CIGNA MEDICAL COVERAGE POLICY The following Coverage Policy applies to all plans administered by CIGNA Companies including plans administered by Great-West Healthcare, which is now a part of CIGNA.

Subject Lung Volume Reduction Surgery (LVRS)

Effective Date ..........................11/15/2008Next Review Date……………...11/15/2010 Coverage Policy Number ................. 0218

Table of Contents Coverage Policy ..................................................1 General Background ...........................................2 Coding/Billing Information ...................................7 References ..........................................................8 Policy History.....................................................12

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INSTRUCTIONS FOR USE Coverage Policies are intended to provide guidance in interpreting certain standard CIGNA HealthCare benefit plans as well as benefit plans formerly administered by Great-West Healthcare. Please note, the terms of a participant’s particular benefit plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a participant’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a participant’s benefit plan document always supercedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable group benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. Proprietary information of CIGNA. Copyright ©2008 CIGNA Coverage Policy CIGNA covers lung volume reduction surgery (LVRS) for individuals with severe emphysema when ALL of the following criteria are met:

• radiological evidence of bilateral upper-lobe (heterogeneous) emphysema • smoking cessation for at least six months • low functional capacity after pulmonary rehabilitation • pulmonary function test results showing:

forced expiratory volume in one second (FEV1) ≤ 45% of predicted and, if age 70 or older, FEV1 ≥15% of predicted value

post-bronchodilator total lung capacity (TLC) ≥100% of predicted and residual volume (RV) ≥ 150% of predicted value

• resting partial pressure of oxygen (PaO2) ≥45 mm Hg and resting partial pressure of carbon dioxide (PaCO2) ≤60 mm Hg on room air

• six-minute walk test > 140 meters • cardiology clearance for the presence of ANY of the following:

unstable angina left-ventricular ejection fraction (LVEF) cannot be estimated from the echocardiogram LVEF < 45 % nuclear cardiac scan indicates coronary artery disease (CAD) or ventricular dysfunction arrhythmia with greater than five premature ventricular contractions (PVCs) per minute

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cardiac rhythm other than normal sinus rhythm (NSR) PVCs on electrocardiogram (EKG) at rest

CIGNA does not cover LVRS for individuals with severe emphysema and ANY of the following, as it is considered not medically necessary:

• FEV1 ≤ 20% of predicted value and EITHER of the following: carbon monoxide diffusion capacity (DLCO) ≤20% of predicted value radiological evidence of diffuse, homogeneous emphysema

• high functional capacity (i.e., maximum workload > 25 W (Watts) for women and > 40 W for men, cycling for three minutes while breathing 30% oxygen)

• high oxygen requirement (i.e., six liters at rest to maintain saturation level at a minimum of 90%) • presence of undiagnosed pulmonary nodules or interstitial disease • previous thoracotomy • pulmonary hypertension • uncontrolled hypertension (i.e., systolic > 200 mm Hg or diastolic > 110 mm Hg) • significant cardiac arrhythmias • LVEF < 45% and myocardial infarction or congestive heart failure within the previous six months

General Background Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the United States, affecting 32 million adults. Asthma, chronic bronchitis, and emphysema are the three major disease categories of COPD. Men are more likely than women to have COPD, and it is most prevalent in individuals over age 40. Pulmonary emphysema is an irreversible condition characterized by progressively increasing dyspnea on exertion and eventually at lower levels of activity. The fine architecture and elasticity of the lungs are destroyed, resulting in obstruction of the airways, trapping of air, and difficulty exchanging oxygen. In the United States, two-thirds the population of men and one-fourth of women are found to have emphysema at death. An estimated two million individuals are affected, most of them over age 50. While there are many known causes of emphysema, including alpha-1-antitrypsin deficiency, cystic fibrosis, air pollution, occupational exposure, and bronchiectasis, the disease process generally results directly from tobacco abuse. The importance of smoking cessation is stressed as the single most effective way to reduce the risk of developing emphysema and stop its progression. Medical therapy for COPD typically includes smoking cessation intervention, bronchodilators, anti-inflammatory agents, oxygen, mucolytic drugs, influenza and pneumococcal vaccinations, antibiotics, pulmonary rehabilitation, and alpha-1-antitrypsin replacement therapy in patients who are deficient. Malnutrition is associated with a poor prognosis for patients with COPD, since it predisposes such patients to infections, as well as reducing respiratory muscle force, exercise tolerance and quality of life. Poor nutritional status can be modified through appropriate and efficacious diet therapy and monitoring (Fernandes and Bezerra, 2006). Long-term home oxygen use in hypoxemic patients has been proven to decrease mortality rates, and smoking cessation has been shown to slow the rate of progression of COPD. Medical therapy has a limited impact on the quality of life and survival in patients with end-stage emphysema (Hayes, 2003). Surgical treatments available for severe emphysema that is unresponsive to medical therapy include bullectomy for patients with bullous lung disease, lung transplantation, and lung volume reduction surgery. Lung Volume Reduction Surgery (LVRS) LVRS was first used to treat emphysema in the 1950s. Although some patients seemed to improve following the surgery, its association with high mortality and morbidity prevented its widespread use. The early 1990s saw renewed interest in and increased use of the procedure (Department of Health and Human Services [DHHS], National Institutes of Health [NIH] and National Heart, Lung, and Blood Institute [NHLBI], 2003). LVRS involves resecting emphysematous lung tissue, usually from both upper lobes. The procedure may be performed by video-assisted thoracic surgery (VATS) or by median sternotomy. The affected lung tissue is stapled, resected and removed from the chest cavity. Laser excision has been utilized in an attempt to decrease the rate of complication due to air leaks. The goal of the surgery is to reduce the overall volume of the lung by

