Summary & Overview
CPT 0444U: Aventa FusionPlus™ NGS 361-Gene Solid Tumor Panel
CPT code 0444U designates a proprietary next-generation sequencing (NGS) targeted panel — Aventa FusionPlus™ from Aventa Genomics — that evaluates DNA from formalin-fixed, paraffin-embedded tumor tissue across 361 genes linked to solid-organ neoplasms. As a PLA code, 0444U is specific to a single manufacturer's test and signals precision oncology testing that can inform molecular diagnosis, tumor profiling, and potential therapeutic decision-making. Nationally, PLA codes like 0444U matter because they standardize reporting for unique commercial assays and affect coverage pathways, prior authorization workflows, and claim adjudication for advanced molecular diagnostics.
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 test's clinical purpose and technical scope, a summary of payer coverage considerations and typical sites of service, and benchmarks or policy context relevant to proprietary NGS assays. The publication will also highlight common modifier usage and identify gaps where input data were not provided. This material is intended to inform billing, coding, and policy teams managing claims and coverage for high-complexity, tumor-based NGS panels.
Billing Code Overview
CPT code 0444U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Aventa FusionPlus™ test from Aventa Genomics. The test uses next-generation sequencing (NGS) targeted sequence analysis to evaluate DNA from a formalin-fixed, paraffin-embedded tumor tissue sample for a panel of 361 genes associated with solid-organ neoplasms.
Service Type: Laboratory — Molecular Pathology / NGS Targeted Panel
Typical Site of Service: Clinical laboratory or reference molecular diagnostics laboratory, with specimen originating from hospital, outpatient clinic, or pathology service
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
Clinical & Coding Specifications
Clinical Context
A 64-year-old patient with a newly diagnosed metastatic colorectal adenocarcinoma undergoes tumor biopsy. The treating oncologist orders comprehensive genomic profiling to identify actionable somatic alterations that guide targeted therapy and clinical trial eligibility. Formalin-fixed, paraffin-embedded (FFPE) tumor tissue from the biopsy is sent to the reference laboratory that performs the Aventa FusionPlus™ assay. The laboratory uses next-generation sequencing (NGS) targeted panel analysis of 361 cancer-associated genes to detect single nucleotide variants, insertions/deletions, copy number alterations, and gene fusions relevant to solid-organ neoplasms. The clinical workflow includes: tissue accessioning and pathology review for tumor content, nucleic acid extraction, library preparation, sequencing, bioinformatic analysis, variant interpretation by molecular pathologists, and a final report returned to the ordering oncologist to inform systemic therapy selection, targeted agents, and clinical trial matching.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard use when no modifier applies |
22 | Increased procedural services | Use when additional work or complexity in laboratory processing or interpretation is documented beyond typical assay performance |
26 | Professional component | Use when billing only the professional interpretation/reporting component separate from technical laboratory processing |
52 | Reduced services | Use when the test is partially performed or a limited panel was completed and documented |
53 | Discontinued procedure | Use if testing was started but discontinued for documented reasons (e.g., insufficient tissue) |
62 | Two surgeons/dual operator | Rare for laboratory testing; use only if billing rules require reporting dual-operator oversight in a hybrid facility setting and documentation supports it |
78 | Return to operating/procedure room for related procedure | Not typically applicable; include only when a documented return for additional tissue collection occurs and insurer requires modifier reporting |
80 | Assistant at surgery | Not typically applicable; use only if facility billing requires an assistant modifier tied to specimen procurement documentation |
82 | Assistant (when qualified resident not available) | As above, use only when applicable to specimen procurement billing requirements |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery | Generally not used for lab test billing; include only if payer requires linkage to specimen collection by allied provider |
QK | Medical direction of two, three or four concurrent anesthesia procedures | Not applicable to lab assay; include only if billing bundle requires anesthesia-related modifiers for the visit during specimen collection |
QX | CRNA service with medical direction | Not applicable to lab assay; include only when tied to specimen collection visit with CRNA involvement and required by payer |
QY | Medical direction of one CRNA by an anesthesiologist | Not applicable to lab assay; include only when required by payer for the procedural visit |
TC | Technical component | Use when billing only the technical component (laboratory processing, sequencing, and data generation) separate from professional interpretation |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208000000X | Hematology & Oncology | Oncologists order genomic profiling and interpret results for therapy selection |
| 207P00000X | Anatomic Pathology | Pathologists perform tumor content assessment and oversee preanalytic tissue handling |
| 208100000X | Medical Oncology | Medical oncologists coordinate testing for systemic therapy decisions |
| 208600000X | Molecular Genetic Pathology | Specialists in molecular diagnostics interpret NGS results and sign reports |
| 363L00000X | Clinical Laboratory | Laboratory directors and personnel perform technical sequencing and assay validation |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C18.9 | Malignant neoplasm of colon, unspecified | Common primary tumor where comprehensive NGS can identify actionable mutations for targeted therapy |
C50.912 | Malignant neoplasm of unspecified site of left female breast | Breast cancers frequently undergo genomic profiling for therapy selection and clinical trial eligibility |
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Non–small cell lung cancers often require broad NGS panels to detect driver mutations and fusions |
C61 | Malignant neoplasm of prostate | Advanced prostate cancers may undergo genomic testing to identify actionable alterations and homologous recombination deficiency |
C71.9 | Malignant neoplasm of brain, unspecified | Select central nervous system tumors may be profiled to identify targetable mutations or biomarkers |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Performed by pathology to examine biopsy specimens and determine tumor content before sending tissue for NGS |
88342 | Immunohistochemistry (IHC) for one marker | Used when reflex IHC (e.g., mismatch repair proteins) is performed on the same FFPE block to guide molecular testing strategy |
88360 | Morphometric analysis or computer-assisted image analysis | Occasionally used to quantify tumor cellularity to confirm adequacy for NGS input |
0008M | Molecular pathology procedure; interpretation and report of DNA sequencing (e.g., targeted) | Other molecular assay codes commonly accompany reporting and interpretation workflows; used when separate molecular interpretation services are billed |
G0452 | Cancer gene panel analysis for targeted high throughput sequencing | Alternative or complementary panel-level codes used by some payers for large genomic panels; relates as a comparable panel service in the workflow |