Pathology/Lab Coding Alert

Look for additions to drug, molecular tests, and more.

New clinical laboratory test codes are coming your way next year, and we have the rundown of what you need to know based on the CMS Annual Clinical Laboratory Public Meeting held June 22, 2020.

Get this: The 2021 CPT^® codes aren’t finalized and numbers aren’t fully assigned, but CMS provides the code definitions for stakeholder comment. The open meeting is part of the process to determine the basis of payment for the codes, according to CMS’s meeting facilitator, Rasheeda Arthur, PhD.

Greet New Drug Testing Codes

You’ll find the following new chemistry codes in CPT^® 2021, many in the therapeutic drug assay section, according to the list provided at the meeting:

• 80XX1 (Salicylate)
• 80XX2 (Amiodarone)
• 80XXX (Acetaminophen)
• 80XX3 (Carbamazepine; 10,11-epoxide)
• 80XX4 (Felbamate)
• 80XX5 (Flecainide)
• 80XX6 (Itraconazole)
• 80XX7 (Leflunomide)
• 80XX8 (Methotrexate)
• 802XX (Rufinamide)
• 81XX3 (Alcohol (ethanol); any specimen except urine and breath, immunoassay (eg, IA, EIA, ELISA, RIA, EMIT, FPIA) and enzymatic methods (eg, alcohol dehydrogenase))
• 82XX1 (Estradiol; free, direct measurement (eg, equilibrium dialysis))

Although the final code numbers are not yet assigned, remember that CPT^® organizes codes for therapeutic drug tests alphabetically by drug or drug class. You can expect the new codes to conform, which means that some of the codes may be out of numerical sequence.

Remember: “Each therapeutic drug assay includes testing for any metabolites of the listed drug, if performed,” reminds William Dettwyler, MT AMT, president of Codus Medicus, a laboratory coding consulting firm in Salem, Ore.

Expand Genetic Testing Options

You’ll find the following new test codes in CPT^® 2021 for chromosomal-related tests involving translocation analysis:

• 8X010 (CCND1/IGH (t(11;14)) (eg, mantle cell lymphoma) translocation analysis, major breakpoint, qualitative and quantitative, if performed)
• 8X009 (IGH@/BCL2 (t(14;18)) (eg, follicular lymphoma) translocation analysis, major breakpoint region (MBR) and minor cluster region (mcr) breakpoints, qualitative or quantitative)
• 8X020 (NTRK (neurotrophic-tropomyosin receptor tyrosine kinase 1, 2, and 3) (eg, solid tumors) translocation analysis)
• 8X000 (NTRK1 (neurotrophic receptor tyrosine kinase 1) (eg, solid tumors) translocation analysis)
• 8X001 (NTRK2 (neurotrophic receptor tyrosine kinase 2) (eg, solid tumors) translocation analysis)
• 8X002 (NTRK3 (neurotrophic receptor tyrosine kinase 3) (eg, solid tumors) translocation analysis)

Beginning Jan. 1, 2021, you’ll have a few new Tier 1 Molecular Pathology codes for genes with tests currently assigned to Tier 2 codes:

• 8X008 (JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) targeted sequence analysis (eg, exons 12 and 13))
• 8X007 (MPL (MPL proto-oncogene, thrombopoietin receptor) (eg, myeloproliferative disorder) gene analysis; sequence analysis, exon 10
• 8X006 (MPL (MPL proto-oncogene, thrombopoietin receptor) (eg, myeloproliferative disorder) gene analysis; common variants (eg, W515A, W515K, W515L, W515R)

You’ll also find three new codes for tumor protein 53 testing for full, targeted, and known familial sequences (8X003, 8X004, 8X005 - TP53 (tumor protein 53) (eg, Li-Fraumeni syndrome) gene analysis…).

Don’t miss these other additions to molecular testing in CPT^® 2021:

• 8XX00 (SF3B1 (splicing factor [3b] subunit B1) (eg, myelodysplastic syndrome/acute myeloid leukemia) gene analysis, common variants (eg, A672T, E622D, L833F, R625C, R625L))
• 8XX01 (SRSF2 (serine and arginine-rich splicing factor 2) (eg, myelodysplastic syndrome, acute myeloid leukemia) gene analysis, common variants (eg, P95H, P95L))
• 8XX02 (U2AF1 (U2 small nuclear RNA auxiliary factor 1) (eg, myelodysplastic syndrome, acute myeloid leukemia) gene analysis, common variants (eg, S34F, S34Y, Q157R, Q157P))
• 8XX03 (ZRSR2 (zinc finger CCCH-type, RNA binding motif and serine/arginine-rich 2) (eg, myelodysplastic syndrome, acute myeloid leukemia) gene analysis, common variant(s) (eg, E65fs, E122fs, R448fs))

Expect New MAAA and PLA Codes

Look for several new Category I codes next year for Multianalyte Assays with Algorithmic Analysis (MAAA) tests. These codes describe tests that use a panel of diagnostic procedures, then integrate the test results into an algorithm to provide a single “score” or probability for a specific prognostic outcome.

CPT^® 2021 includes new codes for thyroid cancer gene [removed]81XX2), idiopathic pulmonary fibrosis gene [removed]81XX1), infectious disease markers for bacterial vaginosis/vaginitis (81XX4, 815X3), and an epilepsy genomic sequence analysis panel (81XX6).

More PLAs: Introduced to CPT^® in 2018, the Proprietary Laboratory Analyses (PLA) are alpha-numeric codes assigned with approval by the AMA CPT^® Editorial Panel for unique lab tests that a specific clinical laboratory or test manufacturer produces or provides.

At the June 22 public meeting, CMS heard stakeholder comments about pricing for more than 80 new PLA codes (0139U-0222U). Here’s a quick peek at the variety of analyses addressed by various PLA codes:

Neoplasm: Many of the tests target diagnosis, prognosis, or treatment indications for cancers such as colorectal (0157U-0163U), breast (0153U, 0155U, 0177U, 0220U), and other oncology (0154U, 0174U, 0179U, 0204U, 0208U, and 0211U).

Drug monitoring: Several new PLA codes (0143U-0150U) describe broad drug monitoring assays for 60 to 120 drugs.

Blood typing: PLA codes 0180U-0201U and 0221U, 0222U introduce proprietary tests for red cell antigen typing from various blood groups such as ABO, RH, Duffy, and Kell.

Many other new PLA codes to appear in CPT^® 2021 include testing for infectious agents, heritable disorders, immunology, and more.

To read more about PLA codes, including how to apply for a code, and for a current list of AMA approved codes, visit www.ama-assn.org/practice-management/cpt/cpt-pla-codes.