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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0211UCPTProprietary Laboratory AnalysesNGSwhole exome sequencingwhole transcriptome sequencingmolecular oncologyFFPE tumor tissue

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

00

Taxonomy Code	Specialty	Notes
`207RG0200X`	Medical Oncology	Ordering clinician for systemic therapy decisions and targeted therapy selection
`2085R0202X`	Molecular Genetic Pathology	Directs test selection, interpretation, and complex molecular pathology oversight
`207L00000X`	Pathology	Oversees tissue processing, accessioning, and coordination with reference laboratory
`363A00000X`	Clinical Laboratory	Performs high-complexity testing and NGS operations within the laboratory setting
`207T00000X`	Hematology/Oncology (if applicable)	Oncology subspecialist ordering tumor profiling for hematologic malignancies

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C78.7`	Secondary malignant neoplasm of liver and intrahepatic bile duct	Used when tumor has metastasized to the liver and molecular profiling is ordered to guide systemic therapy
`C34.90`	Malignant neoplasm of unspecified part of bronchus or lung, unspecified	Common primary diagnosis prompting comprehensive genomic profiling for non-small cell lung cancer
`C18.9`	Malignant neoplasm of colon, unspecified	Colorectal primary where tumor sequencing identifies actionable mutations or MSI status
`C50.912`	Malignant neoplasm of unspecified site of right breast	Breast cancer cases may undergo comprehensive RNA/DNA profiling for targeted therapy and trial eligibility
`C61`	Malignant neoplasm of prostate gland	Advanced prostate cancer may be tested for genomic alterations relevant to therapy decisions
`D49.1`	Neoplasm of uncertain behavior of bone, connective tissue and skin	Used when tumor behavior is uncertain and molecular profiling assists diagnostic classification
`Z85.118`	Personal history of malignant neoplasm of skin of other and unspecified parts of face	History codes used when prior malignancy informs current molecular testing strategy
`Z85.3`	Personal history of malignant neoplasm of breast	Used in longitudinal care when prior cancer history factors into current testing and therapy planning

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0211U`	MI Cancer Seek™ – NGS Analysis; whole exome sequencing of DNA and whole transcriptome sequencing of RNA from FFPE tumor tissue	Primary PLA code used to bill the comprehensive tumor DNA/RNA NGS assay performed by Caris Life Sciences
`88305`	Level IV surgical pathology, gross and microscopic examination	Performed by pathology for initial tumor biopsy review and diagnosis prior to sending specimen for molecular testing
`88342`	Immunohistochemistry, per single antibody stain	Performed on tumor tissue to support diagnosis or biomarker assessment that may accompany molecular testing
`81275`	EGFR gene analysis (if applicable)	Single-gene or panel testing that may be ordered in addition to or prior to comprehensive NGS for specific actionable mutations
`81599`	Unlisted molecular pathology procedure	Rarely used as a placeholder when reporting molecular tests not otherwise specified; not appropriate if PLA `0211U` is available
`88360`	Morphometric analysis; immunohistochemical (IHC) semiquantitative image analysis	May be used when image analysis supports interpretation of molecular results and biomarker quantification