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 | Increased procedural services | Use if laboratory performs substantially greater effort or complexity documented (rare for PLA lab tests; applicable when add‑on work documented). |
26 | Professional component | Use when billing only the professional interpretation/reporting component separate from technical testing, if payer allows split billing. |
52 | Reduced services | Use if testing was partially completed and reduced in scope with documentation (e.g., limited analysis performed). |
53 | Discontinued procedure | Use when test processing was started but discontinued for documented clinical reasons. |
62 | Two surgeons (or practitioners) | Use when two qualified providers share responsibility for services requiring split billing; rarely applicable to lab testing but available for interpreted components when applicable. |
78 | Return to the operating/procedure room for a related procedure by the same physician | Uncommon for laboratory services; used only if a subsequent related invasive procedure occurs and affects specimen processing. |
80 | Assistant surgeon | Rare for lab testing; used only for procedures requiring assistant involvement if billing a professional surgical component. |
82 | Assistant surgeon (when qualified resident not available) | Same context as 80; rarely applicable to molecular testing. |
QK | Medical direction of two, three, or four concurrent anesthesia procedures involving qualified individuals | Not typically applicable to PLA testing but listed among available modifiers; include only per payer guidance if relevant. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Anatomic and Clinical Pathology (AP/CP) | Pathologists who oversee test validation, interpretation, and reporting. |
207LP0001X | Laboratory Director | Medical directors or pathologists responsible for laboratory operations and quality. |
207U00000X | Molecular Genetic Pathology | Specialists in molecular diagnostics who interpret NGS results. |
208000000X | Medical Oncology | Ordering clinicians who request molecular testing to guide systemic therapy. |
207L00000X | Clinical Laboratory Services | Clinical laboratory technologists and directors performing testing workflow. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Common diagnosis prompting tumor tissue molecular profiling for targeted therapy decisions. |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancers frequently undergo targeted NGS panels to identify actionable mutations. |
C19 | Malignant neoplasm of rectosigmoid junction | Rectosigmoid tumors are included in colorectal panels when tissue is available for molecular testing. |
Z85.118 | Personal history of other malignant neoplasm of bronchus and lung | Used when prior lung cancer history influences current molecular testing strategy. |
R91.8 | Other nonspecific abnormal finding of lung field | Radiologic findings that prompt biopsy and subsequent molecular profiling. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Used for initial histopathologic diagnosis and tumor confirmation before molecular testing; tissue must be evaluated to ensure adequate tumor content. |
88112 | Cytopathology, cell block preparation | Applies when cytology specimens are converted to cell blocks for FFPE processing prior to NGS. |
81162 | BRCA1 and BRCA2 full sequence analysis (example of single-gene NGS) | Represents other molecular sequencing tests that may be ordered alongside or instead of a targeted PLA panel; illustrates single‑gene NGS testing workflow. |
0022U | Example PLA code for another vendor-specific NGS assay (illustrative) | Other Proprietary Laboratory Analyses may be performed concurrently for broader genomic profiling or confirmation; billed separately when applicable. |
GENERIC | Technical component billing (TC) and professional component (26) split | Represents billing practice where the laboratory bills the technical component and the interpreting clinician bills the professional component; use modifiers TC and 26 accordingly per payer rules. |