Blogs

Stay informed with expert insights, trends, and best practices in life sciences compliance.

Medical Device Manufacturer: Fined $646M FOR Paying Kickbacks to Hospitals

In the first quarter of the year, Olympus Corp., the United States’ largest distributor of endoscopes and related equipment, agreed to pay $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. It was further announced that a subsidiary of the distributor will pay $22.8 […]

DOJ Doubles FCA Penalties for Life Sciences Companies

The U.S. Department of Justice (DOJ) doubled the penalties for False Claims Act (FCA) violations on the 1st of August, 2016. As of August 1, the penalties have been increased from $5,500 to $11,000 per claim to $10,781.40 and $21,562.80 per claim. Of course, the threat of triple damages remains in place. Announced back in […]

Off Label Spending – Using Transparency Data to Sniff Out Clues

Since 2013, Federal regulators have stepped up scrutiny of the relationships between pharmaceutical manufacturers and healthcare providers. Considering the potential fines that are in place, this isn’t a time when companies can sit back complacently. Instead, they must dedicate this time to verifying the accuracy of their data and reporting systems so they can identify […]

Next Generation Compliance: Using Analytics to Reduce Compliance Risks

Government agencies are increasingly using publicly available data sets in support of their allegations against pharmaceutical and device manufacturing companies. A recent example is the government’s allegation of kickbacks against Insys Therapeutics, Inc. and their use of both Open payments and Medicare Part D data. Managing the Risk of Open Payments Data CMS published the […]