Latest Review Date: January 2024

Category: Medicine                                                               

Note: Coverage may be subject to legislative mandates, including but not limited to the following, which apply prior to the policy statements:

Federal Women's Health and Cancer Rights Act (WHCRA)

In accordance with the mandate listed above, devices using bioimpedance (bioelectrical impedance spectroscopy)  are covered when used to treat lymphedema resulting from a mastectomy and ordered by the individual’s treating physician.

POLICY:

Devices using bioimpedance (bioelectrical impedance spectroscopy) is considered investigational for use in the diagnosis, surveillance, or treatment of individuals with lymphedema, including use in subclinical secondary lymphedema.

DESCRIPTION OF PROCEDURE OR SERVICE:

Secondary lymphedema may develop following treatment for breast cancer. Bioimpedance, which uses resistance to electrical current in comparing the composition of fluid compartments, could be used as a tool to diagnose lymphedema.

Lymphedema

Lymphedema is an accumulation of fluid due to disruption of lymphatic drainage. 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 is one of the most common causes of secondary lymphedema. Both the surgical removal of lymph nodes and radiotherapy are associated with development lymphedema in patients with breast cancer. In a systematic review of 72 studies (N=29,612 women), DiSipio et al (2013) reported that approximately 1 in 5 women who survive breast cancer will develop arm lymphedema. Risk factors for development of lymphedema that had a strong level of evidence were extensive surgery (i.e., axillary-lymph-node dissection, greater number of lymph nodes dissected, mastectomy) and 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 (magnetic resonance imaging), computed tomography, ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from others causes of edema in diagnostically challenging cases.

Table 1 lists International Society of Lymphology guidance for staging lymphedema based on "softness" or "firmness" of the limb and the changes with an elevation of the limb.

Table 1. Recommendations for Staging Lymphedema

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

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.

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through November 27, 2023.

SUMMARY OF EVIDENCE:

For individuals who have known or suspected lymphedema who receive bioimpedance spectroscopy (BIS) , the evidence includes systematic reviews, 1 RCT, one prospective comparative observational study, and multiple uncontrolled observational studies. The 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.

PRACTICE GUIDELINES AND POSITION STATEMENTS

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines on Survivorship (v.1.2023) recommends that survivors at risk for lymphedema should be regularly screened for lymphedema by symptom assessment, clinical exam, and, if available, bioimpedance spectroscopy.

NCCN Clinical Practice Guidelines on Breast Cancer (v.4.2023) recommend education, monitoring, and referral for lymphedema management as needed. For further information they refer the reader to the Survivorship Guidelines.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not applicable.

KEY WORDS:

Bioelectrical impedance testing, Bioimpedance spectroscopy, Lymphedema, bioimpedance testing, Bioimpedance analysis, BIS, Impedance plethysmography, Impedimed, LDex, Plethysmography, MoistureMeterD, SOZO, WHCRA, Women's Health and Cancer Rights Act

APPROVED BY GOVERNING BODIES:

Devices that have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process to aid in the assessment of lymphedema are summarized below:

FDA product code: OBH

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:   

REFERENCES:

