HEALTH CARE REFORM

PAMA Implementation: PLA Codes for Advanced Dx Tests Are Off to a Flying Start

PAMA implementation is so sweeping that it requires a shift in not just payment paradigm but also CPT codes. This has served as the impetus for development of a new class of codes known as Proprietary Laboratory Analyses (PLA) codes. Here’s a quick overview of what’s going on with PLA codes.

What PLA Codes Are All About
To the extent that the new PAMA lab payment regime is supposed to be based on market pricing, CMS had to create a coding system that could be used to track and monitor newfangled advanced diagnostic laboratory tests (ADLTs) and FDA-approved clinical diagnostic laboratory tests (CDLTs) reimbursed under PAMA. The new coding system is proprietary-based with codes being issued for specific products at the request of test developers and manufacturers.

PLAs are a new class of CPT codes developed by the American Medical Association (AMA) to meet that demand. The AMA has issued nearly two dozen PLA codes so far, all of which end in “U”, including six that went into effect this October. In addition to ADLTs and CDLTs, the AMA has issued codes for “a range of tests” including genomic sequencing procedures and multi-analyte algorithm assays. Interpace Diagnostics, Vermillion, Thermo Fisher, Exosome Diagnostics and the Mayo Clinic are among those that have secured PLAs for their products. Here is the entire PLA roster to date:

CPT Code Long Descriptor Proprietary Test Name & Lab(s)/Manufacturer(s) Effective Date
0001U Red blood cell antigen typing, DNA, human erythrocyte antigen gene analysis of 35 antigens from 11 blood groups, utilizing whole blood, common RBC alleles reported PreciseType® HEA Test,

Immucor, Inc

Feb. 1, 2017
0002U Oncology (colorectal), quantitative assessment of 3 urine metabolites by liquid chromatography with tandem mass spectrometry using multiple reaction monitoring acquisition, algorithm reported as likelihood of adenomatous polyps PolypDX,™

Atlantic Diagnostic Laboratories, LLC +

Metabolomic Technologies Inc.

Feb. 1, 2017
0003U Oncology (ovarian) biochemical assays of 5 proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum, algorithm reported as a likelihood score Overa (OVA1 Next Generation),

Aspira Labs, Inc. +

Vermillion, Inc.

Feb. 1, 2017
0004U Infectious disease (bacterial), DNA, 27 resistance genes, PCR amplification and probe hybridization in microarray format (molecular detection and identification of AmpC, carbapenemase and ESBL coding genes), bacterial culture colonies, report of genes detected or not detected, per isolate Gram-Negative Bacterial Resistance
Gene PCR Panel,

Mayo Clinic +
Check-Points Health
BV, Wageningen,

Netherlands

May 1, 2017
0005U Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score ExosomeDx® Prostate (IntelliScore),

Exosome Diagnostics, Inc.

May 1, 2017
0006U Prescription drug monitoring, 120 or more drugs and substances, definitive tandem mass spectrometry with chromatography, urine, qualitative report of presence (including quantitative levels, when detected) or absence of each drug or substance with description and severity of potential interactions, with identified substances, per date of service Aegis Drug-Drug Interaction Test,

Aegis Sciences Corpora

Aug. 1, 2017
0007U(*) Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, includes specimen verification including DNA authentication in comparison to buccal DNA, per date of service

 (For additional PLA code with identical clinical descriptor, see 0020U. See Appendix O to determine appropriate code assignment)

ToxProtect,

Genotox Laboratories LTD

Aug. 1, 2017
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, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline and rifabutin AmHPR Helicobacter pylori Antibiotic Resistance Next Generation Sequencing
Panel,

American Molecular

Laboratories, Inc

Aug. 1, 2017
0009U Oncology (breast cancer), ERBB2 (HER2) copy number by FISH, tumor cells from formalin-fixed paraffin-embedded tissue isolated using image-based dielectrophoresis (DEP) sorting, reported as ERBB2 gene amplified or non-amplified DEPArray™ HER2,

PacificDx

Aug. 1, 2017
00010U Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate Bacterial Typing by Whole Genome Sequencing,

Mayo Clinic

Aug. 1, 2017
00011U Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, using oral fluid, reported as a comparison to an estimated steady-state range, per date of service including all drug compounds and metabolites Cordant CORE™,

Cordant Health Solutions

Aug. 1, 2017
00012U Germline disorders, gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood, report of specific gene rearrangement(s) MatePair Targeted Rearrangements, Congenital,

Mayo Clinic

Aug. 1, 2017
00013U Oncology (solid organ neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, fresh or frozen tissue or cells, report of specific gene rearrangement(s) MatePair Targeted Rearrangements, Oncology,

Mayo Clinic

Aug. 1, 2017
00014U Hematology (hematolymphoid neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood or bone marrow, report of specific gene rearrangement(s) MatePair Targeted Rearrangements, Hematologic,

Mayo Clinic

Aug. 1, 2017
00015U Drug metabolism (adverse drug reactions), DNA, 22 drug metabolism and transporter genes, real-time PCR, blood or buccal swab, genotype and metabolizer status for therapeutic decision support OneOme RightMed
Pharmacogenomic Test,

OneOme, LLC

Aug. 1, 2017
00016U Oncology (hematolymphoid neoplasia), RNA, BCR/ABL1 major and minor breakpoint fusion transcripts, quantitative PCR amplification, blood or bone marrow, report of fusion not detected or detected with quantitation BCR-ABL1 major and minor breakpoint fusion transcripts,

University of Iowa,
Department of
Pathology +

Asuragen

Aug. 1, 2017
00017U Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of exons 12-14 and sequence analysis, blood or bone marrow, report of JAK2 mutation not detected or detected JAK2 Mutation,

University of Iowa,
Department of

Pathology

Aug. 1, 2017
00018U 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 ThyraMIR,

Interpace Diagnostics

Oct. 1, 2017
00019U 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 OncoTarget/OncoTreat,

Columbia University Department of Pathology and Cell Biology +

Darwin Health

Oct. 1, 2017
00020U(*) 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 clinical descriptor, see 0007U. See Appendix O to determine appropriate code assignment)

ToxLok,

InSource Diagnostics +

Agena Bioscience, Inc.

Oct. 1, 2017
00021U 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 Apifiny®,

Armune BioScience, Inc.

Oct. 1, 2017
00022U 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 Oncomine™ Dx Target Test,

Thermo Fisher Scientific

Oct. 1, 2017
00023U Oncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or non-detection of FLT3 mutation and indication for or against the use of midostaurin LeukoStrat® CDx FLT3
Mutation Assay,

LabPMM LLC, an Invivoscribe Technologies, Inc. company +

Invivoscribe Technologies, Inc.

Oct. 1, 2017

(*) More than one PLA with an identical descriptor

Takeaway: While they make it easier to monitor sales of advanced tests, it remains to be seen whether the issuance of PLAs will have any measurable impact on market performance or persuade payors to cover the products.

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