Key Takeaways
- DOJ’s Fraud Division is now the single point of contact for voluntary self-disclosure of potential criminal healthcare conduct, and companies that disclose to DOJ will automatically receive HHS-OIG’s self-disclosure benefits.
- The reverse is not true: Disclosure only to HHS-OIG generally will not qualify for DOJ’s self-disclosure benefits, and a later referral to DOJ could cost a company voluntary self-disclosure credit.
- Separately, companies facing potential civil liability under the FCA and HHS administrative authorities may take advantage of the new DOJ Civil Division and HHS FCA Self-Disclosure Pilot Program before the April 22, 2027, deadline.
- Healthcare and life sciences companies, as well as investors conducting diligence, should assess whether potential conduct is criminal or civil before choosing a disclosure channel.
On Oct. 15, 2026, DOJ’s National Fraud Enforcement Division and the Department of Health and Human Services Office of Inspector General (HHS-OIG) jointly announced that potential criminal healthcare conduct voluntarily self-disclosed to DOJ can receive the self-disclosure benefits of both DOJ and HHS-OIG.[1] This policy clarifies that a company now needs to disclose potential criminal healthcare conduct only to DOJ in order to receive both agencies’ self-disclosure benefits. One week later, on Oct. 22, 2026, the DOJ Civil Division and HHS jointly announced a Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP), which provides companies a path to obtain a coordinated civil release through self-disclosure.[2] Together, these announcements reflect DOJ and HHS’s continued emphasis on encouraging and rewarding voluntary self-disclosure by companies in the healthcare space. Healthcare and life sciences companies and potential investors should take note of these announcements that build on the Trump administration’s healthcare anti-fraud enforcement priorities.
DOJ and HHS Frameworks for Self-Disclosure Benefits
Healthcare fraud can give rise to parallel civil, criminal, and administrative proceedings, potentially involving both DOJ and HHS-OIG. The two agencies grant different self-disclosure benefits and have published different guidelines defining the requirements to obtain those benefits.
1. DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP) provides the framework for how DOJ treats corporate self-disclosures. Under the CEP, DOJ will decline to prosecute if a company (1) voluntarily self-discloses, (2) fully cooperates with the investigation, and (3) timely and appropriately remediates its misconduct, absent aggravating circumstances that, in the prosecutors’ discretion, warrant prosecution.[3] The CEP outlines situations in which aggravating factors warrant criminal resolution and explains the treatment of “near miss” self-disclosures, which occur when a company fully complies, but its disclosure does not qualify as voluntary.[4]
2. HHS-OIG has its own guidance for self-disclosures contained in the Health Care Fraud Self-Disclosure Protocol (SDP).[5] All healthcare providers, suppliers, or other persons who are subject to OIG’s civil monetary penalty (CMP) authorities at 42 C.F.R. Part 1003 are eligible to use the SDP to facilitate the resolution of matters that, in the disclosing party’s reasonable assessment, potentially violate federal law for which CMPs are authorized.[6] To encourage voluntary self-disclosure, the SDP identifies several potential benefits of self-disclosure, including release from permissive exclusion, lower damages multiplier, and suspension of overpayment reporting obligations.[7]
DOJ and HHS-OIG Joint Policy on Self-Disclosure Benefits
Overlapping matters, multiple agencies with investigative authority, and differing self-disclosure guidelines have led healthcare and life sciences companies to question which agency to disclose to and whether multiple self-disclosures are required.[8] To eliminate the confusion, DOJ and HHS-OIG jointly issued a new policy on Oct. 15, selecting DOJ’s Fraud Division as the singular point of contact for voluntary self-disclosure of criminal healthcare conduct.[9] HHS-OIG updated its SDP to reflect this change, stating, “the SDP is not available for disclosure of Federal crimes.”[10] When companies disclose to DOJ, the SDP’s benefits will be applied automatically.[11]
It is important to note that the reverse is not true. A company that discloses only to HHS-OIG will not be considered to have disclosed to DOJ and generally will not qualify for DOJ’s self-disclosure benefits.[12] Depending on the nature of the conduct, however, disclosure to HHS-OIG may be a better fit. The CEP applies to corporate criminal matters, so if the conduct is not criminal in nature, DOJ’s self-disclosure benefits are likely inapplicable.[13]
