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

Additionally, the American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) policy statements (Wiener, 2015) include comments on radiology imaging screening facility low dose CT eligibility criteria, such as the number of milligrays for radiation dosing (Wiener, 2015), likely for independent diagnostic testing facilities (IDTFs). Radiology imaging screening facility eligibility criteria, such as radiation dosing by low dose CT, is discussed in the body of the current National Comprehensive Cancer Network (NCCN) guidelines, but it is noted as a footnote in the clinical pathway algorithm for lung cancer screening, and is not part of the topline recommendation statement as part of the eligibility criteria for low dose CT lung cancer screening, of which age and pack-year history of smoking are such topline criteria. Further, the current NCCN guidelines state that to help ensure good image quality, all chest LDCT screening program should use CT scanners that meet the standards of the American College of Radiology (ACR) (NCCN, 2020). There were no changes to radiation dose in the updated 2021 NCCN guidelines (Wood, NCCN, 2021).Multi-society multi-disciplinary organizations with extensive expertise in low dose CT scans, such as the American College of Radiology, have published guidelines on the radiation dose that should be emitted by the low dose CT scan. Additionally, the guidelines appear to support the effort to standardize the protocol for administering the low dose CT scan, including the radiation dosing, indicating a maturing technology. Thus, we will remove the radiology imaging facility eligibility criteria for volumetric CT dose index by the number of milligrays, which is likely to reduce the burden of documentation paperwork on providers and institutions.Low Dose CT Lung Cancer Screening Imaging Facilities: Lung Nodule Reporting SystemWe will not finalize the proposal to remove the radiology imaging facility eligibility criteria for utilizing a standardized lung nodule identification, classification and reporting system, based on guidelines published by multi-society multi-disciplinary stakeholders. Several multi-society guideline organizations have comments on utilizing a standardized lung nodule identification, classification and reporting system that focuses primarily on the reporting system developed by the American College of Radiology. The 2021 USPSTF recommendation reports that to standardize low dose CT screening and the evaluation and management of abnormal lung nodule findings, the USPSTF endorses the use of the American College of Radiology Lung Imaging Reporting and Data System (Lung-RADS) classification system for lung cancer screening with low dose CT in adults (USPSTF, Krist; 2021). According to the recent American College of Chest Physicians (CHEST) guidelines for low dose CT lung cancer screening (Mazzone, Panel Report 2021), there is a suggestion to use a lung nodule reporting and management system such as the American College of Radiology Lung-RADS, likely useful for independent diagnostic testing facilities (IDTFs). Similarly, the American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) policy statement (Wiener, 2015) include comments on radiology imaging screening facility low dose CT eligibility criteria, such as the use of the Lung-RADS lung nodule reporting and management system (Wiener, 2015), Radiology imaging screening facility eligibility criteria, such as the use of Lung-RADS in lung nodule reporting and management, is discussed in the body of the current National Comprehensive Cancer Network (NCCN) guidelines, but it is noted as a footnote in the clinical pathway algorithm for lung cancer screening, and not part of the topline recommendation statement as part of the eligibility criteria for low dose CT lung cancer screening, of which age and pack-year history of smoking are such topline criteria. The updated 2021 NCCN guidelines contain detailed recommendations for evaluating and follow up on lung screening findings including immediate assessment of nodules that are highly suspicious for lung cancer. The 2021 NCCN guidelines and the Lung-RADS recommendations have been harmonized to provide consistent and clear recommendations to clinicians seeking to interpret low dose CT scans (Wood, NCCN, 2021).Societal organizations with expertise in low dose CT scans have published guidelines recommending the use of a lung nodule reporting and management system, such as the American College of Radiology Lung Imaging Reporting and Data System (Lung-RADS) classification system. Given that societal organizations with extensive expertise in low dose CT scans have opined about the use of a lung nodule reporting and management system, and more specifically in response to the public comments, the radiology imaging facility eligibility criterion for utilizing a standardized lung nodule identification, classification and reporting system will remain. This is likely to standardize LDCT screening and the evaluation and management of abnormal lung nodule findings, and as noted in the public comments, reduce ambiguity in follow up and clinical management recommendations made to ordering providers by providing clear and consistent communication between the reading radiologist and the ordering providers.Low Dose CT Lung Cancer Screening Imaging Facilities: Smoking CessationAs noted in the above section on smoking cessation, we determine that as a policy requirement for low dose CT screening as a radiology imaging facility eligibility criterion, it is not required for Medicare beneficiaries to receive smoking cessation interventions for current smokers within the setting of a radiology imaging facility, and that this eligibility criterion be removed from the radiology imaging facility eligibility criteria as part of this NCD.  This modification should simplify and streamline the patient workflow for lung cancer screening at the radiology imaging facility.Low Dose CT Lung Cancer Screening RegistryWe will remove the radiology imaging facility eligibility criteria for collecting and submitting data to a CMS-approved low dose CT lung cancer screening registry along with the minimum required data elements. From the 2015 decision memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT), [t]he primary purpose for requiring the submission of data to the registry is to document compliance with the coverage criteria that are not evidenced on the health care claim. Furthermore, based on the public comments and the evidence reviewed, we strongly believe that the registry will serve as an aid to those seeking to study the clinical benefits of this screening (CAG-00439N; CMS,2015).For the purpose of showing the benefit of low dose CT screening, three studies were published using the Lung Cancer Screening Registry administered by the American College of Radiology.  