Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer. 

Treatment: Oncotype DX  Genomic Prostate Score (GPS) Test. 

The insurer denied coverage for Genetic Testing. 

The denial is Upheld. 

This male patient has a history of Gleason 3+3 prostate cancer. A Biopsy continued to show Gleason Grade 6 prostate cancer.  The patient is on active surveillance (AS) for his prostate cancer. He also had frequency/urgency.  Magnetic resonance imaging (MRI) showed an increase in prostate size.  An Oncotype Dx Genomic Prostate Score (GPS) test was ordered for further evaluation and possible risk stratification.  The GPS score indicated intermediate risk and the patient decided to continue with Active Surveillance of his prostate cancer.

The insurer has denied coverage for the Oncotype Dx GPS test. 

While both current National Comprehensive Cancer Network (NCCN) guidelines and American Society of Clinical Oncology (ASCO) guidelines state that use of gene expression tests such as Oncotype Dx Prostate Cancer (PCA) are reasonable and can be considered in the evaluation of men with low risk and favorable intermediate risk prostate cancer and at least a 10-15 year life expectancy,  they also note the absence of any randomized prospective trials in the literature which point to or reference a clinical benefit of any kind from usage of this test.  In fact, regarding management of localized prostate cancer, the guidelines state that: "Tissue based genomic biomarkers have not shown a clear role in Active Surveillance, and are not necessary for follow-up."  The impact of tissue based gene expression tests, such as Oncotype Dx PCA, on clinical practice and long term patient outcomes remains to be empirically demonstrated.  Unfortunately, prospective studies of these tests yielding a true clinical benefit when implemented in clinical practice are still lacking. 

NCCN notes regarding genetic testing that this test can be considered but they note that "future comparative effectiveness research may allow these tests and others like them to gain additional evidence regarding their utility for better risk stratification of men with prostate cancer". As stated in the latest ASCO guideline "Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up." NCCN Prostate Cancer V 3.2020
	
Furthermore ASCO state in their guideline "There are currently commercially available biopsy-based multigene expression classifiers (ie, Decipher, Oncotype Dx Prostate, and Prolaris) and one protein-based biomarker (ProMark). Each seems to independently improve the prognostic accuracy of clinical multivariable models for identifying men with biologically significant disease. The clinical benefit of integrating these classifiers in selecting patients for surveillance has not been prospectively demonstrated."

The healthcare plan acted reasonably and with sound medical judgment and in the best interest of the patient.

The genetic testing on prostate tissue with Oncotype Dx PCA test is not considered medically necessary (CPT code 00470).  There is no level of evidence that substantiates a clinical benefit or improvement in health outcomes as a result of utility of this test.

The carrier's denial of coverage for genetic testing of prostate tissue with Oncotype DX for prostate cancer (CPT code 00470) is upheld.  The medical necessity is not substantiated.