Pharmaceuticals

On May 11, New York Gov. Kathy Hochul announced the establishment of the Pharmacy Benefits Bureau within the State’s Department of Financial Services (DFS). The Bureau will handle the licensing and supervision of pharmacy benefit managers (PBMs), and in particular their impact on consumers and the cost of healthcare. The Bureau will also have authority

With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the Department of Justice for years to come. Biopharma companies and manufacturers must carefully consider the facts and safeguards applicable to any sponsored

A New York woman was sentenced last month to 78 months in prison for defrauding healthcare programs, including obtaining more than $6.5 million from Medicare Part D plans and Medicaid drug plans.

Queens resident Aleah Mohammed owned five pharmacies, four of which operated under variations of the name “Superdrugs.” Between 2015 and 2020, the pharmacies

Rivkin Radler’s Michael Sirignano wrote an article, “The Opioid Crisis: An Epidemic Exacerbated by Fraud,” that appeared in the March 3 issue of the New York Law Journal. The article discussed the various types of opioid fraud, including illegal distribution, fake prescriptions, illegal dispensing by pharmacies, and medically unnecessary procedures.

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The federal government will delay for six months its enforcement of key portions of the Transparency in Coverage (TiC) final rule that goes into effect on January 1, 2022. The change was announced in guidance issued jointly by the U.S. Departments of Labor, Health and Human Services, and the Treasury on August 20.

The TiC

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.

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

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

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