340B Drug Discount Program Compliance (Virtual)

June 4, 2024 to June 5, 2024

Please Note: This training is limited to covered entities. If you are not a covered entity and would like to register for this training, please contact us.


Meeting the requirements of the 340B drug discount program has always been challenging, even more so in the past few years as covered entities have had to respond to restrictions on the use of contract pharmacies and declining revenues. But failure to satisfy the basic 340B compliance elements continues to be a significant operational and financial risk, and the potential consequences cannot be ignored. Now is an ideal time to review and, potentially, “reboot” 340B program policies and oversight practices.

Feldesman Training Solutions offers this two-day intensive training session designed for health center and other covered entity executives and staff who are responsible for or need to understand the basics of 340B compliance. Whether you are new to the 340B program or have been participating in the program for years, the curriculum is designed to help you assess your organization’s 340B compliance risks and to implement strategies that promote compliance.

  • Compliance with 340B program requirements
  • Billing, reimbursement, and sliding fee discount scale issues
  • Medicaid and duplicate discount compliance
  • Referral and discharge prescriptions
  • Scope of grant and site participation considerations
  • 340B drug inventory management approaches
  • Policy and procedure development
  • Development of in-house pharmacies
  • Contract pharmacy and vendor issues
  • Preparing for the future of 340B

Participants can expect to leave the training with a greater understanding of the 340B program, and with tools they can use in their organization to develop robust policies and procedures and implement compliant 340B programs.

Target Audience

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

 

Learning Objectives

After this training, you will be able to:

  • Develop 340B policies and procedures that demonstrate health center compliance with 340B program requirements
  • Prepare for a HRSA Office of Pharmacy Affairs 340B program audit, understand what to expect, and be informed of options when responding to adverse audit findings
  • Use a deeper understanding of 340B program compliance expectations to respond to any situation that might arise
Course summary
Available credit: 
  • 12.00 Certificate of Attendance
Course opens: 
11/01/2022
Course expires: 
12/06/2024
Event starts: 
06/04/2024 - 9:00am EDT
Event ends: 
06/05/2024 - 5:00pm EDT
Cost:
$1,799.00

Agenda

Washington, DC or Virtual Classroom
Tuesday, June 4, 2024 - Wednesday, June 5, 2024
*Agenda times are all ET*
 

Day 1

Tuesday, June 4, 2024
9:00 a.m. - 5:00 p.m. ET
9:00 - 9:30 a.m.Introductions and Icebreaker
9:30 - 10:00 a.m.340B Refresher
10:00 - 11:00 a.m.

Diversion   

  • How and when does diversion happen?
  • How to ensure your 340B policies and procedures detect diversion
  • What to do when a breach related to diversion occurs
11:00 - 11:15 a.m.Break
11:15 a.m. - 12:00 p.m.

Duplicate Discounts 

  • What to know about duplicate discounts 
  • How do the risks change with:
    • Medicaid fee-for-service versus managed care?
    • In-house versus contract pharmacy?
  • What to do if a breach related to duplicate discounts occurs
12:00 - 1:00 p.m. Break
1:00 - 1:45 p.m.Wrap-Up Diversion and Duplicate Discounts and Answer Questions 
1:45 - 2:45 p.m.Medicaid Reimbursement 
2:45 - 3:00 p.m.Break
3:00 - 3:45 p.m. Private Entities and Reimbursement
3:45 - 4:45 p.m.340B Compliance Case Studies on Day 1 Material 
4:45 - 5:00 p.m.Wrap-Up Day 1 and Answer Questions 
 

Day 2

Wednesday, June 5, 2024
9:00 a.m. - 5:00 p.m. ET
9:00 - 10:30 a.m.Contract Pharmacies - Where to begin with contract pharmacy compliance?
10:30 - 10:45 a.m.Break
10:45 - 11:15 a.m.Disputes with Vendors 
11:15 - 11:45 a.m.In-House Pharmacy - What is the future of in-house pharmacy models?
11:45 a.m. - 12:15 p.m.Non-Audit Inquiries
12:15 - 1:15 p.m.Break
1:15 - 3:00 p.m.

How to Prepare for Audits 

  • Office of Pharmacy Affairs (OPA) versus manufacturer audits
  • What are common OPA Audit findings?
  • What are the best tactics for responding to audit findings?
  • What is a Corrective Action Plan (CAP) and what are best practices in writing them?
3:00 - 3:15 p.m.Break
3:15 - 4:15 p.m.340B Compliance Case Studies on Day 2 Material 
4:15 - 4:45 p.m. Flexible Time and Hot Topics for 340B Legislation and Regulation
4:45 - 5:00 p.m.Training Wrap-Up 
 

FELDESMAN TRAINING SOLUTIONS VIRTUAL CLASSROOM

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 M. 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 11.0 CPE credits in Specialized Knowledge and Applications upon completion of all course requirements.

ADDITIONAL INFORMATION

  • 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 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

  • 12.00 Certificate of Attendance

Price

Cost:
$1,799.00
Please login or register to take this course.

Training is Not Recorded

This training will not be recorded for later viewing, as we would like attendees to be comfortable and candid, sharing their experiences and asking scenario-based questions. The discourse between the attorneys and participants is a valued part of each training.


Registration Fees

Early Registration
(Through April 30)
Regular Registration
(May 1 and later
$1,599$1,799

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 us 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 training@feldesman.com to complete group registration

If you encounter problems or have questions contact us.


Payment Policy

We accept the following forms of payment: American Express, Mastercard, Visa, ACH, PayPal, electronic check, and check. For information about the methods of payment we accept, please review our Payment FAQs


Refunds/Cancellations

Review our Cancellation Policies.


Can I transfer from the virtual classroom to attend in-person?

Yes, you can transfer to attend in-person, providing there is an open seat.  Any additional registration cost is due at the time of transfer.  All transfer requests must be submitted in writing.

If there are extenuating circumstances regarding your cancellation, please reach out to the Feldesman Training Solutions Team directly at training@feldesman.com.

Required Hardware/Software

Google Chrome or Mozilla Firefox are the preferred browsers.