Oncotype Dx denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: The patient is a 43-year-old woman who recently was diagnosed with stage I breast cancer. She underwent a diagnostic breast biopsy in October 2004, which revealed a 6 mm intermediate grade (grade II) invasive ductal carcinoma (DCIS). The tumor is ER positive, PR positive, and Her2/neu 2+ (but FISH negative). She underwent a second excision for a positive DCIS margin as well as a sentinel lymph node biopsy in November 2004. This revealed additional DCIS, but with a narrowly negative margin. Two sentinel lymph nodes were excised, both are negative by routine histopathology as well as immunohistochemistry. A post-op MRI did not reveal any additional disease. The patient’s family history is important in that she is of Ashkenazi Jewish heritage.

Physician 1: This patient is a 48-year-old premenopausal female diagnosed with breast cancer, stage II. She is status post bilateral mastectomy. The pathology report indicated nodes were negative and the tumor was ER/PR positive, HER-2/neu negative and mitotic rate grade II. The patient’s provider recommended adjuvant chemotherapy which the patient refused, apparently based on the Oncotype result indicating a low recurrence score of 16. The patient has requested reimbursement for the cost of the tumor assay. The Health Plan denied her request citing the experimental/investigational nature of the Oncotype DX assay.Oncotype DX testing is a validated assay able to predict the rate of distant recurrence of breast cancer. Oncotype studies have been published in peer-reviewed journals and papers have been presented at major oncology meetings.

Where the denial was upheld

Physician 1: The patient is a 52-year-old female who was diagnosed with invasive ductal carcinoma of the breast found to be T2N0M0, ER positive, PR positive, and HER2 positive. The Oncotype DX assay was performed to help guide her choice of therapy. The patient now requests reimbursement for the diagnostic procedure. The Health Plan considers the Oncotype DX experimental/investigational and has denied reimbursement and coverage.There are no prospective clinical trials that have demonstrated that this assay can be used to select a specific therapy that will provide the individual patient with a better therapeutic outcome than would be achieved with the current guidelines for selection of therapy. Such studies are currently in progress, and until such data are available, use of this test is investigational.

Physician 1: This case involves a 50-year-old female patient with bilateral lobular breast cancer that is hormone receptor positive. Her oncologist indicated there was microscopic involvement of one lymph node on the right. The patient’s chemotherapy regimen was reportedly selected based on the risk category identified with the Oncotype DX assay. The Health Plan considers this diagnostic procedure investigational, and has denied reimbursement.The Oncotype DX tumor assay provides prognostic groupings related to the risk of recurrence. To date, it is not sufficiently precise and has not been validated for predictions regarding the benefit of chemotherapy or the need or lack of need for a specific chemotherapeutic course. The patient had bilateral involvement and lymph node positivity, which are also factors to be considered.

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, then check the rights and deadlines that apply to your plan.