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

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 CessationWe will retain the furnishing of information on smoking cessation or smoking abstinence during the counseling and shared decision-making visit, based on the guidelines published by the societal organizations. Many guideline organizations discuss smoking cessation as an important part of low dose CT screening. For annual lung cancer screening with low dose CT in adults, the 2021 USPSTF recommendation has that if a person currently smokes, they should receive smoking cessation interventions. Further, persons referred for lung cancer screening through primary care should receive these interventions concurrent with a referral. Because many persons may enter screening through pathways besides referral from primary care, the USPSTF encourages incorporating such interventions into all screening programs (USPSTF, Krist; 2021). However, the 2021 USPSTF recommendation does not state within what setting that smoking cessation should occur in except that smoking cessation should occur within the setting of the screening program. The 2021 USPSTF recommendation also discusses other resources on smoking cessation developed by the Centers for Disease Control and Prevention and the National Cancer Institute.In the section on shared decision-making, the National Comprehensive Cancer Network (NCCN) guidelines state that smoking cessation counseling is recommended (NCCN, 2020). Thus, while the NCCN guidelines recommend advising smokers to quit smoking tobacco, the guidelines do not explicitly comment on whether the discussion of smoking cessation should be part of shared decision-making. Additionally, the NCCN guidelines do not comment on the setting for the discussion of smoking cessation or when and where to discuss quitting smoking with the patient. The issue of setting remains unchanged in the updated 2021 NCCN guidelines (Wood, NCCN, 2021). According to the American College of Chest Physicians (CHEST) guidelines for low dose CT lung cancer screening (Mazzone, Panel Report 2021), evidence-based tobacco cessation treatment is recommended to be provided by the low dose CT screening program, even though the panel reported that the most effective intervention to promote smoking cessation in the setting of lung cancer screening is not known. The American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) policy statements include comments on smoking cessation, but the statement notes that the best strategy to optimize smoking abstinence in the setting of LDCT screening is unknown (Wiener 2015). The ATS/CHEST policy statement (Wiener, 2015) does not comment on the setting, such as the specific imaging facility, for discussing smoking cessation with the patient or whether it should be included in shared decision-making. However, one organization suggests that smoking cessation intervention be integrated with shared decision-making. In the American College of Chest Physicians (CHEST) guidelines for low dose CT lung cancer screening (Mazzone, Panel Report 2021), counseling about smoking cessation is suggested as a component of thecounseling and shared decision-making visit of the patient with the clinical provider.We will retain the requirement for furnishing information about tobacco cessation interventions or maintaining cigarette smoking abstinence within the shared decision-making visit. Given the current rates of smoking, we believe it is vitally important to provide information about tobacco cessation or cigarette smoking abstinence to the patient when possible. Based on the organizations guidelines on smoking cessation for low dose CT screening, we will retain the eligibility criterion that lung cancer screening with low dose CT is appropriate for Medicare beneficiaries who meet the other eligibility criteria and who have furnished information about tobacco cessation interventions if current smoker, or maintaining cigarette smoking abstinence if former smoker, during the shared decision-making visit. 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.Written OrderWe will modify the criterion for a written order by removing the word written and removing the  data elements that are required as part of the order. As stated above, orders for lung cancer screening with LDCT are now standard practice and we no longer believe it is necessary to specify each data element on the order.While it is important and necessary for the facility to receive an order for the appropriate Medicare beneficiary to have a low dose CT scan to screen for lung cancer, the order does not have to be written since it is more likely that an order is transmitted electronically with the use of an electronic health record system. Additionally, the information we had previously specified is available in the medical record such as smoking history and years since quitting smoking, is in the patients medical records. Another reason for removing the detailed data elements is that we are removing the low dose CT lung cancer screening registry requirement and many of these elements were required as part of the registry data submission.Written Orders for Subsequent Annual Lung Cancer Screenings with Low Dose CTWe will remove the requirement for written orders for subsequent annual lung cancer screening with low dose CT. Consistent with our previous discussion, we believe that specifying the order be written is outdated and that orders for subsequent annual lung cancer screening with LDCT are standard practice and are no longer necessary as part of the NCD.Reading Radiologist Training and Eligibility CriteriaWe will modify the reading radiologist eligibility criteria by removing the training documentation requirement, the 300 chest CT acquisitions in 3 years requirement, the documented participation in continuing medical education in accordance with current American College of Radiology standards requirement, and the radiology facility eligibility criteria.We will retain the eligibility criterion that the reading radiologist must be board certified or board eligibility with the American Board of Radiology or equivalent organization in order to maintain the standards of the American Board of Radiology, the national medical specialty board that certifies radiologists. The mission of the American Board of Radiology is to certify that our diplomats demonstrate the requisite knowledge, skill, and understanding of their disciplines to the benefit ofpatients. . . . We were founded to protect the public by assessing and certifying doctors who meet specific educational, training, and professional requirements (American Board of Radiology, 