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1 | Calendar Year (CY) 2022 Clinical Laboratory Fee Schedule (CLFS) Preliminary Payment Determinations1 This worksheet “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 21, 2021 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 2020 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 Panel Item # | ALM Item # | Code Type | Category | Code # | Long Code Descriptor | CDLT Panel Voting Results | CMS 2021 Prelim Recommendation | Rationale | |||||||||||||||||
3 | 1 | 7 | NEW | Proprietary Laboratory Analyses/ Immunology | 0226U | Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum | 1. Crosswalk to: 86769: 12 | 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). | |||||||||||||||||
4 | 2 | 8 | NEW | Immunology / Immunology | 86413 | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody,quantitative | 1. Crosswalk to: 86769 x 1.25: 3 2. Crosswalk to 86769 x 2: 8 3. Abstain: 1 | 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). | |||||||||||||||||
5 | 3 | 63 | NEW | Immunology / Immunology | 863X4 | Mitochondrial antibody (eg, M2), each | 1. Crosswalk to 86146: 12 | Crosswalk to 86146 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
6 | 4 | 64 | NEW | Immunology / Immunology | 865X0 | Voltage-gated calcium channel antibody, each | 1. Crosswalk to 84586: 12 | Crosswalk to 83519 | CMS disagrees with the Panel Recommendation and instead is recommending a different crosswalk. Currently a VGCC antibody panel is billed using 83519x2 and looks at 2 antibodies. Therefore, CMS recommends that for each VGCC antibody, the crosswalk should be to 83519x1. | |||||||||||||||||
7 | 5 | 65 | NEW | Immunology / Immunology | 86XX0 | Actin (smooth muscle) antibody (ASMA), each | 1. Crosswalk to 86146: 2 2. Crosswalk to 83516: 10 | Crosswalk to 83516 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
8 | 6 | 66 | NEW | Immunology / Immunology | 86X00 | Antineutrophil cytoplasmic antibody (ANCA); screen, each antibody | 1. Crosswalk to 86146: 2 2. Crosswalk to 86255: 10 | Crosswalk to 86255 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
9 | 7 | 67 | NEW | Immunology / Immunology | 86X01 | Antineutrophil cytoplasmic antibody (ANCA); titer, each antibody | 1. Crosswalk to 86256: 12 | Crosswalk to 86256 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
10 | 8 | 79 | NEW | Proprietary Laboratory Analyses: Immunology/ Immunology | 0X65U | Hematology (heparin-induced thrombocytopenia) platelet antibody reactivity by flow cytometry, serum | 1. Gapfill: 12 | Crosswalk to 86022 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
11 | 9 | 80 | NEW | Proprietary Laboratory Analyses: Immunology/ Immunology | 0X66U | Hematology (von Willebrand disease [VWD]), von Willebrand factor (VWF) and collagen IV binding by enzyme-linked immunosorbent assays (ELISA), plasma, report of collagen IV binding | 1. Crosswalk to 83520: 11 2. Abstain: 1 | Crosswalk to 83520 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
12 | 10 | 81 | NEW | Proprietary Laboratory Analyses: Immunology/ Immunology | 0X67U | Hematology (von Willebrand disease [VWD]), von Willebrand propeptide, enzyme-linked immunosorbent assays (ELISA), plasma, diagnostic report of von Willebrand factor (VWF) propeptide antigen level | 1. Crosswalk to 83520: 6 2. Crosswalk to 85246: 5 3. Abstain: 1 | Crosswalk to 83520 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
13 | 11 | 82 | NEW | Proprietary Laboratory Analyses: Immunology/ Immunology | 0X68U | von Willebrand factor (VWF), type 2B, platelet-binding evaluation, radioimmunoassay, plasma | 1. Crosswalk to 83519: 11 2. Abstain: 1 | Crosswalk to 83519 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
14 | 12 | 83 | NEW | Proprietary Laboratory Analyses: Immunology/ Immunology | 0X69U | von Willebrand factor (VWD), type 2N, factor VIII and VWF binding evaluation, enzyme-linked immunosorbent assays (ELISA), plasma | 1. Crosswalk to 83520: 1 2. Crosswalk to 85246 x 1.5: 4 3. Crosswalk to 85246 x 2: 6 | Crosswalk to 83520 | CMS agrees with the minority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
15 | 13 | 40 | NEW | Immunology / Immunology | 860XX | Aquaporin-4 (neuromyelitis optica [NMO]) antibody; enzyme-linked immunosorbent immunoassay (ELISA) | 1. Crosswalk to 86146: 11 2. Abstain: 1 | Crosswalk to 83516 | 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 | 41 | NEW | Immunology / Immunology | 860X1 | Aquaporin-4 (neuromyelitis optica [NMO]) antibody; cell-based immunofluorescence assay (CBA), each | 1. Crosswalk to 86341: 11 2. Abstain: 1 | 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. | |||||||||||||||||
17 | 15 | 42 | NEW | Immunology / Immunology | 860X2 | Aquaporin-4 (neuromyelitis optica [NMO]) antibody; flow cytometry (ie, fluorescence-activated cell sorting [FACS]), each | 1. Crosswalk to 86367: 11 2. Abstain: 1 | 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. | |||||||||||||||||
