Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Salivary Gland Carcinoma

Treatment: Genomic sequencing testing

The insurer denied coverage for genomic sequencing testing

The denial is upheld 

This is a patient that has a diagnosis of salivary gland tumor. The notes indicated the oncologist told the patient that the preferred approach is surgery.  It is also noted that Foundation testing "may not be applicable if the patient is a surgical candidate". The treating provider has requested testing with genomic sequencing testing on block specimen obtained and received by Foundation., which is under review. The request noted this was a "salivary gland carcinoma"  and the specimen was "block". The surgical pathology report "favors a mucosa based tumor over the salivary gland origin (the tumor appears to arise from the buccal mucosa).  Histology suggests adenosquamous carcinoma. No other data are provided.  The provided data do not indicate what the patient decided regarding surgery.

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.      

Genomic sequencing testing performed is not medically necessary for this patient.

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 of The Targeted Agent and Profiling Utilization Registry (TAPUR) and The Molecular Analysis for Therapy Choice (MATCH). 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 (i.e. breast cancer with er and her2) 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, molecularly targeted therapy based on tumor molecular profiling versus conventional therapy for advanced cancer (SHIVA), which demonstrated that this testing approach does not improve clinical outcomes for patients with advanced cancer.  

"Tumor sequencing frequently occurs in the setting of advanced cancer to identify potential therapeutic targets. Use of such testing has rapidly increased, with further growth anticipated.1 Mutations identified on tumor sequencing may be acquired somatically, caused by postzygotic mosaicism, or inherited through the germline. Identification of germline mutations potentially influences treatment of the current cancer, may provide prognostic information about the potential development of future cancers, and has important implications for family members in terms of risk and prevention of disease. However, guidelines on both how to determine which somatic findings may be potentially germline and the optimal clinical practice for referral and germline testing of patients undergoing tumor sequencing are not widely available, and there is no established standard of care" (Clark, D. F. et al. 2019).       

Finally, the National Comprehensive Cancer Network (NCCN) regarding salivary gland cancer only recommends NGS testing with recurrence of tumor and distant metastases.  They do not recommend NGS testing for unresected or incompletely resected tumor.                                                 

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 genomic sequencing testing is not substantiated.