Summary & Overview
CPT 0291U: MindX Blood Test™ – Mood, NGS RNA Gene-Expression Risk Score
CPT code 0291U designates a proprietary laboratory assay — the MindX Blood Test™ – Mood — that uses next-generation sequencing (NGS) of RNA to measure expression of 144 genes and reports an algorithm-derived predictive risk score for mood disorders including depression and bipolar disorder. As a PLA code, 0291U applies only to this specific manufacturer’s test, signaling a single-source molecular diagnostic intended for clinical risk stratification. Nationally, PLA codes like 0291U are important because they identify unique commercial tests that may prompt payer policy development, clinical-validation review, and coding guidance for laboratory services.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the test’s clinical purpose and service setting, common modifier usage, and what to expect in payer engagement for a proprietary molecular diagnostic. The publication outlines benchmark considerations for coverage and reimbursement pathways, summarizes typical sites of service for billing and claims submission, and highlights policy and coding implications that often accompany PLA-designated assays. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0291U is a Proprietary Laboratory Analyses (PLA) code for the MindX Blood Test™ – Mood, performed by MindX Sciences™ Laboratory (MindX Sciences™ Inc.). The test uses a blood specimen and employs next-generation sequencing (NGS) of RNA to evaluate gene expression activity across 144 genes. An algorithmic analysis of those gene-expression results generates a predictive risk score for mood disorders such as depression and bipolar disorder.
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Service type: Proprietary laboratory molecular diagnostic test using NGS-based RNA gene-expression profiling with algorithmic risk-score reporting
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Typical site of service: Clinical laboratory setting using a blood specimen for laboratory-based molecular diagnostic testing
Clinical & Coding Specifications
Clinical Context
A 32-year-old adult presents to an outpatient psychiatric clinic with several months of mood instability, depressive episodes, and unclear response to prior antidepressant trials. The clinician documents a diagnostic and pharmacogenomic evaluation plan and orders the MindX Blood Test™ – Mood (0291U) to assess gene expression patterns associated with risk for mood disorders. A standard venous blood draw is performed in the clinic or an associated phlebotomy collection site; the specimen is sent overnight to the MindX Sciences™ Laboratory. Results, including a predictive risk score for mood disorders derived from next-generation RNA sequencing of 144 genes, are returned to the ordering clinician. The clinician integrates the report with clinical history, mental status exam, prior medication response, and ongoing risk assessment to guide diagnostic clarification and management planning. Typical sites of service include outpatient psychiatry clinics, behavioral health centers, primary care offices with integrated behavioral health, and contracted phlebotomy or laboratory collection centers. The service type is a Proprietary Laboratory Analysis (PLA) molecular diagnostic blood test using next-generation sequencing of RNA and algorithmic interpretation.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no specific modifier applies to the billed service. |
26 | Professional component | Use when billing only the professional interpretation component separate from technical lab processing. |
TC | Technical component | Use when billing only the technical component for specimen processing and sequencing. |
52 | Reduced services | Use when the test is performed but substantially reduced from the full service (rare for PLA tests). |
53 | Discontinued procedure | Use if specimen collection or testing was started but discontinued for documented clinical reasons. |
78 | Return to operating/procedure room for related procedure during postoperative period | Generally not applicable; include only if an associated procedural return occurs. |
80 | Assistant surgeon | Not typically applicable to lab tests; use only if applicable clinical services require assistant surgeon billing. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for light sedation | Use if advanced practice clinician provided a billable portion of the encounter per payor rules. |
QK | Medical direction by a physician; participation less than medical direction of two or more CRNAs/Anesthetists | Not routinely used for lab testing; include only per payor-specific bundling rules. |
QX | CRNA service with medical direction by physician | Not routinely applicable; include per institutional billing policy. |
QY | Medical direction of one CRNA by an anesthesiologist | Not routinely applicable for this test. |
FX | Service performed by the ordering laboratory’s personnel (distinct from outside lab) | Use when the performing lab and ordering lab relationship requires this modifier per payor guidance. |
FY | Service performed by a physician other than the ordering physician | Use when another physician performs the professional component or interpretation. |
SH | Physician or other qualified health care professional services for outpatient/ASC procedure of a program initiated by the facility | Use per facility billing guidance when applicable. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 2084P0800X | Psychiatry & Neurology | Psychiatrists commonly order mood disorder biomarker testing and interpret results. |
| 208VP0000X | Clinical Pathology | Pathologists or laboratory directors oversee test validation and reporting. |
| 103K00000X | Clinical Laboratory | Clinical laboratory professionals and directors manage specimen processing and sequencing. |
| 208D00000X | Internal Medicine | Primary care internists may order testing when assessing mood disorders and care coordination. |
| 363L00000X | Nurse Practitioner | Psychiatric nurse practitioners often order and act on molecular diagnostic reports. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
F32.9 | Major depressive disorder, single episode, unspecified | Common indication to evaluate molecular risk patterns in patients with depressive symptoms. |
F33.9 | Major depressive disorder, recurrent, unspecified | Used when assessing recurrent depressive illness and potential biological risk markers. |
F31.9 | Bipolar disorder, unspecified | Relevant when differentiating bipolar spectrum versus unipolar mood disorders. |
R45.1 | Restlessness and agitation | Symptom code that may prompt further mood disorder evaluation including biomarker testing. |
Z13.31 | Encounter for screening for depression | Used for screening encounters where adjunctive molecular testing may be considered. |
F41.1 | Generalized anxiety disorder | Anxiety commonly co-occurs with mood disorders and may be part of the clinical assessment accompanying testing. |
Z71.9 | Counseling, unspecified | Behavioral health counseling visits that may accompany diagnostic evaluation and test interpretation. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Phlebotomy required to obtain the blood specimen for the 0291U test. |
86140 | Bacterial antigen detection; multiplex amplified probe technique, each organism | Example of molecular laboratory techniques; not specific to 0291U but represents molecular testing workflow components. |
81479 | Unlisted molecular pathology procedure | Used when additional or supplemental molecular analyses not captured by a PLA code are performed alongside 0291U. |
0000U | Proprietary Laboratory Analyses (example PLA code) | Other PLA codes may be ordered for different proprietary tests in the same diagnostic workup; listed here as a category example. |
G0480 | Drug screen confirmation using chromatography/mass spectrometry | May be ordered in parallel in behavioral health evaluations to assess substance use that can affect mood presentation. |