Lung Cancer Screening with Low Dose Computed Tomography

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=68 | meeting_date=2014-04-30

Effective January 1, 2009, CMS is allowed to add coverage of "additional preventive services" if certain statutory requirements are met. Per Section 1861(ddd) of the Social Security Act and implementing regulations at 42 CFR 410.64, CMS may cover "additional preventive services", if it determines through the national coverage determinations (NCD) process that the service is recommended with a grade A (strongly recommends) or grade B (recommends) rating by the United States Preventive Services Task Force (USPSTF) and that it also meets certain other requirements. CMS has accepted two formal complete requests to initiate a NCA on Lung Cancer Screening with Low Dose Computed Tomography (LDCT), which is recommended with a grade B by the USPSTF for certain persons at high risk for lung cancer based on age and smoking history. The scope of our review is limited to LDCT Screening for lung cancer. We are particularly interested in evidence to inform the identification of patients eligible for screening; the appropriate frequency and duration of screening; facility and provider characteristics that predict benefit or harm; precise criteria for test positivity and the impact of false positive results and followup tests or treatments. We are also soliciting input on the influence of these factors on patient education and informed consent in Medicare beneficiaries including the elderly and younger disabled populations and persons receiving dialysis treatment for end stage renal disease; and on the integration of smoking cessation interventions for current smokers.

Actions Taken: February 24, 2014 Announced MEDCAC meeting February 26, 2014 Posted questions to panel. April 23, 2014 Posted materials for meeting: Agenda , Roster , Speakers List , Presentations , & Written Comments May 1, 2014 Posted scoresheet from meeting. June 12, 2014 Posted minutes and transcript from meeting. Registration Webcast of meeting - Part 1 , Part 2 Information about visiting CMS Driving directions to CMS Recommended hotels Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee April 30, 2014 7:30 AM - 4:30 PM CMS Auditorium Rita Redberg, MD, MSc , Chair Art Sedrakyan, MD, PhD , Vice Chair Tamara Syrek Jensen, JD , Acting Director, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 - 8:00 AM Registration 8:00 - 8:15 AM Opening Remarks— Maria Ellis/Tamara Syrek Jensen, JD/Rita Redberg, MD 8:15 - 8:30 AM CMS Presentation & Voting Questions - Joseph Chin, MD 8:30 - 8:50 Paul Pinsky, MD , Division of Cancer Prevention, National Cancer Institute, National Institute of Health 8:50 - 9:05 AM Peter Bach, MD, MAPP, Attending Physician & Director, Center for Health Policy and Outcomes, Memorial Sloan-Kettering Cancer Center 9:05 - 9:20 AM Laurie Fenton Ambrose, President and CEO, Lung Cancer Alliance 9:20 - 9:35 AM Doug Campos-Outcalt, MD, MPA, Chair, Department of Family, Community and Preventive Medicine, University of Arizona College of Medicine 9:35 - 9:45 AM BREAK 9:45 - 10:50 AM Scheduled Public Comments (Refer to Speaker List) Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. 10:50 - 11:00 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:00 - 12:00 PM Questions to Presenters 12:00 - 1:00 PM LUNCH (on your own) 1:00 - 2:00 PM Initial Open Panel Discussion: Dr. Redberg 2:00 - 3:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions. 3:00 - 4:00 PM Final Open Panel Discussion: Dr. Redberg 4:00 - 4:30 PM Closing Remarks/Adjournment: Tamara Syrek Jensen & Dr. Redberg Associated Nca: Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) Issue: Effective January 1, 2009, CMS is allowed to add coverage of "additional preventive services" if certain statutory requirements are met. Per Section 1861(ddd) of the Social Security Act and implementing regulations at 42 CFR 410.64, CMS may cover "additional preventive services", if it determines through the national coverage determinations (NCD) process that the service is recommended with a grade A (strongly recommends) or grade B (recommends) rating by the United States Preventive Services Task Force (USPSTF) and that it also meets certain other requirements. CMS has accepted two formal complete requests to initiate a NCA on Lung Cancer Screening with Low Dose Computed Tomography (LDCT), which is recommended with a grade B by the USPSTF for certain persons at high risk for lung cancer based on age and smoking history. The scope of our review is limited to LDCT Screening for lung cancer. We are particularly interested in evidence to inform the identification of patients eligible for screening; the appropriate frequency and duration of screening; facility and provider characteristics that predict benefit or harm; precise criteria for test positivity and the impact of false positive results and followup tests or treatments. We are also soliciting input on the influence of these factors on patient education and informed consent in Medicare beneficiaries including the elderly and younger disabled populations and persons receiving dialysis treatment for end stage renal disease; and on the integration of smoking cessation interventions for current smokers. Minutes: Download meeting minutes [PDF, 133KB] Other Material: Transcript 1 Written Comments Panel Voting Questions: Download scoresheet . April 30, 2014 MEDCAC Lung Cancer Screening with Low Dose Computed Tomography (LDCT) in Adult Smokers The focus of this MEDCAC meeting is on lung cancer early detection (screening) with low dose computed tomography (LDCT) in asymptomatic adults