Pharmaceuticals


Bristol-Myers Squibb Settles MDRP Underpayment Claim for $75 Million
April 14, 2021 | Eric D. Fader | False Claims Act | Litigation | Medicare and Medicaid | Pharmaceuticals
The U.S. Department of Justice recently announced that Bristol-Myers Squibb (BMS) agreed to pay $75 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program (MDRP). Of that total, $41 million plus interest will be paid to the federal government and the remainder to various state Medicaid …
Read More
Free Drug Program Avoids Sanctions Under AKS
April 6, 2021 | Ada (Kozicz) Janocinska | FDA | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
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 the …
Read More
FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
March 25, 2021 | Steven Shapiro | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
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 announced that …
Read More
NYC Pharmacy Owner Charged with Healthcare Fraud
March 23, 2021 | Margarita Christoforou | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
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. …
Read More
False Claims Act Cases Poised to Jump Now and for Years to Come
March 4, 2021 | Rivkin Rounds Staff | Behavioral Health | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
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 unnecessary services, and …
Read More
HHS Relaxes Rules on Administering COVID-19 Vaccines
February 5, 2021 | Ada (Kozicz) Janocinska | COVID-19 | Legislation and Public Policy | Pharmaceuticals
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 …
Read More
New AKS Safe Harbors Finalized
December 3, 2020 | Geoffrey R. Kaiser | Electronic Health Records | Fraud and Abuse | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective …
Read More
OIG Issues Special Fraud Alert on Speaker Programs
November 20, 2020 | Eric D. Fader | Fraud and Abuse | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose inherent fraud and abuse risks. OIG is “skeptical about the educational value of such programs” and cautioned that remuneration to referring practitioners …
Read More
Psychedelic Therapy Training Program Launched
October 19, 2020 | Rivkin Rounds Staff | Behavioral Health | FDA | Hospitals | Pharmaceuticals
Mind Medicine, Inc. (MindMed) and NYU Langone Medical Center (NYU) recently announced a joint project to launch a clinical training program focused on psychedelic-assisted therapies and psychedelic-inspired medicines. MindMed, a psychedelic drug startup, is studying the use of hallucinogenic drugs in the treatment of mental health conditions. This venture is the first step in establishing a …
Read More
Gilead Reaches $97 Million FCA/AKS Settlement
September 30, 2020 | Eric D. Fader | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
On September 23, the U.S. Department of Justice announced that pharmaceutical company Gilead Sciences, Inc. agreed to pay $97 million to resolve claims that it illegally used a foundation as a conduit to pay the copays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug Letairis. In addition to the False Claims Act …
Read More

Authors
show more

Get legal updates and news delivered to your inbox