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1 | Calendar Year (CY) 2023 Clinical Laboratory Fee Schedule (CLFS) Preliminary Payment Determinations1 This worksheet “A. Preliminary Determinations” of this Excel workbook contains all of the new CLFS codes and CMS preliminary payment determinations. We welcome public comments on our preliminary determinations for the basis of payment. All comments must be submitted electronically by October 24, 2022 to the following CMS mailbox: CLFS_Annual_Public_Meeting@cms.hhs.gov, and final determinations will be announced in November. When submitting public comments, please refer to the specific code and its rationale so that we may best respond in the final payment determinations. 1CPT codes, descriptions and other data only are copyright 2021 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. | |||||||||||||||||||||||||
2 | FACA Mtg. Item | ALM Code List Item # | Code # | Code Type | Category | Long Code Descriptor | Panel Recommendation | CMS 2022 Preliminary Recommendation | Rationale | |||||||||||||||||
3 | 1 | 75 | 84XXX | NEW | Chemistry | Thiopurine S-methyltransferase (TPMT) | Crosswalk to 82657: 1 Gapfill: 11 Abstain: 0 | Crosswalk to 82657 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
4 | 2 | 39 | 80220 | Reconsideration | Chemistry | Hydroxychloroquine | Crosswalk to 80204: 10 Crosswalk to 80299: 2 Gapfill: 0 Abstain 0 | Crosswalk to 80299 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code and continues to believe a crosswalk to CPT 80299 is appropriate as both codes use similar methods. | |||||||||||||||||
5 | 3 | 41 | 83529 | Reconsideration | Chemistry | Interleukin-6 (IL-6) | Crosswalk to 83006: 9 Crosswalk to 83520: 3 Gapfill: 0 Abstain: 0 | Crosswalk to 83520 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code and continues to believe a crosswalk to CPT 83520 is appropriate as both codes use similar methods. | |||||||||||||||||
6 | 4 | 96 | 0X46U | PLA | Chemistry | Hepatology (nonalcoholic fatty liver disease [NAFLD]), semiquantitative evaluation of 28 lipid markers by liquid chromatography with tandem mass spectrometry (LC-MS/MS), serum, reported as at-risk for nonalcoholic steatohepatitis (NASH) or not NASH | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
7 | 5 | 98 | 0X48U | PLA | Chemistry | Beta amyloid, Aβ40 and Aβ42 by liquid chromatography with tandem mass spectrometry (LC-MS/MS), ratio, plasma | Gapfill: 12 Abstain: 0 | Crosswalk to 82542 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
8 | 6 | 14 | 0298U | PLA | Genomic Sequencing Related Tests WHOLE GENOME Drug metabolism pharmacogenomics/pharmcogenetics | Oncology (pan tumor), whole transcriptome sequencing of paired malignant and normal RNA specimens, fresh or formalin-fixed paraffin-embedded (FFPE) tissue, blood or bone marrow, comparative sequence analyses and expression level and chimeric transcript identification | Crosswalk to 0266U TIMES 1.5: 10 Gapfill: 2 Abstain: 0 | Crosswalk to 0204U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
9 | 7 | 13 | 0297U | PLA | Genomic Sequencing Related Tests WHOLE GENOME Drug metabolism pharmacogenomics/pharmcogenetics | Oncology (pan tumor), whole genome sequencing of paired malignant and normal DNA specimens, fresh or formalinfixed paraffin-embedded (FFPE) tissue, blood or bone marrow, comparative sequence analyses and variant identification | Crosswalk to 0265U TIMES 1.5: 10 Crosswalk to 0013U: 0 Crosswalk to 81425: 0 Gapfill: 2 Abstain: 0 | Crosswalk to 81425 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
10 | 8 | 15 | 0299U | PLA | Genomic Sequencing Related Tests WHOLE GENOME Drug metabolism pharmacogenomics/pharmcogeneticsts | Oncology (pan tumor), whole genome optical genome mapping of paired malignant and normal DNA specimens, fresh frozen tissue, blood, or bone marrow, comparative structural variant identification | Crosswalk to 0264U TIMES 1.5: 10 Gapfill: 2 Abstain: 0 | Gapfill | CMS agrees with the minority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
11 | 9 | 16 | 0300U | PLA | Genomic Sequencing Related Tests WHOLE GENOME Drug metabolism pharmacogenomics/pharmcogeneticsts | Oncology (pan tumor), whole genome sequencing and optical genome mapping of paired malignant and normal DNA specimens, fresh tissue, blood, or bone marrow, comparative sequence analyses and variant identification | Crosswalk to 0267U TIMES 1.5: 10 Gapfill: 2 Abstain: 0 | Gapfill | CMS agrees with the minority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
12 | 10 | 70 | 8X000 | NEW | Genomic Sequencing Related Tests TARGETED Drug metabolism pharmacogenomics/pharmcogenetics | Drug metabolism (eg, pharmacogenomics) genomic sequence analysis panel, must include testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysis | Crosswalk to 81225 + 0070U: 1 Crosswalk to 81435 + 81436: 0 Crosswalk to 81413 + 81414: 0 Gapfill: 11 Abstain: 0 | Crosswalk to 0029U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
