FTC, DOJ Open ACO Antitrust Guidelines to Public Comment

Some accountable care organizations could fall into designated antitrust "safety zones" while other ACOs could be eligible for expedited antitrust reviews under proposed rules issued jointly Thursday by the Federal Trade Commission and Department of Justice.

The two agencies are asking for public comment on their joint proposed policy guidelines that are designed to ensure that ACOs can serve Medicare beneficiaries and patients with private health insurance without raising competitive concerns.

The proposed rules were issued the same day that The Department of Health and Human Services released for public comment its long-awaited proposed rules governing accountable care organizations.

"The Administration has led an unprecedented, collaborative effort among all of the agencies responsible for developing guidance for ACOs," said FTC Chairman Jon Leibowitz. "This guidance will help ensure that ACOs meet their goals of improving quality and lowering costs while minimizing the regulatory burden on healthcare providers."

ACO collaborations among competitors could raise concerns about competitiveness, DOJ and FTC said. So they developed the proposed antitrust policy statement to coordinate competition analysis with CMS's review of ACO applications to ensure they do not lead to reduced competition and higher prices for consumers.

The policy statement describes:

1. The ACOs to which it will apply;
2. When the FTC and DOJ will apply particular antitrust analyses to those ACOs;
3. An antitrust safety zone for certain ACOs;
4. The CMS-mandated antitrust review process for certain other ACOs;
5. Options for ACOs to gain additional antitrust clarity if they fall outside the safety zone but below the CMS-mandated antitrust threshold.

The FTC and DOJ will evaluate applicants that meet CMS eligibility criteria based on the ACOs' share of services in each participant's primary service area. ACOs with high PSA shares may pose a higher risk of being anticompetitive, could restrict competing ACOs, and could allow an ACO to raise prices charged to commercial health plans above competitive levels, the two agencies said.

Depending on an ACO's range of PSA shares, CMS may mandate, or an ACO may choose to seek, an expedited antitrust review. An ACO will submit its request for an expedited 90-day review to both the FTC and DOJ, and the agencies will determine which of the two will review the request. In addition, the FTC and DOJ will establish a Joint ACO Working Group to discuss issues arising out of ACO reviews.

The two agencies have opened a public comment period on the proposed policy statement through May 31 on issues including:

• Whether the proposed policy statement should be changed in any respect;
• Whether other data sources exist that ACO applicants could use to determine relevant PSA shares for: 1) physician services rarely used by Medicare beneficiaries (e.g., pediatrics, obstetrics); and 2) inpatient hospital services located in states where all-payer hospital discharge data are unavailable; and
• Whether providing the documents and information for an expedited antitrust review will present an undue burden on ACO applicants.

Comments can be submitted electronically here.  The proposed policy statement can be found here.