1. -1- Copyright © 2014 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. DRAFT Copyright © 2014 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. ER/LA Opioid REMS Program Management REMS CE Data Aggregation Update January 7, 2014 Report to MedBiquitous Working Group

2. -2- Copyright © 2014 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. DRAFT REMS CE Data Aggregation  Accreditor Inquiry: Background Information  Synopsis of CE Data Reporting Process and Timing Factors  ER/LA Opioid Analgesic REMS Data Reporting Requirements

3. -3- Copyright © 2014 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. DRAFT We will now review a summary of the information received from Accreditors. REMS CE Data Aggregation Accreditor Inquiry: Background Information Background  During the last Working Group meeting, it was suggested that an inquiry be sent to all Accreditors to obtain insights into their respective data reporting practices / time periods.  MedBiquitous worked with the third-party data aggregator (Polaris), Campbell, and the RPC to develop a questionnaire which was sent to AAFP, AANP, AAPA, ACCME, ACPE, ADA, ANCC, AOA, and ARBO.  MedBiquitous has asked Campbell to present a synopsis of the information received from the Accreditors to help inform today’s Working Group discussion. In follow-up to the last MedBiquitous Working Group Meeting, an inquiry was sent to all Accreditors regarding data reporting periods and related information.

4. -4- Copyright © 2014 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. DRAFT Accreditor reporting periods and data transfer processes vary. During today’s Working Group Meeting, MedBiquitous will lead a discussion on data collection and reporting considerations that meet the Accreditor/Provider needs, while maximizing the CE data that can be included in the FDA Assessment Reports. REMS CE Data Aggregation Synopsis of CE Reporting Process and Timing Factors A summary of responses received from all 9 Accreditors is provided below. *Accreditor accredits a current RPC-supported grant.

5. -5- Copyright © 2014 Campbell Alliance, Ltd. All Rights Reserved. Confidential and Proprietary. DRAFT The REMS requires the RPC to report to FDA the number of ER/LA opioid prescribers who have completed REMS CE through May 10 th of each year. REMS CE Data Aggregation ER/LA Opioid Analgesics REMS Data Reporting Requirements Valerie/Francis will now lead the Working Group discussion of how REMS data reporting may best meet the needs of Accreditors/Providers while maximizing the CE completer data that is included in the FDA Assessment Reports. Additional Information / Questions for Discussion by the Working Group  The FDA requires that data be current through May 10 th or later.  REMS CE activities include enduring activities that span multiple years which can still be in-progress when data is reported. Questions for Working Group’s consideration/discussion:  Cumulative vs non-cumulative reporting of data?  How to distinguish new data in subsequent reporting periods from previously-submitted data?  Would activity “status field” that distinguishes between “completed” vs “in-progress” activities help disambiguate data?  MedBiquitous implementation guidelines can be modified accordingly to handle reporting for multi-year activities. May 10 th Data Period End Date ER/LA Opioid Analgesic REMS CE Activities FDA Report Preparation and Finalization FDA Report Due to FDA by July 9 th FDA-Required REMS 60-Day Data Currency: Reporting of ER/LA Prescribers Who Completed REMS CE through the May 10 th Data Period End Date