On October 22, 2026, the Department of Justice (“DOJ”) Civil Division and the Department of Health and Human Services (“HHS”) announced a six-month Healthcare False Claims Act Self-Disclosure Pilot Program (“FCA SDPP” or the “Pilot”). The Pilot provides healthcare providers, suppliers, manufacturers, payors, and related entities with a pathway to obtain a coordinated release of potential liability under the False Claims Act (“FCA”) and certain HHS administrative authorities. The Pilot follows in the wake of a new criminal healthcare self-disclosure policy issued by DOJ, and builds on DOJ’s broader policies encouraging companies to voluntarily disclose misconduct and cooperate with government investigations.
To participate in the Pilot, a company must provide DOJ with all relevant details concerning the conduct that potentially violated the False Claims Act and produce documents sufficient to fully reflect the “nature, terms, and operation” of the potential violations. The company must also describe the remedial measures it has taken and make a financial payment that includes a Base Self-Disclosure Repayment and a 1.25 to 1.6 multiplier. The applicable multiplier will depend on several factors including the timeliness of the disclosure, the duration and scope of the misconduct, senior leadership’s involvement, the financial benefit obtained by the company, and, where successor liability is involved, whether the successor promptly remediated the misconduct.
The Pilot offers more predictable benefits than have historically been available to companies that self-disclose potential FCA violations. However, it also leaves open several important questions about coordination between DOJ components, the scope of the administrative relief offered, the interaction with DOJ’s existing FCA cooperation-credit guidelines, and how the base repayment will be calculated in kickback cases. We summarize five key takeaways relating to the new FCA SDPP below.
Only a week before the Pilot’s announcement, on October 15, 2026, DOJ’s National Fraud Enforcement Division (“NFED” or the “Fraud Division”) and the HHS Office of Inspector General (“HHS-OIG”) announced that companies seeking to voluntarily self-disclose potential criminal conduct related to healthcare only need to make a self-disclosure to NFED to receive the benefit of both the DOJ’s Corporate Enforcement and Voluntary Self-Disclosure Policy (“CEP”) and HHS-OIG’s Health Care Fraud Self-Disclosure Protocol (“SDP”) (“NFED Policy”). HHS-OIG simultaneously updated the SDP to clarify that criminal conduct should be disclosed to DOJ, and a disclosure made only to HHS-OIG generally will not qualify for a CEP declination. Notably, the NFED Policy did not address a disclosing entity’s FCA exposure.
The Pilot fills part of that gap, but the interplay between the two programs is not fully defined. The Pilot states that it is available only for conduct that potentially violates civil laws, and that a company seeking to self-disclose healthcare-related potential criminal conduct “must” disclose that conduct to the NFED under the NFED Policy. The Pilot further provides that a company that makes a voluntary self-disclosure of criminal matters to NFED within the meaning of the CEP “need not make a duplicative submission” to the Pilot, and that where the company “also seeks a civil FCA release through the FCA SDPP, supplementation of its Fraud Division disclosure will be requested only to the extent necessary.” However, the Pilot does not specify whether a company will automatically be considered for a civil release if it makes a disclosure to NFED and, if not, what process a company should follow to request a civil release. The Pilot also does not address what coordination, if any, will occur between the Civil Division and NFED when a company makes only a civil disclosure. Given that many FCA theories in the healthcare space (including those premised on the Anti-Kickback Statute (“AKS”)) rest on conduct that is potentially criminal, the uncertainty regarding how the Pilot and the NFED disclosure policy intersect should be taken into account in deciding whether and to whom any disclosure should be made. Companies disclosing to NFED that also want Pilot treatment should consider affirmatively notifying the Civil Division and requesting a civil release, rather than assuming the disclosure will be routed automatically.
