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New PLA Codes Billable Under the Medicare CLFS to Be Aware Of

by | Mar 10, 2023 | Essential, National Lab Reporter, Reimbursement-nir

Here’s a quick briefing of the new codes that come into effect on April 1 that your billing staff should know about.

Labs that provide tests to beneficiaries covered by Medicare Part B need to be aware of upcoming Clinical Laboratory Fee Schedule (CLFS) changes. The Centers for Medicare & Medicaid Services (CMS) announced the changes in its quarterly Medicare Learning Network transmittal (CR 13082) on Feb. 2 and they officially take effect on April 1, 2023.1 One of the key changes that your billing staff may have to know about to ensure full and proper reimbursement is the addition of new Proprietary Laboratory Analysis (PLA) codes that Medicare will pay for under the CLFS. Here’s a quick briefing on the coding changes.

The Importance of PLA Codes

Proprietary Laboratory Analysis (PLA) codes are alpha numeric codes consisting of four digits and ending with the uppercase letter “U” that the AMA incorporated into its CPT coding system to enable labs or manufacturers to specifically identify their test products. PLA codes are assigned only if the lab or manufacturer requests them. PLA tests include:

    • Advanced diagnostic laboratory tests (ADLTs)

    • Clinical diagnostic laboratory tests (CDLTs) that are not ADLTs

    • Multianalyte assays with algorithmic analyses (MAAA)

  • Genomic sequencing procedures

PLA coded tests may be performed either by “one, sole source” lab or multiple labs to whom that lab licenses the test. Every year, CMS expands the list of PLA tests paid by Medicare. Initially, Medicare Administrative Contractors (MACs) decide on the price for PLA tests performed by labs in their jurisdiction until they’re nationally priced by CMS.

The New PLA Codes

Medicare will pay for 22 additional PLA tests, starting April 1, 2023:

