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

Recording of a 90-minute CLE webinar with Q&A


Conducted on Thursday, June 2, 2016

Recorded event now available

or call 1-800-926-7926
Program Materials

This CLE webinar will provide guidance to healthcare counsel on contract pharmacy arrangements and the key legal and regulatory considerations for structuring and documenting the arrangements.

Description

Contract pharmacy arrangements have increased significantly since HRSA issued guidance permitting covered entities to utilize multiple contract pharmacies in 2010. To properly structure and document these arrangements, counsel must have a detailed understanding of the legal and business issues in contract pharmacy arrangements.

Whether a contract pharmacy arrangement is beneficial for a covered entity depends on the compliance issues and the legal consequences. These arrangements require vigilant oversight to ensure compliance and counsel should structure the arrangement to protect the entity from liability for 340B violations.

Healthcare counsel face a number of legal and regulatory hurdles in assisting clients with crafting and negotiating contract pharmacy arrangements and need to anticipate common pitfalls.

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. Structuring and implementing contract pharmacy arrangements
    1. Need for services
    2. Due diligence
    3. Fee structures
  2. 340B entity compliance issues
    1. Certifications
    2. Contractor associated liability
    3. Covered entity requirements
  3. Enforcement and sanctions

Benefits

The panel will review these and other key issues:

  • What compliance challenges must be overcome when structuring a contract pharmacy arrangement?
  • What compliance measures is HRSA likely to adopt in the final version of the proposed mega-guidance that was published last year?
  • What operational and contractual considerations should counsel keep in mind when structuring and implementing these arrangements?

Faculty

Travis F. Jackson
Travis F. Jackson

Principal
Polsinelli

Mr. Jackson counsels health systems and hospitals in a wide array of areas, including pursuing mergers and...  |  Read More

Miley, Claire
Claire F. Miley

Member
Bass Berry & Sims

As a senior healthcare regulatory and transactional attorney, Ms. Miley focuses on complex healthcare...  |  Read More

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