340B Drug Discount Program Compliance (In-Person)
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.
- 340B Covered Entity Executive Staff
- Financial Leadership
- Pharmacy/340B Staff
- Legal/Compliance Teams
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
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.|
|10:00 a.m. - 11:00 a.m.|
|11:00 a.m. - 11:15 a.m.||Break|
|11:15 a.m. - 12:00 p.m.|
|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|
|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|
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 - 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
|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|
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 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 13.4 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-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).
- 12.00 Certificate of Attendance
- 13.40 CPEFTLF 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.
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.
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% off||20% off||Call us!|
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
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Can I transfer from in-person to the virtual classroom?
You can transfer from attending in-person to virtually according to the following schedule:
- Within 45 days of the event start date, transfers from in-person to virtually will be subject to a transfer fee.
- Within 14 days of the event start date, no transfers from in-person to virtual will be permitted.
Please note that no refunds of the price difference, if any, will be given. All cancellation or transfer requests must be received in writing at firstname.lastname@example.org.