(Medicare National Coverage Determinations Manual)

Group I :  Single -Chamber Cardiac Pacemakers (Effective March 16,  1983)   A.  Nationally Covered Indications   Conditions under which cardiac pacing is generally considered acceptable or necessary, provided that the conditions are chronic or recurrent and not due to transient causes such as acute myocardial infarction, dr ug toxicity, or electrolyte imbalance.  (In cases where there is a rhythm disturbance, if the rhythm disturbance is chronic or recurrent, a single episode of a symptom such as syncope or seizure is adequate to establish medical necessity.)   1.  Acquired complete (also referred to as third -degree) AV heart block.   2.  Congenital complete heart block with severe bradycardia (in relation to age), or significant physiological deficits or significant symptoms due to the bradycardia.   3.  Second- degree AV heart block of Type  II (i.e., no progressive prolongation of P -R interval prior to each blocked beat.  P -R interval indicates the time taken for an impulse to travel from the atria to the ventricles on an electrocardiogram).   4.  Second- degree AV heart block of Type I (i.e., progressive prolongation of P -R interval prior to each blocked beat) with significant symptoms due to hemodynamic instability associated with the heart block.   5.  Sinus bradycardia associated with major symptoms (e.g., syncope, seizures, congestive heart failure (CHF)); or substantial sinus bradycardia (heart rate less than 50) associated with dizziness or confusion.  The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.   6.  In selected and few patients, sinus bradycardia of lesser severity (heart rate 50- 59) with dizziness or confusion.  The correlation between symptoms and bradycardia must be documented, or the symptoms must be cl early attributable to the bradycardia rather than to some other cause.   7.  Sinus bradycardia is the consequence of long- term necessary drug treatment for which there is no acceptable alternative when accompanied by significant symptoms (e.g., syncope, sei zures, CHF, dizziness, or confusion).  The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.   8.  Sinus node dysfunction with or without tachyar rhythmias or AV conduction block (i.e., the bradycardia -tachycardia syndrome, sino- atrial block, sinus arrest) when accompanied by significant symptoms (e.g., syncope, seizures, CHF, dizziness, or confusion).   9.  Sinus node dysfunction with or without sym ptoms when there are potentially life -threatening ventricular arrhythmias or tachycardia secondary to the bradycardia (e.g., numerous premature ventricular contractions, couplets, runs of premature ventricular contractions, or ventricular tachycardia).   10.  Bradycardia associated with supraventricular tachycardia (e.g., atrial fibrillation, atrial flutter, or paroxysmal atrial tachycardia) with high -degree AV block which is unresponsive to appropriate pharmacological management and when the bradycardia is associated with significant symptoms (e.g., syncope, seizures, CHF, dizziness, or confusion).   11.  The occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures.   12.  Bifascicular or trifascicular block accompanied by syncope which is attributed to transient complete heart block after other plausible causes of syncope have been reasonably excluded.   13.  Prophylactic pacemaker use following recovery from acute myoc ardial infarction (MI) during which there was temporary complete (third- degree) and/or Mobitz Type II second -degree AV block in association with bundle branch block.   14.  In patients with recurrent and refractory ventricular tachycardia, "overdrive pacing " (pacing above the basal rate) to prevent ventricular tachycardia.   (Effective May 9, 1985)   15.  Second- degree AV heart block of Type I with the QRS complexes prolonged.  B.  Nationally Non -Covered Indications   Conditions which, although used by some physicians as a basis for permanent cardiac pacing, are considered unsupported by adequate evidence of benefit and therefore should not generally be considered appropriate uses for single -chamber pacemakers in the absence of the above indications.  A/B MACs s hould review claims for pacemakers with these indications to determine the need for further claims development prior to denying the claim, since additional claims development may be required.  The object of such further development is to establish whether the particular claim actually meets the conditions in a) above.  In claims where this is not the case or where such an event appears unlikely, the A/B MAC may deny the claim:   1.  Syncope of undetermined cause.   2.  Sinus bradycardia without significant symptoms.  3.  Sino- atrial block or sinus arrest without significant symptoms.   4.  Prolonged P -R intervals with atrial fibrillation (without third -degree AV block) or with other causes of transient ventricular pause.   5.  Bradycardia during sleep.   6.   Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent AV block).   7.  Asymptomatic second -degree AV block of 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).   Effective October 1, 2001   8.  Asymptomatic bradycardia in post -MI patients about to initiate long -term beta -blocker drug therapy.   C.  Other   All other indications for single -chamber cardiac pacing for which CMS has not specifically indicated coverage remain nationally non -covered, except for Category B Investigational Device Exe mption (IDE) clinical trials, or as routine costs of single -chamber cardiac pacing associated with clinical trials, in accordance with section 310.1 of the NCD Manual.   Group II :  Dual -Chamber Cardiac Pacemakers  (Effective May 9, 1985)   A.  