By Lauren Norris Donahue & Brian Smith, K&L Gates LLP
On 3 February 2023, the U.S. Department of Justice Antitrust Division (Division) announced its withdrawal of three long-standing antitrust policy statements related to enforcement in the health care industry. The policy statements were issued jointly with the Federal Trade Commission (FTC), which has not yet announced a similar withdrawal but it is anticipated to follow suit. While the statements were never binding on the antitrust agencies, they served as important guidance to health care providers and counsel across a range of antitrust issues pertinent to the health care industry, including mergers, joint ventures, joint purchasing arrangements, information exchanges, and the formation and operation of financially and clinically integrated networks.
In describing its rationale for the withdrawal of the guidance documents, Principal Deputy Assistant Attorney General Doha Mekki of the Division explained, “we believe the health care industry has evolved considerably since the statements were issued and that they no longer serve their intended purposes to provide encompassing guidance to the public on relevant health care competition issues.” The withdrawal is part of an aggressive antitrust enforcement agenda set forth by the Biden Administration, with a focus on the health care industry, and signals increased antitrust scrutiny for collaborations and information exchanges within the health care industry.
What has Changed?
The Division withdrew three policy statements:
- Department of Justice and FTC Antitrust Enforcement Policy Statements in the Health Care Area (1993);
- Statements of Antitrust Enforcement Policy in Health Care (1996) (1996 Guidance); and
- Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (2011) (2011 Guidance).
These statements provided guidance in the form of “safety zones,” which described conduct that the antitrust agencies would not challenge under the antitrust laws, absent extraordinary circumstances. The safety zones covered a wide variety of collaborations between health care providers, including mergers, joint ventures, joint purchasing arrangements, information exchanges, and the formation and operation of financially and clinically integrated networks. The statements also provided guidance on how the agencies would analyze conduct and collaborations that fell outside of the safety zones. Below are a few of the safety zones that the Division withdrew.
