Making digital interventions accessible and affordable

By Heather Stringer, Reprinted from American Psychological Association

As the nation grapples with soaring demand for mental health services amid a provider shortage, more psychologists are considering the benefits of digital therapeutics—evidence-based interventions available to patients on their mobile devices. These tools have the potential to help people struggling with substance use disorders, anxiety, insomnia, and other conditions.

But there is a major hurdle blocking widespread access: Using digital therapeutics in practice is not usually covered by health insurance. The costs for the software alone can range from approximately $300 to $1,500 annually—fees that are out of reach for many patients.

“If patients are forced to pay out of pocket for the products, this is not a sustainable business model,” said Vaile Wright, PhD, senior director for health care innovation in the practice directorate at APA.

It’s also not sustainable for the companies that create the products, Wright notes. For example, in April 2023, Pear Therapeutics—a company that developed apps to treat substance use disorders and insomnia—filed for bankruptcy. The company’s reSET product, used in conjunction with standard outpatient treatment for substance use disorders related to stimulants, cannabis, cocaine, and alcohol, was cleared by the FDA in 2016—the first mental health digital therapeutic cleared by the agency. “Unless we find a traditional health care pathway to cover the cost, digital therapeutics companies will not likely make it in our country,” Wright said. “This would be a significant loss for patients because the technology has the potential to bring evidence-based treatment to people who may not have access to care through the traditional psychotherapy model.”

Momentum is building in a few states to address this reimbursement issue. Early this year, state legislators began considering bills that would authorize Medicaid reimbursement for digital therapeutics in Arkansas, Minnesota, Hawaii, Arizona, and Maryland.

And at the national level, U.S. Senators Jeanne Shaheen (D-New Hampshire) and Shelley Moore Capito (R-West Virginia) and U.S. Representatives Kevin Hern (R-Oklahoma) and Mike Thompson (D-California) reintroduced bills that would create a new benefit category in Medicare to pay for the software component of these tools. To make these mental health interventions more accessible to the public during the pandemic, the FDA also streamlined the formal clearance process.

Although the federal and state bills are encouraging signs for advocates of these products, many of the bills limit which providers can use them and which fees are deemed reimbursable. “Payers should not only cover the cost of the software but also the provider time used to identify the appropriate digital therapeutic, teach the patient to use it, and monitor the patient’s progress,” said Wright.

Progress in Maryland

Forensic psychologist Paul Berman, PhD, who owns a private practice in Towson, Maryland, and serves as the professional affairs officer at the Maryland Psychological Association, learned of new digital therapeutics legislation in his state in February 2023 when APA contacted his association. Although leaders at the state organization were supportive of the bill, the language in the legislation would have excluded psychologists from using digital therapeutics because they require a prescription. The association’s lobbyists worked with the bill’s sponsors to amend the wording to allow non-prescribing providers to “order” the software for patients.

“Mental health digital therapeutics are interventions that fall within psychologists’ scope of practice, and we want to make sure payors don’t inadvertently assume only physicians can use them,” said Deborah Baker, JD, director of legal and regulatory policy at APA.

In late February, Berman testified before subcommittees in both the Maryland House of Delegates and the Senate to explain why the bill was needed. The legislators expressed significant interest in supporting technology that would increase access to mental health services, but it was also clear that they did not understand the differences between digital therapeutics and wellness apps, said Berman. “They wanted to understand why the tools required oversight and how they worked,” he said. In Maryland, testimonies are limited to two minutes, which is not sufficient time for a visual demonstration of the tools. “In the future, we hope to offer demonstrations with the legislators and their staff in follow-up meetings or in additional subcommittee hearings that the legislators request,” Berman said.

Although the bill did not move beyond the subcommittees by the end of the legislative session, Berman and others at the association are preparing to testify again during the next session in the fall.

“Our plan is to do more grassroots work with psychologists who are familiar with these products and have them visit legislators in their districts,” he said. “ Legislators are very accessible and curious about bills that are before the committee, and it is not difficult to reach out and set up a meeting with a legislator or aide.”

In Hawaii, legislators introduced a bill calling for the state’s Department of Health to conduct a pilot program that would integrate digital therapeutics into outpatient substance use disorder treatment programs. The bill failed to pass in the Senate Ways and Means Committee, and leaders at the Hawaii Psychological Association are planning to advocate for the bill in 2024. “We believe digital therapeutics can increase access to care in rural parts of the islands and increase motivation to engage in treatment,” said Nozanin Yusufbekova, PsyD, who works in private practice in Honolulu and is past president of the Hawaii Psychological Association.

The digital therapeutic difference

Unlike wellness apps that aim to help people stop smoking, reduce stress, or lose weight, digital therapeutics use evidence-based methods of treating diseases. Regulators use the term “software as a medical device,” or SaMD, to describe digital therapeutics and similar apps that function as a medical device and can treat a specific condition. Developers of wellness apps, such as Headspace (for meditation) and Calm (for sleep and meditation), also do not typically conduct studies to verify the claims of the product.

Big Health, a digital therapeutics company based in San Francisco, validated the safety and effectiveness of its products for anxiety and insomnia before making them available to patients. Patients who download the Daylight and Sleepio apps complete an initial assessment on their mobile devices, and this data informs the treatment algorithm. For example, users of Sleepio, which helps people with sleep problems, may receive a suggestion to practice a relaxation exercise before bedtime.

