ModifiedCentenePolicy CP MP.132

Clinical Policy: Heart-Lung Transplant

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Medical necessity criteria and coverage considerations for heart-lung transplantation for Centene members, including indications, contraindications, and coding implications. Applies to providers requesting authorization for combined heart and lung transplant services.

Policy Summary

PayerCentene

PolicyClinical Policy: Heart-Lung Transplant

Policy CodePolicy CP MP.132

Change TypeMaterial content revisions and operational updates

Effective Date

Next Review Date

Key ActionObtain prior authorization for heart‑lung transplant procedures and provide required clinical documentation demonstrating indication, severity, and absence of contraindications.

SourceLink

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ModifiedCentenePolicy CP MP.132

Clinical Policy: Heart-Lung Transplant

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Policy Summary

PayerCentene

PolicyClinical Policy: Heart-Lung Transplant

Policy CodePolicy CP MP.132

Change TypeMaterial content revisions and operational updates

Effective Date

Next Review Date

Key ActionObtain prior authorization for heart‑lung transplant procedures and provide required clinical documentation demonstrating indication, severity, and absence of contraindications.

SourceLink

POLICY UPDATE CHANGES

Added indication to criteria I.A.1;j and expanded criteria I.C.1. to I.C.1.a through c.

Replaced contraindication language about psychological/behavioral/cognitive disorders and poor family support with a single criterion: inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.

Updated substance-use criterion to exclude marijuana when prescribed by a licensed practitioner and allow commitment to reducing behaviors if urgent transplant timelines exist.

Updated functional and age-related criteria (I.A.1.b now reflects 'nonspecific idiopathic' and pediatric age specifications refined).

33930/33933/33935/S2152procedure codes referenced

ISHLT refsguideline sources cited

6.5 yrsmedian survival

NotedMedicaid precedence

Centene-ownedpolicy ownership

Coverage Criteria for Heart‑Lung Transplantation

Initial candidate indications and age

Covered when ALL of the following are met:

Age

Indications: Member has end-stage disease of both heart and lungs due to one of the listed diagnoses (examples include irreversible primary pulmonary hypertension with severe heart failure; Eisenmenger syndrome with irreversible pulmonary hypertension and heart failure; cystic fibrosis with severe heart failure; COPD/emphysema with severe heart failure; nonspecific idiopathic severe pulmonary fibrosis; pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure; congenital heart disease meeting specified subcriteria including single ventricle with Fontan physiology; lymphatic abnormalities such as plastic bronchitis or protein-losing enteropathy refractory to interventions)
See policy text for full list of qualifying diagnoses

Re-transplantation and special indications: Includes candidates for heart re-transplant and selected congenital or neonatal high-risk conditions (e.g., neonatal hypoplastic left heart syndrome with high-risk features; CHD with Fontan physiology meeting symptomatic criteria)

Policy lists re-transplant and specific CHD subcriteria

Disease severity

AND meets ONE of the following disease severity criteria:

Severity: Adults: New York Heart Association (NYHA) Class III or IV heart failure; Pediatrics: American Heart Association (AHA) Stage C or D heart disease; OR life expectancy in the absence of cardiopulmonary disease <= 2 yearsNYHA III/IV or AHA Stage C/D; life expectancy <= 2 years

See Table 1 and policy text for staging definitions

Absolute/relative contraindications

AND does NOT have any of the following contraindications:

Contraindications

Infection and sepsis: Active uncontrolled infection, active extrapulmonary or disseminated infection, septic shock, or active tuberculosis infection
Active infections are exclusionary until resolved
Recent major cardiovascular events: Stroke, acute coronary syndrome, or myocardial infarction (excluding demand ischemia) within 30 days30 days
Malignancy and severe comorbidity: Malignancy with high risk of recurrence or death; other severe uncontrolled medical condition expected to limit survival after transplant

This policy excludes requests for retransplantation within <6 months of the primary heart-lung transplant and excludes members with active tuberculosis infection. The policy also lists related operational and clinical exclusion details such as ongoing acute allograft rejection when retransplantation is requested and other active or disseminated infections that preclude coverage.

Coverage determinations under this clinical policy are subject to the member’s specific benefits and the Health Plan’s governing documents. Coverage and administration of benefits remain subject to all terms, conditions, exclusions, and limitations set forth in the member’s evidence of coverage, certificate of coverage, policy, contract of insurance and to applicable state and federal requirements.

Operational exclusions include retransplantation requests less than six months after the primary transplant and situations of ongoing acute allograft rejection when retransplantation is being requested. These conditions should be identified during authorization and evaluation, as they render retransplantation requests not consistent with the policy criteria unless addressed per the policy’s contraindication framework.

