Biventricular Pacemakers for the Treatment of Congestive Heart Failure

Medical Policy: 02.02.01 
Original Effective Date: May 2002 
Reviewed: November 2011 
Revised: November 2010 

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

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Prior Approval: 

Not applicable

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Policy: 

Biventricular pacemakers, with or without an accompanying cardiac defibrillator, may be considered medically necessary as a treatment of congestive heart failure in patients who:

• Are currently compensated on a stable pharmaceutical regimen
• Have a left ventricular ejection fraction ≤ 35%

AND

Have ONE of the following:

• QRS duration ≥ 120msec OR
• Left bundle branch block

An intrathoracic fluid monitoring sensor is considered investigational as a component of a biventricular pacemaker.

Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator are considered investigational in patients not meeting the above criteria.

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
• 33224 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or pacing cardioverter-defibrillator pulse generator (including revision of pocket, removal, insertion and/or replacement of generator)
• 33225 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of pacing cardioverter-defibrillator or pacemaker pulse generator (including upgrade to dual chamber system)

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Selected References: 

• Bradley DJ et al. Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. JAMA 2003;289(6):730-740.
• Abraham WT. Et al. Cardiac resynchronization in chronic heart failure. New England Journal of Medicine 2002;346(24):1845-1853.
• Del Negro A. Cardiac resynchronization therapy: concerns, mechanisms and alternatives. Medscape Cardiology 2002;6(2).
• ECRI. Biventricular Pacing Systems (Cardiac Resynchronization Therapy) for Heart Failure. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2002 Aug. (Windows on medical technology; no 81). 
• Kass DA Ventricular resynchronization: Pathophysiology and identification of responders.  Rev Cardiovasc Med. 2003;4 Suppl 2:S3-S13.
• Kass DA Predicting cardiac resynchronization response by QRS duration. J Am Coll Cardiol. 2003 Dec 17;42(12):2125-2127.
• Bristow MR, Saxon LA, Boehmer J et al. Cardiac resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004; 350(21):2140-50.
• Linde C, Leclercq C, Rex S et al. Long-term benefits of biventricular pacing in congestive heart failure: results from the Multisite Stimulation in Cardiomyopathy (MUSTIC) study. J Am Coll Cardiol 2002; 40(1):111-8.
• Young JB et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD trial. JAMA 2003 May 28;289(20):2719-21.
• Philippon F. Cardiac resynchronization Therapy: Device-Based Medicine for Heart Failure. Journal of Cardiac Surgery. 2004 May-June; 19(3):270-74.
• Tada H, Toide H, Naito S et al. Tissue Doppler imaging and strain Doppler imaging as modalities for predicting clinical improvement in patients receiving biventricular pacing. Circ. J. 2005 Feb;69(2):194-200.
• Blue Cross Blue Shield Association. Biventricular Pacemakers for the Treatment of Congestive Heart Failure. Medical Policy Reference Manual (MPRM);2005.
• Dzemali O, Bakhtiary F, Dogan S et al. Perioperative biventricular pacing leads to improvement of hemodynamics in patients with reduced left-ventricular function-interim results. Pacing Clin Electrophysiol. 2006 Dec;29(12):1341-5.
• Epstein AE, DiMarco JP, 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.  J Am Coll Cardiol. 2008 May 27;51(21):e1-62.
• Moss AJ, Hall J, Cannom DS et al. Cardiac resynchronization therapy for the prevention of heart failure events. N Engl J Med 2009; 361 [Epub ahead of print].
• Linde C, Abraham WT, Gold MR et al. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol 2008; 52(23):1834-43.
• Jessup J. MADIT-CRT-Breathtaking or time to catch our breath? N Engl J Med 2009; 361 [Epub ahead of print]
• Tang ASL, Wells GA, Talajic M et al. Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure. N Engl J Med 2010 Dec 16; 363(25):2385-95.
• Lubitz SA, Leong-Sit P, Fine N et al. Effectiveness of cardiac resynchronization therapy in mild congestive heart failure: systematic review and meta-analysis of randomized trials. Eur J Heart Fail. 2010; 12(4):360-66.
• Daubert C, Gold MR, Abraham WT et al. Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the European cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. J Am Coll Cardiol. 2009; 54(20):1837-46.
• Chan PS, Khumri T, Chung ES et al. Echocardiographic dyssynchrony and health status outcomes from cardiac resynchronization therapy: insights from the PROSPECT trial. JACC Cardiovasc Imaging. 2010; 3(5): 451060. 

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Policy History: 

Date                                        Reason                                Action

November 2010                      Interim review                     Policy revised

November 2011                      Annual review                     Policy renewed

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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.