On March 31, 2011, a little over a year after the Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), became law, the Centers for Medicare & Medicaid Services (CMS) released proposed regulations (the Proposed Rule) addressing the operation and structure of Accountable Care Organizations (ACOs) and creating the Medicare Shared Savings Program (the Program).1 The arrangements that may be necessary or desirable to form ACOs and to participate in the Program raise new fraud and abuse concerns. Providers will need to understand and address the fraud and abuse provisions of the Proposed Rule in order to assure initial and ongoing compliance. The deadline for submitting comments on the proposed regulations is June 6, 2011.

A previous Mintz Levin advisory addressed the fact that, as part of the Program, CMS and the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) anticipate waiving certain existing federal fraud and abuse laws for qualifying participating ACOs.2 While much attention has been given to these anticipated waivers, the Proposed Rule itself contains its own fraud and abuse provisions that, if implemented, will not be subject to waiver.