How CMS Coverage Decides Whether Your Device Succeeds in the U.S.
Featured Article | Originally published on NAMSA's website, written by Steven Farmer, MD, PhD, FACC, FASE
FDA clearance is a necessary milestone for bringing a medical device to the U.S. market, but it is not the same as achieving market access. In this article, Steven Farmer, MD, PhD, FACC, FASE, Senior Partner at ABIG Health and former Chief Strategy Officer for Coverage at the Centers for Medicare & Medicaid Services (CMS), explains why CMS coverage decisions are often the determining factor in whether a device reaches patients and generates revenue.
The article explores how CMS evaluates whether a technology is "reasonable and necessary" for Medicare beneficiaries, why evidence generation must extend beyond FDA approval, and how gaps in clinical trials can create challenges for coverage even after a successful regulatory submission. It also breaks down the three primary pathways to Medicare coverage—National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and individual claim determinations—and explains how each pathway can shape commercialization strategy.
Dr. Farmer also examines CMS's evolving approach to coverage modernization, including Coverage with Evidence Development (CED), the role of real-world data in post-market evidence generation, and the changing policy landscape surrounding NTAP, TCET, and RAPID.
Dr. Steven Farmer, MD, PhD is a Senior Partner at ABIG Health, a practicing cardiologist, and a nationally recognized expert in healthcare policy and real-world evidence who previously served as Chief Strategy Officer for Coverage at the Centers for Medicare & Medicaid Services.
