NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo

In the 2021 USPSTF recommendation statement, [t]he USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have a 20 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 surgery. (B recommendation) (USPSTF, Krist; 2021). The 2021 USPSTF lung cancer screening statement recommends annual lung cancer screening with low dose CT for adults who have quit within the past 15 years. This eligibility criterion for quitting smoking that is under reconsideration aligns with the 2021 USPSTF recommendation statement on low dose CT.Among the organizations making recommendations for the selection of individuals for lung cancer screening, the American College of Chest Physicians (CHEST) has two recommendations. 1. For asymptomatic individuals age 55 to 77 who have smoked 30 pack-years or more and either continue to smoke or have quit within the past 15 years, we recommend that annual screening with low-dose CT should be offered. (Strong recommendation, moderate-quality evidence). 2. For asymptomatic individuals who do not meet the smoking and/or age criteria in Recommendation #1, are age 50 to 80, have smoked 20 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 should be offered. (Weak recommendation, moderate-quality evidence) (Mazzone, Panel Report 2021). Thus, for the smoking cessation history for persons who have quit smoking within the past 15 years, the American College of Chest Physicians (CHEST) guidelines recommend low dose CT since this is a strong recommendation.In the National Comprehensive Cancer Network (NCCN), Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Lung Cancer Screening Version 1.2021, the NCCN Lung Cancer Screening Panel defined the risk status of high risk as age  50 years and  20 pack-year history of smoking with these high-risk persons candidates for low dose CT (LDCT) screening (category 1) where shared  patient/physician decision-making is recommended, including a discussion of benefits/risks (NCCN, 2020). In addition, the most current National Comprehensive Cancer Network (NCCN) guidelines Version 1.2021 do not discuss the eligibility criterion for history of quitting smoking and this eligibility criterion is not included in the most recent NCCN guidelines Version 1.2021 recommendation statement on low dose CT screening (NCCN, 2020). There were no changes to the history of quitting smoking criterion in the updated 2021 NCCN guidelines Version 1.2022 (Wood, NCCN, 2021).In summary of their recommendations, the American College of Radiology Appropriateness Criteria expert panel concluded that for Variant 1: Lung cancer screening with low-dose CT chest without IV contrast is usually appropriate in patients 55 to 80 years of age and 30 or more packs per year smoking history and currently smoke or have quit within the past 15 years. Variant 2: The panel did not agree on recommending lung cancer screening with low dose CT chest without IV contrast in patients 50 years of age or older and 20 or more packs per year history of smoking plus one additional risk factor. There is insufficient medical literature to conclude whether or not these patients would benefit from CT screening for lung cancer. Screening in this patient population is controversial but may be  appropriate. Variant 3: Lung cancer screening is usually not appropriate in patients younger than 50 years of age or older than 80 years of age or in patients of any age with less than 20 packs per year history of smoking and no additional risk factors (Donnelly, 2018). The American  College of Radiology recommends lung cancer screening with low dose CT for persons who have quit within the past 15 years.The American Cancer Society 2013 guideline recommends that clinicians with access to high-volume, high-quality lung cancer screening and treatment centers should initiate a discussion about screening with apparently healthy patients aged 55 years to 74 years who have at least a 30 [or more]pack-year smoking history and who currently smoke or have quit within the past 15 years (Wender, 2013). However, the 2013 American Cancer Society guideline is being updated and, in the meantime, the American Cancer Society recommends yearly lung cancer screening with low dose CT scans for people who: are 50 to 80 years old and in fairly good health, currently smoke, or have quit in the past 15 years, and have at least a 20 pack-year smoking history. The American Academy of Family Physicians gives the clinical preventive services recommendation for lung cancer screening in adults a B grade recommendation. The AAFP supports the United States Preventive Services Task Force (USPSTF) recommendation for annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have a 20 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 surgery (AAFP, 2021). Both the American Cancer Society and the American Academy of Family Physicians  recommends lung cancer screening with low dose CT for persons who have quit within the past 15 years.We find the empiric evidence is sufficient to conclude that screening for lung cancer with low dose CT is reasonable and necessary for Medicare beneficiaries with the specific eligibility criterion for the quit smoking history of quitting smoking within the past 15 years. However, we find the human clinical evidence is not sufficient to conclude that screening for lung cancer with low dose CT is reasonable and necessary for Medicare beneficiaries with the specific eligibility criterion for the quit smoking history of quitting smoking more than 15 years ago. The Medicare beneficiary eligibility criterion for quitting smoking will not be changed and will remain at quitting smoking within the past 15 years. This recommended screening population for quitting smoking within the past 15 years does align with the 2021 USPSTF recommendation statement on low dose CT screening.Question 3: Is the evidence sufficient to determine that screening for lung cancer with low dose computed tomography is appropriate for Medicare beneficiaries?Lung cancer is a burdensome condition for the Medicare population due to the advanced stage and age at diagnosis and death. Early detection with various screening tests has been studied for many years without positive results but the benefits of low dose CT screening have been confirmed with extended  follow up data from the high quality NLST and NELSON trials. Based on the results of the NLST and NELSON, lung cancer screening using low dose CT was shown to reduce lung cancer mortality compared to screening with chest radiogram (x-ray) or no screening, respectively, for a very defined screening population including a broader portion of the Medicare population (aged 65 or greater). The low dose CT scan is relatively simple and attempts to balance radiation exposure to acceptable image quality, compared to standard diagnostic chest CT scans that are not