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

Several societies and the USPSTF have developed statements on the impact of changing the lung cancer screening eligibility criteria for age and smoking history. In the American College of Chest  Physicians CHEST) guidelines for low dose CT lung cancer screening, the authors reported that [l]imited data comparing lung cancer mortality outcomes by race, smoking status, malignancy risk, and the presence of COPD were available. The NLST was the only trial for which there is data reporting lung cancer mortality stratified by race. Black individuals had a non-statistically significant larger benefit [from lung cancer screening] than white individuals (HR 0.61 vs. 0.86, p = 0.29) (Mazzone, Panel Report 2021). Additionally, [c]urrent age and smoking history-based eligibility criteria engender disparities with respect to race/ethnicity, sex, smoking intensity, years since quitting, and for special populations such as people living with HIV; see [citation in Mazzone] for a comprehensive review. By reducing the age and the pack-years eligibility for screening from 55 to 50 and 30 to 20, respectively, as in the USPSTF draft recommendations, more African Americans will be eligible for screening which may partially eliminate this particular disparity (Mazzone, Executive Summary; 2021).In agreement with the American College of Chest Physicians (CHEST) guidelines, the American Thoracic Society (ATS) statement on healthcare disparities reported that [l]ung cancer is diagnosed in African American individuals, women, and PLHIV [persons living with HIV] at an earlier age than white individuals, men, and non-HIV populations, and the former populations may thus benefit from a lower minimum age for eligibility. Decreasing the eligibility criteria for smoking pack-years to a minimum of 20 pack-years has been shown to increase the percentage of African Americans who smoke who would be eligible for LCS. Further reducing the eligible age to 50 years for African Americans in addition to allowing a minimum history of 20 pack-years resulted in a similar eligibility percentage between African American individuals and white individuals in whom lung cancer was diagnosed. Current USPSTF LCS guidelines under select women, who are more likely to smoke with low intensity or be former high-intensity smokers with >15 YSQ [Years Since Quitting]. Modifying the smoking history and/or age eligibility criteria for LCS, which the 2020 [sic] USPSTF draft recommendations propose, would increase the percentage of lung cancer cases eligible for screening; however, there is not sufficient evidence that this proposal alone will ensure equitable screening for all individuals who have equal risk of lung cancer (Rivera, 2020).Finally, regarding the impact of changing the eligibility criteria for age and smoking history, Krist and colleagues (2021), on behalf of the USPSTF, concluded in a similar fashion to the above societal guideline statements that [s]creening for lung cancer in persons at an earlier age and with fewer pack-years of smoking (i.e., 20 pack-years) may also help partially ameliorate racial disparities in screening eligibility. Data suggest that Black persons who smoke have a higher risk of lung cancer than do White persons, and this risk difference is more apparent at lower levels of smoking intensity. One recent analysis of Southern Community Cohort Study participants found that 17% of Black persons who smoke were eligible for lung cancer screening based on the 2013 USPSTF eligibility criteria compared with 31% of White persons who smoke. In the same study, among persons diagnosed with lung cancer, a significantly lower percentage of Black persons who smoke (32%) were eligible for screening than were White persons (56%). Data also suggest that Latinx/Hispanic persons who smoke accumulate fewer pack-years than White persons who smoke. A strategy of annually screening persons aged 50 to 80 years who have at least a 20 pack-years smoking history and currently smoke or have quit within the past 15 years (A-50-80-20-15) would increase the relative percentage of persons eligible for screening by 87% overall78% in non-Hispanic White adults, 107% in non-Hispanic Black adults, and 112% in Hispanic adults compared with 2013 USPSTF criteria (A-55-80-30-15). Similarly, a strategy of screening persons aged 50 to 80 years who have at least a 20 pack-year smoking history and currently smoke or have quit within the past 15 years (A-50-80-20-15) would increase the relative percentage of persons eligible for screening by 80% in men and by 96% in women, because they accumulate fewer pack-years than men. (USPSTF, Krist; 2021).The available evidence, including the health disparity study results and the societal organizations clinical guideline statements, suggest that the CMS proposal to revise the lung cancer screening eligibility criteria by lowering the starting age to 50 years and reducing the smoking history to 20 pack-years may help to partially ameliorate gender and race/ethnicity-related health disparities in eligibility for lung cancer screening.SummaryGiven the burden of lung cancer on the United States population, a suitable screening test for lung cancer has been sought for many years. Lung cancer screening has been recommended by the USPSTF with a grade B recommendation for certain individuals. Based on our review of the available evidence, including clinical guidelines and public comments, we find that the evidence is sufficient to conclude that broadening the eligibility criteria for lung cancer screening with low dose CT is reasonable and necessary for the prevention or early detection of illness or disability and appropriate for Medicare beneficiaries under conditions established in this NCD. These conditions are supported by the evidence reviewed, including conditions in the randomized controlled clinical trials and evidence-based multi-society, multi-disciplinary recommendations. The results of ongoing trials will provide additional evidence. We believe that specific beneficiary and practitioner eligibility requirements are necessary to ensure that the benefits of screening outweigh harms in the Medicare population, consistent with the various randomized controlled clinical trials. Lung cancer screening with low dose CT has not been implemented broadly in any population to date. While we are establishing coverage for this additional preventive service under Medicare part B, we believe we need to proceed in a responsible manner and will continue to monitor the evidence as stewards of the Medicare program.X. ConclusionThe Centers for Medicare & Medicaid Services (CMS) reconsidered the national coverage determination established at section 210.14 of the Medicare National Coverage Determinations manual and determines that the evidence is sufficient to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT) when the following criteria are met:Beneficiary eligibility criteria:Age 50  77 years;Asymptomatic (no signs or symptoms of lung cancer);Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);Current smoker or one who has quit smoking within the last 15 years; andReceive an order for lung cancer screening with LDCT.Counseling and Shared Decision-Making VisitBefore the beneficiarys first lung cancer LDCT screening, the beneficiary must receive a counseling and shared decision-making visit that meets all of the following criteria, and is appropriately documented in the beneficiarys medical records:Determination of beneficiary eligibility;Shared decision-making, including the use of one or more decision aids;Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; andCounseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions.Reading Radiologist Eligibility CriteriaFor purposes of Medicare coverage of lung cancer screening with LDCT, the reading radiologist must have board certification or board eligibility with the American Board of Radiology or equivalent organization.Radiology Imaging Facility Eligibility CriteriaFor purposes of Medicare coverage,lung cancer screeningwith LDCT must be furnished in a radiology imaging facility that utilizes a standardized lung nodule identification, classification and reporting system.The above policy simplifies requirements for the counseling and shared decision-making visit, removes the restriction that it must be furnished by a physician or non-physician practitioner, reduces the eligibility criteria for the reading radiologist, and reduces the radiology imaging facility eligibility criteria (including removes the requirement that facilities participate in a registry). See Appendix B for the expected manual language.