DESCRIPTION
Lymphedema is a chronic accumulation of fluid and fibrous tissue that results from the disruption of lymphatic drainage. Secondary lymphedema of the upper extremity may develop following surgery for breast cancer. Lymphedema can be difficult to diagnose and manage. One challenge is identifying the clinically significant limb swelling through simple noninvasive methods. The detection of subclinical lymphedema (i.e., the early detection of lymphedema before clinical symptoms become apparent) is another area of study. The subclinical disease may exist for months or years before overt edema is noted. This approach generally involves comparison of preoperative (i.e., baseline) with postoperative measurements.
Bioimpedance spectroscopy (e.g., SOZO®, MoistureMeterD, ImpediMed L-Dex™ U400) is based on the theory that the level of opposition to the flow of electric current (impedance) through the body is inversely proportional to the volume of fluid in the tissue. In lymphedema, with the accumulation of excess interstitial fluid, tissue impedance decreases. Bioimpedance has been proposed as a diagnostic test for this condition, and management via bioelectric impedance spectroscopy has been proposed as a way to implement early treatment of subclinical lymphedema to potentially reduce its severity.
POLICY
Bioimpedance spectroscopy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Bioimpedance devices for all other conditions/diseases are considered investigational.
MEDICAL APPROPRIATENESS
Bioimpedance spectroscopy is considered medically appropriate if ANY ONE of the following are met:
Individual is at high risk for lymphedema as evidenced by ANY ONE of the following:
History of cancer treatment (e.g., surgery, radiation, and/or chemoradiation) to the lymph node system of ANY ONE of the following:
Axillary
Supraclavicular
Cervical
Pelvic inguinal
Individual is at high risk for lymphedema as a result of cancer treatment damage to the lymphatic system and ANY ONE of the following:
Body mass index (BMI) equal to or greater than 30 kg/m2
Localized infection
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
SOURCES
BlueCross BlueShield Association. Evidence Positioning System. (2:2024). Bioimpedance devices for detection of lymphedema (2.01.82). Retrieved June 18, 2024 from http://www.bcbsaoca.com/eps/. (21 articles and/or guidelines reviewed)
Kaufman, D.I., Shah, C., Vicini, F.A., & Rizzi, M. (2017). Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema. Breast Cancer Research and Treatment, 166 (3), 809-815. (Level 3 evidence)
National Comprehensive Cancer Network. (2024, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Survivorship v.1.2024. Retrieved June 18, 2024 from the National Comprehensive Cancer Network.
Ridner, S. H., Dietrich, M. S., Boyages, J., Koelmeyer, L., Elder, E., Hughes, T. M., et al. (2022). A Comparison of bioimpedance spectroscopy or tape measure triggered compression intervention in chronic breast cancer lymphedema prevention. Lymphatic Research and Biology, Advance online publication. doi.org/10.1089/lrb.2021.0084 (Level 2 evidence)
Seward, C., Skolny, M., Brunelle, C, Asdourian, M., Salama, L, & Taghian, A. (2016). A comprehensive review of bioimpedance spectroscopy as a diagnostic tool for the detection and measurement of breast cancer-related lymphedema. Journal of Surgical Oncology, 114 (5), 537-542. Abstract retrieved January 27, 2020 from PubMed database.
Shah, C., Arthur, D.W., Wazer, D., Khan, A., Ridner, S., & Vicini, F. (2016). The impact of early detection and intervention of breast cancer-related lymphedema: a systematic review. Cancer Medicine, 5 (6), 1154-1162. (Level 2 evidence)
Shah, C., Zambelli-Weiner, A., Delgado, N., Sier, A., Bauserman, R., & Nelms, J. (2020). The impact of monitoring techniques on progression to chronic breast cancer-related lymphedema: a meta-analysis comparing bioimpedance spectroscopy versus circumferential measurements. Breast Cancer Research and Treatment, 185 (3), 709–740. (Level 1 evidence)
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.
U. S. Food and Drug Administration. (2018, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K180126. Retrieved April 24, 2023 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2023, March). Bioelectrical impedance (Bioimpedance) analysis for assessment of lymphedema. Retrieved April 18, 2023 from www.Hayesinc.com/subscribers. (48 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 5/12/2012
MOST RECENT REVIEW DATE: 8/8/2024
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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