evekhm/cms_iom_500 huggingface dataset:
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
More specifically on smoking and race and gender disparities, the authors of the American Thoracic Society (ATS) statement reported that incidence and mortality rates vary by race, ethnicity, and sex. African American and Native Hawaiian individuals have the highest incidence, and white individuals have midlevel incidence, whereas Hispanic and Asian individuals have the lowest rates. These differences in incidence are more evident by sex at low levels of smoking exposure and at younger ages. Although the national decline in the incidence of lung cancer among men has been greater than that among women, in the 40- to 44-year-old age group, the female-to-male incidence rate ratio of lung cancer increased from 0.82 in the 19951999 period to 1.13 in the 20102014 period. The crossover in rates to higher incidence rates in younger women occurred in birth cohorts born after 1965 and was limited to white and Hispanic individuals; among white individuals, the rate rose from 0.88 in the 19951999 period to 1.17 in the 20102014 period, and among Hispanic women, who smoke less than young Hispanic men, the rate rose, more notably, from 0.79 to 1.22. African American men have the highest lung cancer mortality of all groups, and lung cancer is the leading cause of mortality in Hispanic men and the second leading cause of cancer mortality in Hispanic women. Socioeconomic and racial disparities account for approximately 37% of premature cancer deaths in the United States and are a major public health concern. The largest socioeconomic disparity is reported for lung cancer with mortality rates five times higher in the least educated men than in the most educated men. Secondary analyses of the NLST data show that African American individuals are more likely to benefit from LCS [lung cancer screening] in terms of mortality reduction (hazard ratio, 0.61 in African American individuals vs. 0.86 in white individuals). In addition, the reduction in lung cancer mortality after LCS is suggestive of being more favorable in women than in men (Rivera, 2020).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
For health disparities by gender in lung cancer screening, as noted earlier in the NCA, Becker et al. (2020) reported an intriguing observation in LUSI [in that there] is the apparent heterogeneity (although only borderline significant, P value for heterogeneity= 0.09) in the effect of LDCT screening on lung cancer mortality by sex, suggesting a mortality reduction among the women only, (Becker, 2020) and the authors go on to report that the findings from LUSI are in line with those from other trials, including NLST [National Lung Screening Trial], that suggest a stronger reduction of lung cancer mortality after LDCT screening among women as compared to men (Becker, 2020). Additionally, the LUSI study authors report that this gender heterogeneity could be the result of different relative counts of lung tumor [histologic] subtypes occurring in men and women, but that the numbers of cancer deaths in LUSI were too small to examine whether the apparent heterogeneity in relative mortality hazards for men and women could be explained by differences in tumor histology, or whether it could have been entirely due to chance (Becker, 2020).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Regarding the impact of health disparities on eligibility for lung cancer screening, the authors of the American Thoracic Society (ATS) statement reported that [r]acial and ethnic differences in lung cancer risk that are not accounted for in current eligibility criteria for LCS are striking. African American individuals exhibit higher smoking-adjusted risk of cancer, despite smoking less than white individuals. Recent data from a large cohort study demonstrated that lung cancer cases in African American individuals were less likely to be eligible under USPSTF screening guidelines than lung cancer cases in white individuals (17% vs. 31%, respectively), primarily because of fewer pack-years smoked (Rivera, 2020). Further, [s]creening eligibility also does not account for sex-based differences in lung cancer risk. Lung cancer tends to be diagnosed in women at younger ages than in men, and women start smoking at a later age and smoke less intensively than men. A recent study reported that although smoking prevalence was lower in women born after 1965, the incidence rate of lung cancer was significantly higher than in men, especially in white and Hispanic women, suggesting that sex differences in smoking behavior do not fully explain increased lung cancer rates in young women (Rivera, 2020).Strategies to Address Health DisparitiesTo address health disparities in lung cancer screening, the authors of the American Thoracic Society (ATS) statement on healthcare disparities reported that [d]isparities in lung cancer incidence, diagnosis, treatment, and mortality are well documented. There is concern that disparities in the implementation of and access to lung cancer screening (LCS) will further widen existing gaps in lung cancer care and mortality among racial and ethnic minorities, individuals of low socioeconomic status (SES), and uninsured or underinsured populations (Rivera, 2020). One of the key conclusions of the ATS statement was that in the United States, lung cancer incidence and mortality rates vary by race, ethnicity, sex, and SES [socioeconomic status]. LCS saves lives, and the mortality reduction benefit has been shown to be more favorable in African American individuals than in white individuals and is suggestive of being more favorable in women than in men (Rivera, 2020).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Additionally, the authors of the American Thoracic Society (ATS) statement on healthcare disparities suggest several strategies to address health disparities in lung cancer screening. Healthcare providers and organizations should provide access to evidence-based tobacco treatment that includes behavioral counseling and should develop programs that address differences in cultural beliefs, language, and literacy; healthcare institutions should provide training for providers on communication techniques in LCS [lung cancer screening] SDM [shared decision-making] to build and improve patient trust[; and] research scientists and healthcare providers should develop and test SDM tools that are culturally sensitive and understandable by those with lower literacy and numeracy and by those of differing cultural backgrounds (Rivera, 2020). The American Thoracic Society statement concludes that [s]ocially and economically disadvantaged populations are among the most vulnerable populations at risk