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) |
26 | Professional component | When only the physician professional component is reported for the test (rare for PLAs) |
52 | Reduced service | When the laboratory performs a reduced test or partial testing due to specimen limitations |
53 | Discontinued procedure | If testing cannot be completed because the specimen is inadequate and work stopped |
62 | Two surgeons | Not commonly used for lab tests; included when two surgeons share responsibility in the episode of care |
78 | Unplanned return to the operating room | Not typically applicable to the lab assay itself but may apply to related operative care |
80 | Assistant surgeon | Not applicable to the lab test; used when an assistant surgeon participates in the operative episode |
QK | Medical direction of two or more assistants | Not typically used for this lab test; applies to surgical assistants |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RP0000X | Surgical Oncology | Ordering surgeon frequently involved in decision to order DCIS Score™ |
207Q00000X | General Surgery | Breast surgeons commonly order the assay |
207RC0000X | Medical Oncology | Medical oncologists interpret recurrence risk for adjuvant therapy planning |
2085P0202X | Pathology | Surgical pathologists handle specimen submission and correlation |
3336C0003X | Molecular Diagnostic Laboratory | Laboratory specialists perform the assay and reporting |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
D05.10 | Lobular carcinoma in situ of breast, unspecified breast | LCIS is a noninvasive lesion; genomic assays are typically for DCIS rather than LCIS but may be considered in differential diagnosis contexts |
D05.11 | Lobular carcinoma in situ of right breast | Laterality coding for in situ lesions when relevant to specimen and billing |
D05.12 | Lobular carcinoma in situ of left breast | Laterality coding for in situ lesions when relevant to specimen and billing |
D05.90 | Unspecified intraductal carcinoma in situ of breast, unspecified breast | General code for DCIS when laterality or anatomic detail is not specified; directly relevant indication for the DCIS Score™ |
D05.91 | Unspecified intraductal carcinoma in situ of breast, right breast | Specific laterality for DCIS; commonly used on orders for the Oncotype DX® DCIS test |
D05.92 | Unspecified intraductal carcinoma in situ of breast, left breast | Specific laterality for DCIS; commonly used on orders for the Oncotype DX® DCIS test |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Surgical pathology reported after biopsy or lumpectomy provides diagnosis of DCIS and material for the assay |
88185 | Cytopathology, cell block preparation; immunocytochemistry or special stains (per specimen) | Ancillary pathology procedures possible during diagnostic workup prior to ordering molecular assay |
88342 | Immunohistochemistry or immunocytochemistry, each antibody stain | IHC stains (e.g., ER/PR, Her2) commonly performed as part of tumor characterization before genomic testing |
0045U | Oncotype DX® Breast DCIS Score™ (Proprietary Laboratory Analyses) | The PLA code describing the genomic assay performed by the reference laboratory to generate a DCIS recurrence score |
88360 | Morphometric analysis (e.g., image analysis), per specimen | Digital image analysis may be used by pathology labs as part of specimen evaluation feeding into test selection |