Summary & Overview
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 & Coding Specifications
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 |