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April 21, 2023
Every year, the Centers for Medicare & Medicaid Services (CMS) adds to the list of Proprietary Laboratory Analysis (PLA) codes reimbursable by Medicare Part B under the Clinical Laboratory Fee Schedule (CLFS). On Feb. 2, CMS issued its quarterly Medicare Learning Network transmittal (CR 13082), revealing the new PLA code additions for 2023.1 Among them are oncology, infectious agent, and other assays produced by major lab companies like Thermo Fisher Scientific, DiaCarta, and Adaptive Biotechnologies. There’s a possibility that your lab provides at least some of these newly recognized PLA code tests to Medicare patients.
There’s a lot at stake. When a PLA code is available to report a given proprietary laboratory service, that same service shouldn’t be reported with any other Current Procedural Terminology (CPT) code(s) and other CPT code(s) shouldn’t be used to report services that may be reported with that specific PLA code.
Bottom Line: To ensure proper Medicare Part B billing and coding, your billing staff must be aware of all 22 of the newly recognized PLA codes that will become officially payable, starting on April 1, 2023.
PLA Codes 101
While most lab test products are manufactured by multiple companies, some assays are proprietary to and associated with a single company or lab. The American Medical Association (AMA) incorporated PLA codes into its CPT coding system to identify these tests. PLA codes are alphanumeric codes consisting of four digits and ending with the uppercase letter “U.” Each PLA code also includes a code descriptor. It’s up to each lab or manufacturer to decide whether it wants to have a PLA code assigned to identify its product.
The Protecting Access to Medicare Act (PAMA) defines four kinds of lab tests that should be assigned PLA codes, including:
PLA coded tests may be performed either by “one, sole source” lab or multiple labs to whom that lab licenses the test. When CMS first recognizes a PLA code test, it leaves it to the Medicare Administrative Contractors (MACs) to decide how much to reimburse for the test in their jurisdiction. Eventually, CMS sets a national price for each PLA test.
The Newly Recognized 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 Code |
Long Descriptor |
Short Descriptor |
|
clonoSEQAssay, Adaptive Biotechnologies |
0364U |
Oncology (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 appropriate |
ONC HL NEO GEN SEQ ALYS ALG |
|
Oncuria Detect, DiaCarta Clinical Lab, DiaCarta, Inc |
0365U |
Oncology (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 cancer |
ONC BLDR 10 PRB BLDR CA |
|
Oncuria Monitor, DiaCarta Clinical Lab, DiaCarta, Inc |
0366U |
Oncology (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 cancer |
ONC BLDR 10 PRB RECR BLDR CA |
|
Oncuria Predict, DiaCarta Clinical Lab, DiaCarta, Inc |
0367U |
Oncology (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 resection |
ONC BLDR 10 FLWG TRURL RESCJ |
|
GI assay (Gastrointestinal Pathogen with ABR), Lab Genomics LLC, Thermo Fisher Scientific |
0369U |
Infectious 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 technique |
IADNA GI PTHGN 31 ORG&21 ARG |
|
Lesion Infection (Wound), Lab Genomics LLC, Thermo Fisher Scientific |
0370U
|
Infectious 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 swab |
IADNA SURG WND PTHGN 34&21 |
|
Qlear UTI, Lifescan Labs of Illinois, Thermo Fisher Scientific |
0371U |
Infectious 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), urine |
IADNA GU PTHGN SEMIQ DNA16&1 |
|
Qlear UTI - Reflex ABR, Lifescan Labs of Illinois, Thermo Fisher Scientific |
0372U
|
Infectious disease (genitourinary pathogens), antibiotic-resistance gene detection, multiplex amplified probe technique, urine, reported as an antimicrobial stewardship risk score |
NFCT DS GU PTHGN ARG DETCJ |
|
Respiratory Pathogen with ABR (RPX), Lab Genomics LLC, Thermo Fisher Scientific |
0373U |
Infectious 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 specimen |
IADNA RSP TR NFCT 17 8 13&16 |
|
Urogenital Pathogen with Rx Panel (UPX), Lab Genomics LLC, Thermo Fisher Scientific |
0374U |
Infectious 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, urine |
IADNA GU PTHGN 21 ORG&21ARG |
|
OvaWatchSM, Aspira Women's HealthSM, Aspira Labs, Inc |
0375U |
Oncology (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 score |
ONC OVRN BCHM ASY 7 PRTN ALG |
|
ArteraAI Prostate Test, Artera Inc |
0376U |
Oncology (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 appropriate |
ONC PRST8 CA IMG ALYS 128 |
|
Liposcale, CIMA Sciences, LLC |
0377U |
Cardiovascular 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 Laboratories |
0378U |
RFC1 (replication factor C subunit 1), repeat expansion variant analysis by traditional and repeat-primed PCR, blood, saliva, or buccal swab |
RFC1 REPEAT XPNSJ VRNT ALYS |
|
Solid Tumor Expanded Panel, Quest Diagnostics |
0379U |
Targeted 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 burden |
TGSAP SL OR NEO DNA523&RNA55 |
|
PersonalisedRX, Lab Genomics LLC, Agena Bioscience, Inc |
0380U |
Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis, 20 gene variants and CYP2D6 deletion or duplication analysis with reported genotype and phenotype |
RX METB ADVRS TRGT SQ ALY 20 |
|
Branched-Chain Amino Acids, SelfCollect, Blood Spot, Mayo Clinic, Laboratory Developed Test |
0381U
|
Maple 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 Test |
0382U |
Hyperphenylalaninemia 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 Test |
0383U |
Tyrosinemia 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, Inc, Journey Biosciences, Inc |
0384U |
Nephrology (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 disease |
NEPH CKD RSK HI STG KDN DS |
|
PromarkerD, Sonic Reference Laboratory, Proteomics International Pty Ltd |
0385U |
Nephrology (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 disease |
NEPH CKD ALG RSK DBTC KDN DS |
|
Envisage, Capsulomics, Inc |
0386U |
Gastroenterology (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 cancer |
GI BARRETT ESOPH MTHYLTN ALY |
Source: CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 11829.2
|
Discontinued Codes CMS also removed two discontinued Healthcare Common Procedure Coding System (HCPCS) codes from the CLFS:
|
Labs will want to make sure that their billing staff know about these discontinued HCPCS codes, as well as the 22 new PLA ones, in order to ensure proper billing and coding for reimbursement under Medicare Part B.
References:
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This article originally appeared in G2 Intelligence, Lab Compliance Advisor, April 2023.
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