with histories of significant smoking. CMS is particularly interested in evidence that informs the identification of eligible Medicare patients who are most likely to benefit from screening; the appropriate frequency and duration of screening; facility and provider characteristics that optimize patient benefits or minimize patient harms; precise criteria for identifying a test as positive and the impact of false positive results and follow-up tests or treatments. We are also soliciting input on the influence of these factors on patient education and informed consent in Medicare beneficiaries which include the elderly and younger disabled populations and persons receiving dialysis treatment for end stage renal disease; and on the integration of smoking cessation interventions for current smokers. Medicare Coverage of Preventive Services Section 1861(ddd) of the Social Security Act (and implementing regulations at 42 CFR 410.64 (a)) authorizes the Secretary to cover “additional preventive services” if determined via the Medicare national coverage determination (NCD) process, that all of the following criteria are met: Reasonable and necessary for prevention or early detection of an illness or disability; Either A or B grade recommendation from USPSTF; and Appropriate for individuals eligible for benefits under Medicare Part A or enrolled in Medicare Part B. The December 2013 United States Preventive Services Task Force (USPSTF) Recommendation The USPSTF recommends annual screening for lung cancer with low-dose computed tomography in adults ages 55 to 80 years who have a 30 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. Grade: B recommendation. The USPSTF recommendation is based largely on results of the National Lung Screening Trial (NLST), which found benefit of a screening program (3 annual LDCTs) in high risk individuals. The NLST enrolled patients who were “between 55 and 74 years of age at the time of randomization, had a history of cigarette smoking of at least 30 pack-years, and, if former smokers, had quit within the previous 15 years.” Of the participants, 26.6% were 65-74 years of age at enrollment. The extension of the USPSTF recommendation to adults from 75 to 80 years of age and annual screening beyond 3 years was based primarily on modeling with no data from NLST. Questions remain regarding the application of the available evidence to the Medicare population; and the likelihood that community based screening would replicate the positive results of the NLST without the safeguards of a rigorous randomized controlled trial, such as strict inclusion and exclusion criteria and training and accreditation of CT reading. Inherent to these questions are the ability to accurately identify high risk individuals in practice, patient adherence to lung cancer screening programs, the definition of a positive finding, and impact of incidental findings on scans that may lead to unnecessary invasive procedures and adverse events. Voting Questions Please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence. How confident are you that there is adequate evidence to determine if the benefits outweigh the harms of lung cancer screening with LDCT [CT acquisition variables set to reduce exposure to an average effective dose of 1.5 mSv (please see footnotes)] in the Medicare population? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence If at least intermediate confidence (score ≥ 2.5 above), how confident are you that there is adequate evidence to determine that screening in asymptomatic high risk adults over 74 years of age improves health outcomes? how confident are you that there is adequate evidence to determine that annual screening beyond 3 annual LDCT screens improves health outcomes? how confident are you that there is adequate evidence to determine that a lung cancer screening program implemented outside a clinical study improves health outcomes? How confident are you that the harms of lung cancer screening with LDCT (average effective dose of 1.5 mSv) if implemented in the Medicare population will be minimized? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Discussion: What harms are likely to be relevant in the Medicare population, including (a) harms from the LDCT itself , (b) harms from follow-up diagnostic evaluation of findings in the lungs and incidental findings outside the lungs, and (c) harms from treatment arising from positive and false positive results? What provider and facility criteria or protocols are helpful in minimizing harms? How confident are you that clinically significant evidence gaps remain regarding the use of LDCT (average effective dose of 1.5mSv) for lung cancer screening in the Medicare population outside a clinical trial? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Discussion: If there is at least intermediate confidence (score ≥ 2.5 above), please discuss any significant gaps identified and how CMS might support their closure. Additional Discussion Question Please discuss whether these or other topics should be considered for further research in the beneficiary population. If yes, why? Risk factors/criteria for eligibility of screening asymptomatic individuals. Frequency and duration of testing. What impact will adherence have on lung cancer detection (National Lung Screening Trial adherence was 95%)? Definition of a positive screen and variability of false positives and how false positives should be resolved. The rate, classification and standard evaluation of incidental findings? Impact of lung cancer screening on smoking cessation rates? One millisievert (mSv) is defined as the dose produced by the exposure to 1 