The Counseling and Shared Decision-Making Visit for Lung Cancer Screening: A Thematic Analysis of Public Comments to the Centers for Medicare & Medicaid Services During the 2021-2022 National Coverage Analysis Process.

The Counseling and Shared Decision-Making Visit for Lung Cancer Screening: A Thematic Analysis of Public Comments to the Centers for Medicare & Medicaid Services During the 2021–2022 National Coverage Analysis Process - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Search Log in Primary site navigation Search Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice Chest . Author manuscript; available in PMC: 2026 Jun 4. Published in final edited form as: Chest. 2025 Dec 22;169(5):1402–1414. doi: 10.1016/j.chest.2025.12.016 The Counseling and Shared Decision-Making Visit for Lung Cancer Screening A Thematic Analysis of Public Comments to the Centers for Medicare & Medicaid Services During the 2021–2022 National Coverage Analysis Process Robert J Volk 1 , Kristin G Maki 2, 3 , Anastasia Rogova 4 , Ashlyn Tu 5 , Claire V T Nguyen 6 , Hilary Ma 7 , Richard M Hoffman 8 Author information Article notes Copyright and License information 1 Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX 2 Department of Oncology, Karmanos Cancer Institute, Detroit, MI 3 Wayne State University School of Medicine; the Population Studies and Disparities Research Program, Karmanos Cancer Institute, Detroit, MI 4 Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX 5 Biological Sciences, Northwestern University, Chicago, IL 6 Department of Public Health Policy and Management, New York University School of Global Public Health, New York, NY 7 Department of General Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 8 University of Iowa Carver College of Medicine, Iowa City, IA Author contributions: R. J. V. takes full responsibility for the content of the manuscript. R. J. V., K. G. M., A. T., and C. V. T. N. conceived of the study. R. J. V., K. G. M., A. R., A. T., and C. V. T. N. performed data acquisition and analysis. R. J. V., K. G. M., A. R., and R. M. H. contributed to drafting the manuscript. All authors reviewed the manuscript and approved the final version. ✉ CORRESPONDENCE TO: Robert J. Volk, PhD; bvolk@mdanderson.org Issue date 2026 May. This is an open access article under the CC BY-NC-ND license ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ). PMC Copyright notice PMCID: PMC13231591  NIHMSID: NIHMS2164096  PMID: 41443390 The publisher's version of this article is available at Chest Abstract BACKGROUND: Uptake of lung cancer screening (LCS) in the United States has been limited, and some groups have argued that the unprecedented Centers for Medicare & Medicaid Services (CMS) coverage mandate for shared decision-making (SDM) contributed to the low screening rates. Late in 2021, the CMS initiated an update of its LCS coverage determination, which included 2 public comment periods. RESEARCH QUESTION: What comments were offered by the public about SDM in response to the proposed CMS update and how did CMS address commenters’ concerns? STUDY DESIGN AND METHODS: Public comments on SDM from the 2 periods were downloaded into a searchable database and commenter affiliations were categorized. Thematic analysis was used to analyze the verbatim comments. RESULTS: A total of 170 comments were submitted during the initial comment period and 49 during the second, with the largest number coming from individuals affiliated with radiology and/or LCS programs. Ninety-one comments addressed SDM. Recommendations about the SDM visit included complete removal, endorsing its importance without making it mandatory, and retaining the requirement with changes to reduce its administrative burden. Objections to the required SDM visit included the following: it is a barrier to screening initiation, it is a burden for clinicians, it is not required of other cancer screening tests, and the process is too complex. Relevant evidence supporting the objections was lacking. Comments in support of SDM recognized its importance in the context of LCS while proposing changes that allow nonclinical professionals to conduct the SDM visit and allowing for telehealth visits. INTERPRETATION: Commenters raised concerns that the CMS requirement for SDM led to many LCS implementation challenges. In response, the coverage decision was modified to decrease the administrative burden on screening programs while retaining the patient counseling and SDM requirement. Keywords: cancer screening, clinical guidelines, health care policy, lung cancer screening, lung neoplasms, national health policy, shared decision-making In 2011, the National Lung Screening Trial (NLST) reported that 3 rounds of annual screening with low-dose CT (LDCT) scans, compared with chest radiography, reduced lung cancer mortality by 20% among adults 55 to 74 years of age with a history of heavy tobacco use. 1 Investigators, however, also noted numerous potential harms from screening, including false-positive test results, harms from invasive diagnostic procedures, incidental findings, overdiagnosis, and radiation exposure. In 2014, the US Preventive Services Task Force (USPSTF) issued a grade B recommendation for annual lung cancer screening (LCS) with LDCT scans. 