What To Do When The Government Knocks On Your Lab’s Door -
The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more
7/15/2022
/ Clinical Laboratories ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Price Transparency ,
Virus Testing
On October 14, 2021, the Massachusetts Attorney General (MA AG) announced a $25 million settlement with South Bay Mental Health Center, Inc.’s (SBMHC) private equity owner and two former executives for allegedly causing false...more
12/20/2021
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Pharmaceutical Industry ,
Pharmacies ,
Private Equity Firms ,
Qui Tam ,
Whistleblowers
On September 18, 2019, the Department of Justice (DOJ) announced a $21.36 million settlement with compounding pharmacy Patient Care America (PCA), as well as PCA’s Chief Executive, PCA’s former Vice President of Operations,...more
9/25/2019
/ Department of Justice (DOJ) ,
Drug Compounding ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Investment ,
Kickbacks ,
Patient Referrals ,
Pharmaceutical Industry ,
Pharmacies ,
Private Equity Firms ,
Settlement Agreements ,
TRICARE
In a 3-0 decision issued September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a three-year-old district court ruling in United States v. AseraCare, Inc. that a Medicare claim for hospice services...more
9/17/2019
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraudulent Charges ,
Health Care Providers ,
Healthcare Facilities ,
Hospice ,
Medicare ,
Medicare Beneficiaries ,
Objective Falsity ,
Reversal
A recent complaint filed by the United States against a private equity firm regarding an alleged kickback further illustrates new concerns private equity should be aware of in the healthcare arena and working with counsel to...more
On June 14, 2016, a federal district court in the Northern District of Illinois denied a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger of Advocate Health Care...more
7/19/2016
/ Antitrust Investigations ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Hospital Mergers ,
Hospitals ,
Mergers ,
Penalties ,
Preliminary Injunctions ,
Stark Law
In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more
The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more
10/8/2015
/ 60-Day Rule ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Fee-for-Service ,
GPOs ,
Healthcare ,
HIV ,
HRSA ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Overpayment Recovery Time Limits ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Whistleblowers
The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more
9/9/2015
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Generic Drugs ,
Healthcare ,
HEAT ,
Kickbacks ,
Kmart ,
Medicare ,
Pharmacies ,
Prescription Drugs
The Centers for Medicare and Medicaid Services (CMS) announced on February 13, 2015, that it will delay publishing final regulations concerning the “60-Day Rule.” The final rule will be published on or before February 17,...more