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20–30%, while preserving non-diseased tissue and the normal anatomical shape of the lung. The remaining lung tissue has enhanced recoil and improved gas-exchange properties, which are presumed mechanisms leading to improved survival, functional gains and symptomatic relief. Lung function is improved by reversing the adverse effects of hyperinflation and uneven ventilation, in turn, decreasing the work of breathing and improving alveolar gas exchange. LVRS is palliative, however, not curative; its objective is to improve functional status and quality of life. Minimally invasive techniques to attain lung volume reduction without open thoracotomy are under investigation. Devices and techniques being investigated include one-way bronchial valves inserted by fiberoptic bronchoscopy to promote atelectasis in the emphysematous lung, bronchopulmonary fenestrations to enhance expiratory flow, and thoracoscopic compression of the affected lung. The goal of these procedures is to duplicate the benefit of LVRS without the trauma, risks, and extended recovery of open LVRS (Maxfield, 2004). Literature Review The National Emphysema Treatment Trial (NETT) helped to define the subset of patients who might benefit the most from LVRS, as well as those patients who would be at the highest risk for the procedure. The NETT, conducted between January 1998 and July 2002, was a multicenter, randomized, controlled clinical trial that compared LVRS to medical therapy for severe emphysema. The study, supported by the NHLBI and the CMS, set out to evaluate the long-term efficacy, morbidity and mortality associated with LVRS compared to medical therapy alone and to define patient selection criteria. Selection criteria for the study included: FEV1 ≤45%, but ≥15% for patients ≥70 yrs; TLC ≥100% predicted; RV ≥150%; PaCO2 ≤60 mm Hg; PaO2 ≥45 mm Hg; six-minute walk test > 140 meters; body mass index (BMI) ≤ 31.1 for males and ≤ 32.3 for females; abstinence from smoking for at least six months and completion of the NETT pulmonary rehabilitation program. Exclusion criteria included the following (Fishman, et al., (2003):

• diffuse emphysema deemed unsuitable for LVRS • pleural or interstitial disease precluding surgery • pulmonary nodule requiring surgery • previous sternotomy or lobectomy • uncontrolled hypertension • pulmonary hypertension • LVEF < 45% AND myocardial infarction or congestive heart failure within the previous six months • cardiac dysrythmias which might pose a risk during exercise testing • oxygen requirement that exceeds six liters at rest to maintain saturation level at a minimum of 90%

The study evaluated 3777 patients, of whom a total of 1218 with severe emphysema underwent pulmonary rehabilitation and were randomly assigned to undergo LVRS (n=608) or to receive continued medical treatment (n=610). The two groups had similar baseline characteristics after pulmonary rehabilitation, except for a higher percentage of men in the medical therapy group. The surgical group was stratified by type of emphysema (upper-lobe vs. non-upper-lobe). All analyses compared the treatment groups to which patients were originally assigned by randomization (intention-to-treat principle). The primary outcome measures were overall mortality and maximal functional capacity two years after randomization. Secondary outcomes included the six-minute walk test, lung function tests and general health-related quality of life (HRQL). The results revealed no difference in overall mortality between the two groups after a mean follow-up observation period of 29 months. The risk of death during the first three months after randomization was higher in the surgical group than in the medical treatment group, but maximal functional capacity, pulmonary function as measured by FEV1, and quality of well-being were also higher in the surgical group. Researchers found that two characteristics helped predict if an individual participant would benefit from LVRS: whether the emphysema was concentrated in the upper lobes of the lungs and whether functional capacity was low or high. For those in the LVRS group, functional capacity was measured after medical therapy but before surgery. A functional capacity score ≤ 25 W for females or ≤ 40 W for males was considered low; a score > 25 W for females or > 40 W for males was considered high. These two characteristics combined to form four groups of participants who accrued different risks and benefits from LVRS:

1. Patients with mostly upper-lobe emphysema and low functional capacity were more likely to live longer and more likely to function better after LVRS than after medical treatment. Thirty percent of the surgical

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group demonstrated at least a 10 W improvement in functional capacity compared to no improvement in those treated with medical therapy alone.

