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The CPT® Code 81276 pertains to the molecular genetic testing of the KRAS gene, specifically focusing on the analysis of additional variants such as those found at codon 61 and codon 146. The KRAS gene is crucial as it encodes the K-Ras protein, which plays a significant role in regulating cell growth, division, maturation, and differentiation through signal transduction. This process involves the K-Ras protein acting as a GTPase, functioning like a molecular switch that toggles 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 mutations, a single alteration in the protein structure 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, particularly at codons 12 or 13 in exon 2. Mutations in the KRAS gene can lead to various genetic disorders, including a severe form of Noonan syndrome, characterized by symptoms such as intellectual disability, short stature, congenital heart defects, and skeletal anomalies. Another condition associated with KRAS mutations is cardiofaciocutaneous (CFC) syndrome, which presents with similar intellectual challenges, 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 linked to lung and colorectal cancers, while mutations at codon 146 in exon 4 are primarily associated with colorectal cancers and, less commonly, with acute myeloid leukemia and acute lymphoblastic leukemia. Additionally, the presence of mutations at codon 61 and codon 146 has been shown to predict resistance to EGFR-targeted therapies, such as cetuximab. The testing for these mutations is typically performed on blood or tissue samples using polymerase chain reaction-based Sanger sequencing of DNA, making it a vital tool in the diagnosis and management of related conditions and cancers.
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The molecular genetic testing for the KRAS gene analysis (CPT® Code 81276) is indicated for individuals who exhibit symptoms associated with specific genetic syndromes and those diagnosed with certain types of cancer. The following conditions warrant this testing:
The procedure for KRAS gene analysis involves several critical steps to ensure accurate detection of mutations. The process begins with the collection of a blood or tissue sample from the patient. This sample serves as the source of DNA for the analysis. Once the sample is obtained, it undergoes a preparation phase where the DNA is extracted and purified to eliminate any contaminants that may interfere with the testing. Following DNA extraction, the next step involves the application of polymerase chain reaction (PCR) techniques, specifically Sanger sequencing, which amplifies the regions of interest within the KRAS gene. This method allows for the precise identification of mutations at specific codons, such as codon 61 and codon 146. The amplified DNA is then subjected to sequencing, where the nucleotide sequence is determined. The results are analyzed to detect any mutations present in the KRAS gene, which can provide valuable information regarding the patient's condition and potential treatment options. The entire procedure is designed to be thorough and reliable, ensuring that any mutations that may influence disease progression or treatment response are accurately identified.
After the KRAS gene analysis is completed, the results are typically reviewed by a healthcare professional who will interpret the findings in the context of the patient's clinical situation. If mutations are detected, this information can significantly impact treatment decisions, particularly in the case of cancers where targeted therapies may be affected by the presence of specific KRAS mutations. Patients may require follow-up consultations to discuss the implications of the test results, potential treatment options, and any further testing that may be necessary. It is essential for healthcare providers to communicate the results clearly and provide support to patients as they navigate their treatment pathways based on the findings of the genetic analysis.
| Short Descr | KRAS GENE ADDL VARIANTS | Medium Descr | KRAS GENE ANALYSIS ADDITIONAL VARIANT(S) | Long Descr | KRAS (Kirsten rat sarcoma viral oncogene homolog) (eg, carcinoma) gene analysis; additional variant(s) (eg, codon 61, codon 146) | 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 |
| 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. | 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. | GW | Service not related to the hospice patient's terminal condition | GZ | Item or service expected to be denied as not reasonable and necessary | 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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| 2016-01-01 | Added | Added |
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