2019 Codes Subject To Or Excluded From CLIA Edits

2019 Codes Subject To Or Excluded From CLIA EditsThe 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
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 carcinom

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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For More Information: https://www.aapc.com/blog/46092-2019-codes-subject-to-or-excluded-from-clia-edits/

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