Sponsors (5)
The bill expands Medicare and Medicaid coverage and creates clearer payment pathways for prescription digital therapeutics—improving access and transparency—while imposing reporting and compliance requirements, administrative burdens, and risks of higher public spending if utilization or effectiveness are uncertain.
Medicare beneficiaries will gain coverage for FDA-cleared prescription digital therapeutics starting Jan 1, 2026, expanding access to software-based treatments.
Medicaid beneficiaries will be able to receive covered access to prescription digital therapeutics, expanding non-drug treatment options for patients with chronic and other conditions covered by Medicaid.
Manufacturers, clinicians, and hospitals will get clearer billing predictability through creation of permanent HCPCS codes within two years and a required Medicare payment methodology within one year, reducing payment uncertainty.
Medicare coverage could drive increased utilization of prescription digital therapeutics without long-term outcomes data, potentially raising Medicare spending and taxpayer costs if effectiveness varies.
State Medicaid programs will face added program costs to cover and reimburse prescription digital therapeutics, potentially increasing state spending and fiscal pressure.
Reporting requirements and civil monetary penalties (up to $10,000/day) create compliance costs and legal risk 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 Part B coverage, payment coding, and manufacturer reporting for FDA-cleared/approved prescription digital therapeutics and adds them to Medicaid's covered services.
Official title: Amend titles XVIII and XIX of the Social Security Act to provide for coverage of prescription digital therapeutics under such titles, and for other purposes.
Introduced May 8, 2025 by Shelley Moore Capito · Last progress May 8, 2025
Creates a new Medicare benefit and adds Medicaid coverage for FDA-cleared or approved software-based prescription digital therapeutics (PDTs). It requires Medicare Part B to cover PDTs furnished on or after January 1, 2026, establishes payment coding and methodology rules, and mandates annual manufacturer reporting of private-payor prices, distribution volumes, and user counts with civil monetary penalties for noncompliance.