DTS Cleared Blood Glucose Monitors Surveillance Program: Payer's Meeting

November 5, 2014 at the Residence Inn Bethesda Downtown

Bethesda, Maryland

AGENDA

            09:15              Welcome
                                    David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
                                    Mills-Peninsula Health Services, San Mateo, California

Session 1: Performance of Currently Cleared Blood Glucose Monitors

                                    Moderator
                                    Robert Vigersky, MD, Colonel, Medical Corps
                                    Walter Reed National Medical Center, Bethesda, Maryland

            09:20              Current Status of Cleared Blood Glucose Monitor Accuracy
                                    Mitchell Scott, PhD
                                    Washington University, Saint Louis, Missouri
                                   
            09:40              Performance Data for Blood Glucose Monitors
                                    Andreas Pfützner, MD, PhD          
                                    Pfützner Science & Health Institute, Mainz, Germany

Session 2: Clinical Outcomes from Poorly Performing Blood Glucose Monitors

                                    Moderator
                                    Courtney Lias, PhD
                                    U.S. Food and Drug Administration, Silver Spring, Maryland

            10:00              Modeled Outcomes from Poorly Performing Blood Glucose Monitors
                                    Boris Kovatchev, PhD
                                    University of Virginia, Charlottesville, Virginia

            10:20              How Patients are Affected by Poorly Performing Blood Glucose Monitors
                                    Robert Vigersky, MD, Colonel, Medical Corps
                                    Walter Reed National Medical Center, Bethesda, Maryland

            10:40              Break

Session 3: The Need for Surveillance of Cleared Blood Glucose Monitors

                                    Moderator   
                                    David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
                                    Mills-Peninsula Health Services, San Mateo, California

            11:05              Regulatory Considerations for Cleared Blood Glucose Monitors
                                    Courtney Lias, PhD
                                    U.S. Food and Drug Administration, Silver Spring, Maryland
                                   
            11:20              The DTS Surveillance Program for FDA-Cleared Blood Glucose Monitors
                                    David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
                                    Mills-Peninsula Health Services, San Mateo, California

            11:35              How Payers View Product Performance
                                    Patricia Salber, MD, MBA
                                    Health Tech Hatch, Larkspur, California

            11:50              Current Trends in Payer Preferences
                                    Todd Prewitt, MD
                                    Humana, Louisville, Kentucky

            12:05              Q&A

            12:20              Lunch

Session 4: Patient Perspectives on Blood Glucose Monitoring

                                    Moderator
                                    Robert Vigersky, MD, Colonel, Medical Corps
                                    Walter Reed National Medical Center, Bethesda, Maryland

            13:25              Panel Discussion
                                    Christel Marchand Aprigliano
                                    StripSafely, Tampa, Florida

                                    LaVonne Clark
                                    Bethesda, Maryland

                                    Mark Ginevan
                                    Bethesda, Maryland

                                    Manny Hernandez
                                    Diabetes Hands, Berkeley, California

                                    Matthew Lewin
                                    Bethesda, Maryland

                                    Amy Tenderich
                                    Diabetes Mine, San Francisco, California

            13:55              Break

Session 5: Liability for Prescribing Non-Compliant Blood Glucose Monitors

                                    Moderator
                                    David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
                                    Mills-Peninsula Health Services, San Mateo, California

            14:20              Panel Discussion
                                    Eric Lasker
                                    Hollingsworth, Washington, DC

                                    Joshua Levy
                                    Cunningham Levy, Washington, DC
                       
                                    Peter Pilszka
                                    Fasken Martineau, Toronto, Ontario, Canada

            15:20              Meeting Summary                         
                                    David Klonoff, MD, FACP, FRCP (Edin), Fellow AIMBE
                                    Mills-Peninsula Health Services, San Mateo, California

