Summary & Overview

CPT 0628U: RenaDx™ Comprehensive Renal Disease Genetic Panel

CPT code 0628U identifies a Proprietary Laboratory Analyses (PLA) test specific to the RenaDx™ Comprehensive Renal Disease Panel, a next-generation sequencing assay of 449 genes performed on saliva-derived DNA. As a PLA code, 0628U applies exclusively to a single manufacturer's proprietary test and signals growing use of broad genetic panels in nephrology for diagnosing inherited kidney disorders, informing prognosis, and guiding family risk assessment. Nationally, PLA codes like 0628U matter because they standardize billing for unique molecular tests while highlighting issues of coverage, clinical utility, and price transparency across payers.

Key payers examined include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of payer coverage considerations and typical sites of service, clinical context for renal genetic panels, and guidance on what information is typically reported by the assay (pathogenic/likely pathogenic variants, variants of uncertain significance, and risk alleles). The publication also outlines common benchmarking topics and policy updates relevant to proprietary laboratory codes, including coding practice, documentation expectations, and implications for laboratory reporting and clinician communication. Data not available in the input is noted where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0628UCPTProprietary Laboratory Analysesgenetic testingrenal panelnext-generation sequencinglaboratory diagnosticsnephrologymolecular pathology

Billing Code Overview

CPT code 0628U is a Proprietary Laboratory Analyses (PLA) code reported only for the RenaDx™: Comprehensive Renal Disease Panel Test from Personalized Medicine Care Diagnostics. The test analyzes DNA from a saliva sample using next-generation sequencing of 449 genes associated with kidney disease and reports findings as pathogenic or likely pathogenic variants, variants of uncertain significance, or risk alleles.

Service Type: Genetic diagnostic testing — laboratory molecular pathology (next-generation sequencing), renal disease panel

Typical Site of Service: Clinical laboratory or independent diagnostic testing facility (saliva collection may occur in clinic or via home collection with laboratory processing)

Clinical & Coding Specifications

Clinical Context

A 28-year-old patient with a family history of early-onset end-stage renal disease and multiple relatives with cystic kidney disease presents to a nephrology clinic after persistent proteinuria and declining estimated glomerular filtration rate (eGFR). The nephrologist obtains informed consent for genetic testing to clarify etiology, guide prognosis, and inform family counseling. A saliva specimen is collected in clinic using the manufacturer-approved collection kit and shipped to Personalized Medicine Care Diagnostics. Laboratory performs next-generation sequencing of 449 genes on the RenaDx™: Comprehensive Renal Disease Panel (reportable under 0628U). Results are returned as pathogenic or likely pathogenic variants, variants of uncertain significance (VUS), or risk alleles. The clinic receives the report, incorporates findings into the patient’s problem list, and documents genetic counseling and family testing recommendations in the electronic medical record. Typical site of service includes outpatient nephrology clinics or specialty genetic counseling centers; sample collection may occur in clinic or at home with courier return to the performing lab.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	When billing separate professional interpretation by a physician/geneticist is reported apart from the laboratory technical work (rare for PLAs billed by the performing lab).

Taxonomy Code	Specialty	Notes
`207RN0400X`	Nephrology	Nephrologists order renal genetic panels and interpret clinical relevance in renal disease management.

ICD-10 Code	Description	Clinical Relevance
`N18.9`	Chronic kidney disease, unspecified	CKD of unclear etiology where genetic testing may clarify cause and guide management.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0628U`	RenaDx™: Comprehensive Renal Disease Panel Test — next-generation sequencing of 449 genes; saliva specimen	Primary reporting PLA code for the performed renal genetics assay; identifies pathogenic/likely pathogenic variants, VUS, and risk alleles.

81479 | Unlisted molecular pathology procedure | Used cautiously when a specific PLA code is not available or for supplemental molecular testing not captured by 0628U.

81161 | Exome sequencing, interpretation and report of single gene(s) or genomic region (if applicable) | May be used if targeted exome or custom gene analysis outside the PLA is required as follow-up (billing depends on payer rules).

89240 | Microbiologic culture, specimen handling and transport (specimen collection code) | If a separate specimen collection service or courier handling is billed by the clinic (most labs include collection in test price).

99401 | Preventive medicine counseling, individual, 15 minutes (historical example of counseling codes) | Representative of evaluation and counseling services by genetic counselor or clinician documented in the visit note; exact code selection depends on payer and encounter type.

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