Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
The Center for Medicare and Medicaid Services (CMS) published data every year, and similarly, they published Open Payments data for the year of 2021. This data was for the previous program years hence it includes the payments/transactions that took place between January 1st and December 31st. The applicable manufacturers reported a total of $10.9 billion […]
In November 2020, the Office of Inspector General (OIG) issued a critical Special Fraud Alert highlighting the key risks associated with speaker programs sponsored or organized by life sciences companies. These programs, often involving healthcare professionals (HCPs) as paid speakers, are under intense scrutiny by regulatory authorities for potentially violating the anti-kickback statute. This article […]
Compliance challenges, evolving rules and regulations, building a data-driven compliance program, and false claims that lead to indictment and penalties continue to be trending topics in the world of compliance. The Department of Justice (DOJ) recovered over $3 Billion from the False Claims Act case in the fiscal year 2019. Of the more than $3 […]
The design of a compliance program determines its effectiveness in preventing and detecting compliance risks, i.e., misconduct, breach of internal policies, or the policies imposed by the government. It is responsible for determining if the corporate management is enforcing the program or is tacitly encouraging employees to engage in misconduct. This is one of the […]
The U.S Department of Justice (DOJ) updated its compliance program evaluation guideline outlining exactly how it evaluates corporate compliance programs. The new guidance instructed prosecutors to ask life sciences companies’ compliance teams whether they have data sources for timely, effective, and efficient monitoring and whether they are continuously testing and updating policies, controls, and transactions. […]
The answer to “is managing compliance really that difficult?” is that it is and isn’t at the same time. To understand this, we must look beyond conventional compliance practices, evaluate factors influencing compliance positively or negatively, and determine what makes compliance difficult and how companies can reduce the pressure. So, let’s explore both sides to […]
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