Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

QualChoice maintains a national network of Centers of Excellence for members who require transplantation.

 

Transplants and transplant related services are covered only when performed at a transplant center previously approved by QualChoice.

1. Progressive lung disease that severely limits daily quality of life despite optimal medical and other surgical therapy is known as end-stage lung disease.
2. End-stage lung disease is frequently treated with lung transplantation.  Lung transplantation is a treatment option used for end-stage lung disease when certain criteria are met.
3. Lung transplantation and related services require preauthorization.
4. Lung Transplant services may be confined to the QualChoice transplant network.

Note: All transplants must be approved by the Medical Director prior to authorization.

1. QualChoice considers lung transplantation medically necessary for any of the following qualifying conditions for members who meet the transplanting institution`s selection criteria. In the absence of an institution`s selection criteria, members must meet both the general selection criteria (see section on General Selection Criteria) and any applicable disease-specific selection criteria (see Disease-Specific Selection Criteria accompanying the list of Qualifying Conditions below):
Qualifying Conditions for Lung Transplantation (Not an All-Inclusive List)
A. Alpha1-antitrypsin deficiency (E88.01): Persons who meet the emphysema/alpha1-antitrypsin deficiency disease-specific selection criteria below
B. Bronchopulmonary Dysplasia (P27.1)
C. Congenital Heart Disease (Eisenmenger`s Defect or Complex) (Q21.8): Persons who meet the disease-specific criteria for Eisenmenger`s below
D. Cystic Fibrosis (E84.0 – E84.9): Persons who meet the disease-specific selection criteria for cystic fibrosis
E. Graft-Versus-Host Disease (D89.810 – D89.813) or failed Primary Lung Graft.
F. Obstructive Lung Disease (e.g., emphysema, chronic obstructive pulmonary disease, bronchiolitis obliterans, bronchiectasis) (J41.8, J43.0 – J43.2, J43.8 - J43.9, J44.0 – J44.1, J44.9, J47.0 – J47.1, J47.9): Persons with pulmonary fibrosis, see the disease-specific selection criteria for pulmonary fibrosis below
G. Primary Pulmonary Hypertension (I27.0): Persons who meet the disease-specific selection criteria for primary pulmonary hypertension
H. Restrictive Lung Disease (e.g., idiopathic pulmonary fibrosis, desquamative interstitial fibrosis, post-chemotherapy, allergic alveolitis, systemic sclerosis [scleroderma], collagen vascular disease, asbestosis, eosinophilic granuloma, and sarcoidosis) (C96.5 – C96.6, D86.0, D86.2, J61, J67.0 – J67.9, J84.112, J84.117, J98.4, M34.0 – M34.9, M35.9, M36.8): Persons with sarcoidosis, see the disease-specific selection criteria below
I. Lymphangioleiomyomatosis (LAM) (J84.81) with End-Stage Pulmonary Disease
General Selection Criteria:
The member must meet the transplanting institution`s selection criteria. In the absence of an institution`s selection criteria, all of the following selection criteria must be met, and none of the contraindications listed below should be present:
A. Adequate liver and kidney function, defined as a bilirubin of less than 2.5 mg/dl and a creatinine clearance of greater than 50 ml/min/kg; and
B. Adequate cardiac status (e.g., no angiographic evidence of significant coronary artery disease, ejection fraction greater than 40%, no myocardial infarction in last 6 months, negative stress test). Persons with any cardiac symptoms may require heart catheterization to rule out significant heart disease; and
C. Adequate functional status. Under established guidelines, active rehabilitation is considered important to the success of transplantation. Mechanically-ventilated or otherwise immobile persons are considered poor candidates for transplantation; and
D. Absence of acute or chronic active infection (pulmonary or non-pulmonary) that is not adequately treated; and
E. Limited life expectancy of less than 2 years; and
F. No uncontrolled and/or untreated psychiatric disorders that interfere with compliance to a strict treatment regimen; and
G. No active alcohol or chemical dependency that interferes with compliance to a strict treatment regimen. Persons with a history of drug or alcohol abuse must be abstinent for at least 3 months before being considered an eligible transplant candidate; and
H. Absence of inadequately controlled HIV/AIDS infection, defined as:
a. CD4 count greater than 200 cells/mm3 for greater than 6 months; and
b. HIV-1 RNA (viral load) undetectable; and
c. On stable antiviral therapy greater than 3 months; and
d. No other complications from AIDS, such as opportunistic infection (e.g., aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections) or neoplasms (e.g., Kaposi`s sarcoma, non-Hodgkin`s lymphoma).
Contraindications: Lung transplantation is considered experimental and investigational for persons with the following contraindications to lung transplant surgery as the safety and effectiveness of lung transplantation in persons with these contraindications has not been established:
A. Multi-system disease. Persons with potentially multi-system diseases such as systemic sclerosis (scleroderma), other collagen vascular diseases such as systemic lupus erythematosus, or sarcoidosis must be carefully evaluated to ensure that their disease is primarily confined to the lung. Persons with diabetes must be carefully evaluated to rule our significant diabetic complications such as nephropathy, neuropathy or retinopathy.
B. Smoking. Persons with a history of smoking must be abstinent for 6 months before being considered eligible for lung transplantation.
