US Senators Shelley Moore Capito (R-West Virginia) and Jeanne Shaheen (D-New Hampshire) have reintroduced bipartisan legislation to increase access to prescription digital therapeutics (PDTs). The Access to Prescription Digital Therapeutics Act would expand Medicare coverage to include PDTs and create a reimbursement pathway for software, thus decreasing barriers to care.1
“PDTs are an excellent example of how innovative technology can address some of the health challenges providers and patients continue to face,” said Senator Capito. “The Access to Prescription Digital Therapeutics Act would allow more patients living with a broad variety of diseases and conditions to more efficiently access the care and support they need and deserve.”1
In 2021, the number of individuals using digital therapeutics reached 44 million. In 2022, the number of digital therapeutics users doubled and reached 90.2 million. This number is expected to reach 652.4 million by the end of 2025.2
“Our bipartisan legislation reduces outdated barriers to increase access to innovative treatments that can help Granite Staters fighting diseases get better,” said Senator Shaheen. “PDTs can be a powerful tool in combatting the opioid and mental health crises affecting so many across our state – but right now, those treatments are out of reach for too many in need. I am proud to lead the bipartisan Access to Prescription Digital Therapeutics Act with Senator Capito to bring this innovative care in line with traditional treatment so Medicare patients can get the therapies that work best for them.”1
The last time this bill was introduced, the potential cost stymied its progress, as legislators feared that expanding access to PDTs could result in tens of billions of dollars in Medicare spending. Thus, the Congressional Budget Office (CBO) declined to score the bill because it did not understand how to estimate the cost impact. Now, advocates will bring new economic data and estimates from Germany to make a case for PDTs to Congress; the Centers for Medicare & Medicaid Services director, Mehmet Oz, MD; and the Department of Health and Human Services Secretary, Robert F. Kennedy Jr.
Germany found that in 4 years of paying for PDTs, it spent 234 million euros ($263 million) and had 861,000 activations of PDT products between the fourth quarter of 2020 and the fourth quarter of 2024. Now, it covers more than 50 products. While Germany and the US approach health care differently, this data could give Congress and its budget office a glimpse into possible spending levels for Medicare.3
This could expand access to PDTs such as Rejoyn, which was approved by the US Food and Drug Administration in 2024 and is aimed to help patients with depression. Developed in part by Dennis S. Charney, MD, Rejoyn is an emotional face memory task designed to correct abnormal neural circuits associated with depression. Users complete the program, which combines cognitive-emotional training exercises and brief therapeutic lessons, over a 6-week period.4
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References
1. Capito, Shaheen Reintroduce Access to Prescription Digital Therapeutics Act. News release. May 14, 2025. Accessed June 11, 2025. https://www.capito.senate.gov/news/press-releases/capito-shaheen-reintroduce-access-to-prescription-digital-therapeutics-act
2. Number of people using digital therapeutics worldwide from 2020 to 2025. Statista. September 7, 2023. Accessed June 11, 2025. https://www.statista.com/statistics/1223250/number-of-digital-therapeutic-users-worldwide/
3. Beavins E. Access to Prescription Digital Therapeutics Act reintroduced in Congress. Fierce Healthcare. May 9, 2025. Accessed June 11, 2025. https://www.fiercehealthcare.com/regulatory/access-prescription-digital-therapeutics-act-reintroduced-congress
4. Charney DS. Digital therapy Rejoyn utilizes neuroplasticity in treating depression. Psychiatric Times. March 12, 2025. https://www.psychiatrictimes.com/view/digital-therapy-rejoyn-utilizes-neuroplasticity-in-treating-depression
