/>iOn May 12, 2025, the Criminal Division of the Department of Justice (“DOJ”) published a memorandum to all Criminal Division personnel with the subject “Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime.” The memo sets forth the priorities for DOJ enforcement of corporate crime. The number one priority listed in the memo is a focus on waste, fraud, and abuse, including health care fraud and federal program and procurement fraud. The government’s primary vehicle for prosecuting such misconduct and recovering fraudulently obtained funds is the False Claims Act (“FCA”), which permits whistleblowers (called “relators”) to initiate a lawsuit on the government’s behalf, provides a portion of recovery to the relator, and carries the potential for treble damages for companies that have committed fraud against the government.
The DOJ memorandum also referenced the Criminal Division’s update of its “Corporate Enforcement and Voluntary Self-Disclosure Policy.” The updated policy includes a focus on encouraging corporate self-reporting and self-remediation efforts through a policy of automatic declinations for cooperating companies. According to the memo, “[i]t is critical to American prosperity to promote policies that acknowledge law-abiding companies and companies that are willing to learn from their mistakes,” specifically companies that self-report potential misconduct to the DOJ.
This DOJ guidance and recent enforcement actions, including a $202 million settlement of an FCA lawsuit against Gilead Sciences, provide a reminder that corporations operating in the health care industry must continue to ensure their compliance standards conform to corporate best practices and are consistent with all applicable laws. While the risk of FCA cases brought by DOJ and by relators for healthcare fraud has not abated, DOJ’s willingness to deal favorably with cooperating companies as expressed in the newly announced policies provides potential opportunities to bring any non-compliant behavior into compliance without risk of prosecution.
Medical Speaker Programs
One recent area of focus for DOJ FCA enforcement relates to medical speaker programs, which are programs in which medical professionals provide presentations and information on specific medical topics—often related to specialized prescription medications—to other healthcare professionals. These programs are commonly used by pharmaceutical and medical device companies to educate and engage with physicians and other healthcare providers. For such programs to comply with the federal Anti-Kickback Statute and avoid FCA risk, such programs cannot constitute renumeration in exchange for referring patients or services that are reimbursable by federal healthcare programs. That is, compliant medical speaker programs cannot use financial incentives to encourage clinical decision-making.
On April 29, 2025, the DOJ announced a $202 million FCA settlement with Gilead Sciences in connection with a relator’s allegations that Gilead used speaker programs to pay illegal kickbacks to doctors to induce them to prescribe Gilead’s drugs. According to the DOJ, as part of its marketing efforts, and to increase sales, Gilead conducted a medical speaker program in which it would pay a physician to present a slide deck (prepared by Gilead) and facilitate discussion with other healthcare providers about one of the drugs manufactured by Gilead. While the speaker programs were supposed to be educational in nature and the cost of any meals provided was supposed to be modest, DOJ considered the program to constitute illegal renumerations because the speaker events were held at high-end restaurants, Gilead permitted attendees to attend the same event multiple times despite a lack of educational need, and Gilead provided free travel to physicians and their families to speak at desirable locations, among other allegations. The speaker program did not comply with Gilead’s internal compliance policy, which is often a significant red flag. Gilead admitted responsibility for the alleged misconduct.
Compliance, Reporting, and Voluntary Self-Disclosure
In addition to articulating the Department’s enforcement priorities, the DOJ’s memorandum also referenced the Criminal Division’s update of its “Corporate Enforcement and Voluntary Self-Disclosure Policy,” which provides, under certain circumstances, a “presumption that [a cooperating] company will receive a declination absent aggravating circumstances involving the seriousness of the offense or the nature of the offender.”
The Corporate Enforcement and Voluntary Self-Disclosure Policy reflects the DOJ’s “first priority” of prosecuting the individuals who actually perpetrate a crime, “often at the expense of shareholders, workers, and American investors and consumers.” Before prosecuting a company, the DOJ policy requires the consideration of factors “including whether the company reported the conduct to the Department, its willingness to cooperate with the government, and its actions to remediate the misconduct.” Cooperation in this context requires companies to enter “into agreements with the Criminal Division [to] agree to implement corporate compliance programs, report relevant misconduct, cooperate with the government, and more.” Cooperating companies must also “pay all disgorgement/forfeiture, and/or restitution/victim compensation payments resulting from the misconduct at issue.”
Absent aggravating circumstances, such as “involvement by executive management of the company in the misconduct; egregiousness or pervasiveness of the misconduct within the company; or criminal recidivism,” cooperating companies should expect to receive automatic declinations of prosecution under the policy. And even if aggravating circumstances are present, “prosecutors may nonetheless determine that a declination is an appropriate outcome if the company demonstrates to the Criminal Division that it has met” certain requirements, including voluntary self-disclosure, an effective compliance program and internal accounting controls, and “extraordinary remediation.”
In the event that corporate prosecution is warranted, the DOJ has expressed a preference for recommending fine reductions and avoiding long-term corporate monitoring regimes where companies have voluntarily self-disclosed and remediated their misconduct.
Key Takeaways
Companies that promote medical speaker programs should be reminded that speaking fees for physicians must be consistent with the market value of the speaker’s time. Speaker programs must also meet an actual educational need, meaning that providers cannot attend the same educational program multiple times, and health care companies cannot offer lavish food and drink amenities during the programs. Likewise, any other perks given to health care providers must take into account the total value being transferred, including the cost of traveling to conferences, accommodations, appearing on advertisements, and the like. Family members of health care providers should never receive benefits of any kind. Significantly, the best practice is for medical speaker programs to be coordinated by a company’s medical educational group rather than its salespeople.
Moreover, with the DOJ’s increased focus on combatting fraud against the government, companies should review their internal guidelines and ensure that company policies are consistent with current best practices and are actually implemented and adhered to by the company and its employees. The DOJ’s updated self-reporting policy provides potential opportunities to bring any non-compliant behavior into compliance without risk of prosecution. Self-monitoring of internal compliance is particularly important due to the DOJ’s focus on whether companies are complying with their own guidelines, and whether those guidelines are consistent with the law. Due to the updated incentives for companies with compliance and self-reporting programs in place, companies should ensure that they have implemented an adequate compliance program, provided internal reporting mechanisms, and have policies in place to encourage whistleblowers and protect whistleblowers from retaliation. Self-investigating and self-reporting to the DOJ any deviations from company policy or other violations of the law will best position the company to be protected under the voluntary self-disclosure program.
Footnotes
1) https://www.justice.gov/criminal/media/1400046/dl?inline.
2) https://www.justice.gov/criminal/criminal-fraud/file/1562831/dl?inline=.
4) https://www.justice.gov/criminal/criminal-fraud/file/1562831/dl?inline=.