appropriate for lung cancer screening.Counseling and Shared Decision-MakingDue to the complexities of lung cancer screening with LDCT including specific patient selection criteria, benefits, harms, and adherence, we continue to support the need for shared decision-making. However, we believe that the requirements should be modified to reflect a service that is no longer considered new. Professional societies and provider groups have noted that providers have gained considerable experience and expertise and believe flexibility will reduce burden. We will remove specificity regarding the type of provider who must furnish the counseling and shared decision-making and remove some specificity around documentation of the information on the beneficiary eligibility criteria.Several organizations have commented on the type of provider who should furnish shared decision-making. The American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) policy statement (Wiener, 2015) includes comments on who should perform shared decision-making on low dose CT screening with the patient, which can include health educators or midlevel providers like lung cancer screening coordinator. The 2021 USPSTF recommendation (USPSTF, Krist; 2021) states that providers should engage in shared decision-making about screening, but there is no statement on who should conduct the shared decision-making with the patient or what level of the provider of shared decision-making should be. According to the American College of Chest Physicians (CHEST) guidelines for low dose CT lung cancer screening (Mazzone, Panel Report 2021), they do not provide detailed comments beyond the need for a screening program provider on who should deliver the shared decision-making visit to the patient. While the National Comprehensive Cancer Network (NCCN) guidelines recommend shared decision-making before an initial screening LDCT scan is performed (NCCN, 2020), the guidelines do not comment on who the provider should be for the shared decision-making discussion with the patient. The updated 2021 NCCN guidelines changed the terminology for shared decision-making from physician to provider (Wood, NCCN, 2021). None of the organizations specify what type of provider should conduct shared decision-making with the patient.We do not believe there is an evidentiary reason to continue to limit the shared decision-making visit to physician and non-physician practitioners. We note that this expansion can allow for this service to be furnished incident to a physicians professional service. Removing the specification for the type of practitioner should expand the individuals that can conduct shared decision-making to other health care practitioners, such as health educators and others beyond physicians or non-physician practitioners. Thischange may broaden access to LDCT screening.While we continue to have the requirement for making an appropriate determination of the patients eligibility for lung cancer screening with low dose CT at the shared decision-making visit, it is no longer necessary to specify the documentation requirement. We believe stating this requirement under the subheading of documentation to be redundant and that the medical record will continue to reflect a patients eligibility and adherence to the eligibility criteria such as calculation of cigarettesmoking pack-years and years since quitting smoking; age; and absence of signs and symptoms of lung cancer Additionally, it is routine that the patients age is already in the patients medical records, since age is a fundamental sociodemographic characteristic that should already have been entered into the patients medical record at the initial clinical visit. Finally, smoking history in pack-years, years since quitting smoking, and absence of signs or symptoms of lung cancer is inherent in the clinical assessment of lung cancer.Several organizations have commented on the use of shared decision-making aids during the shared decision-making visit. According to the American College of Chest Physicians (CHEST) guidelines for low dose CT lung cancer screening (Mazzone, Panel Report 2021), shared decision-making is suggested prior to the performance of the low dose CT screening exam, and it is suggested that ordering providers have the tools necessary to deliver an effective counseling and shared decision-making, which may include decision aids, information brochures, videos, and links to electronic resources. The American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) policy statement (Wiener, 2015) includes comments on shared decision-making as part of the low dose CT screening process and has examples of shared decision-making tools. Examples are provided of potential patient decision aid tools that could be used in shared decision-making by the provider with the patient (Wiener, 2015). While these guidelines suggest the use of shared decision aids during the shared decision-making visit, these guidelines do not specify the elements required as part of a shared decision-making tool. To reduce the burden of documentation paperwork, we will remove the specifications for the components of the shared decision-making tools. We believe this is appropriate as the tools and guidance has matured since the early inception of shared decision-making. Based on the organizations guidelines on shared decision-making tools, we determine that lung cancer screening with low dose CT is appropriate for Medicare beneficiaries who meet the other eligibility criteria and who participate in shared decision-making when the provider uses at least one decision aid.We will retain the eligibility criterion on counseling on the importance of adherence to annual lung cancer low dose CT screening, the impact of comorbidities, and ability or willingness to undergo diagnosis and treatment, since, as discussed above in the introductory comments on shared decision-making, these concepts are an integral and important component of the discussion of the benefits and harms of low dose CT lung cancer screening between the patient and provider and will have a majorimpact on the values attached to the patients preferences.We will retain the eligibility criterion for providing information on smoking cessation interventions within the shared decision-making visit.We are removing the excessive requirement for a written order. Additionally, having an order for the low dose CT screening test is standard practice and no longer needs to be specified as part of the NCD.We believe that removing the restriction for the type of practitioner who can furnish the counseling and shared decision-making visit, removing the specificity of redundant documentation requirements, and eliminating the excessive requirement for a written order will reduce administrative burden and facilitate improved access to lung cancer screening with LDCT.Smoking Cessation