Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Breast Cancer.
Treatment:  Bioimpedance spectroscopy.
The insurer denied Bioimpedance spectroscopy. 
The determination is upheld.

The patient was diagnosed with right breast ductal carcinoma in situ (DCIS). She underwent a right partial mastectomy with the pathology demonstrating microinvasive carcinoma. She was taken back to surgery for re-excision of margins and sentinel lymph node biopsy, followed by an oncoplastic mastopexy and a contralateral symmetry procedure. The re-excised margins were free of residual carcinoma, and three right axillary sentinel lymph nodes were negative for metastatic disease. She then went on to receive adjuvant whole breast radiation therapy. As part of her follow-up, Bioimpedance Spectroscopy (BIS) was ordered to assess her for subclinical lymphedema and is under review.

In this case, Bioimpedance Spectroscopy is not likely to be more beneficial than any other modality for lymphedema screening.

The rationale for the use of BIS assessment is that this modality can detect lymphedema before it is evident clinically and that early intervention for sub-clinical lymphedema can prevent progression to clinically detectable lymphedema. Further, the earlier that lymphedema is detected, the greater the chances that interventions will be effective. (1)
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% reduction in the rate of progression to lymphedema requiring complex decongestive therapy, which was deemed to be clinically significant. (3)

In this particular case, the patient underwent a sentinel lymph node biopsy (three lymph nodes were removed) and whole breast radiation therapy. She did not have a full axillary lymph node dissection or comprehensive nodal radiation. Her risk of lymphedema is, therefore, quite low. The studies evaluating the efficacy of BIS for detection of subclinical lymphedema were performed on patients at high risk for lymphedema, specifically, those who had comprehensive nodal radiation, complete lymphadenectomy, or sentinel lymph node biopsy wherein six or more lymph nodes were removed. These studies have not evaluated the efficacy of BIS in the setting of patients who underwent sentinel lymph node biopsy alone with fewer than 6 lymph nodes removed.

In patients with a high risk of developing lymphedema, Bioimpedance Spectroscopy has been shown to be clinically useful in identifying patients with subclinical lymphedema to initiate early intervention which decreases the incidence of progression of lymphedema. However, in this patient's case, Bioimpedance Spectroscopy is not likely to be more beneficial than any other modality for lymphedema screening.