Implantable Defibrillators

On December 28, 2004, CMS issued a decision memorandum closing the 2^nd reconsideration of the implantable cardioverter defibrillator (ICD) national coverage determination (http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=139). That reconsideration was a request to expand current coverage of ICDs based upon data collected in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). However, data from the trial had not yet been published in a peer-reviewed journal and Section 731 of the Medicare Modernization Act required that CMS issue a final decision within 9 months of having accepted the request for an NCD, which in this case occurred on March 30, 2004. CMS had initiated the NCD process with the expectation that the results of SCD-HeFT, which is the major source of evidence for this decision, would be published no later than December 28, 2004. Since that did not occur, CMS posted a decision memorandum that maintained previous ICD coverage.

This NCD is being opened as a 3^rd reconsideration to continue analysis of data from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) as part of a formal request from Medtronic Inc. to expand coverage to include the study population. We will expedite finalizing this NCD as soon as the trial data is published. Information related to this request is available at http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=139.

December 29, 2004

January 27, 2005

February 4, 2005

February 15, 2005