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

Response:Based on the trials included in our analysis, we believe the evidence supports the use of permanent single chamber or dual chamber cardiac pacemakers for treatment of documented non-reversible symptomatic bradycardia due to SND or second degree and/or third degree AVB.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.Comment:Commenters requested coverage for patients with medically refractory symptomatic hypertrophic cardiomyopathy or provoked left ventricular outflow obstruction, and coverage for patients with recurrent and refractory ventricular tachycardia (overdrive pacing  pacing above the basal rate) to prevent ventricular tachycardia.Response:Overdrive pacing, generally considered to be related to the use of implanted cardiac defibrillators (ICDs) and treatment of medically refractory symptomatic hypertrophic cardiomyopathy were not considered.  As discussed in the background section, the scope of this reconsideration and this coverage determination does not address biventricular pacemakers, pacemakers that stimulate more than two heart chambers, those devices used to treat tachyarrhythmias and cardiac dyssynchrony, cardiac resynchronization therapy, cardiac pacemaker evaluation services, or self-contained pacemaker monitors.  Therefore, we believe these indications fall outside the scope of this national coverage analysis.Comment:Commenters disagreed with our assessment that dual chamber pacemakers are neither superior nor inferior to single chamber pacemakers and believe the statement should be deleted from the decision memorandum.  Some suggested that we modify statements that address higher complication rates with dual chamber pacing.Response:Our statement was based on the trials included in our analysis that reported no difference in mortality, the primary outcome of interest, between single chamber and dual chamber cardiac pacemakers.  As noted in the analysis, there is some indication of better secondary outcomes from use of dual chamber pacemakers compared to single chamber, although not uniformly significant.  Health outcomes are comparable for patients who receive dual chamber pacemakers compared to those who receive single chamber pacemakers for symptomatic bradycardia but the choice of device may be influenced by the reduced rate of AF and higher perioperative complications seen with implantation of dual chamber pacemakers.  We recognize the statement may be generally interpreted to apply to all outcomes whether primary or secondary and, therefore, have revised the analysis accordingly.Comment:Some commenters disagreed with the need to document and provide justification of therapeutic choice in the medical record, while other commenters requested guidance regarding the type of information that should be included in the patients medical record.Response:Shared decision making between the physician and patient remains important for device choice on an individual basis.  We expect that physicians will carefully document the need for dual chamber pacemakers in the medical record, and that patients will be informed of the potentially higher complication rates following implantation of dual chamber devices as reported in the randomized controlled trials.  The use of evidence-based guidelines and expert consensus statements may also help to inform the device selection process.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.Practitioners may wish to contact their local Medicare Administrative Contractors for additional guidance regarding medical record documentation.Comment:The majority of commenters requested that this coverage determination be applied retroactively three to five years due to concerns about enforcement of existing coverage requirements.Response:This NCD is effective for claims with dates of service on or after the date of the NCD.  NCDs are not applied retroactively.VIII.  CMS AnalysisNational coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally by Medicare (1862(l) of the Social Security Act).  In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage.  Moreover, section 1862(a)(1) of the Social Security Act in part states, with limited exceptions, no payment may be made under Part A or Part B for any expenses incurred for items or services, which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (1862(a)(1)(A)).As noted earlier, our review sought to answer the following question, which has been repeated here for the convenience of the reader.Is the evidence sufficient to determine that implantation and use of permanent single or dual chamber cardiac pacemakers improve health outcomes in Medicare beneficiaries?Since the first successful use of a permanent single chamber cardiac pacemaker in 1960 resulted in a post-implant survival of 18 months for a patient with complete heart block (Chardack, 1960; Beck, 2010), various studies and reviews (Edhag, 1976; Hansen, 1974; Mller, 1988; Rosenqvist, 1992) have supported the improvements in health outcomes from implantation and use of single chamber pacemakers.  Hansen and Meibom (1974) reported one year survival of 87 percent for patients with complete heart block treated with permanent pacemakers compared to 50 percent for similar patients without pacemakers (Johansson, 1969).  Rosenqvist and Norlander (1992) reported that [i]n spite of lack of controlled studies it has been convincingly shown that VVI [fixed rate ventricular] pacing prolongs life in patients with high-grade AV block.  There is an established and well-accepted association of implantation and use of permanent single chamber pacemakers and improved health outcomes.Over the past five decades, as medical knowledge and technology have advanced, the cardiac pacemaker has evolved from a bulky single lead device to a category of sophisticated devices with one or more leads capable of administering complex pacing programs and auto-monitoring.  Greenspon (2012) noted the rapid uptake and utilization of these advanced devices in place of the single lead pacemaker, which is historically the recognized standard for symptomatic bradycardia.  