Summary & Overview
CPT 0261U: Immunoscore® for Colon Cancer Immune Response
CPT code 0261U designates Immunoscore®, a Proprietary Laboratory Analyses (PLA) test from HalioDx that quantifies tumor-infiltrating immune cells (CD3 and CD8) on FFPE colon cancer tissue to produce an immune response score and a high/low risk-of-recurrence classification. The test matters nationally as an emerging tissue-based prognostic tool that informs adjuvant treatment considerations for patients with localized colon cancer and may affect utilization of chemotherapy and surveillance strategies. Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical context for Immunoscore®, how the test is reported using CPT code 0261U, and what to expect in payer coverage patterns and benchmarking. The publication summarizes common billing and claim considerations, typical sites of service, and the clinical role of immune scoring in risk stratification for colon cancer. Data not available in the input is noted where applicable; the report does not provide specific state-level policies but presents national-level implications for laboratory and oncology stakeholders.
Billing Code Overview
CPT code 0261U is a Proprietary Laboratory Analyses (PLA) code for the Immunoscore® test from HalioDx. The test is performed on a formalin–fixed paraffin–embedded (FFPE) colon cancer tissue specimen and uses digital assessment of CD3 and CD8 to generate an immune response score and a risk-of-recurrence classification of high or low. Clinicians may order the test for patients with localized colon cancer to guide treatment decisions.
Service type: Proprietary laboratory molecular/diagnostic test, performed on FFPE tumor tissue.
Typical site of service: Clinical laboratory or specialized pathology/molecular diagnostics laboratory.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a recent resection for stage II colon adenocarcinoma has formalin–fixed paraffin–embedded (FFPE) tumor tissue available and seeks risk stratification for recurrence to inform adjuvant therapy decisions. The surgical oncologist orders the Immunoscore® test (Proprietary Laboratory Analysis 0261U) from HalioDx. The pathology laboratory selects representative FFPE tumor sections, performs immunohistochemical staining for CD3 and CD8, and digitizes the slides. A digital image analysis platform quantifies intra-tumoral and stromal CD3/CD8 densities, and the proprietary algorithm generates an Immunoscore result and a binary risk-of-recurrence classification (high or low). The laboratory reports results to the ordering clinician, who integrates the score with stage, mismatch repair status, and other clinical factors during the multidisciplinary treatment planning visit.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default — no modifier | Use when no special circumstances apply and the service is billed routinely |
26 | Professional component | Use when billing only the professional interpretation portion of the test separated from technical component |
TC | Technical component | Use when billing only the technical component (laboratory processing, staining, imaging) |
52 | Reduced services | Use when the laboratory is unable to complete parts of the test and a reduced service is provided |
53 | Discontinued procedure | Use when testing is started but discontinued for patient- or specimen-related reasons before completion |
59 | Data not provided in the input | Data not available in the input. |
62 | Two surgeons | Use rarely when two surgeons are involved in specimen procurement that affects billing splits (surgical context) |
78 | Unplanned return to the operating room | Use when a reoperation affects specimen handling or repeat testing billing considerations |
80 | Assistant surgeon | Use when an assistant surgeon's involvement affects global surgical billing tied to specimen procurement |
82 | Assistant surgeon (when qualified assistant not available) | Use similarly to 80 in specific workforce scenarios |
QK | Locum tenens physician’s services — primary physician | Use when a locum tenens ordered or interpreted the test on behalf of the regular clinician |
QX | Qualified nonphysician practitioner | Use when a qualified nonphysician practitioner orders or signs for the test per local policy |
QY | Qualified nonphysician practitioner — assistant at surgery | Use when relevant to the surgical procurement workflow affecting billing |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | Use when these clinicians bill for their professional services related to ordering or interpretation |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207P00000X | Anatomic Pathology | Pathologists perform specimen processing, IHC oversight, and interpretation of laboratory results |
| 208000000X | Surgical Oncology | Surgical oncologists procure the specimen and apply results to adjuvant therapy planning |
| 207L00000X | Pathology — Clinical | Clinical pathologists/directors oversee laboratory testing workflows and quality assurance |
| 207LP2900X | Molecular Genetic Pathology | Specialists involved when molecular correlations or integrated reports accompany Immunoscore results |
| 207RA0000X | Hematopathology (related lab specialty) | May be involved in complex immune-marker interpretation and lab validation |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
| Data not available in the input. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV — surgical pathology, gross and microscopic exam | Performed on resected colon specimen to establish histopathology before ordering Immunoscore; supplies tissue blocks (FFPE) used for 0261U |
88342 | Immunohistochemistry, per specimen; initial single antibody stain | May be used for CD3 or CD8 stains if billed separately by the performing laboratory prior to digital analysis |
88360 | Morphometric analysis, e.g., computer-assisted image analysis | Represents image analysis work that parallels the digital quantification step used in generating the Immunoscore result (often included in PLA billing) |
88361 | Computer-assisted morphometric analysis, each additional lesion or specimen | Billed when multiple separate tissue areas require additional image analysis iterations in the workflow |
81599 | Unlisted molecular pathology procedure | Sometimes used historically for novel molecular/immune assays when PLA codes were unavailable; clinical workflows for novel tests may reference it prior to PLA assignment |