Centers for Medicare and Medicaid Services’ Decision to Reconsider Coverage Indications for ICDs
Where to Now?
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- Centers for Medicare and Medicaid Services (U.S.)
- defibrillators, implantable
- randomized controlled trials as topic
Several well-designed and -conducted randomized clinical trials (RCTs) have proven the survival benefit of implantable cardioverter defibrillators (ICDs).1 This benefit has been demonstrated in patients who survive a cardiac arrest attributable to a ventricular tachyarrhythmia or have sustained ventricular tachycardia not attributable to a transient or a reversible cause.1 The survival benefit of ICDs has also been shown in patients with significant systolic dysfunction (left ventricular ejection fraction [LVEF] ≤35%) attributable to ischemic or nonischemic cardiomyopathy.1 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.
In their Coverage with Evidence Development Decision Memorandum for ICDs (CAG-00157R3) issued in 2005, CMS stated that they had determined that the evidence is adequate to conclude that an ICD is reasonable and necessary for patients with ischemic cardiomyopathy and nonischemic dilated cardiomyopathy >9 months (>3 months if patient data are entered into a registry), New York Heart Association class II and III heart failure, and measured LVEF≤35% (as long as they do not have any of the exclusionary criteria such as a limited life expectancy <1 year). These criteria are aligned with recommendations in professional …