PURPOSE: Provide an overview of the importance of Value Based Contracting (VBC) in today’s healthcare landscape and share tactical recommendations and best practices from different stakeholders involved in the implementation of these agreements including Legal, Regulatory Affairs, Payers, and Industry.

DESCRIPTION: VBC is trending globally in the medical device industry. These contracts offer an innovative approach to collaboration between manufactures and customers that may include evidence-based discounts, product guarantees, and financial-risk sharing arrangements. In some cases payments tied to outcome guarantees encourage clinicians to use innovative healthcare technologies with minimal financial risk. As part of this workshop, we will define VBCs, provide an overview of their current use, highlight benefits and challenges, and identify a pathway/framework for successful implementation.

VBCs require alignment across teams to ensure success. This workshop will consider each of these perspectives inclusive of Legal, Regulatory Affairs, and HEOR/Market Access. A VBC needs to consider legal and regulatory guidance related to the FDA, disclosures that are necessary in the contract, allowable discounts, and privacy issues for disclosing patient data. The Regulatory Affairs aspect addresses the latest developments from the FDA affecting VBCs for medical devices. For example, until recently, the FDA's advertising and promotional requirements for restricted medical device were seen as a significant hurdle that hindered VBC. FDA's interpretation of its regulations has changed and that change was made explicitly to enable greater VBC. Lastly, the HEOR perspective will discuss emerging trends in Europe and the US, showcase differences between device and pharmaceutical manufacturers, and how to overcome some of the challenges with identifying a meaningful outcome measures, collect appropriate data, and conduct real-time analytics.

We will share case studies of VBCs between medical device manufacturers and payers or providers and how these agreements align with the outlined framework and address team needs.