Wednesday, September 29, 2010

FDA and CMS: A Marriage Made In Heaven

Medicare reimbursement for medical devices can be a key component in their success in the marketplace.  On September 17th, the Association for the Advancement of Medical Instrumentation announced that the FDA and CMS are considering parallel reviews for medical devices.  By implementing a parallel review, this should reduce the time between the FDA marketing approval or clearance decision and CMS national coverage determination (NCD).

Many of our bloggers know that Medicare reimbursements for medical devices is a key component in market success.  Both agencies were quoted as saying that this overlapping process would be implemented when the product sponsor and both agencies agree to such a review.  Both agencies are seeking public comment until December 16th, 2010 about what products would be appropriate, what procedures should be developed, how a parallel review should be implemented, and any other potential issues or challenges related to this program.  Based on  your feedback, the agencies intend to implement a pilot program.  This is an opportunity to provide constructive feedback for the future approval process in spine.


  1. Haven't seen the details, but from your post, this sounds like a very sensible change. It's clearly an easy approach for IDE related products, and now instead of CMS waiting for a technology to clear the regulatory hurdle, then even taking a look, they'll be engaged from the beginning. Don't think it'll change much for the companies, as most have recently been building some form of cost-effectiveness analysis into their IDE study designs, specifically for payor review presuming product approval. Just speeds up the process for the work the industry is already doing. Good move.

  2. The last time I was involved with this process, CMS was still basically deferring to the Blue Shield TEC. Having presented to the TEC, I can say that they just aren't going to pay for a new technology at the premium price with only the sponsor's data to consider.

    Therefore, any serious attempt at "reforming" this process will need to take this into consideration.

  3. They should start with PRP/Platelet Gel and give it a thumbs up or thumbs down once and for all!!!!!!