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    v1.0.28
    OpenPayerPolicy Updatesmediviewcurativemediviewcurative Heart Transplant Coverage Update …
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    CurrentmediviewcurativePolicy MM-PNP-032

    Heart transplantation medical necessity criteria and technology positions

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    Defines Curative Health Plan's medical necessity, selection criteria, contraindications, and related coverage positions for human heart transplantation and certain related technologies; intended for use by the Medical Utilization Management (UM) department.

    Policy Summary
    Payermediviewcurative
    PolicyHeart transplantation medical necessity criteria and technology positions
    Policy CodePolicy MM-PNP-032
    Change TypeNo material change
    Effective DateDec 1, 2023
    Next Review Date
    Key ActionSubmit heart transplant prior authorization requests for medical necessity review when member meets transplant center protocol or listed selection criteria and has no absolute contraindications.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    NYHA III-IVrequired severity for adult candidates
    CD4 >200HIV criterion
    AlloMap >6mAlloMap allowed
    Bridge onlyTotal Artificial Heart

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    MultipleContraindications

    Heart Transplant Coverage Criteria & Technology Positions

    Heart transplant coverage criteria and technology positions

    Covered when the member meets the transplanting institution’s protocol eligibility criteria. In the absence of a protocol, the following indications, selection criteria, and absence of contraindications apply.

    ALL of the following

    • ANY of the following

      • Cardiac arrhythmia
      • Cardiac re-transplantation due to graft failure
      • Cardiomyopathy (nutritional, metabolic, hypertrophic, restrictive)
      • Congenital heart disease
      • End-stage ventricular failure
      • Idiopathic dilated cardiomyopathy
      • Inability to be weaned from temporary cardiac-assist devices after myocardial infarction or non-transplant cardiac surgery
      • Intractable coronary artery disease
      • Myocarditis
      • Postpartum cardiomyopathy
      • Right ventricular dysplasia/cardiomyopathy
      • Valvular heart disease

    ALL of the following

    • NYHA class III or IV for adults (NYHA criteria do not apply to pediatric members)
    • Member has potential for conditioning and rehabilitation after transplant (not moribund)
    • Life expectancy greater than 2 years in the absence of cardiovascular disease
    • No active malignancy (exceptions: non-melanomatous skin cancer or low-grade prostate cancer), or malignancy completely resected or adequately treated with low likelihood of recurrence
    • Adequate pulmonary, liver, and renal function
    • Absence of active infections that are not effectively treated

    ANY of the following

    • Irreversible end-organ disease (e.g., renal, hepatic, pulmonary) unless dual-organ transplantation is planned
    • Severe pulmonary hypertension with irreversibly high pulmonary vascular resistance
    • Recent intracranial cerebrovascular event with significant persistent deficit
    • Bleeding peptic ulcer
    • Presence of hepatitis B antigen
    • Diverticulitis
    • Immediately life-threatening neuromuscular disorders

    ALL of the following

    • Total Artificial Heart: FDA‑approved total artificial hearts (e.g., CardioWest/SynCardia) are medically necessary when used as a bridge to transplant for transplant‑eligible members at imminent risk of death (NYHA Class IV) due to biventricular failure awaiting heart transplantation. Total artificial heart used as permanent destination therapy is considered experimental/investigational.
    • AlloMap gene expression profile: medically necessary for monitoring rejection in heart transplant recipients more than 6 months post‑transplant; considered experimental/investigational for all other indications.
    • The following are considered experimental/investigational because clinical value/safety/effectiveness have not been established: cardiac xenotransplantation (porcine xenografts); Heartsbreath Test; cytokine gene polymorphism testing for graft rejection; immune repertoire sequencing assay; myTAIHEART testing; measurement of cardiac troponins for acute cellular rejection diagnosis or primary graft failure prognosis; donor‑derived cell‑free DNA tests (Allosure/Prospera) for rejection monitoring; Heart Molecular Microscope Diagnostic System (MMDx‑Heart); TransMedics Organ Care System for donor heart preservation and transport; and use of machine learning/artificial intelligence in cardiac transplantation.

