On the same day that the U.S. Department of Justice (“DOJ”) announced the filing of criminal charges against 36 defendants for alleged schemes involving more than $1.2 billion in fraudulent telemedicine claims, the U.S....more
AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics.
In this edition, we analyze a recent Eleventh Circuit decision addressing False Claims Act penalties and the...more
2/28/2022
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Discount Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Government Investigations ,
Healthcare ,
Healthcare Fraud ,
Infectious Diseases ,
OIG ,
Paycheck Protection Program (PPP)
In a recent Advisory Opinion, the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) stated that, although the Arrangement would generate prohibited remuneration, it would not impose...more
On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more
2/19/2021
/ Anti-Kickback Statute ,
Biotechnology ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Investigations ,
Life Sciences ,
OIG ,
Penalties ,
Pharmaceutical Industry ,
Speaker Programs
On July 28, 2020, the Office of the Inspector General (OIG) of the Small Business Administration (SBA) released a Management Alert entitled “Serious Concerns of Potential Fraud in the Economic Injury Disaster Loan Program...more
On December 7, 2016, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a final rule to implement revisions to certain Anti-Kickback Statute (AKS) safe harbors, as well as revisions to...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
On March 31, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report on hospice billing for general inpatient care (GIP). According to the OIG, hospices billed Medicare for...more
The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently released its 2016 Work Plan. The Work Plan may offer evidence of a growing shift in the agency’s priorities, particularly with regard...more
On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more
10/27/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Testing ,
False Claims Act (FCA) ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG ,
Qui Tam
On September 30, 2015, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its fifth report in five years on billings for therapy services in SNFs. The Medicare Payment System For...more
On August 27, 2015, following notification by the government that it had decided not to intervene, the United States District Court for the Middle District of North Carolina, ordered that a qui tam complaint charging...more
9/15/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Declination ,
Department of Labor (DOL) ,
Employee Retirement Income Security Act (ERISA) ,
False Claims Act (FCA) ,
Hospitals ,
Medicare ,
OIG ,
PPOs ,
Qui Tam ,
Relators ,
Self-Funded Health Plans ,
Self-Insurance ,
Wage Index
On June 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) released another study in its continuing scrutiny of skilled nursing facilities (SNFs) and therapy services: Skilled Nursing...more