The DOJ and HHS Launch Six-Month Healthcare FCA Self-Disclosure Pilot Program

The Department of Justice’s Civil Division and the Department of Health and Human Services (HHS) have announced a six-month Healthcare False Claims Act Self-Disclosure Pilot Program. The program offers eligible healthcare entities a defined pathway to disclose potential False Claims Act (FCA) violations that were previously unknown to the federal government, resolve related civil liability through a coordinated settlement, and receive specified benefits for timely and complete disclosures.

The pilot began on October 22, 2026, and submissions must be received by 11:59 p.m. on April 22, 2027. It is available to healthcare providers, suppliers, manufacturers, payors, and related entities involved in furnishing, arranging, manufacturing, distributing, insuring, administering, or billing for items or services reimbursed directly or indirectly by HHS federal healthcare programs.

Eligibility Requires New Information and a Complete Submission

To qualify, a disclosure must concern a potential FCA violation not previously known to the federal government. The entity must provide the relevant facts, identify the legal requirements implicated, describe the period and operation of the conduct, produce documents sufficient to reflect the nature and terms of the conduct, explain remedial measures, and provide financial information sufficient to calculate the Base Self-Disclosure Repayment. An authorized representative must certify that the submission is truthful and complete.

Potential FCA violations already known to the government are not eligible for the pilot, although entities may still seek ordinary self-disclosure and cooperation credit under the Justice Manual. The pilot is limited to civil matters. Potential criminal healthcare conduct must be disclosed through the National Fraud Enforcement Division’s voluntary self-disclosure process, with supplementation for the civil component only as necessary.

Coordinated Resolution and a 1.25-to-1.6 Repayment Multiplier

An eligible disclosure may be resolved for 1.25 to 1.6 times the Base Self-Disclosure Repayment, as opposed to the up to treble damages and per-claim penalties permitted under the FCA. The government will consider the timeliness of the disclosure; the duration and scope of the conduct; senior leadership involvement; the financial benefit received; successor-liability considerations; and the promptness and adequacy of remediation.

A qualifying resolution may include an FCA release from the Civil Division without factual admissions. HHS’s Office of Inspector General (OIG) will not require a corporate integrity agreement to resolve conduct within its exclusion authority, and the Centers for Medicare & Medicaid Services (CMS) will not impose civil monetary penalties or seek revocation for the disclosed conduct. Participants also need not make duplicative civil disclosures through the HHS-OIG Self-Disclosure Protocol or the CMS Stark Law Self-Referral Disclosure Protocol.

Acquisition Diligence and Post-Closing Remediation Matter

The pilot expressly addresses post-acquisition discoveries. One government example involves an acquirer that uncovers potential Anti-Kickback Statute (AKS) violations after closing, terminates the conduct, and promptly discloses it. In that setting, the government may calculate the base repayment using the remuneration, related revenue, and absence of aggravating factors rather than the full value of claims paid. The example makes clear that successor-liability risk, integration diligence, and the speed of post-closing remediation can materially affect the settlement framework.

Healthcare companies considering the pilot should assess eligibility before approaching the government, preserve and investigate relevant evidence, quantify potential exposure using defensible financial data, and document remediation. Because the required certification is binding and incomplete submissions will not be reviewed, the decision to participate should follow a privileged factual and legal assessment rather than an abbreviated internal inquiry.

GWB represents healthcare companies and other organizations in connection with government investigations, self-disclosures, and False Claims Act litigation. If you need assistance evaluating or preparing a disclosure, contact us today.