2. Among patients with mostly upper-lobe emphysema and high functional capacity, there was no

difference in survival between the LVRS and medical participants. Those in the surgical group, however, were more likely to function better than those who received medical treatment without surgery. Fifteen percent of LVRS participants, but only 3% of medical participants, had ≥ 10 W improvement in functional capacity.

3. Patients with mostly non-upper-lobe emphysema and low functional capacity had similar survival and

functional ability after either treatment, but had less shortness of breath after LVRS than after medical treatment.

4. Patients with mostly non-upper-lobe emphysema and high functional capacity had poorer survival after

LVRS than after medical treatment; both LVRS and medical participants had similarly low chances of functioning better.

The NETT suggests that the best predictors of postsurgical improvement are upper-lobe predominance emphysema and low postrehabilitation functional capacity, measured while breathing 30% inspiratory oxygen fraction on cycle ergometry. Three smaller, randomized controlled trials (RCTs) compared LVRS with medical management (Criner, et al., 1999; Geddes, et al., 2000; Goldstein, et al., 2003). All the trials (except Criner, et al. [1999], which lasted only three months) found significant improvements in functional capacity with LVRS compared to medical treatment. Objective measures of lung function, such as FEV1 and residual volume (RV), consistently improved following surgery in these studies. Geddes et al. (2000) and Goldstein et al. (2003) observed that peak improvement occurred six to nine months after surgery and declined thereafter, returning to baseline within a year or two, on average. However, since lung function in the medical treatment groups declined continuously throughout this period, LVRS patients actually had better lung function at one to two years (Geddes, et al., 2000; Goldstein, et al., 2003). Similarly, dyspnea and quality of life improved more for the LVRS patients following surgery and then declined at a rate similar to that of the medical treatment group. Short-term mortality was between 4% and 10% for all the studies reviewed, higher than the short-term mortality rate associated with medical treatment. An Institute for Clinical Systems Improvement (ICSI) technology assessment of the evidence regarding LVRS for the treatment of emphysema The report stated that typical indications for LVRS are: end-stage emphysema with severe dyspnea, forced expiratory volume in 1 second (FEV1) predicted >20% but <45%, hyperinflated lungs with flattening or inversion of the diaphragm, no isolated bullae of >5 cm, and motivation and ability to complete pulmonary rehabilitation. Typical contraindications for the procedure include: age ≥ 70 years with a FEV1<15%, cigarette use within four months of surgery, severe obesity, severe comorbid illness, severe pulmonary hypertension, ventilator dependence, oral corticosteroid use (dose of >15 mg/day prednisone equivalent), and inability to complete a 6 minute walk of over 140 meters. In summary, it was concluded that LVRS resulted in a survival advantage only for those patients with upper-lobe emphysema and low baseline exercise capacity. Improvement in exercise capacity was seen in those with upper-lobe disease; however, most patients’ improvement returned to baseline after two years. Compared to nonsurgical patients, those with upper-lobe emphysema who underwent LVRS reported improved quality of life after two years. Based on the available evidence, the possible rate of decline in lung function and any potential change in life expectancy are unknown. According to the ICSI committee, LVRS should only be performed in medical centers with appropriately trained surgeons and the availability of necessary equipment (ICSI, 2003; 2007). A Blue Cross Blue Shield Technology Evaluation Center (TEC) assessment concluded that LVRS for the treatment of severe emphysema met TEC criteria if patients are non-high-risk patients, as defined by the NETT, with predominantly upper-lobe disease and meet criteria for surgery as in the NETT. “The available evidence shows that in low-risk patients with severe emphysema predominantly of the upper lobe of the lung, LVRS can improve exercise capacity and quality-of-life findings. Beyond pulmonary rehabilitation and continued medical management, there are no commonly available alternatives to LVRS.” The report further stated that LVRS for the treatment of severe emphysema in other patient populations such as those defined as high-risk or non-high-risk patients with predominantly non-upper-lobe disease, did not meet TEC criteria (Blue Cross Blue Shield Association, 2003).

