On October 20, 2011, the Department of Justice and Federal Trade Commission jointly issued their “Final Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medical Shared Savings Program.” The policy statement, which largely mirrors the agencies’ proposed policy statement issued on April 19, 2011, outlines how the agencies will enforce U.S. antitrust laws with regard to accountable care organizations (“ACOs”). However, the final policy statement differs from the proposed policy statement in two material respects.
First, the final policy statement applies to all collaborations that are eligible or have been approved to participate in the Medicare Shared Savings Program (“MSSP”). The proposed policy statement was limited to collaborations formed after March 23, 2010.
Second, and more importantly for those contemplating the formation of an ACO, the final policy statement eliminates the mandatory antitrust review for ACOs meeting certain market share thresholds. This change tracks the MSSP final rule, which no longer requires a mandatory antitrust review for certain collaborations as a condition of entry into the MSSP.
The final policy statement otherwise retains many of the elements of the proposed statement. Specifically, the statement provides that ACOs satisfying CMS’s eligibility requirements for, and participating in, the MSSP will receive rule of reason treatment under the antitrust laws, and the statement preserves the antitrust “safety zone” for certain ACOs, as described in the proposed policy statement.
Finally, the FTC and DOJ will offer voluntary expedited 90-day reviews for newly formed ACOs that are seeking additional antitrust guidance. Parties seeking expedited review must submit their request for review prior to entering into the MSSP, and they will be required to produce strategic planning and other materials as outlined in the policy statement before the 90-day review period will begin. Thus, parties seeking expedited review face a potentially significant production burden and should consider whether expedited review will be sought, and, if so, begin gathering and submitting documents to the agencies well before they plan on entering the MSSP.