18 | 16 | 43 | NEW | Immunology / Immunology | 863X2 | Myelin oligodendrocyte glycoprotein (MOG-IgG1) antibody; cell-based immunofluorescence assay (CBA), each | 1. Crosswalk to 86357: 11 2. Abstain: 1 | 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. | |||||||||||||||||
19 | 17 | 44 | NEW | Immunology / Immunology | 863X3 | Myelin oligodendrocyte glycoprotein (MOG-IgG1) antibody; flow cytometry (ie, fluorescence-activated cell sorting [FACS]), each | 1. Crosswalk to 86367: 11 2. Abstain: 1 | 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. | |||||||||||||||||
20 | 18 | 45 | NEW | Immunology / Immunology | 862X0 | Endomysial antibody (EMA), each immunoglobulin (Ig) class | 1. Crosswalk to 86038: 5 2. Crosswalk to 86038 x 2: 6 3. Abstain: 1 | 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. | |||||||||||||||||
21 | 19 | 46 | NEW | Immunology / Immunology | 862XX | Gliadin (deamidated) (DGP) antibody, each immunoglobulin (Ig) class | 1. Crosswalk to 86147: 11 2. Abstain: 1 | Crosswalk to 83516 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
22 | 20 | 47 | NEW | Immunology / Immunology | 862X1 | Tissue transglutaminase, each immunoglobulin (Ig) class | 1. Crosswalk to 86147: 11 2. Abstain: 1 | Crosswalk to 83516 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
23 | 21 | 98 | NEW | Proprietary Laboratory Analyses: Immunology/ Immunology | 0X85U | Hematology (von Willebrand disease [VWD]), von Willebrand factor (VWF) and collagen III binding by enzyme-linked immunosorbent assays (ELISA), plasma, report of collagen III binding | 1. Crosswalk to 83520: 4 2. Crosswalk to 85246: 7 3. Abstain: 1 | Crosswalk to 83516 | CMS disagrees with the Panel Recommendation and instead is recommending a crosswalk. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
24 | 22 | 4 | NEW | Immunology / Immunology | 86408 | Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); screen | 1. Crosswalk to 86769: 1 2. Gapfill: 11 | 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 | 5 | NEW | Immunology / Immunology | 86409 | Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); titer | 1. Gapfill: 12 | 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 | 1 | NEW | Microbiology: Immunoassay/ Microbiology | 87426 | Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) | 1. Crosswalk to 87430 x 2.5: 1 2. Crosswalk to 87430 x 2: 11 | 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). | |||||||||||||||||
27 | 25 | 2 | NEW | Proprietary Laboratory Analyses: Microbiology/ Microbiology | 0223U | Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected | 1. Crosswalk to 87633: 12 | 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. | |||||||||||||||||
28 | 26 | 3 | NEW | Proprietary Laboratory Analyses: Microbiology/ Microbiology | 0224U | Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), includes titer(s), when performed | 1. Crosswalk to 86769: 11 2. Abstain: 1 | 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). | |||||||||||||||||
29 | 27 | 9 | NEW | Proprietary Laboratory Analyses: Microbiology/ Microbiology | 0240U | Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 3 targets (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], influenza A, influenza B), upper respiratory specimen, each pathogen reported as detected or not detected | 1. Crosswalk to 87631: 11 2. 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. | |||||||||||||||||
30 | 28 | 10 | NEW | Proprietary Laboratory Analyses: Microbiology/ Microbiology | 0241U | Infectious disease (viral respiratory tract infection), pathogen-specific RNA, 4 targets (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], influenza A, influenza B, respiratory syncytial virus [RSV]), upper respiratory specimen, each pathogen reported as detected or not detected | 1. Crosswalk to 87631: 11 2. 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. | |||||||||||||||||
31 | 29 | 57 | NEW | Microbiology/ Microbiology | 87636 | Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique | 1. Crosswalk to 87631: 11 2. 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. | |||||||||||||||||
32 | 30 | 58 | NEW | Microbiology/ Microbiology | 87637 | Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique | 1. Crosswalk to 87631: 11 2. 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. | |||||||||||||||||
33 | 31 | 60 | NEW | Microbiology/ Microbiology | 87811 | Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) | 1. Crosswalk to 87804 x 2.5: 1 2. Crosswalk to 87804 x 2: 11 | 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). | |||||||||||||||||
