At long last, the oft-delayed Proposed Rule for Accountable Care Organizations (the Proposed Rule) has been issued with only nine months remaining before the Medicare Shared Savings Program is implemented on January 1, 2012. The question now is whether there will be a sufficient number of ACO applicants around the country standing in line to manage the health care needs of an expected 5,000,000 Medicare beneficiaries.

The Proposed Rule, along with a new statement on antitrust enforcement and possible waivers of certain federal laws, such as Stark and the Anti-Kickback Statute, reflects considerable thought and unprecedented coordination between CMS, the Federal Trade Commission, the Department of Justice, the Office of the Inspector General and the IRS (the Agencies). However, more questions have been raised than necessarily answered. CMS and the other Agencies are actively seeking comments on many of the key standards that are still in flux and which need to be finalized before a potential ACO participant can make a truly informed decision on whether to submit a certification application to CMS.

Examples of the unresolved standards include issues and questions relating to the shared savings methodologies, especially the two-sided risk model; the full extent of the final waivers; and the identification of the final quality benchmarks and how performance results will be collected and reported. There are also important questions associated with the ACO leadership, governance and management requirements that, for all practical purposes, will necessitate the establishment of a new legal entity as opposed to the utilization of an existing corporation, partnership or LLC. Moreover, the start-up costs and infrastructure required to comply with the Proposed Rule would appear to favor well-capitalized health care systems and payors over small physician groups and standalone provider facilities.

Despite these challenges, providers will feel compelled to review the provisions of the Proposed Rule and standards.