S. 1702: Access to Prescription Digital Therapeutics Act of 2025

This bill, known as the Access to Prescription Digital Therapeutics Act of 2025, aims to amend the Social Security Act to include coverage for prescription digital therapeutics under Medicare and Medicaid. Here are the main provisions of the bill:

Definition of Prescription Digital Therapeutics

The bill establishes a definition for "prescription digital therapeutics." These are products, devices, applications, or technologies that:

• Have received clearance or approval from the Federal Food and Drug Administration (FDA)
• Are intended for the prevention, management, or treatment of medical conditions or disorders
• Primarily use software to achieve their intended health outcomes
• Are exempt from certain regulations under food and drug law

Coverage Under Medicare

The bill expands Medicare coverage to include prescription digital therapeutics starting January 1, 2026. Key provisions include:

• The Secretary of Health and Human Services is required to develop a payment methodology for these therapeutics within one year of the bill's enactment. This may involve either one-time or periodic payments to manufacturers.
• The payment method will take into account factors like the actual list charge, median payment rates, and ongoing usage costs for certain therapeutics.

Coding and Manufacturer Reporting

The bill mandates that, within two years of enactment, the Secretary will create specific product codes for these therapeutics to facilitate billing. In the interim, temporary codes will be established.

Starting in 2026, manufacturers must report payment rates, the volume of distribution, and the number of users for their prescription digital therapeutics annually or face potential financial penalties for non-compliance.

Coverage Under Medicaid

The legislation also seeks to amend Medicaid coverage to include prescription digital therapeutics, making similar provisions to those established for Medicare. Specifically, a new coverage category for these therapeutics will be created within the Medicaid framework.

Enforcement and Penalties

The bill includes mechanisms for handling cases of manufacturers failing to report information accurately. This could result in civil monetary penalties for misrepresentation or failure to report essential data.

Implementation Timeline

Overall, the bill aims for a systematic implementation of coverage for prescription digital therapeutics, focusing on establishing regulatory frameworks, payment methodologies, and reporting requirements over the next few years.

Relevant Companies

• PDCO - A company that may develop or provide prescription digital therapeutics could see increased demand and sales as these products become covered services under Medicare and Medicaid.
• CHKP - Companies specializing in health technology solutions may also be influenced by the potential for increased market needs in the digital therapeutic space due to new coverage implementations.