Summary & Overview
CPT 0250U: PGDx elio tissue complete NGS Tumor Genomic Profiling
CPT code 0250U designates a Proprietary Laboratory Analyses (PLA) test — PGDx elioTM tissue complete from Personal Genome Diagnostics Inc. — that uses next-generation sequencing (NGS) to profile formalin–fixed paraffin–embedded (FFPE) solid tumor tissue across 505+ genes for somatic mutations, indels, SNVs, and translocations. This high-complexity genomic assay supports personalized oncology care by identifying actionable variants that can inform targeted therapies and clinical trial eligibility, making it a nationally relevant code as precision oncology grows.
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 code’s clinical purpose, typical site and service type, and the payer landscape addressed in the analysis. The publication provides benchmarks and coverage context, outlines common billing modifiers and operational considerations, and summarizes clinical context for use in solid tumor management. Data not available in the input includes associated taxonomies, specific ICD-10 diagnoses, related billing codes, and service line detail.
Billing Code Overview
CPT code 0250U is a Proprietary Laboratory Analyses (PLA) code for PGDx elioTM tissue complete, a next-generation sequencing (NGS) assay from Personal Genome Diagnostics Inc. The test evaluates formalin–fixed paraffin–embedded (FFPE) solid tumor tissue across more than 505 genes to detect somatic mutations, including insertions and deletions (indels), single nucleotide variants (SNVs), and translocations, to guide treatment decisions across a broad range of solid tumor types and organ systems.
Service type: Comprehensive tumor genomic profiling using NGS
Typical site of service: Clinical laboratory performing NGS on FFPE solid tumor tissue
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a history of metastatic non-small cell lung cancer (NSCLC) presents after progression on first-line therapy. A recent tumor biopsy of a lung mass was formalin-fixed and paraffin-embedded (FFPE). The oncology team requests comprehensive genomic profiling to identify actionable somatic alterations across a broad panel of cancer genes to guide subsequent targeted therapy and immunotherapy decisions. Tissue is forwarded to the molecular pathology laboratory performing NGS-based testing.
The laboratory performs the PGDx elioTM tissue complete assay (0250U), a Proprietary Laboratory Analysis that sequences >505 cancer-associated genes from FFPE tumor tissue to detect single nucleotide variants (SNVs), insertions and deletions (indels), copy-number alterations, and structural rearrangements (translocations). A pathology review confirms tumor content and suitability for testing, DNA/RNA extraction is completed, library preparation and sequencing are performed, bioinformatics pipelines analyze variants, and a clinical report is issued to the treating oncologist describing detected alterations and their potential therapeutic relevance. Typical sites of service include hospital outpatient laboratories, independent molecular pathology laboratories, and specialized commercial reference labs. The service type is high-complexity molecular diagnostic testing (next-generation sequencing), billed as a PLA test specific to Personal Genome Diagnostics Inc.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified modifier | Rarely used; avoid unless payer requires a placeholder |
22 | Increased procedural services | Report if testing required substantially greater effort or complexity than typical due to sample quality or extensive validation steps
26 | Professional component | Use when reporting only the professional interpretation/reporting portion separate from the technical component
52 | Reduced services | Use if testing was performed but with reduced components (e.g., partial panel due to limited tissue)
53 | Discontinued procedure | Use if testing was aborted for technical reasons before meaningful analysis
62 | Two surgeons/paired providers | Not typically applicable; include only for provider-specific billing arrangements where two board-certified laboratory directors share responsibility
78 | Unplanned return to the operating/procedure room by the same physician following initial procedure | Not applicable for lab-based NGS testing; include only if clinically relevant in combined procedural settings
80 | Assistant surgeon | Not applicable for lab testing; use only if billing for an assistant in a procedural service tied to specimen collection
QK | Medical direction of two or more technicians/clinical staff | Use when a physician directs a laboratory team performing the technical assay under Medicare rules
QX | Qualified nonphysician practitioner billing | Use when a qualified nonphysician practitioner performs billable interpretation under payer rules
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Pathology | Molecular pathology and clinical laboratory oversight for NGS testing |
208000000X | Hematology/Oncology | Ordering and utilizing results for cancer treatment selection
207L00000X | Anatomic Pathology | Tissue handling, pathology review, and ensuring specimen adequacy
2086S0102X | Medical Oncology | Oncology subspecialty focused on systemic therapy decisions informed by NGS
363L00000X | Laboratory Director | Clinical laboratory medical director responsible for test validation and reporting
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Represents primary lung cancer cases commonly subjected to broad NGS profiling to identify actionable mutations |
C78.7 | Secondary malignant neoplasm of liver and intrahepatic bile duct | Metastatic sites often sampled for molecular profiling when primary tumor tissue is unavailable
C50.919 | Malignant neoplasm of unspecified site of unspecified breast | Breast cancers frequently undergo multigene somatic testing for targeted therapy selection
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancers are commonly tested for multiple somatic alterations including RAS, BRAF, and MSI status
C61 | Malignant neoplasm of prostate | Advanced prostate cancers may undergo broad-panel NGS to identify actionable genomic changes
C80.1 | Malignant (primary) neoplasm, unspecified | Used when a confirmed malignancy lacks a more specific site code but tissue-based genomic profiling is indicated
D78.3 | Tumor of uncertain behavior, connective and other soft tissue | Selected soft tissue tumors may be profiled to clarify diagnosis and guide targeted therapies
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Pathologist review and initial diagnosis of the FFPE tumor specimen before NGS testing |
88342 | Immunohistochemistry, per single antibody stain | May be used to assess protein expression (e.g., PD-L1) on the same specimen to complement genomic results
81210 | EGFR gene analysis — sequence analysis of an oncogene (example single-gene test) | Single-gene or small-panel tests that may be ordered prior to or instead of broad NGS panel; related clinically when reflex testing strategy is used
81445 | Oncology (solid organ) panel, 5-50 genes | Smaller targeted NGS panels that may be performed instead of or prior to a large-panel PLA like 0250U
99000 | Handling and/or conveyance of a specimen for transport to another facility | Administrative/transport codes sometimes used when sending FFPE blocks or slides to an external reference laboratory for 0250U testing