13 | 11 | 95 | 0X45U | PLA | Genomic Sequencing Related Tests TARGETED Drug metabolism pharmacogenomics/pharmcogenetics | Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 27 gene report, with variant analysis including reported phenotypes and impacted gene-drug interactions | Gapfill: 12 Abstain: 0 | Crosswalk to 0029U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
14 | 12 | 97 | 0X47U | PLA | Genomic Sequencing Related Tests TARGETED Drug metabolism pharmacogenomics/pharmcogenetics | Psychiatry (eg, depression, anxiety, attention deficit hyperactivity disorder [ADHD]), genomic analysis panel, variant analysis of 15 genes, including deletion/duplication analysis of CYP2D6 | Crosswalk to 0175U: 12 Gapfill: 0 Abstain: 0 | Crosswalk 0175U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
15 | 13 | 99 | 0X50U | PLA | Genomic Sequencing Related Tests TARGETED Drug metabolism pharmacogenomics/pharmcogenetics | Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 25 gene report, with variant analysis and reported phenotypes | Gapfill: 12 Abstain: 0 | Crosswalk to 0029U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
16 | 14 | 100 | 0X51U | PLA | Genomic Sequencing Related Tests TARGETED Drug metabolism pharmacogenomics/pharmcogenetics | Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 16 gene report, with variant analysis and reported phenotypes | Crosswalk to 0175U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 0175U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
17 | 15 | 101 | 0X52U | PLA | Genomic Sequencing Related Tests TARGETED Drug metabolism pharmacogenomics/pharmcogenetics | Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 27 gene report, with variant analysis and reported phenotypes | Crosswalk to 0175U: 4 Gapfill: 8 Abstain: 0 | Crosswalk to 0175U | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
18 | 16 | 2 | 0286U | PLA | Genomic Sequencing Related Tests TARGETED Drug metabolism pharmacogenomics/pharmcogenetics | CEP72 (centrosomal protein, 72-KDa), NUDT15 (nudix hydrolase 15) and TPMT (thiopurine S-methyltransferase) (eg, drug metabolism) gene analysis, common variants | Gapfill: 12 Abstain: 0 | Crosswalk to 0030U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
19 | 17 | 67 | 0331U | PLA | Genomic Sequencing Related Tests WHOLE GENOME | Oncology (hematolymphoid neoplasia), optical genome mapping for copy number alterations and gene rearrangements utilizing DNA from blood or bone marrow, report of clinically significant alternations | Crosswalk to 81229: 12 Gapfill: 0 Abstain: 0 | Gapfill | CMS disagrees with the recommendation of the CDLT Panel and recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
20 | 18 | 88 | 0X38U | PLA | Genomic Sequencing Related Tests WHOLE GENOME | Rare diseases (constitutional/heritable disorders), whole genome sequence analysis, including small sequence changes, copy number variants, deletions, duplications, mobile element insertions, uniparental disomy (UPD), inversions, aneuploidy, mitochondrial genome sequence analysis with heteroplasmy and large deletions, short tandem repeat (STR) gene expansions, blood or saliva, identification and categorization of genetic variants, each comparator genome (eg, parent) | Crosswalk to 0215U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 0215U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
21 | 19 | 86 | 0X36U | PLA | Genomic Sequencing Related Tests WHOLE GENOME | Rare diseases (constitutional/heritable disorders), whole genome sequence analysis, including small sequence changes, copy number variants, deletions, duplications, mobile element insertions, uniparental disomy (UPD), inversions, aneuploidy, mitochondrial genome sequence analysis with heteroplasmy and large deletions, short tandem repeat (STR) gene expansions, fetal sample, identification and categorization of genetic variants | Crosswalk to 0214U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 0214U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
22 | 20 | 91 | 0X41U *Code has Advanced Diagnostic Laboratory Test (ADLT) status | PLA | Genomic Sequencing Related Tests WHOLE GENOME | Oncology (pan-cancer), analysis of minimal residual disease (MRD) from plasma, with assays personalized to each patient based on prior next-generation sequencing of the patient’s tumor and germline DNA, reported as absence or presence of MRD, with disease-burden correlation, if appropriate | Gapfill: 12 Abstain: 0 *Code has Advanced Diagnostic Laboratory Test (ADLT) status | Test is ADLT. | N/A | |||||||||||||||||
