Medical Policy: 06.01.19
Original Effective Date: February 2003
Reviewed: February 2016
Revised: March 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
In the United States, lung cancer is the most commonly occurring noncutaneous cancer in men and women combined, and is the leading cause of cancer deaths. The most important risk factor for lung cancer is tobacco use. Other risk factors are small compared with cigarette smoke, these causal factors include exposures to environmental and occupational substances and family history of lung cancer. Most lung cancer patients are diagnosed when their disease is advanced. Due to the prevalence and mortality associated with lung cancer, there has been much interest in developing screening tests for lung cancer, in particular, for at-risk individuals at an earlier and more curable stage. Chest x-ray (CXR) and sputum cytology have been the most common methods used for screening lung cancer, but previous studies have failed to demonstrate that screening with these modalities resulted in improved health outcomes.
More recently, low-dose computed tomography (LDCT) has been proposed as a method of screening asymptomatic, high risk individuals for lung cancer. It has been suggested that spiral CT may be an improved early lung cancer detection tool based on the advantages it appears to have over CXR and sputum cytology to detect lung cancer at an earlier stage. Compared with conventional CT scans, these scans allow for the continuous acquisition of images, thus shortening the scan time and radiation exposure. A complete CT scan using LDCT can be obtained within 10 to 20 seconds, or during 1 breath hold in most patients. The radiation exposure for this examination is greater than that of a chest radiography but less than a conventional CT scan.
National Lung Screening Trial
The National Lung Screening Trial (NLST), a screening trial sponsored by the National Institute of Health, was launced in 2002 which compared the effects of two ways of detecting lung cancer:
This study examined the consequences of these screening methods screening in 3 consecutive years on large, randomized populations of heavy smokers and former smokers ages 55-74, using death from lung cancer as the primary end point. NLST researchers found approximately 15 to 20 percent fewer lung cancer deaths among trial participants screened with low dose computed tomography (LDCT) compared to the participants screened with chest x-ray.
Summary
The evidence on computed tomography (CT) screening for lung cancer includes several randomized controlled trials (RTCs) some of which are still ongoing. The largest RCT, the National Lung Screening Trial (NLST) was a multicenter trial published in 2011. This was a high quality trial that reported a decrease in both lung cancer mortality and overall mortality in a high risk population screened with 3 annual low dose CT scans compared with chest radiographs. There is considerable uncertainty regarding the optimal length and interval screening. Therefore, screening for lung cancer with low dose CT annually may be considered medically necessary for high risk patients who meet criteria and investigational otherwise.
Computer Aided Detection (CAD) with Low Dose Computed Tomography for Lung Cancer Screening
Computer aided detection (CAD) systems describe a class of pattern-recognition software designed to analyze radiologic images for patterns suggestive of cancer and highlight them for radiologist review to reduce false-negative readings. Most CAD products for radiology are intended for use with radiographs (x-rays). The most widespread use of CAD technology is associated with mammography to enhance effectiveness of breast cancer screening. However, some manufacturers have developed CAD systems to complement CT exams. To use most CAD products, a radiologist initially reviews the images without CAD, then activates the software to reexamine CAD marked items before issuing a final report. CAD systems are not intended to replace the radiologist review. Adding CAD technology to CT exams has been proposed to enhance the effectiveness of lung cancer screening with chest CT. However, there is few data available to establish whether the addition of CAD to LDCT could improve lung cancer detection rates compared to LDCT alone.
Patient Safety Issues
A primary concern with CAD for LCDT would be the risk of increasing the rate of false-positive results that could lead to over-diagnosis of lung lesions unlikely to cause clinical symptoms, resulting in additional unnecessary testing and possible unnecessary treatment. Another concern would be patients increased cancer risk from increased exposure to ionizing radiation from repeated CT scans. Several investigators have linked the overuse of CT scans to an increased cancer risk over the long term. However, these concerns have prompted manufacturers to introduce new technologies to reduce radiation dose in CT scans.
Although the American Medical Association (AMA) has issued Category III Current Procedural Terminology codes to enable billing for CAD with chest x-rays and magnetic resonance imaging (MRI), it has not issued codes for CAD with CT for lung imaging.
