ModifiedAmbetter NevadaPolicy N/A

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

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Defines medical necessity and coverage criteria for donor-derived cell-free DNA, gene expression panels, and HLA typing used in evaluation, monitoring, and rejection assessment for solid organ transplant recipients and donors.

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ModifiedAmbetter NevadaPolicy N/A

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

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Policy Summary

PayerAmbetter Nevada

PolicyTransplant molecular testing: dd-cfDNA, peripheral blood and tissue GEP, HLA typing

Policy CodePolicy N/A

Change TypeConsolidationage restrictionwording revision

Effective DateN/A

Next Review DateN/A

Key ActionConfirm transplant status, timing since transplant, and clinical indication when requesting dd-cfDNA or gene expression testing and document prior testing within 12 months where required.

SourceLink

POLICY UPDATE CHANGES

New policy developed consolidating criteria from prior Concert policies into a unified transplant molecular testing policy.

Member must be age 18 years or older for specified criteria, aligning with guideline recommendations.

Replaced language 'investigational' with 'current evidence does not support' for some emerging dd-cfDNA statements.

Added phrase 'for all indications' to post-heart transplant tissue gene expression criteria for consistency.

12 monthsdd-cfDNA default surveillance frequency

2–5 yrsPost-heart peripheral blood GEP window

>=18Age requirement for specified GEP

once/12moSurveillance default (when no guideline exists)

examplesClinical indications listed

L38582MolDX LCD referenced

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

1–10 of 17

1/2

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.

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.

Policy Summary

PayerAmbetter Nevada

PolicyTransplant molecular testing: dd-cfDNA, peripheral blood and tissue GEP, HLA typing

Policy CodePolicy N/A

Change TypeConsolidationage restrictionwording revision

Effective DateN/A

Next Review DateN/A

Key ActionConfirm transplant status, timing since transplant, and clinical indication when requesting dd-cfDNA or gene expression testing and document prior testing within 12 months where required.

SourceLink

On This Page

Risk requirementMember must be low-risk for organ rejection to qualify

inv-20: Surveillance frequency — default once every 12 months

Default surveillance frequencyOnce every 12 months (default for routine monitoring when no specific guideline frequency exists)

RationaleAdopted where clear, specific, evidence-based guideline recommendations for serial dd-cfDNA are absent

Applies toSerial dd-cfDNA surveillance and routine monitoring in post-transplant recipients absent test-specific guideline regimen

Tests may be particularly useful when biopsy is contraindicated or when biopsy results are inconclusive.

Documentation Required

Intended Use Requirements

Intended use requirements per MolDX LCD: The test must be ordered for one of the following intended uses: to assess adequacy of immunosuppression (as a non‑invasive alternative when biopsy information would change management); as a rule‑out test for acute rejection in validated populations to help decide on biopsy; to further evaluate allograft status after physician pretest assessment; or to assess rejection when a biopsy is inconclusive or insufficient.

Documentation Required

Supporting Clinical Documentation Required

Supporting clinical documentation: Medical records must support the intended use at time of order and prior authorization. Documentation should include transplant status, organ type and transplant date, clinical indication (e.g., suspected rejection, monitoring immunosuppression), prior test timing, and any biopsy results or reasons biopsy is contraindicated or inconclusive.

Include date and type of transplant and whether prior dd‑cfDNA or GEP testing was performed (and date).
State the clinical intent (rule‑out rejection, assess immunosuppression adequacy, or evaluate inconclusive biopsy).
Attach relevant biopsy reports and other clinical evaluations when available.

Denial Risk

Denial Risk for Unsupported Indications

Unsupported indications risk denial: Tests ordered without a demonstrated transplant status, without documentation of intended use per the MolDX LCD, or for indications outside the medically necessary criteria (e.g., routine screening outside specified surveillance intervals or non‑validated uses) may be denied.

Orders lacking clear intended use related to evaluation of immunosuppression or suspected rejection risk denial.
Testing for indications not supported by the policy or MolDX LCD is not covered.

