On March 31, 2011, the Federal Trade Commission (FTC) and Department of Justice (DOJ) issued a joint proposed Statement of Enforcement Policy to explain how the agencies intend to enforce U.S. antitrust laws with respect to Accountable Care Organizations (ACOs) - groups of health care providers that will be collaborating under the Patient Protection and Affordable Care Act. The proposed Statement is intended to ensure that health care providers have the guidance they need to form ACOs that comply with the federal antitrust laws. The proposed Statement explains: 1) which combinations of providers are affected; 2) when the FTC and DOJ will apply particular antitrust analyses to those ACOs; 3) an antitrust “safety zone” for certain ACOs; 4) the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS)-mandated antitrust review process for certain other ACOs; and 5) options for ACOs to gain additional antitrust clarity if they fall outside the “safety zone” but below the CMS-mandated antitrust threshold. As set forth in the proposed Statement, the FTC and DOJ will evaluate applicants that meet CMS eligibility criteria for the Shared Savings Program based on the ACO’s share of services in each participant’s Primary Service Area (PSA). CMS has further clarified the eligibility criteria through its proposed regulations.
The FTC and DOJ are accepting public comment from health care providers, payers, consumers, antitrust practitioners, and others on the proposed Statement of Enforcement Policy through May 31, 2011. If you have any questions regarding the proposed Statement or would like assistance in preparing public comments to submit to the agencies, please contact one of the authors.