This document addresses heart and lung (heart/lung) transplantation criteria for individuals who have both cardiac (heart) and lung disease. A heart/lung transplant refers to the harvesting of one or both lungs and the heart from a single cadaver donor, which is then implanted into a single recipient in a coordinated surgical procedure.

Note: Please see the following related documents for additional information:

• TRANS.00009 Lung and Lobar Transplantation
• TRANS.00033 Heart Transplantation

Position Statement

Medically Necessary:

Heart/lung transplantation is considered medically necessary when the following clinical indications and the general individual selection criteria listed below are met.

Clinical Indications - Individuals must meet one of the following criteria:

1. Irreversible primary pulmonary hypertension with heart failure; or
2. Secondary pulmonary hypertension and resulting heart failure due to pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease or emphysema; or
3. Eisenmenger's complex or other types of congenital heart disease with irreversible pulmonary hypertension and heart failure.

Investigational and Not Medically Necessary:

A heart/lung transplantation is considered investigational and not medically necessary when the above criteria are not met.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with concurrent medical conditions which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member’s candidacy for transplantation.

General Individual Selection Criteria

In addition to having one of the clinical indications above, the member must not have a contraindication, as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.

Absolute Contraindications – for Transplant Recipients* include, but are not limited to, the following:

1. Metastatic cancer;
2. Ongoing or recurring infections that are not effectively treated;
3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery;
4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured;
5. Active, systemic lupus erythematosus or sarcoid with multisystem involvement;
6. Any systemic condition with a high probability of recurrence in the transplanted heart;
7. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations;
8. Potential complications from immunosuppressive medications are unacceptable to the patient;
9. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200cells/mm³) unless the following are noted:
   1. CD4 count greater than 200 cells/mm³ for greater than 6 months;
   2. HIV-1 RNA undetectable;
   3. On stable anti-retroviral therapy greater than 3 months;
   4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm);
   5. Meeting all other criteria for heart-lung transplantation.

*Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. 2022; 71(9):1189-1204.