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

Key Points

• On October 22, 2026, the DOJ Civil Division and HHS announced a six-month Healthcare False Claims Act Self-Disclosure Pilot Program that lets health care companies resolve potential civil False Claims Act liability through voluntary self-disclosure of conduct previously unknown to the federal government. 
• DOJ’s False Claims Act self-disclosure pilot program accepts submissions only through April 22, 2027, and late or partial submissions will not be accepted or reviewed. 
• In exchange for repaying 1.25 to 1.6 times the Base Self-Disclosure Repayment, companies that self-disclose under DOJ’s False Claims Act pilot program receive a coordinated civil release with no factual admissions, and HHS-OIG will not require a Corporate Integrity Agreement. 
• For potential Anti-Kickback Statute violations, DOJ indicated that its False Claims Act self-disclosure pilot program may forgo damages based on claim-paid amounts and instead calculate repayment based on the amount of remuneration, the revenue derived from the conduct, and the absence of aggravating factors such as patient harm. 
• Because DOJ’s False Claims Act self-disclosure pilot program covers civil liability only, a company seeking to self-disclose potential criminal health care conduct must disclose it to DOJ’s National Fraud Enforcement Division.

On October 22, 2026, the Civil Division of the U.S. Department of Justice (DOJ), in partnership with the Department of Health and Human Services (HHS), announced the Healthcare False Claims Act Self-Disclosure Pilot Program (FCA SDPP or Pilot Program). The Pilot Program will run for six months and is intended to provide “a clear and predictable pathway” to resolve potential civil liability under the FCA. It is also designed for issues that arise under HHS administrative authorities, including revocation of enrollment in Medicare, permissive exclusion for false or improper claims, and permissive exclusion based on fraud and kickbacks or other prohibited activities. The DOJ and HHS made clear that the Pilot Program is for “legitimate American healthcare businesses endeavoring to quickly and cooperatively resolve prior misconduct and move forward with a clean slate.” In contrast, illegitimate businesses that knowingly exploit the United States do not qualify for the Pilot Program.

The hallmark of the Pilot Program is voluntary self-disclosure. The steps required to participate and the benefits for the disclosing company are outlined below. Given that the government recently rolled out the program, there are no real-world examples of how the program would apply in practice, or which companies stand to benefit the most by participating. The DOJ offered two hypothetical examples in its press release of how the Pilot Program would operate. The examples offer insight into the kinds of scenarios where utilization of the Pilot Program is most advantageous.

In the first example, a hospital that realized it had not been complying with Medicare’s 14-day rule prepared a sample chart review for the relevant time period. In doing so, the hospital identified an error rate that it then extrapolated over the population of claims. The hospital produced both the chart review results and information about the sampling and extrapolation methodologies to the government. Based on this example, it appears that run-of-the-mill, easily quantifiable rule violations are well suited for the Pilot Program. Whether that is true for FCA or federal rule violations that involve multiple components, and more discretion on the part of the disclosing company, is less clear.

In the second example, a company that acquired a health care company learned that the health care company engaged in conduct that could establish FCA liability through the Anti-Kickback Statute (AKS). The acquiring company then produced documents of the payments and associated revenue of the health care company for the government to review. By doing so, the acquiring company avoided damages based on the claim-paid amounts. Instead, the government calculated the company’s repayment based on the consideration of the amount of the remuneration, the revenue derived from the disclosed conduct, and the absence of aggravating factors such as patient harm. As a result, companies going through a merger, acquisition, or the like stand to benefit by self-disclosing through the Pilot Program. Companies may reduce their overall exposure and resolve potential violations more efficiently, without the potential for costly, years-long litigation.

Eligibility and Timing

Health care providers, suppliers, manufacturers, payors, and related entities that furnish, arrange for, manufacture, distribute, insure, administer, or bill for items or services paid for, directly or indirectly, by HHS federal health care programs are eligible to participate in the Pilot Program. Critically, the disclosure must involve a potential FCA violation previously unknown to the federal government. If the government is already aware of the conduct, the company may still earn self-disclosure and cooperation credit under existing DOJ policy (Justice Manual Section 4-4.112) but will not be eligible for a Pilot Program resolution.

Submissions must be made to FCA-SDPP@usdoj.gov by 11:59 p.m. on April 22, 2027, and late or partial submissions will not be accepted or reviewed.

Required Contents of a Self-Disclosure

A qualifying self-disclosure must be complete at the time of submission and must:

• Describe all relevant details of the conduct that, in the company’s reasonable assessment, potentially violates the FCA, including the specific laws, regulations, or other binding requirements at issue and the time period in which the violations occurred; 
• Append as exhibits all documents sufficient to fully reflect the nature, terms, and operation of the disclosed potential FCA violations, and cross-reference the exhibits in its written disclosure of potential FCA violations; 
• Describe the remedial and corrective measures taken to stop the offensive conduct and prevent recurrence; 
• Provide financial information sufficient for DOJ to calculate the “Base Self-Disclosure Repayment,” that is, the amount due to the government; 
• Include a certification from an authorized representative of the disclosing company that, to the best of that individual’s knowledge, the submission is truthful and complete; and 
• Identify a designated point of contact for follow-up questions and include that person’s phone number and email address (the person may, but need not be, the authorized representative).

