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Bi-Ventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure

Policy Number: MP-055

Latest Review Date: May 2022

Category:  Surgery                                                                

POLICY:

Effective for dates of service on or after June 8, 2018:

Biventricular Pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) may be considered medically necessary for the treatment of heart failure (HF) when ALL of the following criteria are met:

New York Heart Association (NYHA) Class III or IV

  • Left ventricular ejection fraction ≤ 35%.
  • Sinus rhythm
  • Individuals treated with guideline-directed medical therapy*
    AND
  • Either QRS duration of ≥ 120 ms** or left bundle branch block
     

New York Heart Association (NYHA) Class II

  • Left ventricular ejection fraction ≤30%
  • Sinus rhythm
  • Individuals treated with guideline-directed medical therapy*
    AND
  • Either QRS duration of ≥120ms** or left bundle branch block
     

For individuals who do not meet the criteria outlined above, but have an indication for a ventricular pacemaker, biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) may be considered medically necessary as an alternative to a right ventricular pacemaker in individuals who meet ALL of the following criteria:

  • NYHA class I, II, III, or IV heart failure
  • Left ventricular ejection fraction ≤50%
  • The presence of atrioventricular block with requirement for a high percentage of ventricular pacing***
  • Individuals treated with guideline directed medical therapy*

*Guideline-directed medical therapy for heart failure is outlined in 2013 American College of Cardiology Foundation/American Heart Association guidelines for the management of heart failure.
 
**The FDA-labeled indications for QRS duration vary by device. For some devices, FDA approval is based on QRS duration of ≥130 (e.g., InSync® device) while for others, it is based on QRS duration ≥120 ms (e.g., Guidant). These differences in QRS duration arise from differences in the eligibility criteria in the trials on which the FDA approval is based.
 
***Atrioventricular block with a requirement for a high percentage of ventricular pacing is considered to be present when there is either:

  • 3rd degree atrioventricular block; OR
  • 2nd degree atrioventricular block or a PR interval of 300ms or more when paced at 100 beats per minute.
     

A combined biventricular pacemaker and implantable cardiac defibrillator(ICD) may be considered medically necessary for individuals who meet criteria for BOTH a biventricular pacemaker and an ICD.  Please see policy # 168 (Cardiac Defibrillators) for criteria for the ICD.
 
Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator are considered investigational for the following indications:

  • Treatment for individuals with NYHA class I heart failure who do not meet the above criteria including but not limited to the following:
    • ​​​​​​atrial Fibrillation
    • unstable angina
    • myocardial infarction
    • prior coronary artery revascularization or angioplasty within the past 3 months

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

Triple-site (triventricular) CRT, using an additional pacing lead is considered investigational.

Cardiac resynchronization therapy with wireless left ventricular endocardial pacing is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 (LVEF).

Heart Failure

An estimated 6 million adults in the US 20 years of age and older had heart failure between 2015 and 2018. The prevalence continues to increase over time with aging of the population. Prevalence of disease is higher in women than men 80 years of age and older. 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.

Treatment

Biventricular pacemakers using 3 leads (1 in the right atrium, 1 endocardial in the right ventricle, 1 epicardial for the left ventricle), also known as cardiac resynchronization therapy (CRT), have been investigated as a technique to coordinate the contraction of the ventricles, thus improving patients' hemodynamic status. Originally developed CRT devices typically used 2 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. Wireless left ventricular endocardial pacing is also being evaluated for patients who are not candidates for or do not respond to standard epicardial pacing leads.

KEY POINTS:

The most recent literature review was updated through April 5, 2022.

