evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: cobas® EGFR Mutation Test Guidelines (A54189)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after 5/14/13, CGS Administrators and the MolDX program contractor will cover the FDA approved, cobas EGFR Mutation Test for the detection of epidermal growth factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to help select patients with NSCLC for whom Tarceva (erlotinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.To report a cobas service, please submit the following claim information:CPT code 81479  Unlisted chemistry procedureEnter ZBA66 in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for part A or Loop 2400 NTE02/SV 101-7 for Part BSubmit ZBA66 on an attachment to the claim form for paper claim(Form locator 80 fro Part A or Box 19 for Part B)Select at least one ICD-10-CM diagnosis code from the following tables for dates of service on and after 10/01/2015C34.11 Malignant neoplasm of upper lobe, right bronchus or lungC34.12 Malignant neoplasm of upper lobe, left bronchus or lungC34.2 Malignant neoplasm of middle lobe, bronchus or lungC34.31-Malignant neoplasm of lower lobe, right bronchus or lungC34.32-Malignant neoplasm of lower lobe, left bronchus or lungC34.81-Malignant neoplasm of overlapping sites of right bronchus and lungC34.82-Malignant neoplasm of overlapping sites of left bronchus and lungC34.91-Malignant neoplasm of unspecified part of right bronchus or lungC34.92-Malignant neoplasm of unspecified part of left bronchus or lung
Article - Billing and Coding: MolDX: cobas® EGFR Mutation Test Guidelines (A54189)
NOTE:CGS and the MolDX Program contractor will apply NPI to ID editing. All labs that submit claims for the cobas EGFR kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. For lab developed tests (LDT) or tests that modify the cobas EGFR kit, CPT code 81235 should be reported and submitted with the assigned LDT test ID.
Article - Billing and Coding: MolDX: FDA-Approved BRAF Tests (A54191)
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:Effective 09/07/2012cobas 4800 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.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, please submit the following claim information:CPTcode 81210Enter 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 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 Exchangehttps://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 (A54192)
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 06/01/2016cobas 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:Patients 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.Effective 7/12/13therascreen 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.DrugFFPETPlasmaTARCEVA  (erlotinib)Exon 19 deletions and L858RExon 19 deletions and L858RTAGRISSO  (osimertinib)T790MTo report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information:CPTcode: 81235Enter the appropriate DEX Z-Code identifier adjacent to the CPTcode in the comment/narrative field for the following Part B claim field/types:
Article - Billing and Coding: MolDX: FDA-Approved EGFR Tests (A54192)
CPTcode: 81235Enter 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 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. Tests may be registered on the McKesson Diagnostics ExchangeTM: https://app.mckessondex.com/#/loginFor lab developed tests (LDT) or tests that modify an EGFR test, CPT code 81235 and NO modifier should be reported and submitted with the assigned LDT test ID.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: MammaPrint (A54194)
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.MammaPrintwas 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 MammaprintNGS test has demonstrated technically equivalent performance to the predicate microarray test.To bill for MammaPrintservices, submit the following claim information:Enter 1 in the Days/Unit fieldFor CPTnon-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 1/1/2022, use CPT code 81523 for the test if performed by NGS.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 formOnly 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: Oncotype DX® Breast Cancer Assay (A54195)
CMS National Coverage PolicyN/AArticle TextNOTE: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 DX & reg Breast 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 nodesTo bill an Oncotype Breast service, please provide the following claim information:CPTcode 81519  Oncology (breast)Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM code.Enter 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: Oncotype DX® Colon Cancer Assay Update (A54196)
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:CPT code 81525-Oncology (colon), mRNA gene expression of 21 genesEnter 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.Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for thefollowing Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM code:
Article - Billing and Coding: MolDX: Progensa® PCA3 Assay Coverage Update (A54197)
CMS National Coverage PolicyN/AArticle TextProgensa PCA3 Assay, an FDA approved test by Gen-Probe Incorporated, is an mRNA expression assay used alone or in combination with other molecular tests for prostate cancer determination to identify patients with increased risk of prostate cancer. PCA3 may help to improve the specificity of prostate cancer detection providing additional information about the risk of prostate cancer over the use of the PSA test alone. Based on the ratio of PCA3 mRNA/PSA mRNA x1000, the PCA3 assay is performed on the first urine collected following an attentive digital rectal examination. PCA3 testing is coveredONLYwhen all biopsies in previous encounter(s) are negativeandwhen the patient or physician wants to avoid repeat biopsy (watchful waiting). When the physician plans to biopsy the prostate, MolDX will consider a PCA3 test as investigational and thus, not a covered Medicare benefit. MolDX considers all other indications for PCA3 not reasonable and necessary. Medical record documentation must indicate the rationale to perform a PCA3 assay. Providers who report a PCA3 service AND perform a biopsy may be referred for additional action. To report a PCA3 service, submit the following claim information:Enter CPTcode 81313 - PCA3/KLK3For 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 formSelect the appropriate ICD-10-CM diagnosis
Article - Billing and Coding: MolDX: Progensa® PCA3 Assay Coverage Update (A54197)
Line SV202-7 for 837I electronic claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM diagnosisNOTE:Effective 10/15/2012, MolDX will deny all laboratory developed tests (LDT) for PCA3 as statutorily excluded services that do not support the required clinical utility for the established Medicare benefit category. Only the unmodified FDA approved test, will be reimbursed.
