Sponsors (5)
The bill expands public coverage and creates clearer payment rules for prescription digital therapeutics—broadening patient access and billing predictability—while raising risks of higher public and private costs, compliance burdens, and potential competitive/privacy concerns from reporting requirements.
Medicare and Medicaid beneficiaries gain covered access to FDA-cleared prescription digital therapeutics, expanding non‑drug treatment options for many patients (Medicare coverage effective Jan 1, 2026).
Manufacturers and clinicians will have clearer payment codes and a required payment methodology (permanent HCPCS codes within 2 years and payment methodology within 1 year), improving billing predictability for health systems and suppliers.
Reporting of private-payor rates and volumes can create price transparency data that the Secretary may use to align Medicare payments more closely with market rates, potentially improving payment accuracy.
Medicare coverage could incentivize greater use of prescription digital therapeutics before long-term real-world outcomes are established, risking higher Medicare spending and exposing beneficiaries/taxpayers to uncertain value.
State Medicaid programs will face added program costs to cover and reimburse prescription digital therapeutics, potentially increasing state spending or shifting costs elsewhere.
Reporting requirements and potential civil monetary penalties (up to $10,000/day) create compliance costs for manufacturers that may be passed on to payors or patients through higher prices.
Based on analysis of 3 sections of legislative text.
Requires Medicare and Medicaid coverage of FDA-cleared prescription digital therapeutics, sets Medicare coding/payment rules, and mandates manufacturer reporting of private-payor prices and use.
Introduced May 8, 2025 by Shelley Moore Capito · Last progress May 8, 2025
Requires Medicare Part B and Medicaid to treat FDA-cleared or -approved software-based prescription digital therapeutics as covered medical services, sets Medicare coding and payment rules, and makes manufacturers report private-payor prices, distribution by payor, and user counts. Establishes deadlines for CMS to create a payment methodology and permanent HCPCS codes, and creates civil monetary penalties for deficient or false manufacturer reports.