MEDICAL POLICY 2.02.506

Wearable Cardioverter-Defibrillators as a Bridge to

Implantable Cardioverter-Defibrillator Placement

BCBSA Ref. Policy: 2.02.15

Effective Date: July 1, 2017

Last Revised: June 22, 2017

Replaces: 2.02.15

RELATED MEDICAL POLICIES:

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POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | APPENDIX | HISTORY

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Introduction

Sudden cardiac arrest is when the heart stops beating. It can cause death within minutes if not

treated. A cardiac defibrillator is a device that shocks the heart back into normal rhythm to

prevent sudden cardiac arrest. A wearable cardiac defibrillator is one type of defibrillator. Its

strapped around the chest and worn underneath clothes. Electrodes (small patches applied to

the skin) monitor the hearts rhythm. Other electrodes deliver the current. The electrodes are

attached to a small defibrillation unit, usually worn at the waist. When a life threatening heart

rhythm is detected, an alarm alerts the person and the defibrillator sends a shock to return the

heart to a normal rhythm. These vests are useful when surgery to implant a permanent

defibrillator is temporarily delayed due to a medical reason. This policy describes when a

wearable cardioverter-defibrillator may be considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

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Policy Coverage Criteria

Device Medical Necessity Wearable cardioverter-

defibrillator

The use of a wearable (external) cardioverter-defibrillator

(WCD) to prevent sudden cardiac arrest or death (SCD) may be

considered medically necessary as a bridge to permanent

implantable (internal) cardioverter-defibrillator (ICD) surgery

or replacement of an ICD that was removed, when ALL of the

following criteria are met:

The criteria for an ICD placement is met (see Additional

Coverage Criteria section)

AND

A temporary contraindication to the ICD

placement/replacement surgery exists such as when:

o A current systemic infection is being treated before the ICD

can be placed

OR

o An ICD was removed due to a current infection that is being

treated

OR

o A new onset of nonischemic cardiomyopathy is being

treated medically for 90 days per American College of

Cardiology and the American Heart Association (ACC/AHA)

guidelines (see Additional Coverage Criteria section)

AND

The ICD placement or an ICD replacement surgery, if

appropriate, will be scheduled once the temporary

contraindication is treated or managed.

Device Investigational Wearable cardioverter-

defibrillator

Use of a wearable cardioverter-defibrillator for the prevention

of sudden cardiac death (SCD) is considered investigational for

all other indications not listed in the Medical Necessity section

above, including immediately (ie, less than 40 days) following

an acute myocardial infarction (AMI).

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Additional Coverage Criteria Temporary Contraindications for ICD placement

A short-lived or temporary contraindication to implantable cardioverter-defibrillator (ICD)

placement occurs infrequently. Reasons for temporary use of the wearable (external) cardioverter-

defibrillator (WCD) include:

While a current systemic infection is being treated before the ICD can be placed or

When an ICD was removed due to a current infection with plans for a replacement after the

infection resolves or

While a new onset of nonischemic cardiomyopathy is being treated medically for 90 days per

ACC/AHA guidelines.

Note: If the patient with nonischemic cardiomyopathy responds to maximal medical treatment after 90 days, and ICD

surgery is cancelled, coverage for the WCD will stop.

American College of Cardiology and the American Heart Association (ACC/AHA)

The ACC/AHA Guidelines state that immediate ICD placement is contraindicated for nonischemic

cardiomyopathy until the patient has had maximal medical treatment for 90 days.6 In some cases

the condition improves with medical treatment and the ICD placement is no longer necessary.

Indications for Implantable Cardioverter-Defibrillator (ICD) implantation

Indications for ICD implantation can be broadly subdivided into two categories:

1. Primary prevention, in patients who are considered at high risk for sudden cardiac death but

who have not yet experienced life-threatening ventricular arrhythmia such tachycardia (VT) or

ventricular fibrillation (VF).