C. Malignancy involving the lung (primary or metastatic). Persons with a history of non-pulmonary cancer must be in remission before being considered a lung transplant candidate. Note: Because of disappointing results, lung transplantation is considered experimental and investigational as a treatment for bronchioloalveolar carcinoma.
D. Presence of gastrointestinal disease (e.g., bleeding peptic ulcer, diverticulitis, chronic hepatitis).
E. Refractory uncontrolled hypertension.
F. Other effective medical treatments or surgical options are available.
G. Single-lung transplantation is contraindicated in persons with chronic pulmonary infections (e.g., bronchiectasis, chronic bronchitis, and cystic fibrosis).
2. QualChoice considers lobar (from living-related donors or cadaver donors) lung transplantation medically necessary for persons with end-stage pulmonary disease when selection criteria are met (see above).
3. QualChoice considers lung xenotransplantation (e.g., porcine xenografts) experimental and investigational for any pulmonary conditions.
Disease-Specific Selection Criteria:
A. Lung transplant for cystic fibrosis is considered medically necessary for persons who meet the general selection criteria for lung transplantation and exhibit at least two of the following signs and symptoms of clinical deterioration:
1. Initiation of supplemental enteral feeding by percutaneous endoscopic gastrostomy or parenteral nutrition.
2. Cycling intravenous antibiotic therapy.
3. Non-invasive nocturnal mechanical ventilation.
4. Increasing frequency of hospital admission.
5. Increasing severe exacerbation of cystic fibrosis - especially an episode requiring hospital admission.
6. Recurrent massive hemoptysis.
7. Development of CO2 retention (pCO2 greater than 50 mm Hg).
8. Worsening arterial-alveolar (A-a) gradient requiring increasing concentrations of inspired oxygen (FiO2).
9. Decreasing FEV1.
10. FEV1 less than 30% predicted.
B. Lung transplant for emphysema (including alpha 1-antitrypsin deficiency) is considered medically necessary for persons who meet the general criteria for lung transplantation and both of the following clinical criteria:
1. Hospitalizations for exacerbation of chronic obstructive pulmonary disease associated with hypercapnia in the preceding year. Hypercapnia is defined as pCO2 greater than or equal to 50 mm Hg with hospitalizations and/or the following associated factors:
a. reduced serum albumin
b. declining body mass index
c. increasing oxygen requirements
d. presence of cor pulmonale (defined as clinical diagnosis by a physician or any 2 of the following:
i. right ventricular hypertrophy or right atrial enlargement on EKG
ii. enlarged pulmonary arteries on chest X-ray
iii. pedal edema or jugular venous distention
iv. mean pulmonary artery pressure by right heart catheterization of greater than 25 mm Hg at rest or 30 mm Hg with exercise
2. FEV1 less than 30% predicted.
C. Lung transplant for Eisenmenger`s Complex is considered medically necessary for persons who meet the general criteria for lung transplantation and any of the following disease-specific criteria:
1. Signs of right ventricular failure -- progressive hepatomegaly, ascites.
2. Marked deterioration in functional capacity (New York Heart Association (NYHA) Class III).
3. Pulmonary hypertension with mean pulmonary artery pressure by right heart catheterization greater than 25 mm Hg at rest or 30 mm Hg with exercise.
D. Lung transplant for pulmonary fibrosis is considered medically necessary for persons who meet the general criteria for lung transplantation and any of the following disease-specific criteria:
1. Presence of cor pulmonale (indicative of severe pulmonary fibrosis) or pulmonary hypertension.
2. Diffusing capacity for carbon monoxide (DLCO) less than 39%.
3. A 10% or greater decrement in the FVC during 6 months of follow up.
4. A decrease in pulse oximetry below 88% during a 6-minute walk test (6-MWT).
E. Lung transplant for pulmonary hypertension is considered medically necessary for persons who meet the general criteria for lung transplantation plus any of the following criteria:
1. Persons who are New York Heart Association (NYHA) III, failing conventional vasodilators (calcium channel blockers or endothelin receptor antagonists).
2. Persons who are New York Heart Association (NYHA) III, and have initiated or being considered for initiation of parenteral or subcutaneous vasodilator therapy.
Refer to the Prognostic Factors for PH in the ISHLT consensus report. Note: NYHA Class III for heart failure is defined as follows:
Persons with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity (i.e., mild exertion) causes fatigue, palpitation, dyspnea, or anginal pain.
F. Lung transplant for sarcoidosis is considered medically necessary for persons who meet the general criteria for lung transplantation plus any of the following disease-specific criteria:
1. Presence of cor pulmonale (indicative of severe pulmonary fibrosis) or pulmonary hypertension.
2. Total lung capacity less than 70% predicted.
3. Diffusion capacity (DLCO) less than 60% predicted.
Codes Used In This BI:
32850 Donor pneumonectomy(s) (incl. cold preservation), from cadaver donor
32851 Lung transplant, single; w/out cardiopulmonary bypass
32852 Lung transplant, single; w/ cardiopulmonary bypass
32853 Lung transplant, double (bilateral sequential or en bloc); w/out cardiopulmonary bypass
32854 Lung transplant, double (bilateral sequential or en bloc); w/cardiopulmonary bypass
32855 Backbench standard preparation of cadaver donor lung allograft prior to transplantation, incl. dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; unilateral
32856 Backbench standard preparation of cadaver donor lung allograft prior to transplantation, incl. dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; bilateral


