Prior Authorization Required: Additional Information:

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1 Genetic Testing for Somatic Tumor Markers MP9486 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below No A first-degree relative is defined as an individual s parents, full siblings, and children. A second-degree relative is defined as an individual s grandparents, grandchildren, aunts, uncles, nephews, nieces and half-siblings. A third-degree relative is defined as first cousins, great-aunts, great-uncles, great-grandchildren, or great-grandparents. Medicare Policy: BadgerCare Plus Policy: Prior authorization is dependent on the member s Medicare coverage. Prior authorization is not required for Medicare Cost (Dean Care Gold) and Medicare Supplement (Select) when this service is provided by participating providers. Prior authorization is required if a member has Medicare primary and Dean Health Plan secondary coverage. This policy is not applicable to our Medicare Replacement product (Dean Advantage). Dean Health Plan covers when BadgerCare Plus also covers the benefit. Dean Health Plan Medical Policy: 1.0 Individual tumor biomarker or gene expression classifier tests are considered medically necessary when ALL of the following criteria are met: 1.1 The individual is a candidate for a targeted therapy associated with a specific tumor biomarker or disease site; and 1.2 Results of testing will directly impact clinical decision making; and 1.3 The testing method is considered to be scientifically valid to identify the specific tumor biomarker; and 1.4 Either of the following: Identification of the specific gene or biomarker is required in order to initiate a related therapy and the therapy has been validated by the National Genetic Testing for Somatic Tumor Markers 1 of 11

2 Comprehensive Cancer Network (NCCN Guidelines ) as a category 1, 2A, or 2B recommendation for the individual s tumor type or disease site; or Identification of the specific biomarker has been demonstrated in published peer-reviewed literature to improve diagnosis, management or clinical outcomes for the individual s condition being addressed. 2.0 Multi-gene panels to direct proven therapy or management changes for hematologyoncology indications when all of the following criteria are met: 2.1 Sequential testing of individual genes or biomarkers is not practical (i.e., limited tissue available, urgent treatment decisions pending); and Identification of the genes or biomarkers on the panel has been demonstrated in published peer-reviewed literature to improve diagnosis, management, or clinical outcomes for the individual s tumor type or disease site; and The panel is targeted (e.g., < 10 genes) and limited to genes or biomarkers that are associated with the specific tumor type or disease site. 2.2 Use of multi-gene panel is validated by the NCCN as category 1, 2A, or 2B recommendation for the individual s tumor type or disease site. 3.0 Molecular testing for hematology-oncology indications and are considered experimental/investigational for the following situations: 3.1 There is insufficient evidence to support molecular testing for the specific tumor type or disease site and/or not recommended by NCCN guidelines; and 3.2 The requested gene(s) or biomarker(s) are correlated with a known therapy, but that therapy has not been validated for the specific tumor type or disease site. 4.0 Genetic testing for the following tumor types are medically necessary when an individual meets the testing criteria outline in the relevant NCCN guidelines. 4.1 Acute Lymphoblastic Leukemia BCR-ABL1 Fusion gene testing may be indicated when 1 or more of the following is present: Initial diagnosis of acute lymphoblastic leukemia, and need for risk stratification or treatment planning; or Philadelphia chromosome-positive acute lymphoblastic leukemia, and for assessment of minimal residual disease, as indicated by one or more of the following: Following completion of initial induction therapy; or Following complete remission; or Prior to and following stem cell transplant. Genetic Testing for Somatic Tumor Markers 2 of 11

