Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
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 […]
The Physician Payments Sunshine Act aims to increase transparency around the financial relationships between healthcare professionals and Life Sciences companies. This requires the submission of aggregate spend reports to the Centers for Medicare & Medicaid Services (CMS). For the most part, the approach to meeting aggregate spend reporting requirements makes it easier or extremely difficult […]
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 […]
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