FTC/DOJ Final Policy on Accountable Care Organizations: Important Antitrust Issues Remain Uncertain for Healthcare Collaborations

Morgan Lewis
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The Federal Trade Commission (FTC) and Department of Justice (DOJ) (together, the Agencies) issued their final "Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program" (Policy Statement) on October 20, on the same day that the Centers for Medicare and Medicaid Services (CMS) issued extensive regulations governing the formation, registration, and operation of accountable care organizations (ACOs). The Policy Statement outlines in general terms the standards the Agencies will apply in analyzing the legality of ACO formation and conduct under the antitrust laws. ACOs formed pursuant to the CMS regulations are not subject to mandatory antitrust review by the Agencies, but the Agencies have committed to an expedited process for the review of any ACO that voluntarily requests such a review. The Policy Statement also (a) outlines the standard that will be applied in the review by the Agencies (the Rule of Reason), (b) defines a "safe harbor" for ACOs that are below certain market share thresholds, and (c) outlines some conduct by ACOs that would be problematic from the Agencies' perspectives.

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