If your organization will participate in the Medicare Shared Savings Program as an accountable care organization (ACO), you should consult with antitrust counsel so that you can minimize the risk of criminal and civil liability arising from the antitrust laws. As noted in a prior legal alert from Ballard Spahr’s Health Care Group, several federal agencies recently issued rules and guidance for assisting health care providers in the formation of ACOs effective November 2.

In a joint Policy Statement, the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) issued their “Final Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” on October 20. The agencies warned that they “will vigilantly monitor complaints about an ACO’s formation or conduct and take whatever enforcement action may be appropriate.”

In the Policy Statement, the agencies provide guidance as to how to form ACOs that are unlikely to raise antitrust concerns. Among the key requirements are that the providers are “financially or clinically integrated,” and that the joint price agreement among the providers is “reasonably necessary to accomplish the procompetitive benefits of integration.”

Because the agencies have refused to list specific criteria that would qualify as “integrated” or “reasonably necessary,” it will be important for ACOs to understand how the agencies have approached antitrust enforcement in the health care field in the past. The Policy Statement also outlines an “antitrust safety zone.” An ACO that falls within the safety zone is less likely to pique the interest of the agencies.

Finally, the Policy Statement sets forth a 90-day review process that ACOs may use to determine whether the agencies view the ACO’s formation and operation as raising competitive concerns. To mitigate the risk of becoming the subject of an investigation or lawsuit, ACOs that intend to participate in the Medicare Shared Savings Program should ensure that they will comply with the Policy Statement and may want to consider seeking agency review.