Clinical Context
A 62-year-old patient with a newly diagnosed or recurrent solid-organ tumor (for example, lung adenocarcinoma, colorectal adenocarcinoma, or metastatic carcinoma of unknown primary) undergoes tumor tissue sampling during diagnostic biopsy or surgical resection. The formalin-fixed, paraffin-embedded (FFPE) tumor specimen is sent to the clinical laboratory offering the Oncotype MAP™ PanCancer Tissue Test (0244U) for genomic sequence analysis of 257 cancer-associated genes. The laboratory performs nucleic acid extraction, next-generation sequencing, bioinformatic interpretation, and produces a report describing genomic alterations, mutational signatures, and potential therapeutic targets or resistance markers. Results are returned to the ordering oncologist or surgical pathologist to guide systemic therapy selection, targeted therapy consideration, immunotherapy eligibility, or enrollment in clinical trials. Typical workflow includes specimen accessioning, pathology review for tumor content, test performance at a centralized molecular laboratory, and electronic or paper reporting to the treating team. Typical site of service is an outpatient oncology clinic, hospital-based pathology/molecular laboratory, or reference laboratory. Patient counseling and treatment planning occur in oncology clinic visits after results are reviewed.
Coding Specifications
| Modifier | Description | When to Use |
|---|
00 | No modifier | Default when no modifier applies |
26 | Professional component | When billing only the professional component (interpretation) separated from technical services
TC | Technical component | When billing only the technical component (laboratory processing/sequencing) separated from professional interpretation
QK | CLIA waived test performed at a patient's home | Not typically used for this laboratory-based PLA; included for completeness when point-of-care waived testing occurs
QX | Modifier for qualified nonphysician practitioner | When a qualified nonphysician clinician furnishes the professional component under applicable rules
QY | Laboratory test ordered by a qualified nonphysician practitioner | When ordering/provider requirements dictate
AS | Physician assistant or nurse practitioner in a teaching setting | When teaching physician rules apply for services by PAs/NPs in certain settings
62 | Two surgeons | Rare for this test; used when two surgeons share responsibility for a procedure related to specimen acquisition
78 | Unplanned return to the operating room | Not directly applicable to the lab test; used when an operative complication requires reoperation related to specimen acquisition
52 | Reduced services | When specimen processing or testing is limited or partially performed
| Taxonomy Code | Specialty | Notes |
|---|
207RH0000X | Hematology & Oncology | Medical oncologists who order tissue genomic profiling |
207K00000X | Pathology | Surgical pathologists who review tumor specimens and coordinate molecular testing
363A00000X | Clinical Laboratory | Pathology/molecular lab directors overseeing test performance
208000000X | Internal Medicine | Hospitalists or internists involved in coordinating oncology care
208D00000X | Family Medicine | Primary care physicians who may refer patients for oncology evaluation
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|
C34.9 | Malignant neoplasm of bronchus and lung, unspecified | Lung cancers commonly undergo comprehensive genomic profiling to guide targeted therapies |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal tumors are frequently tested for actionable genomic alterations
C50.912 | Malignant neoplasm of unspecified site of left female breast | Breast cancers may be included for broad pan-cancer panels when additional genomic information is needed
C80.1 | Malignant (primary) neoplasm, unspecified | Used when tumor primary site is uncertain and broad genomic panels assist in diagnosis and therapy selection
C76.2 | Malignant neoplasm of pleura | Thoracic tumors and metastatic lesions often require molecular profiling for management
C78.7 | Secondary malignant neoplasm of liver and intrahepatic bile duct | Metastatic disease specimens are commonly profiled to identify origin and therapeutic targets
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Pathology review and diagnosis of the tumor specimen prior to molecular testing |
88342 | Immunohistochemistry, per single antibody stain | Performed on tumor tissue to characterize histology and select cases for molecular testing
81275 | EGFR (epidermal growth factor receptor) gene analysis (if performed separately) | Individual molecular tests that may be ordered in addition to or prior to comprehensive panel testing
81445 | Oncology (solid organ) gene panel, quantitative sequence analysis of 5-50 genes | Smaller targeted panels that can be alternatives or complements to a larger PLA like 0244U
0001U | Example PLA code (placeholder) | Other PLA codes representing manufacturer-specific genomic tests that may be performed in parallel or as alternatives