2018 Annual Update for Clinical Laboratory Fee Schedule
- By Renee Dustman
- In Billing
- January 23, 2018
- Comments Off on 2018 Annual Update for Clinical Laboratory Fee Schedule
The codes that are considered a laboratory test under Clinical Laboratory Improvement Amendments (CLIA) change each year. These codes require a facility to have either a CLIA certificate of registration (type code 9), a CLIA certificate of compliance (type code 1), or a CLIA certificate of accreditation (type code 3). A facility with a CLIA certificate of waiver (type code 2) or a CLIA certificate for provider-performed microscopy procedures (type code 4) without one of these certificates cannot be paid for the following tests.
Codes Added Mid-year 2017
Effective Feb. 1, 2017:
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
0002U – 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
0003U – 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
Effective May 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
0005U – Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score
Effective Aug. 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
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
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
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
0010U – Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate
0011U – 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
0012U – Germline disorders, gene rearrangement detection by whole genome next generation sequencing, DNA, whole blood, report of specific gene rearrangement(s)
0013U – 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)
0014U – Hematology (hematolymphoid neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood or bone marrow, report of specific gene rearrangement(s);
0015U – 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
0016U – 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 – 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
Discontinued effective Dec. 31, 2017:
83499, 84061, 86185, 86243, 86378, 86729, 86822, 87277, 87470, 87477, 87515, 88154
New Codes Subject to CLIA Edits for 2018
81105 – Human Platelet Antigen 1 genotyping (HPA-1), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa], antigen CD61 [GPIIIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant, HPA-1a/b (L33P)
81106 – Human Platelet Antigen 2 genotyping (HPA-2), GP1BA (glycoprotein Ib [platelet], alpha polypeptide [GPIba]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant, HPA-2a/b (T145M)
81107 – Human Platelet Antigen 3 genotyping (HPA-3), ITGA2B (integrin, alpha 2b [platelet glycoprotein IIb of IIb/IIIa complex], antigen CD41 [GPIIb]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant, HPA-3a/b (I843S)
81108 – Human Platelet Antigen 4 genotyping (HPA-4), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa], antigen CD61 [GPIIIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant, HPA-4a/b (R143Q)
81109 – Human Platelet Antigen 5 genotyping (HPA-5), ITGA2 (integrin, alpha 2 [CD49B, alpha 2 subunit of VLA-2 receptor] [GPIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant (eg, HPA-5a/b (K505E))
81110 – Human Platelet Antigen 6 genotyping (HPA-6w), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa, antigen CD61] [GPIIIa]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant, HPA-6a/b (R489Q)
81111 – Human Platelet Antigen 9 genotyping (HPA-9w), ITGA2B (integrin, alpha 2b [platelet glycoprotein IIb of IIb/IIIa complex, antigen CD41] [GPIIb]) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant, HPA-9a/b (V837M)
81112 – Human Platelet Antigen 15 genotyping (HPA-15), CD109 (CD109 molecule) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura) gene analysis, common variant, HPA-15a/b (S682Y)
81120 – IDH1 (isocitrate dehydrogenase 1 [NADP+], soluble) (eg, glioma), common variants (eg, R132H, R132C)
81121 – IDH2 (isocitrate dehydrogenase 2 [NADP+], mitochondrial) (eg, glioma), common variants (eg, R140W, R172M)
81175 – ASXL1 (additional sex combs like 1, transcriptional regulator) (eg, myelodysplastic syndrome, myeloproliferative neoplasms, chronic myelomonocytic leukemia) gene analysis; full gene sequence
81176 – ASXL1 (additional sex combs like 1, transcriptional regulator) (eg, myelodysplastic syndrome, myeloproliferative neoplasms, chronic myelomonocytic leukemia) gene analysis; targeted sequence analysis (eg, exon 12)
81230 – CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism) gene analysis, common variant(s) (eg, *2, *22)
81231 – CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism) gene analysis, common variants (eg, *2, *3, *4, *5 *6, *7)
81232 – DPYD (dihydropyrimidine dehydrogenase) (eg, 5-fluorouracil/5-FU and capecitabine drug metabolism) gene analysis, common variant(s) (eg, *2A, *4, *5, *6)
81238 – F9 (coagulation factor IX) (eg, hemophilia B) full gene sequence
81247 – G6PD (glucose-6-phosphate dehydrogenase) (eg, hemolytic anemia, jaundice)gene analysis; common variant(s) (eg, A, A-)
81248 – G6PD (glucose-6-phosphate dehydrogenase) (eg, hemolytic anemia, jaundice) gene analysis; known familial variant(s)
81249 – G6PD (glucose-6-phosphate dehydrogenase) (eg, hemolytic anemia, jaundice) gene analysis; full gene sequence
81258 – HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; known familial variant
81259 – HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; full gene sequence
81269 – HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; duplication/deletion variants