None of the clinical guidelines cited below address the use of CAD as part of lung cancer screening with LDCT.
Summary
The use of computer aided detection (CAD) software may assist in lung cancer screening. However, there is insufficient evidence to determine whether CAD technology may improve the accuracy of CT scanning interpretation. While CAD systems have been shown to detect additional lung nodules compared to the results of human readers alone, the issue is how many detected nodules are lung cancers. The effectiveness of CAD in detecting lung cancer has not been fully investigated. Highly quality randomized trials examining the effect of CAD systems for CT scans on lung cancer morbidity and mortality are necessary to determine the true impact of this technology on health outcomes. Therefore, the use of computer aided detection (CAD) with LCDT for screening for lung cancer is considered investigational.
Practice Guidelines and Position Statements
U.S. Preventative Services Task Force (USPSTF) (B recommendation)
December 2013, the USPSTF recommended annual screening for lung cancer with low dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack year smoking history and currently smoke or have quit within the past 15 years.
Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surger.
A rating of A and B from the USPSTF applies to the Affordable Care Act (ACA) preventative services.
National Comprehensive Cancer Network (NCCN)
Lung Cancer Screening (Version 1.2016)
Recommend lung cancer screening using low dose CT scan for high risk individuals:
Risk Assessment
(Catefory 1)
Age 55-74 years and
> 30 pack year history of smoking and
Smoking cessation <15 years; OR
(Category 2A)
For individuals who test negative on the initial screen:
Baseline low dose CT (LDCT) → No lung nodules on LDCT → Annual LDCT for 2 years (category 1) and suggest annual LDCT until patient no longer eligible for definitive treatment.
The guideline notes: “there is uncertainty about the appropriate duration of screening and the age at which screening is no longer appropriate.”
Discussion Section: Risk Factors for Lung Cancer
Individuals with risk factors who are candidates for screening should not have symptoms suggestive of lung cancer (e.g. cough, pain, weight loss).
American Cancer Society (ACS)
In 2013, the American Cancer Society (ACS) website published guidelines on lung cancer screening with low dose CT. The guidelines recommend doctors initiate a discussion about lung cancer screening with people who meet criteria that put them at risk for developing the disease. These high risk patients must be:
Aged 55 to 74 years and in fairly good health
Have a smoking history equivalent to a pack a day for 30 years, and
Currently smoking or have quit within the past 15 years
For patients who meet the above criteria and choose screening, screening is recommended annually until age 74 for individuals who otherwise remain healthy. In addition, the ACS recommends that adults who choose to undergo lung screening preferably should enter an organized screening program at an institution with expertise in LDCT screening, with access to a multidisciplinary team skilled in the evaluation, diagnosis, and treatment of abnormal lung lesions.
American College of Chest Physicians (ACCP) and the American Society for Clinical Oncology (ASCO)
In May 2012, American College of Chest Physicians (ACCP) and the American Society of Clinical Oncology (ASCO) issued a joint statement on low dose computed tomography (LDCT) screening for lung cancer. The statement included the following recommendations:
American College of Chest Physicians (ACCP) For smokers and former smokers who are age 55 to 74 and who have smoked for 30 pack years or more and either continue to smoke or have quit within the past 15 years, we suggest that annual screening with low dose CT (LDCT) should be offered over both annual screening with CXR or no screening, but only in settings that can deliver the comprehensive care provided to National Lung Screening Trial Participants. (Grade 2B) For individuals who have accumulated fewer than 30 pack years of smoking or are either younger than age 55 or older than 74, or individuals who quit smoking more than 15 years ago, and for individuals with severe comorbidities that would preclude potentially curative treatment and/or limit life expectancy, we suggest that CT screening should not be performed. (Grade C).
In 2013 The American College of Chest Physicians (ACCP) issued evidence based clinical practice guidelines on screening for lung cancer. The guideline included the following recommendation:
In 2012, American Association for the Thoracic Surgery published guidelines for lung cancer screening. The guidelines recommend annual lung cancer screening with low dose computed tomography (LDCT) for the following individuals:
Also, low dose computed tomography lung cancer screening should be offered at 50 to 79 years with a 20 pack year smoking history and additional comorgidity that produces cummulative risk of developing lung cancer of > 5% in 5 years.
