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

This recorded workshop is closed to new enrollments. For more trainings on the 340B Drug Discount program, click here.

Duration:  4 hours
Workshop recorded on: 4/13/2021

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.”

The one-size-fits-all Guidelines 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, 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 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
Course opens: 
Course expires: 


A Partner with the firm, Mike practices in the Federal Grants and Health Law 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]


As of June 2023, Jason Reddish is no longer with the firm.

Jason focuses his practice on the federal 340B drug discount program and the complex legal and compliance issues facing safety net providers, pharmacies, and other 340B program stakeholders. Jason began his career representing pharmaceutical manufacturers before finding his passion helping 340B program covered entities, including disproportionate share hospitals, Federally Qualified Health Centers, Ryan White HIV/AIDS clinics, and other grantees navigate the 340B program.

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


Please login or register to take this course.

This recorded workshop is closed to new enrollments. For more trainings on the 340B Drug Discount program, click here.


Recorded webinars are available for 90 days after the date of purchase or date of the workshop. Once posted to your account, you can view this workshop anytime on-demand during the access period identified in your purchase confirmation. For additional information on viewing and accessing webinars, view our full terms and conditions here.


If you pay by credit card or PayPal, you will be able to access the recorded workshop immediately (unless the live webinar has not yet occurred). If you pay by check, we will grant access to the recording when we receive your check. You will receive a confirmation email once access is granted. FTLF reserves the right to suspend access to the workshop if payment is not received within 30 days. For more information on payments and registration, please visit our FAQ page.


No refunds will be provided for recorded workshops. FTLF can transfer a registration to someone else within your organization or, provided you have not already viewed the workshop, transfer the registration to another on-demand program. Where the registration fee for the new workshop is higher, you must also pay the difference between the original course and the new course registration fee at the time of transfer. Administrative fees may also apply. If your organization purchased a workshop under the account of a staff member who no longer works for your organization, please Contact Us. View our full policy on refunds and cancellations here.

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