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Home 5 Lab Industry Advisor 5 Essential 5 Billing & Coding Alert: CMS Adds 15 New PLA Codes to Medicare Clinical Laboratory Fee Schedule

Billing & Coding Alert: CMS Adds 15 New PLA Codes to Medicare Clinical Laboratory Fee Schedule

by | Jul 31, 2023 | Essential, National Lab Reporter, Reimbursement-nir

Here’s what to know about the new codes that CMS recently added to the national HCPCS table as well as which ones were removed.

iStock, AlexanderFord

On May 4, the Centers for Medicare & Medicaid Services (CMS) issued a new Medicare Learning Network transmittal (CR 13195) announcing several new billing, coding, and reimbursement policies that took affect July 1.1 Among the key changes is the addition of 15 new Proprietary Laboratory Analyses (PLA) codes to the national Healthcare Common Procedure Coding System (HCPCS) table. CMS is also deleting several codes. These changes could have significant reimbursement and liability ramifications for your lab. Here’s a briefing of the coding changes:

Reminder of CDLTs PAMA Reporting Delay

At the end of 2022, Congress once more delayed the next reporting round for CDLTs that are not ADLTs. Barring further PAMA delays or changes, the next reporting period will be January 1, 2024, through March 31, 2024, and will be based on the original collection period of January 1, 2019, through June 30, 2019. From that point forward, there will be a three-year data reporting cycle for CDLTs that are not ADLTs, i.e., reporting will be required in 2027, 2030, 2033, etc.

The Significance of PLA Codes

CMS derives its legal authority for Medicare reimbursement of PLA coded tests through the Protecting Access to Medicare Act (PAMA), which allows for assignment of PLA codes to four types of lab tests, including:2

    • Advanced diagnostic laboratory tests (ADLTs)

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

    • Multianalyte assays with algorithmic analyses (MAAA)

  • Genomic sequencing procedures

Basic Rules for Billing and Coding PLA Tests

CMS maintains a list of PLA codes that are reimbursable by Medicare Part B under the Clinical Laboratory Fee Schedule (CLFS). The agency adds new PLA codes to the list each year while eliminating others. That’s why it’s important to closely track the CMS changes. Significantly, when a PLA code is available to report a test, it must be used. Using any other CPT code to report a proprietary test that has an available PLA code is likely to lead to Medicare claim denials or improper payments.

In terms of billing and reimbursement, 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 Contractor (MAC) to decide how much to reimburse for the test in its jurisdiction. Eventually, CMS sets a national price for each PLA test. Such is the case with the newly recognized PLA codes that took effect in July.

The 15 Recently Recognized PLA Codes

The 15 PLA codes that CMS has added to the CLFS cover novel assays, including MAAA risk scores for preeclampsia, Kawasaki disease, Barret’s esophagus, and coronary disease, as well as companion diagnostics and a genetic test for assessing the drug metabolism of patients treated for depression, ADHD, anxiety, and other neuropsychiatric conditions. Here’s a listing of all 15 codes:2

