CPT 0630U BluePrint® Molecular Subtyping Reimbursement | OpenPayer

Summary & Overview

CPT 0630U: BluePrint Molecular Subtyping Test for Breast Cancer

CPT code 0630U identifies the BluePrint® Molecular Subtyping Test (Agendia® Inc.), a proprietary molecular diagnostic that uses mRNA gene expression profiling by microarray on FFPE breast cancer tissue to report an algorithm-derived molecular subtype index (e.g., luminal, basal, HER2). Nationally, PLA codes like 0630U are important because they capture uniquely manufactured or single-source laboratory tests with clinical implications for tumor classification and treatment planning.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical context for molecular subtyping in breast oncology, expected sites of service, and the implications of single-source PLA coding for billing and payer coverage reviews. The publication also summarizes benchmark topics, common policy considerations from major payers, and areas where payers often request clinical documentation or evidence for medical necessity.

This executive summary is written for a national audience and focuses on code definition, clinical relevance, and the payer landscape. Data not available in the input are noted where applicable in detailed sections below.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0630UCPTProprietary Laboratory Analysesmolecular diagnosticsbreast cancergene expressionFFPEmicroarrayoncology testing

Billing Code Overview

CPT code 0630U is a Proprietary Laboratory Analyses (PLA) code that applies only to the BluePrint® Molecular Subtyping Test from Agendia® Inc. The test performs messenger ribonucleic acid (mRNA) gene expression profiling by microarray to evaluate 80 genes from formalin–fixed paraffin–embedded tissue (FFPE) and reports an index that classifies a breast cancer sample into molecular subtypes such as luminal, basal, or HER2.

Service type: molecular diagnostic oncology test performed on tumor tissue using gene expression microarray and an algorithmic subtype index.

Typical site of service: clinical laboratory or reference diagnostic laboratory processing FFPE tumor specimens for oncology molecular profiling.

Clinical & Coding Specifications

Clinical Context

A 55-year-old woman with early-stage invasive breast carcinoma undergoes lumpectomy with sentinel lymph node biopsy. Histopathology confirms estrogen receptor–positive tumor, and the treating oncologist requests molecular subtyping to refine prognosis and systemic therapy planning. A formalin-fixed paraffin-embedded (FFPE) tumor block from the surgical specimen is sent to Agendia® Inc. for the BluePrint® Molecular Subtyping Test. The laboratory performs mRNA gene expression profiling by microarray on the FFPE sample, evaluates an 80-gene panel, and uses a proprietary algorithm to generate a molecular subtype index (for example, luminal, basal, or HER2). The report is returned to the ordering clinician and incorporated into multidisciplinary treatment planning.

Typical clinical workflow:

Clinician documents indication for molecular subtyping and places a lab order for the BluePrint® test.
Specimen processing staff selects an appropriate FFPE block and prepares slides/cores per lab submission requirements.
Sample is shipped to the performing laboratory (Agendia® Inc.) with required pathology report and order form.
The performing laboratory runs the proprietary microarray assay, interprets the algorithmic subtype index, and issues the test report.
The ordering clinician reviews the result and integrates the molecular subtype into prognosis discussion and therapeutic decision-making.

Coding Specifications

Modifier

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Taxonomy Code	Specialty	Notes
`207Q00000X`	Anatomic Pathology	Pathologists order, interpret, or oversee tissue-based molecular testing workflows.
`207L00000X`	Hematopathology & Oncology Pathology	Specialists involved when complex tumor profiling is required.
`2085P0200X`	Medical Oncology	Medical oncologists commonly order tumor molecular subtyping to guide systemic therapy.
`208000000X`	General Practice / Family Medicine	Primary care or surgeons may initiate ordering for referral to oncology.
`207K00000X`	Surgical Pathology	Surgical pathologists coordinate tissue selection and submission for molecular assays.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C50.911`	Malignant neoplasm of unspecified site of right female breast	Breast cancer diagnosis that warrants molecular subtyping to guide prognosis and therapy.
`C50.912`	Malignant neoplasm of unspecified site of left female breast	Breast cancer diagnosis that warrants molecular subtyping to guide prognosis and therapy.
`C50.919`	Malignant neoplasm of unspecified site of female breast, unspecified	General breast cancer diagnosis used when laterality or exact site is not specified on initial claim.
`D05.90`	Unspecified carcinoma in situ of unspecified breast	DCIS cases may undergo molecular assays when invasive potential or subtype clarification is needed.
`Z85.3`	Personal history of malignant neoplasm of breast	Used when evaluating recurrence risk or when prior breast cancer history prompts molecular profiling of a new lesion.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0630U`	BluePrint® Molecular Subtyping Test; mRNA gene expression profiling by microarray, 80 genes, algorithmic molecular subtype index	Primary PLA code representing the proprietary assay performed by Agendia® Inc.
`88305`	Level IV surgical pathology, gross and microscopic examination	Commonly billed for histopathologic examination of the excised breast tumor prior to selection of FFPE block for molecular testing.
`88141`	Cytopathology, smears, single cell, using certain automated methods (example)	May be used when cytologic samples are submitted for ancillary molecular testing (less common for BluePrint®).
`84999`	Unlisted chemistry procedure	Rarely used historically for novel assays before PLA assignment; now superseded by the PLA `0630U`.
`99000`	Handling and/or conveyance of a specimen for transfer from elsewhere to the performing laboratory (example)	Used by some facilities to bill specimen handling or courier services associated with sending FFPE blocks to reference labs.

`26`	Professional component	Use when billing only the professional interpretation component if applicable (rare for PLA tests when split billing applies).
`TC`	Technical component	Use when billing only the technical component of the test if the performing lab bills separately.
`90`	Reference laboratory	Use when the service is performed by a reference laboratory outside the billing entity.
`91`	Repeat clinical diagnostic laboratory test	Use when the exact same test is repeated on the same day to obtain a confirmatory result.
`59`	Distinct procedural service	Use when another distinct service on the same day is unrelated and needs separation from the test.
`CG`	Items or services paid under a clinical diagnostic laboratory test accessory payment mechanism	Use per payer rules when required for specific lab payment arrangements.
`RT`	Right side	Use when laterality is required by payer (not typically applicable to molecular assays but used if payer mandates).
`LT`	Left side	Use when laterality is required by payer (not typically applicable to molecular assays but used if payer mandates).
`QW`	CLIA waived test	Not generally applicable; include only if payer requires when a waived test is reported (not applicable to BluePrint®).
`XE`	Separate encounter	Use when the test was performed at a separate encounter distinct from other services that same day.