Summary & Overview

CPT 0195U: KLF1 Sequencing for Lutheran Blood Group Antigens

CPT code 0195U identifies a proprietary genetic sequencing assay — the Navigator KLF1 Sequencing test from Grifols Immunohematology Center — used to detect Lutheran (LU) blood group antigens. This specialized laboratory test has clinical importance for preventing incompatible blood transfusions, managing transplant compatibility, and assessing risk in pregnancy and newborn care. As a PLA code, 0195U applies to a single manufacturer-specific test, which affects how payers evaluate coverage and reimbursement nationally.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines payer coverage patterns, coding and billing considerations for PLA-designated tests, and the clinical contexts in which the test is employed. Readers will find benchmarks on payer recognition of PLA codes, summaries of policy language relevant to proprietary laboratory analyses, and clinical context describing when KLF1 sequencing informs transfusion and transplant decision-making. The report also highlights documentation and claim considerations specific to manufacturer-specific tests and notes where input data was not available.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0195UCPTProprietary Laboratory AnalysesGenetic SequencingKLF1Blood GroupImmunohematologyTransfusion Medicine

Billing Code Overview

CPT code 0195U is a Proprietary Laboratory Analyses (PLA) code for the Navigator KLF1 Sequencing test from Grifols Immunohematology Center. The test analyzes specific gene sequences to identify Lutheran (LU) blood group antigens. Results can inform clinical decisions to minimize adverse blood–type incompatibility reactions in blood transfusions, organ transplants, pregnancy, and newborn care.

Service type: Genetic sequencing of the KLF1 gene to determine Lutheran blood group antigen status
Typical site of service: Clinical laboratory or specialized immunohematology reference laboratory using blood or other appropriate specimens

Clinical & Coding Specifications

Clinical Context

A patient with a prior transfusion reaction, complex alloimmunization, or a pregnant patient with suspected maternal–fetal blood group incompatibility is referred for specialized immunohematology testing. A clinician (hematologist, transfusion medicine specialist, or obstetrician) orders the Navigator KLF1 Sequencing test to determine Lutheran (LU) blood group antigen status by sequencing the KLF1 gene from a peripheral blood specimen. The clinical workflow: the provider places the order in the electronic medical record, a phlebotomy draw is performed and the specimen is labeled and shipped to Grifols Immunohematology Center. The laboratory performs targeted sequencing of the specific KLF1 gene regions described by the PLA code 0195U, interprets variants relevant to Lutheran antigen expression, and issues a report to the ordering provider. Results inform transfusion compatibility decisions, selection of antigen-negative donor units, organ transplant planning, or management of hemolytic disease of the fetus and newborn.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when reporting only the physician professional interpretation component separate from technical testing, if applicable and allowed by payer.

TC

Taxonomy Code	Specialty	Notes
207RH0000X	Hematology	Specialists who evaluate transfusion-related indications, anemia, and alloimmunization.
207L00000X	Pathology	Pathologists directing immunohematology and molecular blood group testing.
2080P0208X	Obstetrics & Gynecology	OB clinicians managing pregnancies with maternal–fetal blood group incompatibility risks.
208000000X	Transfusion Medicine	Physicians specializing in transfusion practice, donor selection, and compatibility testing.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`D67`	Hereditary factor VII deficiency	Data not available in the input.
`O36.0XX0`	Maternal care for known or suspected fetal blood incompatibility, unspecified trimester, not applicable or unspecified fetal status	Used when managing pregnancies at risk for hemolytic disease of the fetus and newborn related to blood group incompatibility.
`D58.9`	Hereditary hemolytic anemia, unspecified	May be relevant when hemolytic anemia prompts extended antigen/genetic testing.
`Z51.89`	Encounter for other specified aftercare	May be used for follow-up care after transfusion reaction and related testing.
`T80.89XA`	Other complications following infusion, initial encounter	Relevant when investigating transfusion reactions that trigger molecular antigen testing.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0033U`	Targeted sequencing for blood group antigen determination (example PLA)	May be ordered alongside `0195U` when additional molecular blood group loci are tested in parallel for comprehensive antigen typing.
`88172`	Morphologic examination and interpretation of blood smear, special stain when performed	Performed before or after molecular testing to evaluate hemolysis or red cell morphology that may prompt molecular testing for blood group variants.
`86900`	Blood grouping; ABO	Performed routinely in transfusion workup and often ordered before or with molecular antigen testing.
`86901`	Blood grouping; Rh (D)	Standard serologic Rh typing that complements molecular Lutheran antigen assessment.
`86850`	Antibody identification; serum or plasma	Often performed in alloimmunized patients to detect clinically significant antibodies that drive the need for molecular antigen genotyping.