340B Contract Pharmacy Arrangements: Structuring Arrangements, Meeting Legal and Regulatory Requirements

A live 90-minute CLE video webinar with interactive Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Tuesday, March 14, 2023

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, February 17, 2023

or call 1-800-926-7926

This CLE course will provide guidance to healthcare counsel on contract pharmacy arrangements and the key legal and regulatory considerations for structuring and documenting the arrangements in an uncertain regulatory environment.

Description

Certain drug companies have recently begun taking steps to curb the use of contract pharmacies under the federal 340B drug pricing program, and HRSA has taken enforcement action against manufacturers that is the subject of federal litigation. Nevertheless, the use of contract pharmacy arrangements continues to be a key part of the 340B program.

To properly structure and document these arrangements, counsel must have a detailed understanding of the legal, business, and payor issues in contract pharmacy arrangements.

In the evolving landscape, it is important for counsel to stay abreast of new developments.

Listen as our authoritative panel of healthcare attorneys examines contract pharmacy arrangements and the key legal and regulatory concerns when structuring and documenting the arrangements.

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Outline

  1. Recent 340B developments: What is the going forward impact on 340B contract pharmacy arrangements?
  2. Structuring and implementing contract pharmacy arrangements
    1. HRSA essential compliance elements
    2. Fee structures
    3. Discounts for uninsured patients
    4. Reconciliation (including DIR Fees)
  3. 340B entity compliance issues
    1. Prohibition against diversion
    2. Prohibition against duplicate discounts
    3. Inventory management issues
  4. HRSA audit enforcement, and litigation

Benefits

The panel will review these and other key issues:

  • What compliance challenges must be overcome when structuring a contract pharmacy arrangement?
  • What does the future compliance landscape for contract pharmacy arrangements look like?
  • What operational and contractual considerations should counsel keep in mind when structuring and implementing these arrangements?

Faculty

Davis, Jeffrey
Jeffrey I. Davis

Member
Bass Berry & Sims

Mr. Davis advises healthcare organizations on Medicare and Medicaid billing and reimbursement issues, with a special...  |  Read More

Dresser, Jesse
Jesse C. Dresser

Partner
Frier Levitt

Mr. Dresser heads the firm’s Pharmacy Practice Group. In this role, his practice is dedicated to representing a...  |  Read More

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Early Discount (through 02/17/23)

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Early Discount (through 02/17/23)

You may pre-order a recording to listen at your convenience. Recordings are available 48 hours after the webinar. Strafford will process CLE credit for one person on each recording. All formats include course handouts.

To find out which recorded format will provide the best CLE option, select your state:

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