Episode 379 -- Update on False Claims Act and Customs Evasion Liability
2 Gurus Talk Compliance: Episode 55 – The From Worse to Worser Edition
Daily Compliance News: July 17, 2025, The COSO Yanked Edition
Podcast - Persistence and Determination
Episode 377 -- Refocusing Due Diligence on Cartels and TCOs
Blowing the Whistle: What Employers Should Know About DEI & the False Claims Act
Regulatory Ramblings: Episode 73 - Geopolitical Risk: Thai Tensions / Sanctions, Tariffs & FCPA Enforcement in Asia
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
Episode 376 -- DOJ's Unicat Settlement and the Future Look of Trade Enforcement Actions
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Current Regulatory, Legislative, and Litigation Developments on ADA Website Accessibility for Consumer Finance Digital Platforms — The Consumer Finance Podcast
Podcast - How Do You Define Success?
Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
10 For 10: Top Compliance Stories For the Week Ending June 21, 2025
2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition
Understanding the DOJ's Recent Corporate Enforcement Policy Changes
Compliance Tip of the Day – New FCPA Enforcement Memo – What Does it Mean?
Daily Compliance News: June 17, 2025, The JBS Goes Public Edition
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more
The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more
The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more
The HHS Office of Inspector General (OIG) issues an unfavorable advisory opinion regarding the provision of a value-added free hearing aid; the OIG issues comprehensive general compliance program guidance; the FDA issues an...more
After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more
The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more
On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more
Senior DOJ Official Michael Granston Discusses COVID Relief Enforcement, Granston Memo, and other FCA Issues - Michael Granston, the Deputy Assistant Attorney General of the DOJ Civil Division, sat down this week with Jody...more
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
On November 16, 2020, OIG issued a significant Special Fraud Alert that warns about certain “inherent” fraud and abuse risks raised by speaker programs sponsored by pharmaceutical and medical device companies. OIG expressed...more
In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as...more
Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs - A Special Fraud Alert issued by the U.S....more
On Nov. 16, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued a special fraud alert addressing fraud and abuse concerns with speakers programs conducted by pharmaceutical...more
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose...more
In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more
Recently, the United States Department of Justice and the Department of Health and Human Services’ Office of Inspector General entered into a Settlement Agreement with a medical drug company that caught our eye because of the...more
As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the...more
Corporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) in 2019. Notably, pharmaceutical and device manufacturers saw...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...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