mp-151 - Medical Policies - Alabama
Lung Volume Reduction Surgery for Severe Emphysema
Policy Number: MP-151
Latest Review Date: June 2022
Lung volume reduction surgery as a treatment for emphysema may be considered medically necessary in individuals with emphysema who meet all of the following criteria, as based on the NETT trial:
- Age < 75 years;
- Predominantly upper lobe emphysema with hyperinflation and heterogeneity (i.e., target areas for removal);
- For individuals who are younger than 70 years of age, the FEV1 must be no more than 45% of the predicted value;
- For individuals who are 70 years of age or older, the FEV1 must be no more than 45% of the predicted value and greater than or equal to 15% of the predicted value;
- Acceptable nutritional status, i.e., 70% -- 130% of ideal body weight;
- Marked restriction in activities of daily living despite maximal medical therapy;
- Ability to participate in a vigorous pulmonary rehabilitation program;
- No coexisting major medical problems that would significantly increase operative risk;
- Understands and agrees to undertake the risk of morbidity and mortality associated with LVRS;
- Abstains from cigarette smoking for at least 4 months.
Lung volume reduction surgery for all other individuals is considered not medically necessary.
Lung volume reduction surgery performed using the unilateral or thorascopic laser, or bronchoscopic approach is considered not medically necessary.
DESCRIPTION OF PROCEDURE OR SERVICE:
Lung volume reduction surgery (LVRS) is proposed as a treatment option for patients with severe emphysema who have failed optimal medical management. The procedure involves the excision of diseased lung tissue in order to reduce symptoms and improve quality of life
Emphysema is an anatomically defined condition characterized by the destruction and enlargement of lung alveoli. It is one of the conditions considered as a chronic obstructive pulmonary disease along with chronic bronchitis and small airway disease. The pathogenesis of emphysema is primarily related to cigarette smoking leading to inflammation and recruitment of immune cells to the terminal air spaces of the lung. The resultant extracellular matrix proteolysis damages the lung. Destruction of the gas exchanging air spaces and ineffective repair of the extracellular matrix results in airspace enlargement. Emphysema can be characterized into distinct pathologic subtypes. Centriacinar emphysema is most frequently associated with cigarette smoking, is usually most prominent in the upper lobes and superior segments of the lower lobes, and is focal. Panacinar emphysema is characterized by abnormally large air spaces evenly distributed across acini in the lower lobes. It is associated with α1-antitrypsin deficiency. Key pulmonary function parameters are the volume of the first forced expiratory volume in 1 second (FEV1) and the total volume of air exhaled during the spirometry (forced vital capacity [FVC]). Airflow obstruction related to chronic obstructive pulmonary disease is characterized by reduced ratio of FEV1/FVC, and reduction in FEV1 correlates with long-term mortality risk.
The 2022 Global Initiative for Chronic Obstructive Lung Disease (GOLD) report states that chronic obstructive pulmonary disease is 1 of the top 3 causes of death globally and 90% of these deaths occur in low- and middle-income countries. Evidence exists that the prevalence of the disease is appreciably higher in smokers and ex-smokers compared to non-smokers, in those ≥40 years of age compared to those <40, and in men compared to women. Although in developed countries with less smoking, the prevalence is approximately equal between men and women. The COPD Genetic Epidemiology (COPDGene®) study aimed to determine the influence of race, gender, and GOLD stage on prevalence of prior COPD diagnosis at enrollment. Results revealed that African-Americans had increased odds of not having a prior COPD diagnosis at all GOLD stages of airflow obstruction versus non-Hispanic whites (p<.0001). Women had higher odds of having a prior COPD diagnosis at all GOLD stages versus men (p<.0001).
Lung Volume Reduction Surgery
Lung volume reduction is a surgical treatment for patients with severe 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 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.
Research on LVRS has focused on defining the sub-group of patients most likely to benefit from the procedure. Potential benefits of the procedure e.g., improvement in functional capacity and quality of life, must be weighed against the potential risk of the procedure (e.g., risk of post-operative mortality).
The most recent literature review was conducted through April 13, 2022. Following is a summary of the key published literature to date.
