The Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced in late April the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. Designed to streamline approvals, the pathway aims to deliver Medicare national coverage within two months of FDA market authorization—a significant improvement over the current one-year (or longer) delays faced by families and manufacturers.
As someone who has spent over a decade assisting small companies in navigating FDA reviews—including several breakthrough device designations—I strongly support this initiative. Faster, more predictable coverage is long overdue, and RAPID represents a meaningful step forward.
However, this announcement does little to address the persistent lag in coverage for pediatric and orphan devices, which continue to fall behind adult-focused technologies. In some cases, the new pathway may even widen this gap.
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