On January 16, 2026, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics, announcing that FCA settlements and judgments exceeded $6.8 billion in the fiscal year (FY) ending...more
As we noted in our recent Insight, at least eight decisions from district courts around the country have rejected the reasoning in the September 30, 2024, opinion of District Judge Kathryn Kimball Mizelle from the U.S....more
On December 12, 2025, the U.S. Court of Appeals for the Eleventh Circuit is scheduled to hear oral arguments in Zafirov v. Florida Medical Associates LLC, No. 24-13581, a case that squarely presents the question of the...more
The U.S. Court of Appeals for the Eleventh Circuit held in United States ex rel. Sedona Partners LLC v. Able Moving and Storage Inc., No. 22-13340 (11th Cir. Jul. 25, 2025), that while a district court has the discretion to...more
In the latest in a series of recent cases involving the “but-for” causation standard for Anti-Kickback Statute (“AKS”) claims, Judge Waverly D. Crenshaw in the U.S. District Court for the Middle District of Tennessee has...more
10/9/2025
/ Anti-Kickback Statute ,
But For Causation ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
Medicare Advantage ,
Motion to Dismiss ,
Remuneration ,
Rule 9(b)
On September 25, 2025, the Department of Justice announced a new office within the Civil Division—the Enforcement & Affirmative Litigation Branch—“dedicated to safeguarding public health and safety through proactive...more
10/6/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
Immigration Enforcement ,
Pharmaceutical Industry ,
Public Health ,
Unfair or Deceptive Trade Practices
By the third quarter of 2025, the Department of Justice (DOJ) has made plain that it will continue using the False Claims Act (FCA) to advance administration priorities....more
On July 17, 2025, the U.S. Court of Appeals for the Fourth Circuit held that a federal district court was “within bounds to order a do-over” in the case of Ron Elfenbein, a Maryland doctor who was found guilty of...more
On July 29, 2025, Attorney General Pam Bondi issued a memorandum to all federal agencies providing guidance addressing “unlawful discrimination” on the basis of race, color, national origin, sex, religion, or other protected...more
Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more
7/3/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medicare ,
Whistleblowers
On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more
On May 19, 2025, the U.S. Department of Justice (DOJ) announced a new Civil Rights Fraud Initiative that will leverage the federal False Claims Act (FCA) to investigate and litigate against universities, contractors, health...more
On May 19, 2025, the U.S. Department of Justice (DOJ) announced a new Civil Rights Fraud Initiative that will leverage the federal False Claims Act (FCA) to investigate and litigate against universities, contractors, health...more
The U.S. Court of Appeals for the Eleventh Circuit has concluded that a successful False Claims Act (FCA) claim should “allege not just a scheme, but a scheme that actually led to false claims being submitted to the...more
Dating back to the 19th century, the U.S. Supreme Court has held that when construing a statute, the courts are to “give effect, if possible, to every clause and word of a statute, avoiding, if it may be, any construction...more
In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA)....more
On January 21, 2025, President Trump issued an executive order titled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” (the “EO”), which aims to eliminate diversity, equity, and inclusion (DEI) policies...more
What may have seemed like an out-of-the-blue question to the casual observer was no surprise to those who represent individuals and entities in the health care and life sciences industries: U.S. Attorney General (AG) nominee...more
On January 6, 2025, the U.S. District Court for the District of Massachusetts granted a defendant laboratory’s motion for summary judgment in a False Claims Act (FCA)/Anti-Kickback Statute (AKS) case brought by a physician...more
On January 15, 2025, the U.S. Department of Justice (DOJ) issued a press release announcing its fiscal year (FY) 2024 False Claims Act (FCA) recoveries and reported that settlements and judgments exceeded $2.9 billion in...more
1/17/2025
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Life Sciences ,
Medicare Fraud ,
Qui Tam ,
Settlement ,
Trump Administration ,
Whistleblowers
In August, the United States filed a Complaint-in-Intervention in a False Claims Act (FCA) whistleblower suit alleging that the Georgia Institute of Technology (“Georgia Tech”) and an affiliate, Georgia Tech Research Corp....more
Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more
8/13/2024
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Physician Fee Schedule ,
Proposed Rules ,
Regulatory Reform
In a recent landmark decision, the U.S. Supreme Court overruled the Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo.
This ruling has significant implications for employers and other entities in the...more
On February 22, 2024, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2023, which ended on September 30, 2023. While the $2.68 billion in total...more
2/28/2024
/ Civil Investigation Demand ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Government Investigations ,
Healthcare ,
Healthcare Fraud ,
Medicare Advantage ,
Opioid ,
Private Equity ,
Qui Tam ,
Whistleblowers
FBI! Open up! Is your organization prepared to handle a government investigation?
Guilty or not, having a preparedness plan in place for when a government agency comes knocking is just as important as conducting a company...more