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A Laboratory of Regulation: The Untapped Potential of the HHS Advisory Opinion Power

Posted by on Monday, November 23, 2015 in Notes, Volume 68, Volume 68, Number 6.

A Laboratory of Regulation: The Untapped Potential of the HHS Advisory Opinion Power


Facing mounting cost and quality pressures, healthcare providers are in a difficult position. The rigid structure of the federal anti-kickback statute compounds the problem by restricting providers’ abilities to pursue innovative business arrangements in response to those pressures. Recognizing the need for thoughtful experimentation with novel arrangements, Congress permits the Department of Health & Human Services to issue case-specific advisory opinions permitting specific arrangements to proceed without fear of adverse administrative action. This Note examines the exercise of that power in practice. It ultimately proposes that HHS should use the evidence it has amassed through the advisory opinion process to promulgate new safe harbor provisions to insulate certain arrangements from AKS liability. Specifically it argues in favor of safe harbors to cover prosocial, but technically violative, arrangements that have received uniformly favorable treatment within the advisory opinion process over a period several years.


J.D. Candidate, 2016, Vanderbilt Law School; B.A., 2011, Vanderbilt University. This Note is the product of the work of many skilled hands, but special thanks go to: Professor James Blumstein for suggesting the HHS advisory opinion process as a possible note topic; Tim Dougherty for helping to hone my early drafts; Hannah McSween for serving as an incredibly effective interlocutor; Samiyyah Ali and Matt Gornick for sharpening my argument and my language; my family for their constant love and support; and—last on this list, but first in my heart—Macy Cullison, my (brand new) fiancée, for providing endless encouragement throughout this entire process. Any remaining errors are my own.