2. Secondary prevention, in patients who have experienced a life-threatening episode of VT, after

reversible causes have been excluded.

Primary Prevention criteria32,33 for the use of the automatic ICD in adults includes:

Ischemic cardiomyopathy with New York Heart Association (NYHA) functional Class II or Class

III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left

ventricular ejection fraction of 35% or less

OR

Ischemic cardiomyopathy with NYHA functional Class I symptoms, a history of myocardial

infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30% or

less

OR

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Additional Coverage Criteria Nonischemic dilated cardiomyopathy (NIDCM) and left ventricular ejection fraction of 35% or

less, after reversible causes have been excluded, and the response to optimal medical therapy

has been adequately determined

OR

Hypertrophic cardiomyopathy (HCM) with one or more major risk factors for sudden cardiac

death (history of premature HCM-related sudden death in one or more first-degree relatives

younger than 50 years; left ventricular hypertrophy greater than 30 mm; one or more runs of

non-sustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-

hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin)

and judged to be at high risk for sudden cardiac death by a physician experienced in the care

of patients with HCM.

Coding

Code Description

CPT 93292* Interrogation device evaluation (in person) with physician analysis, review and report,

includes connection, recording and disconnection per patient encounter; wearable

defibrillator system

93745 Initial set-up and programming by a physician 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

HCPCS

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

*Code 93292 cannot be reported with code 93745.

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

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Related Information

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Evidence Review

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.

The WCD performs the monitoring and electrical shocks like an ICD, when a potential life-

threatening heart rhythm is detected, without requiring an invasive procedure. The system

consists of a vest that is worn continuously underneath the patients 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 patients 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. (See Appendix for graphic.)

Some patients with coronary artery disease may suddenly die of a heart rhythm disorder. 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, use of ICDs has been potentially 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.

Background

ICDs consist of implantable leads in the heart that connects to a pulse generator implanted

beneath the skin of the chest or abdomen. ICD placement is a minor surgical procedure, with

the ICD device placed under the skin on the chest wall and the cardiac leads placed

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percutaneously. Potential adverse effects of ICD placement are bleeding, infection,

pneumothorax, and delivery of unnecessary counter shocks.

The wearable cardioverter defibrillator is an external device that is intended to perform the same

tasks as an ICD, without requiring 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 patients 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.

Summary of Evidence

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. Relevant outcomes are overall survival, morbid events, functional

outcomes, and treatment-related morbidity. The available data establish that the WCD device

can detect lethal arrhythmias and can successfully deliver a countershock in most cases. 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. In patients scheduled for ICD

placement, the WCD will improve outcomes as an interim treatment. The evidence has shown

that these patients benefit from a cardioverter defibrillator in general, and the WCD can detect

and treat lethal arrhythmias in these patients. The evidence is sufficient to determine

qualitatively that the technology results in a meaningful improvement in the net health

outcome.

For individuals who are in the immediate post myocardial infarction period who receive a WCD,

the evidence includes randomized controlled trials (RCTs) and a technology assessment.

Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-

related morbidity. For the immediate post myocardial infarction period, the evidence does not

support the conclusion that the WCD improves outcomes. Two RCTs have reported that overall

survival did not improve after treatment with a permanent ICD. While these 2 trials both

reported a decrease in sudden cardiac death (SCD), there was a corresponding increase in non-

SCD, resulting in no net survival benefit. Similarly, for high-risk post coronary artery bypass graft

patients, 1 RCT reported no difference in overall survival associated with early ICD placement.

Thus, given the lack of evidence that a permanent ICD improves outcomes for these indications,

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a WCD is not expected to improve outcomes. The evidence is insufficient to determine the

effects of the technology on health outcomes.

