Wearable Cardioverter Defibrillators

POLICY NUMBER

A.2.02.15

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 the period 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 implantable cardioverter defibrillator (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 and reduced ejection fraction.

Implantable cardioverter defibrillators consist of implantable leads, which are placed percutaneously in the heart, that are connected to a pulse generator placed 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 the Medical Policy Number A.7.01.44,  Implantable Cardioverter Defibrillator policy for further information.

The wearable cardioverter defibrillator (WCD) is an external device intended to perform the same tasks as an ICD, without invasive procedures. It consists of a vest 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 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.

U.S. Food and Drug Administration (FDA)–labeled indications for the WCD are adults at risk for sudden cardiac arrest (SCA) who either are not candidates for or refuse an implantable ICD. Some experts have suggested that the indications for a WCD should be broadened to include other populations at high risk for SCA. The potential indications include:

• Bridge to transplantation (ie, the Use of a Wearable Defibrillator in Terminating Tachyarrhythmias in Patients at High Risk for Sudden Death [WEARIT] study population);

• Bridge to implantable device or clinical improvement (ie, the Patients at High Risk for Sudden Death after a Myocardial Infarction or Bypass Surgery not receiving an ICD for up to four months [BIROAD] study population):

  • Post bypass with ejection fraction less than 30%,

  • Post bypass with ventricular arrhythmias or syncope within 48 hours of surgery,

  • Post myocardial infarction with ejection fraction less than 30%,

  • Post myocardial infarction with ventricular arrhythmias within 48 hours;

• Drug-related arrhythmias (during drug washout or after, during evaluation of long-term risk);

• Patients awaiting revascularization;

• Patients too ill to undergo device implantation; and

• Patients who refuse device therapy.

In 2001, the Lifecor WCD® 2000 system was approved by the FDA through the premarket approval process 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 the LifeVest®.

In 2015, the 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.”

In 2021, the FDA approved the ASSURE® WCD for adult patients at risk for SCA who are not candidates for (or refuse) an ICD.

Related medical policies - 

• Cardiac Rehabilitation in the Outpatient Setting ,

  L.8.03.400

• Implantable Cardioverter Defibrillator ,

  A.7.01.44

POLICY

A. WCD Due to Contraindication to Receiving an ICD

     Use of a WCD for the prevention of sudden cardiac death is considered medically necessary as      interim treatment for those who:

• Meet the criteria for an ICD

  (established by the Medical Policy Number A.7.01.44, Implantable Cardioverter Defibrillator )

  ;

  AND

• Have a temporary contraindication to receiving an ICD, such as a systemic infection, at the current time; AND

• Have been scheduled for an ICD placement or who had an ICD removed and have been rescheduled for placement of another ICD once the contraindication is treated. 

B. WCD for Ischemic Cardiomyopathy Following An Acute Myocardial Infarction     Prior authorization is required.

1. Prior authorization is required for a WCD in the immediate period for ischemic cardiomyopathy following an acute myocardial infarction. Care Management approval required.

2. A complete Discharge Plan from the Discharging Hospital that includes post discharge Cardiac Care must be submitted and approved prior to initiation of treatment. 

3. The Prior Authorization request for the WCD must be submitted by the ordering Cardiologist for consideration using the Outpatient and Professional Services Request* form. Medical necessity documentation and a treatment plan from the Cardiologist, including participation in cardiac rehabilitation as outlined in Medical Policy Number L.8.03.400, Cardiac Rehabilitation in the Outpatient Setting , must be submitted with the request for the WCD.

4. Requests for a WCD from Durable Medical Equipment (DME) Companies will not be accepted.

Initiation of Wearable Cardioverter Defibrillator:

Use of WCD for the prevention of sudden cardiac death is considered medically necessary as a bridge to left ventricular improvement or possible ICD implantation for those who:

• Have ischemic cardiomyopathy due to a recent [less than 40 days] myocardial infarction AND left-ventricular ejection fraction (LVEF) is less than or equal to 35% [by most recent ECHO]:

  • If revascularization was not performed and LVEF is not expected to improve, the WCD is covered for up to 3 months rental [maximum benefit 90 days or less]OR

  • If revascularization (percutaneous or surgical) was performed, and there is an expectation of possible improvement in left ventricular function, the WCD is covered for up to 4 months rental [maximum benefit 120 days or less]

Length of approval: 30 days rental

Continuation of Wearable Cardioverter Defibrillator:

After 30 days, monitoring data downloaded from the WCD that includes patient events and daily compliance AND an updated treatment plan must be submitted by the ordering Cardiologist for further authorization.

Length of approval: 60 days rental if revascularization was not performed                                90 days rental if revascularization was performed 

C. WCD for Newly Diagnosed Nonischemic Cardiomyopathy

     Prior authorization is required.

1. Prior authorization is required for a WCD in newly diagnosed nonischemic cardiomyopathy. Care Management approval required.

2. A complete Discharge Plan from the Discharging Hospital that includes post discharge Cardiac Care must be submitted and approved prior to initiation of treatment.

3. The Prior Authorization request for the WCD must be submitted by the ordering Cardiologist for consideration using the the Outpatient and Professional Services Request* form. Medical necessity documentation and a treatment plan from the Cardiologist must be submitted with the request for the WCD.

