evekhm/cms_iom_500 huggingface dataset:
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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 Memo
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
TO: 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 Criteria
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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 Association
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
HR - 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 quitting
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
UKLS - 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).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
(NCI, 2021)Overall mortality rates for lung and bronchus cancer have decreased over the past decade, averaging 3.8% each year over 20102019 (NCI, 2021). The majority of cases are still diagnosed at a late stage with a low five-year relative survival (NCI, 2021). Most patients diagnosed with lung cancer present with distant or metastatic disease; less than 20% are diagnosed with localized (i.e., stage 1) disease (NCI, 2021). Patients with localized disease have a 60% five-year survival rate, compared with 33% for those with regional spread to lymph nodes and 6% for those with distant pulmonary metastases (NCI,2021).Lung cancer has a generally poor prognosis, with overall observed five-year relative survival of 22.1% in 2013 (NCI, 2021). However, early-stage lung cancer has a better prognosis and is more amenable to treatment (USPSTF, Krist; 2021). By leading to earlier detection and treatment, screening for lung cancer can give patients a greater chance for cure (USPSTF, Krist; 2021).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
(Stage and Survival for Lung Cancer; NCI, 2021)Lung cancer is a proliferation of malignant cells arising in the tissues or airways of the lungs. Lung cancer has traditionally been classified into 2 major categories based on cell type and immunohistochemical and molecular characteristics: (1) nonsmall cell lung cancer (NSCLC), which collectively comprises adenocarcinoma, squamous cell carcinoma, and large cell carcinoma (ACS, Lung Cancer; 2019), and (2) small cell lung cancer, which is more aggressive and has worse survival rates (Jonas, 2021; Travis, 2015; USPSTF, Krist; 2021). About 80% to 85% of lung cancers are non-small cell lung cancer (NSCLC) (ACS, Lung Cancer; 2019). These subtypes, which start from different types of lung cells are grouped together as NSCLC because their treatment and prognoses (outlook) are often similar. About 10% to 15% of all lung cancers are small cell lung cancer (SCLC) (ACS, Lung Cancer; 2019). This type of lung cancer tends to grow and spread faster than NSCLC. About 70% of people with SCLC will have cancer that has already spread at the time they are diagnosed (ACS, Lung Cancer; 2019). Screening is aimed at early detection of NSCLC rather than small cell lung cancer because the latter is much less common and typically spreads too quickly to be reliably detected at an early, potentially curable stage by screening (USPSTF, Krist; 2021).
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
The most important risk factor for lung cancer is smoking (Alberg, 2013). The risk of developing lung cancer is largely driven by age and smoking status, with smoking estimated to account for nearly 90% of all lung cancer cases (ACS, Risk Factors, 2019; Alberg, 2013; Siegel, 2021; USPSTF, Krist, 2021), with a relative risk of developing lung cancer approximately 20-fold higher in smokers than in nonsmokers (Samet, 1992). Just as important, older age is also associated with increasing incidence of lung cancer (USPSTF, Krist; 2021). Other risk factors for lung cancer include environmental exposures such as radon and asbestos, radiation therapy, other (noncancer) lung diseases, race/ethnicity, and family history (ACS, Risk Factors, 2019; Jonas, 2021). About 80% of lung cancer deaths are thought to result from smoking (ACS, Risk Factors; 2019).Computed TomographyThe National Institutes of Health (NIH) National Cancer Institute (NCI) describes computed tomography (CT) as an imaging procedure that uses special x-ray equipment to create detailed pictures, or scans, of areas inside the body. It is sometimes called computerized tomography or computerized axial tomography (CAT). . . . Each picture created during a CT procedure shows the organs, bones, and other tissues in a thin slice of the body. The entire series of pictures produced in CT is like a loaf of sliced breadyou can look at each slice individually (2-dimensional pictures), or you can look at the whole loaf (a 3-dimensional picture). Computer programs are used to create both types of pictures. Modern CT machines take continuous pictures in a helical (or spiral) fashion rather than taking a series of pictures of individual slices of the body, as the original CT machines did. Helical CT (also called spiral CT) has several advantages over older CT techniques: it is faster, produces better quality 3-D pictures of areas inside the body, and may detect small abnormalities better (NIH, NCI; 2019).United States Preventive Services Task Force (USPSTF)
