ATA Action Announces Support of Access to Prescription Digital Therapeutics Act

WASHINGTON—ATA Action, the advocacy arm of the American Telemedicine Association, voiced its strong support for the Access to Prescription Digital Therapeutics Act. This legislation would establish a benefit category for prescription digital therapeutics (PDTs) under Medicare and Medicaid. It would also direct the Centers for Medicare & Medicaid Services (CMS) to develop payment methodologies and assign product-specific Healthcare Common Procedure Coding System (HCPCS) codes for PDTs to establish reimbursement frameworks supporting access to cost-effective and urgently needed treatments for some of America’s most vulnerable populations.

Prescription digital therapeutics are software programs granted market authorization by the U.S. Food and Drug Administration (FDA). The purpose of these programs is to evaluate, diagnose, manage symptoms or treat an illness, injury or disease—either alone or in combination with other treatments – including substance and opioid use disorders, mental health, women’s health, cancer, stroke, diabetes, multiple sclerosis and other chronic conditions. PDTs are available 24/7 on mobile phones, tablets, smartwatches or laptop computers. The first prescription app received FDA clearance in 2010 for diabetes management. The number of PDTs has since increased rapidly, with new products in development, including treatments for Alzheimer’s disease.

“Digital therapeutics deliver medical interventions directly to patients, closing gaps in care caused by unmet patient needs, provider shortages or economic or geographic disparities,” said Andy Molnar, head of digital health at ATA Action. “From a reimbursement perspective, PDTs have gained traction under existing benefit categories since the first bill, the Prescription Digital Therapeutics to Support Recovery Act, was introduced in 2020. However, addressing coverage under existing frameworks is a necessary but sometimes imperfect solution for PDTs, and significant gaps in Medicare and Medicaid coverage for these products remain.”

Molnar, former CEO of the Digital Therapeutics Alliance (DTA), is leading ATA Action’s new Advancing Digital Health Coalition, which is dedicated to ensuring continued advocacy for innovative technologies that transform patient care. Priority areas of focus include efforts to support digital therapeutics, FDA’s draft guidance for Prescription Drug Use Related Software (PDURS), the newly defined digital mental health treatment (DMHT) devices in the 2025 Physician Fee Schedule, and remote monitoring devices, as well as artificial intelligence, digital diagnostics and devices that support care at home.

“Following our recent acquisition of the DTA in March, one of ATA Action’s top priorities is to work with policymakers to ensure this important legislation passes, clearing the path for innovative, clinically validated solutions that will improve care for millions of Americans and enable health systems and clinicians to better manage capacity and enhance patient care,” said Kyle Zebley, executive director, ATA Action. “As we continue our work to establish telehealth as a permanent and essential modality of care, our Advancing Digital Health Alliance will build upon the work of the DTA, focusing on collaboration, influence and leadership in digital health policy.”