Ambetter Nevada transplant testing Coverage Update

Coverage Criteria for Transplant Molecular Testing

Donor-Derived Cell-free DNA for Heart Transplant Rejection

Covered when ALL of the following are met:

Heart dd-cfDNA criteria: (A) The member has undergone a heart transplant; AND (B) peripheral blood donor-derived cell-free DNA (dd-cfDNA) testing has not been performed in the past 12 months; AND (C) dd-cfDNA is being used to manage the patient after heart transplantation (e.g., to assist evaluation of allograft status).not performed within previous 12 months

Routine coverage default frequency once every 12 months per policy.

Post Heart Transplant Gene Expression Panels (Peripheral Blood)

Covered when ALL of the following are met:

Post-heart peripheral blood GEP criteria: (A) The member is age 18 years or older; AND (B) the member has undergone heart transplantation; AND (C) the member is classified as low-risk for organ rejection; AND (D) the transplant was performed at least 2 months ago and less than 5 years ago.age >=18; time 2 months to <5 years post-transplant

Use per ISHLT guidance to identify low-risk adults and potentially reduce endomyocardial biopsy frequency.

Post Heart Transplant Gene Expression Panels (Tissue)

Tissue GEP (MMDx) not supported for routine use; current evidence does not support for all indications.

Tissue GEP: Current evidence does not support use of post-heart transplant gene expression panels performed on allograft tissue (e.g., MMDx) for all indications; the test may improve discrimination between rejection types but is not routinely used or universally available.

Not supported for routine coverage per policy.

Donor-Derived Cell-free DNA for Kidney Transplant Rejection

Covered when ALL of the following are met:

Kidney dd-cfDNA criteria: (A) The member has undergone kidney transplantation; AND (B) peripheral blood dd-cfDNA testing has not been performed in the previous 12 months; AND (C) the member meets at least one of the following: clinical signs of acute rejection OR biopsy performed for rejection that is inconclusive/insufficient OR monitoring for adequacy of immunosuppression.not performed within previous 12 months

Intended use should align with MolDX LCD (assist immunosuppression evaluation, rule-out AR in validated populations, further evaluation after physician-assessed pretest, or assess when biopsy inconclusive).

Donor-Derived Cell-free DNA for Lung Transplant Rejection

Covered when ALL of the following are met for tests with sufficient evidence of clinical validity and utility:

Lung dd-cfDNA evidence-based criteria: (A) The member has undergone lung transplantation; AND (B) peripheral blood dd-cfDNA testing has not been performed in the last 12 months.not performed within previous 12 months

Only dd-cfDNA assays with sufficient evidence of clinical validity and utility are considered medically necessary; tests lacking such evidence are not supported.

HLA Typing for Transplantation

Covered when ALL of the following are met:

HLA typing criteria: (A) The member is being evaluated as a donor or recipient for hematopoietic stem cell transplantation or solid organ transplantation; AND (B) the member meets at least one of: clinical signs of acute rejection OR a biopsy was done and is inconclusive for rejection OR the member is being monitored for adequacy of immunosuppression.

Full HLA typing is required for HCT; laboratories must report specified loci (see reporting requirements).

Post-Heart Transplant Peripheral Blood GEP

Peripheral blood GEP details and limits: covered when ALL criteria met (age/time limits apply):

Post-heart peripheral blood GEP operational limits: (A) Member is age 18 years or older; AND (B) member has undergone heart transplantation; AND (C) member is low-risk for rejection; AND (D) transplant occurred >=2 months and <5 years prior.age >=18; 2-<60 months post-HT

Used to identify low risk of acute cellular rejection and may reduce EMB frequency in selected adult patients; pediatric use not supported by guideline evidence.

Post-Heart Transplant Tissue GEP (MMDx)

Tissue GEP (MMDx) details: not routinely supported or may be limited by availability:

Post-heart tissue GEP (MMDx): Gene expression testing of allograft tissue (e.g., Molecular Microscope/MMDx) may improve discrimination between T-cell and antibody-mediated rejection but is not routinely used or clinically available in all settings; current evidence does not support routine coverage for all indications.

Consider availability and local clinical practice.

dd-cfDNA — Permitted Uses

Permitted intended uses (any of the following):

Permitted dd-cfDNA uses: To assist evaluation of adequacy of immunosuppression (as an alternative to biopsy when biopsy information would guide immunosuppression); OR as a rule-out test for acute rejection in validated populations to guide the need for biopsy; OR for further evaluation of allograft status after a physician-assessed pretest; OR to assess rejection when biopsy results are inconclusive or limited by insufficient material.qualified physician; transplant center affiliation

Ordering should be by qualified physicians and used alongside clinical assessment.

dd-cfDNA Surveillance Frequency

Guidance (default) on surveillance frequency when evidence-based regimen absent:

Surveillance frequency default: In the absence of clear, specific, evidence-based guideline recommendations for serial dd-cfDNA surveillance (particularly in kidney transplantation), the default coverage frequency is once every 12 months.once every 12 months

ASTS states optimal frequency unknown; ESOT suggests consideration of serial measurement.

