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

National Institute for Clinical Excellence. Dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome and/or atrioventricular block. Technology Assessment 88. February 2005.The National Institute for Clinical Excellence (NICE) published a technology appraisal with evidence-based guidelines on dual chamber pacemakers for symptomatic bradycardia due to SSS and/or AVB.  A total of 32 studies of dual chamber pacemakers versus single chamber ventricular pacemakers were identified.  Four parallel randomised controlled trials (RCTs) allocated a total of 7006 patients to single- or dual-pacing modes (MOST and PASE studies), or single- or dual-chamber devices (CTOPP and the unpublished UKPACE study).  The Institute noted: Dual-chamber pacing is recommended for the management of symptomatic bradycardia due to sick sinus syndrome, atrioventricular block, or a combination of sick sinus syndrome and atrioventricular block, except:in the management of sick sinus syndrome in patients in whom, after full evaluation, there is no evidence of impaired atrioventricular conduction; in this situation, single-chamber atrial pacing is appropriatein the management of atrioventricular block in patients with continuous atrial fibrillation; in this situation, single-chamber ventricular pacing is appropriatein the management of atrioventricular block (atrioventricular block alone, or in combination with sick sinus syndrome), when patient-specific factors, such as frailty or the presence of comorbidities, influence the balance of risks and benefits in favour of single-chamber ventricular pacing.Vardas PE, Auricchio A, Blanc JJ, Daubert JC, Drexler H, Ector H, Gasparini M, Linde C, Morgado FB, Oto A, Sutton R, Trusz-Gluza M; European Society of Cardiology; European Heart Rhythm Association. Guidelines for cardiac pacing and cardiac resynchronization therapy: The Task Force for Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology. Developed in collaboration with the European Heart Rhythm Association. Eur Heart J. 2007 Sep;28(18):2256-95. Epub 2007 Aug 28.The European Society of Cardiology and European Heart Rhythm Association jointly published guidelines for cardiac pacing.  For sinus node disease, the recommendations are below (copy of Table 1.1.1):For AVB, the recommendations are below (copy of Table 1.2.1):5.  Consensus StatementGillis AM, Russo AM, Ellenbogen KA, Swerdlow CD, Olshansky B, Al-Khatib SM, Beshai JF, McComb JM, Nielsen JC, Philpott JM, Shen WK; Heart Rhythm Society; American College of Cardiology Foundation, HRS/ACCF expert consensus statement on pacemaker device and mode selection.  Developed in partnership between the Heart Rhythm Society (HRS) and the American College of Cardiology Foundation (ACCF) and in collaboration with the Society of Thoracic Surgeons, Heart Rhythm, 2012 Aug;9(8):1344-65, doi: 10.1016/j.hrthm.2012.06.026.Gillis AM, Russo AM, Ellenbogen KA, Swerdlow CD, Olshansky B, Al-Khatib SM, Beshai JF, McComb JM, Nielsen JC, Philpott JM, Shen WK.  HRS/ACCF expert consensus statement on pacemaker device and mode selection. J Am Coll Cardiol. 2012 Aug 14:60(7):682-703. Doi:10.1016/j.jacc.2012.06.011. Epub 2012 Jul 30.Gillis and colleagues reported the opinions of the HRS/ACCF consensus writing group on pacemaker device and mode selection.  The authors noted that recommendations for device selection in the current document apply to situations where the clinical decision for pacing has already been made.  The Class I (see Appendix F - Conditions for which there is evidence and/or general agreement that a given pacing mode is beneficial, useful and effective.) recommendations were:Dual-chamber pacing (DDD) or single-chamber atrial pacing (AAI) is recommended over single-chamber ventricular pacing (VVI) in patients with SND and intact AV conduction (Level of Evidence: A).Dual-chamber pacing is recommended over single-chamber atrial pacing in patients with SND (Level of Evidence: B).Dual-chamber pacing is recommended in patients with AV block (Level of Evidence: C).Single-chamber ventricular pacing is recommended as an acceptable alternative to dual-chamber pacing in patients with AV block who have specific clinical situations that limit the benefits of dual-chamber pacing.  These include, but are not limited to, sedentary patients, those with significant medical comorbidities likely to impact clinical outcomes, and those in whom technical issues, such as vascular access limitations, preclude or increase the risk of placing an atrial lead (Level of Evidence: B).Dual-chamber pacing is recommended over single-chamber ventricular pacing in adult patients with AV block who have documented pacemaker syndrome (Level of Evidence: B).6.  Public CommentsThe comments can be viewed in their entirety on our website athttp://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=267&ExpandComments=n&NcaName=Cardiac+Pacemakers*3a%24+Single-Chamber+and+Dual-Chamber+Permanent+Cardiac+Pacemakers+(3rd+Recon)&bc=AiAAAAAACAAAAA%3d%3d&.Initial 30-day Comment PeriodDuring the initial 30-day comment period, CMS received 98 comments from various entities including:  the American Heart Association/American Stroke Association, the Heart Rhythm Society, device manufacturers, coding consultants, hospital health systems, physicians, health network utilization review departments, hospitals, case managers, and the general public.Ninety-four (94) comments supported modification of Medicare coverage of dual chamber pacemakers, of which 80 comments supported modifications consistent with the opinions of the HRS/ACCF consensus writing group.  Of the 80 comments, 42 were form letter submissions.  Five comments also included suggested changes for coverage of single chamber pacemakers.One commenter did not support modification of the current NCD.  Three comments did not express a position regarding modification of the NCD, but raised issues about coding and enforcement of existing policy.Public Comments on the Proposed Decision MemorandumWe received 50 comments on the proposed decision from various entities including physician specialty societies, hospitals, health networks, physicians, community health networks, a health policy association, device manufacturers, and the general public.  