** ** Compliance with the provisions in this policy may be monitored and
addressed through post payment data analysis and subsequent medical review
audits.  
  
 **History/Background and/or General Information  
  
** Electronic analysis to monitor the patient's pacemaker or cardioverter-
defibrillator is medically necessary on a regular basis to evaluate the
device. Pre and postoperative evaluation of the cardiac rhythm device in
patients with implantable cardioverter-defibrillators (ICDs) or who are pacer
dependent may be necessary because electromagnetic interference can alter the
function of these devices, especially ICDs, in unpredictable ways. They may
need to be re-programmed before and after a surgical procedure.  
  
 **Covered Indications and Limitations  
  
** Please refer to NCD 20.8.1 Cardiac Pacemaker Evaluation Services for
indications and limitations of coverage for the post-implant follow-up and
evaluation of implanted cardiac pacemakers.  
  
 **Transtelephonic Monitoring of Cardiac Pacemakers  
  
** Please refer to NCD 20.8.1.1 Transtelephonic Monitoring of Cardiac
Pacemakers for general information, definition of transtelephonic monitoring,
frequency guidelines for transtelephonic monitoring, and pacemaker clinic
services.  
  
For instances where a patient is monitored both during clinic visits and
remotely or transtelephonically, the combined frequency of monitoring will be
considered in evaluating the reasonableness of the frequency of monitoring
services received by the patient.  
  
 **Note** : Payment for dual-chamber pacemakers operating in single-chamber
mode should be made at the same frequency as monitoring of a single-chamber
pacemaker.  
  
 **Local Medicare Frequency Guidelines for Monitoring of Cardioverter-
Defibrillators  
  
** Electronic analysis of a pacing cardioverter-defibrillator is performed in
an office or outpatient hospital setting. It involves the interrogation and
evaluation of the pulse generator status in addition to evaluation of the
programmable parameters, analysis of event markers, and device response during
periods of rest and activity. The monitoring of these complex devices requires
more frequent monitoring than a single- or dual-chamber pacemaker. Therefore,
Medicare will allow routine electronic analysis of a pacing cardioverter-
defibrillator (single- and dual-chamber) within one month following
implantation and then every three months thereafter. More frequent testing may
be necessary to evaluate patient symptoms suggestive of pacing cardioverter-
defibrillator involvement/origin.  
  
 **Wearable Defibrillator System  
  
** Payment for wearable defibrillators is made by Durable Medical Equipment
(DME) contractors and is subject to the indications and limitations in the DME
Local Coverage Determination "Automatic External Defibrillators."  
  
Coverage (including frequency) for monitoring the wearable system is identical
to that of implantable defibrillator devices.  
  
 **Notice:**  Services performed for any given diagnosis must meet all of the
indications and limitations stated in this policy, the general requirements
for medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.  
  
The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in this LCD.