Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more
7/17/2025
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Funding ,
Gender Identity ,
Healthcare ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Whistleblowers
On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more
On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more
5/29/2024
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Kickbacks ,
OIG ,
Patient Assistance Programs ,
Proximate Cause ,
Regeneron ,
Regulatory Requirements ,
Reimbursements