CurrentWellCarePolicy CP.MP.132

Clinical Policy: Heart-Lung Transplant

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Defines medical necessity criteria, contraindications, and coding implications for heart-lung transplantation for members/enrollees of WellCare (Centene-affiliated) health plans.

Policy Summary

PayerWellCare

PolicyHeart-Lung Transplant

Policy CodePolicy CP.MP.132

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating end-stage heart and lung disease, age-specific indications, disease severity (adult NYHA III/IV or pediatric AHA Stage C/D), and absence of listed contraindications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CP.MP.132Policy ID

NYHA III/IVAdult severity

<30GFR threshold

33930/33933/33935/S2152Referenced codes

3.7→6.5y

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Coverage and Medical Necessity Criteria

Initial transplant coverage criteria

Covered when ALL of the following are met

Overall criteria

Indications (age > 18): Age > 18 years and one of the following: irreversible primary pulmonary hypertension with heart failure; nonspecific severe pulmonary fibrosis; Eisenmenger syndrome with irreversible pulmonary hypertension and heart failure; cystic fibrosis with severe heart failure; chronic obstructive pulmonary disease with heart failure; emphysema with severe heart failure; pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure; non-complex congenital heart disease associated with pulmonary hypertension not amenable to lung transplantation and repair by standard surgery; severe coronary artery disease or cardiomyopathy with irreversible pulmonary hypertension; right ventricular failure with objective evidence of right ventricular fibrosis or infarction or refractory left ventricular failure.
I.A.1.a-j
Indications (age ≤ 18): Age ≤ 18 years and one of the following: Eisenmenger syndrome; heart re-transplant; lung re-transplant; alveolar proteinosis; primary pulmonary hypertension; pulmonary vascular disease; restrictive cardiomyopathy; congenital heart disease meeting additional listed requirements (previously repaired or palliated lesion; or infant with single functional ventricle and severe proximal coronary stenosis/atresia, moderate–severe AV or systemic semilunar valve disease, or severe ventricular dysfunction).
I.A.2.a-h
Disease severity: Meets staging criteria: adults New York Heart Association (NYHA) class III or IV; pediatric American Heart Association (AHA) Stage C or D.
I.B.1.a-b
Life expectancy in the absence of cardiopulmonary disease ≥ two years.>= 2 years
I.B.2
Contraindications: Member/enrollee must not have any of the contraindications listed under I.C (see separate contraindications section).
I.C

The policy lists specific contraindications to heart‑lung transplant. Of particular note, HIV infection with detectable viral load is a contraindication unless all of the following are documented: CD4 cell count > 200 cells/mm3, absence of active AIDS‑defining opportunistic infection or malignancy (or such conditions are being treated/prevented effectively), and the member is currently on effective antiretroviral therapy (ART). Additional contraindications include inability to adhere to required post‑transplant regimens even with caregiver support; severe hypoplasia of central pulmonary arteries or veins; current ongoing acute allograft rejection or requests for retransplantation within 6 months of the primary transplant; malignancy with high risk of recurrence or cancer‑related death; acute renal failure with rising creatinine or dialysis and low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction; recent stroke or acute coronary syndrome/myocardial infarction within 30 days; GFR < 30 mL/min/1.73m2 unless considered for multiorgan transplant; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; progressive cognitive impairment; other severe uncontrolled medical conditions expected to limit survival after transplant; and active substance use or dependence without convincing evidence of risk‑reduction behaviors (including current tobacco/nicotine/vaping or marijuana use except when prescribed by a licensed practitioner, with tobacco/nicotine abstinence typically required for ≥ 6 months when a history exists).

Coverage determinations under this clinical policy are subject to the member's coverage documents. The policy is a guide to medical necessity used to assist in making coverage decisions and administering benefits, but it does not constitute a contract or guarantee of payment. All coverage decisions remain subject to the specific terms, conditions, exclusions, and limitations of the member's evidence of coverage, certificate of coverage, policy or contract of insurance, and to applicable state, federal, and Health Plan administrative requirements.

Requests that do not meet the policy's required indication, disease severity, life‑expectancy threshold, or that present any of the listed contraindications are considered not medically necessary. Examples that commonly trigger a determination of not medically necessary include failure to meet adult or pediatric staging criteria (adult NYHA class III/IV or pediatric AHA Stage C/D), life expectancy < 2 years absent cardiopulmonary disease, GFR < 30 mL/min/1.73m2 without multiorgan transplant consideration, active uncontrolled infection or septic shock, recent major cardiovascular or cerebrovascular events within the specified timeframes, active substance use without documented risk‑reduction, or active malignancy with high risk of recurrence. These elements form the rationale for denying requests that do not satisfy the defined medical necessity criteria.

Candidate Selection Criteria

Candidate criteria

Candidate selection requires meeting disease-specific indications and severity and absence of contraindications.

Candidate prerequisites: Candidate must have both end-stage heart and end-stage lung disease with diagnoses listed by age group, meet severity staging (NYHA class III/IV for adults or AHA Stage C/D for pediatrics), have expected survival ≥2 years absent cardiopulmonary disease, and lack any contraindications listed under I.C.

I.A, I.B, I.C

Absolute and Relative Contraindications

Contraindications include HIV infection with detectable viral load, except when all of the following are present: CD4 cell count > 200 cells/mm3, no active AIDS‑defining opportunistic infection or active malignancy (unless effectively treated or prevented), and the member is currently on effective antiretroviral therapy (ART). Other listed contraindications are inability to adhere to post‑transplant regimens even with caregiver support; severe hypoplasia of central pulmonary arteries or pulmonary veins; ongoing acute allograft rejection or retransplantation requested within 6 months of the primary transplant; malignancy with high risk of recurrence or cancer‑related mortality; acute renal failure with rising creatinine or dialysis and low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction; stroke, acute coronary syndrome, or myocardial infarction within 30 days; GFR < 30 mL/min/1.73m2 unless considered for multiorgan transplant; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; progressive cognitive impairment; other severe uncontrolled medical conditions expected to limit survival; and active substance use or dependence without convincing evidence of risk‑reduction behaviors (with documented tobacco/nicotine abstinence ≥ 6 months required when applicable).