Pham et al. (2020) used data from the Lung Cancer Screening Registry provided by the American College of Radiology in 2016 to collect the total number of LDCT screens performed from all 1962 accredited radiographic screening sites. The 2015 National Health Interview Survey was used to estimate screening eligible smokers per United States Preventive Services Task Force criteria. The number of LDCT screens performed in the US was collected from the 2016 Lung Cancer Screening Registry (LCSR), a part of The American College of Radiology (ACR). Started in 2015, this registry is based on the ACR Lung Imaging Reporting and Data System, which is a quality assurance tool designed to standardize the reporting of LDCT lung cancer screenings, manage recommendations, reduce confusion in LDCT interpretations, and facilitate outcome monitoring. LCSR is approved by CMS to enable providers to meet quality-reporting requirements for Medicare LDCT lung cancer screening reimbursement (Pham, 2020). They found that [i]n 2016, 2.0% of 7.6 million eligible smokers were screened with low dose CT across the United States (Pham, 2020).The authors concluded that [l]ung cancer screening remains heavily underutilized despite [the USPSTF] guideline recommendation since 2013, insurance coverage, and its potential to prevent thousands of lung cancer deaths annually (Pham, 2020). Additionally, Gupta et al. (2021) conducted a quasi-experimental study to compare the annual growth rates in lung cancer screenings between states that expanded Medicaid versus those that did not. Using the American College of Radiology Lung Cancer Screening Registry, they calculated the average annual growth rate between 2016 and 2019 for both groups (Gupta, 2021). The American College of Radiology Lung Cancer Screening Registry is a nationwide registry of accredited screening sites that perform lung cancer screenings. It was created in 2015, is publicly available and has been used to generate national estimates of lung screening coverage rates (Gupta, 2021). The authors found that [n]o significant difference was identified in the average annual growth in lung cancer screenings between Medicaid expanding and non-expanding states (57.6%, 50.3%, p = 0.51) (Gupta, 2021). The authors concluded that [n]o association is found between Medicaid expansion and increasing volumes of lung cancer screenings between 2016 and 2019 (Gupta, 2021). Finally, the aim of the Charkhchi (2017) study was to assess the relationship between the availability of lung cancer screening facilities and the size of the at-risk population as well as state-level clinically relevant epidemiologic and demographic variables. The ACR LCSR [American College of Radiology Lung Cancer Screening Registry] list of participating lung cancer screening facilities was used as a proxy for the availability of lung cancer screening facilities in each state (Charkhchi, 2017). The authors reported that [c]urrently, the only CMS-approved lung cancer screening registry is the Lung Cancer Screening Registry (LCSR) administered by the American College of Radiology (ACR). LCSR registers practices that provide LDCT and collects standardized information regarding those individuals who receive lung cancer screening in these registered practices (Charkhchi, 2017). The authors found that [a]s of 11/18/2016, 2,423 facilities participated in the LCSR. When adjusted by the rate of screening-eligible individuals per 100,000, the median population-normalized facility number was 15.7 (interquartile range (IQR) 25%, 75% 10.7,19.3). There was a positive independent effect (coefficient=12.87, 95% CI= 10.9314.8) between the state-level number of screening facility and rate of screen-eligible individuals rate per 100,000 (Charkhchi, 2017). The authors concluded that [f]acility number [at the state level] correlated with the rate of screening-eligible individuals per 100,000, a measure of the at-risk population (Charkhchi, 2017).Thus, three studies used the American College of Radiology Lung Cancer Screening Registry to ascertain how the rates of low dose CT utilization were affected by Medicaid expansion (Gupta, 2021), the association between the geographic distribution of lung cancer screening facilities and the rate of screening eligible individuals (Charkhchi, 2017), and most importantly, that lung cancer screening remains heavily underutilized despite the positive USPSTF guideline recommendation since 2013 (Pham, 2020). We believe the results of the three studies fulfill the purpose of the low dose CT lung cancer screening registry.Several societal organizations provided comments on whether there is a need for a low dose CT lung cancer screening registry. For annual lung cancer screening with low dose CT in adults, the more recent 2021 USPSTF recommendation has no comments on the use of a low dose CT lung cancer screening registry (USPSTF, Krist; 2021). In the previous 2013 USPSTF recommendation under Other Considerations for Standardizing LDCT Screening and Follow-up of Abnormal Findings, in the context of substantial uncertainty about how best to manage individual lesions, as well as the magnitude of some of the harms of screening, the USPSTF encourages the development of a registry to ensure that appropriate data are collected from screening programs to foster continuous improvement over time (Moyer, USPSTF; 2014). However, these sentences on the development of a registry do not appear in the 2021 USPSTF recommendation under Standardizing LDCT Screening and Follow-up of Abnormal Findings (USPSTF, Krist; 2021).In the American College of Chest Physicians (CHEST) guidelines for low dose CT lung cancer screening (Mazzone, Panel Report 2021), they make suggestions to develop data collection and reporting tools capable of assisting with quality improvement initiatives and reporting to a national registry, but reporting to a registry is likely linked to the 2015 CMS requirement for a national registry, as mentioned in the evidence base for this CHEST guideline. Further, this comment was an ungraded consensus-based statement, and not a recommendation. The American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) policy statement concludes that to maintain performance, programs should collect data on patients undergoing LDCT screening in a registry that should be periodically reviewed to ensure the program is achieving quality metrics (Wiener, 2015). The ATS/CHEST policy statement reports that regardless of nodule size, it is essential to establish mechanisms to prevent loss to follow-up. Two such strategies are the development of registries with data on all patients who have undergone LDCT screening (a CMS requirement) and designation of a screening program coordinator. Registries help monitor recommended follow-up, whether for a repeat screening in 1 year or earlier testing for evaluation of a screen-detected nodule (Wiener, 2015). But similar to the CHEST guidelines, the registry requirement appears to be included in the ATS/CHEST policy statement (Wiener, 2015) because the requirement is included in the 2015 national coverage determination on lung cancer screening as a screening facility eligibility criterion.