Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: ST-Segment Elevation Myocardial Infarction (STEMI).
Treatment: Automatic External Defibrillator.
The insurer denied the Automatic External Defibrillator.
The denial is upheld.

This male presented to the emergency department for evaluation of chest pain and acute anterolateral ST-segment elevation myocardial infarction (STEMI) ruled in. He underwent successful emergency percutaneous coronary intervention (PCI) with drug eluting stent (DES) to the occluded left anterior descending (LAD) on the same day. Left ventricular ejection fraction (LVEF) was 30-35% only by transthoracic echocardiogram (TTE). His past medical history was significant for hypertension (HTN) and diabetes. There was non-sustained ventricular tachycardia (NSVT) by overnight telemetry. Prior to discharge, the patient was referred for wearable cardioverter defibrillator (WCD) therapy, as bridge during the 90 day waiting period to be evaluated for implantable cardioverter defibrillator (ICD) therapy while on guideline-directed medical therapy (GDMT). The requested claim for the use of the LifeVest wearable cardioverter defibrillator (WCD) has been denied for coverage by his medical Plan and the patient is appealing the decision.

No, the health plan should not cover the proposed treatment.
The proposed treatment is not medically indicated.

No. the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.
Based on the current evidence-based literature, the wearable cardioverter defibrillator (WCD) is experimental/investigational and therefore, it is not medically indicated.  Wearable cardioverter defibrillator (WCD) for the prevention of sudden cardiac death (SCD) is considered medically indicated 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 (ICD), such as a systemic infection, at the current time, or is awaiting heart transplantation and have been scheduled for implantable cardioverter defibrillator (ICD) placement or who have had an implantable cardioverter defibrillator (ICD) removed and have been rescheduled for placement of another implantable cardioverter defibrillator (ICD) once the contraindication is treated. The evidence shows that these patients benefit from a cardioverter defibrillator and the wearable cardioverter defibrillator (WCD) 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 (WCD) use. Use of wearable cardioverter defibrillator (WCD) as for the prevention of sudden cardia death (SCD) is considered investigational 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 (WCD) is considered investigational for this patient's medical condition and not medically indicated. 

While the results of the WEARIT/BIROAD study(Wearable Defibrillator Investigative Trial and Bridge to ICD in Patients at Risk of Arrhythmic Death)suggest that wearable cardioverter defibrillator (WCD) is beneficial in detecting and effectively treating ventricular tachyarrhythmias in patients at high risk for sudden cardiac death (SCD) who are not clear candidates for an implantable cardioverter defibrillator (ICD) and may be useful as a bridge to an implantable cardioverter defibrillator (ICD) 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 indicated 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 (MI) to continued optimized medical therapy (OMT) alone or with an implantable cardioverter defibrillator (ICD), and neither study showed a benefit from implantable cardioverter defibrillator (ICD) therapy. 

More recently, the Vest Prevention of Early Sudden Death Trial (VEST), the first controlled randomized, multi-center trial of the wearable cardioverter defibrillator (WCD) designed to test whether this device could effectively reduce sudden cardiac death (SCD) in patients during the first three months after a myocardial infarction (MI) and left ventricular ejection fraction (LVEF) of 35% or less, did not find a significant benefit in terms of reducing sudden cardiac death (SCD), the primary endpoint. As a consequence of these clinical trial data, waiting periods of 40 days post-myocardial infarction (MI) if no revascularization was undertaken, or three months when percutaneous or surgical intervention was done have become standard practice before implantable cardioverter defibrillator (ICD) 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 for reimbursement as dictated by a National Coverage Determination on implantable cardioverter defibrillator (ICD) implantation. Although there has been interest in offering wearable cardioverter defibrillators (WCDs) to individuals in the immediate post myocardial infarction (MI) period when they are considered at high risk of arrhythmia, the current peer-reviewed medical literature does not demonstrate improved health outcomes with wearable cardioverter defibrillator (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 Percutaneous Coronary Intervention (PCI) making implantable cardioverter defibrillator (ICD) therapy unnecessary, as well. Consideration for wearable cardioverter defibrillator (WCD) until implantable cardioverter defibrillator (ICD) treatment is indicated is complicated by tension between clinical judgment, clinical trial data, and reimbursement rules. VEST did not find a significant benefit of wearable cardioverter defibrillator (WCD) in terms of reducing sudden cardia death (SCD), the primary endpoint in this patient group. 

Therefore, wearable cardioverter defibrillator (WCD) is considered investigational and not medically indicated for this patient's medical condition, based on the submitted information, the current published literature evidence-based standards and when there are available alternative therapies.