Lung Cancer Screening with Low Dose Computed Tomography

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.

February 24, 2014

February 26, 2014

April 23, 2014

May 1, 2014

June 12, 2014

• Registration
• Webcast of meeting - Part 1, Part 2
• Information about visiting CMS
• Driving directions to CMS
• Recommended hotels

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  

8:00 – 8:15 AM

8:15 - 8:30 AM

8:30 – 8:50

8:50 – 9:05 AM 

9:05 – 9:20 AM

9:20 – 9:35 AM

9:35 – 9:45 AM

9:45 – 10:50 AM

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

Public Attendees who wish to address the panel will be given that opportunity

11:00 – 12:00 PM

12:00 – 1:00 PM

1:00 – 2:00 PM

2:00 – 3:00 PM

The Chairperson will ask each panel member to state his or her position on the voting questions.

3:00 – 4:00 PM

4:00 – 4:30 PM

Download meeting minutes [PDF, 133KB]

Download scoresheet.

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.

1. Reasonable and necessary for prevention or early detection of an illness or disability;
2. Either A or B grade recommendation from USPSTF; and
3. Appropriate for individuals eligible for benefits under Medicare Part A or enrolled in Medicare Part B.

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.

1. 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),

   1. 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?
   2. how confident are you that there is adequate evidence to determine that annual screening beyond 3 annual LDCT screens improves health outcomes?
   3. 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?



2. 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?




3. 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?

1. Risk factors/criteria for eligibility of screening asymptomatic individuals.
2. Frequency and duration of testing.
3. What impact will adherence have on lung cancer detection (National Lung Screening Trial adherence was 95%)?
4. Definition of a positive screen and variability of false positives and how false positives should be resolved.
5. The rate, classification and standard evaluation of incidental findings?
6. Impact of lung cancer screening on smoking cessation rates?

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

• 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