The much-anticipated proposed regulations for the Medicare Shared Savings Program and accountable care organizations (ACOs) were released late last week by the Centers for Medicare & Medicaid Services (CMS), just over one year after the passage of the Patient Protection and Affordable Care Act (PPACA). In a welcomed display of federal agency coordination, CMS’ proposed rules were coupled with the release of several other affiliated proposals:

• Joint CMS and U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) notice outlining proposals for a waiver of the federal Stark law, the anti-kickback statute, and certain provisions of the civil monetary penalty law in connection with the Shared Savings Program;

• Joint Federal Trade Commission and Department of Justice Proposed Statement of Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program; and

• Internal Revenue Service notice regarding the need for guidance on participation by tax-exempt organizations in the Shared Savings Program through ACOs.

CMS is requesting comment on these proposed regulations over the next 60-day period, ending on June 6, 2011.

What is perhaps most striking about this release is the extent to which CMS acknowledges the complexity of the Shared Savings Program and the conceptualization of ACOs. Given these factors, the proposed regulations, while providing a large amount of detail, are also very much a “proposal”: CMS is requesting comment in connection with almost every concept. It is clear that we should expect the rules governing the formation and operation of ACOs to evolve over time. This is both a blessing and a curse given the complexity of the regulations and the substantial financial and operational investment that will be required to become an ACO.