Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)

always including/must include: Targets that are required in testing described by a CPT code.at least/or greater: Minimum number of genes required to bill for a specific CPT code.For instance, if a CPT code description for a panel requires at least 10 genes, this means the panel size must, at minimum, analyze 10 genes. However, if the panel analyzes 11, 20, 50, or 100 genes and this code is used,no other codes may be used to describe the panel, regardless of presence or absence of modifiers.Common variants/Common deletions/etc.: Genetic variants most predominantly associated with a disease, as defined by professional society guidelines. Billing CPT codes with common variants in the code description should not include testing for uncommon and/or rare variants. If a variant is felt to be common,this designation must be supported by a professional societys guidelines.Deletion/duplication analysis: Testing that evaluates for loss (deletion) or gain (duplication) of stretches of genetic sequence (dosage of a particular genomic region).e.g.,: Examples of  Depending on the context, listed examples following an e.g., may or may not be required in the testing described by a code.Full gene sequence/full sequence analysis: Testing that evaluates, at a minimum, all exons of a gene. Depending on the testing methodology used, a full sequence analysis may also include additional non-coding sequence (e.g., promotor region, introns) and/or may NOT include data on certain types of variants, such as duplication/deletion variants.Qualitative: Results of a test provided as descriptive terms (e.g., positive, negative, inconclusive).Quantitative: Results of a test provided as numeric measurements/values (e.g., International Units per milliliter [IU/mL]).Targeted genomic sequence analysis/targeted sequence analysis: Typically defined as testing that focuses on (targets) a specific part(s) of a gene. This term is also used to describe selective review of larger regions of the genome when the term is used in the context of more comprehensive sequencing, such as whole genome/exome sequencing.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.Per the Medicare NCCI Policy Manual Chapter 10, CPT codes 81445, 81450, and 81455 describe targeted genomic sequence, DNA analysis or combined DNA and RNA analysis. CPT code 81445 applies to solid organ neoplasm type (5-50 genes) and CPT code 81450 applies to hematolymphoid neoplasm type (5-50 genes), while CPT code 81455 applies to the number of genes analyzed for either a solid or hematolymphoid neoplasm (51 or greater genes). Providers/suppliers may not report CPT code 81455 with either CPT code 81445 or 81450. CPT codes 81449, 81451, and 81456 describe targeted genomic sequence RNA analysis using a separate method.All genomic sequencing procedures and molecular multianalyte assays (e.g., CPT codes 81410-81471), many multianalyte assays with algorithmic analyses (e.g., CPT codes 81490-81599, 0004M-XXXXM), and many Proprietary Laboratory Analyses (PLA) (e.g., CPT codes 0001U-XXXXU) are DNA or RNA analytic methods that simultaneously assay multiple genes or genetic regions. A provider/supplier shall not separately report testing for the same gene or genetic region by a different methodology (e.g., CPT codes 81105-81408, 81479, 88364-88377). CMS payment policy does not allow separate payment for multiple methods to test for the same analyte.If one laboratory procedure evaluates multiple genes using a next generation sequencing procedure, the laboratory shall report only one unit of service of one genomic sequencing procedure, molecular multianalyte assay, multianalyte assay with algorithmic analysis, or proprietary laboratory analysis CPT code. If no CPT code accurately describes the procedure performed, the laboratory may report CPT code 81479 (Unlisted molecular pathology procedure) with one unit of service or may report multiple individual CPT codes describing the component test results when medically reasonable and necessary. Procedures reported together must be both medically reasonable and necessary (e.g., sequencing of procedures) and ordered by the physician who is treating the beneficiary and using the results in the management of the beneficiary's specific medical problem.For tests that are genomic sequencing procedures that simultaneously assay multiple genes or genetic regions, coverage would be dependent on the genetic content examined and whether the content is covered for the patients specific medical condition by the LCD.A targeted genomic sequence analysis panel that tests 5 to 50 genes and contains genes that meets LCD coverage criteria for the management of the patients specific medical condition to improve the patients outcome may be billed with CPT codes 81445, 81449, 81450, or 81451.A targeted genomic sequence analysis panel that tests for 51 or greater genes and contains genes that meets LCD coverage criteria for the management of the patients specific medical condition to improve the patients outcome may be billed with the CPT codes 81455 or 81456.A targeted genomic sequence analysis panel that tests five or greater genes and contains NO genetic content covered by the LCD criteria is billed with CPT codes 81445, 81449, 81450, 81451, 81455, or 81456 and the appropriate modifier to indicate a non-covered service.It would not be expected that providers would perform, for an oncologic condition, a genomic sequencing procedure (e.g., next generation sequencing) that simultaneously assays multiple genes or genetic regions which would not be