Implementation of Lung Cancer Screening Proceedings of a Workshop (2017) / Chapter Skim
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. And even for localized lung cancer, the 5-year relative survival rate is low compared to many other common cancers 1 The planning committee's role was limited to planning the workshop.
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require some private insurers to cover USPSTF-recommended preventive health services with a grade A or B without patient cost sharing.3 In addition, the Centers for Medicare & Medicaid Services (CMS) issued a Medicare national coverage determination for lung cancer screening, including counseling for shared decision making in addition to annual screening for beneficiaries who meet the eligibility criteria (which is similar to the NLST trial eligibility criteria)
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At the workshop, experts described the current evidence base for lung cancer screening, the current challenges of implementation, and opportunities to overcome them. Workshop discussions also highlighted capacity and access issues; best practices for screening programs; assessment of patient outcomes, quality, and value in lung cancer screening; and research needs that could improve implementation efforts.
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(Latimer, Mills, Park) • Evaluate screening demand versus existing capacity of lung cancer screening programs, imaging equipment, and medical professionals involved in screening and downstream care.
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• Enhance training and technical assistance for smoking cessation within lung cancer screening programs. (Ostroff, Park, Studts)
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(Ostroff) • tudy communication between patients and clinicians in S lung cancer screening programs to minimize breakdowns in the process.
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. The meta-analysis included the NLST, the Danish Lung Cancer Screening Trial (DLCST)
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lower than that for other cancer screenings (mammography for women who are ages 60-69 = 377 over 11 to 20 years; colonoscopy = 871 over 12 years) (The National Lung Screening Trial Research Team, 2011; Nelson et al., 2009; Schoen et al., 2012)
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into the community where we may be seeing more people with more comorbid conditions, we may see a different efficacy of screening," he said. On average the NLST participants were younger, had higher educational status, and had fewer comorbidities than the general screening-eligible population (The National Lung Screening Trial Research Team, 2010; Pinsky et al., 2014)
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But he noted that ACS has convened a National Lung Cancer Screening Roundtable, composed of more than 70 organizations, to address the challenges of implementing high-quality screening in the community setting. He added that we are "not going to be able to achieve high-quality lung cancer screening if we do not start doing it and start learning from our experiences." Annual screening with LDCT also results in exposure to radiation, which has the potential for harm, including the development of cancer.
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But there is also the harm that comes from denying preventive services from those who may benefit." He added "The NLST creates an important foundation for our guidelines and what we do, but it is only a foundation for them. We do have to consider other risk factors, as well as how we deliver lung cancer screening responsibly and minimize risk not just by limiting access [only to high-risk patients]
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," she said. ELIGIBILITY, CLINICAL PRACTICE GUIDELINES, AND MODELING Some workshop participants provided a comparison of the current recommendations for screening from various clinical practice guidelines, the USPSTF, and an overview of the current eligibility requirements for lung cancer screening under the CMS national coverage decision; the potential role of risk modeling to refine eligibility; and concerns about guideline adherence in clinical practice.
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The National Coverage Determination also includes required data collection and specific coverage eligibility criteria for radiologists and radiology imaging centers, consistent with the National Lung Screening Trial (NLST) protocol, USPSTF recommendation, and multisociety, multidisciplinary, stakeholder evidence-based guidelines.
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There has been some disagreement about identifying the appropriate high-risk population for lung cancer screening, several workshop participants noted. In Figure 1, Bach illustrated that a majority of clinical practice guidelines have eligibility criteria that are consistent with the NLST in terms of pack-year smoking history7 and age.
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. LeFevre noted that the USPSTF used modeling to estimate the effects of changing eligibility requirements for lung cancer screening, including expanding screening eligibility up to age 80, which led to the USPSTF recommendation (USPSTF, 2013)
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. He said risk prediction modeling is better at selecting individu als for lung cancer screening than the NLST-like trial eligibility criteria because it can better predict who is at highest risk for developing lung cancer.
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Risk based on an earlier version of the PLCO model was used to recruit individuals for screening in the Pan-Canadian Early Detection Lung Cancer study, and was found to identify a relatively high proportion of individuals with lung cancer, according to Tammemägi. The PLCOm2012 model risk criteria of greater than 2 percent is also being used to determine entry for Cancer Care Ontario's High-Risk Lung Cancer Screening Pilot Studies.
