This report addresses the challenges in bringing life science innovations to market, specifically focusing on the regulatory gap between FDA approval and CMS coverage determination, often referred to as the "Valley of Death." It proposes reforms to modernize drug and device review processes, streamline FDA management, and improve the predictability of CMS coverage decisions. The authors advocate for a coordinated approach involving political leadership, industry, and Congress to foster innovation, reduce healthcare costs, and expand access to care, emphasizing the economic and moral imperative of facilitating clinical innovation.

Miller, B. & Cho, T., 2025. Crossing the Valley of Death: Reforming FDA and CMS for Innovation, Social Science Research Network. United States of America.