In 2023, we wrote about the Supreme Court’s decision in United States ex. rel. Schutte v. SuperValu Inc. interpreting the False Claims Act’s (FCA) scienter standard to require inquiry into a defendant’s subjective knowledge....more
In the Calendar Year 2025 Medicare Physician Fee Schedule, the Centers for Medicare & Medicaid Services (CMS) finalized changes to the Medicare Parts A and B Overpayment Rule that were proposed in two prior rulemakings. This...more
A recent decision by the Supreme Court clarified the required intent for a defendant to be held liable under the False Claims Act. According to the Court, the FCA’s scienter requirement refers to a defendant’s knowledge and...more
In a unanimous opinion, the United States Supreme Court (“Court”) recently held that the False Claims Act’s (“FCA”) scienter requirement refers to a defendant’s knowledge and subjective beliefs, rather than what a...more
Two separate lawsuits alleging False Claims Act (FCA) violations by retail drug pharmacies made their way to the Supreme Court of the United States this term. The lawsuits decided whether the pharmacies could defeat these...more
On June 1, 2023, in United States ex rel. Schutte v. SuperValu, Inc., the U.S. Supreme Court unanimously held that the scienter requirement of a claim brought under the False Claims Act (FCA) is evaluated based on the...more
There have been several significant rulings on various provisions of the False Claims Act (FCA) in the first quarter of this year, which we highlight in this post. Government Dismissal Authority - To start the year, in...more
On January 25, in United States ex rel. Sheldon v. Allergan, No. 20-2330 (4th Cir., Jan. 25, 2022), the United States Court of Appeals for the Fourth Circuit upheld a lower-court dismissal of a False Claims Act (FCA) case...more
On January 25, 2022, in United States ex rel. Sheldon v. Allergan Sales, LLC, a divided panel of the U.S. Court of Appeals for the Fourth Circuit held that a defendant accused of violating the False Claims Act (FCA) by...more
Medical providers often are left confused by the incredibly complex statutory and regulatory body of law implemented by the Centers for Medicare and Medicaid Services (CMS). Without further administrative guidance, providers...more
In a split decision issued January 25, 2022, the Fourth Circuit strongly endorsed a defense to False Claims Act liability for entities that submit claims to the government in today’s complex regulatory environment, finding:...more
On January 25, in a 2-1 decision in U.S. ex rel. Sheldon v. Allergan Sales, LLC, 2022 WL 211172, the Fourth Circuit became the most recent federal appellate court to hold that the objective scienter standard in the Supreme...more
The Decision: A divided Sixth Circuit panel held that allegations of submitting late-signed supporting documents to Medicare could plead False Claims Act ("FCA") materiality and scienter. The Reasoning: Timing regulations...more
The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more
On October 5, a federal district court in California dealt a significant setback to the government’s efforts to extend False Claims Act (FCA) liability to Medicare risk adjustment submissions....more
Key Points: - Learn the latest case law developments regarding what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the...more