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However, Bach expressed concern with this approach, noting, "I do not think we can say that a radon-induced cancer is the same as a tobacco-induced cancer, so just plugging something into a model and showing that somebody has the same overall risk does not necessarily translate to the same overall benefit. We are probably safest within the confines of the types of people who have been studied." Bach also expressed concern about the use of surrogate endpoints in the assessment of lung cancer screening interventions and their inclusion in risk modeling.
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Andrea Borondy Kitts, a patient advocate, noted that these results are being updated, and although they are not published yet, they also indicate equal incidence of lung cancer in patients who are screened either by the NLST or NCCN eligibility criteria. Wood added that NCCN guidelines on lung cancer screening provide specific algorithms for managing solid or non-solid nodules detected, and lists the potential risks and benefits for each option that can help inform a shared decision-making conversation with patients.
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a Assuming the program includes 3 years of annual screening. Representativeness of the NLST Population Several workshop participants noted there is some concern about the representativeness of the NLST population, the results of which have largely set the recommendations for lung cancer screening implementation in clinical practice.
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Furthermore, Bach noted that none of the NLST participants were older than age 74 years at trial entry, so there are no data on the efficacy of lung cancer screening beyond this age, nor is there information on screening for longer durations than in the NLST trial, which included three annual screens and 6.5 years of follow-up.
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population, Wood said that expanding access to lung cancer screening "is especially relevant because disparities in health care disproportionately affect patients at risk for lung cancer." Adherence to Clinical Practice Guidelines Several workshop participants expressed concern that clinicians and institutions would not adhere to lung cancer screening guidelines. Jane Kim, acting chief consultant for preventive medicine at the Department of Veterans Affairs (VA)
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INSURANCE COVERAGE OF LUNG CANCER SCREENING Workshop participants also discussed insurance coverage of lung cancer screening, including issues with private insurance, Medicaid coverage, as well as the CMS Medicare national coverage determination for lung cancer screening. Although the ACA requires many private insurers to cover lung cancer screening without coinsurance if the USPSTF eligibility requirements are met, several workshop participants said that insurance coverage can still limit access.
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. The MEDCAC noted significant evidence gaps in the effects of lung cancer screening for people in the Medicare population who do not meet the eligibility criteria used in the clinical trial, and concern about the potential for overdiagnosis, higher false-positive rates, more diagnostic evaluations of nodules, and higher mortality rates in older adults.
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"As we get more real-world data perhaps we will have a better sense as to what the criteria for screening should be, especially in the older age ranges." CMS coverage of lung cancer screening also has several requirements of clinicians to ensure that the eligible population is being screened and that patients are aware of the potential benefits and risks of that screening. These requirements are • To determine if patient eligibility requirements for screening are met, including age, absence of signs or symptoms of lung cancer, and appropriate smoking history; • To engage in shared decision making, including the use of one or more decision aids that has information on the potential benefits and harms of screening, follow-up diagnostic testing, overdiagnosis, false-positive rates, and total radiation exposure; • To provide counseling on the importance of adhering to annual lung cancer LDCT screening, the impact of comorbidities, and ability or willingness to undergo diagnosis and treatment; and • To provide counseling on the importance of continuing to avoid smoking if a former smoker, or the importance of smoking cessa tion if a current smoker and, if appropriate, to provide information about tobacco cessation interventions.
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"I have referred several people to our lung cancer screening program and counseled all of them. I doubt that any one of them was picked up by our billing office.
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"Some patients have a lot of comorbidities and they make very reasonable choices that we as physicians struggle to make," he said. "It is a small but real and significant number of patients who opt out for this reason." Jamie Studts, associate professor at the University of Kentucky College of Medicine and director of behavioral and community-based research at the Markey Cancer Center, noted that shared decision making is important because long-term adherence and engagement with screening programs is needed to reduce lung cancer mortality: "There is no way to get a 20 percent reduction in lung cancer mortality with a 30 percent adherence rate." He added, "Lung cancer screening targets a unique population that likely requires substantial engagement efforts to achieve outcomes." Shared deci
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"There are still all these questions that our screening centers are struggling with on a day-today basis that we do not always have clear answers for," Copeland said. She has heard from screening centers about inconsistencies in codes that private payers are using for shared decision making and lung cancer screening, and there are also challenges with making sure all of the CMS requirements are met.
