evekhm/cms_iom_500 huggingface dataset:
Article - Billing and Coding: MolDX: TERC Gene Tests (A55611)
CMS National Coverage PolicyN/AArticle TextSince the associated conditions associated with telomerase RNA component (TERC) gene testing is limited to reproductive risk assessment,the MolDX teamhas 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 procedureFor 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 modifier An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.Select the appropriate diagnosis for the patientEnter theDEX Z-Codeidentifier 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 theDEX Z-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: IKBKAP Genetic Testing (A55612)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Article TextMutations to the IKBKAP (inhibitor of kappa light polypeptide gene enhancer in B-cells, kinase complex-associated proteins) are associated with familial dysautonomia (FD), a condition that affects the development of sensory, sympathetic, and parasympathetic neurons. Genetic testing may be performed at birth to diagnose FD. For adults, IKBKAP genetic testing identifies parents that may be at risk for conceiving a child with the disease. Therefore, Noridian has determined that testing for the IKBKAP is not a Medicare benefit and is a statutorily excluded service. In addition to single disease testing, Noridian will also deny panels of tests that include an IKBKAP gene test as a statutorily excluded service.To receive an IKBKAP test denial, please submit the following claim information:81260-IKBKAP, common variants81412 - Ashkenazi Jewish associated disorders81443  Genetic testing for severe inherited conditionAn 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 appropriateDEX Z-Codeidentifier 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 form
Article - Billing and Coding: MolDX: IKBKAP Genetic Testing (A55613)
CMS National Coverage PolicyTitle XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Article TextMutations to the IKBKAP (inhibitor of kappa light polypeptide gene enhancer in B-cells, kinase complex-associated proteins) are associated with familial dysautonomia (FD), a condition that affects the development of sensory, sympathetic, and parasympathetic neurons. Genetic testing may be performed at birth to diagnose FD. For adults, IKBKAP genetic testing identifies parents that may be at risk for conceiving a child with the disease. Therefore, Noridian has determined that testing for the IKBKAP is not a Medicare benefit and is a statutorily excluded service. In addition to single disease testing, Noridian will also deny panels of tests that include an IKBKAP gene test as a statutorily excluded service.To receive an IKBKAP test denial, please submit the following claim information:81260-IKBKAP, common variants81412 - Ashkenazi Jewish associated disorders81443  Genetic testing for severe inherited conditionAn 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 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: RPS19 Gene Tests (A55614)
CMS National Coverage PolicyN/AArticle TextRPS19 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 Teamhas 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 aknown statutorily excluded service, append with a GY modifierSelect the appropriate diagnosis for the patientEnter 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 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: NSD1 Gene Tests (A55615)
CMS National Coverage PolicyN/AArticle TextNSD1 gene testing may be performed during the diagnosis of Sotos Syndrome. Since testing is limited to reproductive risk assessment, Noridian has determined NSD1 gene testing is a statutorily excluded service. Noridian 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 testsCode 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 modifierEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem 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: TERC Gene Tests (A55616)
CMS National Coverage PolicyN/AArticle TextSince the associated conditions associated with telomerase RNA component (TERC) gene testing is limited to reproductive risk assessment,the MolDX teamhas 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 procedureFor 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 modifier An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.Select the appropriate diagnosis for the patientEnter theDEX Z-Codeidentifier 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 theDEX Z-Codeidentifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: PTCH1 Gene Testing (A55618)
CMS National Coverage PolicyN/AArticle TextEffective for dates of service on and after October 01, 2017PTCH1 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, Noridian has determined that PTCH1 analysis 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 patientEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for paper claimEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:Line SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim form
Article - Billing and Coding: MolDX: Short Tandem Repeat (STR) Markers and Chimerism (CPT® codes 81265-81268) (A55621)
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 Manuals, 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, 60.1.2 Independent Laboratory Specimen Drawing, 60.2 Travel AllowanceArticle TextPlease note that CPT codes 81265 and 81266 describe services performed for recipient/donor testing and twin zygosity. Tests indicated for recipient/donor testing will be considered for payment and tests for twin zygosity will be denied as a statutorily excluded service. The following instructions outline the correct reporting of recipient/donor testing for transplant services.Chimerism analysis to identify appropriate donors and monitor engraftment success or disease reoccurrence is a covered Medicare service.Code 81265 should be reported with 1 unit of service (UOS). Except in rare cases, this service would only be performed once per lifetime.Code 81266, when used in bone marrow transplants to report an additional double-cord blood sample, is a covered service.Code 81267 should be used post transplantation to confirm successful engraftment or disease reoccurrence. Although the original donor specimen may be referenced, an additional 81265 should NOT be submitted in addition to the 81267 service. For labs that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.Note:Code 81267 should be reported for the findings of the pre and post-transplant comparison.Code 81268 should be used to report chimerism using a buccal or other germline tissue specimen from the recipient post-transplantation. For labs that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.
Article - Billing and Coding: MolDX: Short Tandem Repeat (STR) Markers and Chimerism (CPT® codes 81265-81268) (A55621)
MolDX would not expect to see a claim for 81265 pre-transplant and an additional 81265 and 81267 post-transplant or a claim for 81265 pre-transplant and an additional claim for 81268.EXCEPTIONS:Although the initial chimerism testing, code 81265, for engraftment is usually limited to once in a lifetime, MolDX recognizes special circumstances may require an additional service and will consider approval on a case-by-case basis through the appeal process.Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.Select the appropriate CPT codeEnter 1 unit of service (UOS)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: CDH1 Genetic Testing (A55622)
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.Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.Article TextCDH1 testing is utilized in patients with specified cancers as an adjunctive test. CDH1 testing has also been recommended as a screening test for other cancers. However, screening for individuals at risk for cancer is not a Medicare benefit and is statutorily excluded.CPT 81406-CDH1, full gene sequence.An 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 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 formIn rare cases in which Hereditary Diffuse Gastric Cancer (HDGC) is suspected in a Medicare beneficiary, MolDX will review the documentation on a case-by-case basis.
Article - Billing and Coding: MolDX: SEPT9 Gene Test (A55623)
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 TextNoridian 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, Noridian will deny Septin 9 methylation analysis tests as a statutorily excluded service.To receive a SEPT9 service denial, please submit the following claim information:81327 - SEPT9 (Septin9) (e.g., colorectal cancer) methylation analysis.An Advance Beneficiary Notice (ABN) is not required for statutorily excluded servicesFor a voluntary issued ABN, append with GX modifierTo indicate a statutorily excluded service, append with a GY modifierEnter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:Loop 2400 or SV101-7 for the 5010A1 837PItem 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: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55624)
CMS National Coverage PolicyN/AArticle Text
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55624)
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 (A59865)forfurther 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 (A55624)
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 (LOH). 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 (A55624)
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-Codeidentifier 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.
Article - Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer (A55624)
Therefore, to report a CGP service, test providers should use CPT codes 81459 or 81479, in addition to the approved DEX Z-Codefor 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.For NGS-based tests that do not fit under the above definitions of targeted or 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 toBilling and Coding: MolDX: Next-Generation Sequencing for Solid Tumors A57901for CPT/HCPCS codes and ICD-10 codes relevant for solid tumors.Refer toBilling and Coding: MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies A57891for CPT/HCPCS codes and ICD-10 codes relevant for myeloid malignancies.