evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: MolDX: HAX1 Gene Sequencing (A53619)

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
Article - Billing and Coding: MolDX: SMPD1 Genetic Testing (A53624)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after February 7, 2013.Mutations found in sphingomyelin phosphodiesterase 1, (SMPD1) acid lysomal, are associated with Niemann-Pick Disease, characterized by acid sphingomyelinase (ASM) deficiency. For infants and children, SMPD1 genetic testing is used to confirm the clinical findings from blood tests to diagnose ASM. Genetic testing for adults is used to screen the population for potential carriers of the mutation. Therefore, the MolDX team has determined that SMPD1 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 SMPD1 gene test as a statutorily excluded service.To receive a SMPD1 test denial, please submit the following claim information:CPTcode 81330- SMPD1, common variantsCPTcode 81412  Ashkenazi Jewish Associated DisordersFor 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 services
Article - Billing and Coding: MolDX: FANCC Genetic Testing (A53628)

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 variantCPTcode 81412  Ashkenazi Jewish Associated DisorderCPTcode 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 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: MCOLN1 Genetic Testing (A53630)

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: Fragile X (A53638)

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-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.
Article - Billing and Coding: MolDX: ApoE Genotype (A53652)

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 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:CPTcode 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-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 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: 9p21 Genotype Test (A53657)

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: L1CAM Gene Sequencing (A53659)

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: PAX6 Gene Sequencing (A53664)

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, 2013PAX6 is most frequently associated with PAX6-associated aniridia and WAGR syndrome (predisposition to Wilms tumor, Aniridia, Genitourinary anomalies and mental Retardation). Because FISH probes are reported to detect 100% of the WAGR syndrome cases, FISH probes represent the gold standard for patient diagnosis. Although PAX6 sequencing will identify the underlying genetic mutation leading to the development of aniridia in approximately 50% of individuals with sporadic disease, the remaining 50% will have negative test results. Therefore, the MolDX Team has determined PAX6 gene sequencing does not support the required clinical utility for the established Medicare benefit category and is a statutorily excluded test.To receive a PAX6 gene sequencing 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 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: Mitochondrial Nuclear Gene Tests (A53669)

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, 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:CPTcode 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 modifierEnter DEX Z-Code identifier adjacent to the CPTcode 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 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 for
Article - Billing and Coding: MolDX: SEPT9 Gene Test (A53702)

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 TextThe MolDX team has determined that a Septin 9 methylation analysis test for colorectal cancer detection 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 Septin 9 methylation analysis tests as a statutorily excluded service.To receive a SEPT9 service denial, please submit the following claim information:81327- SEPT9 (Septin9) (e.g., colorectal cancer) methylation analysis.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 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: Lab: Immunohistochemistry (IHC) Indications for Breast Pathology (A53704)

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, this A/B MAC 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-assisted3Note: a unit of service applies to a single separately identifiable specimen.
Article - Billing and Coding: Low frequency, non-contact, non-thermal ultrasound (A53773)

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.Title 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 TextLow frequency, non-contact, non-thermal ultrasound (CPTcode 97610) describes a system employed in wound care that uses continuous low frequency ultrasonic energy to atomize a liquid and deliver continuous low frequency ultrasound to the wound bed. MIST therapy or other similar products are included in the payment for the treatment of the same wound with other active wound care management or wound debridement CPTcodes (97597, 97598, 97602, 97605, 97606).
Article - Billing and Coding: The Routine Costs of Investigational Chemotherapy Drugs Studied In a Qualifying Clinical Trial (A53784)

CMS National Coverage PolicyCMS Internet-Only Manual (IOM), Pub 100-04, Medicare Claims Processing Manual, Chapter 32, 69.5CMS Internet-Only Manual (IOM), Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 310.1Article TextPalmetto GBA has been receiving claims for chemotherapy drugs billed as if the drug is a covered charge, when the drug is utilized as the investigational item in a qualifying clinical trial. Generally the investigational item, in this case chemotherapy drugs, used in a qualifying clinical trial is provided free of charge by research sponsors andmay not be billed to be paid by Medicare, and providers are not required to submit the charge to Medicare.Refer to the CMS Internet-Only Manual (IOM), Pub 100-04, Medicare Claims Processing Manual, Chapter 32, 69.5 for general billing requirements for qualifying clinical trials.If the chemotherapy drug(s) is administered for an investigational indication and is billed to Medicare in the course of an outpatient clinical trial, the drug(s) should be billed as a noncovered service (even if the drug is covered by Medicare for other indications) with condition code 30, the Q0 (zero) modifier and diagnosis code Z00.6 (examination of participant or control in clinical research program) included on the claim.Routine costs of clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trialsare covered by Medicare. The CMS Internet-Only Manual (IOM), Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 310.1 includes a description ofcovered routine coststhat are included in a qualifying clinical trial.