2019 Codes Subject to or Excluded from CLIA Edits

2019 Codes Subject to or Excluded from CLIA Edits

The CPT® codes that are considered a laboratory test under the Clinical Laboratory Improvement Amendments (CLIA) change each year, as well as throughout the year, making it difficult for healthcare providers and laboratories to keep up. Here are the CPT codes for 2019 that are subject to or excluded from CLIA edits in easy-to-look up table form.

Excluded from CLIA Edits, CLIA Certificate Not Required
CPT Code Description
0061U Transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin – Effective July 1, 2018
0079U Comparative Deoxyribonucleic Acid (DNA) analysis using multiple selected Single-Nucleotide Polymorphisms (SNPs), urine and buccal DNA, for specimen identity verification – Effective October 1, 2018
Subject to CLIA Edits, CLIA Certificate Required
Effective October 1, 2017
0018U Oncology (thyroid), microRNA profiling by RT-PCR of 10 microRNA sequences, utilizing fine needle aspirate, algorithm reported as a positive or negative result for moderate to high risk of malignancy A3
0019U Oncology, RNA, gene expression by whole transcriptome sequencing, formalin-fixed paraffin embedded tissue or fresh frozen tissue, predictive algorithm reported as potential targets for therapeutic agents
0021U Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5’-UTRBMI1, CEP 164, 3’-UTR-Ropporin, Desmocollin, AURKAIP-1, CSNK2A2), multiplexed immunoassay and flow cytometry serum, algorithm reported as risk score
0022U 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/absence of variants and associated therapy(ies) to consider
0023U Oncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or nondetection of FLT3 mutation and indication for or against the use of midostaurin
Effective January 1, 2018
0011M Oncology, prostate cancer, mRNA expression assay of 12 genes (10 content and 2 housekeeping), RT-PCR test utilizing blood plasma and/or urine, algorithms to predict high-grade prostate cancer risk
Effective April 1, 2018
0012M  Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (mdk, hoxa13, cdc2 [cdk1], igfbp5, and cxcr2), utilizing urine, algorithm reported as a risk score for having urothelial carcinoma
0013M Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (mdk, hoxa13, cdc2 [cdk1], igfbp5, and cxcr2), utilizing urine, algorithm reported as a risk score for having recurrent urothelial carcinoma
0035U Testing for presence of prion protein in cerebrospinal fluid
0036U Exome gene analysis for somatic mutation in tumor tissue
0037U  DNA gene analysis of 324 genes in solid organ tumor tissue
0038U Measurement of vitamin D in serum
0039U Testing for anti-DNA antibody
0040U BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative
0041U IgM antibody detection test for Borrelia burgdorferi
0042U IgG antibody detection test for Borrelia burgdorferi
0043U IgM antibody detection test for Tick-Borne Relapsing Fever Borrelia group
0044U IgG antibody detection test for Tick-Borne Relapsing Fever Borrelia group
Effective July 1, 2018
0045U mRNA gene analysis of 12 genes in breast ductal carcinoma in situ tumor tissue
0046U Gene analysis (fms-related tyrosine kinase 3) for internal tandem duplication variants
0047U mRNA gene analysis of 17 genes in prostate tumor tissue
0048U DNA gene analysis of 468 genes in solid organ tumor tissue
0049U Gene analysis (nucleophosmin)
0050U DNA gene analysis of targeted sequences in 194 genes for acute myelogenous leukemia
0051U Testing for presence of 31 prescription drugs in urine
0052U Measurement of all five major lipoprotein classes and subclasses in blood
0053U FISH analysis of 4 genes in prostate needle biopsy specimen
0054U Measurement of 14 or more drug classes in capillary blood
0055U DNA gene analysis of 96 target sequences in plasma for heart transplant
0056U Whole genome sequencing in blood or bone marrow for acute myelogenous leukemia
0057U mRNA gene analysis of 51 genes in solid organ tumor tissue
0058U Measurement of antibodies to Merkel cell polyoma virus oncoprotein in serum
0059U Test for presence of antibodies to Merkel cell polyoma virus oncoprotein in serum
0060U Gene analysis for identical twins in maternal blood
Effective October 1, 2018
0062U Autoimmune (systemic lupus erythematosus), IgG and IgM analysis of 80 biomarkers, utilizing serum, algorithm reported with a risk score
0063U Neurology (autism), 32 amines by LC-MS/MS, using plasma, algorithm reported as metabolic signature associated with autism spectrum disorder
0064U Antibody, treponema pallidum, total and rapid plasma reagin (RPR), immunoassay, qualitative
0065U Syphilis test, non-treponemal antibody, immunoassay, qualitative (RPR)
0066U Placental alpha-micro globulin-1 (pamg-1), immunoassay with direct optical observation, cervico-vaginal fluid, each specimen
0067U Oncology (breast), immunohistochemistry, protein expression profiling of 4 biomarkers (matrix metalloproteinase-1 [MMP-1], carcinoembryonic antigen-related cell adhesion molecule 6 [CEACAM6], hyaluronoglucosaminidase [HYAL1], highly expressed in cancer protein [HEC1]), formalin-fixed paraffin-embedded precancerous breast tissue, algorithm reported as carcinoma risk score
