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Secondary lymphedema may develop following surgery for breast cancer. Bioimpedance, which uses resistance to electrical current in comparing the composition of fluid compartments, could potentially be used as a tool to diagnose lymphedema.
Secondary lymphedema of the upper extremity may develop following surgical treatment for breast cancer; it has been reported in approximately 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 measuring differences in limb volume (volume displacement) and limb circumference. 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. BIS is based on the theory that the level of opposition to 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.
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 (ie, baseline) with post-operative measurements, since existing differences between upper extremities (like the effects of a dominant extremity) may obscure early, subtle differences resulting from the initial accumulation of fluid. Bioimpedance has been proposed as a diagnostic test for this condition. Those who support this approach to diagnose subclinical disease believe that early treatment of subclinical lymphedema should result in less severe chronic disease.
In 2007, the ImpediMed L-Dex™ U400 was cleared for marketing by the FDA through the 510(k) process as an aid in the clinical assessment of unilateral lymphedema of the arms in women. It is not intended to diagnose or predict lymphedema.
Related medical policies are Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers and End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema.
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.
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.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
01/18/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes to policy statement. Added CPT code 0239T to the Code Reference section.
03/26/2014: Policy title changed from "Bioimpedance Devices for Detection of Lymphedema" to "Bioimpedance Devices for Detection and Management of Lymphedema." Policy statement unchanged.
12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 93702.
01/07/2015: Policy reviewed; description updated. Policy statement unchanged.
07/08/2015: Code Reference section updated for ICD-10.
03/08/2016: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section. Code Reference section updated to remove deleted CPT code 0239T.
06/01/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.82
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.