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 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

TC | Technical component | When only the laboratory technical component is billed by the performing laboratory and the professional interpretation is billed separately (opposite of 26).

59 | Distinct procedural service | When a separately identifiable, unrelated procedure is performed on the same day that is distinct from the genetic test (used sparingly and per payer rules).

RT | Right side | Generally not applicable to this molecular test but included when laterality is required by payer policy (rare).

LT | Left side | Generally not applicable to this molecular test but included when laterality is required by payer policy (rare).

QS | Monitored anesthesia care service | Not applicable to this lab test; listed only if a modifier set is required by billing system (rarely used).

Q0 | Investigational clinical service provided in a clinical research study, not typically billed | Use when the test is investigational and performed as part of an approved research protocol and the payer requires Q0.

Q1 | Routine clinical service provided in a clinical research study, billed as usual | Use when the test is standard-of-care within a research study and payers allow routine care billing.

GA | Waiver of liability statement issued as required by payer policy, optional | Use when patient has signed an Advance Beneficiary Notice or equivalent when payer coverage is uncertain.

GY | Item or service statutorily excluded or does not meet the definition of any Medicare benefit | Use when payer determines the PLA test is not covered and denial is expected.

2080P0208X | Medical Genetics | Clinical geneticists interpret complex results and provide diagnostic oversight.

207K00000X | Internal Medicine | Internists coordinate testing when managing chronic kidney disease and work with specialists.

1223P0001X | Genetic Counseling | Genetic counselors provide pre- and post-test counseling and family cascade testing guidance.

207L00000X | Pediatric Nephrology | Pediatric nephrologists order testing for congenital or early-onset renal disorders in children.

Related Diagnoses

N25.89 | Other disorders resulting from impaired renal tubular function | Genetic tubular disorders (e.g., Fanconi, Gitelman) evaluated by renal gene panels.

Q61.9 | Cystic kidney disease, unspecified | Congenital or hereditary cystic kidney disease suspicion prompting comprehensive genetic panel.

R80.9 | Proteinuria, unspecified | Persistent proteinuria in younger patients may indicate hereditary glomerulopathy assessed by testing.

I12.9 | Hypertensive chronic kidney disease without heart failure | Early-onset or familial forms of kidney disease where genetics are considered in differential.

Z83.49 | Family history of other specified diseases (family history significant for renal disease) | Family history indicating need for cascade testing and panel-based evaluation.

Related CPT Codes

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.