On Feb. 18, in U.S. v. Regeneron Pharmaceuticals, the First Circuit Court of Appeals joined the Sixth Circuit and the Eighth Circuit in holding that, for purposes of establishing that a claim for payment of items or services...more
2/21/2025
/ Anti-Kickback Statute ,
Appeals ,
Appellate Courts ,
Causation ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Government Agencies ,
Healthcare Fraud ,
Medicare ,
Pharmaceutical Industry ,
Qui Tam ,
Regeneron ,
Summary Judgment ,
Whistleblowers
On Oct. 7, the U.S. Supreme Court denied a petition for review and let stand a widely watched Second Circuit Court of Appeals decision in which the court ruled that the term “willfully” as used in the Anti-Kickback Statute...more
The Supreme Court’s recent ruling in Loper Bright Enterprises v. Raimondo (and its companion case, Relentless v. Department of Commerce), in which it overruled the Chevron doctrine, has received a great deal of attention...more
7/29/2024
/ Administrative Procedure Act ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Civil Rights Act ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Loper Bright Enterprises v Raimondo ,
Physician Medicare Reimbursements ,
Relentless Inc v US Department of Commerce ,
Sex Discrimination ,
Stark Law ,
Statutory Interpretation
Last week, the U.S. Supreme Court denied the request of qui tam relators that it review the Sixth Circuit’s recent decision in United States of America ex rel. Martin v. Hathaway, No. 22-1463 (6th Cir.). In so doing, the...more
10/10/2023
/ Anti-Kickback Statute ,
But For Causation ,
Denial of Certiorari ,
False Claims Act (FCA) ,
Health Care Providers ,
Patient Referrals ,
Physicians ,
Qui Tam ,
Relators ,
Remuneration ,
SCOTUS
The False Claims Act’s (FCA) materiality requirement as articulated by the U.S. Supreme Court in Universal Health Servs., Inc. v. United States ex rel. Escobar, 579 U.S. 176 (2016) was again front and center, this time in a...more
Last month in United States ex rel. Schutte, et al. v. SuperValu Inc. et al, the Supreme Court unanimously held (with Justice Thomas writing the opinion) that the False Claims Act’s (“FCA”) scienter element refers to a...more
7/13/2023
/ CIGNA ,
False Billing ,
False Claims Act (FCA) ,
Medicaid ,
Medicare ,
Personal Knowledge ,
Prescription Drugs ,
Reasonable Interpretations ,
Reckless Disregard ,
Relators ,
SCOTUS ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Whistleblowers
On the heels of the Sixth Circuit’s recent decision in Martin v. Hathaway, previously discussed on Health Law Observer, a critical issue in that case, i.e., the meaning of the term “remuneration” for purposes of the federal...more
The U.S. Supreme Court, in an 8-1 decision written by Justice Kagan, held on June 16 that the United States (“Government”), having initially chosen not to intervene in a False Claims Act (“FCA”) qui tam case, but having...more
In a unanimous decision Thrsday, the U.S. Supreme Court, in an opinion written by Justice Thomas, ruled that the False Claims Act’s (“FCA”) scienter element refers to a defendant’s knowledge and subjective beliefs — not to...more
In a prior blog post, we discussed U.S. ex. rel. Shannon Martin, M.D. v. Darren Hathaway, M.D. et al, a Sixth Circuit case involving the questions (1) whether a hospital’s decision not to hire an ophthalmologist (Dr. Martin)...more
Two recently decided federal court cases hone in on the proper interpretation and application of three critical components of the Anti-Kickback Statute (“AKS”), namely:
•the requirement that a violation of the AKS must...more
4/17/2023
/ Affordable Care Act ,
Anti-Kickback Statute ,
Bribery ,
Causation ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Patient Referrals ,
Qui Tam ,
Rebates ,
Remuneration
A recent U.S. District Court decision provides a good example of how federal courts will apply the public disclosure/original source rules in whistleblower cases alleging that health care providers violated the False Claims...more
An important threshold question in qui tam cases under the False Claims Act is whether the relator-whistleblower is the original source of the information forming the basis for the claim. This is because qui tam actions under...more