Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: ST elevation myocardial infarction (STEMI).
Treatment: Zoll Life Vest, code K0606.
The insurer denied coverage for Zoll Life Vest, code K0606.
The denial is upheld.

This is the case of a male that presented to the hospital with an ST (interval on an ECG) elevation myocardial infarction (STEMI). Cardiac catheterization revealed a proximal left anterior descending coronary artery occlusion that was revascularized with a drug eluting stent. The patient's post operative course was characterized by systolic congestive heart failure (CHF) and cardiogenic shock requiring an intra-aortic balloon pump. Echocardiogram (ECG) revealed a left ventricular ejection fraction (LVEF) of 25-30%. The patient was treated with guideline directed medical therapy and an external LifeVest defibrillator was placed at discharge. A follow up echocardiogram revealed a LVEF of 50%.

This patient presented with an acute myocardial infarction (MI) and a depressed LVEF. The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) demonstrated a survival benefit in patients that were implanted with defibrillators when they demonstrated New York Heart Association (NYHA functional class II symptoms of CHF (congestive heart failure) and an LVEF less than or equal to 35%. (1) However, this trial enrolled patients that were remote from acute MI. Several subsequent trials have enrolled patients following acute MI or revascularization. The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) failed to show a benefit for implantable cardioverter defibrillator (ICD) therapy in patients with depressed LVEF following MI. (2) Although, sudden cardiac death with appropriate ICD shocks were noted in patients that received defibrillators, these patients had an increased non cardiac mortality, negating the benefit of ICD therapy. The Vest Prevention of Early Sudden Death Trial (VEST) specifically randomized patients following myocardial infarction to external life vest therapy or medications. (3) Results revealed no significant difference in the primary endpoint of sudden cardiac death. There is specific approval for wearable LifeVest defibrillator use for prevention of sudden cardiac death in patients with low ejection fraction that are not candidates for an implantable device. 

This patient's ECG (electrocardiogram) and hospital course was not significant for any ventricular arrhythmia and had a relatively low risk of sudden cardiac death following revascularization. Based on current available guidelines and clinical trial data the proposed treatment was unlikely to be more beneficial for the patient than standard anticongestive therapy. (3)

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome for this patient. The Life Vest is Food and Drug Administration (FDA) approved for prevention of sudden cardiac death. The Zoll Life Vest is not the best available treatment for this patient at this time. 

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments. 

The carrier's denial of coverage for Zoll Life Vest, code K0606 should be upheld.