Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Myocardial infarct
Treatment: Durable Medical Equipment (K0606- Wearable Cardiac Defibrillator)
The insurer denied durable medical equipment (K0606 - wearable cardiac defibrillator).
The denial is upheld.

This adult male was approved for wearable cardioverter defibrillator (WCD) therapy for one month during the 90-day waiting period while he was treated with guideline-directed medical therapy (GDMT) until re-evaluated for implantable cardioverter defibrillator (ICD) therapy. The patient had an anterior ST-elevation myocardial infarction (STEMI) treated with successful percutaneous coronary intervention (PCI) with drug-eluting stent (DES) to the left anterior descending (LAD). His estimated left ventricular ejection fraction (LVEF) was 30 to 35 percent. The request for extended coverage for WCD therapy for an additional month was denied and the patient is appealing the decision.

The proposed treatment (wearable cardiac defibrillator) was not medically necessary.

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

In this particular case, the patient does not meet any of the criteria for WCD use for dates of service under review. Use of WCD as for the prevention of SCD 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 WCD is considered unproven for this patient's medical condition and not medically necessary. 

Although there has been interest in offering WCD to individuals in the immediate post MI period when they are considered at high risk of arrhythmia, the current peer-reviewed medical literature does not demonstrate improved health outcomes with WCD during the waiting period and is more effective in reducing the overall death rate compared to optimal conventional medical therapy, such as ace inhibitors, aspirin, statins, and beta-blockers for this patient group. There is no information submitted that this patient was not able to take optimal medical therapy. Several clinical trials have demonstrated that alterations of heart rate variability with ace inhibitors and beta-blockers have a beneficial effect on mortality and often there is significant recovery of left ventricular systolic function over time on optimal medical therapy and following successful myocardial revascularization from PCI making ICD therapy unnecessary, as well. Therefore, WCD is not medically necessary for this patient's medical condition.