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Printer Friendly Version Bioimpedance Devices for Detection of Lymphedema
DESCRIPTIONSecondary lymphedema of the upper extremity may develop following surgical treatment for breast cancer; it has been reported in about 25 to 50% of women following mastectomy. This can be a chronic disfiguring condition. It results from lymphatic dysfunction or disruption, and can be difficult to accurately diagnose and manage. One challenge is identifying the presence of clinically significant limb swelling through simple noninvasive methods. Many techniques have been used for documenting lymphedema including differences in limb volume (volume displacement) and limb circumference measurements. A number of newer techniques are being evaluated including bioimpedance with use of bioimpedance spectroscopy (BIS) analysis, which uses resistance to electrical current in comparing the composition of fluid compartments. Bioelectrical impedance analysis measures the body’s response to an electrical current. Current flows along the path of least resistance and thus follows tissues with the highest water content; this allows edema to be measured.The detection of subclinical lymphedema; that is, the early detection of lymphedema before clinical symptoms become apparent is another area of study. Detection of subclinical lymphedema (referred to as Stage 0 lymphedema) is problematic. Subclinical disease may exist for months or years before overt edema is noted. This approach generally involves comparison of pre-operative with post-operative measurements, since existing differences between upper extremities (like the effects of a dominant extremity) may obscure early, subtle differences due to initial accumulation of fluid. Bioimpedance has been proposed as one diagnostic test for this condition. Those who support the approach to diagnose subclinical disease believe that early treatment of subclinical lymphedema should result in less severe chronic disease. One of the devices is the ImpediMed LDex™ U400 cleared for marketing by the FDA through the 510(k) process in 2007 and in 2008. According to the FDA letter, the device is “to aid in the clinical assessment of unilateral lymphedema of the arm in women. The device is not intended to diagnose or predict lymphedema of an extremity.” Related medical policies are Lymphedema Pumps and End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema.
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POLICYDevices using bioimpedance (bioelectrical impedance spectroscopy) are considered investigational for use in the diagnosis, surveillance, or treatment of patients with lymphedema, including use in subclinical secondary lymphedema.
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POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
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POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee01/18/2012: Policy reviewed; no changes. 03/13/2013: Policy reviewed; no changes to policy statement. Added CPT code 0239T to the Code Reference section.
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SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.82
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CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.All codes billed for this procedure are considered investigational and not eligible for coverage. Non-Covered Codes
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