Sponsors (4)
The bill expands public insurance coverage and billing predictability for prescription digital therapeutics—increasing patient access to software-based care—while introducing risks of higher public and private spending, compliance costs and competitive-privacy concerns, and implementation burdens for providers and state programs.
Medicare and Medicaid beneficiaries (large populations of older adults and low-income patients) gain covered access to FDA-cleared prescription digital therapeutics, expanding non-drug treatment options starting Jan 1, 2026 for Medicare and via state Medicaid programs.
Manufacturers and clinicians (and the hospitals/health systems that employ them) get clearer, more predictable billing through permanent HCPCS codes within two years and a required payment methodology within one year, reducing reimbursement uncertainty.
States can deliver potentially cost‑effective, non‑drug interventions through Medicaid, which may reduce downstream medical costs for beneficiaries and state budgets over time.
Medicare beneficiaries and taxpayers could face higher Medicare spending if coverage incentivizes greater use of software therapeutics before robust long-term outcomes and comparative-effectiveness data exist.
Manufacturers face new reporting obligations and civil monetary penalties (up to $10,000/day) that raise compliance costs and could be passed on to payors or patients as higher prices.
Requiring disclosure of net private-payor rates and volumes may expose competitively sensitive information (despite confidentiality promises), risking legal disputes, settlements, or a chilling effect on competition and market entry.
Based on analysis of 3 sections of legislative text.
Requires Medicare and Medicaid to cover FDA-cleared/approved prescription digital therapeutics, creates Medicare payment/coding rules, and mandates manufacturer reporting starting 2026.
Introduced May 8, 2025 by Shelley Moore Capito · Last progress May 8, 2025
Requires Medicare and Medicaid to cover “prescription digital therapeutics” and adds a Medicare payment and coding framework plus manufacturer reporting requirements. It defines prescription digital therapeutics as FDA-cleared or -approved software-based medical devices with an approved clinical indication and sets Medicare coverage for items furnished on or after January 1, 2026. Directs the Department of Health and Human Services to create a Medicare payment methodology within one year, establish permanent HCPCS codes within two years (with temporary codes allowed in the interim), and requires manufacturers to report private-payor net payment rates, distribution volumes by payor, and user counts annually starting January 1, 2026, with civil monetary penalties for noncompliance. It also adds prescription digital therapeutics to the statutory list of Medicaid-covered services, making them a required category of Medicaid medical assistance.