           
            15:30              Adjourn

William Clarke, PhD, MBA, DABCC
Dr. Clarke received his Ph.D. in Analytical Chemistry from the University of Nebraska in Lincoln in 2000, followed by a post-doctoral fellowship in Clinical Chemistry at the Johns Hopkins School of Medicine, ending in 2002.  In addition, he received an MBA focused on medical services management from the Carey School of Business at Johns Hopkins in 2007.  Following his post-doctoral fellowship, he remained at Johns Hopkins, where he is an Associate Professor in the Department of Pathology, as well as the director of both Point-of-Care Testing and Clinical Toxicology for the hospital.  Dr. Clarke is board certified in Clinical Chemistry by the American Board of Clinical Chemistry, and is a Fellow of the National Academy of Clinical Biochemistry.  His research interests include clinical mass spectrometry, method development and evaluation for therapeutic drug monitoring, clinical toxicology, point-of-care testing, and development/validation of biomarkers for use in drug management.  Dr. Clarke has published as author or co-author over 80 peer-reviewed manuscripts or book chapters.

Karen W. Dyer, MT (ASCP) DLM
Karen Dyer is the Deputy Director of the CLIA program at CMS. She is a registered Medical Technologist with certification in Laboratory Management. She received a BA degree from the University of Maryland Baltimore County in Health Science and Policy. Prior to joining the CLIA program at CMS, Karen was employed by the Johns Hopkins Hospital Medical Laboratories, as an Affiliate Laboratory Supervisor and Point of Care Testing Coordinator.

Tony Furnary, MD
Cardiothoracic surgeon Tony Furnary is the senior surgeon and chief operating officer of Starr-Wood Cardiac Group in Portland, Oregon. Dr. Furnary is the Director of the Portland Diabetes Project – the pioneering study of tight glycemic control that began in 1987. Both the Wall Street Journal and New York Times have lauded Professor Furnary’s groundbreaking discoveries in glycemic control. He was named as a runner-up in the Wall Street Journal’s Medical Innovator of the Year award in 2005 for his work on the Portland Protocol. Professor Furnary is the author of more than 100 original scientific publications, three book chapters and has given hundreds of lectures around the globe.  

Jeffrey I Joseph, DO
Jeffrey I Joseph, D.O. is the Vice-Chairman and Director of Research in the Department of Anesthesiology of Thomas Jefferson University in Philadelphia, PA.  Dr. Joseph is a Professor of Anesthesiology and Director of the Jefferson Artificial Pancreas Center and the Anesthesiology Program for Translational Research.  His research has focused on the development and testing of minimally invasive and long-term implantable glucose monitoring systems, insulin delivery systems, closed-loop AP systems, vital sign monitoring systems, and glucose monitoring systems for the hospital. He is a co-founder of Animas Corporation (long-term implantable optical blood glucose monitoring system and external insulin pumps), RTM Vital Signs, Inc. (long-term implantable vital sign sensors with diagnostic algorithms and real-time data to a central monitoring station), and Capillary Biomedical, Inc. (long-term implantable ISF glucose monitoring system). 

Victoria A. Kark, RN, MSN, CCRN, CCNS, CSC
Victoria Kark has been a nurse for 40 years and is currently employed at Walter Reed National Military Medical Center as the Clinical Nurse Specialist for Critical Care and the Wounded Warriors Program.  Vicky is a graduate of Alexandria Hospital School of Nursing (diploma), The University of Maryland (BSN), and The Catholic University of America (MSN). Publications include articles on critical care, trauma, palliative care and cardiac surgery topics.  Vicky lectures for the Greater Washington Area Chapter of  AACN, and at the AACN National Teaching Institute, as well as  multiple local, regional, and national meetings. Vicky is the only two time recipient of advance for nurses’ best nursing team award for two different cardiac surgery intensive care units. She has been on the faculty at Georgetown University (8 years) and Columbia Union College (13 years). Previous jobs have included: WRAMC, Washington Adventist Hospital, Suburban Hospital and Dimensions Healthcare System. She has been certified as a critical care nurse (CCRN) since 1978, and is also certified as a clinical nurse specialist (CCNS) and in cardiac surgery (CSC).

Mary Korytkowski, MD
Dr. Mary Korytkowski is a professor of medicine and interim chief of the Division of Endocrinology at the University of Pittsburgh School of Medicine.  She also serves as the Chair of the UPMC Diabetes InPatient Safety Committee and as Director of Quality Improvement in the Division of Endocrinology. 

