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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.

02-33000-34

Original Effective Date: 12/15/13

Reviewed: 12/03/15

Revised: 12/15/15

Subject: Implantable Cardioverter Defibrillators (ICD)

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:

The automatic implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient’s heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death. A subcutaneous ICD has been developed that does not employ transvenous leads, with the goal of reducing lead-related complications.

The standard implantable cardioverter defibrillator (ICD) involves placement of a generator in the subcutaneous tissue of the chest wall. Transvenous leads are attached to the generator and threaded intravenously into the endocardium. The leads sense and transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces an electrical shock when a malignant arrhythmia is recognized.

A totally subcutaneous ICD (S-ICD®) has also been developed. This device does not employ transvenous leads and thus avoids the need for venous access and complications associated with the venous leads. Rather, the S-ICD® uses a subcutaneous electrode that is implanted adjacent to the left sternum. The electrodes sense the cardiac rhythm and deliver countershocks through the subcutaneous tissue of the chest wall.

NOTE: ICDs may be combined with other pacing devices, such as pacemakers for atrial fibrillation, or biventricular pacemakers designed to treat congestive heart failure. This policy addresses ICDs alone, when used solely to treat patients at risk for ventricular arrhythmias.

POSITION STATEMENT:

ADULTS

The use of the automatic implantable cardioverter defibrillator (ICD) meets the definition of medical necessity in adults who meet ONE of the following criteria:

Primary Prevention (use of ICDs in members who are considered at high risk for sudden cardiac death, but who have not yet experienced life-threatening ventricular tachycardia (VT) or ventricular fibrillation (VF))

1. 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

2. 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

3. nonischemic dilated cardiomyopathy 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

4. hypertrophic cardiomyopathy (HCM) with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in 1 or more first-degree relatives younger than 50 years; left ventricular hypertrophy greater than 30 mm; 1 or more runs of nonsustained 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 members with HCM OR

5. diagnosis of ONE of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:

congenital long QT syndrome

Brugada syndrome

short QT syndrome OR

catecholaminergic polymorphic ventricular tachycardia.

Secondary Prevention (use of ICDs in members who have experienced a potentially life-threatening episode of near sudden cardiac death)

Members with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia after reversible causes (eg, acute ischemia) have been excluded.

The use of the ICD is considered experimental or investigational in primary prevention members who do not meet the above criteria or have had ANY of the following as there is a lack of published clinical evidence to support effects on health outcomes:

• have had an acute myocardial infarction (i.e., less than 40 days before ICD treatment);

• have NYHA Class IV congestive heart failure (unless member is eligible to receive a combination cardiac resynchronization therapy ICD device);

• have had a cardiac revascularization procedure in past 3 months (coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) or are candidates for a cardiac revascularization procedure; OR

• have noncardiac disease that would be associated with life expectancy less than 1 year.

The use of the ICD for secondary prevention is considered experimental or investigational for members who do not meet the criteria for secondary prevention. There is a lack of published clinical evidence to support effects on net health outcomes.

PEDIATRICS

The use of the ICD meets the definition of medical necessity in children who meet ANY of the following criteria:

A. survivors of cardiac arrest, after reversible causes have been excluded;

B. symptomatic, sustained ventricular tachycardia in association with congenital heart disease in members who have undergone hemodynamic and electrophysiologic evaluation; OR

C. congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias;

D. HCM with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in 1 or more first-degree relatives younger than 50 years; massive left ventricular hypertrophy based on age-specific norms; 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 members with HCM; OR

E. diagnosis of any ONE of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:

congenital long QT syndrome;

Brugada syndrome;

short QT syndrome; OR

catecholaminergic polymorphic ventricular tachycardia.

The use of the ICD is considered experimental or investigational for all other indications in pediatric members. The available clinical evidence published in the peer-reviewed literature does not support the safety and efficacy of ICDs used in other pediatric applications.

SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

The use of a subcutaneous ICD meets the definition of medical necessity for adults or children who meet the criteria for ICD implantation for primary or secondary prevention AND meet ALL of the following criteria:

Have a contraindication to a transvenous ICD due to one or more of the following: (1) lack of adequate vascular access; (2) compelling reason to preserve existing vascular access (ie, need for chronic dialysis; younger members with anticipated long-term need for ICD therapy); or (3) history of need for explanation of a transvenous ICD due to a complication, with ongoing need for ICD therapy

Have no indication for antibradycardia pacing; AND

Do not have ventricular arrhythmias that are known or anticipated to respond to antitachycardia pacing.

