In late April, the Centers for Medicare and Medicaid Services and the Food and Drug Administration announced the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway. On paper, it is exactly what the medical device community has been asking for: a synchronized process that could deliver Medicare national coverage as soon as two months after FDA market authorization, rather than the year or more families and manufacturers currently endure.
I want this pathway to succeed. I have spent more than a decade helping small companies bring novel devices through FDA review, including several that earned breakthrough device designation. I have watched reimbursement delay strangle technologies that children desperately need. Faster, more predictable coverage is a real problem, and RAPID is a real step.
But this announcement does not fix the way pediatric and orphan devices chronically lag behind their adult counterparts. In some ways, in fact, it deepens that gap.