Perhaps more importantly, where the disclosed conduct may also implicate an underlying criminal violation, such as a violation of the AKS, companies will need to consider carefully how they describe the conduct being reported. The Pilot requires a description of conduct that, in the company’s reasonable assessment, potentially violates the FCA, along with a certification that the submission is truthful and complete. Although the Pilot states that a disclosing party will receive a release “with no factual admissions,” a disclosing entity should keep in mind the potential for either the government or a third party to claim that the company’s submission constitutes an acknowledgement that the company committed a criminal offense. It is not clear whether a disclosure that is caveated to make clear the company has not concluded that the underlying offense occurred (for example, that the requisite intent under the AKS was present) will be treated as a qualifying submission. Companies should therefore pay close attention to the framing of any disclosure, with an eye toward both eligibility and potential collateral use.
The Pilot, as currently announced, is a temporary six-month program. Submissions must be made to FCA-SDPP@usdoj.gov through April 22, 2027, and “[l]ate or partial submissions will not be accepted or reviewed.” A qualifying submission must, among other things, (i) describe all relevant details of the conduct that, in the company's reasonable assessment, potentially violates the FCA, including the specific requirements violated and the time period; (ii) append documents sufficient to fully reflect the nature, terms, and operation of the conduct, cross-referenced in the narrative; (iii) specify remedial measures or corrective actions taken by the disclosing company to terminate the violations and prevent them from reoccurring; (iv) provide financial information sufficient for the Civil Division to calculate the Base Self-Disclosure Repayment; and (v) include a certification from an authorized representative that the submission is truthful and complete.
The Pilot applies only to a potential FCA violation “previously unknown” to the federal government. On its face, the eligibility test turns on the government's actual knowledge. The Pilot thus does not appear to disqualify a company that is aware of an imminent qui tam filing, a pending internal whistleblower complaint, or another imminent disclosure, so long as the government itself is not yet aware of the potential violation. That reading differs from existing practice for rewarding self-disclosures involving False Claims Act violations (discussed below), and it remains to be seen how DOJ interprets the Pilot’s “previously unknown” limitation. At a minimum, the filing of a qui tam complaint (or a whistleblower's report to the government) will presumably render the Pilot unavailable, which places a premium on speed for any company considering a self-disclosure.
Even if an entity is ineligible under the Pilot because the government “was already aware” of a potential violation, the Pilot states that the entity may still be eligible for “self-disclosure and cooperation credit pursuant to Justice Manual Section 4-4.112.” That statement raises at least two questions.
- What type of cooperation credit is available under § 4-4.112? Justice Manual § 4-4.112, which predates the new Pilot program, provides that entities may earn cooperation credit when settling a False Claims Act case if they make a voluntary self-disclosure, cooperate with the government’s investigation, or take appropriate remedial actions. The policy states that a defendant will receive maximum credit if they meet all three requirements, but may still earn partial credit if they engage in any conduct warranting cooperation credit. Section 4-4.112 appears to define a voluntary self-disclosure more narrowly than the Pilot, by excluding any “disclosure of information that is under an imminent threat of discovery or investigation” even if that information was not yet known by the government. Accordingly, an entity that fails the Pilot’s disclosure standard is unlikely to qualify for self-disclosure credit under § 4-4.112 - despite the Pilot’s express reference to such credit – and by extension is unlikely to be eligible for maximum cooperation credit. However, a company should remain eligible to receive partial credit if it either cooperates with the government’s investigation or takes appropriate remedial measures.
- Can both the Pilot and § 4-4.112 apply? Nothing on the face of the Pilot precludes a company that qualifies for the Pilot from also seeking credit under § 4-4.112 for cooperation and remediation. In many instances, however, the conduct that would earn credit under § 4-4.112—a complete disclosure, document production, and remediation—is already a prerequisite for a Pilot resolution, and DOJ may be unwilling in practice to credit any conduct that is already covered by the Pilot. Companies may nonetheless wish to document cooperative steps that go beyond the Pilot’s requirements, which may provide an opportunity to argue for an additional credit beyond what would be available under the Pilot alone.
The Pilot’s principal benefits include:
- A defined multiplier range. The repayment will be 1.25 to 1.6 times the Base Self-Disclosure Repayment, with the multiplier varying based on the timeliness of the disclosure, the duration and scope of the misconduct, senior leadership’s involvement, the financial benefit to the company, and whether the company has successor liability but promptly remediated. Some resolutions involving cooperation credit under § 4-4.112 have already fallen within this range, but the Pilot provides enhanced certainty by specifying a concrete range in advance.
