DOJ and HHS Expand Healthcare Self-Disclosure With New Civil Pilot

DOJ is keeping healthcare fraud squarely within its sights — and giving companies more reasons to report it. On October 15, 2026, the U.S. Department of Justice (DOJ) National Fraud Enforcement Division and the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) announced a coordinated policy for disclosures of potential criminal healthcare fraud. As we recently discussed, qualifying disclosures can lead to declination and favorable civil and administrative resolutions. But the policy did not establish a corresponding process for potential civil violations. One week later, on October 22, 2026, DOJ’s Civil Division, HHS-OIG, and the Centers for Medicare & Medicaid Services (CMS) announced the Healthcare False Claims Act Self-Disclosure Pilot Program (the Pilot). We examine this Pilot — and what healthcare companies should consider before participating in it — below.

How the Pilot Works

The Pilot offers eligible healthcare companies a coordinated resolution of potential False Claims Act (FCA) liability and specified HHS administrative exposure. Providers, suppliers, manufacturers, payors, and related entities connected to items or services funded directly or indirectly by HHS federal healthcare programs may participate. But the potential FCA violation must be previously unknown to the federal government. Companies disclosing violations already known to the government may still receive credit under DOJ’s existing policies, but cannot obtain a resolution under the Pilot.

For qualifying companies that submit complete disclosures, the Pilot offers several benefits. First, companies receive a coordinated civil release covering the disclosed potential FCA violations and specified HHS administrative exposure, without factual admissions. HHS-OIG will not impose permissive exclusion or require a Corporate Integrity Agreement as part of the resolution, and CMS will not revoke Medicare enrollment and billing privileges. Neither agency will impose civil monetary penalties. For companies that depend on federal healthcare program participation, these protections can preserve access to those programs while avoiding ongoing integrity agreement obligations. Companies also need not separately disclose the same conduct through existing civil self-disclosure programs.

Second, the Pilot offers favorable financial resolutions within a defined repayment range. Companies must pay between 125% and 160% of a calculated “Base Self-Disclosure Repayment” — meaning that a $1 million base would result in a payment of $1.25 million to $1.6 million. The applicable percentage depends on factors including disclosure timing, the misconduct’s scope and duration, senior leadership involvement, financial benefit, and whether the company inherited liability but promptly remediated. This range gives companies greater predictability when assessing the potential cost of disclosure, although the calculation of the underlying base remains critical.

For potential violations of the Anti-Kickback Statute (AKS), the Pilot offers an especially significant benefit. In resolving FCA cases based on AKS violations, DOJ has generally measured damages by the claims paid. Under the Pilot, DOJ will instead calculate the repayment by considering the amount of the improper remuneration, together with the revenue derived from the conduct. Because remuneration is often considerably lower than claims-based damages, that choice can substantially reduce the cost of resolution. Coupled with a damages multiplier of 1.25 to 1.6 and a release that reaches both FCA liability and specified HHS administrative authorities, the Pilot can give a disclosing company meaningful advantages over a government-initiated resolution.

But these benefits require substantive submissions. Companies must “describe all relevant details” regarding the potential violations and must “append as exhibits” sufficient supporting documentation. Companies must also describe “the remedial measures or other corrective action” taken to terminate the potential violations and prevent additional violations from occurring. The Pilot specifies that the remedial measures outlined in Justice Manual Section 4-4.112 are particularly “responsive.” And companies must provide financial information sufficient to allow the Civil Division to calculate the “Base Self-Disclosure Repayment” figure.

Clearer Incentives Still Require Careful Decisions

The Pilot gives healthcare companies more concrete terms for evaluating voluntary disclosure: a defined repayment range, coordinated releases, and relief from potentially significant administrative consequences. But those benefits do not resolve the threshold questions of whether to disclose, when to do so, and what the disclosure may set in motion.

Companies should consult with experienced counsel to assess potential civil and criminal exposure early and revisit that assessment as their investigations develop. They should also evaluate available defenses, substantiate the proposed repayment base, and identify exposure beyond the contemplated release. The repayment percentage alone will not establish the financial value of participation, and a civil resolution will not necessarily address every consequence of the disclosed conduct.

Timing matters. Complete submissions are due by April 22, 2027, and late or incomplete submissions will not be reviewed. Companies considering the Pilot should allow sufficient time to investigate, document corrective action, and prepare the required financial analysis. For questions about self-disclosures under this Pilot, please contact the authors or any member of Arnold & Porter’s White Collar Defense & Investigations or False Claims Act Investigations & Defense practice groups. 

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.