mp-438 - Medical Policies - Alabama
Bioimpedance Devices for Detection of Lymphedema
Policy Number: MP-438
Latest Review Date: January 2020
Policy Grade: C
Devices using bioimpedance (bioelectrical impedance spectroscopy) is considered not medically necessary and investigational for use in the diagnosis, surveillance, or treatment of patients 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 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
Stage 0 (subclinical)
Swelling is not evident and most patients are asymptomatic despite impaired lymphatic transport
Stage I (mild)
Accumulation of fluid that subsides (usually within 24 hours) with limb elevation; soft edema that may pit, without evidence of
Stage II (moderate)
Does not resolve with limb elevation alone; limb may no longer pit on examination
Stage III (severe)
Lymphostatic elephantiasis; pitting can be absent; skin has trophic changes
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 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.
The review has been updated regularly with MEDLINE searches, most recently through November 14, 2019.
SUMMARY OF EVIDENCE:
For individuals who have known or suspected lymphedema who receive bioimpedance spectroscopy, the evidence includes a systematic review, one 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). Interim results from an ongoing RCT comparing bioimpedance with standard tape measure following treatment for breast cancer have been published. Overall, 109 of 508 (21.5%) patients received early treatment due to reaching a pre-determined threshold to trigger an intervention. A total of 12 triggering patients progressed to clinical lymphedema (2 in the bioimpedance group [4.9%] and 10 in the tape measure group [14.7%]; P=0.130). 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 bioimpedance 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 the effects of the technology on health outcomes.
PRACTICE GUIDELINES AND POSITION STATEMENTS
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines on Survivorship (v.2.2019), and Breast Cancer (v.3.2019), recommend education, monitoring, and referral for lymphedema management as needed. Neither guideline mentions bioimpedance.
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Bioelectrical impedance testing, Bioimpedance spectroscopy, Lymphedema, bioimpedance testing, Bioimpedance analysis, BIS, Impedance plethysmography, Impedimed, LDex, Plethysmography, MoistureMeterD, SOZO
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:
510 (k) Number
ImpediMed (Carlsbad, CA)
For adults at risk of lymphedema.
Supports the measurement of extracellular fluid
volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of
The device is only indicated for patients who will
have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.
Delfin Technologies (Stamford, CT)
Supports local assessment of tissue water
differences between affected and contralateral
non-affected arm tissues to aid in forming a
clinical judgment of unilateral lymphedema in
women. The device is not intended to make
diagnosis or predict arm lymphedema.
ImpediMed L-Dex™ U400
ImpediMed, Limited (Carlsbad, CA)
Supports the measurement of extracellular fluid
volume differences between the arms to aid in the
clinical assessment of unilateral lymphedema of
the arm in women. This device is not intended to
diagnose or predict lymphedema of an extremity
FDA product code: OBH
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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
93702 Bioimpedance spectroscopy (BIS), extracellular fluid analysis for lymphedema assessment(s)
- 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.
- 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.
- 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.
- 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.
- Centers for Medicare and Medicaid Services (CMS). www.cms.hhs.gov/mcd/viewmcac.asp?where=index&mid=51. Last accessed March 2010.
- Cornish BH, Chapman M, Hirst C, et al. Early diagnosis of lymphedema using multiple frequency bioimpedance. Lymphology 2001; 34(1):2-11.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Warren AG, Janz BA, Slavin SA, et al. The use of bioimpedance analysis to evaluate lymphedema. Ann Plast Surg 2007; 58(5):541-3.
- 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.
- 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.
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.
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.
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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.