evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: HEXA Gene Analysis (A54268)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Article TextEffective for dates of service on and after February 7, 2013The clinical diagnosis of Hexosaminidase A deficiency, a disorder also known as Tay-Sachs disease characterized by progressive weakness, loss of motor skills, and increased startle reflex in infants, relies on blood tests that result in absent or near absent beta-hexosaminidase A (HEXA) enzymatic activity. Molecular genetic testing identifies HEXA gene mutation carriers at risk for conceiving offspring with the disease. Therefore, HEXA genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include the HEXA gene as a statutorily excluded service.To receive a HEXA gene test service denial, please submit the following claim information:Select the appropriate CPTcode based on type of testing81255  HEXA, common variants81406  HEXA, full gene sequence81412 - Ashkenazi Jewish associated disorders81443  Genetic testing for severe inherited conditionsAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.For a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: HTTLPR Gene Testing (A54269)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 26, 2013.Serotonin Transporter genotyping (HTTLPR) has been associated with response to selective serotonin reuptake inhibitors. However since the literature is conflicting and limited by small sample sizes, the MolDX Team has determined there is insufficient evidence to support coverage. Therefore, HTTLPR testing is a statutorily excluded service.To receive a HTTLPR analysis service denial, please submit the following claim information:CPTcode 81479An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.For a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: IKBKAP Genetic Testing (A54270)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Article TextEffective for dates of service on and after February 7, 2013Mutations to the IKBKAP (inhibitor of kappa light polypeptide gene enhancer in B-cells, kinase complex-associated proteins) are associated with familial dysautonomia (FD), a condition that affects the development of sensory, sympathetic, and parasympathetic neurons. Genetic testing may be performed at birth to diagnose FD. For adults, IKBKAP genetic testing identifies parents that may be at risk for conceiving a child with the disease. Therefore, the MolDX Team has determined that testing for the IKBKAP is not a Medicare benefit and is a statutorily excluded service. In addition to single disease testing, MolDX will also deny panels of tests that include an IKBKAP gene test as a statutorily excluded service.To receive an IKBKAP test denial, please submit the following claim information:81260-IKBKAP, common variants81412 - Ashkenazi Jewish associated disorders81443  Genetic testing for severe inherited conditionFor a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier. An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.Enter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: Immunohistochemistry (IHC) Indications for Breast Pathology (A54271)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.Article TextBased on recommendations from the College of American Pathologists, the American Society of Clinical Oncologists (ASCO), and the National Comprehensive Cancer Network (NCCN), hormone receptor assays, estrogen receptor (ER), progesterone receptor (PR), and Her-2/neu are the only current biomarkers that demonstrate standardized value in breast cancer pathology evaluation. Although other biomarkers, such as Ki-67, PI3K, and gene expression assays, have been studied, no proven standardized value has been established. Therefore, CGS Administrators and the MolDX program contractor will allow ER, PR, and Her2 testing by IHC for patients with primary invasive breast cancers and recurrent or metastatic cancers.To report an IHC service for an ER, PR, Her2, submit the following claim information:CPTCodeSpecimenUOS88342First single/multiplex stain188341Each additional2To report morphometric analysis,select oneof the following codes based on the type of morphometric analysis:CPTCodeService TypeUOS88360Manual388361Computer-assisted3
Article - Billing and Coding: MolDX: KIF6 Genotype (A54272)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Article TextThe MolDX Team has completed a review on the KIF6 genotype test. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the KIF6 genotype test is a statutorily excluded test.To receive a KIF6 service denial, please submit the following claim information:CPT code 81479 Unlisted molecular pathology procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: know error® (A54273)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextThe know error DNA Specimen Provenance Assay is a forensic assay to confirm that a surgical specimen belongs to the patient evaluated for treatment. Although MolDX agrees the healthcare community should define and follow strict procedures regarding patient and patient specimen identification and handling, tests performed to measure the quality of a process do not provide information to diagnose or treat a patient illness or injury as defined in the Medicare benefit category. Therefore, the know error DNA Specimen Provenance Assay is a statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not required for a statutory exclusion, providers supplying this test (directly or through a purchased service) should ensure patients understand the test is not a covered benefit.To receive a DNA Specimen Provenance Assay service denial, please submit the following claim information:CPT code 84999  unlisted chemistry procedureFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifier. An Advance Beneficiary Notice (ABN) is not required for statutorily excluded serviceSelect the appropriate diagnosis for the patientIf you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:Complete a Self-Auditidentify incorrect submissionscontain further claim submission errorsConsider Self-Disclosure Protocolself-disclosure guidelines available @ the following pathway: http://www.oig.hhs.gov/compliance/self-disclosure-info/index.asp
