Best Practices to Implementing Proactive Communications Between Manufacturers and Payers

ACPE UAN #:  0233-0000-18-028-H04-P

Release DateWednesday, April 25, 2018

Expiration Date:  April 25, 2021

Activity Type:    Knowledge-based

Contact Hours1.25

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

Target Audience: Pharmacists who practice in managed care settings.

Activity Overview

The recent enactment of the 21st Century Cures Act, and specifically Section 3037 (Cures 3037), modernized provisions of the Food and Drug Administration Modernization Act of 1997, Section 114 (FDAMA 114), which governs proactive dissemination of health care economic information (HCEI) by manufacturers to payers post-approval. In January 2017, the Food and Drug Administration released long-awaited draft guidance clarifying the provisions of FDAMA 114 as updated by Cures 3037, and also outlined its current thinking around preapproval information exchange. While the recent legislative changes and guidance have profound immediate and long-term implications for managed care pharmacy, there are still unanswered questions and areas requiring further clarification to truly operationalize proactive communications between manufacturers and payers.

This session will briefly review the evolution of payer and manufacturer communications, and the impact on managed care pharmacy, manufacturers and evidence generators. This session will also discuss best practices for operationalizing proactive communications and additional areas for improvement in the future.

Learning Objectives:  

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

  1. Summarize the latest changes in the legislative and regulatory environment governing proactive communications between manufacturers and payers and the impact on managed care pharmacy.
  2. Define the type of information and level of evidence payers need from manufacturers to make informed formulary and coverage decisions.
  3. Describe how enabling proactive communications between manufacturers and payers will benefit patients.
  4. Define the characteristics, training, and expertise for the individuals who deliver proactive health care   economic information communications to payers.

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 Annual Meeting 2018. 

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.

Moderator/Faculty:

Soumi Saha, PharmD, JD | Director of Pharmacy and Regulatory Affairs | Academy of Managed Care Pharmacy | Alexandria, Virginia

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-18-028-H04-P 1.25 Contact Hours April 25, 2018 - April 25, 2021