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Seven Things To Know When You Receive A Notice Of Investigation From The Department Of Health

DOJ Withdraws Outdated Antitrust Policy Statements For Healthcare Industry; “Safety Zones” Abolished

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On February 3, 2023, the Antitrust Division of the U.S. Department of Justice (DOJ) announced its withdrawal of three “outdated” antitrust policy statements applicable to healthcare markets. These have been in effect and relied upon for decades by those in the healthcare industry. The Division determined that the withdrawal of the three statements is the best course of action for promoting competition and transparency, according to a statement it issued.

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.


The Withdrawn Policy Statements.

When the DOJ and FTC issued the Withdrawn Statements, they did so to make healthcare more accessible and affordable. Specifically:

1.    The 1993 Department of Justice and FTC Antitrust Enforcement Policy Statements in the Health Care Area (“1993 Statement”);

2.    The 1996 Statements of Antitrust Enforcement Policy in Health Care (“1996 Statement”) (which revised and expanded the 1993 statement); and

3.    The 2011 Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (“2011 Statement”).[2]

The withdrawal of the statements is effective immediately.  In lieu of the guidance, DOJ is evaluating behavior on a “case-by-case enforcement approach.”

Key Takeaways For the Future.

The withdrawal of DOJ’s prior statements establishing information-sharing “safety zones” creates uncertainty around whether DOJ will now treat exchanges of information that were encompassed by these safety zones as problematic.  Moreover, there is considerable doubt about what conditions must be satisfied for information sharing to be considered lawful by DOJ and the FTC, in the healthcare industry and other industries. Therefore, in the future, companies may want to take the following steps:

1.    Examine the extent of reliance on the safe-harbor criteria. Companies that relied on now-withdrawn safe harbors to engage in information exchanges (including industry indexes or benchmarks) involving old, aggregated data should reassess antitrust risk using the traditional rule of reason criteria. In addition, companies that relied on the now-withdrawn joint purchasing safe harbor also should reassess risk, even though DOJ did not specifically signal a greater emphasis on enforcement in this area.

2.    Re-assess the antitrust risk of information sharing even if the company did not rely on the safe harbor. DOJ’s announcement signals that it will be more skeptical of some factors that traditionally were seen to decrease the antitrust risk of information exchanges, including lack of industry concentration, use of old data, and use of third parties to aggregate data. Accordingly, a reassessment is recommended to the extent a company’s analysis or antitrust policies relied on these factors.

3.    Carefully review and revise policies. Companies should periodically review their compliance policies and employee training to ensure that they reflect DOJ’s emerging guidance on information exchanges.


Click here to view the DOJ’s press release in full to learn more.

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Sources:

Zaslavsky, Sergei. “DOJ Withdraws Longstanding Policy Statements on Information Sharing and Eliminates Safe Harbors.” O’Melveny. (February 6, 2023). Web.

Berger,Lee.”Tracking Antitrust Agencies’ Pursuit Of Biden’s Labor Mandate.” American Hospital Law360. (February 5, 2023). Web.

Kully, David. “Another One Bites the Dust: DOJ Pulls 3 Policy Statements, Leaving Trade Associations Guessing.” Holland & Knight. (Februry 5, 2023). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: [email protected] or fax them to (407) 331-3030.

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