On February 3, 2023, the U.S. Department of Justice announced the withdrawal of three statements of antitrust enforcement policy in health care (the “Statements”). DOJ’s press release, which is available online at Justice Department Withdraws Outdated Enforcement Policy Statements | OPA | Department of Justice, states:
The Justice Department’s Antitrust Division announced today the withdrawal of three outdated antitrust policy statements related to enforcement in healthcare markets: Department of Justice and FTC Antitrust Enforcement Policy Statements in the Health Care Area (Sept. 15, 1993); Statements of Antitrust Enforcement Policy in Health Care (Aug. 1, 1996); and Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (Oct. 20, 2011).
After careful review and consideration, the division has determined that the withdrawal of the three statements is the best course of action for promoting competition and transparency. Over the past three decades since this guidance was first released, the healthcare landscape has changed significantly. As a result, the statements are overly permissive on certain subjects, such as information sharing, and no longer serve their intended purposes of providing encompassing guidance to the public on relevant healthcare competition issues in today’s environment. Withdrawal therefore best serves the interest of transparency with respect to the Antitrust Division’s enforcement policy in healthcare markets. Recent enforcement actions and competition advocacy in healthcare provide guidance to the public, and a case-by-case enforcement approach will allow the Division to better evaluate mergers and conduct in healthcare markets that may harm competition.
“The healthcare industry has changed a lot since 1993, and the withdrawal of that era’s out of date guidance is long overdue,” said Assistant Attorney General Jonathan Kanter of the Justice Department’s Antitrust Division. “The Antitrust Division will continue to work to ensure that its enforcement efforts reflect modern market realities.”
Guidance documents are non-binding and do not create legal rights or obligations. Antitrust enforcement and competition advocacy in healthcare remain important parts of the division’s mission, and the division will continue to vigorously enforce the antitrust laws in the healthcare industry.
Our review of this announcement suggests a few immediate points for health care entities to consider. First, DOJ has been increasingly active recently in pursuing alleged unlawful agreements to fix wages in the health care industry. Statement 6, “Statement of Department of Justice and Federal Trade Commission Enforcement Policy on Provider Participation in Exchanges of Price and Cost Information” (August 1996) creates a “safety zone”:
The Agencies will not challenge, absent extraordinary circumstances, provider participation in written surveys of (a) prices for health care services, or (b) wages, salaries, or benefits of health care personnel, if the following conditions are satisfied:
the survey is managed by a third-party (e.g., a purchaser, government agency, health care consultant, academic institution, or trade association);
the information provided by survey participants is based on data more than 3 months old; and
there are at least five providers reporting data upon which each disseminated statistic is based, no individual provider’s data represents more than 25 percent on a weighted basis of that statistic, and any information disseminated is sufficiently aggregated such that it would not allow recipients to identify the prices charged or compensation paid by any particular provider.
DOJ now describes the Statements as “overly permissive on certain subjects, such as information sharing.” As DOJ is now espousing a case-by-case approach, it may well have encountered an alleged unlawful agreement to fix wages, in which the target of the investigation raised this safety zone as a defense.
Second, the practical effect of DOJ’s announcement is to eliminate the antitrust safety zones described in the Statements, which otherwise largely describe an analytical approach to antitrust in health care that is familiar to antitrust practitioners and well-supported by other precedents and guidance. Arrangements that were previously protected by a safety zone will now require a fact-specific analysis, in the same way that arrangements outside a safety zone always have. In particular, provider networks can no longer assume that the level of clinical integration needed to qualify for participation in the Medicare Shared Savings Program automatically confers antitrust protection for joint negotiating with payors.
Third, in the absence of the antitrust safety zones, it will be increasingly important to review any proposed arrangement on its own merits. If there is any question about whether a particular arrangement may raise antitrust concerns, obtaining case-specific guidance from the antitrust enforcement agencies may be appropriate. The FTC issues advisory opinions (see Competition Advisory Opinions | Federal Trade Commission (ftc.gov) and advisoryopinionguidance-hc_updated_links_oct2015.pdf (ftc.gov)), and DOJ issues business reviews (see Business Reviews (justice.gov)); either avenue may be appropriate depending on the nature of the issue.
Finally, the Federal Trade Commission does not appear have mirrored DOJ’s announcement. As the Statements are joint statements of DOJ and the FTC, and as the FTC frequently takes the lead in health care antitrust matters outside of criminal enforcement, it remains to be seen how the FTC’s approach may be affected by DOJ’s announcement.
Kozak & Gayer is available to help with antitrust compliance following this development. Please contact Joe Kozak or Ben Townsend with any questions.