Summary & Overview
CPT 0626U: TruD MDS Parkinsons DNA Methylation Blood Test
CPT code 0626U designates a Proprietary Laboratory Analyses (PLA) test for TruD MDS Parkinsons by TruDiagnostic™ Inc., a DNA methylation–based blood assay that evaluates over 20,000 CpG sites and uses an algorithm to produce a positive or negative risk result for Parkinson disease. As a PLA code, 0626U is unique to a single manufacturer's test and identifies a specialized molecular diagnostic service rather than a class of tests. Nationally, PLA codes like 0626U matter because they signal manufacturer-specific assays with potential implications for coverage policy, laboratory billing, and utilization tracking.
Key payers addressed in this publication include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose and service setting for the test, the implications of its PLA designation, and the types of benchmarks and policy considerations typically relevant for novel, proprietary molecular diagnostics. The publication summarizes expected service lines and where the test is usually performed, highlights what payers commonly consider when evaluating coverage for single-vendor assays, and identifies areas where further coding or coverage detail is often required. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 0626U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single, specific laboratory test: TruD MDS Parkinsons from TruDiagnostic™ Inc. The test analyzes DNA methylation at more than 20,000 sites using a whole blood sample and reports an algorithm-derived positive or negative risk result for Parkinson disease.
Service type: Neurology — molecular diagnostic blood test (DNA methylation analysis); laboratory service.
Typical site of service: Clinical laboratory or independent diagnostic testing facility (blood draw performed at outpatient phlebotomy site or clinic, analysis performed in the manufacturer's lab).
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult presenting to a neurology clinic with new or worsening parkinsonian features (rest tremor, bradykinesia, rigidity, postural instability) or diagnostic uncertainty between Parkinson disease and other parkinsonian syndromes. The clinician documents a focused history and neurologic exam, orders routine laboratory evaluation and neuroimaging as indicated, and discusses genomic/epigenetic testing to aid risk stratification. A venous whole blood draw is obtained at the clinic or an affiliated phlebotomy center, labeled for TruDiagnostic™ Inc., and shipped per the laboratory's specimen handling instructions. The laboratory performs DNA methylation profiling at >20,000 sites and applies the proprietary algorithm. Results are reported as a positive or negative risk for Parkinson disease and returned to the ordering neurologist for integration into the diagnostic assessment and counseling. Typical site of service is an outpatient neurology clinic, independent laboratory, or outpatient phlebotomy service.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When only the interpretation/reporting component is separately billable and performed by a physician or qualified provider |
TC |