34 | 32 | 68 | NEW | Microbiology/ Microbiology | 8715X | Culture, typing; identification of blood pathogen and resistance typing, when performed, by nucleic acid (DNA or RNA) probe, multiplexed amplified probe technique including multiplex reverse transcription, when performed, per culture or isolate, 6 or more targets | 1. Crosswalk to 87506: 11 2. Gapfill: 1 | Crosswalk to 87632 | CMS disagrees with the majority CDLT Panel recommended crosswalk for this code. Instead, CMS recommends a different crosswalk that appears to use similar methods and resource utilization. | |||||||||||||||||
35 | 33 | 59 | NEW | Microbiology/ Microbiology | 87428 | Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B | 1. Crosswalk to 87430 x2.5 + 87400 x 2: 2 2. Crosswalk to 87430 x 2 + 87400 x 2: 10 | Crosswalk to 87400+87449 | CMS agrees with the recommended crosswalk codes for this test, but disagrees with the use of multipliers. | |||||||||||||||||
36 | 34 | 11 | NEW | Proprietary Laboratory Analyses Chemistry / Drug Testing, Metabolism and Therapeutic monitoring | 0227U | Drug assay, presumptive, 30 or more drugs or metabolites, urine, liquid chromatography with tandem mass spectrometry (LC-MS/MS) using multiple reaction monitoring (MRM), with drug or metabolite description, includes sample validation | 1. Crosswalk to 80307: 12 | Crosswalk to 80307 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
37 | 35 | 53 | Reconsidered | Other Methods of Sequencing: Common variants / Other Methods of Sequencing/ Reconsidered | 81338 | MPL (MPL proto-oncogene, thrombopoietin receptor) (eg, myeloproliferative disorder) gene analysis; common variants (eg, W515A, W515K, W515L, W515R) | 1. Crosswalk to 81120: 12 | Crosswalk to 81402 | CMS disagrees with the recommendation of the CDLT Panel and commenters to crosswalk molecular pathology tests to different gene analysis tests. In the most recent years, CMS utilized codes known as “Tier 2 molecular pathology” test codes as crosswalks for these types of tests. Tier 2 molecular pathology test codes are based on ranges of genetic analysis (i.e. 2-5 exons, 3-5 genes). We finalized this crosswalking approach for the past three years as we believe it to be a more transparent and consistent method. | |||||||||||||||||
38 | 36 | 54 | Reconsidered | Other Methods of Sequencing: Targeted sequence analysis / Other Methods of Sequencing / Reconsidered | 81339 | MPL (MPL proto-oncogene, thrombopoietin receptor) (eg, myeloproliferative disorder) gene analysis; sequence analysis, exon 10 | 1. Crosswalk to 81310: 12 | Crosswalk to 81403 | CMS disagrees with the recommendation of the CDLT Panel and commenters to crosswalk molecular pathology tests to different gene analysis tests. In the most recent years, CMS utilized codes known as “Tier 2 molecular pathology” test codes as crosswalks for these types of tests. Tier 2 molecular pathology test codes are based on ranges of genetic analysis (i.e. 2-5 exons, 3-5 genes). We finalized this crosswalking approach for the past three years as we believe it to be a more transparent and consistent method. | |||||||||||||||||
39 | 37 | 61 | NEW | Therapeutic Drug Assay / Drug testing, Metabolism and Therapeutic monitoring | 801XX | Hydroxychloroquine | 1. Crosswalk to 80204: 12 | Crosswalk to 80299 | CMS disagrees with the majority CDLT Panel recommended crosswalk for this code. Instead, CMS recommends a different crosswalk that appears to use similar methods and resource utilization. | |||||||||||||||||
40 | 38 | 32 | NEW | Proprietary Laboratory Analyses Oncology therapeutic response / Drug Testing, Metabolism and Therapeutic monitoring | 0248U | Oncology (brain), spheroid cell culture in a 3D microenvironment, 12 drug panel, tumor-response prediction for each drug | 1. Gapfill: 12 | 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). | |||||||||||||||||
41 | 39 | 48 | Reconsidered | Chemistry: Drug Testing, Monitoring / Drug Testing, Metabolism and Therapeutic monitoring / Reconsidered | 80151 | Amiodarone | 1. Crosswalk to 80155: 12 | Crosswalk to 80299 | CMS disagrees with the majority CDLT Panel recommended crosswalk for this code. CMS continues to believe the original crosswalk recommendation is appropriate for this test. | |||||||||||||||||
42 | 40 | 49 | Reconsidered | Chemistry: Drug Testing, Monitoring / Drug Testing, Metabolism and Therapeutic monitoring / Reconsidered | 80161 | Carbamazepine; 10,11-epoxide | 1. Crosswalk to 80155: 12 | Crosswalk to 80299 | CMS disagrees with the majority CDLT Panel recommended crosswalk for this code. CMS continues to believe the original crosswalk recommendation is appropriate for this test. | |||||||||||||||||
43 | 41 | 50 | Reconsidered | Chemistry: Drug Testing, Monitoring / Drug Testing, Metabolism and Therapeutic monitoring / Reconsidered | 80167 | Felbamate | 1. Crosswalk to 80199: 12 | Crosswalk to 80299 | CMS disagrees with the majority CDLT Panel recommended crosswalk for this code. CMS continues to believe the original crosswalk recommendation is appropriate for this test. | |||||||||||||||||
