Summary & Overview
CPT 0412U: PrecivityAD® Plasma Beta-Amyloid and ApoE Phenotype Assay
CPT code 0412U designates the PrecivityAD® proprietary blood test from C2N Diagnostics LLC, a laboratory-based assay that quantifies plasma beta-amyloid 40 and 42 and identifies ApoE protein phenotype, producing an algorithmic probability score for cerebral amyloid plaque consistent with Alzheimer’s disease. As a PLA code, 0412U is specific to a single manufacturer’s test and is used for reporting this unique biomarker service nationally. The code matters because blood-based biomarkers are changing diagnostic pathways for Alzheimer’s disease, potentially affecting utilization, coverage policies, and access to diagnostic services.
Key payers in scope include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a compact review of what the code represents, expected service settings, and the clinical context for its use. The publication will also summarize payer coverage considerations and benchmarking where available, outline common billing modifiers associated with laboratory and professional components, and note gaps where data are not provided.
The content is written for a national audience and focuses on clinical and billing context rather than state-specific policy. Data not provided in the input is noted as unavailable.
Billing Code Overview
CPT code 0412U is a Proprietary Laboratory Analyses (PLA) code for the PrecivityAD® blood test from C2N Diagnostics LLC. The test uses liquid chromatography with tandem mass spectrometry (LC–MS/MS) to measure plasma beta-amyloid 40 and 42 levels and to determine the patient’s apolipoprotein E (ApoE) protein phenotype. An algorithmic analysis of these biomarkers produces a probability score that indicates the likelihood of amyloid plaque presence associated with Alzheimer’s disease.
Service type: Laboratory test — proprietary plasma biomarker assay with algorithmic interpretation
Typical site of service: Clinical laboratory or hospital outpatient laboratory; blood draw may occur in ambulatory clinic or phlebotomy site.
Clinical & Coding Specifications
Clinical Context
A 72-year-old patient with progressive cognitive complaints is evaluated in a neurology clinic. The clinician documents gradual memory decline, difficulty with daily tasks, and concern for possible Alzheimer’s disease after initial history, cognitive screening (eg, Mini‑Mental State Examination or Montreal Cognitive Assessment), and basic laboratory and imaging (basic metabolic panel, TSH, B12, and brain MRI) rule out reversible causes. The neurologist orders the proprietary plasma biomarker test PrecivityAD® (0412U) from C2N Diagnostics LLC to assess plasma beta‑amyloid 42/40 ratio and apolipoprotein E (ApoE) phenotype using LC–MS/MS. A phlebotomy is performed in an outpatient laboratory or clinic setting; the specimen is processed and shipped per the manufacturer’s instructions to the performing laboratory. The laboratory runs the assay, generates an algorithmic probability score for brain amyloid plaque presence, and reports results to the ordering clinician. Results inform diagnostic discussions about the likelihood of underlying Alzheimer neuropathology and may influence decisions about further confirmatory testing (such as PET amyloid imaging or CSF analysis), treatment planning, or enrollment in clinical trials. Typical sites of service include outpatient neurology clinics, memory centers, accredited clinical laboratories, and outpatient phlebotomy centers. Billing uses the Proprietary Laboratory Analyses code 0412U to specifically report the PrecivityAD® test.
Coding Specifications
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