Summary of Evidence

For individuals who have NYHA class III or IV heart failure with an LVEF of 35% or less who are in sinus rhythm, treated with guideline-directed medical therapy, and have either LBBB or a QRS interval of 150 ms or more who receive CRT with or without defibrillator, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are OS, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. There is a large body of clinical trial evidence supporting the use of CRT in patients with NYHA class III or IV heart failure. The RCTs have consistently reported that CRT reduces mortality, improves functional status, and improves quality of life for patients with NYHA class III or IV heart failure. Multiple subgroup analyses of RCTs have demonstrated that the benefit of CRT is mainly restricted to patients with LBBB or QRS interval greater than 150 ms. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have NYHA class II heart failure with a left ventricular ejection fraction of 30% or less who are in sinus rhythm, treated with guideline-directed medical therapy, and have either LBBB or a QRS interval of 150 ms or more who receive CRT with or without defibrillator, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. For patients with NYHA class II heart failure, at least 4 RCTs assessing CRT have been published. A mortality benefit was reported in 1 of the 4 trials, the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial. None of the other 3 RCTs reported a mortality difference, but a subgroup analysis of the MADIT-CRT trial reported a mortality benefit for patients with LBBB. Among other outcome measures, hospitalizations for heart failure showed consistent reductions, but quality of life and functional status did not improve The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have NYHA class I heart failure who receive CRT with or without defibrillator, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. Few patients with NYHA class I heart failure have been included in RCTs. The MADIT-CRT trial included 265 patients with class I. While the treatment effect on death and hospitalization favored combined implantable cardiac defibrillator plus CRT devices vs implantable cardiac defibrillator alone for class I patients, the confidence interval was large and included a 25% to 30% increase in events. The evidence is insufficient to determine that the technology results in an improvement in net health outcomes.

For individuals who have NYHA class I, II, III or IV heart failure with left ventricular ejection fraction of 50% or less and the presence of atrioventricular block with requirement for a high percentage of ventricular pacing, treated with guideline-directed medical therapy, who receive CRT with or without defibrillator, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are OS, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. For patients who have atrioventricular nodal block, some degree of left ventricular dysfunction, and who would not necessarily meet conventional criteria for CRT but would require ventricular pacing, a large RCT has demonstrated improvements in heart failure-related hospitalizations and urgent care visits among patients treated with CRT instead of RV pacing alone. For patients who require ventricular pacing but have no left ventricular dysfunction, results of a small RCT have suggested that biventricular pacing is associated with improved measures of cardiac function, but the trial was small and underpowered to detect differences in clinical outcomes. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with atrial fibrillation and heart failure who receive CRT, the evidence consists of 6 RCTs and a registry study. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. Results from RCTs have reported conflicting results, with 3 reporting improvements for patients with atrial fibrillation (AF) and others reporting no significant improvements. A registry study reported significant improvements in mortality and hospitalizations for patients with heart failure and AF treated with CRT plus defibrillator compared with ICD alone. The evidence is insufficient to determine that the technology results in an improvement in the health outcomes.

For individuals who have heart failure and atrioventricular (AV) nodal block who receive CRT, the evidence includes RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. One large RCT demonstrated that CRT led to reductions in heart failure-related hospitalizations and urgent care visits among patients with heart failure and AV block but who would not necessarily meet conventional criteria for CRT. For patients who require ventricular pacing but have no left ventricular dysfunction, results of a small RCT have suggested that biventricular pacing is associated with improved measures of cardiac function, but the trial was small and underpowered to detect differences in clinical outcomes. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have heart failure who receive triple-site CRT, the evidence includes small RCTs and a meta-analysis that included nonrandomized studies. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. The available RCTs have reported improved outcomes on at least 1 measure of functional status or quality of life with triple-site CRT compared to conventional CRT. However, the trials are small and have methodologic limitations. In addition, outcomes reported differed across studies. Triple-site CRT was also associated with higher radiation exposure and a greater number of additional procedures postimplantation. Larger, high-quality RCTs are needed to better define the benefit-risk ratio for triple-site CRT compared to conventional CRT. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have heart failure who receive CRT combined with remote fluid monitoring, the evidence includes 3 RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. Three RCTs have reported no improvement in outcomes associated with remote fluid monitoring for patients with heart failure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

American College of Cardiology et al.

The ACC and American Heart Association and Heart Rhythm Society (2019) published joint guidelines on the evaluation and management of patients with bradycardia and cardiac conduction delay. These guidelines included the following recommendations on CRT (see Table 1).

Table 1. Joint Guidelines on Treatment of Patients with Bradycardia and Cardiac Conduction Delay

Recommendation

COR

LOE

"In patients with atrioventricular block who have an indication for permanent pacing with a LVEF between 36% and 50% and are expected to require ventricular pacing more than 40% of the time, it is reasonable to choose pacing methods that maintain physiologic ventricular activation (e.g., cardiac resynchronization therapy [CRT] or His bundle pacing) over right ventricular pacing."

