DOJ Actions Suggest Expansion of Healthcare Enforcement

James Koukios and Liz Aloi wrote an article for Law360 entitled "DOJ Actions Suggest Expansion of Healthcare Enforcement" about recent shifts in federal healthcare enforcement priorities. The article discusses how the U.S. Department of Justice and FDA are increasingly focusing on product integrity, regulatory transparency, and telehealth marketing, moving beyond traditional program-based fraud involving Medicare and Medicaid. Notable cases, such as those involving ExThera Medical Corp. and Kimberly-Clark Corp., illustrate the DOJ's willingness to pursue criminal charges for regulatory violations, including failures in safety reporting and the distribution of adulterated products, even when government health programs are not implicated. The authors highlight that companies across the healthcare sector face expanded criminal exposure and emphasize the importance of robust compliance measures to mitigate these risks.

Read the full article.