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CMS recommends that clinicians provide patient decision aids when counseling patients about lung cancer screening. These aids are tools that help patients think about their choices by providing relevant information about options and their tradeoffs in a standardized way, according to Volk.
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Patient decision aids are tools to help facilitate that process, but they do not ensure that shared decision making happens. It is not enough just to give a patient a decision aid and say ‘read this' and then claim shared decision-making victory." Studts agreed: "I am very concerned that we are going to see patients being given aids with really no conversation or a very subpar conversation going on." Studts also emphasized that decision aids "are not designed to increase uptake [of lung cancer screening]
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. "We do not know how patient decision aids are going to play out for lung cancer screening," Volk noted.
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. These decision aids use visuals and language to describe the potential harms and benefits of lung cancer screening.
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CHALLENGES TO IMPLEMENTATION OF LUNG CANCER SCREENING PROGRAMS Steven Blumenfrucht, medical director of the New York market for Aetna, reported that there has been relatively low uptake of lung cancer screening thus far, at least in Aetna's current experience. Aetna reimburses LDCT lung cancer screening for patients who meet the USPSTF eligibility criteria; however, claims for screening did not significantly increase after release of the USPSTF recommendation, or the CMS national coverage decision (see Figure 3)
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Hoffman highlighted several areas of clinician concern regarding the implementation of lung cancer screening in clinical practice, including: skepticism about the evidence base and clinical practice guidelines, uncertainty regarding insurance coverage, and medical liability.
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. Clinicians also expressed concern in several surveys that lung cancer screening is not cost-effective, Hoffman reported, with some clinicians in New Mexico suggesting that the resources for lung cancer screening might be better allocated for smoking cessation interventions.
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Some clinicians may be worried about the legal implications of not offering lung cancer screening if they think a specific patient may not benefit, or if they have provided adequate shared decision making for informed consent. He suggested that clinicians use good documentation to describe the decisions and conversations about lung cancer screening.
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If a patient is not ready to quit, she added that a clinician's role is to ask that they think about it. Incorporation of Lung Cancer Screening in Clinical Practice Some workshop participants also discussed issues that may hamper greater uptake of lung cancer screening in clinical practice, including
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The complexity of lung cancer screening may be another challenge, several participants noted. "Lung cancer screening is so much more complicated than your average screening test, not to mention the shared decisionmaking visit.
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. These clinicians also wanted more information about the eligibility criteria for lung cancer screening, and were concerned about having tools available to engage patients in shared decision making.
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.9 "This is a major issue," Lathan stressed, because the ACA expanded access to Medicaid insurance with the intent of improving patient outcomes. Brawley noted that the Medicaid expansion might improve access to lung cancer screening for some, but might also contribute to worsened stateby-state health disparities.
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OVERCOMING IMPLEMENTATION CHALLENGES Several workshop participants proposed suggestions for overcoming challenges to lung cancer screening implementation. Clinician and Practice Strategies Hoffman suggested clarifying the roles of primary care clinicians in lung cancer screening, including their responsibility for identifying appropriate patients, ensuring shared decision making, and overseeing appropriate follow-up.
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But the primary care physicians do not feel comfortable with the data, so the easy thing is to refer and assume that [shared decision making] is going to happen someplace else." However, LeFevre was concerned about a lung cancer screening program conducting the shared decision-making process: "I am fairly skeptical that somebody [who]
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It includes the pack-year calculation formula, describes the follow-up process to a shared decision-making visit, and lists other tools and resources, including tips on how to provide shared decision making, talking points for the clinical encounter, and teach-back examples to ensure patient comprehension. Joanna Stoms, cancer plan manager at the Pennsylvania Department of Health, described their lung cancer screening toolkit.
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When it becomes a quality measure, I will not get graded on how many people I counsel about cancer screening, but on how many [people receive lung cancer screening] ." Hoffman said that in order for primary care clinicians to embrace lung cancer screening, "we need to have confidence that it can be safely, efficiently, and effectively implemented." That will require more populationbased data from the "real world," he said, as well as building capacity so all patients have access to high-quality screening programs.
