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
On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more
9/30/2024
/ Administrative Procedure Act ,
Class Action ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
PHI ,
Proposed Rules ,
Regulatory Requirements ,
Tracking Systems ,
Web Tracking
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
The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more
12/8/2023
/ Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Legislative Agendas ,
National Security ,
New Guidance ,
OCR ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements