Pharmaceuticals


Compounding the Fraud: Questionable Billing by Pharmacies
July 6, 2021 | Rivkin Rounds Staff | FDA | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
Rivkin Radler partners Evan Krinick and Michael Sirignano authored an article, “Compounding the Fraud: Questionable Billing by Pharmacies,” in the July 6 issue of the New York Law Journal. The article discussed the U.S. Department of Justice’s continued concern over fraudulent claims for reimbursement to federal healthcare programs for compounded prescription drugs. …
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Sham Speaker Fees Lead to Jail Term
June 17, 2021 | Eric D. Fader | False Claims Act | Fraud and Abuse | Litigation | Pharmaceuticals
On June 16, Jeffrey Goldstein, a former Manhattan physician, was sentenced to 57 months in prison for taking $196,000 in kickbacks from Insys Therapeutics, a defunct Arizona-based opioid manufacturer. Goldstein pled guilty to conspiracy in 2019 for accepting purported “speaker fees” from Insys in 2013-15 to prescribe the company’s fentanyl spray, Subsys. Goldstein was one …
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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 …
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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 …
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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 …
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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. …
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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 …
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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 …
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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 …
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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 …
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