Welcome and Introductions. R. Mack Harrell, MD, FACP, FACE, ENCU AACE President

Transcription

1 Welcome and Introductions R. Mack Harrell, MD, FACP, FACE, ENCU AACE President

2 Medicare Bill Eagles Fan Retired, fixed income HgbA1c 9.5% on 4 shots 150 glucose strips/month Keeps running glucose log- 5x daily Average glucose 150 Doctor labors over his strip attestation 4x/yr He sells the strips to a reseller Makes $1000 tax free per year Re-seller gets him 3 Eagles home games Fingersticking hurts his fingers

3 Medi-Betty Type 1 DM x 45 years Brittle with hypoglycemic seizures Started using CGM technology in 2011 No seizures or hospital visits Now wearing a hospital gown again Turned 65, December 25, 2013 Merry Christmas, she s on Medicare No more reimbursement for CGM Fixed income, can t afford sensors Hypoglycemic seizures have resumed

4 Google Diabetes Instant uploads Standardized data stream Horizontally integrated registry Constant technology performance assessment Decreased MD paper 1990 s Privacy Laws EMR and registry competition Lack of interoperability Reimbursement fear Fear of Big Brother

5 Conference Mission To outline possible solutions to assure patients' access to high quality glucose monitoring systems and to identify regulatory pathways for effective approval process and post-marketing surveillance of these devices.

6 Deliverables Consensus Conference Statement Introduction Question-oriented evidence base Consensus Conclusions Recommendations Present Conference Statement Congressional Briefing, Tuesday, September 30 Publication in Endocrine Practice

7 Conference Task Force & Writing Committee Dr. George Grunberger Task Force Chair Dr. R. Mack Harrell, AACE President Dr. Yehuda Handelsman, ACE President Dr. Timothy Bailey Dr. Pauline Camacho Dr. Daniel Einhorn Dr. Alan J. Garber Dr. Howard Lando Dr. Bill Law Dr. Jonathan Leffert Dr. Eric Orzeck

8 Corporate Support Gold Silver Bronze Insulet Corporation

9 George Grunberger, MD, FACP, FACE Chair, Task Force for Consensus Conference on Glucose Monitoring AACE President Elect Chairman, Grunberger Diabetes Institute, Bloomfield Hills, MI Clinical Professor, Department of Internal Medicine, Center for Molecular Medicine & Genetics, Wayne State University School of Medicine Professor, Department of Medicine, Oakland University William Beaumont School of Medicine

10 VIDEO HERE

11 Why Are We Here? Reason No year old man on insulin pump, self-monitoring glucose 4-6x per day (Medicare does not cover CGM), total hypoglycemia unawareness; overall well controlled Received his free glucose strips (courtesy of Medicare competitive bidding process) Administers 3 additional insulin boluses within 4 hours when his readings are in mg/dl range and don t seem to go down Involved in his first ever car accident; his glucose at the time 32 mg/dl 11

12 Why Are We Here? Reason No year old woman with 52-year history of type 1 diabetes (hypoglycemia unawareness) on insulin pump and CGM over past 5 years Doing well, no EMS calls, no ER visits, no hospitalizations for hypoglycemia over the 5 years On joining Medicare she finds out her CGM will be no longer covered; her doctor had to certify she still had diabetes, and she had to have C-peptide level checked to qualify for continuing her pump therapy Medicare will cover, however, her future expenses due to hypoglycemia-related interventions 12

13 Why Are We Here? Reason No year old self-employed widowed man with type 2 diabetes, well controlled on multiple drug therapy including sulfonylurea Lives alone and, after experiencing several episodes of severe hypoglycemia in the past, always checks (in addition to fasting) his bedtime glucose as well as any time he has symptoms and then re-checks after treating the episode The insurance policy he can afford only covers one strip a day because he is not on insulin - he runs out by 10th of the month This in spite of his physician filling out forms every 6 months asking for more reasonable strip coverage 13

14 Question 1 What data support glucose monitoring (as distinct from glycemic control) as a means to prevent diabetic macro- and microvascular complications? A. Does frequency of glucose monitoring correlate with better outcomes? B. Which patients benefit the most from rigorous glucose monitoring? C. Does strip accuracy and/or CGM accuracy correlate with better outcomes?

