Cardiac Event Detection Monitoring
An event monitor, or event recorder, is a patient-activated or event-activated EKG device that intermittently records cardiac arrhythmic events as they occur. The EKG is recorded on magnetic tape or other digital medium.

Cardiac event monitor technology varies among different devices. For patient-activated event monitors, the patient initiates recording when symptoms appear or when instructed to do so by a physician (e.g., following exercise). For self-sensing, automatically triggered monitors, an EKG is automatically recorded when the device detects an arrhythmia, without patient intervention. Some devices permit a patient to transmit EKG data trans-telephonically (i.e., via telephone) to a receiving center where the data is reviewed. A technician may be available at these centers to review transmitted data 24 hours per day. In some instances, when the EKG is determined to be outside certain preset criteria by a technician or other non-physician, a physician is available 24 hours per day to review the transmitted data and to make clinical decisions regarding the patient. These services are known as "24-hour attended monitoring". In other instances, transmitted EKG data is reviewed at a later time and are, therefore, considered "nonattended."

Cardiac event monitors without trans-telephonic capability must be removed from the patient and taken to a location for review of the stored EKG data. Some devices also permit a "time sampling" mode of operation. The "time sampling" mode is not covered under ambulatory EKG monitoring technology. Some cardiac event monitoring devices with trans-telephonic capabilities require the patient to dial the phone number of a central EKG data reception center and initiate transmission of EKG data. Other devices use Internet-based in-home computers to capture and store EKG data. When such devices detect pre-programmed arrhythmias, data is automatically sent via modem and standard telephone lines to a central receiving center, where the data is reviewed. Internet-based in-home computer systems may also provide the receiving center with a daily computer-generated report that summarizes 24 hours of EKG data.

Dynamic Electrocardiogram (Holter Monitoring)
Dynamic electrocardiography devices that continuously record a real-time EKG, commonly known as Holter™ monitors, typically record over a 24-hour period. The recording is captured either on a magnetic tape or other digital medium. The data is then computer-analyzed at a later time, and a physician interprets the computer-generated report. A 24-hour recording is generally adequate to detect most transient arrhythmias.

Transtelephonic EKG
Transtelephonic EKG monitoring involves the recording of arrhythmia in patients where the symptoms may be significant but occur very infrequently. Consequently, the arrhythmia is difficult to identify on a 24 or 48-hour Holter monitor.

Cardiac Event Detection Monitoring
Certain cardiac event monitors capture electrical activity with a single electrode attached to the skin. Other devices may employ multiple electrodes in order to record more complex EKG tracings. Additionally, devices may be individually programmed to detect patient-specific factors, electrode malfunction, or other factors. Cardiac event monitors can be further categorized as either "pre-event" or "post-event" recorders, based on their memory capabilities.

Pre-symptom Memory Loop Recorder (MLR)
Upon detecting symptoms, the wearer presses a button, which activates the recorder to save (i.e., memorize) an interval of pre-symptom EKG data along with data during and subsequent to the symptomatic event. Self-sensing recorders (also known as event-activated or automatic trigger) do not require patient input to capture these data. Single or multiple events may be recorded. The device is worn at all times, usually for up to 30 days. Charges billed more frequently within the thirty-day period should be denied as not covered and not billable to the member.

• Implantable (or Insertable Loop) Recorder (ILR)
  This is another type of pre-symptom MLR. It is implanted subcutaneously in a patient's upper left chest and may remain implanted for many months. An ILR is used when syncope is thought to be cardiac-related, but is too infrequent to be detected by either a Holter monitor or a traditional pre-symptom MLR.

Post-symptom Recorder
The patient temporarily places this device against the chest when symptoms occur and activates it by pressing a button. These recorders represent old technology, as they do not include a memory loop. The device transmits EKG data telephonically in real-time and is usually used for up to 30 days. Charges billed more frequently within the thirty-day period should be denied as not covered and not billable to the member.

The following indications are covered:

1. Computer analysis of EKGs when furnished in a setting and under the circumstances required for coverage of other EKG services.
   
