CurrentCentenePolicy N/A

Concert Genetic Testing: Kidney Disorders

Defines medical necessity criteria for genetic testing related to polycystic kidney disease panels, comprehensive kidney disease panels, APOL1 targeted variant analysis, donor-derived cell-free DNA testing for kidney transplant rejection, and other genetic kidney disorders. Also lists related CPT/PLA codes and ICD-10 code groupings as examples and provides background and references.

Policy Summary

PayerCentene

PolicyConcert Genetic Testing: Kidney Disorders

Policy CodePolicy N/A

Change TypeRevised coverage + criteria updates

Effective Date

Next Review Date

Key ActionDocument that standard-of-care workup was performed and inconclusive before ordering a comprehensive kidney disease panel.

SourceLink

POLICY UPDATE CHANGES

Donor-Derived Cell-Free DNA for Kidney Transplant Rejection coverage status changed from non-covered to covered based on LCD and society guidelines; covered PLA codes added.

Comprehensive Kidney Disease Panels criteria expanded to include syndromic/multisystem features and potential for identifying conditions amenable to targeted treatment.

Polycystic Kidney Disease - Targeted Variant Analysis retired; tests will be reviewed using General policy.

Polycystic Kidney Disease Panels criteria simplified by removing several previously listed criteria (intracranial aneurysm; poor corticomedullary differentiation; hepatobiliary abnormalities with progressive portal hypertension; congenital hepatic fibrosis with portal hypertension).

Other Covered Kidney Disorders: additional CPT codes (81400-81408, 0268U) added to Policy Reference Table.

4Major policy sections with medical necessity criteria (Polycystic, Comprehensive, APOL1, dd-cfDNA)

Coverage Summary

This policy defines medical necessity criteria for genetic and molecular testing related to kidney disorders, including Polycystic Kidney Disease panels, Comprehensive Kidney Disease panels, APOL1 targeted variant analysis, donor-derived cell-free DNA (dd-cfDNA) testing for kidney transplant rejection, and testing for other genetic kidney disorders. The purpose is to guide diagnosis, management, and family counseling by identifying genetic causes of inherited kidney disease and to provide criteria for when testing (including next-generation sequencing panels and exome-level testing) and dd-cfDNA are considered medically necessary versus investigational.

Quick reference — thresholds & stats

Default dd-cfDNA routine monitoring frequencyOnce every 12 months (coverage default limit)

Major policy sections with medical necessity criteria (Polycystic, Comprehensive, APOL1, dd-cfDNA)4

Example CPT/PLA codes listed (primary)8

Default dd-cfDNA routine monitoring frequency (years)>=1

Medical Necessity Criteria

Polycystic Kidney Disease Panels - Investigational

Polycystic kidney disease panels (81404, 81405, 81406, 81407, 81408, 81479) are investigational when:

Any other indications not listed under medically necessary

Comprehensive Kidney Disease Panels - Investigational

Comprehensive kidney disease panels (81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81479) are investigational when:

Any other indications not listed under medically necessary

APOL1 Targeted Variant Analysis - Investigational

APOL1 targeted variant analysis (0355U, 81479) is investigational when:

Coding

Polycystic Kidney Disease Panels - CPT examplesCPTCovered

81404	Targeted genomic sequence analysis panel (example listed for polycystic kidney disease panels)
81405	Targeted genomic sequence analysis panel (example)
81406	Targeted genomic sequence analysis panel (example)
81407	Targeted genomic sequence analysis panel (example)
81408	Targeted genomic sequence analysis panel (example)
81479	Unlisted molecular pathology procedure (used for example tests)

Comprehensive Kidney Disease Panels - CPT examplesCPTCovered

81401	Exome or comprehensive panel (example listed for comprehensive kidney disease panels)
81402	Comprehensive panel (example)
81403	Comprehensive panel (example)
81404	Included as part of comprehensive panel examples
81405	Included as part of comprehensive panel examples
81406	Included as part of comprehensive panel examples
81407	Included as part of comprehensive panel examples
81408	Included as part of comprehensive panel examples
81479	Unlisted molecular pathology procedure (used for example tests)

APOL1 Targeted Variant Analysis - CPT/PLAmixedCovered

0355U	APOL1 targeted variant genotyping (PLA) - example code listed
81479	Unlisted molecular pathology procedure (used as example)

Donor-Derived Cell-free DNA for Kidney Transplant Rejection - CPT/PLAmixedCovered

81479	Unlisted molecular pathology procedure (used for dd-cfDNA tests)
0493U	Prospera (Natera) PLA example
0118U	Allosure Kidney (CareDx) PLA example
0508U	VitaGraft Kidney Baseline +1st Plasma Test (Oncocyte) PLA example
0509U	VitaGraft Kidney Subsequent (Oncocyte) PLA example

