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

(Wood, NCCN; 2021)Professional Society RecommendationsAAFP (American Academy of Family Physicians). Clinical Preventive Service Recommendation: Lung Cancer: Lung Cancer Screening, Adult. https://www.aafp.org/family-physician/patient-care/clinical-recommendations/all-clinical-recommendations/lung-cancer.html. Accessed 6/17/2021.The American Academy of Family Physicians gives the clinical preventive services recommendation for lung cancer screening in adults a B grade recommendation. The AAFP supports the United States Preventive Services Task Force (USPSTF) recommendation for annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery (AAFP, 2021). The clinical preventive services recommendation further states that the AAFP has reviewed the evidence and has determined there is sufficient evidence to support a recommendation for lung cancer screening in adults at increased risk. However, the AAFP acknowledges that the harms from annual screening with LDCT are not well documented at this time and that there are considerable barriers to screening for lung cancer in the community setting. Further research is needed to determine the harms of annual screening with LDCT including overdiagnosis, unnecessary procedures due to incidental findings, and barriers to care among communities of color (2021) (AAFP, 2021).Wender R, Fontham ET, Barrera E Jr, et al. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11. PMID: 23315954In 2013, before the 2021 updated USPSTF recommendation statement on lung cancer screening, the American Cancer Society issued an initial guideline for lung cancer screening. As of August, 18, 2021, the American Cancer Society website does not have a more recent updated lung cancer screening guideline other than the 2013 lung cancer screening guideline.The American Cancer Society 2013 guideline recommends that clinicians with access to high-volume, high-quality lung cancer screening and treatment centers should initiate a discussion about screening with apparently healthy patients aged 55 years to 74 years who have at least a 30 [or more]pack-year smoking history and who currently smoke or have quit within the past 15 years. A process of informed and shared decision-making with a clinician related to the potential benefits, limitations, and harms associated with screening for lung cancer with low-dose computed tomography should occur before any decision is made to initiate lung cancer screening (Wender, 2013).The American Cancer Society has taken down the 2013 lung cancer screening guideline while it is being updated. The current guidance from the American Cancer Society is that health care providers and people at increased risk for lung cancer follow the recently updated recommendations for annual lung cancer screening from the US Preventive Services Task Force (USPSTF), the American Academy of Family Physicians (AAFP), or the American College of Chest Physicians. These organizations recommend yearly lung cancer screening with LDCT scans for people who: are 50 to 80 years old and in fairly good health, currently smoke or have quit in the past 15 years, and have at least a 20 pack-year smoking history. In addition, people who are going to be screened should receive counseling to quit smoking if they currently smoke, have been told by their doctor about the possible benefits, limits, and harms of screening with low dose CT scans, and can go to a center that has experience in lung cancer screening and treatment: (https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/detection.html).Wiener RS, Gould MK, Arenberg DA, et al. An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. Am J Respir Crit Care Med. 2015 Oct 1;192(7):881-91. doi: 10.1164/rccm.201508-1671ST. PMID: 26426785Rivera MP, Katki HA, Tanner NT, et al. Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement. Am J Respir Crit Care Med. 2020 Oct 1;202(7):e95-e112. doi: 10.1164/rccm.202008-3053ST. PMID: 33000953The American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) convened a committee with expertise in lung cancer screening, pulmonary nodule evaluation, and implementation science. The committee reviewed the evidence from systematic reviews, clinical practice guidelines, surveys, and the experience of early-adopting LDCT screening programs and summarized potential strategies to implement LDCT screening programs successfully (Wiener, 2015). Additionally, this policy statement offers pragmatic strategies to assist medical centers and healthcare systems that seek to establish comprehensive low-radiation-dose computed tomography (LDCT) lung cancer screening programs that are safe and effective. The strategies listed herein address the nine core components of LDCT screening programs proposed by the American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) (Wiener, 2015).The ATS/CHEST policy statement concludes that during the implementation phase, programs should be attentive to establishing systems to screen the right patients at the right time, [and] to performing shared decision-making to help eligible patients decide whether to undergo screening (Wiener, 2015).The ATS/CHEST policy statement notes that core programmatic functions often conducted by a midlevel provider serving as screening coordinator, but sometimes tasked to PCPs [primary care physicians] or other clinicians can include to counsel and communicate with the patient about screening, [such as] initial shared decision-making about whether to undergo LDCT screening (Wiener, 2015).4. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)A MEDCAC meeting was not convened on this issue.VIII. Public CommentPublic comments sometimes cite published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. Public comments that contain personal health information will not be made available to the public.CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum. All comments that were submitted without personal health information may be viewed in their entirety by using the following linkhttps://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=304.Initial Public Comment Period: 05/18/2021  06/17/2021During the 30-day comment period following the release of the tracking sheet, CMS received 170 comments. All of the commenters supported revising the NCD to align with the updated USPSTF recommendations for lung cancer screening with LDCT. Some commenters also requested additional updates such as eliminating or increasing the upper age limit and the quit smoking limit; revising or removing the counseling and shared decision-making requirement; and clarifying the radiology imaging facility criteria to ensure that independent diagnostic testing facilities (IDTFs) qualify to perform lung cancer screening with LDCT.Comments were provided by advocacy organizations, cancer centers, cancer coalitions, imaging