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

Test, Laboratory CPT Code Long Descriptor Short Descriptor
AMBLor® melanoma prognostic test, Avero® Diagnostics 0387U Oncology (melanoma), autophagy and beclin 1 regulator 1 (AMBRA1) and loricrin (AMLo) by immunohistochemistry, formalin-fixed paraffin-embedded (FFPE) tissue, report for risk of progression
(Do not report 0387U in conjunction with 88341, 88342)		 ONC MLNMA AMBRA1&AMLO
InVisionFirst®-Lung Liquid Biopsy, Inivata, Inc 0388U Oncology (non-small cell lung cancer), next-generation sequencing with identification of single nucleotide variants, copy number variants, insertions and deletions, and structural variants in 37 cancer-related genes, plasma, with report for alteration detection ONC NONSM CLL LNG CA 37 GEN
KawasakiDx, OncoOmicsDx Laboratory, mProbe 0389U Pediatric febrile illness (Kawasaki disease [KD]), interferon alpha-inducible protein 27 (IFI27) and mast cell-expressed membrane protein 1 (MCEMP1), RNA, using reverse transcription polymerase chain reaction (RT-qPCR), blood, reported as a risk score for KD PED FBRL KD IFI27&MCEMP1 RNA
PEPredictDx, OncoOmicsDx Laboratory, mProbe 0390U Obstetrics (preeclampsia), kinase insert domain receptor (KDR), endoglin (ENG), and retinol-binding protein 4 (RBP4), by immunoassay, serum, algorithm reported as a risk score OB PE KDR ENG&RBP4 IA ALG
 Strata SelectTM, Strata Oncology, Inc 0391U Oncology (solid tumor), DNA and RNA by next-generation sequencing (NGS), utilizing FFPE tissue, 437 genes, interpretive report for single nucleotide variants, splice site variants, insertions/deletions, copy number alterations, gene fusions, tumor mutational burden, and microsatellite instability, with algorithm quantifying immunotherapy response score ONC SLD TUM DNA&RNA 437 GEN
Medication Management Neuropsychiatric Panel, RCA Laboratory Services LLC d/b/a GENETWORx 0392U Drug metabolism (depression, anxiety, attention deficit hyperactivity disorder [ADHD]), gene-drug interactions, variant analysis of 16 genes, including deletion/duplication analysis of CYP2D6, reported as impact of gene-drug interaction for each drug RX METAB GENRX IA 16 GENES
SYNTap® Biomarker Test, Amprion Clinical Laboratory 0393U Neurology (e.g., Parkinson’s disease, dementia with Lewy bodies), cerebrospinal fluid (CSF), detection of misfolded α-synuclein protein by seed amplification assay, qualitative NEU PRKSN MSFL α-SYNCLN PRTN
PFAS Testing & PFASureTM, National Medical Services, NMS Labs, Inc 0394U Perfluoroalkyl substances (PFAS) (e.g., perfluorooctanoic acid, perfluorooctane sulfonic acid), 16 PFAS compounds by liquid chromatography with tandem mass spectrometry (LC-MS/MS), plasma or serum, quantitative PFAS 16 PFAS COMPND LC MS/MS
OncobiotaLUNG, MicronomaTM 0395U Oncology (lung), multiomics (microbial DNA by shotgun NGS and carcinoembryonic antigen and osteopontin by immunoassay), plasma, algorithm reported as malignancy risk for lung nodules in early-stage disease ONC LNG MULTIOMICS PLSM ALG
Spectrum PGT-M, Natera, Inc 0396U Obstetrics (pre-implantation genetic testing), evaluation of 300,000 DNA single-nucleotide polymorphisms (SNPs) by microarray, embryonic tissue, algorithm reported as a probability for single-gene germline conditions OB PREIMPLTJ TST 300000 DNA
 Agilent Resolution ctDx FIRST, Resolution Bioscience, Inc 0397U Oncology (non-small cell lung cancer), cell-free DNA from plasma, targeted sequence analysis of at least 109 genes, including sequence variants, substitutions, insertions, deletions, select rearrangements, and copy number variations ONC NONSM CLL LNG CA 109
ESOPREDICT® Barrett’s Esophagus Risk Classifier Assay, Capsulomics, Inc d/b/a Previse 0398U Gastroenterology (Barrett’s esophagus), P16, RUNX3, HPP1, and FBN1 DNA methylation analysis using PCR, FFPE tissue, algorithm reported as risk score for progression to high-grade dysplasia or cancer GI BARET ESPH DNA MTHYLN ALY
FRAT® (Folate Receptor Antibody Test), Religen Inc 0399U Neurology (cerebral folate deficiency), serum, detection of anti-human folate receptor IgG-binding antibody and blocking autoantibodies by enzyme-linked immunoassay (ELISA), qualitative, and blocking autoantibodies, using a functional blocking assay for IgG or IgM, quantitative, reported as positive or not detected NEURO CERE FOLATE DEFNCY SRM
Genesys Carrier Panel, Genesys Diagnostics, Inc 0400U Obstetrics (expanded carrier screening), 145 genes by NGS, fragment analysis and multiplex ligation-dependent probe amplification, DNA, reported as carrier positive or negative OB XPND CAR SCR 145 GENES
CARDIO inCodeScore (CICSCORE), GENinCode U.S. Inc 0401U Cardiology (coronary heart disease [CAD]), 9 genes (12 variants), targeted variant genotyping, blood, saliva, or buccal swab, algorithm reported as a genetic risk score for a coronary event CRD C HRT DS 9 GEN 12 VRNTS
Source: CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 12021.2

Discontinued PLA Codes

Effective July 1, CMS also dropped nine PLA codes from the CLFS. All but one of the dropped codes are for reporting urine toxicology tests that use liquid chromatography with tandem mass spectrometry (LC-MS/MS) and multiple reaction monitoring (MRM) to perform definitive drug testing.2

 PLA Codes Removed from Medicare CLFS, Effective July 1, 2023

    • 0053U: Oncology (prostate cancer), FISH analysis of 4 genes (ASAP1, HDAC9, CHD1, and PTEN), needle biopsy specimen, algorithm reported as probability of higher tumor grade

    • 0143U: Drug assay, definitive, 120 or more drugs or metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using multiple reaction monitoring (MRM), with drug or metabolite description, comments including sample validation, per date of service

    • 0144U: Drug assay, definitive, 160 or more drugs or metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using MRM, with drug or metabolite description, comments including sample validation, per date of service

    • 0145U: Drug assay, definitive, 65 or more drugs or metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using MRM, with drug or metabolite description, comments including sample validation, per date of service

    • 0146U: Drug assay, definitive, 80 or more drugs or metabolites, urine, by quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using MRM, with drug or metabolite description, comments including sample validation, per date of service

    • 0147U: Drug assay, definitive, 85 or more drugs or metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using MRM, with drug or metabolite description, comments including sample validation, per date of service

    • 0148U: Drug assay, definitive, 100 or more drugs or metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using MRM, with drug or metabolite description, comments including sample validation, per date of service

    • 0149U: Drug assay, definitive, 60 or more drugs or metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using MRM, with drug or metabolite description, comments including sample validation, per date of service

  • 0150U: Drug assay, definitive, 120 or more drugs or metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS) using MRM, with drug or metabolite description, comments including sample validation, per date of service

References:

    1. https://www.cms.gov/files/document/mm13195-clinical-laboratory-fee-schedule-laboratory-services-reasonable-charge-payment-quarterly.pdf

    1. https://www.g2intelligence.com/medicare-to-pay-for-22-additional-pla-codes-starting-april-1/

    1. https://www.cms.gov/files/document/r12021CP.pdf#page=8

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