Access to Prescription Digital Therapeutics Act of 2025
Sponsored By: Senator Shelley Capito
Introduced
Summary
Medicare and Medicaid coverage and payment for prescription digital therapeutics. This bill would create a framework so software-based, FDA-cleared therapeutics can be paid for and tracked by Medicare and Medicaid, and it would set rules for coding, payment, and manufacturer reporting.
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- Families and patients: People on Medicare and Medicaid would gain coverage for prescription digital therapeutics as medical services. Medicare coverage would apply to PDTs furnished on or after January 1, 2026 and Medicaid would add PDTs to its list of covered items.
- Manufacturers: Makers of PDTs would have to annually report private-payor payment rates, distribution volume, and number of users starting January 1, 2026, including all discounts and price concessions. Civil monetary penalties up to $10,000 per day per failure could apply for misreporting or failures to report.
- Medicare administration and providers: The Secretary would have 1 year after enactment to establish a PDT payment methodology that may be one-time or periodic and must consider list price, a weighted median of reported rates, and ongoing-use amounts. The Secretary would also have 2 years to create product-specific HCPCS codes and provide temporary codes until then.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
Medicare Part B covers digital therapies
If enacted, Medicare Part B would cover prescription digital therapeutics furnished on or after January 1, 2026. Covered products must meet the bill's new statutory definition of a prescription digital therapeutic. This could help Medicare patients pay less for software-based treatments that meet the rules.
New Medicare rules for digital therapeutics
If enacted, HHS would set a payment method for PDTs within one year and product billing codes within two years. Manufacturers would start annual reporting on private-payor prices, volumes, and user counts on January 1, 2026. Companies could face civil money penalties up to $10,000 per day for bad or missing reports.
Definition of prescription digital therapeutics
If enacted, the bill would define a "prescription digital therapeutic" for Medicare and Medicaid. To qualify, a product must have FDA clearance or approval, a cleared indication for prevention, management, or treatment, primarily use software, and meet a device exemption rule. This definition would decide which products can get program coverage.
Medicaid may cover digital therapies
If enacted, Medicaid would add prescription digital therapeutics to its list of covered items upon enactment. Coverage would apply only to products that meet the new PDT definition. If you are on Medicaid, this could lower your out-of-pocket costs for qualified software-based treatments.
Sponsors & CoSponsors
Sponsor
Shelley Capito
WV • R
Cosponsors
Jeanne Shaheen
NH • D
Sponsored 5/8/2025
Cory Booker
NJ • D
Sponsored 7/15/2025
Roll Call Votes
No roll call votes available for this bill.
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