IIa

B-RSR

"In patients with atrioventricular block who have an indication for permanent pacing with a LVEF between 36% and 50% and are expected to require ventricular pacing less than 40% of the time, it is reasonable to choose right ventricular pacing over pacing methods that maintain physiologic ventricular activation (e.g., CRT or His bundle pacing)."

IIa

B-R

COR: class of recommendation; LOE: level of evidence; LVEF: left ventricular ejection fraction.

A focused update to 2008 guidelines for device-based treatment of cardiac rhythm abnormalities was published jointly by ACC Foundation, American Heart Association, and Heart Rhythm Society in 2012. The ACC and American Heart Association (2013) subsequently published guidelines for the management of heart failure. These guidelines made recommendations on CRT for heart failure that are in line with those made by the ACC, American Heart Association, and Heart Rhythm Society related to CRT for heart failure in 2012. The ACC, American Heart Association, and Heart Failure Society of America published guidelines on the management of heart failure (2022) this year to replace the 2013 guidelines. These most recent recommendations on CRT for heart failure from the guidelines are included in Table 2.

Table 2. Joint Guidelines on Device-Based Treatment of Cardiac Rhythm Abnormalities

Recommendation

COR

LOE

CRT is indicated for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT

I

Ba

CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT

IIa

Bb

CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class II, III, or ambulatory class IV symptoms on GDMT

IIa

Ba

CRT is reasonable in patients with high-degree or complete heart block and LVEF of 36% to 50%

IIa

Ba

CRT can be useful in patients with atrial fibrillation and LVEF less than or equal to 35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT

IIa

Bb

CRT can be useful for patients on GDMT who have LVEF less than or equal to 35% and are undergoing new or replacement device placement with anticipated requirement for significant (>40%) ventricular pacing

IIa

Bb

CRT may be considered for patients who have LVEF less than or equal to 30%, ischemic etiology of heart failure, sinus rhythm, LBBB with a QRS duration of greater than or equal to 150 ms, and NYHA class I symptoms on GDMT

IIb

Bb

CRT may be considered for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with QRS duration 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMT

IIb

Bb

CRT is not recommended in patients with QRS duration less than 120 ms

IIIc

Ba

CRT is not recommended for patients with NYHA class I or II symptoms and non-LBBB pattern with QRS duration less than 150 ms

IIc

Bb

CRT-Dis not indicated for patients whose comorbidities and/or frailty limit survival with good functional capacity to less than 1 year

IIc

Cd

AV: atrioventricular; COR: class of recommendation; CRT: cardiac resynchronization therapy; CRT-D: cardiac resynchronization therapy with defibrillation; GDMT: guideline-directed medical therapy; LBBB: left bundle

branch block; LOE: level of evidence; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association.

aModerate quality evidence from 1 or more RCTs.

bModerate-quality evidence from 1 or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies.

cNo benefit.

dLimited data.

Heart Failure Society of America

The Heart Failure Society of America released comprehensive guidelines on the management of heart failure in 2010. The guidelines include the following recommendations related to the use of CRT:

Table 3. Guidelines on Management of Heart Failure

Recommendation

LOE

Biventricular pacing therapy is recommended for patients in sinus rhythm with a widened QRS interval (≥120 ms) and severe LV systolic dysfunction (LVEF ≤35%) who have persistent, moderate to severe HF (NYHA III) despite optimal medical therapy.

A

Biventricular pacing therapy may be considered for patients with atrial fibrillation with a widened QRS interval (≥120 ms) and severe LV systolic dysfunction LVEF ≤35% who have persistent, moderate to severe HF (NYHA III) despite optimal medical therapy

B

Selected ambulatory NYHA IV patients in sinus rhythm with QRS ≥120 ms and LV systolic dysfunction may be considered for biventricular pacing therapy

B

Biventricular pacing therapy may be considered in patients with reduced LVEF and QRS ≥150 ms who have NYHA I or II HF symptoms.

B

In patients with reduced LVEF who require chronic pacing and in whom frequent ventricular pacing is expected, biventricular pacing may be considered.

C

HF: heart failure; LOE: level of evidence; LV: left ventricular; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association.

National Institute for Health and Care Excellence

The NICE (2014) guidance provided recommendations on CRT for heart failure. The recommendations for patients with left ventricular ejection fraction of 35% or less are listed in Table 4.