With the changes in the past decades, CMS has conducted this analysis to update the coverage decision from the early 1980s.  Ideally there should be robust evidence on benefits of new technology prior to widespread adoption, to support clinically important advancements in the health of the population.For symptomatic bradycardia, five randomized controlled trials (CTOPP, DANPACE, MOST, PASE, UKPACE), two systematic evidence reviews (Cochrane and UK HTA) and evidence-based guidelines from professional societies were included in our analysis for the health outcome of all-cause mortality (primary outcome in DANPACE and UKPACE; pre-specified secondary outcome in CTOPP, PASE, and MOST).  None of the trials demonstrated significant differences in all-cause mortality between dual chamber pacemakers and single chamber pacemakers.  In other words, the  mortality rate in patients receiving dual chamber pacemakers was comparable to the rate in patients who received single chamber pacemakers for symptomatic bradycardia due to SND or AV conduction blocks.  There were also no reported significant differences in stroke or cardiovascular death.  While the Cochrane review was published in 2004 and did not include two trials (DANPACE, UKPACE), the findings were consistent with our review.  The UK HTA appraisal (2005), which did not include DANPACE and the final published results of UKPACE, also found no significant effect on mortality.  Although there are no suggestions that the reviews will be revised, it seems unlikely that the  inclusion of the results of these two trials would markedly alter the conclusions of the Cochrane review and UK HTA appraisal given the reported findings of DANPACE and UKPACE.While there is no reported difference in mortality between single chamber and dual chamber cardiac pacemakers, there is some indication of better secondary outcomes from use of dual chamber pacemakers, including reduction in occurrence of AF and improved quality of life.  For AF, two trials (CTOPP, MOST) found small but significant absolute reductions in rate of AF in patients receiving dual chamber pacemakers compared to single chamber.  Connolly and colleagues (CTOPP) noted that for every 100 patients treated for three years with physiologic rather than  ventricular pacing, the occurrence of atrial fibrillation would be prevented in 4 patients.  Kerr (2004) reported that there is a persistent significant reduction in the development of atrial fibrillation with physiological pacing after analysis of six year follow-up data from CTOPP.  Lamas (MOST) reported when compared with ventricular pacing, dual-chamber pacing reduces newly  diagnosed and chronic atrial fibrillation.  Nielsen (DANPACE) reported a difference in paroxysmal AF but not chronic AF, although the other trials did not make this fine differentiation.  Toff (UKPACE) did not find any significant difference in AF.Quality of life was a primary outcome in one study (PASE) and a secondary outcome in another (MOST).  Lamas (PASE) reported that health related quality of life improved with permanent pacemaker implantation but there was no significant difference between single and dual chamber pacemakers.  Similar results were reported by Fleischmann (MOST) who noted that [p]acemaker implantation improved health-related QOL but QOL subscale results were mixed according to pacemaker mode.  Quality of life is an important patient-centered outcome but measurement of this outcome may be subject to participant and recall bias.  Periprocedural complications (usually within 30 days of implantation) were specifically reported in two trials (CTOPP, UKPACE) and were significantly higher for dual chamber pacemakers compared to single chamber pacemakers.Based on our review of the published evidence of these trial results, health outcomes are comparable for patients who receive dual chamber pacemakers compared to those who receive single chamber pacemakers for symptomatic bradycardia but the choice of device may be influenced by the reduced rate of AF and higher perioperative complications seen with implantation of dual chamber pacemakers.  The trial populations were representative of the Medicare population on age, comorbidities and indications for cardiac pacing so generalizability is acceptable.  Since historically the implantation and use of single chamber pacemakers have resulted in improved survival, these devices are generally considered the gold standard for patients with symptomatic bradycardia.  Dual chamber pacemakers may be considered alternatives for individuals who may benefit from more complex pacing.  This position is consistent with evidence based guidelines from ACC/AHA/HRS (2008) and ESC (2007) that state that permanent cardiac pacemakers for symptomatic bradycardia due to either SND or third degree and advanced second degree AVB are recommended.Shared decision making between the physician and patient remains important for device choice on an individual basis.  We expect that physicians will carefully document the need for dual chamber pacemakers in the medical record, and that patients will be informed of the potentially higher complication rates following implantation of dual chamber devices as reported in the randomized controlled trials.  The use of evidence-based guidelines and expert consensus statements may also help to inform the device selection process.Based on our review of the published evidence, we did not find specific evidence to support making many modifications to the list of specific non-covered indications identified in section 20.8 of the NCD Manual.  Due to changes to the covered indications, however, we are revising the descriptions of the non-covered indications for clarity and to ensure there is internal consistency with covered indications.  For instance, we are eliminating without significant symptoms as used to describe certain non-covered indications in existing policy because we use symptomatic to describe covered indications.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).