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 | Unspecified | Rarely used; reserved when no other modifier applies and payer requires explicit code |
11 | Regular decision | Use when service is performed as scheduled, routine molecular test submission |
22 | Increased procedural services | Use if laboratory documents substantially greater complexity or work than usual (rare for PLA) |
26 | Professional component | Use when reporting only the professional component of a test (interpretation) if separated by payer |
52 | Reduced services | Use if specimen collection or processing was partially performed or truncated |
53 | Discontinued procedure | Use if specimen collection was attempted but aborted for documented clinical reasons |
62 | Two surgeons | Generally not applicable; include only if two providers of record share significant work |
78 | Return to operating/procedure room | Use if test-related complication requires return for procedural management (rare) |
80 | Assistant surgeon | Use if an assistant participated in specimen collection and payer requires reporting |
82 | Assistant surgeon (when qualified assistant not available) | Same context as 80 if appropriate documentation exists |
AD | Medical supervision by a physician (teaching setting) | Use when physician supervised a trainee who performed collection and payer requires the modifier |
QK | Medical direction of two, three or four technicians | Use if a physician directs multiple non-physician staff during specimen collection/processing and payer recognizes QK for laboratory context |
QX | Services performed by a qualified non-physician under a physician's supervision | Use when a nurse or medical assistant performs the adhesive patch collection under physician supervision |
TC | Technical component | Use when reporting only the technical component (laboratory processing) if payer requires separation |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208000000X | Dermatology | Primary specialty ordering and performing lesion evaluation and patch collection |
| 207P00000X | Pathology | Laboratory oversight and interpretation of molecular diagnostic reports when pathologist signs out results |
| 208D00000X | Dermatopathology | Specialist involvement when molecular results are correlated with histopathology after biopsy |
| 363L00000X | Clinical Laboratory | Laboratory personnel and molecular diagnostics labs performing RT-qPCR analysis |
| 1223P0001X | Nurse Practitioner | Frequently performs clinic assessment and patch specimen collection under supervising dermatologist |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
D22.9 | Melanocytic nevus, unspecified | Common benign pigmented lesion that may be clinically equivocal and tested to exclude melanoma |
D03.9 | Melanoma in situ, unspecified | Relevant when PLA is positive or suspicion for early melanoma exists guiding biopsy decisions |
C43.9 | Malignant melanoma of skin, unspecified | High-concern diagnosis the PLA aims to detect or help triage toward biopsy |
L81.4 | Lentigo, solar | Pigmented lesion subtype that can mimic melanoma clinically and prompt molecular testing |
R23.0 | Palpable mass of skin | Nonspecific skin mass descriptor used when documenting a suspicious lesion prior to testing |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0089U | Pigmented Lesion Assay (PLA) — RT-qPCR of PRAME and LINC00518 on stratum corneum collected by adhesive patch (proprietary laboratory analysis) | The primary PLA molecular test performed on adhesive patch specimens to assist in melanoma risk assessment |
11102 | Tangential biopsy of skin (e.g., shave), single lesion | Performed when clinical or molecular results prompt immediate tissue removal for histopathology |
11300 | Shaving of benign lesion; single lesion | May be used for removal of small benign-appearing lesions during clinic visit if indicated |
11600 | Excision, benign lesion including margins, trunk, arms or legs; simple closure | Used for excisional biopsy or definitive removal following positive PLA or concerning clinical findings |
88305 | Level IV surgical pathology, gross and microscopic examination | Histopathology reporting code commonly used when an excisional or incisional biopsy specimen is submitted after PLA-guided decision-making |