Bioimpedance Devices for Detection and Management of Lymphedema Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 01|01|2015 POLICY LAST REVIEWED: 03|19|2025 OVERVIEW Secondary lymphedema may develop following treatment for breast cancer. Bioimpedance, which uses resistance to electrical current to compare the composition of fluid compartments, could be used as a tool to diagnose lymphedema. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION
Not applicable POLICY STATEMENT Medicare Advantage Plans Devices using bioimpedance (bioelectrical impedance spectroscopy) are not covered for use in the diagnosis, surveillance, or treatment of individuals with lymphedema, including use in subclinical secondary lymphedema as the evidence is insufficient to determine the effects of the technology on health outcomes. Commercial Products Devices using bioimpedance (bioelectrical impedance spectroscopy) are considered not medically necessary for use in the diagnosis, surveillance, or treatment of individuals with lymphedema, including use in subclinical secondary lymphedema as the evidence is insufficient to determine the effects of the technology on health outcomes. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not medically necessary benefits/coverage. BACKGROUND Lymphedema is an accumulation of fluid due to disruption of lymphatic drainage. It is characterized by nonpitting swelling of an extremity or trunk, and is associated with wound healing impairment, recurrent skin infections, and decreased quality of life. Lymphedema can be caused by congenital or inherited abnormalities in the lymphatic system (primary lymphedema) but is most often caused by acquired damage to the lymphatic system (secondary lymphedema). Breast cancer treatment (surgical removal of lymph nodes and radiotherapy) is one of the most common causes of secondary lymphedema. In a systematic review of 72 studies (N=29612 women), DiSipio et al (2013) reported that nearly 20% of breast cancer survivors will develop arm lymphedema. Risk factors with robust evidence for development of lymphedema included extensive surgical procedures (such as axillary lymph node dissection, a higher number of lymph nodes removed, and mastectomy) as well as being overweight or obese. Lymphedema is treated using elevation, compression, and exercise. Conservative therapy may consist of several features depending on the severity of the lymphedema. Individuals are educated on the importance of self-care including hygiene practices to prevent infection, maintaining ideal body weight through diet and exercise, and limb elevation. Compression therapy consists of repeatedly applying padding and bandages or compression garments. Manual lymphatic drainage is a light pressure massage performed by trained physical therapists or by individuals designed to move fluid from obstructed areas into functioning lymph vessels and lymph nodes. Complete decongestive therapy is a multiphase treatment program involving all of the Medical Coverage Policy | Bioimpedance Devices for Detection and Management of Lymphedema

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

previously mentioned conservative treatment components at different intensities. Pneumatic compression pumps may also be considered as an adjunct to conservative therapy or as an alternative to self-manual lymphatic drainage in patients who have difficulty performing self-manual lymphatic drainage. In individuals with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques such as liposuction may be performed.

Bioimpedance spectroscopy 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. In usual care, lymphedema is recognized clinically or via limb measurements. However, management via bioelectrical impedance spectroscopy has been proposed as a way to implement early treatment of subclinical lymphedema to potentially reduce its severity.

A selection of devices that have been cleared for marketing by the U.S. Food and Drug Administration (FDA)through the 510(k) process to aid in the assessment of lymphedema. Among the FDA-approved bioimpedance devices are SOZO (ImpediMed), MoistureMeterD (Delfin Technologies), and the L-Dex U400 (ImpediMed). The L-Dex U400 was discontinued by its manufacturer in November 2018.

For individuals who have known or suspected lymphedema who receive bioimpedance spectroscopy (BIS), the evidence includes systematic reviews, 1 randomized control trial (RCT), 1 prospective comparative observational study, and multiple uncontrolled observational studies. Relevant outcomes are test validity, symptoms, and quality of life. Diagnostic accuracy studies have found a poor correlation between bioimpedance analysis and the reference standard (volume displacement or circumferential measurement). Results from the PREVENT RCT comparing bioimpedance with standard tape measure following treatment for breast cancer have been published. At a median follow-up of 32.9 months, BIS patients triggered intervention at a lower rate than tape measured patients (20.1% vs 27.5%) and fewer patients progressed in this group (7.9% vs 19.2%). The RCT was limited by its open-label design and lack of reporting of important health outcomes. The single prospective comparative study found a significantly lower rate of clinical lymphedema in patients managed with BIS devices but had several limitations, including nonrandomized design, lack of blinding, lack of complete data on a substantial proportion of enrolled patients, and lack of a systematic method for diagnosing lymphedema in the control group. Retrospective studies suggested that postoperative bioimpedance monitoring is feasible but provide limited information about its efficacy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:
93702 Bioimpedance spectroscopy (BIS), extracellular fluid analysis for lymphedema assessment(s)

RELATED POLICIES None

PUBLISHED Provider Update, May 2025 Provider Update, May 2024 Provider Update, April 2023 Provider Update, April 2022 Provider Update, March 2021

