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 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…)
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.