CONCERT GENETIC TESTING: TRANSPLANT
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Defines medical necessity and coding guidance for donor-derived cell-free DNA, gene expression panels, and HLA typing used in evaluation and monitoring of solid-organ and bone marrow transplantation for members of Arizona Complete Health.
A default frequency of coverage of once every 12 months for serial dd-cfDNA testing in kidney and lung transplant recipients was adopted.
Post Heart Transplant Gene Expression Panels for Rejection Risk via Peripheral Blood criteria: added criterion that the member must be age 18 years or older.
Post Heart Transplant Gene Expression Panels for Rejection Risk via Tissue criteria: the phrase 'for all indications' was added to the criteria set.
Policy language changed from 'investigational' to 'current evidence does not support' for certain lung dd-cfDNA testing statements.
Coverage Criteria for Molecular and Genetic Tests in Transplantation
Donor-Derived Cell-free DNA for Heart Transplant Rejection
Covered when ALL of the following are met
ASTS/ISHLT guidance referenced; default frequency once every 12 months for routine monitoring.
Post Heart Transplant Gene Expression Panels via Peripheral Blood
Covered when ALL of the following are met
ISHLT 2023 supports use in low-risk adults to reduce endomyocardial biopsy frequency.
Post Heart Transplant Gene Expression Panels via Tissue
MMDx may improve discrimination between rejection types but is not routinely used or widely available.
Donor-Derived Cell-free DNA for Kidney Transplant Rejection
Covered when ALL of the following are met
Evidence supports use in these scenarios; example tests: AlloSure Kidney, Prospera.
Evidence-Based Donor-Derived Cell-free DNA for Lung Transplant Rejection
Covered when ALL of the following are met
Examples include Prospera Lung and AlloSure Lung when evidence supports use; ordering by qualified transplant-affiliated physicians per MolDX LCD.
HLA Typing for Transplantation
Covered when ALL of the following are met
Full HLA typing is required for HCT donor selection; OPTN/UpToDate/NMDP guidance referenced.
Donor-Derived Cell-free DNA: Covered with criteria
dd-cfDNA testing is covered when ONE of the following intended uses is documented:
Follow CMS MolDX LCD criteria; tests should be ordered by qualified physicians affiliated with a transplant center.
Post-Heart Transplant Peripheral Blood GEP: Covered with criteria
Peripheral blood GEP (e.g., AlloMap) is covered when ALL of the following are met:
ISHLT 2023 recommendation specific to adults; pediatric use not generally recommended.
Post-Heart Transplant Tissue GEP: Informational/conditional
Tissue-based molecular testing (e.g., MMDx):
Informational/conditional; availability limits routine coverage.
HLA Typing: Required for transplant evaluation and listing processes
HLA typing for transplantation is required as part of transplant evaluation and listing processes:
OPTN requirements effective 10/31/2024; technical recommendations from Tait et al. and NMDP/ASTCT referenced.
The policy identifies certain tests as emerging/insufficient evidence and not routinely covered when evidence of clinical validity or utility is lacking. Specifically, tissue‑based gene expression panels (post‑heart transplant GEP via tissue) and donor‑derived cell‑free DNA (dd‑cfDNA) assays for lung transplant that do not have sufficient supporting evidence are not supported for routine use. Coverage is limited to the organ‑ and indication‑specific criteria explicitly listed elsewhere in this policy; tests without established evidence are excluded outside those criteria.
Tests that lack established clinical validity or utility as defined by the plan’s general genetic testing policy do not meet the threshold for coverage. Evidence of validity may include independent technology assessments or evidence‑based society guidelines; when such evidence is not identified for a given test, that test is not covered for transplant management.
Current evidence supports use of peripheral blood dd‑cfDNA and gene expression panels (GEP) only for the specific organ‑ and indication‑based scenarios listed in this policy. Use of peripheral blood dd‑cfDNA or GEP testing for transplant management for indications other than those explicitly enumerated for each organ (heart, kidney, lung) is not supported by the available evidence and therefore is not covered.
For lung transplantation, the policy explicitly does not support use of dd‑cfDNA tests that lack evidence of clinical validity. Only dd‑cfDNA assays with sufficient published evidence of validity and clinical utility (i.e., tests meeting the policy’s evidence criteria) are considered for coverage; tests without such evidence are not supported for diagnosis of lung allograft rejection.
Coding and Billing Guidance
| T86.11 | |
| T86.12 | |
| T86.810 | |
| Z48.21 | |
| Z48.24 | |
| Z94.1 | |
| Z94.0 | |
| Z94.2 |
| MolDX L38582 | MolDX: Molecular Testing for Solid Organ Allograft Rejection LCD |
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Provider action: Prior authorization is required for donor-derived cell-free DNA (dd-cfDNA) and other molecular tests used to evaluate solid organ allograft status. Prior authorization must document the clinical indication and intended use per MolDX/CMS guidance (see items).