2 The USPSTF also highlighted the harms from LCS and advised that patients engage in shared decision-making (SDM) before undergoing screening. In 2015, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) for LCS with LDCT scan that essentially aligned with USPSTF eligibility criteria. 3 Decisions from the CMS such as for LCS undergo public comment periods which can shape the final coverage determination. Although the CMS addresses comments from leading professional organizations in releasing its final coverage decisions, most comments are submitted by individuals or clinical groups. Little is known about the content of these comments and the extent to which guideline organizations address them. The CMS mandated that beneficiaries undergo a counseling and SDM visit, led by a licensed independent practitioner, using a LCS decision aid that addressed benefits and specific harms of screening. The expectation for an SDM and counseling visit was unprecedented and implementation concerns emerged related to time constraints created by the brief duration of primary care visits, and clinicians needing to address competing health demands, lacking accessible decision support tools, and being unaware of screening trial results and guidelines. 4 , 5 The LCS coverage requirement for an SDM visit has led to considerable debate about the visit, with some seeing it as a barrier to LCS. 6 On March 9, 2021, the USPSTF released an updated LCS recommendation. 7 Based on a new systematic evidence review 8 and a revised modeling study, 9 the USPSTF retained a grade B recommendation but lowered the starting age to 50 years and reduced the pack-year requirement to 20. Anticipating that the CMS would be reconsidering its 2015 NCD, the GO 2 Foundation for Lung Cancer, the Society for Thoracic Surgeons, and the American College of Radiology jointly signed a letter requesting numerous changes in the NCD. 10 They recommended that the CMS revise the SDM requirement or eliminate it entirely, arguing that it was a barrier to screening uptake. The National Coverage Analysis process to update the NCD involved an evidence review supplemented by comments from the public ( Fig 1 ). The CMS opened a 30-day public comment period on May 18, 2021. Subsequently, the CMS released a proposed NCD on November 21, 2021, with a second 30-day public comment period. Key components of the revised NCD included lowering the starting age to 50 years and reducing the pack-year smoking history threshold to 20. The final decision memo, released on February 10, 2022, confirmed the counseling and SDM visit requirement. 11 However, the CMS removed the restriction on the types of providers who could conduct the visit and allowed the visit to be delivered through telemedicine. We conducted a thematic analysis of all submitted comments about the counseling and SDM visit to gain insights into perceptions of the public and professional groups about the value and challenges in implementing this requirement. We also discuss how the modified CMS coverage determination addressed commenters’ concerns. Figure 1 – Timeline of the Centers for Medicare & Medicaid national coverage analysis process. Open in a new tab Study Design and Methods This study was a qualitative analysis of comments submitted to the CMS during the first and second public comment periods of the NCD process to update the coverage determination about LCS. The data for this analysis are publicly available at CMS.gov. 12 Data Abstraction and Commenter Affiliation Public comments from the 2 periods were downloaded into a searchable database and included the name of submitter, title, organization (if given), and verbatim text of each comment. We then categorized the commenters’ affiliations by organization and assigned each commenter to a specific group. Comments submitted by leaders of organizations indicating they were representing the organization and comments submitted on behalf of an organization were categorized under the organization. We categorized commenters as individuals if they were not representing an organization or did not provide an affiliation. We obtained descriptions of organizational affiliations from public websites to include with the commenter descriptions. Members of the research team (R. J. V., K. G. M., A. T., C. V. T. N.) reviewed organizational affiliations and came to consensus about how to assign each commenter. Organizations were grouped as national associations/professional societies, with notation of whether the organization provides LCS recommendations or guidelines. Organizations included cancer centers, academic institutions, advocacy groups, cancer coalitions, hospital/health care group, and other (eg, industry, insurer). We ensured our grouping of national associations/professional societies aligned with the categorization used in CMS’ responses to both comment periods. We classified individual commenter affiliations as academic affiliation, cancer center; LCS or radiology affiliation (with grouping split by academic and hospital/health care group); academic affiliation (specialty unspecified); hospital/health care group; hospital/health