Summary & Overview
CPT 0194U: Navigator KEL Sequencing for Kell Blood Group Antigens
CPT code 0194U is a Proprietary Laboratory Analyses (PLA) code for the Navigator KEL Sequencing test from Grifols Immunohematology Center. The test sequences specific gene regions to detect Kell blood group antigens, which can inform transfusion compatibility, organ transplant matching, and perinatal care to reduce adverse blood–type incompatibility reactions. As a PLA code, 0194U represents a single manufacturer- or lab-specific assay with a unique billing identifier.
Key payers examined include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a national perspective on clinical context, billing and reporting considerations for a PLA sequencing assay, and what to expect in payer coverage patterns. The publication summarizes typical sites of service (clinical or reference laboratory processing of blood specimens), relevant coding characteristics for PLA tests, and common modifiers used with laboratory sequencing services. The analysis clarifies where data are available and notes areas labeled “Data not available in the input” for items not provided. This brief is intended to inform billing staff, laboratory managers, and clinicians about the clinical purpose of the test, the payer landscape, and the types of benchmarks and policy updates that commonly affect adoption and reimbursement of proprietary molecular assays.
Billing Code Overview
CPT code 0194U is a Proprietary Laboratory Analyses (PLA) code for the Navigator KEL Sequencing test from Grifols Immunohematology Center. The code describes sequence analysis of specific gene regions associated with the Kell blood group system to identify Kell blood group antigens.
Service Type: Genetic sequencing for blood group antigen identification
Typical Site of Service: Clinical laboratory or specialized immunohematology reference laboratory, using a patient specimen such as blood.
Clinical & Coding Specifications
Clinical Context
A typical patient is a pregnant person, a blood transfusion candidate, or an organ transplant recipient whose care team needs high-resolution Kell blood group genotyping to minimize immune-mediated hemolytic reactions. A prenatal scenario: a 28-year-old pregnant patient with a history of alloimmunization or a positive maternal antibody screen is referred for molecular Kell antigen genotyping to determine fetal risk and guide perinatal management. A transfusion scenario: a hospitalized adult requiring multiple red blood cell transfusions with discrepant serologic typing or a history of transfusion reactions undergoes testing to identify variant Kell alleles. A pre-transplant scenario: a kidney transplant candidate with complex serology is tested to refine donor compatibility.
Clinical workflow: a clinician orders the Navigator KEL Sequencing test (0194U) at the hospital or outpatient clinic. A peripheral blood specimen is collected and sent to Grifols Immunohematology Center. The laboratory performs targeted sequencing of Kell gene regions, interprets alleles relevant to Kell blood group antigens, and issues a report indicating antigen predictions and any variant alleles. Results are used by transfusion medicine, obstetrics, or transplant teams to match blood products, monitor pregnancies for hemolytic disease of the fetus/newborn, or inform donor selection.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier; standard reporting | Use when no specific modifier applies and service is billed normally |
26 | Professional component | Use if reporting the professional interpretation separate from the technical lab work when allowed |
TC | Technical component | Use when billing only the laboratory technical component of the test |
22 | Increased procedural services | Use when test requires substantially greater resources or complexity than typical for the code (document justification) |
52 | Reduced services | Use if testing was partially completed or limited and full service was not provided |
53 | Discontinued procedure | Use when specimen collection or testing was started but discontinued for clinical reasons |
QK | Ordering physician attests that the lab test was ordered as part of a qualified clinical trial | Use when the test is ordered under a qualifying clinical trial and attestation is required |
QX | Ordering physician billed separately for services furnished by a laboratory | Use in coordination scenarios with separate billing arrangements (modifier rules per payer) |
AD | Attending physician | Use to indicate the attending physician's role when provider attribution rules require it |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist | Use when an advanced practitioner orders or is responsible for the service according to payer rules |
SH | Diagnostic tests ordered by another physician (Medicare/Medicaid) | Use when another physician orders the test and reporting requires identifying that ordering provider relationship |
QY | Laboratory test furnished under an arrangement with an independent lab (payment adjust) | Use when test is furnished under an independent lab arrangement subject to payment modifiers |
78 | Unplanned return to the operating/procedure room | Rarely applicable; use only if testing was directly associated with an unplanned procedural return requiring modifier documentation |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Clinical Laboratory | Laboratory directors and molecular diagnostics labs performing sequencing |
| 207L00000X | Pathology | Transfusion medicine and molecular pathology specialists interpreting results |
| 2080P0206X | Obstetrics & Gynecology | Maternal–fetal medicine or obstetricians ordering prenatal Kell genotyping |
| 207P00000X | Transfusion Medicine | Physicians specializing in blood banking and transfusion compatibility |
| 2084N0400X | Nephrology | Transplant physicians ordering pre-transplant compatibility testing |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
O36.5XX1 | Maternal care for known or suspected fetal damage from infection, first trimester | Used when fetal risk from maternal alloimmunization is assessed in early pregnancy requiring Kell genotyping |
O36.5XX2 | Maternal care for known or suspected fetal damage from infection, second trimester | Used for mid-pregnancy evaluation when alloimmunization or fetal anemia risk is present |
O36.5XX3 | Maternal care for known or suspected fetal damage from infection, third trimester | Applied during late pregnancy monitoring for hemolytic disease risk related to Kell antibodies |
D59.0 | Autoimmune hemolytic anemia | Hemolytic processes where Kell antigen incompatibility may be relevant in differential diagnosis |
Z51.81 | Encounter for therapeutic drug management | Relevant when managing immunomodulatory therapy in alloimmunized patients (contextual) |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
81025 | Urinalysis, automated, with microscopy | Pre-test screening in hospitalized patients; not directly related but part of baseline labs prior to transfusion or transplant |
36415 | Collection of venous blood by venipuncture | Specimen collection for the Navigator KEL Sequencing test; commonly performed at the time of order |
88045 | Antibody identification; including adsorption/elution techniques (per sample) | Serologic workup often performed before or alongside molecular Kell genotyping to resolve discrepant or complex antibody results |
86850 | Blood typing; ABO (including Rh antigen) | Routine serologic blood typing performed as part of transfusion compatibility evaluation prior to molecular testing |
86880 | Antibody screen (indirect antiglobulin test) | Initial screen for alloantibodies that may prompt Kell genotyping with 0194U |
0000U | Proprietary Laboratory Analyses example (placeholder) | Example of other PLA codes that may be ordered alongside 0194U when comprehensive antigen genotyping panels are performed |