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Medical Policy Biventricular Pacemakers - Cardiac Resynchronization Therapy for the Treatment of Heart Failure Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies Policy: Medicare Description References Authorization Information Policy History Policy Number: 101 BCBSA Reference Number: 2.02.10 Related Policies Implantable Cardioverter Defibrillator (ICD), #070 Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting, #287 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) may be MEDICALLY NECESSARY to treat heart failure in patients who have the following conditions: New York Heart Association class III or IV o Left ventricular ejection fraction ≤35%, AND o Sinus rhythm, AND o QRS duration of ≥120–130* msec, AND o Patients treated with a stable pharmacological medical regimen prior to implant, such as an angiotensin-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta blocker (or angiotensin receptor blocker), digoxin, and/or diuretics. New York Heart Association class II o Left ventricular ejection fraction ≤30%, AND o Sinus rhythm, AND o QRS duration of ≥120–130* msec, AND o Patients treated with a stable pharmacological medical regimen prior to implant, such as an angiotensin-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta blocker (or angiotensin receptor blocker), digoxin, and/or diuretics. Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) to treat NYHA class I heart failure are INVESTIGATIONAL. Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) as a treatment for heart failure in patients with atrial fibrillation, are INVESTIGATIONAL. 1 Intrathoracic fluid monitoring sensor as a component of a biventricular pacemaker is INVESTIGATIONAL. Triple-site (triventricular) CRT, using an additional pacing lead, is INVESTIGATIONAL. Prior Authorization Information Pre-service approval is required for all inpatient services for all products. See below for situations where prior authorization may be required or may not be required for outpatient services. Yes indicates that prior authorization is required. No indicates that prior authorization is not required. Outpatient No Commercial Managed Care (HMO and POS) No Commercial PPO and Indemnity SM No Medicare HMO Blue SM No Medicare PPO Blue CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes CPT Codes Description 33208 Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular Insertion or replacement of temporary transvenous dual chamber pacing electrodes (separate procedure) Insertion or replacement of pacemaker pulse generator only; with existing dual leads Upgrade of implanted pacemaker system, conversion of single chamber system to dual chamber system (includes removal of previously placed pulse generator, testing of existing lead, insertion of new lead, insertion of new pulse generator) 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) 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 and pocket revision) (List separately in addition to code for primary procedure) 33211 33213 33214 33224 33225 HCPCS Codes HCPCS Codes Description C1785 C1779 C1900 Pacemaker, dual chamber, rate-responsive (implantable) Lead, pacemaker, transvenous VDD single pass Lead, left ventricular coronary venous system 2 ICD-9 Diagnosis Codes ICD-9-CM diagnosis codes: 428.0 428.1 428.20 428.21 428.22 428.23 428.33 428.40 428.41 428.42 428.43 428.9 Code Description Congestive heart failure, unspecified Left heart failure Systolic heart failure, unspecified Acute systolic heart failure Chronic systolic heart failure Acute on chronic systolic heart failure Acute on chronic diastolic heart failure Combined systolic and diastolic heart failure, unspecified Acute combined systolic and diastolic heart failure Chronic combined systolic and diastolic heart failure Acute on chronic combined systolic and diastolic heart failure Heart failure, unspecified ICD-9 Procedure Codes When the following ICD 9 procedure codes are associated with the service(s) described in this document coverage for the service(s) is aligned with the policy statement. ICD-9-CM procedure codes: Code Description Implantation of cardiac resynchronization pacemaker without mention of defibrillation, 00.50 total system [CRT-P] 00.51 Implantation of cardiac resynchronization defibrillator, total system [CRT-D] Implantation or replacement of transvenous lead [electrode] into left ventricular 00.52 coronary venous system Implantation or replacement of cardiac resynchronization pacemaker pulse generator 00.53 only [CRT-P] Implantation or replacement of cardiac resynchronization defibrillator pulse generator 00.54 only [CRT-D] ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: I50.20 I50.1 I50.21 I50.22 I50.23 I50.33 I50.40 I50.41 I50.42 I50.43 I50.9 Code Description Unspecified systolic (congestive) heart failure Left ventricular failure Acute systolic (congestive) heart failure Chronic systolic (congestive) heart failure Acute on chronic systolic (congestive) heart failure Acute on chronic diastolic (congestive) heart failure Unspecified combined systolic (congestive) and diastolic (congestive) heart failure Acute combined systolic (congestive) and diastolic (congestive) heart failure Chronic combined systolic (congestive) and diastolic (congestive) heart failure Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure Heart failure, unspecified ICD-10 Procedure Codes ICD-10-PCS procedure Code Description 3 codes: 02H40JZ 02H43JZ 02H43KZ 02H43MZ 02H44JZ 02H60JZ 02H63JZ 02H64JZ 02HK0JZ 02HK0KZ 02HK3JZ 02HK3KZ 02HK4JZ 02HK4KZ 02HL0JZ 02HL0KZ 02HL3JZ 02HL3KZ 02HL4JZ 02HL4KZ 02PA0MZ 02PA3MZ 02PA4MZ 0JH607Z 0JH609Z 0JH637Z 0JH639Z 0JH807Z 0JH809Z 0JH837Z 0JH839Z 0JPT0PZ 0JPT3PZ Insertion of Pacemaker Lead into Coronary Vein, Open Approach Insertion of Pacemaker Lead into Coronary Vein, Percutaneous Approach Insertion of Defibrillator Lead into Coronary Vein, Percutaneous Approach Insertion of Cardiac Lead into Coronary Vein, Percutaneous Approach Insertion of Pacemaker Lead into Coronary Vein, Percutaneous Endoscopic Approach Insertion of Pacemaker Lead into Right Atrium, Open Approach Insertion of Pacemaker Lead into Right Atrium, Percutaneous Approach Insertion of Pacemaker Lead into Right Atrium, Percutaneous Endoscopic Approach Insertion of Pacemaker Lead into Right Ventricle, Open Approach Insertion of Defibrillator Lead into Right Ventricle, Open Approach Insertion of Pacemaker Lead into Right Ventricle, Percutaneous Approach Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Approach Insertion of Pacemaker Lead into Right Ventricle, Percutaneous Endoscopic Approach Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Endoscopic Approach Insertion of Pacemaker Lead into Left Ventricle, Open Approach Insertion of Defibrillator Lead into Left Ventricle, Open Approach Insertion of Pacemaker Lead into Left Ventricle, Percutaneous Approach Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Approach Insertion of Pacemaker Lead into Left Ventricle, Percutaneous Endoscopic Approach Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Endoscopic Approach Removal of Cardiac Lead from Heart, Open Approach Removal of Cardiac Lead from Heart, Percutaneous Approach Removal of Cardiac Lead from Heart, Percutaneous Endoscopic Approach Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Chest Subcutaneous Tissue and Fascia, Open Approach Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Chest Subcutaneous Tissue and Fascia, Open Approach Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Abdomen Subcutaneous Tissue and Fascia, Open Approach Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Abdomen Subcutaneous Tissue and Fascia, Open Approach Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Abdomen Subcutaneous Tissue and Fascia, Percutaneous Approach Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Abdomen Subcutaneous Tissue and Fascia, Percutaneous Approach Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and Fascia, Open Approach Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and Fascia, Percutaneous Approach Description 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). It is estimated that 20–30% 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 4 electrocardiogram (ECG). This abnormality appears to be associated with increased morbidity and mortality. Biventricular pacemakers using 3 leads (1 in the right atrium and 1 in each ventricle) have been investigated as a technique to coordinate the contraction of the ventricles, thus improving patients’ hemodynamic status. Two strategies are being explored: incorporating biventricular pacing into automatic implantable cardiac defibrillators and the development of stand-alone biventricular pacemakers. One stand-alone biventricular pacemaker (InSync® Biventricular Pacing System, Medtronic) has received approval by the U.S. Food and Drug Administration (FDA) 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 msec or longer and a left ventricular ejection fraction (LVEF) of 35% or less. Biventricular pacemakers have also been combined with automatic implantable cardiac defibrillators (ICDs). Both Guidant (CONTAK CD® CRT-D System) and Medtronic (InSync® ICD Model 7272) have received FDA approval 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 msec or longer (120 msec or longer for the Guidant device), and remain symptomatic despite a stable, optimal heart failure drug therapy. In September 2010, the FDA expanded the indications for cardiac resynchronization therapy (CRT) to include patients with class I and II heart failure. In addition to NYHA class I/II heart failure, indications for CRT in mild heart failure include a LVEF of less than 30% and a QRS duration of 130 msec or greater. 