Glycemic Control

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=36 | meeting_date=2006-08-30

Diabetes mellitus is a chronic condition associated with abnormally high levels of glucose in the blood whereas the body does not produce enough insulin or the insulin that is produced is ineffective. The blood sugar level may be monitored by the patient at various frequencies. The high blood glucose levels can sometimes be controlled with diet and exercise alone but may also require the use of insulin or other medications. The main goal of diabetes management is to control blood glucose levels and thereby to prevent the complications of diabetes. Diabetes when not well controlled is a leading cause of adult blindness, lower-limb amputation and kidney disease. The hemoglobin A1C test is a blood test that measures average blood glucose control over a three-month period that helps to identify longer-term trends in glucose levels and where adjustments in treatment are needed. The MCAC will be reviewing evidence on: (1) glycemic control using continuous glucose monitors; (2) the relationship of outpatient glucose monitoring (type and frequency) to glycemic control and/or clinical outcomes in the various Medicare populations; (3) the relationship of outpatient glycemic control to the clinical outcomes in the various Medicare populations; (4) The linearity of the effects of glycemic control; and (5) the relationship of increase hypoglycemic risk to glycemic control and/or clinical outcomes. The clinical outcomes reviewed will include blunting the progression of disease, reversing diabetic complications, and altering morbidity/mortality in the Medicare populations. The role of variables such as the type of diabetes, the therapeutic regimen employed, the age of hyperglycemic onset, the duration of diabetes, the duration of poor glycemic control, the level of hyperglycemia, and concomitant disease will be discussed. In addition to evaluating the available data, the committee will identify areas in which the current data are deficient and in which additional research is warranted.