23 | 21 | 22 | 0306U | PLA | Genomic Sequencing Related Tests TARGETED; cf DNA | Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis, cell-free DNA, initial (baseline) assessment to determine a patient-specific panel for future comparisons to evaluate for MRD (Do not report 0306U in conjunction with 0307U) | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
24 | 22 | 23 | 0307U | PLA | Genomic Sequencing Related Tests TARGETED; cf DNA | Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis of a patient-specific panel, cell-free DNA, subsequent assessment with comparison to previously analyzed patient specimens to evaluate for MRD (Do not report 0307U in conjunction with 0306U) | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
25 | 23 | 34 | 0318U | PLA | Genomic Sequencing Related Tests TARGETED METHYLATION ANALYSIS | Pediatrics (congenital epigenetic disorders), whole genome methylation analysis by microarray for 50 or more genes, blood | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
26 | 24 | 57 | 0229U | Reconsideration/ Substantially Revised | Genomic Sequencing Related Tests TARGETED METHYLATION ANALYSIS | BCAT1 (Branched chain amino acid transaminase 1) and IKZF1 (IKAROS family zinc finger 1) (eg, colorectal cancer) promoter methylation analysis | Crosswalk to 81327 x 2: 11 Crosswalk to 81327: 1 Gapfill: 0 Abstain: 0 | Crosswalk to 81327 x 2 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
27 | 25 | 40 | 81349 | Reconsideration | Genomic Sequencing Related Tests TARGETED CHROMOSOME | Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number and loss-of-heterozygosity variants, low-pass sequencing analysis | Crosswalk to 81229 x 2: 1 Crosswalk to 81229: 11 Gapfill: 0 Abstain: 0 | Crosswalk to 81229 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
28 | 26 | 92 | 0X42U | PLA | Genomic Sequencing Related Tests TARGETED CHROMOSOME | Fetal aneuploidy DNA sequencing comparative analysis, fetal DNA from products of conception, reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplication, mosaicism, and segmental aneuploid | Gapfill: 11 Abstain: 1 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
29 | 27 | 71 | 814XX | NEW | Genomic Sequencing Related Tests TARGETED | Inherited bone marrow failure syndromes (IBMFS) (eg, Fanconi anemia, dyskeratosis congenita, Diamond-Blackfan anemia, Shwachman-Diamond syndrome, GATA2 deficiency syndrome, congenital amegakaryocytic thrombocytopenia) sequence analysis panel, must include sequencing of at least 30 genes, including BRCA2, BRIP1, DKC1, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, GATA1, GATA2, MPL, NHP2, NOP10, PALB2, RAD51C, RPL11, RPL35A, RPL5, RPS10, RPS19, RPS24, RPS26, RPS7, SBDS, TERT, and TINF2 | Crosswalk to 81443: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81443 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
30 | 28 | 85 | 0X35U | PLA | Genomic Sequencing Related Tests TARGETED VARIANTS, REARRANGEMENTS, MICROSATELLITE INSTABILITY | Oncology (solid organ), targeted genomic sequence analysis, formalin-fixed paraffin-embedded (FFPE) tumor tissue, DNA analysis, 84 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden | Crosswalk to 0244U: 11 Gapfill: 1 | Crosswalk to 81455 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
31 | 29 | 82 | 0276U | Revision | Genomic Sequencing Related Tests TARGETED | Hematology (inherited thrombocytopenia), genomic sequence analysis of 42 genes, blood, buccal swab, or amniotic fluid | Crosswalk to 81443: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81443 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
32 | 30 | 69 | 0022U | Reconsideration | Genomic Sequencing Related Tests TARGETED VARIANTS; DNA and RNA | Targeted genomic sequence analysis panel, cholangiocarcinoma and non-small cell lung neoplasia, DNA and RNA analysis, 1-23 genes, interrogation for sequence variants and rearrangements, reported as presence/absence of variants and associated therapy(ies) to consider | Crosswalk to 0022U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81445 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
33 | 31 | 72 | 814X1 | NEW | Genomic Sequencing Related Tests TARGETED VARIANTS, REARRANGEMENTS | Targeted genomic sequence analysis panel, solid organ neoplasm, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed; RNA analysis | Crosswalk to 81445: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81445 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
34 | 32 | 76 | 81445 | NEW | Genomic Sequencing Related Tests TARGETED VARIANTS, REARRANGEMENTS | Targeted genomic sequence analysis panel, solid organ neoplasm, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed; DNA analysis or combined DNA and RNA analysis | Crosswalk to 81445: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81445 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
