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Cardioverter Defibrillators: Wearable or External

Policy Number: MP-557

 

Latest Review Date:  June 2020

Category: DME                                                            

Policy Grade:  A

 

POLICY:

Effective for dates of service on and after March 1, 2019:

The wearable cardioverter-defibrillator for the prevention of sudden cardiac death may be considered medically necessary for coverage in patients who meet both of the following criteria:

  • meet the criteria for an implantable cardioverter-defibrillator  (established by medical policy No.168 Cardioverter Defibrillators: Implantable); AND
  • require interim treatment BUT cannot be treated with an implantable cardioverter defibrillator;

And must also have one of the following criteria:

  • Have a temporary contraindication to receiving an ICD such as a systemic infection, at the current time and has been scheduled for an ICD placement; OR
  • Have a temporary contraindication to receiving an ICD such as a systemic infection, at the current time and had an ICD removed and has been rescheduled for placement of another ICD once the contraindication is treated.

 

The wearable cardioverter-defibrillator for the prevention of sudden cardiac death may be considered medically necessary for coverage as a bridge to left ventricular improvement or possible ICD implantation for the following indications:

  • LVEF is less than or equal to 35%; AND
  • Have had a recent diagnosis of nonischemic dilated or hypertrophic cardiomyopathy and within the 3 month waiting period after starting guideline directed medical therapy; OR 
  • Have had a recent myocardial infarction and within the 40 day period that an ICD implantation is not indicated or is deferred. This will be considered for up to 3 months. 

 

The use of WCDs is considered not medically necessary and investigational for the following indications when they are the sole indication for a wearable cardioverter defibrillator:

  • Patients post coronary artery bypass graft surgery
  • Women with peripartum cardiomyopathy
  • High-risk patients awaiting a heart transplant

 

Automatic External Defibrillators (AEDs) for home use may be considered medically necessary in patients who meet criteria for implantation of ICD, but cannot be treated with an implantable cardioverter defibrillator or have a contraindication to ICD placement.  Contraindications for ICD are the same as described in the previous paragraph under the wearable cardioverter-defibrillator.

 

The use of WCDs is considered not medically necessary and investigational for all other indications.

 

 

Effective for dates of service prior to March 1, 2019:

The wearable cardioverter-defibrillator for the prevention of sudden cardiac death may be considered medically necessary for coverage in patients who meet both of the following criteria:

  • meet the criteria for an implantable cardioverter-defibrillator  (established by medical policy No.168 Cardioverter Defibrillators: Implantable); AND
  • require interim treatment BUT cannot be treated with an implantable cardioverter defibrillator

 

And must also have one of the following criteria:

 

  • Have a temporary contraindication to receiving an ICD such as a systemic infection, at the current time and has been scheduled for an ICD placement; OR
  • Have a temporary contraindication to receiving an ICD such as a systemic infection, at the current time and had an ICD removed and has been rescheduled for placement of another ICD once the contraindication is treated.

 

The use of WCDs is considered not medically necessary and investigational for the following indications when they are the sole indication for a wearable cardioverter defibrillator:

  • Patients post coronary artery bypass graft surgery
  • Patients with newly diagnosed nonischemic cardiomyopathy (excluding hypertrophic cardiomyopathy)
  • Women with peripartum cardiomyopathy
  • High-risk patients awaiting a heart transplant

 

The wearable cardioverter-defibrillator for the prevention of sudden cardiac death may be considered medically necessary in patients who have had a recent myocardial infarction and cannot be treated with an implantable cardioverter defibrillator until at least 40 days post MI. This will be considered for up to 3 months.

 

The wearable cardiac defibrillator may be considered medically necessary for 4 months for patients with hypertrophic cardiomyopathy whose measured left ventricular ejection fraction is less than or equal to 35%.

 

The use of WCDs is considered not medically necessary and investigational for all other indications.

 

Automatic External Defibrillators (AEDs) for home use may be considered medically necessary in patients who meet criteria for implantation of ICD, but cannot be treated with an implantable cardioverter defibrillator or have a contraindication to ICD placement.  Contraindications for ICD are the same as described in the previous paragraph under the wearable cardioverter-defibrillator.

 

 

DESCRIPTION OF PROCEDURE:

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.

 

Sudden Cardiac Arrest

Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease.

 

Treatment

The ICD has proven effective in reducing mortality for survivors of SCA and for patients with documented malignant ventricular arrhythmias. More recently, the use of ICDs has been broadened by studies reporting a reduction in mortality for patients at risk for ventricular arrhythmias, such as patients with prior myocardial infarction (MI) and reduced ejection fraction.

