Wearable Cardioverter-Defibrillator

Policy ID: E-58-019

Section: Durable Medical Equipment

Effective Date: July 01, 2018

Revised Date: November 19, 2020

Revision Effective Date: January 04, 2021

Last Reviewed: November 19, 2020

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.

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) years 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 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 explanation;

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% 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).

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 than10mmHg from the maximal BP during exercise.

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

“Coverage beyond 90 days for an additional 30 days will be given individual consideration based upon additional documentation.

Procedure Codes

93292

93745

K0606

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

Classification	Characteristics
Class I (mild)	No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, rapid/irregular heartbeat (palpitation) or shortness of breath (dyspnea).
Class II (mild)	Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, rapid/irregular heartbeat (palpitation), or shortness of breath (dyspnea).
Class III (moderate)	Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, rapid/irregular heartbeat (palpitation), and shortness of breath (dyspnea).
Class IV (severe)	Inability to carry on any physical activity without discomfort. Symptoms of fatigue, rapid/irregular heartbeat (palpitation) or shortness of breath (dyspnea) are present at rest. If any physical activity is undertaken, discomfort increases.

Modified Ross Heart Failure Classification for Children

Classification	Characteristics
Class I	No limitations or symptoms.
Class II	Infants: Mild tachypnea or diaphoresis with feeding. Older children: Mild to moderate dyspnea on exertion.
Class III	Infants: Growth failure and marked tachypnea or diaphoresis with feeding. Older children: Marked dyspnea on exertion.
Class IV	Symptoms at rest such as tachypnea, retractions, grunting, or diaphoresis.

*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 Life Vest Network on-line individual management system allowing for monitoring of the individual’s data reports downloaded from a the Life Vest wearable defibrillator.

Diagnosis Codes

A18.84	I21.3	I21.4	I21.9	I21.01	I21.02	I21.09
I21.11	I21.19	I21.21	I21.29	I21.A1	I21.A9	I22.0
I22.1	I22.2	I22.8	I22.9	I25.2	I40.0	I40.1
I40.8	I40.9	I42.0	I42.1	I42.2	I42.3	I42.4
I42.5	I42.6	I42.7	I42.8	I42.9	I43	I45.81
I46.2	I46.8	I46.9	I47.0	I47.1	I47.2	I47.9
I49.1	I49.2	I49.3	I49.01	I49.02	T82.6XXA	T82.7XXA
T82.110A	T82.111A	T82.118A	T82.119A	T82.120A	T82.121A	T82.128A
T82.129A	T82.190A	T82.191A	T82.198A

Professional Statements and Societal Positions Guidelines

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

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

The individuals listed in this recommendation are represented in clinical series and registries that demonstrate the safety and effectiveness of the wearable cardioverter-defibrillator. Individuals 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 individuals 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.

ND Committee Review

Internal Medical Policy Committee 9-21-2020 Added Covered Diagnosis codes for Procedure Codes 93292, 93745 and K0606: A18.84; I21.3; I21.4; I21.9; I21.01; I21.02; I21.09; I21.11; I21.19; I21.21; I21.29; I21.A1; I21.A9; I22.0; I22.1; I22.2; I22.8; I22.9; I46.2; I46.8 and I46.9.

Links

References

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.