BlueCross BlueShield of Tennessee Medical Policy Manual

Bioimpedance Devices for Detection of Lymphedema

DESCRIPTION

Bioimpedance devices or bioelectrical impedance spectroscopy devices are a non-invasive technology and have been proposed for use as a tool to diagnose lymphedema. Bioimpedance compares resistance to electrical current in different compartments as tissue impedance decreases with the accumulation of excess interstitial fluid.

Secondary lymphedema may develop following surgery for breast cancer. This condition results from lymphatic dysfunction or disruption and can be difficult to accurately diagnose and manage. One challenge is identifying the presence of clinically significant limb swelling through simple noninvasive methods. Many techniques have been used for documenting lymphedema including measuring differences in limb volume (volume displacement) and limb circumference. A number of newer techniques are being evaluated, including bioimpedance with use of bioimpedance spectroscopy (BIS) analysis (e.g., ImpediMed L-Dex®  U400). BIS is based on the theory that the amount of opposition to flow of electric current (impedance) through the body is inversely proportional to the volume of fluid in the tissue.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

There is a lack of scientific evidence to verify the technical and diagnostic performance of bioimpedance testing in the diagnosis of secondary lymphedema, especially for subclinical disease. There are no data from comparative clinical trials that demonstrate the impact of the test on clinical outcomes.

SOURCES   

Agency for Healthcare Research and Quality. Technology Assessment Program. (2010, May). Diagnosis and treatment of secondary lymphedema. Retrieved September 26, 2013 from http://www.cms.gov.

Barrio, A., Eaton, A., & Frazier, T. (2015). A prospective validation study of bioimpedance with volume displacement in early-stage breast cancer patients at risk for lymphedema. Annals of Surgical Oncology, 22 (03), 370-375. (Level 3 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2018). Bioimpedance devices for detection of lymphedema (2.01.82). Retrieved March 5, 2018 from BlueWeb. (8 articles and/or guidelines reviewed)

Fu, M., Axelrod, D., Guth, A., Cartwright, F, Qiu, Z., Goldberg, J., et. al. (2014) Proactive approach to lymphedema risk reduction: a prospective study. Annals of Surgical Oncology, 21 (11), 3481–3489. (Level 3 evidence)

Smoot, B., Zerzan, S., Krasnoff, J., Wong, J., Cho, M., & Dodd, M. (2014). Upper extremity bioimpedance before and after treadmill testing in women post breast cancer treatment. Breast Cancer Research and Treatment, 148 (2), 445-453. Abstract retrieved May 27, 2015 from PubMed database.

U. S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080825. Retrieved September 26, 2013 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2013, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130338. Retrieved September 27, 2013 from http://www.accessdata.fda.gov.

Vicini, F. A., Arthur, D., Shah, C., Anglin, B. V., Curcio, L. D., Laidley, A. L., et al. (2013). Multi-institutional analysis of bioimpedance spectroscopy in the early detection of breast cancer related lymphedema. Journal of Cancer Research & Therapy, 1 (1), 1-7. (Level 3 evidence)

Winifred S. Hayes, Inc. Medical Technology Directory. (2015, March; last update search March 2017). Bioelectrical impedance (Bioimpedance) analysis for assessment of lymphedema. Retrieved March 5, 2018 from www.Hayesinc.com.  (53 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  5/12/2012

MOST RECENT REVIEW DATE:  4/12/2018

ID_BA

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.

This document has been classified as public information.