Electrical impedance scanning of the breast involves the transmission of continuous electricity into the body using either an electrical patch attached to the arm or a handheld cylinder. The electrical current travels through the breast where it is then measured at skin level by a probe placed on the breast. It is proposed that cancerous tissue conducts electricity differently than normal tissue; therefore, cancerous images may show up on the resulting imaging as a bright white spot.
An example of an electrical impedance scanning device is the T-Scan™ 2000. This device received approval for marketing from the U. S. Food and Drug Administration (FDA) in 1999 with the following labeled indication: “The T-Scan™ 2000 is intended for use as an adjunct to mammography in individuals who have equivocal mammographic findings with ACR Bi-RADS™ categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy.
Electrical impedance scanning of the breast is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
There is a lack of evidence in the published literature to show that electrical impedance scanning for the detection and classification of breast lesions can predict clinical events, be used to alter treatment or is effective as or more effective than currently used methods.
Dagler, G., Senol, K., Yakut, Z., Yuksek, Y., Tutuncu, T, Tez, M., & Yesiltepe, C. (2016). Effectiveness of breast electrical impedance imaging for clinically suspicious breast lesions. Bratislavske Lekarske Listy, 117 (9), 505-510. Abstract retrieved June 22, 2017 from PubMed database.
U. S. Food and Drug Administration. (1999, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. P970033. Retrieved December 19, 2003 from http://www.fda.gov/cdrh/pdf/p970033.html.
U. S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. Advisory Committees. Obstetrics and Gynecology Devices Panel. Retrieved February 10, 2011 from http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm125145.htm.
Vreugdenburg, T., Willis, C., Mundy, L., & Hiller, J. (2013). A systematic review of elastography, electrical impedance scanning and digital infrared thermography for breast cancer screening and diagnosis. Breast Cancer Research and Treatment, 137 (3), 665-676. Abstract retrieved June 22, 2017 from PubMed database.
ORIGINAL EFFECTIVE DATE: 6/1/2004
MOST RECENT REVIEW DATE: 5/9/2019
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