340B Program in Tumult: Where We Are and What’s Next?

The 340B Program has been a hive of activity, with numerous recent developments that have begun to seismically shift how 340B stakeholders operate within the 340B space. To ensure you and your clients are prepared to navigate these changes, this presentation will cover the following:

An overview of key 340B Program tenets and requirements, including key differences between statutory requirements and those disseminated via HHS/HRSA guidance.

Update on the 340B Rebate Model Pilot Program and how expansion of the pilot would significantly impact how the 340B Program operates moving forward.

Summary of recent 340B-related litigation and legislative activity on the state and federal level, particularly within the 340B contract pharmacy space, and expected impact on 340B stakeholders

Richard Davis is an attorney at Quarles with extensive experience with the 340B Program having worked with all types of 340B stakeholders to develop and optimize their Program participation. Richard has frequently represented 340B participating entities during HRSA OPA audits and has successfully disputed and mitigated financial payback obligations related to those findings. More generally, Richard helps clients with a wide range of pharmacy regulatory issues such as controlled substances and state licensure compliance. Richie regularly assists pharmacy benefit managers (PBM), utilization review agents (URA) and third-party administrators (TPA) in navigating the complex and evolving regulatory landscape facing these entities. He also focuses on the convergence of traditional healthcare and technology and has assisted in developing innovative and legally compliant automated dispensing models for pharmacy clients in a variety of health settings.

Mike French is an attorney at Quarles. Although his practice is wide ranging, he maintains a particular focus on 340B drug pricing program issues. Mike has conducted client-facing on-site 340B and pharmacy operational assessments, assisted clients in preparing for Health Resources and Services Administration (HRSA) 340B audits, provided on-site support during audits and assisted with drafting Notice of Disagreements to mitigate and overturn associated government findings. Leveraging his previous consulting experience, Mike provides usable, practical guidance that accounts for both legal and business considerations. He takes the time to learn the ins and outs of his clients’ operational models and crafts his advice to compliantly further his clients’ goals.

To Register

Regardless of membership, you must login to purchase tickets. To do so:

1. Under ticket information, click “login to purchase”
2. This will take you to the login page. If you are a member, use the login information utilized for your membership. If you are a non-member, you will need to create an account to purchase a ticket. Non-members who have not created an account yet, must select “Register” along the bottom next to “Lost your password?”
3. From there, you will create an Account by entering a username, name, email address, and password. Then select “Complete Sign Up.”
4. The account will need to be activated by using the link in a confirmation email sent to the registered email address. Once the account is activated, you will login using the credentials provided (username and password).
5. Once logged in, navigate to the Program page and select the number of tickets needed and select “Get Tickets” to proceed with the checkout process.

Should you have any questions or issues with the registration process, please contact us at [email protected].

Once you have registered online, you will receive a calendar invitation and information about accessing the program. This program will be held via video conference through Zoom. The program cost is as follows:

• Member – $20
• Non-Member – $40
• Student Member – $5
• Student Non-Member – $25

Interested in becoming an AzSHA Member? Sign-Up Here.

The State Bar of Arizona does not approve or accredit CLE activities for the Mandatory Continuing Legal Education requirement. This activity may qualify for up to 1 hour of CLE credit, 0 hours of ethics, toward your annual requirement for the State Bar of Arizona.