Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 65-year-old woman who has been diagnosed with two breast cancers. In October 2004 she was found to have a moderately differentiated 1cm invasive ductal cancer with negative sentinel node and positive estrogen receptor. Her cancer was submitted to Oncotype DX assay, and was found to have a score of 11, which corresponds to a 7% risk of recurrence within 10 years if treated with hormonal therapy alone. Because on these findings, adjuvant chemotherapy was not recommended.In December 2005 she was found to have a second cancer, this time in the other breast. Findings revealed a 0.6cm well differentiated invasive lobular carcinoma with negative nodes and positive estrogen receptor. This cancer was also submitted to an Oncotype DX assay, and was found to have a score that placed the patient at a 35% risk of recurrence. For that reason, she underwent adjuvant chemotherapy.The Oncotype DX assay performed in January 2005 is the subject of this appeal.The Oncotype DX assay 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 applying it to older studies retrospectively, such that it appears to be quite reliable not only in terms of prognosis, but potential usefulness of adjuvant chemotherapy. Specifically, there is data to suggest that those in the low risk group get no benefit from adjuvant chemotherapy, and those in the high risk group get significant benefit from adjuvant chemotherapy. There remains a great deal of controversy about those who fall into the intermediate risk category. 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: A 65-year-old female patient has requested reimbursement for the Oncotype DX tumor assay performed in January 2005 as part of her evaluation for the diagnosis of invasive ductal carcinoma of the left breast in October 2004, treated initially with lumpectomy and radiation therapy. The Oncotype DX assay predicted a low risk of recurrence (score of 11).  Based in part on the results of this procedure the patient did not receive chemotherapy and was placed on Arimedex.At issue in this case is whether the Oncotype DX tumor assay performed in January 2005 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.  The 2004 article in the 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. The use of Oncotype DX assays to guide therapeutic decisions is becoming a common clinical practice option for breast cancer diagnosis and treatment. This particular patient is one in whom the use of the Oncotype DX assay was likely to be more beneficial than any available standard therapy. Accordingly, the Health Plans denial should be overturned.Physician 3: A 65-year-old-woman with early-stage (negative nodes, positive estrogen receptor, HER-2-neu negative) left breast ductal carcinoma in-situ (DCIS). She is seeking reimbursement for an Oncotype DX tumor assay performed in January 2005.  At issue is whether this test was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The available standard therapy for DCIS was radiation and hormonal manipulation, which the patient completed.Medicare has begun to cover the Oncotype DX assay for women who meet specific criteria, and the assay is now widely used based on positive validation studies using the NSABP database and a prospective study by Kaiser-Permanente. The American Society of Clinical Oncology and the National Comprehensive Cancer Network practice guidelines endorse the use of this study as a part of the decision-making process in patients with early stage breast cancer which classically involves an invasive, not an in-situ histopathologic diagnosis.  DCIS, the histopathologic entity in the patients first breast cancer diagnosis, is considered distinct from invasive breast cancer. There is insufficient evidence that Oncotype DX profiling is beneficial in making treatment decisions in the setting of DCIS. Although some practitioners will consider systemic chemotherapy in DCIS patients based on features such as multi-focal disease, the standard of care is breast-sparing therapy (local excision), radiation, and hormonal agents rather than Oncotype testing.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.