For individuals who are post coronary artery bypass graft surgery and at high risk for lethal

arrhythmias, awaiting heart transplantation and at high risk for lethal arrhythmias, or have newly

diagnosed nonischemic cardiomyopathy, or have peripartum cardiomyopathy who receive a

WCD, the evidence includes case series and registry data. Relevant outcomes are overall survival,

morbid events, functional outcomes, and treatmentrelated morbidity. It is not possible to

conclude from the available evidence that the WCD will improve patient outcomes. The evidence

is insufficient to determine the effects of the technology on health outcomes.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1: Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Ongoing

NCT01446965a Prevention of Sudden Death After Myocardial Infarction

Using a LifeVest Wearable Cardioverter-defibrillator

1900 Dec 2017

NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial

Clinical Input Received from Physician Specialty Societies and Academic

Medical Centers

While the various physician specialty societies and academic medical centers may provide

appropriate reviewers who collaborate with and make recommendations during this process,

input received does not represent an endorsement or position statement by the physician

specialty societies or academic medical centers, unless otherwise noted.

https://www.clinicaltrials.gov/ct2/show/NCT01446965?term=NCT01446965&rank=1

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2014 Input

In response to requests, further input was received from 7 academic medical centers and 2

physician specialty societies while this policy was under review in 2014. Input related to the role

of WCDs in preventing SCD among high-risk patients awaiting a heart transplant. Overall, input

on the use of WCDs in this patient population was mixed. Some reviewers indicated that it may

have a role among certain patients awaiting heart transplant, but there was no consensus on

specific patient indications for use.

2013 Input

In response to requests, input was received from 8 academic medical centers and 3 physician

specialty societies while this policy was under review in 2013. Overall, the input was mixed. Most,

but not all, providing comments suggested that the WCD may have a role in select high-risk

patients following acute MI or in newly diagnosed cardiomyopathy. However, reviewers

acknowledged the lack of evidence for benefit and that available evidence was not consistent in

defining high-risk subgroups that may benefit.

2010 Input

In response to requests, input was received from 4 academic medical centers and no physician

specialty societies while this policy was under review in 2010. Most, but not all, providing

comment suggested that the WCD may have a role in selected high-risk patients following acute

MI or in newly diagnosed cardiomyopathy.

Practice Guidelines and Position Statements

American College of Cardiology and the American Heart Association

(ACC/AHA)

In 2016, the American Heart Association (AHA) published a scientific advisory on the wearable

cardioverter defibrillator (WCD).27 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

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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.

Heart Rhythm Society, American College of Cardiology and the American

Heart Association (ACC/AHA)

In 2014, the Heart Rhythm Society, ACC, and AHA issued a consensus statement on the use of

ICD therapy in patients who are not included or not well-represented in clinical trials.29 The

statement does not contain formal recommendations on WCD use, but states: The wearable

cardioverter-defibrillator (WCD) may be an option as a bridge to ICD for selected patients at

high risk of sudden cardiac death due to ventricular arrhythmias, although the data are scant.

In 2014, ACC and AHA issued guidelines on the management of non-ST-elevation acute

coronary syndrome (NSTE-ACS).30 These guidelines do not make specific recommendations

regarding the use of WCDs, but do state the following:

Life-threatening ventricular arrhythmias that occur >48 hours after NSTE-ACS are usually

associated with LV [left ventricular] dysfunction and signify poor prognosis. RCTs

[randomized controlled trials] in patients with ACS [acute coronary syndrome] have shown

consistent benefit of implantable cardioverter-defibrillator therapy for survivors of VT

Page | 10 of 15

[ventricular tachycardia] or VF [ventricular fibrillation] arrest. For other at-risk patients,

especially those with significantly reduced LVEF [left ventricular ejection fraction], candidacy

for primary prevention of sudden cardiac death with an implantable cardioverter-defibrillator

should be readdressed 40 days after discharge. A life vest may be considered in the

interim.

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.31 Recommendations

related to the use of WCDs include:

Class I recommendations: An implanted or wearable ICD should be provided for Status 1B

patients [ie, 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).

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage

decisions are left to the discretion of local Medicare carriers.

