CPT Proprietary Laboratory Analyses (PLA) Codes: Long Descriptors

Transcription

1 CPT Proprietary Laboratory Analyses (PLA) Codes: Long Descriptors It is important to note that further CPT Editorial Panel (Panel) or Executive Committee actions may affect these codes and/or descriptors. For this reason, code numbers and/or descriptor language in the CPT code set may differ at the time of publication. In addition, further Panel actions may result in gaps in code number sequencing. Most recent changes to the CPT Proprietary Laboratory Analyses (PLA) Long Descriptor document Addition of 21 PLA codes (0084U-0104U) and deletion of one PLA code (0057U) accepted at the February CPT Editorial Panel meeting. Deleted codes in this document appear with a strikethrough. Proprietary laboratory analyses (PLA) codes describe proprietary clinical laboratory analyses and can be either provided by a single ( sole-source ) laboratory or licensed or marketed to multiple providing laboratories (eg, cleared or approved by the Food and Drug Administration [FDA]). This subsection includes advanced diagnostic laboratory tests (ADLTs) and clinical diagnostic laboratory tests (CDLTs), as defined under the Protecting Access to Medicare Act (PAMA) of These analyses may include a range of medical laboratory tests including, but not limited to, multianalyte assays with algorithmic analyses (MAAA) and genomic sequencing procedures (GSP). The descriptor nomenclature follows, where possible, existing code conventions (eg, MAAA, GSP). These codes are not required to fulfill the Category I criteria. The standards for inclusion in this section are: The test must be commercially available in the United States for use on human specimens and The clinical laboratory or manufacturer that offers the test must request the code. For similar laboratory analyses that fulfill Category I criteria, see codes listed in the numeric series. When a PLA code is available to report a given proprietary laboratory service, that PLA code takes precedence. The service should not be reported with any other CPT code(s) and other CPT code(s) should not be used to report services that may be reported with that specific PLA code. These codes encompass all analytical services required for the analysis (eg, cell lysis, nucleic acid stabilization, extraction, digestion, amplification, hybridization and detection). For molecular analyses, additional procedures that are required prior to cell lysis (eg, microdissection [codes and 88381]) may be reported separately. Codes in this subsection are released on a quarterly basis to expedite dissemination for reporting. PLA codes will be published electronically on the AMA CPT website ( distributed via CPT data files on a quarterly basis, and, at a minimum, made available in print annually in the CPT codebook. Go to for the most current listing. All codes that are included in this section are also included in Appendix O, with the procedure s proprietary name. In order to report a PLA code, the analysis performed must fulfill the code descriptor and must be the test represented by the proprietary name listed in Appendix O. In some instances, the descriptor language of PLA codes may be identical and the code may only be differentiated by the listed proprietary name in Appendix O. When more than one PLA has an identical descriptor, the codes will be denoted by the symbol.

2 Proprietary Name and Clinical Laboratory and/or Manufacturer Code Long Code Descriptor Released to AMA Website Effective Date Publication AmHPR H.elicobacterpylori Antibiotic Resistance Next Generation Sequencing Panel, American Molecular Laboratories, Inc 0008U Helicobacter pylori detection and antibiotic resistance, DNA, 16S and 23S rrna, gyra, pbp1, rdxa and rpob, next generation sequencing, formalin-fixed paraffin-embedded or fresh tissue or fecal sample, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline, and rifabutin June 1, 2017 Revision Released to AMA Website November 30, August 1, 2017 Revision Effective 1, CPT Revision Publication ToxLok, InSource, Agena Bioscience, Inc. InSource 0020U Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, with specimen verification including DNA authentication in comparison to buccal DNA, per date of service (For additional PLA code with identical linical descriptor, see 0007U. See Appendix O to determine appropriate code assignment) 2017 Released to AMA Website 1, 2017 Effective 1, CPT Publication CYP2D6 Genotype Cascade, Mayo Clinic, Mayo Clinic RNA-Sequencing by NGS, OmniSeq, Inc, Life Technologies Corporation 0028U 0057U (0020U has been deleted) metabolism) gene analysis, copy number variants, common variants with reflex to targeted sequence analysis (0028U has been deleted) Oncology (solid organ neoplasia), mrna, gene expression profiling by massively parallel sequencing for analysis of 51 genes, utilizing formalin-fixed paraffinembedded tissue, algorithm reported as a normalized percentile rank (0057U has been deleted) December 1, 2017 Released to AMA Website June 1, Released to AMA Website 1, Effective 1, Effective CPT Publication CPT Publication

