Appeal type: Experimental/Investigational
Decision: Upheld

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 patients 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. The impact of bilaterality, which is common for lobular cancer (in situ), is not known to be associated with a worse prognosis and is not predictive of chemotherapy benefits, in general, or of one specific type over another.  The question of microscopic lymph node positivity remains controversial, but this element may trump any Oncotype DX predictions that are based upon a node negative database.Based upon the information set forth above, I have determined that the diagnostic procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2: The patient is a 50-year-old female of unknown menopausal status, with bilateral lobular carcinoma of the breasts. She apparently had a micro metastasis in a lymph node on the right. It is not known if this was a sentinel node or how the metastasis was detected. It appears the patient is in otherwise good health with no significant comorbid conditions.  The patient had the Oncotype DX tumor assay performed on the recommendation of her treating physician.  The Health Plan considers this diagnostic procedure experimental/ investigational and has denied her request for reimbursement.The Oncotype DX tumor assay is utilized to determine the risk of distant relapse, and often aids in decision making related to adjuvant chemotherapy.  This patient did indeed warrant adjuvant chemotherapy assuming the N1 status was based on a metastasis detected by H and E staining. Because the Oncotype DX assay revealed a  low risk tumor, her physician was able to appropriately limit the patients chemotherapy regimen and avoid the additional toxicity.  Based upon the information set forth above, I have determined that the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3: The patient is a 50-year-old woman with bilateral breast carcinoma. Her tumor was estrogen receptor positive, HER2neu unknown, and T1, N0, M0.  The treating oncologist noted that the patient clearly required adjuvant chemotherapy, and the purpose of the Oncotype DX assay was to determine how aggressive the regimen should be. This diagnostic procedure is deemed investigational by the Health Plan and not a covered benefit.  Therefore, reimbursement was denied.The purpose of Oncotype DX is to determine the risk of distance metastases. If there were a question as to whether or not this patient was to receive chemotherapy (in addition to hormonal manipulation) then Oncotype DX would have been appropriate. However, her oncologist clearly stated in September 2005 that she was to receive chemotherapy. Oncotyping does not allow the clinician to choose between regimens; it simply provides an estimation, based on multiple factors, of the patients chance of distance metastases.  Therefore, I have determined that the diagnostic procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.