This policy brief examines the “valley of death” between FDA approval of new medical devices or drugs and Medicare coverage, where statutory standards and regulatory processes delay patients’ access to innovation. The authors highlight the consequential economic and medical costs of this gap, review prior Medicare coverage reform efforts, and offer targeted policy recommendations to provide regulatory clarity, streamline the coverage decision process, and ultimately expand access to medical innovations.
Key Takeaways:
- Delays in Access to Innovation: Differing regulatory standards between FDA approval and Centers for Medicare and Medicaid Services (CMS) coverage delay access to the life-changing innovations in medical devices and health technology over the past several decades, with a median 5.7-year lag.
- Prior Regulatory Reform Efforts Have Lagged: For 30 years, policymakers and regulators have introduced advisory committees, new coverage pathways, and other process improvements, but access remains limited—underscoring the failure of these reforms.
- Urgent Need for CMS Reform: Policymakers and CMS can provide clarity of coverage principles, improve local coverage determination processes, and expand transparency to facilitate access to innovation.
Crossing the Valley of Death, Part 1: The Innovation Imperative and Medicare Coverage Reform by Hoover Institution
Cite this essay:
Ted Cho and Brian J. Miller, “Crossing the Valley of Death, Part 1: The Innovation Imperative and Medicare Coverage Reform,” Hoover Institution, Healthcare Policy Working Group, June 2025.