Noridian Healthcare Solutions, LLC

Noridian Healthcare Solutions, LLC the contractor for jurisdiction D has an LCD for Automatic

External Defibrillators (L13690) that includes coverage criteria for beneficiaries at high risk for

sudden cardiac death (SCD) due to one of the conditions described in the coverage guideline.33

Page | 11 of 15

Regulatory Status

In December 2001, the Lifecor WCD 2000 system was approved by the U.S. Food and Drug

Administration (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 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.

FDA product code: MVK.

References

1. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data, P010030, Lifecor, Inc, WCD 2000 System.

http://www.accessdata.fda.gov/cdrh_docs/pdf/p010030b.pdf Accessed June 2017.

2. Beauregard LA. Personal security: Clinical applications of the wearable defibrillator. Pacing Clin Electrophysiol. Jan 2004;27(1):1-

3. PMID 14720147

3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Wearable cardioverter-defibrillator as a bridge to

implantable cardioverter-defibrillator treatment. TEC Assessments. 2010;Volume 25, Tab 2.

4. Auricchio A, Klein H, Geller CJ, et al. Clinical efficacy of the wearable cardioverter-defibrillator in acutely terminating episodes of

ventricular fibrillation. Am J Cardiol. May 15 1998;81(10):1253-1256. PMID 9604964

5. Chung MK, Szymkiewicz SJ, Shao M, et al. Aggregate national experience with the wearable cardioverter-defibrillator: event

rates, compliance, and survival. J Am Coll Cardiol. Jul 13 2010;56(3):194-203. PMID 20620738

6. Tanawuttiwat T, Garisto JD, Salow A, et al. Protection from outpatient sudden cardiac death following ICD removal using a

wearable cardioverter defibrillator. Pacing Clin Electrophysiol. May 2014;37(5):562-568. PMID 24762055

7. Feldman AM, Klein H, Tchou P, et al. Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for

sudden death: results of the WEARIT/BIROAD. Pacing Clin Electrophysiol. Jan 2004;27(1):4-9. PMID 14720148

8. Mitrani RD, McArdle A, Slane M, et al. Wearable defibrillators in uninsured patients with newly diagnosed cardiomyopathy or

recent revascularization in a community medical center. Am Heart J. Mar 2013;165(3):386-392. PMID 23453108

9. Kao AC, Krause SW, Handa R, et al. Wearable defibrillator use in heart failure (WIF): results of a prospective registry. BMC

Cardiovasc Disord. 2012;12:123. PMID 23234574

10. Goldenberg I KH, Zareba W et al. Eighteen Month Results From The Prospective Registry And Follow-up Of Patients Using The

Lifevest Wearable Defibrillator (WEARIT-II Registry) - LB02-02. Heart Rhythm 2013 - 34th Annual Scientific Sessions; May 10,

2013.

11. Kutyifa V, Moss AJ, Klein H, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac patients: data from the

Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator (WEARIT-II Registry). Circulation. Oct 27

2015;132(17):1613-1619. PMID 26316618

http://www.accessdata.fda.gov/cdrh_docs/pdf/p010030b.pdf

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12. Gregoratos G, Cheitlin MD, Conill A, et al. ACC/AHA guidelines for implantation of cardiac pacemakers and antiarrhythmia

devices: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

(Committee on Pacemaker Implantation). J Am Coll Cardiol. Apr 1998;31(5):1175-1209. PMID 9562026

13. Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with

implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias N Engl J Med. Nov 27

1997;337(22):1576-1583. PMID 9411221

14. Wilber DJ, Zareba W, Hall WJ, et al. Time dependence of mortality risk and defibrillator benefit after myocardial infarction.

