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REVIEW REQUEST FOR Gene Expression Profiling for Managing Breast Cancer Treatment Provider Data Collection Tool Based on Coverage Guideline GENE.00011 Policy Last Review Date: 05/07/215 Policy Effective Date: 07/07/2015 Provider Tool Effective Date: Individual’s Name: Date of Birth: Insurance Identification Number: Individual’s Phone Number: Ordering Provider Name & Specialty: Provider ID Number: 07/07/2015 Office Address: Office Phone Number: Office Fax Number: Rendering Provider Name & Specialty: Provider ID Number: Office Address: Office Phone Number: Office Fax Number: Facility Name: Facility ID Number: Facility Address: Date/Date Range of Service: Service Requested (CPT if known): Place of Service: Outpatient Home Inpatient Other: Diagnosis Code(s) ( if known): This data collection tool is based on medical policy and is intended to facilitate the provider’s medical necessity review request for genetic profiling of breast tumors to predict breast cancer recurrence and response to therapy. Please check all of the following that apply to individual: Request is for gene expression profiling for managing the treatment of ductal carcinoma in situ (DCIS) Request is for gene expression profiling with the Oncotype™ DX® breast cancer assay for the same tumor (for example a metastatic focus) or from more than one site when the primary tumor is multifocal REVIEW REQUEST FOR Gene Expression Profiling for Managing Breast Cancer Treatment Provider Data Collection Tool Based on Coverage Guideline GENE.00011 Policy Last Review Date: 05/07/215 Policy Effective Date: 07/07/2015 Provider Tool Effective Date: 07/07/2015 Request is for gene expression profiling for managing breast cancer treatment using: (check all that apply) Oncotype™ DX breast cancer assay BluePrint™ (also referred to as “80-gene profile”) Breast Cancer Gene Expression Ratio (also known as Theros H/ISM) Breast Cancer IndexSM BreastNext™ BreastOncPX™ BreastPRS Endopredict Insight® DX Breast Cancer Profile MammaPrint® (also referred to as the "Amsterdam signature" or “70-gene signature”) Mammostrat NexCourse® Breast IHC4 NuvoSelect™ eRx 200-Gene Assay Oncotype DX DCIS PAM50 Breast Cancer Intrinsic Classifier™ Prosigna™ Breast Cancer Prognostic Gene Signature Assay SYMPHONY™ Genomic Breast Cancer Profile TargetPrint® TheraPrint ™ The 41-gene signature assay The 76-gene "Rotterdam signature" assay THEROS Breast Cancer IndexSM Other (please list): Individual has had surgery and full pathology evaluation of the specimen has been completed Specimen histology is (check the following that applies to the individual): Ductal Lobular Mixed Metaplastic NOT Tubular NOT Colloid Other (please list): Individual is (check all that apply): Exclusively Estrogen receptor positive (ER+) Exclusively Progesterone receptor positive (PR+) Estrogen receptor positive (ER+) AND Progesterone receptor positive (PR+) HER2 (human epidermal growth factor receptor-2) receptor negative is based on (check all that apply) ISH Testing Single-probe average HER2 copy number less than 4.0 signals/cell ISH Dual-probe HER2/CEP17 ratio less than 2.0 with an average HER2 copy number less than 4.0 signals/cell IHC Testing: Zero IHC Testing: 1+ Other (please list): Tumor staging is (check all that apply): pN0 (node negative) pN1mi with axillary lymph node micrometastasis less than or equal to 2mm Tumor is less than 0.6 cm Tumor size 0.6-1.0 cm moderate/poorly differentiated REVIEW REQUEST FOR Gene Expression Profiling for Managing Breast Cancer Treatment Provider Data Collection Tool Based on Coverage Guideline GENE.00011 Policy Last Review Date: 05/07/215 Policy Effective Date: 07/07/2015 Provider Tool Effective Date: 07/07/2015 Tumor size 0.6-1.0 cm and well-differentiated with any of the following unfavorable features angiolymphatic invasion or high nuclear grade or high histologic grade Tumor size greater than 1.0 cm and less than or equal to 4.0 cm Tumor size is greater than 4.0 cm Other (please list): Chemotherapy is being considered as a therapeutic option Chemotherapy will be supervised by the practitioner ordering the gene expression profile Request is for indication other than those listed above. (Please list and provide clinical support): This request is being submitted: Pre-Claim Post–Claim. If checked, please attach the claim or indicate the claim number I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its designees may perform a routine audit and request the medical documentation to verify the accuracy of the information reported on this form. _____________________________________________________________ Name and Title of Provider or Provider Representative Completing Form and Attestation (Please Print)* Date *The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization management services on behalf of your health benefit plan or the administrator of your health benefit plan.