Summary & Overview
CPT 0089U: Pigmented Lesion Assay (RTqPCR) for PRAME and LINC00518
CPT code 0089U designates the DermTech Pigmented Lesion Assay (PLA), a proprietary RTqPCR gene expression test performed on stratum corneum samples collected with an adhesive patch to detect and quantify PRAME and LINC00518, genes associated with melanoma. As a PLA code, 0089U applies to a single manufacturer's test and signals a growing role for noninvasive molecular diagnostics in dermatology and skin cancer detection. Nationally, the code matters for payers, health systems, and dermatology practices evaluating coverage, utilization, and clinical integration of adhesive-patch molecular testing.
Key payers covered in the analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication reviews payer coverage considerations and how these payers approach molecular diagnostic laboratory tests used to triage suspicious pigmented lesions.
Readers will learn: clinical context for the Pigmented Lesion Assay and its specimen collection method; the service type and typical sites of service; expected documentation and coding practice when reporting PLA testing using 0089U; and where to find policy and reimbursement updates relevant to PLA proprietary codes. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0089U is a Proprietary Laboratory Analyses (PLA) code for the Pigmented Lesion Assay (PLA) test manufactured by DermTech. The test uses RTqPCR molecular analysis of gene expression performed on stratum corneum tissue collected with an adhesive patch applied to suspicious pigmented skin lesions to identify and quantify the genes PRAME and LINC00518, biomarkers associated with melanoma.
Service Type: Molecular diagnostic laboratory test (RTqPCR gene expression assay)
Typical Site of Service: Clinical laboratory or outpatient dermatology setting where adhesive patch specimen collection and specimen handling for molecular analysis occur
Clinical & Coding Specifications
Clinical Context
A middle-aged adult presents to a dermatology clinic with a solitary, clinically atypical pigmented skin lesion noted on the forearm. The lesion has irregular borders and recent change in color reported by the patient. A full skin exam is completed and dermoscopic evaluation is performed. Because the lesion is equivocal for melanoma but not clearly malignant on clinical and dermoscopic exam, the dermatologist offers a noninvasive molecular triage test to help guide management. The clinician applies an adhesive epidermal patch to collect stratum corneum cells from the suspicious lesion, labels and ships the specimen to the proprietary laboratory (DermTech) for the Pigmented Lesion Assay (PLA) which uses RT-qPCR to quantify expression of PRAME and LINC00518. Results returned from the laboratory report presence or absence of gene expression patterns associated with increased melanoma risk. A positive PLA result supports excisional biopsy or referral for surgical management; a negative result may support continued observation and documentation in the medical record. Typical documentation includes lesion location, size, clinical impression, informed consent for testing, specimen collection details, and the lab report results. Typical sites of service: outpatient dermatology clinic, ambulatory surgical center for procedural visits, or dermatologist office. Service type: molecular diagnostic laboratory test (Proprietary Laboratory Analysis). Typical patient scenario: adult with a solitary clinically suspicious pigmented lesion where noninvasive molecular testing is used to triage need for biopsy.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 |