Earlier this year, the Access to Prescription Digital Therapeutics Act of 2023 (S.723/H.R. 1458) was introduced by a set of bipartisan Senators and Representatives in Congress. The legislation would authorize coverage of prescription digital therapeutics (PDTs) by Medicare and Medicaid, which could help patients receive innovative care to treat a range of illnesses and conditions. This legislation was also introduced last year by some of the same Senators and Representatives, but unfortunately did not go anywhere.
PDTs are software-based therapies that deliver clinical benefits to patients. PDTs often have many uses, including helping patients to identify, treat, and manage a wide range of conditions, including PTSD, diabetes, substance and abuse disorder, and chronic back pain However, they do not currently fit into a statutorily defined coverage category in either the Medicare or Medicaid program.
PDTs are reviewed and approved by the Food and Drug Administration (FDA) for safety and efficacy via randomized clinical trials, and they are prescribed by a health care provider. Because of their format, many PDTs can be used on a cell phone, which can help to improve patient outcomes by displaying care reminders and allowing patients to access their necessary therapies in a variety of settings.
While private health payers may elect to cover PDTs, previous attempts to expand Medicare and Medicaid coverage to include these PDTs have been ineffective at actually improving access for patients. This legislation would 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.
The Academy of Managed Care Pharmacy (AMCP) also created several recommendations for federal agencies to enact to improve the coverage landscape for PDTs, including: the FDA should issue a definition of 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; and CMS should issue a Request for Information (RFI) on industry practices and experiences in covering PDTs under HCPCS Level II Code A9291.
“The Access to Prescription Digital Therapeutics Act will ensure Americans have timely and efficient access to treatments that will help address their conditions and improve their peace of mind,” said AMCP CEO Susan Cantrell, MHL, RPh, CAE. “PDTs are an impressive example of harnessing technological innovation to treat and manage illnesses for millions of Americans. AMCP has been a leading advocate for authorizing coverage of PDTs, and we look forward to working with the bipartisan group of bill sponsors to advance this important legislation through Congress.”