(120) Coverage gaps and reimbursement barriers for FDA-authorized prescription digital therapeutics: a systematic review of U.S. health plan policies from 2018 to 2025
Student MCPHS Boston, Massachusetts, United States
Background: : Prescription digital therapeutics (PDTs) are FDA-authorized software-based treatments for conditions such as substance use disorder, ADHD, insomnia, and type 2 diabetes. Despite strong clinical evidence and regulatory approval, coverage by U.S. payers has remained limited due to challenges in benefit classification, billing infrastructure, and reimbursement policies.
Objective: : To assess trends in U.S. payer coverage of FDA-cleared PDTs from 2018 to 2025, focusing on benefit designation, formulary status, billing practices, and policy-level access barriers.
Methods: : A systematic review of literature published from January 2018 to June 2025 was conducted using PubMed, Embase, and CINAHL. A total of 12 studies met inclusion criteria. Eligible sources described Medicare, Medicaid, or commercial payer coverage of FDA-authorized digital therapeutics. Data were extracted on benefit type (e.g., pharmacy, medical, or telehealth), billing codes, coverage policies, and formulary placement. Additional grey literature, including CMS documents, payer websites, and trade publications, was reviewed to capture recent developments.
Results: : Coverage remained inconsistent across payers. By 2022, around 20 percent of PDTs, including reSET-O, Somryst, and EndeavorRx, were included on commercial formularies, typically under pharmacy or specialty tiers. Roughly 30 percent of commercial plans covered at least one PDT for diabetes, while fewer than 15 percent covered behavioral health-related PDTs. Medicare lacked a defined benefit category for PDTs, creating reimbursement challenges. Although CMS introduced a general billing code for digital behavioral therapies in 2022, product-specific codes were not yet available. Medicaid coverage varied by state, with limited adoption through pilot programs. Most payers had not formally incorporated PDTs into their technology assessment or formulary review processes. Coverage was often limited to case-by-case approvals or short-term initiatives.
Conclusions: : Despite clinical and regulatory advancement, prescription digital therapeutics face persistent coverage and reimbursement barriers across U.S. payers. The absence of formal benefit categorization, product-specific billing codes, and consistent evaluation frameworks limits widespread adoption. Addressing these gaps through CMS guidance, standardized coding, and evidence-based coverage criteria may improve access and support broader integration into care delivery.