Forty-nine (49) comments supported the proposed decision, with nine of those comments suggesting modifications to the proposed covered and non-covered indications.  One comment opposed the proposed decision.  Three comments included references to guidelines, consensus statements, and articles that were previously included in our review of the evidence.  Among the three comments that furnished references, one included a reference to the NCD for implantable cardiac defibrillators, which is outside the scope of this analysis.  Another commenter included references to general clinical articles on medical management, which are not considered primary clinical research studies.  The same commenter referenced articles that address topics that are outside the scope of this national coverage analysis.  Specific issues and suggested modifications furnished by commenters are discussed below.Comment:Commenters opined that coverage was appropriate for patients with sinus node dysfunction and sick sinus syndrome.Response:In the background section of this decision memorandum we state that sinus node dysfunction is also known as sick sinus syndrome; we believe these terms to be synonymous.  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 symptomatic bradycardia due to SND.Comment:Commenters requested coverage for asymptomatic second degree AVB 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).Response:In general, individuals without symptoms are not treated with permanent implantable single chamber or dual chamber pacemakers.  The patients in the studies we evaluated were symptomatic.  Patients with progressive heart block may develop symptoms in the future that could lead to a patient having a covered indication.  Based on our review of the published evidence, we did not find specific evidence to support coverage for this indication.  Therefore, we are finalizing non-coverage for this indication.Comment:Commenters requested coverage 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, which we proposed to non-cover.Response:We recognize that various arrhythmias may occur in patients with acute myocardial infarctions and that this indication has been covered for single chamber pacemakers under existing policy, meaning that patients may have received this treatment under certain circumstances.  We are permitting local Medicare contractors to make the coverage determination under section 1862(a)(1)(A) 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.Comment:Commenters suggested that hypersensitive carotid sinus syndrome should be considered a covered indication based on consensus recommendations that stated permanent pacing is indicated for recurrent syncope caused by spontaneously occurring carotid sinus stimulation and carotid sinus pressure that induces ventricular asystole of more than three seconds (Class I Recommendation, Level of Evidence C); and permanent pacing is reasonable for syncope without clear, provocative events and with a hypersensitive cardioinhibitory response of three seconds or longer (Class IIa Recommendation, Level of Evidence C).  Commenters also suggested that we remove the example from one of the non-covered indications since it references hypersensitive carotid sinus syndrome.Response:Our covered indications do not specifically address hypersensitive carotid sinus syndrome, thus we are permitting local Medicare contractors to make the coverage determination for this indication under section 1862(a)(1)(A).  We are modifying one non-covered indication for clarity and to ensure there is internal consistency with our covered indications, to read as follows:  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.Comment:One commenter suggested that there was a technical error in our proposed non-coverage of P-R intervals with atrial fibrillation (without third-degree atrioventricular block).Response:We appreciate the commenters feedback.  In patients with atrial fibrillation, the P-R interval may be difficult to detect and relate to bradycardia.  In this final decision, we are permitting local Medicare contractors to make the coverage determination under section 1862(a)(1)(A) for this indication.Comment:One commenter suggested that patients with symptomatic reversible sinus bradycardia that results from required drug therapy for medical conditions should be covered.Response:Reversible causes of bradycardia (such as electrolyte abnormalities, medications or drugs, or hypothermia) are transient and not permanent in nature.  The published evidence does not support permanent pacemaker implantation for conditions that are transient or not permanent in nature.  Therefore, we are not making the requested change.Comment:Some commenters requested that we allow coverage for the non-covered indications when evaluated in Category B IDE clinical trials.Response:Local contractors are bound by national coverage determinations in their review of claims for payment, including evaluations for coverage in Category B IDE clinical trials.  Nationally non-covered indications would not be coverable by local contractors.  Based on the evidence reviewed, we are not making the requested change in this NCD.Comment:Commenters identified the following indications that were not specifically addressed in the proposed decision, but believed these indications should be covered:Any form of brady-tachy syndrome;Pacemaker syndrome or indications that pacemaker syndrome may develop in the future;Asymptomatic second and third degree AVB;Asymptomatic Mobitz type II AVB or complete heart block, which are infrequently picked up on 24 hour monitoring or while a patient is in the hospital;Symptomatic or asymptomatic chronotropic incompetence, irrespective of whether a patients heart rate is above or below 60 bpm;Second degree Mobitz Type I AVB when QRS complexes are prolonged, regardless of the presence of symptoms;Patients in sinus rhythm that develop indications for heart block;Symptomatic or at high risk of congenital long QT syndrome; andBifascicular or trifascicular block accompanied by syncope which is attributed to transient complete heart block after other plausible causes of syncope have been reasonably excluded.