Medical Policy: 06.01.19
Original Effective Date: February 2003
Reviewed: February 2017
Revised: February 2017
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 leading cause of cancer-related death among genotypical men and genotypical women. 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. Individuals with high risk factors who are candidates for screening should not have any symptoms suggestive of lung cancer (e.g. cough, pain, weight loss). The goal of screening is to detect disease at a stage when it is not causing symptoms and when treatment will be most successful. Screening should benefit the individual by increasing life expectancy and increasing quality of life.
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. LDCT refers to a non-contrast study with a multi-detector CT scanner during a single maximal inspiratory breath-hold with a scanning time of under 25 seconds. New multi-detector CT scanners generate high-resolution imaging with radiation exposure significantly less than for diagnostic CT scanning. It has been suggested that LDCT 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.
Shared patient/physician decision making may be the best approach before deciding whether to do LDCT lung cancer screening, especially for patients with comorbid conditions. Wherever possible those individuals who choose to undergo lung cancer screening 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.
While screening for lung cancer has the potential benefits of decreased morbidity and mortality from lung cancer it also has potential harms, which include:
The National Lung Screening Trial (NLST) was a randomized trial sponsored by the National Institute of Health comparing the annual screening by low dose CT scanning with standard chest x-ray for three years in 53, 454 high risk persons at 33 United States medical centers. Participants were men and women 55 to 74 years of age with a history of at least 30 pack years of smoking, current smokers and those who had discontinued smoking within 15 years of enrollment. 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: Randomized controlled trials and cohort studies of screening with chest radiography or low dose computerized tomography (LDCT) demonstrate that chest radiograph screening does not reduce mortality from lung cancer and that LDCT screening is significantly more sensitive than chest radiography for identifying small asymptomatic lung cancers. 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. Society guidelines recommend annual screening, and that 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 surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcomes. Therefore, screening for lung cancer with low dose CT (LDCT) annually may be considered medically necessary for high risk patients who meet criteria and investigational otherwise.
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.
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.
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. This recommendation is Grade B.
Recommend lung cancer screening using low dose CT scan for high risk individuals:
Age 55-74 years and
≥ 30 pack year history of smoking and
Smoking cessation <15 years;
OR
Age ≥ 50 years and
≥ 20 pack year history of smoking and
One additional risk factor (other than second hand smoke)
Screening Findings: No lung nodule(s) on LDCT - annual screening LDCT until patient is no longer a candidate 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.”
In candidates for screening, shared patient/physician decision making is recommended, including a discussion of benefits and risks.
Individuals with risk factors who are candidates for screening should not have symptoms suggestive of lung cancer (e.g. cough, pain, weight loss).
In 2013, the American Cancer Society (ACS) 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.
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:
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:
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 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.
In 2012, the American Lung Association Lung Cancer Screening Subcommittee released an interim report with the following recommendations:
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.
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:*
*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) 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 low dose computed tomography (LDCT) screening for lung cancer includes several randomized clinical trials and cohort studies. 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. Society guidelines recommend annual screening, and that 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 surgery. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcomes. 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 for all other screening indications.
Lung cancer screening using low dose computed tomography (LDCT) would be considered not medically necessary for the following indications:
Computer Aided Detection with LDCT
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 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.
*CPT® is a registered trademark of the American Medical Association.