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

May 9, 2024

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 

The on-demand version of this training will be available for purchase after the conclusion of the live training. 

Target Audience

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

Learning Objectives

After this training, 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
  • 3.80 CPE
    FTLF is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors.
Course opens: 
Course expires: 
Event starts: 
05/09/2024 - 12:00pm EDT
Event ends: 
05/09/2024 - 4:00pm EDT


Virtual Classroom
Thursday, May 9, 2024
*Agenda times are all ET and subject to change*
Thursday, May 9, 2024
12:00 p.m. - 4:00 p.m. ET
12:00 - 12:15 p.m.Introductions and Agenda Setting
12:15 - 1:30 p.m.Elements of the Patient Definition Guidelines
1:30 - 1:40 p.m.Break
1:40 - 2:10 p.m.Gray Areas and Emerging Treatment Areas
2:10 - 2:50 p.m.Risk Areas - Contract Pharmacies and Problematic Arrangements
2:50 - 3:00 p.m.Break
3:00 - 3:45 p.m.Importance of Compliance - Audits, Self-Disclosures, and Recordkeeping
3:45 - 4:00 p.m.General Q&A and Wrap-Up


This live, interactive training will take place in the Feldesman Training Solutions Virtual Classroom, hosted by Zoom.  Should you have any technical questions or would like more information, please contact us at training@feldesman.com or 1-855-200-3822.

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]

Participants can earn up to 3.8 CPE credits in Specialized Knowledge and Applications upon completion of all course requirements.


  • Prerequisites: None 
  • Target Audience: 340B covered entity executive staff, financial leadership, pharmacy and 340B staff, and legal and compliance teams
  • Advanced Preparation: None  
  • Program Level: All
  • Delivery Method: Group Internet Based

Feldesman Leifer LLP is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website www.nasbaregistry.org (formerly www.learningmarket.org).

Available Credit

  • 3.50 Certificate of Attendance
  • 3.80 CPE
    FTLF is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors.


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