This week, we are joined by Emily Cook, partner at McDermott Will & Emery LLP. At the 340B Coalition Winter Conference, Emily spoke on a new panel about the importance of 340B professionals understanding compliance issues related to 340B that are not covered by the 340B statute. We hear from her about that session, including the process for preparing for government inquiries and the need for hospitals to self-disclose government overpayments. Before the interview, we provide updates on multiple developments in the 340B contract pharmacy dispute.

Working with the Legal and Compliance Department 

Emily explains the expertise that legal counsel brings to meeting compliance required tied to the 340B statute. She also discusses what expertise is needed to form the ideal compliance team.   

Legal and Compliance Issues Related to 340B 

Emily discusses the types of compliance obligations that are not covered by the 340B statute, including issues associated with Medicaid and Medicare billing requirements.  

Trends in 340B Compliance

States are becoming more interested in 340B drug payments, including at least one state that is requiring self-audits from 340B hospitals. Emily speaks about the increased focus on overpayments of federal and state funds, how 340B hospitals should prepare for inquiries, and how these inquiries are different from HRSA audit requests. 

The Inquiry and Self-Disclosure Process 

Emily shares her insights on what a 340B professional should do if they receive an inquiry notice, what the process of resolving an inquiry or a self-disclosure entails, and the potential penalties for noncompliance.  

Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].

Resources 

1. HRSA Disputes Court Decision on 340B Contract Pharmacies in Favor of AstraZeneca
2. GlaxoSmithKline Contract Pharmacy Conditions Follow Familiar Playbook