New reimbursement pathways have opened doors for using digital therapeutics

Like many mental health providers, Michelle Drerup, PsyD, a psychologist at Cleveland Clinic in Ohio, worried about patients who were spending months on a waiting list before seeing a clinician. With new digital interventions, now her patients will have access to care while they wait.

Cleveland Clinic is one of several large health care systems in the United States that is starting to offer mental health digital therapeutics that provide evidence-based treatment through mobile devices or the web. In November 2024, the Centers for Medicare and Medicaid Services (CMS) approved three new reimbursement codes for these digital interventions, which typically collect data on mood, sleep, substance use, or other behaviors and offer cognitive-behavioral therapy to the user.

“The CMS billing codes opened up an insurance pathway and that is a key part of increasing access, but we are still in the early stages,” said Leanna Fortunato, PhD, director of quality and innovation in APA’s Office of Health Care Innovation. “This is a new way to provide and receive care, so awareness about this treatment is critical.”

The CMS DMHT (digital mental health treatment) codes were designed to close the reimbursement gap, and they allow providers to bill for the following:

• G0522: Supplying a digital mental health treatment device
• G0553: Reviewing data and managing treatment for 20 minutes per month
• G05524: Adding extra time for each additional 20 minutes of monthly treatment management

There are currently a handful of research-backed mental health digital therapeutics that have been cleared by the FDA that qualify for reimbursement under the new codes:

• SleepioRx and Somryst: For chronic insomnia
• RESET and RESET-O: For substance use disorders and opioid use disorder
• Rejoyn: For depression
• DaylightRx: For generalized anxiety disorder
• MamaLift Plus: For postpartum depression

Although the CMS codes only cover Medicare patients for now, early adopters of these digital tools are optimistic that their efforts will build a case for commercial insurance companies to start reimbursing providers for these treatments. In September 2025, Cigna Healthcare, a large commercial insurance company, announced that the health plan will start covering FDA-approved digital therapeutics.

Evidence suggests that patients benefit when they stay engaged with the interventions, and providers can use the tools to augment treatment between visits, support people as they wait for openings, or even offer care to patients who cannot or prefer not to meet with a live practitioner. “There is no question that they work, but we need more people on the ground trying to use them in the real world,” said Philip Cheng, PhD, a clinical psychologist in the Department of Sleep Medicine at Henry Ford Health who studies digital therapeutics.

Psychologists who are championing these interventions agree that it is critical to check in with patients to see how they are doing as they begin and continue to use the tools. To integrate SleepioRx into workflows at Cleveland Clinic, Drerup worked with a team that included not only clinicians, but also stakeholders from billing, training, registration, EPIC (the hospital’s electronic health record system), and other disciplines to plan how to educate providers about the tool, help patients use it, and bill for the product.

If a provider diagnoses a patient with insomnia disorder and decides that SleepioRx is appropriate, the provider educates the patient about how to download and use the app. The digital treatment includes six modules of CBT techniques that address the cognitive and behavioral factors that maintain insomnia. The treatment is customized for each patient based on daily sleep tracking that is collected by patient self-report or wearable devices.

A patient navigator—who is a licensed mental health professional—can see in the electronic health record if the patient is using the app and monitor the sleep diary and symptom data. If the patient stops engaging with the app, the navigator reaches out to check in. Drerup will meet regularly with the navigator to triage patients who are not improving and decide if they should be escalated to treatment with a provider who specializes in insomnia.

In some cases, patients may simply need additional coaching to continue following the guidance from the app. “One of the biggest challenges to cognitive behavioral therapy for insomnia is sleep restriction because it is counterintuitive,” Cheng said. With this strategy, people limit the time they are in bed to the time they are sleeping. Rather than lying in bed awake for long periods of time, the goal is to spend time in bed only when asleep. This forces the body to reconsolidate sleep within a shorter time, and eventually people start to increase their time in bed as long as they are sleeping.

“Our studies have shown that when we provide collaborative support with a nurse who is tracking progress with SleepioRx, patients are more likely to stay in the digital treatment,” Cheng said. “We regularly get messages from people telling us that SleepioRx has changed their lives because they are sleeping better.” The tool is also helping patients who are struggling with co-morbidities. “Patients who are getting better sleep are more able to implement CBT for anxiety, depression, and other conditions,” said Cheng.