for poor lung cancer outcomes. Significant disparities across the continuum of LCS implementationnot getting screened for tobacco use, not meeting eligibility criteria, not having access to quality screening and tobacco treatment, and lack of insurance, among manythreaten to worsen disparities in lung cancer. Dedicated efforts are needed to address existing multilevel barriers to LCS that widen disparities and to respond and develop actionable plans to implement strategies using multipronged approaches deployed simultaneously to decrease disparities. Thoughtful implementation of strategies that address racial, ethnic, socioeconomic, and sex-based differences in smoking behaviors and lung cancer risk; address inequitable distribution of LCS resources and access to health insurance coverage for LCS; and provide education and resources will be necessary to achieve equitable outcomes in LCS (Rivera, 2020).CMS encourages shared decision-making between patients and practitioners that is culturally sensitive and understandable by those with lower literacy and numeracy and by those of differing cultural backgrounds; and if appropriate, participation in a lung cancer screening program. CMS also encourages the use of tobacco cessation and abstinence programs that address differences in cultural beliefs, language, and literacy.Modification of Eligibility Criteria for Age and Smoking History
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Modification of Eligibility Criteria for Age and Smoking HistoryTwo studies evaluated the impact of the revised USPSTF eligibility criteria for age and smoking history on health disparities in lung cancer screening. In an ongoing prospective observational cohort study of community health centers across 12 southern US states, there were a total of 48,364 Southern Community Cohort Study participants who were ever smokers, of which 5,654 of 32,463 African American smokers (17%) were eligible for USPSTF screening compared with 4,992 of 15,901 white smokers (31%) (P < .001) (Aldrich, 2019). The study authors found that [l]owering the smoking pack-year eligibility criteria to a minimum 20-pack-year history was associated with an increased percentage of screening eligibility of African American smokers from 17.4% to 28.5% (Aldrich, 2019). This finding was likely due to African American smokers [tending] to smoke fewer cigarettes per day compared with white smokers and [having] a lower overall smoking pack-year history (Aldrich, 2019). Additionally, [r]educing the minimum age criterion for screening to 50 years for African American smokers in addition to lowering the smoking pack-year requirement would further increase the eligibility of African American persons diagnosed with lung cancer to 57.8% (457 of 791) (Aldrich, 2019). The authors concluded that [c]urrent USPSTF lung cancer screening guidelines may be too conservative for African American smokers. The findings suggest that race-specific adjustment of pack-year criteria in lung cancer screening guidelines would result in more equitable screening for African American smokers at high risk for lung cancer (Aldrich, 2019).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Reese et al. (2021) conducted a study to determine [w]hat change will be associated with the revised US Preventive Services Task Force (USPSTF) lung cancer screening guideline for screening eligibility among female, Black, and Hispanic populations (Reese, 2021). In the revised criteria, age was modified to 50 to 80 years [from 55 to 80 years]; smoking history, to 20 pack-years (Reese, 2021). The authors found that [i]n this cross-sectional study of the [Centers for Disease Control and Preventions] Behavioral Risk Factor Surveillance System for 2017 and 2018 [across 19 states], the proportion eligible for screening among current and former smokers increased by 30.3% for men, 40.5% for women, and 31.9% for White, 76.7% for Black, and 78.1% for Hispanic populations. Compared with men, women had lower odds of eligibility, and compared with White [individuals], Black and Hispanic individuals had lower odds of eligibility (Reese, 2021). The authors concluded that [t]he revised USPSTF guideline may likely increase lung cancer screening rates for female, Black, and Hispanic populations. However, despite these potential improvements, lung cancer screening inequities may persist without tailored eligibility criteria (Reese, 2021).
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).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
APPENDIX AGeneral Methodological Principles of Study Design(Section VI of the Decision Memorandum)When making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary. The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve health outcomes for patients.We divide the assessment of clinical evidence into three stages: 1) the quality of the individual studies; 2) the generalizability of findings from individual studies to the Medicare population; and 3) overarching conclusions that can be drawn from the body of the evidence on the direction and magnitude of the interventions potential risks and benefits.The methodological principles described below represent a broad discussion of the issues we consider when reviewing clinical evidence. However, it should be noted that each coverage determination has its unique methodological aspects.Assessing Individual StudiesMethodologists have developed criteria to determine weaknesses and strengths of clinical research. Strength of evidence generally refers to: 1) the scientific validity underlying study findings regarding causal relationships between health care interventions and health outcomes; and 2) the reduction of bias. In general, some of the methodological attributes associated with stronger evidence include those listed below:Use of randomization (allocation of patients to either intervention or control group) in order to minimize bias.Use of contemporaneous control groups (rather than historical controls) in order to ensure comparability between the intervention and control groups.Prospective (rather than retrospective) studies to ensure a more thorough and systematical assessment of factors related to outcomes.Larger sample sizes in studies to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare  population. Sample size should be large enough to make chance an unlikely explanation for what was found.Masking (blinding) to ensure patients and investigators do not know to that group patients were assigned (intervention or control). This is important especially in subjective outcomes, such as pain or quality of life, where     enthusiasm and psychological factors may lead to an improved perceived     outcome by either the patient or assessor.