Ghost Generics: 505(b)(2) Approved Medications - On Demand

Participants will learn to Identify products approved via the 505(b)(2) NDA pathway and how they differ from generic molecules and explain recent Centers for Medicare & Medicaid Services (CMS) coding changes for reimbursement of 505(b)(2) approved products. They will also become aware of the financial and operational challenges regarding 505(b)(2) approved products and discuss practice considerations

Target Audience

  • Pharmacists
  • Pharmacy Technicians
  • Other Healthcare Professionals

Learning Objectives

At the conclusion of this activity, pharmacists should be able to:  

  • Identify products approved via the 505(b)(2) NDA pathway and how they differ from generic molecules 
  • Explain recent Centers for Medicare & Medicaid Services (CMS) coding changes for reimbursement of 505(b)(2) approved products
  • Discuss financial and operational challenges regarding 505(b)(2) approved products and discuss practice considerations

At the conclusion of this activity, pharmacy technicians should be able to:  

  • Identify products approved via the 505(b)(2) NDA pathway and how they differ from generic molecules 
  • Explain recent Centers for Medicare & Medicaid Services (CMS) coding changes for reimbursement of 505(b)(2) approved products
  • Discuss financial and operational challenges regarding 505(b)(2) approved products and discuss practice considerations
Course summary
Available credit: 
  • 1.00 ACPE Pharmacist
  • 1.00 ACPE Pharmacy Technician
  • 1.00 General CE - Attendance
Course opens: 
02/21/2025
Course expires: 
02/20/2026

FACULTY & PLANNERS

Faculty

Carolyn Liptak, MBA, BS Pharm
Pharmacy Executive Director
Vizient, Inc.

Dmitry Walker, PharmD, MS 
Director of Oncology and Investigation Drug Pharmacy Services
West Virginia University

Lubna Mazin
Pharmacy Revenue Cycle Manager
Children's Hospital Colorado

Francie Carney, RPh, MHA
Manager of Pharmacy Revenue Integrity
MedVenta (Novant Health Enterprises)

Tyler Wood, PharmD, BCBBS 
System Director for Pharmacy Oncology & Biosimilars
Providence St. Josephs Health

 

Planning Committee

Stacy Lauderdale, PharmD, BCPS
Associate Vice President of Evidence-Based Medicine and Drug Information
Vizient, Inc.

Jackie Stokes, BBS
Pharmacy Services Manager
Vizient, Inc.

Samantha Gordon, MS
CE Programs Manager      
Vizient, Inc.

Marilu Kelly, MSN, RN, NPD-BC, CHCP
Director, Continuing Education       
Vizient, Inc.

DISCLOSURE

As an accredited provider of continuing education, Vizient, Inc. is dedicated to ensuring this activity presents learners with only accurate, balanced, scientifically justified recommendations, and is free from promotion, marketing, and commercial bias. In accordance with The Standards for Integrity and Independence in Accredited Continuing Education, all planners, faculty, and others in control of the educational content have disclosed the absence or existence of all financial relationships (of any dollar amount) with ineligible companies within the past 24 months.
 
Ineligible companies – those companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
 
It is Vizient’s policy that owners and employees of ineligible companies, and any individuals who refuse to disclose the absence or existence of financial relationships with any ineligible companies are disqualified from participating as planners or faculty.
 
Disclosure Statements
 
Relevant Financial Relationships
Vizient, Inc., Jointly Accredited for Interprofessional Continuing Education, defines companies to be ineligible as those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

An individual is considered to have a relevant financial relationship if the educational content an individual can control is related to the business lines or products of the ineligible company.

Lubna Mazin, speaker for this educational activity, is a consultant for The Dedham Group and Orva.

Dmitry Walker, PharmD, MS, speaker for this educational activity, is an advisor for Pharmacosmos.

All relevant financial relationships listed for these individual(s) have been mitigated.

All others in a position to control content for this educational activity have no relevant financial relationship(s) to disclose with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

 

Statement of Content Validity
 
Vizient, Inc. educational activities are intended to assist healthcare teams advance their professional responsibilities in accordance with the definition of continuing education. It is the policy of Vizient, Inc. to review and ensure that all content and recommendations for patient care within accredited CE is evidenced-based, based on current science and clinical reasoning while ensuring the content is fair and balanced. All recommendations must conform to the generally accepted standards of experimental design, data collection, analysis, and interpretation. Vizient, Inc. does not permit accredited continuing education if it advocates for unscientific approaches to diagnosis or therapy, or if the education promotes recommendations, treatment, or manners of practicing healthcare that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.
 
FDA Off-Label Use
 
Faculty presenters are also expected to disclose any discussion of (1) off-label or investigational uses of FDA approved commercial products or devices or (2) products or devices not yet approved in the United States.

 

Disclaimer

The education provided through this activity is for continuing education purposes only. The views and opinions expressed in this activity are those of the faculty/presenters and do not necessarily reflect the views of Vizient, Inc.

 

Joint Accreditation Statement

In support of improving patient care, Vizient, Inc. is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

 

 
Designation Statement(s)

Pharmacists (CPE)

Vizient, Inc. designates this enduring material for a maximum of 1.0 contact hours for Pharmacists.
 
Universal Activity Number: JA0006103-0000-25-013-H99-P
 
Pharmacy Technicians (CPE)
 
Vizient, Inc. designates this enduring material for a maximum of 1.0 contact hours for pharmacy technicians.
 
Universal Activity Number: JA0006103-0000-25-013-H99-T
 
Other Healthcare Professionals (General CE Credit)
 
Vizient, Inc. will award all other healthcare professionals who successfully complete the activity a Certificate of Participation. Various state license boards and credentialing bodies accept certificates of participation from accredited CE activities to meet CE requirements for license renewals and re-certification. It is the responsibility of the participant to contact their state licensing board and/or certifying body for verification on credit eligibility reciprocity.

Available Credit

  • 1.00 ACPE Pharmacist
  • 1.00 ACPE Pharmacy Technician
  • 1.00 General CE - Attendance
Please login or register to take this course.

 

Select the “Obtain Credit” button to access the activity evaluation and to claim CE Credit.
 
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Please click here to enter the code you received at the end of the activity to verify your attendance if you have not already done so: https://continuingeducation.vizientinc.com/code

 

 

Required Hardware/software

 

The Vizient CE Learner Portal is compatible with most modern web browsers (such as Firefox, Google Chrome, Microsoft Edge, Apple Safari) and can also be accessed with mobile devices.