The Department of Justice (DOJ) along with other health care fraud enforcement agencies, continue to send strong signals that they want businesses to police themselves for potential compliance issues and self-disclose where infractions are found.  The fact of the matter is the government simply does not have enough resources to track down and take action on all potential instances of fraud and abuse.  The system really relies on providers taking affirmative steps to assure they remain in compliance.

The most recent iteration of the government’s need for businesses to “self-comply” and “self-report” comes from the DOJ that recently issued revised guidelines for prosecutors to follow with parties who chose to cooperate in connection with False Claims Act (FCA) investigations and prosecutions.  The DOJ issued new “Guidelines for Taking Disclosure, Cooperation, and Remediation into Account in False Claims Act Matters” that state a strong government policy encouraging and incentivizing affirmative compliance actions, self-disclosure of regulatory infractions, and cooperation in civil FCA investigations. These guidelines are of particular importance to health care providers who make numerous claims per day and can easily fall victim to the rather draconian application of the FCA penalty provisions.

The new DOJ guidelines describe the manner in which the DOJ credits cooperation in connection with its investigation of potential violations of the False Claims Act.  Even though the guidelines are issued to guide DOJ enforcement personnel on how to consider cooperation, it is clear the guidelines are at least partially intended to send a strong signal to businesses that their cooperation is considered if requirements for cooperation are met through the investigation and prosecution of FCA cases.  Factors are laid out in the guidelines for prosecutors to consider when determining how to award cooperation and self-disclosure.  The factors laid out by the DOJ should be considered in connection with the development and operation of a compliance program.  Companies should consider implementing policies based on the DOJ factors in order to set organizational tone that mandates cooperation.

The recently released guidelines should not be considered in a vacuum.  There have been numerous policy statements and regulatory enactments consistent with the governments encouragement of cooperation.  For example, the Office of Inspector General has issued Self Disclosure Protocols clarifying procedures to be followed for health care providers who wish to self-disclose certain regulatory violations to the federal government.  The DOJ has also recently clarified its policy requiring investigation of individual accountability and wrongdoing as a requirement to receive cooperation credit.  Just last month, the DOJ revised its two-year-old Evaluation of Corporate Compliance Programs, putting additional focus on the need for effective organizational compliance programs.  Organizational compliance was also mentioned as a factor indicating cooperation in the FCA guidance issued earlier this month.

All of these actions clearly indicate that the government really wants you to take compliance into your own hands, to self-disclose where you find areas of regulatory noncompliance, and to cooperate in connection with governmental enforcement activities.

Source: Blue Ink Blog