Other Covered Kidney Disorders - CPT examplesCPTCovered

81400	Molecular pathology procedure, Tier 0 (example added to reference table)
0268U	Example single-gene/other PLA added to reference table (example)

Associated ICD-10 code groupings (examples)ICD-10

Q61	Congenital malformations of kidney (example for polycystic/comprehensive panels)
N18	Chronic kidney disease (example)
N00-N08	Glomerular diseases (examples for comprehensive panels and APOL1)
N10-N19	Other renal tubulo-interstitial diseases / renal failure (examples)
R31	Hematuria and related (example)
T86.11	Kidney transplant rejection (used with dd-cfDNA tests)
T86.12	Kidney transplant failure (used with dd-cfDNA tests)
Z94.0	Kidney transplant status (used with dd-cfDNA tests)

Provider Actions & Utilization Rules

Documentation Required

Standard-of-care workup required before comprehensive panel

Comprehensive kidney disease panels require documentation that a standard-of-care workup was performed and was inconclusive prior to ordering the panel. Required documentation elements include: history and physical examination, biochemical/serologic testing, renal imaging, and renal biopsy when indicated.

History and physical examination
Biochemical and serologic testing
Renal imaging
Renal biopsy, if indicated

Prior Authorization

Donor-derived cell-free DNA utilization limit

Donor-derived cell-free DNA (dd-cfDNA) tests (81479, 0493U, 0118U, 0508U, 0509U) are covered only if the test has not been performed in the prior 12 months. For routine monitoring when specific guideline frequency is lacking, the policy adopts a default coverage frequency of once every 12 months.

Background & Evidence

Background: Identifying genetic causes of inherited kidney disorders can inform treatment decisions and family counseling; advanced next-generation sequencing approaches (e.g., exome sequencing and comprehensive gene panels) are increasingly used as first-line diagnostic tools for chronic kidney disease after standard nephrologic workup. For post-transplant care, peripheral blood measurement of donor-derived cell-free DNA (dd-cfDNA) provides a noninvasive biomarker to assist evaluation for allograft rejection and to inform biopsy decisions.

Scope note: This policy applies to the test categories summarized in the scope (Polycystic panels, Comprehensive panels, APOL1 targeted analysis, dd-cfDNA for transplant rejection, and other genetic kidney disorder testing), and specifies CPT/PLA examples, clinical indications for medical necessity, documentation expectations (e.g., standard-of-care workup before comprehensive panels), and utilization limits including the default coverage frequency for routine dd-cfDNA monitoring of once every 12 months when specific guideline screening intervals are not provided.

Reference	Takeaway
KDIGO 2024 guideline	Recommends considering genetic testing for early-onset CKD, syndromic/multisystem features, consanguinity, when biopsy not informative, and when identification may guide targeted treatment
CMS LCD L38582	Provides limited coverage guidance for molecular diagnostic tests including donor-derived cell-free DNA to inform evaluation/management of solid organ transplant patients and to assist decisions about biopsy or immunosuppression
Freedman et al. 2021	Consensus recommends considering APOL1 testing in all patients of African ancestry with kidney disease or in any patient with kidney disease who has a family member with a confirmed APOL1 high-risk genotype

Definitions

Close relativesIncludes first-, second-, and third-degree blood relatives on the same side of the family (first-degree: parents, siblings, children; second-degree: grandparents, aunts/uncles, nieces/nephews, grandchildren, half-siblings; third-degree: great grandparents, great aunts/uncles, great grandchildren, first cousins).

APOL1 high-risk genotypeTwo copies of APOL1 variants (G1/G1, G1/G2, or G2/G2).

Medicare Determinations

Name	Number	Type	Effective Date
MolDX: Molecular Testing for Solid Organ Allograft Rejection	L38582	LCD

Revision History

11/24revisedLatest

Donor-Derived Cell-Free DNA coverage changed from non-covered to covered; added PLA codes (0493U, 0118U, 0508U, 0509U) and adopted default routine monitoring frequency of once every 12 months when no specific guideline frequency exists. Detail: coverage status updated to covered based on LCD and society guidelines; PLA codes added to be consistent with LCD. Text: 'Donor-Derived Cell- Free DNA for Kidney Transplant Rejection: Coverage status changed from non-covered to covered based on LCD and society guidelines; Added covered PLA codes to be consistent with LCD; For routine monitoring absent clear guideline recommendations, default frequency = once every 12 months.' Is_material: true.

11/24revised

Comprehensive Kidney Disease Panels criteria expanded to reflect KDIGO and literature support. Detail: added syndromic/multisystem features and the possibility of identifying conditions amenable to targeted treatment; criteria based on KDIGO 2024 and Hays et al. Text: 'Comprehensive Kidney Disease Panels: Added criteria — Syndromic/multisystem features; There is a possibility of identifying a condition amenable to targeted treatment.' Is_material: true.