The Centers for Medicare & Medicaid Services (CMS) today proposed to expand coverage of implantable cardioverter defibrillators (ICDs), a move expected to save thousands of lives a year.
"With this announcement, we're once again taking a major step to save lives and improve the quality of life for America's seniors, " said HHS Secretary Tommy G. Thompson. "By increasing the use of defibrillators we are striking a blow against the leading cause of death among older Americans."
"This coverage decision demonstrates our determination to act promptly when convincing medical evidence shows that a technology can save and improve lives," said CMS Administrator Mark B. McClellan, M.D., Ph.D.
The expansion, when made final, will increase the number of Medicare beneficiaries eligible for an ICD by one-third, to nearly 500,000. CMS expects to provide this therapy to at least 25,000 patients in the first year of coverage, potentially saving up to 2,500 lives.
Coronary heart disease is the single most common cause of death in the United States. Sudden death, frequently from heart arrhythmias, is estimated to account for approximately 50 percent of all coronary heart disease deaths. An ICD is implanted in a patient's chest to monitor the heart's rhythm and deliver an electrical shock when a life-threatening arrhythmia is detected.
The expanded coverage for the implantable defibrillators is based on new clinical studies, showing for the first time that certain patients who have never had a heart attack are likely to benefit from these devices. The coverage decision was prompted by results of a well-designed trial, labeled the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which was sponsored by the National Heart, Lung and Blood Institute. It is a prospective, randomized trial to compare the effectiveness of medication, implantable defibrillators and placebo on survival in patients with heart failure.
Based on the clinical trial results, the draft coverage decision recommends coverage for most of the population studied in the trial, including patients with heart failure and poor function of their left ventricle.
In addition, careful analysis of the new data from this trial in combination with data from all previous ICD trials showed that patients with a certain finding on electrocardiograms of their heart, called a narrow QRS, may also derive a small but measurable, significant benefit from having an ICD.
As part of the coverage decision, CMS will work with product manufacturers and experts from the clinical community, including the National Institutes of Health, to develop a practical registry that can track the progress of patients who receive the devices. The registry will also help develop additional evidence on who is most likely to benefit from the devices.