Summary of Evidence
For individuals who have upper-lobe emphysema who receive LVRS, the evidence includes RCTs and systematic reviews of the trials. The relevant outcomes are overall survival, symptoms, functional outcomes, QOL, and treatment-related mortality. Findings from the NETT, a multicenter RCT, have suggested that LVRS is effective at reducing mortality and improving QOL in select patients with severe emphysema. In subgroup analysis, LVRS offered a survival advantage only to patients not considered at high-risk who had predominately upper-lobe emphysema and low initial exercise capacity. Patients with upper-lobe emphysema, regardless of initial exercise capacity, experienced significant improvement in exercise capacity and QOL after LVRS. Other, smaller RCTs have generally had similar findings, though they have tended to be underpowered for some outcomes and did not stratify by the distribution of emphysema. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have non-upper-lobe emphysema who receive LVRS, the evidence includes a subgroup analysis of a large RCT. The relevant outcomes are overall survival, symptoms, functional outcomes, QOL, and treatment-related mortality. In the subgroup analysis of the NETT, LVRS offered a survival advantage only to patients who had predominately upper-lobe emphysema. For the subgroup with predominately non-upper-lobe emphysema, the NETT did not find significant mortality advantages or symptom improvement with LVRS. Although the NETT had positive findings for the study population as a whole, given the surgical risks, additional data are needed to confirm the net health outcome in patients with non-upper-lobe emphysema. The evidence is insufficient to determine that the technology results in an improvement in an health outcome.
Practice Guidelines and Position Statements
American Thoracic Society and European Respiratory Society
The American Thoracic Society and the European Respiratory Society (2015) published a joint statement on current research questions for chronic obstructive pulmonary disease. The statement discussed lung volume reduction surgery and asserted that, due to the significant complications from the procedure that may result in prolonged hospital stays and morbidity, additional studies would be needed to evaluate minimally invasive techniques that might reduce complications.
U.S. Preventive Services Task Force Recommendations
Lung volume reduction surgery (LVRS), emphysema, National Emphysema Treatment Trial (NETT)
APPROVED BY GOVERNING BODIES:
Lung volume reduction surgery is a surgical procedure and as such is not subject to regulation by the U.S. Food and Drug Administration.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
|32491||Removal of lung, other than pneumonectomy; with resection -plication of emphysematous lung(s) (bullous or non-bullous) for lung volume reduction, sternal split or transthoracic approach, includes any pleural procedure when performed|
|32672||Thoracoscopy, surgical; with resection-plication for emphysematous lung (bullous or non-bullous) for lung volume reduction (LVRS), unilateral includes any pleural procedure, when performed|
|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|
Post-discharge pulmonary surgery services after LVRS, minimum of 6 days of services
- Agzarian J, Miller JD, Kosa SD, et al. Long-term survival analysis of the Canadian Lung Volume Reduction Surgery trial. Ann Thorac Surg. Oct 2013; 96(4):1217-1222.
- Arroliga Alejandro C. Lung volume reduction and bullectomy in COPD. www.utdol.com/utd/content/topic.do?topicKey=copd/10845&view=print.
- Baldi S, Oliaro A, Tabbia G et al. Lung volume reduction surgery 10 years later. J Cardiovasc Surg (Torino) 2012; 53(6):809-815.
- Celli BR, Decramer M, Wedzicha JA, et al. An official American Thoracic Society/European Respiratory Society statement: research questions in COPD. Eur Respir Rev. Jun 2015;24(136):159-172.
- Center for Medicare & Medicaid Services. National coverage determination (NCD) for lung volume reduction surgery (reduction pneumoplasty) (240.1). 2005; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=119&ncdver=3&CoverageSelection=National&KeyWord=lung+volume+reduction+surgery& KeyWordLookUp=Title&KeyWordSearchType=And&clickon=search&bc=gAAAABAAAAAAAA%3d%3d&. Accessed April 13, 2022.
- Clarenbach CF, Sievi NA, Brock M, et al. Lung volume reduction surgery and improvement of endothelial function and blood pressure in patients with chronic obstructive pulmonary disease. a randomized controlled trial. Am J Respir Crit Care Med. Aug 1 2015; 192(3):307-314.
