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

Other commenters supported the removal of this requirement and applauded CMS for streamlining the process to allow independent diagnostic testing facilities (IDTFs) the ability to perform and receive reimbursement for lung cancer screening. Since IDTFs are enrolled as a facility for the purpose of performing diagnostic tests and smoking cessation interventions are considered therapeutic interventions, they did not satisfy the NCD criteria and were unable to receive reimbursement for the lung cancer screening service. Commenters believe the removal of this requirement expands access to lung cancer screening by increasing accessibility to screening sites.Response:CMS strongly supports all opportunities to provide appropriate smoking cessation services to beneficiaries. It was not our intent to convey a message that implied otherwise. Removing the requirement for imaging facilities to furnish smoking cessation services was not intended to downplay the importance of this intervention but rather to expand the availability of LDCT screening. There are separate rules and regulations that determine the services that are legally able to be furnished in certain Medicare recognized settings. We determined that while smoking cessation services are of critical importance we have a need to balance the accessibility of LDCT screening. While smoking cessation services are appropriate for patients, we are not making it a requirement that imaging facilities furnish the service because it would prevent IDTFs from furnishing LDCT screening. We have updated the language in the analysis section in order to correct any misunderstanding that may have implied that CMS was not supportive of smoking cessation services.In order to avoid any further misunderstanding, we have revised and clarified the language used in the analysis. Specifically, we have removed the word appropriate from the final decision memorandum Section IX (CMS Analysis, Smoking Cessation) and replaced it with required, indicating (as we have noted), that as a policy requirement for low dose CT screening NCD, a smoking cessation intervention is not a radiology imaging facility eligibility criterion. The sentence now reads as, it is not required for Medicare beneficiaries to receive smoking cessation interventions for current smokers within the setting of a radiology imaging facility. It remains critically important to provide information about tobacco cessation or cigarette smoking abstinence to the patient at touchpoints between provider and patient along the clinical pathway.CMS-Approved RegistryComment:Some commenters did not support the removal of the requirement for radiology imaging facilities to submit data to a CMS-approved registry for each LDCT lung cancer screeningperformed. Commenters noted that the registry provides guidance for required and optional fields, facilitates additional research, aids in quality audits, quality improvements and establishes best practices. They are concerned that removing this requirement will likely result in lower overall quality of lung cancer screening. One commenter agreed with the original purpose of the registry as outlined in the proposed DM, but believes the three published studies reinforced the purpose of the registry rather than fulfilled it.Other commenters supported the removal of the registry requirement stating that it creates a financial disincentive to small radiology imaging facilities and a barrier to overall lung cancer screening, particularly for rural and minority populations. They point out that the only CMS-approved lung cancer screening registry requires that providers pay a fee to input their data into the registry. The commenters believe by removing this requirement it will expand access by encouraging more providers to offer lung cancer screenings.Response:We appreciate the comments. The primary purpose for requiring the submission of data to a CMS-approved registry, as stated in the 2015 Decision Memo, was to document compliance with the coverage criteria that are not evidenced on the health care claim. The registry will help ensure that only eligible beneficiaries will receive this screening service since only beneficiaries that meet the eligibility requirements will benefit from such screening.In addition, the most recent 2021 USPSTF recommendation statement changed from encouraging the development of a registry in 2014 to having no comment on the need for a lung cancer registry. Since the published studies, using data from the LCSR, fulfilled the purpose as outlined in the previous NCD, it is no longer necessary to mandate data collection through this NCD. This will also reduce the administrative burden on providers and institutions.Comment:Several commenters supported the development of a free lung cancer screening registry.Response:We agree that a registry that would be free to access would aid in eliminating the financial burden for smaller providers. We are aware of a proposed bill in Congress (H.R. 107-The Lung Cancer Screening Registry and Quality Improvement Act of 2021) that if passed would provide grant funding for the development of free lung cancer screening registries and encourage the development of quality measures in lung cancer.Comment:Two commenters suggested CMS make the Lung Cancer Screening Registry (LCSR) data publicly available.Response:The LCSR is maintained by the American College of Radiology (ACR). We encourage our commenters and any interested party to reach out directly to the ACR for more information about data access.Additional CommentsComment:The American Cancer Society (ACS) and the National Comprehensive Cancer Network (NCCN) requested we update their respective sections within the Decision Memorandum (DM). ACS informed us that their 2013 guideline is currently being updated and has been taken down from their website. They provided interim language and asked that we replace our language in the final DM. NCCN provided us with the most recent version of the NCCN Guidelines and requested we update the risk assessment image in the final DM.Response: We thank ACS and NCCN for advising us of the current information. We updated the ACS and NCCN sections within the Evidence-based Guidelines section of the DM to reflect their requests.Comment:Several commenters advocated that lung cancer screening be added to hospital performance and quality measures in such reporting systems such as the Healthcare Effectiveness Data