The Food and Drug Administration (FDA) has cleared them. And now the private sector may be going all in on digital therapeutics (DTx). At least that looks like the direction we’re headed with the latest move from Highmark, a Pittsburgh-based insurer that serves around 5.6 million people across the U.S., that describes itself as the country’s “fourth-largest Blue Cross and Blue-Shield-affiliated company.” Hallmark’s decision to cover some of the FDA-cleared prescription digital therapeutics could be a bellwether signaling the permanent addition of DTx to the healthcare landscape.

So what’s covered now? That’s unclear, as we’ll have to see how this thing shakes out in real-world practice. For now, we know that Hallmark is saying it may cover a wide range of DTx. These could include treatment for substance-use disorders including opiate use (with reSET and reSET-O), PTSD-related issues (with NightWare), insomnia (with Somryst), chronic lower back pain (with RelieVRx), and irritable bowel syndrome (with Mahana IBS). For pediatric use only, Hallmark says it may also cover Attention Deficit Hyperactivity Disorder (ADHD) with the video-game-treatment EndeavorRx, and eyesight-related issues with the digital theraputic Luminopia One.

And what are the rules of the road? According to Hallmark, eligible prescribers of DTx include medical doctors and advanced practice providers, such as physician assistants and nurse practitioners. In the mental-health realm, prescriber coverage extends to psychologists, as well as licensed mental health counselors, social workers, and family therapists. DTx use is for outpatient-only, and the patient must be 18 years or older in most cases.

While this expansion of digital care through a private insurer is notable, it’s not unexpected given the FDA’s momentum with DTx, having authorized all the therapeutics Hallmark is now covering and then some. And the industry has taken note, responding with an exponential growth in funding for digital health companies. In the first quarter of last year alone, DTx investment totaled a staggering $14.7 billion, adding to the substantial support in 2020 and 2019, with respective annual investments of $14.6 billion and $7.7 billion. The FDA is tracking and gauging the effectiveness of the DTx that comes out of this investment with a Streamlined Review process and Real-World Performance data. While Hallmark’s “may” cover isn’t as solid as “does” cover, the change certainly means one thing: more DTx care for more people.