3 SLE-key Rule Out, Veracis Inc, Veracis Inc 0062U Autoimmune (systemic lupus erythematosus), IgG and IgM analysis of 80 biomarkers, utilizing serum, algorithm reported with a risk score 1, NPDX ASD ADM Panel I, Stemina Biomarker Discovery, Inc, Stemina Biomarker Discovery, Inc d/b/a NeuroPointDX 0063U Neurology (autism), 32 amines by LC- MS/MS, using plasma, algorithm reported as metabolic signature associated with autism spectrum disorder 1, BioPlex 2200 Syphilis Total & RPR Assay, Bio-Rad Laboratories, Bio-Rad Laboratories 0064U Antibody, Treponema pallidum, total and rapid plasma reagin (RPR), immunoassay, qualitative 1, BioPlex 2200 RPR Assay, Bio-Rad Laboratories, Bio-Rad Laboratories 0065U Syphilis test, non-treponemal antibody, immunoassay, qualitative (RPR) 1, PartoSure, Parsagen, Inc, Parsagen, Inc, a QIAGEN Company 0066U Placental alpha-micro globulin-1 (PAMG- 1), immunoassay with direct optical observation, cervico-vaginal fluid, each specimen 1, BBDRisk Dx, Silbiotech, Inc 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 1,

4 MYCODART Dual Amplification Real Time PCR Panel for 6 Candida species, RealTime Laboratories, Inc 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 1, mir-31now, GoPath Laboratories, GoPath Laboratories 0069U Oncology (colorectal), microrna, RT-PCR expression profiling of mir-31-3p, formalinfixed paraffin-embedded tissue, algorithm reported as an expression score 1, CYP2D6 Common Variants and Copy Number, Mayo Clinic, 0070U 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) 1, CYP2D6 Full Gene Sequencing, Mayo Clinic, Laboratory Developed 0071U metabolism) gene analysis, full gene sequence (List separately in addition to code for primary procedure) 1, CYP2D6-2D7 Hybrid Gene Targeted Sequence Analysis, Mayo Clinic, 0072U (Use 0071U in conjunction with 0070U) metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene) (List separately in addition to code for primary procedure) 1, CYP2D7-2D6 Hybrid Gene Targeted Sequence Analysis, Mayo Clinic, 0073U (Use 0072U in conjunction with 0070U) metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene) (List separately in addition to code for primary procedure) 1, (Use 0073U in conjunction with 0070U)

5 CYP2D6 transduplication/ multiplication nonduplicated gene targeted sequence analysis, Mayo Clinic, CYP2D6 5 gene duplication/ multiplication targeted sequence analysis, Mayo Clinic, CYP2D6 3 gene duplication/ multiplication targeted sequence analysis, Mayo Clinic, 0074U 0075U 0076U metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans) (List separately in addition to code for primary procedure) (Use 0074U in conjunction with 0070U) metabolism) gene analysis, targeted sequence analysis (ie, 5 gene duplication/multiplication) (List separately in addition to code for primary procedure) (Use 0075U in conjunction with 0070U) metabolism) gene analysis, targeted sequence analysis (ie, 3 gene duplication/ multiplication) (List separately in addition to code for primary procedure) (Use 0076U in conjunction with 0070U 1, 1, 1, M-Protein Detection and Isotyping by MALDI-TOF Mass Spectrometry, Mayo Clinic, Laboratory Developed 0077U Immunoglobulin paraprotein (M-protein), qualitative, immunoprecipitation and mass spectrometry, blood or urine, including isotype 1, INFINITI Neural Response Panel, PersonalizeDx Labs, AutoGenomics Inc 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 1,

6 ToxLok, InSource, InSource 0079U Comparative DNA analysis using multiple selected single-nucleotide polymorphisms (SNPs), urine and buccal DNA, for specimen identity verification 1, BDX-XL2, Biodesix, Inc DecisionDx -UM, Castle Biosciences, Inc 0080U 0081U 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 Oncology (uveal melanoma), mrna, geneexpression profiling by real-time RT-PCR of 15 genes (12 content and 3 housekeeping genes), utilizing fine needle aspirate or formalin-fixed paraffinembedded tissue, algorithm reported as risk of metastasis November 30, November 30, 1, 1, NextGen Precision ing, Precision LBN Precision Toxicology, LLC Onco4D, Animated Dynamics, Inc 0082U 0083U 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 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 November 30, November 30, 1, 1, BLOODchip ID CORE XT, Grifols Diagnostic Solutions Inc 0084U Red blood cell antigen typing, DNA, genotyping of 10 blood groups with phenotype prediction of 37 red blood cell antigens

