A major step forward in using digital treatments to extend care

This summer, federal regulators announced decisions that carry strong potential to increase access to innovative tech designed to promote mental health and reduce psychological distress as the nation grapples with a mental health crisis.

In July, CMS proposed three new reimbursement codes for mental health digital therapeutics, which provide evidence-based treatments to patients through mobile devices or the web. The apps typically collect data related to mood, sleep, or other behaviors that inform the cognitive-behavioral therapy (CBT) a user will receive. If CMS approves the proposed codes in November, for the first time mental health providers, including psychologists, can bill Medicare for these digital products and the time they spend working with patients using the apps.

“This is a potential third revolution in mental health,” said David Mohr, PhD, director of the Center for Behavioral Intervention Technologies at Northwestern University. The first revolution was the development of psychoanalysis in the 1890s and the second was the development of psychopharmacology in the 1950s, he said. “Now we can use technology to extend treatment to virtually anyone in need, including the 169 million people in the United States who live in mental health professional shortage areas.”

Another big win for this effort: Big Health, a company that develops digital therapeutics, recently received clearance from the U.S. Food and Drug Administration (FDA) for digital interventions that treat chronic insomnia (SleepioRx) and generalized anxiety disorder (DaylightRx). The company, which was co-founded by a psychologist, specified in the FDA application that the prescription device can be ordered by psychologists and other licensed health care providers, rather than limiting access solely to providers with prescriptive authority.

“FDA’s clearance model has traditionally caused regulatory confusion among health care professionals about who can ‘prescribe’ digital therapeutics,” said Vaile Wright, PhD, APA’s senior director of health care innovation. “But with the clearance of Big Health’s products, we now know that psychologists and other nonphysicians can order these tools as part of their scope of practice.”

Unlike wellness apps that help users meditate, lose weight, or reduce stress, digital therapeutics are research-backed tools that have demonstrated safety and efficacy in randomized controlled trials. In two randomized controlled clinical trials, DaylightRx showed rates of remissionopens in new window of more than 70% for generalized anxiety disorder and significantly reduced anxiety up to 6 months or more. SleepioRx has been evaluated in more than 25 clinical trials and up to 76% of participants with chronic sleep issues or insomnia disorder achieved healthy sleep.

For clinicians who are overburdened by the demand for mental health services, digital treatments could “increase the capacity to support patients,” said Jenna Carl, PhD, chief medical officer at Big Health and a practicing psychologist. If a patient is suffering from both depression and insomnia, a provider could initially focus on addressing the depression during therapy sessions and order a digital therapeutic for insomnia as a form of concurrent treatment pursued outside of sessions. For a patient struggling primarily with anxiety, CBT for anxiety via a digital treatment could build on the skills patients are learning from a psychologist during a session. In cases when waitlists are months-long, digital treatments could serve as a form of treatment while waiting for additional care.

Though the progress with CMS and the FDA is significant, the next hurdle will be integrating digital therapies into the workflows in medical systems, said Mohr. Psychologists can take the lead by learning about these innovative tools and by advocating to incorporate them into practice. “Most psychologists are unfamiliar with digital therapeutics, but they are eager to learn more about them,” said Wright. “We need people who are willing to visit state psychological associations and other groups to get the word out.”

While it may seem daunting to delve into the world of digital therapeutics, Mohr encourages all practicing psychologists to start by first exploring a product’s website to see if there are studies that support their claims. John Torous, MD, director of the digital psychiatry division at Harvard’s Beth Israel Deaconess Medical Center, helped develop a databaseopens in new window that provides information about the clinical foundations, cost, and the treatment approach for different mental health apps.

Incorporating these digital tools into practice may require providers to become familiar with a new method of delivering treatment, which can seem intimidating at first. But for many patients, this support may be the only option or a supplement to treatment that ultimately helps reduce their psychological distress. “The mental health crisis is a health equity issue, and digital tools that are safe and effective are filling a gap,” said Wright. “Psychologists have an important role in making these tools accessible.”