MEDICAL POLICY Proprietary Laboratory Analyses (PLA) Codes

Transcription

1 POLICY: PG0417 ORIGINAL EFFECTIVE: 12/15/17 LAST REVIEW: 10/25/18 MEDICAL POLICY Proprietary Laboratory Analyses (PLA) Codes GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement. DESCRIPTION Proprietary Laboratory Analyses (PLA) codes are a new addition to the CPT code set approved by the AMA CPT Editorial Panel. They are alpha-numeric CPT codes with a corresponding descriptor for labs or manufacturers that want to more specifically identify their test. Tests with PLA codes must be performed on human specimens and must be requested by the clinical laboratory or the manufacturer that offers the test. PLA codes are contained in a non-category I subsection of the Pathology/Laboratory CPT codes. When a specific PLA code is not listed, the test must be reported using either a CPT Category I laboratory code or an Administrative MAAA code, the later separately listed in Appendix O. PLA codes, which include many types of tests, have been assigned an alphanumeric structure to expand the code number capacity in the CPT code set and to distinguish these codes from other CPT codes. These codes describe proprietary clinical laboratory analyses and can be provided either 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]). POLICY Paramount does not cover investigational or experimental medical or surgical procedures that are not medically necessary and have not been strongly supported in research and for which there is a safe and medically accepted alternative available. Some procedures require prior authorization. A provider must refer to the Paramount prior authorization list and specific medical policy in reference to specific procedures for coverage determinations (this list may not be all-inclusive): PG0301 Genetic Expression Assays for Breast Cancer Prognosis (0045U) PG0367 Genetic and Protein Biomarkers for Diagnosis and Risk Assessment of Prostate Cancer (0005U & 0047U) PG0438 Next Generation Sequencing (NGS) Tests for Advanced Cancer (0022U,0037U) PreciseType HEA test (0001U) requires prior authorization for Elite. PreciseType HEA test (0001U) is non-covered for HMO, PPO, Individual Marketplace, & Advantage. Proprietary Laboratory Analyses (PLA) Codes 0002U-0021U, 0023U-0036U, 0038U-0046U, 0048U-0061U are non-covered for all product lines. HMO, PPO, Individual Marketplace, Advantage Paramount has determined that Proprietary Laboratory Analyses (PLA) Codes 0002U-0021U, 0023U-0036U, 0038U-0046U, 0048U-0061U are experimental and investigational and therefore non-covered because there is insufficient evidence in the peer-reviewed medical literature of the effectiveness of these procedures. Elite While there is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and longterm outcomes of PreciseType HEA test (0001U), The Centers for Medicare & Medicaid Services (CMS) requires this procedure be reviewed for medical necessity. Therefore it may be covered with a prior authorization for Elite members per CMS guidelines.

2 Paramount has determined that Proprietary Laboratory Analyses (PLA) Codes 0002U-0021U, 0023U-0036U, 0038U-0046U, 0048U-0061U are experimental and investigational and therefore non-covered because there is insufficient evidence in the peer-reviewed medical literature of the effectiveness of these procedures. CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. PLA CODE 0001U 0002U 0003U EFFECTIVE 02/01/ /01/ /01/2017 Proprietary Name and Clinical Laboratory and/or Manufacturer PreciseType HEA Test Immucor, Inc. PolypDX Atlantic Diagnostic Laboratories, LLC Metabolomic Technologies Inc. Overa (OVA1 Next Generation) Aspira Labs, Inc. DESCRIPTION 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 Oncology (colorectal), quantitative assessment of three urine metabolites (ascorbic acid, succinic acid and carnitine) by liquid chromatography with tandem mass spectrometry (LC-MS/MS) using multiple reaction monitoring acquisition, algorithm reported as likelihood of adenomatous polyps Oncology (ovarian) biochemical assays of five proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum, algorithm reported as a likelihood score 0004U 0005U 0006U 0007U 0008U 0009U 0010U 0011U 0012U 05/01/ /01/2017 Vermillion, Inc. Gram-Negative Bacterial Resistance Gene PCR Panel Check-Points Health BV, Wageningen, Netherlands ExosomeDx Prostate (IntelliScore) Exosome Diagnostics, Inc. Aegis Drug-Drug Interaction Test Aegis Sciences Corporation ToxProtect Genotox Laboratories LTD AmHPR Helicobacter pylori Antibiotic Resistance Next Generation Sequencing Panel American Molecular Laboratories, Inc. DEPArray HER2 PacificDx Bacterial Typing by Whole Genome Sequencing Cordant CORE Cordant Health Solutions MatePair Targeted Rearrangements, Congenital 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 (Deleted effective 01/01/18) Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score 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 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 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 Oncology (breast cancer), ERBB2 (HER2) copy number by FISH, tumor cells from formalin fixed paraffin embedded tissue isolated using imagebased dielectrophoresis (DEP) sorting, reported as ERBB2 gene amplified or non-amplified Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate 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 Germline disorders, gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood, report of specific gene rearrangement(s)