care group (specialty unspecified); other affiliations; and not specified. The data for this analysis are public comments that are exempt for institutional review board oversight. Coding the Recommendations We used the thematic analysis approach to analyze all comments submitted to the CMS. Initially, 3 team members (R. J. V., K. G. M., A. T.) reviewed a preliminary set of comments to identify common codes using a combination of deductive and inductive approaches. The remaining comments were then independently coded by 2 team members, who met regularly to further refine and update codes. They addressed any areas needing further analysis and discussed discrepancies to reach consensus before arriving at the final categories and themes reflecting respondents’ views and recommendations. Additionally, a modified framework method 13 was applied to compare and analyze comments provided by professional organizations, societies, and insurer to identify commonalities and variations in their recommendations regarding the SDM requirement. Finally, we provide citations in the results section to the exact sources cited by the commenters in making their arguments about the SDM requirement. We looked at each of these sources to determine the degree to which the arguments were based on relevant and high-quality evidence. Results Characteristics of the Commenters Overall, 170 comments were submitted during the initial public comment period, and 49 were submitted during the second period after the proposed NCD ( Table 1 ). Most were submitted by individuals, with a smaller proportion submitted on behalf of organizations, national associations, or professional societies. Ninety-one comments (53.5%) mentioned the counseling and SDM visit. TABLE 1 ]. Characteristics of Commenters During the CMS National Coverage Analysis Process About the Updated Coverage for LCS Category/Subcategory First Comment Period Second Comment Period No. % No. % National associations/professional societies 8 4.7 9 18.4 Issues LCS guidelines 3 1.8 4 8.2 Does not issue LCS guidelines a 5 2.9 5 10.2 Comments on behalf of organizations 35 20.5 21 42.9 Cancer center 2 1.2 2 4.1 Academic institution, LCS, or radiology program 5 2.9 4 8.2 Advocacy group 13 7.6 6 12.2 Cancer coalition 3 1.8 — — Consortia — — 2 4.1 Hospital/health care group 9 5.3 3 6.1 Other (eg, industry, insurer) 3 1.8 4 8.2 Individual commenters 127 74.7 19 38.8 LCS or radiology, academic b 9 5.3 1 2.0 LCS or radiology, hospital/health care b 73 42.9 6 12.2 Cancer center 3 1.8 1 2.0 Academic affiliation, other 6 3.5 2 4.1 Hospital/health care group, other 12 7.1 6 12.2 Other affiliations (eg, patient advocate) 5 2.9 2 4.1 Not specified 19 11.2 1 2.0 Total 170 49 Open in a new tab Groupings of national associations/professional societies were aligned with how CMS described these organizations in their responses to comments for each period. CMS = Centers for Medicare & Medicaid Services; LCS = lung cancer screening. a Includes 3 medical imaging professional groups. b Includes 34 comments from the same radiology group. Initially, 9 national associations or professional societies were represented. Humana was the sole insurer to submit comments. Advocacy and hospital groups were also represented. Individuals constituted the largest number of commenters (n = 127); 82 were from individuals affiliated with LCS or radiology programs, with 34 coming from the same imaging group. An additional 49 comments were offered during the second period, including 3 additional professional societies. SDM Visit Although the initial analysis of the comments identified a broad range of themes related to LCS, including nonsmoking risk factors, racial and ethnic disparities, and comparison with other cancer screening, we focused our analysis on the 91 comments that addressed the counseling and SDM visit requirement. Comments About the Proposed NCD (First Comment Period) Four general categories of recommendations about removing or retaining the counseling and SDM visit were identified in the thematic analysis, reflecting 2 major themes: recommendation to remove or retain the requirement ( Table 2 ). Removal of the SDM requirement was endorsed 2 ways: remove entirely (n = 20), and remove the requirement but encourage SDM (n = 18). Recommendations to retain the requirement were also endorsed in the following ways: retain with changes (n = 48), retain to align with USPSTF guidance, and retain as currently mandated by the CMS. However, the latter 2 categories represented the same core recommendation and were therefore combined in 1 category for the analysis (n = 5). TABLE 2 ]. Themes, Categories, and Selected Codes about the Shared Decision-Making Requirement About Lung Cancer Screening From the CMS Theme (Overall Recommendation) Categories of Recommendations Selected Codes (Common Arguments) Quotes 1. Remove 1.1 Remove entirely LDCT programs see it as an administrative barrier “[S]creening lung CT has not had the full impact that it could to save lives, in part because of the hurdles and requirements put in place to get the exam covered by CMS. Physicians are overworked as it is, and further burdensome requirements mean the exam simply does not get