The Department of Justice (DOJ) has released formal guidelines on how it will award credit to entities for cooperating with False Claims Act (FCA) investigations, giving healthcare organizations under scrutiny a way to reduce the potential effect.

The guidelines formalize discretionary practices already in use by investigators, outlining these three ways in which entities can earn cooperation credit in FCA investigations:

  • Voluntarily self-disclose misconduct giving rise to FCA violations;
  • Cooperate with existing government investigation;
  • Implementing meaningful remedial actions.

The guidelines state that entities will qualify for credit by voluntarily disclosing additional misconduct even after an FCA investigation is initiated. (The guidelines are available online at:

A key message in the guidelines is that the government expects entities under investigation to actively aid investigators if they want credit for cooperation, says former assistant U.S. attorney Jason Mehta, JD, now an attorney with Bradley in Tampa, FL.

“Simply responding to subpoenas and producing records in response to requests is not considered cooperation,” Mehta says. “They’re looking for affirmative self-disclosure. If you see something problematic, you disclose it to the government, identify individuals involved with it, and institute remedial actions.”

However, there are risks involved in affirmatively disclosing malfeasance, Mehta says.

“Healthcare practitioners should understand the government’s framework for awarding credit but avail themselves of the advice of legal counsel before taking any of these affirmative steps,” Mehta says.

DOJ explains in the guidelines that cooperation can take many forms. It provides a list of examples that could earn credit, including the following:

  • Identifying the involved or responsible individuals;
  • Disclosing relevant facts and evidence;
  • Preserving, collecting, and disclosing relevant documents and information relating to their provenance beyond existing business practices or legal requirements;
  • Identifying people who may be aware of the misconduct, including an entity’s operations, policies, and procedures;
  • Making employees available for meetings, interviews, examinations, or depositions.