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According to the National Institute for Clinical Excellence (NICE), the current safety and efficacy of LVRS for advanced emphysema appears to be adequate to support the use of this procedure with appropriate arrangements in place for consent, audit and clinical oversight. LVRS may be an option for patients with severe symptoms for whom conservative treatments have proven to be inadequate. In their review of the evidence, NICE noted the most common complication of LVRS to be persistent air leak from the lung. Other complications included pneumonia, inpatient mortality, myocardial infarction (MI), and deep vein thrombosis (DVT) (NICE, 2005). Miller et al. (2005) reported on two similar, independently conducted multicenter, randomized clinical trials. The investigators combined the data from the Canadian Lung Volume Reduction (CLVR) surgery study and the Overholt-Blue Cross Emphysema Surgery Trial (OBEST) to answer questions about the palliative value of LVRS. Both studies compared treatment with LVRS combined with medical therapy and optimal medical therapy alone. Optimal medical therapy included the completion of a program of standardized pulmonary rehabilitation. Selection criteria included severe emphysema, marked airflow limitation (i.e., FEV1 15─40% predicted), hyperinflation (i.e., total lung capacity [TLC] > 120% predicted), carbon dioxide (CO2) < 55 mm Hg, and measurable dyspnea. Of the combined total (n=93), 54 patients were randomized to undergo LVRS, and 39 patients were randomized to receive medical treatment only. Of the original 93 patients, five patients died during the follow-up period, leaving 88 patients for evaluation six months after randomization. Combined results from a comparison of the medical and surgical groups indicated that LVRS was associated with a higher FEV1 (p=0.017), lower residual volume (p<0.001), lower TLC (p<0.001), and higher six-minute walk distance (p=0.019). At six months of follow-up, the surgical group showed statistically significant improvement in all quality-of-life measures compared to the medical group. The authors concluded that LVRS resulted in better short-term palliation than optimal medical management in patients with advanced emphysema (Miller, et al., 2005). Berger et al. (2005) conducted a meta-analysis of six RCTs with 306 patients and follow-up periods of 3–12 months. Baseline features of these studies included heterogeneous emphysema, low walking capacity as measured by the six-minute walk distance (6MWD), and comparable inclusion and exclusion criteria. The LVRS arm of the meta-analysis population showed better results than the medical cohort in terms of pulmonary function, gas exchange and exercise capacity. Mortality was found to be similar in the two study arms 6–12 months after random assignment to treatment. In the opinion of the authors, this meta-analysis indicated that LVRS improves pulmonary function, exercise capacity and respiratory symptoms in selected patients with advanced heterogenous emphysema and low exercise tolerance. LVRS results in better outcomes than medical therapy for this subset of patients (Berger, et al., 2005). Naunheim et al. (2006) presented an updated analysis of NETT data at a median follow-up of 4.3 years. The evidence for differential risk and benefit after LVRS in the four subgroups defined by baseline exercise capacity (i.e., low versus high) and distribution of emphysema (i.e., upper-lobe versus non-upper-lobe) persisted in this analysis. The following observations were reported:

1. For patients with predominantly upper-lobe emphysema and low postrehabilitation exercise capacity, the additional data confirmed the beneficial effects of LVRS. The survival advantage of the LVRS group over the medical treatment group that was previously demonstrated after a median of 2.4 years of follow-up (p=0.005) was sustained in the longer follow-up period (p=0.01). Long-term follow-up strongly supports the performance of LVRS in this subgroup that comprised 24% of the NETT population.

2. For patients with upper-lobe disease and high postrehabilitation exercise capacity, LVRS had no

survival advantage or disadvantage. Patients in this subgroup (34% of all enrolled patients) who are looking primarily for symptomatic improvement may benefit from LVRS.

3. Patients with non-upper-lobe-predominant emphysema and low postrehabilitation exercise capacity had

limited improvement in exercise capacity regardless of treatment. Survival was not found to be different between the LVRS and medical groups. Recommendations regarding LVRS in this subgroup are guarded because the primary benefit is improvement in HRQL, which appears to dissipate within three years after surgery.

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4. For patients in the subgroup characterized by non-upper-lobe-predominant emphysema and high postrehabilitation maximum work, LVRS initially led to a higher mortality. Extended follow-up confirmed that these patients have little chance of functional or symptomatic improvement and, therefore, are poor candidates for LVRS.

