Cardiac pacemakers are covered as prosthetic devices under the Medicare program, subject to the conditions and limitations described in this section. While cardiac pacemakers have been covered under Medicare for many years, until recently there have been no specific guidelines for their implantation other than the general Medicare requirement that covered services be reasonable and necessary for the treatment of the condition. Services rendered for pacemaker implantations on or after the effective dates of this instruction are subject to the guidelines of this section.
These guidelines are based on certain assumptions regarding the clinical goals of pacemaker implantation. While some uses of pacemakers represent relatively certain or unambiguous usage, many others require considerable expertise and judgment
Consequently, the medical necessity for pacemaker implantation must be viewed in the context of the overall management of the particular patient. The appropriateness of such implants may be conditional on other diagnostic or therapeutic modalities having been undertaken. Although significant complications and adverse side effects of pacemakers are relatively rare, they cannot be ignored when considering the use of pacemakers for dubious medical conditions, or marginal clinical benefit.
These guidelines represent current concepts regarding medical circumstances in which pacemaker implantation may be appropriate or necessary. As with other areas of medicine, advances in knowledge and techniques in cardiology are expected. Consequently, judgments about the medical necessity and acceptability of pacemaker implants can be expected to change, and instructions modified as more information becomes available.
It should be noted that this instruction applies only to permanent, implanted pacemakers, and does not address the use of temporary, nonimplanted pacemakers.
The two groups of conditions outlined below deal with the necessity for cardiac pacemaker implants for patients in general. These are intended as guidelines for Medicare contractors to use in assessing the medical necessity of claims for pacemaker implantation. As with other guidelines, final coverage determinations must take account of the circumstances of the particular claim, as well as factors such as the medical history of the individual patient. However, as a general rule, contractors may view the two groups of current medical concepts below as representing:
Group I: Single-Chamber Cardiac Pacemakers A) conditions under which single- chamber pacemaker claims may be considered covered without further claims development; and B) conditions under which single-chamber pacemaker claims would be denied unless further claims development shows that they fall into the covered category, or special medical circumstances exist sufficient to convince the contractor that the claim should be paid.
Group II. Dual-Chamber Cardiac Pacemakers A) conditions under which dual- chamber pacemaker claims may be considered covered without further claims development, and B) conditions under which dual-chamber pacemaker claims would be denied unless further claims development shows that they fall into the covered categories for single-and dual-chamber pacemakers, or special medical circumstances exist sufficient to convince the contractor that the claim should be paid.
GROUP I: SINGLE-CHAMBER CARDIAC PACEMAKERS Effective for services rendered on or after March 16, 1983.
Conditions under which implantation of a cardiac pacemaker 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, drug 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).
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); 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 clearly attributable to the bradycardia rather than to some other cause.
7. Sinus bradycardia which is the consequence of long-term necessary drug treatment for which there is no acceptable alternative, when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, 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 tachyarrhythmias or AV conduction block i.e., the bradycardia-tachycardia syndrome, sino-atrial block, sinus arrest when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness or confusion).
9. Sinus node dysfunction with or without symptoms 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, congestive heart failure, 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 myocardial infarction 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 for services rendered on or after May 9, 1985.
15. Second degree AV heart block of Type I with the QRS complexes prolonged.
B. NOT COVERED Additional claims development may be required.
Conditions which, although used by some physicians as bases for permanent pacemaker implantation, 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 indications cited above. Contractors should review claims for pacemakers with these indications to determine the need for further claims development prior to denying the claim. 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 contractor 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 R-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.
GROUP II: DUAL-CHAMBER CARDIAC PACEMAKERS Effective for services rendered on or after May 9, 1985.
Conditions under which implantation of a dual-chamber cardiac pacemaker is considered acceptable or necessary in the general medical community unless conditions #1 and #2, Group II.B., are present):
1. Patients in whom single-chamber (ventricular pacing) at the 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 pacemaker 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 congestive heart failure despite adequate other medical measures.
4. Patients in whom the pacemaker syndrome 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. (Single-Chamber Cardiac Pacemakers), 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 characteristics of that patient, weighing the magnitude and likelihood of anticipated benefits against the magnitude and likelihood of disadvantages to the patient.
B. NOT COVERED
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 following recovery from acute myocardial infarction during which there was temporary complete (third degree) and/or Type II second degree AV block in association with bundle branch block.