Table 4. Guidelines on Management of Cardiac Resynchronization Therapy for Heart Failure

Indication

Recommendation

NYHA class I-IV with QRS interval <120 ms

CRT not recommended

NYHA class IV with QRS interval 120 to 149 ms and without LBBB

CRT-P recommended

NYHA class II-III with QRS interval 120 to 149 ms and with LBBB

CRT-D recommended

NYHA class III-IV with QRS interval 120 to 149 ms and with LBBB

CRT-P recommended

NYHA class I-III with QRS interval ≥150 ms (with or without LBBB)

CRT-D recommended

NYHA class III-IV with QRS interval ≥150 ms (with or without LBBB)

CRT-P recommended

CRT: cardiac resynchronization therapy; CRT-D: cardiac resynchronization therapy with implantable cardioverter-defibrillator; CRT-P: cardiac resynchronization therapy with pacemaker; LBBB: left bundle branch block; NYHA: New York Heart Association.

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

InSync®, Biventricular Pacemaker, biventricular pacing, congestive heart failure (CHF), pacemaker, cardiac resynchronization, CRT, cardiac resynchronization therapy, Viva™ Quad XT, Viva Quad S, Attain Performa®, Dynagen, Inogen, OptiVol™, Triple site CRT, Triventricular Pacemaker, intrathoracic fluid monitoring sensor; WiSE-CRT, EBR Systems

APPROVED BY GOVERNING BODIES:

There are numerous CRT devices, combined implantable cardiac defibrillator (ICD) plus CRT devices (CRT-D), and combined CRT plus fluid monitoring devices. Some of the devices are discussed here. For example, in 2001, a stand-alone biventricular pacemaker (InSync® Biventricular Pacing System, Medtronic) received approval by U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) 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 or longer and a left ventricular ejection fraction (LVEF) of 35% or less. Both Guidant (CONTAK CD® CRT-D System) and Medtronic (InSync® ICD Model 7272) have received FDA approval through the PMA 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 LVEF of 35% or less, QRS duration 130 ms or longer (≥120 ms for the Guidant device), and remain symptomatic despite a stable, optimal heart failure drug therapy. In 2006, Biotronik Inc. received premarket approval through the 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).
 
On the basis of the MADIT-CRT study, indications for three Guidant (Boston Scientific) CRT-defibrillator devices (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:

  • Moderate-to-severe heart failure (NYHA class III or IV) with ejection fraction less than 35% and QRS duration greater than 120ms.
  • Left bundle branch block with QRS greater than or equal to 130ms, ejection fraction less than 30%, and mild (NYHA class II) ischemic or nonischemic heart failure or asymptomatic (NYHA class I) ischemic heart failure.

In April 2014, FDA further expanded the 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 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 RCT to evaluate the use of CRT in patients with NYHA class I, II, or III heart failure, LVF ≤50%, 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 Medtroinc Attain Performa® left ventricular lead, which received clearance for marketing from FDA in August 2014.  The Dynagen™ X4 and Inogen™ X4 devices incorporate a fourth lead.  Other CRT devices with quadripolar leads have been approved for use outside of the United States (e.g. 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 received FDA approval through the supplemental premarket approval (PMA) process. This combined biventricular pacemaker/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 per 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 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 to provide additional feedback enabling a physician to further tailor medical therapy. (See medical policy #441 – Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting for stand alone devices)
 
The WiSE-CRT (EBR Systems) provides CRT with a small wireless electrode that is implanted within the left ventricle and controlled by ultrasound. It has European CE approval and is being studied in a multicenter pivotal trial.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT codes:

0515T

Insertion of wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming, and imaging supervision and interpretation, when performed; complete system (includes electrode and generator [transmitter and battery]) (Effective 01/01/2019) 

 

0516T

Insertion of wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming, and imaging supervision and interpretation, when performed; electrode only (Effective 01/01/2019)

0517T

Insertion of wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming, and imaging supervision and interpretation, when performed; pulse generator component(s) (battery and/or transmitter) only (Effective 01/01/2019)

0518T

Removal of only pulse generator component(s) (battery and/or transmitter) of wireless cardiac stimulator for left ventricular pacing (Effective 01/01/2019)

0519T

Removal and replacement of wireless cardiac stimulator for left ventricular pacing; pulse generator component(s) (battery and/or transmitter) (Effective 01/01/2019)

0520T

Removal and replacement of wireless cardiac stimulator for left ventricular pacing; pulse generator component(s) (battery and/or transmitter), including placement of a new electrode  (Effective 01/01/2019)

