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 overturned

This patient was diagnosed with lung adenocarcinoma and a right lower lobe (RLL) lobectomy. The treating provider ordered the Guardant 360 test. 

The insurance company has failed to recognize and cover molecular testing for NSCLC (non-small cell lung cancer), even though the guidelines now have a five-page section titled: PRINCIPLES OF MOLECULAR AND BIOMARKER ANALYSIS, which discusses that it is standard practice to test for at least nine biomarkers in a comprehensive panel. A recent population study demonstrated that patients with targetable mutations, who are treated with the associated therapy, have a longer overall survival. Guardant360 is employed to assist physicians to determine the optimal care regimen for late-stage cancer patients. The treating provider ordered Guardant 360 for this patient to determine the optimal treatment regimen to manage care for the patient's late-stage lung adenocarcinoma. The provider ordered Guardant360 to obtain a comprehensive molecular profile to assess for any targetable mutations, since the patient was progressing while on Targrisso. 

"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 (Deoxyribonucleic acid) 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 overturned.