Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
Navigating the Shifting Tides of Pharmaceutical Compliance: Embracing Change for a Data-Driven Future Today, we’re diving deep into the heart of what makes the pharmaceutical compliance industry tick. As US-based compliance professionals, you’re the unsung heroes, the guardians of ethical conduct, and the gatekeepers of patient safety. Strap in, because we’re about to take you […]
For compliance professionals working in life sciences companies, a comprehensive understanding of the diverse payment categories, financial transactions, and transfers of values required by the Center for Medicare and Medicaid Services (CMS) for reporting is crucial. By thoroughly understanding the scope of financial transactions made by reporting entities to covered recipients, compliance professionals can empower […]
The Physician Payments Sunshine Act requires life sciences companies to report any payments or other transfers of value made to physicians and teaching hospitals to the Centers for Medicare & Medicaid Services (CMS) “Physicians” include those legally authorized to practice medicine, osteopathy, dentistry, dental surgery, podiatry, optometry, and chiropractic medicine. Over the years, life sciences companies […]
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 […]
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