The authors also noted that extended follow-up revealed a survival advantage with LVRS for the entire NETT population. It was concluded that the “effects of LVRS are durable, and it can be recommended for upper-lobe-predominant emphysema patients with low exercise capacity. LVRS should be considered for palliation in patients with upper-lobe emphysema and high exercise capacity” (Naunheim, et al., 2006). In a Cochrane review, Tiong et al. (2007) analyzed eight RCTs (n=1663) that studied the safety and efficacy of LVRS in patients with diffuse emphysema. The NETT accounted for 73% of the subjects in this review. Studies included a variety of LVRS approaches and techniques (e.g., VATS, median sternotomy with unilateral or bilateral stapling). Outcome measures included postoperative complications and mortality, lung function parameters, and disability and health status assessed by measures such as exercise performance, symptom scores and quality of life measures. The severity of emphysema across the studies indicated that trial populations suffered significant functional impairment with severe airflow limitation. Control groups consisted of either usual medical follow-up, or different surgical techniques. In many of the studies, a prerequisite for study entry was the completion of a course of pulmonary rehabilitation. This rehabilitation was routinely performed by subjects in either the usual medical care treatment groups or as an additional part of post-intervention treatment, and usually incorporated educational, nutritional and physical exercise components. The 90-day mortality data primarily from the NETT indicated that death was more likely with LVRS, regardless of risk status identified. However, improvements in lung function, quality of life and exercise capacity were more likely with LVRS than with usual medical follow-up. According to the authors, the available evidence suggests that LVRS can only be recommended in patients who have completed a course of pulmonary rehabilitation, and whose candidature for surgery has been established through high-resolution computed tomography findings (Tiong, et al., 2007). Centers for Medicare & Medicaid Services (CMS): The CMS revised its policy on LVRS in 2003. This policy states that patients who are suitable for LVRS must be non-high-risk as defined by NETT and present with severe upper-lobe predominant emphysema, or severe non-upper-lobe emphysema with low exercise capacity. In addition, patients must satisfy all of the following criteria (CMS, 2003): Assessment Criteria

Consistent with emphysema

Body mass index (BMI), ≤ 31.1 kg/m (men) or ≤ 32.3 kg/m (women)

History and physical examination

Stable with ≤ 20 mg prednisone (or equivalent) once per day Radiographic High Resolution Computer Tomography (HRCT) scan evidence of bilateral

emphysema

Forced expiratory volume in one second (FEV) ≤ 45% predicted (≥ 15% predicted if age ≥ 70 years)

Total lung capacity (TLC) ≥ 100% predicted post-bronchodilator

Pulmonary function (pre-rehabilitation)

Residual volume (RV) ≥ 150% predicted post-bronchodilator PCO2, ≤ 60 mm Hg (PCO2, ≤ 55 mm Hg if one mile above sea level) Arterial blood gas

level (pre-rehabilitation)

PO2, ≥ 45 mm Hg on room air (PO2, ≥ 30 mm Hg if one mile above sea level)

Cardiac assessment

Approval for surgery by cardiologist if any of the following are present: Unstable angina; left-ventricular ejection fraction (LVEF) cannot be estimated from the echocardiogram; LVEF < 45%; dobutamine-radionuclide cardiac scan indicates

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coronary artery disease or ventricular dysfunction; arrhythmia (> five premature ventricular contractions per minute; cardiac rhythm other than sinus; premature ventricular contractions on EKG at rest)

Surgical assessment

Approval for surgery by pulmonary physician, thoracic surgeon, and anesthesiologist post-rehabilitation

Exercise Post-rehabilitation six-minute walk of ≥ 140 meters (m); able to complete three-minute unloaded pedaling in exercise tolerance test (pre- and post-rehabilitation)

Consent Signed consents for screening and rehabilitation

Smoking Plasma cotinine level ≤ 13.7 ng/mL (or arterial carboxyhemoglobin ≤ 2.5% if using nicotine products) Nonsmoking for four months prior to initial interview and throughout evaluation for surgery

Preoperative diagnostic and therapeutic program adherence

Must complete assessment for and program of preoperative services in preparation for surgery

The CMS states that patients with the following clinical circumstances are not candidates for LVRS:

• high risk for perioperative morbidity and/or mortality • disease that is unsuitable for LVRS • medical conditions or other circumstances that render the patient unable to complete the preoperative

and postoperative pulmonary diagnostic and therapeutic program required for surgery • FEV1 ≤ 20% of predicted value, and either homogeneous distribution of emphysema on CT scan, or

DLCO ≤ 20% of predicted value (i.e., high-risk group identified by the NETT) • severe, non-upper lobe emphysema with high exercise capacity (i.e., maximum workload > 25 W

