Summary & Overview
CPT 0001U: PreciseType HEA Multiplex Erythrocyte Antigen Assay
CPT code 0001U represents the Immucor PreciseType® HEA Test, a proprietary multiplexed molecular assay on whole blood that identifies 24 polymorphisms tied to 35 erythrocyte antigens across 11 blood groups. As a PLA code, 0001U is linked to a single manufacturer-specific test and is used to document advanced molecular typing of red blood cell antigens for transfusion medicine, compatibility testing, and specialized clinical decision-making. Nationally, PLA codes like 0001U are important because they standardize reporting for unique commercial assays and affect laboratory billing, coverage assessment, and clinical workflow integration.
Key payers addressed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines how these payers commonly approach coverage for proprietary molecular diagnostics and summarizes payer-specific policies where available.
Readers will learn the clinical scope of the test, the typical service setting, and what to expect in terms of coverage considerations for a manufacturer-specific lab assay. The report provides benchmarks and policy context for billing and coding of PLA tests, highlights payer policy topics relevant to molecular transfusion diagnostics, and flags areas where additional documentation or medical necessity rationale is commonly required. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0001U is a Proprietary Laboratory Analyses (PLA) code that describes the Immucor, Inc. PreciseType® HEA Test. The test is a multiplexed molecular assay performed on a whole blood specimen that identifies 24 polymorphisms associated with 35 human erythrocyte antigens from 11 blood groups and reports common red blood cell alleles.
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Service type: Molecular laboratory assay for erythrocyte antigen and allele identification
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Typical site of service: Clinical laboratory or specialized molecular diagnostics laboratory
Clinical & Coding Specifications
Clinical Context
A 34-year-old pregnant patient with a history of prior transfusion and a positive antibody screen is referred for molecular red blood cell (RBC) antigen typing to guide transfusion planning and prenatal care. A venous whole blood specimen is collected and sent to a reference laboratory for the Immucor PreciseType® HEA Test 0001U, a multiplexed molecular assay that detects 24 polymorphisms corresponding to 35 erythrocyte antigens across 11 blood groups. The laboratory performs specimen accessioning, DNA extraction, multiplex PCR and allele detection, analytic interpretation, and issues a report documenting the presence or absence of common RBC alleles. Results inform selection of antigen-negative donor units for transfusion, management of hemolytic disease of the fetus and newborn risk, and resolution of serologic discrepancies. Typical sites of service include outpatient phlebotomy centers, hospital blood banks, prenatal clinics, and reference molecular laboratories. The specimen workflow often follows: provider order → patient consent and blood draw → courier transport to molecular lab → processing and testing under controlled conditions → medical technologist validation and pathologist sign-out → electronic report to ordering clinician and transfusion service.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified | Rarely used; only when no specific modifier applies and payer accepts unspecified modifier |
11 | Office or Other Outpatient Service (default) | Use when the lab test is billed in standard outpatient setting without special circumstances
26 | Professional Component | Use when separate billing distinguishes physician professional interpretation from technical lab component
52 | Reduced Service | Use if testing performed was reduced in scope or components compared with full assay
53 | Discontinued Procedure | Use if testing was started but discontinued for patient safety or sample integrity reasons
59 | Distinct Procedural Service | Use if billing needs to indicate this test is distinct from another service performed the same day
90 | Reference (Outside) Laboratory | Use when the performing laboratory is an outside reference lab and billing needs to indicate outside lab processing
TC | Technical Component | Use when billing only the technical component (laboratory processing) separate from professional interpretation
QK | CLIA Waived Test | Not typically applicable to complex molecular assays; include only if payer requires modifier for test status
QX | Qualified Nonphysician Practitioner | Use when a qualified nonphysician practitioner orders or performs components according to payer rules
| Taxonomy Code | Specialty | Notes |
|---|---|---|
0000C00000X | Clinical Laboratory | Clinical molecular and immunohematology laboratories performing RBC genotyping |
207Q00000X | Pathology | Laboratory directors and pathologists responsible for test validation and interpretation
207LP2900X | Blood Banking/Transfusion Medicine | Specialists coordinating antigen typing for transfusion support and donor selection
363A00000X | Obstetrics & Gynecology | Ordering providers for prenatal patients at risk for hemolytic disease of the fetus and newborn
367A00000X | Internal Medicine | Hospitalists and internists managing transfusion-dependent patients
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
D56.9 | Hereditary hemolytic anemia, unspecified | Molecular RBC typing can help clarify antigen genotypes in hemolytic anemias requiring transfusion |
D59.0 | Drug-induced autoimmune hemolytic anemia | Identifying RBC antigen profile assists in safe transfusion selection when alloantibodies complicate serology
O36.0XX0 | Maternal care for rhesus isoimmunization, unspecified trimester | Genotyping informs fetal risk and management when maternal alloimmunization is present
O36.0XX1 | Maternal care for rhesus isoimmunization, first trimester | Early prenatal molecular typing may guide monitoring and interventions
Z51.81 | Encounter for therapeutic drug monitoring | Represents ongoing management visits where transfusion planning and genotyping results are reviewed
Z51.89 | Encounter for other specified aftercare | Post-transfusion follow-up where antigen typing results are used to prevent future alloimmunization
T86.1 | Rejection of transplanted kidney (example of transfusion history relevance) | Patients with complex transfusion or transplant histories may require extended antigen typing
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
80055 | Hepatic function panel | Ancillary chemistry tests sometimes ordered concurrently in comprehensive pretransfusion or prenatal evaluation |
36415 | Collection of venous blood by venipuncture | Blood draw procedure used to obtain the whole blood specimen for the 0001U molecular assay
86850 | Antibody identification; RBC | Serologic antibody identification that may precede or complement molecular RBC antigen testing for transfusion planning
86900 | Compatibility testing, crossmatch, serologic | Crossmatch testing performed when donor units are selected based on molecular results
87880 | Infectious agent detection by nucleic acid (e.g., viral RNA), amplified probe technique | Representative molecular test category; not specific but aligns with lab molecular workflow and instrumentation