Summary Of Evidence

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Analysis of Evidence

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Abstract:

Cardiac Event Detection (CED) involves the use of a long-term monitor by patients to document a suspected or paroxysmal dysrhythmia. Following the recording of events, the patient transmits data via telephone to a physician's office, hospital facility, Independent Diagnostic Testing Facility (IDTF), or other specified station that is equipped and staffed to assess electrocardiographic (EKG) data and to initiate appropriate management action. The device must be patient or event activated.

The services included in this Local Coverage Determination (LCD) require a 24-hour attended monitoring station to receive transmissions, and that the devices:

• are patient/event activated and intermittently record cardiac arrhythmic events;
• provide either symptom related memory loop or post-symptom recording; and
• are non-insertable (non-implanted).

A single service includes all recordings, transmissions and interpretations during a continuous 30-day period.

Ambulatory outpatient cardiac telemetry (outpatient cardiac monitoring) services are included among the cardiac event detection type of ambulatory EKG monitoring services.

Indications:

CED is covered for:

1. When the frequency of the symptoms is limited or in asymptomatic patients who are at risk for clinically significant arrhythmias, and where a longer monitoring period is more likely to capture, characterize and document the transient symptomatic arrhythmia than the use of a 24- hour ambulatory EKG;
   
   
2. Regulation of antiarrhythmic drug dosage, when needed to assess efficacy of treatment;
   
   
3. To monitor patients who have had surgical or ablative procedures for arrhythmias.

Although the service is a 30-day service, it is recognized that the event recorder may be discontinued once the symptom-producing arrhythmia has been documented and diagnosed or following multiple transmissions during symptoms, without arrhythmia. It is unlikely that the arrhythmias would always be diagnosed on the first day of recording, or that the service would always last only 1 day. The average duration of monitoring is anticipated to last 10-14 days, or more.

Limitations:

1. A CED service is medically unnecessary if it offers little or no potential for new clinical data beyond that which has been obtained from a previous test, (e.g., a standard EKG has already established a diagnosis), or if other tests are better suited to obtain the clinical data relevant to the patient's condition. The CED should be coordinated with results from standard EKGs, Holter monitor tests, and stress tests.
   
   
2. The receiving station must be staffed on a 24-hour basis with personnel trained to read EKGs (e.g., critical care nurses or paramedics), who should be able to direct the patient for the management of all emergencies. An answering service/answering machine would not fulfill this requirement.
   
   
3. Systems utilizing computers to dial the physician's office so the physician receives transmission by way of a relay are not covered since there is no 24-hour personnel attendance.
   
   
4. A test not ordered by a physician or qualified nonphysician practitioner treating the beneficiary will be denied as not medically necessary.
   
   
5. The purpose of CED is the long term monitoring of patients to document a suspected or paroxysmal dysrhythmia. Therefore, it is considered medically unnecessary to utilize a CED service when only a standard EKG or EKG rhythm strip is required (even if it is used to transmit that EKG or rhythm strip to another location).
   
   
6. It is expected that CEDs would not be used for the routine daily transmission of EKG rhythm strips, or monitoring, in the absence of identified symptoms necessitating diagnosis as stated in this LCD.
   
   
7. Event recorders are covered only as diagnostic tests or for evaluating a patient being actively managed on arrhythmic medication.
   
   
8. CED is not covered for patients in hospitals, emergency rooms, skilled nursing facilities or other specialized facilities and will be denied as not medically necessary.
   
   
9. CED is not covered for either outpatient or facility-based cardiac monitoring.
   
   
10. CED is a 30-day service for the purpose of documentation and diagnosis of paroxysmal or suspected arrhythmias. The performance of this test is predicated by the pre-test incidence of symptoms related to arrhythmias or the risk of a clinically significant arrhythmia in asymptomatic patients, and is considered not medically necessary for those patients who are not having significant recurrent arrhythmias which are anticipated to require treatment.
    
    
11. Testing for more than 30 consecutive days is only rarely medically necessary, and the need for the continued testing must be justified by the treating physician. Failure to document an arrhythmia during a 30-day test period is not sufficient justification to reimburse a second or subsequent test. It is unlikely to be medically necessary to repeat a second test within a year in the absence of new or recurrent undiagnosed symptoms.
    
    
12. Event recorders may be patient or auto activated, and may not use time-sampling technology. Accordingly, this test will be considered medically unnecessary for any patient who is unresponsive, comatose, severely confused or otherwise unable to recognize symptoms, or activate the recorder (patient activated devices) or unable to participate in the use of the device.
    
    
13. Event recorders are not covered for outpatient monitoring of recently discharged post-infarct patients, and will be denied as not medically necessary, except in circumstances where the patient is asymptomatic but is considered to be at high risk for clinically significant arrhythmias.
    
    
14. "Routine" continued monitoring in the absence of treatable symptoms is considered screening and is not medically necessary.
    
    
15. Because the CED service requires the diagnosis and evaluation of intermittent arrhythmias, and patients must be continuously attached to symptom related memory loop recorders, each patient is required to have a recorder for his/her own exclusive use throughout the duration of the monitoring period. Recorders may not be "shared" amongst 2 or more patients, regardless of the environment or site of the service. Claims for CED will be denied as not medically necessary when patients do not have exclusive use of a recorder for the entire service period (30 days).
    
    
16. CED is a 30-day packaged service. Tests may not be billed within 30 days of each other, even if the earlier of the tests was discontinued when arrhythmias were documented and the patient is now reconnected for follow-up of therapy or intervention.