Dr. Korytkowski received her MD from the University of North Carolina at Chapel Hill.  She completed her residency in internal medicine at Baltimore City Hospital (now named Bayview Medical Center).  She completed her fellowship training in endocrinology and metabolism at Johns Hopkins University Hospital and Sinai Hospital of Baltimore.

Dr. Korytkowski has over 100 publications relating to her areas of research interest that include contributors to insulin resistance in individuals with or at risk for type 2 diabetes; interventions that promote glycemic and metabolic control in these groups; and inpatient glycemic management. 

She serves on the editorial board for the Journal of Clinical Endocrinology and Metabolism and as associate editor of the British Medical Journal Open–Diabetes Research & Care.  She serves on the Research Grant Review Committee for the American Diabetes Association and will serve on ABIM Endocrinology Board’s Examination Writing Committee beginning in the fall of 2014.

Courtney H. Lias, PhD
Dr. Lias studied at the Johns Hopkins University School of Medicine where she received her Ph.D. in Biochemistry, Cellular, and Molecular Biology.  After leaving Johns Hopkins in 2003, she joined the FDA’s Center for Devices and Radiological Health in the Office of In Vitro Diagnostics and Radiological Health.  Currently, as the Director of the Division of Chemistry and Toxicology devices, she is involved in many diverse activities including premarket clearance/approval, manufacturer assistance, post market regulatory compliance actions, and the development of FDA Guidance for diagnostic devices.  In addition, she has been an ongoing participant in multi-center FDA working groups focused on the developing fields of cardiovascular disease diagnosis, diabetes diagnosis/monitoring, clinical genetic testing, and biomarker development/validation.

Stanley A. Nasraway, Jr., MD, FCCM
Stanley Nasraway is Professor of Surgery, Medicine, and Anesthesia, Tufts University School of Medicine, Boston, Massachusetts. He is Director of the Surgical Intensive Care Units at the Tufts Medical Center in Boston. His interests are in sepsis and shock resuscitation, processes of care and outcomes research, and glycemic control and glucose monitoring. He is the recipient of 6 teaching awards from Tufts University School of Medicine and the Tufts Medical Center Surgical Chief Residents.  He has authored over 100 published articles and abstracts on topics in critical care medicine and is a member of the Editorial Board for Critical Care Medicine.  A fellow of the American College of Critical Care Medicine, the American College of Physicians, and the American College of Chest Physicians, he has received 8 Presidential Citations from the Society of Critical Care Medicine. 

James H. Nichols, Ph.D., DABCC, FACB
James Nichols is a Professor of Pathology, Microbiology, and Immunology and Medical Director of Clinical Chemistry at Vanderbilt University School of Medicine.  Dr. Nichols received his B.A. in General Biology/Premedicine from Revelle College, University of California at San Diego.  He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign.  Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN.  He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry.  Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions.  Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine.  Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.

Deborah A. Perry, MD
Dr. Perry is a board certified anatomic and clinical pathologist with subspecialty board certification in Hematology and Pediatric Pathology.  She is the medical director of pathology at The Children’s Hospital and Medical Center and a pathologist at Nebraska Methodist Hospital and Women’s Hospital, all in Omaha, Nebraska.

She is currently the chair of the College of American Pathologists (CAP) Point-of-Care testing committee, has previously served on the CAP Hematology Resource committee, Publications committee and is an active member of the CAP Spokesperson Network.  She was recently awarded a CAP excellence in teaching award for serving as a facilitator for the Laboratory Medical Director Advanced Practical Pathology Program.  She is active in the Society for Pediatric Pathology (SPP), previously serving as President and as secretary-treasurer.  Dr. Perry served as the president of the Children’s Hospital medical staff for two years.  She has served on the Children’s hospital board, Metro Omaha Medical Society Board and is currently on the Nebraska Leukemia and Lymphoma Society Board.

