With spiraling costs and outcomes that consistently lag many other developed nations, the U.S. healthcare system is in the midst of fundamental change.  In response, payers have been exploring ways to restructure payments (and risk) to increase accountability for cost and quality.  Thus far, most activity has occurred between payers and providers through such mechanisms as value-based contracts and bundled pricing.  Such arrangements obligate providers to manage against agreed-upon quality criteria and pre-set cost targets in return for a share of potential savings and increasingly, financial risk for missing them. Consequently, providers are now increasingly adopting evidence-based care paths to better control their own costs and outcomes.

As pressure for “better outcomes at lower cost” continues to mount, manufacturers must understand that they face a future in which they may be asked – or even required – to take on more of the risks related to the performance and cost of their products.  However, before entering into risk sharing agreements, manufacturers must understand the challenges and implications of these agreements, including considerations for the collection of outcomes data.  In addition, manufacturers must be able to accurately assess when these arrangements are beneficial, and when they are not.