 

Lung transplantation has become a viable treatment option for carefully selected patients with end-stage pulmonary disease (ESPD). Single, double, and lobar-lung transplantation have all been performed successfully for a variety of diseases. Single-lung transplantation appears to be most effective for patients with end-stage pulmonary fibrosis, while double-lung transplantation is most effective for patients with end-stage chronic obstructive pulmonary disease and cystic fibrosis in whom cardiac function has been preserved. Lobar-lung transplantation (from living donors or cadaver donors) is usually reserved for children or adolescents who are appropriate candidates for lung transplantation and will not survive waiting for cadaver lungs. Indications for lung transplantation in pediatric patients include pulmonary vascular disease, bronchiolitis obliterans, bronchopulmonary dysplasia, graft failure due to viral pneumonitis, and cystic fibrosis.

Chronic obstructive pulmonary disease and alpha 1-antitrypsin deficiency, the two principal causes of emphysema, are responsible for approximately 60 % of all single-lung transplantations performed. Other indications for single-lung transplantation include primary pulmonary hypertension, Eisenmenger`s syndrome, as well as a variety of interstitial lung diseases (e.g., interstitial pulmonary fibrosis).

Cystic fibrosis, emphysema, and alpha 1-antitrypsin deficiency are the most common indications for double-lung transplantation, also known as bilateral single-lung transplantations (sequential replacement of both lungs). Comparing patients who have undergone en bloc double-lung transplantation to patients who have undergone bilateral single-lung transplantations, studies have shown a better outcome for those who have undergone the bilateral sequential procedure. The latter is generally considered the procedure of choice for patients with any pulmonary disorder complicated by chronic airway infection, such as bronchiectasis, cystic fibrosis, and chronic bronchitis. The possibility of spillover of infection from the native lung to the allograft precludes single-lung transplantation in such patients.