Big Health, the company that developed SleepioRx and DaylightRx, is working with more than 100 health care systems and clinics throughout the United States to integrate these tools into care, including by developing a 20-minute training for providers to learn how to use the products with their patients. A trainer from Big Health usually joins a staff meeting via Zoom for this, but it can be done in person. Big Health also supports integration of its treatment directly into a system’s electronic health record (EHR) via a third-party health care interoperability platform that is already integrated into most EHRs. The platform allows different health care systems and software vendors to exchange data securely and efficiently. Smaller systems that do not have a common EHR can access a portal for clinicians to track patient progress. APA is partnering with Big Health to advance education on the benefits of digital treatments for common mental health conditions like insomnia, anxiety, and depression.

Researchers have also found that there is a “sensitive window” when a navigator should help a patient download a digital intervention. In one study, if a clinician ordered a digital tool during an appointment, administrative staff would schedule a 15-minute call with a digital navigator before the patient left the office. If patients connected with the digital navigator within 24 hours of their initial appointment, the likelihood of registering for the digital intervention was 97%; 48 hours later, the likelihood dropped to 76%; 5 days later, it dropped to 41% (Jaso-Yim, B., et al., Internet Interventions, Vol. 38, 2024opens in new window).

When multiple digital tools are available, busy clinicians also prefer to see a curated list of specific interventions that could help a patient rather than a laundry list of all the options available, said clinical psychologist Soo Jeong Youn, PhD, a lecturer in the Harvard Medical School Department of Psychiatry who studies digital interventions and former vice president of product and implementation at Reliant Medical Group, OptumCare.

In a recent study, her team developed algorithms that identified patients who might benefit from digital interventions based on electronic health record information and patient responses to a measure with questions about behavioral health functioning areas such as mood, attention and memory, anxiety, and sleep (Youn, S. J., et al., Administration and Policy in Mental Health and Mental Health Services Research, 2025, advance online publicationopens in new window). “Providers were very open to adopting this novel treatment option, and our data showed that patients were happy to have access and they followed through with the recommendations,” said Youn. Data showed that 80% registered for a digital intervention and 74% showed clinical improvement in outcomes (Norberg, S. S., Journal of Medical Internet Research, Vol. 26, 2024opens in new window).

Digital therapeutics also have the potential to address health conditions that affect people psychologically, such as chronic pain. There are FDA-approved digital tools for fibromyalgia (Stanza) and chronic low back pain (RelieVRx). With the RelieVRx device, patients engage in brief virtual reality sessions to learn how to apply self-regulation, body awareness, pain distraction, relaxation, and other techniques to manage pain. The headset includes a respiratory sensor that can collect biometric information to allow users to see how the techniques change in real-time, and what is happening in their bodies. “The exciting thing about digital therapeutics is that we can reach novel populations that would otherwise not have access to this information or care,” said Beth Darnall, PhD, a professor in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University School of Medicine and chief science advisor at AppliedVR, a company that develops immersive therapeutics using virtual reality to treat chronic pain and other health conditions. “They are often relying solely on medication to manage their pain and symptoms because it’s the only thing made available to them.”

There are also tools available to treat attention deficit/hyperactivity disorder (ADHD), such as EndeavorRx. In November 2025, CMS expanded the digital mental health treatment codes to include digital therapeutics for ADHD that will go into effect in 2026.

Although the FDA has approved a number of mental health digital therapeutics, there are many clinically valuable tools that have not been approved by the FDA, which has strict evidence standards. These standards include clinical trials, which often use sham controls, and specific clinical data. There are also products that the FDA will not review because the digital tools are outside of the FDA’s authority. To keep up with the pace of evidence-based digital interventions, organizations such as the Society for Digital Mental Health are recommending that CMS establish a new family of codes for non-FDA-cleared digital behavioral health tools for clinical effectiveness, safety, and usability. “How can we think about ways for tools that don't fall underneath FDA's clearance pathways to still meet certain standards to be accessible to patients?” said Stephen Schueller, PhD, a professor of psychology and informatics at the University of California, Irvine, and president of the Society of Digital Mental Health. To help consumers and clinicians evaluate which digital interventions are safe and effective, APA Labs recently launched the Digital Badge Programopens in new window, which will offer badges to tools that meet certain criteria related to clinical value, regulatory compliance, user safety, and data privacy.

In the coming year, pioneers in the field of digital treatment are eager to track how these tools not only impact mental health outcomes but also decrease health care costs as more people get the help they need. In a recent study assessment of organizations that were using Rejoyn and DaylightRx to treat depression and anxiety, the Peterson Health Technology Institute found that digital tools used in conjunction with usual care generated savings of $8.7 million per million patientsopens in new window.

If the data in the coming years continues to validate the benefit of these treatments, the interventions could improve the lives of many more people. “As increasing numbers of providers start thinking about incorporating digital options into care, I hope to see companies develop treatments for more conditions and age ranges,” said Fortunato. “This is just the beginning.”