evekhm/cms_iom_500 huggingface dataset:
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
The UOS described for CPT code 88373 is both per specimen and each additional single probe stain procedure. Depending on the testing scenario, the code may or may not be used, and should only be used in relation to additional probes NOT additional specimens.If one single probe procedure is used for a specimen from one source (e.g., right iliac crest bone marrow aspiration), only 1 UOS may be claimed, even if multipleslidesfrom the specimen are tested with the same probe:1 UOS with the parent CPT code 88367,0 UOS should be reported with CPT code 88373 since only one single probe procedure was used, regardless of how many slides are made with the single source specimen.If two different single probe procedures are used to evaluate several slides from one source specimen, only 2 UOS may be claimed:1 UOS with the parent CPT code 88367, AND1 UOS with the additional CPT code 88373If one single probe procedure is used on two source specimens (e.g., one bone marrow aspiration specimen from the right iliac crest and another specimen from the left iliac crest), only 2 UOS may be claimed:2 UOS with the parent CPT code 88367,0 UOS should be reported with CPT code 88373 since only one single probe procedure was used.The same logic for single probe stain procedures is also true of using multiplex probe stain procedures (CPT code 88374); the UOS is based on the overall multiplex probe stainprocedureNOT the number ofprobeswithin the multiplex stain.CPT codes that describe a genomic sequencing panel (GSP) often include instructions that define the number of genes covered, for instance using a range (5-50 genes) or using a minimum number required (e.g., at least 10 genes).For instance:CPT code 81436 covers at least five genes and must include the genes MLH1, MSH2, EPCAM, SMAD4, and STK11.This means any test matching the CPT code description for 81436, regardless of whether the test analyzed five genes or 20 genes, would be billed under the CPT code 81436 code with only 1 UOS.
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
This means any test matching the CPT code description for 81436, regardless of whether the test analyzed five genes or 20 genes, would be billed under the CPT code 81436 code with only 1 UOS.Additionally, this means that any test without all five mandatory genes (MLH1, MSH2, EPCAM, SMAD4, and STK11) would NOT be billed with this code.When a CPT code for a panel is used in this context,no other CPT codes may be used to describe the panel, regardless of presence or absence of modifiers.3. Technology/MethodologyWhen a CPT code description specifies a particular technology and/or testing methodology, only that technology and/or methodology may be used when billing that code. Therefore, special attention must be paid to the full code description, especially if the type of content tested has technology that typically varies from CPT code to CPT code. For example, CPT codes describing a gene expression profiling (GEP) test often include the specific methodology used for that test, such as RT-PCR (e.g., 81518), microarray (e.g., 81521), and next-generation sequencing (e.g., 81523).
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
Conversely, if a technology and/or methodology is NOT specified in a code description, there is no need to match the technology and/or methodology to that code (e.g., a full sequence analysis of three different genes can be performed by Sanger Sequencing or NGS). For example, CPT code 81279 describes targeted sequence analysis for the gene JAK2 without specifying a sequencing technology. JAK2 is often part of a sequence of reflexive tests evaluating for a myeloproliferative neoplasm, and commonly each step is performed using real time/quantitative (RT/q) PCR. However, each step of that testing sequence could also be performed with Sanger sequencing technology. Additionally, JAK2 could be part of a small NGS panel test with other genes, which, if less than five genes, could be billed as CPT code 81279 and three additional CPT codes representing three other genes. Finally, as technology advances, whole exome/genome sequencing is being utilized more and more as a backbone to customized testing, wherein all unanalyzed data is masked (only certain genetic content is made visible while the rest of the data is hidden from the interpreter) and only a smaller set of genes is analyzed and billed. The benefit to this newer method is the collected data can be reanalyzed as additional customized panels by unmasking additional genetic content without having to rerun the whole exome/genome sequencing. Again, if the custom panel is small, CPT code 81279 would be billed in tandem with up to three other gene codes.Per the Medicare NCCI Policy Manual Chapter 10, A Tier 1 or Tier 2 molecular pathology procedure CPT codeshould not, in general, be reported with a genomic sequencing procedure, molecular multianalyte assay, multianalyte assay with algorithmic analysis, or proprietary laboratory analysis CPT code where the CPT code descriptor includes testing for the analyte described by the Tier 1 or Tier 2 molecular pathology code. 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.4. Specimen Type
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
4. Specimen TypeSome CPT codes (particularly PLA codes) define what type of specimens or specimen sources are covered by the code description. For instance, some multianalyte assays with algorithmic analyses evaluate gene expression in tumor tissue. Sometimes these tests are restricted to fresh tissue whereas other tests have been optimized to use formalin-fixed, paraffin-embedded tissue. These definitions are often clearly stated within the CPT code description and must be followed when present.DefinitionsProviders should be familiar with all terminology found within the CPT code descriptions before billing Medicare for these codes. Many of the molecular terms utilized in the CPT Codebook describe specific parameters that limit a codes scope of coverage. Definitions are frequently provided at the beginning of sections and subsections within the CPT Codebook. The following are selected definitions of terminology and phrases commonly seen in the code descriptions: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.
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
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.
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
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.
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
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.
