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
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more
On August 23, the U.S. Department of Justice announced that Dallas-based optical lens manufacturer Essilor International and its affiliates agreed to pay $16.4 million to settle alleged violations of the federal Anti-Kickback...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
In this podcast Rob DeConti, Assistant Inspector General for Legal Affairs within the office of counsel to the Inspector General at HHS, was good enough to share a tremendous amount of insight into what the OIG is seeing,...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
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
Medical Device Manufacturer Settles Improper Payment Allegations for $18 Million - Merit Medical Systems Inc. (MMSI), a Utah-based medical device maker, will pay $18 million to settle allegations that it engaged in a...more
Drug Testing Lab Pays Nearly $12 Million to Settle False Claims Act Allegations - On July 20, 2020, the Department of Justice (DOJ) announced a civil settlement with Sterling Healthcare Opco, LLC d/b/a Cordant Health...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
Back in May, we wrote about substantial settlements totaling $125 million to resolve Department of Justice (DOJ) allegations that money donated by Astellas Pharma US, Inc. and Amgen Inc. to drug co-pay charities constituted...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
Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...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
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
Featured Unsealed Cases United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) - Complaint Filed: May 6, 2013 - Complaint Unsealed: October 24, 2016 - ...more
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
If you work in compliance in the healthcare industry, you have a tough job. The number and variety of risks that healthcare providers face is daunting. The False Claims Act is a mighty weapon in the hands of federal...more
Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice. This payment, in addition to modification and an extension of Novartis’s existing...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
On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more
Trends & Analysis: ..We have identified 15 health care–related qui tam cases that were unsealed since our last Qui Tam Update. Of those, 12 were filed from 2012 to the present. All but two cases had been pending more...more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...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