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

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.II.  BackgroundThroughout this document we use numerous acronyms, some of which are not defined as they are presented in direct quotations.  Please find below a list of these acronyms and corresponding full terminology.ACC  American College of CardiologyACCF  American College of Cardiology FoundationAF  atrial fibrillationAHA  American Heart AssociationAV  atrioventricularAVB  atrioventricular blockBPEG  British Pacing and Electrophysiology Groupbpm  beats per minuteCTOPP  Canadian Trial of Physiologic PacingHAS  Haute Autorit de Sant (French: High Authority for Health)HRS  Heart Rhythm SocietyLA  left atrialLV  left ventricularLVFS  left ventricular fractional shorteningMOST  Mode Selection TrialNASPE  North American Society of Pacing and Electrophysiology (now known as the Heart Rhythm Society)PASE  Pacemaker Selection in the ElderlyPR  pulse rateRCT  randomized controlled trialSND  sinus node dysfunctionSSS  sick sinus syndromeUKPACE  United Kingdom Pacing and Cardiovascular EventsNomenclature for cardiac pacemaker mode selection is also referenced throughout this document.  The nomenclature was developed by the North American Society of Pacing and Electrophysiology (now known as the Heart Rhythm Society (HRS)) and the British Pacing and Electrophysiology Group (NASPE/BPEG).  The pacing mode codes currently in use were originally published in 1987 and updated in 2002.  Positions I, II, and III indicate the heart chambers where pacing and sensing occur.  Position IV is used to indicate the presence or absence of an adaptive-rate mechanism, and Position V indicates whether multi-site pacing is present (Bernstein et al., 2002) (see Appendix E).CMS initiated this current national coverage analysis to reconsider coverage indications for single chamber and dual chamber cardiac pacemakers.  The scope of this reconsideration and this decision memorandum does not address biventricular pacemakers, pacemakers that stimulate more than two heart chambers, those devices used to treat tachyarrhythmias and cardiac dissynchrony, cardiac resynchronization therapy, cardiac pacemaker evaluation services, or self-contained pacemaker monitors.Permanent cardiac pacemakers refer to a group of self-contained, battery operated, implanted devices that send electrical stimulation to the heart through one or more implanted leads.  Pacemakers are most often used to treat chronic cardiac arrhythmias (abnormalities in the rate and rhythm of heart beats) such as bradycardia (a heart rate usually less than 60 beats per minute (bpm)) or tachycardia (a heart rate faster than 100 or more bpm) that are pathologic.  Bradycardia that causes symptoms such as syncope (a sudden and brief loss of consciousness associated with a loss of postural tone, from which recovery is spontaneous, Kapoor, 2000) is common in older adults and accounts for a large proportion of permanent pacemaker implantations.  Horgan noted in 1984 that [i]ndeed, symptomatic bradycardia is one of the most important signs of the need for a pacemaker and is considered to be present when symptoms can be directly attributed to a slow heart rate.  Zhan noted in 2008 that patients 65 years or older accounted for over 85 percent of pacemaker implantations.Bradycardia can be generally divided into sinus node dysfunction (SND) and atrioventricular (AV) conduction disturbances or blocks (AVB) (Mangrum and DiMarco, 2000).  In the normal heart beat, the sinus node depolarizes and initiates atrial contraction (P wave on the electrocardiogram).  Depolarization travels from the atrium through the AV node into the Bundle of His and the bundle branches, initiating ventricular contraction (QRS complex) (Noble, Hillis and Rothbaum, 1990; see Appendix D).  Together SND and AVB account for the majority of implantations of permanent cardiac pacemakers (86 percent (Bernstein, 2001)).SND, also known as sick sinus syndrome (SSS), may involve abnormalities in the sinus node itself or exit blocks and may be due to intrinsic disease of the nodal tissue due to degeneration or infarction or extrinsic factors such as medications.  SND is relatively common in adults 65 years or older (Mangrum and DiMarco, 2000).  The American Heart Association (AHA) reported that [s]inus node dysfunction occurs in 1 of every 600 cardiac patients 65 years of age and accounts for 50% of implantations of pacemakers in the United States (Roger, 2012).  AV conduction disturbances refer to abnormalities (delay or block) in the AV node or conduction bundle or branches and may occur after myocardial infarction or infections.  These may occur at one of two levels: at the level of the AV node or beyond the bifurcation of the bundle of Histhat is, at the level of the bundles or ventricle (Noble, Hillis and Rothbaum, 1990).AVB is further divided into first degree, second degree and third degree.  First degree AVB is an electrocardiographic finding of a prolonged pulse rate (PR) (P wave to R wave) > 0.2 second (see Appendix D) and does not by itself cause bradycardia, but it is often seen in conjunction with second-degree or third-degree block or sinus-node dysfunction (Mangrum and DiMarco, 2000).  Second degree AVB occurs when an organized atrial rhythm fails to conduct to the ventricle in a 1:1 ratio but some atrialventricular relation is maintained (Mangrum and DiMarco, 2000).  