A Self-Disclosure Game Changer: DOJ and HHS Announce “Healthcare False Claims Act Self-Disclosure Pilot Program”

On October 22, 2026, the Department of Justice (DOJ) Civil Division and the Department of Health and Human Services (HHS) announced a six-month Healthcare False Claims Act Self-Disclosure Pilot Program (“Pilot Program”). The Pilot Program — the latest in a wave of federal initiatives to promote self-disclosure of healthcare fraud — allows healthcare companies to resolve potential False Claims Act (FCA) violations previously unknown to the government through a coordinated civil release and financial resolution of 1.25 to 1.6 times the self-disclosure amount.

The Pilot Program is a significant development. For the first time, DOJ provides transparent, meaningful incentives under the FCA, one of the federal government’s most powerful enforcement tools for combatting healthcare fraud. By statute, a violation of the FCA triggers liability for three times the amount of actual damages the government sustains, plus additional penalties of up to $28,000 per claim. HHS’s Office of Inspector General (HHS-OIG) has long offered its Health Care Fraud Self-Disclosure Protocol (SDP) for conduct that triggers HHS-OIG’s civil monetary penalty and exclusion authorities, but companies seeking FCA release have historically had to negotiate with DOJ’s Civil Division, with no guarantee the Civil Division would apply the standard HHS-OIG’ 1.5 times multiplier to reduce financial exposure. DOJ’s criminal self-disclosure framework — including its most recent joint policy with HHS-OIG, discussed below — only addresses resolution of criminal matters, leaving open the universe of FCA liability. Given the huge potential financial impact of the FCA (DOJ obtained over $6.8 billion in settlement and judgment awards under the FCA in 2025 alone), FCA exposure is often a key issue in assessing whether to self-disclose. With the Pilot Program, DOJ’s Civil Division has established an unprecedented FCA self-disclosure program with a published repayment multiplier range, favorable treatment of kickback issues, and coordinated DOJ–HHS relief.

Pilot Program Eligibility

The Pilot Program is available to providers, suppliers, manufacturers, payors, and related entities that arrange for, manufacture, distribute, insure, administer, or bill for items or services reimbursed in any part by federally funded healthcare programs. To qualify for resolution under the Pilot Program, the potential FCA violation must be “previously unknown” to the federal government. If the government was already aware of the conduct, existing DOJ cooperation-credit policies under Justice Manual Section 4-4.112 remain available to the disclosing company. Submissions are due by April 22, 2027.

To be eligible, self-disclosures must include the following information, along with a certification from an authorized company representative that the submission is truthful and complete:

• A description of the conduct the disclosing company reasonably believes may violate the FCA, including the specific legal requirements and relevant time period;
• Documents sufficient to fully describe the disclosed potential FCA violations;
• A description of the company’s remedial efforts; and
• Financial information sufficient to calculate the “Base Self-Disclosure Repayment” (which for Anti-Kickback Statute (AKS) conduct will be the amount of remuneration, not the amount of paid claims).

Pilot Program Benefits

• “Coordinated civil release:” Qualifying self-disclosures will receive release from civil liability under the federal FCA (31 U.S.C. §§ 3729-3733) and HHS administrative exclusion and enrollment-revocation authorities (42 C.F.R. §§ 424.535, 1001.901, and 1001.951) with no factual admissions required. HHS-OIG will not require a corporate integrity agreement, and the Centers for Medicare & Medicaid Services (CMS) will not revoke enrollment or impose civil monetary penalties. The same conduct need not be separately disclosed to HHS-OIG or CMS.
• “Favorable financial resolution:”
  • Multiplier: Repayment under the Pilot Program will be 1.25 to 1.6 times the “Base Self-Disclosure Repayment,” with the multiplier depending on factors including the timeliness of the self-disclosure, the duration and scope of the misconduct, senior leadership involvement, financial benefit to the disclosing company, and whether the disclosing company has successor liability for the misconduct but promptly remediated.
  • Anti-Kickback Statute “Damages:” For AKS matters, the Pilot Program will depart from the usual FCA approach: Rather than basing repayment on claims paid, the Pilot Program will look to the remuneration involved, revenue derived from the disclosed conduct, and the absence of aggravating factors, such as patient harm.

The Pilot Program makes significant changes to the self-disclosure playing field through these financial resolution provisions. Although many issues can affect the determination of “damages” in an FCA case, this marks the first time DOJ has made any public, up-front commitment about a reduced multiplier in self-disclosures. Even more significantly, the Pilot Program fundamentally changes the landscape for AKS-related FCA cases. DOJ has traditionally quantified AKS-related FCA damages as the amount of “tainted claims” related to the kickbacks. In contrast, in the SDP, HHS-OIG has used the amount of the remuneration paid as the “damages.” There is often a huge difference between these two damages amounts and DOJ’s approach has greatly disincentivized AKS-related self-disclosures. This Pilot Program will materially change the cost-benefit analysis for a lot of healthcare and life sciences companies considering self-disclosure of an AKS issue.

DOJ’s Broader Emphasis on Self-Disclosure

This groundbreaking Pilot Program for DOJ’s Civil Division follows several recent broader government initiatives aimed at promoting self-disclosure of healthcare fraud. In March 2026, DOJ announced its first-ever department-wide criminal Corporate Enforcement and Voluntary Self-Disclosure Policy, under which DOJ will decline to prosecute companies that meet its disclosure, cooperation, and remediation requirements, absent aggravating circumstances. And as discussed in our recent client alert, on October 15, 2026, DOJ’s National Fraud Enforcement Division (“Fraud Division”) and HHS-OIG announced a coordinated policy (“Policy”) under which a single voluntary self-disclosure of criminal healthcare fraud to DOJ’s Health Care Fraud Section secures benefits under both DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy and HHS-OIG’s SDP.

Further, CMS recently revised its Stark Law Self-Referral Disclosure Protocol forms to “reduce [the] burden” of disclosure, effective for submissions on or after November 1, 2026.

The Pilot Program extends this self-disclosure framework to the DOJ Civil Division context, giving healthcare companies a defined path to resolve FCA exposure voluntarily.

Key Takeaways

• DOJ’s and HHS’s recent actions demonstrate a clear emphasis on establishing defined incentives and pathways for self-disclosure of potential civil and criminal healthcare fraud.
• The Pilot Program provides a defined path for self-disclosure of potential FCA violations, which pose a significant risk for healthcare and life sciences companies.
• Disclosure through the Pilot Program provides for release from FCA civil liability and HHS administrative remedies but does not resolve other federal or state law claims. Companies should evaluate how disclosure might relate to any state or other federal exposure.
• Because the Pilot Program is available only where the potential FCA violation is “previously unknown” to the federal government, companies should carefully assess whether the government may already be aware of the relevant conduct. Though a company that self-discloses previously known conduct has a strong case for cooperation credit, the company risks providing the government a roadmap of its case without the guaranteed benefit of more lenient treatment as a self-disclosing entity.

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The Goodwin Healthcare team will continue to monitor these developments and their potential impact on healthcare providers, life sciences companies, pharmacies, and other industry participants. For more information on the issues discussed in this alert, please contact the authors or reach out to Goodwin’s Government Investigations, Enforcement & White Collar Defense group, or the Goodwin lawyer whom you typically consult.

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