Lung volume reduction surgery (LVRS) is a surgical treatment for patients with emphysema involving the excision of peripheral emphysematous lung tissue, generally from both upper lobes.  The precise mechanism of clinical improvement for patients undergoing lung reduction surgery has not been firmly established.  However, it is believed that the elastic recoil and diaphragmatic function are improved by reducing the volume of diseased lung.  In addition to changes in chest wall and respiratory mechanics, the surgery is purported to correct ventilation perfusion mismatch and improve right ventricular filling.

Medically Necessary:

Lung reduction is considered medically necessary for patients with bilateral emphysema who meet ALL of the following criteria:

1. Generally 75 years old or less, although older patients may be evaluated on a case-by-case basis; AND
2. Severe bilateral disease warranting intervention, as manifested by an FEV₁ of < 45% of predicted; AND
3. Severe upper lobe predominant emphysema (confirmed on CT scan), or severe non-upper lobe emphysema with low exercise capacity (less than or equal to 25W for females and 40W for males after pulmonary rehabilitation); AND
4. Total lung capacity (TLC) > 100% predicted post bronchodilator and Residual Volume (RV) > 150% predicted post bronchodilator; AND
5. PaO2 on room air greater than or equal to 45mm Hg (greater than or equal to 30mmHg at elevations of 5,000 feet or higher); AND
6. PaCO2 on room air less than or equal to 60mm Hg (less than or equal to 55mm Hg at elevations of 5,000 feet or higher); AND
7. Cardiac clearance for surgery if: LVEF < 45%, or known coronary artery disease or significant arrhythmias; AND
8. Post-rehabilitation 6 minute walk of at least 140 m, and able to complete 3 min. unloaded pedaling in exercise tolerance test; AND
9. Abstinence from smoking for at least 4 months.

Investigational/Not Medically Necessary:

Lung volume reduction surgery (LVRS) is considered investigational/not medically necessary when ANY of the following criteria are present:

1. FEV₁ is less than or equal to 20% of predicted value AND either of the following:
   • Homogeneous (i.e., non-heterogeneous) distribution of emphysema as documented on CT, or
   • Diffusing capacity (DLCO) less than or equal to 20% of predicted value; OR
2. MI, unstable angina, or CHF within previous 6 months and LVEF < 45%; OR
3. Pulmonary hypertension (mean PAP > 35 mm Hg [38 mm at 5,000 ft or higher] or peak systolic PAP > 45 mm Hg [50 mm at 5,000 feet or higher]); OR
4. Diffuse emphysema on CT scan judged unsuitable for LVRS; OR
5. Clinically significant bronchiectasis; OR
6. Inability to participate in pulmonary rehabilitation; OR
7. Predominantly non upper lobe emphysema with high exercise capacity ( > 25 W female or > 40 W male before or after pulmonary rehabilitation); OR
8. Presence of other serious disease expected to compromise short term or long term (5 year) survival; OR
9. If ALL the medical necessity criteria listed earlier are not met .   

The National Heart, Lung and Blood Institute (NHLBI) and the Centers for Medicare & Medicaid Services (CMS) (formerly Health Care Financing Administration) have jointly sponsored the National Emphysema Treatment Trial (NETT).  This is a randomized trial that focused on the improvement in overall survival in those undergoing lung volume reduction surgery (LVRS), compared to those treated medically.  The preliminary results of this study, which focused on the results of 139 high-risk patients, were published in 2001. High risk patients were defined as an FEV₁ less than 20% predicted and a homogenous distribution of emphysema or a carbon monoxide diffusing capacity less than 20% predicted.  In this group of patients, the surgical mortality was 16% compared to 0% in the medically treated patients.  Since the publication of these results, the NETT trial has altered the patient selection criteria to exclude patients with an FEV₁  less than 20%, unless the diffusing capacity is greater than 20% predicted and there is a heterogeneous pattern of emphysema.  In 2003, the final results of the NETT trial were published. This report further refined the patient selection criteria for LVRS.  After exclusion of the 140 patients considered to be at high risk, as described above, the authors reported that the mortality was similar in both the surgically and medically treated groups.  However, subgroup analysis identified one subgroup of patients who were most likely to benefit from the surgery, i.e., patients with predominantly upper lobe emphysema and a low maximal workload after rehabilitation had lower mortality and a greater probability of improvement in symptoms if they underwent LVRS, than if they received medical therapy alone. The subgroup of patients with a combination of non-upper lobe emphysema and a high maximal work load had a higher mortality than the medically treated group and did not have greater functional or symptomatic improvement than patients in the medical therapy group. Patients with upper lobe disease and high exercise capacity and patients with non-upper lobe disease and low exercise capacity had no survival advantage, compared to the medically treated group, but did have improvements in function and/or health related quality of life scores.  An updated analysis of the NETT Trial data was prepared in 2006, which provided median follow-up of 4.3 years.  The aforementioned clinical benefit noted in the patient subgroup with predominantly upper lobe emphysema and low exercise capacity persisted, and the authors concluded that, “The effects of LVRS are durable, and it can be recommended for upper-lobe-predominant emphysema patients with low exercise capacity…” (Naunheim, 2006)