ordered.” (ID 1083) Screening rates are low (SDM is the main culprit) “We wholeheartedly support all changes requested especially removing the shared decision making visit as necessary for reimbursement as this acts a barrier for those in rural areas with healthcare professional shortages and impoverished populations.” (ID 1012) SDM not required for other cancer screenings “I am also in favor of eliminating the [SDM] criteria for screening. This is not required for mammography screening and is one more barrier for patients needing annual screening LDCT.” (ID 1036) Process too complex “[S]ome of the elements of [SDM] are more complex than many people can understand and physicians don’t have the time to explain all the elements of lung cancer screening in detail; however important it may seem to be…so I do think that this same requirement be minimized.” (ID 1102) The quality of current SDM for LCS is poor “[R]epairing the current flawed system of shared decision making using badly inaccurate decision aids will take time, ensuring that tragic, unnecessary lung cancer deaths will persist into an uncertain future.” (ID 1059) Need to mirror the USPSTF’s emphasis on “informed discussions” “CMS should revisit the rigid requirements and criteria for SDM within the existing NCD that has the unintended effect of hindering screening access and uptake, and instead mirror the USPSTF approach that emphasizes the importance of informed discussions and decisionmaking among patients and providers.” (ID 1154) 1.2 Remove but encourage Emphasized the importance of SDM for decisions related to LCS but did not support a mandate for SDM “SDM should be integrated into discussion of screening with patients, but not be a rigid reimbursement requirement which creates a referral barrier and is not required with other recommended cancer screenings.” (ID 1049) “We agree that the [SDM] between the ordering physician or qualified nonphysician practitioner and the beneficiary is an essential component to an effective lung care screening program. We also agree that beneficiaries must be provided with sufficient information to weigh the risks, benefits, and commitment necessary to receive the most benefit from the screening program. However, the SDM requirement is experienced as time-intensive, complicated, and a steep obstacle for both beneficiaries and providers to overcome.” (ID 1114) 2. Retain 2.1 Retain as currently mandated SDM is an opportunity to improve knowledge “We believe the SDM is essential to educating patients regarding the potential health risks of tobacco use, the risks and benefits of lung cancer screening, and ensuing medical decisions that may arise from lung cancer screening findings.” (ID 1046) SDM is an opportunity to promote adherence to screening “[SDM] creates an opportunity to build a relationship with the patient which can support lung cancer screening adherence. If we are going to reduce lung cancer mortality, the patients must return for subsequent screens (adherence).” (ID 1086) SDM is needed to ensure patients can make informed decisions “…also urges CMS to require that any physician, qualified non-physician practitioner, or other health professional trained in counseling and [SDM] should inform eligible beneficiaries of the benefits and the risks during any initial (or subsequent) [LCS] counseling and [SDM] visit. Doing so will allow the patient to weigh both the benefits and potential downstream consequences of such screening.” (ID 1069) “There is substantial scientific evidence showing that shared decision making about lung cancer screening is associated with important benefits for patients, including improved patient knowledge, reduced decisional conflict, values-based decision making, and well-informed screening behavior (Fagan et al., 2019; Lowenstein et al., 2020; Volk et al., 2014, 2020; Olazagasti et al., 2019; Percac- Lima et al., 2018).” (ID 1106) 2.2 Retain with changes Broaden eligibility for SDM providers “[ID 1069] recommends adding “other health professional trained in counseling and shared decision making” to the definition of “qualified non-physician practitioners” who are able to provide the service.” (ID 1069) “We encourage CMS to expand the persons qualified to provide SDM to include LCS program nurses, respiratory therapists and navigators. These individuals are well informed about the benefits, potential risks, and eligibility requirements of LDCT and can provide accurate information to patients. They can also provide education about smoking cessation and reinforce the need to adhere to annual screening.” (ID 1087) Allow telehealth visit “[T]here is compelling evidence that the effects of shared decision in patient lung cancer screening rates are comparable when the [SDM] is guided by a clinician as part of an in-person office visit and when a trained care coordinator guides the process during an outreach telehealth contact (Tanner et al., 2019).” (ID 1106) Revise “I respectfully urge CMS to…Revise Counseling and Shared Decision Making criteria.” Note: the same comment was copied and posted verbatim by several respondents (n = 41) Open in a new tab CMS = Centers for Medicare & Medicaid Services; ID = identification; LCS = lung cancer screening; LDCT = low-dose CT; NCD = National Coverage Determination; SDM = shared decision-making; USPSTF = US Preventive Services Task Force. Theme 1: Recommendation to Remove the SDM Requirement The arguments to remove the SDM requirement entirely focused on several reasons. One of the most important arguments against it claimed that LDCT programs see it as an administrative barrier leading to the screening not being ordered by physicians. Some commenters discussed low screening rates implying SDM is the main culprit. Other arguments included that SDM is not required by the CMS for other cancer screenings, the process of facilitating an SDM visit is too complex, the quality of current SDM for LCS is poor and cannot be improved, and that the CMS should mirror the USPSTF approach which emphasizes informed discussions rather than SDM. Another category of comments within this theme recommended to remove the SDM requirement but continue encouraging its application in practice, arguing that SDM is an essential component of LCS programs. Many commenters emphasized the importance of SDM for decisions related to LCS but did not support a mandate for SDM. Suggestions about how to ensure SDM happens in the absence of the mandate were not offered. Theme 2: Recommendation to Retain the SDM Requirement Arguments to retain the SDM requirement included those that favored (1) to retain the requirement in its current form, or (2) to retain it with changes. Proponents of the SDM requirement argued that SDM improves patients’ knowledge, provides an opportunity to promote adherence to screening, and ensures that patients are fully informed about benefits and potential risks of screening. Other arguments focused on facts that SDM is ethically justified by the principle of autonomy, informed patients have variable preferences about LCS, and that patient decision aids are evidence-based tools that can be used to improve the quality of SDM. The category of recommendations to retain the requirement with changes includes arguments that certain modifications to this requirement are needed to facilitate its application in practice. These suggested modifications included not limiting delivery of the SDM visit to clinicians and allowing for telehealth coverage of the SDM visit. Many of the recommendations to revise the requirement to reduce administrative barriers included comments taken directly from the request letter, often verbatim, and lacked specific suggestions about how to minimize these burdens. Many of these comments were primarily made by LCS or radiology programs. Evidence Used in Support of Recommendations About the SDM Requirement Additionally, we examined the type of evidence provided by commentors to support their recommendation to either remove or retain the SDM requirement. Comments about the SDM requirement contained more anecdotal evidence (n = 47) than empirical evidence (n = 28). Commenters cited empirical evidence that SDM may help prepare patients for decision-making by improving knowledge and reducing decisional conflict, 14 – 17 decision counseling or navigation programs were feasible for LDCT programs, 18 – 20 clinicians can be successfully taught SDM skills, 21 patient decision aids improved decision-making on LCS, 22 a digital outreach strategy was feasible for contacting patients who may be eligible for LCS, 23 and a systematic review that showed decision coaching can be effectively used alongside decision aids. 24 Evidence highlighting challenges to delivering SDM included clinician perspectives that it was challenging to perform in routine care—although they were receptive to additional training, 25 studies showing poor quality of SDM in clinical encounters, 26 – 28 an analysis showing that system-level interventions may help facilitate time and resources for SDM and smoking cessation counseling, 29 and a review of Medicare data showing a low percentage of enrollees who received SDM and an LDCT scan. 30 Recommendations From Professional Organizations The American Cancer Society and National Comprehensive Cancer Network aligned with the 2 imaging organizations in recommending removal of the SDM requirement ( Table 3 ). Specifically, the American Cancer Society recommended eliminating the SDM visit as a requirement for the screening order, whereas the National Comprehensive Cancer Network also highlighted that SDM is not required for reimbursement of other cancer screenings covered by the CMS. The Medical Imaging and Technology Alliance and Association for Quality Imaging endorsed leaving the decision about screening up to clinicians and patients. The Association for Quality Imaging further argued for allowing the ordering clinician to determine how the decision should be shared, and that the SDM should take place at the time of the LDCT examination. The American Lung Association and American Thoracic Society/American College of Chest Physicians (CHEST) endorsed the importance of SDM while arguing for strategies to reduce administrative burdens to improve efficiency. The American Thoracic Society/American College of Chest Physicians (CHEST) also endorsed telehealth coverage of SDM visits. Humana endorsed SDM and the