2021). Further, [b]oard certification is the best measure of the knowledge, experience, and skills needed to provide quality patient care (American Board of Radiology, 2021). To maintain the standards of the American Board of Radiology, we will retain the eligibility criterion that lung cancer screening with low dose CT is appropriate for Medicare beneficiaries who meet the other eligibility criteria when the reading radiologist has board certification or board eligibility with the American Board of Radiology or equivalent organization.For initial board certification in diagnostic radiology, the requirements are that [a]s candidates progress through their residency and after completion of training, they will take two exams to gain initial certification in diagnostic radiology: the Core Exam and the Certifying Exam (American Board of Radiology, 2021). There is no mention of a requirement for additional training beyond residency training in diagnostic radiology and radiation safety, or the need for interpretation of at least 300 chest computed tomography acquisitions in the past three years. There is no subspecialty in CT scans. Thus, we will remove the eligibility criterion that the reading radiologist has documented training in diagnostic radiology and radiation safety, and to remove the other eligibility criterion that the reading radiologist be involved in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years, which should reduce the documentation paperwork burden on the provider.Further, we will remove the eligibility criterion that the reading radiologist has documented  training in diagnostic radiology and radiation safety because this requirement is part of the requirements for maintaining board certification in diagnostic radiology. Diagnostic radiology is one of the medical specialties that a radiologist can attain board certification from the American Board of Radiology. To maintain board certification in diagnostic radiology, the radiologist is required to complete training for the Maintenance of Certification for Diagnostic Radiology. Maintenance of Certification (MOC) is an integral part of the quality movement in healthcare. Patients, your physician peers, and your colleagues all value MOC because it demonstrates your support for continuous quality improvement, professional development, and quality patient care. The ABR [American Board of Radiology] believes in the value of Maintenance of Certification. Therefore, all ABR volunteers, including governors and trustees, are required to participate in MOC (American Board of Radiology, 2021). Maintenance of Certification includes documented training requirements for lifelong learning, and a self-assessment of knowledge, judgment and skills in diagnostic radiology, which includes radiation safety. Because maintenance of board certification in diagnostic radiology incorporates documented training in diagnostic radiology and radiation safety, we will remove the eligibility criterion that the reading radiologist has documented training in diagnostic radiology and radiation safety, which should reduce the documentation paperwork burden on the provider.Additionally, none of the guideline organizations mention a need for the reading radiologist for CT scans to be involved in a specific number of chest computed tomography readings. We will remove the  eligibility criterion that the reading radiologist be involved in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years, which should reduce unnecessary requirements for the provider.After reviewing public comments, we will remove the eligibility criterion that the reading  radiologist must have documented participation in CME in accordance with current American College of Radiology standards. CME is already part of the American Board of Radiologys Maintenance of Certification (MOC) Part 2 that requires radiologists seeking board re-certification to attain 75 CME credits every three years. Since the reading radiologist is already required, per the NCD, to be board certified or board eligible, we will not continue a separate CME requirement for reading radiologists.We will remove the reading radiologist eligibility criterion for furnishing lung cancer screening with low dose CT in a radiology imaging facility that meets the radiology imaging facility eligibility criteria because we are removing all but one of the radiology imaging facility eligibility criteria, which should reduce the burden of work on the provider. The rationale for removing radiology imaging facility eligibility criteria is described in the section on the low dose CT lung cancer screening imaging facilities that follows.Low Dose CT Lung Cancer Screening Imaging Facilities, Low Dose CT Lung Cancer Screening Registry, and Radiation DoseWe will modify the radiology imaging facility eligibility criteria. Lung cancer screening with LDCT is now a mature technology that no longer requires the criteria established early in its inception.Low Dose CT Lung Cancer Screening Imaging Facilities: Radiation DoseWe will remove the radiology imaging facility eligibility criteria for volumetric CT dose index by the number of milligrays, based on recently published guidelines. Several multi-society multi-disciplinary guideline organizations, including major professional medical societies such as the American College of Radiology, have comments on radiation dosage. The American College of Radiology (ACR) Appropriateness Criteria expert panel appears to make a statement related to the radiology imaging screening facility low dose CT eligibility criteria that suggests what the specific number of milliSieverts for radiation dosing should be (Donnelly, 2018), likely applicable to independent diagnostic testing facilities (IDTFs). The American College of Chest Physicians (CHEST) guidelines for low dose CT lung cancer screening (Mazzone, Panel Report 2021) has suggestions about radiology imaging screening facility low dose CT eligibility criteria, such as the number of milligrays for radiation dosing. According to the American College of Chest Physicians (CHEST) guidelines for LDCT lung cancer screening, it is suggested that low-dose CT screening programs follow the ACR/STR (American College of Radiology and Society of Thoracic Radiology) protocols for performing low radiation dose chest CT scans. (Ungraded Consensus-Based Statement). Remark: An awareness of the potential for radiation related harm can help programs thoughtfully plan ways to minimize this risk through proper patient selection, the performance of the CT scan, tracking of the radiation dose being administered, and appropriate management of screen detected findings (Mazzone, Panel Report 2021).