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
A March 24 article in Wolters Kluwer’s Health Law Daily, “STRATEGIC PERSPECTIVES: Pandemic response, fraud and abuse top Biden’s enforcement priorities,” quoted healthcare industry experts who predict increased enforcement in the areas of fraud and abuse, False Claims Act (FCA) cases, and pandemic-related waivers. Rivkin Radler’s Robert Hussar was quoted in the
A March 26 article in Vitamin Retailer, “FDA Warns Selling of Topical CBD Products Violates FD&C Act,” discussed the two warning letters recently issued by the U.S. Food and Drug Administration (FDA) to two companies for selling topical pain relief products containing CBD. The FDA claims that the sale of the products
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.
A March 11 article in the Health Care Compliance Association’s Report on Patient Privacy, “In Wake of 16th OCR Settlement, Time For CEs, BAs to Take Right of Access Seriously,” discussed the Right of Access Initiative that the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has been pursuing since
Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study published in Communications Biology.
When a person sits within two feet of a smart speaker, the system sends out inaudible
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
For those providers who somehow missed or ignored the first 15 settlements in the series, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced that Sharp HealthCare, doing business as Sharp Rees-Stealy Medical Centers, agreed to pay a $70,000 fine for failing to provide a patient with timely access
A February 15 article in Part B News, “Provider Relief Fund audits coming; pick your method and keep good records,” discussed the Provider Relief Fund (PRF) authorized under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Rivkin Radler’s Bob Iseman was quoted in the article.
Healthcare providers who received PRF