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Date Printed: June 28, 2017: 11:45 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-93000-30

Original Effective Date: 09/15/03

Reviewed: 04/28/16

Revised: 05/15/16

Subject: Wearable and Non-Wearable Cardioverter-Defibrillators (WCD) for the Prevention of Sudden Cardiac Death

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. The automatic implantable cardioverter defibrillator (AICD) has proven effective in reducing mortality for survivors of SCA and for patients with documented malignant ventricular arrhythmias. More recently, the use of AICDs 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 (MI) and reduced ejection fraction. AICDs consist of implantable leads in the heart that connects to a pulse generator implanted beneath the skin of the chest or abdomen. In the past, AICD placement required a thoracotomy, but current technology allows implantation with only a minor surgical procedure, with the cardiac leads placed percutaneously.

Potential adverse effects of AICD placement are bleeding, infection, pneumothorax, and delivery of unnecessary countershocks.

Automatic external defibrillators include wearable cardioverter-defibrillators (WCD) and non-wearable automatic defibrillators with integrated electrocardiogram analysis capabilities.

The wearable cardioverter-defibrillator (WCD) is an external device that is intended to perform the same tasks as an AICD, without requiring any 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 patients to certain conditions by lights or voice messages. 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 sudden cardiac arrest and are either not candidates for or refuse an implantable defibrillator.”

The non-wearable automatic defibrillator is a portable automatic device used to restore normal heart rhythm to patients in cardiac arrest. An external electric shock is administered through conductive adhesive electrode pads applied to the person by a user. Built-in computers analyze the person’s rhythm and determine if rhythm requires defibrillation shocks. The user is guided through the process by voice and visual prompts. The U.S. Food and Drug Administration (FDA) approved over-the-counter sale of these types of AEDs in September 2004.

The U.S. Food and Drug Administration (FDA) approved the LifeVest Wearable Cardioverter Defibrillator (The LifeVest system) via premarket application approval in December 2015 for patients under 18 years of age who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator (lack of parenteral consent). Patients must have a chest circumference of 26 inches (66 centimeters) or greater and a weight of 18.75 kilograms (41.3 pounds) or greater.

POSITION STATEMENT:

An FDA approved wearable cardioverter defibrillator (K0606) meets the definition of medical necessity for ANY of the following indications:

An FDA approved wearable cardioverter defibrillator (K0606) for pediatric members (below age 18) 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 meets the definition of medical necessity when the following indications are met:

AND

Non-wearable automatic defibrillators (E0617) used for the prevention of sudden cardiac death are considered experimental or investigational, as there are no clinical studies that demonstrate improvement in health outcomes for the use of non-wearable automatic defibrillators in the home by untrained persons.

BILLING/CODING INFORMATION:

CPT Coding:

93292

Interrogation device evaluation (in person) with 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

HCPCS Coding:

E0617

External defibrillator with integrated electrocardiogram analysis (investigational)

K0606

Automatic external defibrillator, with integrated electrocardiogram analysis, garment type

K0607

Replacement battery for automated external defibrillator, each

K0608

Replacement garment for use with automated external defibrillator, each

K0609

Replacement electrodes for use with automated external defibrillator, each

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT and PROGRAM EXCEPTIONS.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Automatic External Defibrillators (L33690) located at cgsmedicare.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names for wearable cardioverter-defibrillators:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

AICD, wearable
LifeCor WCD System
LifeVest Wearable Cardioverter Defibrillator (The LifeVest system)
Wearable cardiac defibrillator
Wearable cardioverter defibrillator

REFERENCES:

