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HEADLINE: Increased Coverage of ICDs ...


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  • HEADLINE: Increased Coverage of ICDs ...

    Copyright 2003 Washington Business Information, Inc., All Rights Reserved

    Devices & Diagnostics Letter

    June 16, 2003

    SECTION: Vol. 30, No. 24

    LENGTH: 683 words



    Although the Centers for Medicare & Medicaid Services (CMS) has expanded
    national coverage for implantable cardioverter defibrillators (ICDs),
    devicemakers are not entirely pleased because the policy does not cover all
    heart attack survivors.

    In a decision summary, CMS said there was not enough evidence to conclude
    that an ICD implant is reasonable and necessary for all Medicare beneficiaries
    with a prior myocardial infarction.

    This view differs dramatically from that of Guidant, which submitted a
    request for expanded coverage in May 2002. The company said its Multicenter
    Automatic Defibrillator Implantation Trial (MADIT II) clearly demonstrates a
    significant reduction in mortality rates among all patient populations implanted
    with the device.

    The company backed up its claim with data from a trial designed to determine
    whether the ICD, in conjunction with optimal drug therapy, prevented more deaths
    than drugs alone in survivors with moderate impairment of the left ventricular,
    the heart's main pumping chamber.

    To be included in the MADIT II study, which enrolled 1,232 patients at 71
    U.S. centers, patients had to:

    * Be male or female, 21 years old or older;

    * Have had one or more myocardial infarctions three weeks or more prior to
    enrollment; and

    * Demonstrate left ventricular ejection fraction (proportion of blood pumped
    out of the heart with each beat) of less than or equal to 30 percent.

    Guidant's request sought increased coverage of the implants to match the
    inclusion criteria of the MADIT II study. But in a decision memorandum issued
    earlier this month, CMS said it would limit coverage of the implants to patients

    * A documented episode of cardiac arrest due to ventricular fibrillation
    (VF), not due to a transient or reversible cause;

    * Documented sustained ventricular tachyarrhythmia, either spontaneous or
    induced by an electrophysiology (EP) study, not associated with myocardial
    infarction and not due to a transient or reversible cause;

    * Documented familial or inherited conditions with a high risk of
    life-threatening ventricular tachyarrhythmias, such as long QT syndrome or
    hypertrophic cardiomyopathy;

    * Coronary artery disease with a documented prior myocardial infarction, a
    measured left ventricular ejection fraction of less than 0.35, and inducible,
    sustained ventricular tachycardia or VF during EP study. (The myocardial
    infarction must have occurred more than four weeks prior to implantable
    defibrillator insertion. The EP test must be performed more than four weeks
    after the qualifying myocardial infarction.); and

    * A determination from CMS that the evidence is adequate to conclude that an
    implantable defibrillator is reasonable and necessary for patients with a
    documented prior myocardial infarction and a measured left ventricular ejection
    fraction < 0.30 and a QRS duration of > 120 milliseconds.

    "Best medical science and evidence-based medicine signals that this coverage
    stops short of that which is warranted," said Fred McCoy, president of Cardiac
    Rhythm Management at Guidant. "The scientific evidence convincingly demonstrates
    that, in patients who met the MADIT II criteria, ICDs offer life-saving

    CMS said the decision to limit coverage was partially based on a key question
    posed before the Medicare Coverage Advisory Committee during a meeting in
    February. The panel unanimously voted "no" when asked if the evidence is
    adequate to apply the findings of the MADIT II trial to all Medicare patients
    with a prior myocardial infarction and an ejection fraction of .3 without
    requiring evidence of an arrhythmia.

    "While the MADIT II trial was a good randomized trial, it is a single
    clinical trial with a number of potential significant methodological
    limitations," CMS said. "The evidence is not currently adequate to conclude that
    implantable defibrillator therapy is reasonable and necessary for the entire
    population of MADIT II eligible criteria."

    CMS said it will reconsider its conclusions when additional data from risk
    stratification studies and other trials become available.

    LOAD-DATE: June 23, 2003
    Thanks, Tim
    Forum Administrator

  • #2
    Re: HEADLINE: Increased Coverage of ICDs ...

    The US government had included HCM and long QT years back...I think it was 1999 or 2000 so this is not something "new".
    The need for the deviced in the post MI population is a differenct issue than HCM so please do not think that this changes ANYTHING in the world of HCM.
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)