"Calendar Year (CY) 2024 Clinical Laboratory Fee Schedule (CLFS) Final Payment Determinations1

This  worksheet ""Final Determinations of this Excel workbook contains all of the new CLFS codes and CMS final payment determinations. 

We welcome reconsideration requests on our final determinations for the basis of payment.  All comments must be submitted electronically by January 20, 2024 to the following CMS mailbox: CLFS_Annual_Public_Meeting@cms.hhs.gov.  When submitting reconsideration requests, please refer to the specific code and its rationale.

1CPT codes, descriptions and other data only are copyright 2022 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."									
									
Code #	Code Type	Category	Long Code Descriptor	Panel Recommendation	CMS CY 24 Preliminary Recommendation	CMS CY 24 Final Recommendation	Rationale		
0377U	PLA	Chemistry	"Cardiovascular disease, quantification of advanced serum or plasma lipoprotein profile, by nuclear magnetic resonance (NMR) spectrometry with report of a lipoprotein profile (including 23 variables) "	"Crosswalk to 83704 + 80061: 9
2. Crosswalk to (83704 X 2) + 80061: 0
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 83704 + 80061	Crosswalk to 83704 + 80061	Finalize as proposed. CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0381U	PLA	Chemistry	"Maple syrup urine disease monitoring by patient-collected blood card sample, quantitative measurement of alloisoleucine, leucine, isoleucine, and valine, liquid chromatography with tandem mass spectrometry (LCMS/MS) "	"1. Gapfill: 8
2.Abstain: 1"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0382U	PLA	Chemistry	"Hyperphenylalaninemia monitoring by patient-collected blood card sample, quantitative measurement of phenylalanine and tyrosine, liquid chromatography with tandem mass spectrometry (LC-MS/MS)"	"1. Gapfill: 8
2. Abstain: 1"	Gapfill	Gapfill	Finalize as proposed. CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0383U	PLA	Chemistry	"Tyrosinemia type I monitoring by patient-collected blood card sample, quantitative measurement of tyrosine, phenylalanine, methionine, succinylacetone, nitisinone, liquid chromatography with tandem mass spectrometry (LC-MS/MS)"	"1. Gapfill: 8
2.Abstain: 1"	Gapfill	Gapfill	Finalize as proposed. CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0394U	PLA	Chemistry	"Perfluoroalkyl substances (PFAS) (eg, perfluorooctanoic acid, perfluorooctane sulfonic acid), 16 PFAS compounds by liquid chromatography with tandem mass spectrometry (LC-MS/MS), plasma or serum, quantitative"	"1. Crosswalk to 0263U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to G0482	Crosswalk to G0482	"FInalize as proposed.  CMS reviewed comments and continues to disagree with the crosswalk recommendation.  0263U involves the use of an algorithm, which 0394U's descriptor does not include.  Although drug test monitoring is a different use of the methodology, both G0482 and 0394U make use of the tandem mass spectrometry (LC-MS/MS) for a similar number of analytes.  "		
82166	NEW	Chemistry	Anti-mullerian hormone (AMH)	"1. Crossalk to 82024: 8
2. Gapfill: 0
3. Abstain: 1"	Crosswalk to 82397	Crosswalk to 82024	"After reviewing public comments, CMS agrees a more appropriate crosswalk for this code is CPT 82024.  The comments CMS received included detailed information as to how these tests are more similar than what CMS initially proposed. "		
0404U	NEW	Multianalyte Assays with Algorithmic Analyses	"Oncology (breast), semiquantitative measurement of thymidine kinase activity by immunoassay, serum, results reported as risk of disease progression"	"1. Crosswalk to 0058U: 5
2. Gapfill: 4
3. Abstain: 0"	Gapfill	Crosswalk to 0058U	"After reviewing public comments, CMS agrees with the minority CDLT panel to crosswalk this code to 0058U.  The comments CMS received included detailed information as to how these tests are similar enough to crosswalk.  "		
0376U	PLA	Multianalyte Assays with Algorithmic Analyses	"Oncology (prostate cancer), image analysis of at least 128 histologic features and clinical factors, prognostic algorithm determining the risk of distant metastases, and prostate cancerspecific mortality, includes predictive algorithm to androgen deprivationtherapy response, if appropriate "	"1.Crosswalk to 0261U X 0.5: 1
2.Crosswalk to 0220U: 6
3. Gapfill: 1