The use of a subcutaneous ICD is considered experimental or investigational for all individuals who do not meet the criteria outlined above. The evidence is insufficient to determine the effects of the technology on health outcomes for all other indications.

Refer to section entitled DECISION TREE.

BILLING/CODING INFORMATION:

CPT Coding:

33215

Repositioning of previously implanted transvenous pacemaker or implantable defibrillator (right atrial or right ventricular) electrode

33216

Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator

33217

Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator

33218

Repair of single transvenous electrode, permanent pacemaker or implantable defibrillator

33220

Repair of 2 transvenous electrodes for permanent pacemaker or implantable defibrillator

33223

Revision of skin pocket for implantable defibrillator

33224

Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator)

33225

Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system) (List separately in addition to code for primary procedure)

33230

Insertion of implantable defibrillator pulse generator only; with existing dual leads

33231

Insertion of implantable defibrillator pulse generator only; with existing multiple leads

33240

Insertion of implantable defibrillator pulse generator only; with existing single lead

33241

Removal of implantable defibrillator pulse generator only

33243

Removal of single or dual chamber implantable defibrillator electrode(s); by thoracotomy

33244

Removal of single or dual chamber Implantable defibrillator electrode(s); by transvenous extraction

33249

Insertion or replacement of permanent implantable defibrillator system with transvenous lead(s), single or dual chamber

33262

Removal of implantable defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; single lead system

33263

Removal of implantable defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; dual lead system

33264

Removal of implantable defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; multiple lead system

33270

Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed

33271

Insertion of subcutaneous implantable defibrillator electrode

33272

Removal of subcutaneous implantable defibrillator electrode

33273

Repositioning of previously implanted subcutaneous implantable defibrillator electrode

93260

Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system

93261

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; implantable subcutaneous lead defibrillator system

93644

Electrophysiologic evaluation of subcutaneous implantable defibrillator (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters)

HCPCS Coding

G0448

Insertion or replacement of a permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber with insertion of pacing electrode, cardiac venous system, for left ventricular pacing

LOINC Codes:

The following information may be required documentation to support medical necessity: physician history and physical, conservative treatment plan, physician progress notes, and all laboratory studies.

Documentation Table

LOINC Codes

LOINC

Time Frame Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Medication Current

19009-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Current, Discharge, or administered medications

34483-8

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Implantable Automatic Defibrillators (20.4) located at cms.gov.

DEFINITIONS:

New York Heart Association (NYHA) Functional Classification of heart failure symptoms: A classification for the extent of heart failure. Places patients in one of four categories based on the patient’s physical activity limitations. These limitations/symptoms are relevant to normal breathing and varying degrees in shortness of breath and or angina pain:

NYHA Class

 

I

No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

II

Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

III

Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest.

IV

Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

RELATED GUIDELINES:

Wearable and Non-Wearable Cardioverter-Defibrillators (WCD) for the Prevention of Sudden Cardiac Death, 01-93000-30

OTHER:

Other terms for ICDs:

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.

Guidant ICD

Medtronic

S-ICD® system

REFERENCES:

