DEFINITION:

A cardiac pacemaker is a prosthetic device that helps to set the heartbeat rhythm when a heart is unable to maintain a consistent rhythm on its own. The small device is inserted under the skin on a patient's chest or abdomen, and communicates electrically with the heart through connecting wires.

COVERAGE:

Permanent implanted cardiac pacemakers are generally covered subject to the Indications/Limits listed below.

Indications that are covered

Chronic or recurrent conditions not due to transient causes such as acute myocardial infarction, drug toxicity, or electrolyte imbalance.

• Acquired complete (3^rd Degree) AV heart block
• Congenital complete heart block with severe bradycardia (in relation to age), or significant physiological deficits or significant symptoms due to the bradycardia
• 2^nd Degree AV heart block of Type II (i.e., no progressive prolongation of P-R interval prior to each blocked beat)
• 2^nd Degree AV heart block of Type I (i.e., Progressive prolongation of P-R interval prior to each blocked beat) with significant symptoms due to hemodynamic instability associated with the heart block
• Sinus bradycardia associated with major symptoms (e.g., syncope, seizures, congestive heart failure, dizziness or confusion). The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.
• In selected and few patients, sinus bradycardia of lesser severity (heart rate 50-59) with dizziness or confusion. The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.
• Sinus bradycardia which is the consequence of long term necessary drug treatment for which there is no acceptable alternative, when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness, or confusion). The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.
• Sinus node dysfunction with or without tachyarrhythmias or AV conduction block--i.e., the bradycardia-tachycardia syndrome, sino-atrial block, sinus arrest--when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness, or confusion).
• Sinus node dysfunctions with or without symptoms when there are potentially life-threatening ventricular arrhythmias or tachycardia secondary to the bradycardia (e.g., numerous premature ventricular contractions, couplets, runs of premature ventricular contractions, or ventricular tachycardia).
• Bradycardia associated with supraventricular tachycardia (e.g., atrial fibrillation, atrial flutter, or paroxysmal atrial tachycardia) with a high degree AV block with is unresponsive to appropriate pharmacological management and when the bradycardia is associated with significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness, or confusion).
• The occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive due to prophylactic medical measures.
• Bifascicular or trifascicular block accompanied by syncope, which is attributed to transient complete heart block after other plausible causes of syncope have been reasonably excluded.
• Prophylactic pacemaker use following recovery from acute myocardial infarction during which there was temporary complete (3^rd degree) and/or Mobitz Type II 2^nd degree AV block in association with bundle branch block.
• In patients with recurrent and refractory ventricular tachycardia, "overdrive pacing" (pacing above the basal rate) to prevent ventricular tachycardia.
• 2^nd degree AV heart block of Type I with the QRS complexes prolonged.

The following conditions are generally considered unsupported by adequate evidence of benefit, unless patient also has one of the above indications.

• Syncope of undetermined cause
• Sinus bradycardia without significant symptoms
• Sino-atrial block or sinus arrest without significant symptoms
• Prolonged R-R intervals with atrial fibrillation (without 3^rd degree AV block) or with other causes of transient ventricular pause
• Bradycardia during sleep
• Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent AV block.
• Asymptomatic 2^nd degree AV block of Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle.

Indications that are covered

Here is a list of conditions under which implantation of a permanent dual chamber cardiac pacemaker would be covered.

• Patients who have had a definite drop in blood pressure, retrograde conduction, or discomfort at the time of single-chamber pacemaker insertion.
• Patients with a history of Pacemaker Syndrome (atrial ventricular asynchrony), with significant symptoms with a previous pacemaker.
• Patients in whom even relatively small increases in cardiac efficiency will importantly improve the quality of life, e.g., patients with congestive heart failure despite adequate other medical measures.
• Patients in whom the pacemaker syndrome can be anticipated, e.g., in young and active people, etc.
• Dual-chamber pacemakers may also be covered for the conditions as listed for single-chamber implanted permanent cardiac pacemakers, if the medical necessity is sufficiently justified through adequate claims development.

Whenever the following conditions (which represent overriding contraindications) are present, dual-chamber pacemakers are not covered:

• Ineffective atrial contractions--e.g., chronic atrial fibrillation or flutter, or giant left atrium.
• Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of tachycardia.
• A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged, e.g., the occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures.
• Prophylactic pacemaker use following recovery from acute myocardial infarction during which there was a temporary complete (3^rd degree) and/or Type II 2^nd degree AV block in association with bundle branch block.

Does not require Prior Authorization

PRODUCTS:

This policy applies:

• to all products administered by Medicare

Details of the Medicare Coverage Issues Manual, and the Medicare National Coverage Decisions Index with the bibliography of related research that supports these policies can be viewed at: http://www.hcfa.gov/pubforms/06_cim/ci00.htm or http://hcfa.gov/coverage/8e.htm.