HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Medical Device Legal News with Sam Bernstein: Episode 14
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more
In this podcast Rob DeConti, Assistant Inspector General for Legal Affairs within the office of counsel to the Inspector General at HHS, was good enough to share a tremendous amount of insight into what the OIG is seeing,...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
In a Special Fraud Alert issued on November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS-OIG) raised significant fraud and abuse concerns with companies offering or providing...more
On November 16, 2020, the U.S. Health & Human Services (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically used to signal enforcement priorities – “to highlight certain...more
On July 28, 2020, the Department of Justice (DOJ) announced a $3.5 million settlement to resolve allegations against Pacira Pharmaceuticals Inc. that it paid kickbacks to doctors in the form of “bogus” research grants to...more
On July 24, 2020, President Trump signed three Executive Orders aimed at lowering prescription drug costs and increasing patients’ access to life-saving medications. A fourth Executive Order was discussed, which could reduce...more
Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act. While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
The U.S. Department of Health and Human Services Office of Inspector General's (OIG) chief counsel indicated in 2007 that the government's fraud enforcement focus on large organizations was an "ineffective strategy" and that...more