7 IBSchek, Commonwealth International, Inc 0085U Cytolethal distending toxin B (CdtB) and vinculin IgG antibodies by immunoassay (ie, ELISA) Accelerate Pheno BC kit, Accelerate, Inc 0086U Infectious disease (bacterial and fungal), organism identification, blood culture, using rrna FISH, 6 or more organism targets, reported as positive or negative with phenotypic minimum inhibitory concentration (MIC)-based antimicrobial susceptibility Molecular Microscope MMDx Heart, Kashi Clinical Laboratories 0087U Cardiology (heart transplant), mrna gene expression profiling by microarray of 1283 genes, transplant biopsy tissue, allograft rejection and injury algorithm reported as a probability score Molecular Microscope MMDx Kidney, Kashi Clinical Laboratories 0088U Transplantation medicine (kidney allograft rejection), microarray gene expression profiling of 1494 genes, utilizing transplant biopsy tissue, algorithm reported as a probability score for rejection Pigmented Lesion Assay (PLA), DermTech 0089U Oncology (melanoma), gene expression profiling by RTqPCR, PRAME and LINC00518, superficial collection using adhesive patch(es) mypath Melanoma, Myriad Genetic Laboratories 0090U Oncology (cutaneous melanoma), mrna gene expression profiling by RT-PCR of 23 genes (14 content and 9 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a categorical result (ie, benign, indeterminate, malignant)

8 FirstSight CRC, CellMax Life 0091U Oncology (colorectal) screening, cell enumeration of circulating tumor cells, utilizing whole blood, algorithm, for the presence of adenoma or cancer, reported as a positive or negative result REVEAL Lung Nodule Characterization, MagArray, Inc 0092U Oncology (lung), three protein biomarkers, immunoassay using magnetic nanosensor technology, plasma, algorithm reported as risk score for likelihood of malignancy ComplyRX, Claro Labs 0093U Prescription drug monitoring, evaluation of 65 common drugs by LC-MS/MS, urine, each drug reported detected or not detected RCIGM Rapid Whole Genome Sequencing, Rady Children's Institute for Genomic Medicine (RCIGM) 0094U Genome (eg, unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis Esophageal String (EST), Cambridge Biomedical, Inc HPV, High-Risk, Male Urine, Molecular ing Labs 0095U 0096U Inflammation (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]), specimen obtained by swallowed nylon string, algorithm reported as predictive probability index for active eosinophilic esophagitis Human papillomavirus (HPV), high-risk types (ie, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), male urine

9 BioFire FilmArray Gastrointestinal (GI) Panel, BioFire BioFire FilmArray Respiratory Panel (RP) EZ, BioFire BioFire FilmArray Respiratory Panel (RP), BioFire 0097U 0098U 0099U Gastrointestinal pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 22 targets (Campylobacter [C. jejuni/c. coli/c. upsaliensis], Clostridium difficile [C. difficile] toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio [V. parahaemolyticus/v. vulnificus/v. cholerae], including specific identification of Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative Escherichia coli [EAEC], Enteropathogenic Escherichia coli [EPEC], Enterotoxigenic Escherichia coli [ETEC] lt/st, Shiga-like toxin-producing Escherichia coli [STEC] stx1/stx2 [including specific identification of the E. coli O157 serogroup within STEC], Shigella/Enteroinvasive Escherichia coli [EIEC], Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia [also known as G. intestinalis and G. duodenalis], adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, sapovirus [Genogroups I, II, IV, and V]) Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 14 targets (adenovirus, coronavirus, human metapneumovirus, influenza A, influenza A subtype H1, influenza A subtype H3, influenza A subtype H1-2009, influenza B, parainfluenza virus, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae) Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus, coronavirus OC43, human metapneumovirus, influenza A, influenza A subtype, influenza A subtype H3, influenza A subtype H1-2009, influenza, parainfluenza virus, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumonia, Mycoplasma pneumoniae)

10 BioFire FilmArray Respiratory Panel 2 (RP2), BioFire ColoNext, Ambry Genetics, Ambry Genetics BreastNext, Ambry Genetics, Ambry Genetics OvaNext, Ambry Genetics, Ambry Genetics CancerNext, Ambry Genetics, Ambry Genetics 0100U 0101U 0102U 0103U 0104U Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza A, including subtypes H1, H1-2009, and H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, Bordetella parapertussis [IS1001], Bordetella pertussis [ptxp], Chlamydia pneumoniae, Mycoplasma pneumoniae) Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (15 genes [sequencing and deletion/duplication], EPCAM and GREM1 [deletion/duplication only]) Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (17 genes [sequencing and deletion/duplication]) Hereditary ovarian cancer (eg, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (24 genes [sequencing and deletion/duplication], EPCAM [deletion/duplication only]) Hereditary pan cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial cancer, hereditary colorectal cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (32 genes

11 [sequencing and deletion/duplication], EPCAM and GREM1 [deletion/duplication only])