340B Contract Pharmacy Arrangements: What Does the Future Hold?

Structuring Arrangements, Meeting Legal and Regulatory Requirements

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

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Conducted on Wednesday, January 27, 2021

Recorded event now available

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Course Materials

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

The number of contract pharmacies in the 340B space has grown exponentially over the last several years. However, certain drug companies have recently begun taking steps to curb this trend. In recent months, several drug manufacturers began notifying 340B participants that they plan to limit the use of contract pharmacies. At least one drug maker has taken the unprecedented step of filing suit against a 340B covered entity and its contract pharmacies over prescriptions dispensed through the 340B program. This has ignited a battle that involves 340B covered entities, contract pharmacies, drug manufacturers, and Congress.

Contract pharmacy arrangements have increased significantly since HRSA issued guidance permitting covered entities to use multiple contract pharmacies. 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. Enforcement, sanctions, 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
Of Counsel/Senior Advisor
Baker Donelson Bearman Caldwell & Berkowitz

Mr. Davis provides clients with healthcare regulatory counsel on issues affecting healthcare providers, including...  |  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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