4. Requests for a WCD from Durable Medical Equipment (DME) Companies will not be accepted. 

Initiation of Wearable Cardioverter Defibrillator:

Use of WCD for the prevention of sudden cardiac death is considered medically necessary as a bridge to left ventricular improvement or possible ICD implantation for those who:

• Are newly diagnosed with dilated nonischemic cardiomyopathy not due to recent myocardial infarction, WCD is covered for up to 4 months rental [maximum benefit 120 days or less] if ALL of the following criteria are met:

  • LVEF is less than or equal to 35% [by most recent ECHO]AND

  • Patient has been started on the following guideline-directed medical therapy:

    1. Angiotensin-converting enzyme inhibitors (ACEI) or angiotensin-receptor blockers (ARB) for all patients without contraindications

    2. Evidence-based beta blockers (bisoprolol, carvedilol, metoprolol succinate)

    3. Diuretics for relief of symptoms as neededAND

  • Optimal medical management has not yet been determined.

Length of approval: 30 days rental 

Continuation of Wearable Cardioverter Defibrillator:

After 30 days, monitoring data downloaded from the WCD that includes patient events and daily compliance AND an updated treatment plan must be submitted by the ordering Cardiologist for further authorization.

Length of approval: 90 days rental

Use of WCD for the prevention of sudden cardiac death is considered investigational for the following indications when they are the sole indication for a WCD:

• Individuals post-CABG [coronary artery bypass graft] surgery

• Women with peripartum cardiomyopathy

• High-risk individuals awaiting heart transplant.

Use of WCDs is considered investigational for all other indications.

POLICY EXCEPTIONS

Federal Employee Program (FEP)

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

It is uncommon for individuals to have a temporary contraindication to ICD placement. The most common reason will be a systemic infection that requires treatment before the ICD can be implanted. The wearable cardioverter defibrillator should only be used short-term while the temporary contraindication (eg, systemic infection) is being clinically managed. Once treatment is completed, the permanent ICD should be implanted.

*WCD requests from Out-of-State Cardiologists can be submitted using the  Blue Cross & Blue Shield of Mississippi Prior Authorization Request  form.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2003: Approved by Medical Policy Advisory Committee (MPAC).

1/21/2004: Code Reference section completed.

3/22/2005: Code Reference section updated, CPT code 93741, 93742, 93745 added non-covered codes.

11/16/2006: Policy archived.

1/2/2007: Policy clarified and re-activated.

1/9/2007: Code reference section updated. Non-covered table deleted. Codes moved to covered with note to see Policy section for medically necessary and investigational indications. Added ICD-9 codes 425.1, 426.81-426.89, 427.0, 427.1, 427.41, 427.42, 427.81, 427.89, and 427.9.

4/29/2008: Policy reviewed, no changes.

12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions.

08/17/2010: Policy description unchanged. Medically necessary policy statement re-worded for clarity, and the statement regarding awaiting a heart transplant and have a contraindication to placement was removed. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Added CPT code 93292 to the Covered Codes table. Removed CPT codes 93741 and 93742 from the code table as they were deleted as of 12/31/2008.

12/29/2010: Policy reviewed; no changes.

01/17/2012: Policy reviewed; no changes.

12/13/2012: Policy reviewed; no changes.

04/14/2014: Policy reviewed; removed "have all of the following" from the medically necessary policy statement. Added "post-CABG surgery, newly diagnosed nonischemic cardiomyopathy, women with peripartum cardiomyopathy, and high-risk patients awaiting heart transplant" to investigational policy statement. Added additional policy statement that "Use of wearable cardioverter-defibrillators is considered investigational for all other indications." Policy title changed from "Wearable Cardioverter Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator (ICD) Placement" to "Wearable Cardioverter-Defibrillators."

02/09/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated regarding temporary contraindications to ICD placement.

08/31/2015: Medical policy revised to add ICD-10 codes. Added fifth digit to ICD-9 diagnosis code 425.1 (425.11).

06/06/2016: Policy number A.2.02.15 added. Policy Guidelines updated to add medically necessary and investigative definitions.

06/21/2016: Policy description updated regarding devices. Policy statements unchanged.

06/01/2017: Policy description updated. Policy statements unchanged.

06/01/2018: Policy description updated regarding indications for a wearable cardioverter defibrillator. Policy statements unchanged.

06/04/2019: Policy reviewed; no changes.

11/15/2019: Policy revised to add medical necessity criteria and prior authorization requirements for use of wearable cardioverter defibrillator due to ischemic cardiomyopathy following a recent myocardial infarction and for newly diagnosed dilated nonischemic cardiomyopathy not due to recent myocardial infarction. Added I21.0-I21.9, I25.5, and I42.0 to the Covered Codes table. Sources section updated.

12/12/2019: Policy updated to state that the Prior Authorization request for the WCD must be submitted by the ordering Cardiologist for consideration using the Outpatient and Professional Services Request form.

08/24/2021: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/23/2022: Policy description updated regarding FDA approvals. Policy statements updated to change "patients" to "individuals."

09/21/2022: Code Reference section updated to add new ICD-10 diagnosis codes I47.20, I47.21, and I47.29, effective 10/01/2022.

03/31/2023: Policy reviewed; no changes.

06/06/2023: Policy reviewed; no changes.

09/29/2023: Code Reference section updated to add new ICD-10 diagnosis codes I47.10, I47.11, and I47.19, effective 10/01/2023.

04/10/2024: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted ICD-10 diagnosis code I47.2.

06/11/2024: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

03/27/2025: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted ICD-10 diagnosis code I47.1.

08/07/2025: Policy reviewed; no changes.

SOURCE(S)

1. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America, Circulation. 2017;136:e137–e161

2. Arkansas Blue Cross Blue Shield Cardioverter Defibrillator; Implantable, Subcutaneous, and Wearable Cardioverter Medical Policy

3. Blue Cross Blue Shield Association policy # 2.02.15

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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