Emphysema is the fourth leading cause of death in the United States and claims approximately 120,000 lives annually. The most common form of emphysema is referred to as “acquired emphysema” and is typically caused by chronic smoking.  A second type, Alpha 1 antitrypsin deficiency-related emphysema (AAT), is a genetic condition, whereby a protein responsible for lung protection is not produced by the body.  Approximately 90% of all emphysema deaths are related to acquired emphysema.

The most significant risk factor for the development of emphysema is cigarette smoking.  Other forms of smoking, including second-hand smoke, have been identified as risk factors, but are not as significant as smoking cigarettes.  Smoking is especially harmful in individuals with AAT.

The symptoms of emphysema range from chronic cough and phlegm production to severely disabling shortness of breath.  Symptoms usually progress slowly over time, increasingly limiting breathing ability and often leading to a complete inability to breathe.  There is no cure for emphysema, and non-surgical treatment is aimed at relieving symptoms with medication and preventing complications with physical exercise programs, breathing exercises, and patient education programs.

In emphysema, the walls between the air sacs in the lungs lose elasticity, causing them to remain in the “open” position, which impedes the ability of the lungs to expand and contract during breathing. This, in turn, causes the air in the sac to become stagnant, as the body absorbs the oxygen available and expels carbon dioxide (CO2).  The diseased “open” sacs further affect the function of the lungs by using more space than normal and crowding the healthy tissues, impeding their function.  In later stages of emphysema, as more and more lung tissue becomes diseased, the healthy tissue is further limited in function.

Lung volume reduction surgery (LVRS) is a treatment for patients with specific types of advanced emphysema.  LVRS is an extensive, invasive surgical procedure that involves the removal of significant portions of both sides of the lungs, theoretically leaving more space in the chest cavity, into which the remaining less diseased tissue can expand.  Various approaches are used to access the lung cavity.  Open methods involve either splitting the breastbone (median sternotomy) or by making an opening between the ribs on each side of the chest (clamshell incision).  An alternative method, Video-Assisted Thoracoscopic Stapled LVRS, uses a camera and long, thin tools to work through small holes in the chest wall.  Up to 30% of lung mass may be removed during LVRS, preferably targeting the regions of most severe disease, while preserving lung tissue that is less diseased.

Lung volume reduction surgery is not a cure for emphysema.  It is intended to alleviate some of the symptoms of the condition, including shortness of breath.  Patients who undergo LVRS continue to have severe emphysema, and their disease will continue to progress over time. This surgery is not hazard-free. The most common complication is creation of an air leak in the lung. Other potential complications include respiratory failure, infection, bleeding, fatigue, rapid heart rate, and death. Recent studies have reported an especially high risk of death in patients with very advanced emphysema.

At present, alternative treatments to LVRS include medical therapy with rigorous physical therapy programs and lung transplantation.