3 4.1.3 Need for -ABL1 kinase domain mutation analysis in patient treated with tyrosine kinase inhibitors as indicated by: During the first-line tyrosine kinase inhibitor therapy, as indicated by 1 or more of the following: Suboptimal treatment response; or Treatment failure During second-line tyrosine kinase therapy, when there is hematologic or cytogenic failure. 4.2 Acute Promyelocytic Leukemia PML-RARA Fusion gene testing may be indicated for one or more of the following: Confirmation of diagnosis of acute promyelocytic leukemia; or Documentation of molecular remission following consolidation therapy; or Documentation of molecular remission following therapy for relapse. 4.3 Chronic Myelogenous Leukemia BCR-ALB1 Fusion gene testing may be indicated when 1 or more of the following are present: Confirmation of diagnosis of chronic myelogenous leukemia; or Need for BCR-ABL1 kinase domain mutation analysis in patient treated with tyrosine kinase inhibitors, as indicated by one or more of the following: At diagnosis for patient in advanced phase of disease (e.g., accelerated phase, blast phase); or During first-line tyrosine kinase inhibitor therapy as indicated by 1 or more of the following: Loss of major molecular response associated with increase in BCR-ABL1 transcript levels; or Suboptimal treatment response; or Treatment failure During second-line tyrosine kinase inhibitor therapy, when there is hematologic or cytogenetic failure Monitoring response to therapy. 5.0 Lynch Syndrome Colorectal Tumor Analysis tumor analysis is medically necessary for ANY of the following: 5.1 Tumor testing for the gene BRAF V600E and MLH1 promoter hypermethlation of an individual with colon cancer when IHC tumor screening identified a loss of MLH1 expression; or Genetic Testing for Somatic Tumor Markers 3 of 11

4 5.2 Microsatellite instability (MSI) testing of endometrial tumor tissue as an initial screen in an individual with colorectal and/or endometrial cancer or colorectal adenomas (when malignant tissue is not available) for ANY of the following indications: Individual with colorectal or endometrial cancer, or colorectal adenomas whose family meets EITHER of the following: Endometrial cancer < 50 years of age; or The Amsterdam II criteria are met, which includes at least three relatives with a Lynch syndrome related cancer and ALL of the following: Genetic Testing for Somatic Tumor Markers 4 of One must be a 1 st -degree relative of the other two; or At least two successive generations must be affected; or No history of FAP in the colorectal cancer cases (if any) The revised Bethesda guidelines are met which includes ONE of the following: Colorectal cancer diagnosed under age 50; or Presence of synchronous, metachronous colorectal, or other Lynch syndrome related cancer, regardless of age; or Colorectal cancer with the MSI-I histology diagnosed in an individual who is under age 60; or Colorectal cancer diagnosed with one or more 1 st degree relatives with a Lynch syndrome related cancer, with one or the cancers diagnosed under age 50; or Colorectal cancer diagnosed in two or more 1 st or 2 nd degree relatives with a Lynch syndrome related cancer, regardless of age. 6.0 The following Metastatic Colorectal Tumor tests are medically necessary for the diagnosis and management of metastatic colorectal tumors: 6.1 NRAS gene analysis; 6.2 KRAS targeted gene analysis; 6.3 BRAF V600E targeted mutation testing 7.0 The following Colon Cancer genetic tests are considered experimental/investigational: 7.1 Colon Cancer Oncotype DX 7.2 Colon Cancer Gene Expression Assay GeneFx Colon

