(Recorded Workshop) 340B Patient Definition Guidelines: How to Be Compliant While Meeting Your Patients’ Needs

Recorded on: 05/09/2024

Register now to receive access to the recorded webinar on May 16. Live webinar registrants will automatically receive access to the recorded webinar. 

Since 1996, the Health Resources and Services Administration (“HRSA”) has used one set of standards to describe the factors that determine when a 340B drug may be dispensed to an individual patient, otherwise known as the “Patient Definition Guidelines.” In the aftermath of the Genesis Health Care, Inc., v. Becerra ruling, will anything change?

The one-size-fits-all Guidelines currently apply to the diverse range of 340B covered entities, but each grant program is likely to have very different relationships with the persons they serve.  Federally Qualified Health Centers (FQHCs), Ryan White HIV/AIDS Program grantees, and others have very specific grant requirements that affect their 340B program. The Patient Definition Guidelines can be difficult to apply in the context of new treatment standards, including telemedicine, specialist referrals, and the development of medical homes and medical case management. Patient ineligibility and 340B drug diversion continue to account for a significant number of 340B audit findings, and potential repayments to affected manufacturers, especially in contract pharmacies. 

This focused four-hour training has been developed specifically to target the ins and outs of the Patient Definition Guidelines, including how to address the many “gray areas” that covered entities may encounter. Designed for both 340B “rookies” and “vets,” the training will cover these topics and more: 

  • Critical elements of the Patient Definition Guidelines 
  • Relationship between grant requirements and the Patient Definition Guidelines 
  • The gray areas, such as telemedicine, clinic administered drugs, and patient referrals, and how to address each to maintain compliance 
  • Documenting patient eligibility – before and after an audit 
  • Patient eligibility issues in 340B contract pharmacy arrangements 
  • Avoiding “too good to be true” deals and other pitfalls 
  • Detecting and addressing instances of non-compliance 

Target Audience

  • 340B Covered Entity Executive Staff 
  • Financial Leadership 
  • Pharmacy and 340B Staff 
  • Legal and Compliance Teams 

Learning Objectives

After this webinar, you will be able to:

  • Understand the basics of the Patient Definition Guidelines and how to document compliance 
  • Apply the Guidelines in gray or rapidly developing areas 
  • Identify and avoid risky arrangements 
Course summary
Available credit: 
  • 3.50 Certificate of Attendance
Course opens: 
Course expires: 


Session 1Introductions and Agenda Setting
Session 2Elements of the Patient Definition Guidelines
Session 3Gray Areas and Emerging Treatment Areas
Session 4Risk Areas - Contract Pharmacies and Problematic Arrangements
Session 5Importance of Compliance - Audits, Self-Disclosures, and Recordkeeping
Session 6General Q&A and Wrap-Up

Michael B. Glomb

Michael Glomb is a Partner in the firm's federal grants and health care groups, and has over three decades of experience advising community-based organizations on a broad range of legal matters. Specifically, he offers guidance to federally qualified health centers, other federal grantees, and several professional and trade associations on the 340B drug discount program, tax exemption, grants law, and fraud matters. [Full Bio]

Steve Kuperberg

Steve Kuperberg is a Partner in the firm's Health Care and Litigation & Government Investigations practice groups. Steve regularly advises clients on issues related to the 340B drug discount program, health care fraud, contract disputes and the False Claims Act. An experienced litigator of over 25 years, he represents many nonprofits in health care and education, such as 340B covered entities and their stakeholders, as well as government contractors. [Full Bio]

Certificates of Attendance: We verify attendance upon completion of a webinar (live or recorded version) and will only issue certificates in the name of the account holder enrolled in the course. If you need to document attendance for someone other than the account holder, we provide blank Certificates of Attendance for a supervisor to sign and certify that a different individual viewed the course. 

Group Attendance: Due to the online nature of webinars, we cannot verify participation by more than one person. For groups, we provide an attendance record form and blank Certificates of Attendance to record attendance at a group viewing session and document each individual's participation. We recommend that a supervisor or colleague sign the certificate to certify attendance. 

Read more about maintaining an attendance record in our FAQs.

Available Credit

  • 3.50 Certificate of Attendance


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