Centers for Medicare and Medicaid Services' Decision to Reconsider Coverage Indications for ICDs: Where to Now?

Abstract

Several well-designed and conducted randomized clinical trials (RCTs) have proven the survival benefit of implantable cardioverter defibrillators (ICDs). This benefit has been demonstrated in patients who survive a cardiac arrest due to a ventricular tachyarrhythmia or have sustained ventricular tachycardia not due to a transient or a reversible cause. The survival benefit of ICDs has also been shown in patients with significant systolic dysfunction (left ventricular ejection fraction (LVEF) ≤35%) due to ischemic or non-ischemic cardiomyopathy. The compelling evidence on the benefits of ICDs led the Centers for Medicare and Medicaid services (CMS) to cover secondary and primary prevention ICDs in Medicare beneficiaries. However, for primary prevention ICDs, CMS provides coverage with evidence development that requires clinicians to enter data on primary prevention ICD implants in Medicare beneficiaries into the National Cardiovascular Data Registry (NCDR) ICD Registry.