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.
CMS WILL NOT PROVIDE PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED HERE.
February 24, 2014
February 26, 2014
April 23, 2014
May 1, 2014
June 12, 2014
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]
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:
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.
Please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing
If at least intermediate confidence (score ≥ 2.5 above),
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?
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?
Rita Redberg, MD, MS ChairProfessor of MedicineUCSF School of MedicineDivision of CardiologyUniversity of California, San Francisco Medical Center
Art Sedrakyan, MD, PhD Vice ChairAssociate Professor and DirectorPatient Centered ComparativeOutcomes Research ProgramWeill Cornell Medical School
Harry Burke, MD, PhDAssociate ProfessorBiomedical Informatics and MedicineUniformed ServicesUniversity of the Health SciencesClinician, Internal Medicine ServiceWalter Reed National Military Medical Center
Allan M. Fendrick, MDProfessorDepartment of Internal MedicineUniversity of Michigan School of Public Health
Mark D. Grant, MD, PhDDirectorTechnology AssessmentTechnology Evaluation CenterCenter for Clinical EffectivenessBlue Cross Blue Shield Association
Jo Carol Hiatt, MD, MBA, FACSChairInter-Regional New Technology CommitteeKaiser Permanente
David Howard, PhDAssociate ProfessorDepartment of Health Policy and ManagementEmory University
Gail Melkus, EdD, C-NP, FAANFlorence and William DownsProfessor in Nursing ResearchDirector, Muriel and Virginia PlessCenter for Nursing Research
Curtis Mock, MD, MBASenior Medical DirectorVice President Medicare AdvantageUnitedHealthcare Medicare & Retirement
Gerald A. White, Jr., MS, FAAPM, FACRMedical PhysicistPenrose Cancer CenterSt. Mary Corwin Regional Medical Center
Martin D. Marciniak, MPP, PhDVice PresidentUS Health OutcomesGlaxoSmithKline
Guest Panel Members
V. Paul Doria-Rose, DVM, PhDEpidemiologistNational Cancer InstituteDivision of Cancer Control and Population SciencesApplied Research ProgramHealth Services and Economics Branch
Michael K. Gould, MD, MSSenior Research ScientistDirector for Health Services Research and Implementation ScienceKaiser Permanente Southern CaliforniaKaiser Permanente ResearchDepartment of Research & Evaluation
Jeffrey B. Rich, MDCardioThoracic SurgeonMid-Atlantic Cardiothoracic Surgeons, Ltd.
Steven H. Woolf, MD, MPHDirector, Center on Society and HealthProfessor, Department of Family Medicine and Population HealthVirginia Commonwealth University
Invited Guest Speakers
Laurie Fenton AmbrosePresident and CEOLung Cancer Alliance
Peter Bach, MD, MAPPAttending Physician & DirectorCenter for Health Policy and OutcomesMemorial Sloan-Kettering Cancer Center
Doug Campos-Outcalt MD, MPAChairDepartment of Family, Community and Preventive MedicineUniversity of Arizona College of Medicine, Phoenix
Paul Pinsky, MDDivision of Cancer PreventionNational Cancer InstituteNational Institute of Health
Tamara Syrek Jensen, JDActing DirectorCoverage and Analysis Group
Maria EllisCoverage and Analysis Group
*4 MINUTES PER SPEAKER*