Centene kidney genetic testing Coverage & Prior Auth

Coverage Criteria

Targeted Variant Analysis (Familial known variant)

Covered when the following specific familial criteria are met:

PKD targeted familial variant: PKD1, PKD2, GANAB, or DNAJB11 targeted variant analysis (81403) is medically necessary to establish ADPKD when the member has a close relative with a known pathogenic or likely pathogenic variant in the tested gene.

Familial known pathogenic/likely pathogenic variant required.

Targeted Variant Analysis (ARPKD familial known variant)

Covered when the following specific familial criteria are met:

PKHD1 targeted familial variant: PKHD1 targeted variant analysis (81403) is medically necessary to establish ARPKD when the member has a sibling with known biallelic pathogenic or likely pathogenic variants in PKHD1.

Sibling with biallelic pathogenic/likely pathogenic variants required.

Single Gene or Multigene Panel — Polycystic Kidney Disease

Covered when ALL of the following are met:

Clinical features requirement: The member has one or more of the listed clinical features of polycystic kidney disease: multiple bilateral renal cysts; cysts in organs other than the kidneys (especially liver, seminal vesicles, pancreas, arachnoid membrane); hypertension younger than age 35; intracranial aneurysm; bilaterally enlarged and diffusely echogenic kidneys; poor corticomedullary differentiation; hepatobiliary abnormalities with progressive portal hypertension; or congenital hepatic fibrosis with portal hypertension.

See GeneReviews for diagnostic context.

Covered genes/panels: Sequencing and/or deletion/duplication analysis of PKD1, PKD2, GANAB, DNAJB11, or PKHD1, or multigene panel analysis (CPTs 81404-81408, 81479) to confirm or establish a diagnosis of polycystic kidney disease is medically necessary when the clinical features above are present.

Specific CPTs listed in policy.

Comprehensive Kidney Disease Panels — Coverage Criteria

Covered when ALL of the following are met:

Undetermined CKD after standard workup: Member has chronic kidney disease with an undetermined cause after undergoing standard-of-care workup (history and physical, biochemical/serologic testing, renal imaging, or renal biopsy).

Standard nephrologic workup required prior to testing.

Additional high-probability features (at least one required): Member meets at least one: onset of chronic kidney disease under 40 years of age; one or more first- or second-degree relatives with chronic kidney disease; consanguineous family history; cystic renal disease; or congenital nephropathy.>=1

If none present, testing is investigational.

Donor-Derived Cell-Free DNA — Not Covered (Investigational)

Policy stance:

dd-cfDNA investigational: Peripheral blood measurement of donor-derived cell-free DNA (dd-cfDNA) for management after renal transplantation (CPT 81479, 0118U) is considered investigational for all indications, including detection of acute renal transplant rejection and graft dysfunction.

Not covered due to investigational status.

Other Genetic Kidney Disorders — Medically Necessary when Clinical Features Present

Covered when the member demonstrates clinical features consistent with the disorder:

List of specific disorders: Genetic testing to establish or confirm diagnoses for listed disorders (Alport syndrome; C3 glomerulopathy; congenital nephrotic syndrome; cystinosis; cystinuria; Fabry disease; familial atypical HUS; primary hyperoxaluria) is medically necessary when clinical features consistent with the disorder are present.

List is not comprehensive; see GeneReviews/OMIM for clinical features.

Genetic testing indications after initial nephrologic evaluation

Genetic testing for kidney disorders is considered when ALL of the following contextual pathway conditions are met:

Initial workup: Initial nephrologic workup completed (biochemical and serologic testing, kidney imaging, and renal biopsy if indicated) with negative or inconclusive results.

Reference: Hays et al. 2020.

High-probability features (one or more): Presence of any of: age of onset under 40 years, positive family history of chronic kidney disease, consanguinity, extrarenal anomalies, cystic renal disease, or congenital nephropathy.

Reference: Hays et al. 2020.

Polycystic kidney disease specific triggers: For ADPKD: multiple bilateral renal cysts; cysts in other organs (especially liver); hypertension <35 years; intracranial aneurysm. For ARPKD: bilaterally enlarged, diffusely echogenic kidneys; increased renal size for age; poor corticomedullary differentiation; and/or clinical signs of congenital hepatic fibrosis/portal hypertension.

Reference: GeneReviews.

Tests and indications that the policy explicitly labels as investigational for all other indications are not considered covered when submitted outside the specific criteria listed. Examples include targeted familial variant analysis or single-gene/multigene panel testing for polycystic kidney disease when the required familial or clinical features are not documented, comprehensive kidney disease panels performed without meeting the policy's post-workup and additional feature requirements, and donor-derived dd-cfDNA assays for transplant management. Providers should ensure the clinical indication matches the policy criteria prior to ordering to avoid claim denials.

Measurement of donor-derived cell-free DNA (dd-cfDNA) in peripheral blood for surveillance or diagnosis after kidney transplantation is described in the literature as a promising biomarker for early graft injury and acute rejection, but the policy considers such testing investigational for all indications. The systematic review cited highlights potential clinical utility but emphasizes that additional studies are required to validate actionable thresholds, monitoring frequency, and outcome benefit before routine clinical adoption.

When the clinical or familial criteria specified in this policy are not met, the following genetic tests are considered investigational / not medically necessary and are not covered: targeted variant analysis (81403) performed for indications other than the documented familial pathogenic variant scenarios; single-gene sequencing or deletion/duplication and multigene panel testing (CPTs 81404–81408, 81479) for polycystic kidney disease when the listed clinical features are absent; comprehensive kidney disease panels (81401–81408, 81479) performed without a prior standard-of-care nephrologic workup demonstrating undetermined cause and at least one qualifying high-probability feature; and donor-derived dd-cfDNA assays (0118U, 81479) for transplant rejection monitoring.

