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

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.Response:We agree that the available evidence in this upper age range of 78-80 years does not include empirical evidence and relies solely on modeling. We consider modeling as a very low level of evidence. In general, we believe data using statistical methods of modeling is inadequate to ensure that the service would be reasonable and necessary for the prevention or early detection of an illness or disability or be appropriate for Medicare beneficiaries. While simulation modeling can be valuable tools that contribute to our understanding of lung cancer screening with LDCT, there are challenges, such as uncertainty inherent about modeling and variability in the results depending on the assumptions used, and uncertainty around the usefulness and applicability of modeling studies. Thus, the modeling information provided by commenters was a very low level of evidence that we did not find persuasive to make changes in the eligibility criteria for lung cancer screening with low dose CT.Evidence ReviewComment:A commenter supported our decision to not focus on meta-analysis studies in the evidence review. They believe there is too much heterogeneity in the existing RCTs of LDCT screening for meta-analysis results to be informative, and there is sufficient evidence in the small number of larger trials.Response:We appreciate the supportive comment.Comment:Two commenters responded to the need for additional studies in populations aged above 77. One commenter remarked that additional studies would likely take several years to conduct any new research and the other commenter suggested CMS conduct coverage with evidence development (CED).Response:We agree with the need for additional evidence as our review concluded that there is an absence of high-quality evidence to support lung cancer screening above age 77 with low dose CT. As stated in our evidence review, data from randomized controlled trials provide the strongest evidence. In response to the commenter suggesting CMS initiate coverage with evidence development (CED), our review, as stated above, determined that there was a lack of evidence as opposed to identifying that the evidence is promising in that age group. It should be noted that the paradigm around CED is that the evidence is promising in demonstrating that an item or service is reasonable and necessary. Therefore, in the absence of relevant published human clinical study evidence, populations aged above 77 will remain non-covered by Medicare.15-Year Quit Smoking HistoryComment:Commenters disagreed with retaining the beneficiary eligibility requirement of having quit smoking within the past 15 years. They support removal of the criteria or at a minimum, to adopt the NCCN guidelines. Many claimed there is no substantive data to support a significant reduction in lung cancer risk in this time frame while others state that multiple studies have concluded that there are benefits beyond the 15-year cut-off. Some claim that the 15-year cut-off is not based on or justified by evidence, rather that the USPSTF and CMS adopted it because it was an eligibility criterion in the National Lung Screening Trial (NLST). Another commenter expressed that we are misrepresenting RCT enrollment criteria as the reason to support the 15-year cut-off. They further state that it is well-known that these RCTs were not intended or designed to limit screening eligibility. Another commenter believed this criterion unintentionally incentivizes Medicare beneficiaries to continue or resume smoking, while another commenter stated it is difficult to obtain a quit date from patients.Response:The 2021 USPSTF recommendation determined with a grade B rating that 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. The studies used to inform the USPSTF recommendation did not examine patients who have a quit smoking history greater than 15 years. We did not identify evidence to determine if persons who quit smoking more than 15 years ago would benefit from low dose CT screening for lung cancer.  Therefore, in the absence of relevant evidence, beneficiaries who have quit smoking greater than 15 years ago remain non-covered by Medicare.Several studies have been cited as purportedly showing benefit of lung cancer screening with low dose CT for the 15-year Quit Smoking History criterion. For instance, the objective of the Tindle et al. (2018) investigation was to relate comprehensive lifetime smoking history to the risk of lung cancer in a large and well-characterized prospective cohort study, the Framingham Heart Study (FHS), which began in 1948 with enrollment of the Original cohort. However, this study did not assess the relevant and important health outcome of mortality, instead assessing the risk of developing lung cancer. Additionally, the Framingham Heart Study did not investigate screening with low dose CT.Two other studies (Reitsma, 2020; Wang, 2015) did not assess mortality and did not investigate screening with low dose CT. The objective of the Reitsma et al. (2020) study was to characterize the percentage of the reducible relative risk (RR) remaining for lung cancer as a function of years since quitting (YSQ). The objective of the Wang et al. (2015) study was to investigate the implications of the USPSTF screening criteria . . . in a well-defined population retrospectively over 28 years to demonstrate trends in the proportion of patients with lung cancer meeting the criteria.Additionally, the objective of the McKee et al. (2018) study was to assess the performance of patients in NCCN high-risk group 2 in a clinical CT lung screening (CTLS) program. However, this study did not assess the health outcome of mortality, instead assessing the risk of developing lung cancer. The overall objective of the Luo et al. (2019) was to directly compare overall survival between patients with lung cancer meeting USPSTF screening criteria and those who are ineligible because they are classified as long-term quitters or in a younger age group at the time of lung cancer diagnosis. This approach allowed Luo et al. (2019) to assess survival outcomes in two subgroups: either long-term quitters (15 years since quitting) or from a younger age group (age 5054 years). However, the Luo et al. (2019) study did not investigate lung cancer screening with low dose CT in this prospective cohort study.While the commenters disagreed with retaining the beneficiary eligibility requirement of having quit smoking within the past 15 years, we concluded that the studies discussed in the prior paragraphs were not sufficient to remove the 15-year quit smoking criterion because the studies did not investigate screening with low dose CT or did not assess the important health outcome of mortality. Thus, we are not adopting the commenters suggestions and will retain the beneficiary eligibility requirement of having quit smoking within the past 15 years.Written OrderComment:Commenters supported the removal of the word written from the written order requirement and the removal of the documentation requirement in the beneficiarys medical record. They stated that written orders are time consuming and electronically transmitted orders are more efficient and improve overall patient compliance. An electronic order is more likely to generate patient follow-up for scheduling and care