Novel coronavirus (“2019-nCoV”, also known as “SARS-CoV-2”) and the disease it causes – “coronavirus disease 2019” (abbreviated as “COVID-19”) has garnered significant public attention since being declared a Public Health...more
In a letter dated March 19, 2019, U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon wrote to the Department of Health and Human Services (HHS) Office of Inspector General...more
On March 6, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) posted Advisory Opinion No. 19-03, which permits a non-profit medical center (Requestor), and its affiliated...more
After a relatively slow first six months, 2018 turned into an active year for HIPAA enforcement, with the Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) announcing the largest-ever HIPAA...more
On January 31, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) proposed a new rule that would amend the safe harbor regulations under the Federal anti-kickback statute (42 U.S.C....more
2/14/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
MCOs ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors
Summary and Practical Tips -
- The federal government can waive certain EMTALA requirements during a flu pandemic.
- Federal and state governments and the hospital must take specific formal actions before these...more
On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more
On August 22, 2016, the Office of Inspector General of the Department of Health and Human Services (OIG) released updated guidance on Independent Review Organization (IRO) independence and objectivity (the “Guidance”). The...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
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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