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After extensive deliberation, on June 6, 2003, the Centers for Medicare and Medicaid Services (CMS) reached a long-awaited decision on coverage of implantable cardioverter defibrillators (ICDs) for patients meeting the clinical profile of the second Multicenter Automated Defibrillator Implantation Trial (MADIT II).1 CMS offered a split decision, extending coverage only to Medicare patients meeting the MADIT II inclusion and exclusion criteria and having a QRS duration >120 ms. Information on and a timeline of the CMS coverage determination process are publicly available at their World Wide Web site,2 which has a link to a detailed decision memorandum.3 Although versions of the “MADIT II debate” have already taken place in many forums, we believe several issues regarding both the trial and the CMS decision require further discussion. We will focus on the intertwined issues of risk stratification and cost that have arisen repeatedly in this debate.The MADIT II debate boils down to the question posed by Dr Alfred Buxton in a recent editorial4: Should all patients with an ejection fraction <30% because of coronary artery disease receive ICDs, regardless of other risk-stratifying tests? Dr Buxton suggested the answer to this question should be “no”: “I believe it is premature to recommend ICDs on the basis of only one trial that may not be generalizable to all patients.”4 Dr Buxton’s remarks and the CMS decision stand in contrast to the otherwise unimpeded march the MADIT II results have made toward clinical acceptance. After publication of MADIT II, the Food and Drug Administration quickly approved the Guidant ICD used in the trial for this new indication, and updated American Heart Association/American College of Cardiology/North American Society of Pacing and Electrophysiology (AHA/ACC/NASPE) consensus guidelines5 recommended the trial’s inclusion/exclusion criteria as a class IIa indication for ICD …

MADIT II (Second Multicenter Automated Defibrillator Implantation Trial) Debate