Although lung transplantation offers acceptable prospects for 5-year survival, chronic rejection and donor shortage remain to be major problems. To address the problem of donor shortage, living-donor lobar-lung transplantation has been performed with satisfactory intermediate survival and functional results. In lobar-lung transplantation, a lobe of the donor`s lung is excised, sized appropriately for the recipient, and transplanted. Common indications for living-donor bilateral lobar-lung transplantation are cystic fibrosis and severe primary pulmonary hypertension. Based on available scientific evidence, there is no significant difference in effectiveness between living-donor lobar-lung transplantation and cadaver lobar-lung transplantation.

There are currently two surgical therapies for the treatment of end-stage emphysema: lung transplantation and lung volume reduction surgery (LVRS) (see CPB 160 - Lung Volume Reduction Surgery). Ideal candidates for LVRS are those with hyperinflation, heterogeneous distribution of disease, FEV1 of more than 20 %, and normal PCO2. Patients with diffuse disease, low FEV1, hypercapnia, and associated pulmonary hypertension are directed toward transplantation. Moreover, lung transplantation provides more satisfactory results than LVRS for patients with emphysema due to alpha1-antitrypsin deficiency. Combinations of lung transplantation and LVRS, simultaneously or sequentially, are feasible but rarely indicated.

Complications of lung transplantation include re-implantation response and airway complications. Rejection may occur in the hyper acute, acute, or chronic settings and requires judicious management with immunosuppression. Infection and malignancy remain potential complications of the commitment to lifelong systemic immunosuppression. Obese (> 20% of ideal body weight), cachectic (< 80% of ideal body weight), mechanically ventilated or otherwise immobile patients are considered poor candidates for transplantation.

There is a steadily increasing need for a greater supply of lung donors. Xenotransplantation offers the possibility of an unlimited supply of lungs that could be readily available when needed. However, antibody-mediated mechanisms cause the rejection of pig organs transplanted into non-human primates, and these mechanisms provide key immunological barriers that have yet to be overcome. Although porcine hearts have functioned in heterotopic sites in non-human primates for periods of several weeks, no transplanted porcine lung has functioned for even 24 hours. Currently, lung xenotransplantation is not a clinically applicable option, and is therefore considered an experimental and investigational procedure.

Amital and colleagues (2008) noted that lung transplantation impairs surfactant activity, which may contribute to primary graft dysfunction (PGD). In an open, randomized, controlled prospective study, these researchers examined if the administration of surfactant during transplantation serves as an effective preventive measure. A total of 42 patients scheduled for single (n = 38) or double (n = 4) lung transplantation were randomly assigned to receive, or not, intra-operative surfactant treatment. In the treated group, bovine surfactant was administered at a dose of 20 mg phospholipids/kg body weight through bronchoscope after the establishment of bronchial anastomosis. The groups were compared for oxygenation (PaO2/FiO2), chest X-ray findings, PGD grade, and outcome. Compared with the untreated group, patients who received surfactant were characterized by better post-operative oxygenation mean PaO2/FiO2 (418.8 +/- 123.8 versus 277.9 +/- 165 mm Hg, p = 0.004), better chest radiograph score, a lower PGD grade (0.66 versus 1.86, p = 0.005), fewer cases of severe PGD (1 patient versus 12, p < 0.05), earlier extubation (by 2.2 hrs.; 95 % CI 1.1 to 4.3 hrs., p = 0.027), shorter intensive care unit stay (by 2.3 days; 95 % CI 1.47 to 3.74 days, p = 0.001), and better vital capacity at 1 month (61 % versus 50 %, p = 0.022). One treated and 2 untreated patients died during the first post-operative month. The authors concluded that surfactant instillation during lung transplantation improves oxygenation, prevents PGD, shortens intubation time, and enhances early post-transplantation recovery. Moreover, they stated that further, larger studies are needed to evaluate if surfactant should be used routinely in lung transplantation.

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