Not applicable.
This policy does not apply to individuals with signs and/or symptoms of lung disease. In symptomatic individuals, a diagnostic work up appropriate to the clinical presentation should be undertaken, rather than screening.
*Patient selection criteria is based on U.S. Preventative Services Task Force (USPSTF) and the National Lung Screening Trail (NLST).
Low-dose computed tomography (LDCT) scanning, no more frequently than annually, may be considered medically necessary as a screening technique for lung cancer in individuals who meet ALL of the following criteria*:
Low-dose computed tomography (LDCT) is considered investigational as a screening technique for lung cancer when the above criteria is not met and for all other screening indications.
The evidence on CT scanning for lung cancer includes several randomized clinical trials, some of which are still ongoing. The largest randomized clinical trial, the National Lung Screening Trial (NLST) was a multicenter trial published in 2011. This was a high quality trail that reported a decrease in both lung cancer mortality and overall mortality in high risk population screened with 3 annual low dose computed tomography (LDCT). There is still uncertainty regarding the optimal length and interval of screening. Therefore, screening for lung cancer with low dose computed tomorgraphy (LDCT) may be considered medically necessary for high risk patients who meet the eligibility criteria above and investigational otherwise.
Lung cancer screening using low dose computed tomography (LDCT) would be considered not medically necessary for the following indications:
The use of computer aided detection (CAD) with low dose computed tomography for lung cancer screening is considered investigational.
There is insufficient evidence to determine whether CAD technology may improve the accuracy of CT scanning interpretation. While CAD systems have been shown to detect additional lung nodules compared to the results of human readers alone, the issue is how many detected nodules are lung cancers. The effectiveness of CAD in detecting lung cancer has not been fully investigated. Highly quality randomized trials examining the effect of CAD systems for CT scans on lung cancer morbidity and mortality are necessary to determine the true impact of this technology on health outcomes. Therefore, the use of computer aided detection (CAD) with LCDT for screening for lung cancer is considered investigational.
Wellmark's policy is based on:
Henschke CI, Yankelevitz DF, Miettinen OS. Computed Tomographic Screening for Lung Cancer: The Relationship of Disease Stage to Tumor Size. Arch Intern Med 2006; 166:321-25.
Lindell RM, Hartman TE, Swensen SJ et al. Five-year Lung Cancer Screening Experience: CT Appearance, Growth Rate, Location, and Histologic Features of 61 Lung Cancers. Radiology. 2007 Feb;242(2):555-62.
The Early Lung Cancer Action Program Investigators. Survival of Patients with Stage I Lung Cancer Detected on CT Screening. N Engl J Med. 2006;355:1763-1771.
Bach PB, Jett JR, Pastorino U et al. Computed Tomography Screening and Lung Cancer Outcomes. JAMA. 2007;297:953-961.
Black C, de Verteuil R, Walker S, Ayres J, Boland A, Bagust A, Waugh N. Population screening for lung cancer using computed tomography, is there evidence of clinical effectiveness? A systematic review of the literature. Thorax, 2007 Feb;62(2):131-8.
American Society of Clinical Oncology (ASCO) 45th Annual Meeting: Abstract CRA 1502. Presented May 30, 2009.
Bach PB, Silvestri GA, Hanger M et al. Screening for Lung Cancer. ACCP Evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep; 132 (3 Suppl) 69S-77S.
Hocking WG, Oken MM, Winslow SD et al. Lung cancer screening in the randomized prostate, lung, colorectal and ovarian (PLCO) cancer screening trial. J Natl Cancer Inst 2010; 102(10):722-31.
van Klaveren RJ Oudkerk M, Prokop M et al. Management of lung nodules detected by volume CT screening. N Engl J Med 2009; 361(23):2221-9.
Croswell JM, Baker SG, Marcus PM et al. Cumulative incidence of false-positive test results in lung cancer screening. Ann Intern Med 2010; 152(8):505-12.