importance of approved clinicians discussing the harms and benefits of screening with eligible patients. TABLE 3 ]. Recommendations From Professional Societies/Organizations and Insurers About the Shared Decision-Making Requirement for Lung Cancer Screening From the Centers for Medicare & Medicaid Services Organization/Society Recommendation Category Summary of Recommendation About SDM Requirement American Cancer Society Remove but encourage “We recommend that CMS consider suspending all criteria related to the requirement for a dedicated, reimbursable shared decision making (SDM) visit as a condition of the written order for LDCT lung cancer screening.” National Comprehensive Cancer Network Remove but encourage “While SDM should be encouraged and utilized, CMS should eliminate the NCD documentation requirement for SDM entirely, especially since it is not required for coverage of screening mammography or colon cancer screening.” American Lung Association Retain with changes “The Lung Association urges CMS to consider whether there are improvements that can be made to this process to reduce administrative and other requirements that create barriers to broad access to the lung cancer screening benefit.” American Thoracic Society and American College of Chest Physicians (CHEST) Retain with changes “We believe the SDM is essential to educating patients regarding the potential health risks of tobacco use, the risks and benefits of lung cancer screening…we believe the low literacy regarding lung cancer screening…justify the requirement for SDM…additional strategies to ensure SDM is conducted efficiently and understandably for all should be pursued. We encourage CMS to consider updating coverage policy to allow for telehealth provision of required SDM visits.” Humana Retain with changes “Humana also urges CMS to require that any physician, qualified non-physician, or other health professional trained in counseling and shared decision making should inform eligible beneficiaries about the benefits and risks…[and] be appropriately documented in the beneficiary’s health record.” American Association for Thoracic Surgery Did not comment This organization did not comment on SDM. Medical Imaging and Technology Alliance Remove but encourage “We are also concerned that maintaining shared decisionmaking requirements would create undue barriers to access for Medicare beneficiaries. CMS does not require shared decision-making for other screening services, such as screening mammography and colonoscopy. Application to lung cancer screening seems arbitrary and is unnecessarily burdensome on patients and providers. We believe that the decision to screen for lung cancer should be left to a patient and their physician who best understand the individual patient’s personal health history and overall health status. Shared decision-making should not be a requirement for CMS coverage.” Association for Quality Imaging Remove but encourage (memo) “Revise the NCD to eliminate or simplify the Counseling and Shared Decision Making requirement, thereby ensuring that this requirement does not act as a barrier to LDCT lung cancer screening for beneficiaries. Consequently, we believe that there must be a balance between engaging patients in thorough discussions regarding their screening program and ensuring that such services are rendered as effectively and efficiently as possible. While an informed discussion is important as the outset of a screening program, it is also equally important to eliminate or consolidate elements of the beneficiary eligibility criteria, e.g., SDM requirement, to ensure that we encourage (rather than hinder) beneficiaries to take advantage of screening exams. Rather than prescribing how the ordering physician or qualified non-physician practitioner shares decision making with the beneficiary, we would encourage CMS to vest the ordering physician or qualified nonphysician practitioner with the responsibility for determining how best to share this decision with each particular beneficiary, taking into account the providerpatient relationship and specific needs of the beneficiary.” Radiology Business Management Association Did not comment This organization did not comment on SDM. Open in a new tab CMS = Centers for Medicare & Medicaid Services; LDCT = low-dose CT; NCD = National Coverage Determination; SDM = shared decision-making. a Comments from the second period only. Comments About the Proposed NCD (Second Comment Period) The second comment period generated only 49 comments, including 9 national associations and professional societies. The analysis of the comments about the SDM visit revealed that they largely mirrored those from the initial comment period. An additional topic addressed removing the requirement that LCS programs must provide tobacco cessation services. This proposed change was met with significant pushback from professional groups ( e-Table 1 ). Discussion The planned update to the NCD decision about LCS drew far less attention during the public comment periods than did the original beneficiary determination in 2014, when there were 330 comments for the initial period and 133 after the proposed NCD. However, the CMS-mandated