Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers

CMS NCA document | source_status=Closed | review_type=3rd Recon | public_comment_open=False | document_id=CAG-00063R3

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute (for example: syncope, seizures, congestive heart failure, dizziness, or confusion). Therefore, the following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers: Documented non-reversible symptomatic bradycardia due to sinus node dysfunction. Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block. The following indications are non-covered since there is insufficient evidence to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary: Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia. Asymptomatic first degree atrioventricular block. Asymptomatic sinus bradycardia. Asymptomatic sino-atrial block or asymptomatic sinus arrest. Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia. Asymptomatic second degree atrioventricular block of Mobitz 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 (a component of the electrical conduction system of the heart). Syncope of undetermined cause. 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 atrioventricular block. Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy. Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of the 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. Medicare Administrative Contractors will determine coverage under section 1862(a)(1)(A) of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination.