Medicare covers FDA approved mental health digital therapeutics
The Food and Drug Administration (FDA) approved several new prescription digital therapeutics for mental health disorders in 2024, including generalized anxiety disorder and depression. Beginning Jan. 1, 2025, Medicare began covering such FDA approved digital apps if the prescription was a medical necessity and fell into a defined benefit category.
Digital therapeutic treatments can be effective as an adjunct to therapy and/or medication and can provide between-session support and skills-based exercises, said Alice Connors-Kellgren, Ph.D., clinical psychologist and director of psychology training at Tufts Medical Center. But, mental health professionals need to keep in mind that these therapeutics are really meant to be a supplement to other interventions, rather than an alternative.
“Providers should be continuing to meet with clients using these therapeutics to assess progress, emerging needs, and any changes in risk, as well as provide the integral therapeutic factor of a warm, supportive relationship,” said Connors-Kellgren, who has used some digital supports for emotion identification and CBT/DBT/mindfulness skills.
Digital therapeutics approved by the FDA in 2024 include:
• Rejoyn. A prescription smartphone app for the treatment of major depressive disorder (MMD), Rejoyn offers a six-week treatment and is designed to be an adjunct to clinician-managed outpatient care for adults age 22 years or older. The app offers cognitive behavioral therapy (CBT)-based video lessons that each take about five minutes, as well as 20-to-30-minute cognitive emotional training (CET) exercises users can access on their own timetable. Nurse support is available to users of the Otsuka Precision Health app.
• DaylightRX. Also for patients age 22 and older, DaylightRX is a prescription app-based 90-day treatment for generalized anxiety disorder. Users of the app, developed by Big Health, have access to CBT with interactive lessons on stimulus control to decrease worry frequency, cognitive restructuring to break the spiral of anxious thoughts, and applied relaxation to reduce tension. Guided practice exercises are designed to help patients integrate these practices into their daily lives.
• MamaLift Plus. Patients suffering from symptomatic mild to moderate postpartum depression are the target base for MamaLift Plus. The neurobehavioral intervention incorporates elements of CTB, as well as dialectical behavior therapy (DBT), behavioral activation therapy (BAT), and interpersonal therapy (IPT). It is designed for adults as an adjunct to clinician-managed outpatient care. According to its website, the app is not yet available for patient use.
• CT-155. The FDA granted breakthrough device designation for CT-155, a digital therapeutic to treat negative symptoms for adults with schizophrenia. The software, which uses psychosocial intervention techniques, is co-developed between Click Therapeutics and Boehringer Ingelheim.
In the fall of 2024, the FDA created a Digital Health Advisory Committee to review policies and regulations about technologies such as digital therapeutics to help gain perspective on the benefits, risks, and critical outcomes.
Studies on therapeutics such as Rejoyn have shown that they are associated with improved cognitive control of emotions, and reduced depression symptoms, Connors-Kellgren said.
“From a therapist perspective, I think these apps provide skills teaching that we don’t always have time to do really well in sessions,” she said. “And they provide support and exercises between sessions so patients can continue to do supported therapeutic work and don’t experience attrition of skills or progress between sessions.”
Connors-Kellgren noted that these therapeutics are targeted to specific diagnoses and may not be as effective for people with comorbidities or complex presentations. Across therapeutic modalities, she said, decades of research has shown that the relationship between a client and therapist is the biggest contributor to treatment outcomes.
“We want to ensure that these therapeutics do not replace the relationship with a therapist. When working with people with depression, [for example,] we’re always attending to changes in coping and risk,” she said. “These apps can’t do crisis evaluations or risk assessments the way a human provider can. Part of the art of therapy is adapting interventions if symptoms worsen, which these therapeutics have a limited ability to do.”
Other digital therapeutics that received FDA approval prior to 2024 include NightWare, designed to reduce sleep disturbances in adults with nightmare disorder or post-traumatic stress disorder (PTSD); EndeavorRX, a prescription video game style treatment for children with ADHD; and RESET and RESET-O, smartphone-based treatments for substance use disorder and opioid use disorder.