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

April 13, 2021

Access the on-demand workshop here.

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: 
  • 3.75 Certificate of Attendance
Course opens: 
Course expires: 
Event starts: 
04/13/2021 - 12:00pm EDT
Event ends: 
04/13/2021 - 4:00pm EDT


FTLF Virtual Classroom

Tuesday, April 13, 2021
*All specific agenda times are ET and subject to change*
Tuesday, April 13, 2021
12:00 pm - 4:00 pm ET

12:00 pm - 12:15 pm

Introductions and Agenda Setting

12:15 pm - 1:30 pm

Elements of the Patient Definition Guidelines

1:30 pm - 2:00 pm

Gray Areas and Emerging Treatment Methods

2:00 pm - 2:15 pm 


2:15 pm - 3:00 pm

Risk Areas – Contract Pharmacies and Problematic Arrangements

3:00 pm - 3:45 pm 

Importance of Compliance – Audits, Self-Disclosures, and Recordkeeping

3:45 pm - 4:00 pm

General Q&A and Wrap Up



This live, interactive training will take place in FTLF's Virtual Classroom, hosted by Zoom.  Should you have any technical questions or would like more information, please contact us at learning@ftlf.com or 1-855-200-3822.


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. [Full Bio]

Participants can earn up to 4.5 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/340B Staff, and Legal/Compliance Teams
  • Advanced Preparation: None  
  • Program Level: All
  • Delivery Method: Group Internet Based

Feldesman Tucker Leifer Fidell 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

  • 3.75 Certificate of Attendance


Please login or register to take this course.

Group Discounts

Bring your team! Discounts are available for groups of three (3) or more individuals from the same organization. Please contact us to process your registration.

Groups of 3 - 6
Groups of 7 - 10
Groups of 11 - 15
Over 15 attendees
10% off 15% off20% offCall us!

Registration Instructions

Each registration must be in the name of the individual(s) who will attend. This allows FTLF to communicate important course information to the actual attendee(s), add training materials and handouts to the right account, and properly assign certificates of attendance or CPE credits. 

To register for this training:

  • For yourself: login to your account and register with your personal information
  • For someone else: login with the ATTENDEE’S login information or create an account for the ATTENDEE and register from the ATTENDEE's account
  • For a group: email Learning@ftlf.com to complete group registration

If you encounter problems or have questions Contact us.


We accept payment by PayPal, credit card, and check. Payment for any live training is due upon registration. If payment is not received in full prior to the start of the event, FTLF reserves the right to cancel your order and deny you entrance to the training.

Cancellation/Transfer Policy

All cancellation or transfer requests must be received in writing at learning@ftlf.com. Requests for refunds or transfers for in-person events will be granted according to the following schedule:

  • 30 or more days prior to the event, requests for a full refund or a transfer without a fee will be granted.
  • Between 11 to 29 days prior to the event, requests for cancellations will be granted a 50% refund and requests for transfers will be granted, space permitting and subject to a transfer fee.
  • Within 10 days of the event start date, no requests for refunds or credits will be granted. At FTLF's discretion, late transfers may be granted, space permitting and subject to a transfer fee.

If there are extenuating circumstances regarding your cancellation, please reach out to the FTLF Training Team directly at learning@ftlf.com.

Required Hardware/Software

Google Chrome or Mozilla Firefox are the preferred browsers.