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Certificate of Medical Necessity Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (Oncotype DX™) Fax this completed Certificate of Medical Necessity form along with other required documentation including: physician history and physical, pathology report, treating physician visit notes that include documentation that the intention to treat or not treat with adjuvant chemotherapy would be contingent, at least in part, on the results of the test for the individual patient in question. Statewide Fax Number:1-813-806-1233 Section A Physician Information Name: BCBSF Number: National Provider Identifier (NPI): Street Address: City: County: Telephone Number: State: ZIP: Fax Number: Contact Name: Lab Information Name: BCBSF Number: National Provider Identifier (NPI): Street Address: City: County: Telephone Number: State: ZIP: Fax Number: Contact Name: Member Information Last Name: First Name: Member/Contract Number (alpha and numeric): Date of Birth: Age: Weight: Procedure Information Procedure Code: Procedure Description: ICD-9 Code: Diagnosis Description: Scheduled/Tentative Procedure Date: Section B Complete ALL of the following questions Yes No Is the requested service a gene expression test other than Oncotype DX (such as MammaPrint, Mammostrat or THEROS Breast Cancer Index)? Yes No Is breast cancer a new diagnosis (6 months or less)? Certificate of Medical Necessity: Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (Oncotype DX™) 1 Are ALL of the following criteria met? Yes No Is the tumor unilateral, non-fixed? Yes No Is the tumor node-negative (lymph nodes with micrometastases (< 2mm in size) are considered node negative)? Yes No Is the tumor hormone-receptor-positive (ER-positive or PR-positive)? Yes No Is the tumor HER2-negative? Yes No Is the tumor size > 0.5 cm? Yes No Will the patient be treated with hormonal therapy? Yes No Is the patient a candidate for chemotherapy? Yes No Has the patient had surgery? Yes No Has full pathological examination of the tumor been completed? Yes No Will the test result determine if adjuvant chemotherapy will be used? Yes No Is the test ordered by the treating physician? Comments: My signature below certifies that the information submitted on this form is accurate and these services are medically necessary. Ordering Physician’s Signature: Certificate of Medical Necessity: Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (Oncotype DX™) Date: 2