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 | Distinct procedural service | When another unrelated, separately reportable service is performed on the same date and documentation supports distinct service (use cautiously for non-overlapping services) |
91 | Repeat clinical diagnostic laboratory test | When the same lab test is repeated on the same day for medical reasons |
KX | Requirements specified in policy are met | When meeting payer-specific documentation criteria for medical necessity (payer-specific; use if required by medical policy) |
QW | CLIA waived test | Not applicable to 0618U generally; include only if payer requires indicating a waived test (rare) |
RT | Right side | Not applicable for 0618U (molecular lab tests), included only if a system requires laterality coding |
LT | Left side | Not applicable for 0618U (molecular lab tests), included only if a system requires laterality coding |
PC | Professional component (alternate) | Use when reporting only the professional component as required by specific payers (alternative to 26 in some systems) |
TC | Technical component | When the billing entity is reporting only the technical component of the laboratory service |
GT | Via interactive audio and video telecommunications | When the test result reporting and counseling occur via telemedicine and payer requires modifier for telehealth services |
EX | Exempt from certain edits (payer-specific) | When a payer requires indicating an exempt circumstance for processing; use per payer guidance |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207Q00000X | Psychiatry & Neurology | Psychiatrists ordering and interpreting test results in outpatient practice |
2084P0800X | Clinical Molecular Genetics | Laboratory directors or lab specialists overseeing molecular epigenetic testing |
208D00000X | Diagnostic Laboratory | Clinical laboratory personnel responsible for performing PLA tests |
103K00000X | Family Medicine | Primary care clinicians who may order psychiatric testing as part of workup |
363L00000X | Clinical Pathology | Pathologists providing oversight and result validation for specialized lab tests |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
F31.9 | Bipolar disorder, unspecified | Primary diagnostic indication for ordering a bipolar risk stratification test |
F31.3 | Bipolar disorder, current episode depressed, moderate | Identifies patients with depressive episodes where adjunctive diagnostic information may influence management |
F31.4 | Bipolar disorder, current episode manic, moderate | Relevant when evaluating risk profile to inform treatment decisions during mania |
F32.9 | Major depressive disorder, single episode, unspecified | Differential diagnosis where epigenetic testing may assist in clarifying bipolar vs unipolar mood disorder |
R45.82 | Suicidal ideation | Symptom prompting more detailed evaluation, potentially including biomarker testing to stratify risk |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0618U | TruD MDS Bipolar — DNA methylation analysis of >10,000 sites from whole blood, proprietary algorithm reporting positive/negative bipolar risk | Primary PLA code for this specific proprietary test; used when billing the TruD MDS Bipolar assay |
80053 | Comprehensive metabolic panel | Often ordered alongside psychiatric evaluation to assess baseline metabolic status prior to medication changes |
81002 | Urinalysis, non-automated, without microscopy (screening) | Commonly performed to screen for substance use or urinary infection during psychiatric assessment |
36415 | Collection of venous blood by venipuncture | CPT for specimen collection when a phlebotomist collects the whole blood sample for the assay |
99000 | Handling and/or conveyance of specimen for transfer from patient to lab (when reported) | Used in some billing contexts to capture specimen handling/transport if payer allows |