Access to Prescription Digital Therapeutics Act of 2025
Sponsored By: Representative Hern (OK)
Introduced
Summary
National coverage and payment framework for prescription digital therapeutics. This bill would add FDA‑cleared software therapies to Medicare Part B and to Medicaid while creating rules for payment, coding, manufacturer reporting, and penalties.
Show full summary
- Medicare beneficiaries would have PDTs added as a covered Part B item for PDTs furnished on or after January 1, 2026.
- Medicaid enrollees would get aligned coverage by adding the same PDT definition to section 1905(a), making Medicaid reimbursement consistent with Medicare rules.
- Providers and payers would operate under a payment methodology the Secretary must set within 1 year, allowing one-time or periodic payments, and product‑specific HCPCS codes must be established within 2 years with temporary codes available until then.
- Manufacturers must submit annual reports starting January 1, 2026 on private payor rates, volumes, and user counts adjusted for discounts and rebates and face civil monetary penalties up to $10,000 per day for failures or misrepresentations.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Medicaid could cover digital therapies
If enacted, state Medicaid programs could cover prescription digital therapeutics that meet the bill’s definition. Whether you get coverage would depend on your state’s Medicaid rules. Coverage would use normal Medicaid processes.
Medicare coverage and payment for digital therapies
If enacted, Medicare Part B would cover prescription digital therapeutics furnished on or after January 1, 2026. The Secretary would set how PDTs are paid within 1 year. Payments could be one-time or ongoing and would consider list price, private payor rates, and any ongoing-use costs. Product-specific billing codes would be set within 2 years, with temporary codes used until permanent ones exist. This could lower what some Medicare patients pay, depending on the final rates.
What counts as a digital therapy
If enacted, the bill would define which software-based treatments count as prescription digital therapeutics. To qualify, a product must be FDA cleared or approved under 510(k), 513(f)(2), or 515, have a medical use for prevention, management, or treatment, and mainly use software. It must also be a prescription device under 21 C.F.R. 801.109. This definition would guide what Medicare and Medicaid could cover.
New reporting and fines for digital therapy makers
If enacted, makers of digital therapeutics billed to Medicare would need to report data by January 1, 2026 and then at least yearly. Reports would include each private payor’s payment rates, volumes distributed, and user counts, with all discounts and rebates reflected. The data would be kept confidential under existing rules. The Secretary could fine a maker up to $10,000 per day for missing, false, or incomplete reports.
Sponsors & CoSponsors
Sponsor
Hern (OK)
OK • R
Cosponsors
Thompson (CA)
CA • D
Sponsored 5/8/2025
Craig
MN • D
Sponsored 5/20/2025
Balderson
OH • R
Sponsored 7/2/2025
Van Duyne
TX • R
Sponsored 7/14/2025
Wittman
VA • R
Sponsored 9/9/2025
Panetta
CA • D
Sponsored 9/26/2025
DelBene
WA • D
Sponsored 10/8/2025
Sewell
AL • D
Sponsored 12/9/2025
Ross
NC • D
Sponsored 3/3/2026
Roll Call Votes
No roll call votes available for this bill.
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