Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Cancer- Breast Cancer.
Treatment: Diagnostic Testing (other than Radiology)- BIS assessment. 
The insurer denied Diagnostic testing-bioimpedance spectroscopy (BIS) assessment using ImediMedL-Dex testing. The denial is overturned.

The patient is a female with a history of multicentric invasive lobular carcinoma of the right breast with nodal micrometastases for which she underwent bilateral mastectomy and right axillary sentinel lymph node biopsy with autologous reconstruction. She received adjuvant post-mastectomy radiation. As a part of her ongoing follow-up, Bioimpedance Spectroscopy (BIS) was ordered to evaluate her for signs of subclinical lymphedema.
At issue is whether the proposed health treatment Diagnostic testing- bioimpedance spectroscopy (BIS) assessment using ImediMedL-Dex testing is likely to be more beneficial than any standard treatment for the patient's condition.

The health plan's determination regarding the proposed health service or treatment is overturned in whole.

The proposed health service or treatment Diagnostic testing- bioimpedance spectroscopy (BIS) assessment using ImediMedL-Dex testing is likely to be more beneficial than any standard treatment or treatments for the patient's condition.
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. 
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 and 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. 
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, as in this case. BIS is not considered to be investigational for the detection of subclinical lymphedema in patients with breast cancer who are at high risk for the development of lymphedema. In fact, BIS is a simple, non-invasive, and relatively inexpensive test that can significantly impact the quality of life of patients with breast cancer and at a high-risk of developing lymphedema.(4)
Therefore, the proposed health service or treatment Diagnostic testing- bioimpedance spectroscopy (BIS) assessment using ImediMedL-Dex testing is likely to be more beneficial than any standard treatment or treatments for the patient's condition.