  1. American Heart Association Rapid Access Journal Report. New implanted defibrillator works well without touching heart. August 26, 2013. Accessed 09/27/13.
  2. Baher A, Valderrabano M. Management of ventricular tachycardia in heart failure. Methodist Debakey Cardiovasc J. 2013 Jan-Mar;9(1):20-5.
  3. Blue Cross Blue Shield Association Medical Policy 7.01.44 Implantable Cardioverter Defibrillator (ICD), 11/15. .
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of implantable cardioverter-defibrillators for prevention of sudden death in patients at high risk for ventricular arrhythmia. TEC Assessments 2002; 17(Tab 10).
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of implantable cardioverter-defibrillators for prevention of sudden death in patients at high risk for ventricular arrhythmia. TEC Assessments 2004; 19(Tab 19).Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010; 363(1):36-44.
  6. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4), Jan 2005; accessed 10/15. .
  7. Cheng A, Dalal D, Butcher B, Norgard S, Zhang Y, Dickfeld T, Eldadah ZA, Ellenbogen KA, Guallar E, Tomaselli GF.Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death: study design and cohort description. J Am Heart Assoc. 2013 Feb 22;2(1):e000083. doi: 10.1161/JAHA.112.000083.
  8. ClinicalTrials.gov. NCT01161589, NCT00399217, NCT01117792.
  9. Dabiri Abkenari L, Theuns DA, Valk SD, Van Belle Y, de Groot NM, Haitsma D, Muskens-Heemskerk A, Szili-Torok T, Jordaens L. Clinical experience with a novel subcutaneous implantable defibrillator system in a single center. Clin Res Cardiol. 2011 Sep;100(9):737-44.
  10. ECRI Forecast. Subcutaneous defibrillator eliminates need for direct connection to heart. Published 05/14/2010.
  11. ECRI Forecast. Cardiac device infections double risk of death. Published 05/09/2011.
  12. ECRI Forecast. Telecardiology: ICD monitoring system shows potential. Published 9/2/2011.
  13. ECRI Forecast. Heart Failure. Published 08/08/2012.
  14. ECRI Forecast. Subcutaneous Implantable Cardioverter-defibrillator for Preventing Sudden Cardiac Arrest. Published 5/1/13.
  15. ECRI Product Brief. Protecta XT Defibrillator (Medtronic, Inc.) for Treating Tachycardia (11/28/11).
  16. ECRI Product Brief. Ellipse Implantable Cardioverter Defibrillator (St. Jude Medical, Inc.) for Preventing Sudden Cardiac Death. Published 06/2012.
  17. ECRI Product Brief. Subcutaneous Implantable Cardioverter-defibrillator (Boston Scientific Corp.) for Preventing Sudden Cardiac Arrest. Published 03/06/2014.
  18. ECRI Trends. Beware of malware on medical devices, experts warn hospitals. Published 12/01/2012.
  19. Epstein AE DJ, Ellenbogen KA et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation 2008; 117(21):e350-408.
  20. Gersh BJ, Maron BJ, Bonow RO et al. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011; 124(24):e783-831.
  21. Hunt SA, Abraham WT, Chin MH, et al. 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009; 53:e1–90.
  22. Jessup M AW, Casey DE et al. 2009 focused update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation 2009; 119(14):1977-2016.
  23. Khairy P, Van Hare GF, Balaji S, et al. PACES/HRS expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease: developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology (ACC), the American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Canadian Heart Rhythm Society (CHRS), and the International Society for Adult Congenital Heart Disease (ISACHD). Can J Cardiol. Oct 2014;30(10):e1-e63; accessed at hrsonline.org 10/15.
  24. 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. J Am Coll Cardiol. 2014;64(11):1143-1177.
  25. Lambiase PD, Barr C, Theuns DAMJ, et al; on behalf of the EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: Early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Mar 26 [Epub ahead of print].
  26. Lobodzinski SS. Subcutaneous implantable cardioverter-defibrillator (S-ICD). Cardiol J. 2011;18(3):326-31.
  27. McKesson InterQual criteria 2012.2.
  28. National Institute for Health and Clinical Excellence (NICE). Implantable cardioverter defibrillators for arrhythmias: Review of Technology Appraisal 11. Technology Appraisal 95. London, UK: NICE; 2006.
  29. National Institute for Health Care and Excellence (NICE) Interventional Procedure Guidance 454, Insertion of a subcutaneous implantable cardioverter defibrillator for prevention of sudden cardiac death: guidance (April, 2013).
  30. Saxon LA. The subcutaneous implantable defibrillator: A new technology that raises an existential question for the implantable cardioverter-defibrillator. Circulation. 2013;128(9):938-940.
  31. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm AbnormalitiesA 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.
  32. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. List of FDA approved Implantable Cardioverter Defibrillators. Accessed 09/25/13.
  33. U.S. Food and Drug Administration (FDA). Press release regarding the S-ICD® System (Cameron Health®, Inc., San Clemente, CA). September 28, 2012.
  34. Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, Rashtian M, Kremers M, Crozier I, Lee KL, Smith W, Burke MC. Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator. Circulation. 2013 Aug 27;128(9):944-953.
  35. Yancy CW, Jessup M, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. AHA Journal 2013(June 2013).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 12/03/15.

GUIDELINE UPDATE INFORMATION:

12/15/13

New Medical Coverage Guideline.

11/15/14

Annual review; position statements unchanged; references updated.

01/01/15

Annual coding update: added 33270, 33271, 33272, 33273, 93260, 93261, and 93644; deleted 0319T, 0320T, 0321T, 0322T,0323T, 0324T, 0325T, 0326T, 0327T, and 0328T; revised 33215, 33216, 33217, 33218, 33220, 33223, 33224, 33225, 33230, 33231, 33240, 33241, 33243, 33244, 33249, 33262, 33263, and 33264.

11/01/15

Revision: ICD-9 Codes deleted.

12/15/15

Revision; position statements, coding, and references updated; formatting changes.

Date Printed: June 25, 2017: 01:25 PM