FCA Enforcement & Compliance Digest — Summer 2025 False Claims Act Newsletter

In this Summer 2025 edition, we cover:

1. Enforcement Trends: DOJ Revisions to White-Collar Crime Enforcement Priorities and Policies
2. Enforcement Trends: Trump Administration Reinforces Illegal DEI Executive Orders With Civil Rights Fraud Initiative
3. Litigation Developments: Insurers Under Scrutiny- Kickbacks, Discrimination, and Medicare Advantage Plans
4. Compliance Corner: Speaker Programs for Health Care Providers- Enforcement Trends and Compliance Lessons
5. ICYMI: DOJ Plans to Use the FCA to Attack DEI Initiatives 

1. Enforcement Trends

DOJ Revisions to White-Collar Crime Enforcement Priorities and Policies

On May 12, the Criminal Division of the US Department of Justice (DOJ) introduced a new white-collar enforcement plan that overhauls the Criminal Division’s corporate enforcement priorities and updates three of its key corporate enforcement policies. The policies are (1) the Corporate Enforcement and Voluntary Self-Disclosure Policy, (2) the policy on selecting monitors, and (3) the Corporate Whistleblower Awards Pilot Program. In announcing the new plan, Matthew Galeotti, head of the DOJ’s Criminal Division, stated it “will focus the Criminal Division’s efforts on the most egregious white-collar crime to make our nation safer and more prosperous, vindicate victims’ rights, maximize the use of the Department’s resources, and provide fairness and transparency to individuals and companies alike.” However, at the American Conference Institute Conference on June 10, Galeotti made clear that “the Criminal Division has not and will not close meritorious investigations or dismiss meritorious cases” and promised to “vigorously pursue” investigations.

In a memorandum to all Criminal Division personnel titled “Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime,” Galeotti identified 10 “high-impact areas” on which the Criminal Division will prioritize its investigative and prosecutorial efforts.

1. Waste, fraud, and abuse, including health care fraud and federal program and procurement fraud.
2. Trade and customs fraud, including tariff evasion.
3. Market manipulation schemes.
4. Investment fraud, including Ponzi schemes, elder fraud, servicemember fraud, and consumer fraud.
5. Conduct that threatens the national security.
6. Material support by corporations to foreign terrorist organizations, including recently designated cartels and transnational criminal organizations (TCOs).
7. Complex money laundering.
8. Violations of the Controlled Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act.
9. Bribery and associated money laundering that impact US national interests, undermine US national security, harm the competitiveness of US businesses, and enrich foreign corrupt officials.
10. Crimes related to digital assets, including investor and consumer fraud, and using digital assets in furtherance of other criminal conduct.

Corporate Enforcement and Voluntary Self-Disclosure Policy

The revisions to the Criminal Division Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP) aim to simplify the policy and clarify outcomes, such as by including a flowchart (reproduced here) to illustrate the various paths to a declination of prosecution, a non-prosecution agreement, or other corporate criminal resolutions.

Furthermore, under the revised CEP, the Criminal Division will automatically (rather than presumptively as under the prior version) decline to prosecute if, in the absence of “aggravating circumstances,” a company self-discloses criminal conduct, fully cooperates with the Criminal Division’s investigation, and timely and appropriately remediates the misconduct. In cases with aggravating circumstances, prosecutors retain discretion to decline prosecution under the CEP based on the severity of the circumstances and the company’s cooperation and remediation.

In Galeotti’s most recent remarks regarding white-collar enforcement, he underscored the importance of cooperation:

This is the time for companies to self-report. It is the time to do the work, come in early, cooperate, and remediate. The Criminal Division’s policies give clear benefits to those who do. And for those who don’t, we will move swiftly and aggressively to bring cases against individuals and companies. We will use all our tools and seek strong sentences. We will hold culpable companies and individuals to account for misconduct.

Policy on Selection of Monitors

A new memorandum on the policy for the Selection of Monitors in Criminal Division Matters details four factors prosecutors must consider when determining if a monitor is appropriate.

1. The nature and seriousness of the conduct and the risk that it will happen again.
2. The availability of other effective independent government oversight.
3. The efficacy of the company’s compliance program and culture of compliance at the time of resolution.
4. The maturity of the company’s controls and ability of the company to test and update its compliance program.

The updated monitor selection policy also outlines a multitude of steps prosecutors must take to ensure that, when a monitor is deemed appropriate, the scope of its role is “appropriately tailored to avoid unnecessary burdens to the business’s operations.”

Corporate Whistleblower Awards Pilot Program

Finally, the plan includes revised guidance on the Corporate Whistleblower Awards Pilot Program, a three-year initiative that has been in effect since August 1, 2024. Managed by the Criminal Division’s Money Laundering and Asset Recovery Section, this program offers monetary rewards to encourage the public to report misconduct related to certain specified subject areas.

