On March 31, 2011, the United States Department of Justice (DOJ) and Federal Trade Commission (FTC) released for public comment a joint Policy Statement regarding how the agencies will enforce the antitrust laws regarding Accountable Care Organizations (ACOs). The Policy Statement accompanies the release on the same day by CMS of its proposed regulations to cover ACOs participating in the Medicare Shared Savings Program. Comments are due by May 31, 2011.
The joint Policy Statement covers five areas: (1) the ACOs to which it will apply; (2) when the FTC and DOJ will apply a “rule of reason” antitrust analyses to those ACOs; (3) an antitrust “safety zone” for ACOs with less than 30 percent market share and non-exclusive ACOs in rural counties; (4) a mandatory antitrust review process for ACOs with market share in excess of 50 percent; and (5) how the agencies will review proposed ACOs with market share between 30 and 50 percent.
In addition, the Policy Statement describes how the parties can obtain an “expedited review” by submitting certain types of information and documents to the reviewing agency at least 90 days before the last day that CMS has stated it will accept ACO application for the relevant calendar year. The agency will provide its opinion (i.e. that the ACO is permissible or that the agency will challenge the ACO) within 90 days of receiving all of the information from the parties.
The Policy Statement is the first major healthcare policy pronouncement from the antitrust enforcement agencies since the FTC/DOJ Competitor Collaboration Guidelines were issued in 2000 and reflects efforts by the DOJ to play a greater role in healthcare antitrust enforcement, as the FTC has historically been the primary agency involved in provider-related healthcare antitrust matters.
The FTC’s press release regarding the Policy Statement is available by clicking here.