0521T

Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording, and disconnection per patient encounter, wireless cardiac stimulator for left ventricular pacing (Effective 01/01/2019)

0522T

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, including review and report, wireless cardiac stimulator for left ventricular pacing (Effective 01/01/2019)

33207

Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); ventricular

33208

Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular

33213

Insertion of pacemaker pulse generator only; with existing dual leads 

33217

Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator

33221

Insertion of pacemaker pulse generator only; with existing multiple leads

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 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 (i.e., upgrade to dual chamber system) (List separately in addition to code for primary procedure

33226

Repositioning of previously implanted cardiac venous system (left ventricular) electrode (including removal, insertion and/or replacement of existing generator)

33228

Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator; dual lead system

33229

Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator; multiple lead system

33233 

Removal of permanent pacemaker pulse generator only

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  26. FDA. Summary of Safety and Effectiveness Data, PMA P030035. 2005; www.fda.gov/ohrms/dockets/dockets/05m0289/05m-0289-aav0001-03-SSED-vol1.pdf. Accessed March 31, 2016
  27. Food and Drug Administration. Summary of Safety and Effectiveness Data: Cardiac Resynchronization Therapy Defibrillator (CRT-D). 2010; www.accessdata.fda.gov/cdrh_docs/pdf/P010012S230b.pdf. Accessed April 8, 2021.
  28. Foley PW, Patel K, Irwin N, et al. Cardiac resynchronisation therapy in patients with heart failure and a normal QRS duration: the RESPOND study. Heart. Jul 2011; 97(13):1041-1047.
  29. Friedman DJ, Bao H, Spatz ES, et al. Association between a prolonged pr interval and outcomes of cardiac resynchronization therapy: a report from the National Cardiovascular Data Registry. Circulation. Nov 22 2016; 134(21):1617-1628.
  30. Ganesan AN, Brooks AG, Roberts-Thomson KC et al. Role of AV nodal ablation in cardiac resynchronization in patients with coexistent atrial fibrillation and heart failure: a systematic review. J Am Coll Cardiol 2012; 59(8):719-26.
  31. Gillis AM, Kerr CR, Philippon F. et al. Impact of cardiac resynchronization therapy on hospitalizations in the resynchronization-defibrillation for ambulatory heart failure trial. Circulation May 20 2014; 129(20): 2021-2030.
  32. Gillis AM, Kerr CR, Philippon F, et al. Impact of cardiac resynchronization therapy on hospitalizations in the Resynchronization-Defibrillation for Ambulatory Heart Failure trial. Circulation. May 20 2014; 129(20): 2021-30.
  33. Gold MR, Padhiar A, Mealing S, et al. Long-Term Extrapolation of Clinical Benefits Among Patients With Mild Heart Failure Receiving Cardiac Resynchronization Therapy: Analysis of the 5-Year Follow-Up From the REVERSE Study. JACC Heart Fail. Sep 2015; 3(9):691-700.
  34. Goldenberg I, Hall WJ, Beck CA et al. Reduction of the risk of recurring heart failure events with cardiac resynchronization therapy: MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). J Am Coll Cardiol 2011; 58(7):729-37.
  35. Goldenberg I, Kutyifa V, Klein HU, et al. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. May 1 2014; 370 (18): 1694-1701.
  36. Gould J, Claridge S, Jackson T, et al. Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block. Europace. Nov 22 2021.
  37. Gula LJ, Wells GA, Yee R, et al. A novel algorithm to assess risk of heart failure exacerbation using ICD diagnostics: validation from RAFT. Heart Rhythm Sep 2014; 11(9): 1626-1631.
  38. Hawkins NM, Petrie MC, MacDonald MR et al. Selecting patients for cardiac resynchronization therapy: electrical or mechanical dyssynchrony? Eur Heart J 2006; 27(11):1270-81.
