Before a medical product can be widely used in the United States, it generally must first be approved or cleared for marketing by the US Food and Drug Administration (FDA). Then, payers such as the Centers for Medicare & Medicaid Services (CMS) must decide whether the product merits coverage and payment. Because the statutes governing these agencies evolved to meet the exigencies of particular moments in the history of medical product development, the degree of convergence in standards and in the underlying evidence needed to support regulatory and payment decisions is not always immediately obvious. The resulting fragmentation—perceived or real—has led to questions about whether FDA approval or clearance for marketing will necessarily result in approval for coverage and payment.
Califf RM, Sherman RE, Slavitt A. Knowing When and How to Use Medical ProductsA Shared Responsibility for the FDA and CMS. JAMA. 2016;316(23):2485-2486. doi:10.1001/jama.2016.16734