CurrentAmbetter NevadaPolicy CP.MP.138

Clinical Policy: Pediatric Heart Transplant

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Medical necessity criteria and coverage guidance for heart transplantation and re-transplantation in pediatric members (under age 18) with end-stage heart disease, including candidate selection, contraindications, and coding implications for Ambetter Nevada.

Policy Summary

PayerAmbetter Nevada

PolicyClinical Policy: Pediatric Heart Transplant

Policy CodePolicy CP.MP.138

Change TypeRevised clinical and operational criteria

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating age <18, candidate meets indications, reversible causes ruled out, GFR ≥30 (unless multiorgan), and for HIV-positive candidates include CD4 >200, viral load and effective ART.

SourceLink

POLICY UPDATE CHANGES

Updated glomerular filtration rate contraindication from < 40 mL/min/1.73m2 to < 30 mL/min/1.73m2.

Expanded qualifying criteria for HIV-positive candidates to include documented CD4 >200, absence of active AIDS-defining opportunistic infection, and current effective antiretroviral therapy.

Added pulmonary hypertension with potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance as an indication for transplant consideration.

Removed BMI appendix and edited BMI-related contraindication language (removal of explicit Appendix A and earlier BMI sentence).

Clarified inability to adhere to post-transplant regimen as a contraindication even with caregiver support.

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CurrentAmbetter NevadaPolicy CP.MP.138

Clinical Policy: Pediatric Heart Transplant

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Policy Summary

PayerAmbetter Nevada

PolicyClinical Policy: Pediatric Heart Transplant

Policy CodePolicy CP.MP.138

Change TypeRevised clinical and operational criteria

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Updated glomerular filtration rate contraindication from < 40 mL/min/1.73m2 to < 30 mL/min/1.73m2.

Expanded qualifying criteria for HIV-positive candidates to include documented CD4 >200, absence of active AIDS-defining opportunistic infection, and current effective antiretroviral therapy.

Added pulmonary hypertension with potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance as an indication for transplant consideration.

Removed BMI appendix and edited BMI-related contraindication language (removal of explicit Appendix A and earlier BMI sentence).

Clarified inability to adhere to post-transplant regimen as a contraindication even with caregiver support.

Coverage Criteria for Pediatric Heart Transplantation

Initial transplant coverage criteria

Covered when ALL of the following are met:

Core eligibility

Primary indications for heart transplantation (I.A.1)
- Stage C severe features: Any of: peak VO2 <50% predicted; systemic ventricular dysfunction with growth failure attributable to heart disease; near sudden death/life-threatening arrhythmias untreatable medically or with ICD; restrictive cardiomyopathy with reactive pulmonary HTN; reactive pulmonary hypertension with risk of fixed PVR
  See I.A.1.b.i-v
- Anatomic/physiologic CHD conditions: Certain anatomic and physiological conditions likely to worsen the natural history of previously repaired or palliated CHD that may lead to consideration for heart transplantation without severe systemic ventricular dysfunction, including pulmonary hypertension at risk for fixed PVR; severe aortic or systemic AV valve insufficiency not amenable to surgical correction; severe arterial oxygen desaturation not amenable to surgical correction
  See I.A.1.b.vi.a-c
- Single ventricle infant conditions: In infant patients with a functional single ventricle: severe proximal coronary artery stenosis/atresia; moderate to severe AV or systemic semilunar valve stenosis/insufficiency; or severe ventricular dysfunction
  See I.A.1.c.i-iii
Re-transplant indication: Moderate to severe cardiac graft vasculopathy
I.A.2
Life expectancy and reversible causes: Life expectancy in the absence of cardiopulmonary disease ≥ 2 years AND all reversible causes of heart failure have been ruled out (examples include anemia, hypertension, renal failure, acidosis, obesity, malnutrition, respiratory disorders, and thyroid disorders)life expectancy ≥2 years
I.B and I.C

Contraindications absent: Does not have any contraindications listed in section I.D (examples include GFR < 30 mL/min/1.73m2 unless multiorgan transplant; uncontrolled infections; severe fixed pulmonary vascular resistance; recent/recurrent malignancy with high risk; advanced liver disease unless multiorgan transplant; inability to adhere to regimen; active substance dependence; inadequate social support)

See I.D for full list

Specific contraindications exclude coverage for pediatric heart transplantation. Key absolute or relative exclusions include a glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 (unless being considered as part of a multi-organ transplant) and active or uncontrolled infections such as active tuberculosis. Other important exclusions are recent or recurrent malignancy with high risk of recurrence or death, chronic infection with highly virulent or resistant microbes that are poorly controlled pre-transplant, inability to adhere to the post-transplant regimen even with caregiver support, absence of adequate social support, progressive cognitive impairment, significant chest wall or spinal deformity expected to severely restrict post-transplant function, and active substance use or dependence (including current tobacco/vaping, marijuana use unless prescribed, or IV drug use without convincing evidence of risk-reduction behaviors).

