Summary & Overview
CPT 0355U: APOL1 Renal Risk Variant Genotyping
CPT code 0355U is a Proprietary Laboratory Analyses (PLA) code for APOL1 Renal Risk Variant Genotyping manufactured and reported by Quest Diagnostics®. The assay detects G1 and G2 variants in the APOL1 gene from blood or saliva specimens and supports risk evaluation for kidney transplant donors and recipients. This code matters nationally as genetic risk stratification for APOL1 variants can influence transplant evaluation workflows, donor selection discussions, and post-transplant risk assessment.
Key payers in analytical coverage reviews include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of what 0355U represents clinically, expected sites of service, and the service type. The publication also summarizes payer coverage patterns, coding and billing considerations for a PLA test tied to a single manufacturer, and how this test fits into clinical pathways for transplant risk assessment. Additionally, the report highlights common modifiers associated with laboratory services and notes where input data was not available for fields such as associated taxonomies, specific ICD-10 diagnoses, or related codes. This summary serves clinicians, laboratory billing staff, and policy analysts seeking a clear, national-level briefing on the code's purpose and operational context.
Billing Code Overview
CPT code 0355U is a Proprietary Laboratory Analyses (PLA) code for Apolipoprotein L1 (APOL1) Renal Risk Variant Genotyping performed by Quest Diagnostics®. The test performs targeted DNA sequence analysis for the G1 and G2 variants in the APOL1 gene using a blood or saliva specimen. The variant results aid in risk evaluation for kidney transplant donors and recipients, informing genetic risk assessment related to renal outcomes.
Service Type: Genetic testing — targeted variant genotyping
Typical Site of Service: Clinical laboratory or diagnostic testing facility (specimen collected at a clinic or patient collection site and analyzed at Quest Diagnostics®)
Clinical & Coding Specifications
Clinical Context
A 35-year-old African American patient is being evaluated as a potential kidney transplant living donor. The transplant team requests genetic risk assessment for APOL1 renal risk variants to inform donor suitability and recipient risk counseling. The ordering clinician (nephrologist or transplant surgeon) collects a blood or saliva specimen at an outpatient transplant evaluation visit. Sample is sent to Quest Diagnostics® for targeted DNA sequence analysis for APOL1 G1 and G2 variants using Proprietary Laboratory Analyses reported with CPT code 0355U. Results are returned to the ordering clinician and incorporated into the transplant risk assessment and donor consent documentation. Typical site of service is an outpatient clinical laboratory draw station, outpatient transplant clinic, or an ambulatory surgery center where pretransplant evaluations occur. Service type: targeted genetic testing / molecular diagnostic assay (PLA).
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified modifier — not used for reporting; reserved | Not used clinically; do not append for this PLA code |
26 | Professional component | When only the professional interpretation component is reported separately by a physician or qualified geneticist |
52 | Reduced services | When testing performed is a reduced version of the full APOL1 assay (rare; document reason) |
53 | Discontinued procedure | If specimen collection or testing was started but discontinued prior to meaningful analysis |
62 | Two surgeons | If two qualified providers share responsibility for ordering/interpretation in complex transplant evaluations (rare) |
78 | Return to operating room | Not typically applicable to laboratory testing; not commonly used |
80 | Assistant surgeon | Not applicable for lab test performance; not commonly used |
82 | Assistant surgeon (when qualified resident not available) | Not applicable for lab testing |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | When an advanced practice provider orders or documents the test per facility policy |
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Not applicable to this lab test |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RG0100X | Nephrology | Most common ordering specialty for APOL1 risk variant testing |
| 2080P0207X | Transplant Surgery | Ordering provider for donor/recipient pretransplant evaluation |
| 207L00000X | Medical Genetics | Provides interpretation of genetic testing results and counseling |
| 363LA2200X | Laboratory/Clinical Laboratory | Performing laboratory specialty (molecular diagnostics) |
| 207Q00000X | Genetic Counseling | Genetic counselors who interpret and communicate results |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
Z48.21 | Encounter for aftercare following kidney transplant | Relevant when APOL1 testing informs donor/recipient risk in transplant follow-up and planning |
Z52.5 | Donors of kidney | Used when assessing living kidney donors, including genetic risk evaluation such as APOL1 testing |
N18.5 | Chronic kidney disease, stage 5 | Relevant when evaluating kidney transplant candidates or recipients for genetic contributors to advanced CKD |
Z31.49 | Encounter for genetic counseling for procreative management, other | Used when genetic counseling is provided related to APOL1 risk variant results in donor/recipient counseling |
R79.89 | Other specified abnormal findings of blood chemistry | Sometimes used when genetic testing ordered for abnormal renal-related laboratory findings |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0355U | Apolipoprotein L1 (APOL1) renal risk variant genotyping (Quest Diagnostics®) | Primary PLA code for the targeted APOL1 G1/G2 sequence analysis performed on blood or saliva |
81162 | BRCA1 and BRCA2 full sequence analysis (example hereditary cancer testing) | Represents typical full-gene sequencing workflows; not specific to APOL1 but analogous for lab processing and interpretation steps when full sequencing is performed |
81479 | Unlisted molecular pathology procedure | Used when a laboratory performs a molecular test not represented by a PLA or CPT code; not typically used when 0355U is reported |
88237 | FISH, each additional probe (example cytogenetic adjunct) | Represents ancillary genetic testing that may be ordered in broader genetic evaluations (not routine with APOL1) |
0900U | Pharmacogenomic or other PLA-coded test (example PLA) | Illustrates other Proprietary Laboratory Analyses workflows and billing; used for comparative coding when multiple PLA tests are ordered |