HLA Typing and Reporting

Reporting and loci requirements for pre-transplant HLA testing and transplant candidate registration:

HLA typing for HCT: Full HLA typing is required for patients undergoing or evaluated for hematopoietic stem cell transplantation, including typing of HLA-A, -B, -C, and -DR for donor selection.

Per UpToDate, NMDP/ASTCT guidance.

OPTN pre-registration requirements: For kidney, kidney–pancreas, pancreas, or pancreas islet candidates, laboratories must report results for HLA A, B, Bw4, Bw6, and DR to the transplant program prior to registration on the waiting list; final crossmatch must be performed and reported prior to transplant for kidney or multi-organ transplants involving a kidney.reporting prior to waitlist registration and pre-transplant crossmatch

OPTN requirement effective 10/31/2024.

Use of post-heart transplant tissue gene expression panels (e.g., MMDx) and donor-derived cell-free DNA tests that lack demonstrated clinical validity for lung transplant indications is not supported. The policy states that current evidence does not support tissue-based post-heart GEP for any indications and that dd-cfDNA tests for lung without sufficient evidence of clinical utility and validity are not considered medically necessary.

The policy and referenced literature make no recommendation to perform routine HLA typing post-transplant. OPTN and guidance documents describe pre-registration and pre-transplant HLA reporting requirements, and technical recommendations emphasize pretransplant donor and recipient typing; the source notes explicitly that there is no mention of performing HLA typing post-transplantation.

Across organ types, the policy clarifies that current evidence does not support use of dd-cfDNA or gene expression panels for indications outside the specific, listed coverage criteria. Each test (heart, kidney, lung, peripheral blood GEP) is described as medically necessary only when its stated conditions are met; otherwise the evidence is insufficient to support use for other indications.

Tests that lack established clinical utility or validity as defined by the Concert policy and absent independent technology assessments or guideline support are considered unsupported and do not meet the threshold for coverage. The policy specifies that evidence such as an independent Technology Assessment or evidence-based society guideline must be identified for coverage; when such evidence is not present, the tests are not covered.

Billing Codes, Diagnosis, and Coding Rules

Common billing / example test CPT/PLA codes referencedmixed

0055U	myTAIHEART (TAI Diagnostics) - example dd-cfDNA for heart
0118U	Viracor TRAC dd-cfDNA - example
0493U	Prospera (Natera) - example
0508U	VitaGraft Kidney Baseline + 1st Plasma Test
0509U	VitaGraft Kidney Subsequent
81479	Unlisted molecular pathology procedure (used as common billing code)
81595	Gene expression profiling (e.g., AlloMap)
0087U	Molecular Microscope (MMDx) - tissue gene expression
81370	HLA typing codes (group includes multiple CPTs listed)
81371	HLA typing

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Diagnosis / transplant status codes referencedICD-10

Z48.21	Encounter for aftercare following heart transplant
Z94.1	Heart transplant status
T86.11	Kidney transplant complication
T86.12	Kidney transplant rejection
Z94.0	Kidney transplant status
T86.810	Lung transplant complication
Z48.24	Encounter for aftercare following lung transplant
Z94.2	Lung transplant status

inv-18: Prior testing interval — Not performed within the previous 12 months

Prior testing intervalNot performed within the previous 12 months

Applies toKidney, lung, and heart dd-cfDNA criteria where specified

Provider actionDocumentation must confirm prior test timing when required (e.g., not performed in past 12 months)

inv-19: Post-heart transplant GEP eligible window — >= 2 months and < 5 years post-transplant

Eligible post-transplant window>= 2 months and < 5 years post-transplant

Age requirementMember must be age 18 years or older

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required: Prior authorization is required for transplant-related molecular testing (peripheral blood dd-cfDNA and post‑transplant gene expression panels). Tests must meet coverage criteria demonstrating transplant status and clinical indication before authorization will be approved.

Ordering clinician must document transplant type and transplant date.
Coverage default: one test per 12 months for routine surveillance unless clinical criteria justify more frequent testing.

Note

Limited Coverage — Qualified Ordering Required

Limited coverage and qualified ordering: CMS MolDX LCD provides limited coverage for molecular diagnostic tests used to evaluate and manage solid organ transplant recipients. Tests should be ordered by qualified physicians affiliated with a transplant center and used as part of an overall clinical assessment.

Qualified ordering clinicians: transplant physicians or clinicians affiliated with transplant centers.
Tests may be particularly useful when biopsy is contraindicated or when biopsy results are inconclusive.

