Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Non-St Elevation (NSTEMI) Myocardial Infarction.
Treatment:  K0606 x3-Month Rental Automatic External Defibrillator.

The insurer denied K0606 x3-Month Rental Automatic External Defibrillator.  The denial is upheld.

This is an adult male with a submitted diagnosis of non-ST elevation myocardial infarction (NSTEMI). He was referred for K0606 x3-month rental automatic external defibrillator. Echocardiogram revealed depressed left ventricular ejection fraction (LVEF) of 35-40% (percent). Cardiac catheterization 7 months prior revealed multi-vessel coronary artery disease (CAD) and left ventricular ejection fraction of 25-30%. The requested coverage has been denied by medical policy as unproven and not medically necessary, and the patient is appealing the decision.

The requested health service was not medically necessary.

Based on the current evidence-based literature, the wearable cardioverter defibrillator (WCD) is unproven and, therefore, it is not medically necessary. Wearable cardioverter defibrillator for the prevention of sudden cardiac death (SCD) is considered medically necessary as an interim treatment for those who meet the criteria for an implantable cardioverter defibrillator (ICD) and have a temporary contraindication to receiving an implantable cardioverter defibrillator, such as a systemic infection, at the current time, or are awaiting heart transplantation and have been scheduled for implantable cardioverter defibrillator placement or who have had an implantable cardioverter defibrillator removed and have been rescheduled for placement of another implantable cardioverter defibrillator once the contraindication is treated. The evidence shows that these patients benefit from a cardioverter defibrillator and the wearable cardioverter defibrillator can detect and treat lethal arrhythmias in these patients. 

However, in this particular case, the patient does not meet any of these criteria for wearable cardioverter defibrillator use. Use of wearable cardioverter defibrillator for the prevention of sudden cardiac death is considered unproven for all other indications, including use in individuals with a history of an acute myocardial infarction (MI) within the last 40 days, because there is insufficient relevant published evidence to conclude that net health outcome will be improved, and so wearable cardioverter defibrillator is considered unproven for this patient's medical condition and not medically necessary. 

The results of the WEARIT/BIROAD study suggest that wearable cardioverter defibrillator is beneficial in detecting and effectively treating ventricular tachyarrhythmias in patients at high risk for sudden cardiac death who are not clear candidates for an implantable cardioverter defibrillator and may be useful as a bridge to an implantable cardioverter defibrillator in some patients, there is insufficient data published in the peer-reviewed medical literature to determine that outcomes are better or that it is medically necessary for this patient's noted medical condition at this time. The DINAMIT (Defibrillator in Acute Myocardial Infarction Trial) and the IRIS (Immediate Risk Stratification Improves Survival) studies randomized patients early post-myocardial infarction to continued optimized medical therapy (OMT) alone or with an implantable cardioverter defibrillator, and neither study showed a benefit from implantable cardioverter defibrillator therapy. As a consequence of the clinical trial data, waiting periods of 40 days post-myocardial infarction if no revascularization was undertaken, or three months when percutaneous or surgical intervention was done, have become standard practice before implantable cardioverter defibrillator implantation, and are endorsed in the American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) device-based therapy guidelines. Furthermore, the Centers for Medicare and Medicaid Services accepted these waiting periods as being necessary.

The health plan did act reasonably, with sound medical judgment and in the best interest of the patient.