Access to Prescription Digital Therapeutics Act of 2025
The Access to Prescription Digital Therapeutics Act of 2025 would add prescription digital therapeutics (PDTs) to Medicare Part B and to Medicaid coverage. PDTs are software-based medical treatments that have FDA-clearance or approval, apply to a medical condition, are primarily software-driven, and are issued as a device exempt from certain drug marketing rules. The bill defines PDTs, adds them to Medicare’s coverage framework starting January 1, 2026, and requires a federal process to pay for them, create billing codes, and track manufacturer data. It also expands Medicaid to cover PDTs. In short, the bill creates a formal federal pathway for reimbursement and coding of PDTs under both Medicare and Medicaid, and imposes reporting and compliance requirements on manufacturers. Key elements include establishing a Medicare payment method within a year, creating product-specific coding within two years, mandating annual manufacturer reporting on prices, usage, and patients, and imposing civil penalties for noncompliance. The Secretary would consider list price, typical payment rates, ongoing-use costs, and other factors when setting payments. The act also protects certain confidential information and describes how data must be treated.
Key Points
- 1Definition and scope of prescription digital therapeutics (PDTs)
- 2- PDTs are FDA-cleared or approved software-based products or devices that treat or manage a medical condition, primarily rely on software, and include devices exempt from certain FDA advertising rules.
- 3Medicare coverage and payment framework
- 4- PDTs furnished on or after January 1, 2026 are to be covered as a medical service under Medicare Part B.
- 5- The Secretary must establish a PDT payment methodology within one year, with factors including list price, weighted payment rates, ongoing-use costs, and other considerations.
- 6Coding and billing
- 7- Within two years, the Secretary must establish product-specific HCPCS codes for PDTs (with temporary codes in the interim).
- 8Manufacturer reporting and transparency
- 9- Manufacturers must report annually (beginning January 1, 2026) data on private-payor payment rates, distribution volumes, and number of users.
- 10- Reports must reflect discounts and rebates; failure to report or misreport can incur civil penalties up to $10,000 per day.
- 11- Privacy protections for reported data align with existing confidentiality standards for similar drug pricing information.
- 12Medicaid expansion
- 13- PDTs become covered under Medicaid by adding PDTs to the list of services in 1905(a)(32).
- 14Definitions and clarifications
- 15- The act provides specific definitions for actual list charge, HCPCS, private payor, and manufacturer to standardize how PDTs are treated within the Medicare system and reporting requirements.