I. Introduction
In a single week, the Department of Justice (DOJ), the Department of Health and Human Services (HHS), and Centers for Medicare and Medicaid Services (CMS) reshaped how health care organizations voluntarily disclose potential fraud, furthering what already has been a year of change within DOJ. On October 15, 2026, DOJ's National Fraud Enforcement Division (Fraud Division) (which only came into existence in 2026) and the HHS Office of Inspector General (HHS-OIG) announced that one disclosure of potentially criminal health care conduct to the Fraud Division now earns the benefits of both DOJ's Corporate Enforcement Policy (CEP) and HHS-OIG's Self-Disclosure Protocol (OIG SDP). On October 22, DOJ's Civil Division, the HHS-OIG and CMS launched a six-month Healthcare False Claims Act Self-Disclosure Pilot Program offering a coordinated civil release, no admissions, no Corporate Integrity Agreement (CIA), and a fixed repayment multiplier. Both build on the Department-wide CEP issued March 10, 2026. The result is the most predictable self-disclosure environment in years, and a threshold decision companies must evaluate: whether a problem is civil, criminal, or both, and which door to use first. The civil pilot closes April 22, 2027. Notably, and almost simultaneously, DOJ released a new fast-track whistleblower program. Baker Donelson previously discussed that new program in a separate alert.
II. The Civil Pathway: The Healthcare FCA Self-Disclosure Pilot Program
A. Eligibility and submission.
The pilot is open to providers, suppliers, manufacturers, payors, and related entities that arrange for, manufacture, distribute, insure, administer, or bill for items or services reimbursed, subsidized, or otherwise paid for, directly or indirectly, by HHS federal health care programs, for potential False Claims Act (FCA) violations previously unknown to the federal government. If the government has knowledge of the violation prior to the submission of a disclosure under the program, the company may still earn Justice Manual cooperation credit but not a pilot resolution. Submissions must be complete when filed and must include a full narrative identifying the laws violated and time period, supporting documents, a description of remediation, financial data sufficient to calculate the repayment, and a certification of truthfulness by an authorized representative.
B. Benefits and repayment.
Participants receive an FCA release, resolution of specified Medicare revocation and HHS-OIG permissive exclusion authorities, no CIA, and no CMS civil monetary penalties, with no factual admissions and no need to file separately under the OIG SDP. Repayment is 1.25 to 1.6 times the amount of the base self-disclosure repayment, with the multiplier driven by timeliness, scope, senior leadership involvement, financial benefit to the disclosing party, and successor liability. This is a lower multiplier than traditionally applied under the existing OIG SDP. For Anti-Kickback Statute (AKS) matters, DOJ will calculate the base self-disclosure repayment from the amount of the improper remuneration, the revenue derived from the disclosed conduct, and the absence of aggravating factors such as patient harm. This represents a fairly substantial change from DOJ's traditional litigation position on damages and could materially reduce exposure. Notably, this approach to resolving AKS violations is more aligned with the OIG's approach to resolving SDP matters, which typically involves the compromise of its CMP authorities based on a multiplier of the remuneration conferred by the referral recipient to the person making the referral. Additionally, under the OIG SDP, the disclosing party, if accepted into the protocol, receives only a CMP release, not an FCA release. The pilot also expressly contemplates acquirers disclosing a target's legacy conduct.
III. DOJ's First Department-Wide Corporate Enforcement Policy
The CEP applies to all corporate criminal matters except antitrust and supersedes component- and U.S. Attorney's Office-specific policies. DOJ will decline to prosecute a health care company that voluntarily self-discloses to an appropriate DOJ criminal component, fully cooperates, and timely remediates the misconduct, absent aggravating circumstances such as egregious or pervasive misconduct, severe harm, or recent recidivism. Declinations require disgorgement and restitution and are made public. A company that falls short only on voluntariness or aggravators receives a non-prosecution agreement of under three years, no monitor, and a 50 percent to 75 percent fine reduction. To qualify as voluntary, the disclosure must be reasonably prompt, made before an imminent threat of discovery, and concern conduct unknown to DOJ; the company bears the burden on timeliness. Full cooperation requires identifying every individual involved, regardless of seniority, though no privilege waiver is required.