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Studts said that messages to patients need to convey "a balanced presentation of potential benefits and harms and avoid fear-based appeals that might engender distrust and stigmatize the group and perhaps push them in the wrong direction." He stressed that people who are eligible for lung cancer screening "are different than our typical screening populations [for other types of cancer] , so we need to think about them differently from the very beginning, to understand who they are when designing our programs to meet their needs and to support them." For example, Studts said focus groups with individuals who were long-term smokers found that they expressed concern about stigma and distrust of the screening process, which could impact the successful implementation of screening programs (Carter-Harris et al., 2015)
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She emphasized that there is a need for access to high-quality services for vulnerable populations and that improving access is dependent on the quality of available services. Fabrice Smieliauskas, assistant professor at the University of Chicago, expressed concern that some community providers would not be able to provide high-quality lung cancer screening, and if such screening is restricted to only high-quality centers, access would be further decreased for those high-risk populations that need the screening the most.
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"We are in a really exciting time and looking at a lot of opportunities to improve access to care, and we will learn a lot from these projects," she said. Smieliauskas added that eventually new innovations in lung cancer screening could potentially be used in place of LDCT screening to screen hard-to-reach-populations, noting that a blood test for circulating tumor DNA is being evaluated for detection of lung cancer.
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. Smieliaukas estimated the capacity constraints of radiologists and CT scanners due to the projected increases in LDCT scans for lung cancer screening by assuming that 75 percent of individuals who meet NLST eligibility criteria will undergo screening (see Figures 4 and 5)
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NOTE: LDCT = low-dose computed tomography. SOURCES: Smieliauskas presentation, June 20, 2016; Fabrice Smieliauskas, Heber MacMahon, Ravi Salgia, Ya-Chen Tina Shih, Journal of Medical Screening (21 and 4)
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Tammemägi noted that his own impression from the experience in Canada is a slow uptake of lung cancer screening. "There has been more gradual growth, which has been acceptable and easier to handle," he said.
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"This is critical -- you must get complete buy-in from the radiology chairperson, primary care, lung cancer specialists, smoking cessation specialists, thoracic surgeons, pulmonologists, oncologists, and hospital and clinic administration," he said. Institutions should allot a fraction of a radiologist's time to organize the program and provide additional personnel, "because there is no radiologist who is going to be doing all the things that need to be done to make a lung cancer screening program viable," Black said.
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Black said that assistance from a computer programmer would be needed to set up an image archiving and communication system, EMRs, and lung cancer screening databases. EMRs need to properly assess and document patient eligibility, shared decision making, and smoking cessation efforts and enable clinicians to order lung cancer screening tests.
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Kim also noted the significant resources needed to implement a systematic approach to lung cancer screening, including radiology equipment and staff; a multidisciplinary team from radiology, oncology, surgery, and pulmonology; and information technology support for the development of a tracking system. In addition, a lung cancer screening program requires primary care clinical staff time for initial training, the conduct of shared decision making, and follow-up of findings.
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Personally, I think it is terribly inefficient to try to train every single provider how to do shared decision making." He added that eligibility assessments and shared decision making are expensive in terms of time and "our primary care doctors are overloaded with other things to do." Smith also noted that the identification and recruitment of eligible individuals is enormously stressful on primary care clinicians and places a lot of demands on them. "We are challenged to perhaps ask if there is an alternative way to engage primary care, but relieve them from many of the responsibilities of recruiting adults for lung cancer screening and following them.
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These tools helped primary care clinicians to determine smoking history, age, and other requirements, and had built-in prompts to select patients for lung cancer screening. As part of the pilot, the VA also developed patient education materials to aid shared decision-making conver sations, both at the time of initial counseling, as well as after the screening result was determined.
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"Even if we did this on a smaller scale, you would still need to have some centralized support to make sure that things are being done according to a national standard," Kim said. Mazzone noted that Cleveland Clinic's lung cancer screening program became more centralized in order to improve efficiency and effectiveness (see Box 5)
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Although initially clinicians could order lung cancer screening, now they can only order a consult with the screening program. If a patient is eligible, the program schedules a shared decision-making visit for the patient, followed by a computed tomography scan, if they choose screening.
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The lung cancer screening program was started at Cleveland Clinic's main campus, and all scans are provided at the main campus.
