Drug Pricing and Medicaid Rebate Reporting: Enforcement Risk Remains
A recent analysis examines ongoing enforcement risks tied to drug pricing and Medicaid rebate reporting under the Medicaid Drug Rebate Program (MDRP), focusing on a federal court decision addressing how “strength” should be defined for products with the same concentration but different volumes. The court adopted a broader FDA-based definition and dismissed False Claims Act allegations, but the absence of clear statutory or regulatory guidance leaves room for continued scrutiny and potential shifts in agency interpretation. Read the full article for key takeaways on how courts may approach undefined MDRP terms, how FDA regulations can influence rebate reporting obligations, and practical steps manufacturers can take to mitigate False Claims Act risk through consistent, well documented compliance practices.
U.S. DOJ Issues Guidance on “Unlawful Discrimination” Related to DEI Programs for Recipients of Federal Funding
On July 30, 2025, the U.S. Department of Justice (DOJ) issued guidance on “unlawful discrimination” for recipients of federal funding and other entities subject to federal antidiscrimination laws, further underscoring Trump administration officials’ commitment to pursuing investigations and enforcement activity in this area.
U.S. DOJ Announces Renewal of FCA Working Group
On July 2, 2025, the U.S. Department of Justice (DOJ) announced the renewal of the DOJ-HHS False Claims Act Working Group (Working Group), a partnership with the U.S. Department of Health and Human Services (HHS) that aims to strengthen use of the False Claims Act (FCA) to combat healthcare fraud. (more…)
U.S. DOJ Civil Division to Investigate Possible Violations of the Food, Drug, and Cosmetic Act by Pharmaceutical Firms Manufacturing Drugs Used in Gender Transition Care
On June 11, 2025, the U.S. Department of Justice (DOJ) Civil Division issued a memorandum outlining five Trump administration policy objectives and “direct[ing] Civil Division attorneys to prioritize investigations and enforcement actions advancing these priorities.”1 The memorandum is signed by Assistant Attorney General Brett A. Shumate, who was confirmed by the Senate two days earlier, on June 9, 2025.2 One of the five policy objectives, entitled “Protecting Women and Children,” has potentially significant enforcement implications for pharmaceutical companies whose drugs may be used in gender transition care — even if they are used off-label.
U.S. DOJ Launches Initiative Leveraging False Claims Act to Target Diversity, Equity, and Inclusion Programs
In a May 19, 2025 memorandum, U.S. Department of Justice (DOJ) Deputy Attorney General Todd Blanche announced the Civil Rights Fraud Initiative, which aims to use the False Claims Act (FCA) to investigate and “pursue claims against any recipient of federal funds that knowingly violates federal civil rights laws” via “racist preferences, mandates, … and activities” — including diversity, equity, and inclusion (DEI) programs. (more…)
DOJ Enforcement Outlook in Health Care Compliance for 2025
Some predicted a drop in False Claims Act (”FCA”) enforcement during the first Trump administration, but setting aside a likely pandemic-related slowdown during 2020–2022, FCA cases — both DOJ-initiated and qui tam — during the early part of the first Trump administration were consistent with the volume in the later part of the Biden administration.
Federal Judge Pauses Enforcement of DEI Executive Order; FCA Risks Remain
On Friday, February 21, a federal district judge in Maryland issued a nationwide preliminary injunction prohibiting the U.S. Department of Justice (DOJ) and defendant federal agencies from enforcing portions of two presidential executive orders (EOs) targeting diversity, equity, and inclusion (DEI) programs at companies that do business with the federal government, including provisions tethering allegedly unlawful DEI programs to potential False Claims Act (FCA) liability.
