Sponsors (4)
The bill expands access to prescription digital therapeutics for Medicare and Medicaid beneficiaries and creates clearer payment paths for providers and manufacturers, but it raises fiscal costs, imposes significant reporting and operational burdens, and risks pricing or quality trade-offs if transparency or evidence safeguards are not carefully managed.
Medicare and Medicaid beneficiaries will gain explicit coverage and reimbursement for FDA-cleared prescription digital therapeutics, expanding access to digital treatments for chronic conditions.
Manufacturers, hospitals, and health systems get clearer reimbursement pathways (Medicare payment methodology, HCPCS coding, and explicit Medicaid billing authority), improving billing predictability and commercial viability.
Patients with chronic conditions gain more non-drug treatment options that may improve disease management and reduce downstream healthcare costs if digital therapeutics are clinically effective and used continuously.
Including prescription digital therapeutics in Medicare Part B and explicit Medicaid coverage could increase federal and state spending, raising costs for taxpayers and potentially pressuring budgets.
Manufacturers face substantial new reporting burdens and risk steep civil penalties (up to $10,000 per day) for reporting failures or misrepresentations, which could disproportionately strain small firms.
Requiring disclosure of net private-payor rates could reduce competitive confidentiality, potentially leading payors or manufacturers to raise prices or alter contracting in ways that increase costs for patients and taxpayers.
Based on analysis of 3 sections of legislative text.
Requires Medicare Part B and Medicaid to cover FDA-cleared prescription digital therapeutics, creates Medicare payment codes and methodology, and mandates annual manufacturer reporting with penalties.
Introduced May 8, 2025 by Shelley Moore Capito · Last progress May 8, 2025
Requires Medicare Part B and Medicaid to cover FDA-cleared or -approved software-based "prescription digital therapeutics" furnished on or after January 1, 2026, establishes Medicare payment rules and coding for those products, and creates annual manufacturer reporting requirements with civil monetary penalties for noncompliance. The bill directs the Health and Human Services Secretary to set a Medicare payment methodology within one year and permanent HCPCS product codes within two years, while temporary codes may be used until then.