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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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
How do enforcement priorities impact your compliance program? Supply chains, tech tools, consumer data, the use of sanctions, the list is long — there are a vast number of organizational processes and procedures under...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
For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance...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 August 30, 2021, the Department of Justice (“DOJ”) announced that Sutter Health and several of its affiliated entities (“Sutter”) agreed to pay a total of $90 million to settle allegations that Sutter violated the False...more
The Department of Justice (DOJ) and U.S. Attorney’s Offices have been quite busy settling False Claims Act (FCA) cases during the first month and a half of 2021. Two recent FCA lawsuits based, at least in part, on allegations...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
As recent developments in corporate enforcement indicate, the United States Department of Justice (DOJ) continues to emphasize transparency, cooperation, and the importance of a strong compliance program. Enforcement trends...more
The Justice Department’s enforcement programs are resuming – False Claims Act, FCPA and other programs will continue. The rate of enforcement, however, is subject to change once again from the impact of the pandemic....more
DOJ’s aggressive enforcement of the opioid industry is a striking example of the power of federal prosecutors when focused on an industry. Once prioritized for enforcement, DOJ has quickly brought together prosecutors and...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
Kickback Allegations Settled for $20.25 Million - Sanford Health, Sanford Medical Center, and Sanford Clinic (collectively, Sanford), a South Dakota health system, will pay $20.25 million to settle allegations that they...more
DOJ News & Litigation Updates - ITT Cannon to Pay $11 Million to Settle False Claims Allegations - ITT Cannon (ITT), a division of ITT Inc., has agreed to pay $11 million to settle whistleblower claims that it supplied...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
The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems...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
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
Banner Health has agreed to pay the federal government $18 million to resolve False Claims Act (FCA) allegations that the health system admitted patients who could have been treated less expensively on an outpatient basis....more
Hospice audits - In late 2017, the Centers for Medicare and Medicaid Services (CMS) expanded its targeted probe and educate (TPE) audit program to include hospices....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
In September 2015, Deputy Attorney General Sally Yates issued a memorandum titled "Individual Accountability for Corporate Wrongdoing." In it, she stressed that one of the most effective ways to combat corporate misconduct is...more
Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an...more