Cardiac Event Detection

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 CFR §410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, §20.15 Electrocardiographic Services

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 CED 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.

N/A

N/A

Documentation Requirements

1. The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See Coverage Indications, Limitations and/or Medical Necessity) This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
   
   
2. Records must include EKG rhythm strips with interpretation for each transmission. The date and time of each transmission, when the symptoms occurred and what the symptoms were must be documented for each transmission. The medical record should also include when the reviewing physician and the ordering physician were notified of the transmission and its results.
   
   
3. The interpretation must be a de novo interpretation by the physician billing the interpretation, in addition to any “preliminary interpretation” by the company, hospital or other provider functioning as the receiving station, or billing the technical component of the test.
   
   
4. The CED provider's records must include the referring physician's request for the test and the indications for the test. This information should be incorporated into a formal report (interpretation) of the test.
   
   
5. Documentation of necessity should include the referring physician's diagnostic impression, and an indication of relevant signs and symptoms.
   
   
6. The provider performing the technical component of the service must retain a written copy of the physician/non-physician practitioner (NPP) order for the test which should include the indication(s) for the test. This provider must also maintain copies of all transmissions, documentation of actions taken and physicians contacted or instructions given to the beneficiary.
   
   
7. Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request.

Utilization Guidelines

1. It is expected that it would not be necessary to perform a CED service (one 30-day service) more frequently than once in 6 months. Claims for services provided in excess of this parameter may be denied as not medically necessary.
   
   
2. It is not appropriate to utilize this service in a patient who is unable to activate the monitor or transmit the data when symptoms occur. These claims may be denied as not medically necessary.
   
   
3. Claims not meeting the criteria stated in these guidelines may be denied.

Kinlay S, Leitch JW, Neil A, et al. Cardiac event recorders yield more diagnoses and are more cost-effective than 48-hour holter monitoring in patients with palpitations: A controlled clinical trial. Ann Intern Med. 1996;124(1 Pt 1):16-20.

Schneller SJ. State-of-the-art ambulatory electrocardiographic monitoring. Cardiology Trends. 1990;10(6):1,15-17.

Wu J, Kessler DK, Chakko S, et al. A cost-effectiveness strategy for transtelephonic arrhythmia monitoring. Am J Cardiol. 1995;75(2):184-185.

• Cardiac Event Detection
• Cardiac