and Information Set (HEDIS), Merit-based Incentive Payment System (MIPS), and National Quality Forum (NFQ).Response:We thank the commenters, but quality measures are beyond the scope of this NCD.Comment:One commenter raised concerns regarding the April 30, 2014 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.Response:The 2014 MEDCAC meeting is not part of this reconsideration. Details regarding this meeting are summarized in the 2015 DM. A MEDCAC meeting was not convened for this reconsideration.Comment:One commenter requested to include ICD-10 diagnosis codes for smoking in remission.Response:Coding guidance is outside the scope of this national coverage analysis.Comment:One commenter asked when the changes are effective.Response:All NCDs are effective on the date the final decision memoranda are posted.Comment:One commenter urged CMS to work with appropriate federal and state stakeholders to address additional barriers that exist for both providers and patients, including ensuring private insurance plans include lung cancer screening as a routine screening for eligible patients; including eliminating LCS as a cost-sharing benefit and to urge the American Academy of Family Physicians (AAFP) to acknowledge the importance of lung cancer screening in eligible patients, thus raising their grade on lung cancer screening to A from its current ranking of B.Response:While CMS does not have direct authority to influence these changes, we agree that continued stakeholder engagement is important. The updated NCD may contribute to opportunities for continued stakeholder engagement to address additional barriers to access to lung cancer screening.IX. CMS AnalysisNational coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act ( 1869(f)(1)(B)). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. CMS is authorized to cover "additional preventive services" if certain statutory requirements are met as provided under  1861(ddd) of the Social Security Act. Regulations at 42 C.F.R.  410.64 provide:(a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of preventive services under 410.2, that identify medical conditions or risk factors for individuals if the Secretary determines through the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following:(1) Reasonable and necessary for the prevention or early detection of illness or disability.(2) Recommended with a grade of A or B by the United States Preventive Services Task Force.(3) Appropriate for individuals entitled to benefits under part A or enrolled underPart B.(b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations.When making national coverage determinations, it is important to consider whether the evidence is relevant to the Medicare beneficiary population. In considering the generalizability of the results of the body of evidence to the Medicare population, it is necessary to consider at least the age, race and gender of the study participants.Due to the natural history of lung cancer, the burden of lung cancer is high in older adults. In this analysis, we will evaluate specific criteria of screening tests as described by Cochrane and Holland (1971) in addition to the hierarchical framework of Fryback and Thornbury (1991). We will utilize the hierarchical framework of Fryback and Thornbury (1991) in our analysis of low dose CT screening tests for lung cancer. As Cochrane and Holland (1971) noted, evidence on health outcomes, for example, evidence that screening can alter the natural history of disease in a significant proportion of those screened," is important in the consideration of screening tests since individuals are asymptomatic and "the practitioner initiates screening procedures." We will look for sound human clinical evidence that shows that changes in the eligibility criteria for a  screening test has clinical utility since lung cancer screening with low dose CT has been shown to improve health outcomes, including lung cancer mortality, which benefits Medicare beneficiaries.Evidence Review Summary:For this reconsideration of the NCD on lung cancer screening with low dose CT, CMS focused on three questions:Question 1: Is the evidence sufficient to determine that screening for lung cancer with low dose computed tomography is recommended with a grade of A or B by the United States Preventive Services Task Force?In 2021, [t]he USPSTF recommends annual screening for lung cancer with 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. (B recommendation) (USPSTF, Krist; 2021). This recommendation replaces the 2013 USPSTF statement that recommended annual screening for lung cancer with LDCT in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years (USPSTF, Krist; 2021).Question 2: Is the evidence sufficient to determine that screening for lung cancer with low dose computed tomography is reasonable and necessary for the prevention or early detection of illness or disability?The human empiric evidence was assessed to determine whether changes in the beneficiary eligibility criteria for age and smoking history when screening with low dose CT show benefit for Medicare beneficiaries in the prevention or early detection of lung cancer by lowering lung cancer mortality.Randomized Controlled Clinical TrialsThe evidence base for this reconsideration of low dose CT for lung cancer screening has a primary focus on randomized controlled clinical trials of the effect of screening with low dose CT on the outcome of lung cancer mortality. Ten randomized controlled clinical trials involving human subjects were included in the evidence: the Continuous Observation of Smoking Subjects trial (COSMOS; Rampinelli, 2017), the Danish Lung Cancer Screening Trial (DLCST; Wille, 2016), the Detection And screening of early lung cancer with Novel imaging Technology and molecular assays trial (DANTE; Infante, 2015), the Italian Lung Cancer Screening Trial (ITALUNG; Paci, 2017), the Lung Cancer Screening Intervention trial (LUSI; Becker, 2020), the Lung Screening Study (LSS; Doroudi, 2018), the Multicentric Italian Lung Detection study (MILD; Pastorino, Silva, Sestini, 2019), the National Lung Screening Trial (NLST; National Lung Screening Trial Research Team [NLST], 2019), the NederlandsLeuvens Longkanker Screenings Onderzoek trial (NELSON, which is the Dutch acronym; de Koning, 2020), and the United Kingdom Lung Cancer Screening pilot study trial (UKLS; Field; May, 2016). In subsequent discussions, each randomized controlled trial will be referred to by its acronym.