Pathology and Laboratory Tier 2 to Tier 1 Code Conversions
CPT Assistant, August 2021, Volume 31, Issue 8, page 10
Important changes were made to the Molecular Pathology subsection of the Pathology and Laboratory section of the Current Procedural Terminology (CPT?®) 2021 code set. In particular, four new Tier 1 codes were established to describe genetic analysis for follicular lymphoma (81278) and myeloproliferative neoplasms or disorders (81279, 81338, 81339). Previously, these services were reported with Tier 2 codes 81402 and/or 81403. However, since the initial inclusion of these codes in the Tier 2 subsection, their usage has increased and warrants conversion to separately identifiable Tier 1 codes. This article provides an overview of the appropriate use of these new codes.
Tier 1 Molecular Pathology Procedures
Translocation is chromosomal rearrangement in which a region of one chromosome attaches to a region of another chromosome following double-stranded breaks in the respective chromosomes. Medically relevant translocations in major breakpoint regions (MBRs) in cancer generate fusion proteins that juxtapose the active sites of oncogenes to promoter-containing regions of other genes, resulting in increased oncogenic activity that drives the malignant process. This process is illustrated by the IGH@/BCL2 translocation, which places the active region of the BCL2 oncogene next to the regulatory regions of the immunoglobulin heavy chain gene and is characteristic of follicular lymphoma. Detection of the IGH@/BCL2 translocation in a patient can help identify potential treatment options.
Code 81278 was established to report analysis of the IGH@BCL2 translocation. This test was previously reported with Tier 2 code 81402, Molecular pathology procedure, Level 3 (eg, >10 SNPs, 2-10 methylated variants, or 2-10 somatic variants [typically using non-sequencing target variant analysis], immunoglobulin and T-cell receptor gene rearrangements, duplication/deletion variants of 1 exon, loss of heterozygosity [LOH], uniparental disomy [UPD]).
Code 81279 was established to report targeted sequence analysis of exons 12 and 13 of the JAK2 gene. Mutations in JAK2 are important pathogenetic drivers of myeloproliferative neoplasms, which are defined by abnormal production of red or white blood cells, platelets, or the development of marrow fibrosis. Previously, this test was reported with Tier 2 code 81403, Molecular pathology procedure, Level 4 (eg, analysis of single exon by DNA sequence analysis, analysis of >10 amplicons using multiplex PCR in 2 or more independent reactions, mutation scanning or duplication/deletion variants of 2-5 exons).
Codes 81338 and 81339 were established for reporting sequence analysis and identifying common variants of MPL, another gene associated with myeloproliferative neoplasms. Code 81338 is used to report analysis for common variants of the MPL gene (eg, W515A, W515K, W515L, W515R), whereas code 81339 is reported for sequence analysis of MPL exon 10. These two tests were previously reported with Tier 2 codes 81402 and 81403, respectively.
The following clinical examples and procedural descriptions reflect typical clinical scenarios for which these new codes would be appropriately reported.
Clinical Example (81278)
A 62-year-old male undergoes a biopsy of an enlarged lymph node and is given a histologic diagnosis of follicular lymphoma. A portion of the biopsied specimen is submitted for IGH@/BCL2(t(14;18)) translocation analysis.
Description of Procedure (81278)
Extract and evaluate high-quality DNA from biopsied material for the IGH@/BCL2(t(14;18)) translocation by real-time PCR amplification. A pathologist or other qualified health care professional analyzes the data and prepares and signs a report. Communicate the results of the patient's translocation status to appropriate health care professionals.
Clinical Example (81279)
A 60-year-old male presents to his physician with pruritis and headaches and was found to have an increased hemoglobin concentration of 18.0 g/dL. There is clinical suspicion for polycythemia vera. Following referral to hematology, a bone marrow biopsy showed panhyperplasia with atypical megakaryocytes. JAK2 V617F point mutation testing was negative. A blood sample was submitted for targeted sequencing evaluation of JAK2 exons 12 and 13.
Description of Procedure (81279)
Isolate and subject high-quality genomic DNA from peripheral blood to targeted sequencing of JAK2 exons 12 and 13. A pathologist or other qualified health care professional analyzes the data and composes a report specifying the patient's mutation status. Communicate the results to the appropriate health care professionals.
Clinical Example (81338)
A 65-year-old female presents to a physician for a routine visit and is found to have a markedly elevated platelet count. Repeat testing on a follow-up visit showed similar results. The patient was referred to a hematologist/oncologist, who ordered fluorescence in situ hybridization (FISH) testing for BCR-ABL1, molecular testing for JAK2 mutations, and a bone marrow biopsy. BCR-ABL1 and JAK2 testing was negative, and the bone marrow biopsy showed increased numbers of enlarged megakaryocytes. To diagnose the patient with a myeloproliferative disorder, the physician requested MPL W515 testing and CALR testing.
Description of Procedure (81338)
Isolate and prepare high-quality genomic DNA from whole blood for targeted variant analysis of the MPL gene. A pathologist or other qualified health care professional analyzes the data and composes a report.
Clinical Example (81339)
A 55-year-old female presents to the physician with episodic transient ischemic attacks and was found to have a markedly elevated platelet count. The patient was referred to a hematologist/oncologist, who ordered FISH testing for BCR-ABL1, molecular testing for JAK2, MPL W515, and CALR mutation testing, and a bone marrow biopsy. BCR-ABL1, JAK2, MPL W515, and CALR testing was negative, and the bone marrow biopsy showed increased numbers of enlarged megakaryocytes. The physician ordered MPL exon 10 sequence analysis to identify a clonal mutation to establish the diagnosis of essential thrombocythemia.
Description of Procedure (81339)
Isolate and subject high-quality genomic DNA from whole blood to sequence analysis of exon 10 of the MPL gene. A pathologist or other qualified health care professional analyzes the data and composes a report.
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