340B Contract Pharmacy & TPA Arrangements

September 11, 2024 to September 12, 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.


Federally Qualified Health Centers (FQHCs), Ryan White HIV/AIDS Program grantees, and other “covered entities” participating in the 340B drug pricing program often rely on contract pharmacies and 340B administrators (sometimes called third-party administrators, or “TPAs”) to carry out their mission, deliver discounted drugs to their patients, and ensure compliance with 340B program requirements. These relationships can be efficient and rewarding when properly understood, monitored, and structured, but missteps can be disastrous.

The majority of 340B program audit findings issued by the Health Resources and Services Administration (HRSA) and its Office of Pharmacy Affairs (OPA) for diversion and duplicate discounts involve contract pharmacies. The findings almost always are the result of the covered entity not fully understanding how its contract pharmacy and/or 340B administrator applies program rules. Covered entities can be surprised to learn that they are solely responsible to the government for compliance and that many contracts proposed by contract pharmacies and 340B administrators leave them with little or no recourse against the vendor.

This two-day intensive training is offered as a comprehensive dive into 340B program contract pharmacy and 340B administrator arrangements. Attendance is limited to a small group of covered entity representatives. Our attorneys will cover these topics and more:

  • Mastering the mechanics of preventing diversion and duplicate discounts, including possible blind spots and pitfalls;
  • Getting the most out of your contracts with contract pharmacies and 340B administrator arrangements, including the protections you need;
  • Understanding the various ways in which covered entities compensate contract pharmacies and TPAs, including compliance concerns with some approaches;
  • Developing sliding fee discount scales that comply with HRSA requirements;
  • Protecting yourself against discriminatory reimbursement contracts;
  • Discussing real-world examples of agreements and disputes using the Firm attorneys' decades of combined experience representing 340B program covered entities; and
  • Implementing best practices and policies and procedures to prevent missteps

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:

  • Identify contract terms that put the covered entity at compliance or financial risk
  • Understand the mechanisms used by contract pharmacies and TPAs to identify eligible 340B claims, ensure that payers and Medicaid are billed correctly, and manage 340B program inventory
  • Review and improve existing policies and procedures to reduce 340B audit risks
Course summary
Course opens: 
11/01/2022
Course expires: 
03/13/2025
Event starts: 
09/11/2024 - 10:00am EDT
Event ends: 
09/12/2024 - 4:00pm EDT

Agenda

Virtual Classroom
September 11 - 12, 2024
*Agenda times are all ET and subject to change*

 

Day 1

Wednesday, September 11, 2024
10:00 a.m. - 5:00 p.m. ET
10:00 - 10:15 a.m.Introductions and Icebreaker
10:15 - 11:30 a.m.
Diversion and Duplicate Discounts
  • How and when do they happen?
  • How do the risks change for Medicaid fee-for-service versus managed care?
11:30 a.m. - 11:45 a.m.Break
11:45 a.m. - 1:00 p.m.
340B and Medicaid Reimbursement
  • How does the Covered Outpatient Drug rule impact 340B?
  • What are states doing to implement the Covered Outpatient Drug Rule?
1:00 - 2:00 p.m.Break
2:00 - 2:45 p.m.
Contract Pharmacy Basics
  • What are key contract terms?
  • How will the contract pharmacy operations occur?
  • How will eligibility of claims be determined and communicated?
  • What are the financial terms of the arrangement?
2:45 - 3:00 p.m.Break
3:00 - 3:45 p.m.
Danger Zones: Monitoring and Oversight of Vendors
  • What is required for monitoring and oversight of contract pharmacies?
  • What are best practices?
  • What is an “annual independent audit” and do we really need one?
3:45 - 4:30 p.m.Current State of Contract Pharmacy
4:30 - 5:00 p.m.Wrap-Up Day 1
 

Day 2

Thursday, September 12, 2024
10:00 a.m. - 4:00 p.m. ET
10:00 - 11:15 a.m.
Case Studies on Day 1 Material
Contracting with TPAs
Fee Structures
340B Inventory Management (Over/Underreplenishment)
11:15 a.m. - 11:30 a.m.
Break

11:30 a.m. - 1:00 p.m.

What Can Go Wrong?
  • Material Breach and Self-Disclosure
  • Vendor Disputes
1:00 - 2:00 p.m.
Break
2:00 - 2:45 p.m.Audits - OPA and Manufacturer
Non-Audit Inquiries
2:45 - 3:00 p.m.
Break
3:00 - 3:45 p.m.Case Study on Day 2 Material
3:45 - 4:00 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 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 11.6 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, 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 9.8 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, 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

Early Registration
(Through June 30)
Regular Registration
(July 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

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Required Hardware/Software

In-Person

No hardware required


Virtual

Google Chrome or Mozilla Firefox are the preferred browsers.