Article - Billing and Coding: MolDX: ResponseDX Tissue of Origin® (A54198)
CMS National Coverage PolicyN/AArticle TextTissue of Origin, a microarray-based gene expression assay designed to determine the similarity of unknown or unresolved tumors to cancers from 1 of 15 known tumors of origin, has been assigned a unique identifier. To bill for Tissue of Origin services, please provide the following claim information:CPTcode 81504  Oncology (tissue of origin)Enter 1 in the Days/Unit fieldSelect the appropriate ICD-10-CM diagnosis.Enter 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 formNote: MolDX expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDX: Therascreen® EGFR RGQ PCR Kit Guidelines (A54199)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after 7/12/13, CGS Administrators and the MolDX Program contractor will cover the FDA approved, therascreen EGFR RGQ PCR kit for the detection of the epidermal growth factor receptor (EGFR) gene from non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.To report a therascreen EGFR service, please submit the following claim information:CPT code 81479  Unlisted chemistry procedureEnter ZBZ25 in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV 101-7 for Part BSubmit ZBZ25 on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)For dates of service (DOS) on or after 10/01/2015, select the appropriate ICD-10-CM diagnosis from the following list:C34.11 Malignant neoplasm of upper lobe, right bronchus or lungC34.12 Malignant neoplasm of upper lobe, left bronchus or lungC34.2 Malignant neoplasm of middle lobe, bronchus or lungC34.31-Malignant neoplasm of lower lobe, right bronchus or lungC34.32-Malignant neoplasm of lower lobe, left bronchus or lungC34.81-Malignant neoplasm of overlapping sites of right bronchus and lungC34.82-Malignant neoplasm of overlapping sites of left bronchus and lungC34.91-Malignant neoplasm of unspecified part of right bronchus or lungC34.92-Malignant neoplasm of unspecified part of left bronchus or lung
Article - Billing and Coding: MolDX: Therascreen® EGFR RGQ PCR Kit Guidelines (A54199)
NOTE:CGS and the MolDX Program will apply NPI to ID editing. All labs that submit claims for the therascreen EGFR kitMUSTregister the test and confirm theUNMODIFIEDuse of the kit. For lab developed tests (LDT) or tests that modify the therascreen EGFR kit, CPT code 81235 should be reported and submitted with the assigned LDT test ID.