   
2. Emergency EKGs (i.e., when the patient is or may be experiencing a lifethreatening event) performed as a laboratory or diagnostic service by a portable x-ray supplier only when a physician is in attendance at the time the service is performed or immediately thereafter.
   
   
3. Home EKG services with documentation of medical necessity.
   
   
4. Trans-telephonic EKG transmissions as a diagnostic service for the indications described below, when performed with equipment meeting the standards described below, subject to the limitations and conditions specified below. Coverage is further limited to the amounts payable with respect to the physician's service in interpreting the results of such transmissions, including charges for rental of the equipment. The device used by the member is part of a total diagnostic system and is not considered DME separately. Covered uses are to:
   1. Detect, characterize, and document symptomatic transient arrhythmias;
   2. Initiate, revise, or discontinue arrhythmic drug therapy; or,
   3. Carry out early post-hospital monitoring of patients discharged after myocardial infarction (MI).
      
      
5. Monitoring performed with a marketed, FDA approved device.

Certain uses other than those specified above may be covered if such use is determined to be medically necessary.

Additionally, the transmitting devices must meet at least the following criteria:

1. They must be capable of transmitting EKG Leads, I, II, or III; and,
2. The tracing must be sufficiently comparable to a conventional EKG.

24-hour attended coverage used as early post-hospital monitoring of patients discharged after MI is only covered if provision is made for such 24-hour attended coverage in the manner described below:

24-hour attended coverage means there must be, at a monitoring site or central data center, an EKG technician or other non-physician, receiving calls and/or EKG data; tape recording devices do not meet this requirement. Further, such technicians should have immediate, 24-hour access to a physician to review transmitted data and make clinical decisions regarding the patient. The technician should also be instructed as to when and how to contact available facilities to assist the patient in case of emergencies.

The following indications are non-covered:

1. The time-sampling mode of operation of ambulatory EKG cardiac event monitoring/recording.
   
   
2. Separate physician services unless rendered by the patient's attending or consulting physician.
   
   
3. Home EKG services without documentation of medical necessity.
   
   
4. Emergency EKG services by a portable x-ray supplier without a physician in attendance at the time of service or immediately thereafter.

Dynamic Electrocardiogram (Holter Monitoring)
Documentation of medical necessity is required for monitoring longer than 24 hours. The recording device itself is not covered as durable medical equipment (DME) separate from the total diagnostic service.

Transtelephonic EKG
Transtelephonic EKG transmissions are covered as a diagnostic service for specific indications, when performed with equipment meeting certain standards. Coverage is further limited to the amount payable with respect to the physician's service in interpreting the results of such transmissions, including charges for rental of the equipment. The device used by the member is part of a total diagnostic system and is not considered DME separately. Covered uses are to:

1. Detect, characterize, and document symptomatic transient arrhythmias;
2. Initiate, revise, or discontinue arrhythmic drug therapy; or,
3. Carry out early post-hospital monitoring of patients discharged after myocardial infarction (MI); (only if 24-hour coverage is provided).

Certain uses other than those specified above may be covered if, in the judgment of the Plan, such use is medically necessary.

Additionally, the transmitting devices must meet at least the following criteria:

1. They must be capable of transmitting EKG Leads I, II, or III; and,
2. The tracing must be sufficiently comparable to a conventional EKG.

24-hour attended coverage used as early post-hospital monitoring of patients discharged after MI is only covered if provision is made for such 24-hour attended coverage in the manner described below:

24-hour attended coverage means there must be, at a monitoring site or central data center, an EKG technician or other non-physician, receiving calls and/or EKG data; tape recording devices do not meet this requirement. Further, such technicians should have immediate, 24-hour access to a physician to review transmitted data and make clinical decisions regarding the patient. The technician should also be instructed as to when and how to contact available facilities to assist the patient in case of emergencies.

The following is non-covered:

• 24-hour attended coverage used as early post-hospital monitoring of patients discharged after MI unless provision is made for such 24-hour attended coverage.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Social Security Act, Section 1156(a)(1). This section states that the health care practitioner must assure services will be provided economically and only when, and to the extent, medically necessary.

CMS Online Manual Pub. 100-3, Chapter 1, Section 20.15