Summary & Overview
CPT 0249U: Theralink RPPA Assay for Breast Tumor Protein Analysis
CPT code 0249U represents a Proprietary Laboratory Analyses (PLA) code for the Theralink® Reverse Phase Protein Array (RPPA) assay, a laboratory-developed test that quantifies and assesses activation of 32 phosphoproteins and cell-surface receptor proteins in breast tumor tissue and delivers an algorithmic interpretive report. As a PLA code tied to a single manufacturer's assay, 0249U signals a specific, high-complexity molecular diagnostic service with potential impact on targeted therapy selection and precision oncology workflows nationally. Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will learn what CPT code 0249U denotes clinically and operationally, how payers approach coverage and billing for proprietary molecular assays, and the clinical context in which RPPA-based reports may inform treatment decisions. The publication summarizes typical sites of service and service type, lists common modifier usage where applicable, and points to the PLA nature of the code for contract and prior authorization considerations. Data not available in the input for associated taxonomies, ICD-10 diagnoses, related codes, and service-line level detail are noted where relevant.
Billing Code Overview
CPT code 0249U is a Proprietary Laboratory Analyses (PLA) code for the Theralink® Reverse Phase Protein Array (RPPA) assay by Theralink® Technologies Inc. The test evaluates a breast tumor tissue sample for the quantity and activation of 32 phosphoproteins and proteins that are cell surface receptors targeted by most cancer therapy drugs. The service includes algorithmic analysis and an interpretive report intended to help guide clinical treatment decisions.
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Service type: Laboratory molecular diagnostic assay with algorithmic interpretation
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Typical site of service: Clinical laboratory or reference diagnostic laboratory processing tumor tissue specimens
Clinical & Coding Specifications
Clinical Context
A 58-year-old woman with recently diagnosed invasive ductal carcinoma of the breast undergoes primary tumor biopsy or surgical resection. Her medical oncologist orders the Theralink® Reverse Phase Protein Array (RPPA) assay (0249U) on formalin-fixed, paraffin-embedded (FFPE) tumor tissue to quantify and evaluate activation state of 32 proteins and phosphoproteins, including cell surface receptors targeted by systemic therapies. The clinical workflow: tissue is selected and macrodissected in the pathology lab, a representative tumor block is sent to Theralink® Technologies Inc. or an authorized lab, the laboratory performs the RPPA analysis and algorithmic interpretation, and a report is returned to the ordering oncologist. The report is used as an adjunctive tool during multidisciplinary tumor board review to inform selection of targeted agents or clinical trial eligibility. Typical site of service is a hospital outpatient clinic, hospital-based pathology laboratory, or a commercial reference laboratory. Specimen collection and handling occur in surgical pathology or interventional radiology settings; the testing itself is performed in the performing laboratory.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified — not a standard CMS modifier for professional/technical separation | Data not typically used; included per input list |