44 | 42 | 51 | Reconsidered | Chemistry: Drug Testing, Monitoring / Drug Testing, Metabolism and Therapeutic monitoring / Reconsidered | 80181 | Flecainide | 1. Crosswalk to 80193: 2 2. Crosswalk to 80155: 10 | Crosswalk to 80299 | CMS disagrees with the majority CDLT Panel recommended crosswalk for this code. CMS continues to believe the original crosswalk recommendation is appropriate for this test. | |||||||||||||||||
45 | 43 | 52 | Reconsidered | Other Methods of Sequencing: Targeted sequence analysis / Other Methods of Sequencing/ Reconsidered | 81279 | JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) targeted sequence analysis (eg, exons 12 and 13) | 1. Crosswalk to 81272: 11 2. Crosswalk to 81403: 1 | Crosswalk to 81403 | CMS disagrees with the majority CDLT Panel recommended crosswalk for this code. CMS continues to believe the original crosswalk recommendation is appropriate for this test. | |||||||||||||||||
46 | 44 | 6 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0225U | Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and RNA, 21 targets, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected | 1. Crosswalk to 87633: 12 | 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. | |||||||||||||||||
47 | 45 | 12 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0228U | Oncology (prostate), multianalyte molecular profile by photometric detection of macromolecules adsorbed on nanosponge array slides with machine learning, utilizing first morning voided urine, algorithm reported as likelihood of prostate cancer | 1. Gapfill: 11 | 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). | |||||||||||||||||
48 | 46 | 55 | NEW | Multi-Analyte Assay with Algorithmic Analyses: Transplantation / Tests with algorithm in code descriptor to report risk/likelihood/predictive score | 815X0 | Transplantation medicine (allograft rejection, pediatric liver and small bowel), measurement of donor and third-party-induced CD154+T-cytotoxic memory cells, utilizing whole peripheral blood, algorithm reported as a rejection risk score | 1. Gapfill: 11 | 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). | |||||||||||||||||
49 | 47 | 56 | NEW | Multi-Analyte Assay with Algorithmic Analyses: Oncology breast / Tests with algorithm in code descriptor to report risk/likelihood/predictive score | 815X1 | Oncology (breast), mRNA, next-generation sequencing gene expression profiling of 70 content genes and 31 housekeeping genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as index related to risk to distant metastasis | 1. Crosswalk to 81521: 11 | Crosswalk to 81521 | 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 | 25 | NEW | Multi-Analyte Assay with Algorithmic Analyses: Oncology lymphoma/ Tests with algorithm in code descriptor to report risk/likelihood/predictive score | 0017M | Oncology (diffuse large B-cell lymphoma [DLBCL]), mRNA, gene expression profiling by fluorescent probe hybridization of 20 genes, formalin-fixed paraffin-embedded tissue, algorithm reported as cell of origin | 1. Crosswalk to 0120U: 11 | Crosswlk to 120U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. | |||||||||||||||||
51 | 49 | 26 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0243U | Obstetrics (preeclampsia), biochemical assay of placental-growth factor, time-resolved fluorescence immunoassay, maternal serum, predictive algorithm reported as a risk score for preeclampsia | 1. Crosswalk to 82731: 11 | Crosswalk to 82731 | 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 | 69 | NEW | Multi-Analyte Assay with Algorithmic Analyses / Tests with algorithm in code descriptor to report risk/likelihood/predictive score | 002XM | Transplantation medicine (allograft rejection, renal), measurement of donor and third-party-induced CD154+T-cytotoxic memory cells, utilizing whole peripheral blood, algorithm reported as a rejection risk score | 1. Gapfill: 11 | 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). | |||||||||||||||||
53 | 51 | 70 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0X56U | Andrology (infertility), sperm-capacitation assessment of ganglioside GM1 distribution patterns, fluorescence microscopy, fresh or frozen specimen, reported as percentage of capacitated sperm and probability of generating a pregnancy score | 1. Gapfill: 11 | 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). | |||||||||||||||||
54 | 52 | 73 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0X59U | Autoimmune (psoriasis), mRNA, next-generation sequencing, gene expression profiling of 50-100 genes, skin- surface collection using adhesive patch, algorithm reported as likelihood of response to psoriasis biologics | 1. Crosswalk to 0019U: 6 2. Gapfill: 5 | 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). | |||||||||||||||||
55 | 53 | 28 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0245U | 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 | 1. Crosswalk to 81455: 9 2. Gapfill: 2 | 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). | |||||||||||||||||
