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

htmlRequired meta tagsNCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision MemoBootstrap is used with permission under the MIT license: https://github.com/twbs/bootstrap/blob/master/LICENSEjQuery is used with permission under the MIT license: https://jquery.org/license/New RelicThe page could not be loaded. The CMS.gov Web site currently does not fully support browsers with"JavaScript" disabled. Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with"JavaScript" disabled.Instructions for enabling "JavaScript" can be found here.Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available.Skip to main contentAn official website of the United States governmentHere's how you knowHere's how you knowThe .gov means it's official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.The site is secure.Thehttps://ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.Resource NavigationSearchReportsDownloadsArchiveAPIopens in new window<button id="toggle-mobile-search" class="mobile-search-btn" aria-expanded="false"><span class="ds-u-visibility--screen-reader">Toggle Mobile Search</span></button>Close SearchCenters for Medicare & Medicaid ServicesMain headerAbout UsNewsroomData & ResearchMCDMedicare Coverage DatabaseSearchReportsNational CoverageWhat's New ReportAnnual ReportNCA/CAL ReportsNCA/CAL Status ReportNCA/CAL Open for Public Comment ReportNCD ReportMedicare Coverage Documents ReportsMedicare Coverage Documents ReportMed Cov Docs Open for Public Comment ReportOther National Coverage ReportsMEDCAC Meetings ReportTechnology Assessments ReportLocal CoverageWhat's New ReportFinal LCD ReportsFinal LCDs by Contractor ReportFinal LCDs by State ReportFinal LCDs Alphabetical ReportProposed LCD ReportsProposed LCDs by Contractor ReportProposed LCDs by State ReportProposed LCDs Alphabetical ReportArticle ReportsArticles by Contractor ReportArticles by State ReportArticles Alphabetical ReportSAD Exclusion List ReportMAC Contacts ReportDownloadsHelp & ResourcesPage HelpTour the SearchTour the ReportsContact UsReset Search DataArchiveAPIBack to Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)ContentsDecision SummaryProposedDecision MemoBibliographyRelated MaterialNational Coverage Analysis (NCA)ProposedDecision MemoScreening for Lung Cancer with Low Dose Computed Tomography (LDCT)CAG-00439RExpand All|Collapse AllDownloadDecision SummaryThe Centers for Medicare & Medicaid Services (CMS) reconsidered the national coverage determination established at section 210.14 of the Medicare National Coverage Determinations manual and has determined that the evidence is sufficient to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT) when the following criteria are met:Beneficiary eligibility criteria:Age 50  77 years;Asymptomatic (no signs or symptoms of lung cancer);Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);Current smoker or one who has quit smoking within the last 15 years; andReceive an order for lung cancer screening with LDCT.Counseling and Shared Decision-Making VisitBefore the beneficiarys first lung cancer LDCT screening, the beneficiary must receive a counseling and shared decision-making visit that meets all of the following criteria, and is appropriately documented in the beneficiarys medical records:Determination of beneficiary eligibility;Shared decision-making, including the use of one or more decision aids;Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; andCounseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions.Reading Radiologist Eligibility CriteriaFor purposes of Medicare coverage of lung cancer screening with LDCT, the reading radiologist must have board certification or board eligibility with the American Board of Radiology or equivalent organization.Radiology Imaging Facility Eligibility CriteriaFor purposes of Medicare coverage,lung cancer screeningwith LDCT must be furnished in a radiology imaging facility that utilizes a standardized lung nodule identification, classification and reporting system.The above policy simplifies requirements for the counseling and shared decision-making visit, removes the restriction that it must be furnished by a physician or non-physician practitioner, reduces the eligibility criteria for the reading radiologist, and reduces the radiology imaging facility eligibility criteria (including removes the requirement that facilities participate in a registry). See Appendix B for the expected manual language.ProposedDecision MemoTO: Administrative File: CAG-00439RFROM: Tamara Syrek Jensen, JDDirector, Coverage and Analysis GroupJoseph Chin, MD, MSDeputy Director, Coverage and Analysis GroupJoAnna Baldwin, MS Acting Director, Division of Policy and Evidence ReviewMelissa Evans, PhD, MSAEActing Deputy Director, Division of Policy and Evidence Review Kimberly LongLead AnalystCarl Li, MD, MPHLead Medical OfficerDhritiman V. Mukherjee, PhD, MS, MPHLead EpidemiologistSUBJECT: Reconsideration Final National Coverage Determination for Lung Cancer Screening withLow Dose Computed Tomography (LDCT)DATE: February 10, 2022I. DecisionThe Centers for Medicare & Medicaid Services (CMS) reconsidered the national coverage determination established at section 210.14 of the Medicare National Coverage Determinations manual and has determined that the evidence is sufficient to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT) when the following criteria are met:Beneficiary eligibility criteria:Age 50  77 years;Asymptomatic (no signs or symptoms of lung cancer);Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);Current smoker or one who has quit smoking within the last 15 years; andReceive an order for lung cancer screening with LDCT.Counseling and Shared Decision-Making VisitBefore the