Summary & Overview
CPT 0478U: Lung HDPCR™ NSCLC DNA/RNA Mutation Panel
CPT code 0478U designates a proprietary, single-source molecular diagnostic—Lung HDPCR™ from Protean BioDiagnostics—that detects DNA and RNA alterations across nine genes in non–small cell lung cancer (NSCLC) tissue using digital PCR. As a PLA code, 0478U identifies a specific manufacturer’s test and is used for reporting the unique assay nationally. This code matters because targeted mutation detection in NSCLC can directly influence systemic therapy selection and enrollment in biomarker-driven care pathways.
Key payers in coverage discussions include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical purpose of the assay, the service setting and typical laboratory workflow, and the payer landscape covered in this analysis. The publication outlines benchmarks and payment context for proprietary molecular tests, summarizes relevant policy considerations for payer coverage and coding, and provides clinical context on how a nine-gene digital PCR panel fits into precision oncology practice.
This national summary is intended for clinicians, laboratory billing staff, and policy professionals seeking a concise reference on the code meaning, common sites of service, and the payer mix addressed in the report. Data not available in the input: detailed payer-specific coverage determinations, associated taxonomies, ICD-10 diagnoses, related and ancillary billing codes, and service line billing elements.
Billing Code Overview
CPT code 0478U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Lung HDPCR™ test from Protean BioDiagnostics. The test analyzes DNA and RNA from non–small cell lung cancer tissue to detect mutations in nine genes using digital PCR, identifying variants that can guide therapy selection.
Service Type: Molecular pathology / tumor mutation profiling
Typical Site of Service: Clinical laboratory or hospital outpatient laboratory
Clinical & Coding Specifications
Clinical Context
A 67-year-old patient with a history of smoking and a newly diagnosed pulmonary mass undergoes bronchoscopy with biopsy. Pathology confirms non–small cell lung carcinoma (NSCLC). The treating oncologist orders 0478U (Lung HDPCR™ from Protean BioDiagnostics) on formalin-fixed paraffin-embedded tumor tissue to evaluate DNA and RNA for actionable driver mutations across nine genes using digital PCR. The laboratory performs nucleic acid extraction, targeted high-definition digital PCR analysis, and a report indicating detected variants and allele frequencies to guide selection of targeted therapies or eligibility for clinical trials. Typical workflow steps include: specimen receipt and accessioning, verification of tumor content and sample adequacy, extraction of DNA/RNA, running the Lung HDPCR™ assay, bioinformatic/interpretive review, and issuance of a molecular report to the ordering oncologist. Typical site of service is an outpatient hospital-based pathology laboratory or independent clinical molecular diagnostic laboratory performing PLA tests. Common clinical actions following results are therapy selection (e.g., targeted agents), reflex confirmatory testing or additional comprehensive genomic profiling, and molecular tumor board review when needed. Common modifiers that may accompany billing are 00, 22, 52, 53 to indicate standard, increased complexity, reduced services, or discontinued procedures respectively.
Coding Specifications
| Modifier | Description | When to Use |
|---|