Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Hematuria
Treatment: Oncology (Urothelial), mRNA (messenger ribonucleic acid), gene expression profiling (code 0012M)
The insurer denied coverage for Oncology (Urothelial), mRNA, gene expression profiling (code 0012M)
The denial is upheld

The patient is an adult with hematuria. A Cxbladder test was sent for the detection of urothelial carcinoma (UC), hematuria investigation, symptoms of dysuria, pain and/or burning during urination.

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines state the following regarding the use of available urinary biomarkers: "Many of these [urinary molecular tests] have a better sensitivity for detecting bladder cancer than urinary cytology, but specificity is lower. Considering this, evaluation of urinary urothelial tumor markers may be considered during surveillance of high-risk non-muscle invasive bladder cancer. However, it remains unclear whether these tests offer additional information that is useful for the detection and management of non-muscle-invasive bladder tumors. Therefore, the panel considers this to be a category 2B. Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate in surveillance." This is not the case in this patient, therefore the scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

Cxbladder is a genomic urine test that purports to quickly and accurately detect or rule out bladder cancer. The test combines clinical risk factor markers with genetic information, measuring five biomarker genes to detect the presence or absence of bladder cancer. According to the manufacturer, levels of messenger ribonucleic acid (mRNA) of five biomarker genes, including Midkine (MDK), Homeobox A13 (HOXA13), Cyclin-dependent kinase-like 2 (CDC2), Insulin Like Growth Factor Binding Protein 5 (IGFBP5), C-X-C Motif Chemokine Receptor 2 (CXCR2), are believed to be in higher concentrations in urine samples of patients with bladder cancer.

For patients with hematuria, the American Urological Association (AUA) guidelines recommend cystoscopic evaluation of all adults older than 40 years with microscopic hematuria and for those younger than 40 years with risk factors for developing bladder cancer. Confirmatory diagnosis of bladder cancer is made by cystoscopic examination, considered to be the criterion standard, and biopsy (AUA, 2020). At this time, gene expression profiling (code 0012M) does not have final approval from the appropriate regulatory bodies for this diagnosis.

Oncology (Urothelial), mRNA, gene expression profiling (code 0012M) does not have final approval from the appropriate regulatory bodies for this patient's clinical scenario.

This patient is not a good candidate for Oncology (Urothelial), mRNA, gene expression profiling (code 0012M).

The Oncology (Urothelial), mRNA, gene expression profiling (code 0012M) is not the best available treatment for this patient at this time. Whether the requested testing is positive or negative a cystoscopy still needs to be performed.

The adverse risks are not increased over standard treatment/services.

In summary, the denial of Oncology (Urothelial), mRNA, gene expression profiling (code 0012M) and coverage for the requested service should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.