Circulation. Mar 9 2004;109(9):1082-1084. PMID 14993128

15. Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial

infarction. N Engl J Med. Dec 9 2004;351(24):2481-2488. PMID 15590950

16. Steinbeck G, Andresen D, Seidl K, et al. Defibrillator implantation early after myocardial infarction. N Engl J Med. Oct 8

2009;361(15):1427-1436. PMID 19812399

17. Epstein AE, Abraham WT, Bianco NR, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early

post-myocardial infarction. J Am Coll Cardiol. Nov 19 2013;62(21):2000-2007. PMID 23916930

18. Uyei J, Braithwaite RS. Effectiveness of wearable defibrillators: systematic review and quality of evidence. Int J Technol Assess

Health Care. Apr 2014;30(2):194-202. PMID 24893969

19. Bigger JT, Jr. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after

coronary-artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. N Engl J Med. Nov 27

1997;337(22):1569-1575. PMID 9371853

20. Zishiri ET, Williams S, Cronin EM, et al. Early risk of mortality after coronary artery revascularization in patients with left

ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. Feb

2013;6(1):117-128. PMID 23275233

21. Opreanu M, Wan C, Singh V, et al. Wearable cardioverter-defibrillator as a bridge to cardiac transplantation: A national

database analysis. J Heart Lung Transplant. Oct 2015;34(10):1305-1309. PMID 26094085

22. Rao M, Goldenberg I, Moss AJ, et al. Wearable defibrillator in congenital structural heart disease and inherited arrhythmias. Am

J Cardiol. Dec 1 2011;108(11):1632-1638. PMID 21890075

23. Kadish A, Schaechter A, Subacius H, et al. Patients with recently diagnosed nonischemic cardiomyopathy benefit from

implantable cardioverter-defibrillators. J Am Coll Cardiol. Jun 20 2006;47(12):2477-2482. PMID 16781376

24. Salehi N, Nasiri M, Bianco NR, et al. The Wearable Cardioverter Defibrillator in Nonischemic Cardiomyopathy: A US National

Database Analysis. Can J Cardiol. Jan 14 2016. PMID 26975224

25. Saltzberg MT, Szymkiewicz S, Bianco NR. Characteristics and outcomes of peripartum versus nonperipartum cardiomyopathy in

women using a wearable cardiac defibrillator. J Card Fail. Jan 2012;18(1):21-27. PMID 22196837

26. Duncker D, Haghikia A, Konig T, et al. Risk for ventricular fibrillation in peripartum cardiomyopathy with severely reduced left

ventricular function-value of the wearable cardioverter/defibrillator. Eur J Heart Fail. Dec 2014;16(12):1331-1336. PMID

25371320

27. Bardy GH, Lee KL, Mark DB, et al. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. Apr 24

2008;358(17):1793-1804. PMID 18381485

28. Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias

and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task

Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for

Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). J Am Coll Cardiol. Sep 5

2006;48(5):e247-346. PMID 16949478

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29. Kusumoto FM, Calkins H, Boehmer J, et al. HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-

defibrillator therapy in patients who are not included or not well represented in clinical trials. Circulation. Jul 1 2014;130(1):94-

125. PMID 24815500

30. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation

acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice

Guidelines. Circulation. Dec 23 2014;130(25):e344-426. PMID 25249585

31. Gronda E, Bourge RC, Costanzo MR, et al. Heart rhythm considerations in heart transplant candidates and considerations for

ventricular assist devices: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant

candidates--2006. J Heart Lung Transplant. Sep 2006;25(9):1043-1056. PMID 16962465

32. Epstein AE, DiMarco JP, et al. 2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 guidelines for

device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American

Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013;61(3):e6-e75. PMID

23265327

33. Noridian Healthcare Solutions, LLC. Local coverage determination (LCD) for automatic external defibrillators (L13690)

jurisdiction D; updated October 1, 2015. URL address:

https://med.noridianmedicare.com/documents/2230703/7218263/Automatic+External+Defibrillators/10f0b92d-0c55-

4b5d-aa15-b952b37c70ce Accessed June 2017.

34. BlueCross BlueShield Association. Medical Policy Reference Manual. Wearable Cardioverter-Defibrillators. Policy No. 2.02.15,

2016.

