Prostate Cancer
Genetic Testing

The patient is a male who underwent a prostate biopsy for an elevated prostate-specific antigen (PSA). The biopsy showed Gleason 6 adenocarcinoma in 3 out of 12 cores. The clinical stage was T2a. An OncotypeDx test was ordered on the biopsy specimens. The Medical necessity of the test is under review.

The health plan's determination is upheld. The Oncotype DX prostate score is not medically necessary for this patient. While Oncotype dx may eventually have a role in making treatment decision about patients with prostate cancer, there is limited data on clinical outcomes to currently support routine use. Hence, it is not considered medically necessary and standard of care for management of patients with a diagnosis of prostate cancer. The American Urological Association (AUA) Guidelines on Clinically Localized Prostate Cancer, 2017 states, "Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up."