Anthem Blue Cross Connecticut TRANS.00009 Lung and Lobar Transplantation Form

This document addresses lung transplantation (lobar, single-lung or double-lung replacement). In a lobar transplantation, a lobe of the donor's lung is excised, sized appropriately for the recipient's thoracic dimensions, and is transplanted into the recipient. Donors for lobar lung transplantation have primarily been living related, but lobes of deceased donors have also been transplanted. In single-lung transplantation, only one lung from a deceased donor is provided to the recipient. In double-lung transplantation, the recipient's lungs are removed and replaced by both deceased donor's lungs.

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

• TRANS.00026 Heart/Lung Transplantation

Position Statement

Medically Necessary:

Lung or lobar transplantation is considered medically necessary for individuals who meet the general individual selection criteria and have irreversible, progressively disabling, end-stage pulmonary disease including, but not limited to, one or more of the conditions listed below.

1. Restrictive lung disease, examples of which include, but are not limited to:
   1. Idiopathic pulmonary fibrosis (IPF);
   2. Interstitial pulmonary fibrosis;
   3. Scleroderma;
   4. Sarcoidosis;
   5. Extrinsic allergic alveolitis;
   6. Post-chemotherapy disease;
   7. Asbestosis.
2. Chronic lung disease, examples of which include, but are not limited to:
   1. Alpha-1 antitrypsin deficiency;
   2. Eosinophilic granuloma (Langerhans cell histiocytosis or histiocytosis X);
   3. Chronic Obstructive Pulmonary Disease (COPD) (emphysema, chronic bronchitis);
   4. Bronchiolitis obliterans;
   5. Bronchopulmonary dysplasia;
   6. Recurrent pulmonary embolus;
   7. Lymphangiomyomatosis (LAM).
3. Pulmonary hypertension, examples of which include, but are not limited to:
   1. Primary pulmonary hypertension;
   2. Pulmonary hypertension due to cardiac diseases and interstitial pulmonary fibrosis;
   3. Eisenmenger's syndrome;
   4. Fibrosing mediastinitis.
4. Septic lung disease, examples of which include, but are not limited to:
   1. Cystic fibrosis;
   2. Bronchiectasis.

Lung or Lobar Retransplantation

Retransplantation in individuals with graft failure of an initial lung or lobar transplant, due to either technical reasons or hyperacute rejection is considered medically necessary.

Retransplantation in individuals with chronic rejection or recurrent disease is considered medically necessary when the individual meets general selection criteria as defined below.

Investigational and Not Medically Necessary:

Lobar or lung transplantation in individuals for all other diagnoses is considered investigational and not medically necessary.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition 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 end stage pulmonary disease, the individual 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. Demonstrated patient noncompliance, which places the organ at risk by not adhering to medical recommendations;
6. Potential complications from immunosuppressive medications are unacceptable to the patient;
7. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200 cells/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 lung transplantation.

* Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. 2002; 71(9):1189-1204.