The "Access to Prescription Digital Therapeutics Act of 2025" mandates the inclusion of prescription digital therapeutics (PDTs) under both the Medicare and Medicaid programs. A PDT is defined as an FDA-cleared or approved software-based technology designed to prevent, manage, or treat a medical condition. Under Medicare, PDTs will be covered as a medical and other health service beginning January 1, 2026. The bill directs the Secretary of Health and Human Services to establish a comprehensive payment methodology for manufacturers within one year, considering factors like actual list charges and weighted median private payor rates. Additionally, the Secretary must develop product-specific HCPCS codes for PDTs within two years, with temporary codes to be used in the interim. To ensure transparency and proper valuation, the legislation requires manufacturers of covered PDTs to submit annual reports to the Secretary starting January 1, 2026. These reports must detail private payor payment rates, including all discounts and rebates, along with distribution volume and the number of individual users. Failure to report or any misrepresentation can result in a civil monetary penalty of up to $10,000 per day . The bill also extends coverage to Medicaid, adding prescription digital therapeutics to the list of covered services under that program.
Access to Prescription Digital Therapeutics Act of 2025
USA119th CongressS-1702| Senate
| Updated: 5/8/2025
The "Access to Prescription Digital Therapeutics Act of 2025" mandates the inclusion of prescription digital therapeutics (PDTs) under both the Medicare and Medicaid programs. A PDT is defined as an FDA-cleared or approved software-based technology designed to prevent, manage, or treat a medical condition. Under Medicare, PDTs will be covered as a medical and other health service beginning January 1, 2026. The bill directs the Secretary of Health and Human Services to establish a comprehensive payment methodology for manufacturers within one year, considering factors like actual list charges and weighted median private payor rates. Additionally, the Secretary must develop product-specific HCPCS codes for PDTs within two years, with temporary codes to be used in the interim. To ensure transparency and proper valuation, the legislation requires manufacturers of covered PDTs to submit annual reports to the Secretary starting January 1, 2026. These reports must detail private payor payment rates, including all discounts and rebates, along with distribution volume and the number of individual users. Failure to report or any misrepresentation can result in a civil monetary penalty of up to $10,000 per day . The bill also extends coverage to Medicaid, adding prescription digital therapeutics to the list of covered services under that program.