35 | 33 | 74 | 814X3 | NEW | Genomic Sequencing Related Tests TARGETED VARIANTS, REARRANGEMENTS, ISOFORM; RNA; EXPRESSION | Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm or disorder, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed; RNA analysis | Crosswalk to 81455: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81455 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
36 | 34 | 62 | 0326U | PLA | Genomic Sequencing Related Tests TARGETED VARIANTS, REARRANGEMENTS, MICORSATELLITE INSTABILITY | Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 83 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden | Crosswalk to 0242U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81455 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
37 | 35 | 73 | 814X2 | NEW | Genomic Sequencing Related Tests TARGETED VARIANTS, REARRANGEMENTS, ISOFORM EXPRESSION | Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed; RNA analysis | Crosswalk to 81450: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81450 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
38 | 36 | 90 | 0X40U | PLA | Genomic Sequencing Related Tests TARGETED; mRNA | Oncology (prostate), mRNA expression profiling of HOXC6 and DLX1, reverse transcription polymerase chain reaction (RT-PCR), first-void urine following digital rectal examination, algorithm reported as probability of high-grade cancer | Crosswalk to 0005U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 0005U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
39 | 37 | 32 | 0316U | PLA | Microbiology | Borrelia burgdorferi (Lyme disease), OspA protein evaluation, urine | Crosswalk to 87449 + 87015: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 87499 + 87015 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
40 | 38 | 77 | 862XX 8X002 | NEW | Microbiology | Hepatitis B surface antigen (HBsAg), quantitative | Crosswalk to 86316: 3 Crosswalk to 84702: 8 Gapfill: 1 Abstain: 0 | Crosswalk to 84702 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
41 | 39 | 68 | 87913 879X1 | NEW | Microbiology | Infectious agent genotype analysis by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), mutation identification in targeted region(s) | Crosswalk to 87910: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 87910 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
42 | 40 | 78 | 87X68 8X009 | NEW | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA); Anaplasma phagocytophilum, amplified probe technique | Crosswalk to 87476: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 87476 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
43 | 41 | 79 | 87X70 8X010 | NEW | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA); Babesia microti, amplified probe technique | Crosswalk to 87476: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 87476 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
44 | 42 | 80 | 87X77 8X011 | NEW | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA); Borrelia miyamotoi, amplified probe technique | Crosswalk to 87476: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 87476 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
45 | 43 | 81 | 87X99 8X012 | NEW | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA); Ehrlichia chaffeensis, amplified probe technique | Crosswalk to 87476: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 87476 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
46 | 44 | 27 | 0311U | PLA | Microbiology | Infectious disease (bacterial), quantitative antimicrobial susceptibility reported as phenotypic minimum inhibitory concentration (MIC)–based antimicrobial susceptibility for each organism identified (Do not report 0311U in conjunction with 87076, 87077, 0086U) | Gapfill: 11 Abstain: 1 | Crosswalk to 87077 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
47 | 45 | 17 | 0301U | PLA | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA), Bartonella henselae and Bartonella quintana, droplet digital PCR (ddPCR); | Crosswalk to 87471: 4 Crosswalk to 87472: 0 Gapfill: 8 Abstain: 0 | Crosswalk to 87471 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
48 | 46 | 18 | 0302U | PLA | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA), Bartonella henselae and Bartonella quintana, droplet digital PCR (ddPCR); following liquid enrichment | Crosswalk to 87471: 3 Crosswalk to 87472: 0 Gapfill: 8 Abstain: 1 | Crosswalk to 87471 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
49 | 47 | 37 | 0321U | PLA | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogens, identification of 20 bacterial and fungal organisms and identification of 16 associated antibiotic-resistance genes, multiplex amplified probe technique | Crosswalk to 87633 + 87632: 11 Gapfill: 1 Abstain: 0 | Crosswalk to 87633 + 87632 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