Nationally Covered Indications   Conditions under dual -chamber cardiac pacing are considered acceptable or necessary in the general medical community unless conditions 1 and 2 under Group II. B., are present:   1.  Patients in who single -chamber (ventricular pacing) at t he time of pacemaker insertion elicits a definite drop in blood pressure, retrograde conduction, or discomfort.  2.  Patients in whom the pacemaker syndrome (atrial ventricular asynchrony), with significant symptoms, has already been experienced with a pac emaker that is being replaced.   3.  Patients in whom even a relatively small increase in cardiac efficiency will importantly improve the quality of life, e.g., patients with CHF despite adequate other medical measures.   4.  Patients in whom the pacemaker s yndrome can be anticipated, e.g., in young and active people, etc.   Dual -chamber pacemakers may also be covered for the conditions as listed in Group I. A., if the medical necessity is sufficiently justified through adequate claims development.  Expert physicians differ in their judgments about what constitutes appropriate criteria for dual-chamber pacemaker use.  The judgment that such a pacemaker is warranted in the patient meeting accepted criteria must be based upon the individual needs and characterist ics of that patient, weighing the magnitude and likelihood of anticipated benefits against the magnitude and likelihood of disadvantages to the patient.  B.  Nationally Non -Covered Indications   Whenever the following conditions (which represent overriding contraindications) are present, dual -chamber pacemakers are not covered:   1.  Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium.   2.  Frequent or persistent supraventricular tachycardias, except  where the pacemaker is specifically for the control of the tachycardia.   3.  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, e.g., the occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures.   4.  Prophylactic pacemaker use fol lowing recovery from acute MI during which there was temporary complete (third- degree) and/or Type II second- degree AV block in association with bundle branch block.  C.  Other   All other indications for dual -chamber cardiac pacing for which CMS has not specifically indicated coverage remain nationally non- covered, except for Category B IDE clinical trials, or as routine costs of dual -chamber cardiac pacing associated with clinical trials, in accordance with section 310.1 of the NCD Manual.  20.8.1 - Cardia c Pacemaker Evaluation Services  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Medicare covers a variety of services for the post -implant follow -up and evaluation of implanted cardiac  pacemakers.  The following guidelines are designed to assist A/B MACs in identifying and processing claims for such services.  NOTE:  These new guidelines are limited to lithium battery -powered pacemakers, because mercury -zinc battery -powered pacemakers ar e no longer being manufactured and virtually all have been replaced by lithium units.  A/B MACs still receiving claims for monitoring such units should continue to apply the guidelines published in 1980 to those units until they are replaced.  There are tw o general types of pacemakers in current use -  single -chamber pacemakers which sense and pace the ventricles of the heart, and dual -chamber pacemakers which sense and pace both the atria and the ventricles.  These differences require different monitoring patterns over the expected life of the units involved.  One fact of which A/B MACs should be aware is that many dual -chamber units may be programmed to pace only the ventricles; this may be done either at the time the pacemaker is implanted or at some time afterward.  In such cases, a dual -chamber unit, when programmed or reprogrammed for ventricular pacing, should be treated as a single -chamber pacemaker in applying screening guidelines.  The decision as to how often any patients pacemaker should be monitored is the responsibility of the patients physician who is best able to take into account the condition and circumstances of the individual patient.  These may vary over time, requiring modifications of the frequency with which the patient should be monit ored.  In cases where monitoring is done by some entity other than the patients physician, such as a commercial monitoring service or hospital outpatient department, the physicians prescription for monitoring is required and should be periodically renewe d (at least annually) to assure that the frequency of monitoring is proper for the patient.  Where a patient is monitored both during clinic visits and transtelephonically, the A/B MAC should be sure to include frequency data on both types of monitoring in evaluating the reasonableness of the frequency of monitoring services received by the patient. Since there are over 200 pacemaker models in service at any given point, and a variety of patient conditions that give rise to the need for pacemakers, the question of the appropriate frequency of monitoring is a complex one.  Nevertheless, it is possible to develop guidelines within which the vast majority of pacemaker monitoring will fall and A/B MACs should do this, using their own data and experience, as well as the frequency guidelines which follow, in order to limit extensive claims development to those cases requiring special attention.  20.8.1.1 - Transtelephonic Monitoring of Cardiac Pacemakers  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A.  General   Transtelephonic monitoring of pacemakers is furnished by commercial suppliers, hospital outpatient departments, and physicians offices.