beneficiarys first lung cancer LDCT screening, the beneficiary must receive a counseling and shared decision-making visit that meets all of the following criteria, and is appropriately documented in the beneficiarys medical records:Determination of beneficiary eligibility;Shared decision-making, including the use of one or more decision aids;Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; andCounseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions.Reading Radiologist Eligibility CriteriaFor purposes of Medicare coverage of lung cancer screening with LDCT, the reading radiologist must have board certification or board eligibility with the American Board of Radiology or equivalent organization.Radiology Imaging Facility Eligibility CriteriaFor purposes of Medicare coverage,lung cancer screeningwith LDCT must be furnished in a radiology imaging facility that utilizes a standardized lung nodule identification, classification and reporting system.The above policy simplifies requirements for the counseling and shared decision-making visit, removes the restriction that it must be furnished by a physician or non-physician practitioner, reduces the eligibility criteria for the reading radiologist, and reduces the radiology imaging facility eligibility criteria (including removes the requirement that facilities participate in a registry). See Appendix B for the expected manual language.II. BackgroundThroughout this document we use numerous acronyms, some of which are not defined as they are presented in direct quotations. Please find below a list of these acronyms and corresponding full terminology:AAFP  American Academy of Family PhysiciansABR - American Board of RadiologyACR  American College of RadiologyACR/STR - American College of Radiology and Society of Thoracic RadiologyACS  American Cancer SocietyAHRQ - Agency for Healthcare Research and QualityALA  American Lung AssociationAPC - average annual percent changeATS - American Thoracic SocietyAWV  annual wellness visitBRFSS  Behavioral Risk Factor Surveillance SystemCAG  Coverage and Analysis GroupCAT  computerized axial tomographyCCI  Charlson comorbidity indexCHEST - American College of Chest PhysiciansCI - confidence intervalCME - Continuing Medical EducationCMS - Centers for Medicare &Medicaid ServicesCOPD  chronic obstructive pulmonary diseaseCOSMOS - Continuous Observation of Smoking SubjectsCT  computed tomographyCTDIvol  computed tomography dose indexCXR  chest x-rayDANTE  Detection and Screening of Early Lung Cancer by Novel Imaging Technology Molecular AssaysDLCST  DanishLung Cancer ScreeningTrialFDA  United States Food and Drug AdministrationFDCA  Federal Food, Drug, and Cosmetic ActGRADE - Grading of Recommendations Assessment, Development, and EvaluationHIV  Human Immunodeficiency VirusHR - hazard ratioIQR - interquartile rangeITALUNG - Italian Lung Cancer Screening TrialIDTF  Independent Diagnostic Testing FacilityIV - intravenousJAMA  Journal of the American Medical AssociationJNCCN  Journal of the National Comprehensive Cancer NetworkKQ  key questionkVp - kilovoltage peakLC  lung cancerLD  low doseLCSR - Lung Cancer Screening RegistryLCS - lung cancer screeningLDCT  low dose computed tomographyLSS - Lung Screening StudyLung-RADS - Lung Imaging Reporting and Data SystemLUSI - Lung Cancer Screening InterventionmAs - milliampere-secondsMCBS  Medicare Current Beneficiary SurveyMCLIR - maximum clinical incidence reductionmGy  milligraymSv  millisievertMILD  Multicentric Italian Lung DetectionMOC - Maintenance of CertificationNCA - National Coverage AnalysisNCCN  National Comprehensive Cancer NetworkNCD - National Coverage DeterminationNCI  National Cancer InstituteNCRP  National Council on Radiation Protection and MeasurementsNELSON - NederlandsLeuvens Longkanker Screenings OnderzoekNHIS - National Health Interview SurveyNIH  National Institutes of HealthNLST  National Lung Screening TrialNPI - National Provider IdentifierNSCLC  non-small cell lung cancerOR - odds ratioPCPs  primary care providers or primary care physiciansPICO - population, intervention, comparator, and outcomePLCO  Prostate, Lung, Colorectal, and Ovarian Cancer Screening TrialPLHIV - persons living with HIVPMA  premarket approval applicationPPV  positive predictive valueRCT  randomized control trialRR - rate ratio or risk ratioRRL - relative radiation levelSCLC  small cell lung cancerSEER  Surveillance, Epidemiology, and End ResultsSES - socioeconomic statusSD  standard deviationSDM  shared decision-makingSR - Society of Thoracic RadiologyT0  time zero, baseline screeningUCLA  University of California at Los AngelesUKLS - UK Lung Cancer Screening trialUS - United StatesUSPSTF  United States Preventive Services Task ForceWHO  World Health OrganizationYR(S)  year(s)YSQ - years since quittingCMS initiated this national coverage determination (NCD) to reconsider coverage under the Medicare Program for lung cancer screening with low dose computed tomography (LDCT). The scope of our review is limited to the consideration of screening for lung cancer with low dose CT. Diagnostic CTs areoutside the scope of this national coverage analysis (NCA).Lung cancer is the third most common cancer and the leading cause of cancer-related death in both men and women in the United States (NCI, 2021). It is an important issue for the Medicare population due to the age at diagnosis and age at death. In 2021, the National Cancer Institute (NCI) estimated that the number of new cases is over 235,000, with a median age at diagnosis of 71 years (NCI, 2021). Cancer of the lung and bronchus is estimated to account for over 130,000 deaths in 2021 (more than the total number of estimated deaths from colon, breast and prostate cancer combined) with a median age at death of 72 years (NCI, 2021).