IV. The Fraud Division and HHS-OIG Protocol for Criminal Health Care Fraud
Under the October 15 coordination policy, a voluntary self-disclosure to the Fraud Division's Health Care Fraud Section involving a federal health care program automatically earns OIG SDP benefits, and the Section will share the disclosure with HHS-OIG. The reverse does not hold: the updated OIG SDP remains unavailable for federal crimes, and a self-disclosure under the existing OIG SDP generally will not support a CEP declination. Companies seeking both sets of benefits should consider disclosure to the Fraud Division. Note, another distinguishing factor is that OIG SDP benefits do not include relief from mandatory exclusion.
V. Where the Frameworks Overlap and Where They Differ
The programs are designed to interlock: a criminal disclosure to the Fraud Division need not be duplicated in the pilot, and DOJ will request supplementation only as needed for a civil release. Several issues nonetheless warrant careful attention.
- The civil-criminal line will be contested. The pilot accepts AKS-based disclosures, yet the AKS is a criminal statute, and disclosures only to civil enforcement agencies generally do not qualify under the CEP. Whether a good-faith pilot filing would earn criminal credit if DOJ later views the conduct as criminal is unclear.
- Prior government knowledge is partly unknown. A company cannot know whether a sealed qui tam complaint has already been filed. If the government has knowledge of the conduct, a company cannot avail itself of the pilot program. This encourages swifter decision-making when contemplating disclosure.
- Release scope. The pilot expressly releases FCA liability and resolves specified revocation and permissive exclusion authorities, and it relieves participants of separate filings under HHS-OIG's SDP. It does not, however, expressly release HHS-OIG's civil monetary penalty authorities, claims against individuals, state claims, or pending qui tam actions.
- Completeness versus the deadline. The pilot rejects partial submissions, while the CEP encourages early disclosure with rolling updates and the OIG SDP allows 90 days to complete a submitted disclosure. Investigations and claims sampling are often complex and can take months. If a company is considering disclosure, they should act with haste to ensure completeness of the disclosure under the pilot program.
- The 60-day overpayment clock. An OIG SDP submission suspends the 60-day obligation to report and return overpayments once HHS-OIG acknowledges receipt. The pilot is silent regarding whether a pilot filing has the same effect, so companies should not assume it stops the clock and should seek guidance once a disclosure is submitted.
VI. Practical Steps for Health Care Organizations
Delay carries real cost: timeliness affects the pilot multiplier, outside discovery forfeits the ability to disclose under pilot, and a late or OIG-only disclosure can forfeit a CEP declination. Organizations should (1) inventory open compliance matters, hotline reports, and audit findings, and calendar the CEP's 120-day window for internal whistleblower reports; (2) investigate credible concerns promptly under privilege, with an early assessment of criminal exposure; (3) conduct targeted post-closing reviews of recent acquisitions to identify compliance risk; (4) identify defensible strategies to address potential repayments; and (5) implement and document remediation thoroughly. Health care providers that the DOJ has identified as presenting a high risk for fraud and abuse, such as nursing homes, DME suppliers, hospice providers, clinical diagnostic laboratories, and other heavily scrutinized sectors should treat these programs as a priority.
VII. Conclusion
The new landscape rewards health care companies that act intentionally and quickly, as the civil pilot window is short. If your organization has identified a potential compliance issue, is completing an internal review, or has acquired a business with legacy risk, now is the time to assess your potential exposure. Deciding whether, what, and where to disclose requires both health care regulatory command and enforcement experience. Baker Donelson's Health Law Group and Government Enforcement and Investigations Group work together to provide that integrated judgment. We advise on internal investigations, disclosure strategy, repayment calculations, and coordinated resolutions with DOJ, HHS-OIG, CMS, and state authorities.
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For more information about the DOJ and HHS self-disclosure pathways or further analysis regarding the impact of the Healthcare FCA Self-Disclosure Pilot Program on your organization, please contact Thomas H. Barnard, Alissa D. Fleming, William E. Wildman, or any other member of Baker Donelson's Health Law Group or Government Enforcement and Investigations Group.