(Watts) for women and > 40 W for men, cycling for three minutes while breathing 30% oxygen) Professional Societies/Organizations The American Thoracic Society’s (ATS) position statement of May 1996 recommends that LVRS be performed in institutions where a multidisciplinary team, including pulmonologists and thoracic surgeons and a high level of diagnostic and surgical expertise, are available. Patients undergoing LVRS should have advanced emphysema with disabling dyspnea and evidence of severe air trapping. Advanced age (i.e., > age 75) and significant comorbid illness have been considered contraindications to LVRS (ATS, 1996). The ATS and European Respiratory Society (ERS) sponsored updated guidelines for the diagnosis and management of COPD in 2004. According to this document, “LVRS may result in improved spirometry, lung volumes, exercise capacity, dyspnea, HRQL, and possibly survival in highly selected patients” (Celli and McNee, 2004). Summary The peer-reviewed literature contains sufficient evidence to conclude that LVRS is indicated for the treatment of patients with end-stage, severe bilateral, upper-lobe emphysema and disabling dyspnea with low functional capacity after a course of pulmonary rehabilitation. LVRS has been shown to produce significant improvement in pulmonary function, dyspnea, functional capacity, and general health-related quality of life (HRQL) for this subset of individuals. LVRS is associated with increased survival and decreased mortality rates for those with predominantly upper-lobe disease and low functional capacity in comparison to those with non-upper-lobe disease. When considering this surgery, physicians must include pulmonary rehabilitation in a patient’s evaluation and as part of the postsurgical and ongoing care. This surgery should not be considered for patients whose pattern of disease is unfavorable and who have a high functional capacity. Coding/Billing Information Note: This list of codes may not be all-inclusive.

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Covered when medically necessary: CPT®* Codes

Description

32491 Removal of lung, other than total pneumonectomy; excision-plication of emphysematous lung(s) (bullous or non-bullous) for lung volume reduction, sternal split or transthoracic approach, with or without any pleural procedure

ICD-9-CM Diagnosis Codes

Description

492.0 Emphysematous bleb 492.8 Other emphysema

Experimental/Investigational/Unproven/Not Covered: ICD-9-CM Diagnosis Codes

Description

Multiple/varied *Current Procedural Terminology (CPT ) 2007 American Medical Association: Chicago, IL.® ©

References

1. American Association for Respiratory Care (AARC). Did You Know? Facts and figures on COPD. November 14, 2003. Accessed Oct 13, 2005. Available at URL address: http://www.aarc.org/headlines/copd_awareness_month_03/copd_facts.asp

2. American Thoracic Society (ATS). Lung Volume Reduction Surgery. May 1996. Accessed Oct 13, 2005.

Available at URL address: http://www.thoracic.org/adobe/statements/volume1-2.pdf#search='ats%20lung%20volume%20reduction%20surgery'

3. Appleton S, Adams R, Porter S, Peacock M, Ruffin R. Sustained improvements in dyspnea and

pulmonary function 3 to 5 years after lung volume reduction surgery. Chest. 2003;123(6):1838-46.

4. Bartels MN, Kim H, Whiteson JH, Alba AS. Pulmonary rehabilitation in patients undergoing lung-volume reduction surgery. Arch Phys Med Rehabil. 2006 Mar;87(3 Suppl 1):S84-8; quiz S89-90.

5. Benditt JO. Surgical options for patients with COPD: sorting out the choices. Respir Care. 2006

Feb;51(2):173-82.

6. Berger RL, Wood KA, Cabral HJ, Goodnight-White S, Ingenito EP, Gray A, et al. Lung volume reduction surgery: a meta-analysis of randomized clinical trials. Treat Respir Med. 2005;4(3):201-9.

7. Blue Cross Blue Shield Association. Technology Evaluation Center. Lung volume reduction surgery for

emphysema. Technology assessment. 2003 Dec. Accessed Sep 2, 2004. Available at URL address: http://www.bcbs.com/tec/Vol18/18_17.pdf

8. Calverley PM. Closing the NETT on lung volume reduction surgery. Thorax. 2003 Aug;58(8):651-3.

9. Celli BR, MacNee W; ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with

COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004 Jun;23(6):932-46.

Page 8 of 12 Coverage Policy Number: 0218

10. Criner GJ, Cordova FC, Furukawa S, Kuzma AM, Travaline JM, Leyenson V, O'Brien GM. Prospective randomized trial comparing bilateral lung volume reduction surgery to pulmonary rehabilitation in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Dec;160(6):2018-27.

11. Criner GJ, Sternberg AL; National Emphysema Treatment Trial Research Group. A clinician's guide to

the use of lung volume reduction surgery. Proc Am Thorac Soc. 2008 May 1;5(4):461-7.

