Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Myocardial Infarction

Treatment: Zoll Life Vest - Code K0606

The insurer denied coverage for Zoll Life Vest - Code K0606

The denial is overturned

Reviewer #2:

The patient presented to the Emergency Department (ED) with severe chest pain. The patient was found to be in a wide complex tachycardia. A second electrocardiogram (ECG) in the ED showed inferolateral ST segment elevation myocardial infarction (STEMI). Cardiac catheterization was performed immediately. It showed 100%(percent) LAD (Left anterior descending) occlusion, 90% first diagonal stenosis, the first obtuse marginal had a 90% stenosis, the third obtuse marginal had a 60% stenosis, and the right coronary artery (RCA) had a 99% proximal stenosis with Thrombolysis in Myocardial Infarction (TIMI) 1 flow and collaterals from the left anterior descending (LAD) artery.  It was elected to perform bypass surgery. The patient underwent a successful coronary artery bypass graft (CABG) x 4. On discharge the provider recommended an external wearable cardioverter defibrillator (WCD) LifeVest.

The purpose of the LifeVest was to protect against a fatal arrhythmia during the 6-8 weeks of GDMT (Guideline-directed medical therapy). Should the left ventricular ejection fraction (LVEF) have remained below 35% at that time, then it would have been indicated to implant a permanent implantable defibrillator (ICD).

The risk of sudden death is increased in patients with severe left ventricular dysfunction as seen in this patient.  It has been shown that in patients with severe LV dysfunction on optimal medical therapy for at least 3 months that an implantable ICD improves survival due to the prevention of sudden death.  The ejection fraction needs to be less than 35% on optimal medical therapy (GDMT) to qualify for an implantable ICD. In patients where the ejection fraction is less than 35%, the wearable cardioverter defibrillator (LifeVest)  may be medically reasonable as a "bridge" to permanent ICD during that period. 

The patient fits into the category of patients that current AHA ( American Heart Association) guideline recommend the WCD with a Class IIb indication. It is one of the treatments during the immediate post-MI period where LV function has suddenly decreased. The patient should be treated with guideline-directed medical therapy (GDMT) at the same time. An implantable defibrillator would be a better treatment in view of its known efficacy in treating ventricular arrhythmias but by guidelines it is not approved for implantation until 2-3 months after the initial event. Thus, although the LifeVest has not been shown unequivocally to improve survival during this period, it is the best current temporizing method to treat a sudden, potentially fatal arrhythmia.

There are no serious risks for wearing the LifeVest.

In this case, the provider instituted guideline-directed medical therapy (GDMT) which is essential with severe LV dysfunction as in this case. Thus, at the end of 2-3 months of treatment it would be clear if an ICD was indicated. In the 2-3-month interval after initiating GDMT prior to implanting an ICD, the LifeVest is a reasonable treatment modality and is included in AHA guidelines as stated above. Thus, the addition of a LifeVest in this case is considered likely to be helpful in conjunction with GDMT.  

In summary, the denial of Zoll Life Vest - Code and coverage for the requested treatment should be reversed. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.