- Prior authorization must indicate the test is being ordered by a qualified physician (e.g., physician affiliated with a transplant center).
- Prior authorization should state the intended use consistent with MolDX LCD: to assist evaluation of adequacy of immunosuppression, as a rule-out test for active rejection (AR) in validated populations, to further evaluate allograft status after physician pretest assessment, or to assess rejection when biopsy is inconclusive/insufficient.
Clinical indication and timing requirement
Documentation must demonstrate the clinical indication and timing for testing. For transplant recipients, document that a transplant occurred and the organ type. For routine monitoring, testing should not have been performed within the prior 12 months unless clinical circumstances justify more frequent testing.
- For heart transplant dd-cfDNA: member has undergone heart transplant; testing not performed in past 12 months (default frequency = once every 12 months for routine monitoring unless guideline-based regimen specifies otherwise).
- For kidney and lung transplant dd-cfDNA: member has undergone the respective transplant and the test was not performed in the prior 12 months.
- When used for clinical suspicion of rejection, include signs/symptoms, biopsy results (if performed), or rationale for assessing immunosuppression adequacy.
Heart dd-cfDNA outside indications
Heart dd-cfDNA outside specified indications is not supported by current evidence. Use of dd-cfDNA for indications other than documented post-heart transplant management or the limited intended uses described by MolDX/CMS may be considered experimental and subject to denial.
- Routine or investigational uses beyond: (a) ruling out subclinical rejection in heart transplant recipients, (b) per-authorized clinical suspicion evaluation, or (c) situations meeting MolDX intended-use criteria are not supported.
- If ordering for an off-label or investigational purpose, include supporting literature and clear clinical rationale in the prior authorization request.
Required clinical documentation
Required clinical documentation must be submitted with the prior authorization request to support the intended use. Documentation should allow the reviewer to verify transplant status, timing of prior dd-cfDNA testing, and the clinical rationale for testing per MolDX/CMS intended uses.
- Proof of transplant (operative note, discharge summary, or transplant center record) and organ type.
- Date and result of any dd-cfDNA or related molecular test within the prior 12 months, if applicable.
- Clinical signs or symptoms suggesting rejection, biopsy results (diagnostic, inconclusive, or insufficient), or documentation that the test is being used to evaluate adequacy of immunosuppression.
- Name and affiliation of ordering clinician (physician affiliated with a transplant center) and how the test result will inform a management decision (e.g., alter biopsy plan or immunosuppression).
Qualified ordering clinician and intended use
Providers should ensure the ordering clinician is qualified and affiliated with a transplant center and clearly state the intended use on the request. Tests ordered outside these parameters may not meet coverage criteria.
- Ordering clinician: physician considering diagnosis of active rejection affiliated with a transplant center.
- Intended-use statement: one of the MolDX/CMS-listed purposes (evaluate immunosuppression adequacy; rule-out AR in validated populations; further evaluate allograft status after physician pretest; assess rejection when biopsy inconclusive).
Background and Context
Donor‑derived cell‑free DNA (dd‑cfDNA) is a peripheral blood assay that measures donor‑derived DNA fragments to assess allograft injury or rejection and is used for noninvasive monitoring after solid‑organ transplantation. Gene expression panels (GEP) can be performed on peripheral blood (e.g., AlloMap) or on allograft tissue (e.g., MMDx) to profile expression patterns and estimate rejection risk. HLA typing is molecular testing of HLA loci performed for donor/recipient matching and transplant evaluation, and is required in candidate evaluation and listing processes per transplant guidance. Policy coverage for these modalities is organ‑ and indication‑specific and depends on demonstrated clinical validity, utility, and guideline alignment.
Definitions
Candidate and Donor HLA Typing Criteria
HLA candidate situations
From HLA Typing section; used to identify candidate-related situations requiring HLA testing.
Candidate HLA typing requirements
HLA typing and reporting requirements for transplant candidates and donors:
OPTN requirements; Tait et al. technical recommendations referenced.
Evaluation and Documentation Requirements
Evaluation requirements: document transplant timing and clinical context
Evaluation submissions must document transplant status, the timing of the test relative to transplant (e.g., months since transplant), and the clinical context such as signs or symptoms of rejection, biopsy results, or reason for immunosuppression monitoring.
- Report months since transplant (e.g., 2–60 months for post‑heart peripheral blood GEP when applicable).
- Provide relevant clinical data: graft function tests, biopsy findings, symptoms, or other assessments supporting the request.
Transplant Center Requirements
Center requirement: order through transplant‑affiliated physicians
Tests such as dd‑cfDNA and related molecular diagnostics should be ordered by physicians affiliated with a transplant center, consistent with the CMS MolDX LCD.
- Authorization should include the ordering clinician’s transplant center affiliation.
Post-Transplant Monitoring and Surveillance Coverage
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