12. Department of Health and Human Services (DHHS), National Institutes of Health (NIH) and National Heart, Lung, and Blood Institute (NHLBI). National Emphysema Treatment Trial (NETT): Evaluation of Lung Volume Reduction Surgery For Emphysema. May 20, 2003. Accessed Sept 21, 2004. Available at URL address: http://www.nhlbi.nih.gov/health/prof/lung/nett/lvrsweb.htm

13. Department of Health and Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS).

NCD for Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1). November 17, 2007. Last modified August 14, 2007. Accessed Oct 14, 2005; Sep 25, 2007. Available at URL address: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=240.1&ncd_version=3&basket=ncd%3A240%2E1%3A3%3ALung+Volume+Reduction+Surgery+%28Reduction+Pneumoplasty%29

14. Drazen JM, Epstein AM. Guidance concerning surgery for emphysema. N Engl J Med. 2003 May

22;348(21):2134-6.

15. Fernandes AC, Bezerra OM. Nutrition therapy for chronic obstructive pulmonary disease and related nutritional complications. J Bras Pneumol. 2006 Sep-Oct;32(5):461-71.

16. Fishman A, Martinez F, Naunheim K, Arbor A, Fessler H, Piantadosi S, et al. A randomized trial

comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003 May 22;348(21):2059-73.

17. Fishmen A, Fessler H, Martinez F, Arbor A, McKenna RJ, Naunheim K , et al. Patients at high risk of

death after Lung-Volume-Reduction Surgery. N Engl J Med. 2001 Oct 11;345(15):1075-83.

18. Geddes D, Davies M, Koyama H, Hansell D, Pastorino U, Pepper J, et al. Effect of lung-volume-reduction surgery in patients with severe emphysema. N Engl J Med. 2000 Jul 27;343(4):239-45.

19. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management

and prevention of chronic obstructive pulmonary disease. Originally published 1998 Apr. Updated November 2006. Accessed Sep 25, 2007. Available at URL address: http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989

20. Goldstein RS, Todd TR, Guyatt G, Keshavjee S, Dolmage TE, van Rooy S, et al. Influence of lung

volume reduction surgery (LVRS) on health related quality of life in patients with chronic obstructive pulmonary disease. Thorax. 2003 May;58(5):405-10.

21. HAYES Medical Technology Directory™. Lung Volume Reduction Surgery for Chronic Obstructive

Pulmonary Disease. Lansdale, PA: HAYES, Inc.; ©2003 Winifred S. Hayes, Inc. 2003 Dec.

22. Hopkinson NS. Bronchoscopic lung volume reduction: indications, effects and prospects. Curr Opin Pulm Med. 2007 Mar;13(2):125-30.

23. Ingenito EP, Wood DE, Utz JP. Bronchoscopic lung volume reduction in severe emphysema. Proc Am

Thorac Soc. 2008 May 1;5(4):454-60.

24. Institute for Clinical Systems Improvement (ICSI), Technology Assessment Committee. Lung volume reduction surgery for emphysema. Technology assessment no. 023. 2003 Oct. Accessed Sep 21, 2004. Available at URL address: http://www.icsi.org/knowledge/detail.asp?catID=107&itemID=291

25. Institute for Clinical Systems Improvement (ICSI), Health Care Guideline: Chronic Obstructive

Pulmonary Disease. January, 2007. Accessed Sep 25, 2007. Available at URL address:

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http://www.icsi.org/chronic_obstructive_pulmonary_disease/chronic_obstructive_pulmonary_disease_2286.html

26. Kaplan RM, Ries AL, Reilly J, Mohsenifar Z. Measurement of health-related quality of life in the national

emphysema treatment trial. Chest. 2004 Sep;126(3):781-9.

27. Martinez FJ, Chang A. Surgical therapy for chronic obstructive pulmonary disease. Semin Respir Crit Care Med. 2005 Apr;26(2):167-91.

28. Maxfield RA. New and emerging minimally invasive techniques for lung volume reduction. Chest. 2004

Feb;125(2):777-83.

29. Miller JD, Berger RL, Malthaner RA, Celli BR, Goldsmith CH, Ingenito EP, et al. Lung volume reduction surgery vs medical treatment: for patients with advanced emphysema. Chest. 2005 Apr;127(4):1166-77.

30. National Collaborating Centre for Chronic Conditions. Chronic obstructive pulmonary disease. National

clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax. 2004 Feb;59 Suppl 1:1-232.

31. National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003 May 22;384(21):2059-73.

32. National Emphysema Treatment Trial Research Group. Patients at high risk of death after lung-volume-

reduction surgery. N Engl J Med. 2001;345(15):1075-83.

33. National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 114. Lung volume reduction surgery for advanced emphysema. February 2005. Accessed Oct 11, 2005. Available at URL address: http://www.nice.org.uk/pdf/ip/IPG114guidance.pdf

34. Naunheim KS, Wood DE, Mohsenifar Z, Sternberg AL, Criner GJ, DeCamp MM, et al. Long-term follow-

up of patients receiving lung-volume-reduction surgery versus medical therapy for severe emphysema by the National Emphysema Treatment Trial Research Group. Ann Thorac Surg. 2006 Aug;82(2):431-43.

