Oncotype Dx Prostate Cancer Assay denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene expression profiling (Oncotype DX prostate cancer assay). The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee’s prostate cancer.Findings: There currently are three major approaches to the management of localized prostate cancer. These include surgery, various forms of radiation therapy, or active surveillance, with no specific anti-cancer treatment being given. Recommendations as to these options are based on risk stratification, which will estimate the risk for the future development of progressive cancer. Various features of an individual’s cancer are put into this assessment, particularly the pathologic details and the PSA.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Oncotype DX Prostate Cancer Assay. Findings: The physician reviewer found that prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by analyzing the grade of tumor and prostate specific antigen (PSA) level. Current studies in the peer-reviewed medical literature have demonstrated that the Oncotype DX Prostate Cancer Assay is beneficial as an addition to standard testing in the assessment and treatment planning of patients with prostate cancer. The Oncotype DX is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score. The Oncotype DX can help guide the most appropriate therapy for patients, as well as determine which patients will not require treatment with surgery or radiation.

Where the denial was 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.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Oncotype Dx prostate cancer assay provided for evaluation of the enrollee’s prostate cancer. Findings: Three physician reviewers found that the Oncotype Dx prostate cancer assay is a real time polymerase chain reaction (RT-PCR) assay designed for analysis of prostate core needle biopsies. The assay measures the expression of 17 genes to calculate a Genomic Prostate Score (GPS). A lower GPS score is suggestive of a more favorable biology and less aggressive disease. This test may be utilized to counsel patients regarding the best course of therapy in newly diagnosed low or low-intermediate prostate cancer.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Oncotype Dx Prostate Cancer Assay, then check the rights and deadlines that apply to your plan.