National Lung Cancer Screening Trial Research Team; Aberle DR, Adams AM, Berg CD et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 2011; 365(5):395-409.
van den Bergh KA, Essink-Bot ML, Borsboom GJ et al. Long-term effects of lung cancer computed tomography screening on health-related quality of life: the NELSON study. Eur Respir J 2011; 38(1):154-61.
American Cancer SocietyExternal Site Lung Cancer (non-small cell). Last revised July, 2011. Last accessed September 2011.
ECRI InstituteExternal Site Professional societies endorse low-dose CT scans for lung cancer screening in high-risk patients. Plymouth Meeting (PA): ECRI Health Technology Assessment InformationService; 2012 August 1. [Health Technology Trends].
Bach PB, Mirkin JN, Oliver TK, et al. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29.
Saghir Z, Dirksen A, Ashraf H, et al. CT screening for lung cancer brings forward early disease. The randomized Danish Lung Cancer Screening Trial: status after five annual screening rounds with low-dose CT. Thorax. 2012 Apr;67(4):296-301.
U.S. Preventative Services Tesk ForceExternal Site (USPSTF) Screening for Lung Cancer Recommendation Statement.
National Comprehensive Cancer NetworkExternal Site (NCCN), Lung Cancer Screening Version 1.2014.
American Cancer SocietyExternal Site New Lung Cancer Screening Guidelines for Heavy Smokers, January 11, 2013.
National Cancer InstituteExternal Site National Lung Screening Trial (NLST), NCI Press Release, NIH Funded Study Shows 20 Percent Reduction in Lung Cancer Mortality with Low Dose CT Compared to Chest X-Ray.
American Association for Thoracic Surgery Guidelines for Lung Cancer Screening Using Low Dose Computed Tomography Scans for Lung Cancer Survivors and Other High Risk Groups, Michael T. Jaklitsch, M.D. et al. The Journal of Thoracic and Cardiovascular Surgery, Volume 144, Number 1. July 2012.
The American Society of Clinical OncologyExternal Site (ASCO), The Role of CT Screening for Lung Cancer in Clinical Practice. The Evidence Based Practice Guideline of the American College of Chest Physicians and the American Society for Clinical Oncology. Peter B. Back, M.D., et al. May 2012.
UpToDateExternal Site Screening for Lung Cancer. Mark E. Deffebach, M.D., Linda Humphrey, M.D. Topic last updated March 11, 2014.
Peter B. Bach M.D., MAPP; Joshua N. Mirkin BA. Et. al. Benefits and Harms of CT Screening for Lung Cancer; A Systemic Review. JAMA May 20, 2012, Vol 307, No 22
National Comprehensive Cancer NetworkExternal Site (NCCN) Lung Cancer Screening Version 1.2015.
American Lung AssociationExternal Site Providing Guidance on Lung Cancer Screening to Patients and Physicians, April 23, 2012.
UpToDateExternal Site Screening for Lung Cancer, Mark E. Deffebach, M.D., Linda Humphrey, M.D.. Topic last updated January 15, 2015.
ECRI Health Technology ForecastExternal Site Computed Tomography with Computer-Aided Detection for Lung Cancer Screening. August 2012.
National Comprehensive Cancer NetworkExternal Site (NCCN) Lung Cancer Screening Version 1.2016. Also available at
American Academy of Family PhysicianstExternal Site Lung cancer clinical recommendations.
Centers for Medicare and Medicaid ServicesExternal Site National Coverage Determination (NCD) for Lung Cancer Screening with Low Dose Computed Tomography (LDCT).
National Cancer InstituteExternal Site Lung Cancer Screening PDQ.
Detterback F, Mazzone P, Naidich D, Back P. Screening for Lung Cancer – Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2013;14395)(Suppl):e78S-e92S
Bach PB, Mirkin JN, Oliver TK, et. al. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA 2012 Jun 13;307(22):2418-29
California Technology Assessment ForumExternal Site (CTAF). Low Dose Spiral Computerized Tomography (LDSCT) Screening for Lung Cancer. Technology Assessment October 19, 2011.
Saghir Z, Dirksen A, Ashraf H, et. al. CT screening for lung cancer brings forward early disease. The randomized Danish Lung Cancer Screening Trial: status after five annual screening rounds with low dose CT. Thorax 2012 Apr;67(4):296-301
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.