evekhm/cms_iom_3000 huggingface dataset:
Article - Billing and Coding: MolDX: Afirma™ Assay by Veracyte (A54358)

CMS National Coverage PolicyN/AArticle TextThe following coding and billing guidance is to be used with its associated Local coverage determination.The MolDXTeam has completed the Afirma assessment and determined that the test meets criteria for analytical and clinical validity, and clinical utility as a reasonable and necessary Medicare benefit. Effective 10/01/2015,MolDX will reimburse Afirma services for patients with the following conditions (patient must have 1 and 2):1. Patients with one or more thyroid nodules with a history or characteristics suggesting malignancy such as:Nodule growth over timeFamily history of thyroid cancerHoarseness, difficulty swallowing or breathingHistory of exposure to ionizing radiationHard nodule compared with rest of gland consistencyPresence of cervical adenopathy2. Have an indeterminate follicular pathology on fine needle aspirationMolDXexpects this test will be performed once per patient lifetime. Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with support documentation.To report an Afirma service, submit the following claim information:Select the appropriate CPT code.Select the appropriate ICD-10-CM diagnosisEnter the 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 837PItem19 for paper claimEnter the DEX Z-Code identifier in the comment/narrative field for the following PartA claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: bioTheranostics Cancer TYPE ID® Update (A54386)

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.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims, 60.1.1 Independent Laboratory Specimen Drawing, 60.2 Travel AllowanceCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 10 Reporting ICD Diagnosis and Procedure CodesArticle TextEffective November 19, 2012, Cancer TYPE ID, an RT-PCR 92-gene assay, has been assigned a DEX Z-codeidentifier.To bill for Cancer TYPE ID, please provide the following claim information:Enter 1 in the Days/Unit fieldEnter 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 837PItem19 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 formSelect the appropriate ICD-10-CM code.Note:MolDX expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDX: bioTheranostics Cancer TYPE ID® Update (A54388)

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.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 80.1.2 A/B MAC (B) Contacts With Independent Clinical LaboratoriesCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims, 60.1.1 Independent Laboratory Specimen Drawing, 60.2 Travel AllowanceCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, 10 Reporting ICD Diagnosis and Procedure CodesArticle TextEffective November 19, 2012, Cancer TYPE ID, an RT-PCR 92-gene assay, has been assigned a DEX Z-codeidentifier.To bill for Cancer TYPE ID, please provide the following claim information:Enter 1 in the Days/Unit fieldEnter 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 837PItem19 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 formSelect the appropriate ICD-10-CM code.Note:MolDX expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDX: FDA-Approved BRAF Tests (A54418)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextTwo tests have met the FDA criteria for BRAF genetic testing:1. Effective 09/07/2012cobas4800 BRAF V600to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf (vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body.2. Effective 5/29/13ThxID BRAF V600/Kto detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, submit the following claim information:CPT code 81210Enter 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 formSelect the appropriate ICD-10-CM diagnosis.NOTE:MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on the DEX Diagnostics Exchange:https://app.dexzcodes.com/login.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: FDA-Approved BRAF Tests (A54420)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextTwo tests have met the FDA criteria for BRAF genetic testing:1. Effective 09/07/2012cobas4800 BRAF V600to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf (vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body.2. Effective 5/29/13ThxID BRAF V600/Kto detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, submit the following claim information:CPT code 81210Enter 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 formSelect the appropriate ICD-10-CM diagnosis.NOTE:MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on the DEX Diagnostics Exchange:https://app.dexzcodes.com/login.This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: FDA-Approved EGFR Tests (A54422)

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:1. 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 anti-coagulated 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:DrugFFPETPlasmaTARCEVA(erlotinib)Exon 19 deletions and L858RExon 19 deletions and L858RTAGRISSO (osimertinib)T790MPatients with positive cobasEGFR 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.Effective7/12/13therascreen EGFR RGQPCR kit 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: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/types:Loop 2400 or SV101-7 for the 5010A1 837PItem19 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 formICD-10-CM codesNOTE: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.This article reflects the FDA-approved indications on articlecreation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: FDA-Approved EGFR Tests (A54424)

