261 Form

1

Medical Policy Bioimpedance Devices for the Detection of Lymphedema Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 261

BCBSA Reference Number: 2.01.82 (For Plan internal use only) NCD/LCD: N/A Related Policies
• Pneumatic Compression Pumps for Treatment of Lymphedema, #354 • Surgical and Debulking Treatments for Lymphedema, #037 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Bioimpedance spectroscopy may be considered MEDICALLY NECESSARY to confirm a diagnosis of lymphedema in the following clinical scenario:

1. The individual is asymptomatic with history of surgery, radiotherapy, or trauma impacting the lymphatic system, and testing would guide decisions regarding early intervention (eg, physical therapy, complete decongestive therapy).

   Bioimpedance spectroscopy may be considered MEDICALLY NECESSARY for surveillance of lymphedema in the following clinical scenarios:

2. The individual is asymptomatic with history of surgery, radiotherapy, or trauma impacting the lymphatic system, and testing would guide decisions regarding early intervention (eg, physical therapy, complete decongestive therapy) OR

3. The individual remains symptomatic following a course of conservative therapy for lymphedema, and testing would guide decisions regarding escalation of therapy (eg, liposuction, surgery) (see Policy Guidelines).

   Bioimpedance spectroscopy is considered INVESTIGATIONAL outside of the aforementioned clinical scenarios.

   Policy Guidelines Medically necessary positions are based on clinical input. Additional details from clinical input are detailed in the Appendix, including addressing the role of a related diagnostic intervention - indocyanine green lymphography - largely considered by lymphedema surgeons to be the most unequivocal diagnostic tool

2

for assessing lymphatic dysfunction and informing patient management. For individuals with clinically diagnosed and/or symptomatic lymphedema, bioimpedance spectroscopy provides limited incremental utility for the optimization of decongestive therapy - but may confirm maximal expected benefit from conservative therapies and thus inform decisions concerning treatment escalation.

An optimal surveillance frequency in individuals at high-risk for the development of secondary lymphedema has not been established. Lymphedema experts generally recommend assessments every 3-6 months for a minimum of 3 years after cancer treatment on the basis of the PREVENT RCT.

Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required.

CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT codes: Code Description 93702 Bioimpedance spectroscopy (BIS), extracellular fluid analysis for lymphedema assessment(s)

ICD10 Diagnosis Codes ICD-10-CM- codes: Code Description I89.0 Lymphedema, not elsewhere classified I97.2 Postmastectomy lymphedema syndrome

Description Lymphedema 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

3

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=29,612 women), DiSipio et al (2013) reported that nearly 20% of breast cancer survivors will develop arm lymphedema.1, The risk factors with robust evidence for the 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.

Diagnosis and Staging A diagnosis of secondary lymphedema is based on history (e.g., cancer treatment, trauma) and physical examination (localized, progressive edema and asymmetric limb measurements) when other causes of edema can be excluded. Imaging, such as MRI, computed tomography, ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from other causes of edema in diagnostically challenging cases. Table 1 lists International Society of Lymphology guidance for staging lymphedema (2023) based on "softness" or "firmness" of the limb and the changes with an elevation of the limb.2,

Table 1. Recommendations for Staging Lymphedema Stage Description Stage 0 (latent or subclinical)

Swelling is not yet evident despite impaired lymph transport, subtle alterations in tissue fluid/composition, and changes in subjective symptoms. It can be transitory and may exist months or years before overt edema occurs (Stages 1- lll).

Stage I (mild) Early accumulation of fluid relatively high in protein content (e.g., in comparison with "venous" edema) which subsides with limb elevation. Pitting may occur. An increase in various types of proliferating cells may also be seen.

Stage II (moderate) Involves the permanent accumulation of pathologic solids such as fat and proteins and limb elevation alone rarely reduces tissue swelling, and pitting is manifest. Later in this stage, the limb may not pit as excess subcutaneous fat and fibrosis develop.

Stage III (severe) Encompasses lymphostatic elephantiasis where pitting can be absent and trophic skin changes such as acanthosis, alterations in skin character and thickness, further deposition of fat and fibrosis, and warty overgrowths have developed. It should be noted that a limb may exhibit more than one stage, which may reflect alterations in different lymphatic territories.

Management and Treatment Lymphedema is treated using elevation, compression, and exercise. Conservative therapy may consist of several features depending on the severity of the lymphedema. Patients 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 patients 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 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 patients 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

4

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.

Summary 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.

Summary of Evidence For individuals who have known or suspected lymphedema who receive bioimpedance spectroscopy, the evidence includes systematic reviews, 1 randomized controlled 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.

Additional Information 2025 Input Clinical input was sought to help determine whether the use of bioimpedance spectroscopy for individuals with lymphedema and/or lipedema would provide a clinically meaningful improvement in net health outcome and represents generally accepted medical practice in selected patients. In response to requests, clinical input was received from 3 respondents identified by the National Commission on Lymphatic Diseases (NCLD) or an academic medical center. In addition to this request, a plastic surgeon specializing in lymphedema research and reconstruction at a major academic center was interviewed.

For individuals with known or suspected (ie, clinically diagnosed or symptomatic) lymphedema, clinical input supports that use of bioimpedance spectroscopy is consistent with generally accepted medical practice. Feedback on whether this use results in a clinically meaningful improvement in net health outcome was mixed, with the primary benefit limited to situations where confirmation of maximal benefit from conservative measures such as decongestive therapy can help inform decisions around escalation of therapy. For individuals who are asymptomatic but are at elevated risk for lymphedema due to prior radiation, surgery, or trauma impacting the lymphatic system, clinical input supports that use of bioimpedance spectroscopy is consistent with generally accepted medical practice and that its clinical use is expected to provide a clinically meaningful improvement in net health outcome. Bioimpedance spectroscopy in this high-risk, asymptomatic, surveillance context can prompt early intervention and limit progression to chronic lymphedema with fibrosis.

Policy History

5

Date Action 12/2025 Annual policy review. Policy updated with literature review through June 16, 2025; no references added. Policy statements revised to medically necessary with criteria based on clinical input. 3/2025 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2024 Annual policy review. Policy updated with literature review through November 27, 2023; references added. Policy statement unchanged. 3/2023 Annual policy review. Minor editorial refinements to policy statements; intent unchanged. 2/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 7/2017 Annual policy review. New references added. 3/2016 Annual policy review. New references added. 1/2015 Clarified coding information. 12/2014 Annual policy review. New references added. 2/2014 Annual policy review. New references added. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
7/2011 Reviewed - Medical Policy Group – Hematology and Oncology. No changes to policy statements. 9/29/2010 Medical Policy 261 created. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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: 2023 Consensus Document of the International Society of Lymphology. 2023; https://journals.librarypublishing.arizona.edu/lymph/article/id/6372/. Accessed June 16, 2025.
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

6

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. Apr 2024; 18(2): 344-
8. PMID 35947288
9. 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
10. 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
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. 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
13. 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 Comparing Bioimpedance Spectroscopy (BIS) Versus Tape Measure. Ann Surg Oncol. Oct 2024; 31(11): 7487-
14. PMID 38965099
15. 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
16. 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
17. 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
18. 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
19. 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
20. 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
21. 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): 184-92. PMID 25141461
22. 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
23. 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
24. 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
25. 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
26. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Survivorship. Version 2.2025. Updated May 23, 2025. https://www.nccn.org/professionals/physician_gls/pdf/survivorship.pdf. Accessed June 17, 2025.

7

25. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2025. Updated April 17, 2025. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed June 16, 2025.