evekhm/cms_iom_3000 huggingface dataset:
Article - MolDX: Algorithm definition as a component of a laboratory test (A58673)

CMS National Coverage PolicyN/AArticle TextThe aim of this article is to promote a shared understanding of the term "algorithm" within the context of a clinical laboratory test. The objective of this article is to communicate the attributes of an algorithm as defined by this contractor within the stated context. The presence or absence of an algorithm as part of a lab service may be relevant to understanding the components of that service for coding or valuation purposes.An algorithm may be considered a meaningful and independent component of a laboratory process when ALL the following conditions are met:It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;The same or similar test result could not be obtained without the use of this process;The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;The process must:Either be required for the analytical result, ORIf adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.Examples:A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.A next generation sequencing (NGS) test that uses computation to identify variants in a sampleis notconsidered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.Calculations using only clinical information not derived from analytical services on biological samplesare notconsidered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.
Article - MolDX: Algorithm definition as a component of a laboratory test (A58674)

CMS National Coverage PolicyN/AArticle TextThe aim of this article is to promote a shared understanding of the term "algorithm" within the context of a clinical laboratory test. The objective of this article is to communicate the attributes of an algorithm as defined by this contractor within the stated context. The presence or absence of an algorithm as part of a lab service may be relevant to understanding the components of that service for coding or valuation purposes.An algorithm may be considered a meaningful and independent component of a laboratory process when ALL the following conditions are met:It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;The same or similar test result could not be obtained without the use of this process;The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;The process must:Either be required for the analytical result, ORIf adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.Examples:A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.A next generation sequencing (NGS) test that uses computation to identify variants in a sampleis notconsidered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.Calculations using only clinical information not derived from analytical services on biological samplesare notconsidered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.
Article - MolDX: Algorithm definition as a component of a laboratory test (A58677)

CMS National Coverage PolicyN/AArticle TextAn algorithm may be considered a meaningful and independent component of a laboratory process when ALL the following conditions are met:It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;The same or similar test result could not be obtained without the use of this process;The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;The process must:Either be required for the analytical result, ORIf adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.Examples:A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.A next generation sequencing (NGS) test that uses computation to identify variants in a sampleis notconsidered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.Calculations using only clinical information not derived from analytical services on biological samplesare notconsidered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.
Article - Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer (A58679)

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, 60.1.2 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 TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer L38972To report a service, please submit the following claim information:Select appropriate CPTcodeEnter 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 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 codeRegarding single-gene and panel testing of genes-Refer to Billing and Coding: MolDX: Testing of Multiple Genes A58120.Tier 1 and/or Tier 2 individual biomarker CPTcodes 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.
Article - Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer (A58681)

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, 60.1.2 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 TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) forMolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with CancerL38974.To report a service, please submit the following claim information:Select appropriate CPTcodeEnter 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 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 codeRegarding single-gene and panel testing of genes-Refer to Billing and Coding: MolDX: Testing of Multiple Genes A58121.Tier 1 and/or Tier 2 individual biomarker CPTcodes 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.
Article - MolDX: Algorithm definition as a component of a laboratory test (A58689)

CMS National Coverage PolicyN/AArticle TextThe aim of this article is to promote a shared understanding of the term "algorithm" within the context of a clinical laboratory test. The objective of this article is to communicate the attributes of an algorithm as defined by this contractor within the stated context. The presence or absence of an algorithm as part of a lab service may be relevant to understanding the components of that service for coding or valuation purposes.An algorithm may be considered a meaningful and independent component of a laboratory process when ALL the following conditions are met:It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;The same or similar test result could not be obtained without the use of this process;The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;The process must:Either be required for the analytical result, ORIf adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.Examples:A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.A next generation sequencing (NGS) test that uses computation to identify variants in a sampleis notconsidered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.Calculations using only clinical information not derived from analytical services on biological samplesare notconsidered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.
Article - Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer (A58700)

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 LaboratoriesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer L38985.To report a Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer service, please submit the following claim information:Select the appropriate CPTcodeEnter 1 unit of service (UOS)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 codeNOTE:When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.Additional information:Only one molecular biomarker test may be performed per date of service.Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.
Article - Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer (A58713)

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 LaboratoriesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer L38997.To report a Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer service, please submit the following claim information:Select the appropriate CPTcodeEnter 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 codeNote: When entering the DEX Z-Code on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.Additional information:Only one molecular biomarker test may be performed per date of service.Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.
Article - Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer (A58718)

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 LaboratoriesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer L39005 .To report a Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer service, please submit the following claim information:Select the appropriate CPTcodeEnter 1 unit of service (UOS)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 837PItem 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 codeNOTE: When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.Additional information:Only one molecular biomarker test may be performed per date of service.Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.
Draft Article - Billing and Coding: MolDX: Melanoma Risk Stratification Molecular Testing (DA57290)

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. 100-04, Medicare Claims Processing Manual, Chapter 23, Section 10 Reporting ICD Diagnosis and Procedure CodesArticle TextThe information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Melanoma Risk Stratification Molecular Testing.To report a molecular diagnostic service, please submit the following claim information:Select the appropriate CPTcodeEnter 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 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 codeCovered tests:The DecisionDx-Melanoma test is coveredas per the MolDX: Melanoma Risk Stratification Molecular Testing policy, when the following additional conditions are met:Patients diagnosed with cutaneous melanoma  0.3 mm without distant metastases in Breslow thickness where additional risk stratification information beyond anatomic and pathologic staging will influence management decisions regarding the following:Sentinel Lymph Node Biopsy decision (T1-T2 only)Appropriateness of adjuvant therapyDetermining the appropriate level of follow up, imaging, and referralsPatients diagnosed with cutaneous melanoma < 0.3 mm in Breslow thickness being considered for sentinel lymph node biopsy:in whom there is significant uncertainty about the adequacy of microstaging (positive deep margin), orwith other adverse features (e.g. very high mitotic index [2/mm2], lymphovascular invasion, or a combination of these factors)
Article - Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer (A58724)

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 LaboratoriesArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer L39007 .To report a Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer service, please submit the following claim information:Select the appropriate CPTcodeEnter 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 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 codeNOTE: When entering the DEX Z-Codeon the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.Additional information:Only one molecular biomarker test may be performed per date of service.Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.