The CMS said it will expand national coverage of implantable cardioverter defibrillators, or ICDs, for a subpopulation of Medicare beneficiaries who have had a previous heart attack, but the decision falls far short of what device manufacturers and physicians wanted. Officials at Guidant, Indianapolis, complained that the "limited coverage decision is inconsistent" with findings of a Guidant-sponsored clinical trial that the risk of death was reduced for all patients who received ICD therapy. The trial focused on patients with previous heart attacks and left ventricular ejection fractions of less than or equal to 30%. The decision "ignored published practice guidelines," said Arthur Moss, a professor of medicine at the University of Rochester (N.Y.) Medical Center and the trial's primary investigator. The North American Society of Pacing and Electrophysiology - Heart Rhythm Society said it was pleased with the expanded coverage but disappointed with the restrictions, arguing "the criteria are not scientifically sound."
The CMS ruling conflicts with a CMS advisory panel's recommendation in February that ICDs be covered for a broader category of patients who had suffered previous heart attacks. CMS officials said the coverage decision will be published in the Federal Register and instructions will be issued before it becomes effective, typically six months. -- by Cinda Becker