Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 42-year-old woman with Stage II (microscopic) breast cancer that is hormone receptor positive.  Biopsy determined there was microscopic involvement of one lymph node out of three. The patient elected not to have chemotherapy based on the low 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. This patient had micrometastasis, which is an additional factor to be considered. The significance of micrometastasis remains controversial, but this element may remove the patient from the class of women who are most likely to benefit from the Oncotype DX predictions based upon a node negative database.  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.Physician 2: The patient is a 42-year-old female who was diagnosed with breast cancer in December 2004. At that time she was found to have a 1.5 cm invasive ductal carcinoma with a micrometastasis in one sentinel node. Her estrogen receptor assay was positive. The patients tumor was submitted for Oncotype DX analysis. She was found to have a recurrence score of 3, which gave her a 4% chance of distant recurrence at ten years, assuming she was treated with Tamoxifen. The patient requested reimbursement for the Oncotype DX assay.  The Health Plan denied the request based on a determination that the diagnostic procedure was experimental/investigational for evaluation of the patients breast cancer.The Oncotype DX assay is increasingly utilized in patients such as this one. Its purpose is to give a more accurate prediction of recurrence along with a statement of the usefulness of adjuvant chemotherapy. Indeed, several studies have now shown the reliability and value of Oncotype DX and there is sufficient data to support that the inclusion of this assay is consistent with the standard of care for selected patients. In this case, it was determined that chemotherapy would be of no value; therefore no chemotherapy was given. Therefore, 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 42-year-old pre-menopausal female who was diagnosed with invasive ductal carcinoma of the left and right breasts in December 2004. The tumor was hormone receptor positive and one of three sentinel nodes revealed micrometastasis. The Oncotype assay was performed and indicated a low-risk of recurrence. As a result, chemotherapy was withheld. The Health Plan has denied reimbursement for the Oncotype DX assay citing the investigational nature of the procedure.This case is a good example of the prognostic value of the Oncotype diagnostic.  Given the patients relatively young age some would argue that chemotherapy was warranted.  However, the Oncotype DX assay was able to quantify the likelihood of distant recurrence and based upon the low recurrence score this patient did not require chemotherapy.  The assay has been performed on a sufficiently large population of women with stage I infiltrating ductal breast cancer and the peer-reviewed published results have unequivocally established its worth. 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.