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The CPT® Code 81315 pertains to the molecular genetic testing aimed at identifying a specific genetic mutation involving the PML (promyelocytic leukemia) gene and the RARalpha (retinoic acid receptor alpha) gene. This mutation results in a chimeric fusion of the two genes, which is significant in the context of acute myeloid leukemia (AML). In approximately 99% of individuals diagnosed with AML, a translocation occurs between chromosome 15, where the PML gene is located, and chromosome 17, which houses the RARA gene. This translocation leads to the formation of a transcript isoform that can vary in length, categorized as either short or long, depending on the specific breakpoint within the PML gene. The analysis performed under CPT® Code 81315 focuses on common breakpoints, specifically those found in intron 3 and intron 6 of the PML gene. The testing can be qualitative or quantitative, achieved through the extraction of RNA and the application of reverse transcription-polymerase chain reaction (RT-PCR) to examine the PML/RARA fusion transcripts. A control sample from the ABL gene is also amplified to ensure the quality of the test and to facilitate relative quantification of the results, which are reported as either positive or negative. In cases where the test yields a positive result, the report will include details about the length of the isoform and the ratio of the target PML/RARA mRNA to the control ABL mRNA. This information is crucial for monitoring the effectiveness of therapy, assessing minimal residual disease (MRD), and predicting the potential for early relapse. The identification of common breakpoints is particularly relevant, as it has been observed that the frequency of these breakpoints can vary by ethnicity, with certain populations exhibiting a higher prevalence of specific breakpoints. Overall, CPT® Code 81315 plays a vital role in the diagnosis and management of acute promyelocytic leukemia (APL) through the detailed analysis of genetic translocations.
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The PML/RARalpha translocation analysis performed under CPT® Code 81315 is indicated for the following conditions:
The procedure for conducting the PML/RARalpha translocation analysis under CPT® Code 81315 involves several key steps:
After the PML/RARalpha translocation analysis is completed, the results are communicated to the healthcare provider, who will interpret the findings in the context of the patient's overall clinical picture. If the test is positive, indicating the presence of the PML/RARA fusion, the healthcare provider may use this information to guide treatment decisions, monitor the effectiveness of ongoing therapy, and evaluate the risk of relapse. Follow-up testing may be scheduled to track changes in the levels of the fusion transcripts, particularly in patients undergoing treatment for APL. It is essential for healthcare professionals to consider the patient's ethnicity, as this may influence the frequency of specific breakpoints and the interpretation of the results.
| Short Descr | PML/RARALPHA COM BREAKPOINTS | Medium Descr | PML/RARALPHA COMMON BREAKPOINTS QUAL/QUANT | Long Descr | PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; common breakpoints (eg, intron 3 and intron 6), qualitative or quantitative | 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. | 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. | GA | Waiver of liability statement issued as required by payer policy, individual case | GZ | Item or service expected to be denied as not reasonable and necessary | XP | Separate practitioner, a service that is distinct because it was performed by a different practitioner | XU | Unusual non-overlapping service, the use of a service that is distinct because it does not overlap usual components of the main service |
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| 2012-01-01 | Added | Added |
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