H.R. 3288: Access to Prescription Digital Therapeutics Act of 2025

This bill, titled the Access to Prescription Digital Therapeutics Act of 2025, aims to make prescription digital therapeutics eligible for coverage under Medicare and Medicaid programs. It introduces a definition for these therapeutics as products that are cleared or approved by the FDA and primarily use software for managing or treating medical conditions.

Key Provisions

Definition of Prescription Digital Therapeutics

The bill defines a prescription digital therapeutic as a technology that:

• Is cleared or approved under specific sections of the Federal Food, Drug, and Cosmetic Act.
• Has a validated indication for treating a medical condition.
• Primarily utilizes software to achieve its intended outcomes.
• Is exempt from certain regulatory restrictions.

Coverage under Medicare

To ensure coverage under Medicare:

• The Secretary of Health and Human Services must establish a methodology for paying manufacturers of these digital therapeutics within one year following the enactment of this legislation.
• Payment may take the form of a one-time payment or ongoing payments, and various factors will influence the payment rates, including the list price and volume of use.
• Within two years of enactment, product-specific coding for these therapeutics must be established to facilitate their coverage.
• Manufacturers will be required to report certain data to the Secretary, including pricing and distribution information.

Coverage under Medicaid

The bill also amends Medicaid statutes to explicitly include prescription digital therapeutics as a covered service, thereby expanding access for eligible individuals under the Medicaid program.

Reporting and Accountability

Manufacturers will need to submit annual reports detailing:

• The payment rates paid by private insurers for their therapeutics.
• The volume of therapeutics distributed.
• The number of individual users.

Failure to accurately report this information could result in significant penalties, emphasizing compliance and accountability.

Implementation Timeline

• The payment methodology for prescription digital therapeutics under Medicare is to be established no later than one year after the bill's enactment.
• Permanent product-specific codes must be in place within two years, with temporary codes allowed during the interim.

Impact on Manufacturers

As the bill requires manufacturers to establish pricing based on real-world metrics and report distribution and usage information, this could lead to changes in how prescription digital therapeutics are marketed and delivered.

Relevant Companies

• AMGN (Amgen Inc.): This company could see increased demand for its digital therapeutics solutions, especially if it aligns its products with the bill's coverage provisions.
• PRGX (PRGX Global, Inc.): This company may face shifts in its healthcare analytics as the market adapts to include more digital therapeutics.