Pre-Transplant Evaluation Requirements

Documentation Required

Document indication, staging, life expectancy; reference ISHLT listing criteria

Evaluation must document the indication(s) for simultaneous end‑stage heart and end‑stage lung disease, the member's disease staging (adults: NYHA class III or IV; pediatrics: AHA Stage C or D), and an estimated life expectancy in the absence of cardiopulmonary disease (≥ 2 years). The policy also references ISHLT listing criteria as additional guidance for evaluation and listing decisions.

Indication documented per age-specific lists (see policy I.A.1–2).
Adult staging: New York Heart Association (NYHA) class III or IV.
Pediatric staging: American Heart Association Stage C or D.
Life expectancy without cardiopulmonary disease ≥ 2 years.
ISHLT listing criteria referenced for listing decisions.

Provider Responsibilities and Prior Authorization

Prior Authorization

Prior authorization required and evaluated against medical necessity criteria

Prior authorization is required for heart‑lung transplant and requests will be evaluated against the policy's medical necessity criteria, including the listed indications, disease severity requirements, and absence of contraindications. Relevant CPT and HCPCS codes are informational for prior authorization submission.

Prior authorization evaluated against policy medical necessity criteria (indications, severity, contraindications).
Referenced procedure codes (e.g., CPT 33930, 33933, 33935, and HCPCS S2152) are informational for submission.

Note

Policy used as guide for medical necessity and prior authorization applicability

This clinical policy is a guide to medical necessity used to assist in making coverage decisions; prior authorization requirements and final determinations are made by the Health Plan and are subject to coverage documents and applicable administrative policies.

Policy guides medical necessity determinations but does not guarantee coverage.

Coding and Billing References

Referenced CPT / HCPCS codesmixed

33930	Donor cardiectomy-pneumonectomy, (including cold preservation).
33933	Backbench standard preparation of cadaver donor heart/lung allograft prior 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; and the number of days of pre- and post-transplant care in the global definition.

inv-06: Glomerular filtration rate (GFR) — numeric contraindication threshold (< 30 mL/min/1.73m2)

Numeric contraindication thresholdGlomerular filtration rate (GFR) < 30 mL/min/1.73m2 (contraindication unless considered for multiorgan transplant)

Related contraindication contextListed among absolute contraindications including active infection, malignancy with high recurrence risk, and organ failure

Implication for retransplantationGFR threshold noted in the contraindications section applies to primary and retransplant considerations as listed

Action for borderline renal functionConsider multiorgan transplant evaluation if GFR < 30 mL/min/1.73m2 rather than automatic exclusion

Comprehensive Transplant Episode Coding Reference

inv-21: Comprehensive transplant episode coding reference (S2152)

HCPCS/S code descriptionS2152: Solid organ(s), complete or segmental, single organ or combination of organs; procurement, transplantation, and related complications including drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition.

CPT codes referenced for heart-lung episode33930: Donor cardiectomy-pneumonectomy; 33933: Backbench preparation of cadaver donor heart/lung allograft; 33935: Heart-lung transplant with recipient cardiectomy-pneumonectomy.

Scope of S2152 coverageEncompasses procurement, transplantation, and related complications as part of a comprehensive transplant episode definition.

Coding guidance noteCodes are informational; inclusion does not guarantee coverage and providers should reference current coding manuals before claim submission.

Transplant Center Standards

Note

Center should follow ISHLT listing criteria and recognized standards

Transplant centers should follow recognized standards and ISHLT listing criteria and best practice recommendations referenced by the policy when evaluating and listing candidates; the policy implies centers adhere to established transplant standards.

Policy references ISHLT listing criteria as guidance for listing decisions.
No explicit numeric accreditation or volume requirements are stated in the policy text.

Clinical Staging and Definitions

inv-16: NYHA classification / AHA pediatric stages — adult disease severity (NYHA I–IV) and pediatric AHA stages A–D (Stage C/D as severe)

Adult severity classificationNew York Heart Association (NYHA) classification I–IV used for adults; policy requires NYHA class III or IV for transplant candidacy.

Pediatric staging systemAmerican Heart Association (AHA) pediatric stages A–D described; Stage C and Stage D represent symptomatic or advanced disease for transplant consideration.

Clinical detail for pediatric Stage C/DStage C: abnormal cardiac structure/function with past or present symptoms; Stage D: abnormal structure/function with continuous inotropic, ventilatory, or mechanical circulatory support.

Use in evaluationDisease severity must meet adult NYHA III/IV or pediatric AHA Stage C/D as part of coverage criteria and documentation requirements.

Background and Clinical Context

Heart‑lung transplantation is performed for selected patients with simultaneous end‑stage heart and lung disease. Typical indications include complex congenital heart disease with pulmonary vascular disease such as Eisenmenger syndrome, primary pulmonary hypertension, cystic fibrosis with severe cardiac involvement, and other conditions in which both organs are irreversibly compromised. Candidates usually meet advanced disease staging (adults: NYHA class III or IV; pediatrics: AHA Stage C or D) and have an expected life expectancy of at least 2 years absent cardiopulmonary disease. Transplant frequency is limited by donor availability and has changed over time with evolving medical therapies; registry data demonstrate improving but still limited median survival after heart‑lung transplant compared with isolated organ transplants, underscoring the need for careful candidate selection.