**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 Medicare Administrative
Contractors (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 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. MACs should
seek written justification for more frequent monitorings from the patients
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.) 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. 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 patients overall
condition, a reprogramming of the patients pacemaker, the development of
better information on the pacemakers longevity or failure mode, etc.
Consequently, changes in the proper set of guidelines may be required. MACs
should inform physicians and monitoring services to alert MACs to any changes
in the patients 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.)

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 patients physician, taking into account, among other
things, the medical condition of the patient. However, 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.