56 | 54 | 30 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0247U | Obstetrics (preterm birth), insulin-like growth factor–binding protein 4 (IBP4), sex hormone– binding globulin (SHBG), quantitative measurement by LC-MS/MS, utilizing maternal serum, combined with clinical data, reported as predictive-risk stratification for spontaneous preterm birth | 1. Crosswalk to 0080U X 0.2: 10 2. Gapfill: 1 | 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). | |||||||||||||||||
57 | 55 | 31 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0252U | Fetal aneuploidy short tandem–repeat comparative analysis, fetal DNA from products of conception, reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplications, mosaicism, and segmental aneuploidy | 1. Gapfill: 11 | 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 | 33 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0249U | Oncology (breast), semiquantitative analysis of 32 phosphoproteins and protein analytes, includes laser capture microdissection, with algorithmic analysis and interpretative report | 1. Crosswalk to 0037U: 2 2. Gapfill: 9 | 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). | |||||||||||||||||
59 | 57 | 36 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP or MAAA) | 0253U | Reproductive medicine (endometrial receptivity analysis), RNA gene expression profile, 238 genes by next-generation sequencing, endometrial tissue, predictive algorithm reported as endometrial window of implantation (eg, pre-receptive, receptive, post-receptive) | 1. Gapfill: 11 | 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). | |||||||||||||||||
60 | 58 | 37 | NEW | Proprietary Laboratory Analyses: MAAA NGS Reproductive medicine | 0254U | Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using embryonic DNA genomic sequence analysis for aneuploidy, and a mitochondrial DNA score in euploid embryos, results reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplications, mosaicism, and segmental aneuploidy, per embryo tested | 1. Gapfill: 11 | 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). | |||||||||||||||||
61 | 59 | 84 | NEW | Proprietary Laboratory Analyses: MAAA Oncology | 0X71U | Oncology (solid tumor), gene expression profiling by real-time RT-PCR of 7 gene pathways (ER, AR, PI3K, MAPK, HH, TGFB, Notch), formalin-fixed paraffin-embedded (FFPE), algorithm reported as gene pathway activity score | 1. Crosswalk to 0011M: 8 2. Gapfill: 3 | 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). | |||||||||||||||||
62 | 60 | 100 | NEW | Proprietary Laboratory Analyses | 0X70U | Oncology (colorectal cancer), image analysis with artificial intelligence assessment of 4 histologic and immunohistochemical features (CD3 and CD8 within tumor-stroma border and tumor core), tissue, reported as immune response and recurrence-risk score | 1. Crosswalk to 0108U: 3 2. Crosswalk to 0108U x 1.2: 4 3. Gapfill: 3 4. Abstain: 1 | 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). | |||||||||||||||||
63 | 61 | 62 | NEW | Chemistry | 826X0 | Elastase, pancreatic (EL-1), fecal; quantitative | 1. Crosswalk to 82715: 10 | Crosswalk to 82715 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
64 | 62 | 71 | NEW | Proprietary Laboratory Analyses: Chemistry | 0X57U | Trimethylamine/trimethylamine N-oxide (TMA/TMAO) profile, tandem mass spectrometry (MS/MS), urine, with algorithmic analysis and interpretive report | 1. Gapfill: 11 | 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). | |||||||||||||||||
65 | 63 | 72 | NEW | Proprietary Laboratory Analyses: Chemistry | 0X58U | Very long chain acyl- coenzyme A (CoA) dehydrogenase (VLCAD), leukocyte enzyme activity, whole blood | 1. Gapfill: 11 | 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). | |||||||||||||||||
66 | 64 | 74 | NEW | Proprietary Laboratory Analyses: Chemistry | 0X60U | Nephrology (chronic kidney disease), nuclear magnetic resonance spectroscopy measurement of myo-inositol, valine, and creatinine, algorithmically combined with cystatin C (by immunoassay) and demographic data to determine estimated glomerular filtration rate (GFR), serum, quantitative | 1. Crosswalk to (83704 x2) + (82610): 2 2. Crosswalk to 83704 + 82610: 6 3. Gapfill: 1 | Crosswalk to 83704 + 82610 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
67 | 65 | 35 | NEW | Proprietary Laboratory Analyses: Chemistry | 0251U | Hepcidin-25, enzyme-linked immunosorbent assay (ELISA), serum or plasma | 1. Crosswalk to 83520: 11 | Crosswalk to 83520 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
68 | 66 | 38 | NEW | Chemistry/ Chemistry | 835X1 | Interleukin-6 (IL-6) | 1. Crosswalk to 83006: 10 2. Abstain: 1 | Crosswalk to 83520 | CMS disagrees with the Panel Recommendation and instead is recommending a different crosswalk that is consistent with other similar tests | |||||||||||||||||