5 7.3 Colon Cancer Gene Expression Assay ColoPrint 8.0 Melanoma (Cutaneous) Gene Expression Profiling is considered experimental/investigational. 9.0 Malignant Melanoma in Tumor genetic testing is considered medically necessary when EITHER of the following criteria are met: 9.1 BRAF V600E mutation (the cobas 4800 BRAF mutation test) for person who are considering ZELBORAF (vemurafenib) for the treatment of unresectable or metastatic melanoma; or 9.2 The THxID BRAF test for detecting mutation of the BRAF gene (V600E or V600K) in persons with unresectable or metastatic melanoma who are being considered for treatment with TALFINALAR (dabrafenib) or MEKINIST (trametinib) Myelodysplastic Syndrome genetic testing including TET2, DNMT3A, TP53, SF3B1, SRSF2, U2AF1, ZRSR2, ASXL1, RUNX1, EZH2, NRAS, CBL, JAK2, SETBP1, IDH1, IDH2, ETV6 is considered medically necessary when EITHER of the following criteria are met: 10.1 MDS will bone-marrow biopsy confirmed intermediate risk using the IPSS, the WPSS, or the IPSS-R classification methods; or 10.2 Patient was treated on a lower-risk scale but did not experience a response to treatment Glioblastoma MGMT (O(6)-methylguanine-DNA methyltransferase) gene mutation assay testing for predicting response to TEMODAR (temozolomid) in persons with glioblastoma is medically necessary Janus Kinase 2 (JAK2) mutation genetic testing is considered medically necessary for the following diagnoses: 12.1 Polycythemia Vera (PV) 12.2 Essential Thrombocythemia or Thrombocytosis (ET) 12.3 Primary Myelofibrosis 13.0 MPL and CALR exon 9 mutation analysis are considered medically necessary for the following diagnosis when JAK2 testing has been performed and was negative: 13.1 Essential Thrombocythemia or Thrombocytosis (ET) 13.2 Primary Myelofibrosis 14.0 Oncotype DX Breast Cancer Assay is medically necessary for breast cancer to assess the need for adjuvant chemotherapy in a woman when ALL of the following criteria are met: 14.1 Recently diagnosed stage 1 or stage 2 breast cancer; and 14.2 Estrogen receptor positive; and Genetic Testing for Somatic Tumor Markers 5 of 11

6 14.3 HER2-receptor negative; and 14.4 No evidence of distant metastasis; and 14.5 Either of the following criteria: Axillary-node status is negative (or any axillary-node micrometastasis is no greater than 2.0 millimeters) whether the woman is pre- or postmenopausal; or Up to three positive axillary nodes in a post-menopausal woman Prosigna Breast Cancer Assay (PAM50) is medically necessary for breast cancer to assess the need for adjuvant chemotherapy in a woman when ALL of the following criteria are met: 15.1 Recently diagnosed stage 1 or stage 2 breast cancer; and 15.2 Estrogen receptor positive; and 15.3 HER2-receptor negative; and 15.4 Postmenopausal; and 15.5 No evidence of distant metastasis; and 15.6 Axillary node status is negative (or any axillary-node micrometastasis is no greater than 2.0 mm) Non-Small Cell Lung Cancer (NSCLC) the following tests are medically necessary for the diagnosis and management of non-small cell lung adenocarcinoma: 16.1 EGFR targeted gene analysis 16.2 Anaplastic lymphoma kinase (ALK) fusion gene (e.g., the Vysis ALK Break Apart FISH Probe Kit) for persons who are considering XALKORI (crizotinib) or ZYKADIA (ceritinib) for the treatment of non-small cell lung cancer (NSCLC) KRAS targeted gene analysis 16.4 HER2 (ERBB2) targeted gene analysis 16.5 BRAF V600E targeted mutation testing 16.6 ROS1 gene rearrangements 16.7 RET gene rearrangements 16.8 MET amplification 17.0 Prostate Cancer Molecular tumor testing of confirmed prostate cancer is experimental/ investigational for the following: 17.1 MicroDNA Detection - Cancer 17.2 Oncotype DX Prostate Genetic Testing for Somatic Tumor Markers 6 of 11

7 17.3 Prostate Cancer Genetic Profiles 17.4 Prostate Cancer HOXB13, MMR, PTEN, and TMPRSS2 Fusion Genes 17.5 Decipher 17.6 Prolaris 18.0 Prostate Cancer screening and prognostic genetic tests, ConfirmDx and PCA3 Assay, are considered medically necessary for prostate cancer when results will impact management and BOTH of the following criteria are met: 18.1 PSA > 3.0 ng/ml; and 18.2 Previous benign prostate biopsy or focal high grade prostatic intraepithelial neoplasia (PIN) 18.3 All other prostate cancer screening and prognostic genetic tests are considered experimental and investigational and not covered Thyroid Nodule Gene Expression Testing (Afirma Thyroid FNA Analysis or Interpace ThyGenX Oncogene Panel) may be medically necessary when ALL of the following are present: 18.1 Age 21 years or older; and 18.2 Thyroid nodule, as indicated by ALL of the following: Atypia of undetermined significance; and Follicular lesion of undetermined significance; and Hurthle/follicular neoplasm suspected Tumor Analysis or Gene Expression Profiling for ANY of the following solid tumor type is considered experimental/investigational: 19.1 Anal carcinoma 19.2 Basal cell carcinoma 19.3 Bone cancer 19.4 Cancer of unknown origin/unknown primary 19.5 Cervical cancer 19.6 Head and neck cancer 19.7 Heptobiliary cancer 19.8 Malignant mesothelioma 19.9 Non-Hodgkin lymphoma Penile cancer Testicular cancer Genetic Testing for Somatic Tumor Markers 7 of 11

