The Federal Trade Commission and Department of Justice have issued guidance on how they will enforce anti-trust laws in an accountable care organization environment.

The guidance is a final policy statement that significantly differs in two areas from a draft proposed policy statement issued for public comment in March 2011.

First, the final policy statement, with the exception of a new voluntary expedited anti-trust review, applies to all collaborations that intend to participate in the Shared Savings Program. Applicability in the draft policy was limited to collaborations formed after March 23, 2010, when the Affordable Care Act was enacted.

Second, because the Shared Savings program no longer will require a mandatory anti-trust review for certain collaborations as a condition of participation, the final policy statement does not contain provisions relating to mandatory review.

There are caveats:

"However, as discussed in the final rule, the agencies will continue to protect competition in markets served by accountable care organizations that participate in the Shared Savings Program, aided by data and information from CMS that will assist the agencies in monitoring the competitive effects of ACO," according to the FTC/Justice statement. "Specifically, CMS will provide the agencies with aggregate claims data regarding allowed charges and fee-for-service payments for all ACOs accepted into the Shared Savings Program of ACOs formed after March 23, 2010. The agencies will vigilantly monitor complaints about an ACO's formation or conduct and take whatever enforcement action may be appropriate. Additionally, upon request, the agencies will provide an expedited 90 day review for newly formed ACOs that wish to obtain additional anti-trust guidance."

The full 18-page policy guidance is available here.


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