Clinical Policy: Heart-Lung Transplant
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Medical necessity criteria and coverage guidance for heart-lung transplantation for members of the health plans affiliated with Centene Corporation (Arizona Complete Health). Applies to evaluation, listing, and contraindications for combined heart and lung transplant.
Added 'Lung transplantation alone will restore right ventricular function' to contraindications.
Updated substance use criteria to exclude marijuana when prescribed by a licensed practitioner and allow required commitment to reducing substance use for urgent transplant timelines.
Removed pediatric indication of Alpha-1 antitrypsin deficiency.
Updated I.C.10 to include 'unless being considered for multi-organ transplant' (GFR threshold exception).
Coverage Criteria and Indications
Initial transplant coverage criteria
Covered when ALL of the following are met:
Overall coverage rule
Indications (age-dependent)
- Adults (Age ≥ 18): One of adult indications present (e.g., irreversible primary pulmonary hypertension with severe heart failure; nonspecific idiopathic severe pulmonary fibrosis; Eisenmenger syndrome with irreversible pulmonary hypertension and heart failure; cystic fibrosis with severe heart failure; chronic obstructive pulmonary disease with severe heart failure; emphysema with severe heart failure; pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure; congenital heart disease meeting specified CHD subcriteria including single ventricle Fontan physiology with symptomatic HF, lymphatic complications refractory to interventions, cirrhosis/CKD from elevated venous pressures, prohibitive risk for further palliation; cyanotic heart disease with severe AV valve regurgitation and prohibitive repair risk)
- Pediatrics (Age < 18): One of pediatric indications present (e.g., Eisenmenger syndrome; heart re-transplant; lung re-transplant; primary pulmonary hypertension; pulmonary vascular disease; restrictive cardiomyopathy; congenital heart disease meeting pediatric CHD subcriteria such as single ventricle Fontan physiology with symptomatic HF, lymphatic complications refractory to interventions, cirrhosis/CKD from elevated venous pressures, prohibitive risk for further palliation; pulmonary atresia with RV-dependent coronaries; neonatal hypoplastic left heart with high-risk features)
- Disease severity: Adults: NYHA class III or IV; Pediatrics: AHA Stage C or D heart disease; and life expectancy in absence of cardiopulmonary disease ≥ two years
- Contraindications absent: Member does not have any listed absolute or relative contraindications including uncontrolled/extrapulmonary/disseminated infection, active tuberculosis, septic shock, recent major cardiac/cerebrovascular events within specified windows, active substance use without documented risk-reduction or abstinence, malignancy with high recurrence risk, severe irreversible organ failure (e.g., GFR < 30 mL/min/1.73m2) unless being considered for multi-organ transplant, inability to adhere to post-transplant regimen, or other listed high-risk conditions
Specific exclusion conditions include: active extrapulmonary or disseminated infection; active tuberculosis; septic shock; acute renal failure with rising creatinine or need for dialysis and low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless being considered for multi-organ transplant; malignancy with high risk of recurrence or death; progressive cognitive impairment; and other severe, uncontrolled medical conditions expected to limit survival after transplant.
Coverage under this clinical policy is a guide to medical necessity and is not a contract or guarantee of payment. Coverage decisions and the administration of benefits remain subject to all terms, conditions, exclusions and limitations of the member's coverage documents and to applicable state and federal requirements; the Health Plan may change or withdraw this clinical policy at any time.
Heart-lung transplant is considered not appropriate when lung transplantation alone will restore right ventricular function; in such cases isolated lung transplantation is the preferred option.
Procedural and Billing Codes
| 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 posttransplant care in the global definition |
Provider Requirements, Prior Authorization, and Documentation
Medical necessity and affected codes
Heart‑lung transplant is medically necessary only when the member meets all listed clinical indications and disease severity criteria and has no listed contraindications. Use the relevant procedure codes when requesting authorization (CPT 33930, 33933, 33935; HCPCS S2152).
- Member meets indications for combined end‑stage heart and end‑stage lung disease and age‑specific criteria.
- Meets disease severity (Adults: NYHA III–IV; Pediatrics: AHA Stage C–D) and life expectancy ≥ 2 years.
- No listed contraindications present.
Prior authorization and plan‑level requirements
The Health Plan may change, amend, or withdraw this clinical policy and authorization requirements at any time; when state Medicaid provisions conflict with this policy, state Medicaid provisions take precedence.
- Providers should follow any Health Plan‑level administrative policies and procedures.
- For Medicaid members, refer to the state Medicaid manual where conflicts exist.
Policy defines listing/selection criteria (no step therapy)
This policy defines listing and selection criteria for heart‑lung transplantation and is not a step therapy protocol; step therapy sequencing is not applicable.
General provider action notes
Maintain complete clinical records supporting indication, severity staging, absence of contraindications, and documentation of multidisciplinary evaluation when requesting authorization or submitting claims.
- Document NYHA or AHA stage and estimated life expectancy without cardiopulmonary disease (≥ two years).
- Document assessment of contraindications (infection, organ dysfunction, substance use, recent major CV/CNS events, etc.).
Coding and documentation on claims
Include applicable procedure codes on claims and provide supporting documentation tying the codes to the clinical indication and transplant event.
Follow plan documents and review Medicare NCDs/LCDs
Providers must follow plan coverage documents and applicable state and federal requirements; for Medicare members, review all applicable NCDs, LCDs, and Coverage Articles before applying these criteria.
