340B Drug Discount Program Compliance (Virtual)

December 4, 2023 to December 5, 2023

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.

FTLF 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
  • 11.00 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: 
10/27/2023
Course expires: 
06/06/2024
Event starts: 
12/04/2023 - 9:00am EST
Event ends: 
12/05/2023 - 5:00pm EST
Cost:
$1,799.00

Agenda

FTLF Virtual Classroom
Monday, December 4, 2023 - Tuesday, December 5, 2023
*Agenda times are all ET*
 

Day 1

Monday, December 4, 2023
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

Tuesday, December 5, 2023
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
10:30 a.m. - 10:45 a.m.Break
10:45 a.m. - 11:15 a.m.Disputes with 340B Vendors 
11:15 a.m.- 11:45 a.m.The Future of In-House Pharmacies
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.

Preparing 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?

340B Audit Response and Defense

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 
 

FTLF'S VIRTUAL CLASSROOM

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.

Michael Glomb

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]

Katie Watson

Katie Watson is the General Counsel and Chief Compliance Officer of Whitman-Walker, a Washington-DC based safety net provider which participates in the 340B program.  Prior to assuming this role, Katie served as Senior Counsel to Maxor National Pharmacy Services (an independent pharmacy company that manages pharmacies on behalf of 340B covered entities as well as operates a 340B third-party administrator) and as in-house counsel with MedStar Health, where she was the attorney responsible for 340B contracts and compliance across the healthcare system.  Katie’s law practice also has been understanding health systems and federally qualified health centers while Senior Associate at Feldesman Tucker Leifer and Fidell, LLP. She holds a bachelor of arts from Brown University, a masters in public health from Johns Hopkins Bloomberg School of Health, a law degree from Georgetown University, and an LLM in business and health law from Loyola University Chicago.  

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 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

  • 12.00 Certificate of Attendance
  • 11.00 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.

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.


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.


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 FTLF Training Team directly at learning@ftlf.com.

Required Hardware/Software

Google Chrome or Mozilla Firefox are the preferred browsers.