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for annual screening Lung cancers 9 (2 stage I) 2 (2 stage I)
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We have learned that screening works best when it is organized." He added, "Organized screening would have a system in place with rules, roles, and relationships defined so that every person can depend on what the other is supposed to do, evaluation is in place, and corrective action can be instituted when needed." Aberle said that in comparison to the diffusion of breast and colorectal cancer screening, the diffusion of lung cancer screening programs has been
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We should work toward high-quality screening so that people are having dinner conversations about lung cancer screening the way they have about breast cancer screening today." ENSURING THE QUALITY OF LUNG CANCER SCREENING Several workshop participants said that it is critical to ensure implementation of high-quality lung cancer screening programs in order to achieve the benefits seen in NLST. Smith said that CMS reinforces the focus on quality by reimbursing screening only if strict requirements are met.
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. Several workshop participants highlighted opportunities to improve the quality of lung cancer screening by focusing on eligibility, adherence to annual screening, smoking cessation services, image interpretation and management of findings, and monitoring screening program results over time.
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Ensuring Access to Smoking Cessation Services Jamie Ostroff, chief of the behavioral sciences service and director of the Tobacco Treatment Program at the Memorial Sloan Kettering Cancer Center, suggested developing a standard set of process and outcome measures related to smoking cessation services within lung cancer screening programs (see also section on smoking cessation and lung cancer screening)
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Kazerooni noted that by increasing the size threshold, there is a tradeoff of potentially delaying diagnosis of a cancerous nodule: analysis of NLST results indicated that increasing the threshold diameter from 5 to 8 millimeters would increase missed or delayed cancer diagnoses from 1.0 to 15.8 percent, but it would also reduce the false-positive rate from 65.8 to 10.5 percent and substantially reduce the use of medical resources (Gierada et al., 2014)
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Kazerooni added, "Lung-RADS is not static, but dynamic and will iterate." But she stressed that "We have a lot to learn about the implications and use of computer-aided diagnostic tools and practice. Learning from the breast imaging world and then applying that to lung cancer screening will help us a lot." Monitoring Results To promote quality improvement in lung cancer screening programs, Lung-RADS facilitates data collection for the ACR registry, Kazerooni said.
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66 TABLE 5 American College of Radiology Lung-RADS Structured Reporting and Management Estimated Probability of Category Description Prevalence Malignancy Management Incomplete -- 1% n/a Additional lung cancer screening CT 0 images and/or comparison with prior chest CT examinations needed Negative No nodules and definitely 1 benign nodules 90% <1% Continue annual screening with Benign Appearance or Nodules with a very low LDCT in 12 months Behavior likelihood of becoming a 2 clinically active cancer due to size or lack of growth Probably Probably benign finding(s) ; 5% 1-2% 6-month LDCT Benign short-term follow-up; includes 3 nodules with low likelihood of becoming clinically active cancer
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NOTE: CT = computed tomography; LDCT = low-dose computed tomography; Lung-RADS = American College of Radiology Lung Imaging Reporting and Data System; PET = positron emission tomography. SOURCES: Kazerooni presentation, June 20, 2016, from ACR, 2014.
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. SMOKING CESSATION AND LUNG CANCER SCREENING Several workshop speakers discussed concerns and challenges in integrating smoking cessation services within lung cancer screening programs.
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Even when smoking cessation and lung cancer screening are not synergistic, Lathan noted, "smoking cessation counseling is integral to the screening because as clinicians, we can use these teachable moments to talk to our patients and help them stop smoking. Tobacco cessation has to be an equal partner to screening and not an afterthought."
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We need to do more work to help active smokers in this age group," Slatore said. Challenges in Implementation Ostroff conducted a survey of site coordinators in lung cancer screening programs to identify the perceived challenges in delivering smoking cessation therapy.
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So we should think about consistency across our messages to our patients." Results of Cessation Efforts Linked to Screening Programs Several workshop participants reported on the results of studies on smoking cessation programs linked to lung cancer screening programs, many of which seem to refute common beliefs and concerns about linking cessation to screening, including that informing people about their risk of developing lung cancer at the time of screening would foster efforts to quit smoking, that negative lung scans would reassure people who smoke and make them less inclined to quit, or that offering smoking cessation services along with screening would drive patients away from the screening. Instead,
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This preliminary evidence suggests telephone-based cessation intervention is feasible and efficacious in the lung cancer screening setting, Taylor said. "The best thing about this intervention is that it is scalable via existing quit lines, and potentially able to reach a large number of current smokers who are undergoing lung cancer screening," she stressed.