Arleta Rewers, MD, PhD
Dr. Arleta Rewers graduated from the Academy of Medicine in Poznan, Poland, in 1981 and received her PhD in 1990. She completed residency in Pediatrics and a fellowship in Pediatric Emergency Medicine at the University of Colorado Denver.  She is an Associate Professor of Pediatrics and Emergency Medicine at the University of Colorado Denver. Dr. Rewers works as an attending physician in a busy Pediatric Emergency Department at the Children’s Hospital of Colorado that provides emergency care to approximately 80 000 children annually. Dr. Rewers serves on the Hospital Insulin Task Group charged with the responsibility to improve processes of care in order to reduce the rate of hypoglycemia and other acute complications among inpatients. Her research in Pediatric Emergency Medicine is focused on complications of diabetes – diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic nonketotic syndrome and severe hypoglycemia. She has published on the epidemiology of acute diabetic complications, modifications of treatment protocols for DKA, and new technological modalities in prevention and treatment of DKA. Dr. Rewers has been a successful collaborator on several clinical trials including the multicenter NIH-funded “FLuid therapies Under Investigation in DKA” study.

Mark J. Rice, MD
Dr. Rice received his MD degree from the University of Wisconsin School of Medicine and is Associate Professor of Anesthesiology at the University of Florida College of Medicine. He is the current section chief for the division of general surgery and past chief of the liver transplantation division. His academic interests include the accuracy, interferences, and statistical analysis of point-of-care blood analyte measurement devices. He has published numerous research articles, reviews, and editorials regarding the use and statistical analysis of various glucose and hemoglobin POC devices.

Robert Rushakoff, MD
Dr. Rushakoff is Professor of Medicine in the Division of Endocrinology and Metabolism at the University of California, San Francisco (UCSF).  He earned a medical degree and master's degree in pharmacology at the Medical College of Wisconsin and completed a residency in internal medicine at UCSF Medical Center at Mount Zion. He completed a research endocrinology fellowship at UCSF and clinical endocrinology fellowship Cedars-Sinai Medical Center in Los Angeles.

Dr. Rushakoff implemented changes in inpatient diabetes management over 25 years ago, changes that many institutions are often just starting to move to now.  15 years ago, he and his group were the first to have mandatory interactive internet based training for nurses and other medical providers.  A current interest is in leveraging use of electronic medical record systems to improve inpatient diabetes management.  The result has been the “virtual inpatient glucose management service” at UCSF that has led to a significant decrease in patients with elevated glucoses and now ongoing improvement in medical provider ordering behavior.

David B. Sacks, MB ChB
David B. Sacks is a Senior Investigator and Chief of Clinical Chemistry at the National Institutes of Health.  Dr. Sacks obtained his medical degree from the University of Cape Town, South Africa.  Further training included residencies in both Internal Medicine at hospitals affiliated with Georgetown Medical School and in Clinical Pathology at Washington University School of Medicine.  He spent 21 years at Harvard Medical School.

Dr. Sacks’s primary clinical focus is in diabetes mellitus, with an emphasis on the interface between the clinical laboratory and patient care. He chaired the CLSI committees for both the 2nd and 3rd editions of POCT Blood Glucose Testing (C30-A and POCT12) and is a liaison to the ISO/TC 212 Working Group. In addition, he serves on or chairs several other national and international committees. Dr. Sacks has authored over 170 research publications in peer-reviewed journals.  He is an Associate Editor of Clinical Chemistry and is a member of several other editorial boards. He was elected a Fellow of the Royal College of Pathologists in 1998.

Garry Tobin, MD
Dr. Tobin received his M.D. from Washington University School of Medicine in 1985 and completed training in internal medicine at Barnes Hospital in 1988 and a fellowship in Endocrinology and Metabolism in 1990. My medical career has subsequently focused on the delivery of care for a wide variety of diabetic patients and on the delivery of post graduate education. After completing my fellowship in endocrinology and metabolism at Washington University School of medicine, I joined the Grant Medical clinic in Midtown Saint Louis and was an adjunct clinical faculty at Washington University School of Medicine. I left the Grant Medical Clinic to take the position as director of the Washington University School of Medicine Diabetes Center at Barnes Jewish Hospital in July 2006. My research interests focus on the delivery of safe diabetes care in the hospital setting, new onset diabetes after transplantation and reinforcing the infrastructure for the care of the diabetes patient in the community.  Society Memberships include: American College of Physician, American Diabetes Association and the American College of Endocrinology.  Awards include: The Neville Grant Award for Clinical Excellence from the Medical staff at Barnes Jewish Hospital and the President’s award from the Barnes Jewish Foundation for the work predicting and preventing severe hypoglycemia in the hospital. 

