On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million (the Settlement Agreement)...more
In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and...more
In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more
1/17/2025
/ Anti-Kickback Statute ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Hospitals ,
Medicaid ,
Medical Bills ,
Medicare ,
Physicians ,
Stark Law
The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically...more
8/14/2024
/ Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Fair Market Value ,
False Claims Act (FCA) ,
Healthcare ,
Hospitals ,
Physicians ,
Public Health ,
Stark Law
The Office of Inspector General (OIG) started 2024 with a flurry of activity by issuing four new Advisory Opinions on January 3, 2024. In one of these Advisory Opinions, the OIG approved a vendor’s referral program that...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
9/21/2022
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Manufacturers ,
Medicare Part D ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Product Labels ,
Qui Tam ,
Self-Disclosure Requirements ,
Settlement
In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth...more
On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more
4/28/2022
/ Advisory Opinions ,
Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Healthcare Facilities ,
Medical Devices ,
OIG ,
Physician-Owned Distributors ,
Sunshine Act
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
11/11/2021
/ Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare Fraud ,
OIG ,
Provider Self-Disclosure Protocol ,
Reporting Requirements ,
Settlement ,
Whistleblowers
On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million...more
11/3/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Kickbacks ,
Medical Devices ,
Open Payments ,
Sunshine Act
On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback...more
9/16/2020
/ Anti-Kickback Statute ,
Breach of Duty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Patient Referrals ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law