Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer
Treatment: Bioimpedance Spectroscopy
The insurer denied Bioimpedance Spectroscopy
The determination is overturned.

The patient has invasive ductal carcinoma of the left breast for which she underwent a left breast lumpectomy and lymphatic mapping. Lymphatic mapping was unsuccessful during this operation. She returned to the operating room for repeat intraoperative lymphatic mapping and left axillary sentinel lymph node biopsy. Two lymph nodes were removed, one of which was found to contain micrometastatic carcinoma. Adjuvant radiation to the left breast and low axillary lymph nodes. is planned. In order to monitor the patient for breast cancer treatment related lymphedema, Bioimpedance Spectroscopy (BIS) was ordered and is under review as to whether it is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Yes, Bioimpedance Spectroscopy (BIS) is likely to be more beneficial than any other assessment for the identification of subclinical lymphedema.
As part of the surgical treatment of breast cancer, the draining axillary lymph nodes are evaluated for evidence of cancer spread. For patients presenting with no clinical evidence of cancer in their draining lymph nodes, sentinel lymph node biopsy is the standard of care to definitively determine the presence or absence of metastatic cancer. For breast cancer, the sentinel lymph node is the first draining lymph node of the breast. It is identified by injecting one or two dyes into the breast, finding the lymph node(s) where that dye has accumulated, and removing those lymph nodes for pathologic analysis. In the case of no metastatic involvement of the axillary lymph nodes, no additional treatment is needed for this area. However, in the case of disease spread to the lymph nodes, additional radiation to the axillary region, sometimes including radiation to the supraclavicular and internal mammary chains is typically recommended.
Lymphedema is a relatively common complication of breast cancer treatment. By removing some or all of the axillary lymph nodes, administering radiation to the axilla, or sometimes due to a high volume of metastatic disease in the lymph nodes, the lymphatic channels that drain fluid from the arm and the breast can be cut, sealed off, or otherwise blocked. This results in a build-up of fluid in the arm, breast, or both that can be painful or debilitating. Aside from asking patients about symptoms of lymphedema (swelling, heaviness or pain of the arm/breast), one method to assess for evidence of lymphedema is to perform circumferential arm measurements and watch for changes in the measurements, as compared to the opposite side, over time. Bioelectric Impedance Spectroscopy (BIS) is a newer method of determining sub-clinical lymphedema, meaning early-stage lymphedema that has not yet caused the patient symptoms or resulted in any differences in arm measurements. Although lymphedema is progressive over time, interventions such as manual lymphatic drainage, compression and elevation have been shown to prevent progression of sub-clinical lymphedema to clinically detectable lymphedema. Furthermore, the earlier that lymphedema is detected, the greater the chances that intervention will be effective. (1)
Depending upon the extent of axillary treatment or disease, a patient may be at low, intermediate or high-risk of developing lymphedema. Factors that are considered to confer a high-risk of lymphedema include complete axillary lymph node dissection, radiation therapy (especially regional nodal or comprehensive nodal radiation) or sentinel lymph node biopsy in which 6 or more lymph nodes were removed. Obesity is a treatment-independent risk factor for the development of lymphedema. The utility of BIS to identify patients at high-risk of developing lymphedema has been studied and results have been published in the peer-reviewed literature.
In a study of 186 patients who underwent axillary dissection, Soran et al. reported that those patients who were monitored using BIS assessments and underwent early intervention for subclinical lymphedema experienced a much lower rate of progression to clinically apparent lymphedema (4.4%) than the group that did not undergo BIS assessments (36.4%). (2)
In a recent interim analysis of a randomized, controlled trial of over 500 patients who received BIS assessment versus (vs) tape measurement to monitor for lymphedema, BIS assessment was associated with a 10 percent (%) reduction in the rate of progression to lymphedema requiring complex decongestive therapy, which was deemed to be clinically significant. (3)
There are several reports in the peer-reviewed literature, including meta-analyses, prospective randomized trials and prospective observational studies that demonstrate the clinical utility and impact on patient management of the use of BIS to assess lymphedema. BIS is a simple, non-invasive test that can significantly impact the quality of life of patients with breast cancer and at a high-risk of developing lymphedema.