0068U Candida species panel (C. albicans, C. glabrata, C. parapsilosis, C. kruseii, C tropicalis, and C. auris), amplified probe technique with qualitative report of the presence or absence of each species
0069U Oncology (colorectal), microRNA, RT-PCR expression profiling of miR-31-3p, formalin-fixed paraffin-embedded tissue, algorithm reported as an expression score
0070U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, common and select rare variants (ie, *2, *3, *4, *4n, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14a, *14b, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, *83, *xN)
0071U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence (list separately in addition to code for primary procedure)
0072U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene) (list separately in addition to code for primary procedure)
0073U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene) (list separately in addition to code for primary procedure)
0074U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans) (list separately in addition to code for primary procedure)
0075U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 5′ gene duplication/multiplication) (list separately in addition to code for primary procedure)
0076U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 3′ gene duplication/ multiplication) (list separately in addition to code for primary procedure)
0077U Immunoglobulin paraprotein (M-protein), qualitative, immunoprecipitation and mass spectrometry, blood or urine, including isotype
0078U Pain management (opioid-use disorder) genotyping panel, 16 common variants (ie, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), buccal swab or other germline tissue sample, algorithm reported as positive or negative risk of opioid-use disorder
Effective January 1, 2019
The following are all new codes and does not include codes for new waived tests or provider-performed procedures.
0080U Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors (age, smoking status, nodule diameter, nodule-spiculation status and nodule location), utilizing plasma, algorithm reported as a categorical probability of malignancy
0081U Oncology (uveal melanoma), mRNA, gene-expression profiling by real-time RTPCR of 15 genes (12 content and 3 housekeeping genes), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis
0082U Drug test(s), definitive, 90 or more drugs or substances, definitive chromatography with mass spectrometry, and presumptive, any number of drug classes, by instrument chemistry analyzer (utilizing immunoassay), urine, report of presence or absence of each drug, drug metabolite or substance with description and severity of significant interactions per date of service
0083U Oncology, response to chemotherapy drugs using motility contrast tomography, fresh or frozen tissue, reported as likelihood of sensitivity or resistance to drugs or drug combinations
81163 BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis)
81164 BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)
81165 BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis
81166 BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)
81167 BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)
81171 AFF2 (AF4/FMR2 family, member 2 [FMR2]) (eg, fragile X mental retardation 2 [FRAXE]) gene analysis; evaluation to detect abnormal (eg, expanded) alleles
81172 AFF2 (AF4/FMR2 family, member 2 [FMR2]) (eg, fragile x mental retardation 2 [FRAXE]) gene analysis; characterization of alleles (eg, expanded size and methylation status)
81173 AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; full gene sequence
81174 AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; known familial variant
81177 ATN1 (atrophin 1) (eg, dentatorubral-pallidoluysian atrophy) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81178 ATXN1 (ATAXIN 1) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81179 ATXN2 (ATAXIN 2) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81180 ATXN3 (ATAXIN 3) (eg, spinocerebellar ataxia, machado-joseph disease) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81181 ATXN7 (ATAXIN 7) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81182 ATXN8OS (ATXN8 opposite strand [non-protein coding]) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81183 ATXN10 (ATAXIN 10) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81184 CACNA1A (calcium voltage-gated channel subunit alpha1 A) (eg, spinocerebellar ataxia) gene analysis; evaluation to detect abnormal (eg, expanded) alleles
81185 CACNA1A (calcium voltage-gated channel subunit alpha1 A) (eg, spinocerebellar ataxia) gene analysis; full gene sequence
81186 CACNA1A (calcium voltage-gated channel subunit alpha1 A) (eg, spinocerebellar ataxia) gene analysis; known familial variant
81187 CNBP (CCHC-type zinc finger nucleic acid binding protein) (eg, myotonic dystrophy type 2) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81188 CSTB (cystatin B) (eg, Unverricht-Lundborg disease) gene analysis; evaluation to detect abnormal (eg, expanded) alleles
81189 CSTB (cystatin B) (eg, Unverricht-Lundborg disease) gene analysis; full gene sequence