Second degree AVB may be Mobitz type I (also known as Wenckebach block where the electrocardiogram shows a stable PP interval and a progressive increase in the PR interval until a P wave fails to conduct) or Mobitz type II (where there is a stable PP interval with no measurable prolongation of the PR interval before an abrupt conduction failure) (Mangrum and DiMarco, 2000).  Ginter described advanced second degree AVB as follows: In advanced second-degree AV block, two or more consecutive P waves are blocked and further explained that a conduction ratio of 2:1 makes distinguishing between type I or type II difficult.  These blocks and those with a conduction ratio of 3:1 or higher are categorized as advanced (Ginter JF, 2011).  Third degree AVB, or complete heart block, refers to instances where atrial activity and ventricular activity are independent of each other (Mangrum and DiMarco, 2000).In the United States, implanted permanent cardiac pacemakers have been used to treat bradycardia since the early 1960s (Chardack, Gage and Greatbatch, 1960).  They are often classified by the number of chambers of the heart that the devices stimulate (pulse or depolarize).  Single chamber pacemakers typically target either the right atrium or right ventricle.  Dual chamber pacemakers stimulate both the right atrium and right ventricle.The implantation procedure is typically performed under local anesthesia and requires only a brief hospitalization.  A catheter is inserted into the chest and the pacemaker's leads are threaded through the catheter to the appropriate chamber(s) of the heart.  The surgeon then makes a small "pocket" in the pad of flesh under the skin on the upper portion of the chest wall to hold the power source.  The pocket is then closed with stitches.  The procedure leaves a small scar and the battery can be felt through the skin.With technological advancements, the use of dual chamber permanent cardiac pacemakers has dramatically increased over the past several years.  Greenspon and colleagues reported that overall use of pacemakers increased by 55.6 percent between 1993 and 2009 with dual chamber pacemakers increasing from 62 percent to 82 percent by 2009 (Greenspon, 2012).  Several trials and evidence reviews on single and dual chamber pacemakers have been completed and reported since the NCD for cardiac pacemakers was originally established.  Professional society guidelines have also been presented and revised over the years.III.  History of Medicare CoverageSection 20.8 of the Medicare National Coverage Determinations (NCD) Manual is a long standing policy that dates back to 1983.  This NCD establishes conditions of coverage and non-coverage for permanent single chamber and dual chamber cardiac pacemakers.  In June 2000, Medtronic requested that CMS review the use of cardiac pacemakers to treat asymptomatic bradycardia in post-MI patients about to initiate long-term -blocker drug therapy.  After a complete systematic review of the evidence provided, CMS posted a coverage decision memorandum (CAG-00063N) on March 20, 2001, that maintained the non-coverage NCD that pacemaker implantation would not be considered reasonable and necessary in these patients.The NCD was last updated in 2004 when CMS issued a decision memorandum to focus the NCD on the indications for pacemaker use rather than on the pacemaker implantation procedure.  This reflected CMS finding that pacemaker implantation was no longer an experimental procedure.  CMS only changed the framework of the NCD and did not review the specific provisions setting forth conditions that indicate that cardiac pacing is reasonable and necessary.A.  Current ReconsiderationCMS received a formal external joint request from HRS and the American College of Cardiology (ACC) for reconsideration of dual-chamber pacemaker coverage.  The request outlined differences between clinical guidelines and current Medicare coverage policy, focusing on revisions to the clinical indications for dual-chamber pacemakers.  The requestor believes that the HRS/American College of Cardiology Foundation (ACCF) Expert Consensus Statement on Pacemaker Device and Mode Selection and additional evidence support expansion and clarification of Medicare coverage policy for the use of dual-chamber cardiac pacemakers.B.  Benefit CategoryMedicare is a defined benefit program.  An item or service must fall within a benefit category as a prerequisite to Medicare coverage [1812 (Scope of Part A); 1832 (Scope of Part B); 1861(s) (Definition of Medical and Other Health Services)].  An item or service must meet one of the statutorily defined benefit categories in the Social Security Act and not otherwise be excluded.  Cardiac pacemakers qualify as:Inpatient hospital services.Physicians services.Prosthetic devices.Thus, cardiac pacemakers qualify as a benefit.Note:  This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.IV.  Timeline of Recent ActivitiesDateActionJanuary 24, 2013CMS initiates this national coverage analysis for reconsideration of Section 20.8 of the NCD Manual.  The initial 30-day public comment period began with this posting date.February 23, 2013The initial 30-day public comment period ended. CMS received 98 comments.May 29, 2013CMS posted the proposed decision memorandum.  The 30-day public comment period began with this posting date.June 28, 2013The 30-day public comment period ended.  CMS received 50 comments.