enforcement Agency mulls new rules potentially rolling back those flexibilities. “I’m deeply concerned by the looming expiration of flexibilities for health care services over telehealth that include the prescription of controlled substances,” Warner said in a statement to STAT. Read more from Lev and Mario.
FDA’s new device safety head’s past industry troubles
My colleague Lizzy Lawrence has some exclusive reporting on the Food and Drug Administration‘s pick to lead its medical device safety office: Ross Segan was formerly chief medical officer at endoscope company Olympus, which itself received FDA warning letters alleging that it didn’t address product defects (including, most worryingly, caps that fell into patients’ bodies.)
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” Jeffrey Shuren, head of FDA’s medical devices center, said at the time. Segan replaces William Maisel, who stepped down as director of evaluation and quality at the Center for Devices and Radiological Health in February after 14 years at FDA. Read more from Lizzy.
Particle Health sues Epic over monopolistic practices
Medical records giant Epic Systems’ market dominance has long been an open secret within the health technology world. But now a young health data startup is taking the rare step of suing Epic, alleging monopolistic practices and using its dominance to undermine competition.
In a federal lawsuit filed this week in the Southern District of New York, Particle Health called Epic a “behemoth” and a “monopolist in the EHR software market,” Casey Ross reports. Epic, for its part, called the allegations “baseless” and accused Particle of revealing patient data on a health information exchange, which led to a dispute between Particle and Epic earlier this year. Read more on the suit from Casey, and reach out with your thoughts and stories.