MEDICARE ANNOUNCES ITS INTENTION TO EXPAND COVERAGE OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
The Centers for Medicare & Medicaid Services (CMS) announced today it intends to refine and expand coverage of implantable cardioverter defibrillators (ICDs) for Medicare beneficiaries.
The following indications were added to Medicare coverage:
- Patients with coronary artery disease with prior myocardial infarction (heart attack), left ventricular ejection fraction less than or equal to 0.35, and inducible, sustained ventricular tachycardia or ventricular fibrillation at electrophysiological study.
- Patients with a prior myocardial infarction and left ventricular ejection fraction less than or equal to 0.30 and an electrical conduction abnormality in the heart (QRS) duration of greater than 120 milliseconds.
"By expanding our coverage policy we are making an important technology available for more Medicare patients who would benefit from it," said CMS Administrator Tom Scully. "Like all CMS coverage determinations, this is based on a thorough review of the available scientific and clinical evidence."
An ICD is implanted in a patient's chest to monitor heart rhythm and deliver an electrical shock when a life-threatening ventricular arrhythmia is detected. It already is covered for a variety of indications.
CMS received a request to expand these indications to include patients with a prior heart attack and an ejection fraction of less than 30 percent without requiring evidence of arrhythmias.
Cardiovascular disease is the single most common cause of death in the United States. Sudden death is estimated to account for approximately 50 percent of all cardiovascular deaths. Many such deaths are due to acute ventricular tachyarrhythmias, often triggered by acute coronary events.
Guidant Corporation and Medtronic Incorporated, manufacturers of these devices, submitted requests to CMS to expand Medicare coverage of ICDs based on the results of the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II). Some of the MADIT II population, but not all, will be included in the new coverage.
CMS will reevaluate today's decision when the results of the National Heart, Lung and Blood Institute's Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) are available early next year. SCD-HeFT is also evaluating the benefits of ICDs in patients with heart disease. Some patients in the SCD-HeFT trial are similar to those treated in the MADIT II trial.
A National Coverage Determination will be published in the Federal Register. Instructions will be issued to the contractors who process and pay Medicare claims before the new coverage becomes effective. This normally takes about six months.