4. Abstain: 1"	Crosswalk to 0220U	Crosswalk to 0220U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0414U	NEW	Multianalyte Assays with Algorithmic Analyses	"X084U: Oncology (lung), augmentative algorithmic analysis of digitized whole slide imaging for 8 genes (ALK, BRAF, EGFR, ERBB2, MET, NTRK1-3, RET, ROS1), and KRAS G12C and PD-L1, if performed, formalin-fixed paraffin-embedded (FFPE) tissue, reported as positive or negative for each biomarker  [**REVISED by CPT 6-12-2023]"	"1. Crosswalk to 0220U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0220U	Crosswalk to 0220U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0418U	NEW	Multianalyte Assays with Algorithmic Analyses: Immunology	"X088U: Oncology (breast), augmentative algorithmic analysis of digitized whole slide imaging of 8 histologic and immunohistochemical features, reported as a recurrence score    [**REVISED by CPT 6-12-2023]"	"1. Crosswalk to 0220U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0220U	Crosswalk to 0220U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0406U	NEW	Multianalyte Assays with Algorithmic Analyses	"Oncology (lung), flow cytometry, sputum, 5 markers (meso-tetra [4-carboxyphenyl] porphyrin [TCPP], CD206, CD66b, CD3, CD19), algorithm reported as likelihood of lung cancer"	"1. Crosswalk to 0021U: 8
2. Gapfill: 1
3. Abstain: 0"	Crosswalk to 0021U	Crosswalk to 0021U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0359U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Oncology (prostate cancer), analysis of all prostate-specific antigen (PSA) structural isoforms by phase separation and immunoassay, plasma, algorithm reports risk of cancer "	"1. Crosswalk to 81539: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81539	Crosswalk to 81539	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0360U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Oncology (lung), enzyme-linked immunosorbent assay (ELISA) of 7 autoantibodies (p53, NY-ESO-1, CAGE, GBU4-5, SOX2, MAGE A4, and HuD), plasma, algorithm reported as a categorical result for risk of malignancy"	"1. Crosswalk to 81490: 7
2. Crosswalk to 0312U: 2
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 81490	Crosswalk to 81490	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0365U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Oncology (bladder), analysis of 10 protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGFA) by immunoassays, urine, algorithm reported as a probability of bladder cancer "	"1. Crosswalk to 81503: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81503	Crosswalk to 81503	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0366U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Oncology (bladder), analysis of 10 protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGFA) by immunoassays, urine, algorithm reported as a probability of recurrent bladder cancer "	"1. Crosswalk to 81503: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81503	Crosswalk to 81503	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0367U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Oncology (bladder), analysis of 10 protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGFA) by immunoassays, urine, diagnostic algorithm reported as a risk score for probability of rapid recurrence of recurrent or persistent cancer following transurethral resection "	"1. Crosswalk to 81503 + 82570: 9
2. Crosswalk to 81503 X 1.5: 0
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 81503 + 82570	Crosswalk to 81503 + 82570	"Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  CMS did receive public comment asking for a 1.2x multiplier for extra work.  However, CMS did not feel there was ample justification to apply this mulitplier.  The crosswalked code(s) appear to use similar methods and resource utilization."		
0375U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Oncology (ovarian), biochemical assays of 7 proteins (follicle stimulating hormone, human epididymis protein 4, apolipoprotein A-1, transferrin, beta-2 macroglobulin, prealbumin [ie, transthyretin], and cancer antigen 125), algorithm reported as ovarian cancer risk score "	"1. Gapfill: 5
2. Abstain: 4"	Crosswalk to 81503	Crosswalk to 81503	"FInalize as proposed.  CMS disagrees with the majority CDLT panel to gapfill the code, and is instead recommending a crosswalk that is similar in methodology and/or resources.  The lab was unable to provide information during the ALM and CDLT panel meeting but subsequesntly provided more information to CMS.  This preliminary crosswalk agrees with the laboratory's recommendation"		
0384U	PLA	Multianalyte Assays with Algorithmic Analyses	"Nephrology (chronic kidney disease), carboxymethyllysine, methylglyoxal hydroimidazolone, and carboxyethyl lysine by liquid chromatography with tandem mass spectrometry (LCMS/MS) and HbA1c and estimated glomerular filtration rate (GFR), with risk score reported for predictive progression to high-stage kidney disease "	"1. Crosswalk to 0247U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0247U	Crosswalk to 0247U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0385U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Nephrology (chronic kidney disease), apolipoprotein A4 (ApoA4), CD5 antigen-like (CD5L), and insulin-like growth factor binding protein 3 (IGFBP3) by enzyme-linked immunoassay (ELISA), plasma, algorithm combining results with HDL, estimated glomerular filtration rate (GFR) and clinical data reported as a risk score for developing diabetic kidney disease "	"1.Crosswalk to 0308U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0308U	Crosswalk to 0308U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0095U	Substantially Revised (PLA)	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Eosinophilic esophagitis),ELISA analysis of (Eotaxin-3 ([CCL26 [{C-C motif chemokine ligand 26}]) and major basic protein ([PRG2 [{proteoglycan 2, pro eosinophil major basic protein}]), enzyme-linked immunosorbent assays (ELISA), specimen obtained by esophageal string test device, algorithm reported as probability of active or inactive eosinophilic esophagitis"	"1. Crosswalk to 0095U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0095U	Crosswalk to 0095U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0390U	PLA	Multianalyte Assays with Algorithmic Analyses; Immunoassay	"Obstetrics (preeclampsia), kinase insert domain receptor (KDR), Endoglin (ENG), and retinol-binding protein 4 (RBP4), by immunoassay, serum, algorithm reported as a risk score"	"1. Crosswalk to 0243U x 3: 8
2. Gapfill: 1
3. Abstain: 0"	Crosswalk to 0243U	Crosswalk to 0243U	"Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code, though does not agree with the multiplier of 3.  "		
81517	NEW	Immunology	"Liver disease, analysis of 3 biomarkers (hyaluronic acid [HA], procollagen III amino terminal peptide [PIIINP], tissue inhibitor of metalloproteinase 1 [TIMP-1]), using immunoassays, utilizing serum, prognostic algorithm reported as a risk score and risk of liver fibrosis and liver-related clinical events within 5 years"	"1. Crosswalk to 0014M: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0014M	Crosswalk to 0014M	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0019M	NEW	Multianalyte Assays with Algorithmic Analyses	"Cardiovascular disease, plasma, analysis of protein biomarkers by aptamer-based microarray and algorithm reported as 4-year likelihood of coronary event in high-risk populations"	"1. Gapfill: 9
2. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0407U	NEW	Multianalyte Assays with Algorithmic Analyses	"Nephrology (diabetic chronic kidney disease [CKD]), multiplex electrochemiluminescent immunoassay (ECLIA) of soluble tumor necrosis factor receptor 1 (sTNFR1), soluble tumor necrosis receptor 2 (sTNFR2), and kidney injury molecule 1 (KIM-1) combined with clinical data, plasma, algorithm reported as risk for progressive decline in kidney function"	"1. Crosswalk to 0105U: 8
2. Gapfill: 1
3. Abstain: 0
"	Crosswalk to 0105U	Crosswalk to 0105U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0415U	NEW	Multianalyte Assays with Algorithmic Analyses: Immunology	"Cardiovascular disease (acute coronary syndrome [ACS]), IL-16, FAS, FASLigand, HGF, CTACK, EOTAXIN, and MCP-3 by immunoassay combined with age, sex, family history, and personal history of diabetes, blood, algorithm reported as a 5-year (deleted risk) score for ACS"	"1. 0309U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0309U	Crosswalk to 0309U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0387U	PLA	Immunology	"Oncology (melanoma), autophagy and beclin 1 regulator 1 (AMBRA1) and loricrin (AMLo) by immunohistochemistry, formalinfixed paraffin-embedded (FFPE) tissue, report for risk of progression 

(Do not report 0387U in conjunction with 88341, 88342)"	"1. Crosswalk to 0067U*0.5: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0067U * .5	Crosswalk to 0067U * .5	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0389U	PLA	Genome Sequencing Procedures; RT-PCR	"Pediatric febrile illness (Kawasaki disease [KD]), interferon alphainducible protein 27 (IFI27) and mast cell-expressed membrane protein 1 (MCEMP1), RNA, using reverse transcription polymerase chain reaction (RT-qPCR), blood, reported as a risk score for KD"	"1. Gapfill: 9
2. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0398U	PLA	Genomic Sequencing Procedures; methylation analysis	"Gastroenterology (Barrett esophagus), P16, RUNX3, HPP1, and FBN1 DNA methylation analysis using PCR, formalin-fixed paraffin-embedded (FFPE) tissue, algorithm  reported as risk score for progression to high-grade dysplasia or cancer"	"1. Crosswalk to 0108U: 2
2. Crosswalk to 0114U: 6
4. Gapfill: 1
5. Abstain: 0"	Crosswalk to 0114U	Gapfill	"Upon review of public comments for this code, CMS is now recommending to Gapfill this code.  CMS received information stating this test does not involve the collection method for the assay, which 0114U does.  Therefore, CMS is recommending to gapfill this code so that resources may be better estimated by a Medicare Administrative Contractor (MAC). "		
0348U	Reconsideration (PLA)	Genomic Sequencing Procedures	"Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 25 gene report, with variant analysis and reported phenotypes"	"1. Gapfill: 4
2. Abstain: 0
3. Crosswalk to 0029U (CMS): 5"	Crosswalk to 0029U	Crosswalk to 0029U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization. CMS did not find ample justification under the reconsideration process to overturn the decision made in 2022. 		
0350U	Reconsideration (PLA)	Genomic Sequencing Procedures	"Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 27 gene report, with variant analysis and reported phenotypes"	"1. Gapfill: 4
2. Abstain: 0
3. Crosswalk to 0175U (CMS): 5"	Crosswalk to 0175U	Crosswalk to 0175U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.  CMS did not find ample justification under the reconsideration process to overturn the decision made in 2022. 		
0355U	PLA	Molecular Pathology	"APOL1 (apolipoprotein L1) (eg, chronic kidney disease), risk variants (G1, G2) "	"1. Crosswalk to 81120: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81401	Crosswalk to 81401	"Finalize as proposed.  CMS disagrees with the CDLT Panel majority recommendation and is instead suggesting a different crosswalk.  Historically, CMS has used the Tier 2 Molecular Pathology Codes for genetic risk variant analyses."		
0356U	PLA	Multianalyte Assays with Algorithmic Analyses	"Oncology (oropharyngeal), evaluation of 17 DNA biomarkers using droplet digital PCR (ddPCR), cell-free DNA, algorithm reported as a prognostic risk score for cancer recurrence"	"1. Gapfill: 9
2. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0378U	PLA	Molecular Pathology	"RFC1 (replication factor C subunit 1), repeat expansion variant analysis by traditional and repeat-primed PCR, blood, saliva, or buccal swab"	"1. Crosswalk 81181: 7
2. Crosswalk 81401: 2
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 81401	Crosswalk to 81401	Finalize as proposed.  CMS agrees with the minority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0403U	NEW	Multianalyte Assays with Algorithmic Analyses	"Oncology (prostate), mRNA, gene expression profiling of 18 genes, first-catch post-digital rectal examination urine (or processed first-catch urine), algorithm reported as percentage of likelihood of detecting clinically significant prostate cancer
"	"1. Crosswalk to 0011M: 9
2. Crosswalk to 0113U: 0
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 0011M	Crosswalk to 0011M	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0413U	NEW	Genomic Sequencing Procedures; optical genome mapping	"Oncology (hematolymphoid neoplasm), optical genome mapping for copy number alterations, aneuploidy, and balanced/complex structural rearrangements, DNA from blood or bone marrow, report of clinically significant alterations"	"1. Crosswalk to 0260U X 1.5: 2
2. Crosswalk 0260U: 6
3. Gapfill: 1
4. Abstain: 0"	Crosswalk to 0260U	Crosswalk to 0260U	Finalize as proposed.  CMS reviewed public comment but continues to agree with the majority CDLT Panel recommendation to crosswalk the code without a multiplier.  The crosswalked code(s) appear to use similar methods and resource utilization.		
87467	PLA	Microbiology; Infectious Disease	"Infectious agent detection by nucleic acid (DNA and RNA), gastrointestinal pathogens, 31 bacterial, viral, and parasitic organisms and identification of 21 associated antibiotic-resistance genes, multiplex amplified probe technique "	"1. Crosswalk to 87507 x 2: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87507	Crosswalk to 87507	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code without the multiplier.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0370U	PLA	Microbiology; Infectious Disease	"Infectious agent detection by nucleic acid (DNA and RNA), surgical wound pathogens, 34 microorganisms and identification of 21 associated antibioticresistance genes, multiplex amplified probe technique, wound swab"	"1. Crosswalk to 87633 x 2: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87633	Crosswalk to 87633	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code without the multiplier.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0371U	PLA	Microbiology; Infectious Disease	"Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogen, semiquantitative identification, DNA from 16 bacterial organisms and 1 fungal organism, multiplex amplified probe technique via quantitative polymerase chain reaction (qPCR), urine "	"1. Crosswalk to 87633: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87633	Crosswalk to 87633	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0372U	PLA	Microbiology	"Infectious disease (genitourinary pathogens), antibiotic-resistance gene detection, multiplex amplified probe technique, urine, reported as an antimicrobial stewardship risk score"	"1. Crosswalk to 87633: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87633	Crosswalk to 87633	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0373U	PLA	Microbiology; Infectious Disease	"Infectious agent detection by nucleic acid (DNA and RNA), respiratory tract infection, 17 bacteria, 8 fungus, 13 virus, and 16 antibiotic-resistance genes, multiplex amplified probe technique, upper or lower respiratory specimen "	"1. Crosswalk to 87633 x 2: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87633	Crosswalk to 87633	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0374U	PLA	Microbiology; Infectious Disease	"Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogens, identification of 21 bacterial and fungal organisms and identification of 21 associated antibiotic-resistance genes, multiplex amplified probe technique, urine "	"1. Crosswalk to 0321U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87633	Crosswalk to 87633	Finalize as proposed.  CMS disagrees with the majority CDLT panel recommendation and is propsing a crosswalk to 87633.  The crosswalked code(s) appear to use similar methods and resource utilization.		
87467	Reconsideration	Microbiology	"Hepatitis B surface antigen (HBsAg), quantitative"	"1. Crosswalk to 87340 X 2: 1
2. Gapfill: 5
3. Abstain: 1
4. Crosswalk 84702 (CMS): 2"	Gapfill	Gapfill	"Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to change the payment rate setting process from Crosswalk to Gapfill.  Based on information presented at the 2023 Annual Lab Meeting, CMS more fully understands that there are no tests similar enough in either methodology or resources to crosswalk the test.  Therefore, CMS agrees with the majority panel recommendation to gapfill this code.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
87523	NEW	Microbiology	"Infectious agent detection by nucleic acid (DNA or RNA); hepatitis D (delta), quantification, including reverse transcription, when performed"	"1. Crosswalk to 87522: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87522	Crosswalk to 87522	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0402U	NEW	Immunology	"Infectious agent (sexually transmitted infection), Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, multiplex amplified probe technique, vaginal, endocervical, or male urine, each pathogen reported as detected or not detected"	"1. Crosswalk to 87631: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87631	Crosswalk to 87631	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0408U	NEW	Immunology	"Infectious agent antigen detection by bulk acoustic wave biosensor immunoassay, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19])"	"1. Gapfill: 9
2. Abstain: 0
"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0416U	NEW	Microbiology	"Infectious agent detection by nucleic acid (DNA), genitourinary pathogens, identification of 20 bacterial and fungal organisms, including identification of 20 associated antibiotic-resistance genes, if performed, multiplex amplified probe technique, urine"	"1. 0321U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87633	Crosswalk to 87633	Finalize as proposed.  CMS disagrees with the majority CDLT panel recommendation and is propsing a crosswalk to 87633.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0380U	PLA	Genomic Sequencing Procedures; targeted sequence analysis	"Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis, 20 gene variants and CYP2D6 deletion or duplication analysis with reported genotype and phenotype"	"1. Crosswalk 0070U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 87633	Crosswalk to 87633	Finalize as proposed.  CMS disagrees with the majority CDLT panel recommendation and is propsing a crosswalk to 87633.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0022U	Substantially Revised (PLA)	Genomic Sequencing Procedures	"Targeted genomic sequence analysis panel, non- small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence/ or absence of variants and associated therapy(ies) to consider"	"1. Crosswalk 81450: 6
2. No Action: 0
3. Gapfill: 2
4. Abstain: 1
"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0388U	PLA	Genomic Sequencing Procedures	"Oncology (non-small cell lung cancer), next-generation sequencing with identification of single nucleotide variants, copy number variants, insertions and deletions, and structural variants in 37 cancer-related genes, plasma, with report for alteration detection"	"1. Crosswalk to 0242U: 8
2. Gapfill: 1
3. Abstain: 0"	Crosswalk to 81445	Gapfill	"CMS continues to disagree with the public comments to crosswalk this code to 0242U.  CMS has previously argued that 0242U is a test based on proprietary lab information specific to the lab that created the test.  Therefore it is not an appropriate crosswalk.  CMS understands, however, that 81445 is not an appropriate crosswalk either and is therefore recommending to gapfill this code so that the resources can be better estimated by a Medicare Administrative Contractor (MAC). "		
0392U	PLA	Genome Sequencing Procedures; dup/del analysis	"Drug metabolism (depression, anxiety, attention deficit hyperactivity disorder [ADHD]), gene-drug interactions, variant analysis of 16 genes, including deletion/duplication analysis of CYP2D6, reported as impact of gene-drug interaction for each drug"	"1. Crosswalk to 0345U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0345U	Crosswalk to 0345U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0395U	PLA	Immunology	"Oncology (lung), multi-omics (microbial DNA by shotgun nextgeneration sequencing and carcinoembryonic antigen and osteopontin by immunoassay), plasma, algorithm reported as malignancy risk for lung nodules in early-stage disease"	"1. Crosswalk 81546: 2
2. Crosswalk 0026U: 0
3. Crosswalk (0112U + 0164U) X 1.2: 2
4. Gapfill: 5
5. Abstain: 0"	Gapfill	Gapfill	"FInalize as proposed.  CMS received public comment for this code, but continues to disagree that a test focused on mRNA analysis is similar to 0395U.  CMS continues to agree with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
0401U	PLA	Genomic Sequencing Procedures; targeted variant analysis	"Cardiology (coronary heart disease [CAD]), 9 genes (12 variants), targeted variant genotyping, blood, saliva, or buccal swab, algorithm reported as a genetic risk score for a coronary event"	"1. Crosswalk to 0011M: 9
2. Gapfill: 0
3. Abstain: 0"	Gapfill	Gapfill	"FInalize as proposed.  CMS received public comment for this code, but continues to disagree that a test focused on mRNA analysis is similar to 0401U.  CMS continues to disagree with the majority CDLT panel recommendation to crosswalk this test to 0011M.  CMS does not agree that a test looking at mRNA gene expression is comparable to a test performing targeted variant analysis.  We believe there are no other tests that perform targeted variant genotyping and then apply an alogrithm as analysis.  Therefore CMS recommends gapfill so that the MACs can better estimate resources necessary for this test. "		
0411U	NEW	Genomic Sequencing Procedures	"Psychiatry (eg, depression, anxiety, attention deficit hyperactivity disorder [ADHD]), genomic analysis panel, variant analysis of 15 genes, including deletion/duplication analysis of CYP2D6"	"1. Crosswalk to 0345U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0345U	Crosswalk to 0345U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0419U	NEW	Genomic Sequencing Procedures	"Neuropsychiatry (eg, depression, anxiety), genomic sequence analysis panel, variant analysis of 13 genes, saliva or buccal swab, report of each gene phenotype"	"1. Crosswalk to 0345U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0345U	Crosswalk to 0345U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0379U	PLA	Genomic Sequencing Procedures	"Targeted genomic sequence analysis panel, solid organ neoplasm, DNA (523 genes) and RNA (55 genes) by nextgeneration sequencing, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burden "	"1. Crosswalk to 0244U: 8
2. Crosswalk 81455: 1
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 0244U	Gapfill	"We acknowledge that we are changing this recommendation to gapfill following a preliminary crosswalk recommendation.  However, after reviewing similar type codes, particularly those that involve MSI and TMB analyses, we feel it would be more consistent to Gapfill.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
0329U	Reconsideration (PLA)	Genomic Sequencing Procedures; exome	"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"	"1. Crosswalk to 0211U: 7
2. Gapfill (cms): 2
3. Abstain: 0"	Gapfill	Gapfill	CMS continues to recommend to gapfill this code.  There is no comparable code on the CLFS for the exome and transcriptome sequencing of variants.  We understand 0211U to involve a fuller sequence analysis than 0329U.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0334U	Reconsideration (PLA)	Genomic Sequencing Procedures; targeted sequence analysis	"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"	"1. Crosswalk to 0244U: 6
2. Gapfill: 0
3. Abstain: 0
4. Crosswalk 81455 (CMS): 3"	Crosswalk to 81455	Gapfill	"CMS continues to disagree that 0244U is an appropriate crosswalk for this test.  By its descriptor, 0244U involves more genomic analysis.  CMS, however, understands that 81455 may not be an appropriate crosswalk either and is therefore recommending to Gapfill this test code.  This is also consistent with other new tests involving similar analyses (i.e. MSI and TMB)which CMS is gapfilling.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
0400U	PLA	Genomic Sequencing Procedures	"Obstetrics (expanded carrier screening), 145 genes by nextgeneration sequencing, fragment analysis and multiplex ligationdependent probe amplification, DNA, reported as carrier positive or negative"	"1. Gapfill: 9
2. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
81457	NEW	Genomic Sequencing Procedures	"Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, microsatellite instability"	"1. Crosswalk to 81455 MINUS 81277: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81445	Gapfill	"After review of several public comments, CMS is recommending to gapfill this code.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
81458	NEW	Genomic Sequencing Procedures	"Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, copy number variants and microsatellite instability"	"1. Crosswalk to 81455: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81445	Gapfill	"After review of several public comments, CMS is recommending to gapfill this code.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
81459	NEW	Genomic Sequencing Procedures	"Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements"	"1. Crosswalk to 0244U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81445	Gapfill	"After review of several public comments, CMS is recommending to gapfill this code.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
0409U	NEW	Genomic Sequencing Procedures	"Oncology (solid tumor), DNA (80 genes) and RNA (36 genes), by next-generation sequencing from plasma, including single nucleotide variants, insertions/deletions, copy number alterations, microsatellite instability, and fusions, report showing identified mutations with clinical actionability"	"1. Crosswalk to 81455 X 1.25: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81455	Crosswalk to 81455	"Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code, but without the use of a multiplier.  The crosswalked code(s) appear to use similar methods and resource utilization."		
0417U	NEW	Genomic Sequencing Procedures; mitochondrial	"Rare diseases (constitutional/heritable disorders), whole mitochondrial genome sequence with heteroplasmy detection and deletion analysis, nuclear-encoded mitochondrial gene analysis of 335 nuclear genes, including sequence changes, deletions, insertions, and copy number variants analysis, blood or saliva, identification and categorization of mitochondrial disorderassociated genetic variants"	"1. Crosswalk to 81460 + 81465: 3
2. Gapfill: 6
3. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0358U	PLA	Chemistry	"Neurology (mild cognitive impairment), analysis of ?-amyloid 1-42 and 1-40, chemiluminescence enzyme immunoassay, cerebral spinal fluid, reported as positive, likely positive, or negative"	"1. Crosswalk to 81500: 8
2. Gapfill: 0
3. Abstain: 1"	Crosswalk to 81500	Crosswalk to 81500	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0361U	PLA	Immunology	"Neurofilament light chain, digital immunoassay, plasma, quantitative "	"1. Gapfill: 8
2. Abstain: 1"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0393U	PLA	Chemistry	"Neurology (eg, Parkinson disease, dementia with Lewy bodies), cerebrospinal fluid (CSF), detection of misfolded ?-synuclein protein by seed amplification assay, qualitative"	"1. Crosswalk to 0035U: 9
2. Gapfill: 0
3. Abstain: 0"	Gapfill	Crosswalk to 0035U	"After review of public comments, CMS agrees with the public and majority panel recommendation to crosswalk this code to 0035U.  WIth the additional material we received, CMS now agrees this is an appropriate crosswalk.  "		
0399U	PLA	Immunology	"Neurology (cerebral folate deficiency), serum, detection of anti-human folate receptor IgGbinding antibody and blocking autoantibodies by enzyme-linked immunoassay (ELISA), qualitative, and blocking autoantibodies, using a functional blocking assay for IgG or IgM, quantitative, reported as positive or not detected"	"1. Gapfill: 9
2. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
86041	NEW	Immunology	Acetylcholine receptor (AChR); binding antibody	"1. Crosswalk to 86341: 8
2. Gapfill: 0
3. Abstain: 1"	Crosswalk to 83519	Crosswalk to 83519	Finalize as proposed.  CMS continues to disagree with the majority of the CDLT Panel and still believes CPT 83519 is an appropiate crosswalk.  The additional information provided during the comment period did not provide  additional rationale to make a change.  		
86042	NEW	Immunology	Acetylcholine receptor (AChR); blocking antibody	"1. Crosswalk to 86341: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 83519	Crosswalk to 83519	Finalize as proposed.  CMS continues to disagree with the majority of the CDLT Panel and still believes CPT 83519 is an appropiate crosswalk.   The additional information provided during the comment period did not provide  additional rationale to make a change.  		
86043	NEW	Immunology	Acetylcholine receptor (AChR); modulating antibody	"1.Crosswalk to 86053: 8
2. Gapfill: 0
3. Abstain: 1"	Crosswalk to 86255	Crosswalk to 86255	Finalize as proposed.  CMS continues to disagree with the majority of the CDLT Panel and still believes CPT 83519 is an appropiate crosswalk.   The additional information provided during the comment period did not provide  additional rationale to make a change.  		
86366	NEW	Immunology	Muscle-specific kinase (MuSK) antibody	"1. Crosswalk to 84586: 8
2. Gapfill: 0
3. Abstain: 1"	Crosswalk to 83519	Crosswalk to 83519	Finalize as proposed.  CMS disagrees with the majority of the CDLT Panel and instead is recommending a different crosswalk.  CPT 83519 has been used as a billing code for this test prior to this time.   The additional information provided during the comment period did not provide  additional rationale to make a change.  		
0412U	NEW	Immunology	"Beta amyloid, A?42/40 ratio, immunoprecipitation with quantitation by liquid chromatography with tandem mass spectrometry (LC-MS/MS) and qualitative ApoE isoform-specific proteotyping, plasma combined with age, algorithm reported as presence or absence of brain amyloid pathology"	"1. Gapfill: 9
2. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0396U	PLA	Multianalyte Assays with Algorithmic Analyses; Microarray	"Obstetrics (pre-implantation genetic testing), evaluation of 300000 DNA single-nucleotide polymorphisms (SNPs) by microarray, embryonic tissue, algorithm reported as a probability for single-gene germline conditions"	"1. Crosswalk 0254U X 1.2: 2
2. Crosswalk 81229: 2
3. Gapfill: 5
4. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0410U	NEW	Multianalyte Assays with Algorithmic Analyses	"Oncology (pancreatic), DNA, whole genome sequencing with 5-hydroxymethylcytosine enrichment, whole blood or plasma, algorithm reported as cancer detected or not detected"	"1. Crosswalk to 81349: 8
2. Gapfill: 1
3. Abstain: 0"	Crosswalk to 81349	Crosswalk to 81349	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0326U	Reconsideration (PLA)	Multianalyte Assays with Algorithmic Analyses	"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
"	"1. Crosswalk to 0242U: 3
2. Crosswalk to 81455 X 1.25: 4
3. Gapfill (CMS): 2
4. Abstain: 0"	Crosswalk to 0242U	Crosswalk to 0242U-remove from gapfill file	"Finalize as proposed.  After careful consideration of public comments, as well as materials presented by the laboratory owner of this test through the reconsideration process under 42 C.F.R.  414.509 and at the 2023 Annual Public Meeting, CMS more fully understands how the resources for 0326U compare to 0242U.  In addition, the information CMS considered shows that the test methods for 0326U are nearly identical to 0242U; both tests are owned by the same laboratory and use similar proprietary technologies.  Therefore, we agree with the minority CDLT Panel that 0242U is an appropriate crosswalk for 0326U and are reconsidering the basis of payment for this test from gapfilling to crosswalking."		
0362U	PLA	Multianalyte Assays with Algorithmic Analyses	"Oncology (papillary thyroid cancer), gene-expression profiling via targeted hybrid captureenrichment RNA sequencing of 82 content genes and 10 housekeeping genes, formalin-fixed paraffin embedded (FFPE) tissue, algorithm reported as one of three molecular subtypes "	"1. Crosswalk to 0287U: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 0287U	Crosswalk to 0287U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0363U	PLA	Multianalyte Assays with Algorithmic Analyses	"Oncology (urothelial), mRNA, geneexpression profiling by real-time quantitative PCR of 5 genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm incorporates age, sex, smoking history, and macrohematuria frequency, reported as a risk score for having urothelial carcinoma"	"1. Crosswalk to 0012M: 8
2. Crosswalk to 0013M: 1
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 0012M	Crosswalk to 0012M	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0364U	PLA	Multianalyte Assays with Algorithmic Analyses	"Oncology (hematolymphoid neoplasm), genomic sequence analysis using multiplex (PCR) and next-generation sequencing with algorithm, quantification of dominant clonal sequence(s), reported as presence or absence of minimal residual disease (MRD) with quantitation of disease burden, when appropriate "	"1. Crosswalk 0171U: 4
2. Gapfill: 5
3. Abstain: 0
"	Gapfill	Gapfill	Finalize as proposed.  CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).		
0368U	PLA	Multianalyte Assays with Algorithmic Analyses	"Oncology (colorectal cancer), evaluation for mutations of APC, BRAF, CTNNB1, KRAS, NRAS, PIK3CA, SMAD4, and TP53, and methylation markers (MYO1G, KCNQ5, C9ORF50, FLI1, CLIP4, ZNF132 and TWIST1), multiplex quantitative polymerase chain reaction (qPCR), circulating cell-free DNA (cfDNA), plasma, report of risk score for advanced adenoma or colorectal cancer"	"1. Crosswalk to 0055U X 0.18: 8
2. Gapfill: 1
3. Abstain: 0"	Gapfill	Gapfill	Finalize as proposed.  CMS disagrees with the CDLT Panel majority to crosswalk this code.  CMS does not agree that the methods described in 0368U are accounted for in 0055U and disagrees with the public comments to apply a .18 multiplier.  Therefore CMS believes the MACs will be able to better estimate resources for this test. 		
0405U	NEW	Multianalyte Assays with Algorithmic Analyses	"Oncology (pancreatic), 59 methylation haplotype block markers, next-generation sequencing, plasma, reported as cancer signal detected or not detected "	"1. Crosswalk to 0318U: 8
2. Gapfill: 1
3. Abstain: 0"	Crosswalk to 0318U	Crosswalk to 0318U	Finalize as proposed.  CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
0391U	PLA	Multianalyte Assays with Algorithmic Analyses	"Oncology (solid tumor), DNA and RNA by next-generation sequencing, utilizing formalin-fixed paraffin-embedded (FFPE) tissue, 437 genes, interpretive report for single nucleotide variants, splicesite variants, insertions/deletions, copy number alterations, gene fusions, tumor mutational burden, and microsatellite instability, with algorithm quantifying immunotherapy response score"	"1. Crosswalk to 0250U: 4
2. Crosswalk to 0287U: 3
3. Gapfill: 2
4. Abstain: 0"	Crosswalk to 0287U	Crosswalk to 0287U	Finalize as proposed.  CMS agrees with the minority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.		
81462	NEW	Genomic Sequencing Procedures; cell free DNA	"Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants and rearrangements"	"1. Crosswalk to 81455 X 1.25: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81445	Gapfill	"After review of several public comments, CMS is recommending to gapfill this code.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
81463	NEW	Genomic Sequencing Procedures; cell free DNA	"Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis, copy number variants, and microsatellite instability"	"1. Crosswalk to 81455 X 1.25: 9
2. Gapfill: 0
3. Abstain: 0"	Crosswalk to 81445	Gapfill	"After review of several public comments, CMS is recommending to gapfill this code.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
81464	NEW	Genomic Sequencing Procedures; cell free DNA	"Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements"	"1. Crosswalk to 81455 X 1.25: 7
2. Crosswalk to 0244U X 1.25: 2
3. Gapfill: 0
4. Abstain: 0"	Crosswalk to 81445	Gapfill	"After review of several public comments, CMS is recommending to gapfill this code.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."		
