DOJ and OIG Streamline Health Care Fraud Self-Disclosures

By Lisa Damhof

DOJ and OIG Establish a Coordinated Self-Disclosure Framework for Criminal Health Care Fraud

On October 15, 2026, the newly established National Fraud Enforcement Division of the Department of Justice (DOJ) and the Office of Inspector General (OIG) of the Department of Health and Human Services announced a new coordinated policy for companies seeking to voluntarily self-disclose potential criminal conduct involving federal health care programs. Under the policy, a company can make a single voluntary self-disclosure regarding potentially criminal conduct to DOJ’s Health Care Fraud Section to obtain the benefits of both DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy and OIG’s Health Care Fraud Self-Disclosure Protocol (SDP). 

Potential Criminal Health Care Matters Should Be Disclosed to DOJ 

The policy recognizes that health care misconduct and compliance concerns may implicate overlapping enforcement authorities. DOJ identifies examples of conduct that may result in criminal, civil, or administrative consequences, including illegal remuneration arrangements, schemes involving medically unnecessary services, and arrangements involving excluded persons. Under the new policy, a voluntary self-disclosure of potentially criminal conduct affecting a federal health care program to DOJ’s Health Care Fraud Section is sufficient to access the benefits of OIG’s SDP, eliminating the need for a separate submission through OIG’s portal.

The new policy creates a coordinated approach, providing a mechanism for addressing conduct that may fall within the enforcement authorities of both DOJ and OIG, while preserving benefits associated with voluntary disclosure, cooperation, and remediation under the applicable policies.

Notably, the disclosure coordination does not operate in both directions. A disclosure made only to OIG generally will not qualify as a voluntary self-disclosure to DOJ’s Fraud Division. This distinction may be important when companies are conducting internal investigations and determining whether identified conduct may present criminal exposure in addition to civil or administrative exposure. OIG is separately updating its SDP to clarify that it is not available for criminal law violations, and that potential criminal health care matters should be disclosed to DOJ.

Key Considerations and Compliance Takeaways for Health Care Companies

The development is relevant for pharmaceutical and medical device manufacturers, as well as other health care companies, as the coordinated self-disclosure framework comes against the backdrop of DOJ’s broader focus on health care fraud enforcement. As discussed in Amanda Johnston’s October 13, 2026 Gardner Law alert, “DOJ Fraud Division Prioritizes Health Care,” DOJ has made health care an enforcement priority. The new policy provides an important additional consideration for companies evaluating how to respond when they identify conduct that may fall within those enforcement priorities.

The new policy also underscores the importance of having robust compliance processes capable of promptly identifying, investigating, and appropriately escalating potential misconduct. When an internal investigation identifies conduct that could present criminal exposure, companies should consider early in the process whether the matter implicates the coordinated disclosure framework. While the decision to disclose remains fact-specific, the coordinated framework makes the timing and characterization of potential misconduct increasingly important.

“The framework under the coordinated policy simplifies the mechanics of self-disclosure, but it also underscores the importance of identifying and escalating potential misconduct early. For health care companies, having effective processes to investigate potential violations and assess criminal, civil, and administrative exposure can be critical to preserving the full range of options available when an issue arises.”

Lisa Damhof, Associate Attorney

Health care companies should ensure their compliance, legal, and investigative processes allow potentially criminal conduct to be recognized and escalated promptly. Companies should evaluate their available disclosure options before delays affect their ability to pursue them.

How Gardner Law Can Help

Gardner Law regularly counsels medical device, pharmaceutical, and other medical products companies on matters involving complex health care fraud and abuse, as well as related compliance issues. We can assist companies in navigating compliance concerns, evaluating potential risks, and considering whether voluntary self-disclosure to DOJ or OIG may be appropriate under the circumstances.

We can also help assess potential criminal, civil, or administrative exposure and advise on whether and when to make a voluntary self-disclosure to DOJ or OIG. If your company decides to disclose, we can help prepare the submission and document corrective steps, such as changes to how consulting payments are approved. To discuss a specific concern, contact our compliance team.