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Molecular pathology procedures are specialized tests conducted at the molecular level to aid in the diagnosis, treatment, and prognostic evaluation of various genetic disorders, cancers, infectious diseases, and to assess tissue histocompatibility in transplant scenarios. These procedures are categorized by complexity, with different levels reflecting the extent of professional involvement and laboratory resources required. Specifically, Level 3 molecular pathology procedures, as denoted by CPT® Code 81402, encompass a range of tests that involve the identification of more than 10 single nucleotide polymorphisms (SNPs), 2 to 10 methylated variants, or 2 to 10 somatic variants, typically utilizing non-sequencing target variant analysis. Additionally, this level includes the analysis of immunoglobulin and T-cell receptor gene rearrangements, duplication or deletion variants of a single exon, loss of heterozygosity (LOH), and uniparental disomy (UPD). The molecular pathologist plays a critical role in this process by reviewing the patient's medical history, clinical findings, and results from other diagnostic tests before proceeding with the Level 3 test. The tests covered under this code are explicitly defined, but it is important to note that other molecular pathology procedures requiring similar levels of expertise, work, and laboratory costs, and employing comparable techniques, may also be reported using CPT® Code 81402 if they do not have a more specific code. Upon completion of the test, the molecular pathologist interprets the results and generates a comprehensive written report detailing the findings, which is essential for guiding further clinical decision-making.
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The Level 3 molecular pathology procedures represented by CPT® Code 81402 are indicated for a variety of conditions and diagnostic needs, including but not limited to the following:
The procedure for Level 3 molecular pathology tests involves several critical steps, each designed to ensure accurate and reliable results. The following outlines the procedural steps associated with CPT® Code 81402:
Following the completion of the Level 3 molecular pathology tests, the molecular pathologist provides a comprehensive report detailing the findings. This report is essential for guiding clinical decision-making and may influence treatment options or further diagnostic evaluations. Patients may require follow-up consultations to discuss the results and any necessary next steps in their care. Additionally, the molecular pathologist may recommend further testing or monitoring based on the findings, particularly if significant genetic variants or abnormalities are identified. It is important for healthcare providers to ensure that the results are communicated effectively to the patient and integrated into their overall treatment plan.
| Short Descr | MOPATH PROCEDURE LEVEL 3 | Medium Descr | MOLECULAR PATHOLOGY PROCEDURE LEVEL 3 | Long Descr | 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]) Chromosome 1p-/19q- (eg, glial tumors), deletion analysis Chromosome 18q- (eg, D18S55, D18S58, D18S61, D18S64, and D18S69) (eg, colon cancer), allelic imbalance assessment (ie, loss of heterozygosity) COL1A1/PDGFB (t(17;22)) (eg, dermatofibrosarcoma protuberans), translocation analysis, multiple breakpoints, qualitative, and quantitative, if performed CYP21A2 (cytochrome P450, family 21, subfamily A, polypeptide 2) (eg, congenital adrenal hyperplasia, 21-hydroxylase deficiency), common variants (eg, IVS2-13G, P30L, I172N, exon 6 mutation cluster [I235N, V236E, M238K], V281L, L307FfsX6, Q318X, R356W, P453S, G110VfsX21, 30-kb deletion variant) ESR1/PGR (receptor 1/progesterone receptor) ratio (eg, breast cancer) MEFV (Mediterranean fever) (eg, familial Mediterranean fever), common variants (eg, E148Q, P369S, F479L, M680I, I692del, M694V, M694I, K695R, V726A, A744S, R761H) TRD@ (T cell antigen receptor, delta) (eg, leukemia and lymphoma), gene rearrangement analysis, evaluation to detect abnormal clonal population Uniparental disomy (UPD) (eg, Russell-Silver syndrome, Prader-Willi/Angelman syndrome), short tandem repeat (STR) analysis | Status Code | Statutory Exclusion (from MPFS, may be paid under other methodologies) | Global Days | XXX - Global Concept Does Not Apply | PC/TC Indicator (26, TC) | 9 - Not Applicable | Multiple Procedures (51) | 9 - Concept does not apply. | Bilateral Surgery (50) | 9 - Concept does not apply. | Physician Supervisions | 09 - Concept does not apply. | Assistant Surgeon (80, 82) | 9 - Concept does not apply. | Co-Surgeons (62) | 9 - Concept does not apply. | Team Surgery (66) | 9 - Concept does not apply. | Diagnostic Imaging Family | 99 - Concept Does Not Apply | CLIA Waived (QW) | No | APC Status Indicator | Service Paid under Fee Schedule or Payment System other than OPPS | Type of Service (TOS) | 5 - Diagnostic Laboratory | Berenson-Eggers TOS (BETOS) | T1H - Lab tests - other (non-Medicare fee schedule) | MUE | 1 | CCS Clinical Classification | 234 - Pathology |
| 90 | Reference (outside) laboratory: when laboratory procedures are performed by a party other than the treating or reporting physician or other qualified health care professional, the procedure may be identified by adding modifier 90 to the usual procedure number. | GZ | Item or service expected to be denied as not reasonable and necessary | GA | Waiver of liability statement issued as required by payer policy, individual case | 26 | Professional component: certain procedures are a combination of a physician or other qualified health care professional component and a technical component. when the physician or other qualified health care professional component is reported separately, the service may be identified by adding modifier 26 to the usual procedure number. | 59 | Distinct procedural service: under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-e/m services performed on the same day. modifier 59 is used to identify procedures/services, other than e/m services, that are not normally reported together, but are appropriate under the circumstances. documentation must support a different session, different procedure or surgery, different site or organ system, separate incision/excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. however, when another already established modifier is appropriate it should be used rather than modifier 59. only if no more descriptive modifier is available, and the use of modifier 59 best explains the circumstances, should modifier 59 be used. note: modifier 59 should not be appended to an e/m service. to report a separate and distinct e/m service with a non-e/m service performed on the same date, see modifier 25. | GC | This service has been performed in part by a resident under the direction of a teaching physician |
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| 2021-01-01 | Changed | Code changed. |
| 2016-01-01 | Changed | Description Changed |
| 2015-01-01 | Changed | Description Changed |
| 2014-01-01 | Changed | Description Changed |
| 2013-01-01 | Changed | Description Changed. Also per AMA 2013 corrections document, added analyte "IGH@BCL2" and revised analyte "TCD@" to "TRD@". |
| 2012-01-01 | Added | Added |
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