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REVIEW REQUEST FOR Gene Expression Profiling for Managing Breast Cancer Treatment Provider Data Collection Tool Based on Medical Policy GENE.00011 Policy Last Review Date: 11/03/2016 Policy Effective Date: 12/28/2016 Provider Tool Effective Date: 12/28/2016 Individual’s Name: Date of Birth: Insurance Identification Number: Individual’s Phone Number: Ordering Provider Name & Specialty: Provider ID Number: 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 medical policy based data collection tool is for a medical necessity review request for the use of 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 with the Oncotype™ DX breast cancer assay for managing the treatment of breast cancer Individual has had surgery with full pathology evaluation of the specimen (If checked, please indicate the documented specimen histology) Histology is ductal Histology is lobular Histology is mixed Histology is metaplastic Histology is NOT Tubular Histology is NOT Colloid Individual is exclusively Estrogen receptor positive (ER+) Individual is exclusively Progesterone receptor positive (PR+) Individual is estrogen receptor positive (ER+) AND Progesterone receptor positive (PR+) Individual is HER2 receptor negative (If checked, please indicate the basis of the HER2 negative receptor findings) ISH Testing Single-probe average HER2 copy number < 4.0 signals/cell ISH Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals/cell IHC Testing: Zero IHC Testing: 1+ REVIEW REQUEST FOR Gene Expression Profiling for Managing Breast Cancer Treatment Provider Data Collection Tool Based on Medical Policy GENE.00011 Policy Last Review Date: 11/03/2016 Policy Effective Date: 12/28/2016 Provider Tool Effective Date: 12/28/2016 The tumor staging is pN0 (node negative) The tumor staging is pN1mi with axillary lymph node micrometastasis less than or equal to 2mm Tumor size is documented in the medical record (If checked, please indicate the tumor size below) Tumor size 0.6-1.0 cm moderate/poorly differentiated Tumor size 0.6-1.0 cm and well-differentiated with angiolymphatic invasion Tumor size 0.6-1.0 cm and well-differentiated with high nuclear grade Tumor size 0.6-1.0 cm and well-differentiated with high histologic grade Tumor size is in the range greater than 1.0 cm and less than or equal to 5.0 cm Chemotherapy is a therapeutic option being considered Chemotherapy will be supervised by the practitioner ordering the gene expression profile Request is for gene expression profiling as a technique of managing the treatment of ductal carcinoma in situ (DCIS) Request is for repeat gene expression profiling with the Oncotype™ DX breast cancer assay (If checked, please mark the following that apply) Profiling is for the same tumor (for example a metastatic focus) Profiling is from more than one site when the primary tumor is multifocal Request is for gene expression profiling using a gene profiling test other than the Oncotype™ DX breast cancer assay Please specify the gene profiling test being requested: ____________________ 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.