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 |