evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: MolDX: 4q25-AF Risk Genotype Guidelines (A54241)

CMS National Coverage PolicyN/AArticle TextEffective for dates of services on and after 06/14/2012The 4q25-AF Risk Genotype Test was developed to help predict the risk of atrial fibrillation and cardioembolic stroke. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category.As reviewed, the developer described the indication to perform a 4q25-AF Risk 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 4q25-AF Risk Genotype Test would continue to be a statutory excluded service.To receive a 4q25-AF Risk genotype 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 the assigned DEX Z-codeTMIdentifier adjacent to the CPTcodein the comment/narrative field for the following claim field/types:Line SV202-7 for part A or Loop 2400 NTE02/SV101-7 for Part BBlock 80 for Part A or Box 19 for Part B on paper claim
Article - Billing and Coding: MolDX: 9p21 Genotype Test (A54242)

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 on the 9p21 Genotype test. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the 9p21 test is a statutorily excluded test.To receive a 9p21 service denial, please submit the following claim information:CPTcode 81479An 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: CHD7 Gene Analysis Guidelines (A54243)

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 June 26, 2013CHD7gene testing may be performed during the diagnosis of CHARGE Syndrome. Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, CGS Administrators and the MolDX Program contractor has determinedCHD7gene testing is a statutorily excluded service. CGS and the MolDX Program contractor will also deny tests that include one or more ofCHD7tests reported with CPT code 81479 as statutorily excluded services.To receive aCHD7analysis service denial, please submit the following claim information:Select appropriate CPT code81407CHD7, full gene sequencing81479 all otherCHD7testingAn 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 modifierSelect the appropriate diagnosis for the patientEnter the appropriate identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for Part A or Loop 2400 NTE02 for Part BForm locator 80 for Part A or Box 19 for Part B on paper claim
Article - Billing and Coding: MolDX: ApoE Genotype (A54244)

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 function of a malformed body member".Article TextCGS Administrators and the MolDX program contractor has determined Apolipoprotein (Apo) E genotype testing, developed to assess the risk of cardiovascular disease, has insufficient evidence to support the required clinical utility for the established Medicare benefit category.As reviewed, the developers described the indication to perform an Apolipoprotein (Apo) E 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, Apolipoprotein (Apo) E genotype tests used for that purpose would continue to be statutory excluded tests.To receive an ApoE service denial, please submit the following claim information:CPT code 81401- APOE, common variantAn 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 837P? Box 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 claim? Block 80 for the UB04 claim form
Article - Billing and Coding: MolDX: Aspartoacyclase 2 Deficiency(ASPA) Testing (A54253)

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 2/7/2013Asparoacyclase 2 Deficiency (ASPA) Testing, also known as Canavan Disease, is an autosomal recessive degenerative disorder that causes progressive nerve damage to nerve cells in the brain. Genetic testing identifies parents that may be at risk for conceiving a child with the disease.and offspring suspected to have or diagnosed with the disease Therefore, the MolDX Team has determined that testing for the ASPA is not a Medicare benefit and is a statutorily excluded test. MolDX will also deny panels that include ASPA testing.To receive an ASPA service denial, please submit the following claim information:Select one of the following CPT codes for the performed service:81200-ASPA, common variant81412-Ashkenazi Jewish associated disorders81443-Genetic testing for severe inherited conditions81479-Unlisted molecular pathology proceduresAn 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-codeTMidentifier adjacent to the CPTcode in the comment/narrative field for the following claim field/types:Line SC202-7 for 837I for part A or Loop 2400 NTE02/SV101-7 for the 5010A1 837P Part BBlock 80 for Part A of Box 19 for Part B on paper claim
Article - Billing and Coding: MolDX: ATP7B Gene Tests (A54254)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after July 24, 2013ATP7B gene mutations have been primarily associated with Wilson Disease, a disorder of copper metabolism. However, serology remains the gold standard for testing and treating the signs and symptoms of this condition. At present the literature does not support that ATP7B gene testing changes physician treatment or improves patient outcomes. Therefore, the MolDX Team has determined ATP7B gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the ATP7B gene.To receive an ATP7B gene test denial, please submit the following claim information:Select the appropriate CPTcode for the performed service:81406 - ATP7B, fgs81443 - Genetic Testing for severe genetic conditions81479 - Unlisted molecular pathology procedureAn 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: BCKDHB Gene Test (A54255)

