Summary & Overview
CPT 0211U: MI Cancer Seek™ NGS Tumor Profiling (WES + WTS)
CPT code 0211U designates a Proprietary Laboratory Analyses (PLA) test — the MI Cancer Seek™ – NGS Analysis from Caris MPI d/b/a Caris Life Sciences — which combines whole exome sequencing of DNA and whole transcriptome sequencing of RNA from formalin-fixed paraffin-embedded tumor tissue. As a PLA code, 0211U maps to a single manufacturer-specific assay and is used to identify high-complexity genomic profiling that can inform oncology diagnostics, genomic characterization, and potential therapeutic decision support. Nationally, PLA codes like 0211U matter because they standardize reporting for unique commercial assays and enable payers and providers to track utilization and spending for advanced molecular diagnostics.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code’s clinical scope, typical service setting, and the payer landscape addressed in the publication. The report summarizes available benchmarking and coverage considerations for high-complexity NGS tumor profiling, highlights policy and coding implications of PLA usage, and provides clinical context for WES and WTS combined testing. Data not available in the input are identified explicitly where applicable.
Billing Code Overview
CPT code 0211U is a Proprietary Laboratory Analyses (PLA) code for the MI Cancer Seek™ – NGS Analysis from Caris MPI d/b/a Caris Life Sciences. The test includes whole exome sequencing (WES) of DNA and whole transcriptome sequencing (WTS) of RNA performed by next-generation sequencing (NGS) using a formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen.
Service type: Laboratory — molecular oncology NGS profiling (WES + WTS)
Typical site of service: Clinical laboratory or hospital outpatient setting using FFPE tumor tissue specimens
Clinical & Coding Specifications
Clinical Context
A middle-aged patient with a recently diagnosed solid organ malignancy (for example, metastatic colorectal cancer or non-small cell lung cancer) presents to oncology for molecular profiling to guide targeted therapy and potential enrollment in clinical trials. The treating oncologist orders the MI Cancer Seek™ – NGS Analysis (0211U) performed on a formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen. A pathology or interventional radiology service obtains the tissue biopsy during a prior procedure; the specimen is processed by the hospital or an external reference laboratory and shipped to Caris Life Sciences for testing.
The clinical workflow: the oncologist completes an order specifying the tumor block or unstained slides and relevant clinical history; the specimen is accessioned by the performing laboratory; DNA whole exome sequencing and RNA whole transcriptome sequencing by next-generation sequencing are performed; a comprehensive molecular report is generated identifying somatic variants, tumor mutational burden, gene expression signatures, and potential actionable targets. The report is returned to the ordering clinician to inform systemic therapy selection, targeted therapy eligibility, or clinical trial matching. Billing for the PLA test is submitted using 0211U with any applicable modifiers reflecting billing circumstance, provider component, or facility arrangements.
Coding Specifications
| Modifier | Description | When to Use |
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