coordination.Response:We appreciate the supportive comments. We believe that eliminating the excessive requirement for a written order will reduce administrative burden and facilitate improved access to lung cancer screening with LDCT.OtherComment:Several commenters suggested expanding the beneficiary eligibility criteria beyond the USPSTF recommendation to include additional risk populations. Commenters suggested CMS should consider how lung cancer screening can further reach at-risk Medicare beneficiaries who have no smoking history but have other potential risk factors including long-term exposure to secondhand smoke, and environmental and occupational exposures. Commenters also noted that the current beneficiary eligibility criteria do not consider beneficiaries who smoked less than one pack per day or smoked for less than 20 years, including beneficiaries with occupational exposures, such as first responders.Response:In order for an additional preventive service to be included for Medicare coverage, it must be recommended with a grade of A or B rating by the USPSTF. The current USPSTF Recommendation (2021) assigned a grade B to 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. A grade B rating determines there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. The studies used to inform the USPSTF recommendation either did not examine these additional at-risk populations or there was no evidence or the evidence did not support an A or B rating. The USPSTF considers all populations that are supported by the available evidence within its analytic framework of the systematic review for lung cancer screening with low dose CT. Thus, we are not adopting the commenters suggestion to expand the beneficiary eligibility criteria to include additional risk populations.Comment:One commenter suggested we incorporate using an accurate risk prediction model in the screening criteria.Response:The risk prediction modeling information provided by commenters was a very low level of evidence that we did not consider sufficient to make changes in the eligibility criteria for lung cancer screening with low dose CT.Counseling and Shared Decision-Making VisitComment:While the majority of commenters supported and appreciated CMS simplifying the requirements for the counseling and SDM visit, many commenters supported removing counseling and SDM as a requirement altogether. They stated that SDM should be encouraged and utilized but eliminated as a documentation requirement for coverage and reimbursement. They believe that even the simplified requirements will pose administrative burden and may create a barrier to screening. Some commenters noted that other screening services such as mammography and colon cancer screening do not have the same SDM requirement and that the USPSTF only recommends an SDM visit prior to lung cancer screening.Other commenters requested CMS strengthen rather than simplify the SDM criteria. They believe currently there is too much flexibility in how these discussions are framed and state that prior evidence has shown SDM to be sub-optimal. The commenters request that CMS retain the documentation of beneficiary eligibility requirements and should also provide explicit guidance related to key benefits and risks for the counseling and SDM visit.Several other commenters supported simplifying the complexity and number of requirements within the counseling and SDM visit. They believe this is a step in the right direction to reducing barriers to screening to create broader uptake of lung cancer screening. One commenter stated that cancer care is a team effort between the patient, their families and the entire clinical staff and these discussions are critical.Response:We appreciate the commenters recognizing the importance of counseling and SDM in lung cancer screening with LDCT and understand the additional concerns expressed. We agree that SDM is a critical component of lung cancer screening with LDCT due to the complexities around the discussion of low dose CT and benefits, harms and patient adherence, therefore SDM will remain a requirement within the NCD. However, we believe that this service has matured since the original 2015 NCD and the documentation requirements can be simplified. Professional societies and provider groups have noted that providers have gained considerable experience over the years. We believe by removing some specificity around documentation of the information on the beneficiary eligibility criteria and SDM elements, it will reduce provider burden and thus, likely improve access to lung cancer screening with low dose CT.The USPSTF includes their support for SDM in the Practice Guidelines section of the Recommendations. Due to the fact that lung cancer screening has the potential to cause harm, including false-positive screening test results and the risks of overdiagnosis of lung cancer and excess radiation exposure, they state the decision to undertake screening should involve a thorough discussion of the potential benefits, limitations and harms of screening. We agree that SDM is a critical component of lung cancer screening with LDCT and therefore, will remain as a requirement.Comment:Several commenters who favored removal of the counseling and SDM visit requested that if CMS chose to retain the requirement, telehealth should be allowed. They pointed out that as part of the COVID-19 Public Health Emergency (PHE) Blanket Waivers for Healthcare, shared decision-making was considered a telehealth service. These commenters advocated for telehealth to be permanently adopted for the shared decision-making visit.Response:We appreciate the comments and support reducing barriers and increasing access through telehealth. CPT code G0296, defined as a Counseling visit to discuss need for lung cancer screening (LDCT) using low dose CT scanning (the service is for eligibility determination and shared decision making), is listed as a permanent telehealth code. The code is payable in the facility and the non-facility setting. You can access the complete list of telehealth services at:https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.Comment:Two commenters who favored removal of the counseling and shared decision-making visit requested that if CMS chose to retain the requirement, CMS should consider allowing the shared decision-making visit to occur in conjunction with the actual lung cancer screening exam ratherthan requiring a separate visit.Response:The NCD states that the counseling and shared decision-making visit must occur before the beneficiarys first lung cancer screening. The NCD does not prevent the SDM visit from occurring on the same day as the lung cancer screening exam or from occurring in conjunction with the actual lung cancer screening exam. As long as the counseling and shared decision-making visit occurs before the beneficiarys first lung cancer screening exam then it satisfies the NCD. As a reminder, this required counseling and shared-decision making visit is only required prior to the first LDCT screening.Comment:One commenter believes that patients current low level of screening may be caused by former smokers, who know they are at higher risk, being fearful of diagnosis, especially if they have loved ones who died of lung cancer. For this reason, they urge CMS to ensure that patients receive accurate, balanced, unbiased information on the benefits and risks of lung cancer screening.