Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector...more
Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions -
Walgreens Boots Alliance has agreed to pay more than $300 million to resolve allegations brought by the US Department of Justice (DOJ)...more
4/28/2025
/ Anti-Kickback Statute ,
Causation ,
Controlled Substances ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Settlement ,
Whistleblowers
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more
Welcome to the Winter 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for AKS-Based FCA Claims -
On February 18, the US Court of Appeals for the First Circuit became the latest court to agree...more
2/24/2025
/ Anti-Kickback Statute ,
But For Causation ,
Causation ,
Compliance ,
Cybersecurity ,
DCIS ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Overpayment ,
Paycheck Protection Program (PPP) ,
Pharmaceutical Industry ,
SBA ,
Settlement ,
TRICARE
Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million -
Pfizer Inc. agreed to pay over $59,746,277 to resolve allegations that its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company...more
2/3/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare Part D ,
Mergers ,
Pharmaceutical Industry ,
Purdue Pharma ,
Sentencing ,
Settlement ,
Whistleblowers
DOJ Reports Nearly $3 Billion in FCA Settlements, Judgments for FY 2024 -
On January 15, the US Department of Justice (DOJ) reported that settlements and judgments under the False Claims Act (FCA) totaled more than $2.9...more
1/20/2025
/ Criminal Prosecution ,
Cryptocurrency ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Investment Fraud ,
Medicare ,
Medicare Advantage ,
Pharmaceutical Industry ,
Pharmacies ,
Settlement ,
Whistleblowers ,
Wire Fraud
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
Most violations of the Health Information Portability and Accountability Act (HIPAA) are addressed through administrative enforcement action. But, in some circumstances of improper conduct affecting the privacy or security of...more
The Centers for Medicare and Medicaid Services (CMS) recently released the CY 2020 Proposed Physician Fee Schedule....more
8/6/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Hospitals ,
Medical Devices ,
Medical Records ,
Medicare ,
Open Payments ,
Opioid ,
Pharmaceutical Industry ,
Physician Assistants ,
Physician Fee Schedule ,
Physicians ,
Sunshine Act ,
Telehealth ,
Telemedicine