Appeal type: Medical necessity
Decision: Upheld

Diagnosis: stage IV (four) adenocarcinoma.
Treatment: Procedure code 81173, genetic testing.
The insurer denied coverage for procedure code 81173, genetic testing.
The denial is upheld.

The patient is a female with non-small-cell lung carcinoma (NSCLC) known to be EGFR (epidermal growth factor receptor) mutated on Tagrisso. The treating provider performed guardant 360.

The use of next-generation sequencing (NGS) panel testing as a means to select anti cancer therapy in advanced cancer remains an area of active research with ongoing studies. The concept of this approach is that all cancers are unique and each cancer has a specific individual molecular driver which can be identified using this testing. Once identified specific therapy can be given to the patient directly treating their tumor. The majority of studies of this approach are fraught with methodological design issues such as lack of randomization and inclusion of large numbers of patients with established molecular drivers and then claiming that the identification and targeting of said known drivers contributes to benefit. There has been only one well designed trial of this approach which demonstrated that this testing approach does not improve clinical outcomes for patients with advanced cancer. Despite a lack of evidence of benefit to this testing, the National Comprehensive Cancer Network (NCCN) has endorsed this approach as part of initial management of NSCLC. However, there is no evidence to support the use of Guardant360 testing in the evaluation of a patient with known EGFR mutated nonsmall cell lung cancer (NSCLC). While the NCCN supports this testing as part of the initial molecular testing for NSCLC, no such recommendation is made for patients with established EGFR mutations who progress on Tyrosine kinase inhibitors (TKIs) therapy. Therefore, the genetic testing is not considered medically necessary.

"Overall, our study provides a real-world experience of the impact of CGP in a community-based academic NCI [National Cancer Institute]-designated cancer center serving a highly diverse patient population, where molecular testing is based on a two-tier testing algorithm. While recognizing that a 10% overall rate of management change that is based on CGP is very modest, its use in certain subsets, such as advanced NSCLC, where the impact currently is most significant appears to be justifiable and it has been found to be cost effective [40,41,42]. In addition, we have identified multiple reasons for the relatively smaller clinical impact of CGP in other tumor types, despite a much larger proportion of patients with actionable genomic alterations reported. The impact however is anticipated to be increasing in light of new advances, e.g., recent studies do suggest expanding impact in breast (PI3kinase inhibitors) and pancreatic malignancies (poly ADP [Adenosine diphosphate ribose] ribose polymerase (PARP) inhibition) [43,44,45,46,47]. Although issues, such as optimal timing, access to clinical trials, and consolidating genomic testing need to be addressed at an institutional level, reports from testing platforms need to be carefully interpreted and ideally discussed in molecular tumor boards to provide the best treatment option possible. More prospective trials are needed that would better inform our choices for personalized treatment by providing assessments of overall survival and quality of life with choosing targeted therapies that are based on CGP when compared to conventional therapies [11]." (Singh, A.P., et al. 2020). 
                                                       
The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The genetic testing is not considered medically necessary for this patient.

The insurer's denial of coverage for proce dure code 81173, genetic testing performed is upheld. Medical Necessity is not substantiated.