Opinion: STAT+: Medicare’s new RAPID pathway is a breakthrough for adults. Children are still waiting

STAT PlusOpinionOpinions+ Medicare’s new RAPID pathway is a breakthrough for adults. Children are still waiting Pediatric medical devices are being left behind Manage alerts for this article Email this article Share this article By Kolaleh EskandanianMay 8, 2026 Eskandanian is a senior research scientist at MedStar Health Research Institute, program director of the BARDA-funded SPARK for Innovations in Pediatrics, and founding principal investigator of the FDA-funded Alliance for Pediatric Device Innovation. 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.Advertisement 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. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In children’s health, CMS, FDA, Medical devices, STAT+ Submit a correction requestReprints Kolaleh Eskandanian Newsletter The smartest thinkers in life sciences on what's happening — and what's to come Recommended First Opinion May 8, 2026 We need more men in nursing First Opinion May 7, 2026 Eugene Braunwald, ‘father of modern cardiology,’ told me he had two dreams. One came true Advertisement Neurotransmissions May 6, 2026 STAT Plus: Ambiguous loss: a peculiar kind of grief in dementia care First Opinion Podcast May 6, 2026 Dr. Glaucomflecken wants to make a stink First Opinion May 6, 2026 Trump’s executive order on psychedelics is the right move. But is my field ready for it? Subscriber Picks