Summary & Overview
CPT 0362U: Thyroid GuidePx® 82‑gene Molecular Subtype Risk Assessment
CPT code 0362U is a Proprietary Laboratory Analyses (PLA) code assigned uniquely to Thyroid GuidePx® from Protean BioDiagnostics. The test performs 82-gene expression profiling on formalin–fixed paraffin–embedded (FFPE) tissue from patients with papillary thyroid cancer and uses an algorithmic classifier to assign a molecular subtype tied to recurrence risk. As a PLA code, 0362U identifies a single manufacturer’s laboratory assay and is important for tracking utilization, coverage decisions, and pricing of novel molecular diagnostics nationally.
Key payers addressed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical purpose and service context, payer coverage patterns and benchmarks, common billing and coding considerations for lab-based molecular diagnostics, and implications for clinical integration in thyroid cancer management. The publication summarizes available policy language, reimbursement trends, and typical sites of service relevant to PLA-coded tests, and highlights areas where further payer clarity or guideline alignment may affect adoption. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0362U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Thyroid GuidePx® test from Protean BioDiagnostics. The assay evaluates a formalin–fixed paraffin–embedded (FFPE) tissue specimen from a patient with papillary thyroid cancer for expression of 82 genes and uses an algorithmic analysis to classify the molecular subtype as it relates to risk of recurrence.
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Service type: Molecular diagnostic laboratory test (gene expression profiling) performed on FFPE tumor tissue
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Typical site of service: Clinical diagnostic laboratory; specimen collected in an outpatient or hospital pathology setting and sent to the performing laboratory for analysis
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult diagnosed with papillary thyroid carcinoma following thyroidectomy or diagnostic hemithyroidectomy. A formalin–fixed paraffin–embedded (FFPE) tissue block or unstained slides from the resected tumor are forwarded from the hospital pathology department to the reference laboratory performing Thyroid GuidePx® (Protean BioDiagnostics). The clinical workflow includes: specimen selection and verification by the surgical pathologist, selection of representative tumor area and macrodissection if needed, nucleic acid extraction and gene expression profiling for an 82-gene panel, and algorithmic classification to stratify molecular subtype and risk of recurrence. Results are returned to the ordering endocrinologist, endocrine surgeon, or oncologist to inform prognosis and potential surveillance intensity. Typical site of service is an outpatient pathology or reference laboratory; the test is billed by the performing laboratory using PLA code 0362U with specimen procurement occurring in the inpatient or outpatient surgical setting and prior pathology processing in a hospital or independent pathology laboratory.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard reporting when no modifier applies |
| 22 | Increased procedural services | Use if substantially greater effort was required for laboratory procedures beyond usual processing (rare for PLA) |