The biventricular pacemaker used for the treatment of heart failure consists of a pulse generator that is implanted in the chest and connected to the heart by three wires (leads) that deliver electrical impulses. One wire is placed in the upper right heart chamber and the others are placed in each of the two lower chambers, where they simultaneously stimulate both the left and right ventricles. This device differs from a standard pacemaker in that it has three leads instead of one or two leads.

FDA approved biventricular pacemakers [Cardiac Resynchronization Therapy (CRT) with or without an accompanying FDA approved implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD)] may be considered medically necessary as a treatment of heart failure in patients who meet ALL of the following criteria:

New York Heart Association Class III or IV

• Left ventricular ejection fraction less than or equal to 35%; and
• Sinus rhythm; and
• Either left bundle branch block (LBBB) or QRS interval greater than or equal to 150 ms; and
• 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

• Left ventricular ejection fraction less than or equal to 30%; and 
• Sinus rhythm; and
• Either left bundle branch block (LBBB) or QRS interval greater than or equal to 150 ms; and
• 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.

The use of an FDA-approved ICD, in combination with cardiac resynchronization therapy (CRT/ICD), may be considered medically necessary when the criteria listed above for CRT therapy AND the criteria within Medically Policy Bulletin, S-59, Implantable Automatic Cardioverter-Defibrillator, are met.

Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD) are considered experimental/investigational, and therefore non-covered, as a treatment for patients with NYHA Class I heart failure.

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

• NYHA class I, II, III, or IV heart failure; and
• Left ventricular ejection fraction less than or equal to 50%; and
• The presence of atrioventricular (AV) block with requirement for a high percentage of ventricularpacing**; and
• Patients treated with guideline-directed medical therapy.

**AV block with a requirement for a high percentage of ventricular pacing is considered to be present when there is either of the following:

• Third-degree AV block; or
• Second-degree AV block or a PR interval of 300 ms or more when paced at 100 beats per minute.

Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a combined biventricular pacemaker/ICD), are considered experimental/investigational and, therefore, non-covered as a treatment for heart failure in patients with atrial fibrillation who do not meet the above criteria.

The use of an FDA-approved ICD, in combination with cardiac resynchronization therapy (CRT/ICD), may be considered medically necessary when the criteria listed above for CRT therapy AND the criteria within Medically Policy Bulletin, S-59, Implantable Automatic Cardioverter-Defibrillator, are met.

An intrathoracic fluid monitoring sensor is considered experimental/investigational and, therefore, non-covered, as a component of a biventricular pacemaker.

Triple-site (triventricular) CRT, using an additional pacing lead, is considered experimental/investigational and, therefore, non-covered.

Refer to Medical Policy S-59 Implantable Automatic Cardioverter-Defibrillator, for additional information.