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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™) For Pre-Service: Statewide Fax (877) 219-9448 For Medicare Advantage (BlueMedicare) HMO and PPO Plans: Fax (904) 301-1614 Fax or mail this completed form Physician Information/ Requesting Provider to: For Post-Service Claims: Florida Blue P.O. Box 1798 Jacksonville, FL 32231-0014 Name: BCBSF No: Contact Name: Facility Information/ Location where services will be rendered Member Information Procedure Information Name: National Provider Identifier (NPI): Phone: BCBSF No: National Provider Identifier (NPI): Contact Name: Phone: Last Name: First Name: Member/Contract Number (alpha and numeric): Date of Birth: Procedure Code(s): Procedure Description: Diagnosis code(s): Diagnosis Description: Date of Service/Tentative Date: Section B Medical Necessity: For detailed information on assays of genetic expression in tumor tissue as a technique to determine prognosis in patients with breast cancer (Oncotype DX™) including the criteria that meet the definition of medical necessity, visit the Florida Blue Medical Coverage Guideline website at http://mcgs.bcbsfl.com. Refer to Medical Coverage Guideline 05-86000-26, Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (Oncotype DX™.) For Medicare members, refer to http://www.cms.gov/medicare-coverage-database, Local Coverage Determination (LCD) Gene Expression Profiling Panel for use in the Management of Breast Cancer Treatment L33541. Section C Check all boxes and complete all entries that apply: Yes No Is this request for a new diagnosis of breast cancer (6 months or less)? Date of diagnosis: Yes No Is the diagnosis a unilateral tumor? Yes No Is the member node-negative (lymph nodes with micrometastases (less than 2 mm in size) are considered node negative) OR is there 1-3 involved ipsilateral axillary lymph nodes? 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 greater than 0.5 cm? Describe: Yes No Will the member be treated with hormonal therapy? Certificate of Medical Necessity: Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (Oncotype DX™) CMN 05-86000-26_111515 1 Yes No Is the member a candidate for chemotherapy? Yes No Has the member had surgery? Yes No Has a full pathological examination of the tumor been completed? Yes No Will the test result determine if adjuvant chemotherapy will be used? Explain: Yes No Is the test being ordered by the treating physician? Yes No Is the use of Oncotype DX to determine recurrence risk for deciding whether or not to undergo adjuvant chemotherapy? Explain: Yes No Is the requested service a gene expression test other than Oncotype DX? (i.e., MammaPrint, Mammostrat or Breast Cancer Index) Additional Comments: I hereby certify that (i) I am the treating physician for above member, (ii) the information contained in and included with this Certificate of Medical Necessity is true, accurate and complete to the best of my knowledge and belief, (iii) the member’s medical records contain all appropriate documentation necessary to substantiate this information. I acknowledge that a determination made based upon this Certificate of Medical Necessity is not necessarily a guarantee of payment and that payment remains subject to application of the provisions of the member’s health benefit plan, including eligibility and plan benefits. Additionally, I further acknowledge and agree that Florida Blue may audit or review the underlying medical records at any time and that failure to comply with such request may be a basis for the denial of a claim associated with such services. Ordering Physician’s Signature: Certificate of Medical Necessity: Date: Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (Oncotype DX™) 2