Summary & Overview
CPT 0191U: Navigator IN Sequencing for Indian Blood Group Antigens
CPT code 0191U designates the Navigator IN Sequencing proprietary laboratory test from Grifols Immunohematology Center that sequences genes to identify Indian (IN) blood group antigens. The result assists clinicians in minimizing adverse blood–type incompatibility reactions in transfusions, organ transplants, and perinatal care. As a PLA code, 0191U applies to a single manufacturer’s test and is specific to that assay.
Key national payers considered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise review of the code’s clinical purpose and service setting, payer coverage context, common billing modifiers, and where this test fits in laboratory and transfusion workflows. The publication summarizes benchmarking and policy-relevant points for national stakeholders and provides clinical context to inform coding and administrative planning.
The content covers: the test’s clinical utility for transfusion and transplant compatibility, the PLA nature of the code, payer coverage landscape, and operational considerations for reporting 0191U in laboratory billing. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0191U is a Proprietary Laboratory Analyses (PLA) code for the Navigator IN Sequencing test performed by Grifols Immunohematology Center. The test analyzes specific gene sequences to identify Indian (IN) blood group antigens and is reported when a specimen such as blood is used. This analysis can help clinicians assess blood–type compatibility for transfusions, organ transplantation, pregnancy and newborn care.
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Service type: Genetic sequencing assay for blood group antigen determination
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Typical site of service: Clinical laboratory or specialized immunohematology reference laboratory
Clinical & Coding Specifications
Clinical Context
A 32-year-old pregnant woman with a history of multiple prior blood transfusions and an unclear transfusion record presents for prenatal care. The obstetric team orders extended immunohematology testing to characterize rare blood group antigens and assess risk of hemolytic disease of the fetus and newborn. A venous blood specimen is collected and sent to a reference laboratory performing the proprietary Navigator IN Sequencing test from Grifols Immunohematology Center. Laboratory personnel perform targeted sequencing of genes encoding Indian (IN) blood group antigens to identify variant alleles that may cause antigen mismatch between donor blood and the patient or fetus. Results guide transfusion selection, donor unit compatibility screening, and peripartum planning to minimize adverse transfusion or alloimmunization events. Typical workflow steps: sample collection in outpatient clinic or inpatient unit; specimen labeling and courier to specialized lab; sequencing and bioinformatic analysis by the performing laboratory; issuance of a report to the ordering clinician and transfusion service; integration of findings into transfusion management and perinatal care plans. Typical site of service: reference laboratory processing with specimen drawn in outpatient clinic, hospital laboratory, or blood bank collection area. Service type: proprietary molecular diagnostic sequencing (Proprietary Laboratory Analyses, PLA) specific to the Navigator IN Sequencing test.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when reporting only the professional (interpretation) portion of the test if separated from technical component |
TC | Technical component | Use when reporting only the technical (laboratory processing) portion of the test |
QK | Advanced diagnostic laboratory test (ADLT) technical component | Use when applicable for ADLT reporting where payer requires QK for technical portion |
QX | Advanced diagnostic laboratory test (ADLT) modifier for CLIA-certified lab performing test | Use when the performing CLIA-certified laboratory meets ADLT requirements and payer requests modifier |
QY | Advanced diagnostic laboratory test (ADLT) modifier for ordering physician | Use when ordering/performing physician meets ADLT ordering criteria as required by payer |
22 | Increased procedural services | Use when test requires substantially greater resources or complexity than usual and documentation supports increased work |
52 | Reduced services | Use when an expected portion of the test was not performed and reduced service is reported |
53 | Discontinued procedure | Use if testing was started but discontinued for clinical or specimen reasons prior to completion |
78 | Unplanned return to the operating/procedure room | Rare for lab testing but use when an unexpected procedure related to specimen collection necessitates a surgical/procedural return |
80 | Assistant surgeon | Use when an assistant is documented for an associated procedural specimen collection requiring surgical assistance |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Clinical Molecular Genetics | Labs and clinicians specializing in molecular blood group genotyping and sequencing |
| 207SG0200X | Clinical Laboratory | Reference laboratory and immunohematology services performing sequencing assays |
| 207L00000X | Clinical Pathology | Pathologists overseeing laboratory testing, interpretation, and reporting |
| 208000000X | Obstetrics & Gynecology | Ordering clinicians for prenatal alloimmunization assessment |
| 207K00000X | Immunology | Specialists involved in complex alloimmunization and transfusion planning |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
O36.0XX0 | Maternal care for known or suspected fetal abnormality, unspecified trimester, not applicable or unspecified | Used in prenatal settings when fetal alloimmune risk is assessed due to maternal alloantibodies; genotyping informs fetal risk for hemolytic disease |
Z51.89 | Encounter for other specified aftercare and medical care | Used for specialized laboratory testing encounters related to transfusion planning or perinatal management |
D50.9 | Iron deficiency anemia, unspecified | Common comorbidity in pregnancy or prior transfusion recipients; genotyping may be ordered as part of broader anemia/transfusion workup |
Z34.90 | Encounter for supervision of normal pregnancy, unspecified trimester | Routine prenatal care where specialized immunohematology testing is ordered for alloimmunization risk assessment |
Z53.09 | Procedure and treatment not carried out because of patient decision for other reason | May be used if sequencing is ordered but patient declines testing; included for documentation scenarios |
T86.19 | Other complication of transplanted organ and tissue | In transplant recipients, antigen matching informed by genotyping can reduce risk of transfusion/transplant incompatibility |
D67 | Paroxysmal nocturnal hemoglobinuria | Rare hematologic disorders requiring specialized transfusion planning; genotyping may assist in complex compatibility decisions |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
86900 | Crossmatch test (indirect antiglobulin) | Performed by blood bank prior to transfusion; sequencing informs selection of compatible donor units and interpretation of crossmatch results |
86901 | Crossmatch test (no specified technique) | Alternate crossmatch coding used in transfusion compatibility testing guided by genotyping results |
88240 | Molecular pathology procedure, Level IV (e.g., microarray, sequencing panels) | Represents molecular testing complexity; related in laboratory workflow when additional molecular analyses are needed beyond the proprietary PLA |
86850 | Blood typing (ABO) and Rh typing | Routine immunohematology tests performed alongside genotyping to establish baseline ABO/Rh status |
86880 | Antibody identification; serum | Antibody identification tests used when alloantibodies are detected; genotyping helps resolve antigen/antibody discrepancies |