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DOJ Targets Laboratory Owner in Nationwide Telehealth Fraud Scheme

Federal prosecutors in Florida and Louisiana have filed multiple indictments related to a nationwide telemedicine fraud scheme involving genetic testing. The arrangement included at least 35 individuals and has resulted in the submission of more than $2.1 billion of fraudulent claims. Earlier this week, federal prosecutors for the United States Department of Justice charged the CEO of LabSolutions, LLC, the owners of telemedicine companies Lotus Health, LLC, MedSymphony, LLC, and...

OCR Settles First Case in HIPAA Right of Access Initiative

Earlier this year, the Department of Health and Human Services Office for Civil Rights (OCR) announced its desire to improve Health Insurance Portability and Accountability Act (HIPAA) right of access failures, including untimely responses to access requests and overcharging for copies of medical records. Right of access allows patients to request copies of their medical records. Covered Entities are required to oblige within certain time parameters, but are permitted to...

Mallinckrodt Agrees to Pay $15.4 Million to Resolve Alleged False Claims Act Liability for “Wining and Dining” Doctors

On September 4, 2019, the United States Department of Justice (DOJ) announced that drug maker Mallinckrodt agreed to pay $15.4 million to resolve claims that its predecessor Questcor Pharmaceuticals paid illegal kickbacks to doctors to induce prescriptions of Questcor's drug H.P. Acthar Gel from 2009 to 2013. The Government intervened in these two whistleblower suits entitled United States of America ex rel. Strunck et al. v. Mallinckrodt ARD, Inc., No....

Southern District of Florida Levels Injunction Against Stem Cell Clinic on Behalf of FDA

On June 25, 2019, the Southern District of Florida issued an injunction on behalf of the Food and Drug Administration (FDA) preventing US Stem Cell Clinic LLC (USSCC) and its parent company US Stem Cell Inc. from manufacturing and distributing certain stem cell treatments. As the FDA increases its oversight and enforcement of stem cell treatments, this decision appears to affirm the agency's position that certain stem cell products should...

Webinar Recording: How Will USP <800> Impact Your Business

With USP <800> Hazardous Drugs soon to be released, it is important for retail and compounding pharmacies to know how it will impact them and their businesses. In this recorded webinar, attorney John E. Morrone, Esq., and attorney-pharmacist Dae Y. Lee, Pharm.D., Esq., CPBS, provide an overview of USP <800>, including: The background and history on why USP <800> was created Regulation and enforcement of USP <800> States that have...