evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: MolDX: LPA-Intron 25 Genotype (A55174)

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: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: MammaPrint® (A55175)

CMS National Coverage PolicyN/AArticle TextMammaPrint is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue samples to assess a patients' risk for distant metastasis.The test can be performed using either a FDA-cleared in vitro microarray assay or a next generation sequencing (NGS)-based assay. Each assay has been assigned a unique Z-code identifier in the DEX Registry.MammaPrint was prospectively validated as a microarray assay in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The MammaPrint NGS test has demonstrated technically equivalent performance to the predicate microarray test.To bill for MammaPrint services, please provide the following claim information:Enter 1 in the Days/Unit fieldFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information. For dates of service on or after 01/01/2022, use CPT code 81523 for the test if performed by NGS.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 formSelect the appropriate ICD-10-CM codes.Only one test - NGS OR microarray may be performed on a given date of service for a given patient.Note:MolDX expects this test may be performed upon occasion twice per patient lifetime for bilateral disease. Should a patient experience an additional occurrence, coverage may be considered with supporting documentation through the appeal process.
Article - Billing and Coding: MolDX: MCOLN1 Genetic Testing (A55176)

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.Article TextEffective for dates of service on and after February 6, 2013.Mutations 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:CPT code 81290, 81412 or 81443.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 modifierEnter 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: ENG and ACVRL1 Gene Tests (A55181)

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, the MolDX Team 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 Identifier, submit CPT code 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 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 837PItem 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: ENG and ACVRL1 Gene Tests (A55182)

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, the MolDX Team 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 Identifier, submit CPT code 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 ENAn 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 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 837PItem 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: FANCC Genetic Testing (A55183)

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 TextFANCC 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 DisorderCPT 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 837PItem 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:SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: FANCC Genetic Testing (A55184)

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 TextFANCC 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 DisorderCPT 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 837PItem 19 for paper claimEnter the appropriate DEX-Z-Code identifier adjacent to each code in the comment/narrative filed 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 (A55189)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after February 19, 2013.Mutations 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 patientLabs 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 tothe 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-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: Mitochondrial Nuclear Gene Tests (A55190)

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 member.Article TextEffective for dates of service on and after January 29, 2013.Mitochondrial disorders are a group of conditions caused by dysfunction in the mitochondrial respiratory chain. Current genetic testing methods are unable to detect mutations in all individuals with suspected mitochondrial disease, and there is no proven effective treatment for persons with a known mitochondrial disease. Therefore, the MolDX Team has determined mitochondrial nuclear gene tests do not support the required clinical utility for the established Medicare benefit category and are statutorily excluded tests.To receive a mitochondrial nuclear panel 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 HCPCS modifierTo indicate a statutorily excluded service, append with a GY HCPCS 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-Codeidentifier adjacent to each 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/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: MMACHC Test (A55191)

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 member.Article TextMethylmalonic aciduria (cobalamin deficiency) cblC type, with homocystinuria (MMACHC) is associated with the most common error of vitamin B12 metabolism. Although considered a disease of infancy or childhood, some individuals develop symptoms in adulthood. However to date, the exact function of the protein encoded by this gene is not known. Therefore, MMACHC testing does not meet the clinical utility requirements for a Medicare Benefit and is considered a statutorily excluded service. MolDX will also deny panels of tests that include the MMACHC gene.To receive a MMACHC service denial, please submit the following claim information:CPT code 81404-MMACHC, fgsAn 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-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or MolDX ID (MID) field 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: L1CAM Gene Sequencing (A55192)

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.Article TextEffective for dates of service on and after January 29, 2013.L1 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/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 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