69 | 67 | 39 | NEW | Chemistry/ Chemistry | 8352X | Immunoglobulin light chains (ie, kappa, lambda), free, each | 1.Crosswalk to 83520: 11 | Crosswalk to 83520 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
70 | 68 | 90 | NEW | Proprietary Laboratory Analyses: Chemistry / Chemistry | 0X77U | Neurology (autism spectrum disorder [ASD]), quantitative measurements of 16 central carbon metabolites (ie, α-ketoglutarate, alanine, lactate, phenylalanine, pyruvate, succinate, carnitine, citrate, fumarate, hypoxanthine, inosine, malate, S-sulfocysteine, taurine, urate, and xanthine), liquid chromatography tandem mass spectrometry (LC-MS/MS), plasma, algorithmic analysis with result reported as negative or positive (with metabolic subtypes of ASD) | 1. Crosswalk to 0063U: 10 | Crosswalk to 0063U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
71 | 69 | 13 | NEW | Proprietary Laboratory Analyses: Oncology colorectal / Genomic Sequencing Related Tests | 0229U | BCAT1 (Branched chain amino acid transaminase 1) or IKZF1 (IKAROS family zinc finger 1) (eg, colorectal cancer) promoter methylation analysis | 1. Crosswalk to 81327 x 2: 9 | Crosswalk to 81287 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. The crosswalked code(s) appear to use similar methods and resource utilization. However, CMS disagrees with the use of the multiplier in the proposed crosswalk. | |||||||||||||||||
72 | 70 | 14 | NEW | Proprietary Laboratory Analyses: Oncology colorectal / Genomic Sequencing Related Tests | 0230U | AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation), full sequence analysis, including small sequence changes in exonic and intronic regions, deletions, duplications, short tandem repeat (STR) expansions, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81173 + 81204: 9 | Crosswalk to 81173 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
73 | 71 | 15 | NEW | Proprietary Laboratory Analyses: GSP neuromuscular disorders / Genomic Sequencing Related Tests | 0231U | CACNA1A (calcium voltage-gated channel subunit alpha 1A) (eg, spinocerebellar ataxia), full gene analysis, including small sequence changes in exonic and intronic regions, deletions, duplications, short tandem repeat (STR) gene expansions, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81184 + 81185: 9 | Crosswalk to 81185 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
74 | 72 | 16 | NEW | Proprietary Laboratory Analyses: GSP neuromuscular disorders / Genomic Sequencing Related Tests | 0232U | CSTB (cystatin B) (eg, progressive myoclonic epilepsy type 1A, Unverricht-Lundborg disease), full gene analysis, including small sequence changes in exonic and intronic regions, deletions, duplications, short tandem repeat (STR) expansions, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81188 + 81189: 9 | Crosswalk to 81189 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
75 | 73 | 17 | NEW | Proprietary Laboratory Analyses: GSP neuromuscular disorders / Genomic Sequencing Related Tests | 0233U | FXN (frataxin) (eg, Friedreich ataxia), gene analysis, including small sequence changes in exonic and intronic regions, deletions, duplications, short tandem repeat (STR) expansions, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81285 + 81286: 9 | Crosswalk to 81286 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
76 | 74 | 18 | NEW | Proprietary Laboratory Analyses: GSP neurodevelopmental disorder / Genomic Sequencing Related Tests | 0234U | MECP2 (methyl CpG binding protein 2) (eg, Rett syndrome), full gene analysis, including small sequence changes in exonic and intronic regions, deletions, duplications, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81302 + 81304: 9 | Crosswalk to 81302 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
77 | 75 | 19 | NEW | Proprietary Laboratory Analyses: GSP Inherited disorders / Genomic Sequencing Related Tests | 0235U | PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome), full gene analysis, including small sequence changes in exonic and intronic regions, deletions, duplications, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81321 + 81323: 9 | Crosswalk to 81321 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
78 | 76 | 20 | NEW | Proprietary Laboratory Analyses: GSP neuromuscular disorders / Genomic Sequencing Related Tests | 0236U | SMN1 (survival of motor neuron 1, telomeric) and SMN2 (survival of motor neuron 2, centromeric) (eg, spinal muscular atrophy) full gene analysis, including small sequence changes in exonic and intronic regions, duplications and deletions, and mobile element insertions | 1. Crosswalk to 81329 + 81337: 9 | Crosswalk to 81336+81405 | CMS disagrees with the recommended crosswalk and instead recommends a crosswalk that represents both genes sequenced in this code. | |||||||||||||||||
