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.