    Billing / Codes & Related Criteria

    No billing or CPT/ICD codes specified in documentmixed
    No codes listed
    Minimum expected non-cardiac life expectancy
    Minimum expected non-cardiac life expectancy> 2 years

    Prior Authorization and Medical Necessity Review

    Prior Authorization

    Prior authorization / medical necessity review required for heart transplantation

    Prior authorization (medical necessity) review required for heart transplantation requests. Review applies when a member meets the transplanting institution's protocol eligibility criteria or, if no protocol exists, when the listed indications and all selection criteria are met and no absolute contraindications are present. Documentation should demonstrate NYHA class III or IV (adults), potential for post‑transplant rehabilitation (not moribund), life expectancy >2 years absent cardiovascular disease, adequate pulmonary/liver/renal function, absence of active untreated infection, HIV control per criteria (CD4 >200 cells/mm3 for >6 months, undetectable HIV‑1 RNA, on stable ART >3 months, no AIDS complications), absence of active or recurrent pancreatitis, absence of diabetes with severe end‑organ damage, and no uncontrolled psychiatric or substance dependence that would impair compliance.

    • Authorize only when member meets transplanting institution protocol or, if none, when all selection criteria are documented and no absolute contraindications exist.
    • Required documentation must include evidence for NYHA class III or IV (adults), life expectancy >2 years (non‑cardiac), and organ function assessments (pulmonary, hepatic, renal).
    • For members with HIV, include CD4 counts (>200 cells/mm3 for >6 months), HIV‑1 RNA results (undetectable), and duration of stable ART (>3 months).
    • Document absence of active/uncontrolled infections, active malignancy (or documentation of adequately treated/resolved malignancy), pancreatitis, severe diabetes end‑organ damage, and behavioral health/substance use stability.

    Definitions and Functional Classifications

    Definitions
    Definitions section statusN/A (no general definitions provided in this policy)
    Selection criteria referenceSelection criteria and terms (e.g., NYHA classification, life expectancy, infection/HIV criteria) are defined within Selection Criteria section
    Technology and procedure termsSpecific device/test terms (Total Artificial Heart, AlloMap) are described in Technology Policy and Experimental lists
    NYHA Class III and IV
    NYHA Class IIIMarked limitation of physical activity; comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
    NYHA Class IVInability to carry on any physical activity without discomfort; symptoms may be present at rest and any activity increases discomfort.
    Policy Summary
    Payermediviewcurative
    PolicyHeart transplantation medical necessity criteria and technology positions
    Policy CodePolicy MM-PNP-032
    Change TypeNo material change
    Effective DateDec 1, 2023
    Next Review Date
    Key ActionSubmit heart transplant prior authorization requests for medical necessity review when member meets transplant center protocol or listed selection criteria and has no absolute contraindications.
    SourceLink
    On This Page
    Heart Transplant Coverage Criteria & Technology PositionsBilling / Codes & Related CriteriaPrior Authorization and Medical Necessity ReviewDefinitions and Functional Classifications
    Absence of uncontrolled HIV infection defined as: CD4 > 200 cells/mm3 for > 6 months; undetectable HIV-1 RNA; on stable antiretroviral therapy > 3 months; and no other AIDS complications (e.g., opportunistic infections or AIDS-related neoplasms)
  1. Absence of active or recurrent pancreatitis
  2. Absence of diabetes with severe end-organ damage (e.g., neuropathy, nephropathy with declining renal function, proliferative retinopathy)
  3. No uncontrolled or untreated psychiatric disorders that would interfere with compliance to a strict treatment regimen
  4. No active alcohol or chemical dependency that would interfere with compliance to a strict treatment regimen
  5. HIV/AIDS with profound immunosuppression (CD4 < 200 cells/mm3)
  6. AL amyloidosis (exceptions may be made when curative therapy has been performed or is planned, e.g., stem cell transplantation or liver transplantation)
    7. ApplicabilityNYHA Class III or IV requirement applies to adult members (does not apply to pediatric members).