The original pilot program covered the following areas: violations by financial institutions and abuse of the financial system not covered by other whistleblower programs, foreign corruption schemes, domestic corruption schemes, health care offenses involving non-public benefits programs, and other health care offenses not covered by the federal FCA.

The updated guidance removes certain language from those categories, expanding the scope of the violations about which an eligible whistleblower’s report must pertain to, including procurement and federal program fraud; trade, tariff, and customs fraud; immigration law; and sanctions violations, material support of foreign terrorist organizations, or those that facilitate cartels and TCOs, including money laundering, narcotics, and CSA violations.

And the Fox Says… The DOJ’s new guidance appears to align white-collar enforcement priorities with the Administration’s overall pro-business agenda and broader efforts to identify and eliminate fraud, waste, and abuse in the federal government and protect national interests. Anyone who may read the new guidance as an indication that the risk profile of their activities has decreased should bear two things in mind. First, criminal statutes of limitations often last longer than presidencies (particularly for conspiracy charges, where the statute of limitations does not even begin to run until the last act in furtherance of the conspiracy). Second, expansion of the Corporate Whistleblower Pilot Awards Program incentivizes both whistleblowers and companies to come forward and report misconduct. Companies would be wise to review their policies and procedures, and to conduct risk assessments to ensure their compliance programs are properly calibrated to mitigate against government procurement fraud, national security risks, customs, trade and tariff offenses, sanctions evasion, money laundering, and other top enforcement priorities.

2. Trump Administration Reinforces Illegal DEI Executive Orders with Civil Rights Fraud Initiative

Earlier this year, we reported on the various executive orders laying out the new Administration’s policies on anti-discrimination, and how those orders signaled use of the FCA in an unprecedented way to enforce those policies. Recently, the DOJ took an even more aggressive step in the crackdown on illegal diversity, equity, and inclusion (DEI) by announcing the creation of the Civil Rights Fraud Initiative (CRFI) (which we reported on here) to target grant recipients and government contractors — and colleges and universities in particular — that falsely certify compliance with federal anti-discrimination laws. Whereas previously we predicted that we may see the DOJ leverage the FCA to enforce the Administration’s policy objectives, this new DOJ initiative confirms that the agency will investigate and pursue allegations of illegal DEI, and as a result we are almost certain to see an increase in whistleblower actions and government enforcement in this area.

Whistleblowers and relator’s counsel have enormous incentive to bring FCA claims pursuant to the CRFI. The memorandum “strongly encourages” private individuals who have knowledge of civil rights fraud to “protect the public interest by filing lawsuits and litigating claims under the False Claims Act.” Additionally, under the FCA, a whistleblower who brings a case that results in a monetary recovery by the government can receive up to 30% of the recovery. Thus, we are likely to see increased complaints from, for example, disgruntled employees alleging they were unfairly denied a promotion, terminated, or otherwise subjected to an adverse employment action because of DEI initiatives.

We may also see increased FCA investigations by the government, or threats of such investigations, as a means of coercing recipients of federal funding to get in line with the Administration’s policy goals. The memorandum, issued in the midst of the Administration’s political battles with Harvard and other top universities, expressly states that “a university that accepts federal funds could violate the False Claims Act when it … refuses to protect Jewish students” from allegedly antisemitic acts or it “allows men to intrude into women’s bathrooms.” Given the broad scope of the CRFI’s directive, however, the government could also use the FCA to target others who have pushed back against the Administration’s policy initiatives.

And the Fox Says… In light of the augmented efforts to eliminate illegal DEI, all recipients of federal funding, including grant recipients and federal contractors, should thoroughly evaluate and mitigate FCA risk, including by (1) reviewing and updating policies and DEI programs to ensure compliance with anti-discrimination laws, (2) conducting a detailed review and analysis of compliance certifications and conditions of payment required for receipt of federal funds, (3) conducting risk assessments to identify areas of potential FCA exposure arising out of DEI programs, and (4) ensuring compliance programs and hotlines are in place to capture and address complaints of discrimination.

3. Litigation Developments

Insurers Under Scrutiny: Kickbacks, Discrimination, and Medicare Advantage Plans

In May, the DOJ filed an FCA complaint against three national health insurance companies and three insurance brokers alleging unlawful kickbacks and discrimination against disabled persons. The DOJ alleges that from 2016 to at least 2021, defendant insurers Aetna Inc. and affiliates Elevance Health Inc. (formerly known as Anthem) and Humana Inc. paid hundreds of millions of dollars in illegal kickbacks to the defendant brokers eHealth, Inc. and an affiliate, GoHealth, Inc., and SelectQuote Inc. in exchange for referring and enrolling Medicare beneficiaries into the insurers’ Medicare Advantage (MA) Plans. While the complaint only names three insurers, if the government is successful in this case, it will likely lead to a significant number of future FCA lawsuits filed by relators against other insurers and insurance brokers alleging similar violations of the law.