Candidate Selection and Requirements

Candidate selection

Candidates must meet disease-specific indications and severity criteria and must not have any contraindications listed below:

Candidate selection: Member has end-stage heart and end-stage lung disease from a qualifying diagnosis AND meets disease severity criteria (NYHA III/IV for adults or AHA Stage C/D for pediatrics; life expectancy <= 2 years without cardiopulmonary disease) AND does not have any contraindications

Includes congenital heart disease subcriteria such as single ventricle with Fontan physiology; see contraindications list for exclusions

Contraindications

Contraindications that preclude coverage include active infection (including active tuberculosis and extrapulmonary/disseminated infections), recent major cardiovascular events such as stroke, acute coronary syndrome, or myocardial infarction within 30 days, and malignancy with high risk of recurrence or cancer-related death. Additional contraindications include acute liver failure or cirrhosis with portal hypertension (unless being considered for multi-organ transplant), acute renal failure requiring dialysis with low likelihood of recovery, progressive cognitive impairment, septic shock, severe malnutrition or chronic wasting, severe pulmonary vascular hypoplasia, active substance use or dependence without evidence of abstinence or commitment to reduction, and inability to adhere to the post-transplant regimen even with caregiver support.

Pre‑Transplant Evaluation Requirements

Documentation Required

EVALUATION REQUIREMENTS — Pre-transplant evaluation and documentation

Pre-transplant evaluation must document the member's heart failure class or stage (NYHA for adults or AHA for pediatrics), estimated life expectancy in the absence of cardiopulmonary disease (≤ 2 years when applicable), HIV control (CD4 > 200 cells/mm3 for at least 3 months and effective ART if applicable), nutritional status (absence of chronic wasting or severe malnutrition), psychosocial/adherence assessment (documented ability to adhere to the regimen necessary to preserve the transplant, even with caregiver support), and resolution or treatment of infections and malignancy where applicable. Include evidence of prior optimal medical, interventional, and device therapies when required by severity criteria and documentation that contraindications listed in the policy are absent or addressed.

Document NYHA class (III–IV) for adults or AHA Stage C/D for <18 per policy (Table references).
Record life expectancy in absence of cardiopulmonary disease (≤ 2 years when specified).
If HIV-positive, provide CD4 > 200 cells/mm3 for ≥ 3 months and evidence of effective ART.
Assess and document nutritional status; note absence of chronic wasting or severe malnutrition.
Provide psychosocial evaluation showing ability to adhere to post‑transplant regimen or documented caregiver support; if inability to adhere exists, note as contraindication.
Provide evidence that listed contraindications (active/uncontrolled infections, recent stroke/ACS/MI within 30 days, active substance use without documented abstinence or commitment to reduction, malignancy with high recurrence risk, severe organ dysfunction unlikely to recover, progressive cognitive impairment, severe pulmonary vessel hypoplasia, recent retransplant <6 months, ongoing acute allograft rejection when retransplant requested) are absent or have been addressed.

Provider Actions and Authorization

Prior Authorization

Procedure prior authorization required (CPT 33935 and related codes)

Prior authorization is required for the heart-lung transplant procedure codes and related donor/procurement services; include the transplant procedure CPT codes and related procurement codes when requesting authorization.

Referenced procedure codes include CPT 33935, 33933, 33930 and HCPCS S2152 (transplant/global service)
Include donor/procurement and bundled transplant service codes in the authorization request

Prior Authorization

Obtain prior authorization and meet medical necessity review

Obtain prior authorization before performing heart-lung transplant services; authorization requests will be reviewed for medical necessity and are subject to the Health Plan's coverage terms and procedures.

Authorization is subject to the Health Plan’s medical necessity determination and coverage documents
Follow plan-specific authorization submission procedures

Coding and Billing

Referenced transplant procedure codesCPTCovered

33930	Donor cardiectomy-pneumonectomy (including cold preservation).
33933	Backbench standard preparation of cadaver donor heart/lung allograft to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, and trachea for implantation.
33935	Heart-lung transplant with recipient cardiectomy-pneumonectomy.
S2152	Solid organ(s), complete or segmental, Single organ Or combination Of organs; deceased or living donor(s), procurement, transplantation, and related complications; including drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services.

inv-08: Life expectancy criterion — Less than or equal to 2 years without cardiopulmonary disease

Life expectancy thresholdLess than or equal to 2 years life expectancy in the absence of cardiopulmonary disease

ApplicabilityUsed as a disease-severity requirement for candidacy (adults: NYHA III/IV; pediatrics: AHA Stage C/D)

Evidence requirementDocumented estimate must be provided in pre-transplant evaluation records

inv-09: CD4 count (HIV) — > 200 cells/mm3 for at least 3 months prior to transplantation

CD4 count requirement> 200 cells/mm3 for at least 3 months prior to transplantation

ART statusMember/enrollee should be on effective antiretroviral therapy (ART) when applicable

Transplant Center Requirements

Note

Center requirements: follow ISHLT guidance and use accredited transplant centers

Use accredited transplant centers consistent with ISHLT best-practice recommendations and registry data when providing heart‑lung transplant services; the policy references ISHLT guidance and registry outcomes informing center expectations.