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
United States Preventive Services Task Force (USPSTF)In 2021, the most recent recommendation was released to update its 2013 recommendation: The 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).The USPSTF assigns one of five letter grades to each of its recommendations (A, B, C, D, I). The following tables from Moyer et al. (2014) on behalf of the USPSTF provide the current grade definitions and descriptions of levels of certainty after July 2012.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
(Moyer, 2014)(Moyer, 2014)III. History of Medicare CoveragePursuant to 1861(ddd)(1) of the Act, the Secretary may add coverage of "additional preventive services" if certain statutory requirements are met. Specifically, the definition of additional preventive services permits coverage under Medicare Part B for certain services that were not already included as preventive services and 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 under Part B.We have established regulations implementing this statute that are codified at 42 CFR  410.64.CMS issued an NCD on February 5, 2015 establishing coverage for lung cancer screeningwith LDCT. The NCD includes beneficiary eligibility criteria, a counseling and shared decision-making visit, reading radiologist eligibility criteria, and radiology imaging facility eligibility criteria.The policy is codified in section 210.14 of the Medicare National Coverage Determinations (NCD) Manual (Pub. 100-03). Section 210.14 of the NCD Manual is included in Appendix C.A. Current RequestCMS received a complete, formal joint request to reconsider the Lung Cancer Screening with Low Dose Computed Tomography (LDCT) NCD from the GO2Foundation for Lung Cancer, The Society of Thoracic Surgeons, and American College of Radiology (ACR).The request letter is available athttps://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=304B. Benefit CategoryMedicare is a defined benefit program. For an item or service to be covered by the Medicare program, it must fall within one of the statutorily defined benefit categories outlined in the Act. CMS is authorized to cover "additional preventive services" if certain statutory requirements are met as provided under 1861(ddd) of the Social Security Act.IV. Timeline of Recent ActivitiesDateActions TakenMay 18, 2021
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
DateActions TakenMay 18, 2021CMS initiates this national coverage analysis. A 30-day public comment period begins.June 17, 2021First public comment period ends. CMS receives 170 comments.November 17, 2021Proposed Decision Memorandum posted. 30-day public comment period begins.December 17, 2021Second public comment period ends.  CMS receives 49 public comments.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
V. Food and Drug Administration (FDA) StatusCT imaging systems and post-processing software go through the 510(k) process at the FDA to obtain clearance for commercial distribution. To obtain 510(k) clearance, the sponsor must demonstrate that the device is substantially equivalent in terms of its intended use, technological characteristics, and safety and effectiveness to CT systems previously cleared or on the market prior to the 1976 Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) that do not require approval of a premarket approval application (PMA). FDA has authorized CT systems with indications for low-dose lung cancer screening.Counseling services are not generally under the purview of the FDA.VI. General Methodological PrinciplesWhen making national coverage determinations concerning additional preventive services, CMS applies the statutory criteria in  1861(ddd) of the Social Security Act and regulations at 42 CFR 410.64, and evaluates relevant clinical evidence to determine whether or not the service is reasonable and necessary for the prevention or early detection of illness or disability, is recommended with a grade of A or B by the USPSTF, and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B of the Medicare program.VII. EvidenceThe evidence summarized in this section includes the peer-reviewed, published clinical research pertinent to lung cancer screening with LDCT. Our assessment focuses on the key evidence questions below.1. Evidence QuestionsQuestion 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?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?Question 3: Is the evidence sufficient to determine that screening for lung cancer with low dose computed tomography is appropriate for Medicare beneficiaries?2. External Technology AssessmentsCMS did not request an external technology assessment (TA) on this issue.3. Internal Technology AssessmentLiterature Search Methods