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:1. 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 anti-coagulated 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:DrugFFPETPlasmaTARCEVA(erlotinib)Exon 19 deletions and L858RExon 19 deletions and L858RTAGRISSO (osimertinib)T790MPatients with positive cobasEGFR 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.Effective7/12/13therascreen EGFR RGQPCR kit 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: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/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 formICD-10-CM codesNOTE: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.This article reflects the FDA-approved indications on articlecreation date. MolDX will allow future FDA approved and amended indications for these tests.
Article - Billing and Coding: MolDX: MammaPrint (A54445)

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, submit 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 837PItem 19 for paper claimEnter the appropriate DEX Z-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formOnly one test- NGS or microarray may be performed on a given date of service for a given patient.Note:Noridian 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: MammaPrint (A54447)

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, submit 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 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-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formOnly one test- NGS or microarray may be performed on a given date of service for a given patient.Note:Noridian 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: FDA-Approved KRAS Tests (A54472)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextTwo tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:Effective 7/6/2012therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux (cetuximab).Effective 5/7/2015cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).To report an FDA approved or laboratory developed test (LDT) KRAS, service, please submit the following claim information:Select the appropriate CPT codeEnter 1 unit of Service (UOS)Enter the appropriate 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 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 formSelect the appropriate ICD-10-CM diagnosis.NOTE:MolDX will apply National Provider Identifier (NPI) to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. Tests may be registered on theDEXTMDiagnostics 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: Oncotype DX® Breast Cancer Assay (A54480)

CMS National Coverage PolicyN/AArticle TextThe following coding and billing guidance is to be used with its associated Local coverage determination.NOTE:The Oncotype DX Breast Cancer Assay and the Oncotype DX DCIS Score are different tests and should NOT be submitted with the same Z-Code Identifier. Because this article ONLY addresses Oncotype DX Breast, the diagnosis codes for breast carcinoma in situ have been removed.Oncotype DXBreast was developed for patients with the following findings:estrogen-receptor positive, node-negative carcinoma of the breastestrogen-receptor positive micrometastases of carcinoma of the breast, andestrogen-receptor positive breast carcinoma with 1-3 positive nodes.To bill an Oncotype Breast service, please provide the following claim information:Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM codeEnter Z-Code Identifier in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem19 for paper claimEnter Z-Code Identifier in the comment/narrative field tor 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: Oncotype DX® Breast Cancer Assay (A54482)

CMS National Coverage PolicyN/AArticle TextThe following coding and billing guidance is to be used with its associated Local coverage determination.NOTE:The Oncotype DX Breast Cancer Assay and the Oncotype DX DCIS Scoreare different tests and should NOT be submitted with the same Z-Code Identifier. Because this article ONLY addresses Oncotype DX Breast, the diagnosis codes for breast carcinoma in situ have been removed.Oncotype DXBreast was developed for patients with the following findings:estrogen-receptor positive, node-negative carcinoma of the breastestrogen-receptor positive micrometastases of carcinoma of the breast, andestrogen-receptor positive breast carcinoma with 1-3 positive nodes.To bill an Oncotype Breast service, please provide the following claim information:Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM codeEnter Z-Code Identifier in the comment/narrative field for the following PartB claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem19 for paper claimEnter Z-Code Identifier in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UBo4 claim form
Article - Billing and Coding: MolDX: Oncotype DX® Colon Cancer (A54484)

CMS National Coverage PolicyN/AArticle TextThe Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence risk for patients with Stage II colon cancer, has been assigned a unique identifier.To bill an Oncotype DX Colon service, please provide the following claim information:Enter 1 unit of service (UOS)Enter the appropriate 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 for the 5010A1 837PItem 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 formSelect the appropriate ICD-10-CM code
Article - Billing and Coding: MolDX: Oncotype DX® Colon Cancer (A54486)

CMS National Coverage PolicyN/AArticle TextThe Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence risk for patients with Stage II colon cancer, has been assigned a unique identifier.To bill an Oncotype DX Colon service, please provide the following claim information:Enter 1 unit of service (UOS)Enter the appropriate 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 837PItem 19 for paper claimsEnter 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 UB04 claim formSelect the appropriate ICD-10-CM code