evekhm/cms_iom_3000 huggingface dataset:
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.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 formIf 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: 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
Article - Billing and Coding: MolDx: ResponseDX Tissue of Origin® (A55204)

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:CPT code 81504  Oncology (tissue of origin)Enter 1 in the Days/Unit fieldLabs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter DEX Z-Code Identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:SV101-7 for the 5010A1 837PSubmit 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 appropriate ICD-10-CM diagnosis.Note: MolDX expects this test to ONLY be ordered by the treating physician.
Article - Billing and Coding: MolDX: RPS19 Gene Tests (A55205)

CMS National Coverage PolicyNAArticle TextEffective for dates of service on and after June 25, 2013.RPS19 gene sequencing, deletion/duplication and known familial mutation analysis may be performed during the diagnosis of Diamond-Blackfan Anemia (DBA). Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, the MolDX Team has determined RPS19 analysis is a statutorily excluded test. MolDX will also deny tests that include one or more of RPS19 analysis reported with CPT code 81479 as statutorily excluded services.To receive a RPS19 analysis service denial, please submit the following claim information:Select appropriate CPT code according to genetic material testedCode 81405 for gene sequencingCode 81479 for combinations of RPS19 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 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
Article - Billing and Coding: MolDX: SEPT9 Gene Test (A55206)

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 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) promoter methylation analysisAn 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 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: SMPD1 Genetic Testing (A55208)

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:CPT code 81330- SMPD1, common variantsCPT code 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: STAT3 Gene Testing (A55209)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 26, 2013.STAT3 gene testing may be performed during the diagnosis of Autosomal Dominant Hyper IgE Syndrome (AD-HIES). Since management is not determined by the presence or absence of a STAT3 mutation in patients with a probable clinical diagnosis, the MolDx Contractor has determined STAT3 analysis is a statutorily excluded test.To receive a STAT3 analysis service denial, please submit the following claim information:CPT code 81405  STAT3, targeted sequence 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 modifierSelect the appropriate diagnosis for the patientFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 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: SULT4A1 Genetic Testing (A55210)

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 TextSulfotransferase 4A1 (SULT4A1) is an enzyme found in the brain that interacts with numerous neuroactive molecules, including some catecholamines and neural steroids. Findings suggest the SULT4A1-1 haplotype of SULT4A1 is associated with enhanced response to antipsychotic drug therapy. At present there is insufficient evidence to support SULT4A1 genotyping to determine medical management. Therefore, the MolDX Team has determined SULT4A1 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 the SULT4A1 gene as a statutorily excluded service.To receive a SULT4A1 test 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 HCPCS modifierTo indicate a statutorily excluded service, append with a GY HCPCS modifierFor CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 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: TERC Gene Tests (A55211)

CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after June 25, 2013.Since the associated conditions associated with telomerase RNA component (TERC) gene testing is limited to reproductive risk assessment, the MolDX team has determined TERC gene testing is a statutorily excluded service. MolDX will also deny tests that include one or more of TERC analysis reported with CPT code 81479 as a statutorily excluded service.To receive a TERC analysis service denial, please submit the following claim information:CPT 81479  Unlisted molecular pathology procedureAn 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 informationEnter 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: Incident To Clarification for OPPS and CAH Outpatient (A55214)

CMS National Coverage PolicyMedicare Benefit Policy Manual Chapter 6 Section 20.5.1Social Security Act (SSA) Section 1861(s)(2)(K)(i)42 CFR410.2742 CFR482.12(c)Article TextIn response to provider requests, Noridian Healthcare Solutions, LLC (Noridian) provides the following key points related to the incident to regulations in the outpatient hospital setting. Note: There is no "incident to" in the inpatient setting.Medicare may reimburse the costs of services provided either:1. delivered personally by eligible practitioners, e.g., MD, NP, PA; or2. delivered by hospital personnel working incident to the eligible practitioners care.When hospital personnel provide services, the following payment requirements must be met. Services delivered incident to the services of an eligible practitioner must:o Be an integral althoughincidental partof a physicians/non-physician practitioners (NPPs) professional service(s) and, hence, must always occur after an initial patient care service is provided by an eligible practitioner;o Be delivered in accordance with avalid and signed order, i.e., written by a practitioner who is authorized to write orders by hospital policy and in accordance with state law 42 CFR482.12(c);o Be delivered under thesupervision of a physicianwho is an employee or has another contractual relationship with the hospital and isimmediately availableto provide assistance to the personnel delivering the service;"Immediately available" in the outpatient hospital setting means that the physician must beavailable in the same time-frame as the personnel designated to manage cardiac arrests(codes) in the hospital.The supervisor need not be in the same department as the ordering physician/NPP or in the same department in which the services are rendered but must beon the physical premiseswhere and when the patient receives services.The physician/NPP that provides the oversight may not bill for the services of hospital employees. Only the hospital may bill for the services of hospital employees.All service providers must work in accordance with their skills, licensure, and/or other hospital and other Medicare requirements.