  39. Healey JS, Hohnloser SH, Exner DV et al. Cardiac resynchronization therapy in patients with permanent atrial fibrillation: results from the resynchronization for ambulatory heart failure trial (RAFT). Circ Heart Fail. Sep 1 2012; 5(5): 566-570.
  40. Heart Failure Society of America, Lindenfeld J, Albert NM et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. Journal of Cardiac Failure 2010; 16(6):e1-194.
  41. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. May 03 2022; 79(17): e263-e421.
  42. Hosseini SM, Moazzami K, Rozen G, et al. Utilization and in-hospital complications of cardiac resynchronization therapy: trends in the United States from 2003 to 2013. Eur Heart J. Mar 13 2017.
  43. Innes Donald, et al.  VDD pacing at short atrioventricular intervals does not improve cardiac output in patients with dilated heart failure.  PACE, May 1994, Vol. 17, Part I, pp. 956-965.
  44. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  45. Kalscheur MM, Saxon LA, Lee BK, et al. Outcomes of cardiac resynchronization therapy in patients with intermittent atrial fibrillation or atrial flutter in the COMPANION trial. Heart Rhythm. Mar 17 2017.
  46. Kang SH, Oh IY, Kang DY et al. Cardiac resynchronization therapy and QRS duration: systematic review, meta-analysis, and meta-regression. J Korean Med Sci. Jan 2015; 30(1): 24-33.
  47. Khazanie P, Greiner MA, Al-Khatib SM, et al. Comparative effectiveness of cardiac resynchronization therapy among patients with heart failure and atrial fibrillation: findings from the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry. Circ Heart Fail. Jun 2016; 9(6).
  48. Kusumoto FM, Schoenfeld MH, Barrett C, et al. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. J Am Coll Cardiol. Aug 20 2019; 74(7): 932-987.
  49. Kutyifa V, Stockburger M, Daubert JP, et al. PR interval identifies clinical response in patients with non-left bundle branch block: a multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy substudy. Circ Arrhythm Electrophysiol. Aug 2014; 7(4): 645-651.
  50. Lenarczyk R, Kowalski O, Sredniawa B et al. Implantation feasibility, procedure-related adverse events and lead performance during 1-year follow-up in patients undergoing triple-site cardiac resynchronization therapy: a substudy of TRUST CRT randomized trial. J Cardiovasc Electrophysiol 2012; 23(11):1228-36.
  51. Lin J, Buhr KA, Kipp R. Effect of PR interval on outcomes following cardiac resynchronization therapy: a secondary analysis of the COMPANION trial. J Cardiovasc Electrophysiol. Feb 2017; 28(2):185-191.
  52. Linde C, Gold MR, Abraham WT et al. Long term impact of cardiac resynchronization therapy in mild heart failure: 5 year results from the resynchronization reverses remodeling in systolic left ventricular dysfunction (REVERSE) study. Eur Heart J. Sep 2013; 34(33): 2592-2599.
  53. Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. Jun 2010; 16(6): e1-194.
  54. Luthje L, Vollmann D, Seegers J, et al. A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Europace. Aug 2015; 17(8):1276-1281.
  55. Martinelli Filho M, de Siqueira SF, Costa R, et al. Conventional versus biventricular pacing in heart failure and bradyarrhythmia: the COMBAT study. J Card Fail. Apr 2010; 16(4):293-300.
  56. Muto C, Solimene F, Gallo P et al. A randomized study of cardiac resynchronization therapy defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic cardiomyopathy with narrow QRS: the NARROW-CRT study. Circ Arrhythm Electrophysiol 2013; 6(3):538-45.
  57. National Institute for Health and Care Excellence (NICE). Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure, technology appraisal guidance [TA314]. 2014; www.nice.org.uk/guidance/ta314. Accessed April 5, 2021.
  58. Nery PB, Ha AC, Keren A et al. Cardiac resynchronization therapy in patients with left ventricular systolic dysfunction and right bundle branch block: a systematic review. Heart Rhythm 2011; 8(7):1083-7.