accurately described by CPT codes 81445, 81449, 81450, 81451, 81455 or 81456. Frequent utilization of CPT code 81479 and/or multiple individual CPT codes describing the component test results will be subject to review.Note: For coverage information regarding CPT codes 0022U, 0037U, 0111U, 0172U, 0239U, and 0242U, please refer to NCD 90.2 Next Generation Sequencing (NGS).Note:For all DNA-only NGS testing for non-hematologic malignancies, the NCD 90.2 section B or section D criteria must be met.The NCD 90.2 is only applicable to DNA sequencing diagnostic laboratory tests using NGS for non-hematologic, somatic (acquired) and germline (inherited) cancers.For non-hematologic DNA sequencing NGS tests that meet CMS FDA approval or clearance in NCD 90.2section B.1.b. or section B.2.b.,follow NCD requirements in section B.1.a. or section B.2.a.For non-hematologic DNA sequencing NGS tests that do not meet CMS NCD 90.2 section B requirements that are performed in CLIA-certified laboratories, refer to NCD 90.2section DANDthe LCD for coverage criteria.For NGS tests with combined DNA and RNA analysis of somatic and germline cancers, RNA analysis of somatic and germline cancers, and NGS tests for hematologic cancers, refer to the LCD for coverage criteria.Note:For coverage information regarding CPT codes 88230 through 88291, please refer to NCD 190.3 Cytogenetics Studies.Note: For coverage information regarding CPT code 81327 and 81528, please refer to NCD 210.3 Colorectal Cancer Screening Tests.Note:Unlisted CPT codes 81479, 81599, and 88299 will be reviewed on a claim-by-claim basis to determine if coverage criteria in an NCD and/or an LCD are met. Include the gene(s) or specific laboratory test name on the claim and submit documentation with the claim to support the service was performed and meets LCD coverage criteria.For coding guidance on Tier 1 and Tier 2 codes, CPT code 81479 (Unlisted Molecular Pathology), testing for multiple genes, -59 Modifier, Next Generation Sequencing (NGS), Genomic Sequencing Profiles (GSP), Multianalyte Assays with Algorithmic Analyses (MAAAs) and Proprietary Laboratory Analyses (PLAs), please refer to the billing and coding article A58917 Molecular Pathology and Genetic Testing.Table 1. Tier 2 codes genes meeting LCD coverage criteriaGene/TestCPT CodeCovered Indications per review of NCCN, OncoKB and/or ClinGenABL1 (ABL proto oncogene 1, non-receptor tyrosine kinase) (e.g., acquired imatinib resistance), T315I variant81401Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, B-Lymphoblastic LymphomaCBFB/MYH11 (inv(16)) (e.g., acute myeloid leukemia), qualitative, and quantitative, if performed81401Acute Myeloid LeukemiaDEK/NUP214 (t(6;9))(e.g., acute myeloid leukemia), translocation analysis, qualitative, and quantitative, if performed81401Acute Myeloid LeukemiaE2A/PBX1 (t(1;19)) (e.g., acute lymphocytic leukemia), translocation analysis, qualitative, and quantitative, if performed81401Acute Lymphoblastic Leukemia, B-Lymphoblastic LymphomaEML4/ALK (inv(2)) (e.g., non-small cell lung cancer), translocation or inversion analysis81401Non-Small Cell Lung CancerETV6/RUNX1 (t(12;21)) (e.g., acute lymphocytic leukemia), translocation analysis, qualitative and quantitative, if performed81401Acute Lymphoblastic Leukemia, B-Lymphoblastic LymphomaEWSR1/ATF1 (t(12;22)) (e.g., clear cell sarcoma), translocation analysis, qualitative, and quantitative, if performed81401Soft Tissue Sarcoma-Angiomatoid Fibrous Histiocytoma,Soft Tissue Sarcoma-Clear Cell SarcomaEWSR1/ERG (t(21;22)) (e.g., Ewing sarcoma/peripheral neuroectodermal tumor), translocation analysis, qualitative and quantitative, if performed81401Bone Cancer  Ewing Sarcoma, Soft Tissue Sarcoma - Ewing Sarcoma/Peripheral Neuroectodermal TumorEWSR1/FLI1 (t(11;22)) (e.g., Ewing sarcoma/peripheral neuroectodermal tumor), translocation analysis, qualitative and quantitative, if performed81401Bone Cancer  Ewing Sarcoma, Soft Tissue Sarcoma - Ewing Sarcoma/Peripheral Neuroectodermal TumorEWSR1/WT1 (t(11;22)) (e.g., desmoplastic small round cell tumor), translocation analysis, qualitative and quantitative, if performed81401Soft Tissue Sarcoma - Desmoplastic Small Round Cell Tumor, Acute Myeloid LeukemiaFGFR3 (fibroblast growth factor receptor 3) (e.g., achondroplasia, hypochondroplasia), common variants (eg, 1138G>A, 1138G>C, 1620C>A, 1620C>G)81401Bladder CancerFIP1L1/PDGFRA (del[4q12]) (e.g., imatinib-sensitive chronic eosinophilic leukemia), qualitative and quantitative, if performed81401Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Fusion Genes, Systemic Mastocytosis, Chronic Eosinophilic Leukemia, Myelodysplastic/Myeloproliferative Neoplasms, Gastrointestinal Stromal TumorFOXO1/PAX3 (t(2;13)) (e.g., alveolar rhabdomyosarcoma), translocation analysis, qualitative and quantitative, if performed81401Soft Tissue Sarcoma - Alveolar RhabdomyosarcomaFOXO1/PAX7 (t(1;13)) (e.g., alveolar rhabdomyosarcoma), translocation analysis, qualitative and quantitative, if performed81401Soft Tissue Sarcoma - Alveolar RhabdomyosarcomaFUS/DDIT3 (t(12;16)) (e.g., myxoid liposarcoma), translocation analysis, qualitative, and quantitative, if performed81401Soft Tissue Sarcoma - Myxoid/Round Cell LiposarcomaIGH@/BCL2 (t(14;18)) (e.g., follicular lymphoma), translocation and analysis; single breakpoint (e.g.) major breakpoint region [MBR] or minor cluster region [mcr]), qualitative or quantitative81401Follicular Lymphoma, High Grade B-Cell LymphomaMLL/MLLT3 (t(9;11)) (e.g., acute myeloid leukemia) translocation analysis, qualitative and quantitative, if performed81401Acute Myeloid Leukemia