 

ICDs consist of implantable leads, which are placed percutaneously in the heart, that are connected to a pulse generator implanted beneath the skin of the chest or abdomen. ICD placement is a minor surgical procedure. Potential adverse events of ICD placement are bleeding, infection, pneumothorax, and delivery of unnecessary counter shocks. See Policy No.168 “Cardioverter Defibrillators: Implantable” for further information on ICDs.

 

The WCD is an external device that is intended to perform the same tasks as an ICD, without requiring invasive procedures. It consists of a vest that is worn continuously underneath the patient's clothing. Part of this vest is the “electrode belt” that contains the cardiac-monitoring electrodes and the therapy electrodes that deliver a counter shock. The vest is connected to a monitor with a battery pack and alarm module that is worn on the patient’s belt. The monitor contains the electronics that interpret the cardiac rhythm and determines when a counter shock is necessary. The alarm module alerts the patient to certain conditions by lights or voice messages, during which time a conscious patient can abort or delay the shock.

 

 

KEY POINTS:

The most recent literature update was conducted through March 9, 2020.

 

Summary of Evidence

Overview of Wearable Cardioverter Defibrillator Versus Implantable Cardioverter Defibrillator

One RCT has compared WCD with usual guideline-based care and found no significant benefit to WCD over usual care. No studies have directly compared the performance of a WCD with a permanent ICD. One small study in an electrophysiology lab demonstrated that the WCD can correctly identify and terminate most induced ventricular arrhythmias. A cohort study of WCD use estimated that the percentage of successful resuscitations was approximately 70%. Multiple studies have demonstrated suboptimal adherence. Device failures were largely attributed to incorrect device use and/or nonadherence. A more recent registry study has reported a high compliance rate, although these results may be biased by self-selection. Collectively, this evidence indicates that the WCD can successfully detect and terminate arrhythmias in at least some patients but that overall performance in clinical practice might be inferior to a permanent ICD.

 

Temporary Contraindications

For individuals who have a temporary contraindication for an implantable cardioverter defibrillator (ICD) who receive a wearable cardioverter defibrillator (WCD), the evidence includes prospective cohort studies and a technology assessment that assessed ICD devices, given the absence of evidence on WCD devices. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related morbidity. A small number of patients meet established criteria for an ICD but have a transient contraindication for an implantable device, most commonly an infectious process. The available data establish that the WCD device can detect lethal arrhythmias and can successfully deliver a countershock in most cases. In patients scheduled for ICD placement, the WCD will improve outcomes as an interim treatment. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

Immediate Post Myocardial Infarction

For individuals who are in the immediate post myocardial infarction period who receive a WCD, the evidence includes a randomized controlled trial (RCT) comparing WCD with guideline-based therapy, a cohort study, and a systematic review. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related morbidity. The RCT did not lead to a significantly lower rate of arrhythmic death during the first 90 days; however, there was successful conversion in 20 participants in the device group who received an appropriate shock. The cohort study of 8453 patients showed that 252 shocks successfully terminated ventricular fibrillation or ventricular tachycardia (82% success rate). The evidence is sufficient to determine the effects of the technology on health outcomes.

 

Newly Diagnosed Nonischemic Cardiomyopathy

For patients with newly diagnosed nonischemic cardiomyopathy, the evidence includes an RCT for ICD and multiple retrospective analyses of registry data for WCD. Relevant outcomes are OS, morbid events, functional outcomes, and treatment-related morbidity. Results of the RCT did not show a statistical significant reduction in all-cause mortality; however, there was a significant reduction in sudden cardiac death in the ICD arm. Overall, retrospective studies have shown low incidences of inappropriate shocks and that WCDs could be an effective treatment in preventing SCD. Because patients with newly diagnosed NICM and LVEF ≤35% show an elevated risk of ventricular arrhythmias during initiation and optimization of heart failure therapy, the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

Post-Coronary Artery Bypass Graft Surgery at High Risk for Lethal Arrhythmias

For individuals who are post coronary artery bypass graft surgery and at high risk for lethal arrhythmias, the evidence includes an RCT for ICD and a registry study. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment–related morbidity. For high-risk post coronary artery bypass graft patients, an RCT reported no difference in overall survival associated with early ICD placement. The registry study found survival benefits with WCD, but had limited interpretation of data. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Awaiting Heart Transplantation at High Risk for Lethal Arrhythmias

For individuals who are awaiting heart transplantation and are at high risk for lethal arrhythmias, the evidence includes analyses of subsets of patients from the manufacturer registry, a subset from a prospective cohort study, and a case series. Relevant outcomes are OS, morbid events, functional outcomes, and treatment-related morbidity. These studies do not provide sufficient evidence to determine whether a WCD is of benefit compared with usual care. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Peripartum Cardiomyopathy