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
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 Lymphoma
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
81401Acute 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 performed81401
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
81401Bone 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 Liposarcoma
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
81401Soft 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 LeukemiaMUTYH (mutY homolog [E.coli]) (e.g., MYH-associated polyposis), common variants (e.g., Y165C, G382D)81401Colorectal CarcinomaNPM1/ALK (t(2;5)) (e.g., anaplastic large cell lymphoma), translocation analysis81401Non-Small Cell Lung CancerPRAME (preferentially expressed antigen in melanoma)(e.g., melanoma), expression analysis81401Uveal MelanomaRUNX1/RUNX1T1 (t(8;21)) (e.g., acute myeloid leukemia) translocation analysis, qualitative and quantitative, if performed81401Acute Myeloid LeukemiaSS18/SSX1 (t(X;18)) (e.g., synovial sarcoma), translocation analysis, qualitative and quantitative, if performed81401Soft Tissue Sarcoma - Synovial SarcomaSS18/SSX2 (t(X;18)) (e.g., synovial sarcoma), translocation analysis, qualitative and quantitative, if performed81401Soft Tissue Sarcoma - Synovial SarcomaChromosome 1p-/19q- (e.g., glial tumors), deletion analysis81402Adult Glioma: Oligodendroglioma
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
Soft Tissue Sarcoma - Synovial SarcomaChromosome 1p-/19q- (e.g., glial tumors), deletion analysis81402Adult Glioma: OligodendrogliomaCOL1A1/PDGFB (t(17;22)) (e.g., dermatofibrosarcoma protuberans), translocation analysis, multiple breakpoints, qualitative, and quantitative, if performed81402Soft Tissue Sarcoma - Dermatofibrosarcoma ProtuberansTRD@ (T cell antigen receptor, delta) (e.g., leukemia and lymphoma), gene rearrangement analysis, evaluation to detect abnormal clonal population81402Myelodysplastic Syndromes, Myeloid/Lymphoid Neoplasms with Eosinophilia and TK Fusion GenesCTNNB1 (catenin [cadherin-associated protein], beta 1, 88kDa) (e.g., desmoid tumors), targeted sequence analysis (e.g., exon 3)81403Adult Medulloblastoma, Soft Tissue Sarcoma - Desmoid FibromatosisDNMT3A (DNA [cytosine-5-]-methyltransferase 3 alpha) (e.g., acute myeloid leukemia), targeted sequence analysis (e.g., exon 23)81403Chronic Myeloid Leukemia, Myelodysplastic SyndromesEPCAM (epithelial cell adhesion molecule) (e.g., Lynch syndrome), duplication/deletion analysis81403Myelodysplastic Syndromes, Hereditary Cancer Testing Criteria: Breast Cancer, Ovarian Cancer, Pancreatic Cancer, and Lynch syndromeFGFR3 (fibroblast growth factor receptor 3) (e.g., isolated craniosynostosis), targeted sequence analysis (e.g., exon 7)(For targeted sequence analysis of multiple FGFR3 exons, use 81404)81403Bladder Cancer
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
81403Bladder CancerUBA1 (ubiquitin-like modifier activating enzyme 1) (e.g., spinal muscular atrophy, X-linked), targeted sequence analysis (e.g., exon 15)81403Myelodysplastic SyndromesVHL (von Hippel-Lindau tumor suppressor) (e.g., von Hippel-Lindau familial cancer syndrome), deletion/duplication analysis81403Central Nervous System Cancers - Primary Spinal Cord Tumors, Malignant Peritoneal Mesothelioma, Malignant Pleural Mesothelioma, Neuroendocrine Tumors of the Pancreas (Well-Differentiated Grade 1/2), Neuroendocrine and Adrenal Tumors -Pheochromocytoma/Paraganglioma, Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine Tumors, Von Hippel-Lindau Syndrome,Hereditary Renal Cell CarcinomaCDKN2A (cyclin-dependent kinase inhibitor 2A) (e.g., CDKN2A-related cutaneous malignant melanoma, familial atypical mole-malignant melanoma syndrome), full gene sequence81404Ampullary Adenocarcinoma, Malignant Peritoneal Mesothelioma, Malignant Pleural Mesothelioma, Cutaneous Melanoma, Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine Tumors, Pancreatic Adenocarcinoma, Soft Tissue Sarcoma - Malignant Peripheral Nerve Sheath Tumor, Acute Myeloid Leukemia with BCR-ABL1, B-Lymphoblastic Leukemia/Lymphoma, T-Lymphoblastic Leukemia/Lymphoma, Hereditary Cancer Testing Criteria: Breast Cancer and Ovarian CancerFGFR2 (fibroblast growth factor receptor 2) (e.g., craniosynostosis, Apert syndrome, Crouzon syndrome), targeted sequence analysis (e.g., exons 8, 10)81404Bladder Cancer
Draft Article - Billing and Coding: Genetic Testing for Oncology (DA59125)
81404Bladder CancerFGFR3 (fibroblast growth factor receptor 3) (e.g., achondroplasia, hypochondroplasia), targeted sequence analysis (e.g., exons 8, 11, 12, 13)81404Bladder CancerHRAS (v-Ha-ras Harvey rat sarcoma viral oncogene homolog) (e.g., Costello syndrome), full gene sequence81404Salivary Gland TumorsMEN1 (multiple endocrine neoplasia I) (e.g., multiple endocrine neoplasia type 1, Wermer syndrome), duplication/deletion analysis81404Adrenal Gland Tumors, Multiple Endocrine Neoplasia, Type 1, Neuroendocrine Tumors of the Gastrointestinal Tract (Well-Differentiated Grade 1/2), Neuroendocrine and Adrenal Tumors -Lung and Thymus, Neuroendocrine Tumors of the Pancreas (Well-Differentiated Grade 1/2), Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine TumorsRAF1 (v-raf-1 murine leukemia viral oncogene homolog 1) (e.g., LEOPARD syndrome), targeted sequence analysis (e.g,, exons 7, 12, 14, 17)81404Erdheim-Chester Disease,Langerhans Cell Histiocytosis,Rosai-Dorfman DiseaseRET (ret proto-oncogene) (e.g., multiple endocrine neoplasia, type 2B and familial medullary thyroid carcinoma), common variants (e.g., M918T, 2647_2648delinsTT, A883F)81404