(2023-05-14) Sorry The Governments Not Paying For Your Therapy App

Sorry, the government’s not paying for your therapy app. New treatments for chronic conditions like opioid addiction, ADHD and insomnia are here and they’re on your smartphone — not in a pill bottle. But the government won’t pay for them. (digital therapeutics)

Though the Food and Drug Administration has cleared dozens of these software-based medicines — which include apps and even video games — the Centers for Medicare and Medicaid Services can’t reimburse providers, in part because Congress hasn’t approved new billing codes that describe the therapy. Because private insurers often take their cues from the government, the companies behind these new ideas are struggling to gain traction.

Rep. Mike Thompson (D-Calif.) said it’s crucial to let the experiment in digital therapy proceed. “Providing alternative ways to access care is essential in the increasingly modern times in which we live,”

She sees the technology as a way to better reach patients with conditions like substance use disorder in rural and other hard-to-reach areas.

Their effort comes too late for Pear Therapeutics. As recently as January, the Boston-based firm seemed to be on the cutting edge of health care as it touted interest from leading providers and state governments in its products melding smartphones with addiction therapy. It all fell apart last month when Pear said it was filing for bankruptcy and selling its assets

Cost may also be an impediment to government reimbursement for Pear’s apps, since they add about $300 to a typical 12-week treatment protocol for opioid use disorder

While there is some evidence the protocol is cost-effective, it may not convince insurers.

Winning FDA authorization and proving a product is cost effective are two different things.

The category is ill-defined, but it’s thought that the FDA has authorized three dozen digital therapeutics.

Akili Interactive makes EndeavorRX, a video game that helps ADHD patients learn to focus, multitask and ignore distractions.

Then there’s AppliedVR’s virtual reality chronic pain treatment EaseVRx, which teaches breathing techniques, among other things, to alleviate back aches.

There’s good cause to encourage this innovation, the companies say, given the limits of existing drug therapies. Mental illness and substance use disorder are ripe targets.

After a drop in 2019 and 2020, the number of suicides nearly returned in 2021 to the 48,344 of 2018

Meanwhile, fatal drug overdoses are also at peak levels and rising.

“There was a belief that if you get FDA clearance, reimbursement will follow,” said Jenna Carl, chief medical officer at Big Health. Carl’s company has long been skeptical of this approach and instead focused on building up robust data proving its interventions work.

In the U.S., Big Health has inked deals with CVS Health to make its products available to employers and plan sponsors via its pharmacy benefit manager Caremark

the lack of a definition of what one is has held up CMS. The agency doesn’t have a benefit category for digital therapeutics or software that’s a medical device and Congress has to approve new reimbursement categories.