Actions Taken: July 10, 2006 FR Notice [PDF, 76KB] Posted announcing MCAC for August 30, 2006 July 17, 2006 Posted questions [PDF, 116KB] to panel. August 25, 2006 Posted MCAC questions updated [PDF, 138KB] to panel. August 29, 2006 Posted agenda and roster . August 30, 2006 Posted technology assessment . August 31, 2006 Posted voting results [PDF, 569KB]. Please note there are 2 worksheets within the file: one for question 1 & one for questions 2-7. November 17, 2006 Posted minutes , transcript [PDF, 608KB], and presentations [ZIP, 775KB]: "Diabetes Considerations from a Medicare Contractor" and "Background Material". Agenda: Federal Register Notice Medicare Coverage Advisory Committee August 30, 2006 7:30 AM – 4:30 PM CMS Auditorium Agenda Alan M. Garber, MD, PhD, Chairperson Alex Krist, MD, Vice-Chairperson Steve Phurrough, MD, MPA, Coverage and Analysis Group Michelle Atkinson, Executive Secretary 7:30 – 8:00 AM Registration 8:00 – 8:10 AM Opening Remarks— M. Atkinson / S. Phurrough, MD, MPA/Alan Garber, MD, PhD 8:10 8:30 AM CMS Presentation of Voting Questions and Clinical Background: Sandra Jones, RN, Elizabeth Koller, MD, FACE 8:3 0 – 8:50 AM DMERC- Arthur Lervey, MD 8:50 – 9:00AM Presentation of the TA: Ethan Balk, MD MPH, Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center 9:00 – 11: 30 AM Presentations ( Refer to Presenter List) 11:30PM – 12:30PM 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. 12:30 – 1:00 PM LUNCH (on your own) 1:00 – 1:30 PM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 1:3 0 – 2:30 PM Questions to Presenters 2:30 – 3:30 PM Open Panel Deliberations: Dr. Garber 3:30 – 4:25 PM Formal Remarks and Vote The Chairperson will ask each panel member to state his or her position on the voting questions 4:25 – 4:30 PM Closing Remarks / Adjournment: Dr. Phurrough, Dr. Garber 4:30 PM ADJOURN Issue: Diabetes mellitus is a chronic condition associated with abnormally high levels of glucose in the blood whereas the body does not produce enough insulin or the insulin that is produced is ineffective. The blood sugar level may be monitored by the patient at various frequencies. The high blood glucose levels can sometimes be controlled with diet and exercise alone but may also require the use of insulin or other medications. The main goal of diabetes management is to control blood glucose levels and thereby to prevent the complications of diabetes. Diabetes when not well controlled is a leading cause of adult blindness, lower-limb amputation and kidney disease. The hemoglobin A1C test is a blood test that measures average blood glucose control over a three-month period that helps to identify longer-term trends in glucose levels and where adjustments in treatment are needed. The MCAC will be reviewing evidence on: (1) glycemic control using continuous glucose monitors; (2) the relationship of outpatient glucose monitoring (type and frequency) to glycemic control and/or clinical outcomes in the various Medicare populations; (3) the relationship of outpatient glycemic control to the clinical outcomes in the various Medicare populations; (4) The linearity of the effects of glycemic control; and (5) the relationship of increase hypoglycemic risk to glycemic control and/or clinical outcomes. The clinical outcomes reviewed will include blunting the progression of disease, reversing diabetic complications, and altering morbidity/mortality in the Medicare populations. The role of variables such as the type of diabetes, the therapeutic regimen employed, the age of hyperglycemic onset, the duration of diabetes, the duration of poor glycemic control, the level of hyperglycemia, and concomitant disease will be discussed. In addition to evaluating the available data, the committee will identify areas in which the current data are deficient and in which additional research is warranted. Minutes: MEETING MINUTES OF THE CENTERS FOR MEDICARE AND MEDICAID SERVICES MEDICARE COVERAGE ADVISORY COMMITTEE August 30, 2006 Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland Medicare Coverage Advisory Committee August 30, 2006 Attendees Alan M. Garber, MD, PhD Chairperson Alexander H. Krist, MD Vice-Chairperson Executive Secretary Michelle Atkinson Voting Members Edgar Black, MD Douglas D. Bradham, Dr. PH Margaret A. Piper, PhD, MPH James E. Puklin, MD Jonathan P. Weiner, PhD A. Mark Fendrick, MD HCFA Liason Steve Phurrough, MD, MPA Consumer Representative Charles J. Queenan, III Industry Representative Donald W. Rucker MD Guest Panel Experts Rodney A. Hayward, MD Mark E. Molich, MD Gayle E. Reiber, PhD, MPH Wednesday, August 30, 2006, 8:05 a.m. The Medicare Coverage Advisory Committee met on August 30, 2006, to discuss the evidence, hear presentations and public comment, and make recommendations regarding glycemic control and the use of glucose monitors by which sensors automatically monitor glucose levels and body fluids, and whether and how the frequency of outpatient glucose monitoring is related to glycemic control and clinical outcomes in various Medicare populations. The meeting began with a reading of conflict of interest issues and an introduction of the Committee. CMS Summary, Presentation of Voting Questions, and Clinical Background. CMS representatives presented the panel with the questions to be considered by the panel, and also presented and overview of he clinical history and CMS coverage regarding glycemic control and glucose monitoring. Presentation by Durable Medical Equipment Regional Contractor (DMERC). A presentation was offered by a representative of DMERC. Presentation of the Technology Assessment. The results of a technology assessment performed by the Tufts New England Medical Center Evidence-Based Practice Center were presented. Other Presentations. The panel heard presentations from seven additional speakers, including researchers and clinicians. After each presentation, the panel was given an opportunity to ask clarifying questions of the presenters. Scheduled Public Comments. Twelve speakers, including representatives of professional societies, manufacturers' representatives, and practicing clinicians, addressed the panel. Open Panel Deliberations. There was an extensive period where the panel discussed each question to be considered, during which several additional questions were posed to the presenters and other speakers. Discussion and Voting. The panel voted on Questions 1 through 7, with the results being recorded on individual tally sheets and compiled by staff. During the voting procedure, further discussion was held among the panelists concerning each question voted upon. Further Discussion. Following the voting, each panelist was afforded an opportunity to make comments concerning information they felt would be helpful to CMS addressing coverage issues in this area. Adjournment. The meeting adjourned at 3:09 p.m. I certify that I attended the meeting of the Medicare Coverage Advisory Committee on August 30, 2006, and that these minutes accurately reflect what transpired. /s/ Michelle Atkinson Executive Secretary, MCAC, CMS I approve the minutes of this meeting as recorded in this summary. /s/ Alan M. Garber, M.D., Ph.D. Chairperson Other Material: Transcript 1 Presentations Panel Voting Questions: Download MCAC Updated Questions [PDF, 138KB]. Download voting results [PDF, 569KB]. Roster: Alan M. Garber, MD, PhD (Chair) Director, Center for Primary Care and Outcomes Research Stanford University Stanford, CA Alexander H. Krist, MD (Vice-Chair) Department of Family Medicine Virginia Commonwealth University Richmond, VA Edgar Black, MD BlueCross BlueShield Association Chicago, IL Douglas D. Bradham, Dr. PH Director, Health Services Research and Development Center Baltimore, MD Margaret A. Piper, PhD, MPH Senior Consultant Technology Evaluation Center, BlueCross BlueShield Association Atlanta, GA James E. Puklin, MD Professor of Ophthalmology Wayne State University, School of Medicine Kresge Eye Institute Detroit, MI Jonathan P. Weiner, PhD Professor & Deputy Director Health Services Research & Development Center The Johns Hopkins University Bloomberg School of Public Health Baltimore, MD Harry B. Burke, MD, PhD Associate Professor of Medicine George Washington University School of Medicine Washington, DC A. Mark Fendrick, MD The University of Michigan Ann Arbor, MI Consumer Representative Charles J. Queenan, III Independent Management Consultant McLean, VA Industry Representative Donald W. Rucker MD Siemens Medical Solutions Malvern, PA Guest Panel Experts Rodney A. Hayward, MD Director, VA Ann Arbor Health Services Research & Development Center of Excellence Professor, Departments of Internal Medicine and Health Management & Policy Director, Measurement Core, Michigan Diabetes Research & Training Center Co- Director, RWJ Clinical Scholars Program Ann Arbor, MI Mark E. Molich, MD Professor of Medicine Northwestern University Feinberg School of Medicine Section of Endocrinology Chicago, IL Gayle E. Reiber, PhD, MPH Research Career Scientist, VA Puget Sound Health Care System, Professor of Health Services and Professor of Epidemiology University of Washington Department of Health Services Seattle, WA