340B Drug Discount Program Compliance

May 15, 2023 to May 17, 2023

Please note: this training is limited to covered entities. Contact Us if you are not a covered entity and would like to attend this workshop.


The federal 340B drug discount program has become critically important to the mission of safety net providers, including certain hospitals, federally qualified health centers (FQHCs), Ryan White HIV/AIDS Program grantees, and other covered entities.  In recent years, compliance with Health Resources and Services Administration (HRSA) and its Office of Pharmacy Affairs (OPA) guidelines has become increasingly complex. 

FTLF offers this three-day intensive training session designed for health center and covered entity executives and staff members who are responsible for or closely involved in the operation and compliance of the center’s pharmacy program.  Whether your entity is new to the 340B program or has been participating in the program for years, the curriculum is designed to address current challenges including:

  • 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 not only with a greater understanding of the 340B program, but with tools (including samples and checklists) they can take back to their health centers 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: 
  • 12.75 Certificate of Attendance
Course opens: 
11/02/2022
Course expires: 
11/18/2023
Event starts: 
05/15/2023 - 11:00am EDT
Event ends: 
05/17/2023 - 4:00pm EDT
Cost:
$1,999.00

Agenda

FTLF Virtual Classroom
Monday, May 15–Wednesday, May 17, 2023
*Agenda times are all ET and subject to change*
 

Day 1

Monday, May 15, 2023
11:00 a.m. - 4:00 p.m. ET
11:00 a.m. - 11:30 a.m.Introductions and Icebreaker
11:30 a.m. - 12:00 p.m.
340B Refresher
12:00 p.m. - 12:15 p.m.Break
12:15 p.m. - 1:15 p.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
1:15 p.m. - 1:30 p.m.
Break
1:30 p.m. - 2:45 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
2:45 p.m. - 3:00 p.m.
Break
3:00 p.m. - 4:00 p.m.Medicaid and Private Reimbursement
 

Day 2

Tuesday, May 16, 2023
11:00 a.m. - 4:00 p.m. ET
11:00 a.m. - 12:00 p.m.
340B Compliance Case Studies
12:00 p.m. - 12:15 p.m.Break
12:15 p.m. - 1:00 p.m.Contract Pharmacies - Where to begin with contract pharmacy compliance? 
1:00 p.m. - 1:15 p.m.Break
1:15 p.m. - 2:15 p.m.Contract Pharmacies (cont.) - current threats
2:15 p.m. - 2:45 p.m.Methods of Paying
2:45 p.m. - 3:00 p.m.Break
3:00 p.m. - 3:30 p.m.Disputes with Vendors
3:30 p.m. - 4:00 p.m.In-House Pharmacy - What is the future of in-house pharmacy models?
 

Day 3

Wednesday, May 17, 2023
11:00 a.m. - 4:00 p.m. ET
11:00 a.m. - 11:30 a.m.Non-Audit Inquiries
11:30 a.m. - 12:30 p.m.
How to Prepare for and Respond to 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?
12:30 p.m. - 12:45 p.m.Break
12:45 p.m. - 1:30 p.m.
How to Prepare for and Respond to Audits (cont.)
1:30 p.m. - 1:45 p.m.Break
1:45 p.m. - 2:45 p.m.340B Compliance Case Studies 
2:45 p.m. - 3:00 p.m.Break
3:00 p.m. - 4:00 p.m.Q&A and 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

Michael Glomb is a Partner in the firm's 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]

Jason Reddish

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

Jason Reddish 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.

Participants can earn up to 12.80 CPE credits in Specialized Knowledge and Applications upon completion of all course requirements.

ADDITIONAL INFORMATION

  • Prerequisites: None 
  • Target Audience: Health Center CEOs, CFOs, COOs, Pharmacists and others working with the 340B program
  • 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

  • 12.75 Certificate of Attendance

Price

Cost:
$1,999.00
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

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:

  • 45 or more days prior to the event, requests for a full refund or a transfer, minus a $75 administrative fee, will be granted.
  • Between 15 to 44 days prior to the event, requests for cancellations will be granted, subject to an administrative fee equal to 50% of the paid registration fee. Requests for transfers may be granted, space permitting and subject to a transfer fee.
  • Within 14 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.

Cancellation of a registration with group pricing may result in the discount being revoked or reduced for the entire group.

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

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