BarbriSFCourseDetails

Course Details

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.

Faculty

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.

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?