Does not apply to Medicare Advantage, please refer to the Medicare policy addressing this topic.
DESCRIPTION
It is estimated that 20–30% of individuals with heart failure have intraventricular conduction disorders resulting in a discoordinated contraction pattern and a wide QRS interval on the electrocardiogram (ECG). This abnormality appears to be associated with increased morbidity and mortality.
Biventricular pacemakers using multiple leads (generally 1 in the right atrium and 1 in each ventricle) have been investigated as a technique to synchronize the contraction of both ventricles, thus improving individuals’ hemodynamic status. Two strategies are being explored: incorporating biventricular pacing into automatic implantable cardiac defibrillators and the development of stand-alone biventricular pacemakers. The combined biventricular pacemaker/ICD can also be equipped to monitor the bioimpedance (electrical resistance to the flow of current). A change in bioimpedance reflects intrathoracic fluid status and has been proposed as an early warning system for cardiac decompensation.
POLICY
Biventricular pacemaker, with or without an accompanying implantable cardiac defibrillator (i.e., combined biventricular pacemaker/ICD), for the treatment of NYHA class II, III, or IV heart failure is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Biventricular pacemaker, with or without an accompanying implantable cardiac defibrillator (i.e., combined biventricular pacemaker/ICD), for the treatment of NYHA class I heart failure or for conditions other than heart failure is considered investigational.
An intrathoracic fluid monitoring sensor as a component of a biventricular pacemaker is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also:
Automatic Implantable Cardioverter Defibrillator for the Prevention of Sudden Death
Ventricular Assist Devices (VAD) and Total Artificial Hearts (TAH)
Wearable Cardioverter Defibrillator for the Prevention of Sudden Death
MEDICAL APPROPRIATENESS
Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator is considered medically appropriate if ALL of the following criteria are met:
ANY ONE of the following:
NYHA New York Heart Association (NYHA) Classification for Heart Failure Functional Class III or IV with left ventricular ejection fraction (LVEF) less than or equal to 35%
NYHA Functional Class II with left ventricular ejection fraction (LVEF) less than or equal to 30%
Sinus rhythm
QRS duration is greater than or equal to 120 msec
Remains symptomatic despite being treated with a stable pharmacological medical regimen prior to implant, including an ACE inhibitor (or an angiotensin receptor blocker) and a beta-blocker, digoxin, and/or diuretics
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
This policy does not apply to Medicare Advantage, please refer to the Medicare policy addressing this topic.
ADDITIONAL INFORMATION
Some uncertainty still exists around the specific populations that benefit from resynchronization. The majority of individuals in clinical trials were in sinus rhythm, and there is not sufficient evidence on individuals who are not in sinus rhythm to evaluate benefit.
Subgroup analyses from the RCT’s provide some insights into factors that predict success, for example, the evidence supports that CRT is beneficial in individuals with a widened QRS complex. Some studies use QRS of 120 msec as the cutoff, others use 130 msec, and subgroup analyses suggest that the most significant benefit is seen in individuals with a QRS of 150 msec or greater. As a result, it is not possible to say for certain which QRS threshold should be used based solely on the evidence. The specific FDA indications for QRS duration conform to the eligibility criteria for the studies on which the approval was based, and vary by device.
The OptiVol enhancement of Medtronics implantable device intended to measure intrathoracic electrical bioimpedance has FDA approval for use outside the United States only.
There are no publications in the peer-reviewed literature that report on outcomes and/or the utility of intrathoracic fluid monitoring in the management of patients with heart failure.
The evidence is insufficient to conclude that cardiac resynchronization therapy for mild heart failure (e.g. NYHA Class I) improves functional status, quality of life, or progression to more advanced stages of heart failure.
No randomized controlled studies were found in the published literature that validates the application of cardiac resynchronization therapy for the treatment of conditions other than heart failure.
SOURCES
Agency for Healthcare Research and Quality. (2004, November). Evidence report/technology assessment No. 106: Cardiac resynchronization therapy for congestive heart failure (AHRQ Publication No. 05-E001-2). Retrieved May 31, 2011 from http://www.ahrq.gov/clinic/tp/resyntp.htm.
Beshai, J. F., Grimm, R. A., Nagueh, S. F., Baker, J. H., Beau, S. L., Greenberg, S. M., et al. (2007). Cardiac-resynchronization therapy in heart failure with narrow QRS complexes. The New England Journal of Medicine, 357 (24), 2461-2471. (Level 1 Evidence - Industry sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Biventricular pacemakers for the treatment of congestive heart failure. (2.02.10). Retrieved May 31, 2011 from BlueWeb.
Cleland, J. G., Calvert, M. J., Verboven, Y., & Freemantle, N. (2009). Effects of cardiac resynchronization therapy on long-term quality of life: An analysis from the Cardiac Resynchronisation-Heart Failure (CARE-HF) study. American Heart Journal, 157 (3), 457-466.
Cleland, J. G., Freemantle, N., Daubert, J. C., Toff, W. D., Leisch, F., & Tavazzi, L. (2008). Long-term effect of cardiac resynchronisation in patients reporting mild symptoms of heart failure: A report from the CARE-HF study. Heart, 94 (3), 278-283. (Level 1 Evidence - Industry sponsored)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Implantable automatic debrillators (NCD 20.4, p. 2.4 – 2.6). Ingenix.
Epstein, A. E., Dimarco, J. P., Ellenbogen, K. A., Estes, N. A., Freedman, R. A., Gettes, L. S., et al. (2008). 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. Journal of the American College of Cardiology, 51 (21), e1-e62.
Heart Failure Society of America. (2010, June). Electrophysiologic testing and use of devices in heart failure: HFSA 2006 comprehensive heart failure practice guideline. Retrieved May 31, 2011 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence. (2010). Cardiac resynchronization for the treatment of heart failure. Retrieved May 31, 2011 from http://www.nice.org.uk/nicemedia/live/11616/33962/33962.pdf.
Technology Evaluation Center. (2011, Auguat). Cardiac resynchronization therapy for mild congestive heart failure. (Vol, 26. No. 1). Retrieved August 22, 2011 from http://www.bcbs.com/blueresources/tec/vols/26/26_1.pdf. (18 articles and/or guidelines reviewed)
U.S. Food and Drug Administration. (2001, August). Medtronic® InSync® ICD Model 7272 Dual Chamber Implantable Cardioverter Defibrillator System with Cardiac Resynchronization Therapy - P010031. Retrieved May 31, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010015.
U.S. Food and Drug Administration. (2002, May). Guidant Cardiac Resynchronization therapy defibrillator system including the CONTACK CD® pulse generator and the EASYTRAC® left ventricular coronary venous lead - P010012. Retrieved May 31, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P010012S230b.pdf.
Winfred S. Hayes, Inc. Medical Technology Directory. (2008, April). Cardiac resynchronization therapy for heart failure. Retrieved May 31, 2011 from www.Hayesinc.com/subscribers (72 articles and/or guidelines reviewed)
Zareba, Wojciech. (2010). Comparison of clinical trials evaluatingcardiac resynchronizationtherapy in mild and moderate heart failure. Cardiology Journal, 17 (6), 543-548. (level 1 Evidence - Independent)
ORIGINAL EFFECTIVE DATE: 12/1/2001
MOST RECENT REVIEW DATE: 12/10/2011
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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