Appendix

Selected components of the wearable cardioverter-defibrillator1

https://med.noridianmedicare.com/documents/2230703/7218263/Automatic+External+Defibrillators/10f0b92d-0c55-4b5d-aa15-b952b37c70cehttps://med.noridianmedicare.com/documents/2230703/7218263/Automatic+External+Defibrillators/10f0b92d-0c55-4b5d-aa15-b952b37c70ce

Page | 14 of 15

History

Date Comments 11/13/12 New Policy. Premera policy created to include in the policy statement, information

about when coverage for the WCD will stop; and to maintain the allowance of newly

diagnosed nonischemic cardiomyopathy (as explained in the Policy Guidelines) as an

indication for the temporary use of the WCD. The Policy Guidelines statement on

nonischemic cardiomyopathy was changed to investigational in the October 2012

version of BCBSA policy 2.02.15. Therefore, Policy 2.02.15 is deleted.

12/09/13 Replace policy. Policy updated with literature review. References 6, 7, 13, 15 added. No

change to policy statement.

03/25/14 Replace policy. Policy statement unchanged. References 5, 6 added. ICD-9 and ICD-10

diagnosis codes removed; these are not utilized in adjudication.

05/12/14 Interim review. Added primary prevention criteria found in 7.01.44 to the Policy

Guidelines section.

12/01/14 Update Related Policies. Remove 2.02.10 as it was archived.

03/31/15 Annual Review. Policy statements unchanged. References 8,17,23,26,27,28 added.

06/09/15 Interim review. Policy statement and policy guidelines rewritten for clarification.

Reference 28 the Noridian LCD on WCD for jurisdiction D added; others renumbered.

Policy statements revised as noted, intent is unchanged.

12/15/15 Update Related Policies. Remove 7.01.44 as it is archived.

04/01/16 Update Related Policies Removed 2.02.505 as it was archived.

08/01/16 Annual Review, approved July 12, 2016. Policy updated with literature review through

March 22, 2016; references added. Policy statements unchanged.

10/07/16 Minor formatting update. Updated hyperlink in reference number 1.

07/01/17 Annual Review, approved June 22, 2017. Updated 2016 ACC -AHA guidelines. Policy

moved into new format.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 2017 Premera

All Rights Reserved.

Page | 15 of 15

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

037338 (07-2016)

Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Premera does not exclude people or treat them differently because of race, color, national origin, age, disability or sex. Premera: Provides free aids and services to people with disabilities to communicate

effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible

electronic formats, other formats) Provides free language services to people whose primary language is not

English, such as: Qualified interpreters Information written in other languages

If you need these services, contact the Civil Rights Coordinator. If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 Email AppealsDepartmentInquiries@Premera.com You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through Premera Blue Cross. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-722-1471 (TTY: 800-842-5357). (Amharic): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357)

:(Arabic) .

Premera Blue Cross. . . . (TTY: 800-842-5357) 1471-722-800

(Chinese): Premera Blue Cross

800-722-1471 (TTY: 800-842-5357)

Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandaa. Guyyaawwan murteessaa taan beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandaa. Kaffaltii irraa bilisa haala taeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Franais (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermdiaire de Premera Blue Cross. Le prsent avis peut contenir des dates cls. Vous devrez peut-tre prendre des mesures par certains dlais pour maintenir votre couverture de sant ou d'aide avec les cots. Vous avez le droit d'obtenir cette information et de laide dans votre langue aucun cot. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyl ayisyen (Creole): Avi sila a gen Enfmasyon Enptan ladann. Avi sila a kapab genyen enfmasyon enptan konsnan aplikasyon w lan oswa konsnan kouvti asirans lan atrav Premera Blue Cross. Kapab genyen dat ki enptan nan avi sila a. Ou ka gen pou pran kk aksyon avan sten dat limit pou ka kenbe kouvti asirans sante w la oswa pou yo ka ede w avk depans yo. Se dwa w pou resevwa enfmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357). Deutsche (German): Diese Benachrichtigung enthlt wichtige Informationen. Diese Benachrichtigung enthlt unter Umstnden wichtige Informationen bezglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie knnten bis zu bestimmten Stichtagen handeln mssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso pu contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

