Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast cancer 

Treatment: Genomic sequencing testing, molecular oncology procedure, code 0037U

The insurer denied coverage for genomic sequencing testing, molecular oncology procedure, code 0037U

The denial is overturned.

This is a patient that has been diagnosed with bilateral breast cancer, one breast with stage one (I) and the other one with intra-cystic papillary 1 centimeter (cm) carcinoma. Despite hormonal therapy, the patient was found to have new nodes and an enlarging pulmonary nodule; lung biopsy showed breast cancer. The patient was treated by adding Ibrance. The request is for genomic sequencing testing, molecular oncology procedure, code 0037U rendered from lung tissue, which is under review.

For metastatic disease, the National Comprehensive Cancer Network (NCCN) Panel recommends at presentation or first recurrence of disease, biopsy should be part of the workup for patients with recurrent or stage four (IV) disease. Currently, it also supports liquid biopsies as equivalent to tissue. This ensures accurate determination of metastatic/recurrent disease and tumor histology and allows for biomarker determination and selection of appropriate treatment. Soft tissue tumor biopsy is preferred over bone sites unless a portion of the biopsy can be protected from harsh decalcification solution to preserve more accurate assessment of biomarkers. Results from genetic testing, in the metastatic setting, may have therapeutic implications. The FoundationOne CDx test is supported by the National Comprehensive Cancer Network (NCCN) and is necessary for this patient.

Per the Food and Drug Administration (FDA) (2019), "FoundationOne CDx (F1CDx) is a laboratory test designed to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor. F1CDx can help doctors identify patients who MAY benefit from treatment with targeted therapies for a variety of cancer types (listed above)."

Per Clark, T. A. et al. (2018). "Genomic profiling of circulating tumor DNA derived from cell-free DNA (cfDNA) in blood can provide a noninvasive method for detecting genomic biomarkers to guide clinical decision making for cancer patients."

"The world of molecular profiling has undergone revolutionary changes over the last few years as knowledge, technology, and even standard clinical practice have evolved. Broad molecular profiling is now nearly essential for all patients with metastatic solid tumors. New agents have been approved based on molecular testing instead of tumor site of origin. Molecular profiling methodologies have likewise changed such that tests that were performed on patients a few years ago are no longer complete and possibly inaccurate today. As with all rapid change, medical providers can quickly fall behind or struggle to find up-to-date sources to ensure he or she provides optimum care." (El-Deiry, W. S. et al. 2019).

Per Kittaneh, M., Montero, A. J., & Gluck, S. (2013), "The rapidly evolving genomic paradigm offers a new approach for predicting an individual patient's prognosis by interpreting the expression pattern of a panel of specific tumor-related genes. Tests may contain completely different gene sets and deliver identical outcomes. Thus, many genetic profiles can be used to examine the same molecular pathway because so many genes are responsible for controlling the multiple biochemical pathways expressed by the tumor."                                                         

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for genomic sequencing testing, molecular oncology procedure, code 0037U is substantiated.