On October 22, 2026, the US Department of Justice (DOJ) Civil Division and the US Department of Health and Human Services (HHS) announced the Healthcare False Claims Act (FCA) Self-Disclosure Pilot Program (the FCA SDPP or the pilot program). The FCA SDPP gives healthcare companies a pathway to obtain a coordinated resolution of civil liability under the federal FCA and certain HHS administrative authorities, as set out in the FCA SDPP protocol (the Protocol). Participating HHS components include the Office of the General Counsel, the Office of Inspector General (HHS-OIG), and the Centers for Medicare & Medicaid Services (CMS). HHS issued a companion press release the same day.
According to DOJ, the pilot program is designed to allow healthcare companies to quickly resolve past misconduct by disclosing potential FCA violations, so the government can focus its resources on “recalcitrant actors.” However, self-disclosure under the pilot program carries risk, which companies should weigh against the potential benefits before submitting a disclosure.
How the Pilot Program Works
Eligibility
- Covered entities: The pilot program applies 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.
- Covered conduct: The disclosure must involve a potential civil FCA violation previously unknown to the federal government. If the government already knew of the conduct, the company may still seek self-disclosure and cooperation credit under Justice Manual Section 4-4.112, but it cannot obtain a resolution under the pilot program. A company seeking to self-disclose potential criminal healthcare conduct must disclose to DOJ’s National Fraud Enforcement Division (NFED), through its Health Care Fraud Section.Under the NFED and HHS-OIG Policy on Coordination of Voluntary Self-Disclosure in Health Care Fraud Matters, which DOJ and HHS-OIG announced on October 15, 2026 (the Coordination Policy). For more on NFED’s enforcement priorities, see this Latham Client Alert.
Submission Requirements
Disclosing companies must submit a self-disclosure to FCA-SDPP@usdoj.gov by 11:59 p.m. on April 22, 2027. Late or partial submissions will not be accepted or reviewed. The submission must:
- describe all relevant details of the conduct that, in the company’s reasonable assessment, potentially violates the FCA, including the specific legal or regulatory requirements violated and the relevant time period;
- attach as exhibits all documents sufficient to fully reflect the nature of the disclosed conduct, cross-referenced in the written description;
- specify the remedial or corrective measures or other corrective action taken to terminate the conduct and prevent recurrence;
- provide financial information sufficient for the DOJ Civil Division to calculate the “Base Self-Disclosure Repayment”;
- include a certification from an authorized representative that, to the best of the representative’s knowledge, the submission is truthful and complete; and
- identify a designated point of contact.
DOJ and HHS reserve the right to request supplemental information as necessary.
Potential Benefits of Disclosure
- Coordinated civil release: The company will receive a coordinated civil release, with no factual admissions. The release will cover civil liability for the disclosed conduct under the federal FCA and certain HHS administrative authorities, including Medicare enrollment revocationSee 42 C.F.R. § 424.535. and permissive exclusion.See 42 C.F.R. §§ 1001.901 and 1001.951.
- No CIA, CMPs, or revocation: HHS-OIG will not require a corporate integrity agreement (CIA) as part of any resolution, and CMS will not impose civil monetary penalties (CMPs) or seek revocation as part of any resolution under the pilot program.
- No duplicative disclosures: Companies need not separately disclose 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.
Financial Terms
- Defined multiplier range: The repayment will be 1.25 to 1.6 times the Base Self-Disclosure Repayment. By comparison, HHS-OIG’s Health Care Fraud Self-Disclosure Protocol generally applies a minimum multiplier of 1.5 times single damages and cannot itself release FCA liability.
- Multiplier factors: Where a company falls within the range will depend on factors such as the timeliness of the disclosure, the duration and scope of the misconduct, involvement of senior management in the disclosed conduct, the financial benefit to the company, and whether the company has successor liability for the misconduct but promptly remediated.
- Anti-Kickback Statute matters: In civil FCA cases premised on Anti-Kickback Statute (AKS) violations, the government will typically seek the full amount of the claims paid. However, for the limited purpose of the pilot program, the government will forgo damages based on claims-paid amounts in AKS-based FCA matters, and will instead calculate the Base Self-Disclosure Repayment based on the amount of the remuneration, the revenue derived from the disclosed conduct, and the absence of aggravating factors such as patient harm.
