Community Health Plan Washington kidney genetic Coverage

Coverage Criteria

Polycystic Kidney Disease Panels (Medically Necessary/Investigational)

Genetic testing using a polycystic kidney disease panel is considered medically necessary when ALL of the following are met:

PKD panel necessity

Clinical features: At least one of: multiple bilateral renal cysts; cysts in organs other than the kidneys (especially liver, seminal vesicles, pancreas, arachnoid membrane); hypertension in an individual younger than age 35; bilaterally enlarged and diffusely echogenic kidneys

Comprehensive Kidney Disease Panels (Medically Necessary/Investigational)

Comprehensive kidney disease panel testing is considered medically necessary when ALL of the following are met:

Comprehensive panel necessity

Standard workup: History and physical, biochemical testing, renal imaging, or renal biopsy as indicated have been done
Risk features: At least one of: onset of CKD under 40 years; one or more first- or second-degree relatives with CKD; consanguineous family history; cystic renal disease; congenital nephropathy; syndromic/multisystem features; possibility of identifying a condition amenable to targeted treatment

APOL1 Targeted Variant Analysis (Medically Necessary/Investigational)

Targeted variant analysis for APOL1 high-risk genotype is considered medically necessary when ALL of the following are met:

APOL1 testing necessity

APOL1 criteria: Member is of African ancestry OR has a family member with confirmed APOL1 high-risk genotype (G1/G1, G1/G2, or G2/G2)

Donor-Derived Cell-free DNA for Kidney Transplant Rejection (Medically Necessary/Investigational)

Peripheral blood dd-cfDNA measurement is considered medically necessary when ALL of the following are met:

dd-cfDNA necessity

Transplant criteria: At least one of: clinical signs of acute rejection; biopsy done for acute rejection and is inconclusive; monitoring for adequate immunosuppression

Other Genetic Kidney Disorders (Medically Necessary)

Genetic testing to establish or confirm the following genetic kidney disorders is considered medically necessary when the member demonstrates clinical features consistent with the disorder:

Listed disorders: At least one of: Alport syndrome; C3 glomerulopathy; congenital nephrotic syndrome; cystinosis; cystinuria; Fabry disease; genetic (familial) atypical hemolytic-uremic syndrome (aHUS); primary hyperoxaluria

Clinical features for each disorder may be referenced from GeneReviews, OMIM, Genetics Home Reference, or other scholarly sources.

Comprehensive Kidney Disease Panels - Medical Necessity

Comprehensive kidney disease panels — covered when criteria met following initial workup

Initial nephrologic workup: Individual has undergone initial nephrologic workup (biochemical/serologic testing, kidney imaging, and renal biopsy if indicated)

Based on Hays et al 2020

Higher probability features for genetic disease: Presence of one or more: early-onset disease (age <40 years), positive family history of CKD, consanguinity, extrarenal anomalies, cystic renal disease, or congenital nephropathy; or syndromic/multisystem features; or possibility of identifying a condition amenable to targeted treatment

KDIGO and Hays et al recommendations

APOL1 Targeted Variant Analysis

APOL1 targeted variant analysis — covered when criteria met

APOL1 testing indications: Consider APOL1 testing in all patients of African ancestry with kidney disease OR any patient with kidney disease and a family member with a confirmed APOL1 high-risk genotype

Definition of high-risk = two APOL1 risk variants (G1/G1, G1/G2, G2/G2)

Donor-derived Cell-Free DNA for Allograft Rejection

Donor-derived cell-free DNA (dd-cfDNA) for kidney transplant rejection — covered when used for specific clinical intents

Permitted intended uses (per LCD): To assist evaluation of adequacy of immunosuppression to inform management without biopsy; OR as a rule-out test for acute rejection in validated populations to determine need for biopsy; OR for further evaluation of allograft status after physician pretest assessment; OR to assess rejection when biopsy is inconclusive or insufficient

CMS MolDX LCD and ESOT/ASTS guidance

Clinical context for use: Ordered by qualified physicians affiliated with a transplant center and considered along with other clinical evaluations; may be used when biopsy is contraindicated or limited

LCD and society statements

Investigational: Genetic and molecular tests described in this policy are considered investigational for any indication that is not explicitly listed as medically necessary for polycystic kidney disease panels, comprehensive kidney disease panels, APOL1 targeted analysis, or donor-derived cell-free DNA (dd-cfDNA). See the specific criteria for each covered test group for permitted indications; uses outside those criteria are not covered.

Polycystic Kidney Disease - targeted variant analysis has been retired from this policy and will no longer be evaluated here. Requests for PKD-targeted testing will be reviewed under the payer's General Approach to Genetic and Molecular Testing policy going forward.

