8:00 am
8:30 am
Charles Washington
Charles Washington, CFE, CPP, CICA
Director, Fraud Investigation Group

8:45 am

The Final Rule effective January 1st presents an update to the 340B program in terms of the Ceiling Price Calculations and Civil Monetary Penalties. The current unknown surrounding the pricing and penalty creates a large topic of discussion for manufacturers. Discuss the future of enforcement and implementation under the Final Rule.

340B Ceiling Price Calculation

  • Discuss the intersection of ceiling pricing and penny pricing in 340B price
  • Examine the impact of the 340B program on new price increases and quarterly price adjustments

Civil Monetary Penalties

  • Consider how this new ruling impacts how your organization approaches to risk taking
  • Understand how manufacturers are operationalizing policies within the Final Rule
  • Discuss the guidelines on which penalties are to be determined
Phillip A. Coburn
Phillip A. Coburn
Director, US Government
Pricing Compliance

William A. Sarraille
William A. Sarraille
Sidley Austin LLP

Michele Zarychta
Michele Zarychta
Corporate Counsel

10:45 am

A constant area of concern for manufacturers is the persistent expansion of the 340B program through contract pharmacies. With an increased number of pharmacies providing 340B drugs there is a continued risk of diversion. Develop approaches to work with covered entities and contract pharmacies to ensure they are reaching eligible patients and reducing the risk of noncompliance.

  • Gain an understanding of the contract pharmacy model, including claims processing and replenishment
  • Understand the claim visibility of CEs, TPAs, and contract pharmacies and examine what strategies are currently in place to prevent diversion
  • Explore models in which contract pharmacies can be developed with the goal of combating diversion
Tess Morgan
Tess Morgan
Senior Manager, Product Diversion and Program Integrity

11:30 am

In many ways manufacturers feel they do not have clear paths to resolve the challenges they face through the 340B program. Many elements of 340B at this moment are ill-defined, creating confusion and contributing to the exponential growth of the program. This session examines varying aspects of the program that can be promoted for reform initiatives.

  • Establish a more accurate patient definition to verify that each patient is that of a covered entity
  • Understand parent and child organizational relationships
  • Discern duplicate discounts and enforcement of the prohibition
  • Evaluate key factors of the program that have contributed to program growth
  • Highlight ways in which guidance can be updated and oversight can be improved
Jack Geisser
Jack Geisser
Director, Healthcare Policy, Medicaid and State Initiatives
Biotechnology Industry Organization (BIO)

12:15 pm

The topic of drug pricing reform is increasingly present not only in industry conversation but in mainstream ones as well. People across the country are voicing their opinions on the current drug prices and the government’s role in regulation. With new pricing models such as the complex International Pricing Index being implemented, in is imperative manufacturers stay on top of changing policies.

  • Discuss the current drug reform initiatives and their impact on the 340B program
  • Examine the latest proposals on drug pricing and their potential impact on 340B drug prices
  • Review the negotiating power of private-sector vendors to lower drug prices
Amanda Bartelme
Amanda Bartelme
US Public Policy

Natalie Morris
Natalie Morris
Director, Federal Government Affairs & Policy

1:00 pm