CMS Rapid Pathway
Is your launch plan build around a timeline that’s about to get shorter?
This week’s Marketing Story Behind Medtech News comes to us from CMS who just proposed a pathway that could dramatically shorten the time between FDA authorization and Medicare coverage for FDA Breakthrough-designated devices.
And we think there’s a marketing warning hiding inside the reimbursement news.
Under the proposed RAPID pathway, CMS could issue a proposed coverage determination the same day a device gets FDA authorization — with national coverage possible as soon as 60 days later. (Diagnostics are excluded from this pathway.)
That collapses the traditional sequence: authorization, then reimbursement, then commercialization.
Obviously, Market Access and Reimbursement teams need to understand what that means.
But marketers should be paying attention, too.
Because if the gap between authorization and coverage gets shorter, Marketing’s runway gets shorter with it. Positioning, payer messaging, sales tools, demand gen — all of it needs to be ready earlier.
So here’s the question we would be asking: If Medicare coverage arrived 60 days after FDA authorization, would your marketing organization actually be ready?