REFERENCES

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

1. DiSipio T, Rye S, Newman B, et al. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. May 2013; 14(6): 500-15. PMID 23540561
2. International Society of Lymphology Executive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2020 Consensus Document of the International Society of Lymphology. 2020; https://isl.arizona.edu/sites/default/files/2021-09/Consensus%20Document-SM.pdf. Accessed November 25, 2024.
3. Pusic AL, Cemal Y, Albornoz C, et al. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. Mar 2013; 7(1): 83-92. PMID 23212603
4. Oremus M, Walker K, Dayes I, et al. Technology Assessment: Diagnosis and treatment of secondary lymphedema. Rockville, MD: Agency for Healthcare Research and Quality; 2010.
5. Cornish BH, Chapman M, Hirst C, et al. Early diagnosis of lymphedema using multiple frequency bioimpedance. Lymphology. Mar 2001; 34(1): 2-11. PMID 11307661
6. Hayes S, Janda M, Cornish B, et al. Lymphedema secondary to breast cancer: how choice of measure influences diagnosis, prevalence, and identifiable risk factors. Lymphology. Mar 2008; 41(1): 18-28. PMID 18581955
7. Whitworth P, Vicini F, Valente SA, et al. Reducing rates of chronic breast cancer-related lymphedema with screening and early intervention: an update of recent data. J Cancer Surviv. Aug 10 2022. PMID 35947288
8. Barrio AV, Eaton A, Frazier TG. A Prospective Validation Study of Bioimpedance with Volume Displacement in Early-Stage Breast Cancer Patients at Risk for Lymphedema. Ann Surg Oncol. Dec 2015; 22 Suppl 3(0 3): S370-5. PMID 26085222
9. Blaney JM, McCollum G, Lorimer J, et al. Prospective surveillance of breast cancer-related lymphoedema in the first-year post-surgery: feasibility and comparison of screening measures. Support Care Cancer. Jun 2015; 23(6): 1549-59. PMID 25398360
10. Ridner SH, Dietrich MS, Boyages J, et al. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphat Res Biol. Dec 2022; 20(6): 618-628. PMID 35099283
11. Ridner SH, Dietrich MS, Cowher MS, et al. A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis. Ann Surg Oncol. Oct 2019; 26(10): 3250-3259. PMID 31054038
12. Shah C, Boyages J, Koelmeyer L, et al. Timing of Breast Cancer Related Lymphedema Development Over 3 Years: Observations from a Large, Prospective Randomized Screening Trial ComparingBioimpedance Spectroscopy (BIS) Versus Tape Measure. Ann Surg Oncol. Oct 2024; 31(11): 7487-7495. PMID 38965099
13. Soran A, Ozmen T, McGuire KP, et al. The importance of detection of subclinical lymphedema for the prevention of breast cancer-related clinical lymphedema after axillary lymph node dissection; a prospective observational study. Lymphat Res Biol. Dec 2014; 12(4): 289-94. PMID 25495384
14. Laidley A, Anglin B. The Impact of L-Dex(®) Measurements in Assessing Breast Cancer-Related Lymphedema as Part of Routine Clinical Practice. Front Oncol. 2016; 6: 192. PMID 27656420
15. Koelmeyer LA, Borotkanics RJ, Alcorso J, et al. Early surveillance is associated with less incidence and severity of breast cancer-related lymphedema compared with a traditional referral model of care. Cancer. Mar 15 2019; 125(6): 854-862. PMID 30521080
16. Kilgore LJ, Korentager SS, Hangge AN, et al. Reducing Breast Cancer-Related Lymphedema (BCRL) Through Prospective Surveillance Monitoring Using Bioimpedance Spectroscopy (BIS) and Patient Directed Self-Interventions. Ann Surg Oncol. Oct 2018; 25(10): 2948-2952. PMID 29987599
17. Whitworth PW, Cooper A. Reducing chronic breast cancer-related lymphedema utilizing a program of prospective surveillance with bioimpedance spectroscopy. Breast J. Jan 2018; 24(1): 62-65. PMID 29063664
18. Erdogan Iyigun Z, Selamoglu D, Alco G, et al. Bioelectrical impedance for detecting and monitoring lymphedema in patients with breast cancer. Preliminary results of the florence nightingale breast study group. Lymphat Res Biol. Mar 2015; 13(1): 40-5. PMID 25526543

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

19. Shah C, Vicini F, Beitsch P, et al. The use of bioimpedance spectroscopy to monitor therapeutic intervention in patients treated for breast cancer related lymphedema. Lymphology. Dec 2013; 46(4): 184-
20. PMID 25141461
21. Lim SM, Han Y, Kim SI, et al. Utilization of bioelectrical impedance analysis for detection of lymphedema in breast Cancer survivors: a prospective cross sectional study. BMC Cancer. Jul 08 2019; 19(1): 669. PMID 31286884
22. Kaufman DI, Shah C, Vicini FA, et al. Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema. Breast Cancer Res Treat. Dec 2017; 166(3): 809-815. PMID 28831632
23. Whitworth PW, Shah C, Vicini F, et al. Preventing Breast Cancer-Related Lymphedema in High-Risk Patients: The Impact of a Structured Surveillance Protocol Using Bioimpedance Spectroscopy. Front Oncol. 2018; 8: 197. PMID 29946531
24. Jeffers EJ, Wagner JL, Korentager SS, et al. Breast Cancer-Related Lymphedema (BCRL) and Bioimpedance Spectroscopy: Long-Term Follow-Up, Surveillance Recommendations, and Multidisciplinary Risk Factors. Ann Surg Oncol. Oct 2023; 30(10): 6258-6265. PMID 37535267
25. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Survivorship. Version 1.2023. Updated March 24, 2023. https://www.nccn.org/professionals/physician_gls/pdf/survivorship.pdf. Accessed November 27,

27. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2023. Updated March 23, 2023. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed November 11, 2024.

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