Retransplantation has specific timing-related exclusions. Coverage is not appropriate when retransplantation is performed during an episode of ongoing, acute allograft rejection, and retransplantation performed within the first six months after the primary transplant is also considered not appropriate.

Candidate Selection

Candidate criteria

Candidate selection requires meeting clinical indications and absence of contraindications.

Candidate eligibility: Age < 18; meets indication(s) in policy I.A; life expectancy ≥ 2 years without cardiopulmonary disease; all reversible causes of heart failure have been evaluated and ruled out; no contraindications listed in I.D

Full candidate evaluation per policy

Absolute and Relative Contraindications

Contraindications — See the policy exclusions for the complete list. Notable contraindications include GFR < 30 mL/min/1.73 m2 (unless part of a planned multi-organ transplant), uncontrolled or chronic severe infections (including active tuberculosis), recent or recurrent malignancy with high risk of recurrence or death, severe fixed pulmonary vascular resistance, active substance dependence or ongoing substance use without demonstrated risk-reduction, inability to adhere to required post-transplant care even with caregiver support, inadequate social support, and other severe uncontrolled medical conditions expected to limit survival after transplant.

Coding and Key Clinical Thresholds

Referenced CPT CodesCPT

33944	Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation.
33945	Heart transplant, with or without recipient cardiectomy

inv-05: GFR threshold

Renal function contraindicationGFR < 30 mL/min/1.73m2 (exclusion to transplant candidacy unless considered for multiorgan transplant)

Operational change notedPreviously GFR < 40 mL/min/1.73m2; revised to < 30 mL/min/1.73m2 in the current policy update

Related exclusion examplesAcute renal failure with rising creatinine or on dialysis and low likelihood of recovery is separately listed as a contraindication

inv-06: HIV CD4 threshold

HIV candidate CD4 thresholdDocumented CD4 count > 200 cells/mm3 required for HIV-positive transplant candidates

Additional HIV documentationAbsence of active AIDS-defining opportunistic infection and evidence of current effective antiretroviral therapy are required

Provider Actions and Requirements

Prior Authorization

Prior authorization required for pediatric heart transplant/re-transplantation

Prior authorization is required for pediatric heart transplant and heart re-transplantation; requests must include the referenced procedure codes (CPT 33944 and 33945) and meet the medical necessity criteria in the policy.

Required CPT codes: 33944 (donor heart backbench preparation) and 33945 (heart transplant).
Authorization request must demonstrate that the member meets the policy's medical necessity criteria (age <18, indication, life expectancy, reversible causes ruled out, and absence of contraindications).

Step Therapy

Step therapy: Not applicable

Step therapy does not apply to this policy; candidate selection is based on meeting transplant indications and contraindication criteria rather than a stepwise treatment pathway.

Evaluation and Assessment Requirements

Note

Evaluation requirements — rule out all reversible causes of heart failure

Before listing or authorizing transplant, verify and document that all reversible causes of heart failure have been evaluated and excluded; the policy lists example reversible causes that must be considered.

Examples to evaluate and rule out include anemia, hypertension, renal failure, acidosis, obesity, malnutrition, respiratory disorders, and thyroid disorders.
Life expectancy in the absence of cardiopulmonary disease must be ≥ 2 years.

Post-Transplant Care Reference

inv-17: post-transplant care (general reference only)

Post-transplant coverage durationPolicy provides background survival estimates but does not specify a coverage duration for post-transplant services

Survival estimates (background)Approximate pediatric recipient survival at 1, 5, and 10 years: 90%, 80%, and 60% respectively

Median survival by age groupMedian survival: 22.3 years (infants), 18.4 years (1–5 yrs), 14.4 years (6–10 yrs), 13.1 years (11–17 yrs)

Definitions and Staging

inv-12: Pediatric heart failure staging

Stage AAt high risk for developing heart failure (no current HF symptoms)

Stage BAbnormal cardiac structure and/or function without symptoms of heart failure

Stage CAbnormal cardiac structure and/or function with past or present symptoms of heart failure

Stage DAbnormal structure and/or function requiring continuous IV inotropes or prostaglandin E1, mechanical ventilatory and/or mechanical circulatory support

Center and Program Requirements

Note

Center requirements — none specified

The policy does not specify center accreditation, minimum volume, or other transplant center requirements in this document.

Background and Rationale

Background — Pediatric cardiomyopathy and congenital heart disease are the leading indications for pediatric heart transplantation. Outcomes vary by age, with reported approximate survival of 1-, 5-, and 10-year ≈ 90%, 80%, and 60%, respectively. Staging of pediatric heart failure (Stages A–D) and specific severe features guide candidacy, with Stage D disease and selected Stage C scenarios supporting transplant consideration.