79 | 77 | 21 | NEW | Proprietary Laboratory Analyses: GSP cardiovascular disorders / Genomic Sequencing Related Tests | 0237U | Cardiac ion channelopathies (eg, Brugada syndrome, long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia), genomic sequence analysis panel including ANK2, CASQ2, CAV3, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, RYR2, and SCN5A, including small sequence changes in exonic and intronic regions, deletions, duplications, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81413 + 81414: 9 | Crosswalk to 81413 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
80 | 78 | 22 | NEW | Proprietary Laboratory Analyses: GSP Oncology / Genomic Sequencing Related Tests | 0238U | Oncology (Lynch syndrome), genomic DNA sequence analysis of MLH1, MSH2, MSH6, PMS2, and EPCAM, including small sequence changes in exonic and intronic regions, deletions, duplications, mobile element insertions, and variants in non-uniquely mappable regions | 1. Crosswalk to 81435 + 81436: 9 | Crosswalk to 81435 | CMS agrees with part of the recommended crosswalk. CMS considers the 'full gene sequence' to include all components described in new code | |||||||||||||||||
81 | 80 | 76 | NEW | Proprietary Laboratory Analyses: GSP constitutional or other heritable disorders or syndromes / Genomic Sequencing Related tests | 0X62U | Rare constitutional and other heritable disorders, whole- genome and mitochondrial DNA sequence analysis, blood, frozen and formalin-fixed paraffin-embedded (FFPE) tissue, saliva, buccal swabs or cell lines, identification of single nucleotide and copy number variants | 1. Crosswalk to 81425+81460: 5 2. Gapfill: 4 | 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). | |||||||||||||||||
82 | 81 | 34 | NEW | Proprietary Laboratory Analyses: GSP Oncology solid organ / Genomic Sequencing Related Tests | 0250U | Oncology (solid organ neoplasm), targeted genomic sequence DNA analysis of 505 genes, interrogation for somatic alterations (SNVs [single nucleotide variant], small insertions and deletions, one amplification, and four translocations), microsatellite instability and tumor-mutation burden | 1. Crosswalk to 81455: 11 | Crosswalk to 81455 | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
83 | 82 | 77 | NEW | Proprietary Laboratory Analyses: GSP constitutional or other heritable disorders or syndromes / Genomic Sequencing Related tests | 0X63U | Unexplained constitutional or other heritable disorders or syndromes, tissue-specific gene expression by whole-transcriptome and next-generation sequencing, blood, formalin-fixed paraffin-embedded (FFPE) tissue or fresh frozen tissue, reported as presence or absence of splicing or expression changes | 1. Crosswalk to 81425: 1 2. Crosswalk to 81415: 6 3. Gapfill: 1 | 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). | |||||||||||||||||
84 | 83 | 78 | NEW | Proprietary Laboratory Analyses: GSP constitutional or other heritable disorders or syndromes / Genomic Sequencing Related tests | 0X64U | Rare constitutional and other heritable disorders, identification of copy number variations, inversions, insertions, translocations, and other structural variants by optical genome mapping and whole-genome sequencing | 1. Crosswalk to 81425 + 81229: 7 2. Gapfill: 1 | 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). In particular, gapfilling this code will help to understand the resources involved in optical genome mapping, which does not have a crosswalk on the CLFS. | |||||||||||||||||
85 | 84 | 86 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X73U | Hematology (atypical hemolytic uremic syndrome [aHUS]), genomic sequence analysis of 15 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81432: 5 2. Crosswalk to 81443: 5 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
86 | 85 | 87 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X74U | Hematology (autosomal dominant congenital thrombocytopenia), genomic sequence analysis of 14 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81432 + 81433: 2 2. Crosswalk to 81443: 8 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
87 | 86 | 88 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X75U | Hematology (congenital coagulation disorders), genomic sequence analysis of 20 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81432: 2 2. Crosswalk to 81443: 8 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
88 | 87 | 89 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X76U | Hematology (genetic bleeding disorders), genomic sequence analysis of 51 genes, blood, buccal swab, or amniotic fluid, comprehensive | 1. Crosswalk to 81430: 10 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
89 | 88 | 91 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X78U | Hematology (genetic platelet disorders), genomic sequence analysis of 43 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81443: 2 2. Crosswalk to 81430: 7 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
