evekhm/cms_iom_500 huggingface dataset:
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 claim
Article - Billing and Coding: MolDX: L1CAM Gene Sequencing (A55192)
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
Article - Billing and Coding: MolDX: FDA-Approved EGFR Tests (A55193)
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 EGFR genetic testing:Effective 6/01/16cobas EGFR Mutation Testis a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anticoagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the Table below in accordance with the approved therapeutic product labeling:DrugFFPETPlamaTARCEVA (erlotinib)Exon 19 deletionsand L858RExon 19 deletions andL858RTAGRISSO (osimertinib)T790MPatients with positive cobas EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.2. Effective 7/12/13therascreen EGFR RGQ PCRkit for the detection of the epidermal growth factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor tissue to help select patients with NSCLC for whom GILOTRIF (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.To report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information.
Article - Billing and Coding: MolDX: FDA-Approved EGFR Tests (A55193)
CPT code: 81235Enter the appropriate DEX Z-Code Identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/typesLoop 2400 or SV101-7 for the 5010A1 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 correct ICD-10-CM diagnosis code(s).NOTE: MolDX will apply NPI to ID editing on FDA approved EGFR kits. All labs that submit claims for an EGFR kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on the DEX Diagnostics Exchange :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: myPAP™ (A55195)
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 myPAP DNA test, developed to complement a Papanicolaou (Pap) test, confirms a Pap specimen belongs to the patient evaluated for treatment. The MolDX Team agrees the healthcare community should define and follow strict procedures regarding patient and patient specimen identification and handling. Tests performed to measure the quality or control of a process and do not provide information to diagnose or treat a patient illness or injury do not meet the criteria for a Medicare benefit. Therefore, the myPAP test 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.Providers must register for a DEX Z-Code identifier prior to claim submission. To access the MolDX registry, go to the DEX Diagnostics Exchange located at:https://app.dexzcodes.com/login. Once an ID has been obtained, please submit the following claim information to receive a myPAP Medicare service denial:CPT code 84999  unlisted chemistry 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 assigned DEX Z-Code identifier 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: myPAP™ (A55195)
If 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
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55197)
CMS National Coverage PolicyN/AArticle Text
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55197)
Next Generation Sequencing (NGS)NGS allows identification of somatic and/or germline alterations in multiple genes simultaneously. This guideline focuses on Targeted and Comprehensive Genomic Profile testing for somatic variant detection using tumor-based panels for cancer that may be performed by NGS.Refer toMolDX: Defining panel services in MolDX A59700for further guidance on the distinction between single analyte and panel tests.Definitions:Targeted Tumor PanelsTargeted tumor-panels are hereby defined as tests that identify somatic alterations known to occur in certain regions (i.e.,'hotspots') within specific genes of interest for cancer management (i.e., diagnosis, selection of molecularly targeted therapies, prognosis in a context where prognostic classification is essential for treatment selection). Generally, these panels are limited to specific variant types at defined sites, such as single nucleotide variants (SNVs), small insertions or deletions (INDELs), single site copy number variants, or gene fusions. These alterations typically represent response or lack of response to corresponding targeted cancer therapies. The hotspot test should include relevant targets required for companion diagnostic testing and/or known to be necessary for proper patient management.Comprehensive Genomic Profile (CGP) Testing
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55197)
Comprehensive Genomic Profile (CGP) TestingCGP testing refers to NGS-based molecular assays that provide additional insight beyond individual gene hotspots; these assays seek to describe the genomic makeup of a tumor and can help identify underlying mechanisms of disease to guide clinical decision making. These tests include not only mutations in individual relevant genes, but also patterns of mutations across related genes in established cancer pathways and often include an assessment of overall mutational burden. These tests typically involve sequencing of entire exonic regions of genes of interest (within a comprehensive gene panel or whole exome sequencing), and may also include select intronic regions. CGP tests can detect multiple types of molecular alterations (i.e., SNVs, small and large INDELs, copy number variants (CNVs), structural variants (SVs), and splice-site variants) in a single assay. Patterns of mutations seen across multiple genes may be used to infer clinically relevant etiologies, such as DNA mismatch repair deficiency and microsatellite instability (MSI), total mutational load/burden (TMB) and chromosome abnormalities such as loss of heterozygosity (LOS). CGP testing may also include RNA sequencing to detect structural variations, such as translocations or large deletions, and to detect functional splicing mutations. CGP testing is not defined as a targeted panel by MolDX. CGP tests are expected to yield information of clinical relevance beyond a targeted panel, for example, to identify relevant clinical trials for patient management or identify possible therapeutic interventions for off-label use. It is expected that a CGP will identify all clinically relevant information attainable for the type of service performed.CPT Coding InstructionsTargeted Tumor PanelsTo bill for DNA based panels that measure specific SNVs, INDELs, CNVs or rearrangements, review CPT codes 81445 and 81450. If a DNA-based targeted panel meeting the coverage requirements is used, and MSI is also performed, 81457 can be billed. If a DNA-based targeted test meeting coverage requirements is performed that includes MSI and CNVs, 81458 can be billed.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55197)
