340B Compliance: Overcoming Challenges With Diversion, Duplicate Discounts, and Orphan Drug Restrictions

Recording of a 90-minute CLE webinar with Q&A

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Conducted on Thursday, August 6, 2015

Recorded event now available

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Course Materials

This CLE course will provide guidance to healthcare counsel for providers who participate in the 340B drug discount program. The panel will discuss key program requirements and compliance concerns, will outline best practices to help ensure compliance with the program requirements, and will address recent developments in 340B program guidance.


Established by Congress in 1992, the 340B Program requires biopharmaceutical manufacturers that participate in Medicaid to offer their drugs to eligible “covered entities” at a steep discount. Covered entities must meet a number of program eligibility rules and compliance requirements in order to enroll in and maintain their participation in the 340B program. As the program continues to grow — and to receive heightened attention from policymakers — it is critical for providers and their counsel to be aware of 340B covered entities’ responsibilities and to remain up-to-date on program guidance.

The Office of Pharmacy Affairs (OPA) is the division within the Department of Health and Human Services’ Health Resources and Services Administration (HRSA) that was created in part to manage the 340B Program. In 2012, OPA conducted 340B compliance audits of approximately 200 covered entities, following a Government Accountability Office report that expressed concerns about OPA’s oversight regarding program compliance. OPA is on track to audit nearly 300 covered entities in 2015. The dramatic rise in government audits — in addition to an increase in audits of covered entities by manufacturers — underscores the importance of assuring 340B program compliance. Additionally, HRSA has announced plans to issue updated “mega-guidance” in 2015 covering a number of program areas.

Healthcare counsel must be prepared to guide clients in establishing, implementing, and maintaining rigorous 340B compliance to maintain eligibility and avoid potential sanctions, including monetary penalties and disqualification. They also must stay updated on new guidance as it is issued.

Listen as our experienced panel of healthcare counsel examines the compliance pitfalls facing counsel for providers participating in the 340B program. The panel will also discuss best practices for developing, implementing and monitoring an effective compliance program and for audit readiness.



  1. Compliance concerns for providers in the 340B program
    1. Diversion
    2. Duplicate discount
    3. GPO prohibition (for certain covered entity types)
    4. Orphan drug exclusion (for certain covered entity types)
  2. Best practices for creating and implementing effective programs to ensure compliance
  3. Tips for preparing for audits
  4. Considerations relating to HRSA’s new mega-guidance and proposed rule on CMPs and ceiling price calculations


The panel will review these and other key issues:

  • What are the key compliance challenges for providers in the 340B drug discount program?
  • What steps should providers and their counsel take to help ensure compliance and be prepared for a 340B audit?
  • What policies and procedures should providers have in place to maintain 340B program compliance?
  • What changes are expected with the HRSA new mega-guidance?


Hales, Stephanie
Stephanie P. Hales

Sidley Austin

Ms. Hales regularly counsels clients on healthcare legislative and regulatory developments and their impact, providing...  |  Read More

Kathryn R. Watson
Kathryn R. Watson

Feldesman Tucker Leifer Fidell

Ms. Watson works with nonprofit healthcare organizations and federal grantees, seeking to identify and implement...  |  Read More

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