The Proposed Waivers of the Fraud & Abuse Laws for ACOs: Have OIG and CMS Gone Far Enough?

McDermott Will & Emery

In early April 2011, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published long-awaited proposals for waivers (Proposed Waivers) of the application of three federal fraud and abuse laws to Accountable Care Organizations (ACOs) participating in Medicare’s Shared Savings Program.1 The Proposed Waivers are authorized by Section 3022(f) of the Patient Protection and Affordable Care Act.2 The comment period for these proposals ends on June 6, 2011. This white paper describes how the Proposed Waivers would insulate ACOs and their participating providers and suppliers from certain risks and liabilities under the federal physician self-referral or Stark law (the Stark Law), the federal anti-kickback law (the Kickback Law), and the civil monetary penalty law’s prohibition on hospital payments to physicians to reduce or limit services to federal program patients (the CMP Gainsharing Prohibition) (collectively, the Fraud & Abuse Laws). In addition, this white paper discusses potential risks and liabilities under the Fraud & Abuse Laws not addressed by the Proposed Waivers, and that we believe that CMS and the OIG should address in the final rule in order for the Shared Savings Program to effectively achieve its objectives.

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