1. 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. Jun 18 2015.
2. Berlit S, Brade J, Tuschy B, et al. Whole-body bioelectrical impedance analysis in assessing upper-limb lymphedema after breast cancer therapy. Anticancer Res. Oct 2013; 33(10):4553-4556.
3. Blaney JM, McCollum G, Lorimer J, et al. Prospective surveillance of breast cancer-related lymphedema in the first-year post-surgery: feasibility and comparison of screening measures. Support Care Cancer. Jun 2015; 23(6):1549-1559.
4. Boccardo FM, Ansaldi F, Bellini C, et al.  Prospective evaluation of a prevention protocol for lymphedema following surgery for breast cancer.  Lymphology 2009; 42(1):1-9.
5. Cornish BH, Chapman M, Hirst C, et al.  Early diagnosis of lymphedema using multiple frequency bioimpedance.  Lymphology 2001; 34(1):2-11.
6. Czerniec SA, Ward LC, Refshauge KM, et al.  Assessment of breast cancer-related arm lymphedema-comparison of physical measurement methods and self-report.  Cancer Invest 2010; 28(1):54-62.
7. 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.
8. Dylke ES, Schembri GP, Bailey DL, et al. Diagnosis of upper limb lymphedema: development of an evidence-based approach. Acta Oncol. Dec 2016; 55(12):1477-1483.
9. 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.
10. 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 2008; 41(1):18-28.
11. International Society of Lymphology Executive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2016Consensus Document of the International Society of Lymphology. 2016;https://journals.uair.arizona.edu/index.php/lymph/article/view/20106.
12. 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.
13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
14. 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.
15. 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
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. Oct2018; 25(10): 2948-2952.
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.
18. Laidley A, Anglin B. The impact of L-Dex((R)) measurements in assessing breast cancer-related lymphedema as part of routine clinical practice. Front Oncol. 2016; 6:192.
19. 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.
20. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Survivorship. Version 3.2021.https://www.nccn.org/professionals/physician_gls/pdf/survivorship.pdf.
21. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Breast Cancer. Version 1.2022.https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
22. 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.
23. Oremus M, Walker K, Dayes I et al. Diagnosis and treatment of secondary lymphedema. Technology Assessment Report Project ID:LYMT0908; May 28, 2010. (Based on research conducted by the McMaster University Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ).) Available at: www.cmms.hhs.gov/determinationprocess/downloads/id66aTA.pdf.
24. 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.
25. 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.
26. Shah C, Arthur DW, Wazer D, et al. The impact of early detection and intervention of breast cancer-related lymphedema: a systematic review. Cancer Med. Jun 2016; 5(6):1154-1162.
27. 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.
28. Smoot BJ, Wong JF, Dodd MJ. Comparison of diagnostic accuracy of clinical measures of breast cancer-related lymphedema: area under the curve. Arch Phys Med Rehabil 2011; 92(4):603-10.
29. 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):289-294.
30. Stout Gergich NL, Pfalzer LA, McGarvey C, et al.  Preoperative assessment enables the early diagnosis and successful treatment of lymphedema.  Cancer 2008; 112(12):2809-19.
31. Vicini F, Shah C, Lyden M et al. Bioelectrical impedance for detecting and monitoring patients for the development of upper limb lymphedema in the clinic. Clin Breast Cancer 2012; 12(2): 133-7.
32. Ward LC, Dylke E, Czerniec S et al. Confirmation of the reference impedance ratios used for assessment of breast cancer-related lymphedema by bioelectrical impedance spectroscopy. Lymphat Res Biol 2011; 9(1):47-51.
33. Warren AG, Janz BA, Slavin SA, et al.  The use of bioimpedance analysis to evaluate lymphedema.  Ann Plast Surg 2007; 58(5):541-3.
34. 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.
35. 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.
36. 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.
37. U.S. Food and Drug Administration (FDA). FDA 510(k) summary: ImpediMed IMP XCA Extracellular Fluid Analysis. www.accessdata.fda.gov/cdrh_docs/pdf5/K050415.pdf. 
38. U.S. Food and Drug Administration (FDA). FDA 510(k) summary: ImpediMed L-Dex U400 BIS Extra Cellular Fluid Analysis. www.accessdata.fda.gov/cdrh_docs/pdf8/K080825.pdf. 

POLICY HISTORY:

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medical Policy Group, December 2010 – Added Code effective Jan 1, 2011

Medical Policy Group, April 2011: Added 2011 Update-Key Points, Updated References

Medical Policy Group, September 2012 (3): 2012 Update to Key Points & References

Medical Policy Group, November 2012 (3): Additional 2012 Updates to Key Points and References

Medical Policy Panel, November 2013

Medical Policy Group, November 2013 (3):  Updated Key Points and References; no change in policy statement

Medical Policy Group, November 2014 (5): 2015 Annual Coding update and annual review.  Added code 93702 to current coding and moved deleted code 0239T to previous coding. Updated Key Points and References.

Medical Policy Panel, January 2016

Medical Policy Group, January 2016 (6):  Updates to Key Points, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Panel June 2017

Medical Policy Group, June 2017 (6): Updates to Description, Key Points, Approved by Governing Bodies, Key Words and References; no change to policy statement.

Medical Policy Panel, January 2018

Medical Policy Group, January 2018 (6): Updates to Description, Key Points and References.

Medical Policy Panel January 2019

Medical Policy Group, February 2019 (6): Updates to Key Points.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (6): Updates to Description, Key Points, Governing Bodies, Key Words (SOZO) and Practice Guidelines.

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (6): Update to References. No change to policy statement.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, November 2022 (6): Updates to Policy statement to include coverage may be subject to legislative mandates: Federal Women's Health and Cancer Rights Act (WHCRA).

Medical Policy Group, December 2022 (6): Added Key Words: WHCRA, Women's Health and Cancer Rights Act

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (6): Updates to Key Points and Practice Guidelines.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (6): Updates to Description, Key Points, Practice Guidelines, Benefit Application and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.