Last week, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) unveiled a proposed program aimed at dramatically accelerating Medicare coverage for breakthrough medical devices. Under the new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, eligible devices can receive national Medicare coverage and payment in as little as two months following market authorization, representing a significant improvement over the year or more the process can take today.
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