CMS Pub. 100-03, ch. 1, § 20.8

Cardiac pacemakers are self-contained, battery-operated units that send electrical

stimulation to the heart. They are generally implanted to alleviate symptoms of

decreased cardiac output related to abnormal heart rate and/or rhythm. Pacemakers are

generally used for persistent, symptomatic second- or third-degree atrioventricular (AV)

block and symptomatic sinus bradycardia.

Cardiac pacemakers are covered as prosthetic devices under the Medicare program,

subject to the following conditions and limitations. While cardiac pacemakers have been

covered under Medicare for many years, there were no specific guidelines for their use

other than the general Medicare requirement that covered services be reasonable and

necessary for the treatment of the condition. Services rendered for cardiac pacing on or

after the effective dates of this instruction are subject to these guidelines, which are based

on certain assumptions regarding the clinical goals of cardiac pacing. While some uses

of pacemakers are relatively certain or unambiguous, many other uses require

considerable expertise and judgment.

Consequently, the medical necessity for permanent cardiac pacing must be viewed in the

context of overall patient management. The appropriateness of such pacing may be

conditional on other diagnostic or therapeutic modalities having been undertaken.

Although significant complications and adverse side effects of pacemaker use 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

permanent cardiac pacing 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 new uses for

cardiac pacing in new classes of patients may change as more conclusive evidence

becomes available. This instruction applies only to permanent cardiac pacemakers, and

does not address the use of temporary, non-implanted pacemakers.

The two groups of conditions outlined below deal with the necessity for cardiac pacing

for patients in general. These are intended as guidelines in assessing the medical

necessity for pacing therapies, taking into account the particular circumstances in each

case. However, as a general rule, the two groups of current medical concepts may be

viewed 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 of the sufficiency to convince the A/B MAC 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

A/B MAC that the claim should be paid.

The Centers for Medicare & Medicaid Services (CMS) opened the National Coverage

Determination (NCD) on Cardiac Pacemakers to afford the public an opportunity to

comment on the proposal to revise the language contained in the instruction. The

revisions transfer the focus of the NCD from the actual pacemaker implantation

procedure itself to the reasonable and necessary medical indications that justify cardiac

pacing. This is consistent with our findings that pacemaker implantation is no longer

considered routinely harmful or an experimental procedure.

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, 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. 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 clearly 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, seizures, 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 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, CHF, 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, 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 myocardial 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 should 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 Exemption (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 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 CHF 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., 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. 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 following 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.