Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Aggressive lung mass
Treatment: FoundationOne Liquid CDx
The insurer denied coverage for: FoundationOne Liquid CDx
The denial is: Upheld
The patient is an adult with an aggressive lung mass, suspicious for node involvement and metastatic spread. The biopsy was not diagnostic, but suggestive of a carcinoid tumor. The special tests were not helpful, because no cancer cells were present on the sections.

The problem is that there is no definitive cancer diagnosis, and the providers were using Foundation One for diagnosing (a purpose for which it is not indicated or well-studied).

In addition, with regard to the suspected tumor type- NCCN states "The molecular basis of neuroendocrine tumor (NETs) remains poorly understood, and additional molecular predictors of outcome remain investigational."  They concluded that "A multinational consensus meeting of experts concluded that, to date, no single currently available biomarker is sufficient as a diagnostic, prognostic, or predictive marker in patients with NETs." Furthermore if one assumes this is a cancer of unknown primary NCCN notes that " Gene sequencing to predict tissue of origin is not recommended."

FoundationOne is one of several panels of tumor markers designed to give the oncologist an option of treating in a personalized manner directed to the specific markers that the cancer expresses. FoundationOne is unique in that it is a pan-cancer profile not restricted to one specific histology. It is a clinical diagnostic test based on sequencing from about 300 cancer related genes. This test includes all existing genes that are currently being tested for any type of cancer (Breast cancer gene (BRCA) 1&2, Kristen rat sarcoma viral oncogene homolog (KRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), human epidermal growth factor receptor 2 (HER2), estimated glomerular filtration rate (EGFR), etc.), but will include all exons and greater diagnostic sensitivity for mutations present in low abundance in heterogeneous samples which may suffer from mixed tumor and normal tissue, multiple clones, mixed aneuploidy etc. It will likely also contain the majority of known pharmacogenomic genes.

The National Comprehensive Cancer Network (NCCN) Panel recommends that metastatic disease at presentation or first recurrence of disease should be biopsied as a part of the workup for patients with recurrent or stage IV disease. 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. Genetic testing: In the metastatic setting, results from genetic testing may have therapeutic implications, but a definitive pathologic diagnosis comes first.



Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for FoundationOne Liquid CDx performed is not substantiated.