Last month, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced that they are requesting data and information to help develop a uniform definition of ultra-processed foods (UPFs) for...more
On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more
Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme -
A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions -
In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
1/13/2025
/ Anti-Kickback Statute ,
Appeals ,
Appointments Clause ,
Article III ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Misrepresentation ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Qui Tam ,
SCOTUS ,
Settlement ,
Stark Law ,
Unconstitutional Condition ,
Whistleblowers
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional -
On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
10/7/2024
/ Anti-Kickback Statute ,
Appointments Clause ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Health Care Programs (FHCP) ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misrepresentation ,
OIG ,
Qui Tam ,
Sentencing ,
Settlement ,
Unconstitutional Condition
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations -
Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more
9/5/2023
/ Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Kickbacks ,
Medical Supplies ,
Medicare ,
OIG ,
Reimbursements ,
Settlement Agreements ,
Suppliers ,
Universal Health Services Inc v United States ex rel Escobar
With the approval of the modified mifepristone Risk Evaluation and Mitigation Strategy (REMS), it has been a momentous few weeks in the reproductive health legal space.
Modification to the REMS for Mifepristone...more
On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more