Article - Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines (A54200)
CMS National Coverage PolicyN/AArticle TextFDA-Approved KRAS TestsTwo tests have met the FDA criteria for KRAS genetic testing:1. Effective 7/6/2012therascreen KRAS to detect seven somatic mutations in the human KRAS oncogene was developed to aid in the identification of CRC patients for treatment with Erbitux (cetuximab).2. 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 a FDA approved KRAS, codon 12 and 13 test kit service, please submit the following claim information:CPT code 81275-22  KRAS codons 12, 13Enter the assigned MolDx identifier in the comment/narrative field for the following claim field/types:Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV101-7 for Part BSubmit the assigned MolDX identifier on an attachment to the claim form for paper claim(Form locator 80 for Part A or Box 19 for Part B)For dates of service (DOS) on or after 10/01/2015, select the appropriate ICD-10-CM diagnosis from the following list:
Article - Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines (A54200)
C77.0 - Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neckC77.1 - Secondary and unspecified malignant neoplasm of intrathoracic lymph nodesC77.2 - Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodesC77.3 - Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodesC77.4 - Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodesC77.5 - Secondary and unspecified malignant neoplasm of intrapelvic lymph nodesC77.8 - Secondary and unspecified malignant neoplasm of lymph nodes of multiple regionsC77.9 - Secondary and unspecified malignant neoplasm of lymph node, unspecifiedC78.01 - Secondary malignant neoplasm of right lungC78.02 - Secondary malignant neoplasm of left lungC78.1 - Secondary malignant neoplasm of mediastinumC78.2 - Secondary malignant neoplasm of pleuraC78.39 - Secondary malignant neoplasm of other respiratory organsC78.4 - Secondary malignant neoplasm of small intestineC78.5 - Secondary malignant neoplasm of large intestine and rectumC78.6 - Secondary malignant neoplasm of retroperitoneum and peritoneumC78.7 - Secondary malignant neoplasm of liver and intrahepatic bile ductC78.80 - Secondary malignant neoplasm of unspecified digestive organC78.89 - Secondary malignant neoplasm of other digestive organsC79.01 - Secondary malignant neoplasm of right kidney and renal pelvisC79.02 - Secondary malignant neoplasm of left kidney and renal pelvisC79.11 - Secondary malignant neoplasm of bladderC79.19 - Secondary malignant neoplasm of other urinary organsC79.2 - Secondary malignant neoplasm of skinC79.31 - Secondary malignant neoplasm of brain
Article - Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines (A54200)
C79.19 - Secondary malignant neoplasm of other urinary organsC79.2 - Secondary malignant neoplasm of skinC79.31 - Secondary malignant neoplasm of brainC79.49 - Secondary malignant neoplasm of other parts of nervous systemC79.32 - Secondary malignant neoplasm of cerebral meningesC79.49 - Secondary malignant neoplasm of other parts of nervous systemC79.51 - Secondary malignant neoplasm of boneC79.52 - Secondary malignant neoplasm of bone marrowC79.61 - Secondary malignant neoplasm of right ovaryC79.62 - Secondary malignant neoplasm of left ovaryC79.71 - Secondary malignant neoplasm of right adrenal glandC79.72 - Secondary malignant neoplasm of left adrenal glandC79.81 - Secondary malignant neoplasm of breastC79.82 - Secondary malignant neoplasm of genital organsC79.89 - Secondary malignant neoplasm of other specified sites
Article - Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines (A54200)
NOTE:CGS and the MolDX contractor will apply NPI to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kit MUST register the test and confirm the UNMODIFIED use of the kit. Tests may be registered on the McKesson Diagnostics ExchangeTM: https://app.mckessondex.com/#/loginFor lab developed tests (LDT) or tests that modify a KRAS, codon 12 and 13 test, CPT code 81275 and NO modifier should be reported and submitted with the assigned LDT test ID.
Article - Billing and Coding: MolDX: MMACHC Test (A54209)
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 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. CGS Administrators and the MolDX Program contractor will also deny panels of tests that include the MMACHC gene.To receive a MMACHC service denial, please submit the following claim information:CPTcode 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 CPTcode in the comment/narrative field for the following claim field/types:Loop 2300 NTE01/SV202-7 for Part A or Loop 2400 NTE02/SV 101-7 for Part BForm locator 80 for Part A or Box 19 for Part B on paper claim
Article - Billing and Coding: MolDX: 4q25-AF Risk Genotype Guidelines (A54241)
CMS National Coverage PolicyN/AArticle TextEffective for dates of services on and after 06/14/2012The 4q25-AF Risk Genotype Test was developed to help predict the risk of atrial fibrillation and cardioembolic stroke. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category.As reviewed, the developer described the indication to perform a 4q25-AF Risk Genotype Test as a risk assessment for developing a disease or condition. Risk assessment for developing a disease or condition in the absence of signs and symptoms of an illness or injury is also not defined as a Medicare benefit. Therefore, the 4q25-AF Risk Genotype Test would continue to be a statutory excluded service.To receive a 4q25-AF Risk genotype service denial, please submit the following claim information:CPTcode 81479  Unlisted molecular pathology procedureAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter the assigned DEX Z-codeTMIdentifier adjacent to the CPTcodein the comment/narrative field for the following claim field/types:Line SV202-7 for part A or Loop 2400 NTE02/SV101-7 for Part BBlock 80 for Part A or Box 19 for Part B on paper claim