Exchange of Health Care Economic Information Between Pharmaceutical Companies and Managed Care Organizations: Current Limitations and Future Possibilities

ACPE UAN #: 0233-0000-16-040-H04-P

Release Date: October 4, 2016

Expiration Date: October 4, 2019

Activity Type: Knowledge-based

Contact Hours: 1.5

Activity Fee:  Member: $15    Non-Member: $30

Target Audience: Pharmacists who practice in managed care settings.

Activity Overview:
Current laws and regulations from the Food and Drug Administration restrict proactive promotion of information outside of a medicine’s approved labeling, including clinical information and health care economic information (HCEI). However, HCEI is becoming more valuable to payers and others who make or influence treatment decisions. Section 114 of the Food and Drug Administration Modernization Act (FDAMA) of 1997 allows for proactive sharing of HCEI to managed care organizations, but to date this provision has been limited in scope by lack of definitions and guidance on what is permissible. This introductory session will provide a background on FDAMA Section 114. This session will also explore opportunities for clarification and expansion of FDAMA Section 114 and the potential implications to managed care professionals.

Learning Objectives:

At the completion of this activity, participants should be able to:

1. Summarize the Food and Drug Administration Modernization Act Section 114.
2. Discuss the implications of the Food and Drug Administration Modernization Act Section 114 to the pharmaceutical industry and managed care organizations.
3. Identify at least three benefits and three challenges to exchanging health care economic information from the pharmaceutical industry and payer perspectives.
4. Describe how specific clarification and definition of Food and Drug Administration Modernization Act Section 114 and other FDA regulations could impact payers in the future.

Schedule of Educational Activity

This activity consists of an audio recording, pre-test assessment questions (not required to pass or continue), post-test questions (required to pass with a score of 70% or higher) and a specific activity evaluation.

CPE Requirements:

Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at AMCP Nexus 2016.  CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor. Please allow 72 hours for processing and posting in your NABP account.

To receive credit for an online activity you must:

• Review the full content of the activity.
• Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
• Complete a specific activity evaluation.

System Technical Requirements/Viewing Requirements: System Requirements Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities you should have a basic comfort level using a computer and navigating web sites. View the minimum technical and system requirements for continuing education online learning activities.

As an accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of continuing pharmacy education (CPE) activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias.

Laura Bartels-Peculis, PharmD
Senior Health Economics and Outcomes Research Liaison
Mallinckrodt Pharmaceuticals
St. Louis, Missouri

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-16-040-H04-P 1.5 Contact Hours October 04, 2016 - October 04, 2019