evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: MolDX: FANCC Genetic Testing (A55160)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after February 6, 2013.FANCC gene testing is performed in association with Fanconi anemia (FA), a condition characterized by physical abnormalities, bone marrow failure, and increased risk of malignancy. For infants and children, FANCC genetic testing is used to confirm the clinical findings, such as blood counts and bone marrow biopsy, to diagnose FA. Genetic testing for adults is used to screen potential carriers of the mutation. Therefore, the MolDX Team has determined that testing for the FANCC 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 FANCC gene.To receive a FANCC test denial, please submit the following claim information:CPT code 81242- FANCC, common variantCPT code 81412  Ashkenazi Jewish Associated DisordersCPT code 81443  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 modifierFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate 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 the appropriate 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: FDA-Approved BRAF Tests (A55161)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextTwo tests have met the FDA criteria for BRAF genetic testing:Effective 09/07/2012.cobas 4800 BRAF V600to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf (vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body.Effective 5/29/2013.ThxID BRAF V600/Kto detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, please submit the following claim information.CPT code 81210Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the assigned DEX Z-Code Identifier in the comment/narrative field for the following Part Bclaim field/types:Loop 2400 or SV101-7 for the 5010A1 837PSubmit the assigned DEX Z-Code Identifier on an attachment to the claim form for paper claimEnter the appropriate 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 formSelect the appropriate ICD-10-CM diagnosis.NOTE:All labs that submit claims for a BRAF V600 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on the DEX Diagnostics Exchangehttps://app.dexzcodes.com/loginThis article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: FDA-Approved KRAS Tests (A55162)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextTwo tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:Effective 7/6/2012therascreen KRAS to detect somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux (cetuximab).Effective 5/7/2015cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).To report an FDA approved or laboratory developed test (LDT) KRAS service, please submit the following claim information.Select the appropriate CPT codeEnter 1 unit of service (UOS).Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the assigned DEXZ-Code Identifier in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PSubmit the assigned Z-Code Identifier on an attachment to the claim form for paper claimEnter the appropriate 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 formSelect the appropriate ICD-10-CM diagnosis.NOTE:All labs that submit claims for a KRAS, codon 12 and 13 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on the DEX Diagnostics ExchangeTM:https://app.dexzcodes.com/loginThis article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: Fragile X (A55163)

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 01/1/2013.The MolDX Team has determined that Fragile X testing is not a Medicare covered service. Screening in the absence of signs and symptoms of an illness or injury is not defined as a Medicare benefit. Therefore, MolDX will deny testing for Fragile X as a statutorily excluded service.To receive a Fragile X service denial, please submit the following claim information:Select the appropriate CPT code:81243- FMR181244- FMR1, methylation analysis81470-X-linked intellectual disability genomic sequence analysis panel81471- X-linked intellectual disability genomic sequence analysis panel duplication/deletionAn 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 modifierFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter 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 claimEnter the appropriate 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 formNOTE:When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters or information on the line.
Article - Billing and Coding: MolDX: GBA Genetic Testing (A55164)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after July 30, 2013.Mutations found in glucosidase, beta, acid (GBA) are associated with Gaucher disease (GD), which encompasses a continuum of clinical findings. Since GBA genetic testing is used to confirm the clinical findings to diagnose GD, the MolDX Team has determined that GBA 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 GBA gene as a statutorily excluded service.To receive a GBA test denial, please submit the following claim information:CPT code 81251- GBA, common variantsAn 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 modifierFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate 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 the appropriate 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: HAX1 Gene Sequencing (A55165)

CMS National Coverage PolicySec. 1862 (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 February 6, 2013.HAX1 gene sequencing may be performed during the diagnosis of HAX1-related Congenital Neutropenia (CN) and Kostmann disease. A HAX1 mutation will only provide reproductive risk stratification for CN. In individuals with Kostmann syndrome, a HAX1 mutation will not change the medical management. Therefore, the MolDX Team has determined HAX1 gene sequencing is a statutorily excluded test. In addition to single gene testing, MolDX will also deny panels of tests that include the HAX1 gene.To receive a HAX1 gene sequencing service denial, please submit the following claim information:CPT code 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 modifierFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate 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 the appropriate 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: HBB Gene Tests (A55166)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after 05/03/2013.HBB gene testing may be performed during the diagnosis of Sickle cell disease (SCD). Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, the MolDX Team has determined HBB gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the HBB gene.To receive a HBB gene sequencing service denial, please submit the following claim information:Select the appropriate CPT code based on gene test:81361- HBB, common variants81362 -HBB, known familial variants81363- HBB, duplication/deletion81364- HBB, full gene sequence81443-Genetic testing for severe inherited conditions.An 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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required informationEnter the appropriate 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 the appropriate 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: HEXA Gene Analysis (A55168)

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, 2013.The 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 (HEX A) 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 CPT code based on type of testingCPT code 81255  HEXA, common variantsCPT code 81406  HEXA, full gene sequenceCPT code 81412  Ashkenazi Jewish Associated DisordersCPT code 81443  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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part Bclaim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Code identifier adjacent to the CPT code 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: HTTLPR Gene Testing (A55169)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article 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:CPT code 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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate DEX Z-Code 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 the appropriate 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: IKBKAP Genetic Testing (A55170)

CMS National Coverage PolicySec. 1862 (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,Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextEffective for dates of service on and after February 7, 2013.Mutations 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 conditionAn 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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate 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 the appropriate 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: KIF6 Genotype (A55171)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, Sec. 1862 (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,Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate 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 the appropriate 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® (A55172)

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: LPA-Aspirin Genotype (A55173)

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: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 modifierLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate 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 claim.Enter the appropriate 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