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.
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.
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.
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.
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.
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.