Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure
Cardiac resynchronization therapy (CRT), which consists of synchronized pacing of the left and right ventricles, is intended to treat patients with heart failure and dyssynchronous ventricular contractions. Treatment involves placement of a device that paces both ventricles and which coordinates ventricular pacing to maximize cardiac pumping function and left ventricular ejection fraction.
It is estimated that 20% to 30% of patients with heart failure have intraventricular conduction disorders, resulting in a contraction pattern that is not coordinated and a wide QRS interval on the electrocardiogram. This abnormality appears to be associated with increased morbidity and mortality. Biventricular pacemakers using three leads (one in the right atrium and one in each ventricle), also known as cardiac resynchronization therapy (CRT), have been investigated as a technique to coordinate the contraction of the ventricles, thus improving the hemodynamic status of the patients. Several types of CRT devices are available, including those that incorporate biventricular pacing into automatic implantable cardiac defibrillators (ICDs), stand-alone biventricular pacemakers, and biventricular pacemakers that incorporate fluid monitoring via bioimpedance.
Originally developed CRT devices typically used two ventricular leads for biventricular pacing. Devices and implantation techniques have been developed to allow for multisite pacing, with the goal of improving CRT response. This may be accomplished in 1 of 2 ways: through the use of multiple leads within the coronary sinus (triventricular pacing) or through the use of multipolar left ventricular pacing leads, which can deliver pacing stimuli at multiple sites.
There are numerous CRT devices, combined implantable cardiac defibrillator (ICD) plus CRT devices (CRT-D), and combined CRT plus fluid monitoring devices. Some devices are discussed here. For example, in 2001, the InSync® Biventricular Pacing System (Medtronic), a stand-alone biventricular pacemaker, was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the treatment of patients with New York Heart Association (NYHA) Class III or IV heart failure, on a stable pharmacologic regimen, who also have a QRS duration of >130 ms and a left ventricular ejection fraction of <35%. Devices by Guidant (CONTAK CD® CRT-D System) and Medtronic (InSync® ICD Model 7272) have been approved by FDA through the premarket approval process for combined cardiac resynchronization therapy defibrillators for patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have NYHA Class III or IV heart failure with left ventricular ejection fraction of <35%, QRS duration >130ms (>120ms for the Guidant device), and remain symptomatic despite a stable, optimal heart failure drug therapy. See the Implantable Cardioverter Defibrillator medical policy. In 2006, Biotronik Inc. received premarket approval from FDA for its combined ICD-CRT device with ventricular pacing leads (Tupos LV/ATx CRT-D/Kronos LV-T CRT-D systems); in 2013, the company received FDA approval for updated ICD-CRT devices (Ilesto/Iforia series).
In September 2010, the FDA expanded the indications for some CRT devices to include patients with class I and II heart failure. Based on data from the MADIT-CRT study, indications for 3 Guidant (Boston Scientific) CRT-ICDs (Cognis®, Livian®, and Contak Renewal devices) were expanded to include patients with heart failure who receive stable optimal pharmacologic therapy for heart failure and who meet any one of the following classifications:
In April 2014, FDA further expanded indications for multiple Medtronic CRT devices to include patients with NYHA functional class I, II, or III heart failure, who have LVEF of 50% or less on stable, optimal heart failure medical therapy, if indicated, and have atrioventricular (AV) block that is expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. The expanded indication was based on data from the BLOCK-HF study, a Medtronic-sponsored randomized controlled trial that evaluated use of CRT in patients with NYHA class I, II, or III heart failure, LVEF of 50% or less, and AV block.
Several CRT devices incorporate a fourth lead, providing quadripolar pacing. The Medtronic Viva™ Quad XT and the Viva Quad S incorporate a fourth lead, the Medtronic Attain Performa® left ventricular lead, which received clearance for marketing from FDA in August 2014. The Dynagen™ X4 and Inogen™ X4 devices (Boston Scientific, Marlborough, MA) also incorporate a fourth lead. Other CRT devices with quadripolar leads have been approved for use outside of the United States (eg, St. Jude Quartet™ left ventricular lead).
Multiple devices manufactured by Medtronic combine a CRT with the OpitVol™ monitoring system. For example, in 2005, the InSync Sentry® system was approved by FDA through the supplemental premarket approval process. This combined biventricular pacemaker plus ICD is also equipped to monitor intrathoracic fluid levels using bioimpedance technology, referred to as OptiVol™ Fluid Status Monitoring. Bioimpedance measures, defined as the electrical resistance of tissue to flow of current, are performed many times a day using a vector from the right ventricular coil on the lead in the right side of the heart to the implanted pacemaker devices; changes in bioimpedance reflect intrathoracic fluid status and are evaluated based on a computer algorithm. For example, changes in a patient's daily average of intrathoracic bioimpedance can be monitored; differences in the daily average are compared with a baseline are reported as the OptiVol Fluid Index. It has been proposed that these data may be used as an early warning system of cardiac decompensation, or may provide feedback that enables a physician to tailor medical therapy. The Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting medical policy addresses the use of external bioimpedance devices as stand-alone devices to noninvasively assess cardiac output.
Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker plus ICD) may be considered medically necessary as a treatment of heart failure in patients who meet all of the following criteria:
NYHA Class III or IV
NYHA Class II
For patients who do not meet the criteria outlined above, but have an indication for a ventricular pacemaker or biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (ie, a combined biventricular pacemaker/implantable cardiac defibrillator) may be considered medically necessary as an alternative to a right ventricular pacemaker in patients who meet all of the following criteria:
The New York Heart Association (NYHA) functional class is a widely used rating system that quantifies the degree of symptom severity. Each class indicates a value that is reflective of the cardiac functional status. The different functional stages are as follows:
Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker plus ICD) are considered investigational as a treatment for patients with NYHA class I heart failure who do not meet the above criteria.
Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker plus ICD), are considered investigational as a treatment for heart failure in patients with atrial fibrillation who do not meet the above criteria.
An intrathoracic fluid monitoring sensor is considered investigational as a component of a biventricular pacemaker.
Triple-site (triventricular) CRT, using an additional pacing lead, is considered investigational.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Atrioventricular (AV) block with a requirement for a high percentage of ventricular pacing is considered to be present when there is either:
Guideline-directed medical therapy for heart failure is outlined in 2013 American College of Cardiology Foundation and American Heart Association guidelines for the management of heart failure.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY2/2000: Approved by Medical Policy Advisory Committee (MPAC)
2/8/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
8/2002: Reviewed by MPAC; investigational status changed to medically necessary
12/16/2002: New York Heart Association (NYHA) functional class added, Code Reference section updated, CPT code 33224, 33225, 33226, 33999 added, ICD-9 diagnosis code 402.01, 402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, 404.93, 428.0, 428.9 added
3/4/2003: CPT code 33215 added
8/29/2003: "Description" section updated to be consistent with BCBSA
8/9/2005: Code Reference section updated, CPT code 33215, 33999 deleted, ICD-9 procedure code 00.52 added
9/13/2006: Coding revised. ICD9 2006 revisions added to policy
12/13/2006: Policy reviewed, intrathoracic fluid monitoring noted to be investigational
2/19/2008: Policy reviewed, no changes
01/14/2010: Description section updated, Policy Statement was updated to include that biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) may be considered medically necessary based on indications. Also corrected typographic error, changed QRS duration from >20 msec to >120 msec. Added that biventricular pacemakers with or without an accompanying implantable cardiac defibrillator are considered investigational as a treatment of NYHA class I or II heart failure. Coding Section updated to add the following verbiage: "*Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section." removed ICD-9 Procedure code 00.52 and added "unspecified" to ICD-9 diagnosis codes 428.0 and 428.9 description.
04/28/2010: Policy description updated to add link to related medical policy. Clarified the policy statement regarding biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator; intent unchanged. Deleted outdated references from the Sources section.
08/03/2011: Policy statement revised to add specific coverage criteria for NYHA class II heart failure. Deleted "congestive" from the policy title and statement.
07/12/2012: Added Cardiac Resynchronization Therapy to the policy title. Deleted "(or angiotensin receptor blocker)" from the fourth bullet after beta blocker in both of the NYHA criteria lists. Added "sinus rhythm" to the class III or IV statement for clarity purposes.
09/25/2012: Added the following investigational policy statement: Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD), are considered investigational as a treatment for heart failure in patients with atrial fibrillation.
05/06/2013: Added the following investigational policy statement: Triple-site (triventricular) CRT, using an additional pacing lead, is considered investigational.
07/16/2014: Policy reviewed; description updated regarding devices. Revised policy statement to state that the FDA-labeled indications for QRS duration vary by device. For some devices, FDA approval is based on QRS duration of >130 (eg, InSync® device), while for others, it is based on QRS duration >120 ms (eg, CONTAK CD® CRT-D System). These differences in QRS duration arise from differences in the eligibility criteria in the trials on which the FDA approval is based.
12/31/2014: Code Reference section updated to revise the description of the following CPT codes: 33224 and 33225.
08/21/2015: Code Reference section updated for ICD-10.
06/08/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
08/24/2016: Policy description updated regarding indications for CRT devices. Medically necessary criteria for NYHA Class II and III/IV updated with the following changes: 1) Third bullet point changed to "patients with guideline-directed medical therapy." 2) Updated criteria to include presence of left bundle branch block OR QRS > 150 ms. Added policy statement that for patients who have an indication for a ventricular pacemaker, biventricular pacemakers with or without an accompanying implantable cardiac defibrillator may be considered medically necessary as an alternative to a right ventricular pacemaker with criteria. Policy guidelines updated to add policy definitions.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.10
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.