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.

This case involves an adult patient with hematuria. The treating provider performed Cxbladder testing to evaluate for bladder cancer (screening).

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

There is insufficient evidence that this testing can be used for screening for bladder cancer. Voided urine cytology had been used historically to evaluate patients with gross and microscopic hematuria but is no longer recommended due to variable sensitivity and specificity. In addition, other urinary biomarkers (such as Nuclear Matrix Protein 22 (NMP22) or BTA-stat (rapid bladder tumor antigen tests)) are not useful because of similarly poor performance characteristics. There may be a role for urinary cytology in patients with suspected carcinoma (such as with risk factors for malignancy and irritative voiding symptoms) but not in simple asymptomatic microscopic hematuria. Therefore, the request for Cxbladder testing is not appropriate for the patient at this time.

Per Soria F. et al. (2018), "To date, there are multiple urine markers that have improved sensitivity over cytology but there is lack of validation of clinical utility. Some of the recently developed markers aim to change the paradigm of bladder cancer (BCa) follow-up by replacing or reducing the need of invasive investigations. Further prospective validations are needed to confirm these findings."

"The use of urine cytology and urine markers (Nuclear Matrix Protein 22 (NMP22), BTA-stat, and UroVysion fluorescence in situ hybridization assay (FISH)) is not recommended as a part of the routine evaluation of the asymptomatic microhematuria patient" (AUA, 2016).      

In this case, the Oncology (Urothelial), messenger ribonucleic acid (mRNA), gene expression profiling (code 0012M) rendered does not have final approval from the appropriate regulatory bodies for this diagnosis.

While the requested testing can be used for surveillance in treated bladder cancer, it can not be used as a screening tool for patients with hematuria.     

This patient is not a good candidate for Oncology (Urothelial), mRNA, gene expression profiling (code 0012M) rendered as the standard of care for unexplained hematuria is cystoscopy.     

Oncology (Urothelial), mRNA, gene expression profiling (code 0012M) rendered is not the best available treatment for this patient at this time.     

The main risk with the requested testing is that a negative result does not rule out cancer which can lead to the patient and treating provider not performing the appropriate testing.     

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

In summary, the denial of Oncology (Urothelial), mRNA, gene expression profiling (code 0012M) rendered 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 substantially increased over standard treatments.