Benefits of Disclosure

• The disclosing company will receive a coordinated civil release with no factual admissions, including a DOJ release under the FCA for the disclosed conduct; 
• The HHS Office of Inspector General (HHS-OIG) will not require a Corporate Integrity Agreement (CIA) as part of resolving its exclusion authorities; 
• The Centers for Medicare & Medicaid Services (CMS) will not impose civil monetary penalties or seek revocation; 
• The disclosing party need not make separate disclosures of the same conduct through other civil channels, including through the HHS-OIG Health Care Fraud Self-Disclosure Protocol or the CMS Self-Referral Disclosure Protocol; 
• The repayment will be 1.25 to 1.6 times the Base Self-Disclosure Repayment. Where a company falls within that range will depend on the timeliness of the disclosure, the duration and scope of the misconduct, the involvement of senior leadership, the financial benefit to the company, and whether the company has successor liability for the conduct but promptly remediated.

Notable Departures From Prior Practice

While DOJ describes the Pilot Program as building on “longstanding Department principles,” several features mark a meaningful shift in how civil health care fraud matters may be resolved:

• Defined pricing in place of discretion. Under existing Justice Manual guidance, the value of self-disclosure and cooperation credit in FCA matters has been left mostly to the government’s discretion. The Pilot Program replaces that uncertainty with a published 1.25-1.6 multiplier band and identified factors that drive placement within it, materially below the treble damages available under the FCA. 
• No admissions and no CIA. The promise of a release “with no factual admissions,” coupled with the commitment that HHS-OIG will not require a CIA, removes two of the most significant collateral consequences of a typical health care fraud settlement. 
• A new approach to kickback damages. The DOJ indicated that the government may forgo damages based on claims-paid amounts for potential AKS violations, and instead calculate repayment based on the amount of remuneration, the revenue derived from the conduct, and the absence of aggravating factors such as patient harm. If this approach applied to a company’s conduct, that company could save substantially given that claims-paid theories can produce exposure far exceeding the value of the underlying remuneration. 
• One coordinated, “one-stop” resolution. Rather than navigating DOJ, HHS-OIG, and CMS processes separately, companies can obtain a single coordinated resolution covering FCA liability and the specified administrative remedies. 
• Express recognition of successor liability. By listing prompt remediation of inherited misconduct as a mitigating factor and illustrating a post-acquisition scenario, the program gives acquirers a concrete incentive to disclose legacy issues found in diligence or integration. 
• A hard deadline. Unlike DOJ’s standing self-disclosure policies, the Pilot Program is time-limited, and incomplete submissions will not be considered.

Interaction With Criminal Exposure

The Pilot Program covers civil liability only. A company seeking to self-disclose potential criminal health care conduct must disclose it to DOJ’s National Fraud Enforcement Division under that Division’s coordination policy with HHS-OIG. A company that has already made a voluntary self-disclosure of criminal matters to the Fraud Division under the Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP), which the Criminal Division revised in May 2025 to offer a clearer path to declination, need not make a duplicative Pilot Program submission. Where such a company also seeks a civil FCA release, DOJ will request supplementation of its Fraud Division disclosure only to the extent necessary. Companies should therefore assess at the outset whether conduct carries potential criminal exposure, because that assessment will determine the appropriate disclosure channel and may affect charging outcomes.

Key Considerations

• Health care companies should promptly assess whether any known or suspected billing, coding, medical necessity, or financial relationship issues could support FCA liability, and whether those issues are already known to the government. Only previously unknown conduct qualifies for the Pilot Program. 
• Because the DOJ identified acquirers of health care businesses as suitable candidates for the Pilot Program, acquirers should revisit recent diligence findings and post-closing integration reviews for legacy issues. 
• The Pilot Program is designed for “legitimate American healthcare businesses” but does not explain what that term might mean. It adds a layer of discretion as to which companies may benefit from the Pilot Program. 
• Given the April 22, 2027 deadline and the requirement that submissions be complete, companies considering disclosure should begin internal investigations, claims sampling, and damages quantification now. Timeliness also affects where a company falls within the 1.25-1.6 multiplier range. 
• Companies should weigh the race-to-disclose dynamic created by the qui tam provisions of the FCA. If a whistleblower reaches the government first, the conduct is no longer “unknown,” and the company loses access to the Pilot Program’s benefits. 
• Self-disclosure under the Pilot Program does not necessarily foreclose liability under other civil or criminal statutes. Companies should be aware of collateral consequences should they choose to participate. 
• Remediation should be completed and documented before submission, as the disclosure must describe corrective actions taken to stop the conduct and prevent recurrence. 
• Companies should evaluate potential criminal exposure before choosing a disclosure path and coordinate any civil and criminal disclosures so that positions taken with the Civil and Fraud Divisions are consistent. 
• Because an authorized representative must certify the submission as truthful and complete, companies should establish a careful verification process and determine who is best positioned to sign. 
• Consistent with DOJ’s broader emphasis on internal reporting, companies should confirm that hotlines and compliance escalation procedures are functioning, so that issues surface internally and can be evaluated before the window closes.

Troutman Pepper Locke’s White Collar Litigation + Investigations Practice Group is closely monitoring DOJ’s evolving self-disclosure policies and health care fraud enforcement priorities. If you have questions about how the Pilot Program may affect your business or wish to evaluate whether a self-disclosure is appropriate, contact a member of our White Collar Litigation + Investigations team, whose attorneys advise on False Claims Act matters, including internal investigations and compliance program enhancement.

Emily Rockwell also contributed to this article. She is not licensed to practice law in any jurisdiction; bar admission pending.