CMS denies coverage for Menaflex
This article was originally published in The Gray Sheet
Executive Summary
Medicare agency issues national non-coverage decision May 25 for ReGen Biologics' Menaflex collagen knee meniscus implant, in-line with a February CMS proposal concluding the device did not improve health outcomes and is therefore not reasonable and necessary (1"The Gray Sheet" March 1, 2010). FDA is expected to conclude a re-review of preclinical and clinical data used to support Menaflex' 510(k) clearance within the next few weeks (2"The Gray Sheet" March 29, 2010)