Access to Prescription Digital Therapeutics Act of 2025
The Access to Prescription Digital Therapeutics Act of 2025 would explicitly add prescription digital therapeutics (PDTs) to coverage under Medicare Part B and extend Medicaid coverage to PDTs. It defines PDTs as software- or device-based products cleared or approved by FDA (through specified clearance pathways), with an FDA-cleared indication for prevention, management, or treatment of a medical condition, that primarily uses software to achieve its effect, and that falls under a specific device exemption. The bill requires the federal government to establish payment methodologies for PDTs, create product-specific billing codes, and mandate annual reporting by PDT manufacturers on private-payor rates, distribution, and user numbers. It also imposes civil penalties for failures to report or misreport and protects confidentiality of reported data. The above changes would take effect for PDTs furnished on or after January 1, 2026, with related coding timelines to follow over the next couple of years.
Key Points
- 1Defines “prescription digital therapeutic” and expands Medicare Part B coverage to PDTs furnished on or after January 1, 2026.
- 2Requires the Secretary to establish a PDT payment methodology within 1 year of enactment, with considerations such as actual list price, median payer rates, ongoing-use costs, and other factors.
- 3Requires creation of product-specific HCPCS codes for PDTs within 2 years (with temporary codes available in the interim).
- 4Mandates annual manufacturer reporting (starting January 1, 2026) of private payor payment rates, distribution volume, and number of users, and imposes civil penalties for noncompliance or misreporting; data reported must be treated as confidential.
- 5Extends Medicaid coverage to PDTs by adding them to the list of covered items/services under the program.