ICD coverage expansion
This article was originally published in The Gray Sheet
Executive Summary
CMS opens second 30-day public comment period May 25 to consider how results from St. Jude Medical's DEFINITE trial and Guidant's COMPANION study should influence the agency's review of a request for implantable cardioverter defibrillator coverage for the patient population in Medtronic's SCD-HeFT trial. While an initial comment period expired in April, the additional data was published May 20 (1"The Gray Sheet" May 24, 2004, p. 4). Comments are now due June 25. The agency's draft decision memo is due Sept. 30...