As hospitals, physicians and other providers establish the infrastructure and ultimately develop methodologies for sharing the savings and risks of ACOs, new financial and referral relationships will arise that are not contemplated – or protected – under the existing statutory and regulatory framework of fraud and abuse laws. In particular, these relationships raise liability concerns under the civil monetary penalties (“CMP”) law, the federal anti-kickback statute (“AKS”), and the federal physician self-referral law (“Stark”). For example, hospitals may contribute up-front human and financial capital in establishing the legal and corporate framework through which ACOs operate; those contributions could constitute “remuneration” to referring physicians who then participate in or otherwise refer to those entities, remuneration that does not neatly fit into existing Stark exceptions or AKS safe harbors. Shared savings methodologies pose similar issues, as well as the potential that such methodologies might be construed as a gainsharing program involving hospital payments to physicians in order to reduce or limit services to Medicare or Medicaid beneficiaries in the physicians’ care, in potential violation of the CMP law.