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, 2013BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) gene testing identifies mutations in the BCKDHA, BCKDHB, DBT, and DLD genes causing maple syrup urine disease (MSUD). Genetic testing identifies parents at risk for conceiving a child with MSUD. Therefore, CGS Administrators and the MolDX Program contractor has determined that BCKDHB gene testing to identify parents at risk is not a Medicare benefit and a statutorily excluded test. In addition to single disease testing, CGS and the MolDX program contractor will also deny panels of tests that include the BCKDHB gene as a statutorily excluded testTo receive a BCKDHB test service denial, please submit the following claim information:81205-BCKDHB, common variants81406-BCKDHM, full gene sequence81443-Genetic testing for severe inherited conditionsAn 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 modifierSelect the appropriate diagnosis for the patientEnter theDEX Z-Codeidentifier adjacent to each CPTcode in the stack in the comment/narrative field for the following claim field/types:Loop SV202-7for Part A or Loop 2400 NTE02/SV101-7 for Part BForm locator 80 for Part A or Box 19 for Part B on paper claim
Article - Billing and Coding: MolDX: BLM Gene Analysis (A54256)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after July 30, 2014The clinical diagnosis of Bloom (BLM syndrome, BSyn), characterized by severe pre and postnatal growth deficiency, highly characteristic sparseness of subcutaneous fat tissue in infants and children, is confirmed through cytogenetic testing. Molecular genetic testing identifies BLM gene mutation carriers at risk for conceiving offspring with the disease. Therefore, BLM genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, CGS Administrators and the MolDX program contractor will also deny panels of tests that include the BLM gene as a statutorily excluded service.To receive a BLM gene test service denial, please submit the followingCPTcode 81209 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 theDEX Z-codeTMidentifier adjacent to the CPTcode in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV 101-7 for Part BForm locator 80 for Part A or Box 19 for Part B on paper claim
Article - Billing and Coding: MolDX: BluePrint® Test (A54257)

CMS National Coverage PolicyN/AArticle TextThe MolDX team has completed a technical assessment on BluePrint, a molecular subtyping assay. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the BluePrinttest is a statutorily excluded test.To receive a BluePrintservice 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 modifierSelect the appropriate diagnosis for the patientEnter appropriate Z-code ID adjacent to the CPTcode in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for Part A and Loop 2400 NTE 02/ SV101-7 for Part BForm locator 80 for Part A and Box 19 for Part B on paper claim. (Note: Only one test/identifier per paper claim may be submitted.)
Article - Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests (A54262)

CMS National Coverage PolicyN/AArticle TextHereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant disorder with variable clinical presentation. Most common manifestations are epistaxis, recurrent gastrointestinal bleeding, iron deficiency anemia, and mucocutaneous telangectasias. Arteriovenous malformations (AVMs), of various organs (lung, liver, brain) are common.The two most prevalent forms of HHT, Type 1 and Type 2, are caused by mutations in the endoglin (ENG) or the ACVRL1 gene respectively. Although identification of these gene mutations can confirm the diagnosis of HHT, these tests are not necessary in many cases. HHT is generally established using well vetted consensus criteria (most often the International Curaao Criteria (ICC)). The ICC uses the clinical characteristics of epistaxis, cutaneous or mucosal telangectasias, visceral AVMs, and a first-degree relative with HHT to judge likelihood of a given patient having HHT. A 'definite' diagnosis is established when a patient has 3 or 4 of these criteria. Genetic testing for ENG/ACVRL1 is not warranted. A patient with 0 to 1 criteria is 'unlikely' to have HHT, and similarly would not be a candidate for genetic testing. Patients with 2 or 3 Curaao criteria are defined as suspected of HHT and are candidates for ENG/ACVRL1 testing.Since screening of patients without signs or symptoms of HHT, who have a first-degree relative with HHT, is not a Medicare benefit, CGS Administrators and the MolDX program contractor has determined ENG and/or ACVRL1 genetic testing and panels of tests that include ENG/ACVRL1 are statutorily excluded services.EXCEPTIONS:For patients with suspected HHT in which diagnosis confirmation would demonstrate an improved outcome, approval will be made on a case-by-case basis through the appeal process.For tests that include ENG and ACVRL1 registered and assigned a single MolDX ID, submit CPTcode 81479.To receive an ENG and/or ACVRL1 gene test denial, please submit the following claim information:Select appropriate CPTcode for test81405-ENG, Duplication/deletion81406-ENG, full gene sequence81479-ACVRL181479-ACVRL1 and ENGAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor 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 CPTnon-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 CPTcode in the comment/narrative field for thefollowing 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 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: FANCC Genetic Testing (A54263)

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 6, 2013FANCC 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:CPTcode 81242- FANCC, common variantCPTcode81412-Ashkenazi Jewish Associated DisordersCPTcode81443-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 thefollowing 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: Fragile X (A54264)

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 01/1/2013The 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 CPTcode: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 CPTnon-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 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 formNOTE: When entering the DEX Z-Code on 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 (A54265)

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:CPTcode 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 CPTnon-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 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: HAX1 Gene Sequencing (A54266)

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 6, 2013HAX1 gene sequencing may be performed during the diagnosis of HAX1-related Congentital 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: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 modifierFor CPTnon-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 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