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The CPT® Code 81275 pertains to the molecular genetic testing of the KRAS gene, specifically focusing on variants located in exon 2, which includes codons 12 and 13. The KRAS gene is crucial as it encodes the K-Ras protein, a key player in cellular processes such as growth, division, maturation, and differentiation. This protein functions as a molecular switch, toggling between an active state when bound to guanosine triphosphate (GTP) and an inactive state when it hydrolyzes GTP to guanosine diphosphate (GDP). In the presence of specific mutations, a single alteration in the amino acid sequence can lead to continuous activation of the K-Ras protein, resulting in uncontrolled cell proliferation. The KRAS gene is classified within the Ras family of oncogenes and is located on chromosome 12. Mutations in this gene can lead to various disorders, including an atypical form of Noonan syndrome, characterized by symptoms such as intellectual disability, short stature, congenital heart defects, and skeletal anomalies. Additionally, the KRAS gene is implicated in cardiofaciocutaneous (CFC) syndrome, which presents with low intellectual function, distinctive facial features, short stature, macrocephaly, and sparse hair. Furthermore, somatic mutations of the KRAS gene are frequently observed in several malignancies, including lung, pancreatic, and colorectal cancers. Notably, mutations at codon 61, which result in a change in the amino acid glutamine, are associated with lung and colorectal cancers, while mutations at codon 146 are primarily found in colorectal cancers and occasionally in acute myeloid leukemia and acute lymphoblastic leukemia. These mutations are also significant as they can predict resistance to EGFR-targeted therapies, such as cetuximab. The testing for these mutations is typically conducted using blood or tissue samples through polymerase chain reaction-based Sanger sequencing of DNA, making it a vital tool in the diagnosis and management of related syndromes and cancers.
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The molecular genetic testing for the KRAS gene analysis (CPT® Code 81275) is indicated for individuals presenting with specific symptoms or conditions that may be associated with mutations in the KRAS gene. These indications include:
The procedure for KRAS gene analysis involves several key steps to ensure accurate identification of mutations in exon 2, specifically codons 12 and 13. The process begins with the collection of a blood or tissue sample from the patient. This sample serves as the source of DNA for testing. Once the sample is obtained, it undergoes a preparation phase where the DNA is extracted and purified to remove any contaminants that may interfere with the analysis. Following DNA extraction, polymerase chain reaction (PCR) is employed to amplify the specific regions of the KRAS gene that are of interest, particularly those containing the potential mutation sites. After amplification, Sanger sequencing is performed, which allows for the precise determination of the nucleotide sequence in the targeted regions of the KRAS gene. This sequencing technique is highly sensitive and enables the detection of even minor mutations within the gene. The results of the sequencing are then analyzed to identify any variants present in codons 12 and 13. If mutations are detected, they are documented and reported, providing critical information that can influence treatment decisions, particularly in the context of cancer therapies. The entire procedure is designed to be thorough and reliable, ensuring that healthcare providers receive accurate genetic information to guide patient management.
After the KRAS gene analysis is completed, the results are typically reviewed by a healthcare professional, who will discuss the findings with the patient. If mutations are identified, this information can significantly impact treatment options, especially in the context of targeted therapies for cancers. Patients may require additional counseling to understand the implications of the results, particularly if they are associated with hereditary syndromes like Noonan or CFC syndromes. Follow-up care may include further genetic testing for family members, ongoing monitoring for associated health issues, and discussions regarding potential treatment strategies based on the mutation status. It is essential for healthcare providers to ensure that patients are informed about the significance of their test results and any necessary next steps in their care plan.
| Short Descr | KRAS GENE VARIANTS EXON 2 | Medium Descr | KRAS GENE ANALYSIS VARIANTS IN EXON 2 | Long Descr | KRAS (Kirsten rat sarcoma viral oncogene homolog) (eg, carcinoma) gene analysis; variants in exon 2 (eg, codons 12 and 13) | 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. | XU | Unusual non-overlapping service, the use of a service that is distinct because it does not overlap usual components of the main service | 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. | GZ | Item or service expected to be denied as not reasonable and necessary | GW | Service not related to the hospice patient's terminal condition | 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. | GC | This service has been performed in part by a resident under the direction of a teaching physician | GV | Attending physician not employed or paid under arrangement by the patient's hospice provider | XS | Separate structure, a service that is distinct because it was performed on a separate organ/structure |
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| 2016-01-01 | Changed | Description Changed |
| 2012-01-01 | Added | Added |
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