CMS Pub. 100-03, ch. 1, § 20.8.3

Pacemakers

(Rev. 187, Issued: 12-10-15, Effective: 08-13-13, Issued: 01-13-16)

A. General

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. 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 the 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 the 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 Centers for Medicare & Medicaid Services (CMS) has determined that the evidence

is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or

dual chamber, are reasonable and necessary for the treatment of non-reversible

symptomatic bradycardia due to sinus node dysfunction and second and/or third degree

atrioventricular block. Symptoms of bradycardia are symptoms that can be directly

attributable to a heart rate less than 60 beats per minute (for example: syncope, seizures,

congestive heart failure, dizziness, or confusion).

B. Nationally Covered Indications

The following indications are covered for implanted permanent single chamber or dual

chamber cardiac pacemakers:

1. Documented non-reversible symptomatic bradycardia due to sinus node dysfunction,

and

2. Documented non-reversible symptomatic bradycardia due to second degree and/or

third degree atrioventricular block.

C. Nationally Non-Covered Indications

The following indications are non-covered for implanted permanent single chamber or

dual chamber cardiac pacemakers:

1. Reversible causes of bradycardia such as electrolyte abnormalities, medications or

drugs, and hypothermia,

2. Asymptomatic first degree atrioventricular block,

3. Asymptomatic sinus bradycardia,

4. Asymptomatic sino-atrial block or asymptomatic sinus arrest,

5. Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left

atrium) without symptomatic bradycardia,

6. 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),

7. Syncope of undetermined cause,

8. Bradycardia during sleep,

9. 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,

10. Asymptomatic bradycardia in post-myocardial infarction patients about to initiate

long-term beta-blocker drug therapy,

11. Frequent or persistent supraventricular tachycardias, except where the pacemaker is

specifically for the control of tachycardia, and

12. 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.

D. Other

A/B MACs 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.

(This NCD last reviewed August 2013.)