Healthcare Reform and the 340B Drug Discount Program Expanded Eligibility and Expanded Compliance Risks 

According to the Health Resources and Services Administration, the component of the U.S. Department of Health and Human Services that administers the 340B drug discount program, the 340B program has yielded average savings of 35%-50% on outpatient drugs for participating healthcare providers, including many academic medical centers. The program has recently been expanded to include more categories of providers, including children's hospitals. This session is intended for hospital internal and external counsel as well as compliance officers and executive leadership. During this presentation, we will provide an overview of the recent changes to the 340B program and highlight compliance risks facing academic medical centers and other hospitals that participate in the program.

The topics covered during this session will include:

• Key changes to the 340B program as a result of the healthcare reform legislation;
  
  
• Recent pharmaceutical manufacturer and Medicaid audit and enforcement actions;
  
  
• New oversight, audit, and compliance risks for participating hospitals and other 340B eligible providers; and
  
  
• Common compliance risks found in many 340B participating hospitals and how to mitigate your own possibility of 340B- related liabilities.

This session is designed for participants who possess a basic awareness of 340B, but who may not fully understand all of the regulatory requirements of the program. Additionally, participants who are well informed about 340B will benefit from discussions of specific recent compliance issues in other 340B entities. The take-away from this session will include a checklist of high-level 340B compliance tests that can be used to assist in determining the likelihood of compliance risks within a participating 340B entity.

Presenters

• Andrew Maurer
  Director
  Macro Helix, Inc., Atlanta, GA
  
  
• Stephanie Webster, Esquire

  King & Spalding LLP, Washington, DC 

Moderator

• Richard G. Korman
  General Counsel/Organizational Integrity Officer
  Saint Joseph Regional Medical Center, Mishawaka, IN
  Associate Counsel
Trinity Health, Novi, MI