3 0013U 0014U 0015U 0016U MatePair Targeted Rearrangements, Oncology MatePair Targeted Rearrangements, Hematologic OneOme RightMed Pharmacogenomic Test OneOme, LLC BCR-ABL1 major and minor breakpoint fusion transcripts University of Iowa, Department of Pathology 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) Hematology (hematolymphoid neoplasia), gene rearrangement detection by whole genome next- generation sequencing, DNA, whole blood or bone marrow, report of specific gene rearrangement(s) 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 (Deleted effective 01/01/18) 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 0017U 0018U 0019U Asuragen JAK2 Mutation University of Iowa, Department of Pathology ThyraMIR Interpace Diagnostics OncoTarget/OncoTreat Columbia University Department of Pathology and Cell Biology Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of exons and sequence analysis, blood or bone marrow, report of JAK2 mutation not detected or detected 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 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 0020U 0021U 0022U 0023U Darwin Health ToxLok InSource Diagnostics Apifiny Armune BioScience, Inc. Oncomine Dx Target Test Thermo Fisher Scientific LeukoStrat CDx FLT3 Mutation Assay Technologies, Inc. company 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 Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5 - UTR-BMI1, CEP 164, 3 -UTR- Ropporin, Desmocollin, AURKAIP- 1, CSNK2A2), multiplexed immunoassay and flow cytometry serum, algorithm reported as risk score 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 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 0024U 0025U Invivoscribe Technologies, Inc. GlycA Laboratory Corporation of America UrSure Tenofovir Quantification Test Glycosylated acute phase proteins (GlycA), nuclear magnetic resonance spectroscopy, quantitative Tenofovir, by liquid chromatography with tandem mass spectrometry (LC-MS/MS), urine, quantitative Synergy Medical Laboratories 0026U 0027U UrSure Inc. Thyroseq Genomic Classifier CBLPath, Inc. University of Pittsburgh Medical Center JAK2 Exons 12 to 15 Sequencing Oncology (thyroid), DNA and mrna of 112 genes, next-generation sequencing, fine needle aspirate of thyroid nodule, algorithmic analysis reported as a categorical result ("Positive, high probability of malignancy" or "Negative, low probability of malignancy") JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, targeted sequence analysis exons 12-15