Policy references ISHLT candidate selection and best-practice recommendations
Registry data and standard transplant center expectations imply use of accredited transplant centers

Post‑Transplant Global Care and Coverage

inv-27: Global transplant care including hospitalization, drugs, supplies, and outpatient follow-up — S2152 global definition referenced

CPT/S code referencedS2152 (global transplant bundle) — includes procurement, transplantation, hospitalization, drugs, supplies, and outpatient follow-up

Scope of S2152Describes inclusion of pre- and post-transplant care, related complications, and associated services in the global definition

Bundle componentsIncludes drugs, supplies, hospitalization with outpatient follow-up, medical/surgical, diagnostic, emergency, and rehabilitative services

Background and Rationale

Heart-lung transplantation is indicated for selected patients with simultaneous end-stage heart failure and end-stage lung disease. Typical indications include complex congenital heart disease (for example, Eisenmenger physiology), primary pulmonary hypertension, and advanced parenchymal lung disease with refractory cardiopulmonary failure. Because donor availability limits procedure frequency and newer medical therapies have reduced demand, candidacy is guided by international society recommendations and registry outcome data when assessing expected benefit and center expertise.

Definitions

inv-20: Heart-lung transplant indication — End-stage heart and end-stage lung disease

Primary indicationSimultaneous end-stage heart disease and end-stage lung disease

Common causesComplex congenital heart disease with Eisenmenger syndrome, primary pulmonary hypertension, and pulmonary fibrosis are common indications

Clinical contextIndicated for selected patients when both heart and lung disease are end-stage and other therapies are insufficient

inv-21: Heart failure staging — NYHA classes I–IV and AHA stages references

NYHA classification (adults)New York Heart Association classes I–IV describe progressive limitation from no symptoms (I) to symptoms at rest (IV)

Severity requirementAdults must meet NYHA class III or IV for disease-severity candidacy (Table 1)

Revision History

2025-04-?revisionLatest

Minor wording change clarifying phrasing from 'could preclude heart failure' to 'could preclude heart transplant' in policy criteria I.C.16.a; background and coding reviewed.

2025-02-?revision

Annual review and substantive updates: reworded I.C.16.a; Table 2 changed to AHA Heart Failure Stages and pediatric staging removed; internal and external specialist review completed.

2024-02-?

Policy Summary

PayerCentene

PolicyClinical Policy: Heart-Lung Transplant

Policy CodePolicy CP MP.132

Change TypeMaterial content revisions and operational updates

Effective Date

Next Review Date

Key ActionObtain prior authorization for heart‑lung transplant procedures and provide required clinical documentation demonstrating indication, severity, and absence of contraindications.

SourceLink

On This Page

Organ dysfunction: Acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction (unless multi-organ transplant considered); acute renal failure on dialysis with low likelihood of recovery; GFR < 30 mL/min/1.73 m2 unless multi-organ transplant is consideredGFR < 30 mL/min/1.73 m2

Allograft and retransplant timing: Current episode of ongoing acute allograft rejection when retransplantation is requested; less than six months since primary transplantation when retransplantation is requested6 months

Nutrition and anatomy: Chronic wasting or severe malnutrition; severe hypoplasia of central branch pulmonary arteries or pulmonary veins

Cognitive and adherence: Progressive cognitive impairment; inability to adhere to the regimen necessary to preserve the transplant even with caregiver support

Substance use and smoking: Active substance use or dependence (including current tobacco use, vaping, intravenous drug use, or marijuana use unless prescribed by a licensed practitioner) without convincing evidence of risk-reduction behaviors or documented abstinence (policy allows commitment to reduce behaviors if urgent transplant timelines exist)6 months abstinence generally required for nicotine/tobacco/alcohol/illicit substances unless documented exceptions per policy

Serial testing may be used to verify abstinence

Step Therapy

Document therapy failure (refractory symptoms despite optimal therapies)

Document that the candidate has persistent, refractory heart failure symptoms or ventricular arrhythmias despite optimal medical, interventional, and device therapies prior to transplantation consideration.

