| | | |   | Good morning. Mario here with exclusive news on reimbursement for digital therapeutics. Also, do not forget to register for our virtual event “Can We Share Health Data and Not Be Evil?” on October 26. We’ve recruited some leading voices from Johns Hopkins, Civitas Networks for Health, MITRE Corporation, and more. Don’t miss it. | | | A large insurer dives into digital therapies First, a scoop from me: Pittsburgh-based Highmark is poised to be the first large insurer to cover a broad swath of prescription digital therapeutics (PDTs) for psychiatric and other conditions. The company quietly published a policy in August describing when these treatments may be “medically necessary,” indicating Highmark’s intention to pay for claims only for PDTs cleared by the Food and Drug Administration when prescribed by a clinician within the appropriate specialty and used as indicated on product labels. While the insurer still needs to iron out contracts with the eight companies it named in the policy, this is huge news for developers that have until now struggled to convince insurers that their products really work. Reliable reimbursement is crucial if developers are to realize the wide adoption they’ve promised their investors. Given the relatively small number of cleared products compared to the glut of health apps overall, using FDA as a bar was “a nice and reasonable standard to start looking at covering these,” Highmark senior medical director Matt Fickie told me.
It’s been fascinating to watch PDTs pick up steam over the last few years, and I’ll be very curious to see if more insurers choose to follow Highmark’s lead. As always, if you know anything I should know about this, please say hello: mario.aguilar@statnews.com | Unsettled questions for health app liability On the other end of the regulatory spectrum, there are a slew of “general wellness” apps and wearables that track activity and other biometrics as a way of helping manage health conditions, like seizures and asthma. The authors of a JAMA Network Open viewpoint argue that these products occupy a legal gray area: Though the companies disclaim diagnostic capabilities, patients and clinicians still use them for this purpose, potentially opening the manufacturers to lawsuits when something goes wrong. “Because product liability for these devices is somewhat unsettled, patients and their lawyers may turn to medical malpractice theories of litigation in hopes of recovering damages,” the authors write. | Most dial the digital doctor only once  By now you’ve surely noticed that we’ve been carefully following numbers about who is using telehealth as the virtual-care hype cycle plays out. In last Thursday’s STAT Health Tech, I reported CDC data finding that over 30% of people in most demographics used telehealth at least once in 2021. That sounds great until you see the analysis above, showing that about half of telehealth users in 2021 used it exactly once. It’s an important reminder that we ought to be very careful when interpreting the real impact of numbers that at first blush suggest soaring telehealth penetration. The data come from market intelligence company Trilliant Health’s sprawling report on health economy trends based on claims data that it says cover patient journeys for 300 million people. | What if you had clinical trials news 51 days early? Earlier this year, STAT Trials Pulse detected roadblocks for TG Therapeutics's Umbralisib 51 days before the company pulled it from the market. Read our latest case study to see how you can get market-moving news like this, ahead of everyone else. | | | What we're reading -
Signify Health expands in-home diagnostics and preventive services, MobiHealthNews -
Abortion pill startups face challenges raising cash — even post-Roe, Bloomberg -
How digital health innovators can successfully navigate evolving FDA regulations, STAT | Thanks for reading! More next week,  | | | |
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