4 0028U 0029U 0030U 0031U 0032U CYP2D6 Genotype Cascade Focused Pharmacogenomics Panel Warfarin Response Genotype Cytochrome P450 1A2 Genotype Catechol-O-Methyltransferase (COMT) Genotype CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, copy number variants, common variants with reflex to targeted sequence analysis Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs ) Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs ) CYP1A2 (cytochrome P450 family 1, subfamily A, member 2)(eg, drug metabolism) gene analysis, common variants (ie, *1F, *1K, *6, *7) COMT (catechol-o-methyltransferase)(drug metabolism) gene analysis, c.472g>a (rs4680) variant 0033U 0034U Serotonin Receptor Genotype (HTR2A and HTR2C) Thiopurine Methyltransferase (TPMT) and Nudix Hydrolase (NUDT15) Genotyping HTR2A (5-hydroxytryptamine receptor 2A), HTR2C (5- hydroxytryptamine receptor 2C) (eg, citalopram metabolism) gene analysis, common variants (ie, HTR2A rs [c t>c], HTR2C rs [c.-759c>t] and rs [c c>g]) TPMT (thiopurine S-methyltransferase), NUDT15 (nudix hydroxylase 15)(eg, thiopurine metabolism), gene analysis, common variants (ie, TPMT *2, *3A, *3B, *3C, *4, *5, *6, *8, *12; NUDT15 *3, *4, *5) 0035U Real-time quaking-induced conversion for prion detection (RT- QuIC) Neurology (prion disease), cerebrospinal fluid, detection of prion protein by quaking-induced conformational conversion, qualitative 0036U National Prion Disease Pathology Surveillance Center EXaCT-1 Whole Exome Testing Lab of Oncology-Molecular Detection Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses 0037U 0038U Weill Cornell Medicine- Clinical Genomics Laboratory FoundationOne CDx (F1CDx) Foundation Medicine, Inc. SensievaTM Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative 0039U InSource Diagnostics Anti-dsDNA, High Salt/Avidity University of Washington, Department of Laboratory Medicine Deoxyribonucleic acid (DNA) antibody, double stranded, high avidity Bio-Rad 0040U MRDx BCR-ABL Test BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative MolecularMD 0041U Lyme ImmunoBlot IgM Borrelia burgdorferi, antibody detection of 5 recombinant protein IGeneX Inc groups, by immunoblot, IgM ID-FISH Technology Inc. (ASR) (Lyme ImmunoBlot IgM Strips Only) 0042U Lyme ImmunoBlot IgG Borrelia burgdorferi, antibody detection of 12 recombinant protein

5 IGeneX Inc groups, by immunoblot, IgG 0043U ID-FISH Technology Inc. (ASR) (Lyme ImmunoBlot IgG Strips Only) Tick-Borne Relapsing Fever (TBRF) Borrelia ImmunoBlots IgM Test Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgM IGeneX Inc 0044U ID-FISH Technology Inc. (Provides TBRF ImmunoBlot IgM Strips) Tick-Borne Relapsing Fever (TBRF) Borrelia ImmunoBlots IgG Test Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgG IGeneX Inc 0045U 0046U 0047U 0048U 0049U 0050U 0051U 0052U 0053U ID-FISH Technology Inc. (Provides TBRF ImmunoBlot IgG Strips) The Oncotype DX Breast DCIS Score Test Genomic Health, Inc. FLT3 ITD MRD by NGS Technologies, Inc. Company Oncotype DX Genomic Prostate Score Genomic Health, Inc. MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) Memorial Sloan Kettering Cancer Center NPM1 MRD by NGS Technologies, Inc. Company MyAML NGS Panel Technologies, Inc. Company UCompliDx Elite Medical Laboratory Solutions, LLC (LDT) VAP Cholesterol Test VAP Diagnostics Laboratory, Inc. Prostate Cancer Risk Panel Oncology (breast ductal carcinoma in situ), mrna, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia) internal tandem duplication (ITD) variants, quantitative Oncology (prostate), mrna, gene expression profiling by real-time RT- PCR of 17 genes (12 content and 5 housekeeping), utilizing formalinfixed paraffin-embedded tissue, algorithm reported as a risk score Oncology (solid organ neoplasia), DNA, targeted sequencing of proteincoding exons of 468 cancer-associated genes, including interrogation for somatic mutations and microsatellite instability, matched with normal specimens, utilizing formalin-fixed paraffin-embedded tumor tissue, report of clinically significant mutation(s) NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, quantitative Targeted genomic sequence analysis panel, acute myelogenous leukemia, DNA analysis, 194 genes, interrogation for sequence variants, copy number variants or rearrangements Prescription drug monitoring, evaluation of drugs present by LC- MS/MS, urine, 31 drug panel, reported as quantitative results, detected or not detected, per date of service Lipoprotein, blood, high resolution fractionation and quantitation of lipoproteins, including all five major lipoprotein classes and subclasses of HDL, LDL, and VLDL by vertical auto profile ultracentrifugation Oncology (prostate cancer), FISH analysis of 4 genes (ASAP1, HDAC9, CHD1 and PTEN), needle biopsy specimen, algorithm reported as probability of higher tumor grade Laboratory Developed Test 0054U AssuranceRx Micro Serum Prescription drug monitoring, 14 or more classes of drugs and substances, definitive tandem mass spectrometry with chromatography, Firstox Laboratories, LLC capillary blood, quantitative report with therapeutic and toxic ranges, including steady-state range for the prescribed dose when detected, per date of service 0055U mytaiheart Cardiology (heart transplant), cell-free DNA, PCR assay of 96 DNA

