Stay informed with expert insights, trends, and best practices in life sciences compliance.
Life sciences risk monitoring is a critical component of ensuring compliance and operational integrity in a highly regulated industry. Life sciences companies operate under strict regulations, overseen by bodies such as the U.S. Department of Justice (DOJ) and the Office of Inspector General (OIG). This intricate regulatory environment requires organizations to adopt robust risk mitigation […]
Before delving into the mechanics of Sunshine Act reporting, it is useful to reflect on the history and rationale behind this significant piece of legislation. The Physician Payments Sunshine Act, now known simply as the Sunshine Act, was signed into law by President Barack Obama on March 23, 2010, as part of the Patient Protection […]
In the pharmaceutical industry, maintaining compliance with the laws and regulations is paramount. The Anti-kickback (AKS) Law prohibits the exchange of any form of remuneration to induce or reward referrals of federal healthcare program business. Violations can lead to severe penalties, including fines, imprisonment, and exclusion from federal healthcare programs. As such, pharmaceutical compliance professionals […]
Life Sciences companies face significant challenges ensuring accuracy and transparency in expense monitoring and auditing. To address these challenges, a few trends have emerged. Each time life sciences companies think they are on top of compliance requirements, rules and regulations change. This generally mounts pressure on compliance teams and drains the organizations of their time […]
Compliance monitoring is a critical aspect of the life sciences industry that enables companies to determine whether they’re efficiently and effectively adhering to relevant laws, regulations, and guidelines the government provides. With heightened scrutiny and expectations of the government, data-driven compliance monitoring has become imperative for safeguarding life sciences companies from business-critical risks. But there’s […]
Earlier this month, the U.S. Attorney’s Office for the District of Massachusetts announced a $100,000 FCA settlement. This settlement resolved allegations of a Pharmaceutical company violating the Anti-Kickback Statute (AKS). In addition, this also caused the submission of false claims through incentive compensation payments to the company’s employees for conduct outside the scope of an […]