For individuals who have peripartum cardiomyopathy, the evidence includes a retrospective registry data analysis and a small cohort study. Relevant outcomes are OS, morbid events, functional outcomes, and treatment-related morbidity. The registry study revealed that no shocks were delivered during use over an average of 124 days. The cohort study identified 4 episodes of appropriate electric shock over 133 days. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

American Heart Association et al

In 2018, the American Heart Association (AHA), the American College of Cardiology and the Heart Rhythm Society published a guideline on the management of patients with ventricular arrhythmias and prevention of sudden cardiac death. The guidelines note that "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." The specific recommendations are summarized in Table 1. Class IIa is moderate recommendation, and class IIb is a weak recommendation

 

Table 1. Guidelines for WCD Therapy

Recommendation

COR

LOE

"In patients with an ICD and a history of SCA or sustained VA in whom removal of the ICD is required (as with infection, the wearable cardioverter-defibrillator is reasonable for the prevention of SCD."

IIa

B-NR

"In patients at an increased risk of SCD but who are not ineligible for an ICD, such as awaiting cardiac transplant, having an LVEF of 35% or less and are within 40 days from an MI, or have newly diagnosed, NICM, revascularization within the past 90days, myocarditis or secondary cardiomyopathy or a systemic infection, the wearable cardioverter-defibrillator may be reasonable."  

IIb

B-NR

B-NR: Level B - nonrandomized; COR: class of recommendation; ICD: implantable cardioverter defibrillator; LOE: level of evidence; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NICM: nonischemic cardiomyopathy; SCD: sudden cardiac death; WCD: wearable cardioverter defibrillator.

 

In 2016, the American Heart Association (AHA) published a scientific advisory on the wearable cardioverter defibrillator (WCD). AHA stated that “because there is a paucity of prospective data supporting the use of the WCD, particularly in the absence of any published, randomized, clinical trials, the recommendations provided in this advisory are not intended to be prescriptive or to suggest an evidence-based approach to the management of patients with FDA-approved indications for use.” The specific recommendations are summarized in Table 2.

 

Table 2: Guidelines for WCD Therapy

Recommendation

COR

LOE

“Use of WCDs is reasonable when there is a clear indication for an implanted/permanent device accompanied by a transient contraindication or interruption in ICD care such as infection.”

IIa

C

“Use of WCDs is reasonable as a bridge to more definitive therapy such as cardiac transplantation”

IIa

C

“Use of WCDs may be reasonable when there is concern about a heightened risk of SCD that may resolve over time or with treatment of left ventricular dysfunction/ for example, in ischemic heart disease with recent revascularization, newly diagnosed nonischemic dilated cardiomyopathy in patients starting guideline-directed medical therapy, or secondary cardiomyopathy (tachycardia mediated, thyroid mediated, etc.) in which the underlying cause is potentially treatable.”

IIb

C

“WCDs may be appropriate as bridging therapy in situation associated with increased risk of death in which ICDs have been shown to reduce SCD but not overall survival such as within 40 D of MI.”

IIb

C

“WCDs should not be used when nonarrhythmic risk is expected to significantly exceed arrhythmic risk, particularly in patients who are not expected to survive >6 mo.”

III

C

AHA: American Heart Association; COR: class of recommendation; ICD: implantable cardioverter defibrillator; LOE: level of evidence; SCD: sudden cardiac death; WCD: wearable cardioverter defibrillator.

 

American College of Cardiology et al

The American College of Cardiology, AHA, and the Heart Rhythm Society jointly published guidelines on the management of adults who have ventricular arrhythmias or who are at risk for sudden cardiac death, including diseases and syndromes associated with a risk of sudden cardiac death from ventricular arrhythmias. Recommendations related to the use of WCDs are provided in Table 3.

 

Table 3. Guidelines for WCD Therapy

Recommendations

COR

LOE

In patients with an implantable cardioverter defibrillator and a history of sudden cardiac arrest or sustained ventricular arrhythmia in whom removal of the implantable cardioverter defibrillator is required (as with infection), the wearable cardioverter defibrillator is reasonable for the prevention of sudden cardiac death.a

IIa

 

B-NR

In patients at an increased risk of sudden cardiac death but who are not ineligible for an implantable cardioverter defibrillator, such as awaiting cardiac transplant, having an LVEF of 35% or less and are within 40 days from an MI, or have newly diagnosed nonischemic cardiomyopathy, revascularization within the past 90 days, myocarditis or secondary cardiomyopathy or a systemic infection, wearable cardioverter defibrillator may be reasonable.b

IIb

B-NR

B-NR: data derived from ≥1 nonrandomized trials or meta-analysis of such studies; COR: class of recommendation; ICD: implantable cardioverter defibrillator; LOE: level of evidence; LVEF: left ventricular ejection fraction; MI: myocardial infarction; WCD: wearable cardioverter defibrillator.