50 | 48 | 59 | 0323U | PLA | Microbiology | Infectious agent detection by nucleic acid (DNA and RNA), central nervous system pathogen, metagenomic next-generation sequencing, cerebrospinal fluid (CSF), identification of pathogenic bacteria, viruses, parasites or fungi | Crosswalk to 0152U: 8 Gapfill: 3 Abstain: 1 | Crosswalk to 0152U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
51 | 49 | 66 | 0330U | PLA | Microbiology | Infectious agent detection by nucleic acid (DNA or RNA), vaginal pathogen panel, identification of 27 organisms, amplified probe technique, vaginal swab | Crosswalk to 87633: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 87633 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
52 | 50 | 103 | 0X54U | PLA | Microbiology | Infectious disease (bacterial vaginosis and vaginitis), multiplex amplified probe technique, for detection of bacterial vaginosis–associated bacteria (BVAB-2, Atopobium vaginae, and Megasphera type 1), algorithm reported as detected or not detected and separate detection of Candida species (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata/Candida krusei, and trichomonas vaginalis, vaginal-fluid specimen, each result reported as detected or not detected | Crosswalk to 87631: 11 Gapfill: 0 Abstain: 1 | Crosswalk to 87631 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
53 | 51 | 104 | 0X55U | PLA | Microbiology | Infectious agent detection by nucleic acid (DNA), Chlamydia trachomatis and Neisseria gonorrhoeae, multiplex amplified probe technique, urine, vaginal, pharyngeal, or rectal, each pathogen reported as detected or not detected | Crosswalk to 87491 + 87591: 11 Gapfill: 0 Abstain: 1 | Crosswalk to 87491 + 87591 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
54 | 52 | 19 | 0303U | PLA | Hematology and Coagulation | Hematology, red blood cell (RBC) adhesion to endothelial/subendothelial adhesion molecules, functional assessment, whole blood, with algorithmic analysis and result reported as an RBC adhesion index; hypoxic | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
55 | 53 | 20 | 0304U | PLA | Hematology and Coagulation | Hematology, red blood cell (RBC) adhesion to endothelial/subendothelial adhesion molecules, functional assessment, whole blood, with algorithmic analysis and result reported as an RBC adhesion index; normoxic | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
56 | 54 | 21 | 0305U | PLA | Hematology and Coagulation | Hematology, red blood cell (RBC) functionality and deformity as a function of shear stress, whole blood, reported as a maximum elongation index | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
57 | 55 | 1 | 0285U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology, response to radiation, cell-free DNA, quantitative branched chain DNA amplification, plasma, reported as a radiation toxicity score | Crosswalk to 81595: 0 Crosswalk to 0118U: 0 Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
58 | 56 | 3 | 0287U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (thyroid), DNA and mRNA, next generation sequencing analysis of 112 genes, fine needle aspirate or formalinfixed paraffin-embedded (FFPE) tissue, algorithmic prediction of cancer recurrence, reported as a categorical risk result (low, intermediate, high) | Crosswalk to 0026U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 0026U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
59 | 57 | 4 | 0288U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (lung), mRNA, quantitative PCR analysis of 11 genes (BAG1, BRCA1, CDC6, CDK2AP1, ERBB3, FUT3, IL11, LCK, RND3, SH3BGR, WNT3A) and 3 reference genes (ESD, TBP, YAP1), formalin-fixed paraffin-embedded (FFPE) tumor tissue, algorithmic interpretation reported as a recurrence risk score | Crosswalk to 81522: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81522 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
60 | 58 | 5 | 0289U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Neurology (Alzheimer disease), mRNA, gene expression profiling by RNA sequencing of 24 genes, whole blood, algorithm reported as predictive risk score | Crosswalk to 0239U: 1 Crosswalk to 0203U: 6 Gapfill: 5 Abstain: 0 | Crosswalk to 0203U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
61 | 59 | 6 | 0290U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Pain management, mRNA, gene expression profiling by RNA sequencing of 36 genes, whole blood, algorithm reported as predictive risk score | Crosswalk to 0239U: 0 Crosswalk to 0203U: 6 Gapfill: 6 Abstain: 0 | Crosswalk to 0203U | CMS agrees with the half of the CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
62 | 60 | 7 | 0291U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Psychiatry (mood disorders), mRNA, gene expression profiling by RNA sequencing of 144 genes, whole blood, algorithm reported as predictive risk score | Crosswalk to 0239U: 0 Crosswalk to 0258U: 2 Gapfill: 10 Abstain: 0 | Crosswalk to 0239U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