- Coverage decisions are subject to the member's evidence of coverage, contract, and state/federal laws.
- For Medicare members, consult CMS NCDs/LCDs and Coverage Articles prior to applying policy criteria.
Contraindication‑based denial triggers
Coverage may be denied if any listed contraindications are present, including active extrapulmonary/disseminated infection, septic shock, recent stroke or myocardial infarction within 30 days, or severe organ dysfunction such as GFR < 30 mL/min/1.73m2 (unless multi‑organ transplant is being considered).
- Active extrapulmonary or disseminated infection or active tuberculosis.
- Septic shock.
- Stroke, acute coronary syndrome, or myocardial infarction within 30 days.
- Glomerular filtration rate < 30 mL/min/1.73m2 unless being considered for multi‑organ transplant.
- Active substance use or dependence without documented risk‑reduction or abstinence.
Coverage subject to plan terms and exclusions
Coverage determinations and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law; this policy does not guarantee payment.
- Providers and members are bound by contractual terms and applicable state/federal requirements.
- This policy is a guide to medical necessity and not a guarantee of coverage or payment.
Candidate Selection and Referral Guidance
Candidate selection
Candidate must meet listed disease-specific indications and severity, and have acceptable peri-transplant risk profile.
Pediatric lung transplant referral guidance (citation)
Referenced specialty guidance
Absolute and Relative Contraindications
HIV infection with a detectable viral load is a contraindication unless the member is on effective antiretroviral therapy (ART), has a CD4 count > 200 cells/µL for at least 3 months, and has no active AIDS‑defining infections or malignancy.
Inability to adhere to the complex post‑transplant regimen, even with caregiver support, is a contraindication to listing for heart‑lung transplant.
Severe hypoplasia of the central branch pulmonary arteries or pulmonary veins is listed as a contraindication due to anatomical factors that preclude successful transplantation.
An active episode of ongoing acute allograft rejection (including when retransplantation is requested) is a contraindication to proceeding with transplant.
Retransplantation requested within six months of a primary transplant is a contraindication until the six‑month interval has elapsed.
Malignancy with a high risk of recurrence or death related to cancer is a contraindication unless oncologic risk is acceptably low per treating oncology specialists.
Acute renal failure with rising creatinine or requirement for dialysis and a low likelihood of renal recovery is a contraindication to transplant listing.
Acute liver failure or cirrhosis with portal hypertension or significant synthetic dysfunction is a contraindication unless the candidate is being considered for multi‑organ transplant including liver.
Recent cerebrovascular or coronary events (stroke, acute coronary syndrome, or myocardial infarction within 30 days) are contraindications until the acute risk period has passed.
A glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 is a contraindication unless the candidate is being considered for a multi‑organ transplant that addresses renal failure.
Septic shock and other uncontrolled systemic infections are contraindications to transplantation until the infection is resolved and the candidate is stabilized.
Active tuberculosis infection is a contraindication until appropriately treated and cleared per infectious disease guidance.
Progressive cognitive impairment that interferes with the ability to consent to or adhere to post‑transplant care is a contraindication.
Any other severe, uncontrolled medical condition expected to limit survival after transplant is considered a contraindication.
Active substance use or dependence (including current tobacco use, vaping, and intravenous drug use) without convincing evidence of sustained risk‑reduction behaviors is a contraindication. Current marijuana use is not an absolute contraindication when it is prescribed by a licensed practitioner. For urgent transplant timelines, documented commitment to reducing substance use behaviors may be acceptable in lieu of a full abstinence period.
Pre-Transplant Evaluation and Testing
Evaluation requirements prior to listing
Prior to listing, document that the patient meets heart failure staging requirements (Adults: NYHA III or IV; Pediatrics: AHA Stage C or D), has estimated life expectancy ≥ two years without cardiopulmonary disease, and has been assessed for contraindications including infection, organ dysfunction, substance use, cognitive impairment, and relevant anatomic issues.
- Record NYHA or AHA stage and life expectancy estimate in the chart.
- Document evaluation of contraindications (e.g., infection, renal or hepatic failure, substance use history) and ability to adhere to post‑transplant regimen.
Medicare‑specific evaluation requirement
For Medicare enrollees, review applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles before applying the policy criteria to ensure consistency with Medicare coverage.
- Consult the CMS website for current NCDs/LCDs and Coverage Articles relevant to heart‑lung transplantation.
Transplant Center and Program Expectations
Center requirements and external guidance
Center-specific accreditation or volume requirements are not specified in this policy excerpt; the policy references ISHLT listing criteria and other external guidance for center practices.
- Refer to ISHLT listing criteria and best practice recommendations for center standards and listing practices.
Additional center notes
Additional center‑related notes preserved; no further center requirements are specified in this portion of the document.
Post-Transplant Services and Billing
Definitions and Clinical Classifications
Background and Rationale
Heart‑lung transplantation is indicated for selected patients with simultaneous end‑stage heart and end‑stage lung disease. Common indications include complex congenital heart disease with Eisenmenger physiology, primary pulmonary hypertension, and cystic fibrosis with progressive cardiac dysfunction. The procedure is limited by donor availability and evolving medical therapies; reported median survival improved to approximately 6.5 years (2010–2017). Selection follows ISHLT guidance and considers disease severity (e.g., adults meeting NYHA class III or IV or pediatric AHA Stage C or D) and absence of listed contraindications.
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