NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo

We are specifically non-covering permanent implantable single chamber or dual chamber cardiac pacemakers for patients with reversible causes of bradycardia (such as electrolyte abnormalities, medications or drugs, or hypothermia), since reversible causes of bradycardia are transient and not permanent in nature.  We are non-covering permanent implantable single chamber or dual chamber cardiac pacemakers for patients with asymptomatic first degree AVB.  Epstein and colleagues noted that there is little evidence to suggest that pacemakers improve survival in patients with isolated first-degree AV block and further noted: Permanent pacemaker implantation is not indicated for asymptomatic first-degree AV block (Epstein, 2008).  Based on the public comments received, we are leaving the coverage determination under section 1862(a)(1)(A) to local Medicare contractors for prophylactic pacemaker use following recovery from acute myocardial infarction during which there was temporary complete (third-degree) and/or Mobitz Type II second-degree AVB in association with bundle branch block; and prolonged P-R intervals with atrial fibrillation (without third-degree atrioventricular block).While pacemaker longevity has increased over the past few decades, replacement of a permanent cardiac pacemaker is occasionally needed due to wear or damage to one or more components (battery, generator, or leads).  We did not find any specific evidence or recommendations on how to replace these devices or on which replacement devices should be used.  Given the nature of the reasons for replacements, prudent clinical judgment should be used on an individual basis, along with documentation in the medical record on the initial indication for the pacemaker, the reason for replacement, and the justification of the type of replacement device selected.  In rare instances, historical medical records may not be immediately available; however, adequate documentation should still be maintained to explain the existing circumstances and situation.DisparitiesGender differences have been reported for various cardiac interventions (Jacobs, 2003) and implanted devices (Curtis, 2007).  For cardiac pacemakers, Nowak and colleagues (2010) reported that gender has an impact [on] pacemaker implantation, with less favourable outcomes for women.  CMS will monitor utilization of permanent implanted cardiac pacemakers for gender differences in the Medicare population.  If gender differences are detected, then modifications may be considered.SummaryThere is an established and accepted association between single chamber cardiac pacemaker use, survival, and improvement in health outcomes.  Historically, the use of single chamber pacemakers has been shown to improve survival for treatment of symptomatic bradycardia.  Studies have demonstrated that health outcomes are similar for individuals that receive dual chamber pacemakers compared with single chamber pacemakers for treatment of symptomatic bradycardia.  A dual chamber pacemaker may be considered as an alternative for individuals who may benefit from more complex pacing.  There is some indication of better secondary outcomes from the use of dual chamber pacemakers, including reduction in occurrence of atrial fibrillation and improved quality of life.  The choice of device may be influenced by reduced occurrence of AF and higher perioperative complications seen with dual chamber pacemakers, emphasizing the importance of informed, shared decision making between the physician and patient.  Therefore, we have determined that permanent implantable single chamber and dual chamber cardiac pacemakers are reasonable and necessary subject to the conditions described in our conclusion below.IX.  ConclusionThe 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: