340B Drug Discount Program Compliance

Washington, DC US
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
Course opens: 
03/20/2024
Course expires: 
12/07/2024
Event starts: 
06/04/2024 - 9:00am EDT
Event ends: 
06/05/2024 - 5:00pm EDT

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
8:30 a.m. - 9:00 a.m.   Continental Breakfast
9:00 a.m. - 9:30 a.m.Introductions and Icebreaker
9:30 a.m. - 10:00 a.m. 

         340B Refresher

10:00 a.m. - 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 a.m. - 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 p.m. - 1:00 p.m. Lunch
1:00 p.m. - 1:45 p.m.Wrap-Up Diversion and Duplicate Discounts and Answer Questions 
1:45 p.m. - 2:45 p.m.Medicaid Reimbursement 
2:45 p.m. - 3:00 p.m.Break
3:00 p.m. - 3:45 p.m. Private Entities and Reimbursement
3:45 p.m. - 4:45 p.m.340B Compliance Case Studies on Day 1 Material 
4:45 p.m. - 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
8:30 a.m. - 9:00 a.m.Continental Breakfast 
9:00 a.m. - 10:30 a.m.Contract Pharmacies - Where to begin with contract pharmacy compliance?
10:30 a.m. - 10:45 a.m.Break
10:45 a.m. - 11:15 a.m.Disputes with Vendors 
11:15 a.m.- 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 p.m. - 1:15 p.m.Lunch
1:15 p.m. - 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 p.m. - 3:15 p.m.Break
3:15 p.m. - 4:15 p.m.340B Compliance Case Studies on Day 2 Material 
4:15 p.m. - 4:45 p.m. Flexible Time and Hot Topics for 340B Legislation and Regulation
4:45 p.m. - 5:00 p.m.Training Wrap-Up 
 
Feldesman Training Solutions Center
1129 20th Street NW
Suite 300
Washington, DC 20036
United States
+1 (855) 200-3822

We have preferred rates with the following hotels (located within 0.3 mi). Use the links to book direct (Hilton and Hyatt don't require adding an additional code): 

Other options (located within 0.4 mi):

 

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]

In-Person Continuing Education

Participants can earn up to 13.4 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/Group-Live

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).


Virtual Continuing Education

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/Group-Live

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).

 
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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

In-Person Registration
Early Registration
(Through April 30)
Regular Registration
(May 1 and later)
$1,799$1,999
Virtual Registration
Early Registration
(Through April 30)
Regular Registration
(May 1 and later)
$1,599$1,799

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/Transfers

Review our Cancellation Policies.

Required Hardware/Software

In-Person

No hardware required


Virtual

Google Chrome or Mozilla Firefox are the preferred browsers.