LCD L39080: Cardiac Resynchronization Therapy (CRT)

Heart failure (HF) is common and carries a poor prognosis. It is also associated with a high burden of illness, high resource utilization, and frequent hospitalizations.

A proportion of patients with HF exhibit dyssynchronous contractions of the left and right ventricles due to conduction system disease. Dyssynchrony further depresses the already impaired pumping ability of the heart.

CRT is a form of cardiac pacing used in patients with systolic HF and dyssynchronous ventricular activation. CRT involves pacing of the left ventricle (LV) and usually simultaneous or nearly simultaneous pacing of the right ventricle (RV) to restore ventricular synchrony and thus improve LV systolic function and clinical outcomes for selected patients.

Electrical dyssynchrony (prolonged QRS on electrocardiogram (ECG)) is associated with adverse clinical outcomes. One-third of patients with HF with reduced ejection fraction (EF) have a QRS complex > 120 ms. 1 Many studies have demonstrated that LV electromechanical activation in patients with baseline or pacing-induced left bundle branch block (LBBB) is hemodynamically impacting in an adverse way. In the patient with cardiomyopathy, this hemodynamic inefficiency further reduces cardiac output, makes functional mitral regurgitation worse, and causes even more adverse LV remodeling. 2

For those who respond to CRT, this therapy provides immediate hemodynamic benefits such as improved LV systolic function, LV reverse remodeling, increased systolic blood pressure, increased cardiac output, and increased contractility. The CARE-HF trial noted that CRT was associated with increases in LVEF and decreases in LV end systolic volume indices. 3 Clearly CRT has progressive cardiac structural benefits. CRT increases myocardial contractility without increasing myocardial oxygen consumption.

Candidacy for CRT is based on LVEF, QRS duration, QRS pattern, New York Heart Association (NYHA) functional class, and need for ventricular pacing.

Some patients with HF are also at high risk for life-threatening heart rhythms such as ventricular tachycardia and ventricular fibrillation. Most patients being considered for CRT due to EFs 35% should also be considered for implantable cardioverter-defibrillator (ICD) placement.

This LCD does not address the decision-making between CRT-pacemaker (CRT-P) or CRT-defibrillator (CRT-D) options other than to emphasize that those patients receiving CRT-D must not only meet coverage criteria in this policy but also meet the NCD for Implantable Automatic Defibrillators (20.4) criteria for the defibrillator portion of their therapy in order to be considered for coverage.

This LCD provides for CRT coverage with a few identified limitations.

Covered Services:

CRT will be considered medically necessary when the following criteria for a given beneficiary are met:

• LVEF 35%, with ischemic or non-ischemic cardiomyopathy, on maximally tolerated guideline-directed medical therapy (GDMT) for at least 3 months and with no reversible causes; and

• QRS > 150 ms; and

• Any type bundle branch block with evidence of dyssynchrony; and

• NYHA class III or ambulatory IV HF

• LVEF 35%, on maximally tolerated GDMT for at least 3 months and with no reversible causes; and

• QRS > 150 ms; and

• LBBB; and

• NYHA classes II, III or ambulatory IV HF

• LVEF 35%, on maximally tolerated GDMT for at least 3 months and with no reversible causes; and

• QRS 130-149 ms; and

• LBBB; and

• NYHA class II, III or ambulatory IV HF

• In patients with atrial fibrillation (AF) or in sinus rhythm who have an indication for pacemaker implant for second or third degree atrioventricular (AV) block (including those who have or will have AV nodal ablation), or very prolonged first degree block with PR > 300 ms, and :

• with an EF

• with NYHA I, II or III class; and

• anticipated frequent ventricular pacing

• Patients who are being paced from the RV frequently (generally considered at least > 40% of the time) and who develop worsening HF symptoms (NYHA class II-IV) with a decline in LVEF to a value

*For an upgrade from standard pacing to CRT, this A/B Medicare Administrative Contractor (MAC) would expect documentation narrative regarding the risk-benefit balance for that individual patient and his/her degree of HF, QRS duration/morphology, etc. A “stand-alone” upgrade in patients with an existing pacemaker or implanted cardiac defibrillator should be considered carefully and based on the individual patient’s unique circumstances. Upgrades to CRT from conventional RV pacing at the time of a needed generator change will be covered per the usual criteria as noted in all preceding coverage bullets.

