Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 59-year-old female diagnosed with breast cancer in June 2005. She is status post right-side mastectomy. Pathology indicated her cancer was node negative, ER positive, PR negative and HER2 negative. The tumor was 1.1 cm in size and moderate grade. An Oncotype DX tumor assay was performed revealing a Recurrence Score of 29, indicating an intermediate risk. The Health Plan denied coverage for the Oncotype DX assay on the basis that there is insufficient evidence of its efficacy.The Oncotype DX is a valid assay with study results published in 2004 in the New England Journal of Medicine as well as at multiple major oncology meetings. Based on the initial characteristics of this patients disease the benefits of chemotherapy were subject to debate. The Oncotype DX assay provided additional information to help guide the patients physician. Therefore, I have determined that the diagnostic procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2:  The patient is a 59-year-old woman diagnosed with breast cancer in June 2005. At that time she was found to have a 1.1 cm moderately differentiated invasive ductal carcinoma with negative axillary nodes, positive estrogen receptor and negative HER2. Her tissue was submitted to Oncotype DX testing. This returned a recurrence score of 29, predicting a 19% chance of distant recurrence within ten years if treated with Tamoxifen alone. The Health Plan deemed the diagnostic procedure experimental/investigational and the patients request for reimbursement was denied.The Oncotype DX is a relatively new assay wherein 21 genes are analyzed in a breast cancer, allowing for the development of a prognostic score. This score then allows one to place a patient into a risk category for recurrence (low, intermediate or high). The test thus far only applies to women with node negative (or micrometastatic positive), estrogen receptor positive cancers.Though the test itself is fairly new, there is a rapidly growing body of data based on the retrospective application of the assay to older studies. It appears to be quite reliable in terms of prognosis and has potential usefulness in decisions regarding adjuvant chemotherapy.  The assay has become very important particularly in this group of breast cancer patients in which it is very difficult to make recommendations about adding adjuvant chemotherapy. Indeed, the assay has been adopted by many oncologists as part of their standard evaluation of such patients and Medicare has approved its use. Based upon the information set forth above, I have determined that the diagnostic procedure at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3:  A 59-year-old female patient has requested reimbursement for the Oncotype DX tumor assay. The Health Plan has denied this request indicating the diagnostic procedure at issue is considered investigational for treatment of the patients breast cancer. In June 2005 the patient was diagnosed with invasive ductal carcinoma of the right breast, which was treated with right mastectomy. The 1.1 cm tumor was staged as node negative, ER positive, PR negative, and HER2/neu negative. Oncotype DX testing in July 2005 reported a Recurrence Score of 29 with an associated intermediate risk of recurrence.  The article in the 2004 New England Journal of Medicine reports results from a study where the Oncotype DX assay was used in a prospective manner to predict risk groups for women with this type and stage of cancer. The data are impressive and convincing. Many oncologists are using the Oncotype DX assay to help them with when to treat decisions. This particular patient is one in whom the use of Oncotype DX testing was likely to be more beneficial for treatment of her medical condition than any available standard therapy. The Health Plans denial should be overturned.