S. 1702 — Access to Prescription Digital Therapeutics Act of 2025

This section defines "prescription digital therapeutic" (i.e., an FDA-cleared or approved software-based product, device, internet application, or other technology exempt from certain labeling requirements, used to prevent, manage, or treat a medical disease, condition, or disorder) and includes such therapeutics furnished on or after January 1, 2026, as a covered medical and other health service under Medicare Part B. It further (1) requires the Secretary, not later than one year after enactment, to establish a payment methodology for manufacturers (considering the actual list charge, weighted median private payor payment rates, ongoing use costs, and other factors); (2) requires the Secretary, not later than two years after enactment, to establish product-specific HCPCS codes (with temporary codes until permanent codes are available); and (3) requires manufacturers to annually report, beginning January 1, 2026, private payor payment rates (reflecting discounts), distribution volumes, and user numbers, subject to civil monetary penalties of up to $10,000 per day for noncompliance. (Thus, Medicare Part B covers these therapeutics with payments made to manufacturers rather than providers, based on private market data.)

This section adds prescription digital therapeutics (as defined in section 1861(nnn) of the Social Security Act) to the list of services covered as medical assistance under the Medicaid program.