15 Question 2 Can the FDA improve post-approval surveillance of strip/meter/cgm quality? A. Does sub-standard glycemic monitoring technology harm patients? If so, what data exist to support such a claim? Are all manufacturers required to report this data to the FDA? B. What is the current state of affairs at the FDA in post marketing meter and CGM surveillance? C. What enforcement options are available to the FDA and how are they implemented?

16 Question 3 Does current private insurance and Medicare policies balance the need to provide patient access to high quality care and effective glucose monitoring and, if not, what policy changes are needed with respect to: A. Patient Access to BGMS supplies i. Competitive Bidding (medical necessity attestation and other paperwork requirements for physicians offices vs. potential fraud and abuse, access to blood glucose test strips that are accurate and reproducible ii. Limiting single strip brand/meter type

17 Cont. Question 3 B. Patient access to CGM technology (access by appropriate patients) C. Limited or lack of coverage for sensor-augmented insulin pump therapy and emerging semi-automated CGM/pump combinations (e.g., threshold suspend systems)?

18 Question 4 What is the most effective way for the key stakeholders (physicians, allied health care professionals, patients, professional associations, educators, investigators, payers, industry, employers, health care systems, regulators) to achieve equitable, evidence-based, cost-effective regulation of glucose (blood, continuous) monitoring technology?

19 Conference Process Sunday, September 28 General Session Opening Keynote Lectures Introductions Conference Overview Detailed information Expert opinions General Session Opening Introductions Monday, September 29 Pillar Breakout Sessions Pillar Forum Formalize pillar responses to questions Interactive discussion by question Evidence base created/vetted Summary of Pillar Breakout Sessions Feedback on Pillar Summaries Conference Statement AACE/ACE Writing Committee Develop Conference Statement

20 Pillars Pillars needed to support a concerted and comprehensive action plan: 1. Medical/Scientific/Professional/Educational Societies 2. Patients/Lay Organizations 3. Government/Regulatory/Payors/Employers 4. Industry

21 Medical/Scientific/Professional/ Educational Societies Dr. Yehuda Handelsman Dr. Eric Orzeck Dr. Richard Bergenstal Mrs. JoJo Dantone Mrs. Helena Duncan Mrs. Marion Franz Dr. Guido Freckmann Dr. Barry Ginsberg Dr. Louis Haenel Dr. Irl Hirsch Dr. David Klonoff Dr. Aaron Kowalski Ms. Betty Krauss Pillar Co-Moderator Pillar Co-Moderator Park Nicollet International Diabetes Center Diabetes Care and Education Group College of American Pathologists Academy of Nutrition and Dietetics IDT Diabetes Technology Consultants American Osteopathic Association University of Washington Diabetes Technology Society JDRF Diabetes Care and Education Group

22 Medical/Scientific/ Professional/Educational Societies (Cont.) Dr. David Marrero Ms. Molly McElwee-Malloy Dr. Gerardo Moreno Dr. Jerry Penso Dr. Gary Puckrein Dr. Robert Ratner Dr. Mitchel Scott Dr. David Sacks Dr. Krishnaswami Vijayaraghavan Ms. Phyllis Zimmer Diabetes Translational Research Center, Indiana University American Association of Diabetes Educators American Geriatrics Society American Medical Group Association National Minority Quality Forum American College of Physicians & American Diabetes Association Clinical Chemistry, Washington University American Association for Clinical Chemistry American College of Cardiology Nurse Practitioner Healthcare Foundation