Interaction With Criminal Disclosures
A company that makes a voluntary self-disclosure of criminal matters to NFED within the meaning of DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP) need not make a duplicative submission to the FCA SDPP. Where that company also seeks a civil FCA release through the pilot program, DOJ will request supplementation of its criminal disclosure only to the extent necessary. For more on the CEP, see this Latham Client Alert.
Key Takeaways
The pilot program provides a degree of predictability in the civil FCA context: a published multiplier range, a defined release, and no CIA. Its reduced calculation of AKS damages — avoiding the full value of claims — may be the feature most likely to motivate companies with potential AKS exposure to consider disclosure.
However, self-disclosure under the pilot program carries some risk, and the published materials leave important questions unanswered, including:
- Conduct already known to the government: A company could unknowingly disclose conduct that was already known to the government through a qui tam complaint filed under seal, government data analytics, or an ongoing audit. In that case, the company would be limited to cooperation credit under Justice Manual Section 4-4.112, and the Protocol does not address whether, or how, the government may use the information and documents the company has already provided.
- Criminal referral: The pilot program is limited to civil conduct, and the line between civil and potentially criminal conduct — particularly in AKS matters — is not always clear. The Protocol does not address whether, or under what circumstances, the DOJ Civil Division may refer disclosed conduct for criminal investigation.
- No guarantee of resolution: Once made, a disclosure cannot be withdrawn. If the parties cannot agree on the scope of the disclosed conduct or the Base Self-Disclosure Repayment, the Protocol does not address any protections for the company — such as preventing the government from using the company’s submission to issue a civil investigative demand or to file suit.
- Certification: The Protocol requires a certification from the company’s “authorized representative” that, to the best of the individual’s knowledge, the submission contains truthful and complete information, but it does not specify who must serve in that role. Nor does the Protocol define what a “complete” disclosure requires, though it does require the company to describe “all relevant details” of the conduct. A certification later shown to be inaccurate or incomplete could create exposure for both the certifying individual and the company. Companies should carefully consider who is best positioned to certify, and the scope of diligence needed to support the certification.
- State law and other exposure: The Protocol describes a release under the federal FCA and specified HHS authorities only. Neither the Protocol nor the HHS press release addresses possible state FCA or Medicaid exposure, coordination with state attorneys general, or the treatment of pending qui tam actions.
Companies contemplating self-disclosure under the FCA SDPP should consider the following practical steps:
- Strategically assess the potential benefits of self-disclosure: Companies that have identified, or suspect, potential FCA issues should move quickly to (1) engage counsel; (2) conduct a privileged internal investigation; (3) evaluate the likelihood of the conduct being already known to the government (such as through a whistleblower or data analytics); and (4) assess whether the potential benefits outweigh the risks for self-disclosure under the pilot program (or another self-disclosure protocol, such as the HHS-OIG Health Care Fraud Self-Disclosure Protocol or the CMS Self-Referral Disclosure Protocol).
- Consider other potential exposure: Companies should assess how a disclosure could implicate state FCA laws or other agencies, and to what extent the disclosed conduct could impact new or existing qui tam actions. Conduct with potential criminal consequences — particularly AKS-based matters — may require a disclosure to NFED in addition to seeking a civil release under the pilot program.
- Quantify early: The Base Self-Disclosure Repayment drives the ultimate resolution amount. Companies should consider engaging statistical and financial experts early to develop defensible sampling, extrapolation, or remuneration and revenue analyses.
- Carefully manage transactions and successor liability: Company acquirers that uncover legacy issues post-closing should evaluate the pilot program promptly, as prompt remediation of inherited conduct is an express multiplier factor.
- Strengthen compliance programs: Ensure that compliance procedures encourage internal reporting and promptly escalate concerns, increasing the likelihood that any disclosure involves information that is new to the government.
Latham & Watkins will continue to monitor the implementation of the FCA SDPP and related developments.