New PLA Codes Added to CLFS, Effective April 1, 2023

Laboratory CPT CodeLong Descriptor Short Descriptor
clonoSEQAssay, Adaptive Biotechnologies0364UOncology (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 appropriateONC HL NEO GEN SEQ ALYS ALG
Oncuria Detect, DiaCarta Clinical Lab, DiaCarta, Inc0365UOncology (bladder), analysis of 10 protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGFA) by immunoassays, urine, algorithm reported as probability of bladder cancerONC BLDR 10 PRB BLDR CA
Oncuria Monitor, DiaCarta Clinical Lab, DiaCarta, Inc0366UOncology (bladder), analysis of 10 protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGFA) by immunoassays, urine, algorithm reported as probability of recurrent bladder cancerONC BLDR 10 PRB RECR BLDR CA
Oncuria Predict, DiaCarta Clinical Lab, DiaCarta, Inc0367UOncology (bladder), analysis of 10 protein biomarkers (A1AT, ANG, APOE, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGFA) by immunoassays, urine, diagnostic algorithm reported as risk score for probability of rapid recurrence of recurrent or persistent cancer following transurethral resectionONC BLDR 10 FLWG TRURL RESCJ
GI assay (Gastrointestinal Pathogen with ABR), Lab Genomics LLC, Thermo Fisher Scientific0369UInfectious 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 techniqueIADNA GI PTHGN 31 ORG&21 ARG
Lesion Infection (Wound), Lab Genomics LLC, Thermo Fisher Scientific0370UInfectious agent detection by nucleic acid (DNA and RNA), surgical wound pathogens, 34 microorganisms and identification of 21 associated antibiotic-resistance genes, multiplex amplified probe technique, wound swabIADNA SURG WND PTHGN 34&21
Qlear UTI, Lifescan Labs of Illinois, Thermo Fisher Scientific0371UInfectious 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), urineIADNA GU PTHGN SEMIQ DNA16&1
Qlear UTI – Reflex ABR, Lifescan Labs of Illinois, Thermo Fisher Scientific0372UInfectious disease (genitourinary pathogens), antibiotic-resistance gene detection, multiplex amplified probe technique, urine, reported as an antimicrobial stewardship risk scoreNFCT DS GU PTHGN ARG DETCJ
Respiratory Pathogen with ABR (RPX), Lab Genomics LLC, Thermo Fisher Scientific0373UInfectious 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 specimenIADNA RSP TR NFCT 17 8 13&16
Urogenital Pathogen with Rx Panel (UPX), Lab Genomics LLC, Thermo Fisher Scientific0374UInfectious 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, urineIADNA GU PTHGN 21 ORG&21ARG
OvaWatchSM, Aspira Women’s HealthSM, Aspira Labs, Inc0375UOncology (ovarian), biochemical assays of 7 proteins (follicle stimulating hormone, human epididymis protein 4, apolipoprotein A-1, transferrin, beta-2 macroglobulin, prealbumin [i.e., transthyretin], and cancer antigen 125), algorithm reported as ovarian cancer risk scoreONC OVRN BCHM ASY 7 PRTN ALG
ArteraAI Prostate Test, Artera Inc0376UOncology (prostate cancer), image analysis of at least 128 histologic features and clinical factors, prognostic algorithm determining risk of distant metastases, and prostate cancer-specific mortality, includes predictive algorithm to androgen deprivation therapy response, if appropriateONC PRST8 CA IMG ALYS 128
Liposcale, CIMA Sciences, LLC0377UCardiovascular disease, quantification of advanced serum or plasma lipoprotein profile, by nuclear magnetic resonance (NMR) spectrometry with report of a lipoprotein profile (including 23 variables)CV DS QUAN ADVSRM/PLSM LPRTN
UCGSL RFC1 Repeat Expansion Test, University of Chicago Genetic Services Laboratories0378URFC1 (replication factor C subunit 1), repeat expansion variant analysis by traditional and repeat-primed PCR, blood, saliva, or buccal swabRFC1 REPEAT XPNSJ VRNT ALYS
Solid Tumor Expanded Panel, Quest Diagnostics0379UTargeted genomic sequence analysis panel, solid organ neoplasm, DNA (523 genes) and RNA (55 genes) by next generation sequencing, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutational burdenTGSAP SL OR NEO DNA523&RNA55
PersonalisedRX, Lab Genomics LLC, Agena Bioscience, Inc0380UDrug metabolism (adverse drug reactions and drug response), targeted sequence analysis, 20 gene variants and CYP2D6 deletion or duplication analysis with reported genotype and phenotypeRX METB ADVRS TRGT SQ ALY 20
Branched-Chain Amino Acids, SelfCollect, Blood Spot, Mayo Clinic, Laboratory Developed Test0381UMaple syrup urine disease monitoring by patient-collected blood card sample, quantitative measurement of alloisoleucine, leucine, isoleucine, and valine, liquid chromatography with tandem mass spectrometry (LC-MS/MS)MAPLE SYRUP UR DS MNTR QUAN
Phenylalanine and Tyrosine, SelfCollect, Blood Spot, Mayo Clinic, Laboratory Developed Test0382UHyperphenylalaninemia monitoring by patient-collected blood card sample, quantitative measurement of phenylalanine and tyrosine, liquid chromatography with tandem mass spectrometry (LC-MS/MS)HYPRPHENYLALNI NMIA MNTR QUAN
Tyrosinemia FollowUp Panel, SelfCollect, Blood Spot, Mayo Clinic, Laboratory Developed Test0383UTyrosinemia 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)TYROSINEMIA TYP I MNTR QUAN
NaviDKDTM Predictive Diagnostic Screening for Kidney Health, Journey Biosciences, Inc0384UNephrology (chronic kidney disease), carboxymethyllysine, methylglyoxal hydroimidazolone, and carboxyethyl lysine by liquid chromatography with tandem mass spectrometry (LC-MS/MS) and HbA1c and estimated glomerular filtration rate (GFR), with risk score reported for predictive progression to high-stage kidney diseaseNEPH CKD RSK HI STG KDN DS
PromarkerD, Sonic Reference Laboratory, Proteomics International Pty Ltd0385UNephrology (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 risk score for developing diabetic kidney diseaseNEPH CKD ALG RSK DBTC KDN DS
Envisage, Capsulomics, Inc0386UGastroenterology (Barrett’s esophagus), P16, RUNX3, HPP1, and FBN1 methylation analysis, prognostic and predictive algorithm reported as a risk score for progression to high-grade dysplasia or esophageal cancerGI BARRETT ESOPH MTHYLTN ALY
Source: CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 11829.2

CMS also removed two discontinued HCPCS codes from the CLFS:

    • 0324U (Oncology (ovarian), spheroid cell culture, 4-drug panel (carboplatin, doxorubicin, gemcitabine, paclitaxel), tumor chemotherapy response prediction for each drug); and

  • 0325U (Oncology (ovarian), spheroid cell culture, poly (ADPribose) polymerase (PARP) inhibitors (niraparib, olaparib, rucaparib, velparib), tumor response prediction for each drug.1

References:

    1. https://www.cms.gov/files/document/mm13082-clinical-laboratory-fee-schedule-laboratory-services-subject-reasonable-charge-payment.pdf

    1. https://www.cms.gov/files/document/r11829cp.pdf

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