23 Patients/Lay Organizations Dr. Bill Law Dr. Pauline Camacho Mrs. Kelly Close Mr. Bennet Dunlap Mr. Larry Ellingson Mr. Larry Smith Mr. Manny Hernandez Mr. Jeff Hitchcock Ms. Cynthia Rice Pillar Co-Moderator Pillar Co-Moderator diatribe.org Strip Safely National Diabetes Leadership Council National Diabetes Leadership Council Diabetes Hands Foundation Children with Diabetes JDRF

24 Government/Regulatory/Payors/ Employers Dr. Jonathan Leffert Dr. Howard Lando Dr. Pamela Allweiss Dr. Guillermo Arreaza-Rubin Dr. Sanford Cohen Dr. Alberto Gutierrez Dr. Kimberly Jinnett Dr. David Knowlton Dr. Courtney Lias Dr. Todd Prewitt Dr. William Rogers Dr. Kenneth Snow Pillar Co-Moderator Pillar Co-Moderator Centers for Disease Control National Institute of Diabetes, Digestive and Kidney Diseases United Healthcare Food & Drug Administration Integrated Benefits Institute New Jersey Healthcare Quality Institute Food & Drug Administration Humana Centers for Medicare and Medicaid Services Aetna

25 Industry Dr. Daniel Einhorn Dr. Timothy Bailey Mr. Chris Arapoff Dr. Alan Cariski Dr. Nathan Carrington Mr. Jacob Drapkin Dr. Claudia Graham Dr. Brian Levy Dr. Robert Morin Mr. Markus Ott Dr. David Price Ms. Melissa Dobson Schooley Mr. Steve Scott Mr. Bruce Taylor Mr. Duncan Williams Dr. Ramakrishna Venugopal Pillar Co-Moderator Pillar Co-Moderator Medtronic Diabetes LifeScan, Inc. Roche Diabetes Care J & J Diabetes Solutions Companies Dexcom, Inc. J & J Diabetes Solutions Companies Bayer HealthCare, LLC Bayer HealthCare, LLC Dexcom Medtronic Abbott Diabetes Care Roche Diagnostics Diabetes Care Abott Diabetes Care Animas Corporation

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27 State of the Art of Glucose Monitoring Technology Richard M. Bergenstal, MD Executive Director Park Nicollet International Diabetes Center

28 Clinical Applications Irl B. Hirsch, MD Professor of Medicine University of Washington School of Medicine

29 Post-Marketing Surveillance David C. Klonoff, MD, FACP, Fellow AIMBE President Diabetes Technology Society

30 Overall Economic Impact William H. Herman, MD, MPH Stefan S. Fajans/GlaxoSmithKline Professor of Diabetes Professor of Internal Medicine and Epidemiology Director, Michigan Center for Diabetes Translational Research University of Michigan

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32 Regulator s Viewpoint Courtney H. Lias, PhD Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health US Food & Drug Administration

33 Private Insurance Perspective Kenneth Snow, MD, MBA Medical Director New England Market Aetna

34 Large Employers Perspective Kimberly Jinnett, PhD, MSPH Executive Vice President Integrated Benefits Institute

35 Industry Perspective Khatereh Calleja AdvaMed Vice President, Technology and Regulatory Affairs Richard Price AdvaMed Vice President, Payment and Health Care Delivery Policy

36 Patient Perspective Kelly Close President Close Concerns Chair of the Board The diatribe Foundation

37 Now we get to work building an evidence base for a comprehensive action plan for Quality, Safety, and Patient Access to Optimize Glucose Control.

38 Monday Morning Breakfast 7:00 am 8:00 pm Regency B General Session 8:00 am 8:30 pm Regency C Pillar Break-Out Discussions 8:30 am 12:00 pm

39 Monday Lunch Break Lunch Break 12:00 pm 1:30 pm Lunch and networking

40 Monday Afternoon Pillar Forum 1:30 pm 4:30 pm Pillar Breakout Sessions Summaries and Participants Input

41 Monday Afternoon Conclusion & Adjourn 4:30 pm 4:45 pm Writing Committee Convenes 5:00 pm