81449 or 81451 for RNA-based targeted testing may also be billed for the same specimen that received a DNA-based NGS test if compliant with the language of A57503, is non-duplicative, and performed serially to DNA testing as a separate service (with a separate order and report). If only RNA-based testing is reasonable and necessary, 81449 or 81451 may be billed alone if policy requirements are met. If two targeted panels (one for DNA and the other for RNA) are always performed together and meet policy criteria, 81479 should be used for such a service to reduce claims processing errors as this would constitute one service.The unit of service (UOS) for an NGS gene panel is one (UOS=1). Providers must also provide the approved DEX Z-Code identifier for the test.Effective July 1, 2017, laboratories with 2 to 4 genes on their targeted NGS panel should use CPT 81479 and one (1) UOS along with their test identifier (DEX Z-Code) to represent this service on their claims.CGPCPT code 81459, based on the inclusion of the comprehensive test components addressed in the definition above, is considered a CGP test by this contractor and may be billed when all stated components of the service have satisfied technical assessment requirements. Because this code includes both DNA-only and DNA/RNA combined services in its description, it is assumed that services that include DNA/RNA combined testing add no additional relevant genomic information beyond that provided by a DNA-only test. For CGP tests that include the use of RNA to interrogate relevant genomic information beyond that captured with DNA-based testing, billing with CPT 81479 is appropriate. Additionally, if a service meets the definition of a CGP but NOT 81459, CPT code 81479 is appropriate.Therefore, to report a CGP service, test providers should use CPT codes 81459 or 81479, in addition to the approved DEX Z-Code for the test. Coverage of CGPs is limited to one test per surgical specimen and precludes the use of any further molecular testing on that specimen.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55197)
For NGS-based tests that do not fit under the above definitions of targeted of Comprehensive panels, billing with the Not Otherwise Classified (NOC) code 81479 along with the approved DEX Z-Codeidentifier is appropriate.Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a single gene or any combination of genes when testing is performed as part of a NGS or other multiplexing technology panel.Refer to Billing and Coding:MolDX: Next-Generation Sequencing for Solid TumorsA57858 for CPT/HCPCS codes and ICD-10 codes relevant for solid tumors.Refer to Billing and Coding:MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid MalignanciesA57878 for CPT/HCPCS codes and ICD-10 codes relevant for myeloid malignancies.
Article - Billing and Coding: MolDX: NSD1 Gene Tests (A55198)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 26, 2013.NSD1 gene testing may be performed during the diagnosis of Sotos Syndrome. Since testing is limited to reproductive risk assessment, the MolDX Team has determined NSD1 gene testing is a statutorily excluded service. MolDX will also deny tests that include one or more of NSD1 analysis reported with CPT code 81479 as statutorily excluded tests.To receive a NSD1 analysis service denial, please submit the following claim information:Select appropriate CPT code according to genetic material testCode 81405 for NSD1 duplication/deletionCode 81406 for NSD1 gene sequencingCode 81479 for combinations of NSD1 analysisAn 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: PAX6 Gene Sequencing (A55199)
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.PAX6 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:CPT code 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 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 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/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: PIK3CA Gene Tests (A55200)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after May 24, 2019.The U.S. Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.To submit a claim for PIK3CA targeted gene sequencing service, please submit the following claim information:Enter the appropriate CPT codeSelect 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-Codeidentifier 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/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: PTCH1 Gene Testing (A55203)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 26, 2013.PTCH1 gene testing may be performed during the diagnosis of Nevoid Basal Cell Carcinoma Syndrome (NBCCS). Since the diagnosis of NBCCS is established using clinical diagnostic criteria and carrier testing is not a covered benefit, WPS GHA has determined PTCH1analysis is a statutorily excluded test.To receive a PTCH1 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 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 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