Covered Indications

Establishing/confirming diagnosis of inherited kidney disorders (ADPKD, ARPKD, other listed genetic kidney disorders) to guide management when specific familial or clinical criteria are met

Covered diagnostic purposes: Genetic testing (targeted familial variant testing, single-gene sequencing/deletion-duplication, multigene panels, or comprehensive panels) to establish or confirm an inherited kidney disorder (including ADPKD, ARPKD, and the other listed genetic kidney disorders) is considered medically necessary when the specific familial or clinical criteria in this policy are met.

Includes tests and genes described in policy (e.g., PKD1, PKD2, GANAB, DNAJB11, PKHD1).

KDUE and high-probability patients: Patients with kidney disease of unknown etiology (KDUE) after an initial negative or inconclusive nephrologic workup may be considered for comprehensive panel testing when they meet high-probability features (early onset <40 years, positive family history, consanguinity, extrarenal anomalies, cystic renal disease, or congenital nephropathy).

See Hays et al. 2020 for stratification guidance.

Suspected ADPKD or ARPKD based on imaging/clinical criteria; KDUE patients with high-probability features after initial nephrologic workup

Coding

Targeted Variant AnalysisCPTCovered

81403

Targeted variant analysis

Single Gene or Multigene PanelsCPTCovered

81404	Multigene panel (example group)
81405	Multigene panel (example group)
81406	Multigene panel (example group)
81407	Multigene panel (example group)
81408	Multigene panel (example group)
81479	Unlisted molecular pathology procedure (used with panels)

Comprehensive Kidney Disease PanelsCPTCovered

81401	Comprehensive kidney disease panels (example)
81402	Comprehensive kidney disease panels (example)
81403	Targeted variant analysis
81404	Multigene panel (example)
81405	Multigene panel (example)
81406	Multigene panel (example)
81407	Multigene panel (example)
81408	Comprehensive kidney disease panels (example)
81479	Unlisted molecular pathology procedure (used with panels)

Donor-Derived Cell-Free DNAmixedNot Covered

0118U	Donor-derived cell-free DNA (dd-cfDNA) for kidney transplant rejection
81479	Unlisted molecular pathology procedure (used with dd-cfDNA)

Related ICD-10 Codes referencedICD-10

T86.11	Kidney transplant failure and rejection
T86.12	Kidney retransplantation status
Z94.0	Kidney transplant status

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for comprehensive kidney disease panels and multigene testing per the member's plan procedures before testing is performed.

Applies to comprehensive kidney disease panels (CPTs: 81401–81408, 81479) and other multigene sequencing tests listed in the policy.
Obtain prior authorization per Centene plan policies to avoid claim denials.

Documentation Required

Initial Nephrologic Workup Required

Initial nephrologic workup is expected before pursuing comprehensive panel testing. Genetic testing via a comprehensive kidney disease panel is considered medically necessary only after standard-of-care nephrologic evaluation is completed and is negative or inconclusive.

Standard workup examples: history and physical exam, biochemical/serologic testing, renal imaging, and renal biopsy when indicated.

Eligibility Requirements

No additional top-level eligibility requirement nodes are specified for this section in the policy brief.

Not Covered

Donor-derived cell-free DNA testing (peripheral blood dd-cfDNA) for detection or management of kidney transplant rejection is considered investigational for all indications and is therefore not covered under this policy.

Targeted variant analysis, single-gene sequencing and deletion/duplication testing, multigene panels, and comprehensive kidney disease panels are considered investigational and not covered for indications other than those explicitly listed in this policy. Coverage is limited to the familial and clinical scenarios detailed in the policy's coverage criteria.

Donor-derived dd-cfDNA assays for transplant monitoring are presented in the evidence base as promising but currently await further validation. Because thresholds for action, monitoring intervals, and outcome benefit are not yet established, these assays are categorized here as investigational and not specified as covered genetic panel testing.

Background

Inherited kidney disorders span a wide prevalence spectrum, from common conditions such as autosomal dominant polycystic kidney disease (ADPKD) to rare syndromic disorders (for example, Fabry disease or Lowe syndrome). Identifying a genetic cause can inform prognosis, direct disease-specific management, and enable family counseling. Next-generation sequencing approaches, including targeted familial variant analysis, single-gene testing, multigene panels, and comprehensive kidney disease panels, are tools used to establish diagnoses when clinical features or family history indicate a high probability of hereditary disease. For comprehensive panels, the policy follows guidance that genetic testing is considered after an initial nephrologic workup is negative or inconclusive and when additional high-probability features (such as early-onset disease, positive family history, consanguinity, extrarenal anomalies, cystic renal disease, or congenital nephropathy) are present.

Definitions

Close relative

DefinitionFirst-, second-, and third-degree blood relatives on the same side of the family.

First-degree examplesParents, siblings, and children.

Second-degree examplesGrandparents, aunts, uncles, nieces, nephews, grandchildren, and half-siblings.

Third-degree examplesGreat-grandparents, great aunts, great uncles, great grandchildren, and first cousins.

ADPKD — diagnostic hints

DefinitionAutosomal dominant polycystic kidney disease (ADPKD): a genetic disorder suspected with multiple bilateral renal cysts and absence of other renal cystic disease.

Revision History

2023-03-01revisionLatest

Policy document 'Concert Genetic Testing: Kidney Disorders V2.2023' last revised.