Description

A wearable cardioverter-defibrillator (WCD) is a temporary, external device that is an alternative to an implantable cardioverter-defibrillator (ICD). It is primarily intended for temporary conditions for which an implantable device is contraindicated, or for a period of time during which the need for a permanent implantable device is uncertain.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person’s unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

A WCD may be considered medically necessary for a period of up to three (3) months and when the following criteria are met:

• At least one (1) year of age or older; and
• At high risk for sudden cardiac death (SCD); and
• Requires the WCD as interim treatment for those who meet the criteria for an ICD; and
• Device must be worn for at least 22 hours per day (greater than 90% wear time); and ANY ONE of the following criteria:

A documented episode of ventricular fibrillation or a sustained (lasting 30 seconds or longer) ventricular tachyarrhythmia. These dysrhythmias may be either spontaneous or induced during an electrophysiologic (EP) study, but may not be due to a transient or reversible cause and not occur during the first 48 hours of an acute myocardial infarction. Transient or reversible causes including but not limited to:

• Drug toxicity; or
• Severe hypoxia; or
• Acidosis; or
• Hypokalemia; or 
• Hypercalcemia; or 
• Hyperkalemia; or
• Systemic infections;

OR

A previously implanted defibrillator now requires explantation.

OR

As a bridge to left ventricular (LV) improvement for ANY ONE of the following indications:

• LV ejection fraction (EF) less than or equal to 35% in adults, and one to two standard deviations below a normal EF (or fractional shortening) of 55% for children, after cardiac events such as:
  • After recent acute myocardial infarction (MI) during the 40-day period under which ICD implantation is not indicated or deferred. Reevaluation of LVEF must occur no later than three (3) months after a MI. If LVEF remains less than or equal to 35%, an ICD is indicated; or
  • Coronary revascularization procedures such as before and after coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) during the 90-day ICD waiting period; or
  • Recently diagnosed non-ischemic cardiomyopathy during the three (3)-month to nine (9)-month period awaiting LV improvement or ICD implantation; or
• Heart transplantation; or
• As an alternative to an ICD in an individual who has a documented contraindication to an ICD (e.g., systemic infection, lack of vascular access).

OR

Inherited or familial conditions with a high risk for life-threatening ventricular tachyarrhythmias.

High-risk factors as evidenced by ANY ONE of the following:

• Hypertrophic cardiomyopathy; or
• Long QT Syndrome; or
• A family history of ANY ONE of the following:
  • SCD in a first degree relative (e.g., sibling, parent or child) less than 40; or
  • SCD in a first degree relative (e.g., sibling, parent or child) with hypertrophic cardiomyopathy; or
  • LV/septal thickness greater than three (3) cm in adults; or
  • LV/septal thickness greater than two (2) standard deviations outside of normal parameters in children, or
  • Abnormal exercise blood pressure (BP) including failure BP to rise greater than 25mmHg from baseline or decrease less than 10mmHg from the maximal BP during exercise.

WCD for any other indications will be considered not medically necessary.

Procedure Codes

New York Heart Association Functional Classification (NYHA) of Heart Disease

Modified Ross Heart Failure Classification for Children

*All documentation include daily wear time must be maintained in the medical record and be available upon request. Beginning with the initial date the device was worn for continuous monitoring; the Cardiologist must reevaluate the need for continued use of the WCD at three (3) months and again at 90 day intervals until the device is discontinued. Documentation requirements including but not limited to the following must be maintained in the medical record: the date the device was first worn for continuous monitoring, the initial indication establishing medical necessity, member tolerance and compliance throughout the use of the WCD as documented by Cardiologist evaluations.

The Cardiologist may access the Zoll LifeVest Network on-line patient management system allowing for monitoring of the individual’s data reports downloaded from a the LifeVest wearable defibrillator.

Professional Statements and Societal Positions

2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.

Removal of an ICD for a period of time, most commonly due to infection, exposes the patient to risk of untreated VT/SCD unless monitoring and access to emergency external defibrillation is maintained. In 1 series of 354 patients who received the wearable cardioverter-defibrillator, the indication was infection in 10%. For patients with a history of SCA or sustained VA, the wearable cardioverter-defibrillator may allow the patient to be discharged from the hospital with protection from VT/SCA until the clinical situation allows reimplantation of an ICD.

The patients listed in this recommendation are represented in clinical series and registries that demonstrate the safety and effectiveness of the wearable cardioverter-defibrillator. Patients with recent MI, newly diagnosed NICM, recent revascularization, myocarditis, and secondary cardiomyopathy are at increased risk of VT/SCA. However, the wearable cardioverter-defibrillator is of unproven benefit in these settings, in part because the clinical situation may improve with therapy and time. In patients awaiting transplant, even with anticipated survival <1 year without transplant, and depending on clinical factors such as use of intravenous inotropes and ambient VA, a wearable cardioverter-defibrillator may be an alternative to an ICD.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes 93292, 93745 and K0606