Laboratory Coding Updates and Changes for 2021

January 1, 2021 has arrived  and with it are the latest CPT® code changes made by the American Medical Association (AMA) effective at the start of the year.  The current codes, guidelines, and parenthetical changes can be found in the 2021 CPT Professional code book. Below is an overview of several key laboratory and pathology changes.

Therapeutic Drug Assay Additions

Several new additions were finalized and added for therapeutic drug assays.

80143 Acetaminophen

80151 Amiodarone

80161 Carbamazepine; -10,11-epoxide

80167 Felbamate

80181 Flecainide

80189 Itraconazole

80193 Leflunomide

80204 Methotrexate

80210 Rufinamide

80179 Salicylate

Molecular Pathology Changes

2021 saw the arrival of a few new key codes for tier 1 molecular pathology procedures. As you may expect this area continues to be one of the fastest growing diagnostic areas.

81168 CCND1/IGH(t(1114))(eg, mantlecell lymphoma) translocation analysis, major break point, qualitative and quantitative, if performed

81278 IGH@/BCL2 (t(14;18)) (e.g., follicular lymphoma) translocation analysis, major breakpoint region (MBR) and minor cluster region (mcr) breakpoints, qualitative or quantitative

81279 JAK2 (Janus kinase 2) (e.g., myeloproliferative disorder) targeted sequence analysis (e.g., exons 12 and 13)

81338 MPL (MPL proto-oncogene, thrombopoietin receptor) (e.g., myeloproliferative disorder) gene analysis; common variants (e.g., W515A, W515K, W515L, W515R)

81339 MPL (MPL proto-oncogene, thrombopoietin receptor) (e.g., myeloproliferative disorder) gene analysis; sequence analysis, exon 10

81191 NTRK1 (neurotrophic receptor tyrosine kinase (e.g., solid tumors) translocation analysis

81192 NTRK2 (neurotrophic receptor tyrosine kinase 2) (e.g., solid tumors) translocation analysis

81193 NTRK3 (neurotrophic receptor tyrosine kinase 3) (e.g., solid tumors) translocation analysis

81194 NTRK (neurotrophic-tropomyosin receptor tyrosine kinase 1, 2, and 3) (e.g., solid tumors) translocation analysis

81347 SF3B1 (splicing factor [3b] subunit B1) (e.g., myelodysplastic syndrome/acute myeloid leukemia) gene analysis, common variants (e.g., A672T, E622D, L833F, R625C, R625L)81348 SRSF2 (serine and arginine-rich splicing factor 2) (e.g., myelodysplastic syndrome, acute   myeloid leukemia) gene analysis, common variants (e.g., P95H, P95L)

81351 TP53 (tumor protein 53) (e.g., Li-Fraumeni syndrome) gene analysis; full gene sequence

81352 TP53 (tumor protein 53) (e.g., Li-Fraumeni syndrome) gene analysis; targeted sequence analysis (e.g., 4 oncology)

81353 TP53 (tumor protein 53) (e.g., Li-Fraumeni syndrome) gene analysis; known familial variant

81357 U2AF1 (U2 small nuclear RNA auxiliary factor 1) (e.g., myelodysplastic syndrome, acute myeloid leukemia) gene analysis, common variants (e.g., S34F, S34Y, Q157R, Q157P)

81360 ZRSR2 (zinc finger CCCH-type, RNA binding motif and serine/ arginine-rich 2) (e.g., myelodysplastic syndrome, acute myeloid leukemia) gene analysis, common variant(s) (e.g., E65fs, E122fs, R448fs)

Revisions

A few revisions were made in this category, for 80415 the description is provided below.

80415 Chorionic gonadotropin stimulation panel; estradiol response This panel must include the following: Estradiol, total (82670 x 2 on 3 pooled blood samples)

Tier 2 codes 81401, 81402, 81403, 81404, 81405 received revisions. Note, due to the vast length of these descriptions, please consult your CPT manual to learn more. Genomic Sequencing Procedures Be ready for a new code that falls under the genomic sequencing centered around epilepsy genomic sequence analysis panels.

Genomic Sequencing Procedures

81419 Epilepsy genomic sequence analysis panel, must include analyses for ALDH7A1, CACNA1A, CDKL5, CHD2, GABRG2, GRIN2A,KCNQ2, MECP2, PCDH19, POLG,PRRT2, SCN1A, SCN1B, SCN2A, SCN8A, SLC2A1, SLC9A6, STXBP1, SYNGAP1 TCF4, TPP1, TSC1, TSC2, and ZEB2

Multianalyte Assays with Algorithmic Analyses

Several new codes are effective as of  January 1.

