Wearable Cardio Defib denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement and prospective authorization and coverage for Zoll LifeVest. Primary prevention implantable cardioverter-defibrillator (ICD) is recommended to prevent sudden cardiac arrest (SCA) and death due to ventricular tachycardia/fibrillation (VT/VF) in patients with heart failure and left ventricular ejection fraction (LVEF) of less than 36% only after a minimum of three months of guideline-directed medical therapy (GDMT). Several studies have examined whether wearable cardioverter-defibrillator (WCD) offers protection against SCA/death during these three months where GDMT is prescribed and titrated.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for a wearable cardioverter defibrillator (automatic external defibrillator with integrated electronic cardiogram analysis, garment type). This patient has non-ischemic cardiomyopathy (NICM) and given his son’s condition and course, genetic testing has been performed to determine a causative etiology and to direct clinical prognosis, with results pending. As no other etiology of NICM is evident, it may be presumed that this patient has titin (TTN)-related NICM until results of genetic testing become available. While patients with NICM are at increased risk of arrhythmic sudden death, patients with TTN-related cardiomyopathy appear to be at especially high risk for life-threatening rhythm disturbances.

Where the denial was upheld

The enrollee requested authorization and coverage, and reimbursement, for an automatic external defibrillator, with integrated electronic cardiogram analysis, garment type. The enrollee was admitted acutely on with new-onset, severe left ventricular dysfunction with fluid overload. The enrollee has longstanding left bundle branch block and no evidence of coronary artery disease or acute myocarditis. Cardiology indicated the enrollee can switch from angiotensin-converting enzyme inhibitors to angiotensin II receptor blockers to allow for a transition to Entresto if needed, and to minimize the side effect of cough. The enrollee was discharged home with an automatic external defibrillator due to being considered high risk for sudden cardiac arrest.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement for a heart monitor. In this case, if cardiac monitoring were thought to be indicated to evaluate for palpitations, then non-real time (off-line) monitoring devices such as extended (48 hour) Holter monitoring or off-line event monitoring should be sufficient for the identification of both symptomatic and asymptomatic dysrhythmias including atrial fibrillation. Continuous off-line 24-to-48 hour Holter monitoring should be able to effectively identify symptomatic or asymptomatic dysrhythmias that occur frequently. Likewise, self-activated non-real time and non-continuous monitoring devices (event recorders) should be effective at recording symptomatic dysrhythmias during less frequent symptoms.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Wearable Cardio Defib, then check the rights and deadlines that apply to your plan.