counseling and SDM visit for LCS beneficiaries generated substantial discussion. Many commenters noted the low uptake of LCS and challenges to implementing SDM. They suggested eliminating the mandate because it was perceived as an unnecessary barrier to screening given that informed discussions were considered sufficient by the USPSTF. As LCS rolled out nationally in the United States, screening programs had to assume the responsibility for completing these visits. For some entities, this appeared to have been an unwelcome burden for which they were not prepared, 31 particularly because SDM was not mandated for other cancer screening decisions. Although commenters cited no direct evidence that SDM impeded LCS uptake, the mandated visit clearly was viewed by some as a barrier to reimbursement for screening programs. However, the value of SDM was recognized even by those who opposed the mandate. Ultimately, the updated NCD kept the requirement for the counseling and SDM visit with important changes to enhance feasibility, including allowing nonclinicians to conduct the visits, being less prescriptive about the discussion elements, and approving the use of telehealth visits. 32 Whether or not supporting the CMS mandate, commenters recognized many challenges to implementing SDM, including lack of time, difficulty explaining complicated screening issues, and not having adequate decision support tools. However, framing the SDM mandate as a potential impediment to increasing screening rates glosses over the complexity of the screening decision. Decisions by informed patients vary substantially after SDM suggesting that this is a preference-sensitive decision. 15 , 16 , 23 , 30 An informed patient may reasonably decide against screening. Given the potential downstream consequences of screening, there is also an ethical imperative to support patient autonomy in decision-making. 6 SDM, particularly with decision aids, improves decision quality by increasing knowledge about eligibility, benefits, and harms, and reducing decisional conflict. 17 The SDM visit may also improve adherence with annual screening, critical for achieving the benefits of a LCS program. 33 Notably, although screening uptake has been low, so has adherence with annual screening where SDM is not required. 34 , 35 This highlights the importance of addressing other important potential barriers to improve screening uptake and adherence. 36 Some of these include challenges in using the electronic health record to accurately identify eligible patients and having insufficient resources for managing abnormal findings and scheduling follow-up tests. 4 , 36 , 37 Furthermore, people who smoke may avoid screening because they feel stigmatized for their tobacco use, 38 be fearful of finding cancer, 39 be at risk for financial burdens related to downstream diagnostic testing and treatment, 40 and have limited access to screening centers. 41 , 42 Some of the arguments against SDM were misleading. For example, the multisociety letter that triggered the revised NCD implied that the USPSTF endorsed informed discussions over an SDM conversation between patients and clinicians. The USPSTF endorses SDM for all recommendations. 43 The USPSTF recommendation does emphasize a thorough discussion of the potential benefits, harms, and limitations of LCS, but states this in the implementation section under the heading shared decision-making. 7 Ideally, the conversation should go beyond conveying information to include addressing patients’ concerns and values related to the screening decision and its associated outcomes and ensuring that patients are making a values-based decision. 44 Commenters also argued that SDM should not be mandated for LCS because no other cancer screening programs have a similar requirement. However, the invasive diagnostic procedures and cancer treatments associated with LCS carry far greater morbidity and mortality risks than seen with other cancer screening programs. 1 Although not explicitly addressing patient decision-making, the Medicare Advisory Committee raised concerns in 2014 about the safety of LDCT screening. 45 Using a 1 (low confidence) to 5 (high confidence) scoring system, the Medicare Advisory Committee rated their confidence that screening harms would be minimized in the Medicare population as only 2.3. Furthermore, unlike other recommended cancer screening tests (aside from the infrequently used CT colonography), LDCT scan also detects numerous clinically significant incidental findings, including cardiovascular abnormalities, lung disease, and visceral tumors. 46 Evaluating and treating these findings may benefit some patients but also exposes them to harms. Although the Affordable Care Act currently ensures first-dollar coverage for preventive health services such as LDCT screening, 47 patients may face substantial out-of-pocket costs for subsequent diagnostic testing and treatment related to LCS and incidental findings. The SDM visit can help make patients aware of the potential outcomes from participating in a LCS program. Recommendations to remove the SDM requirement were often accompanied by endorsements of the importance of SDM. However, expecting busy clinicians to deliver SDM in the absence of a reimbursed mandate is at odds with fee-for-service payment models. A lack of coverage for SDM is a well-known barrier to its implementation in clinical care. 48 Unfortunately, studies have also shown that the quality of screening discussions in primary care is poor, with patients often not hearing about the potential harms of screening and not being asked about their values and preferences. 