evekhm/cms_iom_500 huggingface dataset:
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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.
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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).
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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)).
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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).
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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.
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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 Reconsideration
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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:
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
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.
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
V. Food and Drug Administration (FDA) StatusThe class to which a device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market.  If a device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.  For Class III devices, a premarket approval application (PMA) is required for marketing.  Pacemakers that are currently developed which are considered similar to predicate devices are cleared through the 510k process.  The FDA approves pacemakers for sino-atrial node dysfunction (e.g. sinus bradycardia, sinus arrest) and AV node dysfunction including second or third degree AV node block.VI.  General Methodological PrinciplesWhen making national coverage determinations under 1862(a)(1)(A), CMS generally evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.  The critical appraisal of the evidence enables us to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve health outcomes for patients.  An improved health outcome is one of several considerations in determining whether an item or service is reasonable and necessary.A detailed account of the methodological principles of study design that the agency utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendix A.  In general, features of clinical studies that improve quality and decrease bias include the selection of a clinically relevant cohort, the consistent use of a single good reference standard, the blinding of readers of the index test, and reference test results.  Public comments sometimes cite the published clinical evidence and give CMS useful information.  Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination.  Public comments that contain personal health information (PHI) will be redacted and the PHI will not be made available to the public.  CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum.VII.  EvidenceA.Introduction
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
VII.  EvidenceA.IntroductionIn this coverage analysis, we considered evidence for single or dual chamber permanent cardiac pacemakers for the treatment of symptomatic bradycardia.  Important health outcomes include mortality, morbidity (including adverse events), and quality of life (QOL).  Increased survival has been demonstrated with initial use of single chamber pacemakers.  The first patient to receive an implanted pacemaker was able to leave the hospital and lead a moderately active life for more than two years after receiving the implant.  Given the past research and evidence on survival from use of permanent pacemakers, our analysis focuses on mortality, but also emphasizes other health outcomes.  We note that while quality of life is an important health outcome, it is more difficult to objectively measure and discern potential bias in the reported studies.B. Literature SearchCMS searched PubMed from February 2004 (date of the last NCD) to December 2012 using key words pacemakers, single and dual.  We initially focused our search on randomized controlled trials (RCTs) and large prospective observational studies that evaluated adults  65 years.  Observational studies with sample sizes less than 50 cases were excluded as they may have inherent biases that substantially limit generalizability.  Abstracts, presentations, and articles not written in English were also excluded. In addition to our search, the requestors submitted 100 article summaries which were reviewed; seventeen articles met our criteria and were included in our review (five randomized trials, one randomized controlled comparison, one technology appraisal, one meta-analysis, two evidence reviews, one follow-up analysis of a randomized trial, one registry analysis, one secondary outcome analysis, three evidence-based guidelines, and one consensus statement).CMS does not consider cost when developing NCDs under 1862(a)(1)(A).  Some of the studies included in our review evaluated cost-effectiveness; however, CMS analysis did not rely on cost-effectiveness, nor did any cost effectiveness information impact the decision.C. Discussion of Evidence ReviewedQuestion:Is the evidence sufficient to determine that implantation and use of permanent single chamber or dual chamber cardiac pacemakers improve health outcomes in Medicare beneficiaries?1. External technology assessment
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
C. Discussion of Evidence ReviewedQuestion:Is the evidence sufficient to determine that implantation and use of permanent single chamber or dual chamber cardiac pacemakers improve health outcomes in Medicare beneficiaries?1. External technology assessmentCastelnuovo E, Stein K, Pitt M, Garside R, Payne E. The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation. Health Technol Assess 2005;9(43).Castelnuovo and colleagues reported the results of an evidence review (UK HTA:  United Kingdom health technology assessment) to estimate the effectiveness and cost effectiveness of dual-chamber pacemakers versus single-chamber atrial or single-chamber ventricular pacemakers in the treatment of bradycardia due to sick sinus syndrome (SSS) or atrioventricular block (AVB).  Patients with a primary diagnosis of acquired symptomatic bradycardia, secondary to SSS, AVB, or chronic bifascicular block, and individuals with symptomatic bradycardia in secondary and tertiary care centers were included.  Eligible studies were systematic reviews and randomized trials.  Non-randomized studies, case control, and cohort studies were excluded.  Outcomes were mortality (all-cause and cardiovascular), stroke, atrial fibrillation (AF), heart failure, exercise capacity, symptoms of breathlessness, fatigue, chest pain, dizziness, palpitations, sleep disturbance, functional status, QOL, adverse events of implantation (perioperative mortality and non-fatal complications), and pacemaker syndrome.
