DOJ White-Collar Enforcement Priorities: What Health Care Providers and Life Sciences Companies Need to Know
On May 12, 2025, the U.S. Department of Justice (“DOJ”) Criminal Division issued a new guidance memo titled “Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime,” outlining the DOJ’s current enforcement priorities and policies for prosecuting white-collar crimes.
In the memo, Matthew R. Galeotti, the Trump Administration’s appointed Head of the DOJ’s Criminal Division, sends a clear message: the DOJ remains laser focused on prosecuting health care fraud and other crimes involving health care providers and life sciences companies. The memo identifies ten “high-impact areas” the Criminal Division will prioritize and sets forth the DOJ’s new policies with respect to efficiency of investigations and use of monitorships, while also emphasizing its continued focus on individual accountability and voluntary self-disclosure.
Here are five key takeaways that health care providers and life sciences companies should know:
1. “Rampant” Health Care Fraud is a Continuing Priority
The memo highlights white-collar crimes in ten “high-impact areas” that the Criminal Division will prioritize investigating and prosecuting. The #1 priority on this list is “[w]aste, fraud, and abuse, including health care fraud and federal program and procurement fraud.” The DOJ explains that it is committed to combating “[r]ampant health care fraud” and holding accountable corporations and individuals that defraud and exploit government programs such as Medicare and Medicaid.
The top ten list also includes “[f]raud that victimizes U.S. investors, individuals, and markets including . . . fraud that threatens the health and safety of consumers,” as well as “[v]iolations of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act (FDCA), including the unlawful manufacture and distribution of chemicals and equipment used to create counterfeit pills laced with fentanyl and unlawful distribution of opioids by medical professionals and companies.”
Takeaway: The memo signals the DOJ’s continued focus on priority areas that directly impact health care providers and life sciences companies. Despite the Trump Administration’s widespread efforts to scale back federal agencies that regulate these industries, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, organizations within these industries should not assume that government scrutiny of health care activities is slowing when DOJ scrutiny may instead be intensifying. In addition to enforcement of health care fraud and abuse laws through efforts targeting billing practices, referral arrangements, and drug and device distribution, the DOJ’s broad reference to “fraud that threatens the health and safety of consumers” could encompass a wide variety of other fraudulent conduct in the health care and life sciences industries.
2. Continued Focus on Individual (vs. Corporate) Accountability
The DOJ is intensifying its focus on prosecuting individuals responsible for corporate misconduct—including executives, officers, board members, and other high-ranking employees. Although this position is consistent with the DOJ’s long-standing focus on individual accountability, the memo makes clear that the DOJ’s “first priority is to prosecute individual criminals” rather than corporations.
Throughout the memo, the DOJ emphasizes its commitment to strike an appropriate balance between investigating and prosecuting both individual and corporate wrongdoing “while minimizing unnecessary burdens on American enterprise.” To this end, the memo directs prosecutors to “prioritize schemes involving senior-level personnel or other culpable actors” and to consider additional factors when deciding whether to criminally prosecute corporations. These factors may include whether the company reported the conduct to the DOJ, its willingness to cooperate with the government, and its actions to remediate the misconduct. The memo explains that “[p]rosecution of individuals, as well as civil and administrative remedies directed at corporations, are often appropriate to address low-level corporate misconduct.”
Takeaway: Health care and life sciences organizations can expect continued enforcement not only at the corporate level but also focused on those in senior leadership positions. High-ranking employees and board members should understand these risks and exercise appropriate oversight with respect to the organization’s activities and compliance efforts. Again, this focus is not new, but the memo underscores the importance of ensuring that those in leadership positions comprehend the scope of their responsibilities and the potential risk associated with neglecting these responsibilities.
3. Additional Incentives for Self-Disclosure and Cooperation
The memo further emphasizes opportunities available to companies that are willing to cooperate with the DOJ, report relevant misconduct, and implement corporate compliance programs to address misconduct. Although the Criminal Division’s Corporate Enforcement and Voluntary Self-Disclosure Policy (“CEP”) has been in place for years, the DOJ cites to the revised CEP issued this year to “clarify that additional benefits are available to companies that self-disclose and cooperate.”
