Summary & Overview
CPT 0499U: OptiSeq Dual Cancer Panel NGS for FFPE Tumor Tissue
CPT code 0499U designates the OptiSeq™ Dual Cancer Panel Kit from DiaCarta Inc., a Proprietary Laboratory Analyses (PLA) test that uses next-generation sequencing (NGS) of DNA from formalin-fixed paraffin-embedded (FFPE) tissue to detect mutations in eight genes linked to colorectal and lung cancers. As a PLA code, 0499U is specific to a single manufacturer’s test and is used for precise identification in claims and policy documents.
Key payers addressed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare and Medicare. The code’s PLA status affects coverage reviews, medical necessity assessment, and coding specificity because payers often evaluate proprietary tests individually for clinical utility and billing policy.
Readers will find a concise briefing on the clinical context of targeted NGS panels for oncology, how 0499U is reported in claims, and the implications of PLA coding for national coverage considerations. The publication outlines typical sites of service, commonly reported modifiers, and the operational context for labs and pathology departments. It also summarizes benchmarking and policy themes relevant to proprietary molecular diagnostics, including payer review processes and considerations that influence claim adjudication and coding consistency.
Billing Code Overview
CPT code 0499U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the OptiSeq™ Dual Cancer Panel Kit from DiaCarta Inc. The test uses next-generation sequencing (NGS) to analyze DNA from formalin-fixed paraffin-embedded (FFPE) tissue samples to detect mutations in eight genes associated with colorectal and lung cancers.
Service type: Laboratory molecular diagnostic test (NGS oncology panel)
Typical site of service: Clinical laboratory or hospital pathology/laboratory department
Clinical & Coding Specifications
Clinical Context
A 64-year-old patient with a history of smoking and a newly identified pulmonary mass on chest imaging undergoes diagnostic tissue biopsy. Formalin–fixed paraffin–embedded (FFPE) tumor tissue from the biopsy is submitted to the molecular pathology laboratory for genomic profiling using the OptiSeq™ Dual Cancer Panel Kit. The test performs next-generation sequencing (NGS) on extracted DNA to detect clinically actionable mutations across eight genes associated with colorectal and lung cancers to inform targeted therapy selection and clinical trial eligibility. Typical workflow: tissue receipt and accessioning → pathologist review and tumor content assessment → DNA extraction from FFPE block or unstained slide → library preparation using the OptiSeq™ kit → sequencing and bioinformatic analysis → generation of a molecular report with detected variants and technical metrics. Typical site of service: hospital outpatient laboratory, independent diagnostic laboratory, or hospital pathology department. Service type: Proprietary Laboratory Analysis (PLA) molecular diagnostic NGS assay performed on FFPE tissue.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Applies when no specific modifier is required; use per payer rules. |
22 |