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

htmlRequired meta tagsNCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision MemoBootstrap is used with permission under the MIT license: https://github.com/twbs/bootstrap/blob/master/LICENSEjQuery is used with permission under the MIT license: https://jquery.org/license/New RelicThe page could not be loaded. The CMS.gov Web site currently does not fully support browsers with"JavaScript" disabled. Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with"JavaScript" disabled.Instructions for enabling "JavaScript" can be found here.Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available.Skip to main contentAn official website of the United States governmentHere's how you knowHere's how you knowThe .gov means it's official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.The site is secure.Thehttps://ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.Resource NavigationSearchReportsDownloadsArchiveAPIopens in new window<button id="toggle-mobile-search" class="mobile-search-btn" aria-expanded="false"><span class="ds-u-visibility--screen-reader">Toggle Mobile Search</span></button>Close SearchCenters for Medicare & Medicaid ServicesMain headerAbout UsNewsroomData & ResearchMCDMedicare Coverage DatabaseSearchReportsNational CoverageWhat's New ReportAnnual ReportNCA/CAL ReportsNCA/CAL Status ReportNCA/CAL Open for Public Comment ReportNCD ReportMedicare Coverage Documents ReportsMedicare Coverage Documents ReportMed Cov Docs Open for Public Comment ReportOther National Coverage ReportsMEDCAC Meetings ReportTechnology Assessments ReportLocal CoverageWhat's New ReportFinal LCD ReportsFinal LCDs by Contractor ReportFinal LCDs by State ReportFinal LCDs Alphabetical ReportProposed LCD ReportsProposed LCDs by Contractor ReportProposed LCDs by State ReportProposed LCDs Alphabetical ReportArticle ReportsArticles by Contractor ReportArticles by State ReportArticles Alphabetical ReportSAD Exclusion List ReportMAC Contacts ReportDownloadsHelp & ResourcesPage HelpTour the SearchTour the ReportsContact UsReset Search DataArchiveAPIBack to Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac PacemakersContentsDecision SummaryProposedDecision MemoBibliographyRelated MaterialNational Coverage Analysis (NCA)ProposedDecision MemoCardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac PacemakersCAG-00063R3Expand All|Collapse AllDownloadDecision SummaryThe 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.ProposedDecision MemoTo:Administrative File: CAG-00063R3  From:Louis Jacques, MD Director, Coverage and Analysis Group  Tamara Syrek Jensen, JD Deputy Director, Coverage and Analysis Group  Jyme Schafer, MD, MPH Director, Division of Medical and Surgical Services  Joseph Chin, MD, MS Lead Medical Officer  Jamie Hermansen, MPP Lead Health Policy Analyst  Subject:Decision Memorandum for Reconsideration of Coverage of Cardiac Pacemakers: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers.   Date:August 13, 2013I.  DecisionThe 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.