The MA Program, also known as Medicare Part C, allows Medicare beneficiaries to enroll in health care plans offered by private insurance companies. Medicare beneficiaries often rely on insurance brokers to assist them in choosing a MA plan that best meets the beneficiaries’ individual needs. The complaint contains two principal contentions; that the companies engaged in an illegal kickback scheme and disability discrimination.

The defendant brokers allegedly failed to serve as impartial stewards when they assisted Medicare beneficiaries in enrolling in MA plans. Instead, the DOJ accuses the defendant brokers of steering Medicare beneficiaries toward plans offered by insurers that provided kickbacks to the brokers, disregarding whether those MA plans were suitable for the beneficiaries.

The DOJ further contends that Aetna and Humana each conspired with the broker defendants to discriminate against Medicare beneficiaries with disabilities whom the insurers viewed as less profitable. According to the allegations, Aetna and Humana sought to achieve this by threatening to withhold kickbacks from brokers enrolling disabled Medicare beneficiaries in their plans. The defendant brokers allegedly declined referrals of disabled beneficiaries and dissuaded such individuals from choosing Aetna and Humana plans in response to the financial incentives from these companies.

The US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) previously issued a warning regarding certain marketing arrangements involving suspect payments and referrals between MA plans and third-party marketers, including agents and brokers. In its 2024 Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers, the OIG highlighted the risks associated with arrangements that involve improper steering or that incentivize agents, brokers, or health care professionals to direct enrollees toward specific MA plans or providers based on financial incentives, rather than an enrollee’s best interests. The alert underscores that federal regulators are closely scrutinizing marketing and referral practices in the MA sector, and this scrutiny is reinforced by the government’s position in the recent FCA litigation targeting these types of arrangements.

And the Fox Says… Although the DOJ has currently filed a complaint against only three insurers and three brokers, if the DOJ is successful in this case, it could trigger a flood of future relator-driven FCA actions against other insurers and brokers alleging similar violations of the law. Insurers and brokers should therefore ensure that arrangements involving referrals of Medicare and other federal health care program beneficiaries comply with all federal laws, including the Anti-Kickback Statute (AKS). Insurers and brokers also should closely monitor the evolving litigation landscape and any subsequent attempts to assert similar claims against additional insurers and brokers. Legal counsel can provide expert guidance to help structure arrangements in accordance with the law and keep you informed of all pertinent developments.

4. Compliance Corner

Speaker Programs for Health Care Providers: Enforcement Trends and Compliance Lessons

Recent enforcement efforts illustrate the significant AKS and FCA risks pharmaceutical and medical device manufacturers face when they use speaker programs to promote their products. Three large settlements — Gilead Sciences ($176.9 million, 2025), Biohaven ($59.7 million, 2025), and Biogen ($900 million, 2022) — together with the HHS OIG’s Special Fraud Alert on Speaker Programs illustrate the government’s principal theories and provide a roadmap for effective compliance controls.

OIG Special Fraud Alert: Speaker Program Red Flags

The OIG’s 2020 Special Fraud Alert identifies characteristics that, alone or in combination, suggest an improper intent behind remuneration associated with speaker programs:

• Use of high-end venues or alcohol.
• Meals of more than modest value.
• Repeat attendance by the same clinicians on identical topics or attendance as attendees by speakers who have presented on identical topics.
• Selection of speakers or attendees based on past or expected prescribing.
• Compensation exceeding fair market value.
• Minimal substantive content or a lack of new clinical information.

The OIG emphasized that alternative, lower-risk educational vehicles (e.g., package inserts, accredited continuing medical education, virtual on-demand content) diminish the need for repetitive, in-person, lavish events. Companies that choose to continue speaker programs should therefore implement rigorous controls designed to eliminate the indicia cited by OIG.

Enforcement Insights

Three recent AKS/FCA settlements illustrate the type of enforcement actions manufacturers can face when they are alleged to have operated speaker programs with conduct similar to what the OIG perceives as problematic.

