H.R. 3288 — Access to Prescription Digital Therapeutics Act of 2025

This section establishes Medicare Part B coverage of prescription digital therapeutics (defined in new SSA §1861(nnn) as FDA-cleared or approved software-based products, devices, internet applications, or other technologies for preventing, managing, or treating medical conditions) furnished on or after January 1, 2026, as added to SSA §1861(s)(2)(KK). The section further directs the Secretary of Health and Human Services to (1) establish a manufacturer payment methodology within one year of enactment, considering factors such as actual list charges, weighted median private payer payment rates, and ongoing use costs; (2) implement product-specific HCPCS codes within two years of enactment, with temporary codes in the interim; and (3) require annual manufacturer reporting beginning January 1, 2026, on private payer payment rates (net of discounts), volumes, and user numbers, subject to civil monetary penalties of up to $10,000 per day for noncompliance. (Thus, these evidence-based digital therapeutics—e.g., apps for opioid use disorder or diabetes management—become reimbursable for Medicare beneficiaries, with payments informed by commercial market data.)

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