Appeal type: Experimental/Investigational
Decision: Overturned

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 patients 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. The assay has been approved for coverage by Medicare. The results of the Oncotype assay enabled the patient to choose between hormonal therapy with adjuvant chemotherapy or hormonal therapy alone. She chose not to have adjuvant chemotherapy contrary to the recommendation of her provider.  The Oncotype DX tumor assay is extensively utilized in the oncology community and is no longer considered experimental or investigational.  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 2:  The patient is a 48-year-old premenopausal female with multi-focal (3.0cm, 0.9cm and 0.6cm lesions) breast disease, ER/PR positive and HER-2/neu negative. She underwent bilateral mastectomy and the recommendations from her oncologist and the Scripps tumor board were uniformly in favor of adjuvant chemotherapy based on her high-risk features of premenopausal status and a 3.0cm tumor focus. The patient underwent Oncotype-DX testing that quantified her risk of recurrence with a score of 16; considered low risk as compared to an intermediate risk score of 18 or greater.  Based on this score, the patient decided to forego systemic chemotherapy. She now seeks reimbursement for the Oncotype DX assay which was a factor in her decision not to undergo adjuvant chemotherapy. The Health Plan has classified this diagnostic procedure as experimental/investigational and denied coverage and reimbursement.Medicare has now begun to cover the Oncotype DX assay and it is widely used based on positive validation studies using the NSABP database and a prospective study by Kaiser-Permanente. The National Comprehensive Cancer Network (NCCN) practice guidelines also describe the use of this study as a part of the decision-making process for a select group of early-stage breast cancer patients. The use of the Oncotype DX assay to evaluate treatment decisions has now reasonably become the standard of care for this group of patients. When the risks of short and long-term exposure to chemotherapeutic agents such as neutropenia, neuropathy, cardiomyopathy, and possibly sarcoidosis are considered, this test and the therapeutic decisions facilitated by the results can be considered extremely beneficial when used to weigh the consequences or need for adjuvant chemotherapy. Under these circumstances, Oncotype DX testing is medically appropriate.  The circumstances of this case are unusual, however and the patient is not within that class of patients for whom the assay is likely to provide added benefit in making treatment decisions.  It is contrary to the widely accepted standard of care to forego chemotherapy for patients with primary tumors 3.0cm or greater in size. The NCCN and the International Consensus Group both advocate systemic chemotherapy for patients with this size of primary tumor, stage notwithstanding.  Based upon the clinical factors under review, 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 3:  This patient is a 48-year-old woman diagnosed with breast cancer in December 2005. At that time she was found to have three cancers in one breast. She had a 3.0cm grade II cancer, a 0.9cm grade II cancer, and a 0.6cm grade I cancer. The estrogen receptor was positive, nodes were negative, and HER-2/neu was negative.  Because of the size of her tumor, adjuvant chemotherapy was recommended to her. To further assess her risk, her tissue was submitted for an Oncotype DX assay. This returned a recurrence score of 16, which correlates to a 10% risk of recurrence within ten years if treated with hormonal therapy alone. Because of this low risk of recurrence she chose not to undergo the chemotherapy.  Her request for reimbursement was denied by the Health Plan based upon a determination that the Oncotype assay is an experimental/investigational diagnostic procedure.The Oncotype DX assay is a 21-gene analysis of breast cancer cells, which produces a recurrence score that predicts quite accurately the risk of distant recurrence of the cancer over ten years if the patient is treated with hormonal therapy as the sole systemic treatment. There is good literature support for its reliability. The assay has been shown to be valid only in node-negative, estrogen receptor positive tumors. The assay has become very important as it is particularly difficult to make recommendations about adding adjuvant chemotherapy in this group of breast cancer patients. This assay has been rapidly adopted by oncologists as part of their standard evaluation of such patients, and Medicare has also approved its use.  The Oncotype DX assay is no longer considered investigational, but rather medically necessary with clear clinical benefit in the appropriate patient, such as this patient.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.