Diagnosis: Metastatic gastric cancer.

Treatment: Foundation One companion diagnostic (CDx) -Tumor Marker Panel Testing (CPT [Current Procedural Terminology] 0037U).

The insurer denied coverage for Foundation One CDx-Tumor Marker Panel Testing (CPT 0037U).

The denial is overturned.

This is a male patient with a past medical history of metastatic gastric cancer and a family history of colon cancer. The treating provider is requesting plan approval for Foundation One companion diagnostic (CDx) -Tumor Marker Panel Testing (CPT [Current Procedural Terminology] 0037U), that the patient had done.

The Foundation One CDx results show no reportable alterations with CDx claims. The patient's microsatellite status and tumor mutational burden cannot be determined. The patient has phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA), with therapies with clinical benefit of Alpelisib, Everolimus, and Temsirolimus.

According to the Surgical Pathology Report, this patient had a peritoneum biopsy. The patient is found to have adenocarcinoma of the stomach.

The Office Note shows the patient was seen for Medical Oncology opinion regarding the patient's diagnosis of gastric cancer. Given the patient's history of gastric cancer and family history of colon cancer, genetic testing was suggested.

"Gastric cancer (GC) is one of the most prevalent malignant types in the world and an aggressive disease with a poor 5-year survival. This cancer is biologically and genetically heterogeneous with a poorly understood carcinogenesis at the molecular level. Although the incidence is declining, the outcome of patients with GC remains dismal. Thus, the detection at an early stage utilizing useful screening approaches, selection of an appropriate treatment plan, and effective monitoring is pivotal to reduce GC mortalities. Identification of biomarkers in a basis of clinical information and comprehensive genome analysis could improve diagnosis, prognosis, prediction of recurrence and treatment response" (Matsuoka, et al., 2018).

"Biomarkers currently play an important role in the detection and management of patients with several different types of gastrointestinal cancer, especially colorectal, gastric, gastro-oesophageal junction (GOJ) adenocarcinomas and gastrointestinal stromal tumors (GISTs)" (Duffy, et al., 2014).

"Cancer research is an attractive field in molecular biology and medicine. By applying large-scale tools such as advanced genomics and proteomics, cancer diagnosis and treatment have been improved greatly. Cancers of esophagus, gastric, and colon accounted for major health problem globally. Biomarker panel could bring out the accuracy for cancer evaluation tests as it can suggest a group of candidate molecules specified to particular malignancy in a way that distinguishing malignant tumors from benign, differentiating from other diseases, and identifying each stages with high specificity and sensitivity" (Zamanian-Azodi, et al., 2015).

The patient has been diagnosed with a past medical history of metastatic gastric cancer and a family history of colon cancer. The treating provider is requesting plan approval for Foundation One CDx-Tumor Marker Panel Testing (CPT 0037U). This request is supported by the National Comprehensive Cancer Network (NCCN) and is, therefore, generally accepted.

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The insurer's denial of coverage for the genetic testing, Foundation One CDx-Tumor Marker Panel Testing (CPT 0037U) is overturned. Medical necessity is substantiated.