APFM Section 1 Module 4: Regulatory and Legal Considerations

Module Description

Understanding regulatory and legal considerations is a large part of developing and maintaining a formulary. This module will explore the FDA approval process, patents, and how various regulatory bodies impact different lines of business. In addition, this module will review the regulatory landscape and legislative mandates and considerations for ensuring compliance and mitigating risks associated with formulary decisions.

 

Target Audience

This program is designed for mid-level managed care pharmacists and managed care professionals working in formulary management or considering a transition to formulary management. 

Learning Objectives

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

  • Summarize how the FDA drug approval process and patents impact formulary decision-making.
  • Discuss the role and impact of various regulatory bodies on different lines of business.
  • Describe the regulatory landscape and legislative mandates related to drug pricing, reimbursement, and formulary management strategies.

 

Course summary
Available credit: 
  • 0.75 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 0.75 Certificate of Completion
Course opens: 
12/13/2024
Course expires: 
12/13/2027
Cost:
$0.00
Part of: 
Advanced Principles of Formulary Management

Faculty/Authors:

Lisa LeGette, MBA, RPh
Senior Director, Government Affairs
Express Scripts

Danilo Trivic, PharmD
Director, Pharmacy Formulary Management
Centene Pharmacy Services

Advisory Board

Shawn Barger, PharmD
Lead Director, Medicare Formulary Development and Management
Password

Aimee Loucks, PharmD, BCPS
Director Clinical Pharmacy Services
Kaiser Permanente Washington

Lisa Mahan, PharmD, MS, MTM
Clinical Program Senior Manager
Cigna Healthcare

Kristen Patti, PharmD
Manager, Clinical Drug Evaluation & Policy
Blue Cross Blue Shield of Michigan

Reviewers

Steve Kheloussi, PharmD, MBA, FAMCP
Director, Professional Affairs
AMCP

Katherine Tieu, PharmD
Clinical Account Manager
Capital Rx

Drake Reiter, PharmD
Director, Pharmacy Operations
Priority Health


Blue Cross Blue Shield of Michigan

Financial Relationship Disclosures:

Faculty/Reviewer/PlannerReported Relevant Financial Relationships
Lisa LeGette
Faculty		Evernorth Health Services, PBM
Danilo Trivic, PharmD
Faculty		Centene, Employer
Shawn Barger, PharmD
Planner		None
Aimee Louckes, PharmD, BCPS
Planner

None

Lisa Mahan, PharmD, MS, MTM
Planner		None
Kristen Patti, PharmD
Planner		IngenioRx
Steve Kheloussi, PharmD, MBA
Reviewer		None
Drake Reiter, PharmD
Reviewer		None
Katherine Tieu, PharmD
Reviewer		None
  • AMCP Staff have disclosed no relevant financial relationships.
  • If applicable, relevant financial relationships have been mitigated and documented.
  • Content has undergone a peer review to ensure content validity.

Accreditation:

ACPE UAN:0233-0000-24-069-H04-P • Activity Type: Knowledge-Based
Contact Hours: 0.75
Release Date: December 13, 2024 •  Expiration Date: December 13, 2027

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.

Available Credit

  • 0.75 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 0.75 Certificate of Completion

Price

Cost:
$0.00
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