Prescription Digital Therapeutics

Legislative and Regulatory Position Statement

AMCP supports increased access to Prescription Digital Therapeutics (PDTs).¹ PDTs are software-based therapies that deliver clinical benefits to patients, either alone or in combination with other forms of treatment. These therapeutics require a prescription and are subject to oversight by the Food and Drug Administration (FDA). To be approved by the FDA, PDTs must demonstrate both safety and efficacy. Although some private health payers choose to cover PDTs, expanding coverage to include Medicare and Medicaid would improve care for many American patients and help regulate reimbursement procedures and coding of these therapies across both public and private payers.

PDTs can help manage or treat a variety of mental health and chronic conditions and may help improve patient access to care and disease management.² PDTs may be accessible on a mobile phone, which may be helpful in sending patients care reminders and giving patients access to their therapies in any location. Additionally, PDTs can decrease obstacles to behavioral health care and difficult-to-reach populations, such as youth and those living in rural areas.³ Increased access to PDTs would allow Medicare and Medicaid beneficiaries (millions of whom are seniors and low-income households) to receive access to FDA-approved products with demonstrated clinical benefits.

Although private health payers may elect to cover PDTs, the current landscape is a patchwork of reimbursement strategies and coding practices. PDTs do not currently fit neatly into a statutorily defined coverage category for the Medicare or Medicaid programs, leaving beneficiaries without access to these cost-effective and accessible treatments. AMCP supports adding PDTs to the list of services and products eligible for coverage under Medicare and Medicaid. AMCP encourages the Centers for Medicare & Medicaid Services (CMS) to establish payment methodologies and product-specific Healthcare Common Procedure Coding System (HCPCS) codes for PDTs to help all payers cover and reimburse PDT manufacturers for these therapies. As of April 2022, CMS created one billable procedure code, which may eliminate barriers to provider billing and payer coverage of these therapies. AMCP encourages CMS to develop additional billing codes for PDTs to reflect the diversity of PDTs and allow for reimbursement and utilization management flexibility.

See also:

AMCP Legislative and Regulatory Position Statements: https://www.amcp.org/policy-advocacy/policy-resource-center/legislative-regulatory-positions

_{1. https://www.amcp.org/sites/default/files/2023-08/Access_to_PDTs_Act_1pgr_8.7.23.pdf}

_{2. National Library of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9569000/}

_{3. Digital Therapeutics for Management and Treatment in Behavioral Health (samhsa.gov)}