Medical Policy

Effective Date:02/02/2011 Title:Lung Transplantation
Revision Date:10/01/2015 Document:BI282:00
CPT Code(s):32850-32856
Public Statement

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.
Medical Statement

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


 

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Reference
  1. Orens, Jonathan et al. Guidelines for Selection of Lung Transplant Candidates; The Journal of Heart and Lung Transplantation, vol 25 issue 7.
  2. Steinman TI, Becker BN, Frost AE, et al. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001; 71(9):1189-1204.
  3. Gross TJ, Hunninghake GW. Idiopathic pulmonary fibrosis. N Engl J Med. 2001; 345(7):517-525.
  4. Ivy D. Diagnosis and treatment of severe pediatric pulmonary hypertension. Cardiol Rev. 2001; 9(4):227-237.
  5. Meyers BF, Patterson GA. Lung transplantation versus lung volume reduction as surgical therapy for emphysema. World J Surg. 2001; 25(2):238-243.
  6. Date H. Current status and future of lung transplantation. Intern Med. 2001; 40(2):87-95.
  7. DeMeo DL, Ginns LC. Lung transplantation at the turn of the century. Annu Rev Med. 2001; 52:185-201.
  8. Cooper DK, Keogh AM, Brink J, et al. Report of the Xenotransplantation Advisory Committee of the International Society for Heart and Lung Transplantation: The present status of xenotransplantation and its potential role in the treatment of end-stage cardiac and pulmonary diseases. J Heart Lung Transplant. 2000; 19(12):1125-1165.
  9. Platt JL. Physiologic barriers to xenotransplantation. Transplant Proc. 2000; 32(7):1547-1548.
  10. Liou TG, Adler FR, Cahill BC, et al. Survival effect of lung transplantation among patients with cystic fibrosis. JAMA. 2001; 286:2683-2689.
  11. Sharma S, Unruh H. Lung transplantation. eMedicine Transplantation Topic 2980. Omaha, NE: eMedicine.com; updated February 7, 2003. Available at: http://www.emedicine.com/med/topic2980.htm. Accessed July 29, 2003.
  12. Kelly J, Moss J. Lymphangioleiomyomatosis. eMedicine Pulmonology Topic 1348. Omaha, NE: eMedicine.com; updated December 31, 2001. Available at: http://www.emedicine.com/med/topic1348.htm. Accessed September 25, 2003.
  13. Waddell TK, Peterson MD. Lung transplantation. Xenotransplantation. Chest Surg Clin N Am. 2003; 13(3):559-576.
  14. Starnes VA, Bowdish ME, Woo MS, et al. A decade of living lobar lung transplantation: Recipient outcomes. J Thorac Cardiovasc Surg. 2004; 127(1):114-122.
  15. Barlesi F, Doddoli C, Gimenez C, et al. Bronchioloalveolar carcinoma: Myths and realities in the surgical management. Eur J Cardiothorac Surg. 2003; 24(1):159-164.
  16. Cox A, Zhong R. Current advances in xenotransplantation. Hepatobiliary Pancreat Dis Int. 2005; 4(4):490-494.
  17. Raz DJ, He B, Rosell R, Jablons DM. Bronchioloalveolar carcinoma: A review. Clin Lung Cancer. 2006; 7(5):313-322.
  18. National Institute for Health and Clinical Excellence (NICE). Living-donor lung transplantation for end-stage lung disease. Interventional Procedure Guidance 170. London, UK: NICE; 2006.
  19. Schuurman HJ, Pierson RN 3rd. Progress towards clinical xenotransplantation. Front Biosci. 2008; 13:204-220.
  20. Date H, Yamane M, Toyooka S, et al. Current status and potential of living-donor lobar lung transplantation. Front Biosci. 2008; 13:1433-1439.
  21. Amital A, Shitrit D, Raviv Y, et al. The use of surfactant in lung transplantation. Transplantation. 2008; 86(11):1554-1559.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.