CMS Pub. 100-03, ch. 1, § 20.8.1.1

A. General

Transtelephonic monitoring of pacemakers is furnished by commercial suppliers, hospital

outpatient departments, and physicians’ offices.

Telephone monitoring of cardiac pacemakers as described below is medically efficacious

in identifying early signs of possible pacemaker failure, thus reducing the number of

sudden pacemaker failures requiring emergency replacement. All systems that monitor

the pacemaker rate (bpm) in both the free-running and/or magnetic mode are effective in

detecting subclinical pacemaker failure due to battery depletion. More sophisticated

systems are also capable of detecting internal electronic problems within the pulse

generator itself and other potential problems. In the case of dual-chamber pacemakers in

particular, such monitoring may detect failure of synchronization of the atria and

ventricles, and the need for adjustment and reprogramming of the device.

NOTE: The transmitting device furnished to the patient is simply one component of the

diagnostic system, and is not covered as durable medical equipment. Those engaged in

transtelephonic pacemaker monitoring should reflect the costs of the transmitters in

setting their charges for monitoring.

B. Definition of Transtelephonic Monitoring

In order for transtelephonic monitoring services to be covered, the services must consist

of the following elements:

• A minimum 30-second readable strip of the pacemaker in the free-running mode;

• Unless contraindicated, a minimum 30-second readable strip of the pacemaker in the

magnetic mode; and,

• A minimum 30 seconds of readable ECG strip.

C. Frequency Guidelines for Transtelephonic Monitoring

The guidelines below constitute a system which A/B MACs should use, in conjunction

with their knowledge of local medical practices, to screen claims for transtelephonic

monitoring prior to payment. It is important to note that they are not recommendations

with respect to a minimum frequency for such monitorings, but rather a maximum

frequency (within which payment may be made without further claims development). As

with previous guidelines, more frequent monitorings may be covered in cases where A/B

MACs are satisfied that such monitorings are medically necessary; e.g., based on the

condition of the patient, or with respect to pacemakers exhibiting unexpected defects or

premature failure. A/B MACs should seek written justification for more frequent

monitorings from the patient’s physician and/or any monitoring service involved.

These guidelines are divided into two broad categories - Guideline I which will apply to

the majority of pacemakers now in use, and Guideline II which will apply only to

pacemaker systems (pacemaker and leads) for which sufficient long-term clinical

information exists to assure that they meet the standards of the Inter-Society Commission

for Heart Disease Resources (ICHD) for longevity and end-of-life decay. (The ICHD

standards are: (1) 90% cumulative survival at 5 years following implant; and (2) an end-of-life decay of less than a 50% drop of output voltage and less than 20% deviation of

magnet rate, or a drop of 5 beats per minute or less, over a period of 3 months or more.)

A/B MACs should consult with their medical advisers and other appropriate individuals

and organizations (such as the North American Society of Pacing and Electrophysiology

which publishes product reliability information) should questions arise over whether a

pacemaker system meets the ICHD standards.

The two groups of guidelines are then further broken down into two general categories –

single-chamber and dual-chamber pacemakers. A/B MACs should be aware that the

frequency with which a patient is monitored may be changed from time-to-time for a

number of reasons, such as a change in the patient’s overall condition, a reprogramming

of the patient’s pacemaker, the development of better information on the pacemaker’s

longevity or failure mode, etc. Consequently, changes in the proper set of guidelines may

be required. A/B MACs should inform physicians and monitoring services to alert A/B

MACs to any changes in the patient’s monitoring prescription that might necessitate

changes in the screening guidelines applied to that patient. (Of particular importance is

the reprogramming of a dual-chamber pacemaker to a single-chamber mode of operation.

Such reprogramming would shift the patient from the appropriate dual-chamber guideline

to the appropriate single-chamber guideline.)

Guideline I

1 - Single-chamber pacemakers

1st month - every 2 weeks.

2nd through 36th month - every 8 weeks.

37th month to failure - every 4 weeks.

2 - Dual-chamber pacemaker

1st month - every 2 weeks.

2nd through 6th month - every 4 weeks.

7th through 36th month - every 8 weeks.

37th month to failure - every 4 weeks.

Guideline II

1 - Single-chamber pacemakers

1st month - every 2 weeks.

2nd through 48th month - every 12 weeks.

49th through 72nd month - every 8 weeks.

Thereafter - every 4 weeks.

2 - Dual-chamber pacemaker

1st month - every 2 weeks.

2nd through 30th month - every 12 weeks.

31st through 48th month - every 8 weeks.

Thereafter - every 4 weeks.

D. Pacemaker Clinic Services

1. General

Pacemaker monitoring is also covered when done by pacemaker clinics. Clinic visits

may be done in conjunction with transtelephonic monitoring or as a separate service;

however, the services rendered by a pacemaker clinic are more extensive than those

currently possible by telephone. They include, for example, physical examination of

patients and reprogramming of pacemakers. Thus, the use of one of these types of

monitoring does not preclude concurrent use of the other.

2. Frequency Guidelines

As with transtelephonic pacemaker monitoring, the frequency of clinic visits is the

decision of the patient’s physician, taking into account, among other things, the medical

condition of the patient. However, A/B MACs can develop monitoring guidelines that

will prove useful in screening claims. The following are recommendations for

monitoring guidelines on lithium-battery pacemakers:

• For single-chamber pacemakers - twice in the first 6 months following implant,

then once every 12 months.

• For dual-chamber pacemakers - twice in the first 6 months, then once every 6

months.