Documentary record · published 27 October 2026 · source checked 26 October 2026 (Pacific)

DOJ and HHS open a six-month civil False Claims Act self-disclosure pilot for health-care companies

Status: Pilot open · submissions through 11:59 p.m., 22 April 2027 (no time zone stated) · civil only · not immunity

• Source checked: 26 October 2026 (Pacific)
• Review status: legal review required; not yet completed

What happened

On October 22, 2026, the Justice Department's Civil Division and the Department of Health and Human Services announced the Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP). HHS takes part through its Office of the General Counsel, Office of Inspector General and the Centers for Medicare & Medicaid Services. DOJ describes it as a six-month pilot. The published protocol says self-disclosures must be emailed to FCA-SDPP@usdoj.gov by 11:59 p.m. on April 22, 2027, and that "late or partial submissions will not be accepted or reviewed."

Under the protocol:

• Who is eligible. Health-care providers, suppliers, manufacturers, payors and related entities paid directly or indirectly by HHS federal health-care programs.
• What can be disclosed. A potential FCA violation "previously unknown to the federal government." If the government already knows of the conduct, the company may still be eligible for self-disclosure and cooperation credit under Justice Manual §4-4.112, but it cannot get a pilot resolution.
• What a submission must contain. A full description of the conduct, including the laws and the time period involved; supporting documents attached as exhibits; the remedial steps taken; financial information that lets DOJ calculate a "Base Self-Disclosure Repayment"; a certification by an authorized representative; and a point of contact.
• What the company receives. A "coordinated civil release, with no factual admissions," consisting of a DOJ release under the federal FCA for the disclosed conduct. HHS-OIG will not require a Corporate Integrity Agreement as part of resolving its exclusion authorities. CMS will not impose civil monetary penalties or seek Medicare revocation as part of the resolution. The company does not need to file the same conduct again under the OIG or CMS self-disclosure protocols.
• What the company pays. 1.25 to 1.6 times the base repayment. The multiplier depends on factors including timeliness, the duration and scope of the conduct, senior-leadership involvement, the financial benefit to the company, and whether the company inherited the liability through an acquisition and promptly fixed it.

What this does and does not mean

This is not immunity. The pilot is a civil program that requires repayment above the base amount. It covers only the federal False Claims Act and the HHS authorities the protocol lists: Medicare enrollment revocation and two permissive-exclusion provisions. The documents do not describe any release from criminal liability, state-law claims or private-payer claims.

The pilot does not replace the criminal disclosure route. DOJ states that a company seeking to disclose potential criminal health-care conduct "must disclose that conduct" to the National Fraud Enforcement Division under the October 15, 2026 Fraud Division and HHS-OIG coordination policy, which the site covers in a separate record. The benefits apply only to a timely, complete submission that meets the eligibility rules, and are given in exchange for the required repayment. DOJ and HHS reserve the right to ask for more information.

This record is general information, not legal advice. Whether to disclose, through which program, and what to include are decisions for counsel.

Who it affects

Any company that bills Medicare, Medicaid or other HHS programs could be eligible: hospitals, physician groups, laboratories, suppliers, manufacturers and payors. The protocol's own example includes a buyer that finds possible kickback liability at a company it has acquired. Individual employees are not described as eligible disclosing parties.

What to watch

• 22 April 2027, 11:59 p.m.: The submission window closes. The protocol does not state a time zone.
• Before and after the close: Whether DOJ extends the pilot or makes it permanent, and whether any resolutions under it are announced.
• Ongoing: How DOJ applies the October 15 criminal coordination policy to cases where both civil and criminal conduct are disclosed.

Sources

1. U.S. Department of Justice, Office of Public Affairs, "Justice Department's Civil Division and the Department of Health & Human Services Announce Anti-Fraud Healthcare Self-Disclosure Pilot Program," Press Release No. 26-1218, 22 October 2026. https://www.justice.gov/opa/pr/justice-departments-civil-division-and-department-health-human-services-announce-anti-fraud
2. U.S. Department of Justice and Department of Health and Human Services, "Healthcare Self-Disclosure Pilot Program" (protocol), 22 October 2026. https://www.justice.gov/opa/media/1467546/dl
3. U.S. Department of Justice, Office of Public Affairs, "National Fraud Enforcement Division and the Department of Health and Human Services Announce Self-Disclosure Protocol for Criminal Health Care Fraud," Press Release No. 26-1211, 15 October 2026. https://www.justice.gov/opa/pr/national-fraud-enforcement-division-and-department-health-and-human-services-announce-self