a Removal of an ICD for a period of time, most commonly due to infection, exposes the patient to risk of untreated ventricular tachycardia/sudden cardiac death unless monitoring and access to emergency external defibrillation is maintained. In 1 series of 354 patients who received the WCD, the indication was infection in 10%. For patients with a history of sudden cardia arrest or sustained ventricular arrhythmia, the WCD may allow the patient to be discharged from the hospital with protection from ventricular tachycardia/sudden cardiac death until the clinical situation allows reimplantation of an ICD.

b The patients listed in this recommendation are represented in clinical series and registries that demonstrate the safety and effectiveness of the WCD. Patients with recent MI, newly diagnosed nonischemic cardiomyopathy, recent revascularization, myocarditis, and secondary cardiomyopathy are at increased risk of ventricular tachycardia or sudden cardiac death. However, the WCD 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 ventricular arrhythmia, a WCD may be an alternative to an ICD.

 

International Society for Heart and Lung Transplantation

In 2006, the International Society for Heart and Lung Transplantation issued guidelines for the care of cardiac transplant candidates that addressed use of ICDs or WCDs. Recommendations related to the use of WCDs include:

  • Class I recommendations: “An implanted or wearable ICD should be provided for Status 1B patients [i.e., dependent on intravenous medications or a mechanical assist device] who are discharged home given that the wait for transplantation remains significant (Level of Evidence: C).”
  • Class IIa recommendations: “It is reasonable to consider placement of a defibrillator in patients with Stage D failure who are candidates for transplantation or LVAD [left ventricular assist device] destination therapy (see subsequent considerations for mechanical circulatory support device [MCSD] referral: bridge or destination) (Level of Evidence: C).”

 

U.S. Preventive Services Task Force Recommendations

Not applicable.

 

 

KEY WORDS:

AICD, Wearable Cardioverter Defibrillator, Wearable Vest, LifeCor WCD System, LifeVest, Wearable Cardiac Defibrillator

 

 

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration (FDA) approved the Lifecor WCD® 2000 system via premarket application approval in December 2001 for “adult patients who are at risk for cardiac arrest and are either not candidates for or refuse an implantable defibrillator.” The vest was renamed and is now called the Zoll® LifeVest®.

 

In 2015, FDA approved the LifeVest® “for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.”

 

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

 

CURRENT CODING:

CPT Codes:

 

93292

Interrogation device evaluation (in person) with physician analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; wearable defibrillator system

93745             

Initial set-up and programming by a physician or other qualified   health care professional of wearable cardioverter-defibrillator includes initial programming of system, establishing baseline electronic ECG, transmission of data to data repository, patient instruction in wearing system and patient reporting of problems or events

 

HCPC Codes:

 

E0617            

External defibrillator with integrated electrocardiogram analysis  

K0606            

Automatic external defibrillator, with integrated electrocardiogram analysis, garment type

K0607            

Replacement battery for automated external defibrillator, garment type only, each

K0608            

Replacement garment for use with automated external defibrillator, each

K0609            

Replacement electrodes for use with automated external defibrillator, garment type only, each

 

 

 

REFERENCES:

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POLICY HISTORY:

Medical Policy Panel, January 2014

Medical Policy Group, July 2014 (4): Portions of the original policy 168 “Cardioverter Defibrillators: Implantable, Wearable, or External” were removed and placed on this policy (557) pertaining to the wearable and external defibrillators. No changes were made to the policy at this time.  Key Points and References were updated.

Medical Review Committee, August 2014

Available for comment August 20 through October 3, 2014

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (4): Updates to Key Points and References.  Policy statement rearranged to be more easily read.  Policy statement intent unchanged.

Medical Policy Panel, May 2016

Medical Policy Group, June 2016 (4): Updates to Description, Key Points, Approved Governing Bodies, and References. Added policy statements to include investigational conditions for clarification.  Policy intent unchanged.

Medical Policy Panel, May 2017

Medical Policy Group, June 2017 (4): Updates to Key Points and References.  No change to policy statements.

Medical Policy Panel, May 2018

Medical Policy Group, June 2018 (4): Updates to Description, Key Points, and References.  No change to policy statement.

Medical Policy Group, October 2018 (4): Clarification made to policy statement.  No change in intent of statements.

Medical Policy Group, February 2019 (4): Updates to Policy statement regarding nonischemic dilated cardiomyopathy.  Effective 3/1/19, newly diagnosed dilated cardiomyopathy is medically necessary for WCD.

Medical Policy Administrative Committee: March 2019

Available for comments: February 25, 2019 – April 11, 2019.

Medical Policy Panel, May 2019

Medical Policy Group, May 2019 (4): Updates to Description, Key Points, and References. No change to policy statements.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Description and Key Points.  No change to policy statements.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

 

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

 

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.