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. Impact of Screen Results on Willingness to Quit Although lung cancer screening is seen as an opportunity to encourage smoking cessation in patients who smoke, some people at the workshop expressed concern that negative results from such screening might actu
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But he conducted a systematic review of patients in randomized clinical trials who underwent lung cancer screening and found that screening by itself does not affect smoking behavior, nor does it impact smoking cessation rates (Slatore et al., 2014)
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Intensity of Smoking Cessation Programs and Quitting Success Several presenters noted that the success of smoking cessation interventions embedded in lung cancer screening trials depends on how intensive they are. In one study, Slatore reported, some screened patients were given a brochure about smoking cessation, while others were offered a computerized questionnaire that gave advice about smoking cessation based on participants' answers to questions.
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Once lung cancer screening programs are more under way and able to take this on, then more of it could happen within the lung screening site," she said. Park agreed with both Taylor and Ostroff and added that the reality of providing optimal, intensive smoking cessation interventions may be altered by how much insurers reimburse for such interventions.
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Participants in the smoking cessation program who qualify for lung cancer screening meet with a program facilitator who arranges for a shared decision-making visit with a radiologist at the hospital, who can refer them for the screening. VALUE AND EFFICIENCY IN LUNG CANCER SCREENING Another area of discussion was the value and cost of lung cancer screening.
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However, Roth noted, the cost-effectiveness for lung cancer screening approached or exceeded $100,000 when • Future health care costs beyond the scope of the trial duration were included; • Costs for the screening examination, follow-up, or surgery were increased; • Pessimistic expectations of survival with localized lung cancer were assumed; or • Small reductions in quality of life related to positive screening results and a diagnosis of localized lung cancer were included. Subgroup analyses also found that cost-effectiveness varied substantially according to gender, age, and smoking status (see Table 6)
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Gareen, Samir S Soneji, et al, Cost-Effectiveness of CT Screening in the National Lung Screening Trial, 371, 1793-1802.
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Relying largely on NLST results, this analysis found that implementation of lung cancer screening would result in about a $6.8 billion increase in the Medicare budget over the 5 years of analysis, amounting to about $2.22 per enrollee, per month. The majority of the increase in expenditures is attributable to the screening cost itself, and not to the costs of diagnostic work-ups or cancer care (Roth et al., 2015)
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Patricia Ganz, director of cancer prevention and control research at the University of California, Los Angeles Jonsson Comprehensive Cancer Center, suggested conducting more research that assesses what kinds of cognitive services and strategies can improve access and adherence to lung cancer screening. Mazzone agreed: "We need a better understanding of who makes choices and why, and how we can help them to make the choices that ultimately are best for them as individuals.
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"It might show that a very costly trial could have an even bigger return," Roth said, adding "There are so many uncertainties about real-world community practice that there might be a number of relatively small and inexpensive observational studies that could be really high value. These types of analyses could be used to point out those key studies and move them forward." Ostroff and other workshop participants suggested that there be more research on how to best integrate tobacco cessation programs into lung cancer screening programs.
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that it happened." Shared decision making is reframing the goal for lung cancer screening, she added. "Instead of the ideal outcome being that everybody who is eligible is screened, we want the outcome to be having people be comfortable with the decisions they made, based on their values and their own levels of risk," she said.
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2009. Smoking cessation and relapse during a lung cancer screening program.
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2004. Effectiveness of smoking cessation self-help materials in a lung cancer screening population.
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2012. A pilot test of a combined tobacco dependence treatment and lung cancer screening program.
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2015. Attitudes and beliefs of primary care providers in New Mexico about lung cancer screening using low-dose computed tomography.
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2016. Smoking cessation results in a clinical lung cancer screening program.
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2015. Readiness of lung cancer screening sites to deliver smoking cessation treatment: Current practices, organizational priority, and perceived barriers.
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2015. A combined smoking cessation intervention within a lung cancer screening trial: A pilot observational study.
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2014a. Impact of lung cancer screening results on smoking cessation.
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2015. Readiness of primary care clinicians to implement lung cancer screening programs.
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2015. Attitudes and perceptions about smoking cessation in the context of lung cancer screening.
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