81513 Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, utilizing vaginal-fluid specimens, algorithm reported as a positive or negative result for bacterial vaginosis

81514 Infectious disease, bacterial vaginosis and vaginitis, quantitative real-time amplification of DNA markers for Gardnerella vaginalis, Atopobium vaginae, Megasphaera type 1, Bacterial Vaginosis Associated Bacteria-2 (BVAB-2), and Lactobacillus species (L. crispatus and L. jensenii), utilizing vaginal-fluid specimens, algorithm reported as a positive or negative for high likelihood of bacterial vaginosis, includes separate detection of Trichomonas vaginalis and/or Candida species (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Candida krusei, when reported

81529 Oncology (cutaneous melanoma), mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28 content and 3 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence risk, including likelihood of sentinel lymph node metastasis

81546 Oncology (thyroid), mRNA, gene expression analysis of 10,196 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (e.g., benign or suspicious)

81554 Pulmonary disease (idiopathic pulmonary fibrosis [IPF]), mRNA, gene expression analysis of 190 genes, utilizing transbronchial biopsies, diagnostic algorithm reported as categorical result (e.g., positive or negative for high probability of usual interstitial pneumonia [UIP])

Chemistry Code Updates

Two codes received revisions for 2021:

82075 Alcohol (ethanol); breath

82670 Estradiol; total

Two new codes are also available.

82077 Alcohol (ethanol); any specimen except urine and breath, immunoassay (e.g., IA, EIA, ELISA, RIA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)

82681 Estradiol; free, direct measurement (e.g., equilibrium dialysis)

Immunology Codes

A few new immunology codes now exist for 2021.

86328 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative single-step method (e.g., reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

86769 Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

For 2021, the following code was revised:

86318 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (e.g., reagent strip)

Microbiology

The previously released code for COVID diagnostic testing was added within the microbiology section.

87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique

Check out our monthly compliance manager newsletter to experience more insight and master laboratory coding and compliance challenges.

Subscribe to our compliance question of the week to learn the answers to everyday challenges you and your peers could be facing across the country.

Facebook
Twitter
LinkedIn

Bryan Nordley

Bryan Nordley is a seasoned professional writer, strategist, and researcher with over a decade’s worth of combined experience. Bryan launched his professional health writing career at the University of British Columbia’s Faculty of Medicine, one of the top 30 faculty of medicine programs in the world, working under the School of Public Health as a communications assistant. From there, he expanded his expertise and knowledge into private healthcare and podiatry before taking the role of healthcare writer at MedLearn Media. Bryan is the lead writer for the MedLearn Publishing brand previously producing both the acclaimed radiology and laboratory compliance manager newsletter products, while currently writing the compliance questions of the week which reach over 10,000 subscribers, creating the MedLearn Publishing Insights blogs and collaborating with operations and nationally renowned subject matter experts, in addition to serving as an editor for a variety of MedLearn publications along with marketing initiatives. Bryan continues to keep his pulse on the latest healthcare industry news, analyzing and reporting with strategic insight.

Related Stories

Leave a Reply

Please log in to your account to comment on this article.

Featured Webcasts

Trending News

Featured Webcasts

Ask Dr. Hirsch: Clarifying Medicare’s Most Misunderstood Rules – Part 2

Medicare regulations are complex and even seasoned professionals struggle to apply them consistently. Due to overwhelming demand, Dr. Hirsch returns for Part 2 of Ask Dr. Hirsch: Clarifying Medicare’s Most Misunderstood Rules to answer even more of Medicare’s most misunderstood questions, covering inpatient status, observation, SNF access, Medicare Advantage denials, and more. Join Dr. Hirsch as he provides clear, referenced answers to real-world questions submitted by your peers, helping you navigate Medicare compliance with confidence and clarity.

June 18, 2026

Reengineering Utilization Management: Building an Adaptive Model for the New Payer Era

Traditional utilization management models can no longer keep pace with regulatory shifts, payer scrutiny, and operational pressures. In this webcast, Tiffany Ferguson, LMSW, CMAC, ACM, ACPA-C, introduces an Adaptive Model strategy that modernizes UM through role specialization, technology-driven workflows, and proactive, team-based processes. Attendees will learn how to restructure programs to improve efficiency, strengthen clinical collaboration, and enhance financial performance in a rapidly changing healthcare environment.

May 20, 2026

Compliance for the Inpatient Psychiatric Facility (IPF-PPS): Minimizing Federal Audit Findings by Strengthening Best Practices

Federal auditors are intensifying their focus on inpatient psychiatric facilities, using advanced data analytics to spotlight outliers and pursue high‑dollar repayments. In this high‑impact webcast, Michael Calahan, PA, MBA, Compliance Officer and V.P., Hospital & Physician Compliance, breaks down what regulators are really targeting in IPF-PPS admissions, documentation, treatment and discharge planning. Attendees will learn practical steps to tighten processes, avoid common audit triggers and protect reimbursement and reduce the risk of multimillion-dollar repayment demands.

April 9, 2026

Mastering MDM for Accurate Professional Fee Coding

In this timely session, Stacey Shillito, CDIP, CPMA, CCS, CCS-P, CPEDC, COPC, breaks down the complexities of Medical Decision Making (MDM) documentation so providers can confidently capture the true complexity of their care. Attendees will learn practical, efficient strategies to ensure documentation aligns with current E/M guidelines, supports accurate coding, and reduces audit risk, all without adding to charting time.

March 31, 2026

Trending News

Celebrate Lab Week with MedLearn! Sign up to win one year of our Laboratory All Access Pass! Click here to learn more →

This Memorial Day, we honor those who gave all for our freedom. Take 20% off sitewide through May 29 with code MEMORIAL26 at checkout

CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 1 with code CYBER25

CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 2 with code CYBER24