Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Non-small cell lung cancer. 
Treatment: Genetic Testing (0037U). 

The insurer denied the Genetic Testing (0037U). 
The denial is upheld. 

The patient is a female with non-small cell lung cancer (adenocarcinoma). 

FoundationOne CDx testing was performed. No other clinical information was provided. 

Coverage for the testing his was denied by the health plan as panel testing of multiple genes is not medically appropriate. 

This denial was appealed. This letter requests reconsideration as the testing is supported by the NCCN (National Comprehensive Cancer Network) Guidelines and is reimbursed by CMS (Centers for Medicare and Medicaid Services). 

No, the health plan should not cover the Genetic Testing (0037U). 

The patient had non-small cell lung cancer (adenocarinoma). A FoundationOne CDx test was performed on the tumor.

The FoundationOne CDx test ("companion diagnostic test") is a more focused next generation sequencing-based test that analyzes all guideline-recommended genes in solid tumors. It detects substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens (https://assets.ctfassets.net/vhribv12lmne/4ZHUEfEiI8iOCk2Q6saGcU/671b313cb6bb85bfe861f83e31c9716d/F1CDx_TechInfo_09-03.pdf). It is a somatic mutation panel test performed on tumors to identify mutations for selecting targeted therapies. 

The NCCN (National Comprehensive Cancer Network) Guidelines currently support for sequencing the following genes for mutations at the time of diagnosis: EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase), KRAS (Kirsten rat sarcoma viral oncogene homolog), ROS1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase), BRAF (v-Rapidly Accelerated Fibrosarcoma murine sarcoma viral oncogene homolog B), NTRK1/2/3 (neurotrophic tyrosine receptor kinase), MET (MET proto-oncogene) exon 14 skipping, RET (rearranged during transfection proto-oncogene) (NCCN Guidelines Version 3.2022, Non-Small Cell Lung Cancer, page NSCL-18). 

The NCCN Guidelines do not support the extensive tumor mutation testing performed in the FoundationOne CDx test. 

There are no studies of FoundationOne CDx testing used to direct therapy of metastatic non-small cell lung cancer that show improved outcomes (www.pubmed.gov.). Studies to date only show that the testing is feasible and it can be used to identify potential targeted therapies (Takeda M, Takahama T, Sakai K, et al. Clinical Application of the FoundationOne CDx Assay to Therapeutic Decision-Making for Patients with Advanced Solid Tumors. Oncologist.;26(4):e588-e596; Hirsch B, Endris V, Lassmann S, et al. Multicenter validation of cancer gene panel-based next-generation sequencing for translational research and molecular diagnostics. Virchows Arch.;472(4):557-565. doi:10.1007/s00428-017-2288-7). The data lacking are that the use of the test results to select targeted therapy improves outcomes. 

As the FoundationOne CDx test is in excess of that testing necessary to manage the patient's condition, it would not be medically appropriate and should not be covered.

The health plan's prior denial was correct. 

The form letter of repair requests reconsideration as the testing is supported by the NCCN (National Comprehensive Cancer Network) Guidelines and is reimbursed by CMS (Centers for Medicare and Medicaid Service). As is discussed above, the NCCN (National Comprehensive Cancer Network) Guidelines make no statements in support of large mutation panel testing. 

No, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease. 
There are no well-conducted, prospective studies of FoundationOne CDx testing of non-small cell lung cancer that show improved health outcomes (www.pubmed.gov). It has not been shown to be more beneficial than more directed tumor mutation testing.