Summary & Overview
CPT 0045U: Oncotype DX Breast DCIS Score Test
CPT code 0045U designates the Oncotype DX® Breast DCIS Score™ test, a proprietary laboratory assay that measures expression of 12 genes and uses an algorithm to generate a recurrence score for ductal carcinoma in situ of the breast. As a PLA code, 0045U is specific to a single manufacturer’s test and signals use of a commercial genomic assay with analytic and clinical interpretation performed by a reference laboratory. Nationally, PLA codes like 0045U matter because they affect coverage, coding clarity, and pricing dynamics for precision oncology diagnostics.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context for DCIS recurrence scoring, payer coverage relevance, and the types of benchmarks and policy topics typically associated with proprietary genomic tests. The publication outlines benchmarking and reimbursement themes, insurer policy considerations for PLA codes, and the clinical workflow implications of algorithm-based lab reporting. It also identifies where input data is unavailable for detailed payer-specific rates or associated billing line details. This piece is intended for clinicians, coding staff, laboratory managers, and policy analysts seeking a national-level summary of CPT code 0045U and its role in breast DCIS molecular testing.
Billing Code Overview
CPT code 0045U is a Proprietary Laboratory Analyses (PLA) code for the Oncotype DX® Breast DCIS Score™ test from Genomic Health, Inc. The code applies to a single, unique laboratory test in which a lab analyst performs technical testing of 12 genes and executes an algorithmic analysis combining patient data with laboratory results to produce a patient recurrence score for ductal carcinoma in situ (DCIS) of the breast.
Service type: Proprietary molecular diagnostic laboratory test with algorithmic analysis
Typical site of service: Clinical reference laboratory or specialized molecular diagnostics laboratory (remote specimen processing and analysis)
Data not available in the input for associated taxonomies, ICD-10 diagnoses, related codes, and service line.
Clinical & Coding Specifications
Clinical Context
A typical patient is a woman recently diagnosed with ductal carcinoma in situ (DCIS) following screening mammography and core needle breast biopsy. Surgical pathology confirms DCIS without invasive carcinoma. The treating breast surgeon and medical oncology team order the Oncotype DX® Breast DCIS Score™ to quantify the genomic risk of local recurrence and to aid decisions about adjuvant radiation therapy after breast-conserving surgery. The specimen (formalin-fixed, paraffin-embedded tumor block or unstained slides) is sent to the performing laboratory with the completed requisition. The laboratory analyst performs extraction and quantitative molecular assays for the panel of 12 genes, executes the proprietary algorithm, and reports a recurrence score. Results are returned to the ordering provider and incorporated into multidisciplinary treatment planning and shared decision-making for radiation and follow-up intensity.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifiers | When no modifier applies and standard billing is appropriate |
11 | Professional component | When reporting the professional interpretation component separately (if applicable) |