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
Two evidence reviews, four parallel group randomized controlled trials (RCTs) (the Canadian Trial of Physiologic Pacing (CTOPP), the Mode Selection Trial (MOST), the Pacemaker Selection in the Elderly (PASE), and United Kingdom Pacing and Cardiovascular Events (UKPACE)) and 28 cross-over trials were included in the evidence review.  The authors reported: Dual chamber pacing was associated with lower rates of atrial fibrillation, particularly in SSS, than ventricular pacing, and prevents pacemaker syndrome.  Higher rates of atrial fibrillation were seen with dual-chamber pacing than with atrial pacing.  Complications occurred more frequently in dual-chamber pacemaker insertion.  They concluded: Dual-chamber pacing results in small but potentially important benefits in populations with SSS and/or AVB compared with ventricular pacemakers.Dretzke J, Toff WD, Lip GYH, Raftery J, Fry-Smith A, Taylor RRS. Dual chamber versus single chamber ventricular pacemakers for sick sinus syndrome and atrioventricular block. Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.:CD003710. DOI: 10.1002/14651858.CD003710.pub2.Dretzke and colleagues reported the results of an evidence review (the Cochrane review) to assess the short- and long-term clinical effectiveness of dual chamber pacemakers compared to single chamber ventricular pacemakers in adults with AV block, sick sinus syndrome or both.  Patients 18 years and older with SSS and/or AVB were included.  Eligible studies were randomised controlled trials of either parallel group or crossover design comparing single chamber ventricular pacing with dual chamber pacing, or single chamber atrial pacing with dual chamber pacing.  Primary outcomes were cardiovascular mortality or all-cause mortality and cardiovascular morbidity (pacemaker syndrome, AF, stroke or heart failure).
NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3) - Decision Memo
Up to year 2002, five parallel (CTOPP, MOST, PASE, 1 trial on tachyarrhythmia, 1 trial on AF) and 26 cross-over randomized controlled trials were included in the review.  The authors noted that quality of reporting was found to be poor and reported: Pooled data from parallel studies shows a statistically non-significant preference for physiologic pacing (primarily dual chamber pacing) for the prevention of stroke, heart failure and mortality, and a statistically significant beneficial effect regarding the prevention of atrial fibrillation (odds ratio (OR) 0.79, 95% CI 0.68 to 0.93).  Both parallel and crossover studies favour dual chamber pacing with regard to pacemaker syndrome (parallel: Peto OR 0.11, 95% CI 0.08 to 0.14; crossover: standardised mean difference (SMD) -0.74, 95% CI -0.95 to -0.52).  Pooled data from crossover studies shows a statistically significant trend towards dual chamber pacing being more favourable in terms of exercise capacity (SMD -0.24, 95% CI -0.03 to -0.45).  No individual studies reported a significantly more favourable outcome with single chamber ventricular pacing.  They concluded: This review shows a trend towards greater effectiveness with dual chamber pacing compared to single chamber ventricular pacing, which supports the current British Pacing and Electrophysiology Groups Guidelines regarding atrioventricular block.  Additional randomised controlled trial evidence from ongoing trials in this area will further inform the debate.Grenouilleau-Albertini A, Copie X, Mabo P, et al. Single or dual-chamber pacemakers? The guidelines of the HAS. Archives of Cardiovascular Diseases Supplements. 2010; 2: 61-74.