Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The US government and private plaintiffs use the False Claims Act (FCA) – a federal statute originally enacted in 1863 in response to defense contractor fraud during the American Civil War – to combat various forms of fraud...more
On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health...more
Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more
Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more
The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has...more
In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of...more
The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more
Can a 40-year-old fraud and abuse law that compared to many others is relatively straightforward still get providers into trouble? Answer: You bet! In fact, in the first quarter of 2022 alone, the U.S. Attorney for the...more
The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more
In the final quarter of calendar year 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) released its Semiannual Report to Congress (the “Report”). The Report covers the six-month period...more
Compound Ingredient Supplier to Pay Over $22 Million to Resolve Allegations Brought Under Qui Tam Provisions of FCA - On November 7, 2019, the Department of Justice (DOJ) announced that Fagron Holding USA LLC (Fagron) had...more
In this episode, Mark Rush and John Lawrence discuss the federal government’s expectations related to health care organizations conducting internal investigations and demonstrating a commitment to compliance. The episode also...more
Healthcare Management Associates (HMA) settled criminal and civil charges with the Justice Department for illegal fraud and kickback schemes. HMA billed federal government healthcare programs for inpatient services that...more
The Bipartisan Budget Act of 2018 (BBA 2018) significantly increased civil and criminal penalties for federal health care program fraud and abuse. Below is a summary of some of the BBA 2018 changes to the maximum penalty...more
Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had...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
Enforcement activity under the Obama administration often made headlines for the eye-popping level of fines, with the Foreign Corrupt Practices Act (FCPA), Anti-Money Laundering (AML) regulations, and economic sanctions...more