Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee requested coverage for Oncotype Dx Prostate Cancer Assay (CPT 84999) for newly diagnosed prostate cancer. A review of the records indicates the patient was previously diagnosed with prostate cancer.  The prostate biopsy revealed prostatic adenocarcinoma with Gleason score 3+3 equal 6; 7 mm; 40% of tissue.  There was high-grade prostatic intraepithelial neoplasia.  There was small focus of atypical glands.  The patient had a prostate stage of T1c with a Gleason score 3+3.  Prostate volume was 26 g.  There were 12 biopsy cores collected with one positive core.  The patient underwent Oncotype DX prostate cancer assay testing which revealed a very low risk. It was noted in appeal letter that the patient had the Oncotype Dx prostate cancer assay testing performed to assist in determining an appropriate, individualized treatment decision.  Further documentation submitted indicates the patients physician was considering various treatment options, such as active surveillance or immediate intervention and that the testing has been clinically validated to predict aggressive cancer at the time of diagnosis, helping to identify those men who need immediate surgery or radiation therapy versus those who can confidently choose active surveillance.  While the medical literature guidelines state that men with low or favorable risk prostate cancer may consider the usage of Oncotype Dx PCA test, they also note the absence of randomized prospective trials showing a clinical benefit.  Guidelines regarding management of localized prostate cancer indicate that tissue based genomic biomarkers have not shown a clear role in Active Surveillance for localized prostate cancer, 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 demonstrated.  Perspective studies of these tests yielding a true clinical benefit when implemented in clinical practice are still lacking. Although being studied at different institutions, it is not clear where this test fits into the algorithm of the diagnosis or management of prostate cancer. Not all patients with low risk prostate cancer need additional confirmation of further risk stratification by tissue based gene expression tests.  There is no long-term data showing the clinical utility of Oncotype Dx PCA. The Oncotype Dx PCA test is not likely to be more beneficial than any available standard service for the evaluation of this patients medical condition.Final Result: Three of the three reviewers determined that the requested service is not likely to be more beneficial than any available standard service for evaluation of the enrollees medical condition. Therefore, the health plans denial is upheld.Credentials/Qualifications: Three reviewers are board certified in Urology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.