Healthcare journalist David filmore (MedTech Strategist) has some interesting articles at Linked In on current CMS ideas for NCD coverage - namely, the "RAPID" program.
Find his article here:
https://www.linkedin.com/posts/david-filmore-medtech_medtech-fda-cms-share-7506362779092819968-GgRQ/
It leads also to his subscription-only article here.
See his 3-months-earlier article at Linked In here.
### AI Summary:
David Filmore’s two reports examine RAPID’s central promise: designing pivotal device trials early enough with FDA and CMS that one study can support both regulatory authorization and Medicare coverage.
In the earlier report, Filmore highlights a debate held in Dublin last spring between entrepreneur Josh Makower and former CMS official Steven Farmer. Makower sees an opportunity to accelerate market access through a trial serving both agencies. Farmer questions whether high-risk device studies can realistically satisfy both standards—and whether CMS can commit scarce resources so early, before a product’s commercial prospects are clear. RAPID’s proposed advantage over TCET is earlier engagement, before pivotal trial design is settled.
The newer report finds continued enthusiasm alongside familiar doubts. Former CMS coverage director Tamara Syrek Jensen welcomes early benefit-category decisions and written commitments concerning a proposed national coverage determination. Farmer warns that earlier coordination could bring heavier premarket evidence requirements. Makower urges CMS to adopt a “least burdensome” approach, while Scott Whittaker at AdvaMed considers RAPID a step forward with insufficient scope.
Filmore’s reporting underscores the unresolved tradeoff: earlier coverage certainty may require more evidence upfront, while industry continues seeking legislation offering broader, more automatic coverage and better resources for CMS.