milligray (mGy) of radiation. The National Council on Radiation Protection and Measurements (NCRP) reported that the average annual radiation exposure from natural sources in the U.S. was about 3.1 mSv in 2009. The median effective radiation dose from a routine, diagnostic chest CT without contrast was reported as 8 mSv [interquartile range: 5-11 mSv (San Francisco)] (Smith-Bindman, 2009). Roster: Rita Redberg, MD, MS Chair Professor of Medicine UCSF School of Medicine Division of Cardiology University of California, San Francisco Medical Center Art Sedrakyan, MD, PhD Vice Chair Associate Professor and Director Patient Centered Comparative Outcomes Research Program Weill Cornell Medical School Harry Burke, MD, PhD Associate Professor Biomedical Informatics and Medicine Uniformed Services University of the Health Sciences Clinician, Internal Medicine Service Walter Reed National Military Medical Center Allan M. Fendrick, MD Professor Department of Internal Medicine University of Michigan School of Public Health Mark D. Grant, MD, PhD Director Technology Assessment Technology Evaluation Center Center for Clinical Effectiveness Blue Cross Blue Shield Association Jo Carol Hiatt, MD, MBA, FACS Chair Inter-Regional New Technology Committee Kaiser Permanente David Howard, PhD Associate Professor Department of Health Policy and Management Emory University Gail Melkus, EdD, C-NP, FAAN Florence and William Downs Professor in Nursing Research Director, Muriel and Virginia Pless Center for Nursing Research Curtis Mock, MD, MBA Senior Medical Director Vice President Medicare Advantage UnitedHealthcare Medicare & Retirement Gerald A. White, Jr., MS, FAAPM, FACR Medical Physicist Penrose Cancer Center St. Mary Corwin Regional Medical Center Industry Representative Martin D. Marciniak, MPP, PhD Vice President US Health Outcomes GlaxoSmithKline Guest Panel Members V. Paul Doria-Rose, DVM, PhD Epidemiologist National Cancer Institute Division of Cancer Control and Population Sciences Applied Research Program Health Services and Economics Branch Michael K. Gould, MD, MS Senior Research Scientist Director for Health Services Research and Implementation Science Kaiser Permanente Southern California Kaiser Permanente Research Department of Research & Evaluation Jeffrey B. Rich, MD CardioThoracic Surgeon Mid-Atlantic Cardiothoracic Surgeons, Ltd. Steven H. Woolf, MD, MPH Director, Center on Society and Health Professor, Department of Family Medicine and Population Health Virginia Commonwealth University Invited Guest Speakers Laurie Fenton Ambrose President and CEO Lung Cancer Alliance Peter Bach, MD, MAPP Attending Physician & Director Center for Health Policy and Outcomes Memorial Sloan-Kettering Cancer Center Doug Campos-Outcalt MD, MPA Chair Department of Family, Community and Preventive Medicine University of Arizona College of Medicine, Phoenix Paul Pinsky, MD Division of Cancer Prevention National Cancer Institute National Institute of Health CMS Liaison Tamara Syrek Jensen, JD Acting Director Coverage and Analysis Group Executive Secretary Maria Ellis Coverage and Analysis Group Speakers List: Medicare Evidence Development & Coverage Advisory Committee April 30, 2014 SPEAKER LIST *4 MINUTES PER SPEAKER* Albert A. Rizzo, MD, FACP, FACCP, D’ABSM, Medical Director of E-ICU, Section Chief, Pulmonary/Critical Care Medicine, Christiana Care Health System and Past-Chair, National Board of Directors, American Lung Association – No PowerPoint Elbert Kuo, MD, MPH, MMS, FACS , Director of the Minimally Invasive & Robotic Program, Director of the Lung Cancer Screening and Mediastinal Staging Programs, St. Joseph’s Hospital and Medical Center Michael McNitt-Gray, PhD, DABR, FAAPM , Chair, CT Subcommittee, AAPM, Professor, Department of Radiology, Director, Biomedical Physics Graduate Program, David Geffen School of Medicine at UCLA Claudia I. Henschke, PhD, MD , Professor of Radiology, Icahn School of Medicine at Mount Sinai, New York NY, Principal Investigator of ELCAP, NY-ELCAP, & I-ELCAP Ella Kazerooni, MD, MS , Professor & Director, Division of Cardiothoracic Radiology, Vice-Chair, Department of Radiology, University of Michigan Andrea McKee, MD , Chair, Radiation Oncology, Robert Faust, MD, Associate Program Director, Internal Medicine Residency and Carla Lamb, MD, FACP, FCCP, Director, Interventional Pulmonology, Lahey Hospital and Medical Center Douglas E. Wood, MD , Professor and Chief, Division of Cardiothoracic Surgery, Vice-Chair, Department of Surgery, Endowed Chair in Lung Cancer Research, University of Washington Charles S. White, MD , Society of Thoracic Radiology, Past-President, Director, Cardiothoracic Imaging, Department of Radiology, University of Maryland Richard A. Frank, MD, PhD , Chief Medical Officer, Siemens Healthcare USA, Chair, MITA Coverage Committee, Medical Imaging & Technology Alliance (MITA) Vickie Beckler, RN , Lung Cancer Screening Coordinator, WellStar Health System Richard Wender, MD , Chief Cancer Control Officer, American Cancer Society Jody Ruth Steinhardt, MPH, CHES , Coordinator, Maimonides Medical Center Dan J. Raz, MD, MAS , Division of Thoracic Surgery, Director, Tobacco Exposure Program, Co-Director, Lung Cancer and Thoracic Oncology Program, City of Hope Medical Center Francine Jacobson, MD , Co-Chair, Assistant Professor of Radiology and Michael Jaklitsch, MD , Co-Chair, Associate Thoracic Surgeon, Brigham and Women’s Hospital Bruce Pyenson, FSA, MAAA, Principal & Consulting Actuary, Milliman, Inc. James L. Mulshine, MD , Professor, Internal Medicine, Dean, Graduate College (Acting), Associate Provost for Research, Vice President Research, Rush University