35. Pierson DJ. Clinical practice guidelines for chronic obstructive pulmonary disease: a review and

comparison of current resources. Respir Care. 2006 Mar;51(3):277-88.

36. Pompeo E, Marino M, Nofroni I, Matteucci G, Mineo TC. Reduction pneumoplasty versus respiratory rehabilitation in severe emphysema: a randomized study. Pulmonary Emphysema Research Group. Ann Thorac Surg. 2000 Sep;70(3):948-53.

37. Ramsey SD, Berry K, Etzioni R, Kaplan RM, Sullivan SD, Wood DE, et al. Cost effectiveness of lung-

volume-reduction surgery for patients with severe emphysema. N Engl J Med. 2003 May 22;348(21):239-45.

38. Ramsey SD, Sullivan SD. Evidence, economics, and emphysema: Medicare's long journey with lung

volume reduction surgery. Health Aff (Millwood). 2005 Jan-Feb;24(1):55-66.

39. Ramsey SD, Shroyer AL, Sullivan SD, Wood DE. Updated evaluation of the cost-effectiveness of lung volume reduction surgery. Chest. 2007 Mar;131(3):823-32.

40. Ries AL, Make BJ, Lee SM, Krasna MJ, Bartels M, Crouch R, et al. The effects of pulmonary

rehabilitation in the national emphysema treatment trial. Chest. 2005 Dec;128(6):3799-809.

41. Stoller JK, Gildea TR, Ries AL, Meli YM, Karafa MT; National Emphysema Treatment Trial Research Group. Lung volume reduction surgery in patients with emphysema and alpha-1 antitrypsin deficiency. Ann Thorac Surg. 2007 Jan;83(1):241-51.

Page 10 of 12 Coverage Policy Number: 0218

42. Tiong LU, Davies R, Gibson PG, Hensley MJ, Hepworth R, Lasserson TJ, et al. Lung volume reduction

surgery for diffuse emphysema. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001001.

43. Ware JH. The National Emphysema Treatment Trial--how strong is the evidence? N Engl J Med. 2003 May 22;348(21):2055-6.

44. Washko GR, Fan VS, Ramsey SD, Mohsenifar Z, Martinez F, Make BJ, et al. The effect of lung volume

reduction surgery on chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008 Jan 15;177(2):164-9. Epub 2007 Oct 25.

45. Wood DE. Quality of life after lung volume reduction surgery. Thorac Surg Clin. 2004 Aug;14(3):375-83.

46. Yusen RD, Lefrak SS, Gierada DS, Davis GE, Meyers BF, Patterson GA, Cooper JD. A prospective

evaluation of lung volume reduction surgery in 200 consecutive patients. Chest. 2003 Apr;123(4):1026-37.

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Policy History

Pre-Merger Last Review Policy Title Organizations Date Number CIGNA HealthCare 11/15/2007 0218 Lung Volume Reduction Surgery Great-West Healthcare 10/26/2006 96.243.04 Lung Volume Reduction Surgery “CIGNA” and the “Tree of Life” logo are registered service marks of CIGNA Intellectual Property, Inc., licensed for use by CIGNA Corporation and its operating subsidiaries. All products and services are provided exclusively by such operating subsidiaries and not by CIGNA Corporation. Such operating subsidiaries include Connecticut General Life Insurance Company, CIGNA Behavioral Health, Inc., Intracorp, and HMO or service company subsidiaries of CIGNA Health Corporation and CIGNA Dental Health, Inc. In Arizona, HMO plans are offered by CIGNA HealthCare of Arizona, Inc. In California, HMO plans are offered by CIGNA HealthCare of California, Inc. and Great-West Healthcare of California, Inc. In Connecticut, HMO plans are offered by CIGNA HealthCare of Connecticut, Inc. In North Carolina, HMO plans are offered by CIGNA HealthCare of North Carolina, Inc. In Virginia, HMO plans are offered by CIGNA HealthCare Mid-Atlantic, Inc. All other medical plans in these states are insured or administered by Connecticut General Life Insurance Company.

Connecticut General Life Insurance Company has acquired the business of Great-West Healthcare from Great-West Life & Annuity Insurance Company (GWLA). Certain products continue to be provided by GWLA (Life, Accident and Disability, and Excess Loss). GWLA is not licensed to do business in New York. In New York, these products are sold by GWLA's subsidiary, First Great-West Life & Annuity Insurance Company, White Plains, N.Y.

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