Medication and therapy have long been the standard protocol for treating mental health conditions. But there’s a third option: your smartphone.
In 2017, the FDA began clearing virtual tools to treat conditions like depression, attention-deficit/hyperactivity disorder (ADHD), insomnia, and substance use disorder. These digital mental health treatments (DMHTs) are a type of digital therapeutic, defined by trade group Digital Therapeutics Alliance (DTA) as health software that delivers an evidence-backed medical intervention for a disease or disorder.
Yet despite their potential, these apps have struggled to find success. Developers previously told Healthcare Brew that’s largely because payers have been unwilling to cover them due, in part, to their newness. In a qualitative study published in 2024, 22 pharmacists and health insurance representatives said they were waiting for more evidence or a clearer reimbursement pathway.
On Jan. 1, 2025, the wait ended.
The Centers for Medicare and Medicaid Services (CMS) now covers DMHTs under Medicare, adding three new healthcare common procedure coding system (HCPCS) codes for billing for certain DMHT devices.
If clinicians and patients get on board, this could be a step toward wider coverage. If they don’t, it might mean payer hesitancy wasn’t all that was really holding these apps back, experts say.
“The question is: Will people use these now that they’re available and providers can get paid for them?” American Psychological Association Senior Director for Healthcare Innovation Vaile Wright told Healthcare Brew.
A history of challenges
This latest development is a long time coming.
The FDA cleared the first DMHT for market, Pear Therapeutics’s reSET, in 2017. But in April 2023, Pear declared bankruptcy and reSET, plus its opioid use disorder program reSET-O, were sold to digital treatment provider PursueCare. In a LinkedIn post, Pear’s former CEO partly blamed its collapse on payer denials.
In September 2023, Akili Interactive—a digital medicine company that created an FDA-authorized prescription video game to treat ADHD—abandoned the prescription model after hitting roadblocks from payers, and offered its video game-based treatment over the counter.
These new codes may get more payers on board, Andy Molnar, SVP of industry affairs at trade group American Telemedicine Association (ATA) and head of digital health at advocacy arm ATA Action, told Healthcare Brew.
“We’re in such a better place now in 2025 than we have ever been before,” he said, explaining that now it’s possible to “actually start to show real-world evidence and cost data” to convince Congress to further expand coverage.
The Medicare test
So far, seven apps qualify for CMS’s HCPCS codes, according to the DTA:
- Big Health’s SleepioRx for insomnia and Daylight for anxiety
- Otsuka Precision Health and Click Therapeutics’s Rejoyn for depression
- PursueCare’s reSET for substance use disorder and reSET-O for opioid use disorder
- Nox Health’s Somryst for chronic insomnia
- Curio’s MamaLift Plus for maternal mental health
But even with Medicare coverage, challenges remain.
For one, the HCPCS codes offer a “buy-and-bill” model, meaning providers need to pay up front and are later reimbursed after submitting a claim to Medicare—something that is “not common practice” for mental health professionals, Molnar said. (Normally, pharmacies front the cost and dispense mental health drugs.)
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These programs also often require prescriptions. Depending on the company, these prescriptions can come from professionals who can’t normally prescribe and aren’t familiar with the process, like social workers or psychologists.
David Cooper, executive director of a community for mental health professionals in tech roles, Therapists in Tech, told Healthcare Brew he’s excited about the new codes, but it’s unclear whether providers will go through the hassle when there are thousands of direct-to-consumer mental wellness apps in app stores (though quality varies).
“[This is] a really important test of, I think, the entire premise and model for digital therapeutics,” Cooper said.
Show me some evidence
It’s also not clear how some digital therapeutics will perform beyond clinical trials.
The FDA’s standard for clearing digital therapeutics, typically regulated as software as a medical device, may be lower than clinicians’ standards to use them and payers standards to cover them, Cooper said.
Aetna, for instance, includes many DMHTs on a list of therapeutics “considered experimental, investigational, or unproven because there is insufficient evidence in the published peer-reviewed literature.”
One digital therapeutic, Rejoyn, was cleared in March 2024 to treat major depressive disorder in patients ages 22 and older and taking antidepressants. The clinical trial that led to FDA authorization didn’t produce a statistically significant difference for its primary endpoint, the main result that measures if a treatment works, though it did find some improvements in depression symptoms.
The six-week program offers short cognitive behavioral lessons and cognitive-emotional exercises meant to engage areas of the brain associated with depression. It costs $50 for people who pay out of pocket with a temporary discount through June 30, and health plans covering the program are billed $200 for the six weeks.
“It’s going to be interesting for me, looking at the Rejoyn data, to see if providers and health systems think the juice is really worth the squeeze…‘Is the clinical effect I see from Rejoyn worth what I’m getting paid back from Medicare to actually implement this and upkeep this?’” Cooper said.
The flip side
Some clinicians are already on board with using digital therapeutics.
Wright said some providers prefer FDA-cleared apps because they feel that guarantees “some minimal bar of evidence and safety.”
Saundra Jain, a psychotherapist and paid consultant for Otsuka America subsidiary Otsuka Precision Health, told Healthcare Brew that she’s seen Rejoyn improve depression symptoms in her patients.
“There’s always that group where [antidepressant] medicines aren’t effective or they don’t last like [patients] want them to,” Jain said. “The more options we have, the better it is for our patients and outcomes.”