63 | 61 | 8 | 0292U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Psychiatry (stress disorders), mRNA, gene expression profiling by RNA sequencing of 72 genes, whole blood, algorithm reported as predictive risk score | Crosswalk to 0239U: 0 Crosswalk to 0258U: 1 Gapfill: 11 Abstain: 0 | Crosswalk to 0239U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
64 | 62 | 9 | 0293U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Psychiatry (suicidal ideation), mRNA, gene expression profiling by RNA sequencing of 54 genes, whole blood, algorithm reported as predictive risk score | Crosswalk to 0239U: 0 Crosswalk to 0258U: 1 Gapfill: 11 Abstain: 0 | Crosswalk to 0203U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
65 | 63 | 10 | 0294U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Longevity and mortality risk, mRNA, gene expression profiling by RNA sequencing of 18 genes, whole blood, algorithm reported as predictive risk score | Crosswalk to 0239U: 0 Crosswwalk to 0175U: 2 Gapfill: 10 Abstain: 0 | Crosswalk to 0203U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
66 | 64 | 11 | 0295U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (breast ductal carcinoma in situ), protein expression profiling by immunohistochemistry of 7 proteins (COX2, FOXA1, HER2, Ki-67, p16, PR, SIAH2), with 4 clinicopathologic factors (size, age, margin status, palpability), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a recurrence risk score | Crosswalk to 0045U: 0 Crosswalk to 0067U: 10 Gapfill: 2 Abstain: 0 | Crosswalk to 0067U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
67 | 65 | 24 | 0308U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Cardiology (coronary artery disease [CAD]), analysis of 3 proteins (high sensitivity [hs] troponin, adiponectin, and kidney injury molecule-1 [KIM-1]), plasma, algorithm reported as a risk score for obstructive CAD | Crosswalk to 0105U: 1 Crosswalk to 81506: 10 Gapfill: 1 Abstain: 0 | Crosswalk to 81506 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
68 | 66 | 65 | 0329U | PLA | Genomic Sequencing Related Tests TARGETED EXOME TRANSCRIPTOME, VARIANTS, REARRANGEMENTS, MICORSATELLITE INSTABILITY | Oncology (neoplasia), exome and transcriptome sequence analysis for sequence variants, gene copy number amplifications and deletions, gene rearrangements, microsatellite instability and tumor mutational burden utilizing DNA and RNA from tumor with DNA from normal blood or saliva for subtraction, report of clinically significant mutation(s) with therapy associations | Crosswalk to 0036U: 5 Gapfill: 7 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
69 | 67 | 25 | 0309U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Cardiology (cardiovascular disease), analysis of 4 proteins (NT-proBNP, osteopontin, tissue inhibitor of metalloproteinase-1 [TIMP-1], and kidney injury molecule-1 [KIM-1]), plasma, algorithm reported as a risk score for major adverse cardiac event | Crosswalk to 0105U: 1 Crosswalk to 81506: 9 Gapfill: 2 Abstain: 0 | Crosswalk to 81506 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
70 | 68 | 26 | 0310U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Pediatrics (vasculitis, Kawasaki disease [KD]), analysis of 3 biomarkers (NTproBNP, C-reactive protein, and T-uptake), plasma, algorithm reported as a risk score for KD | Crosswalk to 0105U: 0 Crosswalk to 81506: 11 Gapfill: 1 Abstain: 0 | Crosswalk to 81506 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
71 | 69 | 63 | 0327U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Fetal aneuploidy (trisomy 13, 18, and 21), DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy, includes sex reporting, if performed | Crosswalk to 81420: 0 Crosswalk to 81507: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 81507 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
72 | 70 | 33 | 0317U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (lung cancer), four-probe FISH (3q29, 3p22.1, 10q22.3, 10cen) assay, whole blood, predictive algorithm generated evaluation reported as decreased or increased risk for lung cancer | Crosswalk to 0053U: 1 Gapfill: 11 Abstain: 0 | Crosswalk to 0053U | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
73 | 71 | 35 | 0319U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Nephrology (renal transplant), RNA expression by select transcriptome sequencing, using pretransplant peripheral blood, algorithm reported as a risk score for early acute rejection | Crosswalk to 81542: 0 Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
74 | 72 | 36 | 0320U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Nephrology (renal transplant), RNA expression by select transcriptome sequencing, using posttransplant peripheral blood, algorithm reported as a risk score for acute cellular rejection | Crosswalk to 81542: 0 Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