Evidence of failure/refractoriness to guideline-directed medical therapy, interventions, or device therapy as applicable

Note

Follow administrative and operational provider obligations

Ensure administrative and operational obligations are completed per the Health Plan and transplant center requirements when requesting authorization and delivering care.

Comply with Health Plan-level administrative policies and plan-specific prior authorization processes
Coordinate with the transplant center for required documentation and reporting

Documentation Required

Required clinical documentation to support authorization

Include in the authorization and medical record documentation of heart failure staging (NYHA or AHA), estimated life expectancy without cardiopulmonary disease (≤ 2 years when indicated), HIV documentation (CD4 > 200 cells/mm3 for ≥ 3 months and on ART if applicable), nutritional assessment, psychosocial/adherence assessment, and absence or treatment of listed contraindications.

NYHA class or AHA stage documented
Life expectancy estimate stated
HIV: CD4 > 200 cells/mm3 for ≥ 3 months and documentation of effective ART when applicable
Nutrition: documentation excluding chronic wasting or severe malnutrition
Psychosocial: adherence capability or caregiver support noted

Billing Rule

Follow Health Plan administrative policies and procedures

Providers must follow applicable Health Plan-level administrative policies, procedures, and state/federal requirements when submitting authorization requests and maintaining records.

Ensure documentation aligns with the member's coverage documents (Evidence of Coverage, policy, contract)
Follow plan-specific timelines and submission requirements

Denial Risk

Conditions that may trigger denial of transplant authorization

Do not proceed with transplant authorization or listing if the member has active uncontrolled infection (including active tuberculosis or disseminated infection), recent stroke/acute coronary syndrome/myocardial infarction within 30 days, active substance use without documented abstinence or commitment to risk reduction, malignancy with high recurrence risk, progressive cognitive impairment, septic shock, or other listed contraindications — these conditions can trigger denial.

Active tuberculosis or active extrapulmonary/disseminated infection
Stroke, ACS, or MI within 30 days
Active substance use/dependence without documented abstinence or commitment to reduce (exceptions for urgent timelines require commitment)
Malignancy with high risk of recurrence or death
Progressive cognitive impairment, septic shock, acute organ failures as listed

Note

Coverage decisions subject to plan terms, exclusions, and legal requirements

Coverage and any authorization decisions are subject to all terms, conditions, exclusions and limitations of the member's coverage documents and applicable legal/regulatory requirements.

Authorization does not guarantee payment; decisions follow the member's Evidence of Coverage, policy, or contract
Health Plan may amend or withdraw the clinical policy; plan-level rules apply

Viral load noteHIV with detectable viral load requires additional documentation per policy (see HIV-specific criteria)

inv-10: GFR threshold — GFR < 30 mL/min/1.73 m2 is a contraindication unless multi-organ transplant considered

GFR contraindication thresholdGlomerular filtration rate < 30 mL/min/1.73 m2 is a contraindication to heart-lung transplant

ExceptionGFR < 30 mL/min/1.73 m2 may be acceptable if the member is being considered for a multi-organ transplant

DocumentationCurrent renal function (GFR) must be documented in the evaluation; dialysis with low likelihood of recovery is an exclusion

Pediatric stagingPediatrics use American Heart Association Stages C or D as the equivalent severity threshold

inv-22: Health Plan definition — Health Plan operated or administered by Centene Management Company

Definition of Health PlanHealth Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or its affiliates

Policy roleClinical policy provides guidance for medical necessity and does not constitute a contract or guarantee of payment

Coverage decisionsCoverage decisions are subject to the terms, conditions, exclusions and limitations of the member's coverage documents and applicable legal/regulatory requirements

Annual review with addition of an indication to criteria I.A.1.j, expansion of I.C.1 into I.C.1.a–c, removal of active peptic ulcer disease contraindication, pediatric age refinements, and adjustments to congenital heart disease language.

2023-02-?revision

Updated substance-use criterion to exclude marijuana prescribed by a licensed practitioner and permit commitment to behavior reduction for urgent transplant timelines; ICD-10 diagnosis table removed.

2022-05-?revision

Added specific congenital heart disease criteria and removed a specific congenital lesion-based contraindication.

2022-02-?revision

Criteria I.C. updated to align with select ISHLT 2021 contraindications following annual review.

2021-08-?revision

Replaced prior psychosocial contraindication language with a single criterion focused on inability to adhere to the post-transplant regimen even with caregiver support.

2017-06-17new_policy

New clinical policy established (approval and revision noted 06/17); references reviewed and wording standardized to 'member/enrollee'.