On April 7, 2011, the Centers for Medicare & Medicaid Services and the Office of Inspector General published proposed waivers of federal fraud and abuse laws — specifically the Stark law, the federal anti-kickback statute and the CMP law — as they apply to certain financial arrangements between and among ACOs and their constituent providers and suppliers. Comments on the proposals and on specifically identified outstanding issues and areas of concern will be accepted until June 6, 2011.

Concurrent with the release of the proposed accountable care organization (ACO) regulations on March 31, 2011, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) released a notice with comment period (the Waivers Notice), which then was published in the Federal Register on April 7, 2011. The Waivers Notice proposes waivers of the federal fraud and abuse laws as they apply to certain financial arrangements between and among ACOs and their constituent providers and suppliers. Section 3022 of the Patient Protection and Affordable Care Act, codified at Section 1899(f) of the Social Security Act, grants the Secretary of the U.S. Department of Health and Human Services (Secretary) the authority for such waivers as necessary to carry out the Medicare Shared Savings Program. Specifically, the Waivers Notice outlines proposals for waiving application of the Stark law, the federal anti-kickback statute and the CMP law’s prohibition on hospital payments to induce physicians to reduce or limit services to Medicare or Medicaid patients. The notice requests comments on these proposals and on specifically identified outstanding issues and areas of concern by 5 p.m. ET, June 6, 2011. This newsletter summarizes the Waivers Notice; a more detailed discussion of the Waivers Notice will be published as a White Paper in the coming weeks.