Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
Susan Roberts on Creating a Compliance Program Book
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Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....more
The health care industry has a rich history of commitment and innovation in developing effective compliance programs. Going back to the 1990s, HHS elevated compliance program requirements for healthcare companies. Many of...more
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
Discover today's best practices for your role in healthcare compliance oversight - The Office of Inspector General of Health and Human Services expects healthcare board members, board audit/compliance committee members,...more
On March 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) announced a new, expanded frequently asked questions (FAQs) process. Although OIG has long maintained FAQs on...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
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us virtually at HCCA’s Annual Healthcare Enforcement Compliance...more
OIG periodically makes updates to its Integrity Agreement (IA) and Corporate Integrity Agreement (CIA) model language. It is important for healthcare organizations – even those not subject to a CIA – to monitor changes to...more
The second quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several of $20 million or more. This post summarizes key settlements of interest to healthcare providers....more
The U.S. Department of Justice (DOJ) announced that Flower Mound Hospital Partners LLC, a partially physician-owned hospital in Flower Mound, Texas, agreed to pay $18.2 million to settle its alleged violations of the False...more
On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated and renamed its Self-Disclosure Protocol (SDP). The OIG had last updated the SDP in 2013. The update changes and...more
“Houston, we have a problem:” words no in-house counsel ever wants to hear, especially regarding potential compliance issues with federal fraud prevention statutes and regulations. Fortunately, the Office of the Inspector...more
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...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
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...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
As reflected in recent remarks by Deputy Attorney General Rod Rosenstein, the United States Department of Justice (DOJ) is “reinforcing its relationship with good corporate citizens” by coordinating with, and considering, the...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
The Department of Justice (DOJ) recently announced that Montana’s Kalispell Regional Healthcare System (KRH) and six subsidiaries and related entities agreed to pay $24 million to resolve allegations that they violated the...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more
Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more
In a recent case Hebrew Homes Health Network, Inc. and its former president and executive Director agreed to pay $17 million to settle allegations that Hebrew Homes violated the federal anti-kickback statute. According to the...more