CPT 81519 21‑Gene Recurrence Score Reimbursement

CPT code 81519 covers a multigene molecular diagnostic service that performs technical testing of 21 genes and an algorithmic analysis to produce a breast cancer recurrence score. This code represents an advanced genomic assay used to inform prognosis and treatment planning in breast cancer care. Nationally, such tests influence decisions about adjuvant therapy and contribute to precision oncology pathways, making reimbursement and coverage policies important for access and care consistency.

Key payers included in the analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of payer coverage patterns, coding and billing considerations related to molecular diagnostic and algorithmic reporting services, and clinical context for when this assay is typically ordered. The publication summarizes benchmark elements relevant to billing and claims processing for this type of laboratory service, highlights common modifiers used in reporting, and outlines implications for providers and laboratories seeking reimbursement. Data not available in the input is noted where applicable. The material is intended for a national audience of billing professionals, laboratory directors, and policy analysts seeking concise guidance on the role and billing landscape of CPT code 81519.

Billing Code Overview

CPT code 81519 describes a laboratory service in which a lab analyst performs technical testing of a 21-gene panel and applies an algorithmic analysis combining the gene test results with patient data to generate a breast cancer recurrence score. The reported result is a single, algorithm-derived recurrence score intended to inform prognosis and therapeutic decision-making for breast cancer patients.

Service Type: Multigene molecular diagnostic test with algorithmic reporting

Typical Site of Service: Clinical laboratory or reference molecular diagnostics laboratory

Clinical Context

A 55-year-old woman with newly diagnosed, early-stage, estrogen receptor–positive, HER2-negative invasive breast carcinoma undergoes lumpectomy with sentinel lymph node biopsy. Final pathology shows a 1.8 cm invasive ductal carcinoma, node-negative, and the multidisciplinary team requests genomic risk stratification to inform adjuvant chemotherapy decisions. A pathology specimen (formalin-fixed, paraffin-embedded tumor tissue) is sent to a certified molecular diagnostics laboratory. The lab analyst performs the technical assay measuring expression of 21 genes and integrates patient clinical data (tumor size, node status, ER/PR/HER2 results) with the assay results through a validated algorithm to generate a numerical recurrence score.

The clinical workflow: the clinician orders the test and attaches required clinical data and diagnosis codes. The specimen is shipped to the reference lab, accessioned, and QC performed. The technologist runs the assay, and the laboratory analyst performs the algorithmic analysis to calculate the recurrence score. Results are reported to the ordering physician and incorporated into the oncology treatment planning visit to guide adjuvant chemotherapy recommendations.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when billing only the professional component of a split service (interpretation/analysis) performed by a qualified laboratory director or pathologist.

Taxonomy Code	Specialty	Notes
207Q00000X	Anatomic and Clinical Pathology	Pathologists or laboratory directors who provide professional interpretation and validation of molecular diagnostic tests.
363L00000X	Clinical Laboratory	Clinical laboratory professionals and institutions performing the technical component and reporting test results.
207RC0000X	Hematology & Oncology	Medical oncologists who order the assay and use results for systemic therapy decisions.
207Q00000X	Molecular Pathology	Molecular pathologists who oversee assay validation and algorithmic result interpretation.
2084P0800X	General Surgery	Breast surgeons who obtain tissue specimens and coordinate testing as part of surgical care.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C50.911`	Malignant neoplasm of unspecified site of right female breast	Breast cancer diagnosis commonly associated with ordering a 21-gene recurrence assay to assess recurrence risk and chemotherapy benefit.
`C50.912`	Malignant neoplasm of unspecified site of left female breast	Same clinical relevance for left-sided invasive breast cancers where genomic risk stratification informs adjuvant therapy.
`C50.129`	Malignant neoplasm of upper-inner quadrant of left female breast	Site-specific invasive breast carcinoma codes commonly billed with genomic testing to document primary tumor site.
`C50.221`	Malignant neoplasm of central portion of right female breast	Tumor location codes included on the order to provide clinical context for molecular testing and reporting.
`Z85.3`	Personal history of malignant neoplasm of breast	May be used when assessing recurrence risk in patients with prior breast cancer; clinical context for molecular testing in select cases.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`81519`	Oncology (breast) multigene expression assay, algorithmic analysis and report (recurrence score) for 21 genes	Primary assay code describing the laboratory's algorithmic analysis and report of a 21-gene recurrence score used to guide adjuvant therapy decisions.
`88305`	Level IV surgical pathology, gross and microscopic examination	Performed by pathology to evaluate the surgical specimen; provides tissue diagnosis and selects tissue for molecular testing prior to sending to the reference lab.
`88342`	Immunohistochemistry (per single stain)	Used to report ER, PR, and HER2 immunohistochemical testing that complements the genomic assay and is part of treatment planning.
`88172`	Cytopathology, fine needle aspiration (microscopic)	If FNA is used for diagnosis or molecular testing specimen procurement; less common for this assay but part of specimen collection workflow.
`99000`	Handling and/or conveyance of specimen to a distant site (historical; use payer-specific codes)	Represents specimen handling/shipping activities to an external reference laboratory when payer requires a handling code (apply per payer guidelines).

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Summary & Overview

CPT 81519: 21-Gene Breast Cancer Recurrence Score Test