Summary & Overview
CPT 0479U: ALZpath pTau217 Blood Biomarker Test
CPT code 0479U designates a Proprietary Laboratory Analyses (PLA) test for ALZpath pTau217, a blood assay that quantifies phosphorylated tau protein as a biomarker of Alzheimer’s disease. As a PLA code, 0479U applies only to the specific test produced by Neurocode USA Inc. and Quanterix/ALZpath, and it standardizes reporting for a single proprietary assay. Nationally, blood-based pTau217 testing is notable for its potential to expand access to Alzheimer’s biomarker assessment outside specialized centers and to influence diagnostic pathways and care planning.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of payer coverage posture, common clinical contexts for test utilization, and how the PLA designation affects coding clarity. The publication also summarizes available benchmark considerations, common modifiers used with laboratory billing, and the clinical relevance of pTau217 measurement for Alzheimer’s disease evaluation.
The piece is intended to inform billing staff, laboratory directors, and policy analysts about the code’s scope, service setting, and the implications of a single-manufacturer PLA code on billing consistency and payer communications.
Billing Code Overview
CPT code 0479U is a Proprietary Laboratory Analyses (PLA) code assigned specifically for the ALZpath pTau217 blood test developed by Neurocode USA Inc. and Quanterix/ALZpath. The test measures levels of phosphorylated tau protein (pTau217) in blood, a biomarker used in the evaluation of Alzheimer’s disease pathology.
Service type: Proprietary laboratory blood biomarker test
Typical site of service: Clinical laboratory or reference laboratory; specimen collection typically occurs in outpatient phlebotomy or clinic settings.
Clinical & Coding Specifications
Clinical Context
A typical patient is an older adult referred by a neurologist or memory clinic for blood-based biomarker testing to assist in the evaluation of cognitive decline and suspected Alzheimer’s disease. The patient presents with progressive short-term memory loss, difficulty with complex tasks, and a clinical exam suggesting mild cognitive impairment or early dementia. The clinician orders the proprietary plasma phosphorylated tau 217 assay (0479U - ALZpath pTau217) as part of a diagnostic workup.
The clinical workflow: the patient undergoes venipuncture in an outpatient infusion center, physician office, or hospital outpatient laboratory. A serum or plasma sample is collected, processed per the manufacturer's instructions, and shipped to the performing laboratory (Neurocode USA Inc. or Quanterix/ALZpath) with chain-of-custody and required documentation. The laboratory performs the proprietary assay and returns a quantitative pTau217 result with interpretive guidance. The ordering clinician integrates the pTau217 level with clinical assessment, neuropsychological testing, neuroimaging (when available), and other biomarkers to inform diagnosis and counseling. Billing for the proprietary laboratory analysis is reported using 0479U with applicable place-of-service and payer requirements observed.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 |