Summary & Overview
CPT 0436U: PROphet NSCLC Plasma Protein Biomarker Test
Headline: New CPT PLA Code 0436U Designates PROphet® NSCLC Test for Plasma Protein Profiling
Lead: CPT code 0436U identifies a proprietary laboratory test — the PROphet® NSCLC Test from OncoHost Inc. — that measures 388 plasma proteins and uses an algorithm to predict likely benefit from immune checkpoint inhibitor therapy in patients with non–small cell lung cancer. The designation as a PLA code signals a single‑manufacturer, single‑test billing pathway.
Why it matters: As precision oncology and immunotherapy selection evolve, standardized billing for unique, algorithm‑driven assays affects clinical adoption, coverage decisions, and laboratory reimbursement nationally. PLA coding clarifies the test’s proprietary status for payers and providers and can influence prior authorization, claims adjudication, and medical necessity reviews.
Payers covered: Analysis considers major national payers including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: This publication summarizes the clinical purpose of CPT code 0436U, typical site-of-service implications, the payer landscape relevant to single‑manufacturer biomarker tests, and the kinds of benchmarks and policy considerations that commonly accompany PLA‑coded assays. It highlights how algorithmic protein profiling is positioned in treatment decision pathways for NSCLC and outlines areas where payers often develop coverage policies or require additional clinical documentation.
Note: Data not available in the input for specific coverage decisions, coding modifiers usage beyond those listed, associated taxonomies, ICD‑10 diagnoses, related codes, and service line details.
Billing Code Overview
CPT code 0436U is a Proprietary Laboratory Analyses (PLA) code that applies only to the PROphet® NSCLC Test from OncoHost Inc. The test analyzes a plasma specimen from a patient with non–small cell lung cancer (NSCLC) to measure levels of 388 proteins and uses an algorithmic interpretation to report the probable clinical benefit from immune checkpoint inhibitor therapy such as anti–PD‑1/PD‑L1 treatments.
Service type: Laboratory — proprietary plasma protein biomarker assay with algorithmic interpretation
Typical site of service: Clinical laboratory or reference laboratory processing plasma specimens; specimen collection commonly occurs in outpatient clinics or phlebotomy sites.
Clinical & Coding Specifications
Clinical Context
A 68-year-old patient with a history of smoking presents with newly diagnosed stage IV non–small cell lung cancer (NSCLC) confirmed by tissue biopsy. The oncology team is considering first-line systemic therapy and wants to assess likelihood of benefit from immune checkpoint inhibitor therapy. A plasma specimen is drawn during an outpatient oncology visit or at a hospital outpatient laboratory and sent to the manufacturer-specific laboratory for the PROphet® NSCLC Test. The laboratory performs a high-throughput proteomic assay measuring 388 proteins and applies a proprietary algorithm to stratify probable clinical benefit from anti–PD–1/PD–L1 therapy. Results are returned to the ordering oncologist and incorporated into multidisciplinary treatment planning.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier (default) | Applied when no special circumstances affect the service; report the PLA code as usual. |
22 | Increased procedural services | Use when work or resources for specimen handling, additional documentation, or complex interpretation are substantially greater than typical. |