CAD (Coronary Artery Disease): a form of heart disease where the main blood vessels supplying blood to the heart become partially occluded with deposits

CHF (Congestive Heart Failure): this is a type of heart disease where the heart muscle becomes weakened and cannot pump blood as strongly as needed

D_LCO: the medical notation for “Diffusion Capacity of carbon monoxide;” a test to determine how well oxygen passes from the air sacs of the lungs into the blood

Ejection fraction: the percent of total volume of blood in the left ventricle of the heart that is ejected when the heart contracts; this is used as a measure of heart health and function

Emphysema: a progressive disease of the lungs that leads to difficulty in breathing, decreased ability to exercise and eventually death

FEV₁: the medical notation for “Forced Expiratory Volume after 1 second,” that is a measure of the volume of gas expired after one second from the beginning of the Forced Vital Capacity (FVC) maneuver which involves forcefully exhaling into a FEV meter

MI: (myocardial infarction or heart attack); this is a condition where a portion of the heart is deprived of blood due to blockage of a blood vessel, which causes the heart muscle to stop working

PaCO₂: the medical notation for “Partial Pressure of Carbon Dioxide” in arterial blood; a measurement  that indicates how effectively your lungs are able to rid themselves of a by-product of metabolism, CO₂; the “normal” range for PaCO₂ is 35 to 45 mmHg; elevated values greater than 40-45 mainly indicate that the lungs are not able to adequately rid themselves of the CO₂

PaO₂: the medical notation for “Partial Pressure of Oxygen” in arterial blood; this is a measure of the actual amount of oxygen that is in your arterial blood; the “normal” for PaO₂ is generally greater than 75-80 mmHg

Total Lung Capacity: a measure of the air volume of the lungs

Unstable angina: a condition characterized by chest discomfort that occurs from a temporary lack of blood and oxygen to the heart; stable angina occurs in regular patterns following usual activities, such as exertion; unstable angina does not follow any pattern

Upper-lobe disease: a type of lung disease where the diseased portions are predominantly in the upper lobes of the lungs

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

HCPCS

ICD-9 Procedure

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above, for all other diagnoses not listed; or when the code describes a procedure indicated in the policy section as investigational/not medically necessary.

Peer Reviewed Publications:

1. Appleton S, Adams R, Porter S, et al.  Sustained improvements in dyspnea and pulmonary function 3 to 5 years after lung volume reduction surgery. Chest. 2003; 123(6):1838-1846.
2. Berger RL, Wood KA, Cabral HJ, et al.  Lung volume reduction surgery: a meta-analysis of randomized clinical trials.  Treat Respir Med. 2005; 4(3):201-209.
3. Brenner M, McKenna RJ Jr, Chen JC, et al. Survival following bilateral staple lung volume reduction surgery for emphysema. Chest. 1999; 115(2):390-396.
4. Criner GJ, Cordova FC, Furukawa S, et al.  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; 160(6):2018-2027.
5. Drazen JM, Epstein AM.  Guidance concerning surgery for emphysema. NEJM. 2003; 348(21):2134-6.
6. Fishman A, Fessler H, Martinez F, et al.  Patients at high risk of death after lung-volume-reduction surgery. N Engl J Med. 2001; 345(15):1075-1083.
7. Fishman A, Martinez F, Naunheim K, et al. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema.  N Engl J Med. 2003; 348(21):2059-2073.
8. Flaherty KR, Kazerooni EA, Curtis JL, Iannettoni M, Lange L, Schork MA, Martinez FJ. Short-term and long-term outcomes after bilateral  lung volume reduction surgery: prediction by quantitative CT. Chest. 2001; 119(5):1337-1346.
9. Geddes D, Davies M, Koyama H, et al. Effect of lung-volume-reduction surgery in patients with severe emphysema. NEJM. 2000; 343(4):239-245.
10. Gelb AF. Lung function 4 years after lung volume reduction surgery for emphysema. Chest. 1999; 116(6); 1608-1615.
11. Goldstein RS, Todd TR, Guyatt G, et al. Influence of lung volume reduction surgery (LVRS) on health related quality of life in patients with chronic obstructive pulmonary disease.  Thorax. 2003; 58(5):405-410.
12. Kaplan RM, Ries AL, Reilly J, et al. Measurement of health-related quality of life in the national emphysema   treatment trial.  Chest. 2004; 126(3):781-789.
13. Leyenson V, Furukawa S, Kuzma AM, et al. Correlation of changes in quality of life after lung volume reduction surgery with changes in lung function, exercise, and gas exchange. Chest. 2000;118(3): 728-735.
14. Martinez FJ, Chang A. Surgical therapy for chronic obstructive pulmonary disease.  Semin Respir Crit Care Med. 2005; 26(2):167-191.
15. Maxfield RA. New and emerging minimally invasive techniques for lung volume reduction.  Chest. 2004; 125(2):777-783.
16. Miller JD, Berger RL, Malthaner RA, et al. Lung volume reduction surgery vs. medical treatment: for patients with advanced emphysema.  Chest. 2005; 127(4):1166-1177.
17. Ware JH. The National Emphysema Treatment Trial—how strong is the evidence? NEJM. 2003; 22;348(21):2055-2056.
18. Yusen RD, Lefrak SS, Gierada DS, et al. A prospective evaluation of lung volume reduction surgery in 200 consecutive patients. Chest. 2003; 123(4):1026-1037.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Thoracic Society (ATS).  Lung volume reduction surgery.  May 1996. Available at:    http://www.thoracic.org.  Accessed on March 29, 2007.
2. Blue Cross Blue Shield Association. Lung volume reduction for severe emphysema. TEC Assessment, 2003; 18(17).
3. Canadian Coordinating Office for Health Technology Assessment. (CCOHTA) December 2004. Ottawa, ON Canada. Technology Report: Comparison of Lung Volume Reduction Surgery with Medical Management for Emphysema  Available at:  http://www.ccohta.ca/entry_e.html.  Accessed on March 29, 2007.
4. 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; 23(6):932-946.
5. Centers for Medicare and Medicaid Services. National Coverage Determination for Lung Volume Reduction Surgery (Reduction Pneumoplasty). NCD #240.1.  Effective: 11/17/2005. Implementation date: 03/02/2006. Available at:  http://www.cms.hhs.gov. Accessed on March 29, 2007.
6. Department of Health and Human Services (DHHS), National Institutes of Health (NIH) and the National Heart, Lung, and Blood Institute (NHLBI).  National Emphysema Treatment Trial (NETT): Evaluation of lung volume reduction surgery for emphysema.  May 20, 2003.  Available at:  http://www.nhlbi.nih.gov/health/prof/lung/nett/lvrsweb.htm.  Accessed on  March 29, 2007.
7. Fein AM, Branmna SS, Casaburi R, et al. Lung volume reduction surgery: Official statement of the American Thoracic Society.   Am J Respir Crit Care Med.  1996; 154:1151-1152.
8. Hayes Inc. Hayes Medical Technology Directory. Lung volume reduction for chronic obstructive pulmonary disease. Lansdale, PA: Hayes, Inc; February 1998.  Search updated December 31, 2006.
9. Institute for Clinical Systems Improvement (ICSI), Technology Assessment Committee.  Lung volume reduction surgery for emphysema.  Technology assessment No. 023; 2003.  Available at:    http://www.icsi.org/index.aspx?catID=2.    Accessed on March 29, 2007.
10. National Institute for Clinical Excellence (NICE). Interventional Procedures Guidance document 114. Lung volume reduction surgery for advanced emphysema. February 2005. Available at:  http://www.nice.org.uk/page.aspx?o=228126. Accessed on: April 4, 2006.
11. Naunheim KS, Wood DE, Mohsenifar Z, 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 (NETT).  Ann Thorac Surg. 2006; 82(2):431-443.
12. Tiong LU, Davies R HRH, Gibson PG, et al.  Lung volume reduction surgery for diffuse emphysema.  Cochrane Database Syst Rev. 2006; (4):CD001001.

1. American Lung Association: Emphysema. Available at:  http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=35043.  Accessed on March 29, 2007.
2. American Lung Association: Chronic Obstructive Lung Disease  (COPD): Available at:  http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=35020.  Accessed on March 29, 2007.
3. National Institutes of Health. National Heart, Lung, and Blood Institutes. Chronic Obstructive Pulmonary Disease (COPD) Data Fact Sheet: Available at:  http://www.nhlbi.nih.gov/health/public/lung/other/copd_fact.htm  Accessed on March 29, 2007.
4. National Library of Medicine. MedlinePlus. COPD (Chronic Obstructive Pulmonary Disease). Available at:  http://www.nlm.nih.gov/medlineplus/copdchronicobstructivepulmonarydisease.html.   Accessed on March 29, 2007.

Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Lung Volume Reduction Surgery
Reduction Pneumoplasty
 

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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