facilities, researchers; with the majority of comments provided by physicians, radiologists and other healthcare professionals. Eight comments were provided by national associations/professional societies, including American Association for Thoracic Surgery (AATS), American Cancer Society (ACS), American Lung Association, a joint comment from The American Thoracic Society (ATS) and American College of Chest Physicians(CHEST), Association of Quality Imaging (AQI), Medical Imaging &Technology Alliance (MITA), National Comprehensive Cancer Network (NCCN), and Radiology Business Management Association (RBMA).Second Public Comment Period: 11/17/2021-12/17/2021During the 30-day comment period following the release of the proposed decision memorandum, CMS received 49 comments.All of the commenters supported revising the NCD to expand beneficiary eligibility for lung cancer screening with LDCT. Commenters applauded CMS for reconsidering this NCD in a timely manner following the release of the updated USPSTF recommendation and being responsive to concerns from the stakeholder community. Many commenters disagreed with retaining the upper age screening limit and the 15-year quit smoking history in the beneficiary eligibility criteria. While the majority of commenters supported and appreciated simplifying the requirements for the counseling and SDM visit, many commenters supported removing SDM as a requirement altogether. A few commenters requested CMS strengthen rather than simplify the SDM criteria. Commenters supported expanding the type of provider eligible to furnish the counseling and SDM by removing the restriction that it must be furnished by a physician or non-physician practitioner but one commenter wanted to ensure that SDM conversations still included a patients healthcare provider. Commenters supported modifying the reading radiologist eligibility criteria; however, several commenters disagreed with the removal of the requirement for 300 chest CT acquisitions within three years. While the majority of commenters acknowledged that removing the imaging facility eligibility criteria would reduce barriers and expand access to care, some commenters were concerned that the standards and overall quality of lung cancer screening would be reduced. Specifically, some commenters did not agree with removing smoking cessation interventions from the imaging facility criteria or removing the requirement to submit data to a CMS-approved registry. Detailed summaries of all submitted comments with CMS responses are included below.Comments (22) were provided by academic institutions, advocacy organizations, cancer centers, healthcare systems, consortia, medical technology manufacturers, a Medicare Contractor Medical Director, and researchers; 15 comments were provided by physicians and other healthcare professionals. Two comments did not identify an affiliation or profession and one comment identified themselves as a concerned citizen. Nine comments were provided by national associations/professional societies, including American Association for Cancer Research (AACR), American Cancer Society (ACS), American Lung Association, Association for the Treatment of Tobacco Use and Dependence (ATTUD), Association of Quality Imaging (AQI), Medical Imaging & Technology Alliance (MITA), National Comprehensive Cancer Network (NCCN), Society for Research on Nicotine and Tobacco (SRNT) and a joint comment from the requestor consisting of the GO2Foundation for Lung Cancer, American College of Radiology (ACR) and Society of Thoracic Surgeons (STS).Numerous references were submitted with public comments that were not available or considered for the proposed decision. These references have been reviewed and those that fall within the scope of this NCD as well as our literature search and review parameters have been considered in the analysis section.Beneficiary Eligibility CriteriaComment:All of the commenters supported revising the NCD to expand beneficiary eligibility for lung cancer screening with LDCT by reducing the starting screening age from 55 to 50 and lowering the pack-years tobacco smoking history from 30 to 20 years. This expansion will expand access to at-risk populations; specifically, females, African Americans, and underserved populations. This also enables expansion for screening in persons who have enrolled in Medicare early due to disability or End Stage Renal Disease (ESRD).Response:We agree with the importance of prevention and screening. We appreciate the supportive comments for expanding lung cancer screening with LDCT for Medicare beneficiaries.Upper Age LimitComment:Commenters disagreed with retaining the upper age screening limit of 77. Commenters either supported increasing the age from 77 to 80 to align with the USPSTF recommendation and to be consistent with private insurers or eliminating the upper age limit to mirror the NCCN guidelines. Commenters who supported removal of the upper age limit believe that providers should be allowed to determine if lung cancer screening is appropriate on an individual basis. Commenters claim that the upper age of 77 is not supported by clinical evidence and based on arbitrarily chosen age cutoffs in various lung cancer screening clinical trials.Response:The USPSTF recommended the upper age limit of 80 years in their previous recommendations published in 2014 and in their most recent recommendation. The 2015 NCD included the upper age limit of 77 because there were no clinical trial data or evidence on adults over 77 years. For this reconsideration, we reviewed all the available evidence published from 2014 to the present to determine if there were new data to support increasing the upper age limit from 77 to 80. As noted in our evidence review, we found there is still no empirical data available to support lung cancer screening with low dose CT for adults aged 78-80 years. Data from randomized controlled trials provide the strongest evidence. While the main focus of the review was on randomized controlled trials, we did include relevant prospective cohort and cross-sectional studies that fell within the scope and inclusion parameters of our internal systematic review. There continues to be no relevant published human clinical study literature regarding the use of low dose CT in persons age 77- to 80-years-old and therefore, the evidence is insufficient to determine if patients over 77 years would benefit from low dose CT screening for lung cancer.Comment:Commenters pointed out that CMS should consider modeling data and real-world data instead of or in addition to clinical trials for increasing the upper age from 77 to 80 or removing the upper age limit altogether. They state that while clinical trials are useful in developing levels of evidence, they do not reflect the real-world circumstances. They highlight that the USPSTF review was based heavily on modeling data.