81283 – IFNL3 (interferon, lambda 3) (eg, drug response) gene analysis, rs12979860 variant
81328 – SLCO1B1 (solute carrier organic anion transporter family, member 1B1) (eg, adverse drug reaction) gene analysis, common variant(s) (eg, *5)
81334 – RUNX1 (runt related transcription factor 1) (eg, acute myeloid leukemia, familial platelet disorder with associated myeloid malignancy) gene analysis, targeted sequence analysis (eg, exons 3-8)
81335 – TPMT (thiopurine S-methyltransferase) (eg, drug metabolism) gene analysis, common variants (eg, *2, *3)
81346 – TYMS (thymidylate synthetase) (eg, 5-fluorouracil/5-FU drug metabolism) gene analysis, common variant(s) (eg, tandem repeat variant)
81361 – HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia, hemoglobinopathy); common variant(s) (eg, HbS, HbC, HbE)
81362 – HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia, hemoglobinopathy); known familial variant(s)
81363 – HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia, hemoglobinopathy); duplication/deletion variant(s)
81364 – HBB (hemoglobin, subunit beta) (eg, sickle cell anemia, beta thalassemia, hemoglobinopathy); full gene sequence
81448 – Hereditary peripheral neuropathies panel (eg, Charcot-Marie-Tooth, spastic paraplegia), genomic sequence analysis panel, must include sequencing of at least 5 peripheral neuropathy-related genes (eg, BSCL2, GJB1, MFN2, MPZ, REEP1, SPAST, SPG11, and SPTLC1)
81520 – Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score
81521 – Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffin-embedded tissue, algorithm reported as index related to risk of distant metastasis
81541 – Oncology (prostate), mRNA gene expression profiling by real-time RTPCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin embedded tissue, algorithm reported as a disease-specific mortality risk score
81551 – Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed paraffin embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy
86008 – Allergen specific IgE; quantitative or semiquantitative, recombinant or purified component, each
86794 – Zika virus, IgM
87634 – Infectious agent detection by nucleic acid (DNA or RNA); respiratory syncytial virus, amplified probe technique
87662 – Infectious agent detection by nucleic acid (DNA or RNA); Zika virus, amplified probe technique
0024U – Glycosylated acute phase proteins (GlycA), nuclear magnetic resonance spectroscopy, quantitative GLYCA NUC MR SPECTRSC QUAN
0025U – Tenofovir, by liquid chromatography with tandem mass spectrometry (LCMS/MS), urine, quantitative TENOFOVIR LIQ CHROM UR QUAN
0026U – 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”) ONC THYR DNA&MRNA 112 GENES
0027U – JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, targeted sequence analysis exons 12-15 JAK2 GENE TRGT SEQ ALYS
0028U – 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 CYP2D6 GENE CPY NMR CMN VRNT
0029U – Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs12777823) RX METAB ADVRS TRGT SEQ ALYS
0030U – Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823) RX METAB WARF TRGT SEQ ALYS
0031U – CYP1A2 (cytochrome P450 family 1, subfamily A, member 2)(eg, drug metabolism) gene analysis, common variants (ie, *1F, *1K, *6, *7) CYP1A2 GENE
0032U – COMT (catechol-O-methyltransferase)(drug metabolism) gene analysis, c.472G>A (rs4680) variant COMT GENE
0033U – HTR2A (5-hydroxytryptamine receptor 2A), HTR2C (5-hydroxytryptamine receptor 2C) (eg, citalopram metabolism) gene analysis, common variants (ie, HTR2A rs7997012 [c.614-2211T>C], HTR2C rs3813929 [c.-759C>T] and rs1414334 [c.551- 3008C>G]) HTR2A HTR2C GENES
0034U – 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) TPMT NUDT15 GENES
New Waived Tests, Effective April 1, 2018
83516QW, October 2, 2017, Quidel Corporation, InflammaDry
87809QW, October 3, 2017, Quidel, AdenoPlus Test {Tear Fluid}
82274QW, G0328QW, October 13, 2017, Enterix Inc. InSure One – One Day Fecal
Immunochemical Test
85025QW, November 6, 2017, Sysmex XW-100
Billing Waived Tests
CPT codes approved by the FDA as waived tests under CLIA must be billed with modifier QW. Claims with a date of service prior to the effective date of a waived test code billed with the QW modifier will be denied.
Update to Fees
The annual update to the local clinical laboratory fees for 2018 is 1.10 percent. Beginning Jan. 1, 2018, this update only applies to Pap smear tests. For a Pap smear test, payment is the lesser of the local fee or the NLA, but not less than a national minimum payment amount. Payment may also not exceed the actual charge.
The 2018 national minimum payment amount is $14.65 ($14.49 times 1.10 percent update for 2018).
The affected codes for the national minimum payment amount are: 88142, 88143, 88147, 88148, 88150, 88152, 88153, 88164, 88165, 88166, 88167, 88174, 88175, G0123, G0143, G0144, G0145, G0147, G0148, Q0111, Q0115, and P3000.
The annual update to payments made on a reasonable charge basis for all other laboratory services for 2018 is 1.10 percent.
The Part B deductible and coinsurance do not apply for services paid under the Clinical Laboratory Fee Schedule (CLFS).
Effective Jan. 1, 2018, CLFS rates are based on weighted median private payer rates, as required by the Protecting Access to Medicare Act (PAMA) of 2014. For more details, see PAMA Regulations.
Sources:
MLN Matters Number MM10446
MLN Matters Number MM10418
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