Pre-Transplant HLA Workup

Pre-transplant evaluation and candidate testing (HLA workup):

HCT candidates and donors: If allogeneic hematopoietic cell transplantation is potentially indicated, perform HLA typing of the patient and potential family donors at diagnosis and initiate a preliminary unrelated donor search per NMDP guidance.

Full HLA typing required and early donor search recommended per NMDP/ASTCT.

OPTN reporting for waitlist registration: Perform HLA typing and report HLA A, B, Bw4, Bw6, and DR for kidney/kidney–pancreas/pancreas/pancreas islet candidates prior to waitlist registration; perform and report final crossmatch prior to transplant where applicable.reporting prior to waitlist registration and pre-transplant crossmatch

OPTN policy effective 10/31/2024.

Recommendation specific to adults; pediatric data insufficient

Clinical contextUse to identify low risk of acute cellular rejection and potentially decrease biopsy frequency

inv-47: Peripheral blood GEP (AlloMap), tissue GEP (MMDx), dd-cfDNA testing, HLA typing and reporting — coverage allowed with clinical intent per MolDX LCD; adult age restrictions for some GEP tests

Coverage stancePeripheral blood GEP (AlloMap), tissue GEP (MMDx), dd-cfDNA testing, and HLA typing are allowed when used with appropriate clinical intent per the MolDX LCD

Ordering requirementsTests should be ordered by qualified physicians affiliated with a transplant center and used to inform biopsy decisions or immunosuppression management

Age and test-specific limitsAdult-only restriction applies for some peripheral blood GEP criteria (e.g., AlloMap) per guideline data

Includes peripheral blood GEP (AlloMap) and tissue GEP (MMDx) with different clinical applications and availability

PurposeUsed to identify low risk of acute cellular rejection or to discriminate T-cell versus antibody-mediated rejection on tissue analysis

inv-32: Definition — HLA typing description

DefinitionHLA typing: laboratory testing to determine human leukocyte antigen compatibility for donors and recipients in transplantation

Pre-registration reportingLaboratories must report HLA A, B, Bw4, Bw6, and DR prior to waitlist registration for certain organs per OPTN requirements

UsesRequired for donor selection, transplant compatibility assessment, and final crossmatch prior to transplant when applicable

inv-33: Definition — Peripheral blood GEP description (AlloMap example)

Example testAlloMap (peripheral blood gene expression panel) — used to identify low risk of current acute cellular rejection in adult heart transplant recipients

Indication windowMay be used in low-risk adults between 2 months and 5 years post-heart transplant to reduce EMB frequency

LimitationRecommendation specific to adults; not supported for other indications outside stated criteria

inv-34: Definition — Tissue GEP / MMDx description

DefinitionTissue gene expression testing (MMDx): molecular analysis of allograft tissue to discriminate T-cell mediated vs antibody-mediated rejection and tissue injury

AvailabilityMay improve diagnostic discrimination but is not routinely used or universally available

Coverage stanceCurrent policy does not support routine use of tissue GEP for all indications post-heart transplant

inv-35: Definition — dd-cfDNA (alternate entry) circulating donor-specific cfDNA measurement

Alternate definitiondd-cfDNA: circulating donor-specific cell-free DNA measurement used to evaluate probability of allograft rejection and assist management decisions (e.g., whether to obtain biopsy)

Intended use per MolDX LCDAssist evaluation of immunosuppression adequacy, rule-out of acute rejection in validated populations, further evaluation after physician-assessed pretest, or assess inconclusive biopsy results

Ordering and contextShould be considered alongside other clinical evaluations and may be particularly useful when biopsy is contraindicated

Report HLA A, B, Bw4, Bw6, and DR prior to waitlist registration for kidney and related candidates.
Ensure final crossmatch is performed and reported prior to transplant for kidney or multiorgan transplants involving kidney.

Billing Rule

Laboratory responsibilities — HLA reporting and crossmatch obligations

Laboratories reporting HLA results and performing final crossmatches should follow OPTN guidance—report required loci before registration and complete final crossmatch prior to transplant to meet candidate evaluation requirements.

Follow OPTN effective requirements for pre-registration HLA reporting.
Document completion of final crossmatch and communicate results to the transplant program.