Healthcare and life sciences companies should thoroughly assess whether the conduct they wish to self-disclose is criminal in nature and, if so, disclose to DOJ first to receive the benefits of both self-disclosure programs.[14] The CEP emphasizes that voluntary self-disclosure requires good-faith disclosure to “the appropriate Department component,” so the agency a company decides to approach first has an impact on its qualification for self-disclosure benefits.[15] In addition, to qualify as voluntary, the misconduct cannot be previously known to DOJ nor can the disclosure occur due to an imminent threat of government investigation or disclosure.[16] If a company incorrectly assesses conduct as noncriminal and chooses to report to HHS-OIG first, HHS-OIG may refer the matter to DOJ. Once DOJ learns of the alleged conduct through a referral, the company runs the risk of losing voluntary self-disclosure credit under the CEP. Although the government may consider a company’s disclosure to either agency when assessing cooperation and remediation, a company that concluded that the conduct is potentially criminal and seeks the benefits of both self-disclosure programs should treat DOJ as its primary point of contact.[17]
Anti-Fraud Healthcare Self-Disclosure Pilot Program
On Oct. 22, the DOJ Civil Division and HHS announced a new six-month pilot program designed to further encourage companies to voluntarily self-disclose potential FCA violations not yet known by the government.[18] The civil pilot program builds on longstanding DOJ principles to promote efficient resolution of corporate misconduct. In exchange for self-disclosure, participating companies may obtain a coordinated civil release from liability under the federal FCA and certain HHS administrative authorities.[19] The key incentive is the defined repayment range, which is a reduction from the typical multiplier provided in the FCA. The FCA SDPP requires a company to completely disclose and cooperate, detail remedial actions taken by the company, and repay with a 1.25 to 1.6 multiplier.[20] The multiplier varies depending on the scope and duration of the misconduct, the involvement of senior leadership, the timeliness of the disclosure, the financial benefit to the company and whether the company promptly remediated any successor liability.[21]
Since the FCA SDPP runs for six months, only complete submissions received through April 22, 2027, will be reviewed.[22] Healthcare and life sciences companies considering self-disclosure should be prepared to fully disclose all relevant details and supporting documents before the April 2027 deadline.
Next Steps
Taken together, the two new DOJ/HHS policies focus on rewarding self-disclosure but target different conduct. The Oct. 15 joint policy addresses potential criminal healthcare fraud. The Oct. 22 pilot program focuses on potential civil liability under the FCA specifically, rather than civil exposure more broadly. Healthcare and life sciences companies should carefully assess the nature of potential conduct they plan to self-disclose to ensure they use the appropriate channels, satisfy each program’s requirements, and avoid any foot faults with these new programs. Buyers should also consider the programs in post-closing diligence.
For questions about this alert, the new DOJ and HHS-OIG policies, the self-disclosure process or healthcare regulation generally, contact the authors or a member of the firm’s Healthcare Compliance, Regulatory & Policy Practice Group or Government Investigations & White Collar Litigation Practice Group.
[1] U.S. Dep’t of Justice, National Fraud Enforcement Division and the Department of Health and Human Services Announce Self-Disclosure Protocol for Criminal Health Care Fraud (Oct. 15, 2026), https://www.justice.gov/opa/pr/national-fraud-enforcement-division-and-department-health-and-human-services-announce-self [hereinafter Self-Disclosure Benefits Press Release].
[2] U.S. Dep’t of Justice, Justice Department’s Civil Division and the Department of Health and Human Services Announce Anti-Fraud Healthcare Self-Disclosure Pilot Program (Oct. 22, 2026), https://www.justice.gov/opa/pr/justice-departments-civil-division-and-department-health-human-services-announce-anti-fraud [hereinafter Pilot Program Press Release].
[3] Corporate Enforcement and Voluntary Self-Disclosure Policy, https://www.justice.gov/dag/media/1430731/dl?inline [hereinafter DOJ’s CEP].
[4] Id.
[5] U.S. Dep’t of Health & Human Servs., Office of Inspector Gen., Health Care Fraud Self-Disclosure Protocol (Oct. 2026), https://oig.hhs.gov/documents/self-disclosure-info/11951/hhs-oig-self-disclosure-protocol.pdf [hereinafter HHS-OIG’s SDP].
[6] See id.
[7] Id.
[8] Self-Disclosure Benefits Press Release.
[9] Id.
[10] HHS-OIG’s SDP.
[11] Self-Disclosure Benefits Press Release.
[12] Id.
[13] See DOJ’s CEP.
[14] See Self-Disclosure Benefits Press Release.
[15] See DOJ’s CEP.
[16] Id.
[17] U.S. Dep’t of Justice, National Fraud Enforcement Division and HHS-OIG Policy on Coordination of Voluntary Self-Disclosure in Health Care Fraud Matters (Oct. 15, 2026), https://www.justice.gov/opa/media/1466291/dl?inline.
[18] Pilot Program Press Release.
[19] Id.
[20] Id.
[21] Id.
[22] Id.