Medicare already pays for internal defibrillators each year for about 45,000 patients with certain heart problems. Experts say, however, the new ruling is at odds with the findings of major studies showing that all the heart patients who received defibrillators had a lowered risk of death.

"It's inappropriate for CMS to make a decision that only physicians can make," says NHW editor-in-chief Dr. Douglas Zipes, director of cardiology at Indiana University School of Medicine and one of the leading heart rhythm experts in the country.

"What if I release a patient who doesn't qualify for coverage and that person drops dead?" he continues. "And the patient's spouse comes to me and says, 'Doctor, why didn't you comply with guidelines crafted by experts from the American College of Cardiology, the North American Society of Pacing and Electrophysiology, and the American Heart Association calling for expanded use of ICDs for preventing sudden cardiac death?'"

Data from the Multi-center Automatic Defibrillator Implantation Trial (MADIT II) of 1,232 patients in 76 centers were so convincing that an independent review panel halted the study earlier than planned. Results showed a 31 percent drop in the death rate among heart attack survivors implanted with defibrillators compared to those receiving only drug therapy. Based on the dramatic findings, ICD manufacturers submitted requests to expand Medicare coverage to all patients with a prior heart attack and impaired heart function.

In June, The Centers for Medicare & Medicaid Services (CMS) announced ICD coverage for heart attack survivors with reduced ejection fraction (pumping ability) and evidence of abnormal heart rhythms--excluding those without a history of arrhythmias.

A Medicare official says the ruling means an additional 10,000 patients a year are likely to get the devices, compared with three times that number under the broader coverage sought by the manufacturers and others. He added that Medicare would re-evaluate its position next year when additional study results are available.

Preliminary findings from the COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure) trial help confirm the ICDs reduce mortality and hospitalization rates of advanced heart failure patients. Results from the NIH-funded Sudden Cardiac Death in Heart Failure Trial are expected early in 2004.