Prescription Digital Therapeutics

The Access to Prescription Digital Therapeutics Act of 2023 (S.723/H.R. 1458) is an important bipartisan bill that will improve care for millions of Americans by expanding coverage of prescription digital therapeutics (PDTs). PDTs are software-based therapies that deliver a clinical benefit to patients, either alone or in combination with other treatments. However, they do not currently fit into one of the statutorily defined coverage categories for the Medicare or Medicaid programs. This leaves beneficiaries of those programs, which include some of America’s most vulnerable populations, without access to these cost-effective and accessible treatments. Previous regulatory efforts to expand Medicare and Medicaid coverage of PDTs have been ineffective at improving access for patients. This bill will add PDTs to the list of services and products eligible for coverage under Medicare and Medicaid, as well as direct the Centers for Medicare & Medicaid Services (CMS) to establish payment methodologies and product-specific Healthcare Common Procedure Coding System (HCPCS) codes.

Take Action: Visit AMCP's Take Action page and urge Congress to pass the Access to Prescription Digital Therapeutics Act of 2023.  

Please view the materials below for more information:

• Issue Brief
• Brief: Operational Readiness for Covering Prescription Digital Therapeutics
• Model Benefit Language for Prescription Digital Therapeutics 
• List of Existing PDTs (Q1 2024)
• Regulatory Action Items
  • AMCP has drafted the following recommendations federal agencies can enact now to improve the coverage landscape for PDTs: 
  • The Food & Drug Administration (FDA) should issue a definition of Prescription Digital Therapeutics (PDTs), as well as a definition of digital therapeutics.
  • The Center for Medicaid and CHIP Services (CMCS) should issue guidance clarifying state Medicaid programs’ authority to cover PDTs.
  • The Centers for Medicare and Medicaid Services (CMS) should develop a comprehensive Healthcare Common Procedure Coding System (HCPCS) coding practice for PDTs.
  • CMS should issue a Request for Information (RFI) on industry practices and experiences in covering PDTs under HCPCS Level II Code A9291.
• Introduction Press Release - 118th Congress 
• Introduction Press Release - 117th Congress
• Letter of Support - 117th Congress