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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

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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

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We will now review a summary of the information received from Accreditors.

REMS CE Data AggregationAccreditor 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.

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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 AggregationSynopsis of CE Reporting Process and Timing FactorsA summary of responses received from all 9 Accreditors is provided below.

Summary of Accreditor Responses

QuestionAccreditor

1* 2* 3* 4* 5* 6* 7 8* 9

Fixed / Flexible Data Reporting

Flexible Flexible Fixed on 4/1 annually Flexible Monthly Flexible Fixed on

July 1 Flexible Flexible

When Data is Reported

60 days upon

activity completion

90 days upon

activity conclusion

Any time period with year-to-year consistency

Anytime Monthly90 days

after completion of program

30-60 days upon

activity completion

90 days upon

activity completion

Within 30-60 days of

activity

Data Attestation

Data must be accurate

and complete

Data must be complete

Attested to accuracy

Provider determined

Receive data

monthly for that month

Attested to accuracy

Attested in Provider’s

application

Data must be accurate

and complete

n/a

Turn-around Time to Polaris

30 days 2 weeks As needed 3 daysVaries – at

least 2 weeks

10-14 days 14-30 days 3 weeks n/a

Receipt of Additional Data

Yes Yes Yes Yes See answers above Yes Yes Yes n/a

*Accreditor accredits a current RPC-supported grant.

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The REMS requires the RPC to report to FDA the number of ER/LA opioid prescribers who have completed REMS CE through May 10th 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 10th 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.

Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul

May 10th Data Period End Date

ER/LA Opioid Analgesic REMS CE Activities

FDA Report Preparation and Finalization

FDA Report Due to FDA by July 9th

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