David Klonoff, MD, FACP, Fellow AIMBE
Dr. Klonoff is an endocrinologist specializing in diabetes technology. He is a Clinical Professor of Medicine at UCSF and the Medical Director of the Dorothy L. and James E. Frank Diabetes Research Institute of Mills-Peninsula Health Services in San Mateo, California. Dr. Klonoff received an FDA Director’s Special Citation Award in 2010 for outstanding contributions related to diabetes technology. He has been cited as being in the top 1% of endocrinologists nationally by US News & World Report in collaboration with Castle Connolly Medical Ltd. and as best endocrinologist in San Mateo County by Bay Area Consumer Checkbook. In 2012 Dr. Klonoff was elected as a Fellow of the American Institute of Medical and Biological Engineering (AIMBE) and cited as one of the 1000 top bioengineers in the world, as well as among the top 2% of the world’s bioengineers for his engineering work in diabetes technology. He received the 2012 Gold Medal Oration and Distinguished Scientist Award from the Dr. Mohan’s Diabetes Specialities Centre and Madras Diabetes Research Foundation of Chennai, India. Dr. Klonoff is the Founding Editor-in-Chief of Journal of Diabetes Science and Technology. He has authored over 180 publications. Dr. Klonoff was the lead investigator for the first randomized controlled multicenter trial of an outpatient closed loop control system and he published the results in the New England Journal of Medicine. Dr. Klonoff chaired the scientific advisory board for the first FDA-cleared insulin patch pump and participated in development of the first FDA-cleared dedicated diabetes telemedicine system, the first FDA-approved inhaled insulin, and the first three FDA-approved incretin drugs for diabetes. He is currently an advisor to Google for their smart contact lens project. Dr. Klonoff has chaired or served on grant review panels for NIH, CDC, NASA, NSF, US Army, JDRF, and University of Michigan. He has served as a Civilian Medical Officer for the US Army Telemedicine and Advanced Technology Research Center in the areas of biosensors and physiologic monitoring. Dr. Klonoff is a graduate of UC Berkeley, where he was elected to Phi Beta Kappa in his junior year, and UCSF Medical School, where he was elected to Alpha Omega Alpha in his junior year. His postgraduate training included two years at UCLA Hospital and three years at UCSF Hospitals. Dr. Klonoff organizes four annual international diabetes technology meetings. He was a member of the NIH Diabetes Interagency Coordinating Committee, whose ten-year research plan was released in 2011. Dr. Klonoff chaired the Endocrine Society Task Force on CGM Clinical Guidelines and the CLSI Subcommittee on CGM Metrics (POCT5). He currently chairs the FDA/Diabetes Technology Society/ADA/Endocrine Society/AAMI Error Grid Panel. Dr. Klonoff is a member of the NSBRI Board of Scientific Counselors and the NASA Exploration Medical Capabilities Standing Review Panel.

Robert Vigersky, MD
Bio not available.

Alberto Gutierrez, PhD
Bio not available.

Katie Serrano
Bio not available.

Judith Yost, MA, MT (ASCP)
Bio not available.

Jane Seley, DNP, MPH, MSN, BC-ADM, CDE, CDTC
Jane Seley is a diabetes nurse practitioner in the Division of Endocrinology at NewYork-Presbyterian Hospital/Weill Cornell Medical College in New York City and coordinates the inpatient glycemic control program. She is an adjunct assistant professor at the Hunter-Bellevue School of Nursing in New York City and contributing editor and column coordinator for the Diabetes Under Control column in the American Journal of Nursing. She has published extensively in nursing and diabetes journals on the topics of diabetes care and management and is a frequent presenter at diabetes and general conferences. Dr. Seley is a past-chair of the American Diabetes Association’s (ADA) professional council on education and past course director for the ADA annual scientific sessions and ADA postgraduate courses. She is a current member of the American Association of Diabetes Educators (AADE) Board of Directors (2012-2015) and serves on the editorial board of the Diabetes Technology Society.

Caroline Isbey, RN, MSN, CDE
Bio not available.