81190 CSTB (cystatin B) (eg, Unverricht-Lundborg disease) gene analysis; known familial variant(s)
81204 AR (androgen receptor) (eg, spinal and bulbar muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; characterization of alleles (eg, expanded size or methylation status)
81233 BTK (Bruton’s tyrosine kinase) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, C481S, C481R, C481F)
81234 DMPK (DM1 protein kinase) (eg, myotonic dystrophy type 1) gene analysis; evaluation to detect abnormal (expanded) alleles
81236 EZH2 (enhancer of zeste 2 polycomb repressive complex 2 subunit) (eg, myelodysplastic syndrome, myeloproliferative neoplasms) gene analysis, full gene sequence
81237 EZH2 (enhancer of zeste 2 polycomb repressive complex 2 subunit) (eg, diffuse large B-cell lymphoma) gene analysis, common variant(s) (eg, codon 646)
81239 DMPK (DM1 protein kinase) (eg, myotonic dystrophy type 1) gene analysis; characterization of alleles (eg, expanded size)
81271 HTT (huntingtin) (eg, Huntington disease) gene analysis; evaluation to detect abnormal (eg, expanded) alleles
81274 HTT (huntingtin) (eg, Huntington disease) gene analysis; characterization of alleles (eg, expanded size)
81284 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; evaluation to detect abnormal (expanded) alleles
81285 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; characterization of alleles (eg, expanded size)
81286 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; full gene sequence
81289 FXN (frataxin) (eg, Friedreich ataxia) gene analysis; known familial variant(s)
81305 MYD88 (myeloid differentiation primary response 88) (eg, Waldenstrom’s macroglobulinemia, lymphoplasmacytic leukemia) gene analysis, P.LEU265PRO (L265P) variant
81306 NUDT15 (nudix hydrolase 15) (eg, drug metabolism) gene analysis, common variant(s) (eg, *2, *3, *4, *5, *6)
81312 PABPN1 (poly[A] binding protein nuclear 1) (eg, oculopharyngeal muscular dystrophy) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81320 PLCG2 (phospholipase C gamma 2) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, R665W, S707F, L845F)
81329 SMN1 (survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; dosage/deletion analysis (eg, carrier testing), includes SMN2 (survival of motor neuron 2, centromeric) analysis, if performed
81333 TGFBI (transforming growth factor beta-induced) (eg, corneal dystrophy) gene analysis, common variants (eg, R124H, R124C, R124L, R555W, R555Q)
81336 SMN1 (survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; full gene sequence
81337 SMN1 (survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; known familial sequence variant(s)
81343 PPP2R2B (protein phosphatase 2 regulatory subunit Bbeta) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81344 TBP (TATA box binding protein) (eg, spinocerebellar ataxia) gene analysis, evaluation to detect abnormal (eg, expanded) alleles
81345 TERT (telomerase reverse transcriptase) (eg, thyroid carcinoma, glioblastoma multiforme) gene analysis, targeted sequence analysis (eg, promoter region)
81443 Genetic testing for severe inherited conditions (eg, cystic fibrosis, Ashkenazi Jewish-associated disorders [eg, Bloom syndrome, Canavan disease, Ganconi anemia type C, mucolipidosis type vi, Gaucher disease, Tay-Sachs disease], beta hemoglobinopathies, phenylketonuria, galactosemia), genomic sequence analysis panel, must include sequencing of at least 15 genes (eg, ACADM, ARSA, ASPA, ATP7B, BCKDHA, BCKDHB, BLM, CFTR, DHCR7, FANCC, G6PC, GAA, GALT, GBA, GBE1, HBB, HEXA, IKBKAP, MCOLN1, PAH)
81518 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR OF 11 genes (7 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithms reported as percentage risk for metastatic recurrence and likelihood of benefit from extended endocrine therapy
81596 Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays; (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver
82642 Dihydrotestosterone (DHT)
83722 Lipoprotein, direct measurement; small dense LDL cholesterol

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Source

CPB : Online Medical Billing Course

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11135.pdf

Renee Dustman
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Renee Dustman

Executive Editor at AAPC
Renee Dustman, BS, AAPC MACRA Proficient, is an executive editor at AAPC. She holds a Bachelor of Science degree in Media Communications - Journalism. Renee has more than 20 years experience in print production and content management. Follow her on Twitter @dustman_aapc.
Renee Dustman
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Renee Dustman, BS, AAPC MACRA Proficient, is an executive editor at AAPC. She holds a Bachelor of Science degree in Media Communications - Journalism. Renee has more than 20 years experience in print production and content management. Follow her on Twitter @dustman_aapc.

One Response to “2019 Codes Subject to or Excluded from CLIA Edits”

  1. Natalie says:

    can you bill 22614 with 59
    getting co 97 when billing 22612,63047, 22842, 22614, 63048

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