75 | 73 | 30 | 0314U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 35 genes (32 content and 3 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical result (ie, benign, intermediate, malignant) | Crosswalk to 81529: 8 Crosswalk to 0090U: 4 Gapfill: 0 Abstain: 0 | Crosswalk to 0090U | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
76 | 74 | 31 | 0315U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (cutaneous squamous cell carcinoma), mRNA gene expression profiling by RT-PCR of 40 genes (34 content and 6 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical risk result (ie, Class 1, Class 2A, Class 2B) | Crosswalk to 81529: 7 Gapfill: 5 Abstain: 0 | Crosswalk to 0090U | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
77 | 75 | 12 | 0296U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (oral and/or oropharyngeal cancer), gene expression profiling by RNA sequencing at least 20 molecular features (eg, human and/or microbial mRNA), saliva, algorithm reported as positive or negative for signature associated with malignancy | Crosswalk to 0170U: 8 Gapfill: 4 Abstain: 0 | Crosswalk to 0170U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
78 | 76 | 58 | 0245U | Reconsideration | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (thyroid), mutation analysis of 10 genes and 37 RNA fusions and expression of 4 mRNA markers using next-generation sequencing, fine needle aspirate, report includes associated risk of malignancy expressed as a percentage) | Crosswalk to 81455: 4 Gapfill: 8 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
79 | 77 | 29 | 0313U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (pancreas), DNA and mRNA next-generation sequencing analysis of 74 genes and analysis of CEA (CEACAM5) gene expression, pancreatic cyst fluid, algorithm reported as a categorical result (ie, negative, low probability of neoplasia or positive, high probability of neoplasia) | Crosswalk to 0026U: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 0026U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
80 | 78 | 60 | 0324U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (ovarian), spheroid cell culture, 4-drug panel (carboplatin, doxorubicin, gemcitabine, paclitaxel), tumor chemotherapy response prediction for each drug | Crosswalk to 0248U: 7 Gapfill: 4 Abstain: 1 | Crosswalk to 81535 + 81536 x 3 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
81 | 79 | 61 | 0325U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (ovarian), spheroid cell culture, poly (ADP-ribose) polymerase (PARP) inhibitors (niraparib, olaparib, rucaparib, velparib), tumor response prediction for each drug | Crosswalk to 0248U: 8 Gapfill: 3 Abstain: 1 | Crosswalk to 81535 + 81536 x 3 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
82 | 80 | 83 | 0X33U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score THERAPY | Oncology (pan-tumor), genetic profiling of 8 DNA-regulatory (epigenetic) markers by quantitative polymerase chain reaction (qPCR), whole blood, reported as a high or low probability of responding to immune checkpoint–inhibitor therapy | Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
83 | 81 | 84 | 0X34U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Oncology (liver), surveillance for hepatocellular carcinoma (HCC) in high-risk patients, analysis of methylation patterns on circulating cell-free DNA (cfDNA) plus measurement of serum of AFP/AFP-L3 and oncoprotein des-gamma-carboxy-prothrombin (DCP), algorithm reported as normal or abnormal result | Crosswalk to 81420 + 82107 +83951: 0 Gapfill: 12 Abstain: 0 | Gapfill | CMS agrees with the majority recommendation of the CDLT Panel to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). | |||||||||||||||||
84 | 82 | 94 | 0X44U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score (darkest highlight) | Oncology (prostate), exosome-based analysis of 442 small noncoding RNAs (sncRNAs) by quantitative reverse transcription polymerase chain reaction (RT-qPCR), urine, reported as molecular evidence of no-, low-, intermediate- or high- risk prostate of cancer | Crosswalk to 0005U: 8 Gapfill: 4 Abstain: 0 | Crosswalk to 0005U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
85 | 83 | 38 | 0322U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score/ Chemistry | Neurology (autism spectrum disorder [ASD]), quantitative measurements of 14 acyl carnitines and microbiome-derived metabolites, liquid chromatography with tandem mass spectrometry (LC-MS/MS), plasma, results reported as negative or positive for risk of metabolic subtypes associated with ASD | Crosswalk to 0063U: 7 Gapfill: 5 Abstain: 0 | Crosswalk to 0063U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
