Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Prostate cancer
Treatment: Laboratory Testing (81542 - oncology [prostate], mRNA [messenger ribonucleic acid], microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastatic risk score)
The insurer denied: Laboratory Testing (81542 - oncology [prostate], mRNA [messenger ribonucleic acid], microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastatic risk score)
The denial is overturned

The patient is an adult male with favorable intermediate-risk prostate cancer. His provider has performed Decipher testing.

The health plan should cover the Laboratory Testing (81542 - oncology [prostate], mRNA [messenger ribonucleic acid], microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastatic risk score).

The National Comprehensive Cancer Network (NCCN) has elected to endorse the use of molecular diagnostics for assistance in management of men with prostate cancer. Retrospective case studies have demonstrated that these assays can provide additional prognostic information that is independent of traditional nomogram based risk groups. As a result, several platforms for molecular prognosis in prostate cancer have been approved (Oncotype DX, Decipher, Polaris Promark) for use in the US (United States). These were not approved through Food and Drug Administration (FDA) channels, but through less rigorous biomarker channels. As a result, there will never be quality prospective studies demonstrating any value to this testing. Nevertheless, several clinical utility studies have been performed and have shown that there is a role for this testing. 
One such study of almost 4,000 participants found that rates of active surveillance increased with the use of this testing approach. A second clinical utility study demonstrated that postoperatively this testing altered management recommendations 40 percent (%) of the time. As a result the, NCCN (National Comprehensive Cancer Network) has endorsed the use of Decipher, Oncotype DX, Polaris and Promark as part of initial risk stratification for men with low risk, intermediate risk or high risk disease. 
In addition, the NCCN (National Comprehensive Cancer Network) states that Decipher can be used postoperatively in men with high/very high risk disease to guide adjuvant decisions. Therefore, for this individual with low risk prostate cancer, the requested testing is medically appropriate, as it is supported by the NCCN (National Comprehensive Cancer Network). 

Per the NCCN (National Comprehensive Cancer Network) Prostate Cancer. Version 1.2022,"These molecular biomarker tests have been developed with extensive industry support, guidance, and involvement, and have been marked under the less rigorous FDA [United States Food and Drug Administration] regulatory pathway for biomarkers. Although full assessment of their clinical utility requires prospective randomized clinical trials, which are unlikely to be done, the panel believes that men with low or favorable intermediate disease and life expectancy greater than or equal to 10 years may consider the use of Decipher, Oncotype DX Prostate, Prolaris, or ProMark during initial risk stratifications."