DESCRIPTION
Transtelephonic electrocardiogram (ECG) involves the use of cardiac leads appropriately placed on the individual’s skin that detect the electrical activity associated with the heart and the transmission of the visual record of that electrical activity to a remote receiving station. The devices used for such monitoring are portable (usually pocket-sized) and detect and convert the (ECG) signal for transmission via ordinary telephone apparatus. The received signal is then decoded and transcribed into a conventional ECG. Transtelephonic monitoring may be accomplished by ambulatory event recording or as a real-time monitoring. Real-time monitoring is accomplished when an arrhythmia is detected. Transmission 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.)
Transtelephonic electrocardiographic monitoring as a routine substitute for more conventional methods of diagnosis such as history, physical exam and standard ECG rhythm strip is considered not medically necessary.
Transtelephonic electrocardiographic monitoring for routine assessment of pacemaker function is considered not medically necessary.
Transtelephonic electrocardiographic monitoring for more than 30 days (unless unusual circumstances support additional period of monitoring) to detect transient arrhythmias is considered not medically necessary.
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. Symptoms of transient arrythmias 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 assess function of a pacemaker when the individual has symptoms suggestive of arrhythmia not revealed by the standard ECG or rhythm strip
To perform early post hospital, real-time monitoring of individuals discharged after myocardial infarction / 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 specifications are met:
Capable of transmitting ECG leads I, II, or III
The quality of the lead transmissions must be sufficiently comparable to readings obtained by a conventional ECG to permit proper interpretation of abnormal cardiac rhythms
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is insufficient published evidence demonstrating that the use of a transtelephonic electrocardiography renders a health benefit equal to, or greater than, other established alternatives (e.g., face-to-face physician assessment, EKG rhythm strip, ) for routine assessment of pacemakers function or as a routine method of diagnosis.
SOURCES
Abbott, A. V. (2005). Diagnostic approach to palpitations. American Family Physician, 71 (4), 755 - 756. (Level 5 Evidence)
American College of Cardiology. (2008). 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 11, 2011 from http://content.onlinejacc.org/cgi/reprint/51/21/e1.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2010). Ambulatory event monitors and mobile cardiac outpatient telemetry (2.02.08). Retrieved July 5, 2011 from BlueWeb. (15 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Electrocardiographic services (NCD 20.15, p. 2-20 - 2-21). Ingenix
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Cardiac pacemaker evaluation services. (NCD 20.8.1.; p. 2-13 - 2-14). Ingenix.
Crossley, G., Chen, J., Choucair, W., Cohen, T., Gohn, D., Johnson, W.B., et al. (2009) Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. Journal of American College of Cardiology, 54 (22), 2012-2019. (Level 2 Evidence – Industry sponsored)
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 July, 5, 2011 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 July 5, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060911.pdf.
U.S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K101639. Retrieved July 5, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=34183.
U.S. Food and Drug Administration. (2006, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K052556. Retrieved July, 5, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=19489.
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, 45 (2), 104 - 110. (Level 5 Evidence)
ORIGINAL EFFECTIVE DATE: 9/13/1999
MOST RECENT REVIEW DATE: 9/22/2011
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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