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COVINGTON & BURLING LLP

of market share, for the ACO to fall within the safety zone. Likewise, a “dominant provider” (with a market share of over 50 percent) must be non-exclusive to the ACO in which it participates in order for the ACO to be in the safety zone. The Policy Statement explicitly notes that the safety zone is merely intended to identify ACOs that are “highly unlikely” to raise significant competitive concerns and that ACOs outside the safety zone are not presumptively unlawful.

E.

Mandatory Review of ACOs with Greater than 50 Percent Market Share

CMS regulations provide that an ACO may not participate in the Program if it has two or more providers whose share in the same PSA exceeds 50 percent for any common service, unless that ACO provides a letter from the FTC or DOJ saying it has no present intent to challenge the ACO under the antitrust laws. Thus, such ACOs are subject to mandatory antitrust review before participating in the Program. In conducting the review, the agencies will consider information indicating that the PSA shares do not accurately reflect market power. The Policy Statement requires the agencies to render an initial decision with 90 days of receiving specified documentation regarding the ACO’s business plans, structure, and commercial arrangements.. The FTC and DOJ share authority to review proposed ACOs and the decisions as to which agency will conduct the review will be made on a case- by-case basis.

F.

Activities for ACOs to Avoid to Prevent Antitrust Violations

ACOs that are not subject to the mandatory review, but fall outside the safety zone can request an expedited review on the same terms as the mandatory review process (i.e., 90 days following submission of all required documentation and no CMS approval if antitrust agencies state concerns). However, short of seeking such a review, the Policy Statement identifies five types of conduct that, if avoided, are likely to reduce the likelihood of anticompetitive concerns and thus of an investigation. The types of conduct to avoid are: (1) preventing/discouraging commercial payers from steering patients toward certain providers; (2) tying sales of the ACO’s services to purchasing other services outside the ACO; (3) contracting with providers other than primary care physicians on an exclusive basis; (4) restricting a commercial payer’s ability to disseminate provider quality information to its enrollees; and (5) sharing competitively sensitive pricing or other data within the ACO that could influence activities outside the ACO.

G. Request for Public Comment

The FTC has invited public comment on the Statement from stakeholders regarding whether the proposed Statement should be changed, whether other sources of data could be used to determine relevant PSA shares, and whether the documentation required for expedited review would be unduly burdensome to ACOs. Comments must received by May 31, 2011. Comments may be submitted online or by mail and will be posted online as soon as possible after they have been received.

VI. WAIVER OF FRAUD AND ABUSE LAWS

On March 28, 2011, CMS and the OIG published a notice detailing their proposed waivers of federal fraud and abuse laws as applied to providers participating in the Program. Public comments will be accepted on the following proposed waivers until June 6, 2011.

A.

Purpose and Background of Waiver of Fraud and Abuse Laws

ACOs create new and different types of relationships between physicians, hospitals, suppliers, and patients. The application of existing fraud and abuse laws to ACOs could stifle their growth and

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