The Legal, Regulatory, Business and Compliance Forum on

Health Outcomes Communications, Market Access and Value Based Contracting

Wednesday, January 13 to Friday, January 15, 2016
The Carlton Hotel, New York, NY


Health outcomes data, comparative effectiveness research and pharmacoeconomic analysis — are all essential to the operation and evolution of the modern health care market place. The communication of this data, research and analysis are critical in transforming the current fee for service health care system to one which is value-driven and outcomes based. Despite the recognition of the importance of these communications for the modernization of the U.S. health care system, pharmaceutical manufacturers are still struggling with the antiquated confines of FDAMA 114 in communicating data findings to payors and related parties in formulary placement and market access discussions.

However, recent legislative and judicial activity appears to off er a glimmer of hope in this regard. This past July, the House of Representatives passed the 21st Century Cures Act which in part addresses and attempts to correct FDAMA 114 ambiguities. In August, the Amarin case was decided and while this ruling concerned off -label communications, it may still off er some guidance on FDAMA 114 communications.

These reforms in health care communications are not only essential to fulfi ll the triple aim of health care reform being that of improving care, quality and cost, but more practically and perhaps more importantly, they are quantitative measures by which the medical effi cacy and cost effi ciency of prescription drug products are determined. They off er the proofs which both private and public payors require for market access determinations and formulary placement of manufacturer drug products.

To help you make sense of these new developments and other activity in this area, American Conference Institute (ACI) is proud to present its second annual conference on Health Outcomes Data Communications, Market Access and Contracting which will provide a critical guide on such matters as:

  • Impact of 21st Century Cures Act and Amarin Case on FDAMA 114
  • Formulary determinations
  • Post PPACA market access negotiations with payors and integrated health care entities such as ACOs
  • Value-based contracting and risk sharing agreements
  • Manufacturer — Payor collaborations for real world outcomes data procurement
  • Best practices for outcomes and market access teams to work together efficiently and compliantly

To enhance your learning and networking experience, the conference also features two interactive workshops:

  • Master Class on Effectively and Ethically Communicating Health Outcomes Data to Formulary Committees to Achieve Market Access: Strategies for Preparing the AMCP Dossier and Beyond
  • Master Class on Negotiating, Drafting and Structuring Successful Risk Sharing Agreements

Register today for this unique and timely conference by calling 888-224-2480, faxing your registration form to 877-927-1563, or going online.