26 , 28 Clinicians face important challenges in conducting these discussions, including limited time, competing demands, and lack of decision support tools. The revised NCD no longer requires that physicians or nonphysician practitioners must furnish these visits. Allowing trained auxiliary personnel to perform billable counseling and SDM visits, particularly using telehealth, may address barriers faced by clinicians while supporting high-quality decision-making. 49 Clinicians, however, will always have a central role in the screening decision because many required elements of beneficiary eligibility (eg, importance of comorbidities when determining that the patient is healthy enough for screening and treatment, obtaining an accurate smoking history) are best addressed in the primary care setting. Interestingly, primary care professional organizations did not submit comments to the CMS. Going forward, particularly given the NCD allowing more flexibility in performing the counseling and SDM visit, far greater attention needs to be given to developing feasible and adaptable strategies for counseling patients in busy primary care settings about smoking cessation and making shared decisions about LCS. This analysis is limited to written comments submitted to the CMS by individuals and professional organizations. Comments from the public are used by the CMS to inform its coverage decisions; however, the CMS gives greater weight to arguments based on published clinical evidence. The CMS considers public comments from individual practitioners as less rigorous and less useful in coverage decisions. 11 However, in the context of updating the previous NCD, we think such comments provide valuable insight about the implications of real-world implementation of LCS that had not been anticipated at the time of the initial NCD. Interpretation The updated LCS coverage determination by the CMS was initiated after a request to revisit the 2015 determination that included a call to eliminate the SDM requirement. Criticisms of the requirement from the comment periods were largely anecdotal, not accompanied by high-quality evidence, and appeared to reflect challenges related to implementation rather than rejecting the importance of SDM. After 2 public comment periods, the CMS retained the counseling and SDM visit requirement. Although affirming the importance of SDM in LCS decision-making, the CMS determination also made important changes to enhance the feasibility of delivering SDM. Successfully implementing the counseling and SDM visit in primary care settings will be essential to fully realize the intent of the new coverage determination. Supplementary Material 2 NIHMS2164096-supplement-2.docx (21.4KB, docx) Additional information: The e-Table is available online under “ Supplementary Data .” Take-Home Points. Research Question: What comments were offered by the public about shared decision-making (SDM) in response to the proposed Centers for Medicare & Medicaid Services (CMS) update and how did CMS address commenters’ concerns? Results: Recommendations about the SDM visit included complete removal, endorsing its importance without making it mandatory, and retaining the requirement with changes to reduce its administrative burden. Interpretation: The CMS updated the coverage decision to decrease the administrative burden on screening programs while retaining the patient counseling and SDM requirement. Funding/Support K. G. M. is supported, in part, by the NIH Center [Grant P30 CA022453], awarded to the Karmanos Cancer Institute at Wayne State University. A. R. is supported by a fellowship award from The University of Texas MD Anderson Cancer Center, Halliburton Employees Fellowship in Cancer Prevention Fund. This project is also supported in part by an NCI Cancer Center Support Grant [Grant P30CA16672], a grant from the Cancer Prevention and Research Institute of Texas [Grant RP230213], and the annual distributions of the Permanent Health Fund endowment received by The University of Texas MD Anderson Cancer Center from the state legislature. R. J. V. and R. M. H. are supported by a grant from the NLHBI [Grant 1R01HL158850–01A1]. Role of sponsors: The sponsor had no role in the design of the study, the collection and analysis of the data, or the preparation of the manuscript. ABBREVIATIONS: CMS Centers for Medicare & Medicaid Services LCS lung cancer screening LDCT low-dose CT NCD National Coverage Determination SDM shared decision-making USPSTF US Preventive Services Task Force Footnotes Financial/Nonfinancial Disclosures None declared. Part of this article has been presented at the International Shared Decision Making Society Conference 2022, June 21, 2022, Kolding, Denmark. 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