Daylight, which helps people with moderate-to-severe symptoms of generalized anxiety disorder, provides tailored digital cognitive behavioral therapy that includes principles of applied relaxation, stimulus control, cognitive restructuring, and imaginal exposure. Users can learn skills to interrupt ruminative thinking patterns and change negative interpretation biases. “Modules may teach them how to find a time and a place to worry, and how to postpone worries when they come up at other times,” said Jenna Carl, PhD, a psychologist and chief medical officer at Big Health. Daylight users also complete weekly in‐app brief assessments of anxiety, depressive symptoms, and sleep, which generate personalized feedback.

In a randomized controlled trial of 256 participants who used Daylight, participants reported significant improvements in worry, depressive symptoms, sleep difficulty, well-being, and quality of life compared with controls who did not use the app (Carl, J.R., et al., Depression and Anxiety, Vol. 37, No. 12, 2020). These interventions are also effective because they are designed to be convenient, said Carl. “People can use the app on a bus ride commute if that is the only time that they have available,” she said.

Although the benefits of Sleepio and Daylight have been validated in studies, distribution of the software has been limited in the United States due to a lack of national insurance coverage. As a result, Big Health has sought agreements with large, self-insured employers that are willing to pay for products that could lower an organization’s overall health care costs. The products are more widely available in the United Kingdom, where the National Health Service (NHS) in Scotland covers the cost of the apps for millions of patients.

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Akili’s EndeavorRX, a digital therapeutic for children with attention-deficit hyperactivity disorder (ADHD), can be prescribed by physicians or ordered by psychologists in the United States, but most patients pay out of pocket for the product because it is not covered by insurance. The multitasking racing game activates regions of the brain related to attention, and studies have shown that the tool reduced ADHD-related impairment in areas such as social functioning, academic progress, and self-esteem (Kollins, S.H., et al., npj Digital Medicine, Vol. 4, 2021).

The product costs $99 per month, and prescriptions typically last a few months. For now, the company is providing a discount for the app to families who pay out of pocket, and EndeavorRX is free for families who cannot otherwise afford the treatment. “Payers are limiting access to safe, effective, and regulated medical products, and this directly impacts the choices that patients can make about their mental health care,” said Scott Kollins, PhD, chief medical officer at Akili.

Forging new partnerships

Although relatively few patients in the United States are benefiting from digital therapeutics, Wright is optimistic that reimbursement changes are on the horizon. “Pear’s bankruptcy filing was a wake-up call for the industry, and I’m seeing greater willingness between makers, psychologists, physicians, and legislators to work together to find new solutions to the workforce shortages,” Wright said.

APA representatives have met with leaders from the Centers for Medicare & Medicaid Services to propose a coding and reimbursement model for digital therapeutics. APA is working to create a system that would allow psychologists, physicians, and other eligible providers to bill private or government insurance organizations for using these apps with patients.

Increasing access to these tools depends not only on clearing the financial hurdles but also on raising awareness that digital therapeutics are available and beneficial. To help psychologists learn more about digital therapeutics, APA recently formed a partnership with Big Health with the goal of educating psychologists about how to use the programs with their patients, incorporate them into their workflow, and track patient data.

Dimitri Gavriloff, DClinPsych, a clinical psychologist who specializes in sleep medicine in the UK, has recommended Big Health’s Sleepio app to hundreds of patients. The NHS covers the cost of the app—which trains people to use CBT techniques to overcome insomnia—for people living in Scotland and certain parts of England. Given that insomnia disorder is a pervasive condition that affects about 10% of the adult population in the UK, Gavriloff is pleased to see more people gain access to the help they need. “CBT is the first-line recommended treatment, but many people are not routinely offered this care,” he said. Patients often go to primary care providers who will offer general sleep hygiene advice, such as avoiding screens, alcohol, and caffeine before bed, or a short course of sleep medication, but this is not recommended, Gavriloff said.

The results of a recent study suggest that this digital form of CBT can have lasting effects. To assess whether prior use of Sleepio helped patients cope during the pandemic, researchers reevaluated participants from a previous study. Those who had used Sleepio to overcome insomnia in 2016–2017 reported fewer insomnia symptoms, less general depression, and less general stress in April 2020 than those who had previously received only general sleep education (Cheng, P., et al., Sleep, Vol. 44, No. 4, 2021).

Although the NHS covers the cost of the app in a few areas, widespread access is still limited—which means people in the UK and elsewhere may not be getting the help they need.

“We will never have enough clinicians to meet the demand for evidence-based treatment for insomnia,” Gavriloff said. “While digital therapeutics are not necessarily for everyone, they are effective for many people and increase the opportunity for equal access to quality care.”

Mental health digital therapeutics currently available in the United States

• Canvas Dx: diagnostic aid for autism spectrum disorder (ASD)
• deprexis: CBT for depression
• Daylight: CBT for anxiety
• EndeavorRx: ADHD video game treatment for children ages 8 to 12
• NightWare: app that can reduce sleep disturbances related to nightmare disorder or nightmares from post-traumatic stress disorder (PTSD)
• Prism: digital self-neuromodulation therapy for PTSD
• Sleepio: CBT for insomnia
• TALi: game-based cognitive training platform to assess and improve early childhood attention
• vorvida: CBT for alcohol use disorder

Note: This is not a comprehensive list.

Further reading

It is time to REACT: Opportunities for digital mental health apps to reduce mental health disparities in racially and ethnically minoritized groups
Friis-Healy, E. A., et al., JMIR Mental Health, 2021

Digital mental health care: Five lessons from Act 1 and a preview of Acts 2-5
Insel, T., npj Digital Medicine, 2023

Focusing on digital research priorities for advancing the access and quality of mental health
Torous, J., et al., JMIR Mental Health, 2023

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