DOJ pilot sets civil FCA terms for health-care disclosures

The Justice Department’s Civil Division and the Department of Health and Human Services opened a six-month voluntary pilot on October 22, 2026, for eligible health-care entities to disclose certain potential civil False Claims Act violations and seek a coordinated resolution. Complete submissions are due by April 22, 2027, at 11:59 p.m.

The pilot applies only when the potential violation was previously unknown to the federal government. If the government already knew about it, the company may still be eligible for self-disclosure and cooperation credit under the Justice Manual, but not a resolution through this pilot. Participation does not guarantee a settlement or a particular repayment amount.

Who can apply and what to submit i

Eligible entities include health-care providers, suppliers, manufacturers, payors and related entities that perform specified activities involving items or services paid for, directly or indirectly, by HHS federal health-care programs. Those activities can include furnishing, arranging, manufacturing, distributing, insuring, administering or billing for the items or services.

A complete submission must describe the conduct, the applicable laws or other binding requirements and the period involved. It must include supporting documents, explain corrective actions and provide financial information sufficient to calculate the base repayment. It also needs a truthfulness-and-completeness certification from an authorized representative and the phone number and email address of a designated contact.

Entities must email complete submissions to FCA-SDPP@usdoj.gov. Late or partial submissions will not be accepted or reviewed under the protocol. The protocol gives the deadline as 11:59 p.m. on April 22, 2027, but does not specify a time zone.

Repayment and the separate criminal process i

The protocol sets repayment at 1.25 to 1.6 times the Base Self-Disclosure Repayment. The multiplier depends on circumstances that include when the company discloses, the conduct’s duration and scope, senior-leadership involvement, the company’s financial benefit, and certain successor-liability and remediation factors. For illustration, a $100,000 base amount multiplied by that range would produce $125,000 to $160,000; that example is arithmetic, not a prediction of a company’s actual repayment.

A qualifying resolution provides a coordinated civil release for the disclosed potential False Claims Act violations and specified HHS administrative authorities, without factual admissions. For a resolution of HHS-OIG exclusion authorities under the pilot, HHS-OIG will not require a Corporate Integrity Agreement. CMS will not impose civil monetary penalties or seek revocation as part of a resolution under the pilot.

The pilot covers potential civil violations, not potential criminal health-care conduct. A company disclosing potential criminal conduct must use the separate policy of DOJ’s National Fraud Enforcement Division. A company making a qualifying voluntary criminal disclosure to that division need not make a duplicative pilot submission. If it also seeks a civil False Claims Act release through the pilot, DOJ will request supplementation only to the extent necessary.

DOJ says the pilot is intended to encourage voluntary disclosure and cooperation, resolve potential civil violations and focus government resources on actors that do not self-disclose. It is a voluntary executive-branch program, not a court ruling or an amendment to the False Claims Act.