Access to Prescription Digital Therapeutics Act of 2025
HB3288, the Access to Prescription Digital Therapeutics Act of 2025, would amend the Social Security Act to recognize certain FDA-cleared or FDA-approved software-based therapeutic products as covered health services under both Medicare and Medicaid. The bill defines a “prescription digital therapeutic” as a product, device, internet application, or other technology that is primarily software-based and is authorized for the prevention, management, or treatment of a disease, condition, or disorder.
For Medicare, the bill would add prescription digital therapeutics to the list of covered medical and other health services beginning January 1, 2026, and direct the Secretary of Health and Human Services to create a payment methodology for manufacturers within one year of enactment. It also requires product-specific HCPCS coding, including temporary codes until permanent ones are established, and annual manufacturer reporting on private-payor payment rates, volume distributed, and user counts. The reporting rules include disclosure of discounts and rebates and authorize civil monetary penalties for failures to report or for misstatements.
For Medicaid, the bill would amend the Social Security Act to include prescription digital therapeutics as a covered service under the program. In practical terms, the bill would expand federal health coverage policy to include certain digital medicine products, potentially increasing access for beneficiaries while also creating new administrative and reimbursement obligations for CMS and manufacturers.
The bill would amend Titles XVIII and XIX of the Social Security Act to expressly include prescription digital therapeutics in Medicare and Medicaid coverage. It would require the Centers for Medicare & Medicaid Services to establish payment and coding frameworks for these products and would impose ongoing reporting and compliance duties on manufacturers. The affected parties include Medicare and Medicaid beneficiaries, digital therapeutic manufacturers, private payors whose pricing data must be reported, and federal administrators responsible for coverage, coding, and payment.
Based on the bill text and available context, the measure appears generally supportive of expanding access to emerging digital health treatments. The bipartisan sponsorship by Representatives Hern and Thompson suggests interest across party lines in recognizing software-based therapeutics within federal health programs. No committee debate, votes, or recorded opposition were provided, so there is no documented floor or committee sentiment beyond the bill’s affirmative policy direction.
The main likely points of contention are administrative complexity, payment methodology, and manufacturer reporting requirements. The bill gives the Secretary broad discretion to set payment rates, which could raise concerns among manufacturers about reimbursement adequacy, while payors and program administrators may focus on the burden of collecting and validating pricing and utilization data. Another possible issue is the scope of the definition of prescription digital therapeutics, including which FDA-authorized software products qualify and how ongoing-use products should be paid for. No specific objections were recorded in the provided materials.