Effective Date:02/02/2011 |
Title:Lung Transplantation
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Revision Date:10/01/2015
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Document:BI282:00
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CPT Code(s):32850-32856
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Public Statement
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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.
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Progressive lung disease
that severely limits daily quality of life despite
optimal medical and other surgical therapy is known as end-stage lung
disease.
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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.
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Lung transplantation and related
services require preauthorization.
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Lung Transplant services may be
confined to the QualChoice transplant network.
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Medical Statement
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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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Limits
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Intentially left empty
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Reference
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Orens, Jonathan et al. Guidelines
for Selection of Lung Transplant Candidates;
The Journal of Heart and Lung Transplantation, vol 25 issue
7.
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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.
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Gross TJ, Hunninghake GW.
Idiopathic pulmonary fibrosis. N Engl J Med. 2001; 345(7):517-525.
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Ivy D. Diagnosis and treatment of
severe pediatric pulmonary hypertension. Cardiol Rev. 2001; 9(4):227-237.
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Meyers BF, Patterson GA. Lung
transplantation versus lung volume reduction as surgical therapy for
emphysema. World J Surg. 2001; 25(2):238-243.
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Date H. Current status and future
of lung transplantation. Intern Med. 2001; 40(2):87-95.
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DeMeo DL, Ginns LC. Lung
transplantation at the turn of the century. Annu Rev Med. 2001; 52:185-201.
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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.
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Platt JL. Physiologic barriers to
xenotransplantation. Transplant Proc. 2000; 32(7):1547-1548.
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Liou TG, Adler FR, Cahill BC, et
al. Survival effect of lung transplantation among patients with cystic
fibrosis. JAMA. 2001; 286:2683-2689.
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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.
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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.
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Waddell TK, Peterson MD. Lung
transplantation. Xenotransplantation. Chest Surg Clin N Am. 2003;
13(3):559-576.
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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.
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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.
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Cox A, Zhong R. Current advances
in xenotransplantation. Hepatobiliary Pancreat Dis Int. 2005; 4(4):490-494.
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Raz DJ, He B, Rosell R, Jablons
DM. Bronchioloalveolar carcinoma: A review. Clin Lung Cancer. 2006;
7(5):313-322.
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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.
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Schuurman HJ, Pierson RN 3rd.
Progress towards clinical xenotransplantation. Front Biosci. 2008;
13:204-220.
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Date H, Yamane M, Toyooka S, et
al. Current status and potential of living-donor lobar lung transplantation.
Front Biosci. 2008; 13:1433-1439.
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Amital A,
Shitrit D, Raviv Y, et al. The use of surfactant in lung transplantation.
Transplantation. 2008; 86(11):1554-1559.
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Application to Products
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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.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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