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S1702119th CongressWALLET

Access to Prescription Digital Therapeutics Act of 2025

Sponsored By: Senator Capito, Shelley Moore [R-WV]

Introduced

Summary

This bill expands coverage for prescription digital therapeutics and sets rules for how they are paid, coded, and reported.

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  • Medicare beneficiaries gain coverage for prescription digital therapeutics furnished on or after January 1, 2026. The Centers for Medicare & Medicaid Services must set a payment methodology within one year and create product-specific HCPCS codes within two years, using temporary codes until permanent ones exist.
  • Medicaid enrollees will have prescription digital therapeutics added to Medicaid’s list of covered items consistent with the bill’s PDT definition.
  • Manufacturers must annually report private payor payment rates, distribution volume, and user counts beginning January 1, 2026. Reported rates must include all discounts and concessions and are treated as confidential. Civil monetary penalties for failures or misrepresentations can reach $10,000 per day per violation.

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 2 benefits, 1 costs, 0 mixed.

Medicaid coverage for digital therapeutics

If enacted, the bill would add prescription digital therapeutics to Medicaid's list of covered items and services upon enactment. That would make qualifying digital therapeutics eligible for Medicaid coverage, subject to state administration and existing Medicaid rules. Your out-of-pocket costs would depend on your state's Medicaid rules and the specific product.

Medicare coverage and payment for digital therapeutics

If enacted, Medicare Part B would cover prescription digital therapeutics furnished on or after January 1, 2026. The bill would require HHS to set a payment method for manufacturers within one year. Payments could be a one-time amount or periodic amounts and must consider list prices, reported payment rates weighted by volume, and ongoing-use amounts where relevant. The bill would also require HHS to create product-specific HCPCS codes within two years and use temporary product codes until permanent codes are ready. The statutory definition of "prescription digital therapeutic" would take effect on enactment and determine which products qualify.

Reporting rules for digital therapeutic makers

If enacted, starting January 1, 2026 each maker of a Medicare-covered prescription digital therapeutic would have to report yearly to HHS. Reports would show payment rates paid by each private payor (including all discounts and rebates), volume by payor, and number of individual users. Reported information would receive confidentiality protections like other manufacturer disclosures, but HHS could fine firms up to $10,000 per day for failures, misrepresentations, or omissions.

Sponsors & CoSponsors

Sponsor

Capito, Shelley Moore [R-WV]

WV • R

Cosponsors

  • Sen. Shaheen, Jeanne [D-NH]

    NH • D

    Sponsored 5/8/2025

  • Sen. Booker, Cory A. [D-NJ]

    NJ • D

    Sponsored 7/15/2025

  • Sen. Budd, Ted [R-NC]

    NC • R

    Sponsored 12/10/2025

  • Sen. Blackburn, Marsha [R-TN]

    TN • R

    Sponsored 6/16/2026

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
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