Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Lung adenocarcinoma
Treatment: Procedure codes 81406, 81406 ,81405, 81405, 81404, 81401, 81318, 81299, 81293, 81276, 81275, 81272, 81270, 81235, 81210, 81201, 81173, 81121, and 81120 (panel of gene tests) (circulating tumor DNA (Deoxyribonucleic acid) testing)
The insurer denied coverage for procedure codes 81406, 81406 ,81405, 81405, 81404, 81401, 81318, 81299, 81293, 81276, 81275, 81272, 81270, 81235, 81210, 81201, 81173, 81121, and 81120 (panel of gene tests) (circulating tumor DNA testing)
The denial is upheld

This is a female. The treating provider has diagnosed the patient with non-small cell lung cancer (NSCLC). The treating provider ordered the Guardant 360 test from the blood; however, tissue was available for testing.

"The advent of "precision" medicine has been characterized by improvements in diagnostic, prognostic, and therapeutic approaches. The "liquid biopsy" has recently and rapidly emerged (Figure 1) as a method to minimize the amount of tissue needed for testing, as a less invasive and safer alternative to more traditional procedures. While definitions vary on the precise meaning of this term, it can broadly be thought of as collection of a body fluid sample to test for relevant biomarkers to inform patient management. A "liquid biopsy" does not replace a tissue-based diagnosis, but rather provides alternate sampling for (typically) molecular testing purposes." (College of American Pathologists, n.d.).

"Furthermore, although accuracy in obtaining a precise tumor profile has improved, liquid biopsy tests still carry the risk for false-positive or false-negative results, prompting the FDA (food and drug administration) to recommend confirmation of a negative result from Guardant360 CDx (companion diagnostic) and FoundationOne Liquid CDx with a tissue biopsy test. The 2021 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for molecular and biomarker analysis of NSCLC also specify that cell-free/circulating tumor DNA testing should not replace a histologic tissue diagnosis unless a patient is medically unfit for invasive tissue sampling." (Cavallo, J. 2021).

"Next generation sequencing (NGS) has been an invaluable tool to put genomic sequencing into clinical practice. The incorporation of clinically relevant target sequences into NGS based gene panel tests has generated practical diagnostic tools that enable individualized cancer patient care. The clinical utility of gene panel testing includes investigation of the genetic basis for an individual's response to therapy, such as signaling pathways associated with a response to specific therapies, microsatellite instability and a hypermutated phenotype, and deficiency in the DNA doublestrand break repair pathway." (Nagahashi, M. et al. 2019).

"Molecular testing identifies patients with advanced non-small cell lung cancer (NSCLC) who may benefit from targeted therapy or immunotherapy (i.e., immune checkpoint inhibitor treatment for patients with high tumor mutational burden (TMB), microsatellite instability-high or mismatch repair-deficient tumors). Current guidelines state that molecular testing should be conducted at the time of initial diagnosis and tumor progression on targeted therapy. In real-world clinical practice in the United States (US), molecular testing is often not conducted or happens late in the diagnostic journey, resulting in delayed or inappropriate treatment." (Gregg, J. P. et al. 2019).   
		   
The carrier's denial of procedure codes 81406, 81406 ,81405, 81405, 81404, 81401, 81318, 81299, 81293, 81276, 81275, 81272, 81270, 81235, 81210, 81201, 81173, 81121, 81120 (panel of gene tests) (circulating tumor DNA testing) should be upheld.