86 | 84 | 64 | 0328U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Drug assay, definitive, 120 or more drugs and metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS), includes specimen validity and algorithmic analysis describing drug or metabolite and presence or absence of risks for a significant patient adverse event, per date of service | Crosswalk to 0143U: 5 Crosswalk to 0150U: 1 Gapfill 6 Abstain: 0 | Crosswalk to 0143U | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
87 | 85 | 102 | 0X53U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score | Infectious disease (bacterial or viral), biochemical assays, tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-induced protein-10 (IP-10), and C-reactive protein, serum, algorithm reported as likelihood of bacterial infection | Crosswalk to 81500: 10 Gapfill: 1 Abstain: 1 | Crosswalk to 81500 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
88 | 86 | 93 | 0X43U | PLA | Tests with algorithm in code descriptor to report risk/likelihood/predictive score ELECTROCHEMILUMINESCENT IMMUNOASSAY (ECLIA) + ALGORITHM | Oncology (pancreatic cancer), multiplex immunoassay of C5, C4, cystatin C, factor B, osteoprotegerin (OPG), gelsolin, IGFBP3, CA125 and multiplex electrochemiluminescent immunoassay (ECLIA) for CA19-9, serum, diagnostic algorithm reported qualitatively as positive, negative, or borderline | Crosswalk to 81503: 10 Crosswalk to 81490: 1 Gapfill: 1 Abstain: 0 | Crosswalk to 81503 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
89 | 87 | 28 | 0312U | PLA | Immunology ELISA | Autoimmune diseases (eg, systemic lupus erythematosus [SLE]), analysis of 8 IgG autoantibodies and 2 cell-bound complement activation products using enzyme-linked immunosorbent immunoassay (ELISA), flow cytometry and indirect immunofluorescence, serum, or plasma and whole blood, individual components reported along with an algorithmic SLE-likelihood assessment | Crosswalk to 0062U: 9 Crosswalk to 0003U: 3 Abstain: 0 | Crosswalk to 81490 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
90 | 88 | 42 | 86015 | Reconsideration | Immunology | Actin (smooth muscle) antibody (ASMA), each | Crosswalk to 86146: 9 Crosswalk to 83516: 2 Gapfill: 1 Abstain: 0 | Crosswalk to 86255 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
91 | 89 | 43 | 86036 | Reconsideration | Immunology | ANCA screen, each | Crosswalk to 86146: 10 Crosswalk to 84586: 0 Crosswalk to 86255: 2 Gapfill: 0 Abstain: 0 | Crosswalk to 86255 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
92 | 90 | 44 | 86037 | Reconsideration | Immunology | ANCA titer | Crosswalk to 86146: 8 Crosswalk to 86256: 4 Gapfill: 0 Abstain: 0 | Crosswalk to 86256 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
93 | 91 | 45 | 86051 | Reconsideration | Immunology | Aquaporin-4 (neuromyelitis optica [NMO]) antibody; enzyme-linked immunosorbent immunoassay (ELISA) | Crosswalk to 86146: 11 Crosswalk to 83516: 1 Gapfill: 0 Abstain: 0 | Crosswalk to 83516 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
94 | 92 | 46 | 86052 | Reconsideration | Immunology | Aquaporin-4 (neuromyelitis optica [NMO]) antibody; cell-based immunofluorescence assay (CBA), each | Crosswalk to 86341: 12 Crosswalk to 86255: 0 Gapfill: 0 Abstain: 0 | Crosswalk to 86255 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
95 | 93 | 47 | 86053 | Reconsideration | Immunology | Aquaporin-4, flow cytometry (ie, fluorescence-activated cell sorting [FACS]) | Crosswalk to 86367: 12 Crosswalk to 86255: 0 Gapfill: 0 Abstain: 0 | Crosswalk to 86357 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. A public comment suggested this crosswalk for a different test that also counts cells in a similar way. | |||||||||||||||||
96 | 94 | 48 | 86231 | Reconsideration | Immunology | Endomysial antibody | Crosswalk to 86038 x 2: 5 Crosswalk to 86038: 3 Gapfill: 4 Abstain: 0 | Crosswalk to 86038 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
97 | 95 | 49 | 86258 | Reconsideration | Immunology | Gliadin (deamidated) (DGP) antibody | Crosswalk to 86147: 11 Crosswalk to 83516: 1 Gapfill: 0 Abstain: 0 | Crosswalk to 86255 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
98 | 96 | 50 | 86362 | Reconsideration | Immunology | MOG IgG1, cell-based immunofluorescence assay | Crosswalk to 86357: 12 Gapfill: 0 Abstain: 0 | Crosswalk to 86255 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
99 | 97 | 51 | 86363 | Reconsideration | Immunology | MOG IgG1, flow cytometry (ie, fluorescence-activated cell sorting [FACS] | Crosswalk to 86367: 12 Crosswalk to 86255: 0 Gapfill: 0 Abstain: 0 | Crosswalk to 86357 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
100 | 98 | 52 | 86364 | Reconsideration | Immunology | Tissue transglutaminase, each immunoglobulin | Crosswalk 86147: 11 Crosswalk 83516: 1 Gapfill: 0 Abstain: 0 | Crosswalk to 83516 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||