340B Contract Pharmacy & TPA Arrangements

Washington, DC US
April 24, 2019 to April 25, 2019

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.

FTLF offers this day-and-a-half intensive training as a comprehensive dive into 340B program contract pharmacy and 340B administrator arrangements. Attendance is limited to a small group of covered entity representatives. FTLF attorneys will cover these topics and more in our custom training and education center in Washington, D.C.:

  • 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;
  • Discussing real-world examples of agreements and disputes using FTLF’s 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; and
  • Review and improve existing policies and procedures to reduce 340B audit risks.

 

Course summary
Available credit: 
  • 10.20 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: 
12/04/2018
Course expires: 
10/25/2019
Event starts: 
04/24/2019 - 9:00am EDT
Event ends: 
04/25/2019 - 12:30pm EDT
Cost:
$1,999.00
Washington, DC
Wednesday, April 24, 2019- Thursday, April 25, 2019
*All specific agenda times are subject to change*
 

Day 1

Wednesday, April 24, 2019    
9:00 am - 5:00 pm
8:30 am - 9:00 am Continental Breakfast
9:00 am - 9:15 amIntroductions and Icebreaker
9:15 am - 10:15 am
Diversion and Duplicate Discounts
  • How and when do they happen?
  • How do the risks change for Medicaid fee-for-service versus managed care?
10:15 am - 10:30 amBreak
10:30 am - 12:00 pm
340B and Medicaid Reimbursement
  • How does the Covered Outpatient Drug rule impact 340B?
  • What are states doing to implement the Covered Outpatient Drug Rule?
12:00 pm - 1:15 pm
Lunch
1:15 pm - 2:00 pm
What to Know Before Signing a Vendor Agreement
  • 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?
2:00 pm - 2:45 pm
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?
2:45 pm - 3:00 pmBreak
3:00 pm - 3:45 pm"Too Good to Be True" Proposals
3:45 pm - 5:00 pm
Case Studies on Day 1 Material
Discussion RE: Implementing an Audit Protocol
5:00 pm - 6:00 pmWrap-Up Day 1 and Happy Hour

Day 2

Thursday, April 25, 2019
9:00 am - 12:30 pm
8:30 am - 9:00 am
Continental Breakfast
9:00 am - 10:30 am
What can go wrong?
 
Material Breach and Self-Disclosure
  • What is a material breach and what does a covered entity need to self-disclose?
Non-Audit Inquiries
  • When and to whom must a covered entity provide information on their 340B program?
  • How much information must the covered entity provide?
OPA 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?
10:30 am - 10:45 am
Break
10:45 am - 11:30 am
Vendor Disputes Related to 340B Liability
  • What recourse does a covered entity have if a vendor causes 340B liability?
  • What are key contract terms in a dispute?
11:30 am - 12:15 pmCase Study on Day 2 Material
12:15 pm - 12:30 pmTraining Wrap-Up
FTLF Training Center
1129 20th Street NW
Suite 300
Washington, DC 20036
United States
+1 (855) 200-3822
Feldesman Training Room

Travel

Hyatt Place Washington DC/Georgetown/West End 
2121 M St NW
Washington, DC 20037
(202) 838-2222

Kimpton Hotel Palomar DC 
2121 P Street NW
Washington, DC 20037
Hotel: (202) 448-1800 | Reservations: (877) 866-3070

The Wink - Washington, DC 
1143 New Hampshire Ave NW
Washington, DC 20037
(202) 775-0800

The St. Gregory Hotel - Dupont Circle 
2033 M Street NW
Washington, DC 20037
(202) 530-3600

Kimpton Hotel Madera 
1310 New Hampshire Avenue, NW
Washington, DC 20036
Hotel: (202) 296-7600 | Reservations: (800) 430-1202

The Embassy Row Hotel
2015 Massachusetts Avenue, NW
Washington, DC 20036
Hotel: (202) 265-1600 | Reservations: (855) 893-1011

The Dupont Circle Hotel
1500 New Hampshire Avenue, NW
Washington, DC 20036
(202) 483-6000

Hilton Garden Inn - Washington DC/Georgetown Area
2201 M Street NW
Washington, DC 20037
(202) 974-6010

Embassy Suites - Georgetown
1250 22nd Street, NW
Washington, DC 20037
(202) 857-3388

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]

JASON REDDISH

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

Jason 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. [Full Bio]

ELIZABETH "ISSIE" KARAN

As of January 2020, Elizabeth is no longer with the firm.

Elizabeth is a Senior Associate working in the firm’s Health Law and Federal Grants practice groups counseling a diverse array of organizations including Hemophilia Treatment Centers, Federally Qualified Health Centers, primary care associations, and other Federal grantees. Elizabeth’s practice focuses mainly on assisting clients with the 340B drug pricing program, grants compliance, provider collaborations, Medicaid and Medicare reimbursement issues, and implementation of the Affordable Care Act.

Participants can earn up to 10.2 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-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).

Available Credit

  • 10.20 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:
$1,999.00
Please login or register to take this course.

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. 

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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:

  • 30 or more days prior to the event, requests for a full refund or a transfer without a fee will be granted.
  • Between 11 to 29 days prior to the event, requests for cancellations will be granted a 50% refund and requests for transfers will be granted, space permitting and subject to a transfer fee.
  • Within 10 days of the event start date, no requests for refunds, transfers, or credits will be granted. 

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