SB 1702, the Access to Prescription Digital Therapeutics Act of 2025, would require Medicare and Medicaid to cover certain prescription digital therapeutics. The bill defines a prescription digital therapeutic as a cleared or approved software-based product, device, internet application, or similar technology that is authorized under the Federal Food, Drug, and Cosmetic Act and is intended to prevent, manage, or treat a medical disease, condition, or disorder. It would add these products to the list of covered medical and other health services under Medicare beginning January 1, 2026, and would also make them a covered Medicaid benefit.
For Medicare, the bill directs the Secretary of Health and Human Services to establish a payment methodology for manufacturers within one year of enactment, which could be a one-time or periodic payment. It also requires product-specific HCPCS coding, including temporary codes until permanent ones are created. Manufacturers would have to report private-payor payment rates, distribution volume, and user counts starting January 1, 2026, with civil monetary penalties for failures to report or misreporting. The bill also sets confidentiality rules for the reported information and defines key terms such as actual list charge, private payor, and manufacturer.
The bill’s impact on state and federal health coverage law would be to expand public insurance coverage for FDA-cleared or approved digital therapeutics, potentially increasing access for patients and creating a new reimbursement framework for software-based treatments. Although the bill is a federal measure, its Medicaid amendment would affect state Medicaid programs by requiring them to treat prescription digital therapeutics as a covered service under the federal-state program, subject to federal Medicaid rules and state administration. It would also likely influence provider prescribing practices, manufacturer pricing and reporting behavior, and payer adoption of these products.
Because there were no committee transcripts or recorded votes provided, there is no documented debate or formal vote history to gauge sentiment directly. Based on the bill’s sponsorship and structure, the measure appears to have bipartisan, pro-innovation support focused on expanding access to emerging digital health treatments. The main points of potential contention are likely to be cost, how payment rates are set, whether the reporting requirements are burdensome for manufacturers, and how to ensure that only clinically validated, appropriately regulated digital therapeutics qualify for coverage.
The bill would amend the Social Security Act to add prescription digital therapeutics to Medicare-covered services and Medicaid-covered benefits, creating new federal coverage and payment rules for software-based treatments. It would require HHS to establish Medicare reimbursement methodology, assign HCPCS codes, and collect manufacturer pricing and utilization data, while also extending coverage obligations into state Medicaid programs.
No committee discussion or vote record was provided, so there is no direct evidence of opposition or support from hearings or floor action. The bill’s bipartisan sponsorship and its focus on access to regulated digital health tools suggest generally favorable sentiment, especially among supporters of telehealth, digital medicine, and innovation in treatment delivery.
Likely areas of contention include the fiscal impact on Medicare and Medicaid, whether the Secretary’s payment methodology will adequately control costs, and whether manufacturer reporting obligations are too burdensome. Another possible issue is defining which digital products qualify, since coverage is limited to FDA-cleared or approved therapeutics that primarily use software and meet specific regulatory criteria.