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Access to Prescription Digital Therapeutics Act of 2025

USA119th CongressHR-3288| House 
| Updated: 5/8/2025
Kevin Hern

Kevin Hern

Republican Representative

Oklahoma

Cosponsors (9)
Robert J. Wittman (Republican)Beth Van Duyne (Republican)Terri A. Sewell (Democratic)Jimmy Panetta (Democratic)Suzan K. DelBene (Democratic)Angie Craig (Democratic)Deborah K. Ross (Democratic)Mike Thompson (Democratic)Troy Balderson (Republican)

Ways and Means Committee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Access to Prescription Digital Therapeutics Act of 2025" proposes to expand coverage under the Medicare and Medicaid programs to include prescription digital therapeutics (PDTs). This legislation defines a PDT as an FDA-cleared or approved product, device, or application that primarily uses software to prevent, manage, or treat a medical condition, and is exempt from certain labeling requirements. Under Medicare, the bill mandates coverage for PDTs as a medical and other health service starting January 1, 2026. It directs the Secretary of Health and Human Services to establish a payment methodology for manufacturers within one year, considering factors such as the actual list charge and weighted median private payor rates. Additionally, the Secretary must develop product-specific HCPCS codes for PDTs within two years, with temporary codes to facilitate interim payment. Manufacturers of covered PDTs will be required to submit annual reports detailing private payor payment rates, volume, and user numbers, reflecting all discounts and rebates. Failure to report or misrepresentation can result in civil monetary penalties of up to $10,000 per day. For Medicaid, the bill amends the Social Security Act to explicitly include prescription digital therapeutics as a covered service, aligning with the Medicare definition.
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Timeline

Bill from Previous Congress

HR 117-7051
Access to Prescription Digital Therapeutics Act of 2022

Bill from Previous Congress

HR 118-1458
Access to Prescription Digital Therapeutics Act of 2023
May 8, 2025

Latest Companion Bill Action

S 119-1702
Introduced in Senate
May 8, 2025
Introduced in House
May 8, 2025
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
  • Bill from Previous Congress

    HR 117-7051
    Access to Prescription Digital Therapeutics Act of 2022


  • Bill from Previous Congress

    HR 118-1458
    Access to Prescription Digital Therapeutics Act of 2023


  • May 8, 2025

    Latest Companion Bill Action

    S 119-1702
    Introduced in Senate


  • May 8, 2025
    Introduced in House


  • May 8, 2025
    Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Health

Related Bills

  • S 119-1702: Access to Prescription Digital Therapeutics Act of 2025

Access to Prescription Digital Therapeutics Act of 2025

USA119th CongressHR-3288| House 
| Updated: 5/8/2025
The "Access to Prescription Digital Therapeutics Act of 2025" proposes to expand coverage under the Medicare and Medicaid programs to include prescription digital therapeutics (PDTs). This legislation defines a PDT as an FDA-cleared or approved product, device, or application that primarily uses software to prevent, manage, or treat a medical condition, and is exempt from certain labeling requirements. Under Medicare, the bill mandates coverage for PDTs as a medical and other health service starting January 1, 2026. It directs the Secretary of Health and Human Services to establish a payment methodology for manufacturers within one year, considering factors such as the actual list charge and weighted median private payor rates. Additionally, the Secretary must develop product-specific HCPCS codes for PDTs within two years, with temporary codes to facilitate interim payment. Manufacturers of covered PDTs will be required to submit annual reports detailing private payor payment rates, volume, and user numbers, reflecting all discounts and rebates. Failure to report or misrepresentation can result in civil monetary penalties of up to $10,000 per day. For Medicaid, the bill amends the Social Security Act to explicitly include prescription digital therapeutics as a covered service, aligning with the Medicare definition.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 117-7051
Access to Prescription Digital Therapeutics Act of 2022

Bill from Previous Congress

HR 118-1458
Access to Prescription Digital Therapeutics Act of 2023
May 8, 2025

Latest Companion Bill Action

S 119-1702
Introduced in Senate
May 8, 2025
Introduced in House
May 8, 2025
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
  • Bill from Previous Congress

    HR 117-7051
    Access to Prescription Digital Therapeutics Act of 2022


  • Bill from Previous Congress

    HR 118-1458
    Access to Prescription Digital Therapeutics Act of 2023


  • May 8, 2025

    Latest Companion Bill Action

    S 119-1702
    Introduced in Senate


  • May 8, 2025
    Introduced in House


  • May 8, 2025
    Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Kevin Hern

Kevin Hern

Republican Representative

Oklahoma

Cosponsors (9)
Robert J. Wittman (Republican)Beth Van Duyne (Republican)Terri A. Sewell (Democratic)Jimmy Panetta (Democratic)Suzan K. DelBene (Democratic)Angie Craig (Democratic)Deborah K. Ross (Democratic)Mike Thompson (Democratic)Troy Balderson (Republican)

Ways and Means Committee, Energy and Commerce Committee

Health

Related Bills

  • S 119-1702: Access to Prescription Digital Therapeutics Act of 2025
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted