Value-based arrangements – also referred to as results-based, outcomes-based, or performance-based payment arrangements – may condition payment or modify pricing for health care items or services based upon a clinical, economic, and / or patient-experience outcome, to increase shared accountability for both quality and the total cost of care. 

To maximize the potential of value-based health care, we need to integrate all of the contributors to health care, including medtech manufacturers, who can play a pivotal role in delivering solutions to help physicians and hospitals meet the triple aim (achieve better outcomes, lower cost, and improve the patient experience). 

Medtech Industry Transformation to Deliver Solutions 

Medtech companies no longer just produce devices, they now produce solutions, a combination of technology and services to deliver a targeted outcome. We want to be partners in care to drive comprehensive solutions to detect, treat, and manage disease and share accountability for achieving better outcomes as well as managing costs. 

Anti-Kickback Statute Safe Harbors 

To realize the potential of value-based health care, we need to update the Anti-Kickback Statute (AKS) safe harbors to meaningfully integrate all contributors to health care in value-based arrangements. The current interpretation of the AKS and safe harbor regulations inappropriately deters manufacturers, providers, payors and others from engaging in beneficial value-based health care arrangements. 

Although the current AKS safe harbors may protect some limited value-based offerings, changes are needed to make it easier for the participants to effectively engage in value-based arrangements and to allow for more comprehensive and efficient solutions. The current laws make it difficult or impossible for a medtech company to put its payment for use of its device truly “at risk” in a manner that is dependent on meeting clinical or other predetermined value outcomes.  By modernizing the laws to clearly allow for such arrangements, the system will better promote and reward those whose products deliver value, thereby reducing overall costs to the system and improving patient outcomes.   

AdvaMed recommends creating a new value-based safe harbor to the federal Anti-Kickback Statute–a Value-Based Pricing Arrangements Safe Harbor – that allows for price adjustments based on whether or not specified clinical or cost outcome targets were achieved (i.e., an outcome determined reduction or increase in a buyer’s net cost for reimbursable items or services).