8 19.12 Tracheal cancer Esophageal cancer in certain situations Squamous cell carcinoma of the skin Renal/kidney cancer 20.0 Other Tumor Profile Testing is not covered for ANY the following: 20.1 Molecular testing for detection of or circulating tumor cells for any hematology/oncology indication because it is considered experimental/ investigational Topographic genotyping for an indication is not covered because it is considered experimental/investigational Multi-gene cell-free tumor DNA assays or molecular testing of circulating tumor cells for a hematology/oncology indications are considered experimental/investigational. CPT/HCPCS Codes Related to MP9486 * The list of codes (and their descriptors, if any) is provided for informational purposes only and may not be all inclusive or current. Listing of a code in this medical policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member s policy of health coverage with Dean Health Plan. Inclusion of a code above does not imply any right to reimbursement or guarantee claim payment. Other medical policies may also apply BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative or quantitative BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, qualitative or quantitative BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative or quantitative BRAF (B-Raf proto-oncogene, serine/threonine kinase) (eg, colon cancer, melanoma), gene analysis, V600 variant(s) CALR (calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number variants (eg, bacterial artificial chromosome [BAC] or oligo-based comparative genomic hybridization [CGH] microarray analysis) Genetic Testing for Somatic Tumor Markers 8 of 11

9 81235 EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, p.val617phe (V617F) variant KRAS (Kirsten rat sarcoma viral oncogene homolog) (eg, carcinoma) gene analysis; variants in exon 2 (eg, codons 12 and 13) KRAS (Kirsten rat sarcoma viral oncogene homolog) (eg, carcinoma) gene analysis; additional variant(s) (eg, codon 61, codon 146) MGMT (O-6-methylguanine-DNA methyltransferase) (eg, glioblastoma multiforme), methylation analysis Microsatellite instability analysis (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) of markers for mismatch repair deficiency (eg, BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, exon 12 variants NRAS (neuroblastoma RAS viral [v-ras] oncogene homolog) (eg, colorectal carcinoma), gene analysis, variants in exon 2 (eg, codons 12 and 13) and exon 3 (eg, codon 61) PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; common breakpoints (eg, intron 3 and intron 6), qualitative or quantitative PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; single breakpoint (eg, intron 3, intron 6 or exon 6), qualitative or quantitative Molecular Pathology Procedure Level Molecular Pathology Procedure Level Molecular Pathology Procedure Level Molecular Pathology Procedure Level Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed Genetic Testing for Somatic Tumor Markers 9 of 11

10 81450 Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mrna expression levels, if performed Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed Unlisted molecular pathology procedure Oncology (breast), mrna, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score Oncology (colon), mrna, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffinembedded tissue, algorithm reported as a recurrence score Oncology (colorectal) screening, quantitative real-time target and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result Oncology (tumor of unknown origin), mrna, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed paraffinembedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious) 0008M S3854 Oncology (breast), mrna analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score Gene expression profiling panel for use in the management of breast cancer treatment Genetic Testing for Somatic Tumor Markers 10 of 11

11 Originated: Revised: Reviewed: Committee/Source Date(s) Medical Policy Committee/Quality and Care Management Division April 3, 2017 Medical Policy Committee/Quality and Care Management Division October 18, 2017 Medical Policy Committee/Quality and Care Management Division October 18, 2017 Published/Effective: 11/01/2017 Genetic Testing for Somatic Tumor Markers 11 of 11