Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Heath care fraud remains a top priority for the DOJ. This year’s National Health Care Fraud Takedown was the biggest in United States history, resulting in the prosecution of 324 defendants in connection with over $14.6...more
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more
Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more
A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of...more
Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more
In the case that tested the limits of the “fake it till you make it” approach to a startup business, on January 3, 2022, a jury in the U.S. District Court for the Northern District of California convicted Elizabeth Holmes,...more
Carolina Kidney Partners: Addition of Ga.-based nephrology practice expands Medicare, commercial insurance footprint - Savannah’s Nephrology & Hypertension Medical Associates operates seven clinics in Ga. and S. Car....more
On May 26, the U.S. Department of Justice (DOJ) announced criminal charges against 14 defendants in six states for participation in healthcare fraud schemes related to the COVID-19 pandemic. The coordinated takedown involved...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
With the support of the economic development organization Invest Puerto Rico, Biosimilar Solutions LLC announced that both it and CytoImmune Therapeutics will be establishing operations on the island to conduct biologics and...more
Perhaps nowhere do technology and real estate intersect more deeply than in the life sciences industry, where sophisticated technologies are integral to tenants’ operations. The life sciences industry, which was experiencing...more
Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug...more
In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more
On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more
$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total...more
On October 24, 2018, President Trump signed the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act” (the “SUPPORT...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more
This is the second article in a series on advancements in microbiome research and development. This installment reviews US patents issued in 2015 in "Microbiomics." Upcoming articles will continue to review important topics...more
This is the first installment in a series on advancements in microbiome research and development. Our goal with this series is to inform readers about developments in this important and growing field and to highlight, where...more