DOJ and HHS Launch Healthcare False Claims Act Self-Disclosure Pilot Program

On Oct. 22, 2026, DOJ’s Civil Division, in partnership with HHS, announced the Healthcare False Claims Act Self-Disclosure Pilot Program, “which is designed to give healthcare companies a way to quickly resolve past misconduct” by self-disclosing potential violations of the federal FCA. The Pilot Program will accept submissions for six months, through April 22, 2027.

Background

DOJ and HHS have recently ushered in a new wave of avenues for self-disclosure of potential misconduct, including the March 2026 issuance of DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP) and the Oct. 15 announcement of a joint policy for self-disclosure of criminal healthcare fraud (the Joint Policy). Building on those efforts, DOJ’s Civil Division and HHS (through its Office of the General Counsel, Office of Inspector General (HHS-OIG) and the Centers for Medicare & Medicaid Services (CMS)) launched the Pilot Program to offer a pathway to a coordinated resolution of civil liability under the FCA, 31 U.S.C. § 3729 et seq., and under the following HHS administrative authorities: 42 C.F.R. §§ 424.535 (revocation of Medicare enrollment), 1001.901 (permissive exclusion for false or improper claims) and 1001.951 (permissive exclusion based on fraud and kickbacks or other prohibited activities).

Notably, the Pilot Program covers only conduct that potentially violates civil laws. Companies seeking to self-disclose potential criminal healthcare conduct must disclose that conduct to DOJ’s National Fraud Enforcement Division (NFED) under the CEP as indicated in NFED’s  Joint Policy with HHS-OIG. A company that makes a voluntary self-disclosure of criminal matters to the NFED need not make a duplicative submission to the Pilot Program; if a company also seeks a civil FCA release through the Pilot Program, supplementation of its NFED disclosure will be requested “only to the extent necessary.”

Eligibility Criteria

The Pilot Program is open to healthcare providers, suppliers, manufacturers, payors and related entities that furnish, arrange for, manufacture, distribute, insure, administer or bill for items or services reimbursed, subsidized or otherwise paid for, directly or indirectly, by HHS federal healthcare programs.

Critically, the self-disclosure must involve a potential FCA violation previously unknown to the federal government. If the government was already aware of the potential violation, the disclosing company may still be eligible for self-disclosure and cooperation credit under Justice Manual Section § 4-4.112, but it will not be eligible for a resolution under the Pilot Program.

Disclosures must be submitted by 11:59 p.m. on April 22, 2027, and late or partial submissions will not be accepted or reviewed.

Self-Disclosure Requirements

A qualifying self-disclosure must:

• Describe the conduct. Describe all relevant details of the conduct that, in the disclosing entity’s reasonable assessment, potentially violates the FCA, including the specific laws, regulations or other binding requirements violated and the time period of the violations.
• Include key documentation. Provide documentation sufficient to fully reflect the nature, terms, and operation of the disclosed potential FCA violations.
• Identify remediation. Specify remedial measures or corrective actions taken to terminate the conduct and prevent recurrence.
• Provide financial information. Include financial information sufficient for DOJ’s Civil Division to calculate the actual damages (which the Pilot Program refers to as the “Base Self-Disclosure Repayment”).

The self-disclosure must also be certified by an authorized representative and designate a point of contact for potential follow-up questions regarding the self-disclosure.

Benefits of Disclosure

Coordinated Civil Release. Disclosing entities will receive a coordinated civil release with no factual admissions. Specifically, the disclosing company will receive a release from DOJ’s Civil Division under the FCA for the disclosed conduct. HHS-OIG will not require a Corporate Integrity Agreement as part of any resolution of its exclusion authorities, and CMS will not impose civil monetary penalties or seek revocation.

In an important clarification, the Pilot Program Protocol explains that the disclosing entity need not make separate disclosures of the same conduct through other existing civil self-disclosure programs, such as the HHS-OIG Health Care Fraud Self-Disclosure Protocol or the CMS Self-Referral Disclosure Protocol. Of note, however, the Pilot Program does not directly mention releases of statutory liability under 42 U.S.C. § 1320a-7(b)(7) or § 1320a-7b(b)(2) (penalties and permissive exclusion authority for Anti-Kickback Statute violations) and § 1395nn(g)(3) (penalties for physician self-referral law violations). Whether that omission was inadvertent remains to be seen.

Certainty as to Repayment Obligations. Disclosing entities will have certainty that any repayment under the Pilot Program will be limited to 1.25 to 1.6 times the amount of actual damages. The multiplier applied will vary based on factors such as the timeliness of the disclosure, the duration and scope of the misconduct, the involvement of senior leadership, the financial benefit to the disclosing company, and whether the company has successor liability for the misconduct but promptly remediated.

Key Takeaways

The Pilot Program represents an important new option for healthcare companies weighing whether and how to resolve potential FCA exposure, particularly given its repayment range, coordinated release and avoidance of a Corporate Integrity Agreement. But there are limitations: the Pilot Program is set to expire in six months, eligibility turns on the federal government’s lack of prior knowledge, and DOJ and HHS expect a fulsome disclosure. In the wake of this announcement, healthcare companies should consider the following:

• Assess eligibility now. Confirm that the company falls within the covered categories and evaluate whether the federal government may already be aware of the conduct (e.g., through audits, subpoenas, civil investigative demands or a potential qui tam). Prior government knowledge forecloses a Pilot Program resolution. DOJ and HHS are interested in promoting this program and appear intent on ensuring fair treatment of early disclosing entities.
• Consider State FCA liability. The Pilot Program only resolves liability under the federal FCA. Companies whose relevant conduct may also implicate state FCA analogues (e.g., for potential misconduct related to the Medicaid Program) should consider that issue when weighing whether to self-disclose under the Pilot Program.
• Act quickly. Because timeliness affects the multiplier and the deadline is firm, companies with known or suspected issues should promptly initiate privileged internal reviews and timely prepare any self-disclosure in advance of the April 22, 2027 deadline.
• Distinguish civil from criminal exposure. Evaluate whether the conduct implicates potential criminal liability, which must be disclosed to the NFED through the CEP rather than the Pilot Program. This is particularly true if the conduct involves potential Anti-Kickback Statute (AKS) issues.
• Quantify the repayment. Develop a defensible Base Self-Disclosure Repayment, including, where appropriate, statistically valid sampling and extrapolation. If the disclosure involves AKS issues, careful analysis of both remuneration and derived revenue is important since DOJ and HHS may be more willing to consider remuneration rather than derived revenue in arriving at a Base Self-Disclosure Repayment.
• Document remediation. Implement and document corrective actions before submitting, which may be informed by the remedial measures cited in Justice Manual § 4-4.112.
• Prepare a complete submission. Assemble a detailed narrative cross-referenced to key documentation, identify the authorized representative to certify the submission, and designate a point of contact for any follow-up from DOJ or HHS.
• Review transactions. The Pilot Program is particularly attractive for entities that have acquired another entity that may have potential FCA liability. Acquiring entities should consider post-closing compliance reviews, as the Pilot Program expressly contemplates successor-liability disclosures and treats prompt remediation as a factor in setting the multiplier.

Healthcare companies considering self-disclosure should consult experienced FCA counsel to evaluate whether the Pilot Program is the right path and to prepare a complete, timely submission.