Summary & Overview
CPT 0618U: TruD MDS Bipolar Epigenetic Risk Assay
CPT code 0618U designates a Proprietary Laboratory Analyses (PLA) test specific to TruDiagnostic™ Inc.'s TruD MDS Bipolar assay. The assay evaluates DNA methylation at over 10,000 sites from a whole blood specimen and uses a proprietary algorithm to return a positive or negative risk result for bipolar disorder. As a PLA code, 0618U is uniquely tied to a single manufacturer's test and signals to payers and providers that claims relate to that specific commercial assay.
Key national payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare and Medicare. Readers will find: a concise explanation of the assay's clinical purpose and service setting; coverage and reimbursement considerations tied to the PLA coding status; practical benchmarks for coding and billing workflows; and the clinical context for using an epigenetic risk test for bipolar disorder. The report also highlights where input data is unavailable and indicates areas that typically require payer-specific policy review, prior authorization, or medical necessity documentation for genetic and epigenetic laboratory testing.
This summary is intended for health plan analysts, billing professionals, laboratory compliance teams, and clinicians seeking a national overview of the billing, coding, and clinical positioning of the TruD MDS Bipolar assay under CPT code 0618U.
Billing Code Overview
CPT code 0618U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the TruD MDS Bipolar test from TruDiagnostic™ Inc. The test analyzes DNA methylation at more than 10,000 sites using a whole blood sample and applies an algorithm to report a positive or negative risk result for bipolar disorder in a psychiatric context.
Service type: Proprietary laboratory genetic/epigenetic risk assay
Typical site of service: Clinical laboratory / outpatient collection site (whole blood draw)
Clinical & Coding Specifications
Clinical Context
A 28-year-old patient with a history of mood instability and suspected bipolar disorder presents to an outpatient psychiatric clinic for evaluation after inadequate response to first-line mood stabilizers. The treating psychiatrist orders the proprietary TruD MDS Bipolar test (0618U) to assess methylation-based risk stratification from a whole blood sample. The typical clinical workflow: the clinician documents diagnostic rationale and obtains informed consent for genetic/epigenetic testing, collects a peripheral whole blood specimen in the manufacturer-specified tube, and ships the specimen to TruDiagnostic™ Inc. The laboratory performs DNA methylation analysis at >10,000 sites and applies the proprietary algorithm to report a positive or negative bipolar risk result. Results are returned to the ordering clinician and incorporated into the psychiatric assessment and care planning during follow-up, typically in an outpatient or specialty psychiatry laboratory context.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When reporting only the professional component of a separately billable laboratory service if applicable under local billing rules |
59 |