(Japanese): Premera Blue Cross

800-722-1471 (TTY: 800-842-5357) (Korean): . Premera Blue Cross . . . . 800-722-1471 (TTY: 800-842-5357) . (Lao): . Premera Blue Cross. . . . 800-722-1471 (TTY: 800-842-5357). (Khmer):

Premera Blue Cross

800-722-1471 (TTY: 800-842-5357) (Punjabi): . Premera Blue Cross . . , , 800-722-1471 (TTY: 800-842-5357).

:(Farsi) .

. Premera Blue Cross .

. .

)800-842-5357 TTY( 800-722-1471 .

Polskie (Polish): To ogoszenie moe zawiera wane informacje. To ogoszenie moe zawiera wane informacje odnonie Pastwa wniosku lub zakresu wiadcze poprzez Premera Blue Cross. Prosimy zwrcic uwag na kluczowe daty, ktre mog by zawarte w tym ogoszeniu aby nie przekroczy terminw w przypadku utrzymania polisy ubezpieczeniowej lub pomocy zwizanej z kosztami. Macie Pastwo prawo do bezpatnej informacji we wasnym jzyku. Zadzwocie pod 800-722-1471 (TTY: 800-842-5357). Portugus (Portuguese): Este aviso contm informaes importantes. Este aviso poder conter informaes importantes a respeito de sua aplicao ou cobertura por meio do Premera Blue Cross. Podero existir datas importantes neste aviso. Talvez seja necessrio que voc tome providncias dentro de determinados prazos para manter sua cobertura de sade ou ajuda de custos. Voc tem o direito de obter esta informao e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Romn (Romanian): Prezenta notificare conine informaii importante. Aceast notificare poate conine informaii importante privind cererea sau acoperirea asigurrii dumneavoastre de sntate prin Premera Blue Cross. Pot exista date cheie n aceast notificare. Este posibil s fie nevoie s acionai pn la anumite termene limit pentru a v menine acoperirea asigurrii de sntate sau asistena privitoare la costuri. Avei dreptul de a obine gratuit aceste informaii i ajutor n limba dumneavoastr. Sunai la 800-722-1471 (TTY: 800-842-5357). P (Russian): . Premera Blue Cross. . , , . . 800-722-1471 (TTY: 800-842-5357). Faasamoa (Samoan): Atonu ua iai i lenei faasilasilaga ni faamatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei faasilasilaga o se fesoasoani e faamatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Faamolemole, ia e iloilo faalelei i aso faapitoa oloo iai i lenei faasilasilaga taua. Masalo o lea iai ni feau e tatau ona e faia ao lei aulia le aso ua taua i lenei faasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo oloo e iai i ai. Oloo iai iate oe le aia tatau e maua atu i lenei faasilasilaga ma lenei famatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Espaol (Spanish): Este Aviso contiene informacin importante. Es posible que este aviso contenga informacin importante acerca de su solicitud o cobertura a travs de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura mdica o ayuda con los costos. Usted tiene derecho a recibir esta informacin y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). (Thai): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357) (Ukrainian): . Premera Blue Cross. , . , , . . 800-722-1471 (TTY: 800-842-5357). Ting Vit (Vietnamese): Thng bo ny cung cp thng tin quan trng. Thng bo ny c thng tin quan trng v n xin tham gia hoc hp ng bo him ca qu v qua chng trnh Premera Blue Cross. Xin xem ngy quan trng trong thng bo ny. Qu v c th phi thc hin theo thng bo ng trong thi hn duy tr bo him sc khe hoc c tr gip thm v chi ph. Qu v c quyn c bit thng tin ny v c tr gip bng ngn ng ca mnh min ph. Xin gi s 800-722-1471 (TTY: 800-842-5357).