- A release without admissions. The company will receive a release from the Civil Division under the FCA for the disclosed conduct as part of a “coordinated civil release, with no factual admissions.”
- No Corporate Integrity Agreement. Based on the language of the Pilot, HHS-OIG “shall not require a Corporate Integrity Agreement [“CIA”] as part of any resolution of HHS-OIG's exclusion authorities under this pilot program.” Notably, the Pilot protocol is framed as a commitment regarding the terms of any resolution of OIG's permissive exclusion authorities, but its text does not expressly guarantee that OIG will release those authorities, although the accompanying HHS press release states that OIG “will not impose an exclusion” as part of the resolution. Companies should seek to confirm the scope of any OIG release in the settlement documentation. The Pilot also does not address mandatory exclusion.
- CMS commitments. Centers for Medicare & Medicaid Services (“CMS”) “shall not impose civil monetary penalties or seek revocation” of Medicare enrollment as part of any resolution. This CMS commitment, however, is limited to those remedies— CMS does not agree to release its new exclusion authority, or even to refrain from seeking a CIA.
- One disclosure. Companies need not make separate disclosures of the same conduct under the HHS-OIG SDP or the CMS Self-Referral Disclosure Protocol.
It is unclear whether the Pilot applies to FCA cases handled outside the Civil Division, and the proposed release is limited to the FCA and the listed HHS authorities. Companies should therefore assess other potential exposure before making a disclosure, including under state false claims acts.
The Pilot requires disclosing entities to provide financial information that will serve as the basis for the government’s calculation of the Base Self Disclosure Repayment (to which the government will then apply a multiplier within the designated range). The Pilot includes two examples that offer insight into how the base payment will be determined:
- Non-kickback cases. In the first example, a hospital that delayed submission of physician lab orders to circumvent Medicare's 14-day rule (42 C.F.R. § 414.510) conducts a sample chart review, identifies an error rate, and extrapolates it across the claims population to calculate the base repayment. This suggests that, outside the kickback context, the base payment will generally reflect the amount of false claims at issue, and the government will accept (and may require) statistical extrapolation.
- Kickback cases. In the second example, an acquirer discovers post-closing that the acquired healthcare company may have violated the AKS, and produces documentation of the payments and the associated revenue. The Pilot states that, “for the limited purpose of this pilot program, the government will forego damages based on the claim-paid amounts and instead calculate the Base Self-Disclosure Repayment for Anti-Kickback Statute violations based on consideration of the amount of the remuneration, the revenue derived from the disclosed conduct, and the absence of aggravating factors such as patient harm.”
The example is a potentially significant departure from the government’s more typical position in AKS-based FCA cases that damages equal the amount paid for tainted claims. The Pilot does not define “revenue derived from the disclosed conduct,” and it is unclear how the government will apply that concept—particularly where the disclosing company is the entity that submitted the claims allegedly induced by the kickback. The Pilot also does not indicate how this factor will be reconciled with the other factors referenced in the example, including the amount of the remuneration. How DOJ resolves these questions in early Pilot resolutions will be an important indicator of the program's value in kickback matters, which are often the most consequential FCA exposures for healthcare companies.
Notwithstanding these examples, because the calculation of damages in any particular case is often fact specific, a company contemplating disclosure should keep in mind that the government’s view of the base repayment amount may differ from the company’s expectations.
The Pilot reflects DOJ’s stated effort to pair aggressive healthcare fraud enforcement with a more structured and predictable path to resolution. Given the April 22, 2027 deadline, the “previously unknown” requirement, and the open coordination questions with NFED, companies should promptly evaluate open compliance matters, hotline reports, audit findings, and post-closing diligence issues, and consider carefully whether, where, and in what order a disclosure may be warranted.
If you have any questions concerning the material discussed in this client alert, please contact the members of our White Collar Defense and Investigations, False Claims Act, and Health Care practices.
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