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 |