Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
Susan Roberts on Creating a Compliance Program Book
Donations to Patient Assistance Charities
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
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
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
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...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
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
Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...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
The Compliance Institute is celebrating 25 years! Join us for the Compliance Institute's 25th anniversary, April 19-22, 2021. This year, HCCA is excited to celebrate over two decades of compliance excellence with our...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
Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more
A medical device manufacturer learned what might seem an obvious lesson when it paid $18 million to settle a False Claims Act lawsuit brought by its former Compliance Officer: don’t ignore your compliance officer. The federal...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
Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million. The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...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
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
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