In patients with AF and HF for whom CRT is planned, narrative in the medical record is expected regarding plans for AF control so that CRT may be most effective. It is understood that the future for such patients cannot be predicted and thus future therapy cannot be defined precisely; however, a reference to the need for focus on AF control is desirable.

HF patients with concomitant moderate-severe chronic obstructive pulmonary disease (COPD) should have documentation related to a reasonable hope for CRT response with a clinically guided rationale that the dyspnea is at least in part significantly related to HF.

Patients with end stage or advanced renal disease may benefit less from CRT. Documentation regarding the risk-benefit balance in these patients would also be expected.

Patients who meet all CMS coverage requirements for cardiac pacemakers, and who meet the criteria in the NCD for Implantable Automatic Defibrillators (20.4), may receive the combined devices in 1 procedure, at the time the biventricular pacemaker is clinically indicated.

Patients with an existing CRT device may receive a generator replacement if it is required due to the end of battery life, elective replacement indicator (ERI), or device/lead malfunction.

Limitations:

Noncovered Services: (CRT is unlikely to offer benefit and is probably associated with harm)

• Patients with a QRS (Exception to this non-coverage criterion would be in the case of patients undergoing AV nodal ablation or in need of RV pacing (due to second- or third-degree block or very long first degree block) that is expected to occur a majority of the time.)

• Patients with an EF > 50%

• CRT in patients with non-ambulatory NYHA IV HF symptoms or on chronic inotropic HF therapy or with LV assist devices in place

For purposes of this LCD, international society guidelines were reviewed as well as evidence-based literature.

Major international society guidelines (for a period spanning 2011-2017) for CRT implantation were also reviewed and are noted in the various tables below for reference purposes. The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines published in 2013 agreed with the 2012 focused update of the 2008 guidelines published by the ACCF/AHA/Heart Rhythm Society. These documents, considered together, can be referred to as the ACC/AHA/HRS guidelines. Since these guidelines in 2013, there have been several focused updates of HF published by ACC/AHA/Heart Failure Society of America (HFSA). None of these updates changed the CRT recommendations. Additional guidelines reviewed were the European Society of Cardiology (ESC) guidelines for HF of 2016 and the 2013 ESC European Heart Rhythm Associate guidelines for cardiac pacing and CRT, 2014 National Institute of Health and Care Excellence (NICE) guidelines for ICD and CRT, and the 2017 Canadian Cardiovascular Society Guidelines for the management of HF. Although the international societies provide consistent recommendations for most CRT indications, key differences are noted related to QRS duration, bundle branch block morphology, patient populations with AF, and the patient population likely to be dependent on RV pacing. It is important to note that the timing of the various publications must be considered as the lag time between evidence development and guideline work toward publication no doubt explains some of the discrepancies that currently exist.

Evidence Related to CRT

Cazeau, et al. conducted 1 of the earliest single blind, randomized, controlled crossover studies to examine 67 patients with severe HF (NYHA class III) with normal sinus rhythm (NSR) and a QRS duration > 150 ms who had received a transvenous atrio-biventricular pacemaker. Responses of the patients were compared during 2 periods: a 3-month period of inactive pacing and a 3-month period of active pacing. The primary end point was distance walked in 6 minutes and secondary end points were quality of life by questionnaire, peak oxygen consumption, hospitalization for HF, patients’ treatment preference, and mortality rate. Forty-eight patients completed both phases. The mean distance walked in 6 minutes was 22% greater with active pacing (P 4