Candidate and Recipient Test Eligibility

Organ-specific candidate and recipient criteria

Organ-specific candidate and recipient criteria summary:

Heart transplant: dd-cfDNA covered post-heart transplant if not performed within prior 12 months; peripheral blood GEP covered for low-risk adults between 2 months and <5 years post-transplant; tissue GEP not supported for routine use.

See ASTS/ISHLT contexts; routine dd-cfDNA default frequency once every 12 months.

Kidney transplant: dd-cfDNA covered if not performed within prior 12 months and when there are clinical signs of rejection, inconclusive biopsy, or monitoring of immunosuppression.

Serial testing rationale should be documented when used for surveillance.

Lung transplant: dd-cfDNA assays with sufficient evidence may be covered if not performed within prior 12 months; assays lacking established validity are not supported.

Emerging tests with insufficient evidence are excluded from coverage.

Post-Transplant Monitoring and Surveillance Coverage

inv-45: dd-cfDNA peripheral blood testing — routine monitoring frequency defaulted to once every 12 months when no guideline exists

Routine monitoring frequency (default)Once every 12 months when no evidence-based guideline frequency exists

Intended useUsed for routine surveillance or to inform biopsy decisions alongside clinical assessment

OrderingShould be ordered by qualified physicians affiliated with a transplant center per MolDX LCD guidance

inv-46: Peripheral blood gene expression panel — AlloMap may be used in low-risk adult heart transplant recipients within specified window

Allowed use of AlloMapPeripheral blood GEP (AlloMap) may be used in low-risk adult heart transplant recipients between 2 months and 5 years post-transplant to reduce endomyocardial biopsy frequency

Age restriction

Definitions

inv-30: Definition — dd-cfDNA (donor-derived cell-free DNA) description

DefinitionDonor-derived cell-free DNA (dd-cfDNA): peripheral blood measurement of donor-origin DNA fragments used to assess allograft injury or rejection

Clinical usesUsed to evaluate probability of allograft rejection, assess immunosuppression adequacy, or as a rule-out test in validated populations

Test settingNoninvasive peripheral blood assay to complement clinical assessment and, when appropriate, inform biopsy decisions

inv-31: Definition — Gene expression panels (peripheral blood or tissue) description

DefinitionGene expression panels: assays of peripheral blood or allograft tissue (e.g., AlloMap, Molecular Microscope/MMDx) used to stratify rejection risk after transplantation

Modalities

Pre-testing Evaluation and Laboratory Reporting Requirements

Documentation Required

Evaluation required — confirm transplant status, timing, and clinical context before testing

Before testing, document transplant status, time since transplant, and the clinical context (signs of rejection, biopsy findings, or immunosuppression monitoring) to justify the test.

Include transplant date to verify eligibility windows (e.g., AlloMap: ≥2 months and <5 years post–heart transplant).
Describe current clinical findings or reason for surveillance.

Billing Rule

Laboratory reporting — HLA loci and final crossmatch before waitlist/ transplant

For candidates being registered on transplant waitlists, laboratories must report required HLA loci (OPTN: A, B, Bw4, Bw6, DR) to the transplant program prior to registration and perform the final crossmatch prior to transplant as specified by OPTN policy.

Contraindications and Unsupported Testing

No explicit absolute contraindications to transplantation testing are listed in the policy excerpt. Instead, the document treats tests with insufficient evidence (for example, certain lung dd-cfDNA assays and tissue GEP post-heart) as unsupported and therefore not medically necessary; such insufficient-evidence tests should be considered non-covered rather than contraindicated.

The excerpt does not list any explicit contraindications. It reiterates that where evidence is limited or not identified, those tests are not supported and do not meet coverage criteria.

Center and Ordering Requirements

Note

Center applicability — policy covers transplant molecular testing; no center accreditation required

This policy applies to molecular testing used during the solid organ transplantation process; no explicit center accreditation or minimum volume requirements are specified in the policy.

Policy scope includes tissue and peripheral blood molecular tests used for transplantation.
No center-level accreditation or volume thresholds are listed in this section.

Step Therapy

Center requirement — order tests by qualified transplant-affiliated physicians

Ordering of dd-cfDNA and other molecular diagnostic tests should be performed by qualified physicians affiliated with a transplant center, consistent with MolDX LCD expectations.

Ensure the ordering clinician is a qualified transplant-affiliated physician.
Document the clinician's affiliation with a transplant center when submitting authorization or claims.

OpenPayer

CONCERT Genetic Testing: Transplant — Coverage Criteria for dd-cfDNA, Gene Expression Panels, and HLA Typing

Coverage Criteria for Transplant Molecular Testing

Billing Codes, Diagnosis, and Coding Rules

Provider Requirements, Prior Authorization, and Documentation

Candidate and Recipient Test Eligibility

Post-Transplant Monitoring and Surveillance Coverage

Definitions

Pre-testing Evaluation and Laboratory Reporting Requirements

Contraindications and Unsupported Testing

Center and Ordering Requirements