Federal Trade Commission and Department of Health and Human Services Announce Public Workshops Addressing Legal Implications of Accountable Care Organizations

The Federal Trade Commission, the Centers for Medicare & Medicaid Services (CMS), and the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) have announced that they will be holding a public workshop regarding legal issues relating to Accountable Care Organizations (ACOs) on October 5, 2010.  ACOs are integrated health care delivery systems designed to lower costs and improve quality by allowing physicians to work in groups and receive payments for shared savings.   

A variety of legal regimes—such as the antitrust laws, the physician self-referral prohibition, the Federal anti-kickback statute, and the civil monetary penalty (CMP) law—will apply to ACOs, and the agencies seek to explore how these laws will affect ACOs.  The stated goals of the workshop will be (1) to assess how the variety of possible ACO structures in different health care markets could affect the prices and the quality of health care services; (2) to determine whether and, if so, how the requirements of the laws mentioned above could or should be addressed in the regulations that CMS is developing for the Medicare Shared Savings Program; and (3) to evaluate whether and, if so, to what extent any safe harbors, exceptions, exemptions, or waivers from the applicable laws may be warranted.

The agencies intend to address these goals by holding several moderated panel discussions.  The FTC will hold two morning sessions that will explore the antitrust issues associated with ACOs.  The first will address circumstances under which collaboration among independent health care providers in an ACO permits member providers to engage in joint price negotiations with private payers without running the risk of engaging in illegal price fixing under the antitrust laws.  The second session will explore ways to encourage formation of multiple ACOs among otherwise independent providers so that competition among ACOs in any given geographic market will drive improved quality and affordability of health care.  CMS and OIG will also have a panel discussion as well as a listening session regarding how ACOs will interact with the physician self-referral prohibition, the anti-kickback statute, and the CMP law.

In preparation for these discussions, the agencies are seeking public comment on topics such as: (1) the intersection of the various business models envisioned for ACOs with both the antitrust laws and the fraud and abuse laws; (2) the types of contractual and financial relationships under existing or planned ACOs that might trigger or implicate the antitrust laws, the physician self-referral prohibition, the anti-kickback statute, and the CMP law; (3) whether the public believes that the incentive payments or shared savings to ACOs, or the distribution of these payments to the physicians or other providers and suppliers in the ACO, would trigger or implicate the physician self-referral prohibition, the anti-kickback statute, and/or the CMP law; and (4) any potential impediments, including the inadequacy of current safe harbors, to the success of ACOs as presently constrained by the various laws.