SURG 00022 Lung Volume Reduction Surgery

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SURG 00022 Lung Volume Reduction Surgery

  1. 1. Medical Policy Subject: Lung Volume Reduction Surgery Policy #: SURG.00022 Current Effective Date: 08/11/2006 Status: Revised Last Review Date: 06/08/2006 Description/Scope 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. Policy Statement 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
  2. 2. 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. Rationale 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 is focusing on the improvement in overall survival in those undergoing lung volume reduction surgery, compared to those treated medically. The preliminary results of this study, focusing 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 lung volume reduction. 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 lung volume reduction surgery, 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. Background/Overview 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.
  3. 3. 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. Definitions 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. DLCO: 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.
  4. 4. Coding 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 32491 Removal of lung, other than total pneumonectomy; excision-plication of emphysematous lung(s) (bulbous or non-bulbous) for lung volume reduction, sternal split or transthoracic approach, with or without any pleural procedure HCPCS G0302 Pre-operative pulmonary surgery services for preparation for LVRS, complete course of services, to include a minimum of 16 days of services G0303 Pre-operative pulmonary surgery services for preparation for LVRS, 10 to 15 days of services G0304 Pre-operative pulmonary surgery services for preparation for LVRS, 1 to 9 days of services G0305 Post discharge pulmonary surgery services after LVRS, minimum of 6 days of services ICD-9 Procedure 32.22 Lung volume reduction surgery ICD-9 Diagnosis 492.0 Emphysematous bleb 492.8 Other emphysema When services are Not Medically Necessary: For the procedure codes listed above for the situations considered not medically necessary. 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. References 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):1838-46. 2. 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. 3. 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):2018-27. 4. Drazen JM, Epstein AM. Guidance concerning surgery for emphysema. NEJM. 2003; 348(21):2134-6. 5. 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):2059-73. 6. 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):1337-46. 7. Geddes D, Davies M, Koyama H, et al. Effect of lung-volume-reduction surgery in patients with severe emphysema. NEJM. 2000; 343(4):239-45.
  5. 5. 8. Gelb AF. Lung function 4 years after lung volume reduction surgery for emphysema. Chest. 1999; 116(6); 1608-1615. 9. 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):405-10. 10. 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):781-9. 11. 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. 12. Martinez FJ, Chang A. Surgical therapy for chronic obstructive pulmonary disease. Semin Respir Crit Care Med. 2005; 26(2):167-91. 13. Maxfield RA. New and emerging minimally invasive techniques for lung volume reduction. Chest. 2004; 125(2):777-83. 14. Miller JD, Berger RL, Malthaner RA, et al. Lung volume reduction surgery vs. medical treatment: for patients with advanced emphysema. Chest. 2005; 127(4):1166-77. 15. The 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. 16. Ware JH. The National Emphysema Treatment Trial—how strong is the evidence? NEJM. 2003; 22;348(21):2055-6. 17. Yusen RD, Lefrak SS, Gierada DS, et al. A prospective evaluation of lung volume reduction surgery in 200 consecutive patients. Chest. 2003; 123(4):1026-37. 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: April 3, 2006. 2. Blue Cross and Blue Shield Assoc. Technology Evaluation Center (TEC) assessments. Lung volume reduction for severe emphysema. 2003. 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: April 4, 2006. 4. 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: April 3, 2006. 5. 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. 6. Hayes, Inc. Hayes Medical Technology Directory. Lung volume reduction for chronic obstructive pulmonary disease. Lansdale, PA. Hayes, Inc. February 1998. 7. 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: April 3, 2006. 8. 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. 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/knowledge/detail.asp?catID=107&itemID=291. Accessed on: April 3, 2006. Web Sites for Additional Information 1. American Lung Association: Emphysema. Available at: http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=35043. Accessed on: April 4, 2006. 2. American Lung Association: Chronic Obstructive Lung Disease (COPD): Available at: http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=35020. Accessed on: April 4, 2006. 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: April 4, 2006.
  6. 6. 4. National Library of Medicine. MedlinePlus. COPD (Chronic Obstructive Pulmonary Disease). Available at: http://www.nlm.nih.gov/medlineplus/copdchronicobstructivepulmonarydisease.html. Accessed on: April 3, 2006. Index Chronic Obstructive Pulmonary Disease (COPD) Emphysema Lung Volume Reduction Surgery Reduction Pneumoplasty Policy History Status Date Action Revised 06/08/2006 Medical Policy & Technology Assessment Committee (MPTAC) review. No change to policy criteria. Addition of the term, “bilateral” to policy statement regarding emphysema for clarification; also the required presurgical time period for abstinence from smoking was changed to a 4 month minimum, consistent with the NETT protocols. References were updated. 11/21/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD). Revised 07/14/2005 MPTAC review. Revision based on Policy Harmonization: Pre-merger Anthem and Pre-merger WellPoint. Pre-Merger Organizations Last Review Date Policy Number Title Anthem, Inc. 04/28/2005 SURG.00022 Lung Volume Reduction Surgery WellPoint Health Networks, Inc. 04/28/2005 3.05.01 Lung Reduction 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. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan. © CPT Only – American Medical Association

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