90 | 89 | 92 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X79U | Hematology (congenital neutropenia), genomic sequence analysis of 23 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81443: 8 2. Gapfill: 1 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
91 | 90 | 93 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X80U | Hematology (genetic hyperfibrinolysis, delayed bleeding), genomic sequence analysis of 8 genes (F13A1, F13B, FGA, FGB, FGG, SERPINA1, SERPINE1, SERPINF2, PLAU) blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81443: 4 2. Crosswalk to 81432: 6 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
92 | 91 | 94 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X81U | Hematology (inherited thrombocytopenia), genomic sequence analysis of 23 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81443: 9 2.Gapfill: 1 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
93 | 92 | 95 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X82U | Hematology (genetic platelet function disorder), genomic sequence analysis of 31 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81443: 3 2. Crosswalk to 81430: 7 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
94 | 93 | 96 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X83U | Hematology (genetic thrombosis), genomic sequence analysis of 12 genes, blood, buccal swab, or amniotic fluid | 1. Crosswalk to 81443: 9 2. Gapfill: 1 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to better identify potential crosswalks for the genetic material being analyzed. | |||||||||||||||||
95 | 94 | 97 | NEW | Proprietary Laboratory Analyses: GSP hematology / Genomic Sequencing Related Tests | 0X84U | Red blood cell antigen typing, DNA, genotyping of 12 blood group system genes to predict 44 red blood cell antigen phenotypes | 1. Crosswalk to 0001U: 10 | Crosswalk to 0001U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
96 | 95 | 75 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP / Other Genomic Sequencing Related Tests | 0X61U | Rare diseases (constitutional/heritable disorders), identification of copy number variations, inversions, insertions, translocations, and other structural variants by optical genome mapping | 1. Crosswalk to 81229: 9 2. Gapfill: 1 3. Abstain: 1 | 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). In particular, gapfilling this code will help to understand the resources involved in optical genome mapping, which does not have a crosswalk on the CLFS. | |||||||||||||||||
97 | 96 | 27 | NEW | Proprietary Laboratory Analyses: GSP Oncology solid organ / Other Genomic Sequencing Related Tests | 0244U | Oncology (solid organ), DNA, comprehensive genomic profiling, 257 genes, interrogation for single-nucleotide variants, insertions/deletions, copy number alterations, gene rearrangements, tumor-mutational burden and microsatellite instability, utilizing formalin-fixed paraffin-embedded tumor tissue | 1. Crosswalk to 0037U: 8 2. Gapfill: 1 | 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). In particular, gapfilling this code will help to understand the resources involved in optical genome mapping, which does not have a crosswalk on the CLFS. | |||||||||||||||||
98 | 97 | 29 | NEW | Proprietary Laboratory Analyses: GSP RBC antigens / Other Genomic Sequencing Related Tests | 0246U | Red blood cell antigen typing, DNA, genotyping of at least 16 blood groups with phenotype prediction of at least 51 red blood cell antigens | 1. Crosswalk to 0001U: 10 | Crosswalk to 0001U | CMS agrees with the majority CDLT Panel recommendation to crosswalk the code. Both codes appear to use similar methods and resource utilization. | |||||||||||||||||
99 | 98 | 85 | NEW | Proprietary Laboratory Analyses: Molecular Pathology (Other than GSP / Other Genomic Sequencing Related Tests | 0X72U | Rare diseases (constitutional/heritable disorders), identification of copy number variations, inversions, insertions, translocations, and other structural variants by optical genome mapping | 1. Crosswalk to 81229: 9 2. Gapfill: 1 3. Abstain: 1 | 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). In particular, gapfilling this code will help to understand the resources involved in optical genome mapping, which does not have a crosswalk on the CLFS. | |||||||||||||||||
100 | 99 | 99 | NEW | Molecular Pathology chromosomal abnormalities / Other Genomic Sequencing Related Tests | 812X0 | Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number and loss-of-heterozygosity variants, low-pass sequencing analysis | 1. Crosswalk to 81277: 4 2. Crosswalk to 81229: 6 | Gapfill | CMS disagrees with the recommendations to crosswalk this code and instead recommends to gapfill this code so that the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC). CMS welcomes comments that would help to understand the difference in resources for low-pass sequencing analysis versus the methods used by the codes for proposed crosswalks. | |||||||||||||||||