In recent years—as a result of statements made by the President and others in his administration, government initiatives, and the increasingly competitive healthcare market that is focused on value-based (rather than fee-for-service) arrangements—medical device manufacturers have experienced an interest in responding to this change in environment by offering customers arrangements that involve performance-driven, outcomes-based, or risk-share concepts rather than traditional sales and discount arrangements. However, medical device manufacturers who wish to showcase the benefits of their newest innovation, or who simply want to stand out in a crowded field by pursuing such novel arrangements, face challenges in implementing these arrangements given the current (and rigid) legal framework under the federal healthcare fraud and abuse laws, in particular, the federal Anti-Kickback Statute (‘‘AKS’’), which were enacted and implemented decades before this current industry shift.
Reproduced with permission from Medical Devices Law & Industry Report, 9 MELR 713, 11/11/2015. Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
