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

MEN1 (multiple endocrine neoplasia I) (e.g., multiple endocrine neoplasia type 1, Wermer syndrome), full gene sequence81405Adrenal 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 TumorsNF2 (neurofibromin 2 [merlin]) (e.g., neurofibromatosis, type 2), duplication/deletion analysis81405Malignant Peritoneal Mesothelioma, Malignant Pleural MesotheliomaRET (ret proto-oncogene) (e.g., multiple endocrine neoplasia, type 2A and familial medullary thyroid carcinoma), targeted sequence analysis (e.g., exons 10, 11, 13-16)81405Ampullary Adenocarcinoma, Extrahepatic Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Gallbladder Cancer, Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease, Multiple Endocrine Neoplasia, Type 2A, Neuroendocrine and Adrenal Tumors -Pheochromocytoma/Paraganglioma, Pancreatic Adenocarcinoma, Medullary Thyroid CancerRPS19 (ribosomal protein S19) (e.g., Diamond-Blackfan anemia), full gene sequence81405Myelodysplastic SyndromesSDHB (succinate dehydrogenase complex, subunit B, iron sulfur) (e.g., hereditary paraganglioma), full gene sequence81405Gastrointestinal Stromal Tumors (GIST),Neuroendocrine and Adrenal Tumors - Pheochromocytoma/Paraganglioma, Soft Tissue Sarcoma - Carney-Stratakis syndrome (Gastric GIST and Paraganglioma), Hereditary Renal Cell CarcinomaSDHC (succinate dehydrogenase complex, subunit C, integral membrane protein, 15kDa) (e.g., hereditary paraganglioma-pheochromocytoma syndrome), full gene sequence81405Neuroendocrine and Adrenal Tumors - Pheochromocytoma/Paraganglioma, Soft Tissue Sarcoma - Carney-Stratakis Syndrome (Gastric Gastrointestinal Stromal Tumor and Paraganglioma), Hereditary Renal Cell CarcinomaSMAD4 (SMAD family member 4) (e.g., hemorrhagic telangiectasia syndrome, juvenile polyposis), duplication/deletion analysis81405Hereditary Cancer Testing Criteria: Juvenile Polyposis SyndromeSTAT3 (signal transducer and activator of transcription 3 [acute-phase response factor]) (e.g., autosomal dominant hyper-IgE syndrome), targeted sequence analysis (e.g., exons 12, 13, 14, 16, 17, 20, 21)81405Myelodysplastic Syndromes, T-Cell Lymphomas - Hepatosplenic T-Cell Lymphoma, T-Cell Lymphomas - T-Cell Large Granular Lymphocytic LeukemiaSTK11 (serine/threonine kinase 11) (e.g., Peutz-Jeghers syndrome), full gene sequence81405Ampullary Adenocarcinoma, Pancreatic Adenocarcinoma, Hereditary Cancer Testing Criteria: Breast Cancer, Ovarian Cancer, Pancreatic Cancer, and Peutz-Jeghers SyndromeTSC1 (tuberous sclerosis 1) (e.g., tuberous sclerosis), duplication/deletion analysis81405Neuroendocrine Tumors of the Pancreas (Well-Differentiated Grade 1/2),Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine Tumors, Uterine Sarcoma, Encapsulated Glioma, Hereditary Renal Cell CarcinomaWT1 (Wilms tumor 1) (e.g., Denys-Drash syndrome, familial Wilms tumor), full gene sequence81405Chronic Myeloid Leukemia, Malignant Peritoneal Mesothelioma, Malignant Pleural Mesothelioma, Myelodysplastic Syndromes, Wilms Tumor (Nephroblastoma), Acute Myeloid LeukemiaZEB2 (zinc finger E-box binding homeobox 2) (e.g., Mowat-Wilson syndrome), full gene sequence81405Acute Myeloid Leukemia - Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)BRAF (B-Raf proto-oncogene, serine/threonine kinase) (e.g., Noonan syndrome), full gene sequence81406Ampullary Adenocarcinoma,B-Cell Lymphomas - Splenic Marginal Zone Lymphoma, Adult Gliomas, Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors (GIST), Extrahepatic Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Gallbladder Cancer, Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease, Pancreatic AdenocarcinomaBTK (Bruton agammaglobulinemia tyrosine kinase) (e.g., X-linked agammaglobulinemia), full gene sequence81406Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaCDH1 (cadherin 1, type 1, E-cadherin [epithelial]) (e.g., hereditary diffuse gastric cancer), full gene sequence81406Gastric Cancer, Hereditary Cancer Testing Criteria: Breast Cancer and Ovarian CancerMAP2K1 (mitogen-activated protein kinase 1) (e.g., cardiofaciocutaneous syndrome), full gene sequence81406Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman DiseaseMAP2K2 (mitogen-activated