DESCRIPTION
Cardiac leads are placed on the skin to transmit current from the heart to a recorder that produces a visual record. These devices are portable (usually pocket-sized) and detect and convert the normal electrocardiogram (ECG) signal to be transmitted via ordinary telephone apparatus to a receiving station. The signal is then decoded and transcribed into a conventional ECG. Transtelephonic monitoring may be accomplished by event recording, as described above. Real-time monitoring is another option, which involves applying a monitor device to a specified area ensuring good contact for optimal signal transmission. Real-time monitoring generally requires that the individual remain stable while symptomatic, and that the symptoms be of sufficient duration (5-10 minutes) to permit the individual to place the necessary call to the monitoring center.
POLICY
Transtelephonic electrocardiographic monitoring for the purpose of detecting cardiac rhythm abnormalities is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any Transtelephonic electrocardiographic monitoring device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
MEDICAL APPROPRIATENESS
Transtelephonic electrocardiographic monitoring is considered medically appropriate if ALL of the following criteria are met:
For ANY ONE of the following:
To detect, characterize, and document symptomatic transient arrhythmias which occur sporadically that may include but are not limited to the following, palpitations, chest pain, dizziness, near syncope, syncope, dyspnea, transient ischemic episodes and shortness of breath
To overcome problems in regulating antiarrhythmic drug dosage
To evaluate arrhythmia detection and therapy data associated with an implantable cardioverter defibrillator
For individuals with non-programmable pacemakers with ANY ONE of the following.
Individual is unable to visit a clinic twice a year
Individual has suspected dysfunction of the pacemaker
Symptomatic arrhythmias are suspected
To carry out early post hospital monitoring of individuals discharged after myocardial infarction
Use of the long-term ECG for routine assessment of pacemaker function may be justified when the individual has symptoms suggestive of arrhythmia not revealed by the standard ECG or rhythm strip
Use of the device for more than 30 days to detect transient arrhythmias if unusual circumstances support an additional period of monitoring
To perform post hospital monitoring of individuals discharged after myocardial infarction / real-time monitoring if ALL of the following provisions are met:
The provider of the service must be capable of receiving transmissions 24 hours a day, every day of the year
The individual receiving transmissions must be a technician, nurse or physician trained in interpreting ECG and abnormal rhythms. A technician must be appropriately licensed and/or certified by the state of Tennessee. (Note: Transmissions received by an answering machine for review at a later time does not meet this criteria)
The technician or nurse should have immediate access to a physician
The technician, nurse or physician must have been instructed in when and how to contact available facilities to assist the monitored individual in cases of emergency
The receiving station must also have established policies regarding when and how to contact emergency facilities
ALL device and receiving station specification are met:
Capable of transmitting ECG leads I, II, or III
Lead transmissions must be sufficiently comparable to readings obtained by a conventional ECG to permit proper interpretation of abnormal cardiac rhythms
ABSENCE of ALL of the following:
Use as a routine substitute for more conventional methods of diagnosis such as history, physical exam and standard ECG rhythm strip
Use of the long-term ECG for routing assessment of pacemaker function
Use of the device for more than 30 days to detect transient arrhythmias
SOURCES
Abbott, A. V. (2005). Diagnostic approach to palpitations. American Family Physician, 71 (4), 755 - 756. (Level 5 Evidence)
American College of Cardiology. (2001). ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography. Retrieved July 16, 2009 from http://www.acc.org/qualityandscience/clinical/competence/ECG/ecg_index.htm.
American College of Cardiology. (2002). ACC/AHA/NSAPE 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines. Retrieved July 16, 2009 from http://content.onlinejacc.org/cgi/reprint/51/21/e1.pdf.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, April). Electrocardiographic services (NCD 20.15, p. 2-21 - 2-22). The Ingenix Complete Guide to Medicare Coverage Issues.
Complete Guide to Medicare Coverage Issues [Computer software]. 2009, April). Cardiac pacemaker evaluation services. (NCD 20.8.1.; p. 2-13 - 2-14). The Ingenix Complete Guide to Medicare Coverage Issues.
El-Sherif, N., & Samet, P. (Eds.), Cardiac Pacing and Electrophysiology (3rd ed., pp. 666). Philadelphia: W. B. Saunders Company.
Giulians, E. R., Gersh, B. J., McGuon, M. D., Hayes, D. L., Schaff, H. V. (Ed.). Mayo Clinic Practice of Cardiology (3rd ed., pp. 146). Mosby-Year Book, Inc.
Roth, A., Malov, N., Steinberg, D., Yanay, Y., Elizur, M., Tamari, M., et al. (2009). Telemedicine for post-myocardial infarction patients: an observational study. Telemedicine Journal of e-Health, 15 (1), 24 - 30. (Level 5 Evidence)
U.S. Food and Drug Administration. (2003, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K024365. Retrieved June 24, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/K024365.pdf.
U.S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060911. Retrieved June 24, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060911.pdf.
Vanagas, G., Zaliunas, R., Benetis, R., & Slapikas, R. (2008). Factors affecting relevance of tele-ECG systems application to high risk for future ischemic heart disease events patients group. Telemedicine Journal of e-Health, 14 (4), 345 - 349. (Level 5 Evidence)
Zaliunas, R., Benetis, R., Vanagas, G., & Vainoras, A. (2009). Implementation of international transtelephonic ECG platform for patients with ischemic heart disease. Medicina (Kaunas),45 (2), 104 - 110. (Level 5 Evidence)
ORIGINAL EFFECTIVE DATE: 9/13/1999
MOST RECENT REVIEW DATE: 10/8/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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