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 to 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. Summary Evidence from clinical trials and systematic reviews supports the benefit of CRT treatment for patients with NYHA class III/IV heart failure. For this group, there are improvements in mortality, functional status and quality of life. As a result, CRT treatment may be considered medically necessary for patients with NYHA class III/IV heart failure who have an ejection fraction <35%, sinus rhythm, a QRS duration of at least 120 msec, and who are treated with an optimal pharmacologic regimen. For patients with milder heart failure, RCT evidence from at least one large, high-quality trial reports a mortality benefit for patients with class II heart failure, but other RCTs do not report a mortality benefit. Several studies report a decrease in hospitalizations for class II patients, but no studies provide evidence of treatment benefit on functional status or QOL outcomes. Despite the lower level of evidence available for mild compared to advanced heart failure, it can be concluded that the benefit of CRT outweighs the risk for these patients. Therefore, CRT treatment may be considered medically necessary for class II heart failure patients who meet other clinical criteria for treatment. The evidence on class I heart failure is not sufficient to permit conclusions, as only a small number of class I patients have been included in some of the trials, and no benefit has been demonstrated for this specific subgroup. As a result, CRT is considered investigational for class I heart failure. Treatment of patients with atrial fibrillation and heart failure is controversial. Available evidence establishes that patients with heart failure probably do not derive the same magnitude of benefit as do patients with sinus rhythm and that CRT with AV nodal ablation is probably superior to CRT without AV nodal ablation in patients with heart failure. However, the evidence is insufficient to determine whether CRT treatment is superior to no treatment for this patient group. In addition, clinical input in 2012 was 5 mixed as to whether patients with atrial fibrillation should be treated with CRT. Therefore, CRT remains investigational for patients with atrial fibrillation. The optimal selection of patients for CRT treatment remains uncertain. Accumulating evidence indicates that benefit is concentrated in patients with a QRS duration of greater than 150 msec. This factor offers a potential method to better select patients for CRT and potentially avoid treatment in patients who will not benefit. Clinical input in 2012 demonstrated support for continued use of QRS threshold of 120 msec, rather than restricting treatment to patients with QRS greater than 150 msec. Other factors for selecting patients, such as ventricular dyssynchrony on echocardiography, have not been shown to be good discriminators of responders versus non-responders. Policy History Date Action 7/2014 5/2014 4/2014 10/2013 New references added from BCBSA National medical policy. Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. Coding information clarified BCBSA National medical policy review. New investigational indications described. Effective 10/1/2013. BCBSA National medical policy review. New investigational indications described. Cardiac Resynchronization Therapy” added to policy title. Effective 3/1/2013 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements. BCBSA National medical policy review. Changes to policy statements. Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. New policy, effective 6/2009, describing covered and non-covered indications. 3/2013 11/20114/2012 12/1/2011 4/2011 6/2009 Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References 1. FDA. Summary of Safety and Effectiveness Data: Tupos LV/ATx CRT-D, Kronos LV-T CRT-D. 2006. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050023b.pdf. Last accessed March, 2014. 2. FDA. Approval Order: Biotronic PMA P050023. 2013. 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Antiarrhythmic effect of cardiac resynchronization therapy with triple-site biventricular stimulation. Europace 2013; 15(10):1491-8. 42. Perego GB, Landolina M, Vergara G et al. Implantable CRT device diagnostics identify patients with increased risk for heart failure hospitalization. J Interv Card Electrophysiol 2008; 23(3):235-42. 43. 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. 44. Brachmann J, Bohm M, Rybak K et al. Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink). Eur J Heart Fail 2011; 13(7):796-804. 45. Foreman B FR, Odryzynski NI et al. 10(suppl):abstract 251. 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