  1. Aufderheide T, Hazinski MF, Nichol G, Steffens SS, Buroker A, McCune R, Stapleton E, Nadkarni V, Potts J, Ramirez RR, Eigel B, Epstein A, Sayre M, Halperin H, Cummins RO; American Heart Association Emergency Cardiovascular Care Committee; Council on Clinical Cardiology; Office of State Advocacy. Community lay rescuer automated external defibrillation programs: key state legislative components and implementation strategies: a summary of a decade of experience for healthcare providers, policymakers, legislators, employers, and community leaders from the American Heart Association Emergency Cardiovascular Care Committee, Council on Clinical Cardiology, and Office of State Advocacy. Circulation. 2006 Mar 7; 113(9): 1260-70.
  2. Auricchio A, Klein H, Geller CJ, Reek S, Heilman MS, Szymkiewicz SJ. Clinical efficacy of the wearable cardioverter-defibrillator in acutely terminating episodes of ventricular fibrillation. Am J Cardiol. 1998 May 15; 81(10): 1253-6.
  3. Blue Cross Blue Shield Assosication Wearable Cardioverter Defibrillators Medical Policy 2.02.15, 01/15.
  4. Feldman AM, Klein H, Tchou P, Murali S, Hall WJ, Mancini D, Boehmer J, Harvey M, Heilman MS, Szymkiewicz SJ, Moss AJ; WEARIT investigators and coordinators; BIROAD investigators and coordinators. Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of the WEARIT/BIROAD. Pacing Clin Electrophysiol. 2004 Jan; 27(1): 4-9.
  5. Francis J, Reek S. Wearable cardioverter defibrillator: A life vest till the life boat (ICD) arrives. Indian Heart Journal 2014; 66(1): 68-72.
  6. Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL, Gibbons RI, Antman EM, Alpert JS, Hiratzka LF, Faxon DP, Jacobs AK, Fuster V, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines American College of Cardiology/American Heart Association/North American Society for Pacing and Electrophysiology Committee. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). J Cardiovasc Electrophysiol. 2002 Nov; 13(11): 1183-99.
  7. Hohnloser SH, Kuck KH, Dorian P, Roberts RS, Hampton JR, Hatala R, Fain E, Gent M, Connolly SJ; DINAMIT Investigators. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004 Dec 9; 351(24): 2481-8.
  8. Medicare DME MAC. CGS Administrators, LLC. Jurisdiction J-C. L33690 Automatic External Defibrillators, 10/01/2015.
  9. Murray CL, Steffensen I. Automated external defibrillators for home use [Issues in emerging health technologies issue XX]. Ottawa: Canadian Coordinating Office for Health Technology Assessment; 2005.
  10. Ontario Ministry of Health and Long-Term Care. Use of automated external defibrillators in cardiac arrest – health technology literature review. Toronto: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care (MAS). 2005:28.
  11. Reek S, Geller JC, Meltendorf U, Wollbrueck A, Szymkiewicz SJ, Klein HU. Clinical efficacy of a wearable defibrillator in acutely terminating episodes of ventricular fibrillation using biphasic shocks. Pacing Clin Electrophysiol. 2003 Oct; 26(10): 2016-22.
  12. Sasaki S, Tomita H, Shibutani S et al 2014. Usefulness of the wearable cardioverter-defibrillator in patients at high risk for sudden cardiac death-a single-center primary experience. Circulation Journal 2014; 78(12): 2987-2989.
  13. U.S. Food and Drug Administration (FDA) 510(k) Summary of Safety and Effectiveness Data. #P010030, Lifecor, Inc, WCD® 2000 System.
  14. Zipes, DP, 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. J Am Coll Cardiol, 2006; 48:247-346.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/28/16.

GUIDELINE UPDATE INFORMATION:

09/15/03

New Medical Coverage Guideline; investigational.

07/15/03

Scheduled review and revision of guideline; consisting of updated references and maintain investigational status.

01/01/05

Annual HCPCS coding update: consisting of addition of 93741, 93742 and 93745.

08/15/05

Review and revision of guideline; consisting of updated references.

06/15/06

Review and revision of guideline consisting of updated references.

07/15/07

Review and revision of guideline consisting of updated references and reformatted guideline.

04/15/08

Review and revision of guideline consisting of updated references.

01/01/09

Annual HCPCS coding update: added code 93292. Deleted codes 93741 and 93742.

05/15/09

Scheduled review; no change in the position statement; references updated.

05/15/11

Scheduled review; position statement unchanged; references updated.

10/01/11

4th Quarter coding update; ICD-9 425.1 removed, ICD-9 425.11 and 425.18 added to Medicare Advantage Program Exception.

01/01/13

Annual HCPCS coding update: revised descriptors for 93292 and 93745.

05/11/14

Revision: Program Exceptions section updated.

05/15/16

Reviewed; Added FDA statement to description regarding indication for wearable cardioverter defibrillator for patients under 18 years of age who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Added “an FDA approved” and “cardioverter” to position statement. Added position statement for external wearable cardioverter defibrillator (K0606) for pediatric members. Updated program exception. Added LifeVest Wearable Cardioverter Defibrillator (The LifeVest system) to other section. Updated references.

Date Printed: June 28, 2017: 11:45 PM