Drug Utilization Review (DUR)

As CMS explores strategies to increase the adoption of digital health tools, AMCP urges CMS to support broader coverage of prescription digital therapeutics (PDTs) under Medicare and Medicaid. PDTs represent an emerging class of software-based treatments that deliver clinically validated therapeutic benefits, either independently or in combination with other interventions. These products can play a transformative role in improving access, especially for patients with behavioral health conditions or chronic diseases.

In AMCP's latest comments to the FDA, we emphasize the need for standardized public reporting of confirmatory trial progress, ensuring payers and health care providers have the necessary data to make informed coverage decisions. By supporting proactive communication and rigorous confirmatory trials, AMCP aims to balance early access to innovative treatments with patient safety and long-term therapeutic value.