Article - Billing and Coding: MolDX: L1CAM Gene Sequencing Guidelines (A54274)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body memberArticle TextEffective for dates of service on and after January 29, 2013L1 syndrome refers to multiple disorders including X-linked hydrocephalus with aqueduct of Sylvius (HSAS) stenosis, MASA syndrome (Mental retardation, Aphasia, Spastic paraplegia, Adducted thumbs), SPG1 (X-linked complicated hereditary spastic paraplegia type 1), and X-linked complicated corpus callosum agenesis. Because there are many potential underlying causes for congenital hydrocephalus, including syndromic and nonsyndromic cases, recurrence risk and implications for family members is based upon underlying etiology. Genetic testing of the L1CAM gene is used to confirm a clinical diagnosis and provide recurrence risk. Therefore, the MolDX Team has determined L1CAM full gene sequencing is a statutorily excluded test.To receive a L1CAM gene sequencing service denial, please submit the following claim information:CPT code 81407-L1CAMCPT code 81470- X-linked intellectual disability genomic sequence analysis panelCPT code 81471- X-linked intellectual disability genomic sequence analysis panel duplication / deletionFor a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: LPA-Aspirin Genotype (A54275)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextThe MolDX Team has completed a review of the research on the LPA-Aspirin genotype test, developed to predict increased CVD risk and event reduction during aspirin therapy. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the LPA-Aspirin genotype test is a statutorily excluded test.As reviewed, the developer described the indication to perform a LPA-Aspirin genotype test as a risk assessment for developing a disease or condition. Risk assessment for developing a disease or condition in the absence of signs and symptoms of an illness or injury is also not defined as a Medicare benefit. Therefore, the LPA-Aspirin genotype test would continue to be a statutory excluded test.To receive a LPA-Aspirin service denial, please submit the following claim information:CPTcode 81479 Unlisted molecular pathology procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: LPA-Intron 25 Genotype (A54276)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextThe MolDX Team has completed a review of the research on the LPA-Intron 25 genotype test, developed to predict increased Coronary Heart Disease risk. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the LPA-Intron 25 genotype test is a statutorily excluded service.As reviewed, the developer described the indication to perform a LPA-Intron 25 genotype test as a risk assessment for developing a disease or condition. Risk assessment for developing a disease or condition in the absence of signs and symptoms of an illness or injury is also not defined as a Medicare benefit. Therefore, the LPA-Intron 25 genotype test would continue to be a statutory excluded test.To receive a LPA-Intron 25 service denial, please submit the following claim information:CPTcode 81479 Unlisted molecular pathology procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/typesLine SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: MCOLN1 Genetic Testing Guidelines (A54277)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body memberArticle TextEffective for dates of service on and after February 6, 2013Mutations found in mucolipin 1 (MCOLN1) are associated with Mucolipidosis, type IV, a disease characterized by psychomotor event delay in children evident before the first year of life. For infants and children, MCOLN1 genetic testing is used to confirm the clinical findings to diagnose Mucolipidosis. Genetic testing for adults is used to screen the population for potential carriers of the mutation. Therefore, the MolDX Team has determined that MCOLN1 genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include a MCOLN1 gene test as a statutorily excluded service.To receive a MCOLN1 test denial, please submit the following claim information:CPTcode 81290,81412, or 81443An Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: MECP2 Genetic Testing (A54278)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after February 19, 2013Mutations found in methyl CpG binding protein 2(MECP2) are associated with Rett syndrome. In classic Rett syndrome, suspected cases are identified through specific clinical criteria in female children ages 1-5. Genetic testing is used to confirm the clinical findings. Since 99% of classic cases result in a single random mutation, genetic testing is not useful to screen carriers. Therefore, the MolDX Team has determined that MECP2 genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single disease testing, MolDX will also deny panels of tests that include a MECP2 gene test as a statutorily excluded service.To receive a MECP2 test denial, please submit the following claim information:Appropriate CPT codes:81302- MECP2, full gene sequence81303- MECP2, known familial variant81304- MECP2, duplication/deletion variants81470  X-linked intellectual disability genomic sequence analysis panel81471  X-linked intellectual disability genomic sequence analysis panel duplication / deletion81479-MECP2, panelAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX HCPCS modifierTo indicate a statutorily excluded service, append with a GY HCPCS modifierSelect the appropriate diagnosis for the patientEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/typesLoop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDx: VEGFR2 Tests (A54279)
CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".Article TextEffective for dates of service on and after 05/03/2013.Vascular endothelial growth factor, subtype 2, (VEGFR2) receptor has been found to be oncogenic. Current studies have targeted VEGFR2 as a potential therapeutic option. However, at present there is insufficient evidence to establish a clear association between VEGFR2 mutations and treatment response. Therefore, the MolDX Team has determined VEGFR2 testing is a statutorily excluded service. MolDX will also deny panels of tests that include the VEGFR2 receptor.To receive a VEGFR2 service denial, please submit the following claim information:CPTcode 81479An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.For a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPTcode in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: TP53 Gene Test (A54281)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 24, 2013TP53 gene testing may be performed during the diagnosis of Li-Fraumeni syndrome (LFS), a cancer predisposition syndrome associated with the development of specific tumors. Clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit.To receive a TP53 gene sequencing service denial, please submit the following claim information:Select the appropriate CPTcodeAn Advance Beneficiary Notice (ABN) is not required for statutorily excludedFor a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier services.Select the appropriate diagnosis for the patientEnter the appropriate DEX Z-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claiEnter DEX Z-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: TERC Gene Tests (A54282)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 25, 2013Since the associated conditions associated with telomerase RNA component (TERC) gene testing is limited to reproductive risk assessment, the MolDX team has determined TERC gene testing is a statutorily excluded service. MolDX will also deny tests that include one or more of TERC analysis reported with CPT code 81479 as a statutorily excluded service.To receive a TERC analysis service denial, please submit the following claim information:CPT 81479  Unlisted molecular pathology procedureFor a voluntary issued ABN, append with GX modifierTo indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifierAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.Select the appropriate diagnosis for the patientEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form