Gilead Sciences (April 28, 2025): Gilead paid $176 million (half of which was deemed restitution) to resolve allegations that the company paid physicians more than $23.7 million in honoraria, meals, and travel between 2011 and 2017 via its speaker programs to induce prescriptions of six HIV drugs. Approximately 17,300 events were conducted, with many hosted at luxury restaurants where six-course dinners and wine pairings were served. In its complaint, the government also alleged that the Gilead programs included excessive repeat attendance (some clinicians allegedly participated in 50 to75 dinners on the same topic) and that the company manipulated meal-spend limits by disguising food charges as “room fees.”

Pfizer (January 15, 2025): Pfizer paid $59.7 million to resolve allegations that, from 2020 to 2022, its recently acquired subsidiary, Biohaven, offered honoraria worth 10s of thousands of dollars per physician to promote its migraine therapy, Nurtec ODT. The government alleged that speaking engagements, often virtual or held at upscale restaurants, were provided to high-volume prescribers and sometimes attended by spouses, friends, or colleagues with no clinical need. To be sure, virtual speaker programs typically are seen as less problematic, however, the government’s complaint alleged that despite there being no new meaningful information to present to providers, Biohaven continued to host virtual programs for which they provided speaker honoraria and meals for attendees. Attendees were also mostly non-prescribers or non-targets like office staff and medical students, and attendance sheets were completed by the sales representatives without attendee verification.

Biogen (September 23, 2022): Biogen agreed to pay $900 million to resolve claims that, from 2009 to 2014, it used speaker fees, consulting arrangements, and meals to induce prescriptions for multiple sclerosis drugs. Although the United States declined to intervene initially, the relator pursued the action, and the DOJ later consented to dismissal in light of Biogen’s payment. The settlement underscores relator-driven risk; even when the DOJ does not take the lead, whistleblowers can obtain massive recoveries (the relator received $250 million).

Compliance Takeaways

In light of the OIG’s 2020 Special Fraud Alert and the sizable AKS/FCA settlements discussed above, pharmaceutical and medical device manufacturers’ general counsel offices and compliance officers should consider the following key compliance lessons and considerations.

1. Robust Needs Assessments
   Require documented, data-driven justifications for each program, linking content to genuine knowledge gaps and prohibiting events on topics previously addressed without material updates.
2. Speaker Selection and Compensation
   Implement objective criteria (e.g., board certification, clinical expertise, speaking experience) for selection of speakers where the criteria is unrelated to a proposed speaker’s prescription volume. Ideally, manufacturers will limit sales’ involvement in speaker selection, instead involving medical or other departments whose compensation is not tied to product sales. Manufacturers should also ensure that any honoraria paid to speakers is fair market value, does not take into account the volume or value of the speakers’ prescriptions, and is supported by an external, written valuation methodology.
3. Venue and Hospitality Controls
   Limit programs to modest venues conducive to learning, ban entertainment settings, cap per-person meal costs, and prohibit alcohol. Expense documentation should be granular and routinely audited to uncover miscodings such as excessive “room fees” used to conceal high per-person meal costs.
4. Attendance Management
   Enforce attendee eligibility (health care professionals with a demonstrable professional interest) and cap repeat attendance. Attendance by speakers who previously presented on the same topic should be prohibited. To monitor attendance manufacturers should employ, and routinely review, electronic registration lists cross-referenced against prior program participation.
5. Content Integrity and Delivery
   Mandate company-approved educational slide decks, prohibit off-script comments that could constitute off-label promotion, and require compliance monitoring, ideally unannounced, of a meaningful percentage of events.
6. Training and Certification
   Provide annual AKS/FCA training to commercial and medical personnel, highlighting the red flags set forth by the OIG in its Special Fraud Alert. Manufacturers should also ensure that speakers undergo appropriate training and certify annually that they will adhere to approved content and that compensation is not tied to prescribing.
7. Data Analytics and Monitoring
   Track program frequency, attendance, spend patterns, and unusual clusters of attendee relationships. Manufacturers should proactively investigate trends that could suggest that the company’s speaker programs are being used to induce prescriptions, rather than to educate health care professionals.
8. Corrective Action and Disclosure
   Establish written escalation pathways for investigating and remediating suspected misconduct, including voluntary refund or disclosure protocols, and when to involve legal counsel.

And the Fox Says… Speaker programs remain permissible, but the enforcement environment has shifted decisively. The Gilead, Pfizer, and Biogen resolutions show that repetitive, high-dollar engagements unsupported by clear educational need can trigger nine-figure liabilities. Coupled with OIG’s explicit guidance, these cases demand heightened vigilance from manufacturers using speaker programs to promote their products. Compliance teams should reassess existing speaker-program policies, reinforce controls that eliminate the red flags outlined above, and deploy advanced monitoring to detect issues before they mature into government investigations.

5. In Case You Missed It

Our most popular blog post from the last quarter: DOJ Plans to Use the FCA to Attack DEI Initiatives.