  59. Ogano M, Iwasaki YK, Tanabe J et al. Antiarrhythmic effect of cardiac resynchronization therapy with triple-site biventricular stimulation. Europace 2013; 15(10):1491-8.
  60. Pappone C, Calovic Z, Vicedomini G, et al. Improving cardiac resynchronization therapy response with multipoint left ventricular pacing: Twelve-month follow-up study. Heart Rhythm. Jun 2015; 12(6):1250-1258.
  61. Peterson PN, Greiner MA, Qualls LG et al. QRS duration, bundle-branch block morphology, and outcomes among older patients with heart failure receiving cardiac resynchronization therapy. JAMA 2013; 310(6):617-26.
  62. Rogers DP, Lambiase PD, Lowe MD et al. A randomized double-blind crossover trial of triventricular versus biventricular pacing in heart failure. Eur J Heart Fail 2012; 14(5):495-505.
  63. Ruschitzka F, Abraham WT, Singh JP et al. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. New England Journal of Medicine 2013; 369(15):1395-405.
  64. Santangeli P, Di Biase L, Pelargonio G, et al. Cardiac resynchronization therapy in patients with mild heart failure: a systematic review and meta-analysis. J Interv Card Electrophysiol. Nov 2011; 32(2):125-135.
  65. Sekiguchi Y, Tada H, Yoshida K et al. Significant increase in the incidence of ventricular arrhythmic events after an intrathoracic impedance change measured with a cardiac resynchronization therapy defibrillator. Circ J 2011; 75(11):2614-20.
  66. Shah RM, Patel D, Molnar J, et al. Cardiac-resynchronization therapy in patients with systolic heart failure and QRS interval</= 130ms: insights from a meta-analysis. Europace Feb 2015; 17(2): 267-273.
  67. Sipahi I, Carrigan TP, Rowland DY et al. Impact of QRS duration on clinical event reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled trials. Arch Intern Med 2011; 171(16):1454-62.
  68. Sipahi I, Chou JC, Hyden M et al. Effect of QRS morphology on clinical event reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled trials. Am Heart J. Feb 2012; 163(2): 260-267.
  69. Stavrakis S, Lazzara R, Thadani U. The benefit of cardiac resynchronization therapy and QRS duration: a meta-analysis. J Cardiovasc Electrophysiol. Feb 2012; 23(2): 163-168.
  70. Stockburger M, Moss AJ, Klein HU, et al. Sustained clinical benefit of cardiac resynchronization therapy in non LBBB patients with prolonged PR-interval: MADIT-CRT long-term follow-up. Clin Res Cardiol. Nov 2016; 105(11):944-952.
  71. Sun WP, Li CL, Guo JC, et al. Long-term efficacy of implantable cardiac resynchronization therapy plus defibrillator for primary prevention of sudden cardiac death in patients with mild heart failure: an updated metaanalysis. Heart Fail Rev. Jul 2016; 21(4):447-453.
  72. Tang AS, Wells GA, Talajic M et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med 2010; 363(25):2385-95.
  73. Thibault B, Ducharme A, Harel F, et al. Left ventricular versus simultaneous biventricular pacing in patients with heart failure and a QRS complex >/=120 milliseconds. Circulation. Dec 20 2011; 124(25):2874-2881.
  74. Thibault B, harel F, Ducharme A, et al. Cardiac resynchronization therapy in patients with heart failure and a QRS complex <120 milliseconds: the evaluation of resynchronization therapy for heart failure (LESSER-EARTH) trial. Circulation. Feb 26 2013; 127(8): 873-881.
  75. Tracy CM, Epstein AE, Darbar D et al. 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation 2012; 126(14):1784-800.
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  77. Tu R, Zhong G, Zeng Z et al. Cardiac resynchronization therapy in patients with mild heart failure: a systematic review and meta-analysis of randomized controlled trials. Cardiovasc Drugs Ther 2011; 25(4):331-40.
  78. van Geldorp IE, Vernooy K, Delhaas T, et al. Beneficial effects of biventricular pacing in chronically right ventricular paced patients with mild cardiomyopathy. Europace. Feb 2010; 12(2):223-229.
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POLICY HISTORY:

Medical Review Committee May 2002
Medical Policy Group, June 2002
Available for comment July 2-August 15, 2002
Medical Policy Group, June 2004 (1)
Medical Policy Administration Committee, June 2004
Available for comment July 12-August 25, 2004
Medical Policy Group, August 2006 (1)
Medical Policy Group, August 2009 (1)
Medical Policy Administration Committee August 2009
Available for comment July 17-August 31, 2009
Medical Policy Group, October 2009 (1)
Medical Policy Administration Committee, October 2009
Available for comment October 20-December 3, 2009
Medical Policy Group, April 2011 (1)
Medical Policy Administration Committee May 2011
Available for comment May 11 – June 27, 2011
Medical Policy Group, November 2011(1): 2012 Coding Update: Updated verbiage to match 2012 CPT changes
Medical Policy Group, December 2011 (3): 2012 Coding Update-Added Code G0448
Medical Policy Group, April 2012 (1): Update to Description, Key Points and References related to MPP update; “Cardiac resynchronization therapy” added to policy title; no changes to policy statement
Medical Policy Panel, August 2012
Medical Policy Group, April 2013 (1): Update to Policy statement to add ‘sinus rhythm’ to and remove ‘who remain symptomatic despite’ from NYHA Class III or IV criteria and change LVEF to ≤30% to NYHA Class II criteria; update to Key Points
Medical Policy Panel, April 2013
Medical Policy Group, April 2013 (4): Update to Policy statement to add triventricular pacing as investigational; update to Key Points and References
Available for comment May 22 through July 5, 2013
Medical Policy Panel, April 2014
Medical Policy Group, April 2014 (4): Updated Approved Governing Bodies, Practice Position and Guidelines, Key Points and References. Also added CPT codes 33228 and 33229. There are no changes to the policy statement at this time. 
Medical Policy Group, December 2014: 2015 Coding Update-CPT code 33225-Replaced pacing cardioverter with ‘implantable’; removed ‘and pocket revision’
Medical Policy Panel, April 2015
Medical Policy Group, May 2015 (4): Updates to Description, Key Points, Approved Governing Bodies, Key Words, and References.  Removed codes 33214, 33220, 33229, and G0448 from the coding section which were added previously in error.  Added CPT codes 33208 and 33233. Policy statement updated to criteria points: QRS of >/= 120msec (range to 130 removed) and left bundle branch block for biventricular pacemakers in the treatment of HF.  Also revised criteria point for “Patients treated with a stable pharmacological medical regimen….” to “Guideline directed medical therapy” which aligns with practice guideline verbiage. New policy statement with criteria added for patients who have an indication for pacemaker as an alternative to a RV pacemaker.
Available for comment June 4 through July 18, 2015
Medical Policy Panel, June 2016
Medical Policy Group, June 2016 (4):  Updates to Description, Key Points, Key Words and References. Removed July 2013 policy statement section; Added CPT codes 33221, 33226, and 33229; Removed CPT code 33211.
Medical Policy Group, December 2016: 2017 Annual coding update.  Updated revised CPT code verbiage for 33221.
Medical Policy Panel, May 2017
Medical Policy Group, May 2017 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to policy statements.
Medical Policy Panel, May 2018
Medical Policy Group, June 2018 (4): Updates to Description, Policy, Key Points, Approved by Governing Bodies, Key Words and References. Policy statement was added that considers CRT with wireless left ventricular endocardial pacing investigational. Removed policy statements effective for dates of service July 6, 2013 through May 31, 2015.
Medical Policy Group, December 2018:  2019 Annual Coding Update, Updated coding section to include codes 0515T, 0516T, 0517T, 0518T, 0519T, 0520T, 0521T, 0522T
Medical Policy Panel, May 2019
Medical Policy Group, July 2019 (4): Updates to Description, Key Points, and References.  No change to policy statements.
Medical Policy Panel, May 2020
Medical Policy Group, June 2020 (4): updates to Key Points and References. No change to policy statements. Added CPT codes 33207 and 33217 to Current Coding.
Medical Policy Panel, May 2021
Medical Policy Group, May 2021 (4):   Updates to Key Points and References.  Policy statements effective for dates of service between June 1, 2015 – June 8, 2018 removed.  Policy statement updated to remove “not medically necessary,” no change to policy intent. Removed the following References: Abraham William T.  Rationale and design of a randomized clinical trial to assess the safety and efficacy of cardiac resynchronization therapy in patients with advanced heart failure; Alonso Christine, Leclercq Christophe, et al.  Electrocardiographic predictive factors of long-term clinical improvement with multisite biventricular pacing in advanced heart failure; Auricchio Angelo and Salo Rodney W.  Acute hemodynamic improvement by pacing in patients with severe congestive heart failure; Auricchio Angelo, Stellbrink Christoph, et al.  Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure; Auricchio Angelo, Stellbrink Christoph, et al.  The pacing therapies for congestive heart failure (PATH-CHF) study; Cazeau Serge, Ritter Philippe, et al. Multisite pacing for end-stage heart failure:  Early experience.    

Medical Policy Panel, May 2022

Medical Policy Group, May 2022 (4): Updates to Policy statement (“patients” changed to “individuals”), Description, Key Points, Practice Guidelines and References.

 ​​​

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.