protein kinase 2) (e.g., cardiofaciocutaneous syndrome), full gene sequence81406Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman DiseaseMUTYH (mutY homolog [E. coli]) (e.g., MYH-associated polyposis), full gene sequence81406Colorectal CarcinomaNF2 (neurofibromin 2 [merlin]) (e.g., neurofibromatosis, type 2), full gene sequence81406Malignant Peritoneal Mesothelioma, Malignant Pleural MesotheliomaPTPN11 (protein tyrosine phosphatase, non-receptor type 11) (e.g., Noonan syndrome, LEOPARD syndrome), full gene sequence81406Chronic Myeloid Leukemia, Myelodysplastic Syndromes,Juvenile Myelomonocytic LeukemiaRAF1 (v-raf-1 murine leukemia viral oncogene homolog 1) (e.g., LEOPARD syndrome), full gene sequence81406Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman DiseaseRET (ret proto-oncogene) (e.g., Hirschsprung disease), full gene sequence81406Ampullary Adenocarcinoma, Extrahepatic Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Gallbladder Cancer, Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease, Multiple Endocrine Neoplasia, Type 2A and B, Neuroendocrine and Adrenal Tumors - Pheochromocytoma/Paraganglioma, Pancreatic Adenocarcinoma, Medullary Thyroid CancerSDHA (succinate dehydrogenase complex, subunit A, flavoprotein [Fp]) (e.g., Leigh syndrome, mitochondrial complex II deficiency), full gene sequence81406Neuroendocrine and Adrenal Tumors - Pheochromocytoma/Paraganglioma, Hereditary Renal Cell CarcinomaSMAD4 (SMAD family member 4) (e.g., hemorrhagic telangiectasia syndrome, juvenile polyposis), full gene sequence81406Hereditary Cancer Testing Criteria: Juvenile Polyposis SyndromeTSC1 (tuberous sclerosis 1) (e.g., tuberous sclerosis), full gene sequence81406Neuroendocrine Tumors of the Pancreas (Well-Differentiated Grade 1/2), Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine Tumors, Uterine Sarcoma, Encapsulated Glioma, Hereditary Renal Cell CarcinomaTSC2 (tuberous sclerosis 2) (e.g., tuberous sclerosis), duplication/deletion analysis81406Neuroendocrine Tumors of the Pancreas (Well-Differentiated Grade 1/2), Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine Tumors, Uterine Sarcoma, Encapsulated Glioma, Hereditary Renal Cell CarcinomaNOTCH1 (notch 1) (e.g., aortic valve disease), full gene sequence81407T-Lymphoblastic Leukemia/LymphomaTSC2 (tuberous sclerosis 2) (e.g., tuberous sclerosis), full gene sequence81407Neuroendocrine Tumors of the Pancreas (Well-Differentiated Grade 1/2), Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine Tumors, Uterine Sarcoma, Encapsulated Glioma, Hereditary Renal Cell CarcinomaATM (ataxia telangiectasia mutated) (e.g., ataxia telangiectasia), full gene sequence81408Ampullary Adenocarcinoma, Pancreatic Adenocarcinoma, Prostate Cancer, Hereditary Cancer Testing Criteria: Breast Cancer, Ovarian Cancer, and Pancreatic CancerNF1 (neurofibromin 1) (e.g, neurofibromatosis, type 1), full gene sequence81408Gastrointestinal Stromal Tumors (GIST), Myelodysplastic Syndromes, 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, Soft Tissue Sarcoma - Embryonal rhabdomyosarcoma, Soft Tissue Sarcoma - Malignant peripheral nerve sheath tumor, Neurofibroma, Chronic Myelomonocytic Leukemia, Juvenile Myelomonocytic Leukemia, Hereditary Cancer Testing Criteria: Breast Cancer and Ovarian CancerUtilization ParametersGenetic testing for hereditary cancer syndromes is considered germline testing, and therefore only permitted once per beneficiarys lifecycle.The following tests are germline tests:812028121581217812938129681299813088131881322813538143281433814358143681437814380101U0102U0103U0129U0130U0131U0132U0133U0134U0135U0162U0238UDocumentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code(s) must describe the service performed.The medical record must demonstrate that the treating clinician who is responsible for the management of the patients cancer or substantiated suspicion of cancer is the same person as the ordering clinician.The medical record must include documentation to support an established diagnosis of cancer or a substantiated suspicion of cancer.The medical record must include documentation of how the test results will directly impact the management of the patients specific medical problem.