Specifically, the updated CEP defines the circumstances under which the Criminal Division will decline to prosecute a company for criminal conduct based on self-disclosure, cooperation, remediation, and lack of certain aggravating factors. Even if aggravating circumstances exist, prosecutors can still recommend declination under the CEP based on the company’s efforts. The CEP sets forth two additional paths for resolution of criminal matters, again emphasizing the benefits of cooperation and remediation when it comes to matter resolution in terms of form, term length, compliance obligations, and monetary penalties.
Takeaway: Although offering incentives for company self-disclosure is not new, the DOJ is doubling down on these efforts to further encourage voluntary reporting and corporate cooperation. Nevertheless, health care and life sciences organizations must carefully consider their options if they become aware of potential misconduct. Self-disclosure requires thoughtful analysis and consultation with legal advisors to determine whether the company can cooperate to the full extent required by the DOJ. Companies must also assess the potential impacts of such disclosure outside the context of criminal prosecution. For example, what is the risk of civil litigation or enforcement by other agencies, and what additional disclosures might be required in the U.S. or other jurisdictions?
4. Focus on Efficiency
As the memo title indicates, the DOJ is directing its prosecutors to move expeditiously to investigate and conclude white-collar cases so they do not linger. The memo acknowledges that federal investigations into white-collar crime can be costly and intrusive for businesses, investors, and other stakeholders, causing significant interference with business operations and often leading to reputational harm that may not be warranted. Accordingly, the DOJ is instructing prosecutors to “minimize the length and collateral impact of their investigations.” The DOJ will also be tracking investigations to ensure they are concluded “swiftly.”
Takeaway: Although faster resolution of cases sounds like a win for companies, in practice this could be a mixed blessing. Companies certainly have reason to want to wrap up a DOJ investigation promptly. However, shorter timelines could lead to more intense investigations as prosecutors operate on an accelerated basis. This could strain corporate resources, require much faster responses from companies, and lead to more aggressive tactics by prosecutors. It could also result in prosecutorial decisions based on less complete information in an effort to conclude investigations more quickly.
5. Narrowly Tailored Use of Compliance Monitorships
In support of the efforts towards efficiency, the memo also announces DOJ’s intent to restrict the use and scope of corporate compliance monitors. Specifically, the memo emphasizes that compliance monitors should only be imposed when necessary (i.e., when a company cannot be expected to implement an effective compliance program or prevent recurrence of misconduct without such intervention). When used, monitorships must be narrowly tailored to address the specific risks and minimize expense, burden, and interference with the day-to-day business.
In Galeotti’s remarks announcing the Criminal Division’s new white-collar enforcement plan, he outlined that “[a] monitor’s costs must be proportionate to the severity of the underlying conduct, the profits of the company, and the company’s present size and risk profile.” According to Galeotti, this will be accomplished by requiring a fee cap, approving budgets for workplans, and requiring biannual meetings between the DOJ, the monitor, and the company. He also noted that the money companies spend on monitors could often be better spent investing in compliance programs.
In coordination with these efforts, the DOJ is also ordering individualized review of existing monitorships to determine ongoing necessity. The memo also directs Criminal Division prosecutors to limit corporate resolutions to three years moving forward, “except in exceedingly rare cases” and to regularly assess such agreements to determine if they should be terminated early.
Takeaway: The DOJ’s new approach signals less reliance on monitorships moving forward and a greater focus on company efforts to improve their compliance programs. Some of the factors prosecutors must consider when deciding whether to impose a monitor will include the “the efficacy of the company’s compliance program and culture of compliance” as well as “the ability of the company to test and update its compliance program.” For these and many other reasons, having a robust compliance program has never been more important for health care and life sciences organizations. Compliance policies and procedures should include having strong internal reporting mechanisms to identify potential misconduct, as well as prompt and thorough investigations of alleged misconduct.
Final Thoughts
For health care providers and life sciences companies that face unique regulatory obligations and enforcement risks, this memo reinforces the need for proactive compliance and cooperation when problems arise. Now is the time to reassess your compliance program, review your internal reporting and investigation procedures, and ensure leadership is equipped to support a culture of ethical decision-making.
If your organization needs assistance developing a compliance program or assessing risk, London Legal Consulting, LLC is here to assist. Please contact us today.