6 0056U 0057U 0058U 0059U 0060U 0061U TAI Diagnostics, Inc. MatePair Acute Myeloid Leukemia Panel Laboratory Developed Test RNA-Sequencing by NGS OmniSeq, Inc. Life Technologies Corporation Merkel SmT Oncoprotein Antibody Titer University of Washington, Department of Laboratory Medicine Merkel Virus VP1 Capsid Antibody University of Washington, Department of Laboratory Medicine Twins Zygosity PLA Natera, Inc. Transcutaneous multispectral measurement of tissue oxygenation and hemoglobin using Spatial Frequency Domain Imaging (SFDI) Modulated Imaging, Inc. target sequences (94 single nucleotide polymorphism targets and two control targets), plasma Hematology (acute myelogenous leukemia), DNA, whole genome nextgeneration sequencing to detect gene rearrangement(s), blood or bone marrow, report of specific gene rearrangement(s) Oncology (solid organ neoplasia), mrna, gene expression profiling by massively parallel sequencing for analysis of 51 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a normalized percentile rank Oncology (Merkel cell carcinoma), detection of antibodies to the Merkel cell polyoma virus oncoprotein (small T antigen), serum, quantitative Oncology (Merkel cell carcinoma), detection of antibodies to the Merkel cell polyoma virus capsid protein (VP1), serum, reported as positive or negative Twin zygosity, genomic targeted sequence analysis of chromosome 2, using circulating cell-free fetal DNA in maternal blood Transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [cthbo2], deoxyhemoglobin [cthbr], papillary and reticular dermal hemoglobin concentrations [cthb1 and cthb2]), using spatial frequency domain imaging (SFDI) and multi-spectral analysis TAWG REVIEW DATES: 12/15/2017, 01/25/2018, 04/26/2018, 07/26/2018, 10/25/2018 REVISION HISTORY EXPLANATION 12/15/17: PreciseType HEA test (0001U) is covered with prior authorization for Elite. PreciseType HEA test (0001U) is non-covered for HMO, PPO, Individual Marketplace, & Advantage. Proprietary Laboratory Analyses (PLA) Codes 0002U-0023U are non-covered for all product lines. Policy created to reflect most current clinical evidence per the Technology Assessment Working Group (TAWG). 01/25/18: 01/01/18 deleted codes 0004U and 0015U. 01/01/18 new Proprietary Laboratory Analyses (PLA) Codes 0024U-0034U are non-covered for all product lines. Policy reviewed and updated to reflect most current clinical evidence per the Technology Assessment Working Group (TAWG). 04/26/18: 04/01/18 new Proprietary Laboratory Analyses (PLA) codes 0035U-0044U are non-covered for all product lines. Revision of Laboratory manufacturer name from Agena Bioscience, Inc. to InSource Diagnostics for 0020U. Policy reviewed and updated to reflect most current clinical evidence per the Technology Assessment Working Group (TAWG). 07/26/18: 07/01/18 new Proprietary Laboratory Analyses (PLA) codes 0045U-0046U, 0048U-0061U are non-covered for all product lines. Refer to PG0367 Genetic and Protein Biomarkers for Diagnosis and Risk Assessment of Prostate Cancer for coverage determination for code 0047U. Refer to PG0438 Next Generation Sequencing (NGS) Tests for Advanced Cancer for coverage determination for code 0037U. Policy reviewed and updated to reflect most current clinical evidence per the Technology Assessment Working Group (TAWG). 10/25/18: Refer to PG0438 Next Generation Sequencing (NGS) Tests for Advanced Cancer for coverage determination for code 0022U. Policy reviewed and updated to reflect most current clinical evidence per the Technology Assessment Working Group (TAWG). REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT ) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets

7 Industry Standard Review Hayes, Inc.