In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make the drug from
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).
In a news release issued on March 22, 2021 the FDA
The owner of Brooklyn Chemists in Gravesend, Brooklyn and Lucky Care Pharmacy in Flushing, Queens was recently indicted on charges of conspiracy to commit health care fraud, conspiracy to defraud the United States by paying kickbacks and bribes in connection with the provision of health care services, and unlawfully spending the proceeds of the fraud.
Rivkin Radler’s Evan H. Krinick wrote an article entitled “False Claims Act Cases Poised to Jump Now and for Years to Come” that was published in the March 5, 2021 issue of the New York Law Journal. The article discusses health insurance fraud cases in 2020 that involved kickbacks, provision of medically
On January 28, the U.S. Department of Health and Human Services (HHS) announced that it has amended the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand the types of providers that are qualified to prescribe, dispense and administer COVID-19 vaccines. Under the amendment, any healthcare provider that is licensed or