CPT 0067U: BBDRisk Dx™ Breast Cancer Risk Biomarker Assay

CPT code 0067U designates the BBDRisk Dx™ Proprietary Laboratory Analyses (PLA) test from Silbiotech, Inc., a biomarker assay that estimates five-year breast cancer risk for women with specific precancerous breast lesions. As a PLA code, 0067U applies uniquely to a single manufacturer’s test and signals to payers and providers that the service is a proprietary diagnostic assay with a defined clinical purpose. Nationally, PLA codes like 0067U matter because they streamline identification of novel and company-specific laboratory diagnostics and affect coverage, coding clarity, and claims processing.

Key payers referenced in analyses include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise briefing on the clinical context of the assay, how 0067U is categorized within CPT as a PLA code, and the typical service setting for administration. The publication provides benchmarks and policy-relevant notes useful for billing and payer engagement, including common modifier usage and payer coverage coverage patterns where available. It also summarizes documentation and coding considerations relevant to laboratory and pathology service lines. Data not available in the input is clearly indicated where applicable.

Billing Code Overview

CPT code 0067U is a Proprietary Laboratory Analyses (PLA) code for the BBDRisk Dx™ assay from Silbiotech, Inc. The test is a biomarker assay intended for women with specific precancerous breast tumors to predict the likelihood of developing breast cancer within five years. This code represents a single, manufacturer-specific laboratory test covered under the PLA category.

Service Type: Biomarker assay for cancer risk prediction

Typical Site of Service: Clinical laboratory or specialized diagnostic laboratory

Clinical Context

A 52-year-old woman with a history of atypical ductal hyperplasia diagnosed on core needle breast biopsy presents for risk stratification after multidisciplinary review. Her breast surgeon or breast imaging specialist orders the BBDRisk Dx™ assay to quantify biomarker-based five-year risk of progression from specific precancerous breast lesions to invasive breast cancer. The clinical workflow: the ordering provider places the PLA test order in the electronic health record, obtains the required tissue block or unstained slides from the pathology archive, and sends the specimen to the performing laboratory designated by Silbiotech, Inc. The laboratory performs the proprietary biomarker assay and returns a structured report with a numeric and interpretive risk estimate. The ordering clinician reviews the report during a follow-up visit to inform surveillance intensity, chemoprevention discussions, or surgical planning. Typical sites of service include outpatient breast surgery clinics, breast imaging centers, hospital-based pathology services coordinating specimen release, and the performing reference laboratory.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when reporting only the professional component of a lab-related service if applicable (rare for PLA when lab performs entire test).
`TC`

Taxonomy Code	Specialty	Notes
207UX0100X	General Surgery	Breast surgeons commonly order specialized breast risk assays.
207L00000X	Pathology	Pathologists coordinate retrieval of tissue blocks and may facilitate test send-out.
207Q00000X	Radiology — Diagnostic	Breast imagers (mammography/breast MRI specialists) participate in diagnostic pathway and ordering.
364A00000X	Clinical Laboratory	Laboratory specialists perform and bill proprietary assays when acting as the performing lab.
207V00000X	Obstetrics & Gynecology	Gynecologic oncologists or OB/GYNs involved in breast risk management may order the assay.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`D05.10`	Lobular carcinoma in situ of breast, unspecified	Lobular carcinoma in situ represents a noninvasive lesion for which risk stratification assays may be considered.
`D05.11`	Lobular carcinoma in situ of breast, right breast	Side-specific LOCIS diagnosis relevant when ordering targeted specimen testing.
`D05.12`	Lobular carcinoma in situ of breast, left breast	Side-specific LOCIS diagnosis relevant when ordering targeted specimen testing.
`D07.9`	Carcinoma in situ of breast, unspecified	General in situ lesions for which a risk prediction assay may be clinically applied.
`N60.89`	Other benign mammary dysplasia	Benign proliferative breast disease (atypia) that can confer elevated risk and prompt use of BBDRisk Dx™.
`N60.11`	Solitary cyst of right breast	Example benign lesion diagnosis that may be present in the diagnostic context; included when tissue pathology demonstrates high-risk features.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0067U`	BBDRisk Dx™ — biomarker assay predicting 5-year breast cancer risk for certain precancerous breast lesions (Proprietary Laboratory Analyses)	Primary PLA code for the assay performed by Silbiotech, Inc. and billed by the performing laboratory.
`88305`	Level IV surgical pathology, gross and microscopic examination	Used for the initial pathology evaluation of breast biopsy or excision specimens from which tissue may be retrieved for PLA testing.
`88342`	Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain	May be performed in-house or by reference lab for ancillary biomarker assessment related to risk stratification.
`36415`	Collection of venous blood by venipuncture	If the assay or supporting tests require peripheral blood collection for ancillary biomarkers or germline testing coordination.
`99000`	Handling and/or conveyance of specimen for transfer to another facility	Used by facilities when specimens are sent to an external reference laboratory for the proprietary assay.

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Summary & Overview