- DeCamp NM. Technical issues and controversies in lung volume reduction surgery, Seminars in Thoracic Cardiovascular Surgery, October 2002, 14(4); 391-398.
- Decker MR, Leverson GE, Jaoude WA et al. Lung volume reduction surgery since the National Emphysema Treatment Trial: study of Society of Thoracic Surgeons Database. J Thorac Cardiovasc Surg. Dec 2014; 148(6):2651-2658 e2651.
- Ginsburg ME, Thomashow BM, Yip CK et al. Lung volume reduction surgery using the NETT selection criteria. Ann Thorac Surg 2011; 91(5):1556-1561.
- Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2022 report. https://goldcopd.org/2022-gold-reports-2/. Accessed April 13, 2022.
- Huang W, Wang WR, Deng B, et al. Several clinical interests regarding lung volume reduction surgery for severe emphysema: meta-analysis and systematic review of randomized controlled trials. J Cardiothorac Surg 2011; 6:148.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Kaplan, RM, Sun Q, Naunheim KS, et al. Long-term follow-up of high-risk patients in the National Emphysema Treatment Trial. Ann Thorac Surg. Nov 2014;98(5):1782-1789.
- Kasper D, Fauci A, Longo D, et al. Harrison’s Principles of Internal Medicine 19th Edition. McGraw-Hill Education: Chicago, IL; 2015.
- Lim E, Sousa I, Shah PL, et al. Lung Volume Reduction Surgery: Reinterpreted With Longitudinal Data Analyses Methodology. Ann Thorac Surg. May 2020; 109(5): 1496-1501.
- Pompeo E, Rogliani P, Tacconi F, et al. Randomized comparison of awake nonresectional versus nonawake resectional lung volume reduction surgery. J Thorac Cardiovasc Surg. Jan 2012; 143(1):47-54, 54.e41.
- van Agteren JE, Carson KV, Tiong LU, et al. Lung volume reduction surgery for diffuse emphysema. Cochrane Database Syst Rev. Oct 14 2016; 10:Cd001001.
Medical Policy Group, February 2004
Medical Policy Administration Committee, March 2004
Available for comment March 22-May 5, 2004
Medical Policy Group, February 2007 (1)
Medical Policy Administration Committee, February 2007
Available for comment February 10-March 26, 2007
Medical Policy Group, February 2010 (1) No new studies identified per literature search
Medical Policy Group, June 2010 (1)
Medical Policy Group, June 2011 (1): Update to Policy, Key Points and References related to FEV-1 values
Medical Policy Administration Committee, July 2011
Available for comment July 6 through August 22, 2011
Medical Policy Group, December 2011 (1): 2012 Verbiage update to code 32491 (3), added code 32672 (1)
Medical Policy Group, June 2012 (1): 2012 Updates to Description, Key Points & References
Medical Policy Panel, June 2013
Medical Policy Group, June 2013 (3): 2013 Updates to Key Points and References; no change in policy statement
Medical Policy Panel, June 2014
Medical Policy Group, June 2014 (3): 2014 Updates to Key Points & References; no change in policy statement
Medical Policy Panel, June 2015
Medical Policy Group, June 2015 (2): 2015 Updates to Key Points, Approved by Governing Bodies, and References; no change to policy statement.
Medical Policy Panel, July 2016
Medical Policy Group, July 2016 (7): 2016 Updates to Key Points and References; no change to policy statement.
Medical Policy Panel, July 2017
Medical Policy Group, July 2017 (7): Updates to Description, Key Points, & References. No change to policy statement.
Medical Policy Panel, June 2019
Medical Policy Group, July 2019 (3):2019 Updates to Description, Key Points, Practice Guidelines and Position Statements & References. No change to policy statement or intent.
Medical Policy Panel, June 2020
Medical Policy Group, June 2020 (5): Minor update to Key Points. No change to Policy Statement.
Medical Policy Panel, June 2021
Medical Policy Group, June 2021 (5): Updates to Description, Key Points, and References. Policy statement updated to remove “investigational,” no change to policy intent.
Medical Policy Panel, June 2022
Medical Policy Group, June 2022 (5): Updates to Description, Key Points, and References. Policy Statement updated to replace the word “patients” with the word “individuals.” No change to policy intent.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.