Use of the genetic tests referenced in this policy for indications that do not meet the specific medically necessary criteria is considered investigational (not medically necessary). Providers should confirm that clinical features and prior workup satisfy the listed criteria before ordering panels, targeted analyses, or dd-cfDNA for transplant evaluation.

Change note: Donor-derived cell-free DNA (dd-cfDNA) testing for kidney transplant rejection was previously non‑covered but the coverage status has been changed to covered when criteria are met, aligning with the CMS MolDX LCD and relevant society guidance; covered PLA codes were added. For routine post‑transplant monitoring absent specific guideline regimens, a default coverage frequency of once every 12 months is adopted.

Covered Indications

Broad statement of diagnoses/monitoring covered when criteria met (PKD, KDUE, APOL1, listed rare disorders, dd-cfDNA monitoring)

The following diagnoses and monitoring intents are covered when the specific policy criteria are met:

Covered diagnoses/monitoring: Diagnosis or confirmation of inherited kidney disorders (polycystic kidney disease, comprehensive CKD of unknown etiology with specified risk features, APOL1 high-risk genotype in appropriate patients, listed rare genetic kidney disorders) AND noninvasive monitoring post-renal transplant with dd-cfDNA when criteria met

See individual criteria groups for detailed requirements.

Evaluation of kidney disease of unknown etiology (KDUE)

Evaluation of kidney disease of unknown etiology (KDUE) — genetic testing is indicated after negative or inconclusive initial nephrologic workup and when additional risk features are present:

KDUE testing pathway

Risk-enhancing features:

Coding

Polycystic Kidney Disease Panels CPT codesCPTCovered

81404	Polycystic kidney disease panel (listed among PKD panel CPTs)
81405	Polycystic kidney disease panel (listed among PKD panel CPTs)
81406	Polycystic kidney disease panel (listed among PKD panel CPTs)
81407	Polycystic kidney disease panel (listed among PKD panel CPTs)
81408	Polycystic kidney disease panel (listed among PKD panel CPTs)
81479	Unlisted molecular pathology procedure (used in PKD panels list)

Comprehensive Kidney Disease Panels CPT codesCPTCovered

81401	Comprehensive kidney disease panel CPT (listed among comprehensive panel CPTs)
81402	Comprehensive kidney disease panel CPT (listed among comprehensive panel CPTs)
81403	Comprehensive kidney disease panel CPT (listed among comprehensive panel CPTs)
81404	Comprehensive kidney disease panel CPT (also listed among comprehensive panel CPTs)
81405	Comprehensive kidney disease panel CPT
81406	Comprehensive kidney disease panel CPT
81407	Comprehensive kidney disease panel CPT
81408	Comprehensive kidney disease panel CPT
81479	Unlisted molecular pathology procedure (included in comprehensive panels)

APOL1 Targeted Variant AnalysisCPTCovered

0355U	APOL1 targeted variant analysis (listed for APOL1)
81479	Unlisted molecular pathology procedure (also referenced for APOL1)

Donor-Derived Cell-free DNA CPT/OtherCPTCovered

0493U	Donor-derived cell-free DNA (example code listed)
0118U	Donor-derived cell-free DNA (example code listed)
0508U	Donor-derived cell-free DNA (example code listed)
0509U	Donor-derived cell-free DNA (example code listed)
81479	Unlisted molecular pathology procedure (used for dd-cfDNA listings)

Associated ICD-10 codes for transplant monitoringICD-10

T86.11	Kidney transplant rejection diagnosis code (listed with dd-cfDNA)
T86.12	Kidney transplant failure/rejection (listed)
Z94.0	Kidney transplant status (listed)

Other Covered Kidney Disorders - example CPT/PLA codesCPT | HCPCSCovered

81400	Listed among added codes for Other Covered Kidney Disorders
81401	Listed among added codes for Other Covered Kidney Disorders
81402	Listed among added codes for Other Covered Kidney Disorders
81403	Listed among added codes for Other Covered Kidney Disorders
81404	Listed among added codes for Other Covered Kidney Disorders
81405	Listed among added codes for Other Covered Kidney Disorders
81406	Listed among added codes for Other Covered Kidney Disorders
81407	Listed among added codes for Other Covered Kidney Disorders
81408	Listed among added codes for Other Covered Kidney Disorders
0268U	Listed among added codes for Other Covered Kidney Disorders

inv-19: dd-cfDNA repeat interval — key operational requirement: test not performed in previous 12 months

Repeat-interval requirementDonor-derived cell-free DNA testing is medically necessary only if the test has not been performed in the previous 12 months.

ApplicabilityApplies to peripheral blood dd-cfDNA assays used for post–kidney transplant management (codes listed in policy).

Consequence of prior test within 12 monthsTesting performed within 12 months of a prior dd-cfDNA may be considered investigational and not meet medical necessity criteria.

inv-20: Age threshold for higher genetic disease probability — highlight age < 40 years

Age threshold

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required for Donor-derived cfDNA

Donor-derived cell-free DNA (dd-cfDNA) tests used in post-transplant management require prior authorization before testing. Providers should obtain authorization when dd-cfDNA is being used to inform immunosuppression management, to rule out acute rejection prior to biopsy decisions, to evaluate allograft status after a physician pretest assessment, or when biopsy results are inconclusive. Failure to obtain prior authorization may result in claim denial or delayed payment.

Affected codes: 81479, 0493U, 0118U, 0508U, 0509U (including PLA codes added per LCD)
Prior auth applies when dd-cfDNA is ordered to guide immunosuppression decisions, as a rule-out for acute rejection, as part of allograft status evaluation after physician pretest assessment, or when biopsy is inconclusive
Authorization required if test performed within previous 12 months unless prior auth already obtained

Documentation Required

Eligibility Requirements

Genetic testing via a comprehensive kidney disease panel is covered when the individual has chronic kidney disease of unknown etiology after completing a standard nephrologic workup (history/physical, biochemical/serologic testing, kidney imaging, and renal biopsy if indicated) and the case meets at least one higher‑probability feature (for example: onset of CKD at <40 years of age, a first‑ or second‑degree relative with CKD, consanguinity, cystic renal disease, congenital nephropathy, or syndromic/multisystem features). (See Hays et al. and KDIGO guidance for rationale.)

Targeted APOL1 variant analysis is covered when the member has kidney disease and either is of African ancestry or has a family member with a confirmed APOL1 high‑risk genotype (two risk variants: G1/G1, G1/G2, or G2/G2). Testing for APOL1 outside these criteria is considered investigational.

Polycystic kidney disease panel testing is covered when the member has one or more of the following clinical features: multiple bilateral renal cysts; cysts in organs other than the kidneys (especially liver, seminal vesicles, pancreas, arachnoid membrane); hypertension younger than age 35; or bilaterally enlarged and diffusely echogenic kidneys. Requests that do not meet these features are investigational.

Donor‑derived cell‑free DNA (dd‑cfDNA) testing is covered for post‑renal transplant patients when the individual has undergone transplantation, the test has not been performed in the previous 12 months, and at least one of the following applies: clinical signs of acute rejection; a biopsy performed for suspected rejection that is inconclusive; or monitoring for adequacy of immunosuppression. The intended use must be documented (e.g., to inform biopsy decisions or assess immunosuppression) and tests should be ordered by qualified transplant‑affiliated clinicians per the LCD.

Not Covered

Not covered: Genetic testing for indications that do not meet the specific medically necessary criteria outlined in this policy (including APOL1 testing when the ancestry/family criteria are not met) is considered not medically necessary/investigational. Providers should document how the requested test aligns with the policy criteria to avoid denial.

Although dd‑cfDNA testing for transplant rejection was previously listed as non‑covered, the policy has been updated: dd‑cfDNA is now covered when criteria are met per the LCD and society statements and additional PLA codes were added for consistency. Remaining non‑covered items include any tests or indications that fall outside the explicit medically necessary criteria in this policy.

Background

Background: Inherited kidney disorders range from relatively common conditions such as autosomal dominant polycystic kidney disease to rarer syndromic disorders (e.g., Lowe syndrome, Fabry disease). Identifying a genetic etiology can guide targeted management, family counseling, and prognosis. Next‑generation sequencing panels and exome testing are increasingly used following standard nephrology evaluation for chronic kidney disease of unknown etiology; donor‑derived cell‑free DNA assays provide a noninvasive option to support evaluation of suspected allograft rejection after renal transplantation.

Definitions

inv-32: Close relatives — definition of first- and second-degree relatives

First-degree relativesParents, siblings, and children.

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

Scope noteClose relatives include first, second, and third degree blood relatives on the same side of the family (third-degree listed in policy).

inv-33: APOL1 high-risk genotype definition — two risk variants (G1/G1, G1/G2, G2/G2)

High-risk genotype definitionAPOL1 high-risk genotype = two copies of APOL1 risk variants (G1/G1, G1/G2, or G2/G2).

Testing indicationConsider APOL1 testing in patients of African ancestry with kidney disease or any patient with kidney disease and a family member with a confirmed APOL1 high-risk genotype.

Revision History

2024-11policy_revisionLatest

Donor-derived cell-free DNA (dd-cfDNA) for kidney transplant rejection changed from non‑covered to covered per LCD and society guidance; covered PLA codes were added to align with the LCD.

2024-11criteria_added

Comprehensive kidney disease panels: added criteria including syndromic/multisystem features and the possibility of identifying conditions amenable to targeted treatment based on updated literature and guidelines.

2024-11criteria_retired

OpenPayer

Genetic Testing: Kidney Disorders — Coverage Criteria for Panels, APOL1, and Donor-derived cfDNA