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Clinical Diagnostic Laboratory Fee Schedule- 2023 Gapfill Preliminary Determinations to be implemented in CY 2024
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CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association (AMA).
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As outlined in Sec 1834A(c)(4); Explanation of payment rates.--In the case of a clinical diagnostic laboratory test for which payment is made under this subsection, the Secretary shall make available to the public an explanation of the payment rate for the test.
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Comments may be submitted to clfs_inquiries@cms.hhs.gov by by 06/26/2023
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HCPCS
Descriptor MedianNGS WINOV PA
MOLDX OH
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 6,302 12,502 15,202
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 LOC 00 LOC 00 LOC 00 SDSD as %MAXMIN
MAX OV MIN
MAX MINUS MIN
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81418Drug metabolism (eg, pharmacogenomics) genomic sequence analysis panel, must include testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysis$917.08$900 $168$917 $ 321 35% $ 917 $ 168 5.5 $ 749
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86409Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); titer$79.61$80 $51$80 $ 12 15% $ 80 $ 51 1.5 $ 28
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86413Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative$51.43$51 $51$51 $ - 0% $ 51 $ 51 1.0 $ -
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87428Infectious 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$70.29$62 $59$70 $ 5 7% $ 70 $ 59 1.2 $ 11
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0022UTargeted 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$1,436.30$1,436 $1,950$1,436 $ 222 15% $ 1,950 $ 1,436 1.4 $ 514
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0285UOncology, response to radiation, cell-free DNA, quantitative branched chain DNA amplification, plasma, reported as a radiation toxicity score$443.31$443 $30$443 $ 178 40% $ 443 $ 30 14.8 $ 413
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0291UPsychiatry (mood disorders), mRNA, gene expression profiling by RNA sequencing of 144 genes, whole blood, algorithm reported as predictive risk score $1,755.00$1,755 $760$1,755 $ 429 24% $ 1,755 $ 760 2.3 $ 995
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0292UPsychiatry (stress disorders), mRNA, gene expression profiling by RNA sequencing of 72 genes, whole blood, algorithm reported as predictive risk score$1,755.00$1,755 $760$1,755 $ 429 24% $ 1,755 $ 760 2.3 $ 995
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0297UOncology (pan tumor), whole genome sequencing of paired malignant and normal DNA specimens, fresh or formalinfixed paraffin-embedded (FFPE) tissue, blood or bone marrow, comparative sequence analyses and variant identification$2,919.60$2,920 $7,741$2,920 $ 2,081 71% $ 7,741 $ 2,920 2.7 $ 4,822
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0299UOncology (pan tumor), whole genome optical genome mapping of paired malignant and normal DNA specimens, fresh frozen tissue, blood, or bone marrow, comparative structural variant identification $1,263.53$1,264 $1,972$1,264 $ 306 24% $ 1,972 $ 1,264 1.6 $ 708
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0300UOncology (pan tumor), whole genome sequencing and optical genome mapping of paired malignant and normal DNA specimens, fresh tissue, blood, or bone marrow, comparative sequence analyses and variant identification $4,183.13$2,527 $9,713$4,183 $ 2,662 64% $ 9,713 $ 2,527 3.8 $ 7,186
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0301UInfectious agent detection by nucleic acid (DNA or RNA), Bartonella henselae and Bartonella quintana, droplet digital PCR (ddPCR);$262.72$263 $303$263 $ 17 7% $ 303 $ 263 1.2 $ 40
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0302UInfectious agent detection by nucleic acid (DNA or RNA), Bartonella henselae and Bartonella quintana, droplet digital PCR (ddPCR); following liquid enrichment$361.37$361 $410$361 $ 21 6% $ 410 $ 361 1.1 $ 49
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0303UHematology, red blood cell (RBC) adhesion to endothelial/subendothelial adhesion molecules, functional assessment, whole blood, with algorithmic analysis and result reported as an RBC adhesion index; hypoxic$2,201.62$2,202 $1,297$2,202 $ 391 18% $ 2,202 $ 1,297 1.7 $ 905
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0304UHematology, red blood cell (RBC) adhesion to endothelial/subendothelial adhesion molecules, functional assessment, whole blood, with algorithmic analysis and result reported as an RBC adhesion index; normoxic$2,075.80$2,076 $1,223$2,076 $ 368 18% $ 2,076 $ 1,223 1.7 $ 853
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0305UHematology, red blood cell (RBC) functionality and deformity as a function of shear stress, whole blood, reported as a maximum elongation index $662.58$663 $408$663 $ 110 17% $ 663 $ 408 1.6 $ 255
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0306UOncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis, cell-free DNA, initial (baseline) assessment to determine a patient-specific panel for future comparisons to evaluate for MRD

(Do not report 0306U in conjunction with 0307U) 		$3,084.45$3,084 $2,183$3,084 $ 389 13% $ 3,084 $ 2,183 1.4 $ 901
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0307UOncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis of a patient-specific panel, cell-free DNA, subsequent assessment with comparison to previously analyzed patient specimens to evaluate for MRD
(Do not report 0307U in conjunction with 0306U)		$794.49$794 $444$794 $ 151 19% $ 794 $ 444 1.8 $ 350
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0314UOncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 35 genes (32 content and 3 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical result (ie, benign, intermediate, malignant)$1,950.00$1,755 $1,755$1,950 $ 98 5% $ 1,950 $ 1,755 1.1 $ 195
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0315UOncology (cutaneous squamous cell carcinoma), mRNA gene expression profiling by RT-PCR of 40 genes (34 content and 6 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical risk result (ie, Class 1, Class 2A, Class 2B) $3,159.42$1,755 $1,755$3,159 $ 705 22% $ 3,159 $ 1,755 1.8 $ 1,404
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0318UPediatrics (congenital epigenetic disorders), whole genome methylation analysis by microarray for 50 or more genes, blood $1,373.91$1,374 $900$1,374 $ 205 15% $ 1,374 $ 900 1.5 $ 474
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0319UNephrology (renal transplant), RNA expression by select transcriptome sequencing, using pretransplant peripheral blood, algorithm reported as a risk score for early acute rejection$2,650.00$2,650 $1,755$2,650 $ 386 15% $ 2,650 $ 1,755 1.5 $ 895
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0320UNephrology (renal transplant), RNA expression by select transcriptome sequencing, using posttransplant peripheral blood, algorithm reported as a risk score for acute cellular rejection $2,650.00$2,650 $1,755$2,650 $ 386 15% $ 2,650 $ 1,755 1.5 $ 895
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0326UTargeted 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$3,500.00$3,500 $5,000$3,500 $ 647 18% $ 5,000 $ 3,500 1.4 $ 1,500
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0329UOncology (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$2,919.60$2,920 $4,780$2,920 $ 803 28% $ 4,780 $ 2,920 1.6 $ 1,860
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0331UOncology (hematolymphoid neoplasia), optical genome mapping for copy number alterations and gene rearrangements utilizing DNA from blood or bone marrow, report of clinically significant alternations$1,263.53$1,264 $1,160$1,264 $ 45 4% $ 1,264 $ 1,160 1.1 $ 104
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0332UOncology (pan-tumor), genetic profiling of 8 DNA-regulatory (epigenetic) markers by quantitative polymerase chain reaction (qPCR), whole blood, reported as a high or low probability of responding to immune checkpoint-inhibitor therapy$1,142.06$1,142 $343$1,142 $ 345 30% $ 1,142 $ 343 3.3 $ 799
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0333UOncology (pan-tumor), genetic profiling of 8 DNA-regulatory (epigenetic) markers by quantitative polymerase chain reaction (qPCR), whole blood, reported as a high or low probability of responding to immune checkpoint–inhibitor therapy$662.32$662 $1,335$662 $ 290 44% $ 1,335 $ 662 2.0 $ 672
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0337UOncology (plasma cell disorders and myeloma), circulating plasma cell immunologic selection, identification, morphological characterization, and enumeration of plasma cells based on differential CD138, CD38, CD19, and CD45 protein biomarker expression, peripheral blood$2,435.00$2,435 $251$2,435 $ 943 39% $ 2,435 $ 251 9.7 $ 2,184
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0338URare diseases (constitutional/heritable disorders), whole genome sequence analysis, including small sequence changes, copy number variants, deletions, duplications, mobile element insertions, uniparental disomy (UPD), inversions, aneuploidy, mitochondrial genome sequence analysis with heteroplasmy and large deletions, short tandem repeat (STR) gene expansions, blood or saliva, identification and categorization of genetic variants, each comparator genome (eg, parent)$2,435.00$2,322 $251$2,435 $ 931 38% $ 2,435 $ 251 9.7 $ 2,184
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0341UFetal aneuploidy DNA sequencing comparative analysis, fetal DNA from products of conception, reported as
normal (euploidy), monosomy, trisomy, or partial deletion/duplication, mosaicism, and segmental aneuploid 		$1,900.20$1,900 $1,160$1,900 $ 320 17% $ 1,900 $ 1,160 1.6 $ 740
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0344UHepatology (nonalcoholic fatty liver disease [NAFLD]), semiquantitative evaluation of 28 lipid markers by liquid chromatography with tandem mass spectrometry (LC-MS/MS), serum, reported as at-risk for nonalcoholic steatohepatitis (NASH) or not